1 2 3 4 5 6 7 8 CROWELL & MORING LLP J. Daniel Sharp (SBN 131042) dsharp@crowell.com 275 Battery Street, 23rd Floor San Francisco, CA 94111 Telephone: 415.986.2800 Facsimile: 415.986.2827 Mark A. Romeo (SBN 173007) mromeo@crowell.com Derek Hecht (SBN 273039) dhecht@crowell.com 3 Park Plaza, 20th Floor Irvine, California 92614-8505 Telephone: 949.263.8400 Facsimile: 949.263.8414 9 10 Attorneys for Plaintiff THE REGENTS OF THE UNIVERSITY OF CALIFORNIA 11 12 SUPERIOR COURT OF THE STATE OF CALIFORNIA 13 COUNTY OF SAN DIEGO 14 15 THE REGENTS OF THE UNIVERSITY OF CALIFORNIA, a California Corporation, 16 17 18 19 20 21 22 23 24 Case No. COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF FOR: Plaintiff, V. PAUL S. AISEN, an individual; JEREMY PIZZOLA, an individual; DEBORAH TOBIAS, an individual; GUSTAVO JIMENEZ-MAGGIORA, an individual; PHUOC HONG, an individual; HONG MEI QIU, an individual; STEFANIA BRUSCHI, an individual; JIASING SO, an individual; MAYYA NESSIRIO, an individual; UNIVERSITY OF SOUTHERN CALIFORNIA, a California Corporation; and DOES 1-25, Inclusive, 1. BREACH OF FIDUCIARY DUTY; 2. BREACH OF DUTY OF LOYALTY BY EMPLOYEE; 3. INTERFERENCE WITH CONTRACT; 4. INTERFERENCE WITH PROSPECTIVE ECONOMIC ADVANTAGE; 5. CONVERSION; 6. COMMISSION OF COMPUTER CRIMES; 7. CIVIL CONSPIRACY DEMAND FOR JURY TRIAL Defendants. 25 26 27 28 C ROWELL & M ORING LLP ATTORNEYS AT LAW COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF SFACTIVE-903728301.1 1 Plaintiff The Regents of the University of California alleges upon knowledge as to its own 2 actions, and upon information and belief as to all other matters, against Defendants Paul S. Aisen, 3 Jeremy Pizzola, Deborah Tobias, Gustavo Jimenez-Maggiora, Phuoc Hong, Hong Mei Qiu, 4 Stefania Bruschi, Jia-Sing So, and Mayya Nessirio and the University of Southern California as 5 follows: 6 7 8 9 THE PARTIES 1. The Regents of the University of California (“The Regents” or “Plaintiff”) is a California corporation doing business in the County of San Diego, State of California. 2. Defendants Paul S. Aisen (“Aisen”), Jeremy Pizzola, Deborah Tobias, Gustavo 10 Jimenez-Maggiora, Phuoc Hong, Hong Mei Qiu, Stefania Bruschi, Jia-Sing So, and Mayya 11 Nessirio (sometimes collectively referred to as “Individual Defendants”) are and were at all 12 relevant times individuals residing in the County of San Diego, State of California. 13 14 15 3. Defendant University of Southern California (“USC”) is a California corporation doing business in the Counties of Los Angeles and San Diego, State of California. 4. Plaintiff is informed and believes and thereon alleges that each of the Defendants 16 fictitiously sued hereunder as Does 1 through 25 are in some manner responsible for the 17 occurrences alleged hereunder and the damages which Plaintiff alleges hereunder, and that at all 18 times, each of said Does were acting as the agent for each other or the Defendants within the 19 scope and capacity of said agency. Plaintiff is ignorant of the true names and capacities of such 20 Defendants sued herein as Does 1 through 25 inclusive and therefore sues these Defendants by 21 such fictitious names for the same acts and causes of action alleged against Defendants. Plaintiff 22 will seek leave of Court to amend this Complaint to allege the true names and capacities of said 23 Defendants at such time as they may be ascertained. 24 25 26 JURISDICTION AND VENUE 5. The conduct alleged herein occurred within the County of San Diego, State of California, and jurisdiction and venue is proper within this County. 27 28 C ROWELL & M ORING LLP 1 ATTORNEYS AT LAW COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF SFACTIVE-903728301.1 1 GENERAL ALLEGATIONS 2 The Regents and the ADCS 3 6. The Regents is a California corporation authorized and empowered to administer a 4 public trust known as the University of California (“UC” or “the University”). Under Article IX, 5 section 9, of the California Constitution, the Regents is vested with full powers of organization 6 and government over the University, including all powers necessary or convenient for the 7 effective administration of the public trust and the advancement of the tripartite mission of the 8 University: to provide excellence in teaching, research, and public service. 9 7. The Regents maintains a campus in this county known as the University of 10 California, San Diego (“UCSD”). UCSD operates a School of Medicine as well as the UC San 11 Diego Health System, which is the region’s only academic health system and provides patient 12 care, conducts medical research, and serves as a training ground for health care professionals. 13 8. Since 1991, UCSD has managed a research enterprise known as the Alzheimer’s 14 Disease Cooperative Study (“ADCS”) under a cooperative agreement with the National Institute 15 on Aging (“NIA”), which is an agency of the federal government and one of the National 16 Institutes of Health (“NIH”). The ADCS facilitates the testing of new drugs for the treatment of 17 Alzheimer's disease, particularly drugs that might not otherwise be tested by private industry. To 18 this end, ADCS coordinates clinical trials and other research activities at approximately 70 19 academic medical centers and research clinics in the United States and Canada. The ADCS is in 20 the nature of a joint venture, but instead of operating for profit, it operates for the advancement of 21 the missions of the NIA and The Regents with respect to medical education, research, and public 22 service. 23 9. The work of the ADCS is funded primarily by the federal government and private 24 companies pursuant to the terms of written contracts entered into by The Regents. These 25 contracts are sometimes colloquially referred to as “grants,” and typically carry titles such as 26 “Collaborative Study Agreement” and “Clinical Trial Research Collaboration Agreement.” The 27 value of the grant funding is in excess of $100 million. This funding finances research activity as 28 C ROWELL & M ORING LLP 2 ATTORNEYS AT LAW COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF SFACTIVE-903728301.1 1 well as administrative costs, including the salaries of the approximately 80 employees and 2 administrators who run the ADCS at UCSD. 3 UCSD Entrusted Defendant Aisen with the Directorship of the ADCS 4 10. From the time that the ADCS was established in 1991 until February 2007, the 5 Director of the ADCS was Leon Thal, M.D., a Distinguished Professor and Chair of 6 Neurosciences at UCSD. Dr. Thal had joined the UCSD faculty in 1985 and over the years 7 became the acknowledged leader in the development of drug therapies for Alzheimer disease. In 8 February 2007, he was tragically killed in a plane crash. 9 11. Following the death of Dr. Thal, UCSD conducted a search for a new Director of 10 the ADCS and hired Defendant Paul Aisen, M.D. in November 2007. Dr. Aisen became 11 employed by The Regents as a Professor of Neurology and Medicine at UCSD and was appointed 12 Director of the ADCS. As such, Defendant Aisen was the agent of The Regents and its fiduciary 13 in effectuating UCSD’s participation in the ADCS venture. As an employee of The Regents, 14 Defendant Aisen owed a duty of loyalty to the University during his tenure, including a duty to 15 refrain from actions that are inimical to the interests of The Regents, and to avoid giving 16 preference to his own interests, or those of a rival employer, at the expense of The Regents and 17 UCSD. The position of Director of the ADCS is one of prestige and influence in the field of life 18 sciences, and UCSD placed trust and confidence in Defendant Aisen to discharge his obligations 19 to The Regents with honesty and candor. 20 21 22 Defendant Aisen and Defendant USC Conspire to Misappropriate UCSD’s Role in the ADCS 12. Within the past week, The Regents has learned that, beginning at least as of April 23 2015, Defendant Aisen and Defendant USC began to conspire with one another to displace UCSD 24 in the ADCS, to interfere with The Regents’ contractual and economic relationships with ADCS 25 funders, to interfere with the Regents’ relationships with UCSD employees engaged in work on 26 behalf of the ADCS, and to usurp the beneficial opportunities available to The Regents through 27 UCSD’s role in the ADCS. The Regents do not presently have access to all of the facts showing 28 the extent of the conspiracy and the wrongful acts done in furtherance of their common design, C ROWELL & M ORING LLP 3 ATTORNEYS AT LAW COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF SFACTIVE-903728301.1 1 and will require discovery to present such facts at trial. However, the facts set forth below have 2 been learned within the past week. 3 13. In April 2015, Defendant Aisen reached out to USC Provost Michael Quick to 4 resume discussions, begun at some earlier time, regarding the potential for Defendant Aisen to 5 join the faculty at USC, which operates the Keck School of Medicine (“Keck”) near downtown 6 Los Angeles. Keck has an Alzheimer’s Disease Research Center, also located near downtown 7 Los Angeles. 8 9 14. For reasons known best to Defendants, the discussions between Defendants Aisen and USC soon centered on making arrangements for Dr. Aisen to remain in the vicinity of La 10 Jolla, where USC has no facilities of any kind. Defendants agreed to create a brand new 11 “Institute” in San Diego by hiring away the necessary UCSD employees who serve the ADCS, 12 and seeking to supplant UCSD as the contracting party in connection with research contracts and 13 other agreements related to ADCS, including the lease for the office space that houses the 14 UCSD/ADCS staff. Defendants Aisen and USC thus planned to cripple UCSD’s ability to 15 perform its cooperative agreement with the NIA to administer the ADCS. 16 15. Defendant Aisen demanded, and Defendant USC agreed to provide, significant 17 incentives for Dr. Aisen to betray the trust reposed in him by UCSD. Among other things, USC 18 in or about May 2015 offered Aisen a guaranteed salary of $500,000 per year through 2020, and 19 both interest-free and low-interest financing on a new home, with forgiveness of at least half the 20 debt over time. The terms offered by USC were expressly set forth with the expectation that 21 Aisen’s salary would be paid by “extramural research funding you [i.e., Aisen] obtain.” Thus, 22 thanks to Defendant USC, Defendant Aisen has a strong personal financial incentive to interfere 23 with The Regents’ contractual relationships with UCSD’s research sponsors. 24 16. Defendants further agreed that USC would provide a “start-up loan” of up to $8 25 million to finance the creation of the new “Institute” in San Diego. In making these financial 26 arrangements, Defendant USC expressly stated its expectation that Aisen would arrange a 27 “transition to USC” of existing research activities administered by UCSD, and that the new 28 “Institute” would incur real estate remodeling expenses only “if a relocation from current [UCSD- C ROWELL & M ORING LLP 4 ATTORNEYS AT LAW COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF SFACTIVE-903728301.1 1 leased] facilities is required.” Thus, thanks again to Defendant USC, Defendant Aisen had a 2 strong financial incentive to interfere with The Regents’ relationships with the UCSD faculty and 3 employees who staffed the ADCS. 4 17. The terms of Defendant USC’s May 2015 offer to Defendant Aisen called for 5 Aisen to join USC as of September 1, 2015. In accordance with the incentives he anticipated to 6 receive from USC, Dr. Aisen, while still employed by The Regents, and in violation of his duties 7 of loyalty and fidelity, began to recruit other UCSD employees to join him in his scheme to 8 interfere with the contractual relationships between UCSD and research sponsors, and to attempt 9 to interfere with UCSD’s performance of its agreements both with the NIA and with private 10 11 sponsors of the ADCS. 18. In May 2015, after entering into the conspiracy with USC, Defendant Aisen, using 12 the authority of his position as director of the ADCS, summoned all ADCS employees to a 13 meeting and told them that he would likely be moving to USC, that the ADCS grants would move 14 with him, and falsely advised that none of the employees working on behalf of ADCS would have 15 jobs at UCSD. Aisen told the ADCS staff that USC would offer all of them jobs if they left 16 UCSD. This conduct by Defendant Aisen created fear and unrest and concern among UCSD's 17 employees and disrupted their relationships with The Regents. 18 19. Defendants Jeremy Pizzola, Deborah Tobias, Gustavo Jimenez-Maggiora, Phuoc 19 Hong, Hong Mei Qiu, Stefania Bruschi, Jia-Sing So, and Mayya Nessirio, were UCSD employees 20 who agreed to join Defendant Aisen in a conspiracy to act as “double agents”—ostensibly 21 employed by The Regents but in reality working to undermine UCSD, to advance their own 22 personal interests, and to serve the interests of Defendant USC, in violation of their obligations 23 under California Labor Code 2863, which states “An employee who has any business to transact 24 on his own account, similar to that entrusted to him by his employer, shall always give the 25 preference to the business of the employer.” 26 20. For example, Defendants Aisen, Pizzola, and Tobias, while still employed by The 27 Regents, attempted to pressure and persuade Toyama Chemical Company (“Toyama”), a research 28 sponsor and party to a Collaborative Study with the Regents, to terminate its contractual C ROWELL & M ORING LLP 5 ATTORNEYS AT LAW COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF SFACTIVE-903728301.1 1 arrangement with The Regents and form a new contract with USC. On May 30, 2015, Defendant 2 Pizzola wrote to Toyama: 3 We believe that Paul [i.e., Defendant Paul Aisen] can affiliate with USC and form a new institution that would reside here in San Diego. The new institute will hire on all of the staff members currently working for Paul. We have discussed with USC and they have indicated that they can issue replacement contracts to all TCAD sites [i.e., research facilities under contract with The Regents] simultaneously with precisely the same terms and conditions. . . . This would need to be very carefully timed with Toyama as we believe Toyama could chose to cancel its agreement with UCSD with 30 days notice. 4 5 6 7 8 In short we believe that we can have essentially the same people filling the same roles in the TCAD study simply under a new institutional affiliation. 9 10 11 21. Toyama’s representatives responded to Defendants Aisen, Pizzola, and Tobias on 12 June 3, 2015, stating in part, “Have you already discussed these with UCSD and NIH? It is 13 important for Toyama to confer directly with UCSD to make sure that Toyama honors all of its 14 obligations to UCSD and complies with all applicable laws.” However, rather than advise UCSD 15 of Toyama’s inquiry, Defendant Pizzola replied “we do not think it is time to discuss anything 16 with UCSD,” and told Toyama “we don’t know what’s going to happen with UCSD.” 17 22. 18 On June 8, 2015, Toyama wrote directly to Defendant Aisen, stating in part: After carefully considering the actions that Jeremy [i.e., Defendant Pizzola] and you have recently requested of us, we find that the complexity of these requested actions raises a series of significant logistical, contractual, and regulatory compliance issues. Resolution of these issues, from both business and legal perspectives, requires us to consult with UCSD and its counsel. We thus request that, in addition to the project meeting scheduled for next week in San Diego, that you kindly arrange for us and our counsel to meet separately with the appropriate representatives of UCSD and its counsel so that this consultation can occur. 19 20 21 22 23 24 Notwithstanding this explicit request from Toyama, Defendant Aisen concealed the 25 communication from UCSD and its counsel, and accelerated Defendants’ planned transition to 26 USC. 27 28 23. On or about June 18, 2015, while travelling and away from San Diego, Dr. Aisen sent an email announcing that he would be resigning from UCSD effective July 1, 2015, to take a C ROWELL & M ORING LLP 6 ATTORNEYS AT LAW COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF SFACTIVE-903728301.1 1 position at USC. That same day, UCSD Campus Counsel Dan Park sent Aisen a letter 2 congratulating Aisen on his job offer from USC, and reminding Aisen of his fiduciary duties as 3 Director of the ADCS, and an employee’s duty of undivided loyalty to his employer during the 4 term of employment. Park’s letter further stated: 5 In addition to avoiding any action that could disrupt UC San Diego’s contractual relationships, you should be sure not to remove from UC San Diego’s possession or control any equipment, records, electronic data, or software that were purchased or created for the ADCS at UC San Diego. All such items are the property of UC San Diego, the taking of which without UC San Diego’s express permission would be an illegal conversion. Burlesci v. Petersen (1998) 68 Cal.App.4th 1062. Conversion is a strict liability tort, “meaning questions of the defendant's good faith, lack of knowledge, and motive are ordinarily immaterial.” Id. Similarly, you should not attempt to delete or destroy any records or documents, whether electronic or physical. 6 7 8 9 10 11 In summary, UC San Diego will be pleased to provide you with assistance as you make your transition to your new position. At the same time, UC San Diego hopes that you will provide similar assistance to ensure the continued smooth functioning of the ADCS at UC San Diego as we prepare to search for a new director. 12 13 14 15 24. After receiving Park’s letter requesting Aisen’s compliance with legal obligations 16 and cooperation in transition, Defendant Aisen chose a diametrically opposite course. Without 17 having returned from his travels, on Sunday, July 21, 2015, Aisen sent an email stating, “Because 18 of the tone and implications of the letter I received on 6/18/15 from UCSD general counsel, as 19 well as threatening statements made by UCSD leadership, it is untenable for me to remain at 20 UCSD through my planned resignation date. I resign immediately, effective today, 6/21/15.” 21 25. Defendant Aisen refused to consent to an exit interview with any of his former 22 colleagues at UCSD, and made no arrangements for the transition of his responsibilities as 23 Director of the ADCS, despite multiple requests from UCSD. 24 26. Defendant Aisen and other Individual Defendants arranged for the return of the 25 laptop computers that had been issued to them and which were owned by The Regents. Each 26 laptop had been wiped of all data, notwithstanding The Regents’ ownership of the data. 27 28 27. Worse, upon their departure, and through the present, Defendant Aisen and the Individual Defendants have exerted dominion and control over the ADCS data that has been C ROWELL & M ORING LLP 7 ATTORNEYS AT LAW COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF SFACTIVE-903728301.1 1 entrusted to UCSD as a participant in the ADCS, and have failed and refused to provide UCSD 2 with account data, passwords, and access credentials to enable UCSD to maintain administrative 3 control of ADCS data, as set forth below. 4 Defendants Arrogate Control over ADCS Data After Resigning from The Regents 5 28. One of the core functions that UCSD performs in connection with the ADCS is to 6 receive, monitor, and analyze clinical data from clinical trials and research studies that ADCS 7 administers. Such clinical data includes medical records of the individuals who have volunteered 8 to participate in a clinical trials of new drugs, and other information of a sensitive, confidential, 9 and proprietary nature. Such data is typically transmitted to ADCS from the various sites at 10 which clinical studies are conducted via an internet website with a unique URL and stored on 11 computer servers. UCSD sometimes contracts with commercial vendors such as Amazon to host 12 ADCS data on their computer servers, colloquially referred to as “the Cloud.” 13 29. Maintenance of data pertaining to clinical trials is subject to detailed regulations 14 promulgated by the federal Food and Drug Administration (FDA). Maintenance of study data is 15 also subject to contractual obligations set forth in the contracts between The Regents and the 16 companies and government agencies that sponsor clinical trials. Such contracts specify that all 17 data created or captured by UCSD related to the ADCS program will be jointly owned by The 18 Regents and the sponsors, and will be maintained by UCSD. 19 30. For example, The Regents entered written agreements with Eli Lilly and Company 20 (“Lilly”), and the Toyama Chemical Company (“Toyama”) with respect to research studies that 21 were ongoing at the time of Defendant Aisen’s resignation, and remain ongoing today. A true and 22 correct copy, without exhibits, of The Regents’ agreement with Lilly is attached hereto as Exhibit 23 “A” (the “Lilly Agreement”). A true and correct copy, without exhibits, of The Regents’ 24 agreement with Toyama is attached hereto as Exhibit “B” (the “Toyama Agreement”). 25 26 27 28 31. None of the Defendants are parties to the Lilly Agreement or the Toyama Agreement. 32. Pursuant to Section 18.1 of the Lilly contract, UCSD is required to create and maintain all records required by the Agreement, and Section 16.1 provides that Study Data will be C ROWELL & M ORING LLP 8 ATTORNEYS AT LAW COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF SFACTIVE-903728301.1 1 captured by UCSD and maintained jointly by Lilly and UCSD. See Exhibit A. Pursuant to 2 Section 16.2, the study data is jointly owned by Lilly and UCSD. 3 33. Pursuant to Section 8(C)(i) of the Toyama Agreement, Clinical Study results shall 4 be jointly owned by Toyama (and its parent company) and The Regents. See Exhibit B. Pursuant 5 to Section 8(C)(iii), all joint intellectual property created as a result of the clinical studies will 6 belong jointly to Toyama (and its parent company) and The Regents. Id. 7 34. The ADCS was also partially funded by an award from Department of Health and 8 Human Services, through the National Institutes of Health (“NIH”). The terms of this funding are 9 set forth in the Notice of Award (“NOA”) issued by NIH on December 8, 2014. A true and 10 correct copy, without exhibits, of the NOA is attached hereto as Exhibit “C.” (The financial 11 information on this copy was redacted by the University’s Department of Contracts and Grants in 12 connection with making the NOA publicly available.) Pursuant to the NOA, UCSD is expressly 13 identified as the grant recipient, and funding provided by the NIH is to be received by Defendant 14 Aisen “on behalf of UCSD.” See Exhibit C at Attachment B, p. 3. Further, the NOA expressly 15 provides that a principal investigator such as Defendant Aisen may not transfer the ADCS project 16 to another host institution without first securing advance approval from the NIH and a written 17 release by UCSD approving the transfer. Id. at Attachment B, p. 13. Representatives of NIH 18 have confirmed, following Dr. Aisen’s resignation, that “UCSD is the grant holder and retains 19 custody of the data.” 20 35. In short, the contracts governing the ADCS make it abundantly clear that the data 21 generated by ADCS studies is to be maintained under the control of UCSD for the benefit of the 22 study sponsors and The Regents, who are the owners of the data. There is no plausible 23 interpretation of the governing contracts that would accord Defendant Aisen or any of the 24 Individual Defendants the right, privilege, or power to assume control of ADCS data after 25 severing their employment from UCSD, but this is exactly what Defendants have done. 26 36. While still employed by UCSD, Aisen and one or more of the Individual 27 Defendants, conspired to arrange for ADCS data to be hosted on an Amazon account in the name 28 of a party other than UCSD, presumably one or more of the Individual Defendants, or persons C ROWELL & M ORING LLP 9 ATTORNEYS AT LAW COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF SFACTIVE-903728301.1 1 under their control. The account bears Amazon Account No. (REDACTED). According to 2 UCSD accounting records, Amazon had invoiced UCSD, and The Regents has paid, 3 approximately $96,000 for the maintenance of this account. 37. 4 After the resignations of Defendant Aisen and the other Individual Defendants, 5 representatives of UCSD made repeated requests that the Defendants turn over to UCSD all 6 account data, passwords, and access credentials for any and all repositories holding ADCS data, 7 including Amazon Account No. (REDACTED). The Individual Defendants failed to respond in 8 any substantive or meaningful way, and have failed and refused to relinquish control of ADCS 9 data. 10 38. On Sunday, June 28, 2015, UCSD Dean and Associate Vice Chancellor Gary S. 11 Firestein, M.D., sent an urgent message to his counterpart at USC, Associate Dean for Clinical 12 Research Thomas Buchanan, stating, “Since Dr. Aisen is now an employee and agent of USC, we 13 formally request your assistance in directing Dr. Aisen to turn over to UCSD all account data, 14 passwords, and access credentials for any and all repositories holding ADCS data, of whatever 15 kind or nature.” Dr. Firestein’s message was referred to USC Provost Michael Quick for 16 response. Mr. Quick responded on Monday, June 29, 2015, “I will assume that this issue of 17 access to data, etc., will get resolved today,” but took no steps to do so, and the Defendants 18 continue to assert dominion and control over ADCS data. 19 39. UCSD has attempted to gain access to the Account No. (REDACTED) through 20 Amazon; however, Amazon advised that, because the account is not held in the name of UCSD, 21 that Amazon regarded the account as “owned” by someone else, and Amazon’s internal policies 22 prevented Amazon from identifying the “account holder,” permitting UCSD to reset the password 23 to the account, or granting UCSD administrative control over the account. Amazon suggested 24 that UCSD either obtain the password from the “account holder,” or get a court order. UCSD has 25 continued to work with Amazon in an attempt to gain full access and control over the account. 26 40. The Defendants’ exercise of dominion and control over ADCS data, including 27 Amazon Account No. (REDACTED), causes harm to The Regents and to the ADCS in the 28 following ways: C ROWELL & M ORING LLP 10 ATTORNEYS AT LAW COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF SFACTIVE-903728301.1 1 a. Security patches and other maintenance operations such as software upgrades cannot be conducted. b. System monitoring is not possible, increasing the risk of hacker attacks and data breaches. c. Management of user accounts including the creation of new accounts, updating permissions for existing accounts and removal of deprecated accounts is not possible leading to potential security vulnerabilities. d. Randomization codes may not be accessible, safety monitoring can be compromised. e. Access to the backend database is not possible, thus restricting reports to those that can be obtained through the existing web-based system. f. The codebase cannot be inspected for potential security vulnerabilities including potential backdoors into the system. g. The type or amount of services procured from Amazon cannot be controlled hence leading to potential abuse of account billing. h. All data are at risk for irreversible manipulation, duplication and/or deletion and the creation of local snapshots for data backup/history is not possible. 2 3 4 5 6 7 8 9 10 11 12 13 14 15 41. As a result of the conduct alleged herein, The Regents have suffered damages, and will continue to incur damages, in ways that will be subject to proof at trial. 16 FIRST CAUSE OF ACTION 17 (BREACH OF FIDUCIARY DUTY - AGAINST DEFENDANT AISEN) 18 19 20 21 22 23 24 42. The Regents incorporates herein, by way of reference, all other paragraphs set forth in this Complaint in support of this cause of action. 43. By virtue of being entrusted to act as The Regents’ agent in serving as Director of the ADCS, Defendant Aisen was a fiduciary to The Regents and owed fiduciary duties. 44. Defendant Aisen breached his fiduciary duties by committing the acts complained of herein. 45. As a direct and proximate result of Defendant Aisen’s wrongful and tortious 25 conduct, Defendant Aisen has been unjustly enriched at the expense of The Regents, and The 26 Regents has suffered, and will continue to suffer, substantial damages including, but not limited 27 to, costs incurred recovering data owned or controlled by The Regents, the loss of property owned 28 C ROWELL & M ORING LLP 11 ATTORNEYS AT LAW COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF SFACTIVE-903728301.1 1 by the Regents, and costs incurred with repairing and monitoring UCSD’s network. Defendant’s 2 actions were a substantial factor in causing The Regents’ harm. 3 SECOND CAUSE OF ACTION 4 (BREACH OF DUTY OF LOYALTY - AGAINST INDIVIDUAL DEFENDANTS AND DOES 1-20) 5 6 7 8 9 10 46. The Regents incorporates herein, by way of reference, all other paragraphs set forth in this Complaint in support of this cause of action. 47. By virtue of being employed by The Regents, each of the Individual Defendants owed a duty of loyalty to The Regents during the term of their employment. 48. The Individual Defendants breached his fiduciary duties by committing the acts 11 complained of herein. Defendants acted in violation of their common law duty of loyalty owed to 12 The Regents and in violation of Labor Code §§ 2861 and 2863. Labor Code §2861 specifically 13 states that “[a]n employee shall, on demand, render to his employer just accounts of all his 14 transactions in the course of his service, as often as is reasonable, and shall, without demand, give 15 prompt notice to his employer of everything which he receives for the account of the employer” 16 Labor Code §2863 specifically states that “[a]n employee who has any business to transact on his 17 own account, similar to that entrusted to him by his employer, shall always give the preference to 18 the business of the employer.” While still employed by The Regents, the Individual Defendants 19 violated Labor Code §2863 and also transferred their loyalty to Defendant USC. 20 49. As a direct and proximate result of Defendants’ wrongful and tortious conduct, the 21 Individual Defendants have been unjustly enriched at the expense of The Regents, and The 22 Regents has suffered, and will continue to suffer, substantial damages including, but not limited 23 to, costs incurred recovering data owned or controlled by The Regents, the loss of property owned 24 by the Regents, and costs incurred with repairing and monitoring UCSD’s network. Defendants’ 25 actions were a substantial factor in causing The Regents’ harm. 26 27 28 C ROWELL & M ORING LLP 12 ATTORNEYS AT LAW COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF SFACTIVE-903728301.1 1 THIRD CAUSE OF ACTION 2 (INTERFERENCE WITH CONTRACTUAL RELATIONS - AGAINST AISEN, PIZZOLA, TOBIAS, USC, AND DOES 1-25) 3 4 5 50. The Regents incorporates herein, by way of reference, all other paragraphs set forth in this Complaint in support of this cause of action. 6 51. Valid contracts existed between The Regents and certain third parties. 7 52. Defendants knew of the existence of said contracts. 8 53. Defendants intended to disrupt the performance of the contracts between The 9 10 Regents and certain third parties. 54. Defendants’ conduct made it more expensive and difficult for The Regents to 11 perform under its contracts with third parties, and, unless corrective action is taken by the court, 12 The Regents will likely be unable to perform at all under its contracts. 13 55. By way of specific example, but not limitation, by exercising dominion and control 14 over Cloud-based storage accounts and preventing The Regents from exercising administrative 15 control over the data contained therein, Defendants have made it more difficult, if not impossible, 16 for The Regents to comply with Sections 16.1 of the Lilly Clinical Trial Agreement, which 17 requires UCSD to capture and maintain Study Data jointly with Lilly. Further, Defendants’ 18 actions have made it difficult, if not impossible for The Regents to comply with Section 17.3 of 19 the Clinical Trial Agreement, which forbids either party from disclosing the confidential 20 information of the other. 21 56. Defendants engaged in independently wrongful acts of conduct which violated 22 common and statutory law and which interfered with performance of the contracts and made The 23 Regents performance more expensive and burdensome. The full extent of Defendants’ wrongful 24 conduct will be shown at trial after the opportunity for discovery, 25 26 27 28 C ROWELL & M ORING LLP 13 ATTORNEYS AT LAW COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF SFACTIVE-903728301.1 1 FOURTH CAUSE OF ACTION 2 (INTENTIONAL INTERFERENCE WITH PROSPECTIVE ECONOMIC ADVANTAGE – AGAINST ALL DEFENDANTS) 3 4 5 6 57. The Regents incorporates herein, by way of reference, all other paragraphs set forth in this Complaint in support of this cause of action. 58. Economic relationships existed between The Regents and the sponsors of the 7 ADCS, including Lilly, Toyama, and the NIA, containing a past and probable future economic 8 benefit or advantage to The Regents. 9 59. Defendants knew of these relationships. 10 60. Defendants intended to interfere with these relationships in order to foster their 11 own relationship with the ADCS sponsors, and the relationship between the Individual 12 Defendants and Defendant USC. 13 14 15 61. As described more fully above, Defendants engaged in tortious and wrongful conduct, including the conversion of UCSD property, damage to UCSD’s network and systems. 62. As a result of Defendants’ tortious conduct, The Regent’s relationship with the 16 ADCS program sponsors was disrupted and UCSD has been harmed in ways that will be shown at 17 trial. Defendants’ conduct was a substantial factor in causing The Regent’s harm. 18 19 FIFTH CAUSE OF ACTION (COMMISSION OF COMPUTER CRIMES PURSUANT TO CALIFORNIA PENAL CODE SECTION 502(C) AGAINST ALL DEFENDANTS) 20 21 22 23 63. The Regents incorporates herein, by way of reference, all other paragraphs set forth in this Complaint in support of the above-referenced cause of action. 64. The acts described above, including the knowing and unauthorized actions and 24 attempts to access and download from The Regents’ databases and other information stored on 25 The Regents’ computers and computer systems by Defendants, constitute a violation of one or 26 more of the following provisions of the California Penal Code, Section 502, which imposes 27 liability on one who: 28 • Knowingly accesses and without permission alters, damages, deletes, destroys, or C ROWELL & M ORING LLP 14 ATTORNEYS AT LAW COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF SFACTIVE-903728301.1 1 otherwise uses any data, computer, computer system, or computer network in order 2 to either (A) devise or execute any scheme or artifice to defraud, deceive, or extort, 3 or (B) wrongfully control or obtain money, property, or data; 4 • Knowingly accesses and without permission takes, copies, or makes use of any 5 data from a computer, computer system, or computer network, or takes or copies 6 any supporting documentation, whether existing or residing internal or external to 7 a computer, computer system, or computer network; 8 • Knowingly and without permission uses or causes to be used computer services; 9 • Knowingly accesses and without permission adds, alters, damages, deletes, or 10 destroys any data, computer software, or computer programs which reside or exist 11 internal or external to a computer, computer system, or computer network; 12 • Knowingly and without permission provides or assists in providing a means of 13 accessing a computer, computer system, or computer network in violation of this 14 section; 15 • 16 computer, computer system, or computer network; or 17 • 18 19 Knowingly and without permission accesses or causes to be accessed any Knowingly introduces any computer contaminant into any computer, computer system, or computer network. 65. As a direct and proximate result of Defendants’ wrongful conduct, Defendants 20 have been unjustly enriched, and The Regents has been harmed and The Regents has sustained 21 damages in an amount to be proven at trial. 22 66. The Regents also has suffered irreparable harm as a result of Defendants' activities 23 and will continue to suffer irreparable injury that cannot be adequately remedied at law unless 24 Defendants, and their officers, agents and employees, and all other persons acting in concert with 25 them, are enjoined from engaging in any further such acts. 26 27 28 C ROWELL & M ORING LLP 15 ATTORNEYS AT LAW COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF SFACTIVE-903728301.1 1 SIXTH CAUSE OF ACTION 2 (CONVERSION- ALL DEFENDANTS) 67. 3 4 The Regents incorporates herein, by way of reference, all other paragraphs set forth in this Complaint in support of the above-referenced cause of action. 68. 5 The Regents owned all data related to the ADCS project, as well as the data and 6 contents of Amazon Account No. (REDACTED), and the data contained on the UCSD laptop 7 computers issued to the Individual Defendants (“the ADCS Data”). 69. 8 9 10 The Defendants, and each of them, have wrongfully exercised dominion and control over the ADCS Data, and have intentionally and substantially interfered with The Regents’ ownership of the ADCS Data, as more fully in paragraphs 28-40 of this Complaint. 70. 11 As a direct and proximate result of the wrongful and tortious conduct of 12 Defendants as alleged herein, Defendants have been unjustly enriched and The Regents has 13 suffered, and will continue to suffer, substantial damages including, but not limited to, costs 14 incurred recovering data owned or controlled by The Regents, the loss of property owned by the 15 Regents, and costs incurred with repairing and monitoring UCSD’s network, and in other ways 16 that will be shown at trial. Defendants’ actions were a substantial factor in causing The Regents’ 17 harm. 18 SEVENTH CAUSE OF ACTION – ADDENDUM TO ALL CAUSES OF ACTION 19 (CIVIL CONSPIRACY – ALL DEFENDANTS) 20 21 22 71. The Regents incorporates herein, by way of reference, all other paragraphs set forth in this Complaint in support of the above-referenced cause of action. 72. Defendants, and each of them, were aware the Defendant Aisen and Defendant 23 USC planned to interfere with The Regents’ contractual and economic relations with the NIA, 24 with ADCS sponsors, and with UCSD employees, and that they planned for Dr. Aisen to act as a 25 double-agent by advancing his personal interests and those of USC while he was still employed 26 by The Regents. 27 28 73. Defendants, and each of them, with full knowledge and intent and without justification, agreed to act in concert with Defendants Aisen and USC to commit the tortious acts C ROWELL & M ORING LLP 16 ATTORNEYS AT LAW COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF SFACTIVE-903728301.1 1 against The Regents described in this Complaint in order to further their personal financial gain 2 and to aid in the formation of their new venture, and to harm The Regents and UCSD. 3 74. As a result of the wrongful and tortious conduct of Defendants as alleged herein, 4 Defendants have been unjustly enriched and The Regents has suffered, and will continue to suffer, 5 damages in ways and amounts that will be shown at trial. 6 7 WHEREFORE, The Regents prays for Judgment against Defendants and each of them as follows: 8 1. For compensatory damages, according to proof; 9 2. For preliminary and permanent injunctive relief; 10 3. For restitution and/or disgorgement of profits; 11 4. For attorneys’ fees; 12 5. For costs of suit incurred herein; 13 6. For a trial by jury; and 14 7. For such other and further relief as the Court may deem proper. 15 DATED: July 2, 2015 CROWELL & MORING LLP 16 By: 17 J. Daniel Sharp Mark A. Romeo Derek S. Hecht 18 19 Attorneys for Defendant The Regents of the University of California 20 21 22 23 24 25 26 27 28 C ROWELL & M ORING LLP 17 ATTORNEYS AT LAW COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF SFACTIVE-903728301.1 EXHIBIT A Clinical Trial Research Collaboration Agreement This Clinical Trial Research Collaboration Agreement (“Agreement”) is entered into between Eli Lilly and Company, an Indiana corporation (“Lilly”), and The Regents of the University of California, on behalf of the University of California-San Diego Campus, on behalf of the Alzheimer’s Disease Cooperative Study) (“UCSD”). Introduction and Scope WHEREAS, Lilly is committed to research and development in various therapeutic areas, including Alzheimer’s disease (“AD”); WHEREAS, UCSD possesses the commitment and expertise to plan, engage in, and oversee the conduct of research studies related to AD; WHEREAS, UCSD and Lilly desire to work cooperatively in order to advance research in the AD field by combining each party’s expertise and commitment to making strides in this challenging disease state; WHEREAS, UCSD and Lilly intend to work as partners throughout the clinical research contemplated under this Agreement, including study design, study conduct, and data analysis; WHEREAS, the clinical research contemplated under this Agreement is intended to involve Lilly’s investigational drug product solanezumab and Florbetapir F18 Injection, and Lilly will serve as the regulatory sponsor of the study under applicable laws and regulations; WHEREAS, the clinical research contemplated under this Agreement will be funded by a number of public and private sources, including the National Institutes of Health (“NIH”), Lilly, and several philanthropic organizations; and WHEREAS, the clinical research contemplated under this Agreement is of mutual interest and benefit to Lilly and UCSD and will further the research and development objectives of both parties. NOW THEREFORE, in consideration of the mutual covenants contained in this Agreement, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties, intending to be legally bound, agree as follows: Section 1 Defined Terms 1.1 Capitalized terms are defined in the attached Exhibit A. 1.2 For the purposes of this Agreement, Lilly includes Avid Radiopharmaceuticals, Inc, a wholly owned subsidiary of Eli Lilly and Company. Section 2 Background 2.1 Lilly is a research-based company that develops, manufactures, markets, and sells pharmaceutical and animal health products. 2.2 The Alzheimer’s Disease Cooperative Study (“ADCS”) is a cooperative agreement between the National Institute on Aging and the University of California, San Diego. ADCS works to facilitate the discovery, development and testing of new drugs for the treatment of AD. Page 1 of 40 Ex. A, Pg. 18 2.3 Lilly and UCSD wish to enter into this Agreement in order to facilitate a clinical research study involving the Study Drugs in the field of AD, especially in brain amyloid elevated, preclinical AD. 2.4 Lilly will serve as the regulatory sponsor for the Study for purposes of interacting with regulatory authorities, and UCSD and Lilly will be jointly conducting the study. The nature of the collaboration is further outlined in the joint leadership group memo, which is attached as Exhibit F. 2.5 Study Leadership. The A4 Partnership Leadership Team shall govern the study and shall endeavor to reach consensus on all decisions within its jurisdiction, as further described in Exhibit G. Section 3 Scope of Agreement 3.1 Assignment of Obligations. This Agreement serves to assign to Lilly and to UCSD certain responsibilities imposed by applicable regulations that are outlined in this Agreement and its exhibits in connection with the conduct of the Study. UCSD and Lilly plan to work as partners throughout the Study, including study design, study conduct, and data analysis. 3.2 Performance Period. The effective period of this Agreement will be from the date of execution of this Agreement until completion of the obligations established in this Agreement and the Protocol, unless otherwise terminated in accordance with Section 11. The effective period may be extended by the mutual written consent of the parties hereto. 3.3 Other Parties. Additional parties may provide in-kind and/or philanthropic support for the Study only upon approval by Lilly, which may be withheld only in the event support would jeopardize or conflict with Lilly’s responsibilities as the regulatory sponsor or would result in a conflict of interest. In addition, such support shall not be accepted from any individuals, groups, or entities that appear on any government list of restricted, sanctioned, denied, or debarred parties. UCSD's Rights and Obligations Section 4 UCSD’s General Obligations 4.1 Protocol. UCSD shall exercise reasonable efforts to conduct and manage the multi-center clinical study as set forth in the Protocol, which will be agreed to by Lilly and UCSD as soon as possible after this Agreement is signed and which will be attached as Exhibit H (“the Protocol”). In the event of inconsistency between this Agreement and the Protocol and Study Operations Manuals, the terms of this Agreement shall govern, except that the terms of the Protocol and Study Operations Manuals shall govern with respect to matters of science, medical practice, and subject safety. In the event of inconsistency between the Protocol and Study Operations Manuals, the Protocol shall govern. 4.2 Changes to Protocol and Operations Manuals. Unless there is an amendment needed for urgent safety reasons, changes in the Protocol and Study Operations Manuals may be made only through prior written agreement between Lilly and UCSD and, in the case of the Protocol, may be implemented only after approval is granted by the applicable Institutional Review Board (“IRB”). All changes to the Protocol and Study Operations Manuals necessary for the safety of subjects shall be implemented immediately upon A4 Partnership Leadership Team instruction and the applicable IRB approval. Page 2 of 40 Ex. A, Pg. 19 4.3 UCSD shall conduct the Study under the direction of Clinical Investigator, in accordance with the Protocol, the terms and conditions of this Agreement, and all Applicable Laws. 4.4 The roles and responsibilities of UCSD in conducting and managing the Study are set forth in Exhibit B. UCSD shall make available all personnel, facilities, and resources necessary to efficiently and expeditiously accomplish its responsibilities under this Agreement. 4.5 Pharmacovigilance. UCSD will fulfill pharmacovigilance responsibilities listed in Exhibit B and detailed in the Safety Plan (Exhibit [J]), which will be in place prior to Study enrollment. Obligations include notification of Lilly within twenty-four (24) hours of receiving notification of any Serious Adverse Event (SAE) experienced by a subject participating in the Study and receiving the Study Drugs. 4.6 Clinical Investigator. The Clinical Investigator is Paul Aisen, M.D., who will serve as Investigator for the Study, as defined in 21 C.F.R. § 312.3. The Clinical Investigator is responsible for the management and direction of the Study in accordance with the Protocol, and all Applicable Laws. 4.7 If for any reason, Dr. Aisen is unwilling or unable to continue to serve as Clinical Investigator and a successor who is acceptable to both Lilly and UCSD is not available, this Agreement may be terminated as provided in Section 11. Prior to the commencement of the Study, UCSD shall provide to Lilly true, complete and correct copies of Dr. Aisen’s investigator statement on FDA Form 1572 and curriculum vitae. 4.8 If for any reason the intended Project Director, Dr. Reisa Sperling, is unwilling or unable to continue to serve as Project Director and a successor who is acceptable to both Lilly and UCSD is not available, this Agreement may be terminated as provided in Section 11. 4.9 UCSD may contract with Participating Sites and sub-Investigators to conduct the Study. Any Participating Site and sub-investigator used shall be subject to all of the terms and conditions of this Agreement applicable to UCSD, and UCSD shall ensure that each Participating Site and sub-investigator is aware of such terms and conditions. UCSD shall ensure that each contract with a Participating Site and sub-Investigator includes a representation that the Participating Site or sub-Investigator is not subject to any obligations that would prevent it from complying with the applicable terms of this Agreement. UCSD shall also ensure that each Participating Site signs the Investigator Letter UCSD shall ensure that any sub-award contracts with Participating Sites and subinvestigators are consistent with the relevant terms of this Agreement. 4.10 Institutional Review Board. UCSD shall provide to Lilly documentation verifying review and approval by the applicable IRB of the information to be provided to potential subjects of the Study to secure their informed consent, including information about any compensation being provided to Subjects for participation in the Study, and the Protocol. UCSD shall ensure that any applicable IRB(s) continues to monitor the Study during the term of this Agreement in accordance with Applicable Laws and in any event at least once per year and shall provide Lilly with documentation of any applicable IRB’s continuing review contemporaneously therewith. UCSD shall promptly notify Lilly if any IRB takes, or proposes, threatens or gives notice of its intent to take, any action that could reasonably be expected to affect any duties or clinical activity under the Study, including the safety or welfare of any Subject. 4.11 Informed Consent. UCSD shall obtain the informed consent of each Subject participating in the Study in accordance with 21 C.F.R. parts 50 and 56, including the completion of an informed consent form. Such form shall be reviewed and approved in advance by UCSD, Page 3 of 40 Ex. A, Pg. 20 Lilly, and the appropriate IRB, prior to any Subject’s screening or participation in the Study. Each informed consent shall include (a) safety profiles for the Study Drugs, as provided by Lilly unless an IRB requires changes, and Lilly consents to such changes, (b) a description of the situations under which Subjects will be reimbursed for treatment of injuries related to their participation in the Study, and (c) data privacy terms that secure access and usage rights to Study Data and biological samples as described in Sections 16 and 17. 4.12 Financial Disclosure Information. At Lilly’s request, UCSD shall cause Clinical Investigator to promptly provide to Lilly (a) financial disclosure statements in compliance with 21 C.F.R. Part 54, in the form required by Lilly and (b) such other financial information as Lilly may reasonably request for the sole purpose of fulfilling its regulatory responsibilities, including information documenting the amounts paid to each Investigator participating in the Study. During the term of the Study and for a period of one (1) year thereafter, UCSD shall cause Clinical Investigator and any Sub-Investigators to promptly notify Lilly in writing of any substantive changes to such financial information. 4.13 Project Personnel. UCSD shall ensure that its personnel receive appropriate training, including any training required by Applicable Laws or consistent with established ADCS SOP, and the specifics surrounding the confidentiality obligations stated under Section 17. UCSD shall maintain accurate and current records of all training activities and retain such records in accordance with the terms of this Agreement. 4.14 Changes in Services or Deliverables. If A4 Partnership Leadership Team agrees to make changes to the Study that alters the scope of work required under this Agreement or otherwise makes modifications in the Services or Deliverables being provided by UCSD, UCSD and Lilly shall agree in writing on the resulting change and the related costs or savings, if any. 4.15 Grants. UCSD shall be prohibited from establishing a clinical grant with an Investigator on the behalf of Lilly that uses the outcome of the Study as a basis for compensation or requires payments to a spouse or dependent children. 4.16 Conditions of NIH Funding. UCSD shall have sole responsibility for ensuring that the conduct of the Study meets any requirements imposed by the NIH as a condition of receiving a grant for partially funding the Study. 4.17 Anti-Bribery/Foreign Corrupt Practices Act. In carrying out its responsibilities under this Agreement, UCSD agrees to comply with all applicable anti-bribery laws in the countries where UCSD has its principal place of business and where UCSD conducts activities under this Agreement. Additionally, UCSD understands and agrees to comply with the U.S. Foreign Corrupt Practices Act, as revised, which generally prohibits the offer, promise, payment or giving of anything of value either directly or indirectly to any government official for the purpose of obtaining or retaining business or any improper advantage. For purposes of this section, “government official” means any official, officer, representative, or employee of, including any doctor employed by, any non-U.S. government department, agency or instrumentality (including any government-owned or controlled commercial enterprise), or any official of a public international organization or political party or candidate for political office. Additionally, if UCSD or any of its owners, directors, employees, agents, and consultants are government officials, UCSD agrees that Lilly’s payment of UCSD in connection with this Agreement is not intended to influence any decision that any individual may make in his or her capacity as a government official. UCSD further represent that neither UCSD nor any of its owners, directors, employees, Page 4 of 40 Ex. A, Pg. 21 agents, or consultants will directly or indirectly offer to pay, promise to pay or give anything of value to any government official for purposes of (a) influencing any act or decision of such government official in his official capacity; (b) inducing such government official to do or omit to do any act in violation of the lawful duty of such official; (c) securing any improper advantage; or (d) inducing such government official to use his influence with the government or instrumentality thereof to affect or influence any act or decision of the government or such instrumentality with respect to any activities undertaken relating to this Agreement. Additionally, UCSD will make reasonable efforts to comply with requests for information, including answering questionnaires and narrowly tailored audit inquiries, to enable Lilly to ensure compliance with applicable anti-bribery laws and any applicable provisions of the Anti Bribery Commitments as revised by Lilly from time to time and published at http://supplierportal.lilly.com or otherwise made available to UCSD, to the extent consistent with UC policies. UCSD agrees that Lilly’s payment to UCSD in connection with the Services or Deliverables to be provided under this Agreement is not intended to influence any decision UCSD may make regarding the prescription of Lilly medicines or to otherwise influence any pending or future Lilly business. Section 5 5.1 UCSD’s Certifications, Representations and Warranties UCSD certifies that: 5.1.1 Neither UCSD nor any other Person who provides Services or Deliverables for Lilly or satisfies any other obligation of UCSD under this Agreement is prohibited from doing so by any legal obligation or restriction, including any Applicable Laws or contractual commitment. 5.1.2 UCSD’s performance under this Agreement complies with all Applicable Laws and with any relevant description or specification in this Agreement. 5.1.3 Services and Deliverables will be rendered with at least that degree of skill and competence reasonably expected of, and in accordance with any codes of conduct commonly recognized by, Persons who perform similar Services in the country in which the Services are performed. 5.1.4 Obligations of Clinical Investigator. Clinical Investigator is, and at all times during the course of the Study shall be, qualified, by training and experience, and with appropriate expertise to conduct the Study. UCSD shall cause Clinical Investigator and Participating Sites and sub-investigators to perform the Study appropriately, professionally and efficiently, which includes: (a) exercising independent medical judgment as to the compatibility of each Subject with the Protocol requirements; (b) ensuring that each Subject is provided with information about the Study, has been given an opportunity to ask questions about the Study and his involvement, and has received answers to all such questions; (c) ensuring that UCSD has obtained the informed consent of each of the Subjects participating in the Study; (d) reviewing all case report forms for accuracy and completeness; (e) submitting all Study Data in a timely manner; (f) notifying UCSD’s IRB immediately of any unanticipated or serious adverse reactions to the Study Drug; (g) maintaining adequate and correct records of Subject identification, clinical observations, laboratory tests and drug receipt and disposition; (h) cooperating with Lilly in all of its efforts to monitor the Study; and (i) notifying UCSD immediately of any SAEs. 5.1.5 Licenses, Approvals and Certifications. UCSD and Clinical Investigator have, and at all times during the course of the Study shall have, the appropriate licenses, Page 5 of 40 Ex. A, Pg. 22 approvals and certifications necessary to safely, adequately and lawfully perform the Study. Section 6 6.1 6.2 5.1.6 Absence of Conflicts. No UCSD personnel or Clinical Investigator or any other person involved in performing the Study is, or at any time during the course of their involvement with the Study shall be, subject to any conflicting obligations or is party to any conflicting arrangements that might interfere with the performance of the Study or that might impair the acceptance of the resulting data by the FDA. 5.1.7 UCSD and Clinical Investigator are entering into a collaborative arrangement with Lilly to conduct the Study based on the scientific merits of the project and not, in any way, as an inducement to, or in return for, past, present or future prescribing, purchasing, recommending, using, dispensing or granting preferential formulary status for any Lilly product. 5.1.8 Privacy and HIPAA. UCSD represents, warrants and covenants that it and Clinical Investigator are “Covered Entities” under the provisions of the Health Insurance Portability and Accountability Act of 1996 and any regulations and official guidance promulgated thereunder (“HIPAA”). UCSD shall, and shall cause Clinical Investigator to, handle all Study Data (including Subjects’ medical records) in accordance with HIPAA requirements and all other Applicable Laws and shall ensure that they obtain from each Subject a valid authorization that complies with HIPAA, and is, in form and substance, acceptable to Lilly, permitting UCSD and Clinical Investigator to provide Lilly with the Study Data as contemplated hereby and to satisfy their other obligations under this Agreement with respect to the Study Data or with the applicable provisions of Lilly’s Vendor Privacy and Security Standard as revised by Lilly from time to time and published at http://supplierportal.com or otherwise made available to UCSD and to the extent consistent with UC policy. UCSD acknowledges and agrees that no component of Lilly or any of its affiliates that will be performing Lilly’s obligations under this Agreement (a) is a “Covered Entity” for purposes of HIPAA, (b) will become a “Business Associate” of a Covered Entity for purposes of HIPAA by performing its obligations under this Agreement, or (c) is otherwise governed by HIPAA. Debarment and Exclusion from Certain Health Care Programs UCSD represents and warrants that it has not been: 6.1.1 Debarred by the FDA under any provision of the Generic Drug Enforcement Act; 6.1.2 Excluded by the Office of the Inspector General of the United States Department of Health and Human Services, or by any other authority, from participating in any health care program (such as Medicare or Medicaid) funded by any Governmental Authority; or 6.1.3 Debarred or disqualified from participating in clinical research by any other Governmental Authority. UCSD agrees that no Person who has been debarred or excluded as described above will furnish any of the Services or Deliverables or perform any of UCSD’s obligations under this Agreement. 6.2.1 UCSD will immediately notify Lilly in writing of any actions taken or proceeding pending that threatens or confirms a debarment or exclusion of any such Person. Page 6 of 40 Ex. A, Pg. 23 Lilly’s Rights and Obligations Section 7 Lilly’s General Obligations 7.1 Lilly shall be the Sponsor of the Study, as defined in 21 C.F.R. § 312.3. For the purpose of the study UCSD and Lilly plan to work as partners throughout the A4 study, including study design, study conduct, and data analysis. 7.2 The roles and responsibilities of Lilly are set forth in Exhibit B. 7.3 Subject to UCSD’s material compliance with its obligations under this Agreement, Lilly will provide partial funding in support of the Study in accordance with Exhibit I. 7.4 Lilly shall be responsible for obtaining all necessary regulatory approvals for the conduct of the Study. Lilly will keep UCSD informed regarding the status of regulatory approvals. 7.5 Lilly shall be responsible for complying with applicable requirements to register the Study and results on clinicaltrials.gov or any other database for which registration is required by Applicable Laws. Any such results will be calculated using a mutually agreed upon statistical analysis plan. 7.6 Lilly may contract with contract research organizations or other third parties to conduct the Study. Any vendor or CRO used shall be subject to all of the terms and conditions of this Agreement applicable to Lilly, and Lilly shall ensure each is aware of such applicable terms and conditions. Section 8 Provision of Study Drugs 8.1 Terms of Supply. Lilly shall provide UCSD with the Study Drugs free of charge, in accordance with the Protocol, solely for UCSD’s performance of the Study. Lilly retains all right, title and interest (collectively, “Rights”) in and to the Study Drugs. UCSD shall not, without Lilly’s prior written permission, (i) use the Study Drugs for any purpose other than the performance of the Study, (ii) provide the Study Drugs to any third party (except a contract research organization or other third party receiving Study Drugs under the Protocol), or (iii) take the Study Drugs to any location other than an investigational study site. UCSD shall not, and shall cause Clinical Investigator not to, modify or alter the Study Drugs in any manner. Upon termination or completion of the Study, UCSD shall, at Lilly’s direction, either return to Lilly any quantities of unused Study Drugs, or dispose of the same, in any event in accordance with Lilly’s written instructions. UCSD shall maintain complete and accurate records relating to the disposition of all Study Drugs supplied to UCSD. 8.2 Disclaimer. Without limiting Lilly’s obligations under section 22, LILLY DOES HEREBY DISCLAIM ANY AND ALL WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS OR IMPLIED, WITH RESPECT TO THE STUDY DRUG, INCLUDING ANY WARRANTY OF QUALITY, PERFORMANCE, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE, OR THAT THE USE OF THE STUDY DRUG (FOR PURPOSES OTHER THAN THOSE CONTEMPLATED BY THIS AGREEMENT) WILL NOT INFRINGE THE RIGHTS, PATENT OR OTHERWISE, OF ANY THIRD PARTY. Section 9 9.1 Lilly's Representations and Warranties Lilly represents and warrants that: Page 7 of 40 Ex. A, Pg. 24 9.1.1 Neither Lilly nor any other Person who performs any obligation of Lilly under this Agreement is prohibited from doing so by any: (a) Applicable Laws; (b) covenant not to compete; (c) contract to deal exclusively with another Person; or (d) other legal or professional obligation or restriction. 9.1.2 The performance of Lilly’s responsibilities under this Agreement and Lilly’s use of the Services and Deliverables comply with all Applicable Laws. Payments Section 10 10.1 UCSD's Invoices Schedule. Except to the extent provided by the Statement of Work (Exhibit B) or the Budget (Exhibit I), UCSD will submit invoices on the following schedule: 10.1.1 For hourly fees, for unit-based fees, and for reimbursement of expenses: once a month, as accrued or incurred. 10.1.2 For fixed fees: after Lilly has received and accepted all Services and Deliverables subject to the fixed fee. 10.2 Form and Supplemental Information. Each invoice submitted by UCSD must comply with Lilly's standard forms and procedures (as changed from time to time), to the extent consistent with UCSD’s standard invoice, and published on the internet at http://supplierportal.lilly.com and with any specific requirements in this Agreement. Lilly may at any time request additional invoice information as needed. As requested, each invoice will be accompanied by any information required by this Agreement or that Lilly may reasonably request, including detailed information for any amounts of Taxes UCSD is collecting from Lilly. 10.3 Currency. Invoices will be stated in United States Dollars. 10.4 Payment Terms. Payment will be due sixty (60) days after Lilly's Accounts Payable Department receives an invoice that complies with the requirements of this Agreement, except that Lilly may withhold payment of any amount that it may reasonably dispute in good faith until such dispute is resolved. Payment by electronic transfer will be made on the payment date. Payment by check will be mailed on the payment date. 10.5 Currency. Payment will be in United States Dollars. 10.6 The funding agreed to by Lilly pursuant to this Agreement is based on 1,000 subject enrollment only. Any increase to the subject population due to sample size re-estimation will be made only by written agreement between Lilly and UCSD. Additional funding by Lilly as a result of this re-estimation will occur only by written agreement between Lilly and UCSD. Right to Terminate Section 11 11.1 Termination of Agreement This Agreement may be terminated by either party upon thirty (30) days’ prior written notice if the other party materially breaches any of its obligations or provisions of this Agreement and has not cured the breach during such period. Page 8 of 40 Ex. A, Pg. 25 11.2 UCSD may terminate this Agreement on ninety (90) days’ prior written notice if it is not financially, administratively, or scientifically feasible for UCSD to continue the Study. 11.3 Lilly may terminate this Agreement on ninety (90) days’ prior written notice if for any reason Lilly deems its sponsorship of the Study no longer financially or scientifically feasible, including if UCSD fails to timely obtain NIH funding in the amount of $36 million or if Lilly determines, as a result of a pre-Study enrollment audit, that UCSD does not possess the necessary facilities, personnel, or abilities to adequately perform its obligations under this Agreement. 11.4 This Agreement may be terminated immediately: (a) for safety reasons as in good faith determined by either UCSD or Lilly, (b) if the FDA requests the Study be terminated, (c) if UCSD’s IRB orders the Study terminated, or (d) the Drug Safety Monitoring Board recommends this course of action in accordance with the charter. 11.5 Upon termination for any reason, Lilly shall promptly provide payments for all work completed and non cancellable costs incurred by UCSD in accordance with Exhibit I. Upon termination for any reason, UCSD shall (a) promptly refund any amounts paid to UCSD that exceed Lilly’s obligation to pay for work actually performed, (b) provide a summary status report of the Study, including subjects enrolled, statement of work, and summary of data collected; and (c) deliver to Lilly all unused Study Drugs and any other information or property in the possession or control of UCSD that was supplied by Lilly or derived from the Study that Lilly may request under the terms of this Agreement. 11.6 In the event that the Study is terminated under this Section, the A4 Partnership Leadership Team shall determine an appropriate course of action with regard to winding down the Study or whether the Study shall continue. Except in the case of termination as a result of an uncured breach of this Agreement by UCSD, Lilly shall reimburse UCSD for its reasonable and verifiable direct costs incurred in connection with any such transfer or winding down of the Study. 11.7 Termination of this Agreement by any party shall not affect the rights and obligations of the parties accrued prior to the effective date of the termination. The rights and duties under sections 12 through 17, 19, and 22 survive termination or expiration of this Agreement. Information and Property Rights Section 12 12.1 Publications Lilly encourages the publication of Study Data in reputable scientific journals and at seminars or conferences. UCSD has the sole and irrevocable right, consistent with academic standards, to publish the first manuscript containing results of the Study. This sole right to publish the Study Data shall survive the agreement if Lilly should choose to sell or otherwise relinquish its rights and property to another entity. UCSD shall be responsible for facilitating timely disclosure of the primary publications reporting results of the Study, and it is anticipated that the results of the Study will be published in a joint multi-center primary publication including Lilly authors, as scientifically appropriate, and consistent with the publication plan. UCSD will prepare a proposed disclosure plan for the primary multicenter publication, including proposed title or topic, journal or congress, and submission date for the primary multicenter publication disclosures and provide to Lilly before database lock. UCSD will coordinate the publication of the primary manuscript to simultaneously occur with the first disclosure of primary Study results at a scientific Page 9 of 40 Ex. A, Pg. 26 meeting. Submission of the primary publication is to occur no later than 6 months, unless mutually agreed to be extended by the parties, following the Study database lock if simultaneously publication and presentation is not feasible. The primary publication shall include the results of the primary efficacy measures as prespecified in a mutually agreed upon statistical analysis plan and may contain other key secondary efficacy measures if the parties mutually agree to such secondary efficacy measures and whether to include them within the primary publication. 12.2 Prior to submission for publication or presentation, UCSD shall provide Lilly with at least thirty (30) days for review and comment on the manuscript. Lilly has the right to review all proposed UCSD publications, manuscripts, and presentations of the results of the Study and to require (1) the deletion of Lilly Confidential Information and/or (2) postponement of the publication, manuscript, or presentation for no more than 90 days in order to protect the Intellectual Property Rights of either party. The parties will work cooperatively to ensure the accuracy of statements in registries, publications, manuscripts, and presentations relating to the Study Drugs. 12.3 If UCSD seeks to register the Study or publish the Study results on a web-based registry other than clinicaltrials.gov or any other database for which registration is required by Applicable Laws, UCSD shall provide Lilly with the proposed registration or publication information at least thirty (30) days in advance, and Lilly shall have the right to review such information and to require (1) the deletion of Lilly Confidential Information and/or (2) postponement of the release of such information for no more than 90 days in order to protect the Intellectual Property Rights of either party. 12.4 Subject to the same review process in Section 12.2, Lilly and UCSD will each have the right to make follow-up publications, and the parties will exercise good faith efforts to coordinate such publications in order to avoid identical or overly similar publications. UCSD will provide to the A4 Partnership Leadership Team a record of all planned platform presentations, poster presentations, or publications. Similarly, Lilly will provide to the A4 Partnership Leadership Team a list of all presentations or publications planned by Lilly employees at scientific meetings or in scientific journals. The A4 Partnership Leadership Team or their designees will review and discuss the publication plans of Lilly and UCSD on an as needed basis. A Lilly publication coordinator will assist the A4 Partnership Leadership Team and authors in complying with any applicable Lilly publication procedures and processes. Section 13 13.1 Lilly Property UCSD acknowledges that Lilly owns the entire rights, title and interest in Lilly Intellectual Property and certain processes, know-how, trade secrets, improvements, Records, Confidential Information, other assets, including but not limited to, the Study Drug compounds, database design and an interactive voice study drug randomization system to assign treatments, dispense drugs, monitor clinical supply inventories and obtain data during clinical studies (collectively “Lilly Property”). UCSD, as well as its Affiliates, agents, and vendors, shall be bound to the terms of confidentiality as set forth in this Agreement with regard to such Lilly Property and shall not share such Lilly Property with other sponsors for whom they may later perform work or other third parties. Nothing contained in this Agreement shall be construed as a license to UCSD to any proprietary rights of Lilly, including but not limited to, patent rights to make, sell, reverse engineer, or prepare derivative works based upon the Lilly Property, or any part thereof, outside the purposes contemplated by this Agreement. Page 10 of 40 Ex. A, Pg. 27 Section 14 14.1 Section 15 UCSD Property Lilly acknowledges that UCSD possesses certain processes, know-how, trade secrets, methods, approaches, analyses, improvements, Records, Confidential Information, and other assets, including but not limited to, clinical trial management analyses, analytical methods, procedures and techniques, computer technical expertise and proprietary software, and technical and conceptual expertise in the area of conducting clinical trials, all of which have been developed independently by UCSD without the benefit of any information provided by Lilly (collectively “UCSD Property”). Lilly agrees that any UCSD Property or improvements thereto which are used, improved, modified or further developed by UCSD under or during the term of this Agreement are the sole and exclusive property of UCSD. Except as provided below, nothing contained in this Agreement is to be construed as a license to Lilly under any proprietary rights of UCSD, including but not limited to patent rights to make, use, sell, reverse engineer, or prepare derivative works based upon UCSD Property, or any part thereof, outside the purposes contemplated by this Agreement. Intellectual Property Rights 15.1 Lilly shall maintain ownership of its existing intellectual property related to Study Drugs and its method of use, whether patentable or not. 15.2 To the extent legally possible, Lilly shall be granted a worldwide, non-exclusive, royaltyfree license, to any patents and patent applications that necessarily use, incorporate, or are a result of the Study Drugs provided by Lilly pursuant to this Agreement, including any patents or patent applications filed by third parties as a result of access to Study Data pursuant to Section 15.5 of this Agreement. 15.3 Lilly shall be free, in its sole discretion, to distribute the Study Drugs to others and to use them for its own purposes. 15.4 UCSD shall use reasonable efforts to assist Lilly in complying with the requirements of The Bayh-Dole Act of 1980 (Public Law 96-517; 35 U.S.C. §§ 200-212). 15.5 Subject to Sections 12, 13, 14, 16, 17, and 18 of this Agreement, and its obligations to maintain patient confidentiality, UCSD shall have the right to make available, in whole and in part, any final Study Data to third parties. Such disclosure shall not occur before publication of the primary manuscript referenced in Section 13. Consistent with NIH data sharing policies and precedents, UCSD may make the Study Data available only upon a written request containing a prohibition on using such data as part of a filing with a regulatory authority, whether for a marketing application or supplement or investigational drug application. Such written request must also contain an acknowledgement that Lilly will retain rights to the patents and patent applications as outlined in Section 15.2 of this Agreement. Section 16 Rights to Study Data 16.1 Study Data will be captured by UCSD and maintained jointly by Lilly and UCSD. 16.2 Study Data will be jointly owned by Lilly and UCSD. Lilly has the right to obtain a copy of the Study Data, as well as copies of all regulatory-required Study documentation, including, but not limited to, any IRB approval notifications, investigator qualifications, Page 11 of 40 Ex. A, Pg. 28 and Study subject records, as needed to support a regulatory application or submission in relation to Study drugs or for use as outlined under this Agreement and for other reasonable purposes. 16.3 Biological samples taken during the course of the Study will be retained by UCSD or Lilly for future research purposes. Biological samples related to treatment response shall not be provided to any third-party without the prior written authorization of Lilly which shall not be unreasonably withheld. UCSD shall ensure that the informed consent form for the Study informs Subjects that such samples will be retained by UCSD or Lilly and used for further research but only if the Subjects opt-in for the future use. Lilly and UCSD shall have the right to access and perform research under this Agreement on the samples related to treatment response with prior written notice to the other party. Any publications arising out of the biological samples shall follow the publication process outlined in Section 12 of this Agreement. UCSD and Lilly agree to further work through the specifics surrounding the biological samples through amending the Statement of Work or entering into a Work Plan process as outlined in this Agreement. Any disputes related to the biological samples shall be vetted through the A4 Partnership Leadership Team as further described in Exhibit G. 16.4 Notwithstanding any provision in this Agreement to the contrary, data and publication rights will be governed by the National Institutes of Health’s Grants Policy (dated October 2011), including the requirement that NIH be given a royalty-free, nonexclusive, and irrevocable license for the U.S. Federal government to reproduce, publish, or otherwise use the Study Data and to authorize others to do so for Federal purposes. Consistent with this policy, each publication, press release, or other public document about the Study shall contain an acknowledgment of NIH support and a disclaimer stating that the content does not represent the official views of the NIH. Section 17 17.1 Confidential Information Lilly shall only disclose confidential information necessary for Institution’s performance of the Study. “ Confidential Information” shall mean and include all data and other information which are disclosed by Lilly to UCSD for the purposes of conducting the Study which is marked as “Confidential” at the time of disclosure, or (i) in the case of oral disclosures, identified at the time of such oral disclosure as confidential and reduced to writing and marked as “Confidential” within thirty (30) days of oral disclosure; (ii) if not marked, regarded as confidential if a reasonable person in the relevant field would consider such information to be the Company’s confidential information given its content and the circumstances of the disclosure. The parties anticipate that each party has already or may acquire or have access to Confidential Information owned by the other party, including but not limited to the following types: research and development plans and results; new compounds and processes; evaluation procedures (including clinical and field testing); product formulations; manufacturing methods; applications to government authorities; pricing or cost; construction plans; sales, marketing, and advertising studies and plans; customer lists; computer information and software; special techniques unique to each party's business; information subject to a right of privacy; and information each party maintains under a system of protection against unauthorized access. The parties will cooperate to ensure that Confidential Information does not inhibit or prevent publication including publication required by any Federal sponsor. Page 12 of 40 Ex. A, Pg. 29 17.2 The Confidential Information provided to the receiving party will remain the property of the disclosing party. 17.3 Lilly and UCSD will neither: 17.3.1 disclose the other party’s Confidential Information except as authorized below or by the other party in writing; nor 17.3.2 use the other party’s Confidential Information for any purpose other than the purpose of this Agreement. 17.4 In executing the obligations in this Section 17, each party shall use a standard of care at least as stringent as each party uses to protect its own Confidential Information and in any event, using no less than a reasonable standard of care. 17.5 Each party shall restrict the dissemination of the Confidential Information within its own organization to only those persons who have a need to know it, and shall ensure that all of its employees and representatives involved in carrying out this Agreement and the Study, including Clinical Investigator, (a) are aware that the Confidential Information is confidential and (b) are bound by obligations of confidentiality and non-use at least as protective of the Confidential Information as those set forth in this Agreement. 17.6 Each party may disclose the other party’s Confidential Information only (a) to ADCS employees, (b) to those other persons who require access in order to perform obligations required under this Agreement and who have contractual obligations that prohibit any disclosure and use of the Confidential Information prohibited by this Agreement, or (c) to the extent compelled by Applicable Laws. If permitted by Applicable Law, each party will provide the other with reasonable advance notice of the disclosure. 17.7 The obligations of confidentiality in this Section 17 shall not apply to information that: (a) is published or otherwise generally available to the public at the time of disclosure other than by reason of breach of the provisions of this Agreement; (b) becomes publicly known subsequent to disclosure by either party other than by reason of breach of the provisions of this Agreement; (c) either party can demonstrate by competent evidence was in its possession at the time of disclosure and was not acquired directly or indirectly from the other party; or (d) either party can demonstrate by competent evidence was developed by the party without the use of, and independent from, any information received from the other party. 17.8 Promptly upon termination, expiration, or cancellation of this Agreement, each party will delete or destroy all Records of the other party’s Confidential Information in each party’s possession or control (if such Records are not the property of the other party). For the purpose of Electronic Records, “destroy” includes destroying the physical medium on which a Record is stored or completely and permanently removing a Record from its storage medium. 17.9 Notwithstanding anything to the contrary in this Agreement, each party may make and retain one (1) Record of the other party’s Confidential Information solely for its legal archives. 17.10 The prohibitions on disclosure and use of Confidential Information shall survive for seven (7) years after the end of the study, termination, or cancellation of this Agreement or after UCSD returns or destroys all Records of the relevant Confidential Information in its possession or control, whichever is later. The foregoing notwithstanding, the restrictions on prohibition or use of Lilly’s Trade Secrets shall survive for as long as the information Page 13 of 40 Ex. A, Pg. 30 satisfies the definition of Trade Secret, provided that Lilly informs UCSD in writing at the time of disclosure that the information constitutes a Trade Secret. Section 18 Records and Audits 18.1 Records That Must Be Created and Maintained. UCSD will create and maintain all Records: (a) required by this Agreement and Applicable Laws that relate to this Agreement and to UCSD’s performance under this Agreement; and (b) sufficient to enable Lilly to comply with Applicable Laws and other legal obligations, to the extent that UCSD has or reasonably should have knowledge of those Applicable Laws and other legal obligations. 18.2 Periodic Reports. UCSD shall, and shall cause Clinical Investigator to, provide Lilly, in writing, with data and results arising from the performance of the Study, at such intervals as Lilly shall reasonably request. Lilly shall have free access to all Study Data, provided, however, that the confidentiality of Subjects’ identifiable health information shall be maintained to the extent required by Applicable Laws. 18.3 Record Retention Periods. The Records required to be maintained under this Agreement shall be retained by UCSD for fifteen (15) years commencing upon conclusion or termination of the Services. After the applicable Records retention period ends, at the request of UCSD and at Lilly’s direction, such Records shall be delivered to Lilly, be destroyed, or be retained by UCSD for a standard storage fee to be agreed upon by the parties. 18.4 Access to Participating Sites and Records. Lilly or its authorized representatives or designees shall have the right, with reasonable advance notice, at Lilly’s cost, and during business hours, to audit Participating Sites and Study Records at reasonable times and with reasonable advance notice for regulatory purposes, for ensuring that UCSD is in compliance with the terms of this Agreement. 18.5 NIH Records and Reports. UCSD shall have sole responsibility for maintaining any Records that are required as a condition of the grant received by UCSD to partially fund the Study. UCSD shall also have sole responsibility for any communications with NIH, including reports on the Study. Lilly shall have the right to review reports related to the study before submission to NIH. Section 19 Nondisclosure, Publicity, and Use of Lilly Name or Trademarks 19.1 Neither party shall use the name, insignia, symbol, trademark, trade name or logotype of the other party in any press release, advertising or materials distributed to prospective or existing customers, annual reports or any other public disclosure, except with the other party’s prior written authorization or as required by Applicable Laws. To the extent allowed by Applicable Laws, each party will provide copies of any proposed disclosure for prior review and comment by the other party no less than ten (10) days prior to disclosure. 19.2 Both Lilly and UCSD agrees to confer with the other before responding to inquiries by journalists or financial analysts related to the Study and agree upon a mutual external communication coordination process within a reasonable time after execution of this Agreement. In responding to such inquiries, the parties will endeavor to distinguish between the roles and responsibilities of various entities. In particular, when discussing interactions with regulatory authorities (such as IND filings, safety reports, etc.), it may be helpful to note that Lilly is the regulatory sponsor of the Study under Applicable Laws. When discussing the overall management and conduct of the Study, it may be helpful to Page 14 of 40 Ex. A, Pg. 31 note that the A4 ADCS/Lilly Partnership will be jointly conducting the Study. Finally, when discussing financial support for the Study, it may be helpful to note that NIH, Lilly, and multiple philanthropic organizations have provided funding for the Study. 19.3 In no event will UCSD: 19.3.1 represent, directly or indirectly, that any product or service provided by UCSD has been approved, recommended, certified or endorsed by Lilly; or 19.3.2 use Lilly’s name, logo, or other trademarks on any business cards, letterhead, or similar materials. 19.4 Lilly may, in its sole discretion, revoke any authorization or consent given under this Section 19. Risk Allocation Section 20 Remedies 20.1 The naming of a specific remedy does not preclude any other remedy unless this Agreement clearly states that the specified remedy is the sole or exclusive remedy. 20.2 UCSD acknowledges that monetary damages are inadequate to protect Lilly from a breach or threatened breach of UCSD's duty to protect Lilly's Confidential Information and that any such breach will cause irreparable harm to Lilly. Accordingly, Lilly may seek an injunction restraining any breach or threatened breach without having to prove the inadequacy of monetary damages or irreparable harm. 20.3 Lilly acknowledges that monetary damages are inadequate to protect UCSD from a breach or threatened breach of Lilly's duty to protect UCSD's Confidential Information and that any such breach will cause irreparable harm to UCSD. Accordingly, UCSD may seek an injunction restraining any breach or threatened breach without having to prove the inadequacy of monetary damages or irreparable harm. Section 21 21.1 Section 22 22.1 Insurance UCSD and Lilly will satisfy the requirements of the Insurance Exhibit. Indemnification By Lilly. Lilly agrees to indemnify, defend, and hold harmless UCSD and its officers and administrators, trustees, directors, employees and agents, including Clinical Investigator (collectively, the “UCSD Indemnitees”), from and against any and all claims, damages, liabilities, losses, costs and expenses (collectively, “Claims”) for any personal injury (including death) to Subjects directly arising from the administration or use of the Study Drugs or any clinical intervention or procedure provided for or required by the Protocol to which Subjects would not have been exposed but for their participation in the Study pursuant to the Protocol, except to the extent that such Claims arise from: (a) the violation by any UCSD Indemnitee of the Protocol; (b) the breach by any UCSD Indemnitee of the terms of this Agreement, including UCSD’s failure to obtain from each of the Subjects participating in the Study the informed consent described; (c) the violation by any UCSD Indemnitee of any Applicable Laws; (d) the negligence, recklessness or willful misconduct of any UCSD Indemnitee; (e) any natural processes or complications of an underlying illness, or any other illness or injury the Subject may experience during the course of the Page 15 of 40 Ex. A, Pg. 32 Study, unless such illness or injury is a Study-related injury (i.e., any illness or injury caused by activities described in the Protocol that are different from the medical management the Subject would have received if he had not participated in the Study); or (f) injuries resulting from the use of any drug (including biological material) or device supplied by any third party. 22.2 By UCSD. UCSD shall defend, indemnify and hold harmless Lily, its directors, officers, agents and employees (“Lilly Indemnitees”) from and against any and all claims, liabilities, expenses (including reasonable attorneys’ fees) actions or demands that may be made or instituted against any of them by reason of injury (including death) to any person or damage to property, arising out of or in connection with the Study (“Claims”) but only in proportion to and to the extent such Claims are caused by or result from the negligent or intentional acts or omissions of, or the breach of this Agreement by, UCSD, its directors, officers, agents or employees, including Clinical Investigator. 22.3 Procedures for Indemnification 22.3.1 If an indemnitee becomes aware of a third-party Claim that (if successful) will result in indemnification under this Section, the indemnitee will promptly notify the indemnitor in writing (with a copy of the notice to the indemnitor’s legal counsel). Failure or delay in giving such notice will not affect the right to be indemnified except to the extent that it prejudices the defense of the Claim. If the indemnitor acknowledges that the Claim (if successful) will result in indemnification under this Section, it may assume the defense within fifteen (15) days after receiving the notice of the Claim. In the meantime, the indemnitee may take any action that it deems appropriate to protect its interests or those of the indemnitor, provided it is not prejudicial to the indemnitor. 22.3.2 If the indemnitor acknowledges its obligation to indemnify and assumes the defense, it will have both the duty to defend and the right to control the defense. The indemnitor will conduct the defense in a prudent manner and will keep the indemnitee reasonably informed as to the status of the defense. The indemnitee will cooperate with the defense and may retain separate counsel at its own expense to participate in, but not control, the defense. Neither party may settle a Claim without the consent of the other, and that consent may not be unreasonably withheld or delayed. 22.3.3 If the indemnitor does not timely assume the defense, the indemnitee will have the right (but no duty) to defend or settle the Claim at the risk of the indemnitor. The indemnitor will reimburse the indemnitee for its expenses (including reasonable attorney’s fees) of defending or settling the Claim 22.4 Subject Injury Reimbursement. In addition to any amounts listed in Exhibit I, Lilly will pay UCSD on a cost pass through basis without mark-up or overhead for any reasonable expenses incurred in reimbursing Investigators for costs incurred related to the diagnosis and/or treatment of an injury to a Subject directly arising from the proper administration or use of the Study Drugs or any clinical intervention or procedure provided for or required by the Protocol to which Subjects would not have been exposed but for their participation in the Study pursuant to the Protocol. In order for Lilly to comply with reporting requirements under the Centers for Medicare and Medicaid Services (CMS) Section 111 of the Medicare, Medicaid and SCHIP Extension Act of 2007 (MMSEA 111), UCSD shall submit, upon request, documentation required by Lilly regarding any request for payment Page 16 of 40 Ex. A, Pg. 33 of subject injury costs. Such documentation must be provided to Lilly prior to Lilly making any such payment. Section 23 23.1 Exclusion of Certain Damages Neither party (nor any of its Affiliates) is required to pay, or to indemnify any Person for, consequential, indirect, incidental, punitive, or special damages, including loss of revenues and lost profits, arising from or relating to: 23.1.1 any breach of any provision of this Agreement, except any provision relating to Confidential Information or Intellectual Property Rights, or 23.1.2 any negligence in its performance under this Agreement, except gross negligence or intentional misconduct. General Terms and Conditions Section 24 24.1 Section 25 Work Plans During the course of the Study, the parties may develop written plans designed to further specify the responsibilities of the parties (“Work Plans”) which may be tied to the Statement of Work. These Work Plans will be management tools designed to improve coordination. The Work Plans will provide additional detail regarding Services to be performed by UCSD and Lilly as outlined in the Statement of Work. The Work Plans are not associated with an increase to funding by Lilly and will not constitute a written amendment to this Agreement unless the intention to amend is expressly stated in writing and the Work Plan signed by a duly authorized representative of each party to this Agreement. Taxes 25.1 Payment of Taxes. Each party will be responsible for its own taxes, including Property Taxes on property it owns or leases, Income Taxes on its business, and any other Taxes incurred by such party in connection with its business and with performing its obligations hereunder. Lilly will be responsible for any Transaction Taxes properly collectible from Lilly under Applicable Laws. UCSD will be responsible for payment of any Transaction Taxes that are, under Applicable Laws, properly borne by UCSD. The calculation of Taxes shall not include, and Lilly shall not pay, any Taxes that are related to intra-corporate transfers or intermediate supplies of the Services between UCSD and its Affiliates or between UCSD’s Affiliates and related entities. 25.2 Withholding Taxes. If any payments made by the parties under this Agreement become subject to withholding taxes under Applicable Laws of any state, federal, provincial or foreign government, each party shall be authorized to withhold such Taxes as are required under Applicable Laws, pay such Taxes to the appropriate Governmental Authority, and remit the balance due to the other party net of such Taxes. The party paying the taxes to the Governmental Authority shall secure and deliver to the other party an official receipt for Taxes paid. 25.3 Reports Regarding Application of Funds. In order that Lilly may comply with applicable federal tax laws and regulations, UCSD agrees that if requested by Lilly, UCSD will report to Lilly within sixty (60) days after the close of each calendar year the dollar amount of expenses which UCSD has incurred during the year but has not yet billed to Lilly on Page 17 of 40 Ex. A, Pg. 34 activities covered by this Agreement. In order to assist UCSD in completing the statement, Lilly will endeavor to provide UCSD with a summary of payments made to it during such year for all Lilly studies or activities conducted by it during such year. 25.4 Tax Documents and Information. Each party shall provide and make available to the other party any exemption certificates, resale certificates, information regarding out of state or out of country sales or use of equipment, materials or Services, and any other information reasonably requested by the other party to support the provisions of this Section 25, including the appropriate organization of invoice formats and supporting documents. 25.5 Tax Filings and Audits or Proceedings. Each party represents, warrants, and covenants that it will file appropriate tax returns and pay applicable Taxes owed and arising from or related to the provision of the Services in applicable jurisdictions. Section 26 Independent Contractors 26.1 In performing their obligations under this Agreement, Lilly and UCSD act solely as independent contractors. This Agreement does not create a partnership, joint venture, or any similar relationship between Lilly and UCSD. Neither UCSD nor Lilly has any authority (a) to bind, incur any liability on behalf of, or otherwise commit the other or; (b) to act in any other manner as agent or representative of the other. 26.2 Neither UCSD nor any persons employed by UCSD to perform any obligations under this Agreement are employees of Lilly for any purpose. Lilly will not withhold any taxes, pay any Social Security taxes, pay unemployment compensation, furnish worker's compensation insurance, or provide any employment benefits for UCSD such persons. Section 27 27.1 Delegation and Assignment Neither party may assign its rights or delegate its obligations under this Agreement, except that: 27.1.1 Property rights acquired under this Agreement may be freely assigned unless this Agreement expressly prohibits the assignment. 27.1.2 Accounts receivable may be assigned in accordance with Applicable Laws. 27.1.3 UCSD may engage one or more Subcontractors to perform its obligations under this Agreement, but only with Lilly's prior written consent; however, UCSD will remain fully responsible to Lilly for the performance of all obligations delegated to the Subcontractor. 27.1.4 Lilly may assign any or all of its rights or delegate any or all of its obligations under the Agreement to any of its wholly owned Affiliates. Lilly may assign any or all of its rights or delegate any or all of its obligations under the Agreement to any of its other Affiliates, but only with UCSD’s prior written consent; however, Lilly will remain fully responsible to UCSD for the performance of all obligations delegated to the Affiliate. Section 28 28.1 Regulatory Agency Visits Visitation. At Lilly’s request, a representative of UCSD shall accompany Lilly to meet with representatives of the FDA, U.S. Environmental Protection Agency (“EPA”), or similar domestic or foreign regulatory agencies (collectively “Regulatory Authority”) to explain or discuss any and all aspects of Services provided under this Agreement. Such Page 18 of 40 Ex. A, Pg. 35 visit or visits to the Regulatory Authority shall be arranged at times mutually agreeable to Lilly and UCSD. All reasonable travel and living expenses incurred by UCSD in connection with such visits shall be reimbursed by Lilly. 28.2 Notification. Either party shall immediately notify the other of any request from a Regulatory Authority, other federal or state agencies or any other third-party to inspect or otherwise gain access to the information, data or materials pertaining to the responsibilities assigned under this Agreement. Notification of such requests shall be prior to permitting any third-party access, unless prior notice is not possible. Both parties shall have the right to be present at and to participate in any such inspection or regulatory action with respect to the Study. The contacted party shall provide the other party with copies of all pertinent information and documentation issued by any Regulatory Authority and any proposed response. Both parties shall have the right to review and approve in advance any responses that pertain to the Study. 28.3 Inspection. UCSD agrees to permit inspection of such information, data and materials by authorized representatives of the Regulatory Authority and as otherwise required by Applicable Laws. During such inspections, UCSD shall provide appropriate scientific and quality assurance support for its Services and Deliverables. Lilly reserves the right to provide additional scientific and quality assurance support during regulatory inspections as related to the Services and Deliverables. 28.4 Findings By Regulatory Authorities. UCSD will immediately notify Lilly Medical Quality Assurance if it receives a formal report from a Regulatory Authority (including but not limited to FDA-483s) regarding significant findings by a Regulatory Authority resulting from an inspection, review or audit of UCSD and/or any Investigators participating in Lilly-sponsored Studies. UCSD will provide Lilly with its response to such finding and Lilly shall be given the opportunity to provide assistance to UCSD in responding to any such review, audit or inspection. UCSD shall provide Lilly with the ultimate resolution of such findings. Section 29 Compliance with Law, Regulations and Lilly Policies 29.1 In the performance of its Services and obligations under this Agreement, UCSD shall comply with all Applicable Laws, regulations, and professional standards, including, but not limited to: 29.1.1 .  Any instructions or policies set forth by Lilly which relate to compliance by Lilly or its Affiliates with any US or other Government Authority mandates, settlements or adjudications, including the Corporate Integrity Agreement (the "CIA") between Lilly and the Office of Inspector General, US Department of Health and Human Services, dated January 14, 2009, and any disclosure requirements set forth thereunder; UCSD acknowledges that it or certain of its employees are deemed by Lilly to be Covered Persons under the terms of the CIA. Supplier agrees to perform the activities set forth in Exhibit D and any other obligations required by Lilly to ensure full compliance with the CIA." 29.1.2 Applicable clauses set forth in the U.S. Federal Acquisition Regulation ("FAR") FAR 52.244-6(c)(1) as set forth at http://supplierportal.lilly.com and such other provisions as may be required by Applicable Laws to allow the sale of Products to the U.S. Government from time to time by Lilly; and Page 19 of 40 Ex. A, Pg. 36 29.1.3 Paragraphs (1) through (3) of 29 C.F.R. Part 471, Appendix A to Subpart A regarding the posting of certain notices pertaining to employee rights under the National Labor Relations Act available at http://www.gpoaccess.gov/fr/. 29.2 Notwithstanding anything in this Agreement, the parties expressly agree that the provisions of the Uniform Computer Information Transaction Act and the United Nations convention on Contracts for the International Sale of Goods (including any provision of any state law adopting exactly, or in modified form, such laws) shall not apply to this Agreement, Work Order, Purchase Order, Work Product, Deliverables, software services, or products provided hereunder and that both parties waive any and all rights arising from such laws. 29.3 The parties acknowledge that each maintains its own financial authorization policies on ensuring requisite corporate authority has been given for specific transactions. The parties therefore agree that any communications between the employees of the parties that may impact previously agreed upon financial, economic or legal expectations under this Agreement, must be approved by the authorized individuals of both parties. The parties further agree to periodically meet and/or enter into discussions to identify authorized individuals as well as take any corrective actions necessary for any past discrepancies in order to meet appropriate financial expectations for potential future transactions. 29.4 All the requirements of this Section 29 are in addition to all of UCSD's other obligations under this Agreement. Section 30 Regulatory Submissions 30.1 Lilly shall have responsibility for submitting to the FDA or any other federal, state or foreign agency all documents required under any applicable federal, state or foreign laws or regulations, including annual reports and safety reports. UCSD shall provide Lilly with relevant information for and assist Lilly in the preparation of any required documents, including annual reports and safety reports and shall respond to any and all questions regarding such reports at costs mutually agreed to by the parties in writing in advance. 30.2 A mutually agreed upon statistical analysis plan shall be used for regulatory purposes. Section 31 31.1 Section 32 Severability If a provision of this Agreement is held to be unenforceable, the other provisions will remain in effect. If possible, the offending provision will be modified to the slightest degree necessary to make it enforceable, remaining as close as possible to the parties' original intent for the provision. If not possible, the offending provision will be stricken. Contract Interpretation 32.1 The meaning of a provision of this Agreement will be considered in context with other provisions of this Agreement. 32.2 The following principles apply to the construction of this Agreement unless the construction is plainly contrary to the intent of the parties: 32.2.1 "Including" means "including but not limited to." 32.2.2 Language that has a generally prevailing meaning is given that meaning unless this Agreement expressly assigns a different one. Page 20 of 40 Ex. A, Pg. 37 32.2.3 Technical terms used in the technical field of the subject of this Agreement are given their technical meaning. 32.2.4 Singular words may be treated as plural, and plural words may be treated as singular. 32.2.5 The masculine gender may be treated as feminine, and the feminine gender may be treated as masculine. 32.3 Section 33 33.1 Section 34 In computing any period of time under this Agreement, the day of the act, event, or default from which the designated period of time begins to run is not included. If this Agreement specifies that a period is to run for a certain number of business days, only business days are included in the count, and the period may not end on any other day. Survival The expiration, termination or cancellation of this Agreement will not extinguish the rights of either party that accrue prior to expiration, termination or cancellation or any obligations that extend beyond termination, expiration or cancellation, either by their inherent nature or by their express terms. No Waiver 34.1 No provision of this Agreement is waived unless the waiver is in writing and signed by the party granting the waiver. 34.2 No delay in exercising any right, power or privilege under this Agreement will operate to waive completely or partially any present or future exercise of that right, power or privilege. Section 35 35.1 Notice Unless specifically directed otherwise in this Agreement, whenever written notice is required by this Agreement, it must be delivered to the applicable address indicated below by: 35.1.1 Certified mail, postage pre-paid, return receipt requested; 35.1.2 Hand delivery; 35.1.3 Commercial overnight delivery Service such as Federal Express or United Parcel Service; 35.1.4 Email; or 35.1.5 Facsimile. 35.2 Either party may change its address for notices by written notice to the other. 35.3 Notice is effective when received. If delivery of any written notice under this Agreement cannot be made despite the exercise of diligent efforts, the requirement to give notice is excused. Page 21 of 40 Ex. A, Pg. 38 Address for Notices to Lilly: Address for Notices to Lilly’s Legal Counsel (if required): Eli Lilly and Company Lilly Corporate Center Indianapolis, IN 46285 Attention: Director – LRL Global Procurement Telephone: (317) 276-2000 Eli Lilly and Company Lilly Corporate Center Indianapolis, IN 46285 Attention: General Counsel's Office Address for Notices to UCSD: Address for Notices to UCSD's Legal Counsel (if required): Alzheimer’s Disease Cooperative Study [Address] Nancy Bastian Attention: ______________________________ (858) 246-1313 Telephone: _____________________________ (858) 246-1414 Facsimile: ______________________________ nbastian@ucsd.edu; jpizzola@ucsd.edu Email: _________________________________ Office of Contract and Grant Administration 9500 Gilman Drive La Jolla, CA 92093-0924 Attention: Rachel SievertTelephone: 858-534-3335 Email: rsievert@ucsd.edu 8950 Villa La Jolla Drive, Ste C-227 La Jolla, CA 92037-1712 Section 36 Integration and Amendments 36.1 This Agreement, its exhibits and attachments are the final, complete and exclusive expression of all the statements, promises, terms and conditions within its scope and supersedes any prior written or oral agreements within its scope. In making this Agreement, neither party relies on any promise or statement made by the other party, other than those contained in this Agreement, its exhibits or attachments. 36.2 No amendment to this Agreement will be binding on either party unless it is in writing and signed by each party or executed in another manner expressly provided by this Agreement. Such an amendment does not require the consent or agreement of any third party, even if the third party is beneficiary of this Agreement. 36.3 In the event of a conflict between the provisions of the exhibits or the attachments to this Agreement and the provisions of this Agreement itself, the conflicting provision(s) of this Agreement shall control over the language in the exhibit or attachments, unless otherwise agreed by the parties. Page 22 of 40 Ex. A, Pg. 39 9 ma: 1* semen: 37.i This Agreement is iegaliy hinting Wlteth but net anti]. each party has received team the other a eenntei?part e?lt?zis Agreement signeei s3; an aiitiioi?ized Repi?esentative. The parties? Representatives may Sign sepat?ate? identical countei?pai?ts of this document; taken together, they constitute one agreement. A signed counterpart may be delivered by any reasonable means: including facsimile 03? other Electronic transmission. ELE ANS CGMEANY By: g? Name: {gm fire?fmigi Title: (Nth? ng?ta/ewa?i' ?ags a 3a eel Date: GE GE CALEFQRNIA, SAN I By: Name: Linda Collins Title: Director, Of?ce of Contracts Grants Admin. Au ust 2013 Date 3 Page conditions of this A cement and their potential impact on me. Name: Dr. Paul Aisen, M.D. By signing here, [?zresent that have carefully read and understand all ofthe provisions and By: Title: OiiLg/i? 'f Date: Page EXHIBIT COLLABORATIVE STUDY AGREEMENT This Agreement by and between Toyama Chemical Co., Ltd., a company organized under the laws of Japan (?Toyama? or ?Company?) and The Regents of the University of California; University of California, San Diego (?Institution?) having a place of business at 9500 Gilman Drive, Mail Code 0687, La Jolla, California 92093?0687 is made and effective as of the date of execution that the last party signs below (hereina?er ?Effective Date?). Background WHEREAS, institution, through the activities of the Alzheimer?s Disease Cooperative Study established through a cooperative agreement between the US. National Institute on Aging and institution, and Institution?s employee Dr. Paul S. Aisen (?Principal Investigator? and Director of the ADCS), have experience in conducting Multi-Center Alzheimer?s Disease clinical study programs. WHEREAS, Company desires to collaborate with Institution to conduct a clinical study of the Drug (as de?ned herein) according to a protocol and any related amendments thereto (the "Protocol") entitled Phase 2 multi-center, randomized, double blind, placebo-controlled, parallel group study to evaluate the ef?cacy and safety of 7MA in patients with mild to moderate Alzheimer?s Disease (the "Study"), attached hereto as Exhibit and incorporated herein by reference. WHEREAS, Company and Fuji?lm Corporation are Af?liates (as de?ned herein) of each other and each has rights to develop and commercialize the Drug in various regions of the world; WHEREAS, institution through the ADCS and its other resources is equipped, has the expertise, and desires to undertake the Study in collaboration with Company, under the terms and conditions hereina?er set forth. NOW, THEREFORE, in consideration of the premises and the mutual promises and covenants expressed herein, and for other good and valuable consideration, the suf?ciency and receipt of which is hereby acknowledged, the Parties agree as follows: 1. De?nitions. A. ?Al?liate? means, with respect to either Party or other entity, any person or entity that, directly or indirectly. controls. is controlled by or is under common control with such Party or other entity. As used in this de?nition, ?control? means in the case of corporate entities, direct or indirect ownership of more than ?fty percent of the stock or shares having the right to vote for the election of directors of such entities, and in the case of non-corporate entities, the direct or indirect power to manage, direct or cause the direction of the management and policies of the non-corporate entity or the power to elect more than ?fty percent of the members of the governing body of such non-corporate entity. For the avoidance of doubt, the Company, Fuji?lm Holdings Corporation (a corporation organized under the laws of Japan), Fuji?lm Corporation (a corporation organized under the laws of Japan), and Fuji?lm Pharmaceuticals U.S.A., Inc. (a corporation organized under the law of the Commonwealth of Massachusetts) are Af?liates of each other. B. ?Applicable Law? or ?Applicable Laws? means any and all laws, rules, regulations, guidelines and ethical standards including but not limited to Good Clinical Practices and including laws, regulations and guidelines governing data protection and privacy (including, but not limited to, the the European Union Data Protection Directive and the guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals For Human Use and those regarding the sourcing, handling, storage, banking, transport, use, disposal, releasing, transferring, import or export of Human Biologic Materials and associated data, each as may be amended from time to time, and as appropriate to the performance of the Study under Ex. B, Pg. 42 this Agreement. ?Case Report Forms means the form, in electronic or paper format, which may consist of multiple pages, and is jointly developed by Company and Institution for the purposes of the Study to collect Subject data reporting. . ?Clinical Study Results? means any and all CRFs prepared in part or in whole to record the results of the Study and the data contained therein, deliverables under the Protocol, any results arising from the conduct of the Protocol, compilations and analyses of the data set forth in such CRFs, reports in respect of the Study, including, in each case, without limitation, written, printed, graphic, or video material, and information contained in any computer data base or computer readable form implemented or maintained in connection with the Study by the Institution, Principal Investigator, or the Company in the course of conducting the Study, and speci?cally excludes Institution Data and Direct Identi?ers. . ?Company Con?dential Information? has the meaning given to that term in Section ?Company Intellectual Property? means any Intellectual Property made in the direct performance of the Study that is invented solely by employees, of?cers, agents, or other persons on behalf of Company or otherwise acquired or licensed by Company from one or more third parties. . ?De-Identi?ed Human Biologic Materials? means Human Biologic Materials and associated data that do not include the 18 identi?ers of Protected Health Information as set forth by HIPAA in the HIPAA Privacy Rule and which Human Biologic Materials and associated data are coded and labeled so as to be linked to the CRFs in respect of the Subjects from whom such Human Biologic Materials have been obtained. . ?Direct Identi?ers? means information that directly identi?es a Subject, including, but not limited to, Subject?s name, birth date, street address, telephone, social security, medical record, or health plan bene?ciary numbers. ?Drug? means that certain drug called T-817MA ~benzothiophen-5-yl) ethoxy] propyI}-3-azetidinol maleate; under development by Company as a pharmaceutical to treat Alzheimer?s Disease. ?Effective Date? has the meaning given to that term in the ?rst paragraph of this Agreement. . means the US. Food and Drug Administration and any successor thereto. ?Fundamental Structural Change? means when used with respect to Company, any materially adverse change in the business, assets, liabilities, results of operations, condition (?nancial or otherwise) or prospects of Company taken as a whole (excluding, however, changes in general economic conditions or ?nancial markets) or when used with respect to Institution, any materially adverse change in the legal authority of Institution to perform its respective obligations under this Agreement due to any statute, law, rule, regulatiomjudgment, order, decree, permit, license or injunction of any governmental authority that is applicable to or binding upon Institution or any of its properties, (ii) any materially adverse change in the operations of Institution taken as whole that will jeopardize or disable continuation of the Study, caused by compliance with any order or regulation of any government entity (such as the National Institute on Aging) acting lawfully within Institution?s power, or any event beyond the reasonable control of Institution that in the reasonablejudgment of Institution acting in good faith and a?er consulting with Company prevents, restricts, interferes or delays Institution from being able to satisfy its obligations under this Agreement, provided that Institution, where reasonably possible, has used its reasonable best efforts to avoid or remove such cause, and in each case not caused by the negligence, intentional conduct or misconduct of Institution. Z. . ?Health Authority? means the governmental agency in eachjurisdiction where the Study is conducted responsible for regulating in such jurisdiction the conduct of human clinical trials of medicinal products. including, without limitation, the FDA. means the US. Health Insurance Portability and Accountability Act of I996 and any regulations and of?cial guidance documents promulgated thereunder, including, without limitation, the HIPAA Privacy Rule and the HIPAA Security Rule. Authorization? means the authorization required to be obtained pursuant to HIPAA from Subjects pursuant to 45 CPR. Part 164 in the US. Code of Federal Regulations. ?Human Biologic Materials? may include, but are not limited to, blood, urine, saliva, or other bodily ?uids, products of conception, excess pathology tissue, surgical tissue and any other human tissues. ?Informed Consent Form? means the form of informed consent agreed upon by Company and and to be signed by each Subject prior to Subject?s participation in the Study. ?Institution Data? means source documents, Subject medical records, and raw data generated or collected from Subjects during the performance of the Study. ?Institution Intellectual Property? means any Intellectual Property discovered, conceived, reduced to practice or developed by Institution employees (including, without limitation, the Principal Investigator) arising from the Study that are neither Company Intellectual Property nor Joint Intellectual Property. ?Institutional Review Board? or means the institutional review board from which lnstitution shall seek approval of the Protocol and the lnfonned Consent Form. ?Intellectual Property? means collectively inventions, discoveries, products, mechanisms, substances, formulae, and methods, including improvements. ?Joint Intellectual Property" means any Intellectual Property invented, conceived, and reduced to practice jointly by Company and Institution employees (including, without limitation, the Principal Investigator), as determined by US. Patent Law, in the conduct of the Protocol or directly resulting from the scope of the Study that is neither Company Intellectual Property nor Institution Intellectual Property. ?Option? has the meaning given to that term in Section ?Party? means lnstitution, or Company, as applicable, and ?Parties? means, collectively. Institution and Company. ?Principal Investigator? means the Institution?s employee who will personally supervise the Study and may not delegate this duty. Principal Investigator may, however, delegate other duties to quali?ed personnel in accordance with the Protocol and regulatory requirements. ?Protocol? has the meaning given to that term in the Recitals. AA. ?Samples? has the meaning given to that term in Section BB. ?Site? means the physical locations where the Study is conducted and includes, among other locations, hospital, outpatient, community and other clinics, and physician?s offices. 2. CC. ?Study? has the meaning given to that term in the Recitals. DD. ?Study Stafl? means Principal Investigator and any other employee, contractor, or agent performing or assisting with the Study on behalf of the Institution. EE. ?Sub-Investigator? has the meaning given to that term in Section FF. ?Subject? means each human subject participating in the Study. GG.?Subsequent Derived Intellectual Property? means any Intellectual Property directly arising from the use of the Clinical Trial Results or Joint Intellectual Property for academic non-commercial research purposes by Institution and Principal Investigator. HH.?Term? has the meaning given to that term in Section Performance of Study. A. Compliance With This Agreement. Institution and Principal Investigator agree to perform the Study in strict accordance with the Protocol, including any subsequent Protocol amendments thereto. all Applicable Laws and the terms and conditions of this Agreement. In the event that Institution and/or Principal Investigator use the services of Sub-Investigators, investigational sta??, or others to conduct a portion of the Study, Institution and Principal Investigator shall be responsible for ensuring that all are appropriately licensed and credentialed and in compliance with the terms of this Agreement. Institution and Principal Investigator shall refrain from, and shall cause any other member of the Study Staff to refrain from, using the Drug in any manner that is contrary to the provisions of, or outside the scope of, the Protocol or that is contrary to Applicable Law or written instructions from Company, Institution, or Principal Investigator, as applicable. Institution shall be liable for any breach of this Agreement by such individuals to the extent the breach is caused by or results from the Institution?s negligent or intentional acts or omissions. B. Replacement of Principal Investigator. In the event that the Principal Investigator becomes no longer af?liated with Institution, Institution shall designate another individual to serve as Principal Investigator and provide written notice to Company within three (3) days of such deparmre and designation. Company shall have the right to approve any new Principal Investigator designated by Institution. Institution shall require such new Principal Investigator to agree in writing to abide by the terms and conditions of this Agreement. In the event Company does not approve such new Principal Investigator, Company may terminate this Agreement in accordance with the Section 7(8) (Termination) below and Institution shall comply with the provisions of Section related to such termination. C. Delegation of Investigator Duties. Institution may not replace Principal Investigator or substantially reduce Principal Investigator?s role in the Study without Company?s prior written approval. If Principal Investigator is to be temporarily absent from Institution for more than ?fteen (IS) business days, Institution shall designate a sub-investigator (?Sub-Investigator?) to temporarily supervise the Study on the Principal Investigator?s behalf and inform Company of such designation in writing at least I4 days prior to such absence. Institution shall document this designation. D. Audits by Company. (1) Institution shall make available to Company (or its agent), to the extent allowable under Institution?s policies and procedures, and, subject to applicable law relating to patient confidentiality. all Study documents and Institution Data upon reasonable advance notice from Company and during regular business hours, to allow Company (or its agent) to conduct audits from time to time to con?rm that the Study is being conducted in conformance with the Protocol and in compliance with this Agreement and Applicable Laws. Except as provided in Section of this Agreement, Company shall have a right to conduct up to three (3) audits under this Section during the term of this Agreement. (2) If Company determines based on any such audit, that the conduct of the Study violates or is otherwise not in compliance with the Protocol, this Agreement, or Applicable Laws, Company shall notify the Principal Investigator and Institution to such effect. Upon receipt of any such notice, the Principal Investigator and Institution shall act to cure any circumstances giving rise to such violation or noncompliance. To the extent any such violation or noncompliance was the direct result of Institution failing to adhere to GCP. the cure shall be at the expense of Institution, which shall be accounted for as an offset against payments owed by Company to Institution hereunder. Company shall provide such reasonable and necessary assistance as is requested by the Principal Investigator and Institution in order to effect such cure and shall work with Institution to determine how the expense shall be covered when not the direct result of Institution failing to adhere to GCP. (3) Company shall have the right to conduct audits as needed for the purpose set forth in Section above and in response to any violations or noncompliance by Institution and Principal Investigator of or with the terms and conditions of this Agreement or the Protocol. A pre-quali?cation audit will be conducted as mutually agreed to between the Parties. E. Inspections. Each Party acknowledges that the other Party may respond independently to any regulatory correspondence or inquiry in which such Party or its Af?liates is named. Each Party, however, shall notify the other Party of any FDA or other governmental or regulatory inspection or inquiry conceming any matter relating to the Study. During any such inspection or inquiry, the Parties agree to make reasonable efforts to disclose only the information required to be disclosed. F. Source Documents Veri?cation. Institution shall enter into an agreement with each Site pursuant to which such Site shall be contractually required to respond to any request from Company for veri?cation of any source documents in respect of any Subject treated at such Site in connection with the Study by providing to Company such documents and information as are necessary for such purpose. 3. Institutional Review Board (IRB) - Informed Consent Authorizations. A. Approvals. Institution shall be responsible for obtaining IRB approval of the Protocol, the Informed Consent Form, Study advertisements (ifany). any alteration to or waiver of any subject authorization permitting the disclosure of con?dential subject information in connection with the Study, and any matter involving questions of human subject protections, from the IRB prior to commencement of and during the performance of the Study. In the event the IRB requires changes in the Protocol or any substantive and material changes in the Informed Consent Form, such changes shall not be implemented until Company is noti?ed and gives its written approval. The Protocol, the lnfonned Consent Form, and any Study advertisements each in their original form and prior to commencement of the Study shall be mutually agreed upon by Institution and Company, and each shall not be revised without the prior written agreement of Company and the Principal Investigator. Amendments shall be approved by the IRB prior to implementation. Institution shall conduct the Study in a manner consistent with the lnfonned Consent Form as so approved and all other applicable consents. B. Signed Informed Consent Forms and HIPAA Authorizations. Institution shall be responsible for obtaining the Informed Consent Form validly signed by or on behalf of each Subject and appropriately documented prior to the Subject?s participation in the Study. C. Subject Medical Information. The Informed Consent Form shall include the right for Company and its designees and applicable government authorities to review raw Study data, including original Subject records, and all monitoring and auditing activities required to ensure quality assurance and compliance with the Protocol as well as all legal and regulatory requirements. Company may copy such original Subject records and records relating to such monitoring and auditing activities to the extent permitted by the express authorization in the Informed Consent Form and HIPAA Authorization signed by each Subject and to the extent that Company complies with all Applicable Laws regarding the con?dentiality of Subjects? medical records and other health information, including, without limitation, holding each Subject?s personal identifying information in con?dence. D. Letter of Approval. If requested by Company, Institution and Principal Investigator shall provide Company with copies of the letter of approval from the IRB, the approved Informed Consent Form and any relevant communications with the IRB, which includes, but is not limited to, information which may affect the conduct of the Study. E. HIPAA Matters. Institution represents and covenants that it is a "covered entity" under the provisions of and Institution shall handle all Study records and Institution Data in accordance with HIPAA and other Applicable Law. Such compliance shall include, in each case when required, obtaining from each Subject a HIPAA Authorization or obtaining a waiver valid under 45 C.F.R. Sec. 164.5 I 2(i) that permits the disclosure and use of data collected from the applicable Subject in accordance with the Protocol. Institution acknowledges that Company is not a ?covered entity? (as de?ned by HIPAA) and will not become a "business associate" (as de?ned by HIPAA) of a covered entity by performing its obligations under this Agreement. 4. Adverse Event Reporting. Institution and Principal Investigator shall be solely responsible for complying, within the required timelines, with any safety reporting obligations to the competent Health Authorities, the and the participating (co- or sub-) investigators, as de?ned in the Applicable Law. Principal Investigator and Institution also agree to notify Company within a reasonable time period as written in the Study Scope of Work set forth in Exhibit attached to this Agreement. Safety Plan and the Protocol of any serious and/or unexpected adverse events (as de?ned in the Protocol) affecting any Subject in the Study. 5. Transfer of Human Biologic Materials. A. Generally. Institution shall comply with Applicable Law in the collection, storage, and transfer of any Human Biologic Materials taken from Subjects in the performance Study, and shall obtain any informed consents required from Subjects for the use of such materials in accordance with the Protocol and such other uses as set forth in such informed consents. During the course of the Study, Institution will coordinate with Company to transfer the De-Identi?ed Human Biological Materials taken from the Subjects in the performance of the Protocol (?Samples?) to a third party entity for storage, management, and use in accordance with Section 6. B. Reimbursement. As part of Company?s ?nancial support of this Agreement, Company shall, in accordance with the Reimbursement Schedule set out at Exhibit C, reimburse Institution for its reasonable and documented out-of-pocket expenses incurred in connection with technical and logistical activities associated with de-identi?cation. sourcing, handling, preparing, storing and transferring the Samples as required under this Agreement. Institution acknowledges and agrees that all sums paid by Company under the terms of this Agreement are solely for the performance of the Study and the reimbursement of expenses incurred by Institution in connection with its obligations under this Agreement. Institution certi?es that: i. the sums payable under this Agreement represent the fair market value for the Institution?s services and expenses in the conduct of the Study; and ii. it has the right under Applicable Law to receive the payments contemplated under this Agreement, and no sums under this Agreement are designed to compensate for the sale or purchase of Human Biologic Materials; and iv. the Parties speci?cally intend to comply with all Applicable Laws, including, without limitation, the US. federal anti-kickback statute (42 U.S.C. l3208-7b), the related safe harbor regulations and the Limitation on Certain Physician Referrals, also referred to as the ?Stark Law? (42 U.S.C. 1395 Accordingly, no part of any consideration paid hereunder is a prohibited payment for the recommending or arranging for the referral of business or the ordering of items or services; nor are the payments intended to induce illegal referrals of business. 6. Permitted Uses of Human Biologic Materials. A. Right to Use. Company and its of?cers, employees, agents or their Af?liates have the right to use the Samples, including related data, according to the terms of this Agreement for the Study and for other research, development and commercial uses that are consistent with the informed consent and Applicable Law. Institution, its of?cers, agents and employees shall have the right to use any Human Biological Materials and Samples, including related data, according to the terms of this Agreement for the Study and for other research, education, treatment of subjects who are participating or have participated in the Study and related non-commercial purposes that are consistent with the informed consents and Applicable Law. B. Obligations. Institution agrees to handle and maintain any Human Biologic Materials and related data collected by Institution in accordance with the terms of this Agreement and Applicable Law. Company agrees to handle and maintain the Samples in accordance with this Agreement and Applicable Law. Company and Institution agree that reasonably following the execution of this Agreement they shall agree upon a set of procedures for managing the storage and use of the Human Biologic Materials for purposes beyond those contemplated by the Protocol and the Study (?Post~Study Uses?). Such procedures shall have as their purpose the optimal use and stewardship of the Human Biologic Materials in order to satisfy the requirements of the Protocol and the Study and any Post-Study Uses. Such procedures shall include, among other things, periodic consultations between the Parties as to Post-Study Uses by either Party, maintenance of an information system containing data on the types and quantities of Human Biologic Materials in storage, and shall comply with all Applicable Laws and applicable lnfonned Consent Forms. Post-Study Uses shall include Company further development and commercial uses and shall include Institution further academic non-commercial research and educational uses. C. Agreements with Non-Affiliated Third Parties. Subject to its obligations under Section the Parties shall fully document by a written agreement any transfer or disclosure of the Human Biologic Materials and any related data to any third party that is not an Affiliate of the Parties and to include in any such agreement restrictions and obligations on the third party substantially in accordance with the obligations of this Agreement. 7. Term and Termination. A. Term. The term of this Agreement(?Term?) shall begin on the Effective Date and shall end on the later of May 3 I, 2018, or (ii) upon Company?s agreement that the milestone captioned ?Completion of CSR Review and signing by Principal Investigator" in Exhibit has been satisfactorily completed and Company?s receipt of the ?nal Study report as so signed by Principal Investigator, as required pursuant to the Scope of Work. The Parties agree that the Term may be extended by mutual written agreement. B. Termination. (0 (iv) Notwithstanding the provisions set forth in Section and in addition to those events described elsewhere in this Agreement as permitting immediate termination of this Agreement, this Agreement may be terminated by Company at any time in the exercise of its sole discretion upon thirty (30) days prior written notice to Institution and Principal Investigator. In addition, this Agreement may be terminated by either Party upon written notice to the other Party if any of the following events occur: after prior consultation with the other Party, the terminating Party reasonably believes in good faith that there are valid scienti?c or ethical reasons not known before execution of this Agreement for not commencing or discontinuing, as applicable, the Study; after prior consultation with the other Party, the terminating Party reasonably believes in good faith that commencement or continuation, as applicable, of the Study will compromise patient safety or result in a material violation of data integrity, Good Clinical Practices, or Applicable Laws; the non-terminating Party fails or is unable to remedy within thirty (30) days of prior written notice of a material violation of this Agreement by the terminating Party; or either Party seeks termination not earlier than one-hundred twenty (120) days following prior written notice to the non-tenninating Party that a Fundamental Structural Change with respect to the terminating Party will render the terminating Party unable to satisfy its obligations under this Agreement. Upon receipt of such notice in respect of the circumstances described in clauses and of Section the Parties agree to work together to terminate conduct of the Study, to the extent medically permissible, for all Subjects. Upon receipt of such notice in respect of the circumstances described in clause of Section the Parties agree to continue the Study in accordance with this Agreement until a ?nal resolution of the relevant dispute. In the event of termination hereunder, other than as a result of a material breach by Institution or Principal Investigator, the total sums payable by Company pursuant to this Agreement shall be equitably prorated for actual work performed to the date of termination, with any unexpended funds previously paid by Company to Institution being refunded to Company. Upon the termination of this Agreement by Company pursuant to Section 7(BXich) or by Institution pursuant to or following the delivery of the termination notice, as applicable, each of the following provisions shall take effect: (I) within thirty (30) days of the date of such notice, to the extent feasible, Institution shall complete the de-identi?cation of any Human Biologic Materials then in the possession of Institution or any Site and deliver to Company such De-Identi?ed Human Biologic Materials, and the rights of Institution (provided that prior to the date of such notice all data from the Study has been reviewed and all queries and issues about that data have been resolved and the database containing that data is closed to further entries or revisions (the ?Database Lock?)), Company and its Affiliates to use such De-ldenti?ed Human Biologic Materials in accordance with Section shall survive termination of this Agreement, and Institution?s use rights shall continue in the event of pre-Database Lock termination to the extent it is determined, after consultation with Company, that the use is not adverse to the Study goals and objectives; (2) within ten (l0) days of the date of such notice, to the extent feasible by Institution and the Sites, but in no event more than thirty (30) days of the date of such notice, Institution and the applicable Site shall complete and deliver to Company any and all CRFs then outstanding in respect of any Subject; (3) within thirty (30) days of the date of such notice, Institution, Principal Investigator, and any Site shall deliver to Company a report of Clinical Study Results other than CRFs (which are addressed in subclause (2) of this Section (4) (5) (6) (7) (8) (9) Institution shall deliver to Company, upon request, invention disclosures for any Joint Intellectual Property and Institution Intellectual Property conceived and reduced to practice prior to the termination; the rights and obligations of Company and Fuji?lm Corporation and the rights and obligations of Institution and Principal Investigator under Section shall survive termination of this Agreement; neither Institution nor Principal Investigator shall thereafter use any Company Intellectual Property for any purpose whatsoever, other than to ful?ll Institution?s or Principal Investigator?s obligations under Section and within ten (10) days following the completion of any assistance from Institution and Principal Investigator requested by Company under Section Institution and Principal Investigator shall deliver to Company any and all manifestations of Company Intellectual Property then in the possession of Institution or Principal Investigator, as applicable; within thirty (30) days of the date of such notice, each of Institution and Principal Investigator shall provide Company with copies of any and all writings that are the subject of Copyrights referenced in Section and the rights of Institution, Company and Fuji?lm Corporation under Section shall survive termination of this Agreement; the rights of Company under Section 2(0) in respect of any and all Institution Data shall survive termination of this Agreement and within thirty (30) days following the date of such notice, Institution shall, to the extent permissible under Applicable Law and the Informed Consent Form, deliver to Company copies of any and all Institution Data and Company shall have the right to use the Institution Data for purposes of continuing the undertaking of the Protocol and the Study, and any further research and development of the Drug and successor compounds thereto; The rights of Company and Fuji?lm Corporation rights under Section 8(6) in respect of any and all Institution Intellectual Property and Section 8(C)(iv) in respect of any and all Subsequent Derived Intellectual Property shall survive termination of this Agreement and within thirty (30) days following the date of such notice, Institution shall, to the extent permissible under Applicable Law, disclose any Institution Intellectual Property and Subsequent Derived Intellectual Property to Company, and unless the Database Lock has occurred prior to the date of such notice, from and a?er the date of such notice, Institution shall cease any work or further research that involves the Clinical Study Results; and the rights of Institution, Company and Fuji?lm Corporation to Joint Intellectual Property under this Agreement (including, without limitation, Section shall survive termination of this Agreement; and within thirty (30) days following the date of such notice, Institution shall deliver to Company Joint Intellectual Property disclosures. (l0)Notwithstanding the foregoing, Institution shall retain its rights to Institution Intellectual Property, Joint Intellectual Property, and Institution Data for its own internal and non-commercial research, teaching, and education purposes to the extent the parties determine in good faith that Institution retaining its rights will not be detrimental to completing the Study. Institution will cooperate with Company as needed to assist in transfer of the Study so it may continue post-termination. (I I)Upon completion of the above, Institution shall have no further obligation to Company with respect to disclosing intellectual property, delivering results, or data and Company shall provide Institution with written con?rmation that all actions under this section have been completed and that Institution has no further obligations to Company under this Section unless and until a separate written agreement is entered into between the Parties. (Vi) C. 8. Inte (I2)The Parties agree that Company, uji?lm Corporation and their licensees and assignees, as licensee or assignee of all rights under this Agreement, shall retain and may fully exercise all of such rights after the termination. Notwithstanding the foregoing, the Parties shall take reasonable steps to resolve via the dispute resolution provisions of this Agreement any con?icts prior to terminating. For the sake of clarity, those provisions stated in Section 23 or otherwise stated to survive shall continue to have effect. Disposition of Company Con?dential Information. Institution and Principal Investigator shall account for and return to Company, or otherwise dispose of in accordance with Company's instructions, all Company Con?dential Information upon request of Company or at the earlier of the conclusion of the Study or termination of this Agreement. Final Accounting. Institution shall deliver to Company, by the earlier to occur of sixty (60) days after Company?s approval of the ?nal study report and (ii) ninety (90) days a?er termination or expiration, as applicable, of this Agreement, a ?nal accounting of amounts due (and reasonable supporting documentation, which requirement shall be satis?ed by properly completed Case Report Forms as to completed visits by Subjects), taking into account payments made and not yet made under the payment schedule, and expenses reimbursable pursuant to Section from one Party to the other Party. Undisputed amounts due shall be paid within sixty (60) days thereafter. llectual Property, Copyright, and Con?dentiality. A. Separate Property. 0) (ii) C. (5) Intellectual Property that either Party owned prior to the execution of this Agreement, or develops independently of this Study and the other Party?s Con?dential Information, is that Party's separate property. It is not affected by this Agreement. Neither Party has any claim to or right in such Intellectual Property of the other Party. Institution Data Ownership. Ownership. The Institution owns all Institution Data. Company and Institution may freely use Institution Data in a manner consistent with such lnfonned Consent Form and IRB approval as provided for in Section Use by Company and Fuji?lm Corporation. Subject to the provisions of the preceding Section Company and Fuji?lm Corporation shall have full, unrestricted access and use rights to any Institution Data for lawful purposes (provided that all protected health information contained in the Institution Data is either authorized to be disclosed to Company or dc-identi?ed at Company?s expense) and may make use of (inside and outside the United States) or transfer to one or more Af?liates or third parties the Institution Data without accounting or timber consideration to and without consent from Institution or Principal Investigator; provided that such use thereof shall not be deemed to restrict Institution?s publication rights in accordance with Section 9 of this Agreement. Notices. Institution and the Principal Investigator shall from time to time disclose to Company any and all Company Institution Data discovered, conceived, reduced to practice, or otherwise developed by Institution and/or Principal Investigator. Clinical Study Results. Ownership. The Clinical Study Results shall be jointly and severally owned by Company, Fuji?lm Ex. B, Pg. 51 (iv) (V) (0 E. (ii) Corporation, and Institution. Use by Company and Fujifilm Corporation. Subject to the provisions of this Section 8, and to the extent allowed by law, Company and Fujitilm Corporation shall have full, unrestricted access and unlimited use rights to any Clinical Study Results for lawful purposes (provided that all protected health information contained in the Clinical Study Results is either authorized to be disclosed to Company or at Company?s expense) and may make use of (inside and outside the United States) or transfer to one or more Affiliates or third parties engaged in bona ?de research, development and/or commercial activities the Clinical Study Results without accounting or further consideration to and without consent from Institution or Principal Investigator, provided that such use thereof shall not be deemed to restrict Institution?s publication rights in accordance with Section 9 of this Agreement. Use by Institution and Principal Investigator. Subject to Sections 8(C)(iv) and Institution and Principal Investigator shall have the full, unrestricted right to use the Clinical Study Results for the purpose of conducting academic, non-commercial research, for teaching purposes and for treating patients. Subsequent Derived Intellectual Property. Any Subsequent Derived Intellectual Property derived from the use of the Clinical Study Results shall be subject to the Option granted to Company, Fuji?lm Corporation, and their sublicensees in Section Notices. Institution and Principal Investigator shall from time to time provide Company with reasonably prompt notice of its becoming aware of the discovery, conception, reduction to practice, development or the like of any Clinical Study Results and any Subsequent Derived Intellectual Property derived ??om Institution?s or Principal lnvestigator?s use of any Clinical Study Results. Company Intellectual Property. Ownership. All right, title, and interest to any Company Intellectual Property shall be solely owned by Company and Fuji?lm Corporation. Any information about Company Intellectual Property shall be deemed to be Company Con?dential Information. Assignment by Principal Investigator and Institution; Further Assurances. Each of Institution and the Principal Investigator agrees to cooperate with Company, at Company?s reasonable expense, in preparing, ?ling, and prosecuting any and all patents claiming Company Inventions. and, at the reasonable request of Company. to execute and deliver such other instruments and do and perform such other acts and things as may be reasonably necessary or desirable for perfecting and conveying to Company ownership in and to the Company Intellectual Property as contemplated hereby. Joint Intellectual Property. Ownership. All right, title, and interest to any Joint Intellectual Property shall be owned jointly and severally by Company, Fuji?lm Corporation, and Institution. Subject to Section each owner of any Joint Intellectual Property may dispose of its rights therein without accounting or compensation to the other co-owners . Notices. Each Party shall from time to time provide the other Party with reasonable prompt notice of its becoming aware of the discovery, conception, reduction to practice, development or the like of any Joint Intellectual PrOperty. (iv) (V) F. (0 (ii) G. (0 Patents and Further Assurances. Company, at its expense, shall have the right to prepare, ?le, and prosecute on behalf of Company, Institution, Principal Investigator, and any other applicable inventors any and all patent applications claiming Joint Intellectual Property with the cooperation of Institution and Principal Investigator, it being understood that Institution and Company (or Fuji?lm Corporation, as the case may be) are co-applicants on any such patent application. However, in the case that Company, upon request of Institution, prepares, ?les, and prosecutes a patent application in respect of any such Joint Intellectual Property or Institution and Company agree upon the necessity of preparing. ?ling, and prosecuting any such patent application, Institution and Company shall determine by mutual agreement the Party which shall be responsible for and shall control the preparation, ?ling, and prosecution of such patent application and the maintenance and enforcement of any patent granted in respect thereof and the allocation to Institution and Company (or Fuji?lm Corporation, as the case may be) of the responsibilities for, and expenses of, such actions in respect of such patent applications and patents. Use by Company and Fujifilm Corporation. Subject to the provisions of this Section 8, and to the extent allowed by law, Company and Fujifilm Corporation shall have full, unrestricted access and unlimited use rights to any Joint Intellectual Property for lawful purposes and may make use of (inside and outside the United States) or transfer to one or more Af?liates or third parties ownership and/or use of the Joint Intellectual Property without accounting or further consideration to and without consent from Institution or Principal Investigator. Use by Institution. To the extent allowed by law, Institution shall have full, unrestricted access and unlimited use rights to any Joint Intellectual Property for lawful, non-commercial purposes and may make use or transfer to one or more Af?liates or third parties ownership and/or use of Joint Intellectual Property for Iaw?Jl and non-commercial purposes without accounting to or further consideration to and without consent from Company, provided that Institution shall obligate transferee to comply with this Section and Institution shall remain responsible for providing reasonable assistance to the Company in ensuring that such transferee comply with its obligations under this Section after such transfer. Institution Intellectual Property; Subsequent Derived Intellectual Property. Ownership. All right, title, and interest to any Institution Intellectual Property and Subsequent Derived Intellectual Property (whether derived from Clinical Study Results or Institution Intellectual Property) shall be owned by Institution. Notices. Institution and Principal Investigator each shall from time to time provide Company with reasonable prompt notice of its becoming aware of the discovery, conception, reduction to practice, development or the like of any Institution Intellectual Property and Subsequent Derived Intellectual Property. Patent Applications. Institution agrees to prepare, file, and prosecute all patent(s) on any Institution Invention and any invention comprising Subsequent Derived Intellectual Property, pursuant to the request of Company, provided Company pays all reasonable costs and expenses directly related thereto. License and Option. Grant of Non-Exclusive License. To the extent legally able to do so, Institution shall grant to Company and Fuji?lm Corporation a royalty-free, non-exclusive, worldwide license to make or have made, use or have used, and import or have imported with a right to sublicense to Affiliates of Company and Fuji?lm Corporation and third parties objects or methods embodying Institution Intellectual Property and Subsequent Derived Intellectual Property for purposes of the Study and any other internal research and development programs directly relating to Drug. Further, to the extent legally able to do so, Institution shall grant and agrees to grant to Company and Fuji?lm Corporation a royalty-free, non-exclusive, world wide license to make or have made, use or have used, and import or have imported with a right to sublicense, to bona ?de research, development, and commercialization third parties, Af?liates of Company and Fuji?lm Corporation, all Intellectual Property that necessarily and effectively use or incorporate the Drug and are conceived and reduced to practice in the course of the work performed by Institution and Principal Investigator under this Agreement. For this purpose, Institution and the Principal Investigator shall from time to time disclose to Company any and all Intellectual Property conceived, reduced to practice or otherwise invented by Institution and/or Principal Investigator in the course of the work performed by Institution and Principal Investigator under this Agreement. (ii) Grant of Option. To the extent legally able, Institution hereby grants to Company and uji?lm Corporation an exclusive Option (the ?Option?) to negotiate a royalty-bearing, exclusive, worldwide license to make or have made, use or have used, sell or have sold, import or have imported with a right to sublicense to Af?liates of Company and Fuji?lm Corporation and third parties engaged in bona ?de research, development, and/or commercial activities objects or methods embodying Institution Intellectual Property, Institution?s interest in Joint Intellectual Property and Subsequent Derived Intellectual Property for the diagnosis, treatment, or prevention of Alzheimer?s disease and other diseases. Such Option shall be conditioned upon Company or Fujifilm Corporation paying the reasonable expenses of such patent protection including, but, not limited to, preparation, ?ling, and prosecution. Term of Option. With respect to any item of Institution Intellectual Property and Subsequent Derived Intellectual Property in respect of which Institution has granted the Option to Company and Fuji?lm Corporation, the Option shall expire if not exercised by Company or Fuji?lm Corporation within ninety (90) days after receipt of Institution?s notice of the discovery, conception, reduction to practice, or development thereof. (iv) Negotiation of Exclusive License. Following notice to Institution of the exercise of the Option, Company and Fuji?lm Corporation (the ?Toyama/Fuji?lm Parties?) and Institution, shall negotiate commercially reasonable terms for the exclusive license contemplated by the Option within ninety (90) days, such terms to be embodied in a separate license agreement, and Institution shall not commence license negotiations with any third party relating to such Institution Intellectual Property, Institution?s Interest in Joint Intellectual Property or Subsequent Derived Intellectual Property. If such negotiations are unsuccessful and are terminated by one side or the other, and if the Toyama/Fuji?lm Parties shall have made a written offer for such license prior to the termination of such negotiations, then for a period of twelve months after such termination, Institution may not grant such a license to a third party on terms which, taken as a whole. are substantially similar or more favorable to the third party than those offered by the Toyama/Fujifilm Parties in its ?nal offer in respect of such negotiations, without ?rst offering the Toyama/Fuji?lm Parties an opportunity to obtain the license on those similar or more favorable terms. Institution shall hold open such o?er for the Toyama/Fuji?lm Parties for at least sixty (60) days. If the Toyama/Fuji?lm Parties reject the o?er or such sixty (60) day period expires before the Toyama/Fuji?lm Parties elect to obtain such license on such terms, Institution shall have no further obligation to the Toyama/Fuji?lm Parties with respect to such exclusive license. For the avoidance of doubt, the foregoing release of obligation allows Institution to license to another commercial entity and the non-commercial nature of Institution?s future use rights shall not impede this ability to the extent that the Option has expired and the Toyama/Fuji?lm Parties and Institution have not successfully concluded a license agreement. H. Copyrights. Title to, interest in, and the right to determine the disposition of any copyrights or copyrightable material ?rst authored by Principal Investigator or Institution in connection with the performance of the Study other than contributions to any Study reports prepared for regulatory purposes and except as provided in Section shall remain with Principal Investigator and Institution or be jointly and severally owned by Company, Principal Investigator and Institution, if jointly authored by Company together with Principal Investigator and/or other institution personnel. Institution will grant to Company, Fuji?lm Corporation and their licensees a royalty-free, non-exclusive right and license under such copyrights on the Clinical Study Results as owned by Principal Investigator or Institution to use, reproduce, display, distribute, make derivative works of and perform all such copyrighted and copyrightable materials only for all developing, marketing and promotional materials related to the Drug prepared by Toyama, uji?lm Corporation and their licensees. Each owner of any jointly owned copyrights or copyrightable material may dispose of its rights therein without accounting or compensation to any other, subject to an irrevocable, royalty-free, non-transferable, except to a successor in interest of Company?s rights and obligations under this Agreement, non-exclusive right and license granted to Company, uji?lm Corporation and their licensees to use, reproduce, display, distribute, make derivative works of, and perform all such copyrighted and copyrightable materials. Company Con?dential Information. In order to carry out the Study under this Agreement, it may be necessary for Company to disclose to and provide Institution with certain technical or other con?dential information relating to the Study (hereina?er collectively referred to as "Company Con?dential lnfonnation") which Company considers con?dential and proprietary. To be deemed Company Con?dential lnfonnation for the purposes of this Agreement such information must be clearly marked as such and if orally disclosed clearly marked as Confidential lnfonnation within thirty (30) days of disclosure. Institution agrees to keep any Company Con?dential lnfonnation which comes into its possession in strict con?dence and not to disclose or otherwise use such Company Con?dential Information for any purpose other than for the performance of the Study without the prior written consent of Company, subject to the right of Institution to publish as provided in Section 9 of this Agreement. The de?nition of Company Con?dential lnfonnation shall include subject to the right of Institution to publish as provided in Section 9 of this Agreement, the Clinical Study Results, and (ii) unmarked information that a reasonable person in the relevant ?eld would judge as con?dential. The obligations under this section shall not apply to information: I. that is in the public domain as of the Effective Date or subsequently enters the public domain through no fault of Institution, Principal Investigator or other Study Staff; ii. that is known as of the Effective Date becomes known to Institution from its own independent sources as evidenced by contemporaneous written records; or that Institution receives from any third party not under obligation to keep such information con?dential. Compelled Disclosures. In the event Institution as the recipient of any Company Con?dential Information (or any person to whom Institution has transmitted the Company Con?dential Information received by Institution hereunder) is required by law or legal process to disclose any of such Company Con?dential lnfonnation, the Institution or such receiving person, as applicable, will provide Company with prompt notice of such event so that Company may take appropriate steps, including intervening, to protect the confidentiality of the Company Con?dential lnfonnation and (ii) use reasonable efforts to obtain assurance that con?dential treatment will be accorded to the Company Con?dential Information to be disclosed. The Institution, as an instrumentality of the State of California, is subject to certain state regulations and resolutions regarding access to the Institution?s records, including the requirement that the Institution make available the terms and conditions of contracts. The actual contract agreement must be released upon request, although portions of the document may be withheld when redaction meets one of the legal exemptions under the California Public Records Act. As Such, the general terms and conditions of this Agreement will be released to the public upon request, with prompt noti?cation to Company of such release. To the extent disclosure of other records, including the Protocol, terms of compensation and related documents, is requested, the Institution will use reasonable efforts to provide notice to Company 9. 10. 11. prior to disclosure and work with Company to redact material which can be withheld from disclosure, to the extent permitted by law and at Company?s request and reasonable expense. Furthermore, for the avoidance of doubt, the Institution maintains a publicly accessible listing of all proposals and awards. The listing includes the name of the campus, sponsor, award amount, dates, principal investigator and co-investigator?s name, project type, award instrument, indirect cost rate, account and fund number, department and academic discipline. Publication. A. Multi-Center Primary Publication. The Parties, recognizing the importance of communicating the results of the Study to the public and to the medical and scienti?c communities in an accurate and complete manner, intend for the ?rst publication about the results of the Study to include the results from all of the Sites and for such ?rst publication to appear in a peer-reviewed scienti?c journal, in accordance with the Protocol. Accordingly, Institution has ?rst and sole right (which shall be irrevocable for so long as Institution is not in breach of its obligations under this Agreement) to publish the Study results in ajoint multi-center primary publication following completion or termination of the Study and subject to Section Section 8(1) and this Section 9. For purposes of this Section 9 and the avoidance of doubt, the term ?publish? includes the following: presentation and/or submission for presentation in a peer-reviewed scienti?c or medical journal of any Section, manuscript, abstract, report, poster, presentation, or other material (each a ?publication?) that includes: an analysis of the results of the Study; (ii) a summary of the Protocol; and/or data supporting such analysis generated by the Study; and (iv) identifying information regarding the Drug. Except as otherwise provided in this Agreement. nothing in this Agreement is intended to limit Institution?s ability to publish about the results of the Study. 8. Follow-Up Publications. Institution and Company will each have the right to make follow-up publications, and the Parties will exercise good faith efforts to coordinate such publications in order to avoid duplication. C. Review. Company has the right to review proposed publications about the results of the Study authored by employee of the Institution and/or members of the Study Staff and to require (I) the deletion of Company Proprietary Information and (2) postponement of the publishing of any such item for no more than ninety (90) days in order to protect Company?s intellectual property rights or to avoid material adverse effect on development, manufacture and marketing of the Drug by Company, Fuji?lm Corporation and their licensees. The Parties will work c00peratively to ensure the accuracy of statements in any such publication relating to the Study. Prevention of Commingling. Institution will use reasonable efforts to ensure the Company?s support of the Study is not commingled with other sponsored projects and/or other federally funded research projects. Compliance with Applicable Laws. A. Applicable Laws. Principal Investigator and Institution agree to conduct the Study and maintain records and data during and after the Term in compliance with the Protocol and all Applicable Laws. B. Privacy Laws. i. The Parties agree that Institution's use and disclosure of Subject health and medical information is subject to compliance with applicable national, state, and local privacy and security laws and regulations in thejurisdictions where the Study is conducted. The Parties, therefore, agree to take all reasonable steps to protect the con?dentiality of any Subject health and medical information that it has access to and comply with all such applicable privacy and security laws and regulations. The obligations set forth in this Section shall survive the termination or expiration of this Agreement. ii. Institution agrees to obtain or cause Principal investigator to obtain from each Subject participating in the Study a validly signed Informed Consent Form and a HIPAA Authorization as required in Section of this Agreement. C. Study Noncompliance. In the event that any part of this Agreement is determined to violate any Applicable Laws, the Parties agree to negotiate in good faith revisions to the provision or provisions that are in violation. D. Principal Investigator Notice. Institution shall inform the Principal Investigator and any other key Study Staff, that Company may collect the following personal identifying information about such personnel: name, hospital or clinic address and phone number, and curriculum vitae, and may transfer this information to Company?s Af?liates and their respective agents worldwide for internal study management purposes. Nonetheless, Company and its Af?liates and its agents and business partners will apply adequate privacy safeguards to protect such information. Company and its Af?liates and its agents and business partners may also use and disclose personal information as required by individual regulatory agencies or Applicable Law. Upon written request, Company will provide the Principal Investigator and any other key Study Staff with reasonable access to such individuai?s personal information that is held by Company. Such individual may also request correction of information that such individual demonstrates to be inaccurate or incomplete. E. Compliance With Third Party Health Insurance Programs. It is Institution's policy to conduct activities in accordance with applicable state and federal laws and regulations regarding Medicare, Medicaid, and other third party payer programs. Therefore, Institution certi?es that: i. To the best of institution?s knowledge, neither Institution nor any of its Af?liates providing services pursuant to this Agreement is excluded from participation in any state or federal healthcare program in the United States, as de?ned in 42 USC Section l320a-7b(f) for the provision of items or services for which payment may be made by a US. federal healthcare Program; ii. Institution has not contracted for the performance of any services or supplies required for the performance of this Agreement with any employee, contractor, agent, vendor or vendor?s Af?liate, knowing that the contracting party is excluded from participation in any state or federal healthcare program; and No ?nal adverse action, as de?ned in 42 USC Section l320a-7e and 42 USC Section has occurred or is pending against Institution or its Af?liates or, to the best knowledge of Institution, contractors providing services pursuant to this Agreement. By signing this Agreement, Institution agrees to notify Company of any ?nal adverse action, discovery of contract with an excluded entity or individual or exclusion (as described in clauses (ii) and of this Section within thirty (30) days of such action. F. No Participation of Excluded] Debarred Persons in Performance of this Agreement. Institution shall not employ, contract with or retain any person directly or indirectly to perform the Study under this Agreement if such a person is excluded from a Federal health care program as outlined in Sections I 128 and I 156 of the Social Security Act (see the Of?ce of Inspector General of the Department of Health and Human Services List of Excluded individuals/Entities at G. 0) (li) debarred by the FDA under 2l U.S.C. 335a (see the FDA Of?ce of Regulatory Affairs Debarment List at or excluded from contracting with the federal government (see the Excluded Parties Listing System at Upon written request from Company, Institution shall, within ten (10) days, provide written con?rmation that it has complied with the foregoing obligation. In the event that Institution becomes aware that any person identi?ed above becomes excluded or debarred or receives notice of the threat of an action with respect to such exclusion or debarment, Institution shall provide Company with written notice. Upon receipt of such notice, Company shall have the right to terminate this Agreement immediately. Representations and Warranties and Covenants: Con?ict of Interest Obligations. Where the study funding under this Agreement is subject to professional and/or employment rules (such as con?icts of interest or ethics policies) established by Institution or a professional organization or other institution with which the Principal Investigator or any Sub-Investigator is affiliated, Institution shall cause Principal Investigator and any Sub-Investigator(s) to warrant that he or she shall comply fully with such rules, including, as applicable, obtaining any required approval(s) prior to initiating the Study and making any required reports relating thereto. Further, Institution and Principal Investigator have received no offer by Company or its af?liates or agents of extra bene?t for participation in the Study, including offers to family members. Institution warrants that it has policies and procedures with respect to con?icts of interest, and that these policies meet the applicable FDA requirements, and will report to the Company any such con?icts relating to the Principal Investigator or any Sub-Investigator(s) duties under this Agreement. Institution will notify Company in the event a con?ict of interest prevents a Principal Investigator or Sub-Investigator(s) from conducting his or her duties and responsibilities under this agreement Institution policy information can be found at: (ii) Institution represents and warrants that it is under no agreement or obligation to any third party and has no material con?ict of interest that would prevent it from performing its duties and obligations under this Agreement. Institution shall ensure and certi?es the following: Performance of this Agreement by Principal Investigator and other Study Staff shall not con?ict with, breach, cause a default under, or result in the termination of any contract, employment relationship, grant or funding, agreement or understanding, oral or written, with any third party, including without limitation any noncompetition covenant to which Principal Investigator or other Study Staff is a party or by which Principal Investigator or other Study Staff is bound. Neither Principal Investigator nor Study Staff have any obligation, whether express or implied, to any third party that would interfere with, hamper or limit its ability to perform such person?s duties and obligations under this Agreement. Principal Investigator is not a federal government employee. Principal Investigator is not a member of a pharmacy and therapeutics committee Committee") of a health plan, pharmacy bene?t manager or other health care provider or payor, whether public or private. (iv) Institution a. shall cause the Principal Investigator to provide to Company a signed, completed form 572 and a curriculum vitae or other statement of quali?cations showing the education, training, and experience that quali?es the Principal Investigator to lead the clinical investigation of the Drug for the use under the Study; b. shall cause, before the commencement of the Study, during the course of the Study, and for up to one (1) year a?er the completion or termination of the Study, at Company?s reasonable request, the Principal Investigator and any Sub-Investigator to disclose to Company (and afterwards to notify Company of any relevant changes to) any ?nancial arrangement between Company and the Principal Investigator or Sub-Investigator, as applicable, and including any spouse or dependent child thereof (any such person, a ?clinical investigator?) as to which the value of the compensation could be in?uenced by the outcome of the Study, any signi?cant payments of other sorts from Company to any clinical investigator, any proprietary interest in the Drug held by any clinical investigator, or any signi?cant equity interest in Company held by any clinical investigator (for purposes of this Section the terms "signi?cant equity interests," "proprietary interests," and "signi?cant payment of other sorts" shall have the meanings set out in 2 CF Sec. 54); and c. shall comply, and shall ensure that the Principal Investigator and any sub-investigator comply, with all applicable disclosure requirements related to con?ict of interest that are imposed by the FDA or other regulatory or governmental authorities. 12. Indemni?cation. A. Institution agrees to defend, indemnify and hold harmless Company and its directors, officers, employees, agents and representatives (each a ?Company Indemni?ed Party?) from any loss, claim, damage or liability of any kind (?Liability?), which may arise from or in connection with the negligence or willful misconduct of any Institution Indemni?ed Party in its performance of its obligations under this Agreement, except to the extent such Liability arises from a negligent act or the intentional misconduct of Company; or (ii) any material breach by Institution of this Agreement, including any representations and warranties or covenant provided herein but only in proportion to and to the extent any such Liability is caused by the negligent or intentional acts or omissions of Institution its of?cers, agents or employees. Institution?s obligation to defend, indemnify and hold harmless a Company Indemni?ed Party is conditioned upon the Company Indemni?ed Party providing to Institution with prompt notice of any such Liability and providing all reasonable assistance to Institution in defending against such Liability. Company shall provide reasonable assistance to Institution in defending against such Liability. Institution agrees that it will not settle any claim or admit any liability on behalf of any Company Indemni?ed Party without the prior written consent of Company, which shall not be unreasonany withheld or delayed. Company agrees to defend, indemnify and hold harmless Institution and its directors, of?cers, employees, agents, representatives, and Sites (each an ?Institution Indemni?ed Party?) from any Liability which may arise from or in connection with the negligence or will?Jl misconduct of any Company Indemni?ed Party in its performance of its obligations under this Agreement, except to the extent such Liability arises from a negligent act or the intentional misconduct of Institution; (ii) any personal injury (including death) to Subjects directly arising from the administration or use of the Study Drugs or any clinical intervention or procedure provided for or required by the Protocol to which Subjects would not have been exposed but for their participation in the Study provided, that any such administration or use of the Study Drugs is in accordance with the Protocol or any material breach by Company of this Agreement, including any representations and warranties or covenant provided herein but only in proportion to and to the extent any such Liability is caused by the negligent or intentional acts or l3. I4. IS. 16. I7. omissions of Company its of?cers, agents or employees. Company?s obligation to defend, indemnify and hold harmless an Institution Indemni?ed Party is conditioned upon the Institution Indemni?ed Party providing to Company with prompt notice of any such Liability and providing all reasonable assistance to Company in defending against such Liability. Company agrees that it will not settle any claim or admit any liability on behalf of any Institution Indemnified Party without the prior written consent of Institution, which shall not be unreasonably withheld or delayed. Insurance. Institution shall secure and maintain in full force and effect through the performance of the Study (and following termination of the Study to cover any claims arising from the Study) self -insurance coverage for: medical professional and/or medical malpractice liability; (ii) general liability; and workmen?s compensation, each such insurance coverage in amounts appropriate to the conduct of Institution's and Principal Investigator?s business activities and the services contemplated by the Study. Payment. A. Budget and Compensation. The compensation and fees to be paid by Company for the Study is contained in the budget described in Exhibit C, attached hereto and incorporated by reference in this Agreement. Payment shall be due and payable upon receipt of an Institution invoice that is in accordance with the schedule set forth in Exhibit C. Total contract amount shall not exceed the prior written consent of Company. B. Fair Market Value. The Parties acknowledge and agree that the compensation and support provided by Company to Institution pursuant to this Agreement represents the fair market value for Institution and Principal Investigator?s efforts under this Agreement, has been negotiated in an arms-length transaction, and has not been determined in a manner that takes into account the volume or value of any referrals or other business otherwise generated between Company on the one hand and Institution and Principal Investigator on the other hand. C. Third Party Payor Billing. Neither Institution nor Principal Investigator shall bill any third party for any items or services furnished by Company in connection with the Study, or any services provided to Subjects in connection with the Study for which payment is made as part of the Study. Independent Contractors. Institution and Principal Investigator are acting in the capacity of independent contractors hereunder and not as employees or agents of Company. The Parties will make no claim against the other for compensation, vacation pay, sick leave, retirement bene?ts, social security bene?ts, workers? compensation, disability or unemployment bene?ts or employee bene?ts of any kind. Publicity. Neither Party shall use the name, logo, or trademark of the other Party or its employees or A?iliates for promotional purposes without the prior written consent of the other Party whose name, logo, or trademark is proposed to be used. Notice. Any notices given hereunder shall be deemed given: when delivered personally; (ii) one (I) day after having been sent by facsimile. with a copy sent by registered or certi?ed mail, return receipt requested, postage prepaid; ?ve (5) days after having been sent by registered or certi?ed mail, return receipt requested, postage prepaid; or (iv) two (2) days a?er deposit with a nationally recognized overnight carrier, with written veri?cation of receipt. Notice shall be given to the addressees below at the respective addresses indicated (or to such other addressee and/or address as a Party subsequently designates writing to the other Party pursuant to this Section 16): TO: Toyama Chemical Co., Ltd. 2-5, Nishishinjuku 3-chome I8. 19. 20. 22. 23. Shinjuku-ku Tokyo 160-0023 Japan Attention: Hirohisa Tsuchida, Clinical Planning Group, Clinical Research Department Telephone: Facsimile: +8 I -3-3342-5 I45 email: T0: UNIVERSITY OF CALIFORNIA SAN DIEGO 9500 Gilman Drive Mail Code 0934 La Jolla, CA 92093-0687 United States Attention: Rachel Sievert, Esq. Telephone: +1-858-534-3335 Facsimile: email: rsievert@ucsd.edu Force Majeure. If the performance of this Agreement by Institution or Company is prevented, restricted, interfered with or delayed, (either totally or in part) by reason of any cause beyond the reasonable control of either Party or both Party (such as acts of God, explosion, ?re, disease, weather, ?ood, earthquake, war, terrorism, insurrection, civil commotion, strike or other labor disturbances, riots, destruction of facilities and/or materials, shortage of materials, failure of common carriers, or power failure), the Party so affected shall, upon giving written notice to the other Party, be excused from such performance to the extent of such prevention, restriction, interference or delay, provided that the affected Party shall use its reasonable best efforts to avoid or remove such causes of non-performance and shall continue performance with the utmost dispatch whenever such causes are removed. For purposes of this Section. a lack of funds shall not be considered a cause beyond the reasonable control of the Parties. Agreement Modi?cations. This Agreement and any of its Attachments or Exhibits, may not be altered, amended or modi?ed except by written document signed by both Parties. Assignment. Company shall have the right to assign, in whole or in part, this Agreement to Fuji?lm Corporation and other Affiliates of Company upon prior written notice to Institution and (ii) to third parties upon prior written consent of Institution not to be unreasonany withheld or delayed, and Company may, in whole or in part, delegate its obligations or assign its rights under this Agreement to a contractor, provided that Company remains liable for the performance of all such delegated obligations. In all other instances, neither Party shall assign its rights or duties under this Agreement to another without prior written consent of the other Party. Any assigmnent or delegation of this Agreement not permitted under this Agreement shall be null and void. Subject to the foregoing, this Agreement shall bind and inure to the bene?t of the respective Parties and their successors and assigns. Conflict with Protocol. If any provision of this Agreement con?icts with a provision of the Protocol, the Protocol takes precedence on matters of medicine, science and conduct of the Study. This Agreement takes precedence in any other con?icts. Waiver and Severability. No waiver by either Party of any breach of any provision hereof shall constitute a waiver of any other breach of that or of any other provision hereof. In the event that a court of competent jurisdiction holds any provision of this Agreement to be invalid, such holding shall have no effect on the remaining provisions of this Agreement, and they shall continue in full force and e??ect. SurvivaL The rights and obligations of Company and Institution, which by intent or meaning have validity beyond such termination (including, but not limited to, rights with respect to Section 5, Section 6, Section 7 Ex. B, Pg. 61 24. 25. 26. 27. 28. 29. 30. (Term and Termination), Section 8 (Inventions, Patents, Know-How, Copyrights, and Con?dentiality), Section 9 (Publication), Section 10 (Compliance with Applicable Laws), Section ll (Indemni?cation), and Section 12 (Insurance) and Section 16 (Publicity) shall survive the termination of this Agreement. In addition, any other provision which by its terms is stated to survive this Agreement, and any other provision required to interpret and enforce the Parties' rights and obligations under this Agreement (including without limitation Section 1 (Definitions) and Section 18 (Force Majeure) through Section 31 (Governing Law)), shall survive to the extent required for the full observation and performance of this Agreement by the Parties. Disclosure of Compensation. The Parties acknowledge that certain states require pharmaceutical companies to disclose information on compensation, gifts or other remuneration provided to physicians and other health care professionals. Company may report as required by law, or may voluntarily disclose or make public, information about remuneration provided under this Agreement. Headings. Headings used in this Agreement are for the purpose of convenience only and do not affect the interpretation or construction of the Agreement itself. Entire Agreement. This Agreement constitutes the entire understanding between the Parties and there are no collateral, oral or written agreements or understandings. This Agreement supersedes any prior oral or written agreement or understanding between the Parties. Authorized Representatives. Each signatory to this Agreement personally represents that, such signatory has authority to legally bind such signatory?s respective Party to this Agreement. The signatories are not otherwise Parties to this Agreement, except as elsewhere set forth in this Agreement. Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which is deemed an original, but all of which together constitutes one instrument. Interpretation. Unless the context of this Agreement requires otherwise, words of one gender include the other gender; words using the singular or plural number also include the plural or singular number, respectively; and the term ?including? means ?including, without limitation.? Dispute Resolution. The Parties will work together in good faith to resolve any disputes that arise under this Agreement. All disputes may be submitted to arbitration or mediation upon the mutual agreement of the Parties. Governing Law. This Agreement shall be governed by, and construed and enforced in accordance with the law of California applicable to contract made and to be performed therein without giving effect to the principles thereof the con?ict of laws. [Signaturesfollow on the nu: page. IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their duly authorized representatives. On behalf of Toyama Chemical Co., Ltd. W9me Name Y?m??su Anclo Han Deweloomcnf Pit/I530? On behalf of University of California San Diego SignatumW?' WON: Name: Lynelle Gehrke Title/Department: Associate Director, UCSD Of?ce of Contract Grant Administration Read 8: Agreed. Signature I MIQ Date If Paul Aisen, MD Principal Investigator Attachments: Exhibit A: Protocol or protocol summary Exhibit B: [Other Documents! SOW Exhibit C: Budget and Payment Schedule EXHIBIT Notice of Award RESEARCH PROJECT COOPERATIVE AGREEMENT Issue Date: Department of Health and Human Services National Institutes of Health NATIONAL INSTITUTE ON AGING 12/08/2014 Grant Number: 5U19AG010483-24 FAIN: U19AG010483 Principal Investigator(s): Paul S. Aisen, MD Project Title: Alzheimer's Disease Cooperative Study CONTRACT & GRANT OFFICER UNIVERSITY OF CALIFORNIA, SAN DIEGO OFFICE OF CONTRACT & GRANT ADMIN 9500 GILMAN DRIVE, 0934 LA JOLLA, CA 950930934 Award e-mailed to: nihawards@ucsd.edu Budget Period: 12/15/2014 – 11/30/2015 Project Period: 07/01/1997 – 11/30/2017 Dear Business Official: The National Institutes of Health hereby awards a grant in the amount of (see “Award Calculation” in Section I and “Terms and Conditions” in Section III) to UNIVERSITY OF CALIFORNIA SAN DIEGO in support of the above referenced project. This award is pursuant to the authority of 42 USC 241 31 USC 6305 42 CFR 52 and is subject to the requirements of this statute and regulation and of other referenced, incorporated or attached terms and conditions. Acceptance of this award including the “Terms and Conditions” is acknowledged by the grantee when funds are drawn down or otherwise obtained from the grant payment system. Each publication, press release, or other document about research supported by an NIH award must include an acknowledgment of NIH award support and a disclaimer such as “Research reported in this publication was supported by the National Institute On Aging of the National Institutes of Health under Award Number U19AG010483. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.” Prior to issuing a press release concerning the outcome of this research, please notify the NIH awarding IC in advance to allow for coordination. Award recipients must promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct and reporting of research funded under NIH awards will be free from bias resulting from an Investigator’s Financial Conflict of Interest (FCOI), in accordance with the 2011 revised regulation at 42 CFR Part 50 Subpart F. The Institution shall submit all FCOI reports to the NIH through the eRA Commons FCOI Module. The regulation does not apply to Phase I Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) awards. Consult the NIH website http://grants.nih.gov/grants/policy/coi/ for a link to the regulation and additional important information. If you have any questions about this award, please contact the individual(s) referenced in Section IV. Sincerely yours, Page-1 NIH NGA R Version: 1 - 05/08/2014 13:52:00 Generated on: 12/8/2014 12:28:58 AM Ex. C, Pg. 64 TRACI LAFFERTY Grants Management Officer NATIONAL INSTITUTE ON AGING Additional information follows Page-2 NIH NGA R Version: 1 - 05/08/2014 13:52:00 Generated on: 12/8/2014 12:28:58 AM Ex. C, Pg. 65 SECTION I – AWARD DATA – 5U19AG010483-24 Award Calculation (U.S. Dollars) Salaries and Wages Fringe Benefits Personnel Costs (Subtotal) Consultant Services Equipment Supplies Travel Costs Other Costs Consortium/Contractual Cost Federal Direct Costs Federal F&A Costs Approved Budget Federal Share TOTAL FEDERAL AWARD AMOUNT $ AMOUNT OF THIS ACTION (FEDERAL SHARE) SUMMARY TOTALS FOR ALL YEARS YR THIS AWARD CUMULATIVE TOTALS 24 25 26 Recommended future year total cost support, subject to the availability of funds and satisfactory progress of the project Fiscal Information: CFDA Number: EIN: Document Number: 93.866 1956006144A1 UAG010483E PMS Account Type: Fiscal Year: G (Pooled) 2015 IC AG CAN 8470696 2015 2016 2017 Recommended future year total cost support, subject to the availability of funds and satisfactory progress of the project NIH Administrative Data: PCC: 3CCCTNS / OC: 414P / Released: LAFFERTYT 12/04/2014 Award Processed: 05/08/2014 01:52:21 PM SECTION II – PAYMENT/HOTLINE INFORMATION – 5U19AG010483-24 For payment and HHS Office of Inspector General Hotline information, see the NIH Home Page at http://grants.nih.gov/grants/policy/awardconditions.htm SECTION III – TERMS AND CONDITIONS – 5U19AG010483-24 This award is based on the application submitted to, and as approved by, NIH on the above-titled project and is subject to the terms and conditions incorporated either directly or by reference in the following: a. The grant program legislation and program regulation cited in this Notice of Award. Page-3 NIH NGA R Version: 1 - 05/08/2014 13:52:00 Generated on: 12/8/2014 12:28:58 AM Ex. C, Pg. 66 b. Conditions on activities and expenditure of funds in other statutory requirements, such as those included in appropriations acts. c. 45 CFR Part 74 or 45 CFR Part 92 as applicable. d. The NIH Grants Policy Statement, including addenda in effect as of the beginning date of the budget period. e. This award notice, INCLUDING THE TERMS AND CONDITIONS CITED BELOW. (See NIH Home Page at http://grants.nih.gov/grants/policy/awardconditions.htm for certain references cited above.) This institution is a signatory to the Federal Demonstration Partnership (FDP) Phase VI Agreement which requires active institutional participation in new or ongoing FDP demonstrations and pilots. Carry over of an unobligated balance into the next budget period requires Grants Management Officer prior approval. This award is subject to the requirements of 2 CFR Part 25 for institutions to receive a Dun & Bradstreet Universal Numbering System (DUNS) number and maintain an active registration in the Central Contractor Registration. Should a consortium/subaward be issued under this award, a DUNS requirement must be included. See http://grants.nih.gov/grants/policy/awardconditions.htm for the full NIH award term implementing this requirement and other additional information. This award has been assigned the Federal Award Identification Number (FAIN) U19AG010483. Recipients must document the assigned FAIN on each consortium/subaward issued under this award. This award is not subject to the Transparency Act subaward and executive compensation reporting requirement of 2 CFR Part 170. In accordance with P.L. 110-161, compliance with the NIH Public Access Policy is now mandatory. For more information, see NOT-OD-08-033 and the Public Access website: http://publicaccess.nih.gov/. Treatment of Program Income: Additional Costs SECTION IV – AG Special Terms and Conditions – 5U19AG010483-24 NIH is currently funded through a Continuing Resolution (see NIH Guide Notice NOT-OD-15-001) http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-001.html, Therefore, NIH will issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award. Upward adjustments to awarded levels will be considered after our FY 2015 appropriations are enacted; NIH expects institutions to monitor their expenditures carefully during this period. This award includes funds awarded for consortium activity with the University of Pennsylvania, Seattle Institute for Biomedical and Clinical Research, Columbia University, Regents of the University of California, Indiana University, New York University School of Medicine, Banner Alzheimer's Institute, Mayo Clinic, the University of Rochester, Washington University, Mount Sinai School of Medicine, University of Southern California, The Brigham and Women's Hospital, Georgetown University, University of California - San Francisco, Case Western Reserve University School Of Medicine and Wake Forest University Health Sciences. Consortiums are to be established and administered as described in the NIH Grants Policy Statement (NIH GPS). The referenced section of the NIH Grants Policy Statement, October 2010 is available at: http://odoerdb2.od.nih.gov/gmac/nihgps_2010/nihgps_ch15.htm Page-4 NIH NGA R Version: 1 - 05/08/2014 13:52:00 Generated on: 12/8/2014 12:28:58 AM Ex. C, Pg. 67 The requested budget was considered and determined not to represent significant re-budgeting. Therefore, categorical amounts reflect the direct and facilities and administrative cost (F&A) levels previously recommended for the current year. Funds may be re-budgeted between direct costs and F&A costs, consistent with applicable cost principles and institutional and policy requirements for prior approval. The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies. For additional information concerning the RFA, please refer to: http://grants.nih.gov/grants/guide/rfa-files/RFA -AG -13 -001.html The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below. The PD(s)/PI(s) will have the primary responsibility for: Overall management of the study through the coordinating center and should agree to work cooperatively with the cores/functions and clinical sites developing and implementing systems necessary for communications among the various study organizational components. The coordinating center will facilitate the design and refinement of all protocols, manuals of operations, and forms. All data and samples that shall be placed in the public domain and shared freely by methods and within time periods to be specified by the Steering Committee, as a fundamental purpose of this study is the establishment of an unrestricted public database. Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies. NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below: The designated NIA Project Scientist , Laurie Ryan, PhD, will serve as a member of the Steering Committee and have substantial scientific/programmatic involvement during conduct of this cooperative agreement, through technical assistance, advice, and coordination above and beyond normal program stewardship of grants. The awardee agrees to accept assistance from the designated NIA Project Scientist. This person will participate, through the Steering Committee, in the monitoring of issues relating to recruitment, follow-up, and adherence to protocols and will assist in the development and/or adjustment of study protocols. Additionally, an agency program official or NIA Program Officer, Nina Silverberg, PhD, will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. Areas of Joint Responsibility include: The Steering Committee, comprised of the PD(s)/PI(s) of the cooperative agreement, the leaders of the cores/functions and each of the clinical sites, the bioethicist, the family representative, the FDA representative, and the NIA Project Scientist will have primary responsibility for finalizing standard definitions, procedures, and measures common for all the protocols. The steering committee will meet every three to six months, or as dictated by the needs of the study. Each full member of the Steering Committee will have one vote, and all major scientific decisions will be determined by majority vote of the Steering Committee. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee. Subcommittees appointed by the Steering Committee, comprised of appropriate staff Page-5 NIH NGA R Version: 1 - 05/08/2014 13:52:00 Generated on: 12/8/2014 12:28:58 AM Ex. C, Pg. 68 from the cores and clinical sites, will be involved in the design of protocols and manuals of operations, and in ongoing functions of the study such as preparation of publications. To oversee the allocation and distribution of biological specimens generated from the study, the Steering Committee will nominate members for the Resource Allocation Review Committee (RARC). This group will review applications for use of the biological specimens. The format of the application and criteria for the use of repository biological specimens will be developed by the RARC with advice and approval from the Steering Committee and made available to all potential users. Membership on this committee will rotate periodically according to a procedure developed by the RARC. Final approval of members of the RARC and final approval for disposition of samples to investigators following RARC review will be made by NIA staff. The primary governing body of the study will be the Steering Committee, which will have responsibility for the final details of study design and policy decisions and will define the rules regarding access to data and samples. Dispute Resolution: Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16. STAFF CONTACTS The Grants Management Specialist is responsible for the negotiation, award and administration of this project and for interpretation of Grants Administration policies and provisions. The Program Official is responsible for the scientific, programmatic and technical aspects of this project. These individuals work together in overall project administration. Prior approval requests (signed by an Authorized Organizational Representative) should be submitted in writing to the Grants Management Specialist. Requests may be made via e-mail. Grants Management Specialist: John Bladen Email: bladenj@nia.nih.gov Phone: 301-496-1472 Fax: 301-402-3672 Program Official: Nina B. Silverberg Email: silverbergn@mail.nih.gov Phone: 301-496-9350 Fax: 301-496-1494 STAFF CONTACTS The Grants Management Specialist is responsible for the negotiation, award and administration of this project and for interpretation of Grants Administration policies and provisions. The Program Official is responsible for the scientific, programmatic and technical aspects of this project. These individuals work together in overall project administration. Prior approval requests (signed by an Authorized Organizational Representative) should be submitted in writing to the Grants Management Specialist. Requests may be made via e-mail. Grants Management Specialist: John Bladen Email: bladenj@nia.nih.gov Phone: 301-496-1472 Fax: 301-402-3672 Program Official: Nina B. Silverberg Email: silverbergn@mail.nih.gov Phone: 301-496-9350 Fax: 301-496-1494 SPREADSHEET SUMMARY GRANT NUMBER: 5U19AG010483-24 INSTITUTION: UNIVERSITY OF CALIFORNIA SAN DIEGO Page-6 NIH NGA R Version: 1 - 05/08/2014 13:52:00 Generated on: 12/8/2014 12:28:58 AM Ex. C, Pg. 69 Budget Salaries and Wages Fringe Benefits Personnel Costs (Subtotal) Consultant Services Equipment Supplies Travel Costs Other Costs Consortium/Contractual Cost TOTAL FEDERAL DC TOTAL FEDERAL F&A TOTAL COST Facilities and Administrative Costs F&A Cost Rate 1 F&A Cost Base 1 F&A Costs 1 Year 24 Year 25 Year 26 0 Year 24 Year 25 Page-7 NIH NGA R Version: 1 - 05/08/2014 13:52:00 Generated on: 12/8/2014 12:28:58 AM Year 26 Ex. C, Pg. 70 alaheimer?s Q5 association December 12, 2014 1 Paul S. Aisen, MD University of California, San Diego Alzheimer's Disease Cooperative Study 9500 Gilman Drive, Dept 0934 WC 0949 San Diego, CA 92093-0934 Re: Longitudinal Evaluation of Amyloid Risk and Neurodegeneration (LEARN) Dear Dr. Aisen: The Alzheimer's Association is pleased to inform you that ?Longitudinal Evaluation of Amyloid Risk and Neurodegeneration has been funded. The funding of LEARN comprises three project awards: (1) Dr. Aisen as listed in this letter (2) LEARN-15838729, Reisa Sperling, MD., Massachusetts General Hospital and (3) LEARN-15652131, Colin L. Masters, MD., Florey Institute of Neuroscience and Mental Health. The Project will be funded beginning October 1, 2014. The Project period is October 1, 2014 to September 30, 2018. The total amount of the funding is $7,004,761.00.? ?f-EEFunding: (3) Amount of Funding: The Association will provide University of California, San Diego directly with funding for the Project, over a period of four (4) years, in the bi-annual amount set forward in the project budget. Payment for the ?rst year (Fall 2014) is guaranteed. Payment for the subsequent years (2015, 2016, 2017, 2018) will be forthcoming unless the Association advises University of California, San Diego in writing by January 1"1 of the year in which the payment is clue, that it has elected to not continue such funding. Absent the Association?s election to discontinue funding, the payments will be made accordingly. Payment Cycle Funding Period Anticipated Budget 1 Fall,2014(FY15) 886,452 2 Spring,2015(FY15) 886,452 3 871,541 4 Spring,2016(FY16) 871,541 5 Fall,2016(FYl7) 871,972 6 7 8 Spring, 2017 (FY17) 871,971 872A16 Spring 2018 (FY18) 872,416 7,004,761 OTAL The requirements for this Project are detailed in this document which includes the Award Letter, Conditions of Award and the Patent Policy as one document. The document must be signed, initialed where required and uploaded to your online ?le as a ?pdf?. Ex. C, Pg. 71 alzheimer?s Q) association" The Alzheimer's Association also reguires the following electronic ?les to be uploaded to chentral at: 0 Signed/initialed Award Letter, Conditions of Award and Patent Policy documentation as a ?pdi? A 5? 7" black and white or color photograph of you in your lab 0 A non-technical abstract of the project as a Word document or ?pdt? All of the above are required and must be submitted electronically to activate the funding. Hard copies of the required documents will not be accepted. The Alzheimer?s Association depends upon private support to meet its goals and to {?nd research projects. Therefore, your help and support are very important in the efforts to educate the general public and the scienti?c community about the disease and the Association. in accepting this research award, you agree to credit the Alzheimer?s Association for providing funds for this research whenever you present the research or publish articles about the project. In addition, your acceptance allows the Alzheimer?s Association to use your likeness in presenting your findings through press releases, interviews, or other strategic activities. Please note the attached Conditions of Award for details of this commitment. It is necessary for both you and a representative from the business office or Of?ce of Sponsored Research from the applicant Institution, to sign the form below. The signatures verify that the ?nding is accepted by the Institution with the attendant requirements and that no part of this research project has been ?inded from another source. Also, complete the included form requesting the information for the business of?cial that has ?scal responsibility for this project. Please retain a com' for your ?les and upload the complete Award Letter, Conditions owaat-d. and Patent Polio document to the site. Thank you for your support of the Alzheimer?s Association and commitment to research on Alzheimer?s disease. If you have any questions, please cali Mary Grilli, Post Award Specialist, Medical and Scienti?c Relations department at (312) 335-5727. Sincerely, WW.W Heather M. Snyder, Director Alzheimer's Association Medical Scienti?c Relations Sincerely, Win..- Maria C. Carrillo, Vice President Alzheimer?s Association Medical Scienti?c Relations cc: Deborah Tobias, Director of Administraton, Signing Official Ex. C, Pg. 72 alzheimer?s Q5 association This FY2015 Research Award is accepted on behalf of University of California, San Diego. The requirements as speci?ed in the Award Letter documentation are accepted. No part of this project is receiving duplicate funding from another source. The Alzheimer's Association depends on volunteers for its exemplary grant review process. Your grant could not have been funded without the hard work of those volunteers. The Association assumes you will want to repay those volunteers by aining an active reviewer in our system. It is imperative that you respond when called upon to cont to te to this support of the Alzheimer '3 research community. 1 of the above terms and conditions. Dam Institutional Of?cial Date By signing this document you a Principal Investigator Ex. C, Pg. 73 alzheimer?s Q5 association? Conditions of A ward 09/ I 4 DATA SHARING GAAIN The Alzheimer?s Association is committed to data sharing for Alzheimer?s Association International Research Grant Program grantees. Data sharing is a necessary means to advance Alzheimer research reSults into systemic knowledge, usable products, and research procedures, leading to the overall improvement of human health. We expect the timely release and the sharing of ?nal research data from Alzheimer?s Association funded research studies at no more than incremental cost and within reasonable time frame. Included in the ??nal research data? are the data, samples, physical conditions and other supporting materials created or gathered during the course of the work. The rights and privacy of people who participate in Alzheimer?s Association sponsored research must be protected at all times. When applicable, data collected during these studies and shared for broader use should be free of identi?ers and variables related to individual subjects. To that end, the Alzheimer?s Association requires the data sharing associated with this grant award be connected through the Global Alzheimer?s Association Interactive Network (GAAIN). GAAIN is a federated research repository utilizing a cloud?based, grid network infrastructure spanning centralized computational facilities in North America and Europe. GAAIN is led and managed by the Alzheimer?s Association, Dr. Arthur Toga (USC) and Dr. Giovanni Frisoni (University of Geneva). Awardees are encouraged to discuss potential impediments or time delays to data sharing with their Association contact at the time they negotiate grant agreement to accept the Alzheimer?s Association grant award. Failure to comply with the Alzheimer?s Association Data Sharing Policy will result in termination of the grant funding from the Alzheimer?s Association. 5 Initial-that you accept the terms stated on this page. Ex. C, Pg. 74 alzheimer?s <15 association Conditions of A ward 09/ I4 NOTIFICATION OF PUBLICATIONS One electronic copy of manuscripts and meeting abstracts reporting research acknowledging funds from the Alzheimer?s Association must be submitted ELECTRONICALLY at the time of publication. This copy will become part ofthe of?cial ?le ofthe grant and will be provided to the Communications Division to assist in the efforts to further inform the public about the research program of the Association. These submissions must be made electronically using the same system outlined above for report submissions. The Association will provide publicity assistance when the principal investigator noti?es the staff prior to the release of ?ndings in any scienti?cjoumal or major meeting presentations and will work with the Public Relations Of?cer of the institution to ensure coordination of efforts. Please contact the Communications Division, Media Relations Department at 312-335-5776 as early as possible in the process, for instance as soon as the manuscript is accepted for publication or presentation. An acknowledgment of support provided by the Association must be included in any responses to or interviews with radio, television or printjoumalists when an Association funded grant is discussed. ACKNOWLEDGEMENT OF FUNDING SOURCE An acknowledgment of support provided by the Alzheimer?s Association must appear in publications of any material whether copyrighted or not, if the data is based on or developed under Association-supported projects. The following wording should be used: This work was supported by ?mds ?om the Aizheimer ?3 Association In addition, an acknowledgement of support provided by the Alzheimer?s Association must appear in presentations of any material, if the data is based on or developed under Association- supported PROJECTS. Whenever the principal investigator is informed of sponsorship through the generosity of a donor, the speci?c PROJECT name should be used. For example, the Alzheimer?s Association/Samuel A. Blank Research Grant. Upon completion of projects, the Association encourages award recipients to consider submitting an article describing results to Alzheimer?s Dementia: The Journal ofthe Alzheimer?s Association. For submission information, visit 6 Initial that you accept the terms stated on this page Ex. C, Pg. 75 alzhe'i'mer?s (b association 4 Conditions of Award 09/14 RIGHT TO AUDIT In accordance with generally accepted accounting principles, the grantee institution (?Grantee?) shall maintain reasonably full and complete records of the cost and completion of services performed under this Grant Award and the Conditions of Award Agreement (together, ?Agreements?). During the term of the Agreements, and for a period of two years after their termination or completion, the Alzheimer?s Association shall have the right to inspect and/or audit the Grantee?s records as they pertain to the performance of the Agreements at Grantee?s office. Upon ?ve business days written notice ??om the Alzheimer's Association, Grantee agrees to make available all records for inspection or audit at its of?ces during normal business hours (Monday through Friday, 8 am. - 5 pm. local time). IMPORTANT Overlapping funding of more than one Alzheimer?s Association grant is not allowed, except in instances of Special Grant opportunities as designed by Alzheimer?s Association staff. Investigators who currently have an active Association grant may apply for another award in the last year of their grant if that last year concludes by June 30th prior to the start of the new funding year as ofJulyl. '7 Initial that you accept the terms stated on this page" Ex. C, Pg. 76 alzheimer?s Q) association Conditions of A word 09/ RE UESTS FOR ADMINISTRATIVE ACTIONS Submit requests for administrative actions electronically through the proposalCENTRAL online system used for Interim and Final report submissions (described above). When the request has been uploaded, please advise Mary Grt'lli, Post Award Grant Specialist that a request has been filed (Marv. IMPORTANT ALL letters and reports must be submitted electronically (see instructions above in reporting requirements). Requests for administrative actions re-budgeting, carry-over of unexpended funds, replacement of principal investigator, transfer of institution, overlap, extension of award, administrative supplements) must be submitted electronically via letter which has been signed by the principal investigator of the application or grant and the responsible, bonded business official of the institution. Any request must be submitted 45 days prior to the desired date of action. Association staff will review draft letters for content and appropriateness prior to submission of the ?nal signed request. The preliminary review does not indicate advance approval of the request, rather the preliminary review will ensure that all necessary information has been included. Review and approval of requests for administrative actions is the responsibility of the staff of the Alzheimer?s Association. The Association reserves the right to refer a request to the MSAC for its advice prior to ?nal decision. All requests for administrative supplemental funds will be referred to the MSAC. lie-budgeting Requests for re-budgeting of more than 10% of the total awarded amount (direct indirect costs) for that year must be submitted electronically for prior approval to the Alzheimer?s Association. Requests to re-budget must be clearly explained andjusti?ed against the timely achievement of the specific aims of the grant. If possible, re-budgeting requests should be submitted with the interim/non-competing continuation report. if necessary, re-budgeting requests will be accepted mid-grant year. Carry over of Unexpended Funds In general, permission to carry forward unexpended balances into future funding years is allowed. For example, a $10,000 unexpended balance at the end of the 02 year, of a three year award, will be carried forward automatically and used to supplement to the $60,000 continuation funding of the 03 year (which would provide the investigator a total of 0,000 for the 03 year). 8 Initial that you accept the terms stated on this page Ex. C, Pg. 77 alzheimer?s Q5 association Conditions of A ward 09/14 Replacement of the Principal Investigator The grantee institution may request the replacement of a principal investigator, except for principal investigators of Zenith and Pioneer awards. If the principal investigator of a Zenith or Pioneer award does not wish to complete the grant or leaves research work for some reason, the grant will be terminated and the remaining funds returned to the Alzheimer?s Association. The request to replace a principal investigator must be submitted electronically (see instructions above in reporting requirements) by the appropriate faculty member (usually the Department Chair or Dean) and countersigned by the responsible business of?cial of the grantee institution. The letter requesting replacement of the principal investigator must contain a curriculum vita of the proposed replacement principal investigator. Approval of a replacement principal investigator is the responsibility of the Association and subject to review by staff. Transfer of Institution The Association will consider and approve requests to transfer a grant to another institution when the principal investigator moves during the award period. The key points in determining if a request to transfer will be approved are (1) if the resources and technical personnel at the new institution will adequately support the research through the remaining period of the award and (2) if both institutions and the principal investigator are in agreement about the appropriateness of the transfer. To transfer a grant to a new institution, the following documents are required: 0 A release letter from the current institution An acceptance letter from the new institution stating their new position and the resources available to support the Alzheimer's Association funded research 0 A scienti?c and ?nancial report detailing accomplishments to the date of transfer 0 Transfer of all unexpended funds must be made back to the Alzheimer's Association, who will in turn make a payment of unexpended funds to the new institution The request to transfer a grant should be submitted electronically at least 60 days in advance of the planned move to ensure Association staff have adequate time to review the request and ask for and receive additional information should it be necessary. You may request a six-month extension to complete work proposed in the grant for time loss during your move to the new institution. Overlap with other Funded Applications Investigators must inform the Association of any overlap, or concern about possible overlap, with other grants. Overlap is de?ned as ?two or more grants by the same principal investigator which share at least one speci?c aim?. It is not necessary to provide information about applications that share speci?c aims with an Association grant. The concern about overlap arises only when an investigator has been noti?ed that he/she will be awarded a gran 9 Initial that you accept the terms stated on this page Ex. C, Pg. 78 aizheimer?s ?b association 10 Conditions of Award 09/14 another organization and that application, soon to be awarded, shares specific aim(s) with a grant from the Association. Extension of A ward An extension of the term of a grant without funds (no-cost extension) or with funds remaining at the end of the grant period (extension with cost) may be approved when requested electronically 45 days prior to the grant expiration. Typically, requests range from six to twelve months however you are allowed a 6 month extension for each year of the award a two year award will be eligible for 2 no-cost extensions, up to 6 months each whereas a three year award will be eligible for 3 no-cost extensions, up to 6 months each). The principal investigator and responsible business of?cial must countersign the letter requesting the extension, whether the extension is with funds unexpended at the end of the grant period or at no cost. Although requests may not be made for the sole purpose of spending remaining ?nds, you may expend remaining funds during the no-cost extension period. The duration of the extension and the expected products/accomplishments must be detailed in the letter. An extension of term may only be requested to complete work proposed in the grant. Administrative Supplemental A wards The Association, through review and recommendation of the MSAC, may provide administrative supplemental funds during the period of an ongoing grant. Requests for administrative supplements will be approved only in rare, compelling circumstances. Funds for the award of an administrative supplement must be taken from the pool of funds for new competitive grant awards. Administrative supplemental awards may only be requested to (1) address some emergency that imperils the completion of the grant as approved and funded and (2) cannot be handled by re- budgeting available ?ll?ldS. Supplemental funds may not be requested to expand the goals or scope of the award. Investigators should contact the staff of the Grants Operations of?ce to thoroughly discuss the circumstances and the possible request for an administrative supplement prior to submitting the letter. Investigators whose requests for administrative supplements are denied by the MSAC may not appeal the decision. Change of Names and Addresses If an investigator moves while an application is under review by the Association, it is necessary to submit electronic noti?cation of the new address and the date of the move by updating the PI pro?le in proposalCENTRAL. In some instances, great dif?culty has been encountered trying to ?nd an investigator to inform him/her of the award of a grant. If the business of?cial responsible for the grant or application at the institution is changed, the investigator and new business of?cial should update information electronically in the proposalCENTRAL pro?le as soon as possible. Initial that you accept the terms stated on this page Ex_ C, Pg. 79 alzheimer?s association Conditions of A ward 09/14 11 Prompt online noti?cation through proposalCENTRAL, of changes in names, titles, addresses, phone and fax numbers, email addresses will help to avoid delays in processing any actions or requests. Other A dministrative Actions For other administrative actions not covered in this document, the investigator should submit an electronic letter detailing the request and the rationale. IMPORTANT ALL letters and reports must be submitted electronically (see instructions above in reporting requirements). Initial that you accept the terms stated on this page Ex. C, Pg. 80 alzheimer?s <25 association? PATENT POLICY OF THE The primary purpose of the Alzheimer's Association (the ?Association?) ?inding scienti?cally meritorious research is to advance its mission to eliminate Alzheimer?s disease through the advancement of research; to provide and enhance care and support for all affected; and to reduce the risk of dementia through the promotion of brain health. The Association recognizes that patentable Inventions (de?ned below) having public health, scienti?c, business or commercial application or value may be made in the course of research supported by the Association. It is the desire of the Association that such Inventions will be administered in such a manner that they are brought into public use at the earliest possible time. The Association recognizes that this may be best accomplished through the ?ling of applications for registration of patents and/or copyrights in such Inventions and the commercial licensing of such Inventions to third parties. Discoveries, works of authorship, or Inventions derived from research performed, supervised or subcontracted for by the grantee institution during the term of the grant will be subject to the Association?s Patent Policy as set forth below: 1. ?Invention? is any discovery, data, material, method, process, device, product, program, software, proprietary know-how or other work of authorship, whether or not patentable or copyrightable, that is created, conceived or discovered in the course of research supported in whole or in part by the Association, and in the case of patentable inventions is capable of being reduced to practice, either actually or constructively, during the course of the research. 2. All notices of disclosure of Invention patents must be reported in a timely manner to the Medical Scienti?c Relations Division of the Association. Upon the Association?s request, all documentation relating to the ?ling or assertion of rights shall be provided to the Association. The Association shall agree to maintain the con?dentiality of such documentation by executing a con?dentiality agreement mutually agreed to by the grantee institution /inventor and the Association. All expenses of the Invention patent process should be borne by the grantee institution or individual awardee. 3. Unless otherwise indicated or requested by the grantee institution, title to any invention shall reside in the grantee institution. 4. Distribution of income derived from an Invention shall be according to the policies of the grantee institution, except that the Association shall participate in net income derived ?om the Invention (unless waived in writing by the Association) to the extent, and at a rate of remuneration, to be determined by mutual agreement between the grantee institution and the Association at the time a patent application is ?led. If the grantee institution has no established and applicable patent, intellectual property, or technology transfer policy and procedure for administering Inventions, the Association shall have the sole right to determine the disposition of the Invention rights in a manner consistent with this Patent Policy. 5. The grantee institution shall use reasonable efforts to notify the Research Department of the Association prior to abandoning a patent or patent application claiming an invention supported by funds fumished by the Association. Initial that you accept the terms stated Orr-this page Ex. C, Pg. 81 alzheimer?s Cb associationt 6. The grantee institution shall agree that if it has not taken effective steps, within a reasonable time frame for the research project advancement after a US. patent issues on an Invention supported by Association funds and administered by the institution, to bring that invention to the point of practical application, or has not made such Invention available for licensing, the Association shall have the right to request grantee institution terminate the license for lack of diligence, grant title to the Association and to locate and proceed with another licensee. 7. If any Invention is made with the joint support of the Association and any agency or department of the United States Government, the Association may defer to the patent policy of that agency or department upon written statement by the apprOpriate agency of government notifying the Association of its position with respect to the Invention in question. 8. If any Invention is made with the joint support of the Association and some other organization, not an agency or department of the US. Government, that organization, the institution, the inventor(s), and the Association will confer to arrive at a mutually satisfactory disposition of the Invention rights. Address all correspondence regarding this policy to: Alzheimer's Association? Medical Scientific Relations Grant Operations 225 N. Michigan Avenue 17th Floor Chicago, IL 60601-7633 Initial that you accept the terms stated on this page i 2 Ex. 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