Supply and Manufacturing. The Parties acknowledge and agree that, as of the Effective Date, LICENSOR is not subject to any obligations with a third- party regarding its current source of Licensed Product, and that LICENSEE shall be permitted to enter into a supply agreement with any third-party manufacturer to secure supply of Licensed Product for LICENSEE directly from such third-party manufacturer. In addition, LICENSOR acknowledges that, upon execution and delivery of the Agreement, LICENSEE shall receive all right, title and interest in LICENSOR’s existing inventory of Licensed Product, whether or not vialed, and all other materials related to the manufacture, formulation and vialing of Licensed Product.
Supply and Manufacturing. (a) Except as set forth on Schedule 4.21(a) of the Disclosure Letter, to the Knowledge of Parent, Product at all times has been manufactured in sufficient quantities and of a sufficient quality to satisfy contractual obligations to supply Product in the Territory without the occurrence of any event causing inventory of Product in the Territory to have become exhausted prior to satisfying such obligations. To the Knowledge of Parent, no event has occurred that has caused or could reasonably be expected to cause Product to be manufactured in a quantity or of a quality insufficient to satisfy production of (i) at least 40,000,000 test strips for calendar year 2021; and (ii) at least 50,000,000 test strips for calendar year 2022.
Supply and Manufacturing. (a) Except as set forth on Schedule 4.21(a) of the Disclosure Letter, to the Knowledge of such Credit Party, Product at all times has been manufactured in sufficient quantities and of a sufficient quality to satisfy demand of Product in the Specified Territory, without the occurrence of any event or any series of related events causing inventory of Product to have become exhausted prior to satisfying such demand. To the Knowledge of such Credit Party, no event or circumstance (or series of related events or circumstances) has occurred that has caused or could reasonably be expected to cause inventory of Product to become exhausted in any calendar year prior to satisfying the sales demand (if any) of Product in the Specified Territory in such calendar year.
Supply and Manufacturing. (a) To the knowledge of the Credit Parties, the Products have at all times been manufactured in sufficient quantities and of a sufficient quality to satisfy demand of the Products, without the occurrence of any event causing inventory of the Products to have become exhausted prior to satisfying such demand or any other event in which the manufacture and release to the market of the Products does not satisfy the sales demand for the Products and which has resulted in, or could reasonably be expected to result in, a Material Adverse Effect.
Supply and Manufacturing. (a) To the Knowledge of Borrower, the Product has at all times been manufactured in sufficient quantities and of a sufficient quality to satisfy demand of the Product, without the occurrence of any event causing inventory of the Product to have become exhausted prior to satisfying such demand or any other event in which the manufacture and release to the market of the Product does not satisfy the sales demand for the Product.
Supply and Manufacturing. (a) To the knowledge of Borrower or any of its Subsidiaries, the testing, manufacturing, production, storage, packaging, labeling and release to the market of each Product has at all times been (i) in compliance in all respects with the final release quality specifications in effect for such Product and (ii) in compliance in all material respects with Requirement of Law. Except as set forth on Schedule 5.22(a) of the Disclosure Letter, to the knowledge of Borrower or any of its Subsidiaries, no manufacturer of Product has received in the past five (5) years a Form 483 or is currently subject to a Form 483 impacting any Product with respect to any facility manufacturing Product and that, with respect to each such Form 483, all scientific and technical violations or other issues relating to good manufacturing practice requirements documented therein, and any disputes regarding any such violations or issues, have been corrected or otherwise resolved. To the knowledge of Borrower, each Product has at all times been manufactured in sufficient quantities and of a sufficient quality to satisfy demand of such Product, without the occurrence of any event causing inventory of such Product to have become exhausted prior to satisfying such demand or any other event in which the manufacture and release to the market of such Product does not satisfy the sales demand for such Product.
Supply and Manufacturing. 6.1 KREATECH agrees to sell and supply to LICENSEE such quantities of the LICENSED PRODUCTS as LICENSEE may order in accordance with this AGREEMENT, more specifically in accordance with LICENSEE’s forecasts (see EXHIBIT E-2). LICENSEE acknowledges that, in the event its purchase orders of LICENSED PRODUCTS substantially exceed the TARGET AMOUNT according to the agreed forecast, the specifications, especially with regard to delivery times and other specifications depending on the available production capacity, may deviate and will be agreed upon between Parties in good faith.
Supply and Manufacturing. Roche shall be fully responsible for all supply and manufacturing of Product. Trimeris shall have no say with regard to Roche’s supply and manufacturing efforts. Trimeris shall have no say with regard to Roche’s handling, maintenance or divestiture of its Boulder, Colorado manufacturing facility, and Trimeris has no financial or decision making rights with regard to such manufacturing facility.
Supply and Manufacturing. 5.1 At the direction of the Development Committee, MoliChem shall manage the planning, agreements and operations concerning the supply and manufacture of the Products for the Development Program; provided however, all manufacturing specifications shall be established by the Development Committee.
Supply and Manufacturing. (a) Except as set forth on Schedule 4.21(a) of the Disclosure Letter, to the Knowledge of Borrower, the Product at all times has been manufactured in sufficient quantities and of a sufficient quality to satisfy demand of the Product during its clinical trials, without the occurrence of any event causing inventory of the Product to have become exhausted prior to satisfying such demand. To the Knowledge of Borrower, at all times following the approval of the Product by the FDA for any indication in the United States, no event has occurred that has caused or could reasonably be expected to cause (i) the Product to be manufactured in a quantity or of a quality insufficient to satisfy current or future demand of the Product in the United States for such indication or (ii) inventory of the Product in the United States for such indication to have become exhausted prior to satisfying such demand.
