Common use of Commercial Supply Clause in Contracts

Commercial Supply. GSK shall have the right to conduct a new contractor assessment of Liquidia to determine, in its sole discretion, that Liquidia is acceptable to GSK for the purposes of supplying PRINT Materials, Liquidia Respiratory Product, Research Products and Inhaled Products (but only if Inhaled Products are the same as Research Products and do not require further formulation or other work in order to be considered appropriate for commercial supply and development requiring commercial grade supply) for clinical trials requiring commercial grade supply and, if applicable, for further formulation work by GSK or a Third Party as Inhaled Products for commercialization on a worldwide basis. Such assessment of Liquidia’s manufacturing capabilities will be conducted at the appropriate time to allow for technology transfer, if required, prior to manufacture of pivotal clinical trial material. (a) If GSK determines in its sole discretion, based on GSK standard assessment criteria for contract manufacturing organizations, that Liquidia is acceptable to GSK Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. for the supply of PRINT Materials, Liquidia Respiratory Product, Research Products and/or Inhaled Products, as applicable, for the purposes described above in this Section 9.2, then subject to Section 9.2(b), Liquidia will be responsible for manufacture and supply in accordance with GMP and GSK’s quality standards all of the PRINT Materials, Research Products, Liquidia Respiratory Product and/or Inhaled Products (as applicable) required by GSK, its Affiliates and sublicensees, subject to and in accordance with the commercially reasonable terms and conditions of a commercial supply agreement to be mutually agreed and negotiated by the Parties (the “Commercial Supply Agreement”). Consistent with GSK’s rights as set forth in Section 5.2, such Commercial Supply Agreement shall provide that if Liquidia is unable to supply PRINT Materials, Liquidia Respiratory Product, Research Products or Inhaled Products as required by GSK, its Affiliates and sublicensees under the terms of the Commercial Supply Agreement, then upon GSK’s request, Liquidia shall commence a technology transfer to GSK or GSK’s Third Party manufacturer of PRINT, PRINT Tooling and any other information and technology reasonably necessary for GSK or GSK’s Third Party manufacturer to manufacture and supply such requirements of the PRINT Materials, Liquidia Respiratory Product, Research Products or Inhaled Products. The Parties shall use Commercially Reasonable Efforts to jointly develop and complete a detailed technology transfer project plan within thirty (30) days after GSK’s request to Liquidia to commence such technology transfer. (b) If GSK determines in its sole discretion, based on GSK standard assessment criteria for contract manufacturing organizations, that Liquidia is either (i) not acceptable to GSK, or (ii) acceptable to GSK but GSK elects not to use Liquidia for supply for strategic business reasons, in either case for the supply of PRINT Materials, Liquidia Respiratory Product, Research Products and Inhaled Products for the purposes described above in this Section 9.2, then consistent with GSK’s rights as set forth in Section 5.2, Liquidia shall commence a technology transfer to GSK or GSK’s Third Party manufacturer of PRINT, PRINT Tooling and any other information and technology reasonably necessary for GSK or GSK’s Third Party manufacturer to manufacture and supply such requirements of the PRINT Materials, Liquidia Respiratory Product, Research Products or Inhaled Products. The Parties shall use Commercially Reasonable Efforts to jointly develop and complete a detailed technology transfer project plan within thirty (30) days after GSK’s request to Liquidia to commence such technology transfer. Solely in the event the circumstances set forth in Section 9.2(b)(ii) occur, the provisions of Section 10.6 shall apply.

Commercial Supply. GSK shall have In the right to conduct a new contractor assessment event that it is anticipated that Manufacturing Technology Transfer Completion will not be achieved sufficiently in advance of Liquidia to determinethe launch of the first Licensed Product in the Territory, or at such earlier or later date as may be mutually agreed in its sole discretionwriting, that Liquidia is acceptable to GSK for the purposes of supplying PRINT Materials, Liquidia Respiratory Product, Research Products Parties will negotiate in good faith and Inhaled Products (but only if Inhaled Products are the same as Research Products and do not require further formulation or other work in order to be considered appropriate enter into an agreement for commercial supply and development requiring commercial grade supply) for clinical trials requiring commercial grade supply and, if applicable, for further formulation work by GSK Epizyme to Hutchmed of Drug Substance or a Third Party as Inhaled Products for commercialization on a worldwide basis. Such assessment of Liquidia’s manufacturing capabilities will be conducted at the appropriate time to allow for technology transfer, if required, prior to manufacture of pivotal clinical trial material. (a) If GSK determines in its sole discretion, based on GSK standard assessment criteria for contract manufacturing organizations, that Liquidia is acceptable to GSK Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. for the supply of PRINT Materials, Liquidia Respiratory Drug Product, Research Products and/or Inhaled Products, as applicable, for the purposes described above in and a related quality agreement, each on terms consistent with this Section 9.2, then subject to Section 9.2(b), Liquidia will be responsible for manufacture Agreement and supply in accordance with GMP and GSK’s quality standards all of the PRINT Materials, Research Products, Liquidia Respiratory Product and/or Inhaled Products (as applicable) required by GSK, its Affiliates and sublicensees, subject to and in accordance with the otherwise on commercially reasonable terms and conditions of a commercial supply agreement to be mutually agreed and negotiated by the Parties (collectively, the “Commercial Supply Agreement”). Consistent with GSK’s rights as set forth in The Commercial Supply Agreement contain commercially reasonable terms including terms addressing forecasting, ordering, delivery, acceptance and rejection procedures, indemnification, limitations of liability, and quality assurance and control. From and after the execution of the Commercial Supply Agreement and until Manufacturing Technology Transfer Completion under Section 5.27.2, and subject to the terms of such Commercial Supply Agreement shall provide that if Liquidia is unable to and this Agreement and compliance with Applicable Law, Epizyme will, either itself or through Third Parties, Manufacture and supply PRINT Materials, Liquidia Respiratory Product, Research Hutchmed with Drug Product in reasonably sufficient quantities for the Commercialization of Licensed Products or Inhaled Products as required in the Field in the Territory by GSK, its Affiliates the Hutchmed Entities in accordance with the Commercialization Plan and sublicensees under the terms of this Agreement. Hutchmed Entities shall not use any quantity of Drug Product supplied by Epizyme for any purpose other than Commercialization in the Field and Territory in accordance with the Commercialization Plan and the terms of this Agreement, and Epizyme shall not be obligated under the Commercial Supply Agreement, then upon GSK’s request, Liquidia shall commence a technology transfer Agreement to GSK or GSK’s Third Party manufacturer supply quantities of PRINT, PRINT Tooling and any other information and technology reasonably necessary for GSK or GSK’s Third Party manufacturer to manufacture and supply such requirements Drug Product in excess of the PRINT Materialsforecasted quantity that Hutchmed notifies Epizyme, Liquidia Respiratory Productand Epizyme reasonably agrees, Research Products or Inhaled Productsis needed to perform the Commercialization activities in the Territory. The Parties shall use Commercially Reasonable Efforts to jointly develop and complete a detailed technology transfer project plan within thirty (30) days after GSK’s request to Liquidia to commence such technology transfer. (b) If GSK determines in its sole discretion, based on GSK standard assessment criteria for contract manufacturing organizations, that Liquidia is either (i) not acceptable to GSK, or (ii) acceptable to GSK but GSK elects not to use Liquidia for supply for strategic business reasonsIn addition, in either case no event shall Epizyme supply to Hutchmed under the Commercial Supply Agreement any quantity of Drug Product co-formulated with an Other Combination Drug. For any quantity of Drug Product supplied by Epizyme to Hutchmed for the supply purposes of PRINT Materials, Liquidia Respiratory Product, Research Commercialization of Licensed Products and Inhaled Products for the purposes described above in this Section 9.2, then consistent with GSK’s rights as set forth in Section 5.2, Liquidia shall commence a technology transfer to GSK or GSK’s Third Party manufacturer of PRINT, PRINT Tooling and any other information and technology reasonably necessary for GSK or GSK’s Third Party manufacturer to manufacture and supply such requirements of the PRINT Materials, Liquidia Respiratory Product, Research Products or Inhaled Products. The Parties shall use Commercially Reasonable Efforts to jointly develop and complete a detailed technology transfer project plan within thirty (30) days after GSK’s request to Liquidia to commence such technology transfer. Solely in the event Field in the circumstances set forth in Section 9.2(b)(ii) occurTerritory, Hutchmed shall pay to Epizyme the provisions Commercial Supply Price for such quantity, payable within [**] after receipt of Section 10.6 shall applyan invoice therefor.

Commercial Supply. GSK shall have 9.1 Commercial Supply of the right to conduct a new contractor assessment of Liquidia to determineLicensed Products [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, in its sole discretionMARKED BY BRACKETS, that Liquidia is acceptable to GSK for the purposes of supplying PRINT MaterialsHAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, Liquidia Respiratory Product, Research Products and Inhaled Products (but only if Inhaled Products are the same as Research Products and do not require further formulation or other work in order to be considered appropriate for commercial supply and development requiring commercial grade supply) for clinical trials requiring commercial grade supply and, if applicable, for further formulation work by GSK or a Third Party as Inhaled Products for commercialization on a worldwide basis. Such assessment of Liquidia’s manufacturing capabilities will be conducted at the appropriate time to allow for technology transfer, if required, prior to manufacture of pivotal clinical trial materialAS AMENDED. (a) If GSK determines in its sole discretionIt is a common intention of the Parties, based on GSK standard assessment criteria for contract manufacturing organizationsas of the Effective Date, that Liquidia is acceptable Shionogi will manufacture or have manufactured and supply to GSK Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” Peninsula, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 Peninsula will purchase exclusively from Shionogi, Peninsula's entire requirements of the Securities Exchange Act of 1934, as amended. for the supply of PRINT Materials, Liquidia Respiratory Product, Research Products and/or Inhaled Products, as applicable, for the purposes described above in this Section 9.2, then subject to Section 9.2(b), Liquidia will be responsible for manufacture and supply in accordance with GMP and GSK’s quality standards all of the PRINT Materials, Research Products, Liquidia Respiratory Product and/or Inhaled Licensed Products (as applicable) required by GSK, its Affiliates and sublicensees, subject to in final form and in accordance compliance with GMP) for commercial sale by Peninsula in the commercially reasonable Territory. Promptly after the Effective Date, the Parties shall discuss and negotiate in good faith the terms and conditions for such supply of a the Licensed Products, which terms shall be commercially reasonable and typical for transactions of this type; provided, however, that the price per 250 mg vial of Licensed Product for commercial supply agreement sale shall be [*]. Further, the Parties shall discuss an appropriate form of the Compound (i.e., bulk Compound or nude vial) to be mutually agreed and negotiated by the Parties (the “Commercial Supply Agreement”). Consistent with GSK’s rights as set forth in Section 5.2supplied to Peninsula, such Commercial Supply Agreement shall provide that if Liquidia is unable to supply PRINT Materials, Liquidia Respiratory Product, Research Products or Inhaled Products as required by GSK, its Affiliates and sublicensees under the terms of the Commercial Supply Agreement, then upon GSK’s request, Liquidia shall commence a technology transfer to GSK or GSK’s Third Party manufacturer of PRINT, PRINT Tooling and any other information and technology reasonably necessary for GSK or GSK’s Third Party manufacturer to manufacture and supply such requirements of the PRINT Materials, Liquidia Respiratory Product, Research Products or Inhaled Productsnecessary. The Parties shall use Commercially Reasonable Efforts diligent efforts to jointly develop enter into an agreement governing the terms and complete a detailed technology transfer project plan within thirty conditions of Shionogi's supply of Peninsula's requirements of Licensed Products for commercial sale by the Target Date (30) days after GSK’s request to Liquidia to commence such technology transferas hereinafter defined). (b) If GSK determines [*]. (c) [*]. 9.2 [*] Peninsula and Shionogi agree to discuss in its sole discretion, based on GSK standard assessment criteria for contract manufacturing organizations, that Liquidia is either (i) not acceptable to GSK, or (ii) acceptable to GSK but GSK elects not to use Liquidia for supply for strategic business reasons, in either case for good faith an appropriate mechanism by which the supply price per 250 mg and/or 500 mg vial of PRINT Materials, Liquidia Respiratory Product, Research Licensed Product for commercial sale will be [*] of Licensed Products and Inhaled Products for the purposes described above in this Section 9.2, then consistent with GSK’s rights as set forth in Section 5.2, Liquidia shall commence a technology transfer to GSK or GSK’s Third Party manufacturer of PRINT, PRINT Tooling and any other information and technology reasonably necessary for GSK or GSK’s Third Party manufacturer to manufacture and supply such requirements of the PRINT Materials, Liquidia Respiratory Product, Research Products or Inhaled Products. The Parties shall use Commercially Reasonable Efforts to jointly develop and complete a detailed technology transfer project plan within thirty (30) days after GSK’s request to Liquidia to commence such technology transfer. Solely in the event the circumstances set forth in Section 9.2(b)(ii) occur, the provisions of Section 10.6 shall applypurchased by Peninsula.

Commercial Supply. GSK shall have In the right to conduct a new contractor assessment event that it is anticipated that Manufacturing Technology Transfer Completion will not be achieved sufficiently in advance of Liquidia to determinethe launch of the first Licensed Product in the Territory, or at such earlier or later date as may be mutually agreed in its sole discretionwriting, that Liquidia is acceptable to GSK for the purposes of supplying PRINT Materials, Liquidia Respiratory Product, Research Products Parties will negotiate in good faith and Inhaled Products (but only if Inhaled Products are the same as Research Products and do not require further formulation or other work in order to be considered appropriate enter into an agreement for commercial supply and development requiring commercial grade supply) for clinical trials requiring commercial grade supply and, if applicable, for further formulation work by GSK Epizyme to Hutchmed of Drug Substance or a Third Party as Inhaled Products for commercialization on a worldwide basis. Such assessment of Liquidia’s manufacturing capabilities will be conducted at the appropriate time to allow for technology transfer, if required, prior to manufacture of pivotal clinical trial material. (a) If GSK determines in its sole discretion, based on GSK standard assessment criteria for contract manufacturing organizations, that Liquidia is acceptable to GSK Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. for the supply of PRINT Materials, Liquidia Respiratory Drug Product, Research Products and/or Inhaled Products, as applicable, for the purposes described above in and a related quality agreement, each on terms consistent with this Section 9.2, then subject to Section 9.2(b), Liquidia will be responsible for manufacture Agreement and supply in accordance with GMP and GSK’s quality standards all of the PRINT Materials, Research Products, Liquidia Respiratory Product and/or Inhaled Products (as applicable) required by GSK, its Affiliates and sublicensees, subject to and in accordance with the otherwise on commercially reasonable terms and conditions of a commercial supply agreement to be mutually agreed and negotiated by the Parties (collectively, the “Commercial Supply Agreement”). Consistent with GSK’s rights as set forth in The Commercial Supply Agreement contain commercially reasonable terms including terms addressing forecasting, ordering, delivery, acceptance and rejection procedures, indemnification, limitations of liability, and quality assurance and control. ​ From and after the execution of the Commercial Supply Agreement and until Manufacturing Technology Transfer Completion under Section 5.27.2, and subject to the terms of such Commercial Supply Agreement shall provide that if Liquidia is unable to and this Agreement and compliance with Applicable Law, Epizyme will, either itself or through Third Parties, Manufacture and supply PRINT Materials, Liquidia Respiratory Product, Research Hutchmed with Drug Product in reasonably sufficient quantities for the Commercialization of Licensed Products or Inhaled Products as required in the Field in the Territory by GSK, its Affiliates the Hutchmed Entities in accordance with the Commercialization Plan and sublicensees under the terms of this Agreement. Hutchmed Entities shall not use any quantity of Drug Product supplied by Epizyme for any purpose other than Commercialization in the Field and Territory in accordance with the Commercialization Plan and the terms of this Agreement, and Epizyme shall not be obligated under the Commercial Supply Agreement, then upon GSK’s request, Liquidia shall commence a technology transfer Agreement to GSK or GSK’s Third Party manufacturer supply quantities of PRINT, PRINT Tooling and any other information and technology reasonably necessary for GSK or GSK’s Third Party manufacturer to manufacture and supply such requirements Drug Product in excess of the PRINT Materialsforecasted quantity that Hutchmed notifies Epizyme, Liquidia Respiratory Productand Epizyme reasonably agrees, Research Products or Inhaled Productsis needed to perform the Commercialization activities in the Territory. The Parties shall use Commercially Reasonable Efforts to jointly develop and complete a detailed technology transfer project plan within thirty (30) days after GSK’s request to Liquidia to commence such technology transfer. (b) If GSK determines in its sole discretion, based on GSK standard assessment criteria for contract manufacturing organizations, that Liquidia is either (i) not acceptable to GSK, or (ii) acceptable to GSK but GSK elects not to use Liquidia for supply for strategic business reasonsIn addition, in either case no event shall Epizyme supply to Hutchmed under the Commercial Supply Agreement any quantity of Drug Product co-formulated with an Other Combination Drug. For any quantity of Drug Product supplied by Epizyme to Hutchmed for the supply purposes of PRINT Materials, Liquidia Respiratory Product, Research Commercialization of Licensed Products and Inhaled Products for the purposes described above in this Section 9.2, then consistent with GSK’s rights as set forth in Section 5.2, Liquidia shall commence a technology transfer to GSK or GSK’s Third Party manufacturer of PRINT, PRINT Tooling and any other information and technology reasonably necessary for GSK or GSK’s Third Party manufacturer to manufacture and supply such requirements of the PRINT Materials, Liquidia Respiratory Product, Research Products or Inhaled Products. The Parties shall use Commercially Reasonable Efforts to jointly develop and complete a detailed technology transfer project plan within thirty (30) days after GSK’s request to Liquidia to commence such technology transfer. Solely in the event Field in the circumstances set forth in Section 9.2(b)(ii) occurTerritory, Hutchmed shall pay to Epizyme the provisions Commercial Supply Price for such quantity, payable within [**] after receipt of Section 10.6 shall applyan invoice therefor.

Commercial Supply. GSK Subject to the oversight of the JMC as described in Section 3.4, SeaGen or its Affiliates shall have Manufacture and supply the right to conduct a new contractor assessment of Liquidia to determine, in its sole discretion, that Liquidia is acceptable to GSK commercial requirements for the purposes of supplying PRINT MaterialsLicensed Product in fully packaged and labelled, Liquidia Respiratory Product, Research Products and Inhaled Products finished form (but only if Inhaled Products are except as may otherwise set forth in the same European Collaboration Territory Distribution Agreement or as Research Products and do not require further formulation or other work otherwise set forth in order to be considered appropriate for commercial supply and development requiring commercial grade supplythe Manufacturing Plan) for clinical trials requiring commercial grade supply and, if applicable, for further formulation work by GSK or a Third Party as Inhaled Products for commercialization on a worldwide basis. Such assessment of Liquidia’s manufacturing capabilities will be conducted at the appropriate time to allow for technology transfer, if required, prior to manufacture of pivotal clinical trial material. (a) If GSK determines in its sole discretion, based on GSK standard assessment criteria for contract manufacturing organizations, that Liquidia is acceptable to GSK Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. for the supply of PRINT Materials, Liquidia Respiratory Product, Research Products and/or Inhaled Products, as applicable, for the purposes described above in this Section 9.2, then subject to Section 9.2(b), Liquidia will be responsible for manufacture and supply in accordance with GMP and GSK’s quality standards all of the PRINT Materials, Research Products, Liquidia Respiratory Product and/or Inhaled Products (as applicable) required by GSK, its Affiliates and sublicensees, subject to and in accordance with the commercially reasonable terms hereof (and conditions of a commercial supply agreement to the SeaGen Supply Agreement contemplated by Section 7.4.2, as applicable) for Commercialization worldwide by each Party; provided that Merck shall be mutually agreed and negotiated by responsible for any specific Manufacturing responsibilities for the Parties (the “Commercial Supply Agreement”). Consistent with GSK’s rights Licensed Product as set forth in Section 5.2and designated to Merck in the Manufacturing Plan. For clarity, such Commercial Supply Agreement Licensed Product shall provide be labelled in accordance with the labelling specifications provided by Merck for the Merck Territory, provided by SeaGen for the SeaGen Territory and as agreed upon between the Parties for the Collaboration Territory. With respect to the Licensed Product for sale in a given country: (a) in the Merck Territory, Merck shall be responsible for ensuring that if Liquidia is unable to supply PRINT Materials, Liquidia Respiratory Product, Research Products or Inhaled Products as required by GSK, its Affiliates such labelling complies with the approved label and sublicensees under Applicable Laws for the terms of applicable country in the Commercial Supply Agreement, then upon GSK’s request, Liquidia shall commence a technology transfer to GSK or GSK’s Third Party manufacturer of PRINT, PRINT Tooling and any other information and technology reasonably necessary for GSK or GSK’s Third Party manufacturer to manufacture and supply such requirements of the PRINT Materials, Liquidia Respiratory Product, Research Products or Inhaled Products. The Parties shall use Commercially Reasonable Efforts to jointly develop and complete a detailed technology transfer project plan within thirty (30) days after GSK’s request to Liquidia to commence such technology transfer. Merck Territory; (b) If GSK determines in its sole discretionthe SeaGen Territory, based on GSK standard assessment criteria SeaGen shall be responsible for contract manufacturing organizations, ensuring that Liquidia is either (i) not acceptable to GSK, or (ii) acceptable to GSK but GSK elects not to use Liquidia for supply for strategic business reasons, in either case such labelling complies with the approved label and Applicable Laws for the supply of PRINT Materialsapplicable country in the SeaGen Territory; (c) in the US Collaboration Territory, Liquidia Respiratory ProductSeaGen shall be responsible for ensuring that such labelling complies with the approved label and Applicable Laws in the US Collaboration Territory; and (d) in the European Collaboration Territory, Research Products each Party shall be responsible for ensuring that such labelling complies with the approved label and Inhaled Products Applicable Laws for the purposes described above in this Section 9.2, then consistent with GSK’s rights as set forth in Section 5.2, Liquidia shall commence a technology transfer to GSK or GSK’s Third Party manufacturer of PRINT, PRINT Tooling and any other information and technology reasonably necessary for GSK or GSK’s Third Party manufacturer to manufacture and supply such requirements of the PRINT Materials, Liquidia Respiratory Product, Research Products or Inhaled Products. The Parties shall use Commercially Reasonable Efforts to jointly develop and complete a detailed technology transfer project plan within thirty (30) days after GSK’s request to Liquidia to commence such technology transfer. Solely applicable country in the event the circumstances set forth in Section 9.2(b)(iiEuropean Collaboration -85- [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) occur, the provisions of Section 10.6 shall apply.NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED

Commercial Supply. GSK Subject to the other provisions of this Section 2.4.3, Celgene shall have Manufacture and supply all Commercial Supplies. Within [* * *] after initiation of a Phase 3 Clinical Trial of a Sotatercept Licensed Product in the right to conduct a new contractor assessment of Liquidia to determinePH Field by Acceleron, in its sole discretion, that Liquidia is acceptable to GSK for the purposes of supplying PRINT Materials, Liquidia Respiratory Product, Research Products and Inhaled Products (but only if Inhaled Products are the same as Research Products and do not require further formulation Affiliate or other work in order to be considered appropriate for commercial supply and development requiring commercial grade supply) for clinical trials requiring commercial grade supply andSublicensee, if applicableCelgene elects to Manufacture Sotatercept Drug Product for Commercialization of Sotatercept Licensed Products in the PH Field, for further formulation work by GSK or a Third Party as Inhaled Products for commercialization on a worldwide basis. Such assessment of Liquidia’s manufacturing capabilities will be conducted at the appropriate time to allow for technology transfer, if required, prior to manufacture of pivotal clinical trial material. (a) If GSK determines Parties shall negotiate in its sole discretion, based on GSK standard assessment criteria for contract manufacturing organizations, that Liquidia is acceptable to GSK Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with good faith the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. for the supply of PRINT Materials, Liquidia Respiratory Product, Research Products and/or Inhaled Products, as applicable, for the purposes described above in this Section 9.2, then subject to Section 9.2(b), Liquidia will be responsible for manufacture and supply in accordance with GMP and GSK’s quality standards all of the PRINT Materials, Research Products, Liquidia Respiratory Product and/or Inhaled Products (as applicable) required by GSK, its Affiliates and sublicensees, subject to and in accordance with the commercially reasonable terms and conditions of a commercial supply agreement to be mutually agreed and negotiated by the Parties (the “Commercial Supply Agreement”)) for the supply by Celgene to Acceleron of Sotatercept Drug Product for Commercialization of Sotatercept Licensed Products in the PH Field. Consistent with GSK’s rights as set forth in Section 5.2, such The Commercial Supply Agreement shall provide provide: (i) that if Liquidia is unable to supply PRINT Materials, Liquidia Respiratory Product, Research Products or Inhaled Products as required by GSK, its Affiliates and sublicensees under the terms of the Commercial Supply Agreement, then upon GSK’s request, Liquidia shall commence a technology transfer to GSK or GSK’s Third Party manufacturer of PRINT, PRINT Tooling and any other information and technology reasonably necessary for GSK or GSK’s Third Party manufacturer to manufacture and supply such requirements of the PRINT Materials, Liquidia Respiratory Product, Research Products or Inhaled Products. The Parties Celgene shall use Commercially Reasonable Efforts to jointly develop Manufacture and complete supply to Acceleron or its designee Sotatercept Drug Product for Commercialization of Sotatercept Licensed Products in the PH Field at a detailed technology transfer project plan price equal to [* * *] of Celgene’s Fully Loaded Cost to Manufacture such Sotatercept Drug Product, and (ii) for such other terms and conditions as are reasonable and customary for similar commercial supply agreements in the pharmaceutical industry. In the event that, (a) despite having used good faith commercially reasonable efforts, the Parties are unable to reach agreement on the terms of a Commercial Supply Agreement within thirty (30) days after GSK’s request to Liquidia to commence such technology transfer. [* * *] following initiation of a Phase 3 Clinical Trial of a Sotatercept Licensed Product in the PH Field by Acceleron, its Affiliate or Sublicensee or (b) If GSK determines in its sole discretion, based on GSK standard assessment criteria for contract manufacturing organizations, that Liquidia is either (i) not acceptable to GSK, or (ii) acceptable to GSK but GSK Celgene elects not to Manufacture Sotatercept Drug Product for Commercialization of Licensed Products in the PH Field, Acceleron shall have the right to Manufacture Commercial Supplies of Sotatercept Licensed Compounds and Sotatercept Licensed Products for Commercialization in the PH Field, in which case Celgene shall use Liquidia for good faith efforts to assist Acceleron in securing a source of supply for strategic business reasonssuch Commercial Supplies and shall, in either case for the supply of PRINT Materials, Liquidia Respiratory Product, Research Products and Inhaled Products for the purposes described above in this Section 9.2, then consistent with GSK’s rights as set forth in Section 5.2, Liquidia shall commence a technology transfer to GSK or GSK’s Third Party manufacturer of PRINT, PRINT Tooling and any other information and technology reasonably necessary for GSK or GSK’s Third Party manufacturer to manufacture and supply such requirements of the PRINT Materials, Liquidia Respiratory Product, Research Products or Inhaled Products. The Parties shall use Commercially Reasonable Efforts to jointly develop cause those CMOs engaged by Celgene in the Manufacture of Sotatercept Licensed Compounds and complete Sotatercept Licensed Products to, provide a detailed technology transfer project plan within thirty (30) days after GSK’s request in accordance with Applicable Laws and industry standards to Liquidia Acceleron or its designee of manufacturing processes and Know-How to commence such technology transfer. Solely the extent necessary to Manufacture Sotatercept Licensed Compounds and Sotatercept Licensed Products for Commercialization in the event PH Field; provided that, with respect to any CMO, to the circumstances set forth extent not permitted or provided for in the agreement(s) with such CMO, such transfer shall be subject to such CMO’s consent. The cost of any technology transfer pursuant to this Section 9.2(b)(ii) occur, 2.4.3 shall be borne equally by the provisions of Section 10.6 shall applyParties.