Common use of Responsibility for Regulatory Matters Clause in Contracts

Responsibility for Regulatory Matters. Following the Regulatory Transition Date, Gilead will be solely responsible for all regulatory matters relating to any Licensed Product or Gilead Combination Product in the Territory, and shall use Commercially Reasonable Efforts with respect to such regulatory matters for the first Licensed Product in each Major Market in each Target Indication, and Galapagos shall use Commercially Reasonable Efforts as requested by Gilead to assist Gilead with such regulatory matters. Notwithstanding anything to the contrary in this Agreement, the immediately foregoing obligation with respect to Commercially Reasonable Efforts in the Major Markets and the Target Indications shall be Gilead’s sole diligence obligation with respect to regulatory matters for Licensed Products and Gilead Combination Products, and Gilead shall have the sole right, but not any obligation, with respect to regulatory matters for other Licensed Products and Gilead Combination Products in other countries or for other indications and no diligence obligation of Gilead shall arise under this Agreement with respect to seeking or obtaining Regulatory Approvals for Gilead Combination Products. Gilead’s sole responsibility shall include (i) overseeing, monitoring and coordinating regulatory actions, communications and filings with, and submissions to, Regulatory Authority in the Territory with respect to Licensed Products and Gilead Combination Products; (ii) interfacing, corresponding and meeting with Regulatory Authorities in the Territory with respect to Licensed Products and Gilead Combination Products; (iii) seeking and maintaining regulatory filings in the Territory with respect to Licensed Products and Gilead Combination Products; and (iv) maintaining and submitting records required to be maintained or required to be submitted to any Regulatory Authority in the Territory with respect to Licensed Products and Gilead Combination Products.

Responsibility for Regulatory Matters. Following Under the Regulatory Transition Dateauspices of, Gilead and subject to review and approval by, the Joint Development Committee, the Parties shall have the following responsibilities relating to regulatory matters with respect to the Product in the Territory: (a) BMS shall use all reasonable efforts necessary or desirable to register the Product in all countries in the Territory, in the name of the Party determined pursuant to Section 3.1, as soon as practicable. BMS shall (absent reasonable cause for delay, as determined by the Joint Development Committee) use all reasonable efforts to make each of the regulatory filings relating to the Product on or before the target filing date for such regulatory filing set forth on ANNEX D attached hereto. Sano shall provide all technical data and support necessary for BMS to make such regulatory filings. BMS shall keep Sano informed as to the status of such efforts, permit Sano to review any revisions to any filings or communications with regulatory authorities during their preparation and shall confer with Sano regarding the preparation of such filings and communications and the registration process. During such process, the Parties shall collaborate and cooperate in the preparation and filing of all documents necessary therefor and all regulatory interactions and compliance with regulatory authorities in the Territory. (b) With respect to regulatory filings relating to the Products in the United States, Sano shall assume responsibility for dealing with the FDA in respect of all matters relating to manufacturing compliance and quality assurance with respect to the Finished Products, and shall file with the FDA the required annual report relating thereto. Sano shall provide a copy of any such annual report (excluding any of Sano's proprietary information relating to the formulae and/or manufacturing processes for the Finished Product) to BMS, for review by BMS prior to Sano's filing of such annual report with the FDA. BMS shall assume all responsibility for dealing with the FDA in respect of all other matters relating to the Product, including without limitation the Bulk Materials, labelling, promotional compliance, medical issues and ADR reports. Sano and BMS shall cooperate with each other and deal jointly with any other issue relating to the Product or Sano's NDAs, or any supplements thereto, relating to the Product. Each of Sano and BMS shall be entitled to attend any meeting with the FDA arranged by the other Party, and shall advise the other Party as soon as reasonably possible of any such meetings arranged. All communications with the FDA by BMS or by Sano shall be confirmed in writing to the other Party, and each of the Parties shall provide to the other Party, copies of all documents sent to or received from the FDA regarding the Product. (c) BMS agrees to cooperate with and assist Sano in its efforts to obtain an agreement from the FDA that only one adequate, well controlled clinical study will be solely required for submission and approval of an NDA for a Product indicated for anxiety, provided that the FDA also agrees that such Product approval shall be for QD dosing and that the labelling therefor shall not be substantially different than the current labelling for BuSpar(R). (d) With respect to all other regulatory filings relating to the Products in other countries in the Territory, Sano shall be primarily responsible for all regulatory matters pertaining to the Patents and Know-How and directly relating to any Licensed the transdermal technology or to the formulae and/or manufacturing processes for the Finished Products, and BMS shall be primarily responsible for all other regulatory matters, including without limitation those regulatory matters relating to the Compound and labelling for the Products. (e) BMS shall be responsible for the preparation of all finished, approved art and copy for labelling and packaging of Finished Product or Gilead Combination Product in all countries in the Territory. (f) BMS shall be responsible for all costs associated with the regulatory filing and approval processes for the Products in all countries in the Territory, and except that Sano shall use Commercially Reasonable Efforts be responsible for all costs Sano incurs in connection with respect to such carrying out its responsibilities for regulatory matters for the first Licensed Product in each Major Market in each Target Indication, and Galapagos shall use Commercially Reasonable Efforts as requested by Gilead to assist Gilead with such regulatory matters. Notwithstanding anything to the contrary provided in this Agreement, the immediately foregoing obligation Section 3.4. (g) In connection with respect performing its obligations pursuant to Commercially Reasonable Efforts in the Major Markets and the Target Indications shall be Gilead’s sole diligence obligation with respect to regulatory matters for Licensed Products and Gilead Combination Products, and Gilead shall have the sole right, but not any obligation, with respect to regulatory matters for other Licensed Products and Gilead Combination Products in other countries or for other indications and no diligence obligation of Gilead shall arise under this Agreement with respect to seeking regulatory filings, BMS shall use all reasonable efforts to prevent its employees and other representatives from obtaining Sano's proprietary information relating to the formulae and/or manufacturing processes for the Finished Products, whether or obtaining Regulatory Approvals for Gilead Combination Products. Gilead’s sole responsibility shall include (i) overseeing, monitoring and coordinating regulatory actions, communications and filings with, and submissions to, Regulatory Authority not such proprietary information is included in the Territory with respect to Licensed Products and Gilead Combination Products; (ii) interfacing, corresponding and meeting with Regulatory Authorities in the Territory with respect to Licensed Products and Gilead Combination Products; (iii) seeking and maintaining regulatory filings in the Territory with respect to Licensed Products and Gilead Combination Products; and (iv) maintaining and submitting records required to be maintained or required to be submitted to any Regulatory Authority in the Territory with respect to Licensed Products and Gilead Combination Productsmade by BMS under this Agreement.

Responsibility for Regulatory Matters. Following Under the Regulatory Transition Dateauspices of, Gilead and subject to review and approval by, the Joint Development Committee, the Parties shall have the following responsibilities relating to regulatory matters with respect to the Product in the Territory: (a) BMS shall use all reasonable efforts necessary or desirable to register the Product in all countries in the Territory, in the name of the Party determined pursuant to Section 3.1, as soon as practicable. BMS shall (absent reasonable cause for delay, as determined by the Joint Development Committee) use all reasonable efforts to make each of the regulatory filings relating to the Product on or before the target filing date for such regulatory filing set forth on ANNEX D attached hereto. Sano shall provide all technical data and support necessary for BMS to make such regulatory filings. BMS shall keep Sano informed as to the status of such efforts, permit Sano to review any revisions to any filings or communications with regulatory authorities during their preparation and shall confer with Sano regarding the preparation of such filings and communications and the registration process. During such process, the Parties shall collaborate and cooperate in the preparation and filing of all documents necessary therefor and all regulatory interactions and compliance with regulatory authorities in the Territory. (b) With respect to regulatory filings relating to the Products in the United States, Sano shall assume responsibility for dealing with the FDA in respect of all matters relating to manufacturing compliance and quality assurance with respect to the Finished Products, and shall file with the FDA the required annual report relating thereto. Sano shall provide a copy of any such annual report (excluding any of Sano's proprietary information relating to the formulae and/or manufacturing processes for the Finished Product) to BMS, for review by BMS prior to Sano's filing *THIS PAGE CONTAINS CONFIDENTIAL MATERIAL THAT HAS BEEN REDACTED. of such annual report with the FDA. BMS shall assume all responsibility for dealing with the FDA in respect of all other matters relating to the Product, including without limitation the Bulk Materials, labelling, promotional compliance, medical issues and ADR reports. Sano and BMS shall cooperate with each other and deal jointly with any other issue relating to the Product or Sano's NDAs, or any supplements thereto, relating to the Product. Each of Sano and BMS shall be entitled to attend any meeting with the FDA arranged by the other Party, and shall advise the other Party as soon as reasonably possible of any such meetings arranged. All communications with the FDA by BMS or by Sano shall be confirmed in writing to the other Party, and each of the Parties shall provide to the other Party, copies of all documents sent to or received from the FDA regarding the Product. (c) BMS agrees to cooperate with and assist Sano in its efforts to obtain an agreement from the FDA that only one adequate, well controlled clinical study will be solely required for submission and approval of an NDA for a Product indicated for anxiety, provided that the FDA also agrees that such Product approval shall be for QD dosing and that the labelling therefor shall not be substantially different than the current labelling for BuSpar(R). (d) With respect to all other regulatory filings relating to the Products in other countries in the Territory, Sano shall be primarily responsible for all regulatory matters pertaining to the Patents and Know-How and directly relating to any Licensed the transdermal technology or to the formulae and/or manufacturing processes for the Finished Products, and BMS shall be primarily responsible for all other regulatory matters, including without limitation those regulatory matters relating to the Compound and labelling for the Products. (e) BMS shall be responsible for the preparation of all finished, approved art and copy for labelling and packaging of Finished Product or Gilead Combination Product in all countries in the Territory. (f) BMS shall be responsible for all costs associated with the regulatory filing and approval processes for the Products in all countries in the Territory, and except that Sano shall use Commercially Reasonable Efforts be responsible for all costs Sano incurs in connection with respect to such carrying out its responsibilities for regulatory matters for the first Licensed Product in each Major Market in each Target Indication, and Galapagos shall use Commercially Reasonable Efforts as requested by Gilead to assist Gilead with such regulatory matters. Notwithstanding anything to the contrary provided in this Agreement, the immediately foregoing obligation Section 3.4. (g) In connection with respect performing its obligations pursuant to Commercially Reasonable Efforts in the Major Markets and the Target Indications shall be Gilead’s sole diligence obligation with respect to regulatory matters for Licensed Products and Gilead Combination Products, and Gilead shall have the sole right, but not any obligation, with respect to regulatory matters for other Licensed Products and Gilead Combination Products in other countries or for other indications and no diligence obligation of Gilead shall arise under this Agreement with respect to seeking regulatory filings, BMS shall use all reasonable efforts to prevent its employees and other representatives from obtaining Sano's proprietary information relating to the formulae and/or manufacturing processes for the Finished Products, whether or obtaining Regulatory Approvals for Gilead Combination Products. Gilead’s sole responsibility shall include (i) overseeing, monitoring and coordinating regulatory actions, communications and filings with, and submissions to, Regulatory Authority not such proprietary information is included in the Territory with respect to Licensed Products and Gilead Combination Products; (ii) interfacing, corresponding and meeting with Regulatory Authorities in the Territory with respect to Licensed Products and Gilead Combination Products; (iii) seeking and maintaining regulatory filings in the Territory with respect to Licensed Products and Gilead Combination Products; and (iv) maintaining and submitting records required to be maintained or required to be submitted to any Regulatory Authority in the Territory with respect to Licensed Products and Gilead Combination Productsmade by BMS under this Agreement.