Manufacturing Covenants Clause Samples
Manufacturing Covenants are contractual provisions that set out specific obligations and standards the manufacturer must adhere to during the production process. These covenants may require the manufacturer to use certain materials, comply with industry regulations, maintain quality control procedures, or meet delivery timelines. By clearly defining these requirements, Manufacturing Covenants help ensure product quality, regulatory compliance, and timely delivery, thereby reducing the risk of disputes and protecting the interests of the buyer.
Manufacturing Covenants. The Party that has responsibility for manufacturing all or part of a Product hereunder (the “Manufacturing Party”) covenants to the other Party as follows: any Product (or components thereof) supplied by, or on behalf of, the Manufacturing Party to the other Party or any Third Party shall (a) be manufactured in compliance in all material respects with GMP and with all other Applicable Law, (b) conform to the Specifications therefor in effect at the time of delivery by the Manufacturing Party to the other Party or Third Party; (c) with respect to quantities of a Product sold in the United States following Regulatory Approval in the United States, not, at such time of delivery by the Manufacturing Party to the other Party or Third Party, be adulterated or misbranded within the meaning of the Act; (d) with respect to quantities of a Product sold in the United States, not, at such time of delivery by the Manufacturing Party to the other Party or Third Party, constitute an article that may not be introduced into interstate commerce under the provisions of Section 505 of the Act; (e) at such time of delivery, by the Manufacturing Party to the other Party or Third Party, conform in all material respects to the certificates of analysis supplied with the shipment of the Product or components thereof; and (f) be packaged and shipped in accordance with the Specifications therefor in effect at the time of shipment.
Manufacturing Covenants. (a) Protalix will, within sixty (60) days after the Effective Date, reasonably cooperate with Pfizer to allow Pfizer, at its sole cost and expense, to review Protalix’s supply chain security procedures and their implementation with a view to determining whether such procedures and Protalix’s implementation thereof meet the importer security criteria set forth by the Customs-Trade Partnership Against Terrorism (“C-TPAT”) program of the U.S. Bureau of Customs and Border Protection.
(b) Protalix acknowledges that Pfizer has advised Protalix that (i) Pfizer is a certified member of C-TPAT, (ii) importers that have joined C-TPAT are expected to have substantially fewer of their imports inspected and, hence, fewer supply chain delays (the “C-TPAT Benefits”) and (iii) as a C-TPAT member, Pfizer is required to make periodic assessment of its international supply chain based up C-TPAT security criteria. Protalix agrees that, after completion of the review referred to in Section 5.18(a), it will reasonably cooperate with Pfizer to allow Pfizer, at its sole cost and expense, to conduct an annual security audit at any Protalix Facility and will consider in good faith any corrective actions recommended by Pfizer as a result of such audit intended to ensure the continued eligibility of Pfizer to participate in C-TPAT. Pfizer agrees to share with Protalix the results of such annual audits, and Protalix agrees to advise Pfizer of any corrective actions taken in response thereto and to notify Pfizer if it becomes aware of an event that it knows jeopardizes Pfizer’s retention of its C-TPAT Benefits. Protalix agrees to use Commercially Reasonable Efforts to become a member of a supply chain security program administered by the customs administration in Israel if such a program exists and (a) Protalix determines in its good faith judgment that such a program will advance the parties’ mutual objective of securing each part of the supply chain or (b) Pfizer has determined in good faith that Protalix’s failure to become a member of such a program will jeopardize the continued eligibility of Pfizer to participate in C-TPAT and Pfizer has notified Protalix in writing reasonably setting forth the basis for such determination.
Manufacturing Covenants. The Parties hereby agree and acknowledge that the limitation of remedies provided in [***] shall not apply to a [***] of any [***] of this [***] other than [***] or [***], as relates to [***] with respect to [***] hereunder).
Manufacturing Covenants. Licensor covenants to Licensee that Licensor will develop and manufacture Triplex to be provided to Licensee pursuant to Section 1.a. hereof in compliance with applicable standards and regulations under the relevant laws of each jurisdiction within the Territory, such that the applicable device licenses, establishment licenses or other marketing approvals are obtained for each of the same in each jurisdiction within the Territory. In connection with the foregoing, Licensor agrees to assist Licensee in the compilation, production and submission of all technical documentation and other materials required in connection with any of the foregoing regulatory or other approvals.