Product Returns. VF will have the responsibility for handling customer returns of the Product. CCX will give VF any assistance that VF may reasonably require to handle the returns.
Defective Product. If VF rejects Bulk Drug Product under Section 6.1 and the deficiency is determined to have arisen from CCX’s failure to provide the Manufacturing Services in accordance with the Specifications, cGMPs or Applicable Laws, CCX will for the defective Bulk Drug Product. If VF previously paid for the defective Bulk Drug Product, CCX will promptly, , either: # replace the Bulk Drug Product with conforming Bulk Drug Product within the following months, as of rejection by VF, without VF being liable for payment therefor under Section 3.1. or # .
Recalled Product. If a Recall or return results from, or arises out of, a failure by CCX to perform the Manufacturing Services in accordance with the agreed Specifications, cGMPs, or Applicable Laws, CCX will be responsible for the .
Defective Product. CCX’s maximum aggregate liability to VF for any obligation to # refund, offset or replace any defective Product under Section 6.3(a) or (ii) replace any recalled Products under Section 6.3(b), will not exceed for the defective or recalled Product as applicable. This Section 10.2(a) will not be subject to Section 10.2(b). For clarity, any CCX liability for VF’s out of pocket expenses of a Recall or Product return under Section 6.3(b) will be subject to Section 10.2(b) and not this Section 10.2(a).
Work Product. The Executive agrees that all innovations, improvements, developments, methods, designs, analyses, reports and all similar or related information which relates to the Company's or any of its affiliates' actual or anticipated business, or existing or future products or services and which are conceived, developed or made by the Executive while employed by the Company ("Work Product") belong to the Company or such affiliate. The Executive will promptly disclose such Work Product to the CEO and perform all actions reasonably requested by the CEO (whether during or after the Employment Period) to establish and to confirm such ownership (including, without limitation, assignments, consents, powers of attorney and other instruments).
Licensed Product. Zolgensma is a Licensed Product.
Product Maintenance. Client shall pay Catalent the fees for Product Maintenance Services set forth on Attachment C. Catalent shall submit an invoice to Client for such fees upon the Effective Date or Commencement Date, as applicable and as may be required during the Term.
Product Improvements. Aguettant shall solely own all right, title, and interest in and to the Product Improvements. AcelRx agrees to assign and hereby assigns and transfers to Aguettant all of its right, title and interest in and to the Product Improvements and agrees to take, and to cause its Affiliates, Sublicensees and its or their employees and agents to take, all further acts reasonably required to evidence such assignment and transfer to Aguettant, at Aguettant’s reasonable expense. AcelRx hereby appoints Aguettant as its attorney-in-fact to sign such documents as Aguettant deems necessary for Aguettant to obtain ownership and to apply for, secure, and maintain patent or other proprietary protection of the Product Improvements if Aguettant is unable, after reasonable inquiry, to obtain AcelRx’s (or its employee’s or agent’s) signature on such a document. AcelRx shall notify Aguettant in writing of any and all Product Improvements generated or reduced to practice by or on behalf of AcelRx or its Affiliates, promptly after each such Product Improvement is made or generated. For clarity, the Product Improvements shall be automatically incorporated in the definition of the Aguettant Patents and Aguettant Know-How. AcelRx shall ensure that each individual and entity conducting any activities under this Agreement on its behalf is under written obligation to assign all right, title and interest in and to the Product Improvements to AcelRx.
Product Specifications. Supplier shall supply all Products according to the Specifications in effect as of the date of this Agreement, with such changes or additions to the Specifications of the Products related thereto as shall be requested by Buyer in accordance with this Section or as otherwise agreed in writing by the Parties. All other Products shall be manufactured with such Specifications as the Parties shall agree in writing. "Specifications" means, with respect to any Product, the design, composition, dimensions, other physical characteristics, chemical characteristics, packaging, unit count and trade dress of such Product. The Specifications hereby incorporate the Laws and all rules and regulations promulgated thereunder by any governmental authority, including but not limited to the Oregon Department of Agriculture and the U.S Agricultural Improvement Act of 2018. The Products shall not contain any substance or chemical prohibited by such Laws, rules and regulations.
Product Recalls. In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with 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 voluntary or mandatory recall, market withdrawal or other corrective action regarding Product, such Party will promptly advise the other Party (in the case of Relief, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer; and in the case of Acer, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer) thereof by telephone or email. Relief will 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 will be required) or to take other corrective action in any country in Relief Territory and the manner in which any such recall, market withdrawal or corrective action will be conducted; provided, that Acer will have the right to participate in any meetings and to review and comment in advance on any communications with a Regulatory Authority in connection with a recall or pharmacovigilance matter in the Relief Territory and Relief will notify Acer prior to making any public disclosure of the recall, market withdrawal or corrective action and will keep Acer regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs in the Relief Territory will be borne solely by Relief. Acer will 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 will be required) or to take other corrective action in any country in the Acer Territory and the manner in which any such recall, market withdrawal or corrective action will be conducted; provided, that Acer will notify Relief prior to making any public disclosure of the recall, market withdrawal or corrective action and will keep Relief regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs in the Acer Territory will be borne by the Parties as they will be included in Distribution Costs. The Parties will exercise reasonable cooperation between them, as appropriate, to resolve Product complaints and share related data.
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