Common use of Specific GSK Responsibilities Clause in Contracts

Specific GSK Responsibilities. Without limiting any of the foregoing, following the exercise of a Program Option for a Program hereunder, GSK shall use its Diligent Efforts to: (a) conduct all Pre-Clinical Studies and Clinical Studies on the Option Compounds, as deemed necessary or desirable by GSK, in accordance with this Section 4.4.2; (b) conduct additional formulation Development of the Option Compounds as and if deemed necessary or appropriate by GSK; (c) provide to the JSC reasonable progress updates at each regular meeting of the JSC on the status of GSK’s Development efforts with respect to the Option Compounds and related Licensed Products; (d) prepare and file all regulatory filings for the Option Compounds or related Licensed Products, including all NDAs; (e) Manufacture or have Manufactured (including process development and scale up) all bulk drug substance or drug product material with respect to the Option Compounds and related Licensed Products for ongoing Development and Commercialization requirements, consistent with GSK’s reasonable internal practices, industry standards and all applicable laws and regulations; (f) own and maintain all NDAs, Regulatory Approvals and other regulatory filings and approvals, and all brands and trademarks for any resulting Licensed Products in the Field in the Territory; (g) maintain a safety database with respect to all Option Compounds and related Licensed Products Developed and Commercialized by GSK, and report all adverse drug reaction experiences related to such Option Compounds and Licensed Products in connection with the activities of GSK under this Agreement to the appropriate Regulatory Authorities in the countries in the Territory in which the Option Compounds and Licensed Products are being Developed and Commercialized, in accordance with applicable laws and regulations of the relevant countries and Regulatory Authorities and in accordance with GSK’s internal policies; and (h) conduct, at [...***...] all Commercialization activities in connection with the sales of Licensed Products.

Specific GSK Responsibilities. Without limiting any of the foregoing, following the exercise of a Program an Option for a Collaboration Program hereunder, GSK shall will use its Diligent Commercially Reasonable Efforts to: (a) conduct all Pre-Clinical Studies and Clinical Studies on the Option Compounds, Licensed Compound and related Licensed Product as deemed necessary or desirable by GSKGSK or any applicable Regulatory Authority, but at a minimum consistent with the level and type of activities GSK would reasonably conduct for its other compounds or products of similar market potential at similar stages in accordance with this Section 4.4.2development or product life; (b) conduct additional formulation Development development of the Option Compounds Licensed Compound and related Licensed Product as and if deemed necessary or appropriate by GSK; (c) provide to the JSC Isis reasonable progress updates at each regular meeting of the JSC and product plans in accordance with Section 4.3.2 and Section 4.3.3 below on the status of GSK’s Development and Commercialization efforts with respect to the Option Licensed Compounds and related Licensed Products; (d) prepare and file all regulatory filings for the Option Compounds Licensed Compound or related Licensed ProductsProduct, including all NDAsINDs, NDAs and other filings; (e) except as provided in Section 3.3.2, Manufacture or have Manufactured (including process development and scale up) all bulk drug substance or drug product material with respect to the Option Compounds Licensed Compound and related Licensed Products Product for ongoing Development and Commercialization requirements, consistent with GSK’s reasonable internal practices, industry standards practices and all applicable laws and regulationsApplicable Laws; (f) own and maintain all INDs, NDAs, Regulatory Approvals and other regulatory filings and approvals, and all brands and trademarks for any resulting Licensed Products in the Field in the TerritoryProduct; (g) maintain a safety database with respect to all Option Compounds the Licensed Compound and related Licensed Products Product Developed and Commercialized by GSK, and report all adverse drug reaction experiences related to such Option Compounds Licensed Compound and Licensed Products Product in connection with the activities of GSK under this Agreement to the appropriate Regulatory Authorities in the countries in the Territory in which the Option Compounds Licensed Compound and related Licensed Products Product are being Developed and Commercialized, in accordance with applicable laws and regulations Applicable Laws of the relevant countries and Regulatory Authorities and in accordance with GSK’s internal policiespolicies and, without limiting Section 4.4, GSK will provide Isis with such safety-related information as required under Section 4.4; and (h) conduct, at [...***...] all GSK’s sole expense, Commercialization activities in connection with the sales marketing, promotion, and sale of such Licensed ProductsProduct.

Specific GSK Responsibilities. Without limiting any of the foregoing, following the exercise of a Program Option for a Program hereunder, GSK shall use its Diligent Efforts to: (a) conduct all Pre-Clinical Studies and Clinical Studies on the Option Compounds, as deemed necessary or desirable by GSK, in accordance with this Section 4.4.2; (b) conduct additional formulation Development of the Option Compounds as and if deemed necessary or appropriate by GSK; (c) provide to the JSC reasonable progress updates at each regular meeting of the JSC on the status of GSK’s Development efforts with respect to the Option Compounds and related Licensed Products; (d) prepare and file all regulatory filings for the Option Compounds or related Licensed Products, including all NDAs; (e) Manufacture or have Manufactured (including process development and scale up) all bulk drug substance or drug product material with respect to the Option Compounds and related Licensed Products for ongoing Development and Commercialization requirements, consistent with GSK’s reasonable internal practices, industry standards and all applicable laws and regulations; (f) own and maintain all NDAs, Regulatory Approvals and other regulatory filings and approvals, and all brands and trademarks for any resulting Licensed Products in the Field in the Territory; (g) maintain a safety database with respect to all Option Compounds and related Licensed Products Developed and Commercialized by GSK, and report all adverse drug reaction experiences related to such Option Compounds and Licensed Products in connection with the activities of GSK under this Agreement to the appropriate Regulatory Authorities in the countries in the Territory in which the Option Compounds and Licensed Products are being Developed and Commercialized, in accordance with applicable laws and regulations of the relevant countries and Regulatory Authorities and in accordance with GSK’s internal policies; and (h) conduct, at [...***...] all Commercialization activities in connection with the sales of Licensed Products.