Specific Responsibilities of the JEC. In addition to its overall responsibility for the Collaboration, but subject to Sections 4.1(b) and 4.4(c), the JEC shall, in particular, have the following specific responsibilities: (i) Review and approve the research and Development strategies for each Collaboration Compound and Product; (ii) oversee the Parties’ activities hereunder; (iii) approve budgets for the Exelixis Development Expenses; (iv) review all significant and strategic issues within the purview of the JRDC; (v) oversee the Development of each Product pursuant to its Initial Development Plan and respective Annual Development Plan, up to the initiation of Phase III Clinical Trials; (vi) review and approve any material amendments to the Approved Plans and any other items submitted to the JEC by the JRDC; (vii) provide a forum for disputed matters within the responsibilities of JRDC; and [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (viii) such other responsibilities as may be assigned to the JEC pursuant to the Agreement or as may be agreed between the Parties from time to time.
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Specific Responsibilities of the JEC. In addition to its overall responsibility for the CollaborationDevelopment strategy of the Products, but subject to Sections 4.1(b3.1(b) and 4.4(c3.4(c), the JEC shall, in particular, have the following specific responsibilities:
(i) Review and approve the research Global Development Plan and each Annual Development strategies Plan for each Collaboration Compound and Product;
(ii) oversee the Parties’ activities hereunder;
(iii) approve budgets for the Exelixis Development Expenses;
(iv) review all significant and strategic issues within the purview of the JRDC;
(v) oversee the Development of each Product pursuant to its Initial Development Plan and respective Annual Development Plan, up to the initiation of Phase III Clinical Trials;
(vi) review and approve any material amendments to the Approved Plans and any other items submitted to the JEC by the JRDC;
(vii) provide a forum for disputed matters within the responsibilities of JRDCJDC; and [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(v) oversee the Development of each Product pursuant to its Global Development Plan and respective Annual Development Plan, up to the initiation of Phase III Clinical Trials;
(vi) review and approve any material amendments to the Approved Plans and any other items submitted to the JEC by the JDC;
(vii) provide a forum for disputed matters within the responsibilities of JDC or JEC; and
(viii) such other responsibilities as may be assigned to the JEC pursuant to the Agreement or as may be agreed between the Parties from time to time.
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Samples: License Agreement (Exelixis Inc)
Specific Responsibilities of the JEC. In addition to its overall responsibility for the Collaboration, but subject to Sections 4.1(b2.1(b) and 4.4(c2.6(c), the JEC shall, in particular, have the following specific responsibilitiesresponsibilities with respect to Committee-Governed Products:
(i) Review and approve the research global Development, regulatory and Development Commercialization strategies for each Collaboration Compound and Productthe Collaboration;
(ii) oversee coordinate the Parties’ activities hereunder;
(iii) approve plans and budgets for the Exelixis Development Expenses;
(iv) review all significant and strategic issues within the purview of the JRDC;
(v) oversee the Development of each Product pursuant to its Initial Development Plan and respective Annual Development Plan, up to the initiation of Phase III Clinical Trials;
(vi) review and approve any material amendments to the Approved Plans and any other items submitted to the JEC Collaboration proposed by the JRDC;
(vii) provide a forum for disputed matters within the responsibilities of JRDCJDC or JCC; and [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(iv) review all significant and strategic issues within the purview of the various Committees;
(v) manage and oversee the Development and Commercialization of each Product pursuant to the terms of the Agreement;
(vi) review and approve any material amendments to the Approved Plans and any other items submitted to the JEC by the JDC or JCC;
(vii) oversee life cycle management of, and intellectual property protection for, a Product;
(viii) provide a forum for dispute resolution; and
(ix) such other responsibilities as may be assigned to the JEC pursuant to the Agreement or as may be agreed between the Parties from time to time.
Appears in 1 contract
Specific Responsibilities of the JEC. In addition to its overall responsibility for the CollaborationDevelopment strategy of the Products, but subject to Sections 4.1(b3.1(b) and 4.4(c3.4(c), the JEC shall, in particular, have the following specific responsibilities:
(i) Review and approve the research Global Development Plan and each Annual Development strategies Plan for each Collaboration Compound and Product;
(ii) oversee the Parties’ activities hereunder;
(iii) approve budgets for the Exelixis Development Expenses;
(iv) review all significant and strategic issues within the purview of the JRDC;
(v) oversee the Development of each Product pursuant to its Initial Development Plan and respective Annual Development Plan, up to the initiation of Phase III Clinical Trials;
(vi) review and approve any material amendments to the Approved Plans and any other items submitted to the JEC by the JRDC;
(vii) provide a forum for disputed matters within the responsibilities of JRDC; and [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(iii) approve budgets for the Exelixis Development Expenses;
(iv) review all significant and strategic issues within the purview of the JDC;
(v) oversee the Development of each Product pursuant to its Global Development Plan and respective Annual Development Plan, up to the initiation of Phase III Clinical Trials;
(vi) review and approve any material amendments to the Approved Plans and any other items submitted to the JEC by the JDC;
(vii) provide a forum for disputed matters within the responsibilities of JDC or JEC; and
(viii) such other responsibilities as may be assigned to the JEC pursuant to the Agreement or as may be agreed between the Parties from time to time.
Appears in 1 contract
Samples: License Agreement (Exelixis Inc)