Manufacturing Activities. The Product to be manufactured by or for Novartis for sale in the Territory shall be manufactured to meet all specifications for the Product in accordance with the NDA, cGMP’s and in compliance with all other applicable federal, state and local laws, rules, regulations and requirements of the Territory and at the time of shipment shall not be adulterated or misbranded within the meaning of the Act. It is understood, and Novartis agrees, that it will be accountable for any act or omission of any third party acting for or on behalf of Novartis to comply with Novartis’ obligations under this Agreement.
Manufacturing Activities. Shire will:
(a) upon New River’s request, if Shire is then Manufacturing a Collaboration Product, supply New River with clinical and commercial quantities of such Collaboration Product for the shorter of (i) the period until New River or its designee has established and validated a manufacturing process for such Collaboration Product and is approved to Manufacture clinical trial and commercial supplies of such Collaboration Product or (ii) eighteen (18) months from the effective date of such termination; provided, however, that New River will [*] (as determined pursuant to Exhibit A hereof) with respect to such Collaboration Product; and
(b) if Shire is then Manufacturing a Collaboration Product, transfer the completed manufacturing process (together with any unique mold or tooling used solely in connection therewith) for such Collaboration Product to New River or its designee upon New River’s request and at [*] cost and expense, and shall cooperate with New River to effect the transition of such Manufacturing responsibilities.
Manufacturing Activities. The Product, including all Samples, to be manufactured by or for Depomed for sale in the Territory shall be manufactured to meet applicable specifications for the Product in accordance with the NDA, cGMP and in compliance with all other applicable Legal Requirements.
Manufacturing Activities. New River will:
(a) upon Shire’s request, if New River is then Manufacturing Compound or Collaboration Product, supply Shire with clinical and commercial quantities of such Compound or Collaboration Product for the shorter of (i) the period until Shire or its designee has established and validated a manufacturing process for such Compound or Collaboration Product and is approved to Manufacture clinical trial and commercial supplies of such Compound or Collaboration Product or (ii) eighteen (18) months from the effective date of such termination; provided, however, that Shire will [*] (as determined pursuant to Exhibit A hereof) for such Compound or Collaboration Product; and
(b) if New River is then Manufacturing Compound or Collaboration Product, transfer the completed manufacturing process (together with any unique mold or tooling used solely in connection therewith) for such Compound or Collaboration Product to Shire or its designee upon Shire’s request and at [*] cost and expense, and cooperate with Shire to effect the transition of such Manufacturing responsibilities.
Manufacturing Activities. A. The Parties shall reasonably consult on all matters relating to the manufacture of the Key Biochemistry Components and Sample Collection Kits.
B. Manufacturing activities shall be conducted in compliance with all applicable legal and regulatory requirements in each relevant jurisdiction, including, without limitation, the requirements of the United States Food and Drug Administration (the "FDA"). GP shall perform all of its manufacturing obligations under this Agreement in accordance with all FDA requirements including the Quality Systems Regulations as set forth in 21 C.F.R. 820, "good laboratory practices," and "good clinical practices" to the extent applicable, and GP's own standard operating and quality control standards and applicable industry-wide standards for proper laboratory procedures and practices.
C. GP will allow BMX to audit GP's records and facilities used in the manufacture of KBCs and Sample Collection Kits at least once a year or more frequently if necessary. GP agrees to respond to any comments or observations of potential non-compliance arising from these audits with proposed corrective actions that are acceptable to both Parties and to implement these actions in a reasonable time. BMX shall reasonably compensate GP for employee time and any expenses incurred in connection with such audits, as well as for the cost of any action requested by BMX as a result of such audits. All information obtained in the course of any such audit by BMX shall be considered Confidential Information hereunder, but may be disclosed by BMX to regulatory agencies when and as necessary.
D. In connection with GP's manufacture of KBCs and Sample Collection Kits, GP will provide reasonable assistance, information and documentation to BMX in the investigation of complaints, MDR reportable events, recalls and other quality issues and will be reasonably available in responding to questions posed by the FDA or other authorities (the topics of such questions may include submissions, recalls and inquiries following inspections).
E. GP will manufacture, store, package and ship KBCs in conformance with applicable specifications in order to ensure the suitability, quality and stability of the materials. GP will maintain necessary systems and associated records to ascertain conformance to these specified requirements including environmental, monitoring and calibration systems. GP shall reasonably cooperate in resolving any KBC quality problems identified by BMX upon rec...
Manufacturing Activities. A description of the Manufacturing Activities to be performed may be contained in statements of work attached as individual exhibits to this Agreement in consecutively numbered “Exhibit A’s”, beginning with Exhibit X-0, X-0, X-0 and so forth (each a “Statement of Work” or “SOW”). Each SOW shall be executed by a duly authorized representative of each Party and shall be subject to and deemed a part of this Agreement upon execution. To the extent that any terms and conditions set forth in a SOW conflict with the terms and conditions set forth in this Agreement (excluding other SOWs), the terms and conditions of this Agreement shall control, unless otherwise expressly agreed upon by the Parties in such SOW.
Manufacturing Activities. With respect to the Manufacturing Activities performed hereunder, Seller shall, as applicable, manufacture, supply or assemble the Products or Finished Devices initiated and developed by Buyer in accordance with the Specifications agreed to by Seller and Buyer. Seller will exercise best efforts in the fulfillment of its obligations hereunder and its performance will be in accordance with the regular practices of the injection molded plastics industry and medical device contract manufacturing and the terms and conditions contained herein.
Manufacturing Activities. Except as otherwise contemplated by the Statement of Work, Supplier shall be responsible for the procurement of Raw Materials and the manufacturing, labeling, assembly, packaging and Sterilization (if applicable) in accordance with the applicable Specifications, and delivery of Products in accordance with the Statement of Work.
Manufacturing Activities. With respect to Manufacturing activities for a particular Collaboration Program in the Territory following Takeda’s exercise of its Option for such Collaboration Program, the JPT shall:
(i) oversee supply of the Optioned Biologics and Optioned Products as reasonably necessary to conduct Development activities in a manner consistent with the Development Plan and the conduct of Commercialization activities in a manner consistent with the Global Commercialization Plan in order to be able meet expected demand (as reflected in such Global Commercialization Plan);
Manufacturing Activities. The Manufacturing Lead shall be responsible for Manufacturing or having Manufactured (using a reputable Third Party Provider) each Research Biologic, Optioned Biologic and Optioned Product, as applicable. The Manufacturing Lead shall use Commercially Reasonable Efforts to [***]. The Manufacturing Lead shall obtain supply of the required quantities of Optioned Biologics, Optioned Product and placebo used in Clinical Studies, or otherwise to support the Development activities to be conducted under a Development Plan, either by performing Manufacturing by itself or through its Affiliates, or from a reputable Third Party Provider of manufacturing services, in each case until [***]. Following [***], the Manufacturing Lead will have the sole right to determine which of its or a Third Party Provider’s manufacturing sites will be used to manufacture the Optioned Product or component of the Optioned Product and may transfer the Manufacturing from one site to another, so long as such transfer would not reasonably be likely to have a material adverse effect on continued supply or, unless Denali has exercised the Denali Worldwide Royalty Option with respect to the Optioned Product, [***] increase in costs incurred in connection with or as a result of such transfer. Notwithstanding the foregoing, prior to any such transfer, the Manufacturing Lead will notify the Non-Manufacturing Lead of its intention to transfer Manufacturing from one site to another and shall permit the Non-Manufacturing Lead to carry out an audit of the proposed new site before such transfer takes place. In the event that the Manufacturing Lead [***] then, at the request of the Non-Manufacturing Lead, [***].
