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.the CIA, the Committee shalladopt a resolution, signed by each individual member of the Committee, summarizing itsreview and oversight ofLilly's compliance with Federal health care programrequirements, FDA requiremênts, and the obligations of this CIA.d. For each Reporting Period ofAt minimum, the resolution shall include the following language:"The (insert name of Committee) Committee of the Board of Directors has madea reasonable inquiry into the operations of Lily's Compliance Program, including but notlimited to evaluating its effectiveness and receiving updates about the activities of itsChief Compliance Offcer and other compliance personneL. The Board also has arrangedfor the performance of, and reviewed the result of, the Compliance Program Review.Based on its inquiry, the Committee has concluded that, to the best of its knowledge, Lillyhas implemented an effective Compliance Program to meet Federal health care programrequirements, FDA requirements, and the obligations of the CIA."Ifthe Committee is unable to provide such a conclusion in the resolution, theCommittee shall include in the resolution a written explanation of the reasons why it isunable to provide the conclusion and the steps it is taking to assure implementation byLily of an effective Compliance Program at Lily.Lily shall report to OIG, in writing, any changes in the composition of theCommittee, or any actions or changes that would affect the Committee's ability toperform the duties necessary to meet the obligations in this CIA, within 15 days after sucha change.The Board of Directors may by resolution reserve to itself the powers andresponsibilities assigned to the Committee under this CIA. In that event, all references inthis CIA to the Committee shall be deemed to be references to the Board ofDirectors.Management Accountability and Certifcations: In addition to theresponsibilities setforth in this CIA for all Covered Persons, certain Lilly employees("tertifying Employees") are specifically expected to monitor and oversee activitieswithin their areas of authority and shall annually certify, in writing or electronically, thatthe applicable Lilly component is compliant with Federal health care programrequirements, FDA requirements, and the obligations of this CIA. These CertifyingEmployees shall include, at a minimum, the following individuals from Lilly: Presidentand Chief Executive Officer; and Executive Vice President, Global Marketing and Sales.4.Corporate Integrity AgreementEli Lilly Company6

.They also shall include, at minimum, the following individuals from Lily USA:President, U.S. Operations; Senior Vice President, Account-Based Markets; Senior VicePresident, Health Care Professional Markets; Vice President, ChiefMarketing andOperations Officer; and all national and executive sales directors, brand leaders, andbusiness unit leaders in the HCP Markets, executive directors and directors in AccountBased Markets, and executive directors and directors in Marketing and Operations.For each Reporting Period, each Certifying Employee shall sign a certification thatstates:"I have been trained on and understand the compliance requirements andresponsibilities as they relate to (department or functional area), an area under mysupervision. My job responsibilities include ensuring compliance with regard to thethe department or functional area.) To the best ofmy knowledge,(insert name ofexcept as otherwise described herein, the (insert name of department or functionalarea) ofrequirements,Lily is in compliance with all applicable Federal health care programFDA requirements, and the obligations ofthe CIA."B. Written Standards.1. Code of Conduct. Prior to the Effective Date, Lilly developed,implemented, and distributed a written Code of Conduct (known as "The Red Book") toall Covered Persons. Lily currently requires all newly employed Covered Persons tocertify in writing or electronically, that they have received, read, understood, and shallabide by Lilly's Code of Conduct. Lilly shall continue to make the promotion of, andadherence to, the Code of Conduct an element in evaluating the performance of allCovered Persons.The Code of Conduct sets forth and shall continue to set forth, at aminimum, the following:a. Lilly's commitment to full compliance with all Federal healthcare program and FDA requirements, including its commitment tomarket, sell, promote, research, develop, provide information about,and advertise its products in accordance with Federal health programrequirements and FDA requirements;Corporate Integrity AgreementEli Lily Company7

.,.its Covered Persons shall beexpected to comply with all Federal health care program and FDArequirements and with Lily's own Policies and Procedures asimplemented pursuant to Section IILB (including the requirements ofthis CIA);b. Lilly's requirement that all ofc. the requirement that all ofLilly's Covered Persons shall beexpected to report to the Chief Compliance Officer, or otherappropriate individual designated by Lilly, suspected violations ofany Federal health care program and FDA requirements or ofLily'sown Policies and Procedures;d. the possible consequences to both Lily and Covered Persons offailure to comply with Federal health care program and FDArequirements and with Lily's own Policies and Procedures and thefailure to report such noncompliance; ande. the right of all individuals to use the Disclosure Program describedin Section IILE, and Lilly's commitment to nonretaliation and tomaintain, as appropriate, confidentiality and anonymity with respectto 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 CoveredPerson shall certify, in writing or electronically, that he or she has received, read,understood, and shall abide by Lily's Code ofConduct. New Covered Persons shallreceive the Code of Conduct and shall complete the required certification within 30 daysafter becoming a Covered Person or within 120 days after the Effective Date, whicheveris later.Lily shall periodically review the Code of Conduct to determine if revisions areappropriate and shall make any necessary revisions based on such review. Any revisedC6de of Conduct shall be distributed within 30 days after any revisions are finalized bythe Compliance Office. Each Covered Person shall certify, in writing or electronically,that he or she has received, read, understood, and shall abide by the revised Code ofthe revised Code of Conduct.Conduct within 30 days after the distribution ofCorporate Integrity AgreementEli Lily Company8

.2. Third Party Personnel. Within 90 days after the Effective Date, andannually thereafter by the anniversary of the Effective Date, Lilly shall send a letter toeach entity employing Third Party PersonneL. The letter shall outline Lilly's obligationsunder the CIA and its commitment to full compliance with all Federal health careLily'sprogram and FDA requirements. The letter shall include a description ofCompliance Program. Lily shall attach a copy of its Code of Conduct to the letter andshall request the entity employing Third Party Personnel to either: (a) make a copy ofLilly's Compliance Program available to itsThird Party Personnel; or (b) represent to Lily that it has and enforces a substantiallycomparable code of conduct and compliance program for its Third Party PersonneL.Lily's Code of Conduct and a description of3. Policies and Procedures. Prior to the Effective Date, Lilly implementedthe Compliance Program andLilly's compliance with Federal health care program and FDA requirements (Policies andwritten Policies and Procedures regarding the operation ofProcedures). To the extent not already accomplished, within 90 days after the EffectiveDate, Lilly shall ensure that the Policies and Procedures address or shall continue toaddress:a. the subjects relating to the Code of Conduct identified in SectionIILB.l;b. appropriate ways to conduct Promotional and Product ServicesRelated Functions in compliance with all applicable Federalhealthcare program requirements, including, but not limited to theFederal anti-kickback statute (codified at 42 U.S.c. § 1 320a-7b),and the False Claims Act (codified at 31 U.S.C. §§ 3729-3733);c. appropriate ways to conduct Promotional and Product ServicesRelated Functions in compliance with all applicable FDArequirements;d. the materials and information that may be distributed by Lilysales representatives and account executives about Lily'sGovernment Reimbursed Products and the manner in which Lilysales representatives and account executives respond to requestsfor information about non-FDA approved (or "off-label") uses ofLilly's Governent Reimbursed Products;Corporate Integrity AgreementEli Lilly Company9

.e. the materials and information that may be distributed by the LilyAnswers Center (TLAC) and the mechanisms through, andmanner in which, TLAC receives and responds to requests forinforÎation submitted by sales representatives and accountexecutives about non-FDA approved ("off-label") uses ofLilly'sGovernment Reimbursed Products; the form and content ofinformation disseminated by Lilly in response to such requests;and the internal review process for the information disseminated.The Policies and Procedures shall include a requirement thatTLAC develop database(s) to track requests for informationabout Lily's products that are submitted by Lilly's salesrepresentatives and account executives, or by members ofthepublic, to TLAC. This database shall be referred to as the"TLAC Database." The TLAC Database shall include thefollowing items of information for each unique inquiry (Inquiry)received for information about Lily's products: 1) date ofInquiry; 2) form ofInquiry (e.g., fax, phone, etc.); 3) name oftherequesting health care professional (HCP) or health careinstitution (HCI) in accordance with applicable privacy laws; 4)nature and topic ofrequest (including exact language oftheInquiry ifmade in writing); 5) nature/form ofthe response fromLilly (including a record of the materials provided to the HCP orHCI in response to the request); and 6) the name ofthe Lillyrepresentative who called on or interacted with the HCP or HCI,if known;f. systems, processes, policies, and procedures relating to themanner and circumstances under which Medical Liaisons andOutcomes Liaisons participate in meetings or events with HCPsor HCIs (either alone or with sales representatives or accountexecutives) and the role of the Medical Liaisons and OutcomesLiaisons at such meetings or events, as well as how they handleresponses to unsolicited requests about off-label indications ofLily's Governent Reimbursed Products;g. systems, processes, policies, and procedures relating to thedevelopment, implementation, and review of call plans usingCorporate Integrity AgreementEli Lilly Company10

.Lilly's Territory to Physician (TTP) business rules for field salesrepresentatives who promote Government Reimbursed Products.For each Government Reimbursed Product, the Policies andProcêdures shall require that Lilly review the call plans for theproduct and the bases upon, and circumstances under, whichHCPs and HCIs belonging to specified medical specialties ortypes of clinical practice are included in, or excluded from, thecall plans. The Policies and Procedures shall also require thatLilly modify the call plans as necessary to ensure that Lilly ispromoting its Government Reimbursed Products in a manner thatcomplies with all applicable Federal health care program andFDA requirements. The call plan reviews shall occur at leastannually and shall also occur each time when the FDA approvesa new or additional indication for a Government ReimbursedProduct;h. systems, processes, policies, and procedures relating to thedevelopment, implementation, and review of plans for thedistribution of samples ofLilly's Government ReimbursedProducts (Sample Distribution Plans). This shall include areview ofthe bases upon, and circumstances under, which HCPsand HCIs belonging to specified medical specialties or types ofclinical practice may receive samples from Lilly (including,separately, from Lilly sales representatives or account executivesand/or directly from Lily's medical services department). ThePolicies and Procedures shall also require that Lily modify theSample Distribution Plans as necessary to ensure that Lily ispromoting its products in a manner that complies with allapplicable Federal health care program and FDA requirements;1. consultant or other fee- for-service arrangements entered into withHCPs or HCIs (including, but not limited to speaker programs,speaker training programs, presentations, consultant task forcemeetings, advisory boards, and ad hoc advisory activities, andany other financial engagement or arrangement with an HCP orHCI,) and all events and expenses relating to such engagementsor arrangements. These Policies and Procedures shall bedesigned to ensure that the arrangements and related events areCorporate Integrity AgreementEli Lilly Company11

.used for legitimate and lawful purposes in accordance withapplicable Federal health care program and FDA requirements.The Policies shall include requirements about the content andcircumstances of such arrangements and events;J. programs to educate field representatives, including but notlimited to presentations by HCPs at sales meetings andexperience-based learning activities. These Policies andProcedures shall be designed to ensure that the programs are usedfor legitimate and lawful puroses in accordance with applicableFederal health care program and FDA requirements. The Policiesshall include requirements about the content and circumstances ofsuch arrangements and events;k. sponsorship or funding of grants (including educational grants) orcharitable contributions. These Policies and Procedures shall bedesigned to ensure that Lily's funding and/or sponsorshipcomplies with all applicable Federal health care program andFDA requirements;L. funding of, or participation in, any Third Party EducationalActivity as defined in Section II.C.5 above. These Policies andProcedures shall be designed to ensure that Lilly's funding and/orsponsorship of such programs satisfies all applicable Federalhealth care program and FDA requirements.The Policies and Procedures shall require that: 1) Lilly discloseits financial support ofthe Third Party Educational Activity and,to the extent feasible consistent with subsection 5 below, anyfinancial relationships with faculty, speakers, or organizers atsuch Activity; 2) as a condition of funding, the third party shallagree to disclose Lilly's financial support ofthe Third PartyEducational Activity and any financial relationships that Lillymight have with faculty, speakers, or organizers at such Activity;3) any faculty, speakers, or organizers at the Third PartyEducational Activity disclose any financial relationship withLilly; 4) the Third Party Educational Activity have an educationalfocus; 5) the content, organization, and operation of the ThirdCorporate Integrity AgreementEli Lilly Company12

.Party Educational Activity be independent of Lily control; 6)Lily support only Third Party Educational Activity that is nonpromotional in tone/nature; and 7) Lilly support of a Third PartyEducational Activity shall be contingent on the provider'scommitment to provide information at the Educational Activitythat is fair, balanced, accurate and not misleading;m. review of all promotional and written materials and informationintended to be disseminated outside Lilly by appropriate qualifiedpersonnel (such as regulatory, medical, and/or legal personnel) ina manner designed to ensure that legal, regulatory, and medicalconcerns are properly addressed during Lilly's review andapproval process and are elevated when appropriate. ThePolicies and Procedures shall be designed to ensure that suchmaterials and information, when finally approved, comply withall applicable Federal health care program and FDArequirements;n. sponsorship or funding of research or related activities. ThesePolicies and Procedures shall be designed to ensure that Lilly'sfunding and/or sponsorship complies with all applicable Federalhealth care program and FDA requirements;o. compensation (including salaries and bonuses) for RelevantCovered Persons. These Policies and Procedures shall bedesigned to ensure that financial incentives do not inappropriatelymotivate such individuals to engage in improper promotion,sales, and marketing ofLilly's products; andp. disciplinary policies and procedures for violations ofLily'sPolicies and Procedures, including policies relating to Federalhealth care program and FDA requirements.To the extent not already accomplished, within 120 days after the Effective Date,the relevant portions of the Policies and Procedures shall be made available to all CoveredPersons whose job functions relate to those Policies and Procedures. Appropriate andknowledgeable staff shall be available to explain the Policies and Procedures.Corporate Integrity AgreementEli Lilly Company13

.At least annually (and more frequently, if appropriate), Lily shall assess andupdate, as necessary, the Policies and Procedures. Within 30 days after the effective dateof any revisions, the relevant portions of any such revised Policies and Procedures shallbe made available to all Covered Persons whose job functions relate to those Policies andProcedures.C. Training and Education.Lilly represents that it provides training to its .employees on a regular basis concerninga variety oftopics. The training covered by this CIA need not be separate and distinctfrom the regular training provided by Lily, but instead may be integrated fully into suchregular training so long as the training covers the areas specified below.1. General Training. Within 120 days after the Effective Date, Lilly shallprovide at least two hours of General Training to each Covered Person. This training, at aminimum, shall explain Lily's:a. CIA requirements; andb. Lilly's Compliance Program (including the Code of Conduct andthe Policies and Procedures as they pertain to general complianceissues).To the extent that Lilly provided General Training to Covered Persons during the180 days immediately prior to the Effective Date that satisfied the requirements set forthin Section IILC.l.b above, the OIG shall credit that training for purposes of satisfyingLilly's General Training obligations ofthis Section IILC. 1 for the first Reporting Period.Lily may satisfy its remaining General Training obligations for the Covered Persons whoreceived the training described in the preceding sentence by notifying them within 90days after the Effective Date in writing or in electronic format of the fact that LilyLily's requirements and obligations underentered a CIA and providing an explanation ofthe CIA.(New Covered Persons shall receive the General Training described above within30 days after becoming a Covered Person or within 120 days after the Effective Date,whichever is

Marketing and Sales Organization, Regulatory, Corporate Affairs, and Human Resources. 3. "Government Reimbursed Products" refers to all Lily human pharmaceutical products that are reimbursed by Federal health care programs. This term includes all products promoted or sold by Lilly or Lilly USA in the United States. 4.