Common use of Tech Transfer Clause in Contracts

Tech Transfer. Promptly following the Effective Date, Pfenex and Hospira shall develop and reasonably agree through the Executive Steering Committee on a plan, which plan shall (a) be consistent in form and scope of those technology transfer plans used by Pfenex in connection with its transfer of the process related to both Drug Substance and Product to Third Parties prior to the Signature Date (access to which was provided to Hospira prior to the Signature Date) and (b) include the information, which information will be formatted, in each case as summarized in that certain memorandum exchanged between the Parties on the Signature Date and referencing this Agreement (the “Technical Transfer Plan”) of the activities to be conducted by each Party to facilitate Hospira’s or the Designated Product Manufacturer’s establishment of manufacturing capabilities for the Drug Substance and Product, including transfer of the Manufacturing Strain; provided, that Hospira or the Designated Product Manufacturer shall agree in writing to (i) maintain physical control over the Manufacturing Strain at all times and (ii) not to alter or modify the Manufacturing Strain in any manner. Such Technical Transfer Plan shall provide, among other things, that (A) Pfenex shall, as soon as practicable, deliver to Hospira or the Designated Product Manufacturer the Pfenex Know-How (which for clarity shall not include any equipment but shall include the manufacturing processes for the Drug Substance and Product (including analytical methods with respect thereto), Manufacturing Strain and methods and protocols for assessing the quality of and releasing Product) in the possession of Pfenex and/or its current manufacturer of Drug Substance and Product and reasonably necessary for Hospira or the Designated Product Manufacturer to (I) obtain all required Regulatory Approvals with respect to the manufacture of Product and (II) manufacture the Drug Substance and Product, and (B) each Party shall make available its personnel reasonably necessary for the performance by it of its respective obligations set forth in the Technical Transfer Plan. The Technical Transfer Plan shall also include a target completion date prior to the initiation of the Comparative Clinical Study upon which target completion date Pfenex’s activities and obligations under the Technical Transfer Plan shall end. In connection therewith, Pfenex and Hospira shall form a joint technology transfer committee, consisting of an equal number of representatives of each of Pfenex and Hospira (up to a maximum number of three (3) representatives each), which shall be responsible for overseeing the implementation of the Technical Transfer Plan. Each Party shall be responsible for all of its own costs and expenses incurred in connection with the performance of its obligations under the Technical Transfer Plan and Hospira shall be responsible for any payments owed to any Designated Product Manufacturer in connection with the Technical Transfer Plan. After completion of activities assigned to Pfenex under the Technical Transfer Plan, Pfenex agrees to reasonably [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. support Hospira’s or the Designated Product Manufacturer’s manufacture of Drug Substance and Product hereunder, at Hospira’s reasonable request and Hospira shall pay Pfenex at its Commercial Hourly Rate for the time spent by its personnel providing such support; provided, that Pfenex shall provide [***] of such support without charge. Notwithstanding the foregoing, if Hospira requests Pfenex’s cooperation with respect to the transfer of manufacturing capabilities to a second Person or facility (e.g., to a Designated Product Manufacturer if the Technical Transfer Plan established manufacturing capabilities at Hospira or to a second Designated Product Manufacturer) Hospira shall pay Pfenex at its Commercial Hourly Rate for the time spent by its personnel and reimburse Pfenex for its out-of-pocket costs and expenses incurred, in each case, in connection with Pfenex cooperating at Hospira’s request. For clarity, (x) the Technical Transfer Plan shall not include the scale-up of the manufacturing process to commercial scale, validation of the manufacturing process or validation of the quality control, quality assessment or release methods or protocols for such purposes, all of which Hospira shall be responsible for; and (y) Pfenex shall not have any obligation to manufacture or supply to Hospira any Drug Substance or Product.

Tech Transfer. Promptly following 4.5.1 To facilitate the establishment of AbbVie’s second supply source of ribavirin tablets in twice daily and once daily dosage forms, within *** days of the Effective Date, Pfenex and Hospira shall develop and reasonably agree through the Executive Steering Committee on a plan, which plan shall (a) be consistent in form and scope of those technology transfer plans used by Pfenex in connection with its transfer of the process related to both Drug Substance and Product to Third Parties prior to the Signature Date (access to which was provided to Hospira prior to the Signature Date) and (b) include the information, which information will be formatted, in each case as summarized in that certain memorandum exchanged between the Parties on the Signature Date and referencing this Agreement shall enter into a tech transfer plan (the “Technical Tech Transfer Plan”) ). The Tech Transfer Plan will include provisions requiring Company to make available to AbbVie copies of the activities physical embodiment of those processes, protocols, procedures, methods, tests and other information, relating specifically to be conducted by each Party the Manufacturing of Product. Company shall provide reasonable assistance in order to facilitate Hospira’s the establishment of a back-up supplier or the Designated Product Manufacturer’s establishment of manufacturing capabilities for the Drug Substance and Product, including transfer of the Manufacturing Strain; provided, that Hospira or the Designated Product Manufacturer shall agree in writing to (i) maintain physical control over the Manufacturing Strain at all times and (ii) not to alter or modify the Manufacturing Strain in any manner. Such Technical Transfer Plan shall provide, among other things, that (A) Pfenex shall, as soon as practicable, deliver to Hospira or the Designated Product Manufacturer the Pfenex Know-How (which for clarity shall not include any equipment but shall include the manufacturing processes for the Drug Substance and Product (including analytical methods with respect thereto), Manufacturing Strain and methods and protocols for assessing the quality of and releasing Product) in the possession of Pfenex and/or its current manufacturer of Drug Substance and Product and reasonably necessary for Hospira or the Designated Product Manufacturer to (I) obtain all required Regulatory Approvals with respect to the manufacture of Product and (II) manufacture the Drug Substance and Product, and (B) each Party shall make available its personnel reasonably necessary for the performance by it of its respective obligations set forth in the Technical Transfer Plan. The Technical Transfer Plan shall also include a target completion date prior to the initiation of the Comparative Clinical Study upon which target completion date Pfenex’s activities and obligations under the Technical Transfer Plan shall end. In connection therewith, Pfenex and Hospira shall form a joint technology transfer committee, consisting of an equal number of representatives of each of Pfenex and Hospira (up Product to a maximum number of three (3) representatives each), which shall be responsible for overseeing the implementation of the Technical Transfer Plan. Each AbbVie or such other Third Party shall be responsible for all of its own costs and expenses incurred in connection with the performance of its obligations under the Technical Transfer Plan and Hospira shall be responsible for any payments owed to any Designated Product Manufacturer in connection with the Technical Transfer Plan. After completion of activities assigned to Pfenex under the Technical Transfer Plan, Pfenex agrees to reasonably [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. support Hospira’s or the Designated Product Manufacturer’s manufacture of Drug Substance and Product hereunder, at Hospira’s reasonable request and Hospira shall pay Pfenex at its Commercial Hourly Rate for the time spent by its personnel providing such support; provided, that Pfenex shall provide [***] of such support without chargeAbbVie designates. Notwithstanding the foregoing, if Hospira requests Pfenexthe Parties acknowledge that Kadmon shall not be able to provide access to the DMF for the Company’s cooperation current API CMO. 4.5.2 At AbbVie’s request, and coordinated through the JPMT established under the License Agreement, Company shall cause appropriate employees and representatives of Company and its appropriate Affiliates to meet with respect the employees of AbbVie or its designee at appropriate locations, from time to time, as reasonably requested by AbbVie, to facilitate the transfer of manufacturing capabilities Manufacturing process. Company shall also take all actions reasonably necessary to effectuate the royalty free transfer from Company or any of its CMOs (including Approved Subcontractors) to AbbVie or such Third Party supplier selected by AbbVie of Intellectual Property Rights owned or controlled by Company that are reasonably necessary and useful to Manufacture Product so as to enable AbbVie or such Third Party supplier to Manufacture Product. Company shall also cooperate with AbbVie CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION to promptly prepare and file all necessary regulatory submissions to accommodate such alternative supply arrangements. 4.5.3 In connection with the activities undertaken by Company under the Tech Transfer Plan, AbbVie shall reimburse Company’s (a) pre-approved travel expenses (undertaken in accordance with applicable AbbVie travel policies); (b) personnel expenses incurred on-site at AbbVie’s or its designee’s facility(ies) at a second Person or facility fully burdened rate equal to $200/hour; and (e.g.c) any actual, to a Designated Product Manufacturer if the Technical Transfer Plan established manufacturing capabilities at Hospira or to a second Designated Product Manufacturer) Hospira shall pay Pfenex at its Commercial Hourly Rate for the time spent by its personnel reasonable and reimburse Pfenex for its out-of-pocket documented costs and expenses incurredrequired to be paid to Third Party CMOs. 4.5.4 To the extent agreed upon by the Parties in writing, in each case, in connection with Pfenex cooperating at Hospira’s request. For clarity, (x) the Technical Transfer Plan shall not include Parties will cooperate to identify and qualify an alternative supplier of API for the scale-up purposes of the manufacturing process Parties establishing a second source of API. If the Parties agree to commercial scale, validation cooperate then the Parties shall agree on the manner of sharing the manufacturing process or validation costs of the quality control, quality assessment or release methods or protocols for such purposes, all of which Hospira shall be responsible for; identification and (y) Pfenex shall not have any obligation to manufacture or supply to Hospira any Drug Substance or Productqualification.

Tech Transfer. Promptly (a) MERSANA shall have the right, at any time after the Effective Date, to require SNFX to effect a transfer to MERSANA, or any Affiliate or CMO designated by MERSANA, of SNFX’s Know-How relating to the then-current process for the Manufacture of the Materials or the bioconjugation and Manufacture of remodeled antibodies using the Licensed Technology (collectively, the “Manufacturing Processes”) as is necessary and useful to enable MERSANA to implement the Manufacturing Processes at facilities designated by MERSANA (such transfer, the “Tech Transfer”). SNFX shall provide, and shall use Commercially Reasonable Efforts to cause its CMOs to provide (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such CMOs to do so under agreements entered into following the Effective Date), Pfenex the reasonable assistance requested by MERSANA to enable MERSANA (or its Affiliates or designated CMOs, as applicable) to implement the Manufacturing Processes at the facilities designated by MERSANA. If requested by XXXXXXX, such assistance shall include facilitating the entering into of agreements with applicable CMOs relating to the Manufacture of the Materials and Hospira shall develop the bioconjugation and reasonably agree through Manufacture of the Executive Steering Committee on a planremodeled antibodies using the Licensed Technology. Without limitation to the foregoing, which plan shall (a) be consistent in form and scope of those technology transfer plans used by Pfenex in connection with each Tech Transfer: (1) SNFX shall make available, and shall use Commercially Reasonable Efforts to cause its transfer CMOs to make available (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such CMOs to do so under agreements entered into following the Effective Date), to MERSANA (or its Affiliates or designated CMOs, as applicable) from time to time as MERSANA may reasonably request, all Manufacturing-related Know-How relating to the Manufacturing Processes, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to materials to be used and control methods, that are reasonably necessary or useful to enable MERSANA (or its Affiliates or designated CMOs, as applicable) to use and practice the Manufacturing Processes; (2) SNFX shall cause all appropriate employees and representatives of SNFX and its Affiliates to meet with, and shall use Commercially Reasonable Efforts to cause all appropriate employees and representatives of its CMOs to meet with (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such CMOs to do so under agreements entered into following the Effective Date), employees or representatives of MERSANA (or its Affiliates or designated CMOs, as applicable) at the applicable Manufacturing facility at mutually convenient times to assist with the working up and use of the process related to both Drug Substance Manufacturing Processes and Product to Third Parties prior with the training of MERSANA’s personnel (or its Affiliates’ or designated CMOs’ personnel, as applicable) to the Signature Date extent reasonably necessary or useful to enable MERSANA (access or its Affiliates or designated CMOs, as applicable) to which was provided use and practice the Manufacturing Processes; and (3) SNFX shall provide, and shall use Commercially Reasonable Efforts to Hospira prior cause its CMOs to provide (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such CMOs to do so under agreements entered into following the Signature Effective Date), such other assistance as MERSANA (or its Affiliates or designated CMOs, as applicable) may reasonably request to enable MERSANA (or its Affiliates or designated CMOs, as applicable) to use and practice the Manufacturing Processes and otherwise to Manufacture the Materials and to perform bioconjugation and Manufacture the remodeled antibodies using the Licensed Technology. (b) include the information, which information will be formatted, in each case as summarized in that certain memorandum exchanged between the Parties on the Signature Date and referencing this Agreement (the “Technical Transfer Plan”) of the activities to be conducted by each Party to facilitate Hospira’s or the Designated Product Manufacturer’s establishment of manufacturing capabilities for the Drug Substance and Product, including transfer of the Manufacturing Strain; provided, that Hospira or the Designated Product Manufacturer shall agree in writing to (i) maintain physical control over the Manufacturing Strain at all times and (ii) not to alter or modify the Manufacturing Strain in any manner. Such Technical Transfer Plan shall provide, among other things, that (A) Pfenex shall, as soon as practicable, deliver to Hospira or the Designated Product Manufacturer the Pfenex Know-How (which for clarity shall not include any equipment but shall include the manufacturing processes for the Drug Substance and Product (including analytical methods with respect thereto), Manufacturing Strain and methods and protocols for assessing the quality of and releasing Product) in the possession of Pfenex and/or its current manufacturer of Drug Substance and Product and reasonably necessary for Hospira or the Designated Product Manufacturer to (I) obtain all required Regulatory Approvals with respect to the manufacture of Product and (II) manufacture the Drug Substance and Product, and (B) each Party shall make available its personnel reasonably necessary for the performance by it of its respective obligations set forth in the Technical Transfer Plan. The Technical Transfer Plan shall also include a target completion date prior to the initiation of the Comparative Clinical Study upon which target completion date Pfenex’s activities and obligations under the Technical Transfer Plan shall end. In connection therewith, Pfenex and Hospira shall form a joint technology transfer committee, consisting of an equal number of representatives of each of Pfenex and Hospira (up to a maximum number of three (3) representatives each), which shall be responsible for overseeing the implementation of the Technical Transfer Plan. Each Party shall be responsible for all of its own costs and expenses incurred in connection with the performance of its obligations under the Technical Transfer Plan and Hospira shall be responsible for any payments owed to any Designated Product Manufacturer in connection with the Technical Transfer Plan. After completion of activities assigned to Pfenex under the Technical Transfer Plan, Pfenex agrees to reasonably [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. support Hospira’s or the Designated Product Manufacturer’s manufacture of Drug Substance and Product hereunder, at Hospira’s reasonable request and Hospira MERSANA shall pay Pfenex at its Commercial Hourly Rate for to CMOs all verifiable costs incurred directly as a result of performing the time spent by its personnel providing such support; providedTech Transfer and pay to SNFX all verifiable, that Pfenex shall provide [***] of such support without charge. Notwithstanding the foregoing, if Hospira requests Pfenex’s cooperation with respect to the transfer of manufacturing capabilities to a second Person or facility (e.g., to a Designated Product Manufacturer if the Technical Transfer Plan established manufacturing capabilities at Hospira or to a second Designated Product Manufacturer) Hospira shall pay Pfenex at its Commercial Hourly Rate for the time spent by its personnel and reimburse Pfenex for its out-of-pocket costs and expenses incurredlabor [**] incurred directly as a result of performing the Tech Transfer. MERSANA shall make such payment within [**] days following SNFX or a CMO providing MERSANA with an invoice and reasonable supporting documentation (including receipts) therefor. (c) Without limiting the foregoing, in each casethe event that SNFX makes any modification, in connection with Pfenex cooperating improvement, alteration or enhancement relating to the Manufacture of the Materials or the bioconjugation or Manufacture of the remodeled antibodies using the Licensed Technology after completion of the activities set forth under this Section 2.7, SNFX shall promptly disclose such Improvement to MERSANA, and shall, at HospiraXXXXXXX’s request. For clarity, perform technology transfer with respect to such Improvement in the same manner as provided in this Section 2.7. (xd) the Technical Access to Tech Transfer Plan shall not include the scale-up of the manufacturing process to commercial scale, validation of the manufacturing process or validation of the quality control, quality assessment or release methods or protocols for such purposes, all of which Hospira assistance and consultation shall be responsible for; requested and (y) Pfenex shall not have any obligation coordinated through a single contact person to manufacture or supply to Hospira any Drug Substance or Productbe designated by SNFX.

Tech Transfer. Promptly (a) MERSANA shall have the right, at any time after the Effective Date, to require SNFX to effect a transfer to MERSANA, or any Affiliate or CMO designated by MERSANA, of SNFX’s Know-How relating to the then-current process for the Manufacture of the Materials and/or the bioconjugation and Manufacture of remodeled antibodies using the Licensed Technology (collectively, the “Manufacturing Processes”) as is necessary and useful to enable MERSANA to implement the Manufacturing Processes at facilities designated by MERSANA (such transfer, the “Tech Transfer”). SNFX shall provide, and shall use Commercially Reasonable Efforts to cause its CMOs to provide (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such CMOs to do so under agreements entered into following the Effective Date), Pfenex the reasonable assistance requested by MERSANA to enable MERSANA (or its Affiliates or designated CMOs, as applicable) to implement the Manufacturing Processes at the facilities designated by MERSANA. If requested by MERSANA, such assistance shall include facilitating the entering into of agreements with applicable CMOs relating to the Manufacture of the Materials and Hospira shall develop the bioconjugation and reasonably agree through Manufacture of the Executive Steering Committee on a planremodeled antibodies using the Licensed Technology. Without limitation to the foregoing, which plan shall (a) be consistent in form and scope of those technology transfer plans used by Pfenex in connection with each Tech Transfer: (1) SNFX shall make available, and shall use Commercially Reasonable Efforts to cause its transfer CMOs to make available (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such CMOs to do so under agreements entered into following the Effective Date), to MERSANA (or its Affiliates or designated CMOs, as applicable) from time to time as MERSANA may reasonably request, all Manufacturing-related Know-How relating to the Manufacturing Processes, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to materials to be used and control methods, that are reasonably necessary or useful to enable MERSANA (or its Affiliates or designated CMOs, as applicable) to use and practice the Manufacturing Processes; (2) SNFX shall cause all appropriate employees and representatives of SNFX and its Affiliates to meet with, and shall use Commercially Reasonable Efforts to cause all appropriate employees and representatives of its CMOs to meet with (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such CMOs to do so under agreements entered into following the Effective Date), employees or representatives of MERSANA (or its Affiliates or designated CMOs, as applicable) at the applicable Manufacturing facility at mutually convenient times to assist with the working up and use of the process related to both Drug Substance Manufacturing Processes and Product to Third Parties prior with the training of MERSANA’s personnel (or its Affiliates’ or designated CMOs’ personnel, as applicable) to the Signature Date extent reasonably necessary or useful to enable MERSANA (access or its Affiliates or designated CMOs, as applicable) to which was provided use and practice the Manufacturing Processes; and (3) SNFX shall provide, and shall use Commercially Reasonable Efforts to Hospira prior cause its CMOs to provide (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such CMOs to do so under agreements entered into following the Signature Effective Date), such other assistance as MERSANA (or its Affiliates or designated CMOs, as applicable) may reasonably request to enable MERSANA (or its Affiliates or designated CMOs, as applicable) to use and practice the Manufacturing Processes and otherwise to Manufacture the Materials and to perform bioconjugation and Manufacture the remodeled antibodies using the Licensed Technology. (b) include the information, which information will be formatted, in each case as summarized in that certain memorandum exchanged between the Parties on the Signature Date and referencing this Agreement (the “Technical Transfer Plan”) of the activities to be conducted by each Party to facilitate Hospira’s or the Designated Product Manufacturer’s establishment of manufacturing capabilities for the Drug Substance and Product, including transfer of the Manufacturing Strain; provided, that Hospira or the Designated Product Manufacturer shall agree in writing to (i) maintain physical control over the Manufacturing Strain at all times and (ii) not to alter or modify the Manufacturing Strain in any manner. Such Technical Transfer Plan shall provide, among other things, that (A) Pfenex shall, as soon as practicable, deliver to Hospira or the Designated Product Manufacturer the Pfenex Know-How (which for clarity shall not include any equipment but shall include the manufacturing processes for the Drug Substance and Product (including analytical methods with respect thereto), Manufacturing Strain and methods and protocols for assessing the quality of and releasing Product) in the possession of Pfenex and/or its current manufacturer of Drug Substance and Product and reasonably necessary for Hospira or the Designated Product Manufacturer to (I) obtain all required Regulatory Approvals with respect to the manufacture of Product and (II) manufacture the Drug Substance and Product, and (B) each Party shall make available its personnel reasonably necessary for the performance by it of its respective obligations set forth in the Technical Transfer Plan. The Technical Transfer Plan shall also include a target completion date prior to the initiation of the Comparative Clinical Study upon which target completion date Pfenex’s activities and obligations under the Technical Transfer Plan shall end. In connection therewith, Pfenex and Hospira shall form a joint technology transfer committee, consisting of an equal number of representatives of each of Pfenex and Hospira (up to a maximum number of three (3) representatives each), which shall be responsible for overseeing the implementation of the Technical Transfer Plan. Each Party shall be responsible for all of its own costs and expenses incurred in connection with the performance of its obligations under the Technical Transfer Plan and Hospira shall be responsible for any payments owed to any Designated Product Manufacturer in connection with the Technical Transfer Plan. After completion of activities assigned to Pfenex under the Technical Transfer Plan, Pfenex agrees to reasonably [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. support Hospira’s or the Designated Product Manufacturer’s manufacture of Drug Substance and Product hereunder, at Hospira’s reasonable request and Hospira MERSANA shall pay Pfenex at its Commercial Hourly Rate for to CMOs all verifiable costs incurred directly as a result of performing the time spent by its personnel providing such support; providedTech Transfer and pay to SNFX all verifiable, that Pfenex shall provide [***] of such support without charge. Notwithstanding the foregoing, if Hospira requests Pfenex’s cooperation with respect to the transfer of manufacturing capabilities to a second Person or facility (e.g., to a Designated Product Manufacturer if the Technical Transfer Plan established manufacturing capabilities at Hospira or to a second Designated Product Manufacturer) Hospira shall pay Pfenex at its Commercial Hourly Rate for the time spent by its personnel and reimburse Pfenex for its out-of-pocket costs and expenses incurredlabor [***] incurred directly as a result of performing the Tech Transfer. MERSANA shall make such payment within [***] days following SNFX or a CMO providing MERSANA with an invoice and reasonable supporting documentation (including receipts) therefor. (c) Without limiting the foregoing, in each casethe event that SNFX makes any modification, in connection with Pfenex cooperating improvement, alteration or enhancement relating to the Manufacture of the Materials or the bioconjugation or Manufacture of the remodeled antibodies using the Licensed Technology after completion of the activities set forth under this Section 2.6, SNFX shall promptly disclose such Improvement to MERSANA, and shall, at HospiraMERSANA’s request. For clarity, perform technology transfer with respect to such Improvement in the same manner as provided in this Section 2.6. (xd) the Technical Access to Tech Transfer Plan shall not include the scale-up of the manufacturing process to commercial scale, validation of the manufacturing process or validation of the quality control, quality assessment or release methods or protocols for such purposes, all of which Hospira assistance and consultation shall be responsible for; requested and (y) Pfenex shall not have any obligation coordinated through a single contact person to manufacture or supply to Hospira any Drug Substance or Productbe designated by SNFX.

Tech Transfer. Promptly following 9.1 When any of the Effective Date, Pfenex and Hospira shall develop and reasonably agree through the Executive Steering Committee on a plan, which plan shall events described in clauses (a) be consistent to (g) in form Section 2.3 occurs, if requested by Healios, ATHX shall promptly begin to provide and scope transfer to Healios, its Affiliate or Healios’ designated third party manufacturer, any and all data, information, know-how or technology required for manufacturing the MultiStem Product portion of those technology transfer plans used the Licensed Products for the Licensed Field and support Healios so that Healios may make or have made such MultiStem Product portion of the Licensed Products for the Licensed Field (collectively “Manufacturing Information”). Manufacturing Information shall include, without limitation, any confidential manufacturing dossier such as all specifications, SOPs and testing reports. Manufacturing Information shall cover any and all information that ATHX provides to at least one of the Third Party Manufacturer(s) of the subject MultiStem Product portion of the Licensed Products during all or part of the term of this Agreement. If requested by Pfenex in connection with its Healios, ATHX will use commercially reasonable efforts to facilitate an arrangement between Healios and a Third Party Manufacturer that ATHX retains for the manufacturing of the MultiStem Product portion of the Licensed Products provided to Healios, so that [*]. Such transfer of the process related to both Drug Substance and Product to Third Parties prior to the Signature Date (access to which was provided to Hospira prior to the Signature Date) and (b) include the information, which information will be formatted, in each case as summarized in that certain memorandum exchanged between the Parties on the Signature Date and referencing this Agreement Manufacturing Information (the “Technical Transfer PlanTech Transfer”) of the activities to shall be conducted by each Party to facilitate Hospira’s deemed completed if Healios, its Affiliate or the Designated Product Manufacturer’s establishment of manufacturing capabilities *Confidential treatment has been requested for the Drug Substance and Product, including transfer redacted portions of the Manufacturing Strain; provided, that Hospira or the Designated Product Manufacturer shall agree in writing to (i) maintain physical control over the Manufacturing Strain at all times and (ii) not to alter or modify the Manufacturing Strain in any manner. Such Technical Transfer Plan shall provide, among other things, that (A) Pfenex shall, as soon as practicable, deliver to Hospira or the Designated Product Manufacturer the Pfenex Know-How (which for clarity shall not include any equipment but shall include the manufacturing processes for the Drug Substance and Product (including analytical methods with respect thereto), Manufacturing Strain and methods and protocols for assessing the quality of and releasing Product) in the possession of Pfenex and/or its current manufacturer of Drug Substance and Product and reasonably necessary for Hospira or the Designated Product Manufacturer to (I) obtain all required Regulatory Approvals with respect to the manufacture of Product and (II) manufacture the Drug Substance and Productthis exhibit, and (B) each Party shall make available its personnel reasonably necessary for the performance by it of its respective obligations set forth in the Technical Transfer Plan. The Technical Transfer Plan shall also include a target completion date prior to the initiation of the Comparative Clinical Study upon which target completion date Pfenex’s activities and obligations under the Technical Transfer Plan shall end. In connection therewith, Pfenex and Hospira shall form a joint technology transfer committee, consisting of an equal number of representatives of each of Pfenex and Hospira (up to a maximum number of three (3) representatives each), which shall be responsible for overseeing the implementation of the Technical Transfer Plan. Each Party shall be responsible for all of its own costs and expenses incurred in connection with the performance of its obligations under the Technical Transfer Plan and Hospira shall be responsible for any payments owed to any Designated Product Manufacturer in connection with the Technical Transfer Plan. After completion of activities assigned to Pfenex under the Technical Transfer Plan, Pfenex agrees to reasonably [***] Certain information in this document has such confidential portions have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect Healios’ designated third party manufacturer becomes ready to manufacture or have manufactured the omitted portions. support Hospira’s or subject MultiStem Product portion of the Designated Product Manufacturer’s manufacture of Drug Substance and Product hereunder, at Hospira’s reasonable request and Hospira shall pay Pfenex at its Commercial Hourly Rate Licensed Products for the time spent by requirement. 9.2 Notwithstanding Section 9.1 above, if any of the events described in clauses (a) or (b) in Section 2.3 occurs, Healios may provide ATHX with notice thereof and its personnel providing such support; provided, that Pfenex shall provide [***] intent to exercise its rights under Section 9.1. If ATHX demonstrates within 30 days after receipt of such support without charge. Notwithstanding notice that ATHX is able to supply Healios with the foregoing, if Hospira requests Pfenex’s cooperation with respect to subject MultiStem Product portion of the transfer of manufacturing capabilities to a second Person or facility (e.g., to a Designated Product Manufacturer if the Technical Transfer Plan established manufacturing capabilities at Hospira or to a second Designated Product Manufacturer) Hospira shall pay Pfenex at its Commercial Hourly Rate Licensed Products for the time spent Licensed Field with satisfactory quality and in a stable and continual manner, then Healios may not exercise such rights. If ATHX fails to so demonstrate, Healios may exercise such rights. In response to exercise of such rights by Healios upon or after ATHX’s failure to so demonstrate under this Section 9.2, ATHX shall assume the obligations as set forth in Section 9.1. 9.3 The Parties shall make their reasonable efforts, and shall reasonably cooperate with each other, so that the Tech Transfer may be completed as soon as reasonably possible after any of (a) to (g) in Section 2.3 occurs. 9.4 ATHX shall be responsible for the costs of ATHX and its personnel and reimburse Pfenex for its out-of-pocket costs and expenses incurred, in each case, Affiliates in connection with Pfenex cooperating at Hospira’s requestthe Tech Transfer described in Section 9.1. For clarity, (x) the Technical Transfer Plan shall not include the scale-up of the manufacturing process to commercial scale, validation of the manufacturing process or validation of the quality control, quality assessment or release methods or protocols for such purposes, all of which Hospira Healios shall be responsible for; for the costs of Healios and (y) Pfenex shall not have its Affiliates in connection with the Tech Transfer described in Section 9.1 and any obligation associated costs of Healios’ designated third party manufacturer, if applicable, [*]. 9.5 If, at any time after Healios has exercised its right to manufacture the subject Product pursuant to Section 9.1 and before or after the Tech Transfer is completed, ATHX reasonably demonstrates that it is able to supply Healios with the subject Product for the Licensed Field in the Territory [*], then Healios will purchase a reasonable proportion of its requirements of the subject Product from ATHX on a non-exclusive basis, taking into account the nature and extent of Healios’ fixed manufacturing investment and third party purchase commitments and price competitiveness of ATHX, for so long as ATHX continues to Hospira any Drug Substance or Productdemonstrate its ability to supply [*].