OTHER TRANSACTION AGREEMENT OTHER TRANSACTION FOR ADVANCED RESEARCH ETWEEN GENENTECH, INC. 1 DNA WAY SOUTH SAN FRANCISCO, CA 94080 AND THE UNITED STATES OF AMERICA DEPARTMENT OF HEALTH AND HUMAN SERVICES ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE 330 INDEPENDENCE AVENUE, SW (3640 WASHINGTON, DC 20201 CONCERNING Genentech brella Agreement Agreement No.: Total Amount of the Agreement: I Total Estimated Government Funding of the Agreement: [5900?] Total Estimated Recipient Funding of the Agreement: Funds Obligated: [Milli] Effective Date. September 2013 Period of Performance: September 2018 thru September 26, 2023 Authority: 10 USC 2371 and Sections 319(c] {El} andfor 319Llc) (4) (D) ofthe Pandemic and All? Hazards Preparedness Act, 109-417 Line of Accounting and Appropriation: CLIN Title CAN Object Class Amount (S) {bite This Agreement is entered into between the United States of America, hereinafter called the ?Government", represented by the Department of Health and Human Services and Genentech, Inc., hereinafter called "Recipient?, pursuant to and under US. Federal law. Recipient and the Government are each referred to as a ?Party? and collectively referred to as the ?Pa rties?. FDR GEN ENTECH, INC. FOR THE UNITED STATES OF AMERICA OFFICE OF ACQUISITION MANAGEMENT, CONTRACTS 8: GRANTS SECRETARY FDR PREPAREDNESS AND RESPONSE (DEE) (45" {Signature} (Signature) . 5. Kyle Roberts, Other Transaction Agreement I September 27, 2013 Of?cer, ASPRIBARDA September 2018 (Name, Title] {Date} (Name, Title) (Date) 09 .LSI-I BLVITIHAV 91? SLNEIWEIHIHDEIH 33 LE :iO QELNEI WEIEIHEJV BUILNEI EIWDILHV 9E SLNEIWNSISSV 5IIAX EITDILHV GZ WAX 62 3M 5E .LDV SLHEJIH 1W3 UNIX 8K HTJILHV 82 GNV OJ. 3111;:le EITJILHV LE ASOTONHDEH OJ. SSEIDDV 3IX EITDILHV EZ SLHBIH 3X OZ VLVCI ET HWDILHV SI .LNBWIWCI UNV HTDILHV ET BNIHVHS i503 3m EIWDILHV ZT 1A EITDILHV GI 3H1 3N HTDILHV OI 5 1? 3H1 ARTICLE SCOPE OF THE AGREEMENT A. Introduction I The objective of this Agreement-J which is considered an Other Transaction Agreement is to create a framework for collaboration between Recipient and the Biomedical Advanced Research and Development Authority to advance the development of: 1) novel treatments for in?uenza and other antimicrobial infections and 2 a novel treatment for sulfur mustard gas exposure. - The initial work Under?l'his Agreement will support-? I I The Agreement. may be modi?ed by written mutual agreement of the Parties consistent with Article - Building upon Recipient?s. current Medial CountermEasureend diagnostics efforts, proposed for collaboration with the Government Under This Agreement Recipient as demonstrate expertise, commitment. and to advance important therapies to combat existing and emerging bleleglcal and chemical threats. public?private pa rtnership- between the PartiES formed Under This Agreement will allow the technical and business risks of drug develepment to be mitigated and Increase the probability of successful development and appraval/Iicensure of novel Medical Countermeasures and diagnostics to address Ul?l?'iet medical needs. B. De?nitions Af?liate: Is not a Sub?ecipiem. Af?liates are only these entities identified in Atlachment 3. all of which are a parent, subsidiary, or sister company of Recipient. Agreement: The body ef this Agreement and Attachments 1 a, which are exeressly incorporated in and made a part of this Agreement. Means Computer programs that comprise a series of instructions, rules, routines, or statements, regardless of the media in which recorded, that allow or cause a computer to perform a speci?c operation or series of operations; and Recorded information comprising source code listings, design details, algorithms, processes, flow charts, formulas, and related material that would enable the computer program to be produced, created, or compiled. Control: The term ?Control? as used in this Agreement shall mean the ability of a Party to grant rights to Technology or supply materials to the other Party without violating the terms of any agreement that such Party might have with any other party. Data: Recorded information within the Field, regardless of form or method of recording, which includes but is not limited to, technical data, Computer Software, and trade secrets, made in the performance of work Under This Agreement. However, the term does not include any financial, administrative, patient identification, cost, pricing or management information, even if made in the performance of work Under This Agreement. Field: The development of assets to treat, diagnose, or prevent or provide countermeasures for biothreat infections, pandemic influenza, emerging infectious diseases, and chemical, biological, radiological or nuclear threats or exposures. Financial Status Report: A report prepared by Recipient to address costs. Foreign Firm or Institution: A firm or institution organized or existing under the laws of a country other than the United States, its territories, or possessions. The term includes, for purposes of this Agreement, any agency or instrumentality of a foreign government and firms, institutions or business organizations that are owned or substantially controlled by foreign governments, firms, institutions, or individuals. Specifically excluded from the definition of Foreign Firm or Institution are the entities listed on Attachment 3 along with their non-US affiliates. Government: The United States of America, as represented by HHS. Government Purpose Rights: The rights to use, duplicate, or disclose Data, in whole or in part and in any manner, for Government purposes only, and to have or permit others to do so for Government purposes only. Invention: Any invention or discovery that is or may be patentable or otherwise protectable under Title 35 of the United States Code. Know-How: Information, practical knowledge, techniques, and skill development by Recipient in the performance of work Under This Agreement necessary for the Practical Application of a Subject Invention within the Field. Know?How does not include patents and patent applications. Limited Rights: The rights to use, modify, reproduce, perform, display, or disclose Data, in whole or in part, within the Government solely for research purposes for the Field. HHS will ensure that any Data released or disclosed under Limited Rights is safeguarded in accordance with the restrictions of this Agreement. The Government may not, without the prior written permission of Recipient, release or disclose any Data that is subject to, or designated as falling within, Limited Rights outside the Government, use such Data for competitive procurement or manufacture, release or disclose such Data for commercial purposes, or authorize such Data to be used by another party. The Parties shall maintain the confidentiality of all Data that is subject to, or designated as falling within, Limited Rights. Limited Rights Data: Means (1) Data, other than computer software, that embody trade secrets or are commercial or financial and con?dential or privileged, to the extent that such data pertain to items, components, or processes developed at private expense, including minor modi?cations; and/or Data in a notice reflecting a Subject Invention provided to the agency prior to the filing of a patent application (See Article Made: The conception or first actual reduction to practice of the Invention. Option: An option, entered into by mutual agreement of both Parties pursuant to a Statement of Work and budget, by which, for a specified time, the Government may elect to purchase additional supplies or services called for by the Agreement or may elect to extend the term of this Agreement. Other Transaction for Advanced Research A legally binding, non-acquisition instrument [generally called an ?agreement?] used in instances where the principal purpose is the stimulation andlor support of advanced research and development, where a non?traditional Government awardee participates to significant extent in the work. Other Transaction Agreement Of?cer Is the responsible Government official authorized to bind the Government by signing this Agreement and bilateral modifications. Other Transaction Agreement Specialist Is a supporting official that executes agreement modifications on behalf of the OTAO. Other Transaction Agreement Technical Representative (OTTR): Is the primary Government official for all technical matters on this Agreement. Portfolio: The clinical candidates and diagnostic platform included Under This Agreement. Practical Application: With respect to a Subject Invention, to manufacture, in the case of a com position of product; to practice, in the case of a process or method, or to operate, in the case of a machine or system; and, in each case, under such conditions as to establish that the Subject Invention is capable of being utilized and that its benefits are, to the extent permitted by law or Government regulations, available to the public for a regulatory approved product. Program: Research and development being conducted by the Parties pursuant to this Agreement. Alternatively referred to as "Project." Prohibited Sources: Restrictions administered by the Department of the Treasury on Acquisitions of Supplies and Services: Except as authorized by OFAC, agencies and their recipients and subrecipients must not acquire any supplies or services if any proclamation, Executive order, or statute administered by OFAC, or if implementing regulations at 31 CFR chapter would prohibit such a transaction by a person subject to thejurisdiction of the United States. Except as authorized by OFAC, most transactions involving Cuba, Iran, and Sudan are prohibited, as are most imports from Burma or North Korea into the United States or its outlying areas. In addition, lists of entities and individuals, subject to economic sanctions are included in List of Specially Designated Nationals and Blocked Persons at More information about these restrictions, as well as updates, is available in regulations at 31 CFR Chapter and/or on Website at Property: Any tangible personal property other than property actually consumed during the execution of work Under This Agreement. Recipient: Genentech, Inc. {Genentech]. Subject Matter Expert Members of the BARDA technical team who provide technical insights into development activities being undertaken by the Recipient to satisfy the terms of this Agreement as set forth in the applicable 50W. BARDA generally enters into an agreement with an outside entity to gain the services of SM Es on a contractual basis. As non-Government employees, SMEs are subject to non-disclosure agreements as determined by each contract or agreement that they support. Subject Invention: Any invention of the Recipient Made in the performance of work Under This Agreement. Sub-Recipient: Any supplier, distributor, vendor, or firm that furnishes supplies or services to or for the Recipient or another Sub-Recipient for the performance of this Agreement. Sub-Recipient Agreement: Any contract entered into by a Sub-Recipient to furnish supplies or services for the performance of this Agreement. Technology: Discoveries, innovations, Know-How and Subject Inventions, whether patentable or not, conceived in the performance of work Under This Agreement and Controlled by Recipient, including Computer Software, recognized under U.S. law as intellectual creations to which rights of ownership accrue, including, but not limited to, patents, trade secrets, and copyrights developed Under This Agreement. Under This Agreement: Means activities conducted pursuant to this Agreement that are Government funded or binding cost share by Recipient. C. Scope 1. The Recipient shall perform an advanced research and development program Program} in accordance with the incorporated in this Agreement as Attachment 1. The Recipient will submit or otherwise provide all documentation as required by Attachment 2, Reporting Requirements, unless mutually agreed otherwise by the Parties. The Parties acknowledge that the exercise of Options will be subject to the availability of funds. Before exercising an Option, the JOC will meet and the Parties will mutually agree on updates to the existing 50W, budget and cost share. 2. The Government will have involvement with the Recipient as set forth in the SOW. The Government will also obtain access to research results and certain rights in Data pursuant to Article IX and Attachment 2, Reporting Requirements. The Parties are bound to each other by a duty of good faith and commercially reasonable research effort in achieving the goals of the Program. 3. This Agreement is an "other transaction? pursuant to 42 U.S.C. ?247dJe The Parties agree that the principal purpose of this Agreement is to support commercially reasonable efforts in advanced research in the development of Medical Countermeasure assets and not for the acquisition of Property or services for the direct benefit or use of the Government. ARTICLE II: TERM A. Term of this Agreement l?ll?ll ll3li4i he Government will give Recipient a preliminary written notice of its desire to exercise an Option at least ninety [90] days prior to the contemplated activation of a new Option. The Parties, through a JOC decision, may agree mutually to extend the Term and its Options beyond the maximum by written agreement on or before the expiration of the Term. 8. Termination Provisions Either Party may terminate this Agreement for any reason or no reason by providing at least ninety [90) days prior written notice to the other Party, provided that such written notice is preceded by consultation between the Parties. in the event of a termination of the Agreement, it is agreed that disposition of Data shall be in accordance with the provisions set forth in Article ix. Data Rights. In the event of termination by either Party, the Recipient?s and Government?s termination costs shall be reimbursable pursuant to the terms of Article VI. Upon termination of this Agreement, the Government will also reimburse Recipient for its allowable costs and expenses, including, without limitation, non- cancellable allowable expenses and other costs and expenses incurred prior to or during the ninety (90) day notice period. For purposes of this clause, termination costs shall be those costs identi?ed in Federal Acquisition Regulation 31.205412. The Government and the Recipient will negotiate in good faith a reasonable and timely adjustment of all outstanding issues between the Parties as a result of termination, including disposition of animals acquired for research use. Failure of the Parties to agree to a reasonable adjustment will be resolved pursuant to Article Disputes. In the event of termination by the Government, all of the terms and conditions of this Agreement will expire and neither Party shall have any continuing obligations to perform Under This Agreement, except as provided in this Article with respect to the reimbursement of allowable and/or non-cancellable costs and expenses. In the event of termination by either Party all of the terms and conditions of this Agreement will expire, except for the following provisions, which shall survive termination: Article IX, Sections A., 3., D., and G. and Article and Article XI as specified in that Article. C. Extending the Term The Parties may extend by mutual written agreement the Term if funding is available and research opportunities, which are within scope, reasonably warrant. Any extension shall be formalized through modification of the Agreement by the OTAO and the Recipient. If the Recipient desires an extension to the Term, the Recipient shall submit a request in writing to the OTAO. Any request for an extension should include a revised milestone/project schedule {if applicable}. ARTICLE MODIFICATIONS A. Recommendations for Modifications As a result of quarterly meetings, annual reviews, or at any time during the Term, research progress or results may indicate that a change in the sow would be beneficial to Program objectives. Any modification to the Agreement, excluding minor modifications discussed below, shall be by mutual written agreement of the Parties. Recommendations for modifications, including justifications to support any changes to the sow, will be documented in a letter and submitted by the Recipient to the with a copy to the HHS OTAO and OTAS. This letter will detail the technical, chronological, and financial impact (if any) of the proposed modification to the Program. B. Minor Modifications For minor, non-material Agreement modifications without effect on any obligation of Recipient or the Government or the terms and conditions of this Agreement changes in the paying office or appropriation data, etc.], the Government may make these types of changes unilaterally and no signature is required by the Recipient. The Parties agree that changes to key personnel identi?ed in the Agreement shall be agreed upon by the JDC and OTAO and formalized by amendment if changes are under Article IV. C. Amending the Agreement The OTAO shall be responsible for agreeing to any modifications to this Agreement on behalf of the Government. ARTICLE IV: MANAGEMENT OF THE PROGRAM A. RecipientIGovernment Joint Oversight Committee 1. The Recipienthovernment Joint Oversight Committee (JOC) is comprised of 2 senior level members from Recipient and 2 senior level Government participants. In addition, the OTAD, OTAS, and OTTR will attend as non?voting participants. The Parties may change the number participants upon mutual agreement provided that voting members remain equal between the Recipient and Government. Assuming no objection by the other Party, and upon advance written notice, additional representatives from either Party or external advisors may also be included in this body on an ad hoc 1f} basis, as dictated by the circumstances. Either Party may substitute alternate senior level representatives, on either a temporary or an ongoing basis, by providing advance written notice. Members: (Dita) Non-voting Attendees Ebll?l 2. The responsibility of the JOC is to mutually interrogate risks, manage the progress of assets covered under the agreement, endorse potential new assets, and propose modi?cations to the allocation of funding across activities covered under the agreement. 3. The JDC will meet approximately?ml?f} br as necessary, by phone, video conference or in-person to review progress. The JDC will recommend the strategy to be covered under this Agreement during the subsequent funding period, as well as how Government and Recipient funding will be allocated across these activities. The recommendations would be submitted, as appropriate, to the relevant Recipient governance boardls) for endorsement and decision. If endorsed by the Recipient and by the Government, the recommendations will be incorporated into the sow and this Agreement through modifications as described in Article In the event that a JOC decision cannot be reached, the matter will be escalated to one BARDA and one Recipient senior management member identified at the start of the Program in a good faith effort to achieve resolution. Final JDC decisions will be formalized in a memorandum and signed by both Parties. 8. Project Meetings 1. Project Teleconferences. A conference call between the and the Recipient's project leader shall occur bi-weekly, or as mutually agreed by the Parties. During this call, the project leader will discuss the activities undertaken during the reporting period, any problems that have arisen and the activities planned for the ensuing reporting period. The project leader may choose to include other key personnel on the conference call to give detailed updates on specific projects as may be requested by the OTTR. The or project leader may assign this responsibility to a delegate. The Recipient may choose to include other key personnel on the conference call to give detailed updates on speci?c projects or this may be requested by the OTTR. 2. Other Meetings. ln addition to project teleconferences, Recipient and the Government shall participate in additional project meetings to coordinate the performance of the Agreement. These meetings may include face-to-face meetings with BARDA in Washington, D.C. and at work sites of the Recipient or any Sub?Recipients. Such meetings may include, but are not limited to, meetings of the Recipient (and Sub-Recipients invited by the Recipient] to discuss study designs, site visits to the Recipient?s and Sub-Recipient?s facilities, and meetings with the Recipient and HHS officials to discuss 11 the technical, financial, regulatory and ethical aspects of the Program. In order to facilitate review of Agreement activities, it is expected that the Recipient will provide data, reports, and presentations to Government personnel as reasonably requested by the The Recipient shall provide itineraryfagenda at least five business days in advance of any face to face meeting. The Recipient shall notify the OTTR of formal and informal correspondence with the Food and Drug Administration or other regulatory agencies directly related to the Portfolio assets as speci?ed in Attachment 2. For avoidance of doubt, Recipient shall not be required to notify of any correspondence that does not materially impact a Program or that contains materials unrelated to the performance of this OTA. Recipient shall provide OTTR with un?redacted correspondences that materially impact a Program. To the extent that a relevant correspondence also contains information unrelated to the performance of this DTA, Recipient shall redact only those portions of the correspondence that are not relevant. 3. In Process Review Meeting On an annual or event driven basis, or prior to the exercise of Options, the Government may invite the Recipient to give a presentation at an IPR attended by BARDA, and select, invited interagency representatives and other interested Government parties, as needed. The Recipient will present Data. Successes and challenges of the Program will be discussed, and plans for the future will be presented. 4. The Parties understand that SM Es may be present at Government meetings as it relates to this Agreement. The SMEs are subject to nondisclosure agreements and will comply with the terms and conditions of this Agreement. C. Document Review The Recipient shall provide the Government sufficient opportunity to review study protocols, reports, regulatory and draft correspondence as set forth in Attachment 2. The Government?s review and comments on these documents are non-binding and advisory in nature. Specific timelines for document review and responses are outline in Attachment 2, Reporting Requirements. ARTICLE V: AGREEMENT ADMINISTRATION A. Administrative and contractual matters under this Agreement will be referred to the following representatives of the Parties: Government Points of Contact Kyle Roberts, DTAR [2021 260-074? Kyle.Roberts@hhs.gov Recipient Points of Contact Genentech, Inc. 1 DNA Way, South San Francisco, CA 94080 12 8. Technical matters Under This Agreement will be referred to the following representatives: Government Points of Contact Karl Erlandson, Project Office, Therapeutics branch, Influenza and Emerging Infectious Diseases Division 202?692?46?6 Karl.Erlandson@hhs.goy Alternate OTTR: Kim Branch Chief (Acting), Influenza and Emerging Infectious Diseases Division 202?260?0130 Recipient Points of Contact bil?} Genentech, Inc. 1 DNA Way, South San Francisco, CA 94030 (91(6) ARTICLE VI: COST SHARING A. The terms of this Article VI apply to the cost sharing This framework may be applied by mutual agreement to any of the Options or to any modi?cations to the effort required under the Base Periods. The Parties acknowledge that the exercise of Options will be subject to the availability of funding. 3. (bi-i4) C. The total project cost of completing the activities during WW lshall include all costs incurred by the Recipient in connection with the work performed durin? Fbiifl I Such costs shall be reflected in Recipient?s Financial Status Report. The Government?s projected obligation forl'fWi is approximatel? 13 TOTAL PROJECT COST SUMMARY PERIGD .- 1 - DIRECT LABOR FRINGE BENEFITS OVERHEAD SUBCONTRACTS MATERIALS OTHER DIRECT (2051's (380.5. TOTAL c0515 COST SHARE FOR BASE PERIOD RECIPIENT . ?7 DIRECT LABOR FRINGE ENEF ITS DVE FIH EAD SU BEONTRACTS MATERIALS DIRECT TRAVEL EITHER DIRECT COSTS 63m TOTAL ?0515 US GOVERNMENT DIRECT LABOR FRINGE BENEFITS DVE RH BAD MATERIALS DIRECT TRAVEL OTHER DIRECT COSTS 681A TGTAI. C0515 14 PROJECTED FUNDING PROFILE CLIN Type Segment Area Total Government Drnornm Qharp {mu} D. BARDA will reimburse Recipient for approved costs Under This Agreement during the Base Periodis) (and subsequent Option periods, if exercised] up to the applicable ?Government Share? amount set forth in Paragraph of this Article. E. Recipient will provide a Financial Status Report to the Government, which will, among other things, identify the total actual costs of performing this Agreement, This report is for informational purposes only. Recipient's accounting for government-reimbursed and Recipient costs shall be in accordance with Recipient?s accounting practices but must comply with Intemational Financial Reporting Standards Ilhll?ll. me) u- ful?l iRecipient must comply' with the cost principles set forth in Article VII for Government reimbursed costs. F. For purposes of the Financial Status Report, Recipient shall report Recipient's costs of performing this Agreement lbli4l learn G. Ila)?; (bits?) ARTICLE VII: OBLIGATION AND PAYMENT A. Obligation The Government?s liability to make payments to the Recipient l5 limited to only those funds obligated under Paragraph of Article VI of this Agreement during performance of the contract, by modification to this Agreement, or as otherwise expressly stated in this Agreement. As of the commencement of this Agreement, the Government?s obligated funds are for the Base Periods only. Each of the -5et forth in Article VI is subject to the availability of funds and written agreement of the 'arties. The Parties agree that the Options do not represent an obligation by the Government or Recipient until exercised, following a negotiation on scope and cost. 15 B. Payments The Recipient has and agrees to maintain an established accounting system that complies with International Finance Reporting Standards and the requirements of this Agreement, and shall ensure that appropriate arrangements have been made for receiving, distributing and accounting for Federal funds received hereunder. An acceptable accounting system is one in which all costs, cash receipts and disbursements for which the Recipient is entitled to reimbursement under Article VI are controlled and documented properly. The Recipient will invoice the Government on a basis in accordance with this Article VII. The Recipient?s shared costs incurred during the reporting period shall be reported in the Financial Status Report and on invoices. The Recipient?s properly prepared invoicels] will be submitted for payment not more than once per month in Adobe Acrobat (.pdf] format. The invoice shall be uploaded to a shared electronic file server e?room), with an email copy to the OTAO, OTAS, and PSC {Program Support Center} as cited below. If directed by the DTAO, the invoice shall be accompanied by appropriate documentation to support the payment request; however, Recipient will be required to prepare and maintain records, with supporting documentation that is consistent with commercial practices. Each invoice must contain the following information in order to be deemed properly prepared: 1. Name and address of Recipient 2. Invoice date and invoice number 3. Agreement number 4. Description, quantity, unit of measure, unit price, and extended price (ifapplicable) 5. Recipient cost share 6. Name and address of DTAR official to whom voucher is to be sent 7. Name, title, phone number, and mailing address of person to notify in the event of a defective invoice 8. Taxpayer Identification Number (TIN) 9. Electronic funds transfer (EFT) banking information 10. Conversion of foreign currency using Recipient?s current internal foreign currency translation method actually used on a consistent basis in preparing its audited financial statements. The Recipient will convert foreign currency costs to US dollars each month using the closing spot exchange rate published by Reuters on the last working day of each month 11. invoices must include cumulative total costs submitted for reimbursement to date, adjusted (as applicable) to show any amounts'suspended by the Government Documents should be delivered to the OTAO, OTAS, OTTR, PSC, and e?room electronically. Unless otherwise specified by the OTAO, all deliverables and reports furnished to the Government Under This Agreement [including invoices) shall be addressed as follows: NAME E-mail invoices to: Address Kyle Roberts kyle.roberts@hhs.gov ASPR AMCG 11J2s?5'r - Neil House Office Bldg. 200 Street, SW Washington, D.C. 20515 16 libif?} ASPR - BARDA (OTTRJ O?Neil House Office Bldg. Washington, DC. 20515 1mm) E-Room: TBD The Recipient agrees to notify the OTAO in writing if there is an anticipated overrun (any amount) or unexpended balance {greater than 10 percent) of the estimated costs for the Base Periods or any Option and the reasons for the variance. The Government will pay in US dollars all proper invoices within 30 days of receipt or pay interest on any amounts due in accordance with the Prompt Payment Act. C. Limitation of Payments It is herein understood and agreed that Government funds are to be used solely for this Agreement and must be reasonable in nature and amount. The following cost principles shall be used for determining the allowability of costs for which reimbursement is sought by Recipient. Ilbil?l} 1. Allocability shall be determined in accordance with the standards set forth in FAR 31201-4. (Dim 2. To be reasonable, a cost must: be generally recognized as an ordinary or necessary part of the business; follow sound business practices; follow what a prudent business person would accept; comply with federal, state, and local laws; and be consistent with the Recipient?s or the Sub-Recipient's established practices. 3. In addition, Recipient?s costs that are passed onto the Government for reimbursement shall comply with the procedures and cost principles set forth in this paragraph: Reimbursement is subject to restrictions on allowable costs described in FAR 31.2 unless otherwise stated here: i. The cost principles set forth in FAR 31.2 shall only apply to the reimbursement of direct costs under cost-type Sub-Recipient Agreements. These cost principles will be applicable to the pricing of fixed priced Sub-Recipient Agreements only to the extent required by FAR 31.102. ii. A cost-type Sub-Recipient may propose indirect rates as a component of its proposal to Recipient. The Government will review these indirect rates as part of the Sub?Recipient approval process set forth in Article The Government's approval to issue the Sub-Agreement constitutes the Government?s agreement that the proposed 17' indirect ratels) may be used during the performance of the Sub-Agreement to determine the Sub-Recipient?s reimbursable indirect costs. The approved indirect rate(s} will not be subject to audit or adjustment based upon the Sub-Recipient?s actual cost experience during the performance of the Sub-Agreement. Invoicing and reimbursement for employees of Recipient that perform work under this Agreement will be based on current accounting practices at Recipient. Specifically, reported and reimbursed expenses will include: a) aggregate reported time of individuals working under this Agreement in a specified functional group and at a specified level of compensation during the reporting period; and b} the aggregate average salary of individuals working within the specified functional group at the speci?ed level of compensation. D. Financial Records and Reports As directed by the OTAO, the Recipient shall maintain records in accordance with commercially acceptable business practices to account for all funding Under This Agreement and shall maintain records in accordance with commercially acceptable business practices to account for Recipient funding provided Under This Agreement in support of the Financial Status Report required under Article VI. Upon completion or termination of this Agreement, whichever occurs earlier, the Recipient shall furnish to the OTAO a copy of the Final Technical Report required by Attachment 2, Section D: Deliverables. The Recipient?s relevant financial records are subject to examination or audit on behalf of HHS by the Government for a period not to exceed four (4) years after expiration or earlier termination of the Term. The OTAO or designee shall have direct access to complete records and information of the Recipient, to the extent necessary to audit to ensure full accountability for all amounts reimbursed by the Government Under This Agreement. Such audit, examination, or access shall be performed during business hours on business days upon at least six weeks prior written notice and shall be subject to the security requirements of the audited party. E. Comptroller General Access to Records To the extent that the total Government payment Under This Agreement exceeds $5,000,000, the Comptroller General, at its discretion, shall have access to and the right to examine Recipient records relating to performance Under This Agreement and of any entity that participates in the performance of this Agreement for a period of four (4) years after final payment was made. This requirement shall not apply with respect to any entity that participates in the performance of the Agreement that has not entered into any other agreement (contract, grant, cooperative agreement, or ?other transaction?) that provides for audit access by a Government entity in the year prior to the date of this Agreement. This Paragraph only applies to any record that is created or maintained in the ordinary course of business or pursuant to a provision of law. Recipient shall ensure that its Sub?Recipient agreements are consistent with this Article. 18 ARTICLE DISPUTES A. General The Parties shall communicate with one another in good faith and in a timely and cooperative manner when raising issues under this Article. B. Dispute Resolution Procedures 1. For any disagreement, claim or dispute between the Parties concerning questions of fact or law arising from or in connection with this Agreement, whether or not involving an alleged breach of this Agreement, the Parties agree to make a good faith effort to utilize the procedures described in Subparagraphs 2, 3 and 4 of this Paragraph B. 2. Whenever disputes, disagreements, or misunderstandings arise, the Parties shall attempt to resolve the issuels) involved by discussion and mutual agreement as soon as practicable. In no event shall a dispute, disagreement or misunderstanding, which was known, or should have been known, more than six months prior to the notification made under Subparagraph 8.3 of this Article constitute the basis for relief under Subparagraph 3.3 of this Article. Either Party may waive this requirement in writing. Any waiver on behalf of the Government shall be made by the Head of Contracting Activity for ASPR. 3. Failing resolution by mutual agreement, the aggrieved Party shall document the dispute, disagreement, or misunderstanding by notifying the other Party (through the OTAO or the Recipient, as the case may be) in writing of the relevant facts, identify unresolved issues, and specify the clarification or remedy sought. Within five (5) working days after providing notice to the other Party, the aggrieved Party may, in writing, request a joint decision by the Assistant Secretary for Preparedness and Response Head of Contracting Activity (HCA) and a Recipient senior executive appointed by the Recipient. The other Party shall submit a written position on the matteris) in dispute within thirty [30] calendar days after being notified that a decision has been requested. The ASPR HCA and the Recipient senior executive shall conduct a review of the matteris) in dispute and render a decision in writing within thirty [30) calendar days of receipt of such written position. 4. In the absence of a joint decision, upon written request to the HHS Senior Procurement Executive (SPE), made within thirty (30) calendar days of the expiration of the time for a decision under Subparagraph 8.3 above, the dispute shall be further reviewed. The SPE may elect to conduct this review personally or through a designee or jointly with a senior executive appointed by the Recipient. Following the review, the Chief Acquisition Officer or designee will resolve the issue{s) and notify the Parties in writing. If a decision has not been made within 120 days, the request may be deemed denied. 5. The Parties stipulate that any decision reached under Subparagraph 3.4 of this Article, including a deemed denial, may be submitted to the Court of Federal Claims to the extent permitted by law. 6. The pendency of a dispute shall not interfere with each Party?s right to terminate the Agreement pursuant to Article ILB and recover any resulting terminations costs. 19 C. Limitation of Damages Except for claims of non-payment of amounts due under Article VI, any claims for damages of any nature whatsoever pursued Under This Agreement shall be limited to direct damages only up to the aggregate amount of Government funding disbursed as of the time the dispute arises. In no event shall the Parties be liable for claims for consequential, punitive, special and incidental damages, claims for lost profits, re- procurement costs, or other indirect damages. Either Party may recover interest on any amounts submitted for payment and denied during the disputes process. Interest on an amount found due on a disagreement, claim or dispute shall be paid for the period beginning with the date the HHS Senior Procurement Executive receives a request for a joint decision made pursuant to Subpa ragraph 3.3 of this Article until the date of payment of the claim. Simple interest shall accrue and be paid at the same rate as that which the Secretary of the Treasury shall specify as applicable for each successive 6?month period under the Prompt Payment Act. ARTICLE IX: DATA RIGHTS A. Allocation of Principal Rights 1. The Government shall have unlimited rights for use in the Field in? Preexisting data funded by the Government. For clarity, Government rights in any preexisting data produced by Recipient and funded by the Government under a separate agreement shall be governed by such separate agreement, and this Agreement shall not alter any Government rights in such data produced outside of this Agreement. Data first produced in the performance of this Agreement exclusively with Government funds Form, fit, and function data delivered under this Agreement; Data delivered under this Agreement (except for restricted computer software) that constitute manuals or instructional and training material for installation, operation, or routine maintenance and repair of items, components, or processes delivered or furnished for use under this Agreement; and 2. The Government shall have Government Purpose Rights to all data produced in performance of this contract that was funded jointly by both parties under the cost sharing arrangement contained in this Agreement 3. The Government shall have Limited Rights to all data, other than restricted computer software, that embody trade secrets or are commercial or financial and confidential or privileged, that pertains to items, components, or processes developed at private expense in the performance of this Agreement, and data contained in a disclosure of a Subject Invention provided to the agency prior to the filing of a patent application. (See Article X.C. B. Parties' Obligations 1. Recipient agrees to retain and maintain in good condition all Data necessary to achieve Practical Application of any Subject Invention in accordance with the Recipient?s established record retention practices. In the event of exercise of the Government's March-in Rights as set forth under Article X, Paragraph H, Recipient agrees, upon written request from the Government, to deliver at no 20 additional cost to the Government, all existing Data necessary to achieve Practical Application of the relevant Subject Invention within sixty {60) calendar days from the date of the written request. The Government shall obtain Government Purpose Rights to this delivered Data, except for Data subject to Limited Rights as identified herein. 2. Recipient's right to use Data includes the right under Recipient's established business policies to make public research data (especially human research data) by publication in the scientific literature, by making trial protocols, trial results summaries, and clinical studies reports publicly available, and by making trial patient?level data available for third?party analysis. Recipient?s publication of Data disclosing any Subject Invention shall trigger Recipient?s obligation to file an application for a patent to such Subject Invention per Article X.B.3. C. Marking of Data 1. Recipient will mark any Data delivered under this Agreement with Limited Rights with the following legend. (See Article above): The Government?s right to use, modify, reproduce, perform, display, or disclose this Data is limited to the reproduction, preparation of derivative works, including derivative works necessary to manufacture selected medical countermeasure candidates in the Portfolio for use by the Government in the Strategic National Stockpile, distribution of copies to the public, and performing publicly and displaying publicly by or on behalf of the Government. 2. Lower Tier Agreements The Recipient shall ensure that any agreement entered into after the execution of this Agreement with an Affiliate or Sub-Recipient (regardless of tier) for any experimental, developmental, or research work that will be submitted for reimbursement Under This Agreement is consistent with this Article. 3. Identification and Disposition of Data The Recipient shall keep copies of all Data required by the FDA relevant to this Agreement for the time speci?ed by the FDA. In addition, the Recipient shall provide regulatory data to the and OTAS in accordance with Attachment 2, Reporting Requirements. The Government reserves the right to review any other data determined by the Government to be relevant to this Agreement. The Government further acknowledges that Recipient holds the commercialization rights for all products developed Under This Agreement and will be responsible for their registration with the FDA. 4. Publication and Publicity No Data shall be released or publicized without concurrence from the Recipient. For purposes of this Agreement, the term ?publication? is defined as an issue of printed material offered for distribution or any communication or oral presentation of information, including any manuscript or scientific meeting abstract. Any publication containing Data must be submitted to the Recipient and the OTTR for review 21 and comment no less than thirty {30) calendar days for manuscripts and fifteen (15) calendar days for abstracts before submission for public presentation or publication. The Government?s support shall be acknowledged in all such publications substantially as follows: "This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under 0T number: 5. Review of Press Releases All Parties agree to accurately and factually represent the work conducted Under This Agreement in all press releases. Misrepresenting results or releasing information that is injurious to the integrity of a Party may be construed as improper conduct. The term "Press releases? shall be defined as the public release of information via any medium, excluding peer-reviewed scientific publications. Each Party agrees to provide the other Party with an advance copy of any press release related to this Agreement not less than ten (10) business days prior to the issuance of the press release. BARDA support shall be acknowledged in all such press releases substantially as follows: ?This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority; under OT number: 6. Con?dential Information Unless other terms and conditions outlined within this Agreement apply, each Party may receive Information from the other Party during the Term of this Agreement. The term ?Information" shall mean any and all information, Data or Know?How; whether technical or non?technical; oral or written, that is disclosed by one party {"Disclosing Party") to the other party {"Receiving Party?). For a period of ten (10) yea rs from the date of disclosure of a given item of Information; the Receiving Party agrees: 1. To use the Information only in connection with its performance of this Agreement; 2. To treat the Information as it would its own proprietary and confidential information; 3. To disclose the Information only to employees or agents of Receiving Party who are providing services hereunder and who agree to be bound by these confidentiality obligations; and 4. To take all reasonable precautions to prevent the disclosure of Information to any third- party other than an Af?liate or Sub?Recipient without the prior written consent of the Disclosing Party. Each Party shall be relieved of its obligations under this Paragraph if the Information: 22 1. Was known to the Receiving Party or its Affiliate or Sub-Recipient prior to receipt hereunder and without a duty of confidentiality as set forth in written records; or 2. Is generated by the Receiving Party or its Affiliate or Sub-Recipient by persons who have not had access to or knowledge of the Information disclosed hereunder; or 3. At the time of disclosure by the Disclosing Party to the Receiving Party, was generally available to the public, or which after disclosure hereunder becomes generally available to the public through no fault attributable to the Receiving Party; or 4. Is hereafter made available to the Receiving Party or its Af?liate or Sub-Recipient for use or disclosure by the Receiving Party from a third party having a right to do so; or 5. Is required by law, regulation, subpoena, orjudicial or governmental order to be disclosed, provided that the Receiving Party gives the Disclosing Party suf?cient notice to permit Disclosing Party to seek a protective order or other similar order with respect to such Information. ARTICLE X: PATENT RIGHTS. A. Allocation of Principal Rights and Obligations 1. Ownership. Recipient shall retain ownership of each Subject Invention throughout the world, unless Recipient shall have notified the OTAD that Recipient does not intend to retain ownership of such Subject Invention in accordance with paragraph 3(2) of this Article, {ii} Recipient fails to disclose such Subject Invention to the OTAO in accordance with paragraph 8(1) of this Article, or Recipient fails to file a patent application for such Subject Invention in accordance with paragraph 8(3) of this Article, in which case ownership shall vest with the Government. 2. License to Government For Subject inventions To Which Recipient Retains Ownership. With respect to any Subject Invention Made Under This Agreement in which Recipient retains title, the Government shall have a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced on behalf of the United States the Subject Invention throughout the world. For clarity, this license does not include the right to use or allow others to use the Subject Invention for commercial purposes. 3. License to Recipient for Subject inventions to which Recipient Does Not Eiect to Retain Ownership. i. In the event that Recipient does not elect to retain ownership in a Subject Invention pursuant to paragraph 8(2) of this Article, Recipient shall retain a nonexclusive royalty-free license throughout the world in such Subject Invention to which the Government obtains title pursuant to section of this Article, unless Recipient fails to disclose the invention within the times specified in paragraph Bill of this Article. Recipient?s license extends to any domestic subsidiaries and af?liates within the corporate structure of which Recipient is a part, and includes the right to grant sublicenses to the extent Recipient was legally obligated to do so at award of this OTA. The license is transferable only with the written approval of the Government, except 23 when transferred to the successor of that part of the Recipient?s business to which the invention pertains. ii. Recipient's license may be revoked or modified by the Government to the extent necessary to achieve expeditious practical application of the Subject Invention in a particular country in accordance with the procedures outlined under Article A. Third Party Application a. In response to a third party?s proper application for an exclusive license, Recipient?s domestic license may be revoked or modified to the extent necessary to achieve expeditious practical application of the Subject Invention. The application shall be submitted in accordance with the applicable provisions in 37 CFR part 404 and agency licensing regulations. Recipient's license will not be revoked in that field of use or the geographical areas in which the Recipient has achieved practical application and continues to make the bene?ts of the Subject Invention reasonably accessible to the public. The license in any foreign country may be revoked or modi?ed to the extent the Recipient, its licensees, or its domestic subsidiaries or affiliates have failed to achieve practical application in that country. b. Revocation or modification of Recipient?s minimum rights. Before revoking or modifying Recipient?s license in accordance this Article, the OTAO shall furnish the Recipient a written notice of intention to revoke or modify the license. The Government shall allow Recipient at least 30 days (or another time as may be authorized for good cause by the OTAO) after the notice to show cause why the license should not be revoked or modified. Recipient has the right to appeal, in accordance with applicable regulations in 37 CFR part 404 and agency licensing regulations, any decisions concerning the revocation or modification 4. License To Recipient For Subject inventions To Which Recipient Hos Eiected To Retain Ownership But Does Not Fife PotentAppiication or does Not Prosecute PotentAppiicotion. i. In the event that Recipient has elected to retain ownership of a Subject Invention but subsequently elects not to file a patent application for the Subject Invention or elects not to prosecute a patent application for the Subject Invention, Recipient shall retain a fully paid up, sub?licensable, nonexclusive, royalty?free license throughout the world in each Subject Invention to which the Government obtains title, except if Recipient fails to disclose the Subject Invention within the times specified in Paragraph of this Article. The Recipient?s license extends to the Recipient?s subsidiaries and Affiliates, if any, within the corporate structure of which Recipient is a party and includes the right to grant licenses of the same scope. to the extent that Recipient was legally obligated or permitted to do so at the time the Agreement was executed. The license is otherwise transferable only with the approval of the Government, except when transferred to an Affiliate or successor of that part of Recipient?s business to which the Subject Invention pertains. The Government approval for license transfer shall not be unreasonably withheld. For the purposes of this Paragraph, references to Recipient?s subsidiaries and Affiliates shall not be limited to the entities identified in Attachment 3. ii. The Recipient?s license under this Paragraph may be revoked or modified by the Government to the extent necessary to achieve expeditious Practical Application of the Subject Invention pursuant to an application for an exclusive or nonexclusive license submitted 24 consistent with appropriate provisions at 37 CFR Part 404. Recipient?s license shall not be revoked in that field of use or the geographical areas in which Recipient has achieved Practical Application of the Subject Invention and continues to make the benefits of the Subject Invention accessible to the public. Before revocation or modification of Recipient?s license under this Paragraph, the Government shall furnish Recipient with a written notice of its intention to revoke or modify the license, and Recipient shall be allowed thirty (30) calendar days [or such other time as may be authorized for good cause shown) after the notice to show cause why the license should not be revoked or modified. B. Recipient?s Obligations 1. Recipient shall disclose in writing each Subject Invention to the OTAO within one year after the inventor discloses it in writing to Recipient personnel responsible for patent matters. The disclosure shall identify the inventorls) and this Agreement under which the Subject Invention was made. It shall be sufficiently complete in technical detail to convey a clear understanding of the Subject Invention. The parties agree that the information contained in the disclosure shall qualify as limited rights data as de?ned under Article of this Agreement, and is not subject to further disclosure without mutual agreement by both parties. Both parties agree that such disclosure remains confidential pending filing of a patent application per Article below. 2. The Recipient shall elect in writing whether or not to retain ownership of any Subject Invention by notifying the OTAO within two years of disclosure to the agency under Article above. However, in the event that Recipient?s publication or use of the data as provided under Article IX.B. has initiated the 1 year statutory period during which valid patent protection can be obtained in the United States, the period for election of title may be shortened by the agency to a date that is no more than 60 calendar days prior to the end of the statutory period. 3. The Recipient shall file either a provisional or a non-provisional patent application on an elected Subject Invention within 1 year after election. If the Recipient files a provisional application, it shall file a non?provisional application within 12 months of the filing of the provisional application. The Recipient shall file patent applications in additional countries (or international patent offices within either 12 months of the ?rst filed patent application or 6 months from the date permission is granted by the Commissioner of Patents to file foreign patent applications, where such filing has been prohibited by a Secrecy Order. 4. The Recipient may request extensions of time for disclosure, election, or filing under paragraphs (BMZ), and of this clause. C. Conditions When the Government May Obtain Title Upon the Government?s written request, Recipient shall convey title to any Subject Invention to the Government under any of the following conditions: 1. If Recipient fails to disclose or elects not to retain title to the Subject Invention within the times specified in Paragraph of this Article; provided, that the Government may only request title 25 within sixty (60) calendar days after learning of the failure of Recipient to disclose or elect within the speci?ed times. 2. In those countries in which Recipient fails to file patent applications within the times specified in Paragraph of this Article; provided, that if Recipient has filed a patent application in a country after the times specified in Paragraph of this Article, but prior to its receipt of the written request by the Government, Recipient shall continue to retain title in that country; or 3. In any country in which Recipient decides not to continue the prosecution of any application for, to pay the maintenance fees on, or defend in reexamination or opposition proceedings on, a patent on a Subject Invention. D. Action to Protect the Government's Interest Recipient agrees to execute or to have executed and deliver to the Government all instruments necessary to establish or confirm the rights the Government has throughout the world in those Subject Inventions to which Recipient elects to retain title and (ii) convey title to the Government when requested under Paragraph of this Article and to enable the Government to obtain patent protection throughout the world in that Subject Invention. 1. Recipient agrees to require, by written agreement, its employees, other than clerical and non-technical employees, to disclose in writing to personnel identified as responsible for the administration of patent matters and in a format suggested by Recipient, each Subject Invention made Under This Agreement so Recipient can comply with the disclosure provisions of Paragraph of this Article. Recipient shall instruct employees, through employee agreements or other suitable educational programs, on the importance of reporting inventions in sufficient time to permit the filing of patent applications prior to US. or foreign statutory bars. Recipient also agrees to instruct all employees, in accordance with its regular business practices, on the need to maintain confidentiality of any information covered by the disclosure under Paragraph of this Article. 2. Recipient shall notify the Government of any decisions not to continue the prosecution of a patent application for a Subject Invention, pay maintenance fees, or defend in a reexamination or opposition proceedings on a patent of a Subject Invention, in any country, not less than thirty (30} calendar days before the expiration of the response period required by the relevant patent office. Recipient shall include, within the specification of any United States patent application and any patent issuing thereon covering a Subject Invention, the following statement: "This invention was made with Government support under Agreement awarded by HHS. The Government has certain rights in the invention." E. Lower Tier Agreements The Recipient shall ensure that any agreements entered into after the execution of this Agreement with an Af?liate or Sub-Recipient {regardless of tier) for any experimental, developmental, or research work that will be submitted for reimbursement Under This Agreement are consistent with this Article. (i001) 25 rain F. Reporting on Utilization of Subject Inventions 1. Recipient agrees to submit, during the Term, an annual report on the utilization of a Subject Invention or on efforts at obtaining such utilization that is being made by Recipient or its licensees or assignees. Such reports shall include information regarding the status of development, date of first commercial sale or use, and such other data and information as the agency may reasonably specify. Recipient also agrees to provide additional reports as may be requested by the Government in connection with any march-in proceedings undertaken by the Government in accordance with Paragraph of this Article. Consistent with 35 U.S.C. 202(c)(5), the Government agrees it shall not disclose such information to persons outside the Government without permission of Recipient. 2. All required reports shall be submitted to the e~room, OTAS, OTAO, and OTTR. G. March-in Rights The Recipient agrees that, with respect to any Subject Invention in which it has retained title, the Government has the right to require Recipient, an assignee, or exclusive licensee of a Subject Invention to grant a non?exclusive license within the Field to a responsible applicant or applicants, upon terms that are reasonable under the circumstances, and if Recipient, assignee, or exclusive licensee refuses such a request, the Government has the right to grant such a license within the Field itself if the Government determines that: 1. Such action is necessary because Recipient or assignee has not taken effective steps, consistent with the intent of this Agreement, to achieve Practical Application of the Subject Invention; or 2. Such action is necessary to alleviate health or safety needs, which are not reasonably satis?ed by Recipient, assignee, or their licensees. ARTICLE XI: FOREIGN ACCESS TO TECHNOLOGY This Article shall remain in effect during the Term and for five years thereafter, A. General The Parties agree that research ?ndings and technology developments arising Under This Agreement may constitute a signi?cant enhancement to the national security and to the economic vitality of the United States. Accordingly, access to important technology developments Under This Agreement by Foreign Firms or Institutions must be carefully controlled. The Recipient agrees to comply with all applicable laws regarding export controls and not to export any Technology to any US embargoed countries. The Recipient shall provide timely notice to the Government of any proposed transfers from the Recipient of Technology developed Under This Agreement to Foreign Firms or Institutions; provided that, this Article shall not apply to transfers by Recipient of Technology to Affiliates or as part of the sale, merger, or acquisition of Recipient, or as part of the sale or transfer of that part of Recipient?s business to which the Technology developed Under This Agreement pertains. If the Government determines that 27 a transfer may have adverse consequences to the national security interests of the United States, the Recipient, its vendors, and the Government shall jointly endeavor to find alternatives to the proposed transfer which obviate or mitigate potential adverse consequences of the transfer but which provide substantially equivalent benefits to the Recipient. In any event, the Recipient shall provide written notice to the and DTAD of any proposed transfer to a Foreign Firm or Institution at least thirty (30} calendar days prior to the proposed date of transfer. Such notice shall cite this Article and shall state specifically what is to be transferred and the general terms of the transfer. Within fifteen (15} calendar days of receipt of the Recipient?s written noti?cation, the DTAO shall advise the Recipient whether it consents to the proposed transfer. In cases where the OTAO does not consent to the proposed transfer or the OTAD provides no decision within the fifteen [15] calendar days after receipt of Recipient?s notice, the Recipient may utilize the procedures under Article VI, Disputes. However, no transfer shall take place until a decision is rendered. In the event of a transfer of Technology by Recipient to a Foreign Firm or Institution which is identified as a Prohibited Source pursuant to Federal Acquisition Regulation Subpart 25.7: the Government may terminate this Agreement for cause and lb} the Government shall have a non-exclusive, nontransferable, irrevocable, paid?up license to practice or have Practiced on behalfof the United States the Technology throughout the world for Government and any and all other purposes, particularly to effectuate the intent of this Agreement. Upon request of the Government, the Recipient shall provide written confirmation of such licenses. B. Lower Tier Agreements The Recipient shall ensure that any agreements entered into after the execution of this Agreement with an Affiliate or Sub-Recipient (regardless of tier) for any experimental, developmental, or research work that will be submitted for reimbursement Under This Agreement are consistent with this Article. ARTICLE XII: TITLE TO AND DISPOSITION OF PROPERTY The Government is reimbursing the Recipient for the approved costs up to the limits set forth in Article VI, and Government funding may be used to acquire Property as described in this Agreement and Attachment 1. SUB-RECIPIENTS For any firm?fixed price, time and materials, or labor hour Sub?Recipient agreement with a value in excess of $500,000, the Recipient will provide the OTAO the opportunity to review all Sub~Recipient agreements and related justi?cation for cost or price reasonableness ten {10} calendar days before execution. This shall include the nature of the work that the Sub?Recipient is going to perform, an estimated duration of the work, and the proposed costs for the work. The OTAO will submit a written response within ten (10} calendar days stating approval or disapproval of the Sub-Recipient agreement. In the event that the OTAD disapproves of the Sub?Recipient agreement, the OTACI must provide 23 written justification to support hisfher decision. If a written response is not provided by the DTAO within ten (10) calendar days, the Recipient will elevate concerns to the Section Chief to immediately address the outstanding request. Recipient will provide the with an electronic copy of the final Sub-Recipient agreement. ARTICLE XIV: CIVIL RIGHTS ACT Performance of this Agreement in the US. is subject to the compliance requirements of Title VI of the Civil Rights Act of 1964 as amended (42 U.S.C. relating to nondiscrimination in Federally assisted programs. The Recipient has signed an Assurance of Compliance with the nondiscriminatory provisions of the Act. ARTICLE XV: EXECUTION This Agreement may be revised only by written consent of the Recipient and the HHS OTAO. This Agreement, or modifications thereto, may be executed in counterparts each of which shall be deemed as original, but all of which taken together shall constitute one and the same instrument. ARTICLE XVI: SPECIAL CLAUSES Unless otherwise noted, performance of this Agreement in the US. is subject to the following Special Clauses: A. Protection of Human Subjects 1. The Recipient agrees that the rights and welfare of human subjects involved in research Under This Agreement shall be protected in accordance with 45 CFR Part 46 and with the Recipient's current Assurance of Compliance on ?le with the Office for Human Research Protections (OHRP), Office of Public Health and Science The Recipient further agrees to provide certification that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects, in accordance with 45 CFR Part 46 and the Assurance of Compliance. 2. The Recipient shall bear full responsibility for the performance of all work and services involving the use of human subjects Under This Agreement and shall ensure that work is conducted in a proper manner and as safely as is feasible. The Parties agree that Recipient retains the right to control and direct the performance of all work Under This Agreement. Nothing in this Agreement shall be deemed to constitute Recipient or any Sub-Recipient, agent or employee of Recipient, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. Recipient agrees that it has entered into this Agreement and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent consortium without imputing liability on the part of the Government for the acts of the Recipient or its employees. 3. If at any time during the performance of this Agreement, the HHS OTAO determines, in consultation with the OHRP, DPHS, and ASH, that the Recipient is not in compliance with any of the requirements andlor standards stated in Subparagraphs (1) and above, the HHS OTAO may immediately suspend, in whole or in part, work and further payments Under This Agreement until the 29 Recipient corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Recipient fails to complete corrective action within the period of time designated in the written notice of suspension, the HHS OTAO may, in consultation with OHRP, OPHS, and ASH, terminate this Agreement in a whole or in part, and the Recipient's name may be removed from the list of those performers with approved Health and Human Services Human Subject Assurances. B. Human Materials (Assurance of 0H RP Compliance) 1. The acquisition and supply of all human specimen material [including fetal material) used Under This Agreement shall be obtained by Recipient in full compliance with applicable Federal, state and local laws and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material. 2. The Recipient shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted Under This Agreement, by collaborating sites, or by Sub-Recipients identified Under This Agreement, were obtained with prior approval by the Office for Human Research Protections of an Assurance to comply with the requirements of 45 CFR 46 to protect human research subjects. This restriction applies to all collaborating sites without OHRP- approved Assurances, whether domestic or foreign, and compliance must be ensured by the Recipient. 3. Provision by the Recipient to the HHS of a properly completed "Protection of Human Subjects Assurance Identification/IRE Certification/Declaration of Exemption", Form OMB No. 0990?0263 (formerly Optional Form 310], certifying IRB review and approval of the protocol from which the human materials were obtained constitutes the written documentation required. The human subject certification can be met by submission of a self-designated form provided that it contains the information required by the ?Protection of Human Subjects Assurance Identification/IRE Certification;I Declaration of Exem ption?, Form OMB No. 0990?0263 (formerly Optional Form 310}. C. Research Involving Human Fetal Tissue All research involving human fetal tissue shall be conducted in accordance with the Public Health Service Act, 42 U.S.C. 289g-1 and 289g-2. Implementing regulations and guidance for conducting research on human fetal tissue may be found at 45 CFR 46, Subpart B. The Recipient shall make available, for audit by the Secretary, HHS, the physician statements and informed consents required by 42 USC 239g-1(b} and or ensure HHS access to those records, if maintained by an entity other than the Recipient. D. Needle Exchange The Recipient shall not use Agreement funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug. E. Care of Live Vertebrate Animals 1. Before undertaking performance of any Agreement involving animal-related activities where the species is regulated by the United Sates Department of Agriculture the Recipient shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Recipient shall furnish evidence of the registration to the Contracting Officer. 30 2. The Recipient shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR sections 2.1-2.11, or from a source that is exempt from licensing under those sections. 3. The Recipient agrees that the care, use, and intended use of any live vertebrate animals in the performance of this Agreement shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals IPHS Policy}, the current Animal Welfare Assurance {Assurance}, the Guide for the Care and Use of Laboratory Animals {National Academy Press, Washington, and the pertinent laws and regulations of the United States Department of Agriculture [see 7 U.S.C. 2131 et seq. and 9 CFR subchapter A, Parts In case of conflict between standards, the more stringent standard shall govern. 4. If at any time during performance of this Agreement, the HHS OTAD determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Recipient or their Sub?Recipients are not in compliance with any of the requirements and standards stated in Subparagraphs through above, the HHS DTAO may immediately suspend, in whole or in part, work and further payments Under This Agreement until the Recipient or Sub-Recipient corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Recipient or Sub-Recipient fails to complete corrective action within the period of time designated in the OTAO written notice of suspension, the HHS OTAO may, in consultation with DLAW and NIH, terminate this Agreement in whole or in part, and the Recipient?s or Sub- Recipient?s name may be removed from the list of those contractors with Animal Welfare Assurances. Note: The Recipient may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. Information concerning this program may be obtained by contacting your regional office or the Animal Care Staff, USDAXAPHIS, 4700 River Road, Riverdale, Maryland 20737. F. Animal Welfare All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals. This policy may be accessed at: Primate studies will not begin until the IACUC and the Recipient?s Animal Welfare Department provide final approval of the study protocol. G. Protection of Personnel Who Work with Nonhuman Primates All Recipient personnel who work with nonhuman primates or enter rooms or areas containing nonhuman primates shall comply with the procedures set forth in NIH Policy Manual 3044-2, entitled, ?Protection of NIH Personnel Who Work with Nonhuman Primates,? located at the following URL: H. Information on Compliance with Animal Care Requirements Registration with the USDA is required to use regulated species of animals for biomedical purposes. USDA is responsible for the enforcement of the Animal Welfare Act U.S.C. 2131 et. seq), 31 The PHS Policy is administered by the OLAW An essential requirement of the PHS Policy is that every institution using live vertebrate animals must obtain an approved assurance from DLAW before they can receive funding from any component of the US. Public Health Service. If the Recipient does not have an assurance and will be utilizing a Sub-Recipient to perform the animal work, then the Recipient and Sub- Recipient must have an Inter?Institutional Assurance in place to allow the Recipient to utilize the assurance of the Sub-Recipient to meet the Government?s requirements for assurance. The request for this negotiation of this assurance must be submitted to OLAW by the Government on behalf of the Recipient. The PHS Policy requires that Assured institutions base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals and that they comply with the regulations (9 CFR, Subchapter A) issued by the USDA under the Animal Welfare Act. The Guide may differ from USDA regulations in some respects. Compliance with the USDA regulations is an absolute requirement of this Policy. The Association for Assessment and Accreditation of Laboratory Animal Care International is a professional organization that inspects and evaluates programs of animal care for institutions at their request. Those that meet the high standards are given the accredited status. As of the 2002 revision of the PHS Policy, the only accrediting body recognized by PHS is the While accreditation is not required to conduct biomedical research, it is highly desirable. uses the Guide as their primary evaluation tool. They also use the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching. It is published by the Federated of Animal Science Societies I. Approval of Required Assurance by Law Under governing regulations, federal funds that are administered by the Department of Health and Human Services, BARDA shall not be expended by the Recipient for research involving live vertebrate animals, nor shall live vertebrate animals be involved in research activities by the Recipient under this award unless a satisfactory assurance of compliance with 7 U.S.C. 2136 and 9 CFR Sections 2.25-2.28 is submitted by Recipient 30 days prior to commencing research involving live vertebrate animals and approved by the OLAW. Each performance site (if any} must also assure compliance with 7 U.S.C. 2136 and 9 CFR Sections 2.25-2.28 with the following restriction: Only activities that do not directly involve live vertebrate animals (Le. are clearly severable and independent from those activities that do involve live vertebrate animals) may be conducted by individual performance sites pending CLAW approval of their respective assurance of compliance with 7 U.S.C. 2136 and 9 CFR Sections 2.25-2.23. Additional information regarding OLAW may be obtained via the Internet at Registration with the Select Agent Program for Work Involving the Possession, Use, andfor Transfer of Select Biological Agents or Toxins: Work involving select biological agents or toxins shall not be conducted Under This Agreement until the Recipient and any affected Sub-Recipients are granted a certificate of registration or are authorized to work with the applicable select agents. 32 For Recipient or Sub-Recipient awards to domestic institutions who possess, use, andfor transfer Select Agents Under This Agreement, the institution must complete registration with the Centers for Disease Control and Prevention DHHS or APHIS, USDA, as applicable, before performing work involving Select Agents, in accordance with 42 CFR Part T3. No Government funds can be used for work involving Select Agents, as defined in 42 CFR Part 73, if the final registration certificate is denied. For Recipient or Sub-Recipient awards to foreign institutions who possess, use, and/'or transfer Select Agents Under This Agreement, the institution must provide information satisfactory to the Government that a process equivalent to that described in 42 CFR Part 73 for US. institutions is in place and will be administered on behalf of all Select Agent work sponsored by these funds before using these funds for any work directly involving the Select Agents. The Recipient must provide information addressing the following key elements appropriate for the foreign institution: safety, security, training, procedures for ensuring that only approvedlappropriate individuals have access to the Select Agents, and any applicable laws, regulations and policies equivalent to 42 CFR Part 73. The Government will assess the policies and procedures for comparability to the U.S. requirements described in 42 CFR Part 73. When requested by the DTAO, the Recipient shall provide key information delineating any laws, regulations, policies, and procedures applicable to the foreign institution for the safe and secure possession, use, and transfer of Select Agents. This includes summaries of safety, security, and training plans, and applicable laws, regulations, and policies. For the purpose of security risk assessments, the Recipient must provide the names of all individuals at the foreign institution who will have access to the Select Agents and procedures for ensuring that only approved and appropriate individuals have access to Select Agents Under This Agreement. Listings of HHS select agents and toxins, biologic agents and toxins, and overlap agents or toxins as well as information about the registration process, can be obtained on the Select Agent Program Web site at Product Approval The Recipient agrees to comply with guidelines (21 CFR Parts 210?2 11, 600] for manufacturing, processing and packing of drugs, chemicals, biological, and reagents Under This Agreement. The Recipient agrees to advise the HHS OTAO and OTTR of any relocation of the Recipient?s prime manufacturing facility or the relocation of any Sub-Recipient?s facility during the Term. The Recipient also agrees to advise the HHS OTAO and immediately if at any time during the Term, the items Under This Agreement fail to comply with guidelines and/or the facility receives a negative FDA Quality Assurance Evaluation (Form 483). K. Manufacturing Standards The Current Good Manufacturing Practice Regulations chMP] {21 CFR 210-211} will be the standard applied for manufacturing, processing and packing of a therapeutic product Under This Agreement unless otherwise agreed upon or as required by the development process lab scale experimental manufacturing and pilot scale manufacturing). If at any time during the Term, the Recipient fails to comply with :6 MP in the manufacturing, processing and packaging of a therapeutic product Under This Agreement and such failure results in a material adverse effect on the safety, purity or potency of this therapeutic product [a material failure) as identi?ed by FDA, the Recipient shall have sixty (60) calendar days from the time such material failure is 33 identi?ed to initiate corrective action designed to cure such material failure within three months. If the Recipient fails to initiate such an action within the sixty (60) calendar day period, then the Agreement may be terminated. Willi} Anti-Bribery and Anti-Corruption Each Party agrees to perform its obligations Under This Agreement in accordance with the applicable anti-bribery and anti-corruption laws of the territory in which such Party conducts business with the other Party as set forth herein. Each Party shall be entitled to exercise its termination right, under and in accordance with the terms of this Agreement, to terminate this Agreement immediately on written notice to the other Party, if the other Party fails to perform its material obligations in accordance with this Article X?v?l Paragraph L. M. Salary Rate Limitation 1. Pursuant to the current and applicable prior HHS appropriations acts, payment of the direct salary of an individual at a rate in excess of the Federal Executive Schedule Level it in effect on the date an expense is incurred is an unallowable cost Under This Agreement and shall be addressed in accordance with Article VILC. 2. For purposes of the salary rate limitation, the terms "direct salary, salary", and ?institutional base salary?, have the same meaning and are collectively referred to as ?direct salary", in this clause. An individual?s direct salary is the annual compensation that the Recipient pays for an individual?s direct effort (costs) Under This Agreement. Direct salary excludes any income that an individual may be permitted to earn outside of duties to the Recipient. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and administrative costs). Note: The salary rate limitation does not restrict the salary that an organization may pay an individual working under an HHS contract, order, or it merely limits the portion of that salary that may be paid with Federal funds. 3. The salary rate limitation also applies to individuals under Sub-Recipient agreements. If this Agreement is a multiple?year OTAR, it may be subject to unilateral modification by the OTAO to ensure that an individual is not paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act in effect when the expense is incurred regardless of the rate initially used to establish Agreement funding. 4. See the salaries and wages pay tables on the U.S. Of?ce of Personnel Management Web site for Federal Executive Schedule salary levels that apply to the current and prior periods. 34 N. Person-ln-Plant With seven days advance notice to the Recipient in writing from the the Government may place a person-in-plant in the Recipient?s facility for activities associated with this Agreement, who shall be subject to the Recipient?s policies and procedures regarding security and facility access at all times while in the Recipient?s facility. As determined by federal law, no Government representative shall publish, divulge, disclose, or make known in any manner, or to any extent not authorized by law, any information coming to him in the course of employment or official duties, while stationed in a Recipient plant. 0. Reporting Matters Involving Fraud, Waste and Abuse Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in ASPR funded programs is encouraged to report such matters to the HHS Inspector General?s Office in writing or on the Inspector General?s Hotline. The toll free number is All telephone calls will be handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing address is: Office of Inspector General Department of Health and Human Services TIPS HOTLINE P.O. Box 23489 Washington, D.C. 20026 P. Prohibition on Recipient Involvement with Terrorist Activities The Recipient acknowledges that U.S. Executive Orders and Laws, including but not limited to E.O. 13224 and P.L. 107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the Recipient to ensure compliance with these Executive Orders and Laws. The Recipient shall ensure that any agreements entered into after the execution of this Agreement with an Affiliate or Sub-Recipient [regardless of tier) for any experimental, developmental, or research work that will be submitted for reimbursement Under This Agreement are consistent with this Paragraph. (1. Materials Transfers For distribution to third parties of any material developed Under This Agreement, the Recipient must provide BARDA notice of the requests/transfers in the Recipient?s technical report. R. Inspection and Acceptance 1. The OTAO or the duly authorized representative will perform inspection and acceptance of materials and services to be provided Under This Agreement. 2. For the purposes of this Paragraph, the designated OTTR is the authorized representative of OTAO. The OTTR will assist in resolving technical issues that arise during performance of the Agreement. The however, is not authorized to change any Agreement terms or authorize any changes in the SOW or modify or extend the Term, or authorize reimbursement of any costs incurred during performance of the Agreement. 35 3. Inspection and acceptance will be performed at Recipient or Sub-Recipient?s facilities or at: Biomedical Advanced Research and Development Authority Office of the Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services 330 Independence Ave, SW Room 6644 Washington, DC. 20024 ARTICLE XVII: TRANSFERS 8t ASSIGNMENTS All transfers andlor assignment will be conducted in a manner that is consistent with the Assignment of Claims Act (31 US. Code 372?) and the Prohibition on transfer of contract and certain allowable assignments {41 U.S.C.A. 6305). ARTICLE ENTIRE AGREEMENT Unless otherwise specifically provided, this Agreement and its Attachments embodies the entire understanding between the Parties on the subject matter hereof, and anvr prior or contemporaneous representations, either oral or written, are superseded. No amendments or changes to this Agreement, including without limitation, changes in the sow, total estimated cost, and Term, shall be effective unless made in writing and signed by authorized representatives of the Parties. 36 A1TACHM ENT 1: STATEMENT OF WORK DATED Recipient: Genentech, Inc. Contractual Stat?emnt af Work 1-) Page 150 \Nithld GUFSUEM ID ofthe Freedom of Information Act Page 151 Withheld ID EKEITIDHDH (1321(4) ofthe Freedom of Information Act Page 152 Withheld ID EKEITIDHDH (1321(4) ofthe Freedom of Information Act Page 153 Withheld ID EXEITIDHDH (1321(4) ofthe Freedom of Information Act Page 154 Withheld BUFSUELDI ID (1321(4) ofthe Freedom of Information Act Page 155 \Nithld CUFSUEM ID ofthe Freedom of Information Act Page 155 Withheld ID (1321(4) ofthe Freedom of Information Act Page 15? Withheld t0 EKEITIDHDH ofthe Freedom of Information Act ATTACHMENT 2: REPORTING REQUIREMENTS A. PROJECT TELECONFERENCES ?Reference Article IV Subsection Bl. B. OTHER MEETINGS Reference Article IV Subsection 32. C. REPORT DELIVERABLES Unless otherwise speci?ed by the OTAO, delivery of reports to be furnished to the Government Under This Agreement {including invoices), shall be delivered electronically along with a concurrent email notification in accordance with Article VII, Paragraph B. For electronic delivery of final versions of the deliverables listed below, the Recipient shall upload documents into the appropriate folder on l"eRoom"i which is the designated USG file sharing system. The USG shall provide two Recipient representatives authorized log in access to the file share program. Each representative must complete a mandatorv training provided by the USE prior to gaining user access. A notification email should be sent to the OTAD, DTAS, and upon electronic delivery of any documents in accordance with Article VII, Paragraph B. D. DELIVERABLES Successful performance of the Agreement shall be deemed to occur upon performance of the work set forth in the sow set forth in Attachment 1 of this Agreement and upon delivery, as required by the sow or elsewhere in this Agreement, by the Agreement Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule below: 46 Type of Description of Deliverable Reporting Procedures QuantityfForm Deliverable Periods Project Every two weeks The Parties will participate in The Recipient provides agenda 1 Electronic to Meeting or as agreed to teleconferences other week to the OTTR, DTAD, and the 01TH: and by the Parties to discuss the performance of the OTAS within 2 business days of OTAS Agreement. The Recipient will . Final will be meeting. . prepare a proposed agenda and uploaded Into will provide draft-meeting minutes eRoom to the OTTR for review and concurrence. The Recipient will send a final version of the meeting minutes to the OTTR. The OTTR will distribute the draft and final version to the DTAS and other BARDA staff. [For avoidance of doubt, financial information is not expected at these updates, which will be technically focused} BARDA reserves the right to include financial personnel in these Project Meetings, if needed. 0 (with OTAS concurrence} distributes agenda to BARDA participants prior to meeting. I: The Recipient provides meeting minutes within 3 business days of the meeting. - reviews and comments on minutes within 10 business days. Every third month (Quarterly), if requested by The Parties will participate in quarterly face-to-face site visits or teleconferences in Washington, D.C. andlor at work sites of the Recipient to discuss the performance of the Agreement. The meetings will be used to discuss Agreement progress in relation to the Work Breakdown Structure (WES), Integrated Master Schedule ilMS}, and Agreement Performance Reports (APR) as well as study designs, technical, financial, regulatory, and ethical aspects of the Program. These meetings may also include site visits to the Recipient and Sub?Recipient?s facilities. The Recipient shall provide itinerary and agenda at least 5 business days in advance of site visit. I: OTTR review and distributes itinerary and agenda within 3 business days of meeting. 47 Type of Frequencw'Time Description of Deliverable Reporting Procedures Quantitw'Form Deliverable Periods Members of the JOC will meet a Meeting minutes will be taken Joint DTAR approximatelv event six months as by the Recipient and provided Oversight dEta"Ed Ari'c'e to the 01TH, OTAO, and ores Committee . within 3 business days of the . A ore?meeting may be reqUIred for meeting meeting. (everyr 6 months or on an odhoc basis as needed) larger decisionsfto outstanding questions. will distribute the minutes to the JOC members and return any BARDA edits or comments to the Recipient within 3 business days of original receipt of the draft minutes. - If changes to the agreement are made, the Recipient will draft a decision memo, provide an updated SOW, and a new budget and provide to BARDA within 3 weeks. 43 Type of Description of Deliverable Reporting Procedures Quantityj'Form Deliverable Periods The 30th The Status Report will Reports: 1 Electronic Status Report calendar day of address the items listed below and The Recipient provides Copy to OTTR each month cross?referenced to the Work Status Report deliverables and OTAS following the Breakdown Structure within 30 days after the last day Final will be fractional Scope of Work Integrated . uploaded into portion of the Master Schedule Of that month reflecting the eRoom initial month and first full month of the UTA award. reports are due each month within 30 days after the last day of that month, except on the month when the Annual Technical Progress Reports are due. The reporting period will reflect the prior month?s activities. Performance Measurement Baseline Review report, Agreement Performance Reports (APR), and approval strategy. 1. An Executive Summary highlighting the progress, issues, and relevant manufacturing, non?clinical, clinical, and regulatory activities. The Executive Summary should be limited to 2?3 pages and highlight critical issues for that reporting penod. 2. The report should detail the planned and actual progress of the 50W activities during the period covered, explaining occurrences of any differences between the two, and the corrective steps. 3. The report should list any regulatory submissions relevant to the Medical Countermeasure candidates covered Under This Agreement that have taken place during the reporting penod. prior month?s activities. I and OTAS will review Reports with Recipient and provide feedback. 49 Type of Description of Deliverable Reporting Procedures Quantityj'Form Deliverable Periods Integrated Within 60 days The Recipient will provide an IMS The Recipient shall provide an 1 Electronic Master of OTA award and status updates in the IMS within 50 days of UTA Copy (PDF and Schedule and updated report to reflect changes award and updated within 30 Microsoft in schedule, performance? and days after the last day of each Project critical path. The Recipient will Schedule include BARDA Portfolio Progress month. (.mmp} format Milestones in their WIS and to OTTR and provide updates within IMS shall be in both PDF and Upload their IMS. The IMS will be a Microsoft Form. to eRoom. standalone schedule containing only those activities that are BARDA shall provide the applicable to the sow. Individual Recipient with a written list of for the assets concerng in regponse to the Within the 3'50 be Recipient?s SmeittIEd IMS, and provided on a basis. the Recipient must address, in writing, all concerns raised by BARDA within 10 business days of Recipient?s receipt of this list of concerns. Financial The 30th Recipient will provide a 4- Recipient shall provide a 1 Electronic Status Report calendar day of Financial Status at an Financial Status Report col-W ?00 OTTR each month agreed upon WES using a within 30 days after the last and following the format mutually agreed upon by day of that month. Upload to the Parties. eRoom. fractional portion of the initial month and first full month of the OTA award. Financial Status Reports are updated within 30 days after the last day of that month in the Project Status Report. 0 BARDA may raise, in writing, concerns for Recipient to address; Recipient must address, in writing, all concerns raised by BARDA. 50 Type of Frequencvaime Description of Deliverable Reporting Procedures Quantitw'Form Deliverable Periods Risk 90 days The Recipient will provide a Risk 0 The Recipient will provide a Risk 1 Electronic Management following UTA Management Plan that outlines Management Plan 90 days COPY to OTTR Plan award and the impacts of each risk in relation following UTA award and and updated vearlv to the cost, schedule and update lIluarterlilI in their UpFload to [additional performance objectives. The Risk or Annual Project oom. submissions as Management Plan will include risk Status Reports. requested by mitigation strategies. Each risk ones or mitigation strategv will capture BARDA wi? Provide the how the corrective action will Recipient With a written 0f reduce impacts on cost, schedule concerns (if anv exist} in and performance_ response to the Recipient?s submitted Risk Management Plan, and Recipient must address in writing all concerns raised by BARDA within 20 business days of Recipient?s receipt of this list of concerns. Deviation within 10 days of Process for changing IMS activities I: The Recipient will notifv BARDA 1 Electronic Notification identification associated With (305" and of significant changes to the COPY to OTTR and Mitigation as baselined at the IMS. This includes increases in and Strategvr cost above 10% or schedule Upload to eRoom. slippage of more than 30 days for activities at the WES level, which would require a POP extension. The Recipient will provide a high level management strategy for risk mitigation. ln?Process Annual or event The Recipient will provide a The Recipient will provide an 1 Electronic Review driven review presentation to BARDA and other update to technical progress COPY to 017R Presentation following Intergovernmental agencv invitees made towards Portfolio and completion of a on the Portfolio Progress at an In- Progress at an ln-Process Upload to Process Review meeting. eRoom. pre?defined stage of product development and prior to initiation of a new stage Review meeting and provide the presentation to 10 business davs prior to the meeting. 51 Type of Description of Deliverable Reporting Procedures Quantityj'Form Deliverable Periods Incident Within 24 or 48 The Recipient will communicate 0 Recipient will notify [orally or in 1 Electronic Report of activity or and document all critical writing) BARDA OTTR and OTAS Copy to OTTR incident programmatic concerns, risks or within 43 of Recipient and potential risks with BARDA within identifying a critical project risk Upload to 48 hours. Recipient shall eRoom. communicate via email or telephone. In addition, the Recipient will report to the government any activity or incident that is in violation of established security standards or indicates the loss or theft of government products within 24 of knowledge of activity or incident. Recipient will communicate via email, oral or written communication. or potential risk and within 24 for Security activities or incident. Recipient will provide additional updates within 48 of additional developments, additional information andfor understanding. The Recipient will submit within 5 business days a Corrective Action Plan (if deemed necessary by either Party} to address any potential issues. If corrective action is recommended, the Recipient must address in writing its consideration of concerns raised by BARDA - The Recipient will address BARDA's concerns in writing within 5 business days. 52 Type of Description of Deliverable Reporting Procedures Quantityj'Form Deliverable Periods Draft and Final Draft 7?5 A draft of Final Technical Progress 0 The Recipient shall provide a 1 Electronic Technical calendar daVS Report containing a summation of draft Technical Progress Report Copy to OTTR Progress before and Final the workbpe?DLTed and the TS calendar days before the end inc: resu ts taine or entire . oa to Re ort shall be of the PCP and the Final Agreement POP. The draft report eRoom. submitted on or before the completion date of the POP shall be duly marked as ?Draft?. The Final Technical Progress Report incorporating the feedback received from BARDA and containing a summation of the work performed and the results obtained for the entire Agreement POP. This final report shall detail, document and summarize the results of the entire Agreement. This report shall be in sufficient detail to fully describe the progress achieved under all milestones. The final report shall be duly marked as ?Final?. Technical Progress Report shall be submitted on or before the completion date of the POP. I Sub?Recipientprepared reports will be submitted to the and DTAS for review and comment no later than 5 business days after receipt by the prime Recipient. - provides edits and additional feedback to draft report within 15 calendar days of receipt, which the Recipient will consider incorporating into the Final Technical Progress Report. - The Recipient will submit, with the Final Technical Progress Report, a summary [not to exceed 200 words} of salient results achieved during the performance of the Agreement. I The Recipient will submit one (1) copy of a comprehensive final report to the OTAS and one copy (one electronically on a CD) to the DTTR. 53 it Type of Frequencvaime Description of Deliverable Reporting Procedures Quantitw'Form Deliverable Periods 10. Study At least 10 The Recipient will provide Pre? The Recipient will submit draft 1 Electronic ProtocoIS business dayS CIinical/Non-Clinicalf Clinical Trial and final protocols to BARDA COPY to OTTR prior to FDA Protocols to BARDA for evaluation, for review and comment. and Submission prior to FDA submission. Upload to eRoom. The OTAS and UTFR reserve the right to request within the POP a non?proprietarv Study Protocol for distribution within the United States Government I If the draft protocols are to be submitted to the FDA, BARDA review will take place prior to FDA submission. 0 BARDA will return comments to Recipient on the protocols no later than 10 business davs from the date of receipt. The Recipient will address, in writing, all concerns raised by BARDA. - The Recipient is not required to make any protocol revisions based on concerns andg?or recommendations. 0 In the event that BARDA disagrees with the final studv protocol design, BARDA will notih,f the Recipient of non- concurrence in writing. a Final FDA submissions shall be submitted to BARDA concurrentlv or no later than 5 calendar davs after its submission to FDA. 54 if Type of Description of Deliverable Reporting Procedures Quantityj'Form Deliverable Periods 11. Study Reports Within 5 {five} The OTAS and reserve the The Recipient will provide Draft 1 Electronic calendar days of right to request within the POP a and Final Pre?ClinicalfNon? Copy to OTTR the reports non?proprietary Report for Clinical Study Reports to BARDA and being available distribution within the for review and comment within UpFLoad to to Recipient and The Recipient will submit an 2 {two} calendar days of these oom. 15 business days interim study report to BARDA for reports being available to the prior to any severable discrete work Recipient. anticipated segments. If funding for a submission to severable study is scheduled in I The Recipient will submit FDA two separate PEHOUS 0f proposed Pre-Clinical/Non- Performance?than 3? interim Clinical Study Report to BARDA :E?o?gt?fnd diets: gig: at least 1s business days prior to the anticipated FDA Submission date. I: If corrective action is recommended, Recipient will use reasonable efforts to address, in writing or by corrective action, all concerns raised by BARDA prior to FDA submission. 0 Final FDA submissions shall be provided to BARDA concurrently or no later than 2 business days of its submission to FDA. 12. Regulatory Within 24 hours The Recipient will forward the a The Recipient will notify BARDA 1 Electronic Meeting of the dates and times Of an?! anticipated of an upcoming meeting with COPY t0 OTTR Notification anticipated meeting With the regulatory the regulatory agency within 48 and TYPE agency to BARDA and to hours of being informed that a Upload to A or arrange for appropriate BARDA meeting is scheduled. eRoom. staff to attend the regulatory meetings 0R meetings relevant to within 43 hours funded work. BARDA staff shall of meeting include up to a maximum of four occurrence for ad hoc meetings people. 55 it Type of Frequency/?Time Description of Deliverable Reporting Procedures QuantityfForm Deliverable Periods 13. Regulatory Within three The Recipient will forward I The Recipient provides 1 Electronic Corresponden business days of Recipient and FDA-issued draft Regulatory correspondence and Copy to OTTR ce and receiving minutes and final minutes Of any meeting minutes [as described and Meeting correspondence meeting With the Regulatory In the Description of Upload to . Agency to BARDA relevant to the . . eRoom. Minutes [as described In Portfolio Program. All documents Deliverablesl Within three the Description shall be duly marked as either days Of 0f the of Deliverabiesl ?Draft? or 'Final?. meeting or correspondence. from the Regulatory Agency 14. Regulatory At least 10 The Recipient will provide BARDA The Recipient submits draft 1 Electronic Submissions calendar days the opportunity '33 review and Regulatory Meeting Briefing COPY t0 OTTR prior to sommenttuio:nrresu :tcirv ted Packets to 3mm at least 10 anticrpated t:theeRaeng:llal?t:ry calendar days prior to epREZm. submission to FDA Agency. Such documents shall include responsesfcomments/questions that the Regulatory Agency has passed on to the sponsor regarding the investigational compounds in this Agreement as well as the name and address of the involved in clinical studies. All documents will be duly marked as either ?Draft? or ?Finai?. For avoidance of doubt, the Recipient is not required to provide to BARDA routine, general correspondence or information amendments leg. routine emails). anticipated submission to the Regulatory Agency. BARDA will provide comments to Recipient within 5 business days of receiving the briefing. - If corrective action is recommended, Recipient will address, in writing its considerations of all concerns raised by BARDA. I Final Regulatory submissions shail be submitted to BARDA concurrently or no later than 5 business days of its submission to FDA. 55 it Type of Frequencvaime Description of Deliverable Reporting Procedures Quantitw'Form Deliverable Periods 15. FDA Audits Within 10 In the event of an FDA inspection a The Recipient will notifvr the 1 Electronic busine? days of that occurs as a result of this and OTAS within 1.3 Copy to OTTR a scheduled Agreement and for the business davs of a scheduled and audit or within Investigational compound, or for audit or within 24hours of Upload to any other FDA inspection that has eRoom. 48 hours of an ad hoc site visitsfaudits if the FDA did not provide advanced notification the reasonable potential to impact the performance of this Agreement, the Recipient will provide BARDA with an exact copy (non?redacted} of the FDA Form 483, and the Establishment Inspection Report Recipient shall provide the DTTR and DTAS copies of the plan for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines as identified in the audit report within 10 business days, status updates during the plans execution, and a copy of all final responses to the FDA. The Recipient shall also provide redacted copies of any FDA audit report received from Sub? Recipients that occur as a result of this Agreement or for this product within five business days of receiving correspondence from the FDA andlor third party. The Recipient shall make arrangements, where practical, for a BARDA representativeis) to be present during the final debrief bv the regulatory:f inspector for audits of the Recipient. receiving notice of an ad hoc site visitislfauditis) if the FDA did not provide advanced notification. The Recipient will also provide copies of any FDA audit report received from Sub?Recipients that occur as a result of this Agreement or for the investigational compound within five business days of receiving correspondence from the FDA andlor third partv. 1' Within 10 business days of audit report, the Recipient will provide UTAS with a plan for addressing areas of nonconformance, if any exist. 57 it Type of Frequencw'Time Description of Deliverable Reporting Procedures QuantitvlForm Deliverable Periods 16. CIA Audit 5 business days The Recipient will inform the The Recipient will inform the 1 Electronic Reports of report and OTAS of upcoming, ongoing, and OTAS of upcoming, Copy to OTTR completion or recent auditsfsite visits of Sub? ongoing or recent audits/site and Recipients as a result of this . . . Upload to visits of Sub-ReCIpIents. Agreement and for the eRoom. investigational compound, or for any other FDA inspection that has the reasonable potential to impact the performance of this Agreement as part of the weeklv communications, including goals and agenda. BARDA reserves the right to participate in the audits. Upon completion of the auditg?site visit the Recipient shall provide a report capturing the findings, results and next steps in proceeding with the Sub? Recipient. If action is requested of the Sub?Recipient, details addressing areas of non- conformance to FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to BARDA. Recipient shall provide responses from the Sub?Recipients to address these concerns and plans for corrective action execution For avoidance of doubt, as our Sub?Recipients may be involved in other activities for the Recipient, the reportable audit information will only pertain to that which materially affects those programs funded under the Portfolio partnership. The Recipient will notifv the and DTAS within 5 business days of report completion. 58 if Type of Description of Deliverable Reporting Procedures Quantityj'Form Deliverable Periods BARDA Audit Ad Hoc The Recipient shall accommodate a If BARDA, the Recipient or other 1 Electronic for periodic or ad hoc site visits by parties identifies any issues Copy to OTTR BARDA. If BARDA, Recipient or during an audit, Recipient shall and other parties identifies any issues . . Upload to during an audit, Recipient shall capture the Issues, Identify eRoom. capture the issues, identify potential solutions and provide potential solutions and provide a a t0 BARDA within 10 report to BARDA. business days. I The OTTR and OTAS will review the deliverable and provide a response to Recipient. - Once any corrective action undertaken by Recipient is completed, Recipient will provide a final report to BARDA. 18. Animal Model Within 10 The Reoipient shall provide Animal The Recipient will provide 1 Electronic or Other business days of or Other Animal Model or other COPY '03 OTTR Technology request by Transfer Package relevant data. Technology Transfer Package and Transfer OTASIOTTR within 10 business days of Upfioad to Package request by porn. 19. Raw Data or Within 20 The Recipient shall provide Raw 4- The Recipient will provide Raw 1 Electronic Data Analysis business days, or Data 0" Data Analysis for Data or Data Analysis within 20 COPY t0 OTTR as available, by business days (or as available} Eli-1m: 0:115; after receipt of S: of request by OTASIOTTR. ep?zimo request by privacy policies.) OTASIOTTR 20. Press Releases 5 days prior to Recipient agrees to accurately and 0 Recipient shall ensure that 1 Electronic release factually represent the work BARDA has received an advanced Copy to OTTR conducted Under This Agreement copy of any press release and in all press releases concerning this Agreement not Upload to less than 5 business days prior to eRoom. the issuance of the press release 59 ATTACHMENT 3 60