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Regulatory Submissions. Merus shall develop, produce, oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, the FDA with respect to the Program 1 Product in the United States; provided that Merus shall [**] to enable Incyte to [**]. Incyte shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to: (i) except as provided above, all Regulatory Authorities with respect to the Program 1 Product, provided that Incyte shall [**] to enable Merus to [**], and (ii) all Regulatory Authorities with respect to the Program 2 Product, [**] Products, and Novel Program Products, provided that with respect to the [**] Co-Development Products and an Additional Co-Development Product, if any, Incyte shall provide Merus with copies of [**] to enable Merus to [**]. Each Party shall keep the 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 Program 1 Product, the [**] 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 the Program 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 5.7(a). Unless already the Confidential Information of a Party, any information disclosed pursuant to this Section 5.7(a) shall be the Confidential Information of the Disclosing Party.

Regulatory Submissions. Merus Incyte shall develop, produce, oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, the FDA with respect to the Program 1 Product JAK Licensed Products in the United States; provided that Merus shall [**] to enable JAK Field in the Incyte to [**]Territory. Incyte Novartis shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to: (i) except as provided abovethe EMEA, all MHLW and other Regulatory Authorities in the Novartis JAK Territory with respect to the Program 1 Product, provided that Incyte shall [**] to enable Merus to [**], JAK Licensed Products in the JAK Field and (ii) all Regulatory Authorities with respect to the Program 2 Product, [**] Products, and Novel Program Products, provided that with respect to c-MET Licensed Products in the [**] Coc-Development Products and an Additional Co-Development Product, if any, Incyte shall provide Merus with copies of [**] to enable Merus to [**]MET Field in the Novartis Territory. Each Party shall keep the Program 1 JDC, and Incyte shall keep the [**] JAK 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 Program 1 Product, JAK Licensed Product in the [**] Co-Development Product, or an Additional Co-Development Product, if any, as applicableField; provided that the providing Party shall have the right to redact any information to the extent not related to JAK Licensed Product in the Program 1 Products, the [**] Co-Development Products, or an Additional Co-Development Product, if anyField. 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 5.7(a4.7(a). Unless already the Confidential Information of a Party, any information disclosed pursuant to this Section 5.7(a4.7(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. Merus shall develop, produce, oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, the FDA with respect to the Program 1 Product in the United States; provided that Merus shall [**] to enable Incyte to [**]. Incyte shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to: (i) except as provided above, all Regulatory Authorities with respect to the Program 1 Product, provided that Incyte shall [**] to enable Merus to [**], and (ii) all Regulatory Authorities with respect to the Program 2 Product, [**] Products, and Novel Program Products, provided that with respect to the [**] Co-Development Products and an Additional Co-Development Product, if any, Incyte shall provide Merus with copies of [**] to enable Merus to [**]. Each Party shall keep the 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 Program 1 Product, the [**] Co-Development Product, or an [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Confidential Treatment Requested Under 17 C.F.R.搂搂 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 the Program 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 5.7(a). Unless already the Confidential Information of a Party, any information disclosed pursuant to this Section 5.7(a) shall be the Confidential Information of the Disclosing Party.

Regulatory Submissions. Merus (a) Unless otherwise required by relevant Regulatory Agencies: (i) Subject to Subparagraph (iii) below, BMS shall develop, produce, oversee, monitor and coordinate be the Lead Regulatory Party for all regulatory actions, communications and filings withDevelopment activities under the Development Plan, and submissions toit shall own all corresponding Regulatory Filings, including INDs. (ii) Zymo shall provide to BMS copies of all Regulatory Filings described in Section 4.2.1(b). (iii) Zymo shall be the FDA Lead Regulatory Party with respect to [ * ], and it shall own all corresponding Regulatory Filings, including INDs, until at least the Program 1 Product in the United Statestime of [ * ] clinical trial; provided that, following the earlier of (A) [ * ] and (B) the completion of the [ * ], the JDC shall agree to a plan whereby Zymo shall assign to BMS all Regulatory Filings described in Subparagraph (ii) and this Subparagraph (iii), after which Zymo shall no longer be the Lead Regulatory Party. The parties agree that Merus the target date for such assignment shall [**be the [ * ], however, the parties agree that the timely [ * ] is of a high priority and the JDC may delay such assignment if necessary to enable Incyte to [**expedite the [ * ]. Incyte . (b) For each Licensed Product Developed or Commercialized under this Agreement, the Lead Regulatory Party shall oversee, monitor and coordinate all regulatory actions, communications and filings promptly provide the other party with, and submissions to: as applicable, (i) except as provided above, copies of all material Regulatory Authorities with respect to Filings in the Program 1 Product, provided that Incyte shall [**] to enable Merus to [**], 乐天堂app下载t Development Territory; and (ii) all Regulatory Authorities with respect reasonable advance notice (to the Program 2 extent practicable) of scheduled meetings with the FDA or other relevant Regulatory Agency in the 乐天堂app下载t Development Territory that pertain to such Licensed Product. Consistent with Applicable Laws, [**] Productsthe Lead Regulatory Party shall afford representatives of the other party a reasonable opportunity to comment on such Regulatory Filings, and Novel Program Productsshall reasonably consider such comments, provided that with respect to the [**] Co-Development Products and an Additional Co-Development Productand, if any, Incyte shall provide Merus with copies of [**] to enable Merus to [**]. Each Party shall keep the 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 Program 1 Product, the [**] 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 prohibited by Applicable Law, shall afford medical, scientific and/or regulatory representatives of the other party an opportunity, at such other party鈥檚 option, to attend such meetings with the relevant Regulatory Agency in the 乐天堂app下载t Development Territory, to the Program 1 Products, extent reasonably practicable under the [**] Co-Development Products, or an Additional Co-Development Productcircumstances. In addition, if any. Each Zymo receives written notice from a Regulatory Agency during the time it is the Lead Regulatory Party shall respond within a reasonable time frame that it will become subject to all reasonable inquiries an inspection or audit by the other Party such Regulatory Agency with respect to a Licensed Product, Zymo shall notify BMS and shall afford BMS鈥� regulatory representatives an opportunity, at BMS鈥� option, to attend such inspection or audit pertaining to such Licensed Product, to the extent reasonably practicable under the circumstances. During the time that Zymo is conducting any information provided clinical trials with a Licensed Product pursuant to the 乐天堂app下载t Development Plan, Zymo shall work with BMS to ensure compliance with the clinical trial disclosure obligations as described in the Safety Data Exchange Agreement. (c) The Lead Regulatory Party shall not transfer title or otherwise attempt in any manner to dispose of any Regulatory Filings in the Territory or otherwise impair the other party鈥檚 rights in such filings or subsequent Regulatory Approvals. (d) Prior to a Conversion, the content and language of the proposed package insert, and all changes thereto, including all safety-related package insert changes for Licensed Products in the USA, shall be reviewed and approved by the JDC prior to submission to the applicable Regulatory Agency. BMS shall be responsible for all content and language of the proposed package insert, and all changes thereto, including all safety-related package insert changes for Licensed Products in the rest of the Territory. (e) If the arrangement described in this Section 5.7(a). Unless already 4.4.2 results in significant logistical difficulties or otherwise causes a material delay, the Confidential Information of a Party, any information disclosed pursuant to this Section 5.7(a) JEC shall be the Confidential Information of the Disclosing Partydiscuss alternatives.