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 such Credit Party, Product at all times during the past five (5) years has been manufactured in sufficient quantities and of a sufficient quality to satisfy demand of Product in the 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 Territory in such calendar year. b. Except as set forth on Schedule 4.21(b) of the Disclosure Letter, to the Knowledge of such Credit Party, no event or circumstance (or series of related events or circumstances) has occurred or, in the reasonable business judgment of Borrower, is reasonably likely to occur, that would cause or could reasonably be expected to cause Product (A) to not be manufactured in any calendar year in sufficient quantities to satisfy or exceed the greater of (i) the net sales amount for such calendar year set forth in the Product Revenue Forecast and (ii) the expected needs of patients with the disease or condition for which Product was designated as an Orphan Drug for such calendar year, as reasonably determined by a Responsible Officer of the Borrower in good faith (provided such calendar year occurs during the full term of Orphan Drug exclusive approval granted under 21 C.F.R. § 316.34); or (B) to not be manufactured in a manner that supports Orphan Drug designation under EU Law or Japanese Law, as applicable. c. Except as set forth on Schedule 4.21(c) of the Disclosure Letter, to the Knowledge of such Credit Party, (i) no manufacturer (including a contract manufacturer) or producer of Product has been during the last five (5) years or is currently subject to a material Regulatory Agency shutdown, restriction or import or export prohibition, (ii) no manufacturer (including a contract manufacturer) or 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 Letter, Untitled Letter or request to make changes to Product that could reasonably be expected to impact Product, in either case of sub-clause (1) or (2) above with respect to any facility manufacturing or producing Product for import, distribution or sale or lease in the Territory, and (iii) with respect to each such FDA Form 483 received or other written Regulatory Agency notice (if any), to the Knowledge of such Credit Party all deficiencies relating to Good Manufacturing Practice requirements documented therein, and any disputes regarding any such deficiencies, have been corrected or otherwise resolved. d. Except as disclosed in Schedule 4.21(d) of the Disclosure Letter, no Credit Party or any of its Subsidiaries has received any written or, to the Knowledge of such Credit Party, other notice from any party to any Manufacturing Agreement containing any indication by or intent or threat in writing of, such party to reduce or cease, in any material respect, the supply of Product or any active pharmaceutical ingredient, prodrug, or proprietary technology for administration incorporated therein in the Territory or any other raw materials or other component materials needed to fulfill its contractual obligations related to Product in any Manufacturing Agreement through calendar year 2027 (or such earlier date in accordance with the terms and conditions of such Manufacturing Agreement, as applicable).

Supply and Manufacturing. a. (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 during the past five (5) years 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. b. (b) Except as set forth on Schedule 4.21(b) of the Disclosure Letter, to the Knowledge of such Credit Party, no event or circumstance (or series of related events or circumstances) has occurred or, in the reasonable business judgment of BorrowerParent, is reasonably likely to occur, that would cause or could reasonably be expected to cause Product (A) JELMYTO® not to not be manufactured in any calendar year in sufficient quantities to satisfy or exceed the greater of (i) the net sales amount for such calendar year set forth in the Product JELMYTO® Revenue Forecast and (ii) the expected needs of patients with the disease or condition for which Product JELMYTO® was designated as an Orphan Drug for such calendar year, as reasonably determined by a Responsible Officer Officers of the Borrower Credit Parties in good faith (provided such calendar year occurs during the full 7-year term of Orphan Drug orphan drug exclusive approval granted under 21 C.F.R. § 316.34§316.34 ending April 15, 2027); or (B) to not be manufactured in a manner that supports Orphan Drug designation under EU Law or Japanese Law, as applicable. c. (c) Except as set forth on Schedule 4.21(c) of the Disclosure Letter, to the Knowledge of such Credit Party, (i) no manufacturer (including a contract manufacturer) or producer of Product has been during the last five (5) years or is currently subject to a material Regulatory Agency shutdown, restriction or import or export prohibition, (ii) no manufacturer (including a contract manufacturer) or 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 impact Product, in either case of sub-clause (1) or (2) above with respect to any material facility manufacturing or producing Product for import, distribution or sale or lease in the Territory, and (iii) with respect to each such FDA Form 483 received or other written Regulatory Agency notice (if any), to the Knowledge of such Credit Party all deficiencies scientific and technical violations or other issues relating to Good Manufacturing Practice good manufacturing practice requirements documented therein, and any disputes regarding any such deficienciesviolations or issues, have been corrected or otherwise resolved. d. (d) Except as disclosed in Schedule 4.21(d) of the Disclosure Letter, no Credit Party or any of its Subsidiaries has received any written or, to the Knowledge of such Credit Party, other notice from any party to any Manufacturing Agreement containing any indication by or intent or threat in writing of, such party to reduce or cease, in any material respect, the supply of Product or any the active pharmaceutical ingredient, prodrug, or proprietary technology for administration ingredient incorporated therein in the Territory or any other raw materials or other component materials needed to fulfill its contractual obligations related to Product in any Manufacturing Agreement through calendar year 2027 (or such earlier date in accordance with the terms and conditions of such Manufacturing Agreement, as applicable).

Supply and Manufacturing. a. (a) Except as set forth on Schedule 4.21(a) of the Disclosure Letter, to the Knowledge of such Credit PartyBorrower, Product at all times during the past five (5) years has been manufactured in sufficient quantities and of a sufficient quality to satisfy demand of Product in the 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 Except as set forth on Schedule 4.21(a) of the Disclosure Letter, to the Knowledge of such Credit PartyBorrower, 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 have become exhausted in any calendar year prior to satisfying the sales demand (if any) of Product in the Territory in such calendar yeardemand. b. (b) Except as set forth on Schedule 4.21(b) of the Disclosure Letter, to the Knowledge of such Credit PartyBorrower, no event or circumstance (or series of related events or circumstances) has occurred or, in the reasonable business judgment of Borrower, is reasonably likely to occur, that would cause prevent or could reasonably be expected to cause Product (A) prevent any Product, following the first FDA approval or licensure for the introduction or delivery for introduction thereof into interstate commerce, to not be manufactured in any calendar year in sufficient quantities to satisfy or exceed the greater of (i) the net sales Net Sales amount for such calendar year set forth in the 2021 – 2025 sales plan for Product Revenue Forecast in the Territory approved by (or, if not subject to approval, presented to) Borrower’s Board of Directors and (ii) the expected needs of patients with the disease or condition for which Product was designated as an Orphan Drug for such calendar year, as reasonably determined by a Responsible Officer included in Schedule 5.17 of the Borrower in good faith (provided such calendar year occurs during the full term of Orphan Drug exclusive approval granted under 21 C.F.R. § 316.34); or (B) to not be manufactured in a manner that supports Orphan Drug designation under EU Law or Japanese Law, as applicableDisclosure Letter. c. (c) Except as set forth on Schedule 4.21(c) of the Disclosure Letter, to the Knowledge of such Credit PartyBorrower, (i) no manufacturer (including a contract manufacturer) or producer of Product has been during the last five (5) years or is currently been subject to a material Regulatory Agency shutdown, restriction or import or export prohibition, and (ii) no manufacturer (including a contract manufacturer) or producer of Product has received in the past five (5) years or is currently subject to (1) a FDA Form 483 with respect to any Product that remains unresolved 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 impact Product, in either case of sub-clause (1) or (2) above with respect to any material facility manufacturing or producing Product for import, distribution or sale or lease in the Territory, and (iii) with respect to each such FDA Form 483 received or other written Regulatory Agency notice (if any), to the Knowledge of such Credit Party all deficiencies relating to Good Manufacturing Practice requirements documented therein, and any disputes regarding any such deficiencies, have been corrected or otherwise resolved. d. (d) Except as disclosed in Schedule 4.21(d) of the Disclosure Letter, no Credit Party or any of its Subsidiaries has received any written ornotice, to the Knowledge of such Credit Partyoral or written, other notice from any party to any Manufacturing Agreement containing any indication by or intent or threat in writing of, such party to reduce or cease, in any material respect, the supply of Product or any the active pharmaceutical ingredient, prodrug, or proprietary technology for administration ingredient incorporated therein in the Territory or any other raw materials or other component materials needed to fulfill its contractual obligations related to Product in any Manufacturing Agreement through calendar year 2027 2026 (or such earlier date in accordance with the terms and conditions of such Manufacturing Agreement, as applicable).

Supply and Manufacturing. a. (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 during the past five (5) years 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. b. (b) Except as set forth on Schedule 4.21(b) of the Disclosure Letter, to the Knowledge of such Credit Party, no event or circumstance (or series of related events or circumstances) has occurred or, in the reasonable business judgment of BorrowerParent, is reasonably likely to occur, that would cause or could reasonably be expected to cause Product (A) JELMYTO® not to not be manufactured in any calendar year in sufficient quantities to satisfy or exceed the greater of (i) the net sales amount for such calendar year set forth in the Product JELMYTO® Revenue Forecast and (ii) the expected needs of patients with the disease or condition for which Product JELMYTO® was designated as an Orphan Drug for such calendar year, as reasonably determined by a Responsible Officer Officers of the Borrower Credit Parties in good faith (provided such calendar year occurs during the full 7-year term of Orphan Drug orphan drug exclusive approval granted under 21 C.F.R. § 316.34§316.34 ending April 15, 2027); or (B) to not be manufactured in a manner that supports Orphan Drug designation under EU Law or Japanese Law, as applicable. c. (c) Except as set forth on Schedule 4.21(c) of the Disclosure Letter, to the Knowledge of such Credit Party, (i) no manufacturer (including a contract manufacturer) or producer of Product has been during the last five (5) years or is currently subject to a material Regulatory Agency shutdown, restriction or import or export prohibition, (ii) no manufacturer (including a contract manufacturer) or 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 Letter, Untitled Letter or request to make changes to Product that could reasonably be expected to impact Product, in either case of sub-clause (1) or (2) above with respect to any material facility manufacturing or producing Product for import, distribution or sale or lease in the Territory, and (iii) with respect to each such FDA Form 483 received or other written Regulatory Agency notice (if any), to the Knowledge of such Credit Party all deficiencies scientific and technical violations or other issues relating to Good Manufacturing Practice good manufacturing practice requirements documented therein, and any disputes regarding any such deficienciesviolations or issues, have been corrected or otherwise resolved. d. (d) Except as disclosed in Schedule 4.21(d) of the Disclosure Letter, no Credit Party or any of its Subsidiaries has received any written or, to the Knowledge of such Credit Party, other notice from any party to any Manufacturing Agreement containing any indication by or intent or threat in writing of, such party to reduce or cease, in any material respect, the supply of Product or any the active pharmaceutical ingredient, prodrug, or proprietary technology for administration ingredient incorporated therein in the Territory or any other raw materials or other component materials needed to fulfill its contractual obligations related to Product in any Manufacturing Agreement through calendar year 2027 (or such earlier date in accordance with the terms and conditions of such Manufacturing Agreement, as applicable).