Research Activities. 5.1 Following the designation of a Collaboration Target as an Approved Collaboration Target, the Parties shall commence the Small Molecule Research Project for that Approved Collaboration Target in accordance with this Agreement (including the Research Plan for that Approved Collaboration Target), provided that: (a) there will be no more than [***] active Small Molecule Research Projects (for clarity, excluding any Research Program for a Collaboration NSM Target) at any given time during the Research Term; and (b) the maximum number of active Small Molecule Research Projects in sub-clause (a) will [***] each time [***] Collaboration Development Candidates are selected for an Approved Collaboration Target in accordance with Clause 6.1. For the avoidance of doubt, if one or more Collaboration Development Candidates are selected for [***] Approved Collaboration Targets, neither Party shall be required to carry out any further Small Molecule Research Projects. 5.2 Each Party shall use Commercially Reasonable Efforts to undertake those activities allocated to it in each Research Plan and NSM Research Plan in accordance with such Research Plan or NSM Research Plan and this Agreement. Each Party shall comply with Applicable Laws in performing those activities allocated to it in the Research Plan. 5.3 Each Party shall ensure that all of its personnel engaged in the performance of any of that Party’s responsibilities under each Research Plan or NSM Research Plan (a) are competent and efficient; and (b) have appropriate and relevant qualifications, training and experience for, and are knowledgeable about, that Party’s responsibilities under that Research Plan or NSM Research Plan. 5.4 Any Research Plan or NSM Research Plan may be amended from time to time by the Joint Steering Committee in accordance with Clause 11. 5.5 Each Party (the “Subcontracting Party”) may engage an Affiliate or Third Party subcontractor to perform any of its responsibilities under a Research Plan; provided that: (a) prior to [***] subcontracting such performance to Third Party subcontractors, [***] shall obtain the prior written consent of [***] it being agreed that the subcontractors listed on Schedule 2 are pre-agreed as of the Effective Date); (b) that Affiliate or subcontractor meets the qualifications and standards generally required by the Subcontracting Party for the performance of work similar in scope and complexity to the subcontracted activity; (c) the Subcontracting Party ensures that it retains or obtains Control of any Patent Rights, Know-How or other intellectual property rights created by such Affiliate or subcontractor under or in connection with this Agreement; and (d) the Subcontracting Party shall be responsible for all acts and omissions of any such Affiliate or subcontractor as fully as if they were the acts and omissions of the Subcontracting Party. 5.6 With respect to each Research Plan and NSM Research Plan: (a) EXS will be responsible for [***] and, within [***] Business Days after the end of each Calendar Quarter, Sanofi will provide to EXS an invoice for any such expenses incurred or paid by Sanofi or its Affiliates during the previous Calendar Quarter. EXS shall pay such invoice within [***] days following receipt thereof; and (b) except as provided in Clause 5.6(a) above, [***] will be responsible for all costs and expenses incurred by or on behalf of [***] in relation to the Research Plan or NSM Research Plan. 5.7 With respect to each Approved Collaboration Target that is the subject of a Research Plan, EXS shall (a) promptly provide a written report to Sanofi when EXS believes that any Small Molecule for an Approved Collaboration Target has achieved [***] and (b) provide to Sanofi all data and information in support thereof that is reasonably necessary for Sanofi to determine that such Small Molecule for such Approved Collaboration Target has achieved [***] (“Lead Identification Data Package”). Sanofi shall promptly (and in any event within [***] days after the date of the complete Lead Identification Data Package) evaluate the Lead Identification Data Package to determine whether or not the applicable Small Molecule has achieved [***] and provide prompt written notice of such determination to EXS and, if [***] has been achieved, whether Sanofi wishes to either (i) continue with the Research Program with respect to that Approved Collaboration Target, in which case, to the extent a Research Milestone is payable in accordance with Clause 14.1, Sanofi shall pay the applicable Research Milestone Payment in accordance with this Agreement; or (ii) terminate the Research Program in accordance with the terms of this Agreement. 5.8 With respect to each Approved Collaboration Target that is the subject of a Research Plan, EXS shall (a) promptly provide (and in any event within [***] days following the conclusion of the Research Plan) a written report to Sanofi when EXS believes that a Small Molecule for such Approved Collaboration Target has achieved [***] and (b) provide to Sanofi (i) the corresponding Development Candidate Data Package and (ii) such additional information that Sanofi may reasonably request and reasonable quantities of any assays, reagents, research tools and such Small Molecules for such Approved Collaboration Target that are reasonably necessary for Sanofi to determine whether such Small Molecule for such Approved Collaboration Target have achieved [***]. Except as otherwise set forth in a corresponding Research Plan, EXS shall deliver a Development Candidate Data Package for the Lead Molecule for an Approved Collaboration Target first and shall deliver a Development Candidate Data Package with respect to [***] Back-Up Molecules [***] for such Approved Collaboration Target by no later than [***] months following the delivery of the Development Candidate Data Package for the Lead Molecule. Sanofi shall promptly (and, in any event, within [***] days after the date of EXS’s delivery of each complete Development Candidate Data Package) evaluate such Development Candidate Data Package to determine whether or not the applicable Small Molecule has achieved [***] and provide prompt written notice of such determination to EXS. 5.9 Notwithstanding anything to the contrary in Clause 5.8 (but without limiting EXS’s obligations to deliver Development Candidate Data Packages with respect to any Back-Up Molecules as required in Clause 5.8), if Sanofi provides notice to EXS that, with respect to a given Small Molecule for an Approved Collaboration Target, Sanofi desires to obtain delivery of the corresponding Development Candidate Data Package prior to its anticipated date of delivery because Sanofi believes that [***] with respect to that Small Molecule are likely to be met and desires to progress such Small Molecule into Development at an earlier date, then the Parties shall, acting reasonably and in good faith, discuss appropriate amendments to [***]; provided that the Parties intend to not discuss or make any such amendments during the [***] month period immediately preceding the anticipated date for delivery of such Development Candidate Data Package. If the Parties so agree to amend [***] and the applicable Small Molecule achieves the amended [***], then (a) EXS shall promptly deliver the corresponding Development Candidate Data Package to Sanofi within [***] days following the date that [***] amended and (b) such Small Molecule will be deemed to have been designated as a Collaboration Development Candidate that meets [***] for purposes of Clauses 6.1 and [***] as of the date of EXS’s delivery of the corresponding Development Candidate Data Package. [***] shall not withhold its agreement to any proposed amendment to [***] for the sole purpose of delaying the timing [***]. 5.10 By no later than [***] Business Days following Sanofi’s receipt of a Lead Identification Data Package or Development Candidate Data Package for an Approved Collaboration Target, Sanofi may (a) notify EXS in writing that such Lead Identification Data Package or Development Candidate Data Package is incomplete or inconsistent, in which case EXS shall use Commercially Reasonable Efforts to address Sanofi’s concerns and deliver to Sanofi a complete Lead Identification Data Package or Development Candidate Data Package as promptly as practicable or (b) provide EXS with written notice requesting a discussion with EXS representative(s) who have the relevant knowledge and information regarding such Approved Collaboration Target or the Small Molecules relating to such Approved Collaboration Target, in which case EXS shall require such representatives to meet with Sanofi to discuss as soon as reasonably practicable. 5.11 Each Party shall prepare and maintain complete and accurate written records of all activities performed as well as results and data obtained pursuant to each Research Plan or NSM Research Plan, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes. In addition to the reporting obligations set forth in Clause 5.12, upon reasonable request of Sanofi, EXS will grant Sanofi and its Affiliates reasonable access to all results and data (including all primary data and data contained in laboratory notebooks) that is generated in the course of performance of each Research Plan and NSM Research Plan in a format reasonably acceptable to both Parties (including interim results, chemical structures and drug design strategies arising out of the Research Plan or NSM Research Plan). EXS shall consider in good faith any reasonable comments arising out of Sanofi’s review of such results and data and provided by Sanofi in writing to EXS’s Alliance Manager and make reasonable adjustments to the applicable Research Plan or NSM Research Plan in order to account for those reasonable comments. Sanofi and its Affiliates will also have the right, at reasonable intervals and upon reasonable notice to EXS, to have copies of such records made to use and transfer as permitted hereunder. All such records in their disclosed form will be deemed the Confidential Information of each Party (without affecting the ownership of or confidentiality and non-use obligations related to the information therein). 5.12 Each Party will furnish to the Joint Steering Committee, at each Joint Steering Committee meeting, to the extent applicable to such Party, an update on such Party’s progress under the Research Plan for an Approved Collaboration Target or the NSM Research Plan for any Collaboration NSM Target during the relevant Calendar Quarter, including a summary of any material results and data generated by such Party under such Research Plan or NSM Research Plan since the previous Joint Steering Committee meeting. Such Party shall provide the Joint Steering Committee with such other results, data and other information with respect to the activities under the Research Plan or NSM Research Plan as any member of the Joint Steering Committee may reasonably request that are in such Party’s possession or control and are reasonably necessary or useful for the Joint Steering Committee to perform its responsibilities under Clause 11 or for either Party to exercise its rights under this Agreement. Upon reasonable request by a Party, through the Joint Steering Committee, the other Party shall provide the Joint Steering Committee with such other information and such additional access to records with respect to any Approved Collaboration Target or Collaboration NSM Target that is the subject of a Research Plan or NSM Research Plan as the Joint Steering Committee or such other Party may reasonably request for the conduct or evaluation of the Research Program, including data that is specific to the applicable Research Program (e.g., underlying datasets that are specific to the applicable Research Program and which are used by a Party in the course of conducting its activities with respect to the applicable Research Program). Nothing in this Clause 5.12 will require a Party to provide any data to the other Party if doing so would be contrary to Applicable Laws. 5.13 Sanofi will have the right to perform [***] activities under a Research Plan for each Approved Collaboration Target, including [***]. In the event of a dispute regarding the scope of the activities to be performed by Sanofi under that Research Plan, Sanofi will have final decision-making authority regarding that scope, and EXS shall not unreasonably withhold, delay or condition its approval of that scope. If Sanofi performs any such activities, then EXS shall transfer, upon Sanofi’s request and at no cost to Sanofi, adequate amounts of materials, which Sanofi may use in accordance with the terms and conditions of this Agreement (including the applicable Research Plan) and any Material Transfer Agreement entered into between the Parties). Prior to EXS transferring any such materials to Sanofi, the Parties shall enter into a Material Transfer Agreement in the form attached as Schedule 5. 5.14 Sanofi may provide EXS with (a) Sanofi-Originated Molecules Directed To an Approved Collaboration Target or other materials, in each case developed outside of this Agreement and Controlled by Sanofi or its Affiliates (“Sanofi Materials”) or (b) Sanofi-Provided Data, which Sanofi may use in accordance with the terms and conditions of this Agreement (including the applicable Research Plan) and any Material Transfer Agreement entered into between the Parties. Prior to Sanofi transferring any Sanofi Materials to EXS, the Parties shall enter into a Material Transfer Agreement in the form attached as Schedule 5.
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Samples: Collaboration and License Agreement (Exscientia PLC), Collaboration and License Agreement (Exscientia PLC)
Research Activities. 5.1 Following the designation of a Collaboration Target as an Approved Collaboration TargetIf, the Parties shall commence the Small Molecule Research Project for that Approved Collaboration Target in accordance with this Agreement (including at any time during the Research Plan for that Approved Collaboration Target)Term, provided that: (a) there will be no more than a Change of Control occurs, then at any time prior to the [***] active Small Molecule Research Projects (for clarityanniversary of the closing of such Change of Control, excluding any Research Program for a Collaboration NSM Target) at any given time during the Research Term; and (b) the maximum number of active Small Molecule Research Projects in sub-clause (a) will [***] each time [***] Collaboration Development Candidates are selected for an Approved Collaboration Target in accordance with Clause 6.1. For the avoidance of doubtupon written notice to Isis, if one or more Collaboration Development Candidates are selected for [***] Approved Collaboration Targets, neither Party shall be required to carry out any further Small Molecule Research Projects.
5.2 Each Party shall use Commercially Reasonable Efforts to undertake those activities allocated to it in each Research Plan and NSM Research Plan in accordance with such Research Plan or NSM Research Plan and this Agreement. Each Party shall comply with Applicable Laws in performing those activities allocated to it in the Research Plan.
5.3 Each Party shall ensure that all of its personnel engaged in the performance of any of that Party’s responsibilities under each Research Plan or NSM Research Plan (a) are competent and efficient; and (b) have appropriate and relevant qualifications, training and experience for, and are knowledgeable about, that Party’s responsibilities under that Research Plan or NSM Research Plan.
5.4 Any Research Plan or NSM Research Plan Biogen Idec may be amended from time to time by the Joint Steering Committee in accordance with Clause 11.
5.5 Each Party (the “Subcontracting Party”) may engage an Affiliate or Third Party subcontractor to perform any of its responsibilities under a Research Plan; provided thateither:
(a) prior to [***] subcontracting Extend the Research Term until such performance to Third Party subcontractors, [***] shall obtain time as Isis has completed target validating activities that are Isis Activities under the prior written consent Neurological Disease Research Plan for a total of [***] it being agreed that the subcontractors listed on Schedule 2 are pre-agreed as of the Effective Date)High Interest Targets;
(b) Terminate the Research Term, in which case: (i) Isis will complete all ongoing target validation work that Affiliate or subcontractor meets are Isis Activities under the qualifications and standards generally required by the Subcontracting Party for the performance of work similar in scope and complexity to the subcontracted activity;
(c) the Subcontracting Party ensures that it retains or obtains Control of any Patent Rights, Know-How or other intellectual property rights created by such Affiliate or subcontractor under or in connection with this Agreement; and
(d) the Subcontracting Party shall be responsible for all acts and omissions of any such Affiliate or subcontractor as fully as if they were the acts and omissions of the Subcontracting Party.
5.6 With respect to each Neurological Disease Research Plan and NSM advance each such target to Target Sanction (but for clarity, no target validation work will be initiated for any new target under the Neurological Disease Research Plan:
); (aii) EXS Isis will complete all ongoing Isis Activities under the Core Research Plan (but for clarity, no new work will be responsible initiated under the Core Research Plan); (iii) for [***] andeach Collaboration Target that is not an ALS Target that reaches Target Sanction or each ALS Target designated a Collaboration Target, within [***] Business Days after an ASO Development Candidate Identification Plan will be prepared and Isis will carry out its obligations under such plan, all in accordance with Section 1.10.1; (iv) Isis will continue to perform its obligations under each ongoing ASO Development Candidate Identification Plan until the end of the applicable ASO Development Candidate Identification Term and under each Calendar Quarterongoing Initial Development Plan until completion of all Isis Activities thereunder; (v) for each Collaboration Program for which a Development Candidate is identified as provided herein, Sanofi will provide Biogen Idec may, upon written notice to EXS an invoice for any Isis, such expenses incurred or paid by Sanofi or its Affiliates during the previous Calendar Quarter. EXS shall pay such invoice notice to be delivered within [***] days following receipt thereof; and
after designating a Development Candidate for the applicable Collaboration Program, elect to either (bA) except as provided exercise the applicable Option by notifying Isis in Clause 5.6(a) above, [***] will be responsible for all costs and expenses incurred by or on behalf writing of [***] in relation Biogen Idec’s election to license the Research Plan or NSM Research Plan.
5.7 With respect to each Approved Collaboration Target that is the subject of a Research Plan, EXS shall (a) promptly provide a written report to Sanofi when EXS believes that any Small Molecule for an Approved Collaboration Target has achieved Product [***] and (b) provide will be paid to Sanofi all data and information in support thereof that is reasonably necessary for Sanofi to determine that such Small Molecule for such Approved Collaboration Target has achieved Isis within [***] days after Biogen Idec’s election under clause (“Lead Identification Data Package”A) of this Section 12.5.1(b). Sanofi shall promptly , and after such exercise, Biogen Idec will not be obligated [***], or (B) establish an Initial Development Plan for such Collaboration Program pursuant to Section 1.10.2(d), in which case Isis and in any event Biogen Idec will continue to exercise their rights and perform their respective obligations with respect to the applicable Collaboration Program under the terms of this Agreement; (vi) the Research Term will end upon Isis’ completion of all Isis Activities under clauses (i), (ii) and (iii) above; and (vii) within [***] days after the date end of the complete Lead Identification Data PackageResearch Term, Isis will [***]; or
(c) evaluate the Lead Identification Data Package to determine whether or not the applicable Small Molecule has achieved Allow such [***] and provide prompt written period to lapse without providing any such notice of such determination to EXS and, if [***] has been achieved, whether Sanofi wishes to either (i) continue with the Research Program with respect to that Approved Collaboration Targetelection under this Section 12.5.1, in which case, case Isis and Biogen Idec will continue to the extent a Research Milestone is payable in accordance with Clause 14.1, Sanofi shall pay the applicable Research Milestone Payment in accordance with this Agreement; or (ii) terminate the Research Program in accordance with exercise their rights and perform their respective obligations under the terms of this Agreement.
5.8 With respect to each Approved Collaboration Target that is the subject of a Research Plan, EXS shall (a) promptly provide (and in any event within [***] days following the conclusion of the Research Plan) a written report to Sanofi when EXS believes that a Small Molecule for such Approved Collaboration Target has achieved [***] and (b) provide to Sanofi (i) the corresponding Development Candidate Data Package and (ii) such additional information that Sanofi may reasonably request and reasonable quantities of any assays, reagents, research tools and such Small Molecules for such Approved Collaboration Target that are reasonably necessary for Sanofi to determine whether such Small Molecule for such Approved Collaboration Target have achieved [***]. Except as otherwise set forth in a corresponding Research Plan, EXS shall deliver a Development Candidate Data Package for the Lead Molecule for an Approved Collaboration Target first and shall deliver a Development Candidate Data Package with respect to [***] Back-Up Molecules [***] for such Approved Collaboration Target by no later than [***] months following the delivery of the Development Candidate Data Package for the Lead Molecule. Sanofi shall promptly (and, in any event, within [***] days after the date of EXS’s delivery of each complete Development Candidate Data Package) evaluate such Development Candidate Data Package to determine whether or not the applicable Small Molecule has achieved [***] and provide prompt written notice of such determination to EXS.
5.9 Notwithstanding anything to the contrary in Clause 5.8 (but without limiting EXS’s obligations to deliver Development Candidate Data Packages with respect to any Back-Up Molecules as required in Clause 5.8), if Sanofi provides notice to EXS that, with respect to a given Small Molecule for an Approved Collaboration Target, Sanofi desires to obtain delivery of the corresponding Development Candidate Data Package prior to its anticipated date of delivery because Sanofi believes that [***] with respect to that Small Molecule are likely to be met and desires to progress such Small Molecule into Development at an earlier date, then the Parties shall, acting reasonably and in good faith, discuss appropriate amendments to [***]; provided that the Parties intend to not discuss or make any such amendments during the [***] month period immediately preceding the anticipated date for delivery of such Development Candidate Data Package. If the Parties so agree to amend [***] and the applicable Small Molecule achieves the amended [***], then (a) EXS shall promptly deliver the corresponding Development Candidate Data Package to Sanofi within [***] days following the date that [***] amended and (b) such Small Molecule will be deemed to have been designated as a Collaboration Development Candidate that meets [***] for purposes of Clauses 6.1 and [***] as of the date of EXS’s delivery of the corresponding Development Candidate Data Package. [***] shall not withhold its agreement to any proposed amendment to [***] for the sole purpose of delaying the timing [***].
5.10 By no later than [***] Business Days following Sanofi’s receipt of a Lead Identification Data Package or Development Candidate Data Package for an Approved Collaboration Target, Sanofi may (a) notify EXS in writing that such Lead Identification Data Package or Development Candidate Data Package is incomplete or inconsistent, in which case EXS shall use Commercially Reasonable Efforts to address Sanofi’s concerns and deliver to Sanofi a complete Lead Identification Data Package or Development Candidate Data Package as promptly as practicable or (b) provide EXS with written notice requesting a discussion with EXS representative(s) who have the relevant knowledge and information regarding such Approved Collaboration Target or the Small Molecules relating to such Approved Collaboration Target, in which case EXS shall require such representatives to meet with Sanofi to discuss as soon as reasonably practicable.
5.11 Each Party shall prepare and maintain complete and accurate written records of all activities performed as well as results and data obtained pursuant to each Research Plan or NSM Research Plan, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes. In addition to the reporting obligations set forth in Clause 5.12, upon reasonable request of Sanofi, EXS will grant Sanofi and its Affiliates reasonable access to all results and data (including all primary data and data contained in laboratory notebooks) that is generated in the course of performance of each Research Plan and NSM Research Plan in a format reasonably acceptable to both Parties (including interim results, chemical structures and drug design strategies arising out of the Research Plan or NSM Research Plan). EXS shall consider in good faith any reasonable comments arising out of Sanofi’s review of such results and data and provided by Sanofi in writing to EXS’s Alliance Manager and make reasonable adjustments to the applicable Research Plan or NSM Research Plan in order to account for those reasonable comments. Sanofi and its Affiliates will also have the right, at reasonable intervals and upon reasonable notice to EXS, to have copies of such records made to use and transfer as permitted hereunder. All such records in their disclosed form will be deemed the Confidential Information of each Party (without affecting the ownership of or confidentiality and non-use obligations related to the information therein).
5.12 Each Party will furnish to the Joint Steering Committee, at each Joint Steering Committee meeting, to the extent applicable to such Party, an update on such Party’s progress under the Research Plan for an Approved Collaboration Target or the NSM Research Plan for any Collaboration NSM Target during the relevant Calendar Quarter, including a summary of any material results and data generated by such Party under such Research Plan or NSM Research Plan since the previous Joint Steering Committee meeting. Such Party shall provide the Joint Steering Committee with such other results, data and other information with respect to the activities under the Research Plan or NSM Research Plan as any member of the Joint Steering Committee may reasonably request that are in such Party’s possession or control and are reasonably necessary or useful for the Joint Steering Committee to perform its responsibilities under Clause 11 or for either Party to exercise its rights under this Agreement. Upon reasonable request by a Party, through the Joint Steering Committee, the other Party shall provide the Joint Steering Committee with such other information and such additional access to records with respect to any Approved Collaboration Target or Collaboration NSM Target that is the subject of a Research Plan or NSM Research Plan as the Joint Steering Committee or such other Party may reasonably request for the conduct or evaluation of the Research Program, including data that is specific to the applicable Research Program (e.g., underlying datasets that are specific to the applicable Research Program and which are used by a Party in the course of conducting its activities with respect to the applicable Research Program). Nothing in this Clause 5.12 will require a Party to provide any data to the other Party if doing so would be contrary to Applicable Laws.
5.13 Sanofi will have the right to perform [***] activities under a Research Plan for each Approved Collaboration Target, including [***]. In the event of a dispute regarding the scope of the activities to be performed by Sanofi under that Research Plan, Sanofi will have final decision-making authority regarding that scope, and EXS shall not unreasonably withhold, delay or condition its approval of that scope. If Sanofi performs any such activities, then EXS shall transfer, upon Sanofi’s request and at no cost to Sanofi, adequate amounts of materials, which Sanofi may use in accordance with the terms and conditions of this Agreement (including the applicable Research Plan) and any Material Transfer Agreement entered into between the Parties). Prior to EXS transferring any such materials to Sanofi, the Parties shall enter into a Material Transfer Agreement in the form attached as Schedule 5.
5.14 Sanofi may provide EXS with (a) Sanofi-Originated Molecules Directed To an Approved Collaboration Target or other materials, in each case developed outside of this Agreement and Controlled by Sanofi or its Affiliates (“Sanofi Materials”) or (b) Sanofi-Provided Data, which Sanofi may use in accordance with the terms and conditions of this Agreement (including the applicable Research Plan) and any Material Transfer Agreement entered into between the Parties. Prior to Sanofi transferring any Sanofi Materials to EXS, the Parties shall enter into a Material Transfer Agreement in the form attached as Schedule 5.
Appears in 1 contract
Research Activities. 5.1 Following the designation of a Collaboration Target as an Approved Collaboration TargetIf, the Parties shall commence the Small Molecule Research Project for that Approved Collaboration Target in accordance with this Agreement (including the Research Plan for that Approved Collaboration Target), provided that: (a) there will be no more than [***] active Small Molecule Research Projects (for clarity, excluding any Research Program for a Collaboration NSM Target) at any given time during the Research Term; and (b) the maximum number , Ionis undergoes a Change of active Small Molecule Research Projects in sub-clause (a) Control, then Ionis will [***] each time [***] Collaboration Development Candidates are selected for an Approved Collaboration Target in accordance with Clause 6.1. For the avoidance of doubt, if one or more Collaboration Development Candidates are selected for [***] Approved Collaboration Targets, neither Party shall be required to carry out any further Small Molecule Research Projects.
5.2 Each Party shall use Commercially Reasonable Efforts to undertake those activities allocated to it in each Research Plan and NSM Research Plan in accordance with such Research Plan or NSM Research Plan and this Agreement. Each Party shall comply with Applicable Laws in performing those activities allocated to it in the Research Plan.
5.3 Each Party shall ensure that all of its personnel engaged in the performance of any of that Party’s responsibilities under each Research Plan or NSM Research Plan (a) are competent and efficient; and (b) have appropriate and relevant qualifications, training and experience for, and are knowledgeable about, that Party’s responsibilities under that Research Plan or NSM Research Plan.
5.4 Any Research Plan or NSM Research Plan may be amended from time to time by the Joint Steering Committee in accordance with Clause 11.
5.5 Each Party (the “Subcontracting Party”) may engage an Affiliate or Third Party subcontractor to perform any of its responsibilities under a Research Plan; provided that:
(a) prior to [***] subcontracting such performance to Third Party subcontractors, [***] shall obtain the prior written consent of [***] it being agreed that the subcontractors listed on Schedule 2 are pre-agreed as of the Effective Date);
(b) that Affiliate or subcontractor meets the qualifications and standards generally required by the Subcontracting Party for the performance of work similar in scope and complexity to the subcontracted activity;
(c) the Subcontracting Party ensures that it retains or obtains Control of any Patent Rights, Know-How or other intellectual property rights created by such Affiliate or subcontractor under or in connection with this Agreement; and
(d) the Subcontracting Party shall be responsible for all acts and omissions of any such Affiliate or subcontractor as fully as if they were the acts and omissions of the Subcontracting Party.
5.6 With respect to each Research Plan and NSM Research Plan:
(a) EXS will be responsible for [***] and, notify Biogen within [***] Business Days after of the end public announcement of each Calendar Quarter, Sanofi will provide to EXS an invoice for any such expenses incurred or paid by Sanofi or its Affiliates during Change of Control and the previous Calendar Quarter. EXS following shall pay such invoice within [***] days following receipt thereof; andapply:
(b) except as provided in Clause 5.6(a) above, [***] will be responsible for all costs and expenses incurred by or on behalf of [***] in relation to the Research Plan or NSM Research Plan.
5.7 With respect to each Approved Collaboration Target that is the subject of a Research Plan, EXS shall (a) promptly provide a written report to Sanofi when EXS believes that any Small Molecule for an Approved Collaboration Target has achieved [***] and (b) provide to Sanofi all data and information in support thereof that is reasonably necessary for Sanofi to determine that such Small Molecule for such Approved Collaboration Target has achieved [***] (“Lead Identification Data Package”). Sanofi shall promptly (and in any event within Within [***] days after the effective date of the complete Lead Identification Data Package) evaluate the Lead Identification Data Package to determine whether or not the applicable Small Molecule has achieved [***] and provide prompt written notice such Change of such determination to EXS andControl, if [***] has been achieved, whether Sanofi wishes to either (i) continue with the Research Program with respect to that Approved Collaboration Target, in which case, to the extent a Research Milestone is payable in accordance with Clause 14.1, Sanofi shall pay the applicable Research Milestone Payment in accordance with this Agreement; or (ii) terminate the Research Program in accordance with the terms of this Agreement.
5.8 With respect to each Approved Collaboration Target that is the subject of a Research Plan, EXS shall (a) promptly provide (and in any event within [***] days following the conclusion of the Research Plan) a written report to Sanofi when EXS believes that a Small Molecule for such Approved Collaboration Target has achieved [***] and (b) provide to Sanofi (i) the corresponding Development Candidate Data Package and (ii) such additional information that Sanofi may reasonably request and reasonable quantities of any assays, reagents, research tools and such Small Molecules for such Approved Collaboration Target that are reasonably necessary for Sanofi to determine whether such Small Molecule for such Approved Collaboration Target have achieved Biogen will [***]. Except as otherwise set forth If such Change of Control is between Ionis and a Biogen Competitor, then [***].
(b) At any time after such Change of Control and prior to the applicable Change of Control Trigger Date for such Change of Control, if Biogen reasonably and in a corresponding Research Plan, EXS shall deliver a Development Candidate Data Package for the Lead Molecule for an Approved Collaboration Target first good faith determines that Ionis and shall deliver a Development Candidate Data Package with respect to such Third Party acquirer will not be [***] Back-Up Molecules under each Neurology Plan (in which determination Biogen may take into account [***] ]), then, at any time prior to the applicable Change of Control Trigger Date Biogen may elect (as part of its written notice to Ionis of such belief), on a Strategy-by-Strategy or Collaboration Program-by-Collaboration Program basis with respect to the Strategy or Collaboration Program to which the failure relates or for such Approved this Agreement in its entirety, to (i) assume final decision-making ability with respect to the Neurology Plans and any activities conducted thereunder, and solely make all decisions that this Agreement would otherwise require or permit the Neurology JRC, the applicable Neurology JDC, the JPC, the CSC or any other subcommittees or working groups, or the Parties collectively, to make; provided, however, that Biogen will not have the right to create any obligations or incur any liabilities for or on behalf of Ionis, and (ii) assume responsibility for any or all target validation activities, drug discovery activities or Ionis-Conducted IND-Enabling Toxicology Studies for the applicable existing or new Strategies or Collaboration Target Programs directed to existing or new High Interest Targets or Collaboration Targets. If Biogen elects to take over activities in accordance with subclause (ii) of this Section 12.5.1(b), then by providing timely written notice to Ionis no later than [***] months days following such election, Biogen may request that Ionis performs a technology transfer under Section 12.5.1(d) solely to facilitate the delivery transition of the Development Candidate Data Package activities for which Biogen elects to assume responsibility. If Biogen elects to trigger one or more of the Lead Molecule. Sanofi shall promptly remedies set forth in subclause (and, in any event, within [***] days after the date ii) of EXS’s delivery of each complete Development Candidate Data Package) evaluate such Development Candidate Data Package to determine whether or not the applicable Small Molecule has achieved [***] and provide prompt written notice of such determination to EXS.
5.9 Notwithstanding anything to the contrary in Clause 5.8 (but without limiting EXS’s obligations to deliver Development Candidate Data Packages with respect to any Back-Up Molecules as required in Clause 5.8this Section 12.5.1(b), if Sanofi provides notice to EXS that, with respect to a given Small Molecule for an Approved Collaboration Target, Sanofi desires to obtain delivery of the corresponding Development Candidate Data Package prior to its anticipated date of delivery because Sanofi believes that [***] with respect to that Small Molecule are likely to be met and desires to progress such Small Molecule into Development at an earlier date, then the Parties shall, acting reasonably and in good faith, discuss appropriate amendments to [***]; provided that the Parties intend to not discuss or make any such amendments during the [***] month period immediately preceding the anticipated date for delivery of such Development Candidate Data Package. If the Parties so agree to amend [***] and the applicable Small Molecule achieves the amended (A) [***], then and (aB) EXS [***], and the remainder of this Agreement shall promptly deliver remain in force and un-amended by Biogen’s exercise of such remedies. For the corresponding Development Candidate Data Package to Sanofi within purposes of this Section 12.5, the “Change of Control Trigger Date” means [***] days following the date that [***] amended and (b) such Small Molecule will be deemed to have been designated as a Collaboration Development Candidate that meets [***] for purposes of Clauses 6.1 and [***] as of the effective date of EXS’s delivery such Change of Control transaction occurred. By way of example only, if the corresponding Development Candidate Data Package. [***] shall not withhold its agreement to any proposed amendment to [***] for effective date of a Change of Control transaction occurred July 31, 2021, then the sole purpose Change of delaying the timing Control Trigger Date would be [***].
5.10 By no later than [***] Business Days following Sanofi’s receipt of a Lead Identification Data Package or Development Candidate Data Package for an Approved Collaboration Target, Sanofi may (a) notify EXS in writing that such Lead Identification Data Package or Development Candidate Data Package is incomplete or inconsistent, in which case EXS shall use Commercially Reasonable Efforts to address Sanofi’s concerns and deliver to Sanofi a complete Lead Identification Data Package or Development Candidate Data Package as promptly as practicable or (b) provide EXS with written notice requesting a discussion with EXS representative(s) who have the relevant knowledge and information regarding such Approved Collaboration Target or the Small Molecules relating to such Approved Collaboration Target, in which case EXS shall require such representatives to meet with Sanofi to discuss as soon as reasonably practicable.
5.11 Each Party shall prepare and maintain complete and accurate written records of all activities performed as well as results and data obtained pursuant to each Research Plan or NSM Research Plan, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes. In addition to the reporting obligations set forth in Clause 5.12, upon reasonable request of Sanofi, EXS will grant Sanofi and its Affiliates reasonable access to all results and data (including all primary data and data contained in laboratory notebooks) that is generated in the course of performance of each Research Plan and NSM Research Plan in a format reasonably acceptable to both Parties (including interim results, chemical structures and drug design strategies arising out of the Research Plan or NSM Research Plan). EXS shall consider in good faith any reasonable comments arising out of Sanofi’s review of such results and data and provided by Sanofi in writing to EXS’s Alliance Manager and make reasonable adjustments to the applicable Research Plan or NSM Research Plan in order to account for those reasonable comments. Sanofi and its Affiliates will also have the right, at reasonable intervals and upon reasonable notice to EXS, to have copies of such records made to use and transfer as permitted hereunder. All such records in their disclosed form will be deemed the Confidential Information of each Party (without affecting the ownership of or confidentiality and non-use obligations related to the information therein).
5.12 Each Party will furnish to the Joint Steering Committee, at each Joint Steering Committee meeting, to the extent applicable to such Party, an update on such Party’s progress under the Research Plan for an Approved Collaboration Target or the NSM Research Plan for any Collaboration NSM Target during the relevant Calendar Quarter, including a summary of any material results and data generated by such Party under such Research Plan or NSM Research Plan since the previous Joint Steering Committee meeting. Such Party shall provide the Joint Steering Committee with such other results, data and other information with respect to the activities under the Research Plan or NSM Research Plan as any member of the Joint Steering Committee may reasonably request that are in such Party’s possession or control and are reasonably necessary or useful for the Joint Steering Committee to perform its responsibilities under Clause 11 or for either Party to exercise its rights under this Agreement. Upon reasonable request by a Party, through the Joint Steering Committee, the other Party shall provide the Joint Steering Committee with such other information and such additional access to records with respect to any Approved Collaboration Target or Collaboration NSM Target that is the subject of a Research Plan or NSM Research Plan as the Joint Steering Committee or such other Party may reasonably request for the conduct or evaluation of the Research Program, including data that is specific to the applicable Research Program (e.g., underlying datasets that are specific to the applicable Research Program and which are used by a Party in the course of conducting its activities with respect to the applicable Research Program). Nothing in this Clause 5.12 will require a Party to provide any data to the other Party if doing so would be contrary to Applicable Laws.
5.13 Sanofi will have the right to perform [***] activities under a Research Plan for each Approved Collaboration Target, including [***]. In the event of a dispute regarding the scope of the activities to be performed by Sanofi under that Research Plan, Sanofi will have final decision-making authority regarding that scope, and EXS shall not unreasonably withhold, delay or condition its approval of that scope. If Sanofi performs any such activities, then EXS shall transfer, upon Sanofi’s request and at no cost to Sanofi, adequate amounts of materials, which Sanofi may use in accordance with the terms and conditions of this Agreement (including the applicable Research Plan) and any Material Transfer Agreement entered into between the Parties). Prior to EXS transferring any such materials to Sanofi, the Parties shall enter into a Material Transfer Agreement in the form attached as Schedule 5.
5.14 Sanofi may provide EXS with (a) Sanofi-Originated Molecules Directed To an Approved Collaboration Target or other materials, in each case developed outside of this Agreement and Controlled by Sanofi or its Affiliates (“Sanofi Materials”) or (b) Sanofi-Provided Data, which Sanofi may use in accordance with the terms and conditions of this Agreement (including the applicable Research Plan) and any Material Transfer Agreement entered into between the Parties. Prior to Sanofi transferring any Sanofi Materials to EXS, the Parties shall enter into a Material Transfer Agreement in the form attached as Schedule 5.
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Research Activities. 5.1 Following the designation of a Collaboration Target as an Approved Collaboration TargetIf, the Parties shall commence the Small Molecule Research Project for that Approved Collaboration Target in accordance with this Agreement (including at any time during the Research Plan for that Approved Collaboration Target)Term, provided that: (a) there will be no more than a Change of Control occurs, then at any time prior to the [***] active Small Molecule Research Projects (for clarityanniversary of the closing of such Change of Control, excluding any Research Program for a Collaboration NSM Target) at any given time during the Research Term; and (b) the maximum number of active Small Molecule Research Projects in sub-clause (a) will [***] each time [***] Collaboration Development Candidates are selected for an Approved Collaboration Target in accordance with Clause 6.1. For the avoidance of doubtupon written notice to Ionis, if one or more Collaboration Development Candidates are selected for [***] Approved Collaboration Targets, neither Party shall be required to carry out any further Small Molecule Research Projects.
5.2 Each Party shall use Commercially Reasonable Efforts to undertake those activities allocated to it in each Research Plan and NSM Research Plan in accordance with such Research Plan or NSM Research Plan and this Agreement. Each Party shall comply with Applicable Laws in performing those activities allocated to it in the Research Plan.
5.3 Each Party shall ensure that all of its personnel engaged in the performance of any of that Party’s responsibilities under each Research Plan or NSM Research Plan (a) are competent and efficient; and (b) have appropriate and relevant qualifications, training and experience for, and are knowledgeable about, that Party’s responsibilities under that Research Plan or NSM Research Plan.
5.4 Any Research Plan or NSM Research Plan Biogen may be amended from time to time by the Joint Steering Committee in accordance with Clause 11.
5.5 Each Party (the “Subcontracting Party”) may engage an Affiliate or Third Party subcontractor to perform any of its responsibilities under a Research Plan; provided thateither:
(a) prior to [***] subcontracting Extend the Research Term until such performance to Third Party subcontractors, [***] shall obtain time as Ionis has completed target validating activities that are Ionis Activities under the prior written consent Neurological Disease Research Plan for a total of [***] it being agreed that the subcontractors listed on Schedule 2 are pre-agreed as of the Effective Date)High Interest Targets;
(b) Terminate the Research Term, in which case: (i) Ionis will complete all ongoing target validation work that Affiliate or subcontractor meets are Ionis Activities under the qualifications and standards generally required by the Subcontracting Party for the performance of work similar in scope and complexity to the subcontracted activity;
(c) the Subcontracting Party ensures that it retains or obtains Control of any Patent Rights, Know-How or other intellectual property rights created by such Affiliate or subcontractor under or in connection with this Agreement; and
(d) the Subcontracting Party shall be responsible for all acts and omissions of any such Affiliate or subcontractor as fully as if they were the acts and omissions of the Subcontracting Party.
5.6 With respect to each Neurological Disease Research Plan and NSM advance each such target to Target Sanction (but for clarity, no target validation work will be initiated for any new target under the Neurological Disease Research Plan:
); (aii) EXS Ionis will complete all ongoing Ionis Activities under the Core Research Plan (but for clarity, no new work will be responsible initiated under the Core Research Plan); (iii) for [***] andeach Collaboration Target that is not an ALS Target that reaches Target Sanction or each ALS Target designated a Collaboration Target, within [***] Business Days after an ASO Development Candidate Identification Plan will be prepared and Ionis will carry out its obligations under such plan, all in accordance with Section 1.10.1; (iv) Ionis will continue to perform its obligations under each ongoing ASO Development Candidate Identification Plan until the end of the applicable ASO Development Candidate Identification Term and under each Calendar Quarterongoing Initial Development Plan until completion of all Ionis Activities thereunder; (v) for each Collaboration Program for which a Development Candidate is identified as provided herein, Sanofi will provide Biogen may, upon written notice to EXS an invoice for any Ionis, such expenses incurred or paid by Sanofi or its Affiliates during the previous Calendar Quarter. EXS shall pay such invoice notice to be delivered within [***] days following receipt thereof; and
after designating a Development Candidate for the applicable Collaboration Program, elect to either (bA) except as provided exercise the applicable Option by notifying Ionis in Clause 5.6(a) above, [***] will be responsible for all costs and expenses incurred by or on behalf writing of [***] in relation Biogen’s election to license the Research Plan or NSM Research Plan.
5.7 With respect to each Approved Collaboration Target that is the subject of a Research Plan, EXS shall (a) promptly provide a written report to Sanofi when EXS believes that any Small Molecule for an Approved Collaboration Target has achieved Product [***] and (b) provide will be paid to Sanofi all data and information in support thereof that is reasonably necessary for Sanofi to determine that such Small Molecule for such Approved Collaboration Target has achieved Ionis within [***] days after Biogen’s election under clause (“Lead Identification Data Package”A) of this Section 12.5.1(b). Sanofi shall promptly , and after such exercise, Biogen will not be obligated [***], or (B) establish an Initial Development Plan for such Collaboration Program pursuant to Section 1.10.2(d), in which case Ionis and in any event Biogen will continue to exercise their rights and perform their respective obligations with respect to the applicable Collaboration Program under the terms of this Agreement; (vi) the Research Term will end upon Ionis’ completion of all Ionis Activities under clauses (i), (ii) and (iii) above; and (vii) within [***] days after the date end of the complete Lead Identification Data PackageResearch Term, Ionis will [***]; or
(c) evaluate the Lead Identification Data Package to determine whether or not the applicable Small Molecule has achieved Allow such [***] and provide prompt written period to lapse without providing any such notice of such determination to EXS and, if [***] has been achieved, whether Sanofi wishes to either (i) continue with the Research Program with respect to that Approved Collaboration Targetelection under this Section 12.5.1, in which case, case Ionis and Biogen will continue to the extent a Research Milestone is payable in accordance with Clause 14.1, Sanofi shall pay the applicable Research Milestone Payment in accordance with this Agreement; or (ii) terminate the Research Program in accordance with exercise their rights and perform their respective obligations under the terms of this Agreement.
5.8 With respect to each Approved Collaboration Target that is the subject of a Research Plan, EXS shall (a) promptly provide (and in any event within [***] days following the conclusion of the Research Plan) a written report to Sanofi when EXS believes that a Small Molecule for such Approved Collaboration Target has achieved [***] and (b) provide to Sanofi (i) the corresponding Development Candidate Data Package and (ii) such additional information that Sanofi may reasonably request and reasonable quantities of any assays, reagents, research tools and such Small Molecules for such Approved Collaboration Target that are reasonably necessary for Sanofi to determine whether such Small Molecule for such Approved Collaboration Target have achieved [***]. Except as otherwise set forth in a corresponding Research Plan, EXS shall deliver a Development Candidate Data Package for the Lead Molecule for an Approved Collaboration Target first and shall deliver a Development Candidate Data Package with respect to [***] Back-Up Molecules [***] for such Approved Collaboration Target by no later than [***] months following the delivery of the Development Candidate Data Package for the Lead Molecule. Sanofi shall promptly (and, in any event, within [***] days after the date of EXS’s delivery of each complete Development Candidate Data Package) evaluate such Development Candidate Data Package to determine whether or not the applicable Small Molecule has achieved [***] and provide prompt written notice of such determination to EXS.
5.9 Notwithstanding anything to the contrary in Clause 5.8 (but without limiting EXS’s obligations to deliver Development Candidate Data Packages with respect to any Back-Up Molecules as required in Clause 5.8), if Sanofi provides notice to EXS that, with respect to a given Small Molecule for an Approved Collaboration Target, Sanofi desires to obtain delivery of the corresponding Development Candidate Data Package prior to its anticipated date of delivery because Sanofi believes that [***] with respect to that Small Molecule are likely to be met and desires to progress such Small Molecule into Development at an earlier date, then the Parties shall, acting reasonably and in good faith, discuss appropriate amendments to [***]; provided that the Parties intend to not discuss or make any such amendments during the [***] month period immediately preceding the anticipated date for delivery of such Development Candidate Data Package. If the Parties so agree to amend [***] and the applicable Small Molecule achieves the amended [***], then (a) EXS shall promptly deliver the corresponding Development Candidate Data Package to Sanofi within [***] days following the date that [***] amended and (b) such Small Molecule will be deemed to have been designated as a Collaboration Development Candidate that meets [***] for purposes of Clauses 6.1 and [***] as of the date of EXS’s delivery of the corresponding Development Candidate Data Package. [***] shall not withhold its agreement to any proposed amendment to [***] for the sole purpose of delaying the timing [***].
5.10 By no later than [***] Business Days following Sanofi’s receipt of a Lead Identification Data Package or Development Candidate Data Package for an Approved Collaboration Target, Sanofi may (a) notify EXS in writing that such Lead Identification Data Package or Development Candidate Data Package is incomplete or inconsistent, in which case EXS shall use Commercially Reasonable Efforts to address Sanofi’s concerns and deliver to Sanofi a complete Lead Identification Data Package or Development Candidate Data Package as promptly as practicable or (b) provide EXS with written notice requesting a discussion with EXS representative(s) who have the relevant knowledge and information regarding such Approved Collaboration Target or the Small Molecules relating to such Approved Collaboration Target, in which case EXS shall require such representatives to meet with Sanofi to discuss as soon as reasonably practicable.
5.11 Each Party shall prepare and maintain complete and accurate written records of all activities performed as well as results and data obtained pursuant to each Research Plan or NSM Research Plan, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes. In addition to the reporting obligations set forth in Clause 5.12, upon reasonable request of Sanofi, EXS will grant Sanofi and its Affiliates reasonable access to all results and data (including all primary data and data contained in laboratory notebooks) that is generated in the course of performance of each Research Plan and NSM Research Plan in a format reasonably acceptable to both Parties (including interim results, chemical structures and drug design strategies arising out of the Research Plan or NSM Research Plan). EXS shall consider in good faith any reasonable comments arising out of Sanofi’s review of such results and data and provided by Sanofi in writing to EXS’s Alliance Manager and make reasonable adjustments to the applicable Research Plan or NSM Research Plan in order to account for those reasonable comments. Sanofi and its Affiliates will also have the right, at reasonable intervals and upon reasonable notice to EXS, to have copies of such records made to use and transfer as permitted hereunder. All such records in their disclosed form will be deemed the Confidential Information of each Party (without affecting the ownership of or confidentiality and non-use obligations related to the information therein).
5.12 Each Party will furnish to the Joint Steering Committee, at each Joint Steering Committee meeting, to the extent applicable to such Party, an update on such Party’s progress under the Research Plan for an Approved Collaboration Target or the NSM Research Plan for any Collaboration NSM Target during the relevant Calendar Quarter, including a summary of any material results and data generated by such Party under such Research Plan or NSM Research Plan since the previous Joint Steering Committee meeting. Such Party shall provide the Joint Steering Committee with such other results, data and other information with respect to the activities under the Research Plan or NSM Research Plan as any member of the Joint Steering Committee may reasonably request that are in such Party’s possession or control and are reasonably necessary or useful for the Joint Steering Committee to perform its responsibilities under Clause 11 or for either Party to exercise its rights under this Agreement. Upon reasonable request by a Party, through the Joint Steering Committee, the other Party shall provide the Joint Steering Committee with such other information and such additional access to records with respect to any Approved Collaboration Target or Collaboration NSM Target that is the subject of a Research Plan or NSM Research Plan as the Joint Steering Committee or such other Party may reasonably request for the conduct or evaluation of the Research Program, including data that is specific to the applicable Research Program (e.g., underlying datasets that are specific to the applicable Research Program and which are used by a Party in the course of conducting its activities with respect to the applicable Research Program). Nothing in this Clause 5.12 will require a Party to provide any data to the other Party if doing so would be contrary to Applicable Laws.
5.13 Sanofi will have the right to perform [***] activities under a Research Plan for each Approved Collaboration Target, including [***]. In the event of a dispute regarding the scope of the activities to be performed by Sanofi under that Research Plan, Sanofi will have final decision-making authority regarding that scope, and EXS shall not unreasonably withhold, delay or condition its approval of that scope. If Sanofi performs any such activities, then EXS shall transfer, upon Sanofi’s request and at no cost to Sanofi, adequate amounts of materials, which Sanofi may use in accordance with the terms and conditions of this Agreement (including the applicable Research Plan) and any Material Transfer Agreement entered into between the Parties). Prior to EXS transferring any such materials to Sanofi, the Parties shall enter into a Material Transfer Agreement in the form attached as Schedule 5.
5.14 Sanofi may provide EXS with (a) Sanofi-Originated Molecules Directed To an Approved Collaboration Target or other materials, in each case developed outside of this Agreement and Controlled by Sanofi or its Affiliates (“Sanofi Materials”) or (b) Sanofi-Provided Data, which Sanofi may use in accordance with the terms and conditions of this Agreement (including the applicable Research Plan) and any Material Transfer Agreement entered into between the Parties. Prior to Sanofi transferring any Sanofi Materials to EXS, the Parties shall enter into a Material Transfer Agreement in the form attached as Schedule 5.
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