Provision Language
Definitions
“Licensed Improvement” means any Know-How or Materials that are, or any Patent filed claiming, any improvement, modification, refinement, correction, evolution or enhancement of any (i) Licensed Technology or (ii) any Translate Bio Collaboration Technology, made by Translate Bio and/or its Affiliates and/or its Service Providers which is created or conceived outside of the Collaboration after the Execution Date and is necessary or reasonably useful in the development, manufacture, sale or use of any Product in a Licensed Field, provided, however that “Licensed Improvements” shall not include any Patent, Know-How or Materials which (a) includes or comprises any Third Party technology or (b) are not included in the license under Section 9.1.3 in accordance with Section 6.4.2 or (c) any improvement, modification, refinement, correction, evolution or enhancement of any (i) Licensed Technology or (ii) any Translate Bio Collaboration Technology, in each case made by Translate Bio and/or its Affiliates and/or its Service Providers which is created or conceived more than [**] after the Closing Date.
4.7. Technology and Process Transfer
4.7.1 Technology and Process Transfer Plan. [as updated by Second Amendment] As of the Second Amendment Execution Date, Translate Bio and Sanofi have established a plan for the transfer of Licensed Technology required for the development and manufacturing of Products in the Influenza virus, [**] Licensed Fields. Translate Bio shall use Commercially Reasonable Efforts to deliver to Sanofi the tangible items of the Licensed Technology listed within Technology and Process Transfer Plan within the timeframes prescribed therein. The Technology and Process Transfer Plan, as amended by the mutual agreement by the Parties from time to time, is attached hereto as Schedule 4.7.1 (the “Technology and Process Transfer Plan”).
4.7.2 Timing. The Parties will commence performance of activities described in the Technology and Process Transfer Plan within [**] of the Closing Date and these activities shall be completed within [**] of the Closing Date, provided, however, that by the date of commencement of Technology and Process Transfer, Translate Bio has established a process at (a) [**] for use in Products in the initial Licensed Fields, and (b) a process at [**] in the initial Licensed Fields. If, by the commencement date of the performance of activities described in the Technology and Process Transfer Plan, Translate Bio has not established a process at (a) [**] for use in Products in the initial Licensed Fields, and (b) a process at [**] in the initial Licensed Fields, or that Translate Bio is otherwise not able to complete Technology and Process Transfer within [**] of the Closing Date, then the Parties shall extended the period of time for the completion of Technology and Process Transfer on a day for day basis; provided however that the extension of the period to complete Technology and Process Transfer shall only apply with regard to those items that remain uncompleted as of such commencement date (for example, on a Licensed Field by Licensed Field basis).
4.7.3 Technology and Process Transfer Lead. The Parties shall each appoint a technology and process transfer lead to oversee and manage the technical transfer process in accordance with Technology and Process Transfer Plan.
4.7.4 Success Criteria/Technology and Process Transfer Memorandum. Within [**] following successful completion of the Technology and Process Transfer Plan in accordance with the Success Criteria listed in the Technology and Process Transfer Plan, the Parties shall execute a Technology and Process Transfer memorandum, a form of which Technology and Process Transfer memorandum is attached hereto as Schedule 4.7.4 (the “Technology and Process Transfer Memorandum”).
4.7.5 Qualified Personnel. Each Party will make their respective suitably qualified and experienced employees available (whether, as reasonably necessary, by telephone, e–mail, in person or such other method as the Parties may find mutually convenient) to execute the Technology and Process Transfer in accordance with Technology and Process Transfer Plan. Translate Bio’s personnel that are transferring Licensed Technology under the Technology and Process Transfer Plan shall have actual knowledge of the Licensed Technology and Licensed Improvements, if any, they are transferring. The Technology and Process Transfer may include on–site training at Translate Bio’s facilities and also at Sanofi’s facilities as per the Technology and Process Transfer Plan.
4.7.6 Third Parties. In the event that Sanofi or Translate Bio need to retain any Third Party to assist with any aspect of executing the Technology and Process Transfer Plan, Sanofi or Translate Bio (as the case may be) shall execute an agreement with each such Third Party to protect the other Party’s Confidential Information on terms consistent with this Agreement.
4.7.7 Costs. [**] shall bear [**] costs and expenses associated with the execution of the Technology and Process Transfer Plan. A budget for the cost of executing the Technology and Process Transfer Plan shall be established by the Parties, and mutually agreed by the Parties as part of such plan.
4.7.8 Deemed Completion. In the event that the Parties do not perform or complete the Technology and Process Transfer Plan, and therefore do not execute the Technology and Process Transfer Memorandum, the Technology and Process Transfer shall be deemed to be completed, and Translate Bio shall be paid the Technology Transfer Milestone, if [**] (“Deemed Completion”).
4.8 Manufacturing After Technology and Process Transfer
4.8.1 Unless otherwise agreed by the Parties in writing (for example in a Supply Agreement), following completion of the Technology and Process Transfer Plan in accordance with Section 4.7, Sanofi shall be solely responsible for manufacturing Products in the Licensed Fields.
4.8.2 Technical assistance. Upon (i) execution of the Technology and Process Transfer Memorandum referred to in Section 4.7.4 above or (ii) Deemed Completion referred to in Section 4.7.8 above, and for a period of [**] thereafter, Translate Bio shall use Commercially Reasonable Efforts to provide reasonable assistance to Sanofi in connection with manufacturing of Products, at Sanofi’s expense, and upon Sanofi’s reasonable request.
4.9 Escrow
4.9.1 Escrow Process. At any time during the Escrow Period, Sanofi may request that Translate Bio place the Escrow Materials in escrow, subject to the remainder of this Section 4.9. In such event, Sanofi and Translate Bio shall each use Commercially Reasonable Efforts to promptly agree on an Escrow Agent and negotiate an Escrow Agreement. Upon the execution of the Escrow Agreement, Translate Bio shall deposit the Escrow Materials with the Escrow Agent, in accordance with a schedule to be agreed to in the Escrow Agreement. Upon Sanofi’s request no more frequently [**], Translate Bio shall update the deposit of the Escrow Materials with the Escrow Agent. Upon Sanofi’s request, the Escrow Agreement shall permit the Escrow Agent to test and validate the Escrow Materials, with the assistance of Translate Bio. In the event that such a test and validation discovers a material failure of the Escrow Materials to enable Technology and Process Transfer, Translate Bio shall use Commercially Reasonable Efforts to correct such failure. No portion of the Escrow Materials may be released to Sanofi except upon an Escrow Release Event. Any obligations of Translate Bio or the Escrow Agent shall be at Sanofi’s expense, at the FTE Rate in respect of Translate Bio’s obligations. Upon the expiration of the Escrow Period, if no Escrow Release Event has occurred, the Escrow Agent shall be obligated to return the Escrow Materials to Translate Bio.
4.9.2 “Escrow Agent” means a Third Party that is mutually acceptable to the Parties, with experience in escrowing and manufacturing biological materials.
4.9.3 “Escrow Agreement” means an agreement among the Escrow Agent, Sanofi and Translate Bio, which is consistent with this Section 4.9, which provides that all or any portion of the Escrow Materials can only be released to Sanofi in the event of an Escrow Release Event and requires the Escrow Agent to agree to confidentiality obligations in respect of Escrow Materials that are at least as stringent as those set forth herein, including non–disclosure of any Escrow Materials to Sanofi and/or any Sanofi Affiliates.
4.9.4 “Escrow Materials” includes that information and materials required to facilitate a transfer of Licensed Technology required for the development and manufacturing of Products in the three initial Licensed Fields (which may include the Licensed Field for the Pathogen swapped by Sanofi for [**]), and which may include items such as process diagrams, batch records, material specifications, protocols, analytical methods, and validation reports in respect of the manufacturing process of Translate Bio as of the Closing Date, and material updates thereto made by Translate Bio during the Escrow Period.
4.9.5 “Escrow Period” means the period commencing [**] after the Closing Date and continuing until the earliest of (i) execution of the Technology and Process Transfer Memorandum, (ii) Deemed Completion or (iii) termination of this Agreement.
4.9.6 “Escrow Release Event” means that a Change of Control of Translate Bio has occurred, a material disruption in Technology and Process Transfer following such Change of Control has occurred, Sanofi has notified Translate Bio of such material disruption and Translate Bio has not cured such material disruption in the [**] following receipt of such notice.
Section 4.10. Technology Transfer: SARS–CoV–2 [added by Second Amendment]
4.10.1 SARS–CoV–2 Technology and Process Transfer Plan. Translate Bio and Sanofi will establish a plan for the transfer of Licensed Technology required for the development and manufacturing of Products in the SARS–CoV–2 Licensed Field at [**] scale for each of the mRNA, LNP and formulated drug substance, consistent with Schedule 4.10.1 (the “SARS–CoV–2 Technology and Process Transfer Plan”). Translate Bio shall use Commercially Reasonable Efforts to deliver to Sanofi the tangible items of the Licensed Technology listed within the SARS–CoV–2 Technology and Process Transfer Plan within the timeframes prescribed therein. When such SARS–CoV–2 Technology and Process Transfer Plan is agreed by both Parties, it shall be incorporated herein by reference.”
4.10.2 Timing. The Parties will commence performance of activities described in the SARS–CoV–2 Technology and Process Transfer Plan upon the payment of the first milestone in accordance with Section 7.4.1(b); provided however that if such milestone is not then due and has not been paid, Sanofi may elect, in its discretion, to pay the SARS–CoV–2 Technology and Process Transfer Commencement Fee (defined below in Section 7.3.2) by delivering to Translate Bio notice of such election; further provided however that if the first milestone in accordance with Section 7.4.1(b) is achieved after Sanofi has paid the SARS–CoV–2 Technology and Process Transfer Commencement Fee, then the amount of such SARS–CoV–2 Technology and Process Transfer Commencement Fee shall be fully credited against such milestone payment.
4.10.3 Technology and Process Transfer Lead. The Parties shall each appoint a technology and process transfer lead to oversee and manage the technical transfer process in accordance with SARS–CoV–2 Technology and Process Transfer Plan.
4.10.4 Success Criteria/ SARS–CoV–2 Technology and Process Transfer Memorandum. Within [**] following successful completion of the SARS–CoV–2 Technology and Process Transfer Plan in accordance with the Success Criteria listed in the SARS–CoV–2 Technology and Process Transfer Plan, the Parties shall execute a SARS–CoV–2 Technology and Process Transfer Memorandum, a form of which SARS–CoV–2 Technology and Process Transfer memorandum is attached hereto as Schedule 4.10.4 (the “SARS–CoV–2 Technology and Process Transfer Memorandum”).
4.10.5 Qualified Personnel. Each Party will make their respective suitably qualified and experienced employees available (whether, as reasonably necessary, by telephone, e–mail, in person or such other method as the Parties may find mutually convenient) to execute the SARS–CoV–2 Technology and Process Transfer in accordance with SARS–CoV–2 Technology and Process Transfer Plan. Translate Bio’s personnel or its CMOs that are transferring SARS–CoV–2 Licensed Technology under the SARS–CoV–2 Technology and Process Transfer Plan shall have actual knowledge of the Licensed Technology and Licensed Improvements, if any, they are transferring. The SARS–CoV–2 Technology and Process Transfer may include on–site training at Translate Bio’s or its CMO’s facilities and also at Sanofi’s facilities as per the SARS–CoV–2 Technology and Process Transfer Plan. Translate Bio shall use commercially reasonable efforts to ensure that it has contracts in place with its CMOs necessary to complete any action in respect of the SARS–CoV–2 Technology and Process Transfer Plan that requires the cooperation or participation of such CMO so as to not delay the execution of such SARS–CoV–2 Technology and Process Transfer Plan.
4.10.6 Third Parties. In the event that Sanofi or Translate Bio need to retain any Third Party to assist with any aspect of executing the SARS–CoV–2 Technology and Process Transfer Plan, Sanofi or Translate Bio (as the case may be) shall execute an agreement with each such Third Party to protect the other Party’s Confidential Information the terms of which will be consistent with this Agreement.
4.10.7 Costs. Sanofi shall bear all costs and expenses associated with the execution of the SARS–CoV–2 Technology and Process Transfer Plan. A budget for the cost of executing the SARS–CoV–2 Technology and Process Transfer Plan shall be established by the Parties, and mutually agreed by the Parties as part of such plan. In the event that Sanofi and Translate Bio perform technology transfer by Sanofi observing Translate Bio’s CMO manufacturing of Product, and such Product will be supplied to Sanofi under this Agreement or a Supply Agreement, then Sanofi shall only pay the additional costs incurred by Translate Bio and such CMO for such technology transfer which are not otherwise already paid to Translate Bio pursuant to this Agreement or any Supply Agreement.
4.10.8 Technical Assistance. Upon execution of the SARS–CoV–2 Technology and Process Transfer Memorandum referred to in Section 4.10.4, and for a period of [**] thereafter, Translate Bio shall use Commercially Reasonable Efforts to provide reasonable assistance to Sanofi in connection with manufacturing of Products in the SARS–CoV–2 Licensed Field, at Sanofi’s expense, and upon Sanofi’s reasonable request.