Common use of Regulatory Submissions Clause in Contracts

Regulatory Submissions. Incyte shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, the FDA with respect to JAK Licensed Products in the JAK Field in the Incyte Territory. Novartis shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to: (i) the EMEA, MHLW and other Regulatory Authorities in the Novartis JAK Territory with respect to the JAK Licensed Products in the JAK Field and (ii) all Regulatory Authorities with respect to the c-MET Licensed Products in the c-MET Field in the Novartis Territory. Each Party shall keep the JAK JDC reasonably informed in connection with the preparation of all Regulatory Documentation, Regulatory Authority review of Regulatory Documentation, and Regulatory Approvals, annual reports, annual re-assessments, and variations and labeling, in each case with respect to the JAK Licensed Product in the Field; provided that the providing Party shall have the right to redact any information to the extent not related to JAK Licensed Product in the Field. Each Party shall respond within a reasonable time frame to all reasonable inquiries by the other Party with respect to any information provided pursuant to this Section 4.7(a). Unless already the Confidential Information of a Party, any information disclosed pursuant to this Section 4.7(a) shall be the Confidential Information of the disclosing Party. For the purposes of this Section 4.7(a), each Party grants the other Party a royalty-free license to use, copy and distribute any articles, clinical study summaries or other materials that it has prepared solely for the purposes of preparing and pursuing its regulatory submissions and filings and communication with the Regulatory Authorities. The Parties shall use Commercially Reasonable Efforts to promptly take the actions described in this Section 4.7(a)

Regulatory Submissions. Incyte Merus shall develop, produce, oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, the FDA with respect to JAK Licensed Products the Program 1 Product in the JAK Field in the United States; provided that Merus shall [**] to enable Incyte Territoryto [**]. Novartis Incyte shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to: (i) the EMEAexcept as provided above, MHLW and other all Regulatory Authorities in the Novartis JAK Territory with respect to the JAK Licensed Products in the JAK Field Program 1 Product, provided that Incyte shall [**] to enable Merus to [**], and (ii) all Regulatory Authorities with respect to the cProgram 2 Product, [**] Products, and Novel Program Products, provided that with respect to the [**] Co-MET Licensed Development Products in the cand an Additional Co-MET Field in the Novartis TerritoryDevelopment Product, if any, Incyte shall provide Merus with copies of [**] to enable Merus to [**]. Each Party shall keep the JAK Program 1 JDC, and Incyte shall keep the [**] JDC and Additional JDC, reasonably informed in connection with the preparation of all Regulatory Documentation, Regulatory Authority review of Regulatory Documentation, and Regulatory Approvals, annual reports, annual re-assessments, and variations and labeling, in each case with respect to the JAK Licensed Product in Program 1 Product, the Field[**] Co-Development Product, or an Additional Co-Development Product, if any, as applicable; provided that the providing Party shall have the right to redact any information to the extent not related to JAK Licensed Product in the FieldProgram 1 Products, the [**] Co-Development Products, or an Additional Co-Development Product, if any. Each Party shall respond within a reasonable time frame to all reasonable inquiries by the other Party with respect to any information provided pursuant to this Section 4.7(a5.7(a). Unless already the Confidential Information of a Party, any information disclosed pursuant to this Section 4.7(a5.7(a) shall be the Confidential Information of the disclosing Disclosing Party. For the purposes of this Section 4.7(a), each Party grants the other Party a royalty-free license to use, copy and distribute any articles, clinical study summaries or other materials that it has prepared solely for the purposes of preparing and pursuing its regulatory submissions and filings and communication with the Regulatory Authorities. The Parties shall use Commercially Reasonable Efforts to promptly take the actions described in this Section 4.7(a).

Regulatory Submissions. Incyte Merus shall develop, produce, oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, the FDA with respect to JAK Licensed Products the Program 1 Product in the JAK Field in the United States; provided that Merus shall [*] to enable Incyte Territoryto [*]. Novartis Incyte shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to: (i) the EMEAexcept as provided above, MHLW and other all Regulatory Authorities in the Novartis JAK Territory with respect to the JAK Licensed Products in the JAK Field Program 1 Product, provided that Incyte shall [*] to enable Merus to [*], and (ii) all Regulatory Authorities with respect to the cProgram 2 Product, [*] Products, and Novel Program Products, provided that with respect to the [*] Co-MET Licensed Development Products in the cand an Additional Co-MET Field in the Novartis TerritoryDevelopment Product, if any, Incyte shall provide Merus with copies of [*] to enable Merus to [*]. Each Party shall keep the JAK Program 1 JDC, and Incyte shall keep the [*] JDC and Additional JDC, reasonably informed in connection with the preparation of all Regulatory Documentation, Regulatory Authority review of Regulatory Documentation, and Regulatory Approvals, annual reports, annual re-assessments, and variations and labeling, in each case with respect to the JAK Licensed Product Program 1 Product, the [*] Co-Development Product, or an [*] Certain information in this document has been omitted and filed separately with the FieldSecurities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Confidential Treatment Requested Under 17 C.F.R.§§ 200.80(b)(4) and 240-24b-2 Additional Co-Development Product, if any, as applicable; provided that the providing Party shall have the right to redact any information to the extent not related to JAK Licensed Product in the FieldProgram 1 Products, the [*] Co-Development Products, or an Additional Co-Development Product, if any. Each Party shall respond within a reasonable time frame to all reasonable inquiries by the other Party with respect to any information provided pursuant to this Section 4.7(a5.7(a). Unless already the Confidential Information of a Party, any information disclosed pursuant to this Section 4.7(a5.7(a) shall be the Confidential Information of the disclosing Disclosing Party. For the purposes of this Section 4.7(a), each Party grants the other Party a royalty-free license to use, copy and distribute any articles, clinical study summaries or other materials that it has prepared solely for the purposes of preparing and pursuing its regulatory submissions and filings and communication with the Regulatory Authorities. The Parties shall use Commercially Reasonable Efforts to promptly take the actions described in this Section 4.7(a).