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Product Claims
Product Claims contract clause examples
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Product Recalls. In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with a Co-Developed Product, or in the event a Party reasonably believes that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or other corrective action regarding a Co-Developed Product, such Party shall promptly advise the other Party thereof by telephone or facsimile. Following such notification, Abbott shall decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it shall be required) or to take other corrective action in any country and the manner in which any such recall, market withdrawal or corrective action shall be conducted; provided that Abbott shall keep Enanta regularly informed regarding any such recall, market withdrawal or corrective action. Abbott shall bear all expenses of any such recall, market withdrawal or corrective action (including, without limitation, expenses for notification, destruction and return of the affected Co-Developed Product and any refund to customers); provided, that, any such expenses shall be allocable as Co-Developed Costs or Commercialization Expenses and shared by the Parties in accordance with Section 5.3.

Product Labeling. All product labels for Products shall include the names and logos of both Abbott and Enanta, to the extent consistent with the Applicable Laws of any country in which Products are sold.

Product Materials. Subject to any applicable Laws and the terms and conditions of this Agreement, each Party hereby grants to the other Party a fully-paid up, royalty-free license, with the right to grant sublicenses under multiple tiers, to use Product Materials generated and owned by such Party, solely to the extent reasonably necessary for the Development, Manufacture (with respect to [[3D Medicines:Organization]], solely to the extent applicable under Section 7.2) and Commercialization of the Licensed Compound and Licensed Product in the Field in the other Party’s respective territory during the Term of this Agreement. Notwithstanding the foregoing, no rights shall be granted by either Party to the other Party under this [Section 9.1(b)] with respect to the Development, Manufacture or Commercialization of any products containing the Licensed Compound together with one or more Drug Substances other than the Licensed Compound or for use in combination with one or more Drug Substances other than the Licensed Compound.

Product Trademarks. Zai may use (pursuant to this Section 8.4) the trademarks Controlled by TPTX in the Territory as TPTX may provide to Zai in writing from time to time (the “TPTX Product Marks”) and may use the English mark thereof with Chinese phonetic translation below. TPTX hereby grants to Zai, during the Term and subject to the terms and conditions of this Agreement, a royalty-free, exclusive license under TPTX’s rights to use such TPTX Product Marks in connection with the Commercialization of the Products in the Field in the Territory in compliance with Applicable Laws and this Agreement. Zai shall comply with TPTX’s brand [[Address C:Address]]ge guidelines provided to Zai in its use of the TPTX Product Marks. Zai may also brand the Products in the Territory using other trademarks, logos, and trade names specific for the Products that differ from the TPTX Product Marks and do not contain the name of TPTX; provided, however, that # prior to such use, Zai shall submit such trademarks, logos and trade names for TPTX’s prior written approval (not to be unreasonably withheld, delayed or conditioned), and # such trademarks, logos and trademarks shall be deemed owned by Zai (the “Product Marks”). Zai shall own all rights in the Product Marks in the Territory and shall register and maintain the Product Marks in the Territory that it determines reasonably necessary.

Work Product. All Work Product shall be exclusively owned by BFA, and Provider hereby assigns, and shall cause its Affiliates, Subcontractors and all Provider Personnel to assign, to BFA all right, title and interest in and to the Work Product. To the extent any Work Product has applicability to Provider’s provision of similar services to Provider client’s generally and does not constitute Confidential Information of BFA or BFA Recipients and to the extent not otherwise agreed in writing by BFA and Provider, BFA shall grant to Provider a non-exclusive, worldwide, non-transferable, perpetual, irrevocable, non-terminable (except for terminations in connection with certain breach events), fully paid-up, royalty-free license to use, load, access, execute, store, transmit, copy, display, perform and otherwise exploit such Work Product in connection with the provision of services similar to the Services to Provider’s clients on terms to be negotiated in good faith by BFA and Provider; provided that no such license shall become effective prior to the date that is two (2) years from the date such Work Product is first used commercially or in production by BFA or a BFA Recipient in connection with the Services.

Product Returns. Client will have the responsibility for handling customer returns of the Products. [[Organization A:Organization]] will give Client any assistance that Client may reasonably require to handle the returns.

Defective Product. If Client rejects Products under Section 6.1 and the deviation is determined to have arisen from [[Organization A:Organization]]'s failure to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, [[Organization A:Organization]] will credit Client's account for [[Organization A:Organization]]'s invoice price for the defective Products. If Client previously paid for the defective Products, [[Organization A:Organization]] will promptly, at Client's election, either: # refund the invoice price for the defective Products; # offset the amount paid against other amounts due to [[Organization A:Organization]] hereunder; or # 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, [[Organization A:Organization]]'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.

Recalled Product. If a Recall or return results from, or arises out of, a failure by [[Organization A:Organization]] to perform the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, [[Organization A:Organization]] will be responsible for the documented out-of-pocket expenses of the Recall or return and will use its commercially reasonable efforts to replace the Recalled or returned Products with new Products, 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, [[Organization A:Organization]]'s responsibility for any loss of Active Materials in Recalled Product will be captured and calculated in the Active Materials Yield under Section 2.2. If [[Organization A:Organization]] is unable to replace the Recalled or returned Products (except where this inability results from a failure to receive the required Active Materials and Client-Supplied Components), then Client may request [[Organization A:Organization]] to reimburse Client for the price that Client paid to [[Organization A:Organization]] for Manufacturing Services for the affected Products. In all other circumstances, Recalls, returns, or other corrective actions will be made at Client's cost and expense.

This Agreement is structured so that a Product Agreement may be entered into by the parties for the manufacture of a particular Product or multiple Products at a Patheon manufacturing site. Each Product Agreement will be governed by the terms and conditions of this Agreement unless the parties to the Product Agreement expressly modify the terms and conditions of this Agreement in the Product Agreement. Unless otherwise agreed by the parties, each Product Agreement will be in the general form and contain the information set forth in Appendix 1 hereto.

Work Product. Notwithstanding that Sunovion will be the Disclosing Party with respect to the Work Product or Product Inventions: # the Work Product (including the Government Pricing Reports) and Product Inventions shall be deemed to be the Confidential Information of Urovant, and # Urovant shall be deemed to be the “Disclosing Party” and Sunovion shall be deemed to be the “Receiving Party” with respect thereto.

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