Common use of Commercial Supply Agreement Clause in Contracts

Commercial Supply Agreement. The Parties shall timely negotiate in good faith and enter into a manufacturing and supply agreement (the "Supply Agreement") governing the supply of Bulk API, by or on behalf of Affymax, to Takeda for the manufacture of Finished Product for the Commercialization of the Product by the Parties hereunder, to execute such Supply Agreement [*] for the Product in the Licensed Territory, or [*], whichever is earlier. Such Supply Agreement shall contain customary terms governing such manufacturing and supply relationships, and shall provide as follows: (a) Bulk API meeting the agreed specification and manufactured in accordance with the applicable laws including then current GMP shall be supplied by or on behalf of Affymax to Takeda in a timely manner consistent with established and agreed manufacturing and delivery schedules at a cost equal to [*] the manufacture of such Bulk API (which [*], with such supply to be [*] . (b) Affymax shall establish [*] commercial Bulk API manufacture in a timely manner to ensure that Affymax meets its obligation to supply quantities of Bulk API ordered by Takeda under the Supply Agreement. Upon the material and uncured breach by Affymax of its defined supply obligations as set forth in the Supply Agreement, Takeda shall have the right to obtain transfer and Affymax shall have the obligation to give transfer free of charge to Takeda, without undue delay, of any and all manufacturing technology necessary to enable it to manufacture or have manufactured Bulk API to meet its requirements. If such transfer occurs, Affymax would grant, without prejudice to any other remedies that are available to Takeda, to Takeda any additional licenses necessary to enable Takeda to exercise the foregoing manufacturing right without requiring Takeda to pay any additional consideration for such licenses. (c) Takeda shall be responsible for the Finished Manufacture, testing (including stability testing) and final release of the Finished Product for Commercialization in the Licensed Territory. With regard to the Finished Product manufactured by or on behalf of Takeda and used or sold for Commercialization in the U.S., the Manufacturing Cost incurred by Takeda for the Finished Manufacture of the Finished Product thus used or sold in the U.S. hereunder, as well as the freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Takeda with regard to such Finished Product shall be included in the Cost of Goods Sold in the calculation of the U.S. Product Profit.

Commercial Supply Agreement. The Unless a Party has already exercised its Opt-Out Option or is deemed to have exercised its Opt-Out Option under Section 14.2(b), at least [ * ] prior to the anticipated commercial launch of a Collaboration Product, the Parties shall timely negotiate in good faith and enter into a manufacturing and supply agreement (the "“Commercial Supply Agreement"”) governing the commercial supply of Bulk API, by or on behalf of Affymax, to Takeda for the manufacture of Finished Product for the Commercialization of the Product by the Parties hereunder, to execute such Supply Agreement [*] for the Product in the Licensed Territory, or [*], whichever is earlierCollaboration Product. Such Commercial Supply Agreement shall contain customary terms governing such manufacturing and supply relationships, and but shall in any event provide as follows: (a) Bulk API meeting Collaboration Product (i) shall meet the agreed specification specification, then-current GMP and be manufactured in accordance with the applicable laws Laws including then current GMP prohibitions on adulteration and misbranding, (ii) shall be supplied by or on behalf of Affymax to Takeda the Lead Manufacturing Party in a timely manner consistent with established and agreed manufacturing and delivery schedules schedules; and (iii) shall be supplied at a cost equal to [*] the manufacture Manufacturing Cost of such Bulk API (which [*], with such supply to be [*] Collaboration Product. (b) Affymax shall establish [*] commercial Bulk API manufacture in Upon a timely manner to ensure that Affymax meets its obligation to supply quantities of Bulk API ordered by Takeda under the Supply Agreement. Upon the material and uncured breach by Affymax the Lead Manufacturing Party of its defined supply obligations as set forth in obligations, the Supply Agreement, Takeda other Party shall have the right to obtain the transfer and Affymax the Lead Manufacturing Party shall have the obligation to give (i) effect such transfer free of charge [ * ] to Takedathe other Party, without undue delay, of any and all manufacturing technology reasonably necessary for the Manufacture of the applicable Collaboration Product included in the Trubion Know-How or included in the Facet Know-How that (x) has been applied to the Manufacture of the applicable Collaboration Product prior to Facet ceasing to be the Lead Manufacturing Party, or (y) is [ * ] in the [ * ] applied to the Manufacture of the applicable Collaboration Product [ * ], as applicable, not already in the other Party’s possession in the form and format in which such Know-How is maintained by the Lead Manufacturing Party or its Third Party manufacturers in the ordinary course of business, and to (ii) at the other Party’s request, use Diligent Efforts to obtain an [ * ] = 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 24b-2 of the Securities Exchange Act of 1934, as amended. assignment of any Third Party manufacturing agreement in each case as reasonably necessary to enable it the other Party to manufacture Manufacture or have manufactured Bulk API Manufactured Collaboration Product in accordance with the terms of this Agreement, provided, however, that the Lead Manufacturing Party shall be required to meet its requirements. If assign any such transfer occursagreement solely to the extent assignment is permitted by such agreement, Affymax would grantprovided that the Lead Manufacturing Party uses Diligent Efforts to obtain any consent necessary for such assignment, without prejudice to any other remedies that are available to Takeda, to Takeda any additional licenses necessary to enable Takeda to exercise and the foregoing manufacturing right without requiring Takeda Lead Manufacturing Party is not required to pay any additional consideration for or commence litigation in order to effect an assignment of any such licensesagreement to the other Party. In the event the Lead Manufacturing Party exercises or is deemed to have exercised its Opt-Out Option pursuant to Article 7, Section 8.5 or Section 14.2(b), then Sections 7.5(b)(iii) and 7.5(b)(x) shall apply. (c) Takeda shall be responsible for the Finished Manufacture, testing (including stability testing) and final release The Manufacturing Costs of the Finished commercial supplies of Collaboration Product for Commercialization in the Licensed Territory. With regard to the Finished Product manufactured by or on behalf of Takeda and used or sold for Commercialization in the U.S., the Manufacturing Cost incurred by Takeda for the Finished Manufacture of the Finished Product thus used or sold in the U.S. hereunder, as well as the duty, freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Takeda with regard to such Finished Collaboration Product shall be included in the Cost of Goods Sold in the calculation of the U.S. Product Profitcost of goods sold as part of Commercialization Costs.

Commercial Supply Agreement. The Parties shall timely negotiate (a) Subject to this Section 7.2 and Section 7.4, subject to Ocugen’s ability to qualify a secondary supplier in good faith and enter into limited events of supply failure, pursuant to a manufacturing and commercial supply agreement (the "“Commercial Supply Agreement"”) governing to be entered into between the Parties, BBIL shall be responsible for the Manufacture and supply of Bulk API, by or on behalf all of Affymax, to Takeda for Ocugen’s requirements of commercial quantities of the manufacture of Finished Product for the Ocugen’s Commercialization of the Product by in the Field in and for the Ocugen Territory, subject to any reasonable limitations on BBIL’s capacity (as more fully described in the Commercial Supply Agreement), until such time as the technology transfer described in Section 7.3(a) below has been completed. The Parties hereunder, to execute such will enter into the Commercial Supply Agreement [*] prior to the anticipated First Commercial Sale of the Product in the Ocugen Territory. Except as set forth in the Commercial Supply Agreement: (i) prior to the completion of the technology transfer as provided in Section 7.3(a), BBIL shall be responsible, at its sole cost and expense, for (x) the Manufacture and supply of the finished Product in its commercial packaging presentation, for use by Ocugen in the Field in the Ocugen Territory after Ocugen’s receipt of an EUA, BLA or other Regulatory Approval for the Product in the Licensed Ocugen Territory, or [*], whichever is earlier. Such Supply Agreement shall contain customary terms governing such manufacturing and supply relationships, (y) performing release and shall provide as follows: (a) Bulk API meeting stability testing of the agreed specification and manufactured Product for use in the Field in the Ocugen Territory in accordance with FDA requirements and Applicable Law; and (ii) following the applicable laws including then current GMP completion of the technology transfer as provided in Section 7.3(a), (x) Ocugen shall be supplied responsible, at its sole cost and expense, for the Manufacture and supply of the finished Product in its commercial packaging presentation, for use by Ocugen in the Field in the Ocugen Territory after Ocugen’s receipt of an EUA, BLA or other Regulatory Approval for the Product in the Ocugen Territory, (y) if required under the Commercial Supply Agreement, and subject to any reasonable limitations on behalf Ocugen’s capacity (as more fully described in the Commercial Supply Agreement), Ocugen shall be responsible for the Manufacture and supply of Affymax to Takeda the finished Product in a timely manner consistent with established its commercial packaging presentation, for use by BBIL in the Field in and agreed manufacturing and delivery schedules at a cost equal to [*] for the manufacture BBIL Territory, after BBIL’s receipt of such Bulk API (which [*], with such supply to be [*] Regulatory Approval for the Product in the BBIL Territory. (b) Affymax The Commercial Supply Agreement shall establish contain mutually agreeable terms, including, among other things, that (i) notwithstanding the consummation of the technology transfer pursuant to Section 7.3, for and during the Calendar Year 2021, BBIL shall Manufacture and supply to Ocugen, its Affiliates or Sublicensees not less than (i.e., at least) [***] of finished commercial Bulk API manufacture in Product (sufficient for a timely manner to ensure that Affymax meets minimum of [***] patients) for Ocugen’s, its obligation to supply quantities of Bulk API ordered by Takeda under the Supply Agreement. Upon the material Affiliates’ and uncured breach by Affymax of its defined supply obligations as set forth Sublicensees’ use in the Supply AgreementField in and for the Ocugen Territory, Takeda (ii) the maximum purchase price payable by Ocugen for the Product manufactured and supplied thereunder shall have not exceed [***], and (iii) following the completion of the technology transfer as provided in Section 7.3, notwithstanding Ocugen’s exclusive right to obtain transfer Manufacture the Product in and Affymax for the Ocugen Territory, BBIL shall have continue to be a back-up supplier of the obligation to give transfer free of charge to TakedaProduct for Ocugen, without undue delayits Affiliates or Sublicensees, of as applicable, in and for the Ocugen Territory, provided that the purchase price payable by Ocugen for any and all manufacturing technology necessary to enable it to manufacture or have manufactured Bulk API to meet its requirements. If such transfer occurs, Affymax would grant, without prejudice to any other remedies that are available to Takeda, to Takeda any additional licenses necessary to enable Takeda to exercise the foregoing manufacturing right without requiring Takeda to pay any additional consideration for such licenses. (c) Takeda back-up supply shall be responsible negotiated between the Parties prior to BBIL manufacturing such supply for the Finished Manufacture, testing (including stability testing) and final release of the Finished Product for Commercialization in the Licensed Territory. With regard to the Finished Product manufactured by or on behalf of Takeda and used or sold for Commercialization in the U.S., the Manufacturing Cost incurred by Takeda for the Finished Manufacture of the Finished Product thus used or sold in the U.S. hereunder, as well as the freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Takeda with regard to such Finished Product shall be included in the Cost of Goods Sold in the calculation of the U.S. Product ProfitOcugen.

Commercial Supply Agreement. Subject to the terms and conditions of this Agreement, Seres shall supply, or secure the supply of, Licensee’s requirements for Collaboration 49 Products for commercial purposes for the Licensed Territory and for the purposes of any Development activities Licensee undertakes in accordance with Section 4.4(d), in accordance with the Manufacturing Standards and the terms of this Agreement, pursuant to an arm’s length supply agreement (“Supply Agreement”) between the Parties or their respective Affiliates. The Parties shall timely negotiate in good faith and enter into the Supply Agreement within [***] after the Effective Date. The Supply Agreement will include the terms set forth on Exhibit F and other customary terms and conditions for an agreement of a manufacturing similar nature. Without limiting the foregoing, the Supply Agreement shall provide that the Collaboration Product supplied thereunder shall be supplied to Licensee at a price equal to Seres’ Manufacturing Costs associated with the Collaboration Products supplied to Licensee under the Supply Agreement, plus a xxxx-up of [***] (such xxxx up [***], the “Manufacturing Markup” and supply agreement such Manufacturing Markup plus Seres’ Manufacturing Costs, the “Supply Costs”). Notwithstanding the foregoing, with respect to Collaboration Product Manufactured during the Pre-Launch Period for use in Commercialization activities after the Pre-Launch Period, (a) the Supply Costs therefor (the "“Pre-Launch Supply Agreement"Costs”) governing for each such batch of such Collaboration Product shall be recalculated using Manufacturing Costs in an amount equal to [***], (b) [***] bear the supply of Bulk API, by or on behalf of Affymax, to Takeda for the manufacture of Finished Product for the Commercialization portion of the Product by Pre-Launch Supply Costs exceeding the Parties hereunderupdated Supply Costs as recalculated in (a), to execute such Supply Agreement and (c) [***] for the Product excess portion in (b) no later than (i) the Licensed Territory, or [*]**] of such date of receipt of first Regulatory Approval or (ii) [***] following the Pre-Launch Period, whichever is earlierlater. Such Supply Agreement shall contain customary terms governing such manufacturing and supply relationshipsTo implement the foregoing, and shall provide as follows: (a) Bulk API meeting the agreed specification and manufactured in accordance with the applicable laws Parties will establish a mutually acceptable methodology, including then current GMP shall be supplied by or on behalf of Affymax periodic reconciliation processes to Takeda in a timely manner consistent with established and agreed manufacturing and delivery schedules at a cost equal to [*] the manufacture of such Bulk API (which [*], with such supply to be [*] . (b) Affymax shall establish [*] commercial Bulk API manufacture in a timely manner to ensure that Affymax meets its obligation to supply quantities of Bulk API ordered by Takeda under adjust the Supply Agreement. Upon Costs and, as needed, any related reconciliation of the material Royalty Payment Amounts and uncured breach by Affymax of its defined supply obligations as set forth in True-Up Amounts to accommodate such adjustment to the Supply Agreement, Takeda shall have the right to obtain transfer and Affymax shall have the obligation to give transfer free of charge to Takeda, without undue delay, of any and all manufacturing technology necessary to enable it to manufacture or have manufactured Bulk API to meet its requirements. If such transfer occurs, Affymax would grant, without prejudice to any other remedies that are available to Takeda, to Takeda any additional licenses necessary to enable Takeda to exercise the foregoing manufacturing right without requiring Takeda to pay any additional consideration for such licensesCosts. (c) Takeda shall be responsible for the Finished Manufacture, testing (including stability testing) and final release of the Finished Product for Commercialization in the Licensed Territory. With regard to the Finished Product manufactured by or on behalf of Takeda and used or sold for Commercialization in the U.S., the Manufacturing Cost incurred by Takeda for the Finished Manufacture of the Finished Product thus used or sold in the U.S. hereunder, as well as the freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Takeda with regard to such Finished Product shall be included in the Cost of Goods Sold in the calculation of the U.S. Product Profit.

Commercial Supply Agreement. The Parties shall timely negotiate in good faith and enter into a manufacturing and supply agreement (the "“Supply Agreement"”) governing the supply of Bulk API, by or on behalf of Affymax, to Takeda for the manufacture of Finished Product for the Commercialization of the Product by the Parties hereunder, to execute such Supply Agreement [*[ * ] for the Product in the Licensed Territory, or [*[ * ], whichever is earlier. [ * ] = 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. Such Supply Agreement shall contain customary terms governing such manufacturing and supply relationships, and shall provide as follows: (a) Bulk API meeting the agreed specification and manufactured in accordance with the applicable laws including then current GMP shall be supplied by or on behalf of Affymax to Takeda in a timely manner consistent with established and agreed manufacturing and delivery schedules at a cost equal to [*[ * ] the manufacture of such Bulk API (which [*[ * ], with such supply to be [*] [ * ]. (b) Affymax shall establish [*[ * ] commercial Bulk API manufacture in a timely manner to ensure that Affymax meets its obligation to supply quantities of Bulk API ordered by Takeda under the Supply Agreement. Upon the material and uncured breach by Affymax of its defined supply obligations as set forth in the Supply Agreement, Takeda shall have the right to obtain transfer and Affymax shall have the obligation to give transfer free of charge to Takeda, without undue delay, of any and all manufacturing technology necessary to enable it to manufacture or have manufactured Bulk API to meet its requirements. If such transfer occurs, Affymax would grant, without prejudice to any other remedies that are available to Takeda, to Takeda any additional licenses necessary to enable Takeda to exercise the foregoing manufacturing right without requiring Takeda to pay any additional consideration for such licenses. (c) Takeda shall be responsible for the Finished Manufacture, testing (including stability testing) and final release of the Finished Product for Commercialization in the Licensed Territory. With regard to the Finished Product manufactured by or on behalf of Takeda and used or sold for Commercialization in the U.S., the Manufacturing Cost incurred by Takeda for the Finished Manufacture of the Finished Product thus used or sold in the U.S. hereunder, as well as the freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Takeda with regard to such Finished Product shall be included in the Cost of Goods Sold in the calculation of the U.S. Product Profit.

Commercial Supply Agreement. The Unless a Party has already exercised its Opt-Out Option or is deemed to have exercised its Opt-Out Option under Section 14.2(b), at least [ * ] [ * ] = 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 24b-2 of the Securities Exchange Act of 1934, as amended. prior to the anticipated commercial launch of a Collaboration Product, the Parties shall timely negotiate in good faith and enter into a manufacturing and supply agreement (the "“Commercial Supply Agreement"”) governing the commercial supply of Bulk API, by or on behalf of Affymax, to Takeda for the manufacture of Finished Product for the Commercialization of the Product by the Parties hereunder, to execute such Supply Agreement [*] for the Product in the Licensed Territory, or [*], whichever is earlierCollaboration Product. Such Commercial Supply Agreement shall contain customary terms governing such manufacturing and supply relationships, and but shall in any event provide as follows: (a) Bulk API meeting Collaboration Product (i) shall meet the agreed specification specification, then-current GMP and be manufactured in accordance with the applicable laws Laws including then current GMP prohibitions on adulteration and misbranding, (ii) shall be supplied by or on behalf of Affymax to Takeda the Lead Manufacturing Party in a timely manner consistent with established and agreed manufacturing and delivery schedules schedules; and (iii) shall be supplied at a cost equal to [*] the manufacture Manufacturing Cost of such Bulk API (which [*], with such supply to be [*] Collaboration Product. (b) Affymax shall establish [*] commercial Bulk API manufacture in Upon a timely manner to ensure that Affymax meets its obligation to supply quantities of Bulk API ordered by Takeda under the Supply Agreement. Upon the material and uncured breach by Affymax the Lead Manufacturing Party of its defined supply obligations as set forth in obligations, the Supply Agreement, Takeda other Party shall have the right to obtain the transfer and Affymax the Lead Manufacturing Party shall have the obligation to give (i) effect such transfer free of charge to Takeda[ * ], without undue delay, of any and all manufacturing technology reasonably necessary for the Manufacture of the applicable Collaboration Product included in the Trubion Know-How or included in the Facet Know-How that (x) has been applied to the Manufacture of the applicable Collaboration Product prior to Facet ceasing to be the Lead Manufacturing Party, or (y) [ * ], as applicable, not already in the other Party’s possession in the form and format in which such Know-How is maintained by the Lead Manufacturing Party or its Third Party manufacturers in the ordinary course of business, and to (ii) at the other Party’s request, use Diligent Efforts to obtain an assignment of any Third Party manufacturing agreement in each case as reasonably necessary to enable it the other Party to manufacture Manufacture or have manufactured Bulk API Manufactured Collaboration Product in accordance with the terms of this Agreement, provided, however, that the Lead Manufacturing Party shall be required to meet its requirements. If assign any such transfer occursagreement solely to the extent assignment is permitted by such agreement, Affymax would grantprovided that the Lead Manufacturing Party uses Diligent Efforts to obtain any consent necessary for such assignment, without prejudice to any other remedies that are available to Takeda, to Takeda any additional licenses necessary to enable Takeda to exercise and the foregoing manufacturing right without requiring Takeda Lead Manufacturing Party is not required to pay any additional consideration for or commence litigation in order to effect an assignment of any such licensesagreement to the other Party. In the event the Lead Manufacturing Party exercises or is deemed to have exercised its Opt-Out Option pursuant to Article 7, Section 8.5 or Section 14.2(b), then Sections 7.5(b)(iii) and 7.5(b)(x) shall apply. (c) Takeda shall be responsible for the Finished Manufacture, testing (including stability testing) and final release The Manufacturing Costs of the Finished commercial supplies of Collaboration Product for Commercialization in the Licensed Territory. With regard to the Finished Product manufactured by or on behalf of Takeda and used or sold for Commercialization in the U.S., the Manufacturing Cost incurred by Takeda for the Finished Manufacture of the Finished Product thus used or sold in the U.S. hereunder, as well as the duty, freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Takeda with regard to such Finished Collaboration Product shall be included in the Cost of Goods Sold in the calculation of the U.S. Product Profitcost of goods sold as part of Commercialization Costs.