Manufacture and Supply of Product. (a) The Compound, Programme Carriers and Product will be manufactured by Novartis or a Third Party manufacturer of Novartis’ sole choice, the selection of which shall not be unreasonably withheld by Emisphere unless Emisphere can reasonably demonstrate that the selected Third Party manufacturer is considered a technological competitor of Emisphere and Emisphere would suffer commercially from such selection for such reason alone. Emisphere may raise objection to a maximum of one Third Party manufacturer as proposed by Novartis.
Manufacture and Supply of Product. Xxxxx (itself or through an Affiliate or a Third Party that is selected by Xxxxx and acceptable to Novartis) (the “Approved Manufacturer”) shall have the exclusive right and responsibility to Manufacture and supply Product for Novartis’ requirements and use in Development in the Field in the Territory prior to exercise of the Option, including the Clinical Evaluation Materials, in accordance with the terms and conditions of this Article XVI, the Supply Agreement, and the Quality Agreement. To the extent that Novartis requires additional supply of Product following the exercise of the Option to prevent disruption of supply for subsequent clinical trials, the Parties will negotiate in good faith the terms of a mutually acceptable supply agreement.
Manufacture and Supply of Product. Subject to the terms and conditions set forth in this Agreement, Advanced shall manufacture the Product for sale to Acclarent in the Field of Use and shall supply Acclarent’s requirements for such Product in the Field Of Use as set forth below. All Product manufactured hereunder shall meet the Specifications as set forth in Exhibit A and as may be revised from time to time upon written agreement of the parties and shall be subject to the terms of Section 16.10 below. All Product shall be labeled and packaged in accordance with Acclarent’s written instructions therefore as reasonably provided by Acclarent to Advanced. Advanced agrees to comply with all applicable laws and regulations and to maintain ongoing quality assurance and testing procedures to satisfy and ensure compliance with the QA Standards (as defined in Section 7.1 below). Advanced will maintain, and will allow Acclarent, any designee of Acclarent CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [****], HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. or any governmental agency having appropriate authority, to examine its manufacturing facility and its manufacturing and quality assurance records, such records being limited to those records required by law or regulation as well as lot numbers and other manufacturing documentation reasonably required to ensure traceability of the Product, PROVIDED, HOWEVER, Advanced shall have the right to restrict access or redact portions of documents as required to protect its confidential, proprietary or trade secret information.
Manufacture and Supply of Product. 2.1 Subject to the terms of this Agreement, Piramal agrees to supply the Products to Pxxxxxx, during the term of this Agreement, in accordance with the Specifications set out in Annexure A of this Agreement.
Manufacture and Supply of Product. During the Term, Seller shall, or shall cause its suppliers or Affiliates to, manufacture and supply to Buyer the Products, and Buyer shall purchase from Seller such Products, in each case, subject to the terms and conditions of this Agreement. Seller and its suppliers and Affiliates shall manufacture the Products supplied hereunder in the ordinary course of business and in a manner consistent with the past practice of the Business in the six-month period prior to the date of the Asset Purchase Agreement.
Manufacture and Supply of Product. (a) Except as set forth below, OV shall have sole responsibility (either itself or through one or more contract manufacturers), at its own expense, for manufacturing all clinical supplies of Product for the Phase 2 Clinical Trial(s), in all formulations in bulk and finished form. LP represents and warrants that any of LP’s existing manufacturing agreements do not contain any obligations for OV to obtain all or part of its requirements from such Third Parties and LP will take no action or inaction that would result in any such obligation or that would adversely affect OV’s rights under this Agreement. Commencing on the Effective Date, LP shall not negotiate or enter into any manufacturing or supply agreements for Compound or Products or in any way implicating or impacting on Products, without the express prior written consent of OV.
Manufacture and Supply of Product. Upon final FDA regulatory approval granting Pentech the right to manufacture, sell and distribute the Product, Pentech hereby agrees to manufacture or engage a subcontractor to manufacture the Product exclusively for Pentech (the "Subcontractor"). Pentech hereby appoints Par for the Term and any Renewal Term of this Agreement as Pentech's exclusive distributor of the Product in the Territory. Pentech agrees that during the Term and any Renewal Term of this Agreement, all Product manufactured by or on behalf of Pentech shall not be supplied to any third party for distribution in the Territory. Par agrees to market, distribute, and sell the Product only in the Territory, subject to the terms and conditions of this Agreement. Par shall purchase exclusively from Pentech all of its requirements for the Product in the Territory to the extent that Pentech is able to, and does, supply them in accordance with this Agreement. Notwithstanding anything herein to the contrary, in the event that Par does not place a Firm Order for an aggregate quantity of capsules during the six-month period that commences on the Final Approval Date equal to what would represent ten percent (10%) of the total market share for newly written prescriptions of the Product in its generic form only on the Final Approval Date, the exclusive right granted to Par in this Section 3.1 shall become a nonexclusive right and Pentech may use third parties to distribute and sell the Product in the Territory. For purposes of this Section 3.1, market share of the Product shall be determined using data supplied by NDC Health Corporation. In the event that Pentech shall fail or shall be unable to supply Par's reasonable requirements for any Product hereunder for a period exceeding thirty (30) days, Par may, in its discretion, elect to manufacture such Product, or cause such Product to be manufactured for Par. Par shall give Pentech not less than thirty (30) days notice of Par's intent to manufacture such Product, or cause such Product to be manufactured for Par. If Pentech is able to demonstrate to Par, in Par's reasonable good faith discretion, that it can meet Par's reasonable requirements within such thirty (30) day period, then Par shall continue to procure its supply of the Product from Pentech. If Pentech is unable to demonstrate to Par, in Par's reasonable good faith discretion, that it can meet Par's reasonable requirements within such thirty (30) day period, then Par may manufacture such Product, ...
Manufacture and Supply of Product. (a) Xellia will manufacture Product at Xellia’s United States Food and Drug Administration (“FDA”) approved facilities in *** in accordance with cGMP, the Product Specifications and the Quality Agreement and Applicable Law. ViroPharma shall be fully responsible for the safety and efficacy, and compliance with all Applicable Laws, in connection with the use (and the manner and method of use) of the Products in finished dosage form pharmaceutical products into which the Products are introduced by ViroPharma, except to the extent that any safety or efficacy problem is related to the manufacture of the Product.
Manufacture and Supply of Product. 4.1. Sicor will Manufacture Product at the Sicor Facilities. The foregoing shall not preclude Sicor’s right to subcontract certain Manufacturing activities to qualified Affiliates or Third Parties at other sites and facilities pursuant to Section 2.4 hereof. For the purpose having two alternative sites available for the downstream chemistry processing of AP3 into Portions of this Exhibit were omitted, as indicated by [***], and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Product to be supplied to ImmunoGen hereunder as contemplated in Appendix III of the Quality Agreement, Sicor agrees to have both of the Sicor Facilities qualified and utilizable for such purpose, in accordance with the relevant provisions the Quality Agreement. Furthermore, Sicor may otherwise propose to change the location from one of the Sicor Facilities to the other, or use any additional facility controlled by Sicor or its Affiliates for the Manufacture of Product, pursuant to the terms of the Quality Agreement and in any event only upon (a) providing ImmunoGen with written notice of such proposal at least [***] days commencing any of the preparatory steps necessary to qualify such other facility for such activities, and (b) receiving ImmunoGen’s prior written consent, which consent will not be unreasonably withheld or delayed. The Parties agree that it will be reasonable for ImmunoGen to withhold such consent pending satisfactory completion by each of the Parties of their respective quality assurance audits and/or regulatory impact assessments of the new location or additional facility, as the case may be. Sicor will maintain, at its own expense, the Sicor Facilities (and any additional facility approved for use as described above) and all Equipment required for the Manufacture of Product in a state of repair and operating efficiency consistent with the requirements of cGMP and Applicable Law.
Manufacture and Supply of Product. 4.1 Biocon shall manufacture the Product in accordance with the Manufacturing Requirements at Validated Facilities and supply such manufactured Product to Optimer or its designee(s) against payment of the price in accordance with section 9 and subject to the other terms of this Agreement.
