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.
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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. [***].
Manufacturing and Quality Agreements 

Related to Manufacturing and Quality Agreements

  • Manufacturing and Supply (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D. (b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties): (i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; (ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer; (iv) Depomed shall [***]; (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);

  • SMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment. 4.2 Participates in an annual performance development review. 4.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 4.4 Completes mandatory training (including safety and quality training) as relevant to role. 4.5 Performs duties in accordance with Government, WA Health, South Metropolitan Health Service and Departmental / Program specific policies and procedures. 4.6 Abides by the WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act.

  • EMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment. 4.2 Actively participates in the Peak Performance program. 4.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 4.4 Completes mandatory training (including safety and quality training) as relevant to role. 4.5 Performs duties in accordance with the EMHS Vision and Values, WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act and Government, WA Health, EMHS and Departmental / Program specific policies and procedures.

  • NMHS Governance, Safety and Quality Requirements 2.1 Participates in the maintenance of a safe work environment. 2.2 Participates in an annual performance development review. 2.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 2.4 Completes mandatory training (including safety and quality training) as relevant to role. 2.5 Performs duties in accordance with Government, WA Health, North Metropolitan Health Service and Departmental / Program specific policies and procedures. 2.6 Abides by the WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act.

  • 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 Seller and Buyer, or their Affiliates, shall have executed the Supply Agreement.

  • COUNTY’S QUALITY ASSURANCE PLAN The County or its agent will evaluate the Contractor’s performance under this Contract on not less than an annual basis. Such evaluation will include assessing the Contractor’s compliance with all Contract terms and conditions and performance standards. Contractor deficiencies which the County determines are severe or continuing and that may place performance of the Contract in jeopardy if not corrected will be reported to the Board of Supervisors. The report will include improvement/corrective action measures taken by the County and the Contractor. If improvement does not occur consistent with the corrective action measures, the County may terminate this Contract or impose other penalties as specified in this Contract.

  • SHIPPING AND AIR TRANSPORT 1. Profits of an enterprise of a Contracting State from the operation of ships or aircraft in international traffic shall be taxable only in that State. 2. The provisions of paragraph 1 shall also apply to profits from the participation in a pool, a joint business or an international operating agency.

  • 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.

  • 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.

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