Manufacture and Supply of Products. Section 2.01 Subject to and in accordance with the terms and conditions of this Agreement, during the applicable Product Term, the Supplier shall manufacture and supply to the Recipient the products specified in Schedule 1 (the Products).
Manufacture and Supply of Products. Subject to the terms and conditions set forth herein, Polyzen shall manufacture and assemble Products in accordance with the Specifications, and supply and deliver (collectively, the “Services”) to Company the Products in such quantities as are required to fulfill Purchase Orders (as defined below) issued by Company or its Affiliates from time to time. Any use of secondary suppliers or other outsourcing of the Services to third parties by Polyzen shall be approved in writing in advance by Company and set forth in Exhibit C attached hereto and incorporated herein by reference. Polyzen shall ensure that any approved secondary suppliers and other third parties are bound by written agreements with substantially similar provisions as contained herein; provided that with respect to suppliers of components that are “off-the-shelf”, Polyzen’s obligation under this section shall be to ensure that there are quality agreements in place with such suppliers that ensure that Polyzen can meet its obligations under this Agreement. In the event that Polyzen subcontracts all or part of the Services hereunder to a third party supplier or other third party, Polyzen shall be responsible for such secondary supplier’s or other third parties’ compliance with the terms of this Agreement and will retain primary liability vis-à-vis Company for the performance of all obligations of such secondary suppliers and other third parties.
Manufacture and Supply of Products. Xxxxxx shall be responsible for manufacturing or having manufactured through Third Party contract manufacturers, any materials (including, without limitation, all Candidates) as may be required for all pre-clinical and clinical studies necessary to obtain Regulatory Approval of Products and any materials and quantities of each Candidate as may required for all pre-clinical and clinical studies applicable to such Candidates.
Manufacture and Supply of Products. The Parties shall establish a manufacturing and supply chain working group to oversee Manufacturing (including API Manufacturing of the Collaboration Compound). The Parties shall collaborate through such working group (with Microbia taking the lead) to oversee API Manufacturing of Collaboration Compound for clinical supplies and for commercial distribution and sale as contemplated by the Development Plan and Commercialization Plan. All Manufacturing responsibilities for API Manufacturing shall be allocated to the Parties or Third Parties as mutually agreed by the Parties; provided, however, that nothing herein shall prevent Microbia from contracting with any Third Parties for the supply of API for commercialization outside the Territory. Forest shall be responsible for all Manufacturing other than for API Manufacturing for the Field with respect to the Territory. Unless otherwise mutually agreed, any supply agreement (including agreements for process or scale-up development) with a Third Party pertaining to the supply of Product for sale in the Territory shall be [**] to the extent such agreement pertains to supply of Product for commercialization in the Territory. The Parties will perform all Manufacturing activities allocated to them in accordance with GCP, GLP and GMP.
Manufacture and Supply of Products. During the Term and subject to the provisions of this Agreement, Supplier shall manufacture and deliver or provide to JDSU, and JDSU shall purchase from Supplier, the Products and such other goods and services as this Agreement contemplates and/or as the Parties may mutually agree in separate written Statements of Work. Supplier acknowledges that JDSU may at any time itself manufacture, or have a third party manufacture, the Products. Additional Statements of Work may be added to this Agreement through a subsequent, formal amendment when agreed to in writing by duly authorized representatives of the Parties.
Manufacture and Supply of Products. 4.2.1 Sintetica shall exclusively manufacture and supply the Products to ETON, and ETON shall exclusively purchase from Sintetica the Products and Market the Products in the Territory, except as otherwise expressly provided in this Agreement.
Manufacture and Supply of Products. 2.1 During the Term the Manufacturer shall promptly and diligently manufacture such numbers of the Products as the Company shall from time to time require in accordance with the Product Specifications and such Order as the Company shall serve on the Manufacturer. Purchase Orders may only be given in minimum quantities of 20 units per Product Type and size. The Company shall place these Orders in accordance with a monthly rolling, twelve month forecast of which the first two months should be binding and the third month should be binding with a tolerance of + / - 10 %. The first month has to be detailed in binding purchases Orders. All purchase orders delivered by the Company shall be acknowledged by Manufacturer in writing. In accordance with the above, during the first and second months, the Manufacturer shall produce at least a “Minimum Quantity” of Products per each such months. Starting with 500 units per month, which shall be binding on the Company, the Minimum Quantity may be increased, based on binding notifications in advance as follows:
Manufacture and Supply of Products. MacroPore shall use commercially reasonable efforts to manufacture, or have manufactured, Products in accordance with the Specifications and to ship such Products to Medtronic in the quantities ordered by Medtronic pursuant to Article 5 of this Agreement. MacroPore shall be responsible for packaging in accordance with packaging specifications to be mutually agreed upon by Medtronic and MacroPore, and for any necessary sterilization of Products purchased under this Agreement in accordance with the Specifications.
Manufacture and Supply of Products. During the term of this Agreement, GBI shall manufacture and sell Products to ATS in accordance with the Specifications and the terms and conditions set forth in this Agreement. If GBI fails to manufacture the Products in accordance with the Specification or is unable meet the volume requirements established in accordance with this Agreement, GBI shall promptly notify ATS in writing of such manufacturing deficiency. In addition, if ATS becomes aware of any such manufacturing deficiency, ATS shall have the right provide written notice to GBI of such manufacturing deficiency. If GBI is not able to cure the deficiency within three months of notice from either GBI or ATS will be automatically granted the right to manufacture the Products and GBI shall provide all documentation and assistance necessary for ATS to manufacture the Products.
Manufacture and Supply of Products. 3.1 All Products Manufactured by TEVA Manufacturing Site shall be supplied in accordance with the Manufacturing Standards. TEVA Manufacturing Site will supply with each batch a Certificate of Analysis and other documentation as required by the Spanish Regulatory Authorities. The QA Departments of both Parties shall enter into a Technical Agreement covering aspects including without limitation quality control, quality assurance, documentation and batch release to be attached to this Agreement as an Appendix. Notwithstanding the foregoing, TEVA shall conduct pre-licensing stability studies as detailed in the Dossiers and provide updates to MARKETING AUTHORISATION HOLDERS on their request. TEVA Manufacturing Site shall also conduct post-licensing stability studies on the first three batches of each Product; MARKETING AUTHORISATION HOLDERS shall provide TEVA Manufacturing Site with free samples of the respective Product, the quantity thereof to be agreed upon between the Parties. TEVA Manufacturing Site shall provide the data of such studies to MARKETING AUTHORISATION HOLDERS on their request. * Confidential information has been omitted and filed confidentially with the Securities and Exchange Commission.
