Manufacturing and Quality Agreements Sample Clauses

Manufacturing and Quality Agreements. As part of the Technology Transition Plan described in Section 2.7, during the Transition Period, Buyer and Seller shall negotiate in good faith manufacturing transfer and quality agreements for the Product that will include provisions regarding the transfer of: (i) existing clinical material; (ii) all cGMP and non-cGMP bulk drug substance or partially finished drug Product, including API, along with the corresponding cell lines and any specialized and dedicated equipment (e.g., proprietary media, dedicated purification columns/filters, etc.) required for the production of Teplizumab; and (iii) the CMC and quality support and documentation necessary to label, package, release and ship the existing inventory of cGMP finished drug product vials to clinical trial sites and/or a corresponding storage and distribution subcontractor. After the Transition Period, Seller shall continue to provide support on the manufacturing transfer described in this Section 8.1 in accordance with the Technology Transition Plan and in accordance with the terms of Section 2.7 for a period of eighteen (18) months from the Effective Date. Costs incurred by Seller in connection with this Section 8.1 shall be subject to the cost allocation and reimbursement provisions of Section 2.7.
Sample 1Sample 2Sample 3See All (4)
AutoNDA by SimpleDocs
Manufacturing and Quality Agreements. If Buyer selects Seller as a contract manufacturer for the Compound following the completion of Buyer’s due diligence described in Section 7.7, the Parties shall negotiate in good faith and use commercially reasonable efforts to agree, no later than the earlier of (i) the date that is [***] from the date hereof and (ii) the date that is [***] after Buyer’s delivery of the Option Exercise Notice, on a form of manufacturing agreement containing terms consistent with this Section 7.8 under which Seller would have the right to manufacture and supply to Buyer (a) up to [***]% of Buyer’s demand for the Compound related to the TATCIST Study and (b) up to [***]% of Buyer’s demand for the Compound related to the first Pivotal Clinical Trial of the Compound initiated by Buyer (the “Manufacturing Agreement”), and a quality agreement containing customary terms with respect to the manufacture of the Compound under the Manufacturing Agreement (the “Quality Agreement”). [***]. The supply price for the Compound supplied under the Manufacturing Agreement for use by Buyer in Phase 2 Clinical Trials and any Pivotal Clinical Trial will be $[***], subject to annual adjustments for inflation (using a mutually agreed standard price index benchmark) and for [***]. If Seller supplies the Actinium-225 used in the manufacture of the Compound under the Manufacturing Agreement, Buyer will pay to Seller [***] for each dose of Actinium-225 supplied. No payments for Actinium-225 will be made to Seller if Buyer supplies the Actinium-225 used in the manufacture of the Compound under the Manufacturing Agreement. [***].
Sample 1
Manufacturing and Quality Agreements 
Sample 1

Related to Manufacturing and Quality Agreements

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

  • 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.

  • MARKETING AND REPRESENTATIONS 8.1 The Fund or its underwriter shall periodically furnish Insurance Company with the following documents, in quantities as Insurance Company may reasonably request:

  • 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.

  • 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.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • 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.

  • Marketing Agreement The Company shall have entered into, ------------------- executed and delivered the Marketing Agreement.

  • MARKETING MATERIALS AND REPRESENTATIONS (a) The Participant represents and warrants that it will not make any representations concerning a Fund, Creation Units or Shares, other than those consistent with the Prospectus or any Marketing Materials (as defined below) furnished to the Participant by the Distributor.

Time is Money Join Law Insider Premium to draft better contracts faster.