IRO Review of Arrangements with Independent Charity PAPs Sample Clauses

IRO Review of Arrangements with Independent Charity PAPs. The IRO shall conduct a review and assessment of Amgen’s compliance with the Independent Charity PAP processes, policies, and procedures outlined in Section III.J of the CIA. More specifically, the IRO shall review fifty percent (50%) of the donation arrangements that Amgen entered into with Independent Charity PAPs during the Reporting Period for which the IRO is conducting the Transactions Review. Amgen has represented that, as a matter of practice, Amgen enters a separate agreement with an Independent Charity PAP for each disease state fund of the PAP to which Amgen makes a donation. Amgen shall provide the IRO with a list of all Independent Charity PAPs with which Amgen entered into a donation agreement during the Reporting Period under review (the “applicable Reporting Period”). The IRO will randomly select and review 50% of these donation arrangements for the applicable Reporting Period. For purposes of the Independent Charity PAP Transactions Review, the term “Reviewed Materials” shall mean the following for each Independent Charity PAP arrangement reviewed: 1) the Annual Notice from Amgen to Independent Charity PAPs (which announces Amgen’s willingness to consider written requests for contributions and seeks information regarding: anticipated patient need for particular disease state funds; patient eligibility criteria used by the Independent Charity PAPs; and information about the Independent Charity PAPs);
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IRO Review of Arrangements with Independent Charity PAPs. ‌ The IRO shall conduct a review and assessment of Sanofi’s compliance with the Independent Charity PAP processes, policies, and procedures outlined in Section III.J of the CIA. More specifically, the IRO shall review the arrangements and interactions with all Independent Charity PAPs or disease state funds with which Sanofi entered charitable donation arrangements during the Reporting Period for which the IRO is conducting the review. For purposes of this IRO review, the term “Reviewed Materials” shall include the following for each Independent Charity PAP reviewed: 1) the Annual Notice from Sanofi to Independent Charity PAPs (which announces Sanofi’s willingness to consider written requests for contributions and seeks information regarding: anticipated patient need for particular disease state funds; patient eligibility criteria used by the Independent Charity PAPs; and information about the Independent Charity PAPs); 2) responses from Independent Charity PAPs to the Annual Notice (which includes information on anticipated patient need for particular disease state funds; details regarding patient eligibility criteria used by the Independent Charity PAPs; and information about the Independent Charity PAPs (e.g., information about administrative fees, patient grant amounts, average processing time to assist patients, etc.)); 3) patient needs assessment documentation related to a donation arrangement with an Independent Charity PAP (which includes information on the assessment of patient need in disease states based on non-patient-specific or drug-specific information from eligible Independent Charity PAPs, other publicly available information, and Sanofi’s internal free drug program); 4) allocation documentation that shows the objective criteria used to evaluate Independent Charity PAPs and the allocation of the approved budget across disease states and Independent Charity PAPs (e.g., patient needs assessment information for disease state funds, information about Sanofi’s historical donations; eligibility criteria of the Independent Charity PAPs; and other relevant information, as applicable); 5) documents required by Sanofi policy to evidence or document the review and approval of a decision to provide a donation to a particular fund of an Independent Charity PAP (e.g., minutes from Sanofi’s PAP Governance Committee that memorialize donation decisions, including budget allocation across disease states and Independent Charity PAPs, and final determinations...
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IRO Review of Arrangements with Independent Charity PAPs. ‌ The IRO shall conduct a review and assessment of Lundbeck’ compliance with the Independent Charity PAP processes, policies, and procedures outlined in Section III.J of the CIA. More specifically, the IRO shall review the arrangements and interactions with all Independent Charity PAPs or disease state funds with which Lundbeck entered charitable donation arrangements during the Reporting Period for which the IRO is conducting the review. For purposes of this IRO review, the term “Reviewed Materials” shall include the following for each Independent Charity PAP reviewed: 1) all budget-related documents;‌
Sample 1
IRO Review of Arrangements with Independent Charity PAPs. ‌ The IRO shall conduct a review and assessment of Astellas’ compliance with the Independent Charity PAP processes, policies, and procedures outlined in Section III.J of the CIA. More specifically, the IRO shall review the arrangements and interactions with all Independent Charity PAPs or disease state funds with which Astellas entered charitable donation arrangements during the Reporting Period for which the IRO is conducting the review. For purposes of this IRO review, the term “Reviewed Materials” shall include the following for each Independent Charity PAP reviewed: 1) all budget-related documents;‌
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IRO Review of Arrangements with Independent Charity PAPs. The IRO shall conduct a review and assessment of Jazz’s compliance with the Independent Charity PAP processes, policies, and procedures outlined in Section III.J of the CIA. More specifically, the IRO shall review the arrangements and interactions with all Independent Charity PAPs or disease state funds with which Jazz entered charitable donation arrangements during the Reporting Period for which the IRO is conducting the review. For purposes of this IRO review, the term “Reviewed Materials” shall include the following for each Independent Charity PAP arrangement reviewed:
Sample 1
IRO Review of Arrangements with Independent Charity PAPs. ‌ The IRO shall conduct a review and assessment of Jazz’s compliance with the Independent Charity PAP processes, policies, and procedures outlined in Section III.J of the CIA. More specifically, the IRO shall review the arrangements and interactions with all Independent Charity PAPs or disease state funds with which Jazz entered charitable donation arrangements during the Reporting Period for which the IRO is conducting the review. For purposes of this IRO review, the term “Reviewed Materials” shall include the following for each Independent Charity PAP arrangement reviewed: 1) the information on Jazz’s website regarding Corporate Giving, including the online application portal through which Independent Charity PAPs must submit written requests for contributions; 2) donation requests from Independent Charity PAPs (which includes information on the particular disease state funds; details regarding patient eligibility criteria used by the Independent Charity PAPs; and information about the Independent Charity PAPs (e.g., information about administrative fees, patient grant amounts, average processing time to assist patients, etc.));‌‌ 3) the approved annual budget for charitable giving, allocating the budget for donations to Independent Charity PAPs, and to any disease state funds established by the Independent Charity PAPs;‌ 4) documentation that shows the objective criteria used to evaluate Independent Charity PAPs and the allocation of the approved budget across disease states and Independent Charity PAPs (e.g., Corporate Giving Executive Review Committee presentations and related documentation; documentation of due diligence performed by Jazz; and other relevant information, as applicable);‌ 5) documents regarding donations to Independent Charity PAPs required by Jazz policy to evidence or document the review and approval of a decision to provide a donation to a particular fund of an Independent Charity PAP (i.e., minutes from Jazz’s Corporate Giving Executive Review Committee that memorialize donation decisions, including budget allocation across disease states and Independent Charity PAPs, and final determinations (approvals or rejections) on proposed donations to Independent Charity PAPs);‌ 6) to the extent not covered by item 2 above, all correspondence between Jazz and an Independent Charity PAP relating to any donation arrangement with the Independent Charity PAP;
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Related to IRO Review of Arrangements with Independent Charity PAPs

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  • Transitional Arrangements 1. Subject to the provisions of paragraphs 2, 3 and 4, no Member shall be obliged to apply the provisions of this Agreement before the expiry of a general period of one year following the date of entry into force of the WTO Agreement. 2. A developing country Member is entitled to delay for a further period of four years the date of application, as defined in paragraph 1, of the provisions of this Agreement other than Articles 3, 4 and 5. 3. Any other Member which is in the process of transformation from a centrally-planned into a market, free-enterprise economy and which is undertaking structural reform of its intellectual property system and facing special problems in the preparation and implementation of intellectual property laws and regulations, may also benefit from a period of delay as foreseen in paragraph 2. 4. To the extent that a developing country Member is obliged by this Agreement to extend product patent protection to areas of technology not so protectable in its territory on the general date of application of this Agreement for that Member, as defined in paragraph 2, it may delay the application of the provisions on product patents of Section 5 of Part II to such areas of technology for an additional period of five years. 5. A Member availing itself of a transitional period under paragraphs 1, 2, 3 or 4 shall ensure that any changes in its laws, regulations and practice made during that period do not result in a lesser degree of consistency with the provisions of this Agreement.

  • GOVERNANCE ARRANGEMENTS Enforceability of the Agreement

  • Implementation Arrangements Institutional Arrangements

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