Manufacture and Supply of Product. (a) Alpharma will manufacture Product at Alpharma’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.
(b) Alpharma will notify ViroPharma of any changes, including but not limited to any change in the manufacturing process or Product specifications or control methods which are likely to alter the identity, purity, quality, potency or stability of the Product and which require a regulatory filing with the FDA. Alpharma will notify ViroPharma not less than ninety (90) days prior to implementation of any such change so that ViroPharma will have reasonable time to allow ViroPharma to update applicable regulatory filings and evaluate the effect on its finished product prior to receiving Product which incorporates the change. However, Alpharma will not notify ViroPharma of any Annual Reportable Changes before implementation. In the event that ViroPharma does not agree to accept Products with changes proposed by Alpharma pursuant to this subsection (b), ViroPharma shall promptly notify Alpharma in writing of that decision. The parties shall then attempt in good faith to resolve ViroPharma’s objections over a thirty (30) day period, failing which resolution ViroPharma shall have the right to terminate this Agreement with [***] written notice provided, however, that during this [***] termination period ViroPharma shall have the right to terminate this Agreement [***] Indicates material that has been omitted and for which confidential treatment has been requested. All such omitted material has been filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. immediately upon written notice if at any time during the [***] termination period Alpharma is unable to continue to supply to ViroPharma Product manufactured in accordance with the manufacturing process or Product specifications or control methods, as applicable, which were effective before the change implemented by Alpharma to which Vi...
Manufacture and Supply of Product. (a) The Compound, Development Plan 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.
(b) Any chemical (not including the Commercial Carrier) or formulation components required by Novartis for its own manufacture of the Product, Development Plan Carriers or Compound for the purposes of this Agreement shall be procured by Novartis at its own expense. Novartis shall ensure that supplies of the Product(s) are produced as diligently as any of its products of similar commercial importance. Novartis shall be responsible for the packaging, labeling, distribution and sale of the Product. The manufacture and distribution of supplies of Product for use in clinical studies or as samples in a country shall be carried out in the same manner. Novartis shall have the right to manufacture any Development Plan Carrier during Development and Commercialization.
(c) From the fifth anniversary of the Launch of the Product, subject to the following sentence, Emisphere may itself manufacture up to a maximum of ***% of Novartis’ needs for the Commercial Carrier only if Emisphere is able to produce the Commercial Carrier to the same standards of quality and consistency as Novartis and at a cost acceptable to Novartis. If Emisphere quotes a verifiable price that is ***% of the Novartis Fully Burdened Manufacturing Cost with the same standard of quality and consistency as Novartis, then Emisphere shall be permitted to manufacture up to ***% of the Novartis Commercial Carrier needs.
Manufacture and Supply of Product. 2.1 AstraZeneca agrees to supply the Product to the Purchaser following the granting of Regulatory Approval and in accordance with the terms and conditions of this Supply Agreement; the Purchaser agrees to pay the price for the Product in accordance with the terms and conditions of this 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. 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. (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.
(b) Any chemical (not including the Commercial Carrier) or formulation components required by Novartis for its own manufacture of the Product, Programme Carriers or Compound for the purposes of this Agreement shall be procured by Novartis at its own expense. Novartis shall ensure that supplies of the Product(s) are produced as diligently as any of its products of similar commercial importance. Novartis shall be responsible for the packaging, labeling, distribution and sale of the Product. The manufacture and distribution of supplies of Product for use in clinical studies or as samples in a country shall be carried out in the same manner. Novartis shall have the right to manufacture any Programme Carrier during Development and Commercialization.
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.
2.2 Piramal shall cause the Products to be manufactured in accordance with all due care, diligence and skill.
2.3 The Products shall be dispatched as per the quality and scheduling requirements of Pxxxxxx and must be sent along with their batch number accompanied with the Certificate of Analysis.
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. 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.
4.2 Biocon shall obtain Optimer’s prior written approval before Biocon implements any change in the materials, equipment, process or procedures used to manufacture or test Product that would constitute a major change under cGMPs or that would otherwise require a filing with or notification to a Regulatory Authority.
4.3 Biocon shall use Commercially Reasonable and Diligent Efforts to continuously maintain a sufficient stock of raw materials required to manufacture the Product in quantities no less than those set forth in the applicable Non-Binding Forecast at any time; provided that such quantity does not exceed [***] of Product per calendar quarter. Biocon shall use and rotate all stock of such raw materials on a first-in, first-out basis or as otherwise required by cGMPs and other Applicable Laws. Biocon will use Commercially Reasonable and Diligent Efforts to obtain the most competitive price for any raw materials required in the manufacture of Product and shall ensure such materials are released for use, in accordance with Biocon’s quality system and requirements including the Manufacturing Requirements prior to manufacturing any Batch of Product. Biocon will review its stock levels of raw materials on a regular basis to maintain stock levels in accordance with this section 4.3. Biocon shall purchase all [***] raw materials and use [***] only in accordance with the [***] specifications most recently agreed to by the parties as set forth in [***], each as applicable to “fresh” or “recycled” [***] used at Park or Campus, or as otherwise required by applicable Regulatory Authorities or by Regulatory Approvals. Biocon shall keep Optimer reasonably informed with respect to any changes in [***] prices and shall reasonably cooperate with Optimer should Optimer desire to obtain long-term pricing of [***] supplies.
4.4 Optimer or its designee(s) shall use the Product obtained pursuant to this Agreement solely in the research, development or manufacture of Drug Product in the Territory or in any ROW country or market. For clarification, Optimer shall be permitted to sell or otherwise transfer Product to its commercial partners for such commercial partner’s research, development...
