Supply and Quality Agreements. At Novartis’ request in connection with any Dose Ranging Clinical Trial, Drug-Drug Interaction Study, HCV Combination Clinical Trial or any other activities that are contemplated by this ARTICLE V to be conducted by Novartis, the Parties shall, in good faith, use Commercially Reasonable Efforts to negotiate and enter into a supply agreement and, if necessary, a quality agreement pursuant to which Idenix will supply reasonable quantities of the applicable Idenix HCV Product to Novartis to perform HCV Combination Clinical Trials, at a price equal to [**] percent ([**]%) of COGs for such Idenix HCV Product, on the terms and conditions set forth in the Term Sheet attached hereto as Exhibit G.
Supply and Quality Agreements. The parties agree that at Takeda’s request Xxxxx shall enter into a Supply Agreement(s) and a Quality Agreement(s) for the supply of drug substance or clinical or commercial supply of Licensed Product required in Sections 6.1 and 6.2(a). The Supply Agreement(s) and Quality Agreement(s) shall be negotiated and managed by the Joint Manufacturing Committee.
Supply and Quality Agreements. At least [*] prior to the expected First Commercial Sale of a Pipeline Product in the Collaboration Territory (or in the case of the In-Line Products, prior to the First Commercial Sale in the Collaboration Territory of any such In-Line Product by or on behalf of BeiGene), the Parties shall enter into a Supply Agreement and a Quality Agreement with respect to the supply of such Product by Amgen to BeiGene for commercial use. The Supply Agreement shall incorporate the terms set forth in the Supply Term Sheet Schedule and other customary terms and conditions mutually agreed upon by the Parties including (a) the effect of Amgen’s failure to supply BeiGene with its requirements of a Product for commercial use, (b) [*] and (c) the effect of a shortage of supply of any Product, including actions to be taken to ensure that [*]. Amgen and BeiGene shall enter into a Quality Agreement with any Third Party contract manufacturer, warehouse, transportation or a Third Party test laboratory utilized for the Products. The Manufacturing of Products will comply with the Quality and Compliance Standards, Supply Agreement(s) and Quality Agreement(s).
Supply and Quality Agreements. Notwithstanding anything to the contrary in this Article 5, the Parties shall enter into Supply and Quality Agreements only if and to the extent permitted by Applicable Laws in the Licensee Territory. The Supply and Quality Agreements shall be consistent with the terms and conditions of this Agreement and shall include Licensee’s good faith forecast and related commitments from time to time of its and its Affiliates’ and Sublicensees’ requirements for the Products. The Supply and Quality Agreements shall also include, among other things, comprehensive and commercially reasonable terms regarding: allocation of Products (and/or supplemental Manufacturing arrangements) if supply becomes constrained; Allogene’s commitments regarding compliance with Applicable Laws in the Licensee Territory related to the manufacture and quality of the Products (including Product registration specifications, manufacturing and testing protocols, and monograph requirements); Licensee or its designee’s right to inspect and audit the sites where Products are Manufactured and to audit Supply Prices; change controls related to Products and labeling; the supply to Licensee of Regulatory Materials; and the provision by Allogene of reasonable cooperation, information, and assistance with any inspection of Allogene, its Affiliates, sublicensees or subcontractors within the Allogene Territory (including without limitation, Clinical Trial and Manufacturing sites) that may be requested by any Regulatory Authority inside the Licensee Territory and cost reimbursement for same.
Supply and Quality Agreements. 7.4.1 Between the Parties. After the License Effective Date and within [*****] days after the dosing of the first patient in the first Phase 3 Trial for the Product (or within such other period as the Parties may agree in writing), Dermira and Almirall shall enter into: (a) an agreement under which Dermira shall supply Almirall with Drug Product upon terms and conditions that are consistent with the terms described in Section 7.1 and Schedule 7.4.1, except that to the extent that such terms are dependent on [*****] in a Third Party Supply Agreement, such agreement between the Parties will [*****]; and (b) a separate quality agreement that is consistent with Dermira’s obligations to Third Parties that are Manufacturing the Drug Product or components thereof. Upon such supply agreement and quality agreement becoming effective, the terms and conditions of such agreements shall supersede Section 7.1 and Section 7.3. In the event any provision of Schedule 7.4.1 conflicts with this ARTICLE 7, this ARTICLE 7 will govern.
Supply and Quality Agreements. After the Effective Date, the Parties shall negotiate in good faith and enter into a comprehensive supply agreement pursuant to which Dyax shall supply Drug Substance and Drug Product to CMIC (the "Supply Agreement") together with a quality agreement. The quality agreement shall conform with the industry standards governing the Drug Substance and Drug Product supplied pursuant to the Supply Agreement (the "Quality Agreement"). The Supply Agreement and the Quality Agreement shall include the terms and conditions similar to those set forth in Sections 6.1 through 6.4 of this Agreement and shall contain such other terms and conditions that the Parties mutually agree that are customary for supply agreements and quality agreements of this type.
Supply and Quality Agreements. As soon as practicable, but in any event in advance of Otsuka initiating any Clinical Trial or other studies of Product in the Otsuka Territory, the Parties will agree upon and enter into a clinical supply agreement on reasonable and customary terms for the supply of Bulk Product or Semi-Finished Products and their matching placebo (collectively, “Clinical Samples”) by Aurinia to Otsuka for use in such Development (a “Clinical Supply Agreement”), and reasonably in advance of the First Commercial Sale of the first Product in the Otsuka Territory, the Parties will agree upon and enter into a commercial supply agreement on reasonable and customary terms for supply of Bulk Product or Semi-Finished Product by Aurinia to Otsuka for use in Commercialization in the Otsuka Territory (a “Commercial Supply Agreement”). Each Supply Agreement will be consistent with any applicable CMO Agreement, and will contain reasonable and customary terms for clinical supply or commercial supply, as applicable, and will include shipment and delivery terms on a FCA Origin (Incoterms 2020) basis. Without limiting the foregoing, the Commercial Supply Agreement will include the following terms, unless the Parties agree otherwise: forecasting and ordering terms; criteria regarding manufacturing capacity, quantity, timeliness of delivery, quality and cost; specifications (including shelf life requirements); provisions relating to safety stock, and failure to supply (including appropriate remedies in the event of a failure to supply); acknowledgement of the sensitive and proprietary nature of the Voclosporin Manufacturing Trade Secrets and procedures for the protection of same, including through authorized manufacturers; shortage allocation terms; change control provisions; warranties; acceptance and rejection procedures; provisions relating to audits and inspections; and an arbitration provision consistent with the terms of this Agreement, including with respect to tolling. [Terms of cost sharing redacted.] The Product supplied under any Supply Agreement shall be the Product supplied under Aurinia’s CMO Agreement. In addition to, or as part of, each Supply Agreement, the Parties will agree upon and enter into one or more quality technical agreements (each, a “Quality Agreement”) containing reasonable and customary terms and conditions regarding quality assurance, quality control and compliance with cGMP and cGCP (as applicable). After the execution of the Supply Agreement(s), and Quality...
Supply and Quality Agreements. No later than [***] prior to the anticipated First Commercial Sale of a Product in the Territory, the Parties shall initiate good faith negotiations to enter into a Manufacturing & Supply Agreement and a Quality Agreement with respect to the supply of such Product by Aerie to Santen for commercial use, substantially on the terms set forth in Exhibit I (Manufacturing & Supply Agreement Terms for Commercial Supply), and the Parties will use Commercially Reasonable Efforts to enter into such Manufacturing & Supply Agreement and Quality Agreement within [***] after the commencement of such negotiations. The Manufacturing & Supply Agreement shall incorporate customary terms and conditions mutually agreed upon by the Parties, including terms regarding technology transfer to Santen, Aerie’s Affiliates and Third Parties. The Manufacturing of Products will comply with the Quality and Compliance Standards, Manufacturing & Supply Agreement(s) and Quality Agreement(s).
Supply and Quality Agreements. As soon as possible after the Effective Date, the Parties shall negotiate in good faith and enter into a comprehensive supply agreement pursuant to which Dyax will supply Drug Substance and Drug Product to Sigma Tau (the "Supply Agreement") together with a quality agreement in accordance with industry standards governing the Drug Substance and Drug Product supplied pursuant to the Supply Agreement (the "Quality Agreement"). The Supply Agreement and the Quality Agreement shall include terms similar to those set forth in Sections 6.1 through 6.4 of this Agreement and shall contain such other terms and conditions that the Parties mutually agree upon that are customary for supply agreements and quality agreements of this type. Pending the execution and delivery of a Supply Agreement and a Quality Agreement, Manufacture of Product shall be conducted in accordance with the terms and conditions of this Article VI.
Supply and Quality Agreements. Subject to the oversight of the JCMC as described in Section 2.5, Agensys or its Affiliates shall Manufacture and supply the initial requirements for the Product (in unpackaged, unlabeled form) in accordance with the terms hereof (and the supply and quality agreements contemplated by this Section 5.3) for Commercialization worldwide by each Party, and the Selling Party shall perform Packaging and Labeling and Sales and Distribution for such Product. Within [ * ] days after the Effective Date, the Parties shall negotiate and enter into a supply agreement and a quality agreement consistent with this Agreement setting forth the terms and conditions of such supply for the United States, the SGI Profit Share Territory and the SGI Royalty Territory and, in the case of the quality agreement, quality-related matters globally. Such agreements shall reflect customary terms and conditions for the supply and quality of pharmaceutical products in the context of a profit sharing arrangement, including with respect to forecasting and ordering, payment terms, the calculation and reconciliation of Standard Cost, financial and compliance audits, the engagement of subcontractors, a fair and equitable allocation of Product between the Parties and their Affiliates in the event of any defects or Product shortfalls, and representations and warranties; provided that the Parties agree that the indemnification and limitation of liability provisions of ARTICLE 13 will apply to any and all Manufacturing Losses including those relating to such agreements. Such quality agreement shall govern product distribution holds, recalls, clinical holds, or market withdrawals (as set forth in Section 3.10) and any other quality control and quality assurance-related activities agreed between the Parties. The supply agreement will set forth the details of financial transaction to support the supply of Product with cost sharing consistent with this Agreement..
