Common use of GSK Diligence; Responsibilities Clause in Contracts

GSK Diligence; Responsibilities. During the Product Candidate Commercialization Program, GSK shall exercise its Diligent Efforts in developing and commercializing each Option Compound as a Product Candidate and Licensed Product for whatever Indications are selected by GSK, at GSK’s sole discretion. GSK shall be entitled to make all decisions in good faith with respect to the progression of the Development and commercialization of any Product Candidate in any country and for any Indication consistent with the application of its Diligent Efforts and consistent with its usual business practices and on the basis of any reasonable scientific, medical, safety, marketing, manufacturing, commercial, regulatory, patent and/or strategic factors or considerations, and shall have the right to discontinue (or not to initiate) the development or commercialization of any such Product Candidate for any Indication on the basis of any of such factors or considerations and consistent with its Diligent Efforts, [***]. In particular except as set forth in Section 5.2, GSK, either itself and/or by and through its Affiliates, Sublicensees or contractors, shall be responsible for and shall have sole decision-making authority with respect to, and shall have the exclusive right to engage in, all further Development, manufacturing, marketing, advertising, promotional, launch, commercialization and sales activities in connection with the further development, commercialization, sales and marketing of the Product Candidates and Licensed Products. As part of the Product Candidate Commercialization Program, GSK shall use its Diligent Efforts to: (a) conduct all Clinical Studies following PoC Trials for the Product Candidates, as deemed necessary or desirable by GSK, in accordance with this Section 5.5.2; (b) conduct additional formulation development of Product Candidates as and if deemed necessary or appropriate by GSK and as consistent with the Product Candidate Commercialization Program; (c) develop additional pharmacogenomic and biomarker assays as and if GSK determines them to be useful or desirable for the Product Candidates and/or the potential *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. Licensed Products consistent with the Product Candidate Commercialization Program as necessary; (d) be responsible for preparing and filing all regulatory filings for Product Candidates, including all NDAs; (e) have the exclusive right and responsibility for manufacturing or having manufactured (including process development and scale up) all bulk drug substance or drug product material with respect to Product Candidates for ongoing development and commercial requirements, consistent with GSK’s reasonable internal practices, industry standards and all applicable laws and regulations; (f) own all XXXx, Marketing Approvals and other regulatory filings and approvals, and all brands and trademarks for the Product Candidate(s) and Licensed Products in the Territory; (g) prepare and execute Product Marketing Plans for each of the Licensed Products in the Territory, and all promotional and selling materials for use in connection with the sales of Licensed Products; (h) conduct, or cause to be conducted, manage and oversee all analysis and other support necessary with respect to the manufacture, marketing and sale of all Licensed Products in the Territory; (i) consider in good faith all reasonable suggestions received from ChemoCentryx regarding the Product Candidate Commercialization Program; (j) consider in good faith any reasonable concerns ChemoCentryx may have regarding the launch of Licensed Products within various marketing regions of the Territory and in all cases promptly respond to ChemoCentryx regarding such concerns; and (k) maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Product Candidate Commercialization Program in the form required under all applicable laws and regulations.

GSK Diligence; Responsibilities. During the Product Candidate Commercialization Program, GSK shall exercise its Diligent Efforts in developing and commercializing each Option Compound as a Product Candidate and Licensed Product for whatever Indications are selected by GSK, at GSK’s sole discretion. GSK shall be entitled to make all decisions in good faith with respect to the progression of the Development and commercialization of any Product Candidate in any country and for any Indication consistent with the application of its Diligent Efforts and consistent with its usual business practices and on the basis of any reasonable scientific, medical, safety, marketing, manufacturing, commercial, regulatory, patent and/or strategic factors or considerations, and shall have the right to discontinue (or not to initiate) the development or commercialization of any such Product Candidate for any Indication on the basis of any of such factors or considerations and consistent with its Diligent Efforts, [***]. In particular except as set forth in Section 5.2, GSK, either itself and/or by and through its Affiliates, Sublicensees or contractors, shall be responsible for and shall have sole decision-making authority with respect to, and shall have the exclusive right to engage in, all further Development, manufacturing, marketing, advertising, promotional, launch, commercialization and sales activities in connection with the further development, commercialization, sales and marketing of the Product Candidates and Licensed Products. As part of the Product Candidate Commercialization Program, GSK shall use its Diligent Efforts to: (a) conduct all Clinical Studies following PoC Trials for the Product Candidates, as deemed necessary or desirable by GSK, in accordance with this Section 5.5.2; (b) conduct additional formulation development of Product Candidates as and if deemed necessary or appropriate by GSK and as consistent with the Product Candidate Commercialization Program; (c) develop additional pharmacogenomic and biomarker assays as and if GSK determines them to be useful or desirable for the Product Candidates and/or the potential *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. Licensed Products consistent with the Product Candidate Commercialization Program as necessary; (d) be responsible for preparing and filing all regulatory filings for Product Candidates, including all NDAs; (e) have the exclusive right and responsibility for manufacturing or having manufactured (including process development and scale up) all bulk drug substance or drug product material with respect to Product Candidates for ongoing development and commercial requirements, consistent with GSK’s reasonable internal practices, industry standards and all applicable laws and regulations;; *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. (f) own all XXXx, Marketing Approvals and other regulatory filings and approvals, and all brands and trademarks for the Product Candidate(s) and Licensed Products in the Territory; (g) prepare and execute Product Marketing Plans for each of the Licensed Products in the Territory, and all promotional and selling materials for use in connection with the sales of Licensed Products; (h) conduct, or cause to be conducted, manage and oversee all analysis and other support necessary with respect to the manufacture, marketing and sale of all Licensed Products in the Territory; (i) consider in good faith all reasonable suggestions received from ChemoCentryx regarding the Product Candidate Commercialization Program; (j) consider in good faith any reasonable concerns ChemoCentryx may have regarding the launch of Licensed Products within various marketing regions of the Territory and in all cases promptly respond to ChemoCentryx regarding such concerns; and (k) maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Product Candidate Commercialization Program in the form required under all applicable laws and regulations.

GSK Diligence; Responsibilities. During the Product Candidate Commercialization Program, GSK shall exercise its Diligent Efforts in developing and commercializing each Option Compound as a Product Candidate and Licensed Product for whatever Indications are selected by GSK, at GSK’s sole discretion. GSK shall be entitled to make all decisions in good faith with respect to the progression of the Development and commercialization of any Product Candidate in any country and for any Indication consistent with the application of its Diligent Efforts and consistent with its usual business practices and on the basis of any reasonable scientific, medical, safety, marketing, manufacturing, commercial, regulatory, patent and/or strategic factors or considerations, and shall have the right to discontinue (or not to initiate) the development or commercialization of any such Product Candidate for any Indication on the basis of any of such factors or considerations and consistent with its Diligent Efforts, [***]. In particular except as set forth in Section 5.2, GSK, either itself and/or by and through its Affiliates, Sublicensees or contractors, shall be responsible for and shall have sole decision-making authority with respect to, and shall have the exclusive right to engage in, all further Development, manufacturing, marketing, advertising, promotional, launch, commercialization and sales activities in connection with the further development, commercialization, sales and marketing of the Product Candidates and Licensed Products. As part of the Product Candidate Commercialization Program, GSK shall use its Diligent Efforts to: (a) conduct all Clinical Studies following PoC Trials for the Product Candidates, as deemed necessary or desirable by GSK, in accordance with this Section 5.5.2; (b) conduct additional formulation development of Product Candidates as and if deemed necessary or appropriate by GSK and as consistent with the Product Candidate Commercialization Program; (c) develop additional pharmacogenomic and biomarker assays as and if GSK determines them to be useful or desirable for the Product Candidates and/or the potential *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. -49- Licensed Products consistent with the Product Candidate Commercialization Program as necessary; (d) be responsible for preparing and filing all regulatory filings for Product Candidates, including all NDAs; (e) have the exclusive right and responsibility for manufacturing or having manufactured (including process development and scale up) all bulk drug substance or drug product material with respect to Product Candidates for ongoing development and commercial requirements, consistent with GSK’s reasonable internal practices, industry standards and all applicable laws and regulations; (f) own all XXXx, Marketing Approvals and other regulatory filings and approvals, and all brands and trademarks for the Product Candidate(s) and Licensed Products in the Territory; (g) prepare and execute Product Marketing Plans for each of the Licensed Products in the Territory, and all promotional and selling materials for use in connection with the sales of Licensed Products; (h) conduct, or cause to be conducted, manage and oversee all analysis and other support necessary with respect to the manufacture, marketing and sale of all Licensed Products in the Territory; (i) consider in good faith all reasonable suggestions received from ChemoCentryx regarding the Product Candidate Commercialization Program; (j) consider in good faith any reasonable concerns ChemoCentryx may have regarding the launch of Licensed Products within various marketing regions of the Territory and in all cases promptly respond to ChemoCentryx regarding such concerns; and (k) maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Product Candidate Commercialization Program in the form required under all applicable laws and regulations.

GSK Diligence; Responsibilities. During the Product Candidate Commercialization Program, without limiting or modifying any obligation of GSK expressly provided in any other relevant provision of this Agreement, GSK shall exercise use its Diligent Efforts in developing to Develop and commercializing commercialize each Option Compound (and each [********] that achieves [********] based on completion [********] of the equivalent of [********] for such [********]) as and into a Product Candidate and Licensed Product for whatever Indications are selected by GSKin the Field. Subject expressly to (i) its obligation to use Diligent Efforts with respect to the foregoing and (ii) the requirements of this Section 5.3.2 and Section 5.3.3, at GSK’s sole discretion. GSK shall be entitled to make all decisions in good faith with respect to the progression of the Development and commercialization of any Product Candidate in any country and for any Indication consistent with use in the application of its Diligent Efforts and consistent with its usual business practices and on the basis of any reasonable scientific, medical, safety, marketing, manufacturing, commercial, regulatory, patent and/or strategic factors Field or considerations, and shall have the right to discontinue (the Development, or not to initiate) the development or [********] commercialization of any such Product Candidate for any Indication on the basis of any of such factors or considerations and consistent with its Diligent Efforts, [***]Candidate. In particular except as set forth in Section 5.2particular, GSK, either itself and/or or by and through its Affiliates, Sublicensees or contractors, shall be responsible for and shall have sole decision-making authority with respect to, and shall have the exclusive right to engage in, all further Development, manufacturing, marketing, advertising, promotional, launch, commercialization and sales activities in connection with the further developmentDevelopment, commercialization, sales and marketing of the Product Candidates and Licensed Products, subject to Targacept’s right to conduct Targacept Post-Exercise Activities and to Targacept’s Co-promotion Rights, each as expressly provided in this Agreement. For the avoidance of doubt, the Parties understand and agree that GSK’s diligence obligations under this Agreement shall not apply to any Backup Compound with respect to an Option Compound and shall apply to a Follow-On Compound with respect to a particular Option Compound only to the extent provided in this Section 5.3.2. As part of the Product Candidate Commercialization Program, GSK shall use shall, subject to the application and limitations of its Diligent Efforts toEfforts: (a) conduct all Clinical Studies following the PoC Trials Trial for the Product Candidates, as deemed necessary or desirable by GSK, in accordance with this Section 5.5.2Candidate(s); (b) conduct additional formulation development of Product Candidates as and if deemed necessary or appropriate by GSK and as consistent with the Product Candidate Commercialization Program; (c) develop additional pharmacogenomic and biomarker assays as and if GSK determines them to be useful or desirable for the Product Candidates and/or the potential *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. Licensed Products consistent with the Product Candidate Commercialization Program as necessary; (d) be responsible for preparing and filing all regulatory filings for Product Candidates, including all NDAs; (ed) manufacture or have the exclusive right and responsibility for manufacturing or having manufactured (including process development and scale up) all bulk drug substance or drug product material with respect to Product Candidates for ongoing development Development and commercial requirements, consistent with GSK’s reasonable internal practices, industry standards and all applicable laws and regulations; (fe) own all XXXxNDAs, Marketing Approvals and other regulatory filings and approvals, and all brands and trademarks for the Product Candidate(s) and Licensed Products in the Territory; (gf) prepare and execute Product Marketing Plans for each of the Licensed Products in the Territory, and all promotional and selling materials for use in connection with the sales sale of Licensed Products; (hg) conduct, or cause to be conducted, manage and oversee all analysis and other support necessary with respect to the manufacture, marketing and sale of all Licensed Products in the Territory; (ih) consider in good faith all reasonable suggestions received from ChemoCentryx Targacept regarding the Product Candidate Commercialization Program; (ji) consider in good faith any reasonable concerns ChemoCentryx Targacept may have regarding the launch of Licensed Products within various marketing regions of the Territory and in all cases promptly respond to ChemoCentryx Targacept regarding such concerns; and (kj) maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Product Candidate Commercialization Program in the form required under all applicable laws and regulations.