Common use of Supply and Manufacturing Clause in Contracts

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. (b) Except as set forth on Schedule 4.21(b) of the Disclosure Letter, to the Knowledge of Parent, (i) no manufacturer (including a contract manufacturer) or producer of Product has (A) been subject to a Regulatory Agency shutdown, restriction or import or export prohibition, or (B) received in the past five (5) years or is currently subject to (1) a FDA Form 483 or (2) other written Regulatory Agency notice of inspectional observations, warning letter, untitled letter or request to make changes to Product that could reasonably be expected to materially adversely impact Product, in either case of sub-clause (1) or (2) with respect to any facility manufacturing or producing Product for import, distribution, sale or lease in the Territory, and (ii) 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 any disputes regarding any such violations or issues, have been corrected or otherwise resolved. (c) Except as disclosed in Schedule 4.21(c) of the Disclosure Letter, no Credit Party or any of its Subsidiaries has received any notice, oral or written, from any party to any Manufacturing Agreement containing any indication by or intent or threat of, such party to reduce or cease, in any material respect, the supply of Product in the Territory or the materials (including raw materials), components (including component raw materials and other component materials), equipment, technology (including software, systems, and solutions), or any other element needed to fulfill obligations related to Product in any Manufacturing Agreement through calendar year 2024 (or such earlier date in accordance with the terms and conditions of such Manufacturing Agreement, as applicable).

Supply and Manufacturing. (a) Except as set forth on Schedule 4.21(a) of the Disclosure Letter, to the Knowledge of ParentBorrower, the Product at all times has been manufactured in sufficient quantities and of a sufficient quality to satisfy contractual obligations to supply demand of the Product in the Territory during its clinical trials, without the occurrence of any event causing inventory of the Product in the Territory to have become exhausted prior to satisfying such obligationsdemand. To the Knowledge of ParentBorrower, 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 production current or future demand of (i) at least 40,000,000 test strips the Product in the United States for calendar year 2021; and such indication or (ii) at least 50,000,000 test strips inventory of the Product in the United States for calendar year 2022such indication to have become exhausted prior to satisfying such demand. (b) Except as disclosed in the Exchange Act Documents or set forth on Schedule 4.21(b) of the Disclosure Letter, to the Knowledge of ParentBorrower, (i) no manufacturer (including a contract manufacturer) or producer of any Product has (A) been subject to a Regulatory Agency shutdown, restriction or import or export prohibition, or (B) received in the past five (5) years a Form 483 or is currently subject to (1) a FDA Form 483 or (2) other written Regulatory Agency notice of inspectional observations, warning letter, untitled letter or request to make changes to impacting any Product that could reasonably be expected to materially adversely impact Product, in either case of sub-clause (1) or (2) with respect to any facility manufacturing or producing Product for import, distribution, sale or lease in the TerritoryTerritory manufacturing any Product, and (ii) 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 any disputes regarding any such violations or issues, have been corrected or otherwise resolved. (c) Except as disclosed in Schedule 4.21(c) of the Disclosure Letter), no Credit Party or any of its Subsidiaries has received any notice, oral or written, from any party to any Manufacturing Agreement containing any indication by or intent or threat of, such party to reduce or cease, in any material respect, the supply of Product or the active pharmaceutical ingredient incorporated therein in the Territory or the materials (including raw materials), components (including component raw materials and other component materials), equipment, technology (including software, systems, and solutions), or any other element needed to fulfill obligations related to Product in any Manufacturing Agreement through calendar year 2024 2025 (or such earlier date in accordance with the terms and conditions of such Manufacturing Agreement, as applicable).

Supply and Manufacturing. (a) Except as set forth on Schedule 4.21(a) of the Disclosure Letter, to the Knowledge of ParentBorrower, each Product has at all times has in the past four (4) years been manufactured in sufficient quantities and of a sufficient quality to satisfy contractual obligations to supply demand of such Product in the Territory Territory, without the occurrence of any event causing inventory of such Product in the Territory to have become exhausted prior to satisfying such obligations. To demand or any other event in which the Knowledge manufacture and release to the market of Parent, no event has occurred that has caused or could reasonably be expected to cause such Product to be manufactured in a quantity or of a quality insufficient to the Territory does not satisfy production of (i) at least 40,000,000 test strips the sales demand for calendar year 2021; and (ii) at least 50,000,000 test strips for calendar year 2022such Product in the Territory. (b) Except as disclosed in the Exchange Act Documents or set forth on Schedule 4.21(b) of the Disclosure Letter, to the Knowledge of ParentBorrower, (i) no manufacturer (including a contract manufacturer) or producer of any Product has (A) been subject to a Regulatory Agency shutdown, restriction or import or export prohibition, or (B) received in the past five four (54) years a Form 483 or is currently subject to (1) a FDA Form 483 or (2) other written Regulatory Agency notice of inspectional observations, warning letter, untitled letter or request directly relating to make changes to any Product that could reasonably be expected to materially adversely impact Product, in either case of sub-clause (1) or (2) with respect to any facility manufacturing or producing Product for import, distribution, sale or lease in the TerritoryTerritory manufacturing any Product, except, as of the Tranche B Closing Date (as applicable), in each case, as could not, individually or in the aggregate, reasonably be expected to result in a material adverse effect on any Product in the Territory and (ii) with respect to each such FDA Form 483 received or other written Regulatory Agency notice (if any), all material 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, except, as of the Tranche B Closing Date (as applicable), in each case, as could not, individually or in the aggregate, reasonably be expected to result in a material adverse effect on any Product in the Territory. (c) Except as disclosed in Schedule 4.21(c) of the Disclosure Letter), no Credit Party or any of its Subsidiaries has received any notice, oral or written, written notice from any party to any Manufacturing Agreement containing any indication by or intent or threat of, such party to reduce or cease, in any material respect, the supply of Product or the active pharmaceutical ingredient incorporated therein in the Territory or the materials (including raw materials), components (including component raw materials and other component materials), equipment, technology (including software, systems, and solutions), or any other element needed to fulfill obligations related to Product in any Manufacturing Agreement through calendar year 2024 2023 (or such earlier date in accordance with the terms and conditions of such Manufacturing Agreement, as applicable) except, as of the Tranche B Closing Date (as applicable), in each case, as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change.

Supply and Manufacturing. (a) Except as set forth on Schedule 4.21(a) of the Disclosure Letter, to the Knowledge of Parentany Credit Party, the Product at all times has been manufactured in sufficient quantities and of a sufficient quality to satisfy contractual obligations to supply demand of the Product in the Territory Territory, without the occurrence of any event or series of related events causing inventory of Product in the Territory to have become exhausted prior to satisfying such obligationsdemand. To Except as set forth on Schedule 4.21(a) of the Disclosure Letter, to the Knowledge of ParentBorrower, no event or circumstances (or series of related events or circumstances) 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 production current or future demand of (i) at least 40,000,000 test strips for calendar year 2021; and the Product in the Territory or (ii) at least 50,000,000 test strips for calendar year 2022inventory of the Product in the Territory to have become exhausted prior to satisfying such demand. (b) Except as set forth on Schedule 4.21(b) of the Disclosure Letter, to the Knowledge of ParentBorrower, no event or circumstance (ior series of related events or circumstances) no manufacturer (including a contract manufacturer) or producer of Product has (A) been subject to a Regulatory Agency shutdownoccurred or, restriction or import or export prohibition, or (B) received in the past five (5) years reasonable business judgment of Borrower, is reasonably likely to occur, that would cause or is currently subject to (1) a FDA Form 483 or (2) other written Regulatory Agency notice of inspectional observations, warning letter, untitled letter or request to make changes to Product that could reasonably be expected to materially adversely impact Product, cause Product to be distributed in either case any calendar year in such quantities to exceed any applicable annual distribution number (“ADN”) under 21 U.S.C. § 360j(m)(6)(A) and subsequently require notification to FDA of sub-clause (1) or (2) with respect to any facility manufacturing or producing Product for import, distribution, sale or lease the number of devices distributed in the Territory, and (ii) with respect to each a calendar year exceeding 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 any disputes regarding any such violations or issues, have been corrected ADN or otherwise resolvedresult in a violation of 21 U.S.C. § 360j(m). (cd) Except as disclosed in Schedule 4.21(c4.21(d) of the Disclosure Letter, no Credit Party or any of its Subsidiaries has received any notice, oral or written, from any party to any Manufacturing Agreement containing any indication by or intent or threat of, such party to reduce or cease, in any material respect, the supply of Product in the Territory or the materials (including raw materials), components (including component raw materials and other component materials), equipment, technology (including software, systems, and solutions), or any other element needed to fulfill its contractual obligations related to Product in any Manufacturing Agreement through calendar year 2024 2029 (or such earlier date in accordance with the terms and conditions of such Manufacturing Agreement, as applicable).

Supply and Manufacturing. (a) Except as set forth on Schedule 4.21(a) of the Disclosure Letter, to the Knowledge of ParentBorrower, each Product has at all times has (or, in the case of Acquisition Product, since January 9, 2018) been manufactured in sufficient quantities and of a sufficient quality to satisfy contractual obligations to supply then-current demand of such Product in the Territory Territory, without the occurrence of any event causing inventory of such Product in the Territory to have become exhausted prior to satisfying such obligationsdemand 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 ParentBorrower, there is no event has occurred that has caused or could circumstance which would reasonably be expected to cause Product to be manufactured in a quantity or of a quality insufficient adversely affect the ability to satisfy production the sales demand for such Product in the Territory budgeted as 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 2022the Effective Date. (b) Except as disclosed in the Exchange Act Documents or set forth on Schedule 4.21(b) of the Disclosure Letter, to the Knowledge of ParentBorrower, (i) no manufacturer (including a contract manufacturer) or producer of any Product has (Ai) been subject to a Regulatory Agency shutdown, restriction or import or export prohibition, or (Bii) received in the past five (5) years or is currently subject to (1) a FDA Form 483 or (2) other written Regulatory Agency notice of inspectional observations, warning letter, untitled letter or request to make changes to any Product that could would reasonably be expected to materially adversely impact Product, in either case of sub-clause (1) or (2) any Product with respect to any facility manufacturing or producing such Product for import, distribution, distribution or sale or lease in the Territory, and (iiiii) 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 any disputes regarding any such violations or issues, have been corrected or otherwise resolved. (c) Except as disclosed in Schedule 4.21(c) of the Disclosure Letter), no Credit Party or or, to the Knowledge of Borrower, any of its Subsidiaries has received any notice, oral written or writtenoral, from any party to any Manufacturing Agreement containing any indication by or intent or written threat of, of such party to reduce or cease, in any material respect, the supply of Product or the active pharmaceutical ingredient incorporated therein in the Territory or the materials (including raw materials), components (including component raw materials and other component materials), equipment, technology (including software, systems, and solutions), or any other element needed to fulfill obligations related to Product in any Manufacturing Agreement through calendar year 2024 2025 (or such earlier date in accordance with the terms and conditions of such Manufacturing Agreement, as applicable).

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 4.21(a) of the Disclosure Letter5.22, to the Knowledge 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 ParentBorrower, no event has occurred that has caused or could reasonably be expected to cause Product to be manufactured in a quantity or manufacturer 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. (b) Except as set forth on Schedule 4.21(b) of the Disclosure Letter, to the Knowledge of Parent, (i) no manufacturer (including a contract manufacturer) or producer of Included Product has (A) been subject to a Regulatory Agency shutdown, restriction or import or export prohibition, or (B) received in the past five three (53) years a FDA Form 483 impacting any Included Product or is currently subject to (1) a FDA Form 483 or (2) other written Regulatory Agency notice of inspectional observations, warning letter, untitled letter or request to make changes to impacting any Included Product that could reasonably be expected to materially adversely impact Product, in either case of sub-clause (1) or (2) with respect to any facility manufacturing or producing Included Product for importand that, distribution, sale or lease in the Territory, and (ii) with respect to each such FDA Form 483 received or other written Regulatory Agency notice (if any)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 (cb) Schedule 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 Persons for the supply of Included Product in effect as of the Funding 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, each such Manufacturing Agreement is a valid and binding obligation of each party thereto and is in full force and effect, and no party thereto is in breach thereof or default thereunder. Except as disclosed in described on Schedule 4.21(c) of the Disclosure Letter5.22, no Credit Party or any of its Subsidiaries has received any noticenotice from any party thereto, oral or written, from regarding (i) the cancellation, termination or invalidation of any party to any such Manufacturing Agreement containing or (ii) any indication intention by or intent or threat of, such party party, oral or written, to reduce or cease, in any material respect, cease the supply of Included Product in the Territory or the materials (including raw materials), components (including component raw materials and other component materials), equipment, technology (including software, systems, and solutions), or any other element needed to fulfill obligations related to Product in any Manufacturing Agreement through calendar year 2024 (or such earlier date in accordance with the terms and conditions of such Manufacturing Agreement, as applicable)2019.

Supply and Manufacturing. (a) Except as set forth on Schedule 4.21(a) of the Disclosure Letter, to the Knowledge of Parentany Credit Party, Product at all times in the past five (5) years, has been manufactured in sufficient quantities and of a sufficient quality to satisfy contractual obligations to supply demand of Product in the Territory Territory, without the occurrence of any event or series of related events causing inventory of Product to have become exhausted prior to satisfying such demand. To the Knowledge of Borrower, no event or circumstances (or series of related events or circumstances) has occurred that has caused or could reasonably be expected to cause (i) Product to be manufactured in a quantity or of a quality insufficient to satisfy current demand of such Product in the Territory or (ii) inventory of Product in the Territory to have become exhausted prior to satisfying such obligations. To demand of such Product in 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 2022Territory. (b) Except as set forth on Schedule 4.21(b) of the Disclosure Letter, to the Knowledge of ParentBorrower, in the past five (5) years (i) no manufacturer (including a contract manufacturer) ), licensing partner, or producer of Product has (A) been or is currently subject to a material Regulatory Agency shutdown or voluntary shutdown, restriction or import or export prohibition, (ii) no manufacturer (including a contract manufacturer), licensing partner, or (B) producer of Product has received in the past five (5) years a Form FDA-483 or is currently subject to (1) a FDA Form 483 FDA-483 with respect to any Product or (2) other written Regulatory Agency notice of inspectional observations, warning letterWarning Letter, untitled letter Untitled Letter or request to make changes to Product that could reasonably be expected to materially adversely impact any Product, in either case of sub-clause (1) or (2) above with respect to any facility manufacturing or producing Product for import, distribution, sale or lease in the Territory, and (ii) with respect to each such FDA Form 483 FDA-483 received (if any) or other written Regulatory Agency notice (if any), all scientific and technical violations or other issues relating to good manufacturing practice FDA Good Manufacturing Practice requirements documented therein, and any disputes regarding any such violations or issues, have been corrected or otherwise resolvedresolved or are subject to and in the process of ongoing and sufficient corrections and corrective actions. (c) Except as disclosed in Schedule 4.21(c) of the Disclosure Letter, no Credit Party or any of its Subsidiaries has received any notice, oral or written, from any party to any Manufacturing Agreement containing any indication by or intent or threat of, such party to reduce or cease, in any material respect, the supply of Product or the active pharmaceutical ingredient incorporated therein in the Territory or the materials (including raw materials), components (including component any other raw materials and other component materials), equipment, technology (including software, systems, and solutions), or any other element needed to fulfill its contractual obligations related to Product in any Manufacturing Agreement through calendar year 2024 2029 (or such earlier date in accordance with the terms and conditions of such Manufacturing Agreement, as applicable).

Supply and Manufacturing. (a) Except as set forth on Schedule 4.21(a) of the Disclosure Letter, to the Knowledge of ParentBorrower, each Product has at all times has (or, in the case of Acquisition Product, since January 1, 2019) been manufactured in sufficient quantities and of a sufficient quality to satisfy contractual obligations to supply then-current demand of such Product in the Territory Territory, without the occurrence of any event causing inventory of such Product in the Territory to have become exhausted prior to satisfying such obligationsdemand 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 ParentBorrower, there is no event has occurred that has caused or could circumstance which would reasonably be expected to cause Product to be manufactured in a quantity or of a quality insufficient adversely affect the ability to satisfy production the sales demand for such Product in the Territory budgeted as 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 2022the Closing Date. (b) Except as disclosed in the Exchange Act Documents or set forth on Schedule 4.21(b) of the Disclosure Letter, to the Knowledge of ParentBorrower, (i) no manufacturer (including a contract manufacturer) or producer of any Product has (Ai) been subject to a Regulatory Agency shutdown, restriction or import or export prohibition, or (Bii) received in the past five (5) years or is currently subject to (1) a FDA Form 483 or (2) other written Regulatory Agency notice of inspectional observations, warning letter, untitled letter or request to make changes to any Product that could would reasonably be expected to materially adversely impact Product, in either case of sub-clause (1) or (2) any Product with respect to any facility manufacturing or producing such Product for import, distribution, distribution or sale or lease in the Territory, and (iiiii) 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 any disputes regarding any such violations or issues, have been corrected or otherwise resolved. (c) Except as disclosed in Schedule 4.21(c) of the Disclosure Letter), no Credit Party or or, to the Knowledge of Borrower, any of its Subsidiaries has received any notice, oral written or writtenoral, from any party to any Manufacturing Agreement containing any indication by or intent or written threat of, of such party to reduce or cease, in any material respect, the supply of Product or the active pharmaceutical ingredient incorporated therein in the Territory or the materials (including raw materials), components (including component raw materials and other component materials), equipment, technology (including software, systems, and solutions), or any other element needed to fulfill obligations related to Product in any Manufacturing Agreement through calendar year 2024 2025 (or such earlier date in accordance with the terms and conditions of such Manufacturing Agreement, as applicable).

Supply and Manufacturing. (a) Except as set forth on Schedule 4.21(a) of the Disclosure Letter, to To the Knowledge of ParentBorrower, the Product at all times has been manufactured in sufficient quantities and of a sufficient quality to satisfy contractual obligations to supply demand of the Product in the Territory during its clinical trials, without the occurrence of any event causing inventory of the Product in the Territory to have become exhausted prior to satisfying such obligationsdemand. To the Knowledge of ParentBorrower, 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 production demand of (i) at least 40,000,000 test strips the Product in the United States for calendar year 2021; and such indication or (ii) at least 50,000,000 test strips inventory of the Product in the United States for calendar year 2022such indication to have become exhausted prior to satisfying such demand. (b) Except as disclosed in the Exchange Act Documents or set forth on Schedule 4.21(b) of the Disclosure Letter, to the Knowledge of ParentBorrower, (i) no manufacturer (including a contract manufacturer) or producer of the Product has (A) been subject to a Regulatory Agency shutdown, restriction or import or export prohibition, or (B) received in the past five (5) years a Form 483 or is currently subject to (1) a FDA Form 483 or (2) other written Regulatory Agency notice of inspectional observations, warning letter, untitled letter or request to make changes to impacting the Product that could reasonably be expected to materially adversely impact Product, in either case of sub-clause (1) or (2) with respect to any facility manufacturing or producing the Product for importand that, distribution, sale or lease in the Territory, and (ii) with respect to each such FDA Form 483 received or other written Regulatory Agency notice (if any)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. (c) Except as disclosed in Schedule 4.21(c) of the Disclosure Letter, no No Credit Party or any of its Subsidiaries has received any notice, oral or written, from any third party to any Manufacturing Agreement Agreement, containing any indication by or intent or threat of, such third party to reduce or cease, in any material respect, the supply of Product in the Territory or the materials (including raw materials), components (including component raw materials and other component materials), equipment, technology (including software, systems, and solutions), or any other element needed to fulfill obligations related to Product in any Manufacturing Agreement active pharmaceutical ingredient incorporated therein through calendar year 2024 2025 (or such earlier date in accordance with the terms and conditions of such Manufacturing Agreement, as applicable).

Supply and Manufacturing. (a) Except as set forth on Schedule 4.21(a) of the Disclosure Letter, to the Knowledge of ParentBorrower, Product at all times has been manufactured in sufficient quantities and of a sufficient quality to satisfy contractual obligations to supply demand of Product in the Territory Territory, without the occurrence of any event or any series of related events causing inventory of Product in the Territory to have become exhausted prior to satisfying such obligationsdemand. To the Knowledge of ParentBorrower, no event or series of related events has occurred that has caused or could reasonably be expected to cause inventory of Product to be manufactured in a quantity or of a quality insufficient have become exhausted prior 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 2022satisfying such demand. (b) Except as set forth on Schedule 4.21(b) of the Disclosure Letter, to the Knowledge of ParentBorrower, (i) no manufacturer (including a contract manufacturer) or producer of Product has (A) been subject to a Regulatory Agency shutdown, restriction or import or export prohibition, (ii) no manufacturer (including a contract manufacturer) or (B) producer of Product has received in the past five (5) years or is currently subject to (1) a FDA Form 483 or (2) other written Regulatory Agency notice of inspectional observations, warning letterWarning Letter, untitled letter Untitled Letter or request to make changes to Product that could reasonably be expected to materially adversely impact Product, in either case of sub-clause (1) or (2) with respect to any facility manufacturing or producing Product for import, distribution, distribution or sale or lease in the Territory, in each case, except as could not reasonably be expected to result in a Material Adverse Change, and (iiiii) with respect to each such FDA Form 483 received or other written Regulatory Agency notice (if any), including any subsequent FDA approval for marketing and distribution of such Product, 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 corrected, and all corrective actions described therein as ongoing or otherwise resolvedpromised have been completed. (c) Except as disclosed in Schedule 4.21(c) of the Disclosure Letter, no Credit Party or any of its Subsidiaries has received any notice, oral or written, from any party to any Manufacturing Agreement containing any indication by or intent or threat of, such party to reduce or cease, in any material respect, the supply of Product or the active pharmaceutical ingredient incorporated therein in the Territory or the materials (including raw materials), components (including component any other raw materials and other component materials), equipment, technology (including software, systems, and solutions), or any other element needed to fulfill its contractual obligations related to Product in any Manufacturing Agreement through calendar year 2024 2026 (or such earlier date in accordance with the terms and conditions of such Manufacturing Agreement, as applicable).