" -' CORPORATE INTEGRITY AGREEMENT BETWEN mE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES AND CEPHAON, INC. I. PRAMBLE Cephalon, me. (Cephalon) hereby enters into this Corporate mtegrity Agreement (CIA) with the Offce ofInspector General (OIG) of the United States Deparent of Health and Human Services (HHS) to promot~ compliance with the statutes, regulations, and written directives of Medicare, Medicaid, and all other Federal health care programs (as defined in 42 U.S.c. ? 1320a-7b(t)) (Federal health care program requirements) and the Food and Drug Admistration (FDA requirements). Contemporaneously with this CIA, Cephalon is entering into a Settlement Agreement with the United States. Cephalon wil also enter into settlement agreements with varous States (Related State Settlement Agreements) and Cephalon's agreement to this CIA is a condition precedent to those agreements. with the statutes, regulations, and written directives of Prior to the Effective Date of this CIA (as defined below), Cephalon established a voluntar compliance program (lmown as "Global Compliance" or "Global Compliance Program") applicable to all Cephalon employees including employees.in Worldwide Pharaceutical Operations. Cephalon's Global Compliance Program includes an the Board of Executive Vice President, Chief Compliance Offcer who reports directly to the Audit Commttee of Directors and to the CEO, and a Compliance Commttee. The Global Compliance Progr?m also includes a Code of Conduct applicable to all employees that is regularly reviewed and disseminated, written policies and procedures that, as represented by Cephalon, promote high ethical standards, educational and training initiatives that, as represented by Cephalon, help to ensure compliance with applicable laws and regulations, a Disclosure Program that allows for the confidential disclosure and investigation of potential compliance violations and appropriate disciplinar procedures, screening measures for meligible Persons, and regular internal auditing procedures. Program throughout the term of this CIA and shall do so in accordance with the terms set fort below. Cephalon may modify its Cephalon shall continue its Compliance Corporate Integrity Agreement Cephal on, Inc. i , Compliance Program as appropriate, but, at a minimum, Cephalon shall ensure that during the term of this CIA, it shall comply with the obligations set fort herein. II. TERM AND SCOPE OF THE CIA obligations assumed by Cephalon under this CIA ths CIA, unless.otherwise specified. The effective date shall be the date on which the final signatory of this CIA executes ths CIA (Effective Date). Each one-year period, beginnng with the one-year period following the first day of the first calendar month following the Effective Date, shall be referred to as a A. The period of the compliance shall be five years from the effective date of "Reporting Period." B. Sections VII, IX, X, and XI shall expire no later than 120 days afer OIG's receipt of: (1) Cephalon's final Anual Report; or (2) any additional materials submitted by Cephalon pursuant to OIG's request, whichever is later. C. The scope of this CIA shall be governed by the following definitions: I. "Covered Persons" includes: a. all owners who are natural persons (other than shareholders who: (1) have an ownership interest ofless than 5%; and (2) acquired the ownership interest through public trading), officers, directors, and United States-based employees of Cephalon; and b. all contractors, subcontractors, agents, and other persons who perorm Promotional and Product Services Related Functions (as defined below in Section II.CA) on behalf of Cephalon. Notwithstanding the above, this term does not include par-time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work more than 160 hours per year, except that any such individuals shall become "Covered Persons" at the point when they work more than 160 hours durng the calendar year. Corporate Integrity Agreement Cephalon, Inc. 2 2. ''Relevant Covered Persons" includes all Covered Persons whose job responsibilties relate to Promotional and Product Services Related Functions. 3. "Governent Reimbursed Products" refers to all Cephalon products that are reimbursed by Federal health care programs. This term includes products that are promoted by Cephalon for which it may not hold the New Drug Application. 4. The ter "Promotional and Product Services Related Functions" includes: (a) the promotion, marketing, and sale of Governent Reimbursed Products; and (b) the development or dissemination of materials or information about, or the provision of services relating to, Governent Reimbursed Products. 5. The term ''Tird Par Educational Activity" shall mean any continuing medical education (CME), independent medical education (!ME), disease awareness, or other scientific, educational, or professional program, meeting, or event sponsored by Cephalon, including but not limited to, sponsorship of symposia at medical conferences. ~. The term "Third Par Personnel" shall mean personnel of the entities with whom Cephalon has or may in the future enter into agreements to co-promote a Governent Reimbursed Product in the United States or engage in joint promotional activities in the United States relatig to such a product. Cephalon has represented that: (1) the Third Par P~rsonnel are employed by other independent entities; (2) Cephalon does not control Third Par Personnel; and (3) it would be commercially impracticable to compel the compliance of Third Par Personnel with the requirements set forth in this CIA. Cephalon agrees to promote compliance by Third Par Personnel with Federal health care program and FDA requirements by complying with the provisions set fort below in Sections m.B.2, V.A.3, and V.BA related to Third Par Personnel who meet the definition of Covered Persans. Provided that Cephalon complies with the requiements of Sections III.B.2, V.A.3, and V.BA, Cephalon shall not be required to fulfll the other CIA Corporate Integrity Agreement Cephal on, Inc. 3 obligations that would otherwise apply to Third Par Personnel who meet the defintion of Covered Persons. III. CORPORATE INTEGRITY OBLIGATIONS of Cephalon shall establish and maintain a Compliance Program throughout the term this CIA that includes the following elements: A. Comoliance Responsibilties of Chief Comoliance Offcer. Compliance Committee. the Board of Directors. and Management Certifications. 1. Chief Compliance Offcer. Prior to the Effective Date, Cephalon appointed a Chief Compliance Offcer, and Ceplialon shall maitain a Chief Compliance Offcer during the term of the CIA. The Chief Compliance Offcer shall be responsible for developing and implementing policies, pr()cedures, and practices designed to ensue compliance with the requirements set forth in this CIA and with Federal health care program requirements and FDA requirements. The Chief Compliance Offcer is and shall continue to be a member of executive management of Cephalon, shall make periodic (at least quarerly) reports regarding compliance matters diectly to the Audit Committee of the Board of Directors of Cephalon, and shall be authoried to report on such matters to the Board of Directors at any time. The Chief Compliance Offcer shall not be or be subordinate to the General Counelor Chief Financial Offcer. The Chief Compliance Offcer shall be responsible for monitoring the day-to-day compliance activities engaged in by Cephalon as well as for any reporting obligations creat?d under this CIA. Cephalon shall report to 01G, in writing, any changes in the identity or position description of the Chief Compliance Offcer, or any actions or changes that would affect the Chief Compliance Officer's abilty to perform the duties necessar to meet the obligations in this CIA, within 15 days afer such a change. 2. Compliance Committee. Prior to the Effective Date, Cephalon established a Compliance Committee, and Cephalon shall maintain a Compliance Commttee during the term of this CIA. The Compliance Commttee shall, at a minimum, include the Chief Compliance Officer and other members of senior management necessar to meet the requirements of this CI ~ senior managers of relevant deparents, such as legal, medical affairs, sales, marketing, human resources, and internal audit). The Chief Compliance Offcer shall chair the Compliance Commttee and the Committee shall support the Chief Compliance Offcer in fulfilling his/her Corporate Integrity Agreement Cephal on, Inc. 4 responsibilties (~ shall assist in the analysis of the organzation's risk areas and shall receive reports on compliance-related monitoring, audits, and investigations). Cephalon shall report to OIG, in writing, any changes in the composition of the Compliance Conuittee, or any actions or changes that would affect the Compliance Committee's abilty to perform the duties necessar to meet the obligations in this CIA, within 15 days after such a change. 3. Board of Directors. . The Board of Directors (Board) or a Commttee of the Board, if applicable, shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements, FDA requirements, and the obligations of this CI. The Board, or a Commttee of the Board, shall, at a minimum, be responsible for the following: a. meeting at least quarerly to review and oversee Cephalon's Global Compliance Program, including but not limted to the pedormance of Compliance Offcer and Global Compliance the Chief deparent. b. for each Reporting Period of the CIA, adopting a resolution review and oversight of Cephal (puruant to. the process outlined in the bylaws for adopting resolutions) sumarzing its on's compliance with Federal health care program this CIA. Each individual member of the Board or, if applicable, each member of the Commttee of the Board having responsibilty for compliance, shall sign a statement indicating that he or she agrees with the resolution. requirements, FDA requirements, and the obligations of At minimum, the resolution shall include the following language: liThe Board of Directors (or a Conuittee of the Board) has made a reasonable inquiry into the operations of Cephalon's Global Compliance Program including the performance of the Chief Compliance Offcer and the Global Compliance deparent. Based on its inquiry, the Board (or Committee) has concluded that, to the best of its lrowledge, Cephalon has implemented an effective Global Compliance Program to meet the Federal health care program requirements, FDA requirements, and the obligations of the CIA." Corporate Integrity Agreement Cephal on, Inc. 5 If the Board (or the Board Commttee) is unable to provide such a conclusion in the resolution, the Board (or Commttee) shall include in the resolution a written explanation of the reasons why it is unable to provide the conclusion and the steps it is takg to implement an effective Compliance Program at Cephalon. Cephalon shall report to OIG, in wrting, any changes in the composition of Board, or any actions or changes that would afect the Board's abilty to perfonn the the duties necessar to meet the obligations in this CIA, within 15 days after such a change. 4. Management Accountabilty and Certifcations: Cephalon represents ?hat compliance is a component of each employee's performance objectives. In addition to the responsibilties set fort in this CIA for all Covered Persons,. certain Cephalon employees ("Certifying Employees") are specifically expected to monitor and oversee activities within their areas of authority and shall anually cerify in writing or electronically that the applicable area of authority is compliant with Federal health care program requirements, FDA requirements, and the obligations of this CIA. The Certifying Employees include, at a minimum the following: Chairan and Chief Executive Offcer, Executive Vice President of Worldwide Medical and Regulatory Worldwide Pharaceutical Operations, all. Operations, Executive Vice President of business unit sales vice presidents, all business unt marketig vice presidents, all business unit sales directors, all business unit marketing diectors, the Vice President of Worldwide Medical Affais, and all medical directors of communcations and medical science liaisons (MSLs). For each Reporting Period, each Certifying Employee shall certify in writing or electronically that: "I have been trained on and understand the compliance requirements and responsibilties as they relate to (deparent or fuctional area), an area under my supervision. My job responsibilities include ensuring _ (insert name of the deparent or functional area.) To the best of compliance with regard to the my lmowledge, except as otherwise described herein, the (insert name of deparent or fuctional requirements, FDA requirements, and the obligations of area) of Cephalon is in compliance with all applicable Federal health care program the CIA." Corporate Integrity Agreement Cephalon, Inc. 6 B. Written Standards. I. Code of Conduct. Prior to the Effective Date, Cephalon developed, implemented, and distrbuted a written C?de of Conduct to all Covered Persons. Cephalon curently requires all newly employed persons to cerify in writing or electronically that they have received, read, understood, and shall abide by Cephalon's Code of Conduct. Cephalon shall continue to mae the promotion of, and adherence to, the Code of Conduct an element in evaluating the perormance of all employees. The Code of Conduct sets fort and shall continue to set fort, at a mimum, the following: a. Cephalon's commtment to full ?ompliance with all Federal health care program and FDA requirements, including its commtment to market, sell, promote, research, develop, provide informtion about, and advertise its products in accordance with Federal health program requirements and FDA requirements; its Covered Persons shall be expected to comply with all Federal health care program and FDA requirements and with Cephalon's own Policies and Procedures as implemented pursuant to Section III.B (including the requirements of this CIA); b. Cephalon's requirement that all of c. the requirement that all of Cephalon's Covered Persons shall be expected to report to the Chief Compliance Offcer, or other appropriate individual designated by Cephalon, suspected violations of any Federal health care program and FDA requirements or of Cephalon's own Policies and Procedures; d. the possible consequences to both Cephalon and Covered Persons of failure to comply with Federal health care program and FDA requirements and with Cephalon's own Policies and Procedures and the failure to report such noncompliance; and e. the right of all individuals to use the Disclosure Program described in Section m.E, and Cephalon's commitment to nonretaliation and to Corporate Integrty Agreement Cephal on, Inc. 7 maintain, as appropriate, confidentiality and anonymty with respect to such disclosures. To the extent not already accomplished, within 120 days after the Effective Date, the Code of Conduct shall be distributed to each Covered Person and each Covered Person shall certfy, in writing or electronically, that he or she has received, read, understood, and shall abide by Cephalon's Code of Conduct. New Covered Persons shall receive the Code of Conduct and shall complete the required certification within 30 days after becoming a Covered Person or within 120 days afer the Effective Date, whichever is later. Cephalon shall perodically review the Code of Conduct to determe if revisions are appropriate and shall make any necessar revisions based on such review. Any revised Code of Conduct shall be distrbuted within 30 days afer any revisions are finalized. Each Covered Person shall certify, in writing or electronically, that he or she has received, read, understood, and shall abide by the revised Code of Conduct within 30 . days after the distribution of the revised Code of Conduct. 2. Third Party Personnel. Within 90 days after the Effective Date, and anually thereafer by the aniversar of the Effective Date, Cephalon shall send a letter to each entity employing Third Par PersonneL. The letter shall outline Cephalon's obligations under the CIA and its commitment to full compliance with all Federal health care program and FDA requirements. The letter shall include a description of Cephalon's Compliance Program. Cephalon shall attach a copy of its Code of Conduct to the letter and shall request the entity employing Third Par Personnel to either: (a) make a copy of Cephalon's Code of Conduct and a description of Cephalon' s Compliance Program available to its Third Pary Personnel; or (b) represent to Cephalon that it has and enforces a substantially comparable code of conduct and compliance program for its Third Par PersonneL. 3. Policies and Procedures. Prior to the Effective Date, Cephalon implemented wrtten Policies and Procedures regarding the operation of the Complian?e Program and Cephalon's compliance with Federal health care program and FDA requirements (policies and Procedures). To the extent not already accomplished, within 120 days after the Effective Date, Cephalon shall ensure that the Policies and Procedures address or shall continue to address: Corporate Integrity Agreement Cephal on, Inc. 8 a. the subjects relating to the Code of Conduct identified in Section m.B.!; b. appropriate ways to conduct Promotional and Product Services Related Functions in compliance with all applicable Federal healthcare program requirements, including, but not limited to the Federal anti-kickback statute (codified at 42 U.S.C. ? I 320a-7b ), and the False Claims Act (codified at 31 V.S.C. ?? 3729-3733); c. appropriate ways to conduct Promotional and Product Services Related Functions in compliance with all applicable FDA requirements; d. the mechanisms though, and maer in which, Cephalon receives and responds to requests for information about non-FDA approved (or "off-label") uses of Cephal on's products; the form to such requests; and the internal and content of infonntion disseminated by Cephalon in response review process for the information disseminated. The Policies and Procedures shall include a requirement that . Cephalon develop a database to track requests for inormation about Cephalon' s products that are made to Cephalon' s Medical Services (MS) deparent. This database shall be referred to as the "Inquiries Database." The hiquiries Database shall include the following items of information for each unique inquir (Inquiry) received for information about Cephalon's products: I) , date ofhiquiry; 2) form of Inquir ?t fax, phone, etc.); 3) request (including name of the requestig health care professional (HCP) or health care institUtion (HCI); 4) nature and topic of exact language of the Inquir if made in wrting); 5) natue/form of the response from Cephalon (including a record of the materials provided to the HCP or HCI in response to the request); and 6) the name of the Cephalon representative who called on or interacted with the HCP or HCI. Any response from Medical Services to an HCP or HCI shall identify whether the information provided addresses an indication that is par of the approved Corprate Integrity Agreement Cephalon, Inc. 9 product labeL. The statu aid findings of any follow-up review conducted by Cephalon in situations in which it appears that the hiquiry may have related to improper off-label promotion shall be maintained by Global Compliance and the informtion shal be included in the Inquiry Reports fuher discussed in Section IIT.A.2 of Appendix B; e. development of call plans for field sales representatives who promote Governent Reimbursed Products. For each product, the Policies and Procedures shall require that Cephalon review the call plans for the product and the bases upon which specified physician specialties and institutional provider tyes are included in, or excluded from, the call plans. The Policies and Procedures shall also require that Cephalon modify the call plans as necessar to ensure that Cephalon is promoting its products in a maer that complies with aU applicable Federal health care. program and FDA requirements. The call plan reviews shall occur at least anually and shall.also occur each time the FDA approves a new or additional indication for a Governent Reimbursed Product; f. consultant or other fee-for-service arangements entered into with HCPs or HCIs (including, but not limited to, speaker program, speaker traiing programs, advisory boards, or any other financial relationship with an HCP or HCI) and all events and expenses relating to such engagements or arangements. These Policies and Procedures shall be designed to ensure that the argements and related events are used for legitimate and lawful puroses in accordance with applicable Federal health care program and FDA requirements. The Policies and Procedures shall include requirements about the content and circumstaces of such arangements and events; g. programs to educate field representatives, including preceptorships. These Policies and Procedures shall be designed to ensure that the programs are used for legitimate and lawfu puroses in accordance with applicable Federal health care Corporate Integrity Agreement Cephal on, Inc. 10 program and FDA requirements. The Policies shall include requirements about the content and circumstances of such arangements and events; h. sponsorship or funding of grants (includig educational grants) or chartable contributions. These Policies and Procedures shall be designed to ensure that Cephalon's fuding and/or sponsorship complies with all applicable Federal health care program and FDA requirements; i. funding of, or paricipation in, any Third Par Educational Activity. These Policies and Procedures shall be designed to ensure that Cephalon' s fuding and/or sponsorship of such programs satisfies all applicable Federal health care program and FDA requirements. The Policies and Procedures shall require that: 1) Cephalon disclose its financial support of the Third Par Educational Activity and any financial relationships with faculty, speakers, or organizers at such Activity; 2) as a condition of fuding, the third par shall agree to disclose Cephalon's financial support of the Third Par Educational Activity and any financial relationships that Cephalon might have with faculty, speakers, or organers at such Activity; 3) any faculty, speakers, or organizers at the Third Par Educational Activity disclose any fmancial relationship with Cephalon; 4) the Thrd Par Educational Activity have an educational focus;. 5) the content, organization, and operation of the Third Par Educational Activity be independent of Cephalon control; 6) Cephalon support only Third Par Educational Activity that is non-promotional in tone/natue; and 7) Cephalon's support of a Third Par Educational Activity shall be contingent on the provider's commitment to provide information at the Educational Activity that is fair, balanced, accurate and not misleadig; j. review of promotional materials by appropriate qualified personnel (such as regulatory, medical, and/or legal personnel), . . Corporate Integrity Agreement Cephalon, Inc. 11 and the review of other materials and information intended to be disseminated outside Cephalon in a maier designed to ensure that legal, reguatory, and medical concerns are properly addressed durg Cephalon' s review and approval process and are elevated when appropriate. The Policies and Procedures shall be designed to ensure that such materials and inormation, when finally approved, comply with all applicable Federal health care program and FDA requirements; k. sponsorship or fuding of research or related activities. These Policies and Procedures shall be designed to ensure that Cephalon's funding and/or sponsorship complies with all applicable Federal health care progr and FDA requirements; 1. compensation (including salares and bonuses) for Relevant Covered Persons. These Policies and Procedures shall be designed to ensure that financial incentives do not inappropriately motivate such individuals to engage in improper promotion, sales, and marketig of Cephal on's products; m. disciplinar policies and procedures for violati~ns of Cephal on's Policies and Procedures, including policies relating to Federal health care program and FDA requirements. To the extent not already accomplished, within 120 days afer the Effective Date, the relevant portions of the Policies and Procedures shall be made available to all individuals whose job fuctions relate to those Policies and Procedures. Appropriate and knowledgeable staff shall be available to explain the Policies and Procedures. At least anually (and more frequently, if appropriate), Cephalon shall assess and update, as necessar, the Policies and Pr?cedures. Within 30 days afer the effective date of any revisions, the relevant portions of any such revised Policies and Procedures shall be made available to all individuals whose job functions relate to those Policies and Procedures. Corporate Integrity Agreement Cephalon, Inc. 12 C. Traininiz and Education. Cephalon represents that it provides training to its employees on a regular basis concerning a variety of topics. The training required by this CIA need not be separate and distinct from the regular training provided by Cephalon, but instead may be integrated fully into such regular training so long as the traiing covers the areas specified below. 1. General Training. Within 120 days after the Effective Date, Cephalon shall provide at least two hours of General Training to each Covered Person. This training, at a miimum shall explai Cephalon's: a. CIA requirements; and b. Cephalon's Compliance Program (including the Code of Conduct and the Policies and Procedures as they pertain to general compliance issues). To the extent that Cephalon provided General Training to Covered Persons durg the 180 days immediately prior to the Effective Date that satisfied the requirements set fort in Section III.C. l.b above, the OIG shall credit that training for puroses of satisfying Cephalon's General Training obligations of Section III.C.1 for the first Reporting Period. Cephalon may satisfy its remaining General Training obligations for the Covered Persons who received the training described in the preceding sentence by notifying them within 90 days after the Effective Date in writing or in electronic format of the fact that Cephalon entered a CIA and providing an explanation of Cephal on's requirements and obligations under the CIA. New Covered Persons shall receive the General Training described above within 30 days after becoming a Covered Person or within 120 days afer the Effective Date, whichever is later. Afer receiving the initial General Traiing described above,.each Covered Person shall receive at least one hour of General Training in each subsequent Reporting Period. 2. Specifc Training. Within 120 days afer the Effective Date, each Relevant Covered Person shall receive at least three hours of Specific Traiing in addition to the General Training required above. . on. Inc. Corporate Integrity Agreement Cephal 13 This Specific Training shall include a discussion of: a. all applicable Federal health care program requirements relating to Promotional and Product Services Related Functions; b. all applicable FDA requirements relating to Promotional and Product Services Related Functions; c. all Cephalon policies, procedures, and other requirements applicable to Promotional and Product Services Related Functions; d. the personal obligation of each individual involved in Promotional and Product Services Related Functions to comply with all applicable Federal health care program and FDA requirements and all other applicable legal requirements; e. the legal sanctions for violations of the applicable Federal health care program and FDA requirements; and f. examples of proper and improper practices related to Promotional and Product Services Related Functions. To the extent that Cephalon provided Specific Training to Relevant Covered Persons durg the 180 days immediately prior to the Effective Date that satisfied the requiements set forth in Section II.C.2 above, the OIG shall credit that traing for this Section III.C.2 for purposes of satisfying Cephalon's Specific Training obligations of the first Reporting Period. New Relevant Covered Persons shall receive this traiing within 30 days after the begiing of their employment or becoming Relevant Covered Persons, or with 120. days after the Effective Date, whichever is later. A Cephalon employee who has completed the Specific Training shall review a new Relevant Covered Person's work, to the extent that the work relates to Promotional and Product Services Related Functions, until such time as the new Relevant Covered Person completes his or her Specific Training. Corporate Integrity Agreement Cephalon, Inc. 14 After receiving the initial Specific Training described in this Section, each Relevant Covered Person shall receive at least two hours of Specific Traiing in each subsequent Reportg Period. 3. Certifcation. Each individual who is required to attend training shall certify, in writing or electronically, that he or she has received the required training. The certification shall specify the tye of training received and the date received. The Compliance Officer ( or designee) shall retain the certifications, along with all course materials. These shall be made available to OIG, upon request. 4. Qualifcations of knowledgeable about the subject area of Trainer. Persons providig the traiing shall be the training, including applicable Federal health care program and FDA requirements. The traiing and education required under this Section III.C may be provided by supervisory employees, knowledgeable staff, Cephalon trainers, and/or outside consultant trainers selected by Cephalon or may be satisfied by relevant, accredited continuing education program provided they cover topics outled above in Section III.C.2. 5. Update of Training. Cephalon shall review the training anually, and, where appropriate, update the traig to reflect changes in Federal health care program requirements, FDA requirements, any issues discovered durg any internal audits or any IRO Review, and any other relevant information. 6. Computer-based Training. Cephalon may provide the training required under this CIA though appropriate computer-based traing approaches. If Cephalon chooses to provide computer-based traiing, it shall make available appropriately qualified and knowledgeable staff or trainers to answer questions or provide additional information to the individuals receiving such trainig. In addition, if Cephalon chooses to provide computer-based General or Specific Traiing, all applicable requirements to provide a number of "hours" of training in this Section III.C may be met with respect to computer-based training by providing the required number of "normative" hours as that ter is used in the computer-based training industr. Corporate Integrity Agreement Cephal on, Inc. 15 D. Review Procedures. I. General Description. a. Engagement of Independent Review Organization. Within 90 days afer the Effective Date, Cephalon shall engage an entity (or entities), such as an accounting, auditing, or consulting firm (hereinafter "Independent Review. Organization" or "IRQ"), to perfot1 reviews to assist Cephalon in assessing and evaluating its Promotional and Product Serices Related Functions. The applicable requiements . relating to the IRQ are outlined in Appendix A to this CIA, which is incorporated by reference. Each IRO engaged by Cephalon shall have expertise in applicable Federal health care program and FDA requiements as may be appropriate to the Review for which the IRO is retained. Each IRO shall assess, along with Cephalon, whether it can perform the engagement in a professionally independent and objective fashion, as appropriate to the natue of the review, takng into account any other business relationships or other engagements that may exist. The IRO(s) shall conduct reviews that assess Cephalon's systems, processes, policies, procedures, and practices relatig to Promotional and Product Services Related Functions (Promotional and Product Servces Reviews). b. Frequency and Brief Description of Reviews. As set fort more fully in Appendix B, the Promotional and Product Services Review shall consist of two components - a Systems Review and a Transactions Review. The Systems Review shall assess Cephalon's systems, processes, policies, and procedures relating to Promotional and Product Services Related Functions. If there are no material changes in Cephalon's systems, processes, policies, and procedures relating to Promotional and Product Services Related Functions, the Promotional and Product Services Systems Review shall be performed for the periods covering the first and fourh Reporting Periods. If Cephalon materially changes its systems, processes, Corporate Integrity Agreement Cephalon. Inc. 16 policies, and procedures relating to Promotional and Product Services Related Functions, the IRO shall perform a Systems Review for the Reporting Period in which such changes were made in addition to conducting the Systems Review for the first and four Reporting Periods. The Promotional and Product Services Transactions Review shall be performed anually and shall cover each of the five Reportg Periods. The IRO(s) shall perform all components of each anual Transaction Review. As set fort more fully in Appendix B, the Transactions Review shall include several components, including a review relating to hiquires included in Cephalon's Inquiries Databas~, a review of Cephal on's Call Plan Assessments, and a review of a records relating to a sample of the Payments that are reported by Cephalon pursuant to Section m.M below. hi addition, beging with the second Reporting Period, each Transactions Review shall also include a review of up to thee additional areas or practices of Cephalon identified by the OIG in its discretion (hereafer "Additional Items"). For puroses of identifying the Additional Items to be included in the Transactions Review for a paricular Reporting Period, the OIG wil consult with Cephalon and may consider internal audit work conducted or planed by Cephalon, Cephalon's product portolio, the nature and scope of Cephalon's promotional practices and mangements with HCPs, and other information lmown to it. As set fort more fuly in Section m.D of Appendix B, Cephalon may propose to the OIG that its internal audit(s) be parially substituted for one or more of the Additional Items that would otherise be reviewed by the IRO as par of the Transactions Review. The OIG retains sole discretion over whether, and in what maner, to allow Cephalon's internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify Cephalon of the natue and scope of the lRO review for each of the Additional Items no later than 90 days prior to the end of the second through fift Reporting Periods. Prior to Corprate Integrty Agreement Cephalon, Inc. 17 underaking the review of the Additional Item, the IRO and/or Cephalon shall submit" an audit work plan to the OIG for approval and the IRO shall conduct the review of the Additional Items based on a work plan approved by the OIG. c. Retention of Records. The IRO and Cephalon shall retain and make available to OIG, upon request, all work papers, supporting documentation, correspondence, and draft reports (those exahanged between the IRO and Cephalon) related to the reviews. 2. IRO Review Reports. The IRO(s) shall prepare a report (or reports) based upon each Review performed. The informtion and content to be included in the report is described in Appendix B, which is incorporated by reference. 3. Validation Review. In the event OIG has reason to believe that: (a) any IRO Review fails to conform to the requirements of ths CI; or (b) the IRO's findings or Review results are inaccurate, OIG may, at its sole discretion, conduct its own review to determine whether the applicable IRO Review complied with .the requirements of the CIA and/or the findiigs or Review results are inaccurate (Validation Review). Cephalonshall pay for the reasonable cost of any such review performed by OIG or any of its designated agents. Any Validation Review of Reports submitted as par of Cephal on's final Anual Report shall be initiated no later than one year after Cephalon's fmal submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Cephalon of its intent to do so and provide a written explanation of why OIG believes such a review is necessary. To resolve any concerns raised by OIG, Cephalon may request a meeting with OIG to: (a) discuss the results of any Review submissions or findings; (b) present any additional information to clarify the results of the applicable Review or to correct the inaccuracy of the Review; and/or (c) propose alternatives to the proposed Validation Review. Cephalon agrees to provide any additional information as may be requested by OIG under this Section III.D.3 in an expedited maner. OIG wil attempt in good faith to resolve any Review issues with Cephal?n prior to conducting a Validation Review. However, the fmal determination as to whether or not to proceed with a Validation Review shall be made at the sole discretion of OIG. Corporate Integrity Agreement Cephal on. Inc. 18 4. Independence and Objectivity Certification. The IRO shall include in its report( s) to Cephalon a certification or sworn affidavit that it has evaluated its the professional independence and objectivity, as appropriate to the natue of engagement, with regard to the applicable Review and that it has concluded that it is, in fact, independent and objective. E. Disclosure Proizam. Cephalon represents that it has a disclosure program designed to faciltate communications relating to compliance with Federal health care program and FDA requirements and Cephalon's policies (the "Disclosure Program"). During the term of the CIA, Cephalon shall maitain a Disclosure Program that includes a mechansm (a tollfree compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual's chai ofcnmmand, any identified issues or questions associated with Cephalon's policies, conduct, practices, Qr procedures with respect to a Federal health care program or FDA requirement believed by the individual to be a potential violation of criinal, civil, or admistrative law. Cephalon shall continue to appropriately publicize the existence of the disclosure mechanism (U, via periodic e-mails to employees or by posting the informtion in promient common .areas). The Disclosure Program shall emphasize a nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confdentiality shall be maintained. Disclosures made by individuals residing outside the United States shall be in accordance with applicable laws, including the European Union Data Protection Directive. Upon receipt of a disclosure, the Compliance Offcer (or designee) shall gather all relevant information from the disclosing individuaL. The Compliance Officer (or designee) shall make a prelimar, good faith inquiry into the allegations set fort in every disclosure to ensure that he or she has obtaied all of the information necessar to determine whether a furter review should be conducted. For any disclosure that is sufficiently specific so that it reasonably: (1) permts a deternation of the appropriateness of the alleged improper practice; opportity for takg corrective action, Cephalon shall conduct an internal review of and (2) provides an the allegations set fort in the disclosure and ensure that proper follow-up is con~ucted. The Compliance Offcer ( or designee) shall maintain a disclosure log, which shall include a record and sumar of each disclosure received (whether anonymous or not), Corporate Integrity Agreement Cephalon, Inc. 19 the status of the respective internal reviews, and any corrective action taken in response to the interal reviews. The disclosure log shall be made available to OIG upon request. F. Ineligible Persons. 1. Definitions. For puroses of this CIA: a. an "hieligible Person" shall include an individual or entity who: i. is curently excluded, debared, suspended, or otherwise ineligible to paricipate in the Federal health care program or in Federal procurement or nonprocurement program; or ii. has been convicted of a criminal offense that falls within the ambit of 42 U.S.C. ? 1320a-7( a), but has not yet been excluded, debared, suspended, or otherwise declared ineligible. b. "Exclusion Lists" include: Excluded hidividuals/Entities (available through the Internet at http://ww.oig.hhs.gov); and i. the HHS/OIG List of ii. the General Services Administration's List of Pares Excluded from Federal Program (available though the hiternet at htt://ww.eols.gov). c. "Screened Persons" include: prospective and curent owners of Cephalon (other than shareholders who: (1) have an ownership interest of less than 5%; and (2) acquired the ownership interest through public trading); and prospective and curent offcers, directors, employees, and contractors and agents of Cephalon. For puroses of employees residing outside the United States, "Screened Persons" shall be limited to Covered Persons. Corporate Integrity Agreement Cephalon, Inc. 20 2. Screening Requirements. Cephalon shall ensure that all Screened Persons are not hieligible Persons, by implementing the following screening requirements. a. Cephalon shall screen all Screened Persons agaist the Exclusion Lists prior to engaging their services and, as par of the hiring or contracting process, shall require such Screened Persons to disclose whether they are hieligible Persons. b. Cephalon shall screen all Screened Perons against the Exclusion Lists within 90 days afer the Effective Date and on an anual basis thereafter. c. Cephalon shall implement a policy requiring all Screened Persons to disclose immediately any debarent, exclusion, suspension, or other e~ent that makes that person an Ineligible Person. Nothing in this Section affects the responsibilty of (or liabilty for) Cephalon to refrain (if applicable) from biling Federal health care program for items or. services furished, ordered, or prescribed by an hieligible Person. Cephalon understads that items or services fuished by excluded persons are not payable by Federal health care programs and that Cephalon may be liable for overpayments (if applicable) and/or criminal, civil, and administrative sanctions for employing or contracting with an excluded person regardless of whether Cephalon meets the requirements of Section II.F. 3. Removal Requirement. If Cephalon has actual notice that a Screened Person has become an hieligible Person, Cephalon shall remove such Screened Person from responsibilty for, or involvement with, Cephalon's business operations related to the Federal health care programs and shall remove such Screened Person from any position for which the Screened Person's compensation or the items or serices fuished, ordered, or prescribed by the Screened Person are paid in whole or par, directly or indirectly, by Federal health care program or otherise with Federal funds at least until such time as the Screened Person is reinstated into participation in the Federal health care programs. 4. Pending Charges and Proposed Exclusions. IfCephalon has actual notice that a Screened Person is charged with a criminal offense that falls with the Corporate Integrty Agreement Cephal on, Inc. 21 ambit of 42 U.S.C. ?? 1320a-7(a), 1320a-7(b)(1)-(3), or is proposed for exclusion durng the Screened Person's employment or contract term, Cephalon shall take all appropriate actions to ensure that the responsibilties of that Screened Person have not and shall not adversely affect the accuracy of any claims submitted to any Federal health care program. G. Notification of Governent hivestigation or Leizai Proceedings. Withn 30 days afer discovery by senior management at U.S. corporate headquarers, Cephalon shall notify OIG, in wrting, of any ongoing investigation or legal proceeding known to Cephalon conducted or brought by a governental entity or its agents involving an allegation that Cephalon has commtted a crime or has engaged in fraudulent activities. This notification shall include a description of the allegation, the identity of the investigating or prosecuting agency, and the status of such investigation or legal proceeding. Cephalon shall also provide written notice to OIG within 30 days afer the resolution of the matter, and shall provide OIG with a description of the findings and/or results of the investigation or proceedings, if any. H. Reoortiniz. 1. Reportable Events. a. Definition of Reportable Event. For puroses of this CIA a ''Reportable Event" means anyting that involves: i. a matter that a reasonable person would consider a probable violation of crimal, civil, or administrative laws applicable to any Federal health care program and/or applicable to any FDA requirements relating to the promotion of Cephalon products for which penalties or exclusion may be authorized; or ii.. the filing of a banptcy petition by Cephalon. A Reportable Event may be the result of an isolated event or a series of occurrences. Corporate Integrity Agreement Cephalon, Inc. 22 b. Reporting of Reportable Events. If Cephalon deteres (afer a reasonable opportunity to conduct an appropriate review or investigation of the allegations) through any means that there is a Reportable Event, Cephalon shall notify OIG, in writing, within 30 days after making the deternation that the Reportable Event exists. The report to OIG shall include the following information: i. a complete description of the Reportable Event, including the relevant facts, persons involved, and legal and Federal health care program and/or FDA authorities implicated; ii. a description of Cephal on's actions taken to correct the Reportable Event; and iii. any furher steps Cephalon plans to take to address the Reportable Event and prevent it from recurg. iv. If the Reportable Event involves the filing ofa banptcy petition, the report to the OIG shall include documentation of the filing and a description of any Federal health care progr authorities and/or FDA authorities implicated. v. Cephalon shall not be required to report as a Reportable Event any matter previously disclosed under Section II.G above. i. Notification of Communications with FDA. Within 30 days afer the date of any written report, correspondence, or communication between Cephalon and the FDA that materially discusses Cephalon's or a Covered Person's actual or potential unlawful or improper promotion of Cephal on's products (including any improper dissemiation of indications), Cephalon shall provide a copy of inormation about off-label . the report, correspondence, or communication to the OIG. Cephalon shall also provide written notice to the OIG within 30 days after the resolution of any such disclosed off-label matter, and shall provide the OIG with a description of the findings and/or results of the matter, if any. Corprate Integrity Agreement Cephalon, Inc. 23 J. Review of Records ReflectinlZ the Content ofDetailinlZ Sessions. Cephalon shall implement a Message Recall Monitoring Program designed to identify, for each Reporting Period, potential-off-label promotional activities by Cephalon's field sales force though the analysis of studies generated by an independent the maketing messages delivered by entity (Surey Entity) reflecting physician recall of Cephalon's sales force (Message Recall Studies) for up to thee Covered Products (as defined below). Cephalon shall obtain Message Recall Studies for eac~ Reporting Period. In order to satisfy its obligations under ths Section III.J, Cephalon may propose that it obtai an alternative tye of surey record ~ verbatims or similar records) rather than Message Recall Studies. The OIG wil consider Cephalon's proposal, and after considerig Cephalon's proposal shall, in its discretion, identify the tye of surey records to be obtained. with the Surey Entity to. For each Reporting.Period and for each Covered Product, Cephalon shall contract conduct Message Recall Studies. The OIG shall select and notify the Surey Entity of a one week period within every other quarer of the Reporting Period for which the Message Recall Studies shall be conducted beginning in the second full quarer after the Effective Date. For each Covered Product, Cephalon shall obtain Message Recall Studies coverig the identified week in all regions across the United States. Prior to the star of the second Reporting Period and every Reporting Period thereafter, based on the inormtion provided and other information mown to it, and after consultation with Cephalon, the OIG shall select up to three Governent Reimbursed Products to be the basis for the review outlied in ths Section III. and shall notif Cephalon of its selection. These identified products shall be mown as the "Covered Products." The pares have already identified the Covered Products for the first Reporting Period. Cephalon shall review the records obtaied from the Surey Entity and shall identify any instances in which the records appear to indicate that Covered Persons may the Covered have discussed and/or disseminated information about off-label uses of Products. Cephalon shall make findings based on its review (Off-Label Findings) and shall take any responsive action it deems necessar. If necessar for puroses of its review, Cephalon shall endeavor to gather additional factual information about the circumtances relating to any Off-Label Findings. As par of each Anual Report, Corporate Integrity Agreement Cephal on, Inc. 24 Cephalon shall provide the OrG with copies of interactions, a copy of Cephal the underlyig records of on's Off-Label Findigs, and a description of the detaling the action(s), if any, Cephalon took in response to the Off-Label Findings. K. Field Force Monitoring and Review Efforts. To the extent not already accomplished, within 120 days afer the Effective Date, Cephalon shall establish a FieldForce Monitoring Program (FFMP) to evaluate and monitor field sales force representatives' interactions with HCPs. The FFMP shall be a formlized process designed to directly observe the appropriateness of field sales force representative's interactions with HCPs and to identify potential off-label promotional activities. . Under this program, Cephalon compliance personnel, or appropriately trained designees who are not from marketing or the field sales organzations and who are not within three levels of the field sales force representative's reporting strcture, shall conduct direct field observations (Observations) offield sales force representatives to assess whether the messages delivered and materials distrbuted to HCPs are consistent with Cephalon's Policies and Procedures. These Observations shall be full day ridealongs with field sales representatives, and each Observation shall consist of directly observing all meetings between a sales representative and HCPs durg the workday. The Obserations shall be scheduled throughout the year, randomly selected by Cephalon compliance personnel, include each therapeutic area and actively promoted product, and be conducted across the United States. At the completion of each Obseration, Cephalon compliance personnel or the designee shall prepare a report which includes: 1) the identity of the sales representative; 2) the identity of 3) the date and duration of the Cephal on compliance professiona; the Observation; 4) the product(s) promoted durg the Observation; 5) an overall assessment of compliance with Cephalon policy; and 6) the identification of any potential off-label promotional activity by the field sales representative. Cephalon compliance personnel shall conduct at least 30 full-day Observations during each Reportng Period. The number of inpections conducted for each therapeutic Corporate Integrity Agreement Cephalon, Inc. 25 area and product shall be proportonal in number to the size of each therapeutic area and product, and shall be conducted across the United States. In the event that a compliance issue, including potential off-label promotion, is identified during any Obseration, Cephalon shall investigate the incident consistent with .established Policies and Procedures for the handling of investigations. As par of the forml investigation procedures, findings shall be made and all necessar and appropriate responsive action (including disciplinar action) and corrective action shall be taken. The Compliance Offcer shall ~isclose Reportable Events pursuant to Section TI.H above, if applicable. Any compliance issues identified during an Observation and any corrective action shall be recorded in the files of Global Compliance. Cephalon shall include a sumar of the FFMP and the results of the FFMP as par of each Anual Report. As par of each Anual Report, Cephalon also shall provide the OIG with copies of the Obseration report for any instances in which it was determed that improper promotion occured and a description of the action(s) that Cephalon took as a result of such detenninations. Cephalon shall make the Observation report for all other Observations available to the OIG upon request. L. Notice to Health Care Providers and Entities.' 90 days after the Effective Date, Cephalon shall send, by postage prepaid first class mail, Certificate of Mailing requested, an exact copy of the notice attached hereto as Attchment A, showing the date of the mailing, to any health care provider or entity that Cephalon curently details. This mailing shall notify each health care provider and entity of the global settlement with the United States, includig an the terms of explanation of the conduct to which Cephalon pled guilty and the conduct resolved by the civil settlement. The mailing shall also notify each health care provider or entity that they may report any questionable conduct by Cephalon representatives to a compliance telephone number or e-mail address established by Cephalon or to the FDA. Within. The Chief Compliance Officer (or a designee) shall maintain a log of all calls and messages received by Cephalon in response to the notice. The log shall include a record and sumar of each call and message received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. The disclosure log shall be made available to OIG upon request. As par of the Corporate Integrity Agreement Cephal on, Inc. 26 Implementation Report and each Anual Report, Cephalon shall provide to the OIG a sumar of the calls and messages received. M. Reporting of Physician Pavrents. I. Phase I Reporting By Januar 31, 2010, Cephalon shall post in a prominent position on its website an easily accessible and readily searchable listing of all physicians who received any Phase I Payments (as defmed below in Section III.M.3) directly or indirectly from Cephalon durng Calendar Year 2009 and the aggregate value of such payments ?n the calendar year. After the initial posting, 30 days after the end of each subsequent calendar quarer until March 2011, Cephalon shall also post on its website a listing of updated infomiation about all Phase I Payments provided during the applicable calendar year durg the preceding quarer(s). The quarerly listing shall be easily accessible and readily searchable. Each listing shall include a complete list of all individual physicians to whom Cephalon directly or indirectly made Phase I Payments in the preceding calendar year. Each listing shall be aranged alphabetically accordig to the physicians' last name. The Payment amounts in the lists shall be reported in $10,000 increments (e.g., $0 - $10,000; $10,001- $20,000; etc.) For each physician, the applicable listing shal include the following information: i) full name; ii) city and state the aggregate value of of the physician's practice; and ii) the payment(s) in the preceding quarer(s) or year (as applicable). The reporting described in this Section III.M.l shall be referred to hereafter as "Phase I Reporting. " 2. Phase II Reportng the CIA, Cephalon shall post in a promient position on its website an easily accessible and readily searchable listing of physicians and Related Entities (as derined in Section nI.M.3) who received any Payments directly or indirectly from Cephalon and the aggregate value of such Payments in the preceding Calendar Year. After the initial posting, 30 days after the end of each subsequent calendar quarer Cephalon shall also post on its website a listing No later than March 31,2011 and during the remaining tenn of Corporate Integrity Agreement Cephalon, Inc. 27 of updated information about all Payments provided during the applicable calendar yea durng the preceding quarer(s). The quarerly listing shall be easily accessible and readily searchable. Each listing shall include a complete list .of all individual physicians and Related Entities to whom Cephalon directly or indirectly mae Payments in the preceding calenda year. Each listing shall be aranged alphabetically according to the physicians' last name and the name of the Related Entity. The Payment amounts in the lists shall be reported in $10,000 increments (e.g., $0 - $10,000; $10,001- $20,000; etc.) For each physician and Related Entity, the applicable listing shall include the following inonnation: i) full name; ii) city and state of the physician's practice; iii) name, city, and state in which the Related Entity is located; and iv) aggregate value of the Payment(s) in the preceding quarer(s) or year (as applicable). The reporting described in this Section III.M.2 shall be referred to hereafter as "Phase II Reporting." 3. Miscellaneous Provisions Cephalon shall continue to make eachaiuallisting and the most recent quarerly listing of both Phase I Reportg and Phase II Reporting available on its website at least throughout the term of this CIA. Cephalon shall reta and make available to OIG, upon request, all work papers, supportng documentation, correspondence, and records related to all applicable Payments and to the aiual and quarerly listings of Payments. Nothig in this Section III.M affects the responsibilty of Cephalon to comply with (or liabilty for noncompliance with) all applicable Federal health care program requirements and state laws as they relate to all applicable Payments made to physicians or Related Entities. If the proposed Physician Payments Sunshine Act of 2008 or simlar legislation is enacted, the OIG shall determe whether the puroses of this Section III.M are reasonably satisfied by Cephalon's compliance with such legislation. In such case, and in its sole discretion, the OIG may agree to modify or terminate provisions of Section III.M as appropriate. this Section m.M, the term "Payments" is defined to include all value (whether in cash or in kind) made to physicians and/or to Related Entities. The term Payments includes, for example, payments or compensation for services rendered, grants, fees, honoraria, and payments relating to research or education. The term Payments also includes food, entertainent, gifts, trips or travel, For puroses of payments or transfers of Corporate Integrty Agreement Cephaloii Inc. 28 product(s)/item(s) provided for less than fai market value; or other economic benefit. The term Payments does not include: i) samples of drg products that meet the definition set fort in 21 C.F.R. ? 203.3(i), or ii) discounts, rebates, or other pricing terms. this Section III.M, the term "Phase I Payments" is defined as those For puroses of Payments made in connection with physicians serving as speakers, paricipating in speaker traiing, or serving as consultants (including for advisory boards, or preceptorships. ) For puroses of this Section III.M, the term "Related Entity" is defined to be any entity by or in which any physician receiving Payments is employed, has tenure, or has an ownership interest. IV. CHANGES TO BUSINESS UNITS OR LOCATIONS Unit or Location. hi the event that, after the Effective A. Change or Closure of Date, Cephalon changes locations or closes a business unt or location related t? this Promotional and Product Services Related Functions, Cephalon shall notify OIG of fact as soon as possible, but no later than within 30 days afer the date of change or closure of the location. New Unit or Location. hi the event that, after the Effective Date, Cephalon purchases or establishes a new business unt or location related to Promotional and Product Services Related Functions, Cephalon shall notify OIG no later than the date the purchase or establishment is publicly disclosed. This notification the new business unit or location, phone number, fax number, shall include the address of Federal health care program provider or supplier number (if applicable), and the name and address of the contractor that issued each number (ifapplicable). Each new business unit or location and all Covered Persons at each new business unit or location shall be B. Purchase or Establishment of subject to the applicable requirements of this CIA. C. Sale of Unit or Location. hi the event that, after the Effective Date, Cephalon proposes to sell any or all of its business unts or locations related to the Promotional and Product Services-Related Functions that are subject to this CIA, Cephalon shall notif the proposed sale no later than the date the sale is publicly disclosed. Ths OIG of notification shall include a description of the business unit or location to be sold, a brief Corporate Integrity Agreement Cephalon, Inc. 29 the prospective purchaser. This CIA shall be binding on the purchaser of such business unit description ofthe tenu of the sale, and the name and contact inormtion of or location, unless otherwise deterned and agreed to in writing by the OIG. V. IMPLEMENTATION AND ANNUAL REpORTS A. Imlementation Reoort. Within 150 days afer the Effective Date, Cephalon shall submit a written report to OIG sumizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include: 1. the name, address, phone number, and position description of the Chief Compliance Offcer required by Section III.A.!, and a sumar of other noncompliance job responsibilities the Compliance Offcer may have; 2. the names and positions of the members of the Compliance 'Commtt?e required by Section III.A.2; 3. (a) a copy of the letter (including all attchments) required by Sections II.C.6 and III.B.2 sent to each par employing Thd Par Personnel; (b) a list of all such existing agreements; and (c) a description of the entities' response to Cephalon's letter; the Certifyg Employees required by Section 4. the names and positions of m.A.4; 5. a copy of Cephal on's Code of Conduct required by Section III.B.I; 6. to the extent not already provided to the OIG, a copy of all Policies and Procedures required by Section TII.B.3; . 7. the number of individuals required to complete the Code of Conduct certification required by Section III.B. 1, the percentage of individuals who have completed such cerfication, and an explanation of any exceptions (the documentation supporting this information shall be available to OIG, upon request); 8. the following information regarding each tye of training required .by Section III.C: Corporate Integrity Agreement Cephalon, Inc. 30 a. a description of such traig, including a sumar of the topics covered, the length of sessions, and a schedule of training sessions; b. the number of individuals required to be trained, percentage of individuals actually trained, and an explanation of any exceptions. A copy of all training materials. and the documentation supporting this information shall be available to OIG, upon request; 9. a description of the Disclosure Program required by Section III.E; 10. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; and (c) a sumar and description of any and all curent and prior engagements and agreements between Cephalon and the IRO; 11. a certification from the IRO regarding its professional independence and objectivity with respect to Cephalon; 12. a description of the process by which Cephalon fulfills the requirements of Section III.F regarding Ineligible Persons; 13. the name, title, and responsibilties of any person who is determed to be an Ineligible Person under Section II.F; the actions taken in response to the screening and removal obligations set fort in Section II.F; 14. a list of all of Cephal on , s locations (including locations and mailing addresses); the corresponding name under which each location is doing business; the corresponding phone numbers and fax numbers; each location's Federal health care program provider or supplier number(s) (if applicable), and the name and address of each Federal health care program contractor to which Cephalon curently submits claims (if applicable); 15. a description of Cephal on's corporate strcture, including identification of any parent and sister companies, subsidiares, and their respective lines of business; Corporate Integrity Agreement Cephal on, Inc. 31 by Section III.L was mailed to each health care provider and entity, the number of 16. a certification by the Chief Compliance Officer that the notice required health care providers and entities that received a copy of the notice, a samle copy of the notice , required by Section III.L, and a sum of the calls and messages received in response to the notice; and 17. the certfications required by Section V.C. B. Anual Reports. Cephalon shall submit to OIG anually a report with respect to the statu of, and findings regarding, Cephalon's compliance activities for each of the five Reporting Periods (Anual Report). Each Anual Report shall include, at a mium: 1. an explanation of any change in the identity, position description, or other noncompliance job responsibilties of the Chief Compliance Offcer and any change in the membership of the Compliance Commttee or Certifying Employees described in Sections m.A. 1, 2 or 4; 2. a sumar of any signficant changes or amendments to the Policies and Procedures required by Section m.B.3 and the reasons for such changes Cl change in applicable requirements); 3. the number of individuals required to complete the Code of Conduct certification required by Section m.B.l, the percentage of individuals who have completed such certification, and an explanation of any exceptions (the documentation supporting this information shall be available to OIG, upon request); 4. (a) a copy of the letter (including all attachments) required by Sections the entities' response to Cephalon's .II.C.6 and III.B.2 sent to each entity employing Third Par Personnel; (b) a list of all such existing agreements; and (c) a description of letter; 5. the following information regarding each tye of training required by Section III.C: Corporate Integrity Agreement Cephalon, Inc. 32 a. a description of such training, including a sum of the topics covered, the length of sessions, and a schedule of training sessions; b. the number of individuals required to be trained, percentage of individuals actually trained, and an explanation of any exceptions. A copy of all training materials and the documentation supporting this information shall be available to OIG, upon request. with a copy of 6. a complete copy of all reports prepared pursuant to Section m.D, along the IRO's engagement letter (if applicable); 7. Cephalon's response and corrective action planes) related to any issues raised by the reports prepared pursuat to Section III.D; and prior engagements and agreements between Cephalon and the IRO, if different from what was submitted as 8. a sumar and description of any and all curent par of the Implementation Report; 9. a certification from the IRO regarding its professional independence and objectivity with respect to Cephalon; to. a sumar of Reportable Events (as defmed in Section III.H) identified durng the Reporting Period and the status of any corrective and preventative action relating to all such Reportable Events; 1 1. a summar of the disclosures in the disclosure log required by Section III.E that relate to Federal health care programs; 12. any changes to the process by which Cephalon fulfills the requirements of Section III.F regarding Ineligible Persons; 13. the name, title, and responsibilties of any person who is deternined to be an Ineligible Person under Section III.F; the actions taken by Cephalon in response to the screening and removal obligations set forth in Section m.F; Corporate Integrity Agreement Cephalon, Inc. 33 .14. i; sumar describing any ongoing investigation or legal proceeding required to have been reported pursuant to Section III.G. The sumIar shall include a description of the allegation, the identity of the investigating or prosecuting agency, and the status of such investigation or legal proceedng; 15. a sumar describing any communication with the FDA requied to have been reported pursuant to Section m.i. Ths sumar shall include a description of the matter and the status of the matter; 16. all information required by Section Ill.J; 17. all information required by Section Ill.K; 18. a sumar of the calls and messages received in response to the notice required by Section III.L and the disposition of those calls and messages; 19. a description of all changes to the most recently provided list of Cephalon's locations (including addresses) as requied by Section V.A.14; the corresponding name under which each location is doing business; the corresponding phone numbers and fax numbers; each location's Federal health care progr provider or supplier number(s) (if applicable), and the name and address of each Federal health care program contractor to which Cephalon curently submits clais (if applicable); 20. a cerification from the Chief Compliance Offcer that inormation regarding payments has been posted on.Cephalon's website as required Section III.M; and 21. the certifications required by Section V.C. The first Anual Report shall be received by OIG no later than 60 days afer the the first Reporting Period. Subsequent Anual Reports shall be received by DIG no later than the aniversar date of the due date of the first Anual Report. end of C. Cerfications. The following certifications shall be included in the Implementation Report and Anual Reports: 1. Certifying Emolovees: hi each Anual Report Cephalon shall include the certifications of Certifying Employees as required by Section III.AA. Corporate Integrity Agreement Cephal on, Inc. 34 2. Chief Compliance Offcer: In each Implementation Report and Anual Report, Cephalon shall include the following individual certification by the Chief Compliance Officer: a. he or she has reviewed the Report and has made reasonable inquiry regarding its content and believes that the information in the Report is accurate and trthl; b. to the best of his or her knowledge, except as otherise described in the applicable report, Cephalon is in compliance with Federal health care program and the CIA; FDA requirements and the obligations of his or her lmowledge, Cephalon has complied with its obligations under the Settlement Agreement: (a) not to resubmit to any Federal health c. to the best of care program payors any previously denied claims related to the Covered Conduct addressed in the Settlement Agreement, and not to appeal any such denials of claims; (b) not to charge to or otherwise seek payment from federal or state payors for unalloWable costs (as dermed in the Settlement Agreement); and (c) to identify and adjust any past charges or clai for unallowable costs; d. Cephalon's: 1) Policies and Procedures as referenced in Section III.B.3 above; 2) templates for standardized contracts and other similar documents; and 3) the training materials used for puroses of Section III.C all have been reviewed by competent legal counsel and have been found to be in compliance with all applicable Federal health care program and FDA requirements. In addition, Cephalon's promotional materials containg claims or information about Governent Reimbursed Products and other materials and information intended to be dissemiated outside Cephalon have been reviewed by competent regulatory, medical and/or legal personnel in accordance with applicable Policies and Procedures to ensure that legal, medical, and regulatory concer have been addressed and elevated when requied, and that the materials and informaton when finally approved are in compliance with all applicable Federal health care progr and FDA requirements. If the appli?able legal requirements have not changed, after the initial review of the documents listed above, only material changes to the documents must be reviewed by competent regulatory, medical and/or legal personneL. The certification shall include a description of the document(s) reviewed and approximately when the Corporate Integrity Agreement Cephal on, Inc. 35 review was completed. The documentation supporting this aertfication shall be available to OIG, upon request; and e. Cephalon's call plan for Governent Reimbured Products were reviewed at least once during the Reporting Perod (consistent with Section III.B.3.e) and, for each product the call plans were found to be consistent with Cephalon's policy objectives as referenced above in Section III.B.3.e. D. Designation of Information. Cephalon shall clearly identify any portons of its submissions that it believes are trade secrets, or information that is commercial or financial and privileged or confidential, and therefore potentially exempt from disclosure Information Act (FOIA), 5 U.S.C. ? 552. Cephalon shall refrain under the Freedom of from identifying any information as exempt from disclosure if that informtion does not meet the criteria for exemption from disclosure under FOIA. VI. NOTIFICATIONS AND SUBMISSION OF REpORTS Unless otherwise stated in writing after the Effective Date, all notifications and reports required under this CIA shall be submitted-to the following entities: OIG: Admnistrative and Civil Remedies Branch Offce of Counsel to the Inspector General Offce of hipector General u.s. Deparent of Health and Human Serices Cohen Building, Room 5527 330 hidependence Avenue, S.W. Washington, DC 20201 Telephone: (202) 619-2078 Facsimile: (202) 205-0604 CEPHALON: Executive Vice President, Chief Compliance Officer Cephalon, hic. 40 Moores Road Frazer, P A 19355 Phone: (610) 727-6280 Facsimile: (610) 727-6001 Corporate Integrity Agreement Cephal on, Inc. 36 Unless otherwise specified, all notifications and reports required by this CIA may be made by certfied mail, overnight mail, hand delivery, or other means, provided that there is proof that such notification was received. For puroses of this requirement, internal facsimile confiration sheets do not constitute proof of receipt. Upon request by OIG, Cephalon may be required to provide OIG with an electronic copy of each notification or report required by this CIA in searchable portable document format (pdt), either instead of or in addition to, a paper copy. VII. OIG INSPECTION. AUDIT. AND REVIW RIGHTS In addition to any other rights OIG may have by statute, reguation, or contract, DIG or its duly authorized representative( s) may examne or request copies of Cephalon' s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of Cephal on's locations for the purose of verifyig and evaluatig: (a) this CIA; and (b) Cephalon's compliance with the Federal health care programs in which it paricipates and with all applicable FDA requirements. The documentation described above shall be made available by Cephalon to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, or reproduction. Furherore, for puroses of this provision, DIG or its duly authorized representative(s) may interiew any of Cephalon's employees, contractors, or agents who consent to be intervewed at the individual's place of business during normal business hours or at such other place and tie as may be mutually agreed upon between the individual and OIG. Cephalon shall assist OIG or its duly authoried representative(s) in contacting and aranging interviews with such individuals upon DIG's request. Cephalon's employees may elect to be interiewed with or without a representative of Cephalon present. Cephalon's compliance with the terms of the requirements of VI. DOCUMENT AND RECORD RETENTION Cephalon shall maintain for inspection all documents and records relating to reimbursement from the Federal health care progr, or to compliance with this CIA, for six years (or longer if otherwise required by law) from the Effective Date. Corporate Integrty Agreement Cephal on, Inc. 37 IX. DISCLOSURES Consistent with HHS's FOIA procedures, set forth in 45 C.F.R. Par 5, OIG shall make a reasonable effort to notify Cephalon prior to any release by DIG of information submitted by Cephalon pursuant to its obligations under this CIA and identified upon submission by Cephalon as trade secrets, or information that is commercial or financial and privileged or confidential, under the FOIA rules. With respect to such releases, Cephalon shall have the rights set fort at 45 C.F.R. ? 5.65(d). X. BREACH AND DEFAULT PROVISIONS Cephalon is expected to fully and timely comply with all of its CIA obligations. A. Stipulated Penalties for Failure to Comolv with Certain Obligations. As a contractual remedy, Cephalon and OIG hereby agree that failure to comply with certin obligations as set forth in this CIA may lead to the imposition of the following monetar penalties (hereinafer referred to as "Stipulated Penalties") in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Cephalon fails to establish, implement, or accomplish any of the following obligations as described in Section il: a. a Compliance Officer; b. a Compliance Commttee; c. the Board resolution; d. a written Code of Conduct; e. written Policies and Procedures; f. the training of Covered Persons; g. a Disclosure Program as required by Section III.E; Corporate Integrity Agreement Cephal on, Inc. 38 h. Ineligible Persons screening and removal requirements; i. notification of Governent investigations or legal proceedigs; j. notification of communcations with FDA regarding off-label matters; k. Message Recall Studies (or alternative information permitted by Section III.J); 1. a program for FFMP; m. notification to any health care providers or entities as required by Section II.L; or n. posting of any Payments as required by Section III.M. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Cephalon fails to engage an IRO, as required in Section m.D and Appendices A-B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Ceph?lon fails to submit the Implementation Report or the Anual Reports to OIG in accordance with the requirements of Section V by the deadlines for submission. .4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Cephalon fails to submit the anual . IRO Review Report(s) in accordance with the requirements of Sections III.n and V.B.6 and Appendix B. 5. A Stipulated Penalty of $1 ,500 for each day Cephalon fails to grant access as required in Section VII. (This Stipulated Penalty shall begi to accrue on the date Cephalon fails to grant access.) Corporate Integrity Agreement Cephalon, Inc. 39 6. A Stipulated Penalty of $5,000 for each false certification submitted by or on behalf of Cephalon as par of its Implementation Report, Anual Report, additional documentation to a report (as requested by the OIG), or otherwise required by ths CIA. 7. A Stipulated Penalty of$I,OOO for each day Cephalon fails to comply fully and adequately with any obligation ofthis CIA. DIG shall provide notice to Cephalon, stating the specific grounds for its determation that Cephalon has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Cephalon shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 days afer the failure to comply.) A Stipulated Penalty as Cephalon receives this notice from OIG of described in ths Subsection shall not be demaded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-6 of this Section. the due B. Timelv Written Requests for Extensions. Cephalon may, in advance of date, submit a timely written request for an extension of time to perform any act or fie any notification or report required by this CIA. Notwithstanding any other provision in this Section, if GIG grants the timely written request with resect to an act, notification, or report, Stipulated Penalties for failure to perform the act or fie the notification or report shall not begin to accrue until one day afer Cephalon fails to meet the revised deadline set by OIG. Notwithstanding any other provision in this Section, if OIG denies such a timely written request, Stipulated Penalties for failure to perform the act or fie the notification or report shall not begin to accrue until three business days after Cephalon receives OIG's. written denial of such request or the origial due date, whichever is later. A "timely wrtten request" is defined as a request in writing received by OIG at least five business days prior to the date by which any act is due to be performed or any notification or report is due to be fied. C. Payment of Stioulated Penalties. 1. Demand Letter. Upon a finding that Cephalon has failed to comply with any of the obligations described in Section X.A and after determining that Stipulated Penalties are appropriate, OIG shall notify Cephalon of: (a) Cephalon's failure to the its contractual right to demand payment of coinply; and (b) OIG's exercise of Stipulated Penalties (this notification is referred to as the "Demand Letter"). 2. Response to Demand Letter. Within 10 days afer the receipt of the Demand Letter, Cephalon shall either: (a) cure the breach to OIG's satisfaction and pay Corprate Integrity Agreement Cephal on, Inc. 40 the applicable Stipulated Penalties; or (b) request a hearng before an liS admistrative noncompliance, pursuant to the agreed upon provisions set forth below in Section X.E. In the event Cephalon elects to request an ALl hearg, the Stipulated Penalties shall continue to accrue until CephaIon cures, to OIG's satisfaction, the alleged breach in dispute. Failure to respond to the Demand Letter in one of these two maners within the allowed time period shall be considered a material breach of this CIA and shall be grounds for exclusion under Section X.D. law judge (ALl) to dispute OIG's determation of 3. Form o/Payment. Payment of the Stipulated Penalties shall be made by electronic fuds transfer to an account specified by the OIG in the Demand Letter. 4. Independence from Material Breach Deterination. Except as set forth in Section X.D. l.c, these provisions for payment of Stipulated Penalties shall not affect or otherise set a stadard for OIG's decision that Cephalon has materially br?ached this CIA, which decision shall be made at OIG's discretion and shall be govered by the provisions in Section X.D, below. D. Exclusion for Material Breach of this CIA. 1. Definition 0/ Material Breach. A material breach of ths CIA means: a. a failure by Cephalon to report a Reportable Event and tae corrective action, as required in Section III.H; the obligations under this CIA, including, but not limted to, the obligations addressed in Section . X.A; b. a repeated or flagrant violation of c. a failure to respond to a Demand Letter concerning the payment of Stipulated Penalties in accordance with Section X.C; d. a failure to engage and use an IRO in accordance with Section III.D; or e. a failure of the Board to issue a resolution in accordance with Section III.A.3. Corporate Integrity Agreement Cephal on, Inc. 41 2. Notice of Material Breach and Intent to Exclude. The paries agree that a material breach of this CIA by Cephalon constitutes an independent basis for Cephal?n's exclusion from paricipation in the Federal health care programs. .Upon a determnation by OIG that Cephalon has materially breached this CIA and that exclusion is the appropriate remedy, OIG shall notify Cephalon of: (a) Cephalon's material breach; and (b) OIG's intent to exercise its contractual right to impose exclusion (this notification is hereinafter refered to as the ''Notice of Material Breach and Intent to Exclude"). receipt of 3. Opportunity to Cure. Cephalon shall have 30 days from the date of Material Breach and Intent to Exclude to demonstrate to OIG's the Notice of satisfaction that: a. Cephalon is in compliance with the obligations of the CIA cited by OIG as being the basis for the material breach; b. the alleged material breach has been cured; or c. the alleged material breach canot be cured within the 30-day period, but that: (i) Cephalon has begu to take action to cure the material breach; (ii) Cephalon is pursuing such action with due dilgence; and (ii) Cephalon has provided to OIG a reasonable timetable for curing the material breach. 4. Exclusion Letter. If, at the conclusion of the 30-day period, Cephalon fails to satisfy the requirements of Section X.D.3, OIG may exclude Cephalon .from paricipation in the Federal health care programs. OIG shall notify Cephalon in wrtig of its deternation to exclude Cephalon (this letter shall be referred to hereinafer as the "Exclusion Letter"). Subject to the Dispute Resolution provisions in Section XE, below, the the exclusion shall go into effect 30 days afer the date of Cephalon's receipt of Exclusion Letter. The exclusion shall have national effect and shall also apply to all other Federal procurement and nonprocurement program. Reinstatement to program . paricipation is not automatic. Afer the end of the period of exclusion, Cephalon may apply for reinstatement by submitting a wrtten request for reinstatement in accordance with the provisions at 42 C.F.R. ?? 1001.3001-.3004. Corprate Integrity Agreement Cephalon, Inc. 42 E. Dispute Resolution. 1. Review Rights. Upon OIG's delivery to Cephalon of its Demand Letter or of its Exclusion Letter, and as an agreed-upon contractual remedy for the resolution of disputes arsing under this CIA, Cephalon shall be afforded cerain review rights comparable to the ones that are provided in 42 U.S.C. ? 1320a-7(f) and 42 C.F.R. Par . 1005 as if they applied to the Stipulated Penalties or exclusion sought pursuant to this Stipulated Penalties or to CIA. Specifically;OIGts determination to demand payment of seek exclusion shall be subject to review' by an HHS ALJ and, in the event of an appeal, the HHS Deparental Appeals Board (DAB), in a maner consistent with the provisions in 42 G.F.R. ? ~005.2-io05.2i. Notwithstanding the language in 42 C.F.R. ? io05.2(c), the request for a hearng involving Stipulated Penalties shall be made withn 10 days after receipt of the Demand Letter and the request for a hearg involving exclusion shall be made within 25 days after receipt of the Exclusion Letter. Title 42 Federal Regulations, the only issues of the United States Code or Title 42 of the Code of ?n a proceeding for Stipulated Penalties under ths CIA shall be: (a) whether Cephalon . was ii full and timely compliance with the obligations of this CIA for which OIG demands payment; and (b) the period of noncompliance. Cephalon shall have the burden 2. Stipulated Penalties Review. Notwithstanding any provision of of proving its full and timely compliance and the steps taken to cure the noncompliance, if any. OIG shall not have the right to appeal to the DAB an adverse ALJ decision related to Stipulated Penalties. If the ALJ agrees with OIG with regard to a fiding of a breach of this CIA and orders Cephalon to pay Stipulated Penalties, such StipUlated Penalties shall become due and payable 20 days after the ALJ issues such a decision unless the ALJ decision is the ALJ decision by the DAB. If Cephalon requests review of properly appealed to the DAB and the DAB upholds the determination of OIG, the Stipulated Penalties shall become due and payable 20 days after the DAB issues its. decision. Title 42 of the Federal Regulations, tha only issues in a proceeding for exclusion based on a material breach of this CIA shall be: 3. Exclusion Review. Notwithstanding any provision of the Code of United States Code or Title 42 of a. whether Cephalon was in material breach of this CIA; Corporate Integrity Agreement Cephal on, Inc. . 43 b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-day period, but that: (i) Cephalon had begu to tae action to cure the material breach withn that perod; (ii) Cephalon has pUrsued and is pursuing such action with due dilgence; and (ii) Cephalon provided to OIG within that perod a re?sonable tietable for curng the material breach and Cephalon has followed the timetable. the exclusion herein, exclusion shall take effect only after the ALJ rules for Cephalon, only after a DAB decision in favor ofOIG. Cephalon's election of its contractual right to appeal to the DAB shall not abrogate GIG's authority to exclude Cephalon upon the issuance of an For puroses of an ALJ decision favorable to OIG, or, if ALl's decision in favor ofOIG. If the ALJ sustains the determation ofOIG and determnes that exclusion is authorized, such exclusion shall take effect 20 days afer the ALJ issues such a decision, notwithstading that Cephalon may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG afer an ALJ decision adverse to OIG, the exclusion shall take effect 20 days afer the DAB decision. Cephalon shall waive its right to any notice of such an exclusion if a decision upholdig the exclusion is rendered by the ALJ or DAB. If the DAB fmds in favor of Cephal on, Cephalon shall be reinstated effective on the date of the original exclusion. 4. Finality of Decision. The review by an ALJ or DAB provided for above shall not be considered to be an appeal right arising under any statutes or regulations. Consequently, the parties to this CIA agree that the DAB's decision (or the ALl's decision if not appealed) shall be considered final for all puroses under this CIA. XI. EFFECTIV AND BINDING AGREEMENT Cephalon and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of Cephalon; Corporate Integrity Agreement Cephalon, Inc. 44 B. This CIA shall become final and binding on the date the final signatue is obtaied on the CIA; C. This CIA constitutes the complete agreement between the paries and may not be amended except by written consent of the pares to this CIA; D. The undersigned Cephalon signatories represent and warant that they are authoried to execute this CIA. The undersigned OIG signatory represents that he is signing this CIA in his offcial capacity and that he is authorized to execute this CIA; and E. This CIA may be executed in counterpars, each of which constitutes an which constitute one and the same CIA. Facsimiles of signatues shall constitute acceptable, binding signatures for puroses of this CIA. original and all of Corprate Integrity Agreement Cephal on, Inc. 45 . !. ON BEHA OF CEHAON, Ll\c. ...... ).Rr. ~ I'r) ,. ~ '.o! (..Ll L ~__.._~_____._ .._._..___. i';....L,()i/?t"l. Valii BaldisM() Cephalor Chief CmnpHauee Offwe.t' ~'fL~~~_ Da .j/ _.t..___&#.."'.~...~...*"-.O _...___6?........_ Gerald J..l'app~rr" "W Ce.ph~ik)l1 Gzr$l'l'il (\)uii~.d (?~h.~ . . l../ ..,~.. ..~ t. ."~... ( . ~iL .. ....,.. ~r.~_..y,~ '." ") ..,.. .~_.~ _.t: Q l'...- 11(1 $ IVl) __....1.. ...__.~_......._. Date C:l FJO l~o . Edc W. SitlSChu.E( (? ...2! 22:/ ?.C(. D~itc Cmmsel ttJf C~lhak?', Inc. _!1~IL/~_.o Date t Corpomte Int~gtity Agreet.'lt Cephaloo, In. 46 : '. ON BEHALF OF TH OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF H~ALTH AND HUMAN SERVICES ( __c: Gregory E. Demske Date 1/UI!! (, Assistant hispector General for Legal Affairs Offce of hispector General Health and Human Services U. S. Deparent of Corporate Integrty Agreement Cephalon, Inc. 47 .' Attacbment A Dear Healthcare Provider: As you may be aware Cephalon, Inc. recently entered into a global civil, criminal, and ,admnistrative settement with the United States and individual states in connection with its promotion of three Cephalon products. This letter provides you with additional information about the .settlement, explains Cephalon's commitments going forward, and provides you with access to information about those commitments. In general tems, the Govenuent alleged that Cephalon unlawfully promoted thee drgs (Actiq, Gabitrl, and Provigil) for uses not approved by the Food & Drg Administrtion (FDA). To resolve these matters, Cephalon pled guilty to a misdemeanor criinal violation and agreed to pay a total of $425 milion to the Federal Goverent and state Medicaid programs. In addition, Cephalon paid $6,150,000 in' a companion settlement with the Connecticut Attorney General related to unfair trde practice laws. Additional infornation about the settlements may be found at the following websites (include a link to tbe USAO, Cepbalon (ww.cepbalon.com). and Attorney General of Connecticut's websites.) As part of the federal settlement, Cephalon also entered a five-year corporate integrty Health and the U:S. Deparent of agreement with the Offce ofInspector General of Human Services. The corporate integrity agreement is available at htt://oIii:.hhs.gov/fraudlcia/index.htmL. Under this agreement, Cephalon agreed to undertake certin obligations designed to promote compliance with Federal health care program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by Cephalon's representatives to Cephalon's Compliance Departent or the FDA. Please call or email Cephalon at 1-866-900-7167 orquestions&)cepbalon.com if you have questions about the settlement referenced above or to reort any instances in which you believe that a Cephalon representative inappropriately promoted a product or engaged in other questionable conduct. Alterntively, you may report any such instances Drug Marketing, Advertsing, and Communications at 301-7961200. You should direct medical questions or concerns about the products to Cephalon's Medical Infornation departent. to the FDA's Division of We appreciate your ti.me and attention. We are dedicated to ensurng that we bring you the scientific and medical infornation you need to make well-informed decisions about whether Cephalon products are right for your patients. Sincerely, Chief Executive Offcer Cephalon, Inc. ,. APPENDIX A INDEPENDENT REVIEW ORGANIZATION this Appendix contains the requirements relating to the Independent Review the CIA. Organization (IRO) required by Section III.D of A. IRO EnlZalZement. Cephalon shall engage an IRO that possesses the qualifications set fort in Paragraph B, below, to perform the responsibilties in Paragraph C, below. The IRO shall conduct the review in a professionally independent and objective fashion, as set the identity of fort in Paragraph D. Within 30 days after OIG receives wrtten notice of the selected IRO, OIG wil notify Cephalon if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Cephalon may continue to engage the IRO. If Cephalon engages a new IRO durg the term of the CIA, this IRO shall also meet the requirements of this Appendix. If a new IRO is engaged, Cephalon shall submit the CIA to OIG within 30 days of the inormation identified in Section V.A.10 of engagement of of the IRO. Within 30 days after OIG receives wrtten notice of the identity the IROis unacceptale. Absent notification from OIG that the IRO is unacceptable, Cephalon may continue to engage the IRO. the selected IRO, OIG wil notify Cephalon if B. IRO Qualifications. The IRO shall: 1. assign individuals to conduct the Promotional and Product Serices Review who have expertise in all applicable Federal health care program and FDA requirements relating to Promotional and Product Services Related Functions. The assigned individuals shall also be lmowledgeable about the general requirements of the Federal health care program(s) under which Cephalon products are reimbursed; 2. assign individuals to design and select the samples for the Transaction Reviews who are knowledgeable about appropriate statistical sampling techniques; and 3. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis. Appendix A Cephalon, Inc. , C. IRO Responsibilties. The IRO shall: 1. perform each Promotional and Product Serices Review in accordance with the specific requirements of the CIA; 2. follow all applicable Federal health care program and FDA requirements in making assessments in each Promotional and Product Services Review; 3. if in doubt of the application of a paricular Federal health care program or FDA requirement, policy, or regulation, request clarification from the appropriate authority CM CMS or FDA); 4. respond to all OIG inquires in a prompt, objective, and factual maner; and 5. prepare timely, clear, well-written reports that include all the information required by Appendix B to the CIA. D. IRO hideoendence and Objectivity. The IRO must perform each Promotional and Product Services Review in a the engagement, takg into account any other business relationships or engagements that may exist between the IRO and Cephalon. professionally independent and objective fashion, as appropriate to the nature of E. IRO Removal/Termination. 1. Provider. If Cephalon terminates its IRO during the course of the engagement, Cephalon must submit a notice explaining its reasons to OIG no later than 30 days after termination. Cephalon must engage a new IRO in accordance with Paragraph A of this . Appendix. 2. OIG Removal ofIRO. hi the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to car out its responsibilties as described in Paragraph C, OIG may, at its sole discretion, require Cephalon to engage a new IRO in accordance with Paragraph A of this App.endix. Prior to requiring Cephalon to engage a new IRO, OIG shall notify Cephalon of its why OIG believes such a step is necess.ar. To resolve any concerns raised by OIG, Cephalon may request a meetig with the IRO's qualifications, independence or performance of its OIG to discuss any aspect of intent to do so and provide a written explanation of Appendix A Cephalon, Inc. 2 responsibilties and to present additional information regarding these matters. Cephalon shall provide any additional information as may be requested by OIG under this Paragraph in an expedited maner. OIG will attempt in good faith to resolve any differences regarding the IRO with Cephalon prior to requirig Cephalon to terinate the mo. However, the final determination as to whether or not to require Cephalon to engage a new IRO shall be made at the sole discretion ofOIG. Appendix A Cephalon, Inc. 3 Appendix B to CIA for CephaIon, Inc. Promotional and Product Services Review I. Promotional and Product Services Review, General Description As specified more fully below, Cephalon shall retain an Independent Review Organization (IRO) to perform reviews to assist Cephalon in assessing and evaluating its systems, processes, policies, procedures, and practices related to Cephalon's Promotional and Product Services Related Functions (Promotional and Product Services Review). The Promotional and Product Services Review shall consist of two components - a systems review (the "Promotional and Product Serices Systems Review" or "Systems Review"), and a transactions review (the Review") as described more fully below. Cephalon.mayengage, at its "Promotional and Product Services Transactions ReviewJt or ''Transactions discretion, a single IRO to perform both components of the Promotional and Product Services Review provided that the entity has the necessar experise and capabilties to perform both. Ifthere are no material changes in Cephalon's systems, processes, policies, and procedures relating to Promotional and Product Services Related Functions, the IRO shall perform the Promotional and Product Services Systems Review for the first and four Reporting Perods. If Cephalon materially changes its systems, processes, policies, and procedures relating to Promotional and Product Services Related Functions, the IRO shall perform a Promotional and Product Services Systems Review for the Reporting Period(s) in which such changes were made in addition to conducting the Review for the first and four Reporting Periods. The the material additional Systems Review(s) shall consist of: 1) an identification of changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shal conduct the Promotional and Product Services Transactions Review for each Reporting Period of the CIA. II. Promotional and Product Services Systems Review A. Description of Reviewed Policies and Procedures The Promotional and Product Services Systems Review shall be a review of Cephalon's systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) relating to certain Promotional and Product Services Related Functions. Where practical, Cephalon personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in ~erforming the Systems Review. The IRO is not Appendix B 1 Cephalon, Inc. required to undertake a de novo review of the information gathered or activities underaken by Cephalon pursuant to the preceding sentence. Specifically, the IRO shall review Cephalon's systems, processes, policies, and procedures associated with the following (hereafer "Reviewed Policies and Procedures''): 1) Cephalon's systems, policies, processes, and procedures applicable to the maner in which Cephalon representatives (including sales representatives and/or Medical Services deparent personnel) handle requests or inquiries relatig to information about the uses of Cephal on products (including non-FDA-approved (i.e., off-label) uses) and the dissemination of materials relating to offlabel uses of products. This review includes: a) the maner in which Cephalon sales representatives . and marketing personnel handle requests for Cephal on products (i.e., by referring all such requests to Medical Servces deparent personnel at Cephalon); information about off-label uses of b) the maner in which Medical Servces deparent personnel, including those at Cephalon's headquarers, c) handle and respond to requests for information about off-label uses of Cephalon products (incl?dig tracking the requests and using pre-approved materials for puroses of responding to the request); .the form and content of information and materals related to Cephalon' s products disseminated to physicians, pharacists, or other health care professionals (collectively "HCPs") or health care institutions (HCIs) by Cephalon; d) Cephalon's systems, processes, and procedures inormation about off-label uses of (including the hiquiries Database) to track requests for products and responses to those requests; e) t) the maner in which Cephalon collects and supports information reported in any systems used to track and respond to requests for product information, including its hiquiries Database; the processes and procedures by which the Compliance Offcer (and other appropriate individuals withn. Cephalon) identify situations in which it appears that improper off-label promotion may have occurred; and 2 Appendix B Cephalon, Inc. g) Cephalon's processes and procedures for investigating, documenting, resolving, and takg appropriate disciplinar action for potential situations involving off-label promotion; , 2) Cephalon's policies and procedures applicable to the maner and circumstances under which its Medical Services deparent personnel (including any medical science liaisons (MSLs)) parcipate in meetings or events with HCPs or HCIs (either alone or with sales representatives) and the role of the medical personnel at such meetings or events; 3) Cephalon's systems, policies, processes, and procedures relating to Cephaloils internal review and approval of information and materials related to Cephalon's products dissemnated to HCPs or HCIs by Cephalon; . 4) Cephalon's systems, polices, processes and procedures relating to incentive compensation for Covered P?rsons who are sales representatives, with regard to whether the systems, policies, processes, and procedures are designed to ensure that fmancial incentives do not inappropriately motivate such individuals to engage in the improper promotion, sales, and marketig of Cephal on's products. This shall include a review of the bases upon which compensation is determined and the extent to which compensation is based on product performance; and 5) Cephalon's systems, processes, policies, and procedures relating to the development and review of call plans for Cephalon's products. This shall include a review of the bases upon which HCPs and HCls belonging to specified medical specialties are included in, or excluded from, the call plans based on expected utilzation of Cephalon prqducts for FDA-approved uses or non-fDA-approved uses. B. Promotional and Product Services Systems Review Report The IRO shall prepare a report based upon each Systems Review. For each the Reviewed Policies and Procedures identified in Section II.A above, the report shall include the following items: of I) a description of the documentation (including policies) reviewed and any personnel interviewed; Appendix B Cephalon, Inc. 3 on's systems, policies, processes, and procedures relating to the items identified in Sections 2) a detailed description of Cephal II.A.1-5 above, including a general description of Cephalon' s contrl and accountabilty systems ~ documentation and approval requirements, and tracking mechanisms) and wrtten policies regarding the Reviewed Policies and Procedures; 3) a description of the maner in which the control and accountabilty systems and the wrtten policies relatig to the items identified in Sections II.A. I -5 above are made lmown or disseminated within Cephalon; 4) a detailed description of any system( s) used to track and respond to requests for information about Cephalon's products (including the hiquiries Database); on's incentive compensation system for Covered Persons who are sales representatives, including 5) a detailed description of Cephal a description of the bases upon which compensation is deterined and the extent to which compensation is based on product performance. To the extent that Cephalon may establish compensation differently for individual products, the IRO shall report separately on each such tye of compensation arangement; 6) findings and supporting rationale regardig any weaesses in Cephalon's systems, processes, policies, and procedures relating to the Reviewed Policies and Procedures, if any; and 7) recommendations to improve any of the systems, policies, processes, or procedures relating to the Reviewed Policies and Procedures, if any. III. Promotional and Product Services Transaction Review As described more fully below in Sections III.A-D, the Promotional and Product Services Transactions Review shall include: (1) a review of a sample of on's call plan Cephal hiquires reflected in the hiquiries Database; (2) a review of records relating to a and Cephalon's call plan review process; (3) a review of sample of the Payments that are reported by Cephalon pursuant to Section m.M of up to three additional items identified by the OIG in the CIA; and (4) a review of the CIA (hereafter "Additional Items".) The accordance with Section III.D. l.b of Appendix B Cephalon, Inc. 4 IRO shall report on all aspects of its reviews in the Promotional and Product Services Transactions Review Reports. A. Review of Inquires and hiquiries Database 1) Description of hiquires Database As set forth in Section III.B.3.d ofthe CIA, Cephalon shall establish a database to track inormation relating to requests for information received by Cephalon about its products (hereafter "hiquires"). Specifically, Cephalon shall document and record all hiquires received from HCPs or HCIs regarding Cephalon's products in a database (the "Inquires Database''). Cephalon shall record in the Inquiries Database the following information for each Inquiry received: I) date of Inquir; 2) form of Inquir ~ fax, phone, medical information request form); 3) name of HCI; 4) nature and topic of requesting HCP or the Inquir if made in writing); 5) natue/form of the response from Cephalon (including a record of any materials provided in response request (including exact language of to the request); and 6) the name of the Cephalon representative who called upon or interacted with the HCP or HCI. Any response from Medical Services to an HCP or HCI shall identify whether the information provided addresses an indication that is par of an approved product labeL. The statu and findings of any follow-up review conducted by Cephalon in situations in which improper offhibel promotion is suspected shall be maintained by Global Compliance. 2) hiternal Review ofhiquiries Database On a semi-anual basis, the Compliance Officer or other appropriate personnel shall review the Inquires Database and related information, as appropriate, and shall generate a report sumarizing the items of information outlined in Section III.A. I above for each Inquiry received during the preceding two quarers ("Inquir Report"). The Compliance Officer or other appropriate personnel shall review the hiquir Reports t? assess whether the information contained in the report suggests that improper off-label promotion may have occurred in connection with any Inquir(ies). If the Compliance Offcer or other appropriate personnel, in consultation with other appropriate Cephalon personnel, suspects that improper off-label promotion may have occured in connection with any Appendix B 5 Cephalon, Inc. Inquiry, the Compliance Offcer or other appropriate personnel shall undertake a follow-up review of the hiqui (Off-Label Review), make specific findigs based on his/her Off-Label Review, and tae all appropriate responsive action (including disciplinar action of the Covered Person and reporting of the conduct, including disclosing Reportable Events pursuant to Section III.H of the CIA, if applicable). 3) IRO Review of Inquiries Reflected in hiquires Database The IRO shall select and review a random sample of 60 hiquiries from among the hiquires reflected in the hiquiries Database for each Reporting Period. Fort-five of the hiquires reviewed by the IRO shall be Inquiries for which Cephalon conducted an Off-Label Review, and the other 15 shall be hiquires for which Cephalon did not conduct an Off-Label Review. For each hiqui reviewed, the IRO shall determine: a) Whether each item of information listed above in Section III.A.l is reflected in the hiquires Database for each reviewed hiquiry; and b) For each hiquiry for which the Compliance Offcer or other appropriate personnel conducted an Off-Label Review, the basis for suspecting that improper off-label promotion may have occured; the steps undertaken as par of the Off-Label Review; the findings of the Compliance Officer or other appropriate personnel as a result of the Off-Label Review; and any follow-up actions taken by Cephalon based on the Off-Label Review. findings. B. IRO Review of Cephalon's Call Plans and Call Plan Review Process The IRO shall conduct a review and assessment of Cephalon' s review of its call plans for Governent Reimbursed Products as set fort in Section m.B.3.e of the CIA. Cephalon shall provide the IRO with: i) a list of products promoted by Cephalon durng the Reporting Period; ii) information about the FDA-approved uses for each Cephalon product; and ii) the call plans for each product. Cephalon shall also provide the IRO with information about the reviews of call plans that Cephalon conducted during the Reporting Period and any modifications to the call plans made as a result of Cephal on's reviews. For each call plan, the IRO shall select a sample of 50 of the HCPs and HCIs included on the call plan. For each call plan, the IRO shall compare the Appendix B 6 Cephalon, Inc. sampled HCPs and HCIs against the critera ~ medical specialty or practice area) used by Cephalon in conducting its review and/or modification of the call plan in order to determe whether Cephalon followed its critera and Policies and Procedures in reviewing ~d modifyg the call plan. The IRO shall note any intances in which it appears that the sampled HCPs and HCIs on a paricular call plan are inconsistent with Cephalon's criteria relating to the call plan and/or Cephalon's Policies and Procedures. The IRO shall also note any instances in which it appears that Cephalon failed to follow its criteria or Policies and Procedures. C. IRO Review of Physician Payment Listings 1. hiormation Contained in Physician Payment Listings As set forth in Section III.M of the CIA, Cephalon shall post quarerly and physicians and Related Entities who received Payments, as defined in the CIA, directly or indirectly from Cephalon. For the IRO puroses of review as set fort in this Section III.C, each anual listing shall be referred to as the "Physician Payment Listing" or "Listing." For each physician and Related anual listings of Entity, each Physician Payment Listing shall include the follow?ng information:. i) full name; ii) city and state of the physician; iii) name, city, and state of Related Entity (if applicable); and iv) the aggregate value of the the Payment(s) in the preceding year. this IRO review, the term "Control Documents" shall include all documents or electronic records associated with each Payment reflected in the Physician Payments Listing for the sampled physician and/or Related Entity. For example, the term "Control Documents" includes, but is not limited to, . For puroses of documents relating to the nature, purose, and amount of all Payments reflected in the Listing; contracts relating to the Payment(s) reflected in the Listing; documents relating to the occurrence ofPayment(s) reflected in the Listing; documents reflecting any work product generated in connection with the . . Payment(s); documents submitted by sales representatives or headquarers personnel to request approval for the Payment(s); and business rationale or justification forms relating to the Payment(s). 2. Selection of Sample for Review For each Reporting Period, the OIG shall have the discretion to identify 50 physicians or Related Entities from the applicable Physician Payment Listing that wil be subject to the IRO review described below. If the OIG elects to exercise this discretion, it shall notify the IRO of the 50 physicians and/or Related Entities Cephalon, Inc. Appendix B 7 " the OIG elects not to exercise its discretion as described above, the IRO shall randomly select 50 physicians and/or Related Entities to be included in the review. For each selected physician and/or Related Entity, the IRO shall review the entr in the Physician Payment Listin~ and the. Control Documents relating to Payments reflected in Listing identified by the IRO subject to the IRO review. If as necessar and suffcient to validate the Payment information in the Listing: 3. IRO Review of Control Documents for Selected Physicians and/or . Related Entities For each physician and/or Related Entity selected as par of the sample, the IRO shall review the Control Documents identified by the IRO as necessar and suffcient to validate each Payment reflected in the Llsting to evaluate the following: a) Whether Control Documents are available relatig to each Payment reflected in the Listing for the sampled physician and/or Related Entity; b) Whether the Control Documents were completed and archived in accordance with the requirements set fort in Cephalon's policies; c) Whether the aggregate value of the Payment(s) as reflected in the Listing for the sampled Physician is consistent with the value of the Payments(s) reflected in the Control Documents; and d) Whether the Control Documents reflect that Cephalon's policies were followed in connection with Payment(s) policies.)' . A Material Error is defined as any of the following: reflected in the Listing ~ all required wrtten approvals for the activity were obtained in accordance with Cephalon's 4. Identification of Material Errors and Additional Review a) A situation in which all required Control Documents relating to Payments reflected in the Listing for the sampled physician and/or Related Entity do not exist and: Appendix B on, Inc. Cephal 8 " 1. no corrective action was initiated prior to the selection of the sampled physicians and/or Related Entities; or . 11. the IRO canot confrm that Cephalon otherwise followed its policies and procedures relating to the entr in the Listig for the sampled physician or Related Entity, including its policies and procedures relating to any Payment(s) reflected in the Listing; or b) Information or data is omitted from key fields in the Control Documents that prevents the IRO from assessing compliance with Cephalon's policies and procedures, and the IRO canot obtain this information or data from reviewing other Control Documents. If a Control Document does not exist, but Cephalon has intiated corrective the sampled physicians and/or Related Entities, or if procedures with regard to each entr in the action prior to the selection of a Control Document does not exist but the IRO can determe that Cephalon otherwise followed its policies and Listing for a sampled physician or Related Entity, the IRO shall consider such a situation to be an exception (rather than a Material Error) and the IRO shall report the situation as such. Similarly, the IRO shall note as exceptions any Control Documents for which non-material information or data is omitted. If the IRO identifies any Material Errors, the IRO shall conduct such the underlying Payment associated with the eroneous Additional Review of Control Documents as may be necessar to determne the root cause of the Material Errors. For example, the IRO may need to review additional documentation and/or conduct interviews with appropriate personnel to identify the root cause of the Material Error(s) discovered. D. IRO Review of Additional Items As set forth in Section HI.D. i.b of the CIA and begining with the second Reporting Period, the OIG at its discretion may identify up to thee additional items for the IRO to review (hereafter "Additional Items".) No later than 90 days prior to the end of the second through fifth Reporting Periods, the OIG shall notify Cephalon of the nature and scope of the IRO review to be conducted for each of the Additional Items. Prior to undertakng the review of the Additional Items, the IRO and/or Cephalon shall submit an audit work plan to the GIG for approval and the IRO shall conduct the review of the Additional Items based on a work plan approved by the OIG. The IRO shall include inforiation about its review of each Cephalon, Inc. Appendix B 9 - i. the review conducted for each Additional Item; the IRQ's fmdings based on its review for each Additional Item; and the IRO' s recommendations for any changes in Cephalon's systems, processes, policies, and procedures based on its review of Addition?l Item in the Transactions Review Report (including a description of each Additional Item.) Cephalon may propose to the OIG that .its internal audit(s) be parially substituted for one or more of the Additional Items that would otherwise be reviewed by the IRO for the applicable Reporting Period. The OIG retains sole discretion over whether, and in what maer, to allow Cephalon's internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. In makg its decision, the OIG agrees to consider, among other factors, the nature and scope of Cephalon' s planed internal audit work, the results of the Transactions Review(s) during prior Reporting Period(s), and Cephalon's demonstrated audit capabilties to perform the proposed audit work internally. If the OIG denies Cephalon's request to perit its internal audit work to be substituted for a portion of the IRO's review of Additional Items in a given Reporting Period, Cephalon shall engage the IRO to pedorm the Review as outlined in this Section III. If the OIG agrees to permit certain of Cephal on's interal audit work for a given Reporting Period to be substituted for a portion of Additional Items review, such internal work would be subject to verification by the IRO (Verification Review). hi such an instance, the OIG would provide additional details about the scope of the Verification Review to be conducted by the IRO. However, for puroses of any Verification Review, the IRO shall review o?at least 20% of sampling units reviewed by Cephalon in its internal audits. E. Promotional and Product Services Transactions Review Report the For each Reporting Period, the IRO shall prepare a report based on its Promotional and Product Services Transactions Review. The report shall include the following: 1) General Elements to.Be Included in Report a) Review Objectives: A clear statement of the objectives intended to be achieved by each par of the review; b) Appendix B Cephal Review Protocol: A detailed narative description of the procedures performed and a description of the samplig unit 10 on, Inc. 4. and universe utilzed in performing the procedures for each sample reviewed; and c) Sources of Data: A full description of documentation and other information, if applicable, relied upon by the IRO in performng the Promotional and Product Services Transactions Review. 2) Results to be Included in Report The following results shall be included in each Promotional and Product Services Review Report: (Relating to the Review ofhiquiries) a) in connection with the review ofhiquies, a description of each type of sample unit reviewed, including the number of each tye of sample units reviewed ~ the number of Inquiries) and an identification of the tyes of documents and information reviewed for the Inquires; b) for each hiquiry sample unit, the IRO shall sumare the information about the hiquiry contained in the Inquiries Database; for each Inquir sample unit, findigs and supporting c) rationale as to whether: (1) each item of information listed in Section III.A. I is reflected in the Inquires Dataase; and (?) for each Inquir for which an Off-Label Review was conducted, the basis for suspecting that improper off-label promotion may have occured; the steps undertaken as par of the Off-Label Review; the findings of the Compliance Officer as a result of the Off-Label Review; and any follow-up actions taken by Cephalon as a result of-the Compliance Officer's findings; d) the findings and supporting rationale regarding any weakesses in Cephalon's systems, processes, policies, procedures, and practices relating to the Inquiries, and the Inquiries Database, if any; Appendix B Cephal on. Inc. 11 '" e) recommendations for improvement in Cephalon' s systems, processes, policies, procedures, and practices relating to the Inquiries and the Inquiries Database, if any; (Relating to the Call Plan Reviews) t) a list of the products promoted by Cephalon durg the Reporting Period and a sumar of the FDA-approved uses for such products; g) for each Cephalon product: i) a description of the critera used by Cephalon in developing or reviewing the cal plans and for including or excluding specified tyes ofHCPs or HCIs from the call plans; ii) a description of the review conducted by Cephalon of the cal plans and an indication of whether Cephalon reviewed the call plans as required by Section III.B.3.e of the CIA; i?) a description of al instances for each call plan in which it appears that the HCPs and HCIs included on the call plan are inconsistent with Cephalon's criteria relating to the call plan and/or Cephalon's Policies and Procedures; and iv) a description of all instances in which it appears that Cephalon failed to follow its criteria or Policies and Procedures relating to call plans or the review of the call plans; h) . the findings and supporting rationale regarding any wealmesses in Cephalon's systems, processes, policies, procedures, and practices relating to Cephalon's call plans or the review of the call plans, ifany; i) recommendations, if any, for changes in Cephalon's systems, processes, policies, procedures, and practices that would correct or address any wealmesses or deficiencies uncovered during the Transactions Review with respect to call plans or the review of the call plans; . (Relating to the Physician Payment Listig Reviews) j) a description of the entres in the Physician Payment Listing for each physician or Related Entity sampled and a description of Control Documents reviewed in connection with each selected physician or Related Entity; Appendix B Cephal on, Inc. 12 . ..! k) for each sampled physician or Related Entity, findings and supportmg rationale as. to whether: (i) all required Control Documents exist; (ii) each Control Document was completed in accordance with all of the requirements set fort in the applicable Cephalon policy; (Hi) the aggregate value of the Payment(s) as reflected in the Listing for the sampled physician or entity is consistent with the value of the Payment(s) reflected in the Control Documents; (iv) each Control Document reflects that Cephalon's policies were followed in connection with the underlyig activity reflected in the document ~ all required approvals were obtaied); and (y) any disciplinar action was undertaken in those instances in which Cephalon policies were not followed; 1) for each sampled physician or Related Entity unit reviewed, an identification and description of all exceptions discovered. The report shall also describe those instances in which corrective action was initiated prior to the selection of the sampled physicians or Related Entities, including a description of the circumtaces requiring corrective action and the nature of the corrective action; m) if any Material Errors are discovered in any sample unt reviewed, a description of the eror, the Additional Review procedures performed and a statement of findings as to the . . root cause(s) of the Material Error; (Relating to the Review of Additional Items) n) for each Additional Item reviewed, a description of the review conducted; for each Additional Item reviewed, the IRO's findings based on its review; 0) p) for each Additional Item reviewed, the findings and supportng rationale regarding any wealesses in Cephalon's systems, processes, policies, procedures, and practices relating to the Additional Item, if any; and q) for each Additional Item reviewed, recommendations, if any, for changes in Cephalon's system, processes, policies, and 13 Appendix B Cephalon, Inc. . J! If procedures that would correct or address any weakesses or deficiencies uncovered durg the review. Appendix B Cephal on, Inc. 14