Responsibilities of the JSC. The JSC, subject to Sections 4.5 and 4.6, shall oversee and supervise the overall Collaboration and the relationship between the Parties hereunder, and within such scope shall: 4.4.1.1. define the Collaboration goals and strategic direction; 4.4.1.2. prioritize Projects and respective activities; 4.4.1.3. closely interact with Joint Project Teams and steer Projects towards achievements of Lead Candidate Criteria or Development Candidate Criteria respectively; 4.4.1.4. review the efforts of the Parties under the Collaboration Plan and the Project Plans, as reported by the JPT; 4.4.1.5. approve Project Plans, and approve, with any necessary modifications, changes to the Collaboration Plan and/or Project Plans; provided that such modifications to the Project Plans are made in alignment with the respective Project Leaders; 4.4.1.6. approve the Model and the Primary Screening Assay for each Project; 4.4.1.7. approve the deconvolution of the target for each Project; 4.4.1.8. if applicable, determine lead candidate criteria and development candidate criteria for a Project, provided that, as a general rule, such lead candidate criteria and development candidate criteria shall correspond to the Lead Candidate Criteria and Development Candidate Criteria, unless the Bayer representatives in the JSC agree that a deviation from such Lead Candidate Criteria or Development Candidate Criteria would be acceptable; 4.4.1.9. endorse Lead Candidate Criteria and Development Candidate Criteria achievement and other Lead Candidate and Development Candidate selections, always provided that the achievement of the respective Lead Candidate Criteria and Development Candidate Criteria or Lead Candidate and Development Candidate selection is confirmed by the Bayer Criteria Committee in accordance with Section 4.8; 4.4.1.10. approve the Project Leaders recommendation for Qualified Hits/ Qualified Hit Series and for Lead Series and confirm the JPT’s determination of the specific Project Compounds to be included in a Lead Series; 4.4.1.11. decide whether to discontinue a Project or any activities under a Project Plan, or to reduce activities under a Project Plan, whereby the JSC shall consider a reasonable wind-down period which shall not exceed [***] months in case the Project is discontinued; 4.4.1.12. form such other committees or working groups as the JSC may deem appropriate, provided that such committees may make recommendations to the JSC but may not be delegated JSC decision-making authority; 4.4.1.13. support the filing and prosecution of the Project IP Rights; 4.4.1.14. address such other matters relating to the activities of the Parties under this Agreement as either Party may bring before the JSC, including any matters that are expressly for the JSC to decide as provided in this Agreement; 4.4.1.15. assist the Parties in their efforts to resolve any disputes on an informal basis, including any unresolved disputes from the Joint Project Teams; 4.4.1.16. confirm that a target or combination of targets for Program/Lead Series has been properly deconvoluted; and 4.4.1.17. confirm the Project Know-How, Project Compounds and Project IP Rights along with any Background IP Rights and Background Know-How that would be subject to a License Agreement under such Project.
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Samples: Research Collaboration and Option Agreement (Recursion Pharmaceuticals, Inc.), Research Collaboration and Option Agreement (Recursion Pharmaceuticals, Inc.)
Responsibilities of the JSC. The JSCExcept as otherwise set forth herein, subject to Sections 4.5 and 4.6, shall oversee and supervise the overall Collaboration and the relationship between the Parties hereunder, and within such scope shall:
4.4.1.1. define the Collaboration goals and strategic direction;
4.4.1.2. prioritize Projects and respective activities;
4.4.1.3. closely interact with Joint Project Teams and steer Projects towards achievements of Lead Candidate Criteria or Development Candidate Criteria respectively;
4.4.1.4. review the efforts of the Parties under the Collaboration Plan and the Project Plans, as reported by the JPT;
4.4.1.5. approve Project Plans, and approve, with any necessary modifications, changes to the Collaboration Plan and/or Project Plans; provided that such modifications to the Project Plans are made in alignment with the respective Project Leaders;
4.4.1.6. approve the Model and the Primary Screening Assay for each Project;
4.4.1.7. approve the deconvolution of the target for each Project;
4.4.1.8. if applicable, determine lead candidate criteria and development candidate criteria for a Project, provided that, as a general rule, such lead candidate criteria and development candidate criteria shall correspond to the Lead Candidate Criteria and Development Candidate Criteria, unless the Bayer representatives in the JSC agree that a deviation from such Lead Candidate Criteria or Development Candidate Criteria would be acceptable;
4.4.1.9. endorse Lead Candidate Criteria and Development Candidate Criteria achievement and other Lead Candidate and Development Candidate selections, always provided that the achievement of the respective Lead Candidate Criteria and Development Candidate Criteria or Lead Candidate and Development Candidate selection is confirmed by the Bayer Criteria Committee in accordance with Section 4.8;
4.4.1.10. approve the Project Leaders recommendation for Qualified Hits/ Qualified Hit Series and for Lead Series and confirm the JPT’s determination of the specific Project Compounds to be included in a Lead Series;
4.4.1.11. decide whether to discontinue a Project or any activities under a Project Plan, or to reduce activities under a Project Plan, whereby the JSC shall consider a reasonable windcoordinate all co-down period which shall not exceed [***] months in case the Project is discontinued;
4.4.1.12. form such other committees or working groups as the JSC may deem appropriatepromotion, provided that such committees may make recommendations to the JSC but may not be delegated JSC decision-making authority;
4.4.1.13. support the filing development and prosecution of the Project IP Rights;
4.4.1.14. address such other matters relating to the evidence generation activities of the Parties under this Agreement as either Party may bring before the JSC, including any matters that are expressly for Agreement. The responsibilities of the JSC to decide shall be exercised consistent with this Agreement and shall include, but shall not be limited to, the following:
a) To define, approve and update or amend Development Plans, which shall include the following:
i. the product requirements that define the unique features as provided specified by the Parties using an agile development methodology, as described in this AgreementExhibit F;
4.4.1.15ii. assist development milestones to develop the Parties in their efforts to resolve any disputes on an informal basisproduct with corresponding project deliverables, including any unresolved disputes from program timelines and success criteria. Milestones shall include, inter alia, beta testing, proof of concept and validation and be consistent with the Joint Project Teamsagile development methodology;
4.4.1.16iii. confirm that a target or combination of targets for Program/Lead Series has been properly deconvolutedthe regulatory strategy (as needed); and
4.4.1.17iv. confirm Cost and Payment Schedule based on the Project Know-HowFair Market Value of the activities to be conducted by Dario pursuant to such Development Plan. For clarity, Project Compounds and Project IP Rights along with the amounts due under any Background IP Rights and Background Know-How that would be subject to a License Agreement Development Plan will reflect the Fair Market Value of the activities under such ProjectDevelopment Plan and shall not exceed the amounts listed in Section 7.2. In the event the Parties cannot agree to add an idea proposed by either Party to the Development Plan, with Dario voting against the addition of the idea to the Development Plan, Sanofi will retain a right of first negotiation as described in Section 6.3 with respect to such idea in the event Dario proceeds with such idea individually.
b) determine co-promotion strategy and activities of the Solution;
c) review financial information provided pursuant to Section 4.2.6 and if any financial information provided suggests that Dario may, within the next six (6) months, not have the resources necessary to perform any activities assigned to Dario under the Development Plan, determine where mitigation strategies are necessary under Section 4.2.6;
d) determine pricing and marketing strategy for the Enhanced Solution;
e) determine whether or not a customer or potential customer falls within a Targeted Channel; provided, in the event an account falls into both the Health Plan Channel and Employer Channel, the Parties will discuss in good faith how that account will be address financially. and Sanofi may decide whether or not to make the Introduction based on this determination;
f) determine updates and amendments to Dario Competitor Companies list, Advanced Discussion List and Sanofi Excluded Companies;
g) maintain a list of Introductions;
h) oversee implementation of the (i) Development Plans, (ii) regulatory strategy, and (iii) co-promotion strategy, of Enhanced Solutions;
i) adopt and oversee the Evidence Generation Plans described in Exhibit D;
j) discuss and make a good faith effort to resolve issues or disputes presented to it by the Alliance Managers;
k) determine delivery schedule of Dario Member Data to Sanofi, to be provided no less frequently than every six months; and
l) additional governance responsibilities as defined herein.
Appears in 1 contract
Responsibilities of the JSC. The JSCJSC shall be responsible for overseeing the entire collaboration between GSK and Targacept during the Collaboration Term, subject including each Research Program and Early Development Program. With respect to Sections 4.5 and 4.6the Product Candidate Commercialization Program, the JSC shall oversee and supervise serve [********] as a vehicle to facilitate the overall Collaboration and the relationship transfer of information between the Parties hereunderand will not [********] the Product Candidate Commercialization Program or [********] other Development or commercialization matters after [********] for such Program. Without limiting the foregoing and subject to the final decision-making authority of Targacept as stated in Section 2.3.4(a) and the final decision-making authority of GSK as stated in Section 2.3.4(b), and within such scope shallsubject to the provisions of Sections 2.3.4(c) and 2.3.5, the JSC shall have the following responsibilities and perform the following functions, some or all of which may be addressed directly at any given meeting of the JSC:
4.4.1.1. define (a) review the overall progress of Targacept’s efforts to discover, identify, optimize and develop Collaboration goals Compounds, Development Candidates, Backup Compounds, Follow-On Compounds and strategic directionOption Compounds;
4.4.1.2. prioritize Projects and respective activities;
4.4.1.3. closely interact with Joint Project Teams and steer Projects towards achievements of Lead Candidate Criteria or Development Candidate Criteria respectively;
4.4.1.4. review the efforts of the Parties under the Collaboration Plan and the Project Plans, as reported by the JPT;
4.4.1.5. approve Project Plans, and approve, with any necessary modifications, changes to the Collaboration Plan and/or Project Plans; provided that such modifications to the Project Plans are made in alignment with the respective Project Leaders;
4.4.1.6. approve the Model and the Primary Screening Assay (b) for each Project;
4.4.1.7. approve the deconvolution of the target for each Project;
4.4.1.8. if applicableProgram, determine lead candidate criteria and development candidate establish criteria for a ProjectHit, provided that, as a general rule, such lead candidate criteria and development candidate criteria shall correspond to the Lead Candidate Criteria and Development Candidate Criteria, unless the Bayer representatives in the JSC agree that a deviation from such Lead Candidate Criteria or Development Candidate Criteria would be acceptable;
4.4.1.9. endorse Lead Candidate Criteria and Development Candidate Criteria achievement as soon as practicable following the Effective Date and other modify such criteria for a Hit, Lead Candidate and Criteria or Development Candidate selectionsCriteria, always provided that or the achievement of the respective Lead Candidate Criteria and Development Candidate Criteria Activities, from time to time;
(c) based on applicable criteria (including, without limitation, their respective definitions), determine compounds nominated by Targacept as Leads, Development Candidates, Backup Compounds or Lead Candidate and Follow-On Compounds from time to time to be Leads, Development Candidate selection is confirmed Candidates, Backup Compounds or Follow-On Compounds, as the case may be;
(d) confirm whether each Follow-on Compound determined by the Bayer Criteria Committee in accordance with Section 4.8;
4.4.1.10. approve the Project Leaders recommendation for Qualified Hits/ Qualified Hit Series and for Lead Series and confirm the JPT’s determination of the specific Project Compounds JSC prior to be included in a Lead Series;
4.4.1.11. decide whether to discontinue a Project or any activities under a Project Plan, or to reduce activities under a Project Plan, whereby the JSC shall consider a reasonable wind-down period which shall not exceed [********] months in case the Project is discontinuedremains a Follow-On Compound upon [********];
4.4.1.12. form such other committees or working groups as (e) review, update and approve the Preliminary PoC Plan for each Development Candidate;
(f) review, update and approve the content of all PoC Criteria;
(g) review, modify, update and approve PoC Trial (or, with respect to a Follow-On Compound, the equivalent) design and content, and determine whether a Progressed Compound meets the [********], in each case taking into account the recommendations of the JPS; provided that, with respect to the [********], the JSC may deem appropriate, provided that shall determine whether such committees may make recommendations [********] is met not later than [********] following its receipt of all material [********] in Targacept’s possession or control with respect to the JSC but may not be delegated JSC decision-making authorityapplicable Progressed Compound;
4.4.1.13. support the filing and prosecution (h) confirm Targacept’s determination as to whether, upon completion of the Project IP RightsPoC Trial, the PoC Criteria has been met;
4.4.1.14. address such other matters relating (i) prior to the activities exercise by GSK of its Program Option for a particular Program, review and approve the inclusion of content in any [********] a Progressed Compound in such Program designed for the purpose of [********] for any [********];
(j) following exercise by GSK of its Program Option for a particular Program, review and approve the research or Development by Targacept of any Product Candidate subject to such exercised Program Option [********];
(k) review and approve each Target Product Profile or update thereto as set forth in Section 3.6.1;
(l) review each Research Plan and Early Development Plan or update thereto as set forth in Sections 3.5.1 and 3.7.1 and approve, by Program, any strategy proposed by Targacept for the pursuit of Backup Compound and Follow-On Compounds;
(m) consider for approval any proposal by either Party to terminate a Research Program, Early Development Program or Program;
(n) serve as an [********] vehicle to facilitate the discussion of Development and commercialization of Product Candidates and Licensed Products;
(o) review and coordinate all of the Parties Parties’ activities under this Agreement as either Party may bring before during the JSC, including any matters that are expressly for the JSC to decide as provided in this AgreementCollaboration Term;
4.4.1.15. assist (p) in accordance with the Parties procedures established in their efforts Section 2.3.4 and subject to Section 2.3.5, discuss and attempt to resolve any deadlock issues submitted to it by any Subcommittee;
(q) attempt to resolve any disputes on an informal basis, including any unresolved disputes from the Joint Project Teams;
4.4.1.16. confirm that a target or combination of targets for Program/Lead Series has been properly deconvolutedregarding proposed publications containing Confidential Information; and
4.4.1.17. confirm (r) such other responsibilities as may be assigned to the Project Know-HowJSC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time; provided, Project Compounds and Project IP Rights along with any Background IP Rights and Background Know-How however that would be subject the JSC shall not have the power to a License Agreement under such Projectamend or modify this Agreement.
Appears in 1 contract
Samples: Product Development and Commercialization Agreement (Targacept Inc)
Responsibilities of the JSC. The JSCExcept as otherwise set forth herein, subject to Sections 4.5 and 4.6, shall oversee and supervise the overall Collaboration and the relationship between the Parties hereunder, and within such scope shall:
4.4.1.1. define the Collaboration goals and strategic direction;
4.4.1.2. prioritize Projects and respective activities;
4.4.1.3. closely interact with Joint Project Teams and steer Projects towards achievements of Lead Candidate Criteria or Development Candidate Criteria respectively;
4.4.1.4. review the efforts of the Parties under the Collaboration Plan and the Project Plans, as reported by the JPT;
4.4.1.5. approve Project Plans, and approve, with any necessary modifications, changes to the Collaboration Plan and/or Project Plans; provided that such modifications to the Project Plans are made in alignment with the respective Project Leaders;
4.4.1.6. approve the Model and the Primary Screening Assay for each Project;
4.4.1.7. approve the deconvolution of the target for each Project;
4.4.1.8. if applicable, determine lead candidate criteria and development candidate criteria for a Project, provided that, as a general rule, such lead candidate criteria and development candidate criteria shall correspond to the Lead Candidate Criteria and Development Candidate Criteria, unless the Bayer representatives in the JSC agree that a deviation from such Lead Candidate Criteria or Development Candidate Criteria would be acceptable;
4.4.1.9. endorse Lead Candidate Criteria and Development Candidate Criteria achievement and other Lead Candidate and Development Candidate selections, always provided that the achievement of the respective Lead Candidate Criteria and Development Candidate Criteria or Lead Candidate and Development Candidate selection is confirmed by the Bayer Criteria Committee in accordance with Section 4.8;
4.4.1.10. approve the Project Leaders recommendation for Qualified Hits/ Qualified Hit Series and for Lead Series and confirm the JPT’s determination of the specific Project Compounds to be included in a Lead Series;
4.4.1.11. decide whether to discontinue a Project or any activities under a Project Plan, or to reduce activities under a Project Plan, whereby the JSC shall consider a reasonable windcoordinate all co-down period which shall not exceed [***] months in case the Project is discontinued;
4.4.1.12. form such other committees or working groups as the JSC may deem appropriatepromotion, provided that such committees may make recommendations to the JSC but may not be delegated JSC decision-making authority;
4.4.1.13. support the filing development and prosecution of the Project IP Rights;
4.4.1.14. address such other matters relating to the evidence generation activities of the Parties under this Agreement as either Party may bring before the JSC, including any matters that are expressly for Agreement. The responsibilities of the JSC to decide shall be exercised consistent with this Agreement and shall include, but shall not be limited to, the following:
a) To define, approve and update or amend Development Plans, which shall include the following:
i. the product requirements that define the unique features as provided specified by the Parties using an agile development methodology, as described in this AgreementExhibit F;
4.4.1.15ii. assist development milestones to develop the Parties in their efforts to resolve any disputes on an informal basisproduct with corresponding project deliverables, including any unresolved disputes from program timelines and success criteria. Milestones shall include, inter alia, beta testing, proof of concept and validation and be consistent with the Joint Project Teamsagile development methodology;
4.4.1.16iii. confirm that a target or combination of targets for Program/Lead Series has been properly deconvolutedthe regulatory strategy (as needed); and
4.4.1.17iv. confirm Cost and Payment Schedule based on the Project Know-HowFair Market Value of the activities to be conducted by Xxxxx pursuant to such Development Plan. For clarity, Project Compounds and Project IP Rights along with the amounts due under any Background IP Rights and Background Know-How that would be subject to a License Agreement Development Plan will reflect the Fair Market Value of the activities under such ProjectDevelopment Plan and shall not exceed the amounts listed in Section 7.2. In the event the Parties cannot agree to add an idea proposed by either Party to the Development Plan, with Xxxxx voting against the addition of the idea to the Development Plan, Sanofi will retain a right of first negotiation as described in Section 6.3 with respect to such idea in the event Xxxxx proceeds with such idea individually.
b) determine co-promotion strategy and activities of the Solution;
c) review financial information provided pursuant to Section 4.2.6 and if any financial information provided suggests that Xxxxx xxx, within the next six (6) months, not have the resources necessary to perform any activities assigned to Xxxxx under the Development Plan, determine where mitigation strategies are necessary under Section 4.2.6;
d) determine pricing and marketing strategy for the Enhanced Solution;
e) determine whether or not a customer or potential customer falls within a Targeted Channel; provided, in the event an account falls into both the Health Plan Channel and Employer Channel, the Parties will discuss in good faith how that account will be address financially, and Sanofi may decide whether or not to make the Introduction based on this determination;
f) determine updates and amendments to Dario Competitor Companies list, Advanced Discussion List, Bundling Discussion List and Sanofi Excluded Companies; provided, that if the JSC determines to add an entity to the Bundling Discussion List that is also on the Advanced Discussion List, such entity will be removed from the Advanced Discussion List;
g) determine each Introduction and maintain a list of all Introductions, Qualifying Employer Channel Accounts and Qualifying Health Plan Accounts;
h) determine each Bundled Account and maintain a list of all Bundled Accounts;
i) oversee implementation of the (i) Development Plans, (ii) regulatory strategy, and (iii) co-promotion strategy, of Enhanced Solutions;
j) adopt and oversee the Evidence Generation Plans described in Exhibit D;
k) discuss and make a good faith effort to resolve issues or disputes presented to it by the Alliance Managers;
l) determine delivery schedule of Xxxxx Member Data to Sanofi, to be provided no less frequently than every six months; and m) additional governance responsibilities as defined herein.
Appears in 1 contract
Responsibilities of the JSC. The JSC, subject to Sections 4.5 and 4.6, shall oversee and supervise the overall Collaboration and the relationship between the Parties hereunder, and within such scope shall:
4.4.1.1. define the Collaboration goals and strategic direction;
4.4.1.2. prioritize Projects and respective activities;
4.4.1.3. closely interact with Joint Project Teams and steer Projects towards achievements of Lead Candidate Criteria or Development Candidate Criteria respectivelyCriteria;
4.4.1.4. review the efforts of the Parties under the Collaboration Plan and the Project Plans, as reported by the JPT;
4.4.1.5. approve Project Plans, and approve, with any necessary modifications, changes to the Collaboration Plan and/or Project Plans; provided that such modifications to the Project Plans are made in alignment with the respective Project Leaders;
4.4.1.6. approve the Model and the Primary Screening Assay for each Project;
4.4.1.7. approve the deconvolution of the target for each Project;
4.4.1.84.4.1.7. if applicable, determine lead candidate criteria and development candidate criteria a for a Project, provided that, as a general rule, such lead candidate criteria and development candidate criteria shall correspond to the Lead Candidate Criteria and Development Candidate Criteria, unless the Bayer representatives in the JSC agree that a deviation from such Lead Candidate Criteria or Development Candidate Criteria would be acceptable;
4.4.1.94.4.1.8. endorse Lead Candidate Criteria and Development Candidate Criteria achievement and other Lead Candidate and Development Candidate selections, always provided that the achievement of the respective Lead Candidate Criteria and Development Candidate Criteria or Lead Candidate and Development Candidate selection is confirmed by the Bayer Criteria Committee in accordance with Section 4.8;
4.4.1.104.4.1.9. approve the Project Leaders recommendation for Qualified Hits/ Qualified Hit Series and for Lead Series and confirm the JPT’s determination of the specific Project Compounds to be included in a Lead Series;
4.4.1.114.4.1.10. decide whether to discontinue a Project or any activities under a Project Plan, or to reduce activities under a Project Plan, whereby the JSC shall consider a reasonable wind-down period which shall not exceed [***] months in case the Project is discontinued;
4.4.1.124.4.1.11. form such other committees or working groups as the JSC may deem appropriate, provided that such committees may make recommendations to the JSC but may not be delegated JSC decision-making authority;
4.4.1.134.4.1.12. support the filing and prosecution of the Project IP Rights;
4.4.1.144.4.1.13. address such other matters relating to the activities of the Parties under this Agreement as either Party may bring before the JSC, including any matters that are expressly for the JSC to decide as provided in this Agreement;
4.4.1.154.4.1.14. assist the Parties in their efforts to resolve any disputes on an informal basis, including any unresolved disputes from the Joint Project Teams;
4.4.1.164.4.1.15. confirm that a target or combination of targets for ProgramProject/Lead Series has been properly deconvoluted; and
4.4.1.174.4.1.16. confirm the Project Know-How, Project Compounds and Project IP Rights along with any Background IP Rights and Background Know-How that would be subject to a License Agreement under such Project.
Appears in 1 contract
Samples: Research Collaboration and Option Agreement (Recursion Pharmaceuticals, Inc.)
