Common use of Supply and Manufacturing Clause in Contracts

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. (b) As of the Effective Date, Schedule 5.22(b) of the Disclosure Letter contains a true, correct and complete list of all manufacturing and supply agreements entered into by any Credit Party or any of its Subsidiaries with third parties for the supply of Product and the active pharmaceutical ingredient incorporated therein in effect as of the Effective Date (the “Manufacturing Agreements”). Borrower has delivered or made available to Lender true, correct and complete copies of each Manufacturing Agreement. After giving effect to consummation of the transactions contemplated by this Agreement, except as described on Schedule 5.22(b) of the Disclosure Letter, each Manufacturing Agreement is a valid and binding obligation of the applicable Credit Party or its Subsidiaries and is in full force and effect, and to the knowledge of each Credit Party or any of its Subsidiaries, is a valid and binding obligations of any other party thereto, and neither the applicable Credit Party or its Subsidiaries or, to the knowledge of each Credit Party or any of its Subsidiaries, any other party thereto is in breach thereof or default thereunder. No Credit Party or any of its Subsidiaries has received any notice from any party thereto, oral or written, regarding (i) the cancellation, termination or invalidation of any such Manufacturing Agreement or (ii) any indication by or intent or threat of, such party, oral or written, to reduce or cease the supply of Product and/or the active pharmaceutical ingredient incorporated therein through fiscal year 2021.

Supply and Manufacturing. (a) To the knowledge Knowledge of Borrower or any of its SubsidiariesBorrower, 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 material respects with the final release quality specifications in effect for such Product and (ii) in compliance in all material respects with Requirement Requirements of Law. Except as set forth on Schedule 5.22(a4.22(a) of the Disclosure Letter, to the knowledge Knowledge of Borrower or any of its SubsidiariesBorrower, no manufacturer of any Product has received in the past five (5) years a Form 483 directly relating to a Product or is currently subject to a Form 483 impacting any Product with respect to any facility manufacturing any 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 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. (b) As of the Effective Date, Schedule 5.22(b4.22(b) of the Disclosure Letter contains a true, correct and complete list of all manufacturing and supply agreements entered into by any Credit Party or any of its Subsidiaries with third parties for the commercial supply of any Product and the active pharmaceutical ingredient incorporated therein in effect as of the Effective Date (the “Manufacturing Agreements”). Except as made available in the Exchange Act Documents, Borrower has delivered or made available to Lender upon its request true, correct and complete copies of each Manufacturing Agreement. After giving effect to consummation of the transactions contemplated by this Agreement, except as described on Schedule 5.22(b4.22(b) of the Disclosure Letter, each Manufacturing Agreement is a valid and binding obligation of the applicable Credit Party or its Subsidiaries and is in full force and effect, and to the knowledge Knowledge of each Credit Party or any of its SubsidiariesBorrower, is a valid and binding obligations obligation of any other party thereto, and neither the applicable Credit Party or its Subsidiaries ornor, to the knowledge Knowledge of each Credit Party or any of its SubsidiariesBorrower, any other party thereto is in breach thereof or default thereunder. No Credit Party or any of its Subsidiaries has received any notice from any party thereto, oral or written, regarding (i) the cancellation, termination or invalidation of any such Manufacturing Agreement or (ii) any indication by or intent or threat of, such party, oral or written, to reduce or cease decrease the supply of any Product and/or or the active pharmaceutical ingredient incorporated therein through fiscal year 2021therein.

Supply and Manufacturing. (a) To the knowledge Knowledge of Borrower each Credit Party or any of its Subsidiaries, the testingdevelopment, manufacturing, production, storage, packaging, labeling Manufacturing and release to the market production of each Product has at all times been (i) in compliance in all material respects with the final release quality specifications in effect for such Product and (ii) in compliance in all material respects with Requirement Requirements of Law, including the FDCA (and any foreign equivalent). Except as set forth on Schedule 5.22(a4.22(a) of the Disclosure Letter, to the knowledge Knowledge of Borrower each Credit Party or any of its Subsidiaries, no manufacturer Person currently Manufacturing Product and currently party to a Manufacturing Agreement and, to the actual knowledge of Product each Credit Party or any of its Subsidiaries, no other Person Manufacturing Product, in each case 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 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 Each Product that has been Commercialized has at all times been manufactured Manufactured in sufficient quantities and of a sufficient quality to satisfy at least the forecasted demand of such Product, without the occurrence Product (as reasonably determined by a Responsible Officer of any event causing inventory of such Product to have become exhausted prior to satisfying such demand or any other event Borrower in which the manufacture good faith and release to the market of such Product does not satisfy the sales demand for such Productbased upon reasonable assumptions). (b) As Except as set forth on Schedule 4.22(b) of the Effective DateDisclosure Letter, (i) no Product has been recalled, suspended or discontinued as a result of any action by the FDA or any other Governmental Authority (or any foreign equivalent), by any Credit Party or any of its Subsidiaries or by any licensee, distributor or marketer of such Product and (ii) the Credit Parties and their Subsidiaries have maintained global post-marketing surveillance programs and procedures specifically designed to comprehensively monitor, collect and timely report any medical device reports required to be reported in relation to any of the Products in accordance with any Requirements of Law. To the Knowledge of each Credit Party or any of its Subsidiaries, there are no facts, circumstances, or conditions that could reasonably be expected to result in a recall, suspension, or discontinuance of any Product. (c) Schedule 5.22(b4.22(c) of the Disclosure Letter contains a true, correct and complete list of all manufacturing and supply agreements Contracts entered into by any Credit Party or any of its Subsidiaries with third parties and in effect for the supply of Product and the active pharmaceutical ingredient incorporated therein in effect as of the Effective Date (the “Manufacturing Agreements”)) as of the Tranche A Closing Date. Borrower has delivered or previously made available to Lender true, correct and complete copies of each Manufacturing Agreement. After giving effect to consummation of the transactions contemplated by this AgreementAgreement and the other Loan Documents, except as described on Schedule 5.22(b4.22(c) of the Disclosure Letter, each Manufacturing Agreement is a valid and binding obligation of the applicable Credit Party or its Subsidiaries Subsidiary and is in full force and effect, and to the knowledge Knowledge of each Credit Party or any of its Subsidiaries, is a valid and binding obligations obligation of any other party thereto, and neither the applicable Credit Party or its Subsidiaries or, to the knowledge Knowledge of each Credit Party or any of its Subsidiaries, any other party thereto is in breach thereof or default thereunder. No Except as described on Schedule 4.22(c) of the Disclosure Letter, no Credit Party or any of its Subsidiaries has received any notice from any party thereto, oral or written, regarding (i) the cancellation, termination or invalidation of any such Manufacturing Agreement or (ii) any indication by or intent or threat of, such party, oral or written, to reduce or cease the supply of Product and/or the active pharmaceutical ingredient incorporated therein through fiscal calendar year 20212022.

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(a4.21(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 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 ProductProduct 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 ProductProduct in the Territory budgeted as of the Effective Date and the Tranche B Closing Date. (b) As of Except as disclosed in the Effective Date, Exchange Act Documents or set forth on Schedule 5.22(b4.21(b) of the Disclosure Letter contains Letter, to the Knowledge of Borrower, (i) no manufacturer (including a truecontract manufacturer) or producer of any Product has (i) been subject to a Regulatory Agency shutdown, correct restriction or import or export prohibition, or (ii) received in the past five (5) years or is currently subject to a FDA Form 483 or other written Regulatory Agency notice of inspectional observations, warning letter, untitled letter or request to make changes to any Product that would reasonably be expected to impact any Product with respect to any facility manufacturing or producing such Product for import, distribution or sale in the Territory, and complete list of (iii) with respect to each such FDA Form 483 received or other written Regulatory Agency notice (if any), all scientific and technical violations or other issues relating to good manufacturing practice requirements documented therein, and supply agreements entered into by any disputes regarding any such violations or issues, have been corrected or otherwise resolved. (c) Except as disclosed in Schedule 4.21(c), no Credit Party or or, to the Knowledge of Borrower, any of its Subsidiaries with third parties for has received any notice, written or oral, from any party to any Manufacturing Agreement containing any indication by or written threat of such party to reduce or cease, in any material respect, the supply of Product and or the active pharmaceutical ingredient incorporated therein in effect as the Territory through calendar year 2029 (or such earlier date in accordance with the terms and conditions of the Effective Date (the “Manufacturing Agreements”). Borrower has delivered or made available to Lender true, correct and complete copies of each such Manufacturing Agreement. After giving effect to consummation of the transactions contemplated by this Agreement, except as described on Schedule 5.22(b) of the Disclosure Letter, each Manufacturing Agreement is a valid and binding obligation of the applicable Credit Party or its Subsidiaries and is in full force and effect, and to the knowledge of each Credit Party or any of its Subsidiaries, is a valid and binding obligations of any other party thereto, and neither the applicable Credit Party or its Subsidiaries or, to the knowledge of each Credit Party or any of its Subsidiaries, any other party thereto is in breach thereof or default thereunder. No Credit Party or any of its Subsidiaries has received any notice from any party thereto, oral or written, regarding (i) the cancellation, termination or invalidation of any such Manufacturing Agreement or (ii) any indication by or intent or threat of, such party, oral or written, to reduce or cease the supply of Product and/or the active pharmaceutical ingredient incorporated therein through fiscal year 2021applicable).

Supply and Manufacturing. (a) To 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 or any of its SubsidiariesBorrower, the testing, manufacturing, production, storage, packaging, labeling and release to the market of each Included Product has at all times been (i) in compliance in all respects with the final release quality specifications in effect for such Included Product and (ii) in compliance in all material respects with Requirement Requirements of Law. Except as set forth on Schedule 5.22(a) of the Disclosure Letter5.22, to the knowledge of Borrower or any of its SubsidiariesBorrower, no manufacturer of Included Product has received in the past five three (53) 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. 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.; and (b) As of the Effective Date, Schedule 5.22(b) of the Disclosure Letter 5.22 contains a true, correct and complete list of all manufacturing and supply agreements entered into by any Credit Party or any of its Subsidiaries with third parties Persons for the supply of Included Product and the active pharmaceutical ingredient incorporated therein in effect as of the Effective Tranche A Closing Date (the “Manufacturing Agreements”). Borrower has delivered or made available to Lender true, correct and complete copies of each Manufacturing Agreement. After giving effect to consummation of the transactions contemplated by this Agreement, except as described on Schedule 5.22(b) of the Disclosure Letter5.22, each such Manufacturing Agreement is a valid and binding obligation of the applicable Credit Party or its Subsidiaries each party thereto and is in full force and effect, and to the knowledge of each Credit Party or any of its Subsidiaries, is a valid and binding obligations of any other party thereto, and neither the applicable Credit Party or its Subsidiaries or, to the knowledge of each Credit Party or any of its Subsidiaries, any other no party thereto is in breach thereof or default thereunder. No Credit Party or any of its Subsidiaries has received any notice from any party thereto, oral or written, regarding (i) the cancellation, termination or invalidation of any such Manufacturing Agreement or (ii) any indication by or intent or threat of, such party, oral or written, to reduce or cease the supply of Included Product and/or the active pharmaceutical ingredient incorporated therein through fiscal calendar year 2021.2016;