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. 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 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. (a) Except as set forth on Schedule 4.21(a) of the Disclosure Letter, to the Knowledge of Borrower, each Product has at all times (or, in the case of Acquisition Product, since January 1, 2021) been manufactured in sufficient quantities and of a sufficient quality to satisfy then-current demand of such Product in the Territory, 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 in the Territory does not satisfy such demand. To the Knowledge of Borrower, there is no event or circumstance which would reasonably be expected to adversely affect the ability to satisfy the sales demand for such Product in the Territory budgeted as of the Effective Date and the Tranche B Closing Date.
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.
Supply and Manufacturing. (a) Except as, individually or in the aggregate, has not resulted or could not reasonably be expected to result in a Material Adverse Change, to the knowledge of Borrower, the testing, manufacturing, production, storage, packaging, labeling and release to the market of each Included Product has at all times been (i) in compliance with the final release quality specifications in effect for such Included Product and (ii) in compliance in all material respects with Requirements of Law. Except as set forth on Schedule 5.22, to the knowledge of Borrower, no manufacturer of Included Product has received in the past three (3) years a FDA Form 483 impacting any Included Product or is currently subject to a Form 483 impacting any Included Product with respect to any facility manufacturing Included 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; and
Supply and Manufacturing. 4.1 APN JP will transfer the Materials, including the know-how of manufacturing the Precursor and the Standard, to Yitai in accordance with a material transfer plan to be mutually agreed by the Parties and attached hereto as Schedule 3 (“Material Transfer Plan”). The Material Transfer Plan shall set forth all the Materials to be transferred and the timeline and steps for the transfer of the Materials. APN JP shall submit the Material Transfer Plan within [***] days of the Effective Date for Yitai to review and approve.
