Supply Agreement, Quality Agreement and Manufacturing Responsibility Document Sample Clauses

Supply Agreement, Quality Agreement and Manufacturing Responsibility Document. The Parties shall negotiate in good faith and enter into and adopt a quality agreement (the “Quality Agreement”) within ninety (90) days of the Effective Date, a supply agreement and a Manufacturing Responsibility Document or MRD prior to one (1) year of the anticipated approval of a Product by CFDA, each of which shall be within the purview of the applicable portion of the cGMP. The supply agreement shall include but not be limited to, traditional supply terms, product costing, forecast obligations and access to Manufacturing records and facilities including the right for Lilly at its discretion to have a person in the plant at any Manufacturing site used by Xxxxxxxxx or its Third Party Manufacturer during Manufacturing activities related to the Product. The MRD will contain, among other provisions, certain procedures and personnel contacts relating to the supply of Products for the Territory that will be developed, approved and updated by the Parties, and the shelf-life of the Product and Samples. The supply agreement and the MRD will be subject to and not be inconsistent with the terms of this Agreement and in the event of conflict between the terms of the MRD and this Agreement, the terms of this Agreement will control. Articles of the supply agreement and MRD may be modified from time to time by mutual written agreement of the Parties. The Quality Agreement shall include, but not be limited to, the Specifications for a Product, Product audit rights, including specifications and audit rights for the Samples, which shall contain customary terms as per the cGMP as mandated by the CFDA. Besides the authorized representatives of the Parties, representatives of each Party’s quality units and safety units shall sign the Quality Agreement and Safety Agreement, respectively. Representatives of each Party’s quality unit and supply chain unit shall sign MRD. In the event the information in, or the terms of, the Quality Agreement, Safety Agreement or the MRD conflicts with this Agreement, the terms of this Agreement will control, provided that with respect to specific technical matters that directly impact the quality of a Product, the terms of the Quality Agreement will control.
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Related to Supply Agreement, Quality Agreement and Manufacturing Responsibility Document

  • Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.

  • Supply Agreement Buyer shall have executed and delivered the Supply Agreement to the Company.

  • Quality Agreement Each Party will comply with the terms of the Quality Agreement in the performance of its obligations hereunder including record retention, audits and inspections, change control, adverse events and product recall. The Parties will conduct periodic Product quality reviews in accordance with the terms of the Quality Agreement.

  • Supply Agreements For a period of three years from the consummation of the IPO, Odetics shall not unilaterally terminate or assign its guarantee obligation with respect to any supply agreement pursuant to which it has guaranteed the performance by ATL of ATL's obligations, unless such suppliers have consented to the termination or assignment of such guarantee.

  • Collaboration Agreement The Collaboration Agreement shall not have been terminated in accordance with its terms and shall be in full force and effect.

  • 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.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • Development Agreement That certain Development Agreement dated of even date herewith by and between the Company and Developer providing for the development of the Project on the Property, a copy of which is attached hereto as Exhibit C and incorporated herein by reference. Development Fee. As described in Section 6.8.

  • Statement of Work Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work, SECTION J, ATTACHMENT 1, April 30, 2004, attached hereto and made a part of this contract.

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