Example ContractsClausesClinical Supply
Clinical Supply
Clinical Supply contract clause examples

Clinical Supply. [[Agenus:Organization]] shall use Commercially Reasonable Efforts to supply to [[Organization A:Organization]] the gram quantities of [[Agenus:Organization]] Antibody required by [[Organization A:Organization]] at […​…] of [[Agenus:Organization]]’ fully burdened costs as set forth in a schedule delivered to [[Organization A:Organization]] in the form of [Exhibit B] (the “Cost Schedule”), plus all logistics, shipping, and any VAT or other applicable transfer taxes. Any changes to the costs set forth in the Cost Schedule shall be identified in an updated Cost Schedule delivered to [[Organization A:Organization]] annually, provided that any increase exceeding […​…] in aggregate shall be disclosed to [[Organization A:Organization]] prior to implementation of such change. [[Agenus:Organization]] may Manufacture and supply [[Agenus:Organization]] Antibody for such purpose either itself or through the use of an Affiliate or [[Agenus:Organization]] Subcontractor. All supplies of the [[Agenus:Organization]] Antibody to [[Organization A:Organization]] shall be used solely in preclinical studies or Clinical Trials in accordance with the Development Plan, as applicable, and shall not be incorporated into any Licensed Product that is sold or offered for sale.

Clinical Supply. Unless otherwise determined by the JSC, with respect to each [[Unknown Identifier]] Co-Co Product, Stoke shall be responsible, by itself or through one or more Third Party contract manufacturers (each a “CMO”), to Manufacture and supply to each Party, its Affiliates and Sublicensees such [[Unknown Identifier]] Co-Co Product for Development in the Territory. Within ​ after the selection of a Clinical Candidate resulting from the [[Unknown Identifier]] Research Program, the Parties shall negotiate in good faith and enter into an agreement pursuant to which the supplying Party would supply the corresponding [[Unknown Identifier]] Co-Co Product to each Party for use in performing Development activities under the applicable [[Unknown Identifier]] Co-Development Plan at a transfer price equal to the supplying Party’s Manufacturing Cost (without any markup) (each a “[[Unknown Identifier]] Co-Co Clinical Supply Agreement”). With respect to each [[Unknown Identifier]] Co-Co Clinical Supply Agreement, the Parties shall negotiate in good faith and enter into an agreement governing the quality control of the product Manufactured pursuant to such agreement.

Clinical Supply. Subject to the terms of ​ (“Existing CMO Agreement”), ITEOS shall be solely responsible, through its Existing CMO, for Clinical Manufacture and supply of Licensed Antibodies and Licensed Products required for the performance of activities under the Global Development Plan from the Effective Date until completion ​ (the “October 2021 Campaign”), after which GSK shall be solely responsible for Clinical Manufacture and supply of Licensed Antibodies and Licensed Products throughout the Territory (including for the performance of activities under the Global Development Plan).

Ono shall have the right to purchase from [[Forty Seven:Organization]], and [[Forty Seven:Organization]] shall use Commercially Reasonable Efforts to supply to, Ono Hu5F9-G4 or Hu5F9-G4 Product, in each case, in the same dose and formulation as [[Forty Seven:Organization]] Manufactures or has Manufactured ​ for Ono to conduct non-clinical, preclinical and clinical studies for obtaining any Regulatory Approval in the Ono Territory. Ono shall be ​ relating to the supply of Hu5F9-G4 Product and [[Forty Seven:Organization]] Manufactured Products for the Ono Territory ​. Promptly following the earlier of # Ono’s delivery to the JSC of the Ono Development Plan for a Hu5F9-G4 Product and [[Forty Seven:Organization]] Manufactured Products pursuant to [Section 4.1.2] and # [[Forty Seven:Organization]]’s acceptance of Ono’s Opt-In Request for a Global Study for a Hu5F9-G4 Product and [[Forty Seven:Organization]] Manufactured Products pursuant to [Section 4.3.3], within ​ following the Effective Date, the Parties shall negotiate in good faith a clinical supply agreement and a quality agreement therefor on reasonable and customary terms, including provisions for forecasting and ordering, quality matters and recalls. For clarity, Ono may Manufacture the Product (subject to the Technology Transfer Completion with respect to Hu5F9-G4 Product and [[Forty Seven:Organization]] Manufactured Products) in any Territory for non-clinical, preclinical and clinical studies in the Ono Territory, subject to the terms of the applicable Upstream Agreement.

Clinical Supply. Within ​ days after the Exercise Date with respect to a Collaboration Candidate, the Parties will negotiate in good faith and enter into, in accordance with the provisions of this [Section 3.2], a # master process development, manufacturing and supply agreement governing the terms and conditions under which FATE will manufacture and supply to ONO the Collaboration Products for preclinical and clinical use ("Clinical Supply Agreement"), and # quality agreement for quality control and quality assurance in connection with manufacturing of a Collaboration Product conducted by FATE or its Third Party contract manufacturers, including the cGMP responsibilities of the Parties. During such ​ day period, ONO shall transfer to FATE, in consultation with FATE's process development personnel (or equivalent), all ONO Know-How necessary for FATE to

Clinical Supply. Lytix shall Manufacture and supply, to the extent requested by Verrica, or have Manufactured and have supplied, # API to Verrica for use in clinical trials and other Development and registration activities and # Product being Developed or Commercialized by or on behalf of Lytix for use in Verrica’s initial clinical studies, with respect to Product in the Licensed Field in the Territory, in accordance with a written clinical supply agreement to be negotiated in good faith and entered into by the Parties as soon as practicable following the Effective Date and in accordance with the principles and terms set forth in [Exhibit 0] (the “Clinical API Supply Agreement”). The Clinical API Supply Agreement will contain other normal and customary terms and conditions for such supply arrangement. Verrica shall pay Lytix for API supplied by or on behalf of Lytix to Verrica under the Clinical API Supply Agreement at a price equal to Lytix’s Cost of Goods plus a ​ premium.

Clinical Supply Agreement. ​ the Parties shall enter into # one or more clinical supply agreement(s) (the “Clinical Supply Agreement”) pursuant to which REGENX shall Manufacture and supply Clinical Supply and supply Delivery Systems for such Clinical Supply to PARTNER for Development activities under this Agreement, including Clinical Trials under the Development Plan, and # ​ quality assurance agreement setting forth the terms and conditions on which the Parties shall conduct their quality activities in connection with the applicable Clinical Supply Agreement (the “Clinical Quality Agreement”). ​. Without limitation of the foregoing, the Clinical Supply Agreement(s) shall include terms and conditions that conform in all material respects to those set forth on [Schedule 5.1.2] and in the event that Clinical Supply or Delivery Systems for such Clinical Supply are required by PARTNER prior to the execution of the Clinical Supply Agreement, this Agreement, including the terms set forth on [Schedule 5.1.2], shall govern the Manufacture and supply of such Clinical Supply.

Until the first grant of Marketing Authorization for a Product in the European Union or the European Economic Area, the Clean Room(s) will be used exclusively for clinical supply of the Products (“Clinical Supply Phase”). During the Clinical Supply Phase, the following provisions shall apply notwithstanding anything to the contrary set forth in this Agreement:

Out-of-Pocket Costs incurred for ​;

Clinical Supply Agreement. Within ​ following the Effective Date, the Parties shall negotiate in good faith a clinical supply agreement containing supply terms and conditions consistent with the principles set forth on [Exhibit 5.1] hereto (Supply Agreement Key Terms) and such other terms as are customary for such agreements, including provisions addressing technology transfer of the Eidos Know-How related to the Manufacture of the Licensed Compound and Licensed Products (the “Clinical Supply Agreement”), pursuant to which Eidos will Manufacture and supply to Alexion the Licensed Compound and Licensed Products for the Territory.

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