Catalent-Supplied Components Sample Clauses

Catalent-Supplied Components. Catalent will use [***] to purchase the Catalent-Supplied Components with sufficient lead times and in sufficient quantities to meet Client’s Firm Orders for Product, including additional quantities as necessary for efficient supply chain management practices. Catalent and Client shall review Catalent’s inventory management plan as a routine part of joint governance of the Services in accordance with Section 3.15 (“Business Review Committee”). Client shall reimburse Catalent for the Catalent-Supplied Components as set forth in the applicable Plan. Generation of invoices and payment for Catalent-Supplied Components shall be made in accordance with Section 5.3 (“Payment Terms”) of this Agreement. [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED
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Catalent-Supplied Components. Catalent will use [***] efforts to purchase the Catalent-Supplied Components in quantities sufficient to meet Client’s Firm Orders for Product, including additional quantities as necessary for efficient supply chain management practices. Client shall reimburse Catalent for the Catalent-Supplied Components as set forth in the Project Plan. Stock materials will be invoiced upon consumption. Custom (or non-stock) materials purchased by Catalent for Client will be invoiced (and title shall transfer to Client) upon receipt of such non-stock materials by Catalent. Such materials shall be deemed Client Materials upon transfer of title to Client. Generation of invoices and payment for Catalent-Supplied Components shall be made in accordance with Section 5.3 (“Payment Terms”) of this Agreement.
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Related to Catalent-Supplied Components

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • Defective Product If Client rejects Products under Section 6.1 and the deviation is determined to have arisen from Patheon’s failure to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, Patheon will credit Client’s account for Patheon’s invoice price for the defective Products. If Client previously paid for the defective Products, Patheon will promptly, at Client’s election, either: (i) refund the invoice price for the defective Products; (ii) offset the amount paid against other amounts due to Patheon hereunder; or (iii) replace the Products with conforming Products without Client being liable for payment therefor under Section 3.1, contingent upon the receipt from Client of all Active Materials and Client-Supplied Components required for the manufacture of the replacement Products. For greater certainty, Patheon’s responsibility for any loss of Active Materials in defective Product will be captured and calculated in the Active Materials Yield under Section 2.2.

  • Product Supply 5.1 In the event that Eisai notifies Radius of its desire to purchase bulk substance of Compound from Radius, Radius shall supply Eisai with all amount of such bulk substance of Compound, which meets specifications for the Product determined by Radius in the course of its Development activities pursuant to this Agreement, required by Eisai for commercial sales of Product in Japan With respect to Eisai clinical development activities for Product in Japan, upon Eisai’s request, Radius shall supply Eisai the bulk substance of Compound for * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. the conduct of the Eisai Development activities in the amounts and at the times determined by the SC, having reference to the quantity of the bulk substance of Compound required for clinical trials in Japan. Radius shall charge Supply Price for applicable bulk substance of Compound. Radius shall ship such bulk substance of Compound, FOB point of manufacturing. 5.2 In the event that Eisai notifies Radius of its desire to purchase Semi-Product from Radius which meets specifications determined by Radius in the course of its Development activities pursuant to this Agreement, Radius shall supply Eisai with all amount of Semi-Product required by Eisai for commercial sales of Product in Japan. With respect to Eisai clinical development activities for Product in Japan, upon Eisai’s request, Radius shall supply Eisai Semi-Product for the conduct of the Eisai Development activities in the amounts and at the times determined by the SC, having reference to the quantity of Semi-Product required for clinical trials in Japan. Radius shall charge Supply Price for Semi-Product. Radius shall ship such Semi-Product, FOB point of manufacturing. 5.3 The Parties agree that they shall, in good faith, discuss, negotiate and execute necessary agreements containing mutually acceptable terms, including but not limited to, a supply agreement for either bulk substance of Compound or Semi-Product as well as a quality control agreement of either bulk substance of Compound or Semi-Product, in the event that Eisai notifies Radius as set forth in Article 5.1 or 5.2. 5.4 As manufacturer of the Product, Radius shall be responsible for: (a) the control of the quality of the Product promoted and sold under the Radius trademarks; as provided in Article 2.3; and (b) ensuring that all bulk substance of Compound or Semi-Product supplied to Eisai pursuant to this Article 5 shall be manufactured in accordance with the applicable good manufacturing practices (GMP) and shall meet the then applicable specifications for the bulk substance of Compound or Semi-Product; and Radius warrants that all bulk substance of Compound or Semi-Product supplied to Eisai pursuant to this Article 5 shall be manufactured in accordance with the applicable GMP and shall meet the then applicable specifications for the bulk substance of Compound or Semi-Product and will be free from defects in material and workmanship. Radius shall resolve any product liability issues in the Territory relating to the Product and shall resolve any product liability issues in Japan relating to the Product or the bulk substance of Compound or Semi-Product, as the case may be, supplied to Eisai pursuant to this Article 5 in the event and to the extent related to a breach of the warranty set forth in Article 5.4(b) at its own expense and subject to Article 5.5. 5.5 Radius’ obligations with respect to product liability in the Territory and Japan shall include the following responsibilities, each to be taken at Radius’ expense: (a) Radius shall report, at its expense, to appropriate authorities, in accordance with local requirements, all adverse events related to use of the Product in the Territory or Japan. Eisai shall provide to Radius, upon Radius’ request, reasonable assistance in connection with the reporting of all of adverse events, responding to safety queries and assessing safety issues, in each case, to the extent related to the Product in Japan. Adverse events shall be recorded in a single, centralized database, which shall be held and owned by Radius. Radius will provide, upon request by Eisai, any safety information in Radius’ control and reasonably required by Eisai in connection with the development and commercialization of the Product in Japan and all reasonable assistance in responding to safety queries related to the Product and in assessing safety issues related to the Product in Japan. Details of safety reporting activities relating to the Product will be addressed in a pharmacovigilance contract, which the Parties shall enter into after the Effective Date. (b) In the event that (i) Radius determines that an event, incident, or circumstance may result in the need for a recall or other removal of the Product or any lot or lots thereof from the market; (ii) any regulatory authority in the Territory threatens to remove a Product from the market; or (iii) any regulatory authority in the Territory requires distribution of a “Dear Doctor” letter or its equivalent regarding the use of Product, Radius shall promptly advise Eisai in writing, and shall provide Eisai with copies of all relevant correspondence, notices and the like. Notwithstanding anything the contrary herein, Radius shall have final authority to make all decisions relating to any recall, market withdrawal or other corrective action with respect to the Product in the Territory. After establishing SC pursuant to Article 3.5, all decisions relating to any recall, market withdrawal or other corrective action with respect to the Product shall be decided by the SC as set forth in Article 3.6; provided that in the event that the Parties take different positions with respect to recall, market withdrawal or other corrective action with respect to the Product, then Radius shall have the right to cease supplying bulk substance of Compound or Semi-Product to Eisai for Japan if, after good faith discussions with Eisai, Radius reasonably believes that that continued supply to Eisai exposes Radius to liability as a result of its decision with respect to the Territory. If Radius elects to cease supply, it will terminate supply in an orderly manner, as soon as practical and in accordance with a schedule agreed to by Eisai and Radius. In the event of a recall, market withdrawal or other corrective action with respect to the Product in Japan, and at Radius’ request, Eisai shall provide reasonable assistance to Radius, at Radius’ cost and expense, in conducting any such recall, market withdrawal or other corrective action with respect to the Product in Japan. 5.6 THE WARRANTY IN SECTION 5.4(b) IS IN LIEU OF ANY OTHER WARRANTY WITH RESPECT TO THE PRODUCT, BULK SUBSTANCE OF COMPOUND OR SEMI-PRODUCT SUPPLIED BY RADIUS HEREUNDER, WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL (INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE).

  • Defective Products (a) In the event that Nycomed determines that any shipment of Product, at the time of delivery, (i) does not conform to the Product Specifications, (ii) contains misprinted or non-conforming labelling or packaging, or (iii) has been damaged in transit (collectively, "Defective Products"), then Nycomed shall give Anthra notice thereof (including a sample from such shipment) within fifteen days after receipt thereof, if such defects may be ascertained by the exercise of reasonable diligence (which shall include laboratory testing or other chemical analysis as necessary) upon receipt thereof, and otherwise within fifteen days after discovery thereof. If Anthra confirms such defect, it shall promptly so notify Nycomed. If Anthra does not confirm such defect, it shall promptly so notify Nycomed, and the parties shall submit the disputed shipment for testing to an independent testing laboratory that is mutually acceptable to the parties. The findings of the testing laboratory shall be *** CONFIDENTIAL TREATMENT REQUESTED. 18 binding on the parties. The expenses of such testing shall be borne by Anthra if the testing confirms the defect, and otherwise by Nycomed. (b) If any shipment contains Defective Product, for any reason other than the willful or negligent acts or omissions of Nycomed or its customers or agents, Anthra shall credit Nycomed with the costs incurred by Nycomed with respect to all such Defective Product that has not been sold (or has been sold and returned), which costs shall be deemed equal to the sum of any amounts paid on account of such Defective Product pursuant to Section 3.7 and any and all transportation and storage charges incurred by Nycomed in connection with such Defective Product. In addition, at Nycomed's option, (i) Anthra shall be relieved of any obligation to deliver any Product in replacement of such Defective Product, or (ii) Anthra shall replace such Defective Product as soon as possible after Nycomed notifies Anthra of its election of option (ii) of this Section 3.4, in which case Nycomed shall pay to Anthra any unpaid amounts in respect of the replacement Product in accordance with Section 3.7 following delivery of the replacement Product.

  • Product NYISO will provide Energy Resource Interconnection Service and Capacity Resource Interconnection Service to Developer at the Point of Interconnection.