Third Party Manufacturing Agreements Sample Clauses

Third Party Manufacturing Agreements. To the extent there are Third Party agreements primarily related to the Manufacture of Licensed Products, upon Novartis’ request with respect to any such CMO agreement, Arvinas shall, [**]. If Novartis determines [**]. Any request [**] shall be provided by Novartis [**]. If Novartis elects to [**], then [**]. (f)
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Third Party Manufacturing Agreements. The Clinical Supply Agreement(s) and Commercial Supply Agreement(s) shall include provisions (a) requiring Alnylam to reasonably consult with Genzyme through the JSC regarding proposed supply agreements to be entered into between Alnylam and Third Party Manufacturers to the extent Products to be supplied to Genzyme will be manufactured under such Third Party supply agreements; and (b) requiring Alnylam to use commercially reasonable efforts to include in applicable supply agreements with Third Party manufacturers rights for Genzyme to enforce such agreements against such Third Parties as such agreements relate to the supply of Product(s) for the Genzyme Territory, including by identifying Genzyme as a third party beneficiary under such agreements, and if Alnylam is not able to negotiate such third party beneficiary rights for Genzyme’s benefit, provisions requiring Alnylam to enforce such Third Party supply agreements at Genzyme’s direction and expense as such agreements relate to the supply of the applicable Product(s) for the Genzyme Territory.
Third Party Manufacturing Agreements. If Array proposes to enter into one or more new manufacturing agreements for Product for use in the United States, including without limitation any agreement with a Back-Up Manufacturer as contemplated under Section 9.4, or proposes to materially amend, renegotiate or renew any then-existing Third Party manufacturing agreements for Product for use in the United States, Array shall so notify Oncothyreon and the JCC prior to doing so, along with a detailed description of the proposed terms and circumstances. In addition, if Array proposes to enter into one or more new agreements for the supply of Product for use in the United States, Array shall provide to the JCC evidence of bids for such supply received from at least two (2) other suppliers. To the extent permitted by the potential Third Party manufacturer, Oncothyreon shall have the right to accompany Array on any and all audits and inspections of such Third Party’s facilities conducted in the course of manufacturer selection.
Third Party Manufacturing Agreements. If Array proposes to enter into one or more new manufacturing agreements for Product for use in the United States, including without limitation any agreement with a Back-Up Manufacturer as contemplated under Section 9.4, or proposes to materially amend, renegotiate or renew any then-existing Third Party manufacturing agreements for [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Product for use in the United States, Array shall so notify Oncothyreon and the JCC prior to doing so, along with a detailed description of the proposed terms and circumstances. In addition, if Array proposes to enter into one or more new agreements for the supply of Product for use in the United States, Array shall provide to the JCC evidence of bids for such supply received from at least two (2) other suppliers. To the extent permitted by the potential Third Party manufacturer, Oncothyreon shall have the right to accompany Array on any and all audits and inspections of such Third Party’s facilities conducted in the course of manufacturer selection.
Third Party Manufacturing Agreements 

Related to Third Party Manufacturing Agreements

  • Quality Agreement Concurrently with execution of this Agreement, the Parties will enter into an agreement that details the quality assurance obligations of each Party with respect to the Manufacture and supply of Supplied Products under this Agreement (the “Quality Agreement”). Each Party shall perform its obligations under the Quality Agreement in accordance with the terms and conditions thereof. In the event of a conflict between the terms of the Quality Agreement and the terms of this Agreement, the provisions of the Quality Agreement shall govern.

  • Pharmacovigilance Agreement Within [***] after the Effective Date, BMS and the Company (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall define and finalize the responsibilities the Parties shall employ to protect patients and promote their well-being in connection with the use of the Licensed Compound(s) until such time that all pharmacovigilance responsibilities have transferred from BMS to Company. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Licensed Compound(s). Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill, local and international regulatory reporting obligations to government authorities. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonization (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. Until such guidelines and procedures are set forth in a written agreement between the Parties (hereafter referred to as the “Pharmacovigilance Agreement”), the Party responsible for pharmacovigilance prior to execution of this Agreement shall have sole Pharmacovigilance responsibility for the Licensed Compound(s) subject to all applicable regulations and guidelines. In the event that this Agreement is terminated, the Parties agree to implement the necessary procedures and practices to ensure that any outstanding pharmacovigilance reporting obligations are fulfilled. Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

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