Manufacture of the Products. CPI shall test each lot of Product and certify that each lot of Products conforms with the requirements of Section 3.1, above. CPI shall retain all relevant records pertaining thereto as set forth in the Quality Agreement or as otherwise may be required by applicable Laws, including cGMP requirements.
Manufacture of the Products. 4.1. The Manufacturer shall carry out the manufacture of the Product at its facilities situate at …………………… utilizing raw materials furnished by the Company or its recognized affiliates (hereinafter referred to as the “Materials”).
4.2. Manufacturing of the Products shall be (detailed scope of work) for the Company.
4.3. (state any other obligations of the manufacturer)
Manufacture of the Products. (a) Manufacturing Standards. Abbott shall manufacture and deliver the Products to Hospira at all times in full compliance with the Act, cGMPs, Product Specifications for each Product, any other applicable regulatory requirements and the requirements set forth in the Quality Agreement. Abbott shall maintain during the term of this Agreement and for a period thereafter consistent with Xxxxxx’x policies and standard cGMP requirements, all records as are necessary or appropriate to demonstrate compliance with the Act, cGMPs, Product Specifications, any other applicable regulatory requirements and the Quality Agreement. If Abbott fails to comply with cGMPs in a material manner, as demonstrated by an observation of a Regulatory Authority, Abbott shall use reasonable commercial efforts to remedy such material deviation.
Manufacture of the Products. 13.1 The manufacture of the Products will commence in the Territory, through TF Ltd as soon as the Board of TF Ltd deem it appropriate. All design detail drawings and production processes will be passed to TF Ltd on the signing of this Agreement to allow production to proceed in the Territory as appropriate. Until such time as the manufacture of the Products by TF Ltd occurs in the Territory, TF Inc. will supply the Products against an agreed schedule and price structure as stated in Appendix 2.
13.2 On signing of this Agreement, TF Ltd shall have the right to purchase individual items direct from the established US sourcing which TF Inc. and TFS will make available to TF Ltd as TF Ltd deems desirable and shall have the right to use TF Inc. and TFS existing tooling associated thereto on a no charge basis.
13.3 On this Agreement coming into effect by the passing of the reso- lutions required by Clause 3, the terms of payment requiring 100% of the purchase price of the units, as defined in Appendix 2 attached, purchased from TF Inc., to be paid by wire transfer upon the placing of orders, will become valid providing that this amount will at no time exceed the outstanding balance of $100,000 of unfilled orders and until such time as production commences in the Territory or an alternative source of supply is agreed.
Manufacture of the Products. 2.1. The Contractor shall carry out the manufacture of the Products at its facilities in __________ [location], utilizing raw materials, components, subassemblies and parts (the “Materials”) and machinery, equipment, tooling, fixtures, moulds, dies, jigs, and testing equipment (the “Machinery”) furnished by the Company under gratuitous bailment (under a separate agreement to be simultaneously entered into by the parties)1. [optional: as well as such assets now or hereafter owned or possessed by the Contractor, if any]. For these purposes, the Company shall deliver to the Contractor, all the necessary Materials and Machinery in due course, following the date of this Agreement.
2.2. [optional] The Company shall deliver to the Contractor, on a periodic basis, on consignment, such raw materials, components, subassemblies and supplies as are necessary for the manufacture of the Products.
Manufacture of the Products. Amersham hereby warrants to Life Science that the Products shall be manufactured by it in compliance with the Specifications and in the manner reasonably requested by Life Science. Amersham shall manufacture the Products and undertake the Research and Development at the Site for Life Science in a manner and on a basis which shall be, at a minimum, consistent with the same level of efficiency and in accordance with the same practices and procedures as were used in the manufacture of such products and the conduct of such research and development at the Site immediately prior to the Disposal. Unless, in its absolute discretion it agrees otherwise, Amersham shall be obliged under the terms of this Agreement to manufacture from time to time only such quantity of the Products as Amersham may reasonably be expected to manufacture at the Site (and in assessing what Amersham may reasonably be expected to manufacture in any period, account will be taken of the manufacturing capacity of the Site by the Business in an equivalent period preceding the Disposal).
Manufacture of the Products. KIEL shall manufacture the DESI PRODUCTS exclusively for TEAMM and shall supply TEAMM with all its needs and requirements for the PRODUCTS pursuant to the terms and conditions of this Agreement. KIEL hereby expressly represents and warrants to TEAMM that the PRODUCTS shall: (i) comply with the requirements of the Food, Drug and Cosmetics Act (the “Act”); (ii) be pure, wholesome and unadulterated and contain no foreign or deleterious substances and will not be misbranded within the meaning of the Act and regulations issued thereunder, or any state law substantially similar to the Act; (iii) be transportable and storable in the ordinary manner in which similar such PRODUCTS are transported and stored; (iv) conform to all applicable regulations promulgated by any and all governmental and regulatory authorities, including without limitation the FDA, the Federal Trade Commission (“FTC”) and the various federal, state, municipal, territorial and local governmental and regulatory authorities, as well as any customary and accepted practices in the industry (the “Regulations”); (v) and comply with the specifications set forth in Exhibit “A.” TEAMM is responsible for all required filings under the Regulations during the term of this Agreement relating to its storage, distribution and sale of the PRODUCTS, including but not limited to Annual Updates, Adverse Events and Drug Listing requirements. TEAMM is responsible for the non-compliance of the PRODUCTS with the Regulations arising from its acts or omissions after it takes possession thereof from KIEL. During the term of this Agreement, KIEL shall promptly communicate to TEAMM any and all information and/or data learned or obtained by KIEL in performing its duties under this Agreement relating to the PRODUCTS and/or their manufacture which TEAMM may reasonably require to make complete, timely and accurate filings under, and, otherwise comply with, the Regulations.
Manufacture of the Products. LGIC shall continue to use best --------------------------- efforts to timely manufacture the NeoPoint 1000, 1600 and 2000 (1000x) Products. Company will receive top priority in terms of availability of such Products and availability of production capacity to the exclusion of all third parties."
16. Exhibit A entitled "Product Statement of Work" is hereby deleted and replaced in its entirety by that new Exhibit A entitled "Product Statement of Work" attached to this Amendment No. 1, and incorporated herein by reference.
Manufacture of the Products. Subject to Section 5(b), DCI shall be solely responsible for the timely manufacture of the Products in sufficient quantities to meet forecast demand, and shall ensure that it, or its contract manufacturer, maintains all necessary quality controls, and that the Products are manufactured in accordance with Current Good Manufacturing Practices (“cGMP”), are correctly labeled and, at the time of release, meet all Product specifications and other terms of a Quality Agreement substantially in the form attached to this Agreement as Exhibit F (the “Quality Agreement”). The Parties will enter into a separate Quality Agreement in a mutually acceptable form, setting out the protocols that they will follow to ensure that only conforming Products are distributed and sold.
Manufacture of the Products. Subject to the terms and conditions hereof, TapouT shall use commercially reasonable efforts to cause Manufacturer to supply to MPC such number of Products as may be required during the term of this Agreement to fill orders for the Products. The Parties shall use commercially reasonable efforts to enter into a Manufacturing Agreement with the Manufacturer that includes terms contemplated in this Agreement, including (among other things): (i) Manufacturer to provide MPC with a twelve (12) month limited warranty on all Products purchased by MPC, (ii) any amount payable in connection with such warranty is limited solely to the price paid by MPC for the related Product, (v) any defective Product shall be tested by Manufacturer for quality control and repaired or replaced following conclusion of testing identifying a defect, (vi) Manufacturer shall complete all such testing, and shall repair or replace any defective Product within forty-eight (48) hours from the receipt of defective Product from MPC.
