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).
Section 2.02 The scope of Products identified in Schedule 1 may be amended from time to time to include additional products upon:
(a) mutual agreement of the Parties, or
(b) the Recipient’s request to include a product that is, on the Effective Date, foreseen to be launched and sourced from the Supplier according to existing long-range business plans of the Recipient and is explicitly set out in Schedule 2.
Section 2.03 Upon request of the Recipient, the Supplier shall reasonably support the Recipient in connection with new product launches including by:
(a) prototype making or other development support which will be chargeable based on the standard cost for any standard components used with a charge of USD forty (USD 40) per hour for any additional activities required. Any related sub-supplier costs shall be chargeable to the Recipient. All prototype activity will be subject to a mark-up of fifteen percent (15%); or
(b) quotation preparation and providing required information and documents (at the Supplier’s own cost).
Section 2.04 The Supplier shall manufacture and supply the Products in accordance with:
(a) Firm Orders;
(b) the Specifications;
(c) the (further) requirements of the Recipient’s end customers according to relevant end customer contracts as of the Effective Date, provided that any changes or amendments of these requirements after the Effective Date shall be implemented according to the change process set out in Section 2.06;
(d) any additional policies as and if agreed which may be made available by the Recipient to the Supplier from time to time; and
(e) applicable Law relevant to the manufacture of the Products at the relevant manufacturing site.
Section 2.05 For the avoidance of doubt, the contractual relationship with end customers shall only be vested in the Recipient.
Section 2.06 With respect to changes to the Products, the following shall apply:
(a) Either Party shall be entitled to propose changes to the Products (including their Specifications, design, manufacturing process or manufacturing site) by written notice to the other Party setting out full details of such proposed changes (including any expected impact on the Purchase Price). Any such change request shall only be implemented upon the ot...
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. 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.
2.1 Based on the quality control standards developed mutually by the parties and incorporated herein by reference in the Quality Agreement attached hereto as Exhibit B, which shall meet but in no event exceed the applicable standards set forth in ISO 9001, ISO 13485 and 21 C.F.R. Part 820 for contract manufacturers, Polyzen shall manufacture the Products in accordance with the Specifications and shall perform all quality control and testing of the Products to ensure that they comply with the Specifications. To the extent that any specialized tooling or equipment (as outlined in Exhibit D attached hereto and incorporated herein by reference) is necessary to provide the Services, the parties shall negotiate in good faith the costs of such specialized tooling and/or equipment and agree on the use and ownership of such tooling and/or equipment in writing in advance in accordance with Section 10.8 of this Agreement. At or prior to the purchase of a new tool, Polyzen and Company will discuss in good faith the cost and payment options for such tools. Exhibit D att...
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. (a) During the Term (as defined below), NutraLife shall manufacture and supply the Coviguard Products in accordance with specifications contained in one or more purchase orders (each, a “PO” or “Purchase Order” ) to be delivered by 27 Health to NutraLife in form and substance as agreed to by the Parties, subject to the execution of all Purchase Orders by 27 Health and NutraLife. Furthermore, as provided in Article II, that the Parties acknowledge and agree that NutraLife, in addition to manufacturing to Coviguard Products, may directly sell and distribute (collectively, “Market”) the Coviguard Products on a non-exclusive basis worldwide.
(b) In the event of a conflict between the terms of this Agreement and the terms of a PO, the terms and conditions in each PO shall control.
(c) Each PO shall be for a minimum quantity of Products as set forth in Exhibit A attached hereto, in the column entitled “Minimum Order Quantity.” The Parties agree that the PO’s may be amended from time to time, as the Parties may agree.
(d) Upon acceptance of a PO countersigned by 27 Health, NutraLife shall manufacture and supply the Products to 27 Health in accordance with this Agreement, in compliance with applicable laws and regulation, and using generally accepted industry practice, unless 27 Health shall elect to have NutraLife Market the Coviguard Products manufactured by NutraLife pursuant to each PO.
(e) During the Term, NutraLife shall have the exclusive right to manufacture the Coviguard Products subject to the terms of each PO and subject to NutraLife’s continued ability to meet in all material respects the production requirements of 27 Health for the Coviguard Products. In the event that NutraLife is unable, in the sole determination of 27 Health, to meet said production requirements of 27 Health, 27 Health may: (i) seek other sources for manufacture of the Coviguard Products; or (ii) terminate this Agreement as provided in Article V, Section 5.02 below.
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.
3.2 All Products formulated as tablets or capsules shall be Manufactured and supplied by TEVA Manufacturing Site in bulk packages, unless agreed otherwise between the Parties in writing. All other Product formulations shall be Manufactured and supplied in final finished dosage form, unless agreed otherwise between the Parties in writing. Upon TEVA'S request MARKETING AUTHORISATION HOLDERS shall include on packs, patient information leaflets and package inserts the reference that the respective Product is licensed from Teva(R).
3.3 MARKETING AUTHORISATION HOLDERS shall be entitled on any business day, upon reasonable prior written notice to TEVA Manufacturing Site, to inspect TEVA Manufacturing Site's facilities, in order to verify compliance by TEVA Manufacturing Site with the applicable Manufacturing Standards. MARKETING AUTHORISATION HOLDERS shall use their best efforts to limit audits under this Clause to only one visit in aggregate per year, unless required by special circumstances by the requirements of the Spanish Regulatory Authorities. In the event of dispute between the Parties regarding the conclusions of such audit, the audit report shall be referred for examination to an independent expert mutually selected by the Parties in order to determine its...
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. 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.
4.2.2 Sintetica shall use commercially reasonable efforts to supply on a timely basis one hundred percent (100%) of ETON’s requirement for each Product for commercialization in the Territory.
4.2.3 Sintetica shall use commercially reasonable efforts to provide ETON with Product with expiration date that is at least seventy five percent (75%) of the shelf-life for the applicable Product, but in no event less than eighteen (18) months from the date such Product is delivered to ETON.
4.2.4 Sintetica shall ensure that it has an adequate supply of active and other ingredients required to manufacture the Products in order to meet at least one hundred twenty-five percent (125%) of ETON’s forecasted requirements for the Products in the Territory. In the event that for any reason Sintetica may have insufficient supply of active or other ingredients required to meet its obligations under this Section 4.2.2, Sintetica, upon ETON’s approval, shall obtain a Third-Party source for such active and other ingredients agreed to by ETON.
4.2.5 Sintetica shall manufacture each Product at its own manufacturing site. In the event Sintetica desires to transfer the manufacture of any Product to another site other than those designated in the relevant MA, Sintetica shall require ETON’s written approval.
4.2.6 Sintetica shall, during the Term, maintain its relevant manufacturing site, all property, equipment, machinery and systems therein in the ordinary course of business and in compliance with GMP and Applicable Law (including Drug Security and Supply Chain Act) and free of material defects except for those attributable to wear and tear consistent with age and usage of such assets and except for such defects as do not and will not in the aggregate impair the ability to use such assets in connection with this Agreement.
4.2.7 Sintetica will properly maintain a sample from each batch of Product as required by applicable regulatory standards in the Territory, Territory of Manufacture, Applicable Law or as otherwise agreed in writing by the Parties.
4.2.8 Sintetica will validate all processes, methods, equipment, facilities and utilities used in the manufacture, storage, testing and release of each Product in conformity with all Applicable Laws....
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. Subject to the terms and conditions of this Agreement and the Services Agreement, during the Term, Astellas shall be solely responsible for the manufacture and supply of Products in the Field in the Territory, including CMC-related work necessary for obtaining Regulatory Approval for Products in the Field in the Territory, including all costs associated with such activities. Astellas shall perform all manufacturing activities with respect to Products in the Field in the Territory in compliance with the Manufacturing Plan and all applicable laws, rules and regulations.