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. 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. 2.2 AstraZeneca shall ensure that the volume of Product that is the subject of the Order shall be supplied to the Purchaser in accordance with the obligations under clause 5. 2.3 AstraZeneca shall procure that it, its Affiliates and Subcontractors shall exercise the same level of effort, diligence and care in the Manufacture and supply of the Product to the Purchaser hereunder as AstraZeneca would exercise in carrying out the same or substantially similar services itself. 1.2.13 pojmy „nebo“ a „a/nebo“ se vykládají ve slučovacím významu, který je obvykle spojován s výrazem „a/nebo“; 1.2.14 pokud se pojmy „oznámit“ a „oznámení“ v této Smlouvě o dodávkách týkají oznámení mezi jejími Smluvními stranami (nebo jejich zástupci), pak znamenají písemně oznámit nebo písemné oznámení v souladu s odst. 24.1 této Smlouvy o dodávkách; a 1.2.15 jakýkoli odkaz na výrazy „písemně“ nebo „písemný“ zahrnuje veškeré způsoby reprodukce slov v čitelné, a nikoli přechodné podobě (včetně e-mailu, avšak s výjimkou SMS nebo dočasných zpráv). 1.3 V případě rozporu mezi ustanoveními kterékoli přílohy a ustanoveními hlavního textu této Smlouvy o dodávkách mají přednost ustanovení jejího hlavního textu. 2. VÝROBA A DODÁVKY PŘÍPRAVKU 2.1 Společnost AstraZeneca se zavazuje dodávat Přípravek Kupujícímu po udělení Regulačního schválení a v souladu s podmínkami této Smlouvy o dodávkách, a Kupující se zavazuje platit za Přípravek cenu v souladu s podmínkami této Smlouvy o dodávkách. 2.2 Společnost AstraZeneca zajistí, aby objem Přípravku, který je předmětem Objednávky, byl Kupujícímu dodán v souladu s povinnostmi podle článku 5. 2.3 Společnost AstraZeneca zajistí, aby ona, její Přidružené společnosti a Subdodavatelé vynakládali při Výrobě a dodávkách Přípravku Kupujícímu podle této Smlouvy o dodávkách stejnou míru
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. 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. 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. 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) 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.
Manufacture and Supply of Product. (a) Alpharma will manufacture Product at Alpharma’s United States Food and Drug Administration (“FDA”) approved facility in [***] in accordance with cGMP, the Product Specifications and the Quality Agreement (attached as Exhibit: 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 final pharmaceutical products into which the Products are introduced by ViroPharma, except to the extent that any safety or efficacy problem is related to Alpharma’s 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 ___________ [***] 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. sixty (60) 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 on [***] months written notice.
