Common use of Manufacturing Technology Transfer Clause in Contracts

Manufacturing Technology Transfer. 5.3.1 During the [*] Period, Xxxxxxx shall transfer to Forest or its designee (which designee may be an Affiliate or a Third Party manufacturer, and which Third Party manufacturer may be a backup manufacturer or a second manufacturer of Licensed Product) all Xxxxxxx Know-How constituting the then-current process for the Manufacture of the Licensed Compounds and Licensed Products (the “Manufacturing Process”) and necessary or reasonably useful to implement the Manufacturing Process at facilities designated by Forest. Xxxxxxx shall provide, and shall use commercially reasonable efforts to cause its Third Party manufacturers to provide (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), all reasonable assistance requested by Forest to enable Forest (or its Affiliate or designated Third Party manufacturer, as applicable) to implement, use and practice the Manufacturing Process at the facilities designated by Forest, including (a) to the extent not already provided pursuant to Section 2.6.1, making available all Manufacturing-related Xxxxxxx Know-How, Information and documentation and materials that are necessary or reasonably useful to enable Forest (or its Affiliate or designated Third Party manufacturer, as applicable) to implement, use and practice the Manufacturing Process at the facilities designated by Forest, and (b) assisting Forest (or its Affiliate or designated Third Party manufacturer, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities that are specific for the Manufacture of the Licensed Compounds and the Licensed Products at the applicable facilities. If requested by Forest, Xxxxxxx’x assistance shall include (x) assigning to Forest any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains solely to one or more Licensed Compounds or Licensed Products to the extent permitted under such existing agreement (any such agreement that is assigned to Forest, a “Transferred Agreement”), (y) if (i) the terms of any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains solely to one or more Licensed Compounds or Licensed Products prohibits Xxxxxxx from assigning it to Forest, or (ii) any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains to one or more Licensed Compounds or Licensed Products also relates to other compounds or products, in either case ((i) or (ii)), obtaining for Forest the benefit under such agreement with respect to the Licensed Compounds and the Licensed Products, and (z) otherwise facilitating Forest’s entering into agreements with applicable Third Party suppliers relating to the Licensed Compounds and Licensed Products. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

Manufacturing Technology Transfer. 5.3.1 During the [*] Period, Xxxxxxx Spruce shall transfer permit Kaken to Forest or its designee (which designee may be an Affiliate or a negotiate and enter into with Spruce’s Third Party manufacturer, and which Third Party manufacturer may be a backup manufacturer or a second manufacturer of Licensed Product) all Xxxxxxx Know-How constituting the then-current process for the Manufacture supplier of the Licensed Compounds Compound and Licensed Products Product a separate agreement for the commercial supply of such Licensed Compound and Licensed Product for use in the Field in the Kaken Territory, and Spruce shall use Commercially Reasonable Efforts to facilitate the negotiations of such agreement. Within [***] after the written request of Kaken, the Parties shall negotiate in good faith and endeavor to enter into a manufacturing technology transfer agreement for the Licensed Compound and the Licensed Product (the “Manufacturing ProcessTechnology Transfer Agreement”) ). Under such Manufacturing Technology Transfer Agreement, Spruce shall transfer or have transferred to Kaken such documents and information, and provide such technical assistance and support, necessary or reasonably useful for Kaken to implement the Manufacturing Process at facilities designated Manufacture, or have Manufactured by Forest. Xxxxxxx shall provide, and shall use commercially reasonable efforts to cause its a Third Party manufacturers supplier engaged by Kaken that is reasonably acceptable to provide Spruce, the Licensed Compound and Licensed Product in accordance with the specifications as set forth in the Product Approval, to the extent Controlled by Spruce or Spruce’s Third Party supplier as of such date including the DMF; provided that (including by using commercially reasonable efforts to negotiate contractual obligations for A) Kaken shall notify Spruce of any such Third Party manufacturers supplier and only engage with such Third Party supplier after receiving the prior written consent of Spruce, not to do so under agreements entered into following be unreasonably withheld, conditioned or delayed, (B) such Third Party supplier shall be bound by written obligations of confidentiality, non-use and compliance with applicable Laws (including Proper Conduct Practices, GMP and any regulations required by the Effective DateMHLW or PMDA, the FDA and the EMA), consistent with this Agreement and have agreed in writing to assign to or share with Kaken all Data, Information, inventions or other intellectual property generated by such subcontractor in the course of performing such subcontracted work, and (C) upon reasonable assistance requested prior written notice given by Forest Spruce to enable Forest (Kaken, Kaken shall cause such Third Party supplier to permit Spruce or its Affiliate or designated representatives to audit, during such Third Party manufacturersupplier’s normal business hours and without additional charge, as applicable) to implementthe performance of Manufacturing activities hereunder, use and practice the Manufacturing Process at the facilities designated by Forestused and relevant processes, including systems, books, documents and records, in order to determine Kaken’s compliance with this Agreement. Kaken shall pay any reasonable internal (a) to the extent not already provided budgeted in the Manufacturing Technology Transfer Agreement) and external costs incurred by Spruce in connection with providing such information or assistance pursuant to this Section 2.6.1, making available all Manufacturing-related Xxxxxxx Know-How, Information 7.2(b). Upon the completion of any such Manufacturing technology transfer and documentation and materials Kaken’s confirmation that are necessary Kaken or reasonably useful to enable Forest (or its Affiliate or designated Kaken’s Third Party manufacturersupplier is capable of Manufacturing the Licensed Compound and Licensed Product, as applicable) Spruce will have no further obligation to implement, use and practice the Manufacturing Process at the facilities designated by Forest, and (b) assisting Forest (or its Affiliate or designated Third Party manufacturer, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities that are specific for the Manufacture supply Kaken’s commercial requirements of the Licensed Compounds and the Licensed Products at the applicable facilities. If requested by Forest, Xxxxxxx’x assistance shall include (x) assigning to Forest any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains solely to one or more Licensed Compounds or Licensed Products to the extent permitted under such existing agreement (any such agreement that is assigned to Forest, a “Transferred Agreement”), (y) if (i) the terms of any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains solely to one or more Licensed Compounds or Licensed Products prohibits Xxxxxxx from assigning it to Forest, or (ii) any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains to one or more Licensed Compounds or Licensed Products also relates to other compounds or products, in either case ((i) or (ii)), obtaining for Forest the benefit under such agreement with respect to the Licensed Compounds and the Licensed Products, and (z) otherwise facilitating Forest’s entering into agreements with applicable Third Party suppliers relating to the Licensed Compounds Compound and Licensed Products. [*] = Certain confidential information contained Product for use in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of Field in the Securities Act of 1933, as amendedKaken Territory.

Manufacturing Technology Transfer. 5.3.1 During the [*] Period7.3.1 Upon AbbVie’s request, Xxxxxxx I-Mab shall, and shall cause its Affiliates and shall use Commercially Reasonable Efforts to cause Third Party manufacturers to: (a) with respect to any Existing Product (or component thereof) Manufactured by a Third Party manufacturer, and (b) with respect to any Existing Product (or component thereof) Manufactured by I-Mab, its Affiliates or a Third Party manufacturer, effect a full or partial transfer to Forest AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer, and which Third Party manufacturer may be a backup manufacturer or a second manufacturer ) of Licensed Product) all Xxxxxxx I-Mab Know-How constituting and Joint Know-How relating to the then-current process for the Manufacture of Existing Product (including the Licensed Compounds and Licensed Products Compound contained therein) (the “Manufacturing Process”) and necessary or reasonably useful to implement the Manufacturing Process at facilities designated by ForestAbbVie ((a) and (b) collectively, as more fully described in this Section 7.3, the “Manufacturing Technology Transfer”). Xxxxxxx I-Mab shall, and shall cause its Affiliates to, provide, and shall use commercially reasonable efforts to cause its assist AbbVie in causing Third Party manufacturers to provide (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date)provide, all reasonable assistance requested by Forest AbbVie to enable Forest AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to implement, use and practice implement the Manufacturing Process at the facilities designated by Forest, including (a) to the extent not already provided pursuant to Section 2.6.1, making available all Manufacturing-related Xxxxxxx Know-How, Information and documentation and materials that are necessary or reasonably useful to enable Forest (or its Affiliate or designated Third Party manufacturer, as applicable) to implement, use and practice the Manufacturing Process at the facilities designated by Forest, and (b) assisting Forest (or its Affiliate or designated Third Party manufacturer, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities that are specific for the Manufacture of the Licensed Compounds and the Licensed Products at the applicable facilitiesAbbVie. If requested by ForestAbbVie, Xxxxxxx’x such assistance shall include (x) assigning to Forest any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains solely to one or more Licensed Compounds or Licensed Products to facilitating the extent permitted under such existing agreement (any such agreement that is assigned to Forest, a “Transferred Agreement”), (y) if (i) the terms of any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains solely to one or more Licensed Compounds or Licensed Products prohibits Xxxxxxx from assigning it to Forest, or (ii) any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains to one or more Licensed Compounds or Licensed Products also relates to other compounds or products, in either case ((i) or (ii)), obtaining for Forest the benefit under such agreement with respect to the Licensed Compounds and the Licensed Products, and (z) otherwise facilitating Forest’s entering into of agreements with applicable Third Party suppliers relating to the Existing Product (including the Initial Licensed Compounds Compound contained therein). Notwithstanding the foregoing, any such assistance by a Third Party manufacturer shall be subject to the applicable terms and Licensed Productsconditions of the existing agreement between I-Mab and such Third Party manufacturer; provided that, to the extent any assistance reasonably requested by AbbVie is not contemplated by the applicable terms and conditions of the existing agreement between I-Mab and such Third Party manufacturer, then at AbbVie’s request and expense, I-Mab will use reasonable efforts to cause, or assist AbbVie to cause, such Third Party manufacturer to provide such assistance to AbbVie. [*] = Certain confidential information contained Upon completion of the Manufacturing Technology Transfer, AbbVie shall have the right, in this documentits sole discretion, marked by bracketsto make any improvements to the Manufacturing Process. Without limitation of the foregoing, has been omitted and filed separately in connection with the Securities Manufacturing Technology Transfer and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.extent requested by AbbVie:

Manufacturing Technology Transfer. 5.3.1 During (a) Any time after the [**] Periodanniversary of the Effective Date, Xxxxxxx shall Incyte may request, upon [**] written notice (which notice may be given prior to the [**] anniversary of the Effective Date) to MacroGenics (or immediately upon writing notice to MacroGenics, in the case of a Clinical Supply Shortage), that MacroGenics transfer or have transferred the Manufacturing Process to Forest a manufacturing facility under the control of Incyte (or its designee (designee, which designee may be an Affiliate or Affiliate) or, subject to subsection (d) below, to a facility of a Third Party manufacturercontract manufacturer that is mutually agreed upon by the Parties. MacroGenics shall not withhold such agreement to a proposed contract manufacturer that has not experienced any material documented safety, compliance or quality issues in the preceding [**] and which has demonstrated the ability to manufacture products at the volumes and quality anticipated under this Agreement (such Incyte facility or Third Party manufacturer may facility, the “Incyte Facility” and such Third Party, an “Approved CMO”). Such transfer and implementation shall be a backup manufacturer sufficient to enable Incyte or a second manufacturer such designee to perform the Manufacturing Process and Manufacture of Licensed Product) all Xxxxxxx Know-How constituting the then-current process for the Manufacture of the Licensed Compounds Compound Bulk Drug Substance and Licensed Products Compound Drug Product in accordance with Applicable Law, as more fully described in this Section 7.1 (the “Manufacturing ProcessTechnology Transfer”) and necessary or reasonably useful to implement the Manufacturing Process at facilities designated by Forest. Xxxxxxx shall provide), and shall use commercially reasonable efforts be subject to cause its Third Party manufacturers to provide (including a written plan approved by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), all reasonable assistance requested by Forest to enable Forest (or its Affiliate or designated Third Party manufacturer, as applicable) to implement, use and practice the Manufacturing Process at the facilities designated by Forest, including (a) to the extent not already provided pursuant to Section 2.6.1, making available all Manufacturing-related Xxxxxxx Know-How, Information and documentation and materials that are necessary or reasonably useful to enable Forest (or its Affiliate or designated Third Party manufacturer, as applicable) to implement, use and practice the Manufacturing Process at the facilities designated by Forest, and (b) assisting Forest (or its Affiliate or designated Third Party manufacturer, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities that are specific for the Manufacture of the Licensed Compounds and the Licensed Products at the applicable facilities. If requested by Forest, Xxxxxxx’x assistance shall include (x) assigning to Forest any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains solely to one or more Licensed Compounds or Licensed Products to the extent permitted under such existing agreement (any such agreement that is assigned to Forest, a “Transferred Agreement”), (y) if (i) the terms of any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains solely to one or more Licensed Compounds or Licensed Products prohibits Xxxxxxx from assigning it to Forest, or (ii) any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains to one or more Licensed Compounds or Licensed Products also relates to other compounds or products, in either case ((i) or (ii)), obtaining for Forest the benefit under such agreement JSC with respect to the Licensed Compounds Manufacturing Technology Transfer (the “Manufacturing Transition Plan”), with Incyte having final decision-making authority on the Manufacturing Technology Transfer (provided that Incyte may not expand the scope of the Know-How and the Licensed Products, and (zInformation to be transferred pursuant to Section 7.1(b) otherwise facilitating Forest’s entering into agreements with applicable Third Party suppliers relating beyond that which is required hereunder). The Parties shall use Commercially Reasonable Efforts to the Licensed Compounds and Licensed Products. [**] = Certain Portions of this exhibit have been omitted pursuant to a confidential information contained in treatment request. An unredacted version of this document, marked by brackets, exhibit has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amendedCommission.

Manufacturing Technology Transfer. 5.3.1 During the [*] PeriodIf CASI notifies Cleave in writing that it decides that CASI, Xxxxxxx shall transfer to Forest or its designee (which designee may be an Affiliate of CASI, or a Third Party manufacturerCMO selected by CASI will manufacture the Licensed Product in the Territory and request the manufacturing technology transfer, and (a) the Parties shall discuss in good faith which Third Party manufacturer may be a backup manufacturer or a second manufacturer of entity should manufacture the Licensed Product, ​ taking into account all relevant factors, provided that CASI shall have sole discretion on deciding which entity will manufacture the Licensed Product (but subject to the minimum qualification criteria as set forth on Exhibit H); and (b) all Xxxxxxx Know-How constituting Cleave shall promptly approve CASI and its Affiliates (as well as, if applicable, a further sublicense by CASI to such CMO) to manufacture the then-current process Licensed Product for use in the Field in the Territory. The Parties will promptly establish a plan for the Manufacture transfer of the Licensed Compounds manufacturing process and Licensed Products QC assays that are owned or otherwise controlled by Cleave, from Cleave to CASI, CASI’s Affiliate, or such CMO selected by CASI. The manufacturing technology transfer plan will set out (i) activities and timelines for such manufacturing technology transfer and (ii) the “Manufacturing Process”) support required by CASI from Cleave for such transfer, pursuant to which Cleave will provide access and transfer, to CASI, CASI’s Affiliate, or the CMO selected by CASI, all Cleave Technology that is Controlled by Cleave and is necessary or reasonably useful to implement manufacture the Manufacturing Process at facilities designated by ForestLicensed Product in the Field in the Territory. Xxxxxxx shall provideUpon CASI’s reasonable request, Cleave or its CMO will provide assistance and shall use commercially reasonable efforts on-site support related to cause its Third Party manufacturers to provide (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), all reasonable assistance requested by Forest manufacturing technology transfer to enable Forest CASI, its Affiliate, or the CMO selected by CASI to manufacture the Licensed Product in substantially the same manner as Cleave (or its Affiliate Affiliates, CMOs, or designated Third Party manufacturera third party selected by Cleave, as applicable) to implement, use and practice the Manufacturing Process at the facilities designated by Forest, including (a) to the extent not already provided pursuant to Section 2.6.1, making available all Manufacturing-related Xxxxxxx Know-How, Information and documentation and materials that are necessary or reasonably useful to enable Forest (or its Affiliate or designated Third Party manufacturer, as applicable) to implement, use and practice the Manufacturing Process at the facilities designated by Forest, and (b) assisting Forest (or its Affiliate or designated Third Party manufacturer, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities that are specific for the Manufacture of manufactures the Licensed Compounds and the Licensed Products at the applicable facilities. If requested by Forest, Xxxxxxx’x assistance shall include (x) assigning to Forest any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains solely to one or more Licensed Compounds or Licensed Products to the extent permitted under such existing agreement (any such agreement that is assigned to Forest, a “Transferred Agreement”), (y) if (i) the terms of any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains solely to one or more Licensed Compounds or Licensed Products prohibits Xxxxxxx from assigning it to Forest, or (ii) any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains to one or more Licensed Compounds or Licensed Products also relates to other compounds or products, in either case ((i) or (ii)), obtaining Product for Forest the benefit under such agreement with respect to the Licensed Compounds and the Licensed Products, and (z) otherwise facilitating Forest’s entering into agreements with applicable Third Party suppliers relating to the Licensed Compounds and Licensed ProductsCASI. [*] = Certain confidential information contained **]. Notwithstanding the foregoing, the Parties acknowledge that CASI, at its sole discretion, may never exercise the option to manufacture the Licensed Product in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amendedTerritory.

Manufacturing Technology Transfer. 5.3.1 During (a) Any time after the [**] Periodanniversary of the Effective Date, Xxxxxxx shall Incyte may request, upon [**] written notice (which notice may be given prior to the [**] anniversary of the Effective Date) to MacroGenics (or immediately upon writing notice to MacroGenics, in the case of a Clinical Supply Shortage), that MacroGenics transfer or have transferred the Manufacturing Process to Forest a manufacturing facility under the control of Incyte (or its designee (designee, which designee may be an Affiliate or Affiliate) or, subject to subsection (d) below, to a facility of a Third Party manufacturercontract manufacturer that is mutually agreed upon by the Parties. MacroGenics shall not withhold such agreement to a proposed contract manufacturer that has not experienced any material documented safety, compliance or quality issues in the preceding [**] and has demonstrated the ability to manufacture products at the volumes and quality anticipated under this Agreement (such Incyte facility or Third Party facility, the “Incyte Facility” and such Third Party, an “Approved CMO ”). Such transfer and implementation shall be sufficient to enable Incyte or such designee to perform the [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Manufacturing Process and Manufacture of Licensed Compound Bulk Drug Substance and Licensed Compound Drug Product in accordance with Applicable Law, as more fully described in this Section 7.1 (the “Manufacturing Technology Transfer”), and which Third Party manufacturer shall be subject to a written plan approved by the JSC with respect to the Manufacturing Technology Transfer (the “ Manufacturing Transition Plan”), with Incyte having final decision-making authority on the Manufacturing Technology Transfer (provided that Incyte may be a backup manufacturer or a second manufacturer not expand the scope of Licensed Product) all Xxxxxxx the Know-How constituting and Information to be transferred pursuant to Section 7.1(b) beyond that which is required hereunder). The Parties shall use Commercially Reasonable Efforts to effect the then-current process Manufacturing Technology Transfer to Incyte or its designee pursuant to this Section 7.1. The implementation of the Manufacturing Technology Transfer and Manufacturing Transition Plan shall be subject to the Incyte Facility being suitable for the Manufacture of the Licensed Compounds and Licensed Products (the “Manufacturing Process”) and necessary or reasonably useful to implement Compound Bulk Drug Substance as determined in accordance with this Section 7.1(a), as applicable, using the Manufacturing Process at facilities designated by Forest. Xxxxxxx shall provide, and shall use commercially reasonable efforts to cause its Third Party manufacturers to provide (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), all reasonable assistance requested by Forest to enable Forest (or its Affiliate or designated Third Party manufacturer, as applicable) to implement, use and practice the Manufacturing Process at the facilities designated by Forest, including (a) to the extent not already provided pursuant to Section 2.6.1, making available all Manufacturing-related Xxxxxxx Know-How, Information and documentation and materials that are necessary or reasonably useful to enable Forest (or its Affiliate or designated Third Party manufacturer, as applicable) to implement, use and practice the Manufacturing Process at the facilities designated by Forest, and (b) assisting Forest (or its Affiliate or designated Third Party manufacturer, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities that are specific for the Manufacture of the Licensed Compounds and the Licensed Products at the applicable facilities. If requested by Forest, Xxxxxxx’x assistance shall include (x) assigning to Forest any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains solely to one or more Licensed Compounds or Licensed Products to the extent permitted under such existing agreement (any such agreement that is assigned to Forest, a “Transferred Agreement”), (y) if (i) the terms of any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains solely to one or more Licensed Compounds or Licensed Products prohibits Xxxxxxx from assigning it to Forest, or (ii) any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains to one or more Licensed Compounds or Licensed Products also relates to other compounds or products, in either case ((i) or (ii)), obtaining for Forest the benefit under such agreement compliance with respect to the Licensed Compounds and the Licensed Products, and (z) otherwise facilitating Forest’s entering into agreements with applicable Third Party suppliers relating to the Licensed Compounds and Licensed Products. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amendedApplicable Laws.

Manufacturing Technology Transfer. 5.3.1 During the Within [***] Periodafter the written request of 3D Medicines, Xxxxxxx the Parties shall negotiate in good faith and enter into a manufacturing technology transfer to Forest or its designee (which designee may be an Affiliate or a Third Party manufacturer, agreement for Drug Substance and which Third Party manufacturer may be a backup manufacturer or a second manufacturer of Licensed Product) all Xxxxxxx Know-How constituting the then-current process for the Manufacture of the Licensed Compounds and Licensed Products drug product (the “Manufacturing ProcessTechnology Transfer Agreement”) ). Under such Manufacturing Technology Transfer Agreement, Aravive shall transfer or have transferred to 3D Medicines such documents and information, and provide such technical assistance and support, necessary or reasonably useful for 3D Medicines to implement the Manufacturing Process at facilities designated Manufacture, or have Manufactured by Forest. Xxxxxxx shall provide, and shall use commercially reasonable efforts to cause its a Third Party manufacturers contractor engaged by 3D Medicines that is reasonably acceptable to provide Aravive, the applicable Drug Substance and drug product, to the extent Controlled by Aravive as of such date; provided that (including by using commercially reasonable efforts to negotiate contractual obligations for A) 3D Medicines shall notify Aravive of any such Third Party manufacturers contractor and only engage with such Third Party contractor after receiving the prior written consent of Aravive, not to do so be unreasonably withheld, conditioned or delayed, (B) such Third Party contractor shall be bound by written obligations of confidentiality, non-use and compliance with applicable Laws (including Proper Conduct Practices, GMP and any regulations required by the NMPA, the FDA and the EMA), consistent with this Agreement and have agreed in writing to assign to or share with 3D Medicines all Data, Information, inventions or other intellectual property generated by such subcontractor in the course of performing such subcontracted work, and (C) upon reasonable prior written notice given by Aravive to 3D Medicines, 3D Medicines shall cause such Third Party contractor to (x) provide a sample of each of the first ten (10) batches of the applicable Drug Substance, promptly following the Manufacture thereof, to Aravive for testing purposes, and (y) permit Aravive or its representatives to audit, during such Third Party contractor’s normal business hours and without additional charge, the performance of Manufacturing activities hereunder, the facilities used and relevant processes, systems, books, documents and records, in order to determine 3D Medicines’ compliance with this Agreement. 3D Medicines shall pay any reasonable internal (to the extent budgeted in the Manufacturing Technology Transfer Agreement) and external costs incurred by Aravive in connection with providing such information or assistance pursuant to this Section 7.1(b). Regardless of the manufacturing technology transfer contemplated under agreements entered into following this Section 7.1(b), 3D Medicines covenants that, prior to the fourth (4th) anniversary of the Effective Date), all reasonable assistance requested by Forest to enable Forest (or its Affiliate or designated Third Party manufacturer, as applicable) to implement, use and practice the Manufacturing Process at the facilities designated by Forest, including (a) to the extent not already provided pursuant to Section 2.6.1, making available all Manufacturing-related Xxxxxxx Know-How, Information and documentation and materials that are necessary or reasonably useful to enable Forest (or its Affiliate or designated Third Party manufacturer, as applicable) to implement, use and practice the Manufacturing Process at the facilities designated by Forest, and (b) assisting Forest (or its Affiliate or designated Third Party manufacturer, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities that are specific for the Manufacture of the Licensed Compounds and the Licensed Products at the applicable facilities. If requested by Forest, Xxxxxxx’x assistance shall include (x) assigning to Forest any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains solely to one or more Licensed Compounds or Licensed Products to the extent permitted under such existing agreement (any such agreement that is assigned to Forest, a “Transferred Agreement”), (y) if (i) the terms of any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains solely to one or more Licensed Compounds or Licensed Products prohibits Xxxxxxx from assigning it to Forest, or (ii) any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains to one or more Licensed Compounds or Licensed Products also relates to other compounds or products, in either case ((i) or (ii)), obtaining for Forest the benefit under such agreement with respect to the Licensed Compounds and the Licensed Products, and (z) otherwise facilitating Forest’s entering into agreements with applicable Third Party suppliers relating to the Licensed Compounds and Licensed Products. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended**].