Common use of Communications with Regulatory Authorities Clause in Contracts

Communications with Regulatory Authorities. (a) Following the Effective Date, SANOFI-AVENTIS shall be responsible for all submissions to, and communications and interactions with, Regulatory Authorities in the Territory with respect to Collaboration Compounds and Licensed Products, provided, that: (i) SANOFI-AVENTIS shall keep MERRIMACK promptly informed regarding SANOFI-AVENTIS’s (or its Affiliate’s or sublicensee’s) regulatory strategy, planned regulatory submissions and material communications with Regulatory Authorities in the Major Territories with respect to all Collaboration Compounds and Licensed Products, including any changes to such strategy, submissions or communications; (ii) SANOFI-AVENTIS shall provide MERRIMACK with copies, for information, of regulatory submissions to, and material communications with, any Regulatory Authorities in the Major Territories relating to Collaboration Compounds and Licensed Products and MERRIMACK shall have an opportunity to review and comment on all planned regulatory submissions to, and material communications with, Regulatory Authorities relating to clinical trials referenced in clause (iii) below; and (iii) As to any human clinical trial for a particular Collaboration Compound or Licensed Product for a given indication conducted or to be conducted by MERRIMACK under the Global Development Plan, SANOFI-AVENTIS shall give due consideration in good faith to incorporating any and all comments provided by MERRIMACK on any planned regulatory submissions to, or material communications with, any Regulatory Authorities in the Major Territories with respect to such clinical trial (or the results thereof) or the Collaboration Compound or Licensed Product used in such clinical trial, unless such comments are unreasonable. (b) In addition to each Party’s rights and obligations under clause (a): (i) SANOFI-AVENTIS shall provide MERRIMACK, if feasible, with reasonable advance notice of any material meeting or substantive telephone conference with the FDA, MHLW or EMEA relating to Collaboration Compounds or Licensed Products; and (ii) As to any human clinical trial for a particular Collaboration Compound or Licensed Product for a given indication conducted or to be conducted by MERRIMACK under the Global Development Plan, MERRIMACK shall have the right to attend and participate in any such material meeting or material conference call with such Regulatory Authorities relating to such clinical trial (or the results thereof) or the Collaboration Compound or Licensed Product used in such clinical trial. (c) Without limiting the generality of any of the foregoing in this Section 4.2, SANOFI-AVENTIS shall also promptly provide MERRIMACK with a copy of all material correspondence that SANOFI-AVENTIS (or its Affiliate or sublicensee) receives from, or submits to, any Regulatory Authorities in the Major Territories, including contact reports concerning conversations or substantive meetings, contact reports of all Regulatory Authority interactions concerning conversations or substantive meetings, all IND annual reports (including any equivalent filings outside the US), and cover letters of all agency submissions (it being understood that MERRIMACK may request, and shall then receive, copies of all attachments to any such cover letters) relating to any Collaboration Compound or Licensed Product. SANOFI-AVENTIS shall also provide MERRIMACK with any meeting minutes that SANOFI-AVENTIS prepares that reflect material communications with any Regulatory Authorities in the Major Territories regarding any Collaboration Compound or Licensed Product.

Communications with Regulatory Authorities. (a) Following the Effective Date, SANOFI-AVENTIS 6.3.1 Gilead shall be responsible for all submissions to, and communications and interactions with, Regulatory Authorities in the Gilead Territory for any Licensed Program with respect to Program DARTs and Licensed Products from such Licensed Program, and MacroGenics shall be responsible for all submissions to, and communications and interactions with, Regulatory Authorities in the MacroGenics Territory with respect to Collaboration Compounds *** Program DARTs and *** Licensed Products, provided, that. In connection therewith: (ia) SANOFI-AVENTIS Gilead shall keep MERRIMACK promptly MacroGenics reasonably informed regarding SANOFI-AVENTISGilead’s (or its Affiliate’s or sublicenseeSublicensee’s) regulatory strategy, planned regulatory submissions and material communications with the Regulatory Authorities in the Major Territories *** Licensed Territory with respect to all Collaboration Compounds *** Program DARTs and *** Licensed Products, including any significant changes to such strategy, submissions or communications; (ii) SANOFI-AVENTIS . Gilead shall provide MERRIMACK MacroGenics with copies, for information, copies of key portions of regulatory submissions to, and material key communications with, any the FDA and Regulatory Authorities in the Major Territories EU relating to Collaboration Compounds the *** Program DARTs and *** Licensed Products in the *** Licensed Territory. (b) MacroGenics shall keep Gilead reasonably informed regarding MacroGenics’ (or its Affiliate’s or Sublicensee’s) regulatory strategy, planned regulatory submissions and communications with the Regulatory Authorities in the MacroGenics Territory with respect to Program DARTs and Licensed Products and MERRIMACK from the *** Licensed Program, including any significant changes to such strategy, submissions or communications. MacroGenics shall have an opportunity to review and comment on all planned provide Gilead with copies of key portions of regulatory submissions to, and material key communications with, Regulatory Authorities the PMDA relating to clinical trials referenced in clause (iii) below; and (iii) As to any human clinical trial for a particular Collaboration Compound or the *** Program DARTs and *** Licensed Product for a given indication conducted or to be conducted by MERRIMACK under the Global Development Plan, SANOFI-AVENTIS shall give due consideration in good faith to incorporating any and all comments provided by MERRIMACK on any planned regulatory submissions to, or material communications with, any Regulatory Authorities Products in the Major Territories with respect to such clinical trial (or the results thereof) or the Collaboration Compound or Licensed Product used in such clinical trial, unless such comments are unreasonableMacroGenics Territory. (b) In addition to each Party’s rights and obligations under clause (a): (i) SANOFI-AVENTIS shall provide MERRIMACK, if feasible, with reasonable advance notice of any material meeting or substantive telephone conference with the FDA, MHLW or EMEA relating to Collaboration Compounds or Licensed Products; and (ii) As to any human clinical trial for a particular Collaboration Compound or Licensed Product for a given indication conducted or to be conducted by MERRIMACK under the Global Development Plan, MERRIMACK shall have the right to attend and participate in any such material meeting or material conference call with such Regulatory Authorities relating to such clinical trial (or the results thereof) or the Collaboration Compound or Licensed Product used in such clinical trial. (c) Without limiting the generality of any of the foregoing in this Section 4.2, SANOFI-AVENTIS shall also promptly provide MERRIMACK with a copy of all material correspondence that SANOFI-AVENTIS (or its Affiliate or sublicensee) receives from, or submits to, any Regulatory Authorities in the Major Territories, including contact reports concerning conversations or substantive meetings, contact reports of all Regulatory Authority interactions concerning conversations or substantive meetings, all IND annual reports (including any equivalent filings outside the US), and cover letters of all agency submissions (it being understood that MERRIMACK may request, and shall then receive, copies of all attachments to any such cover letters) relating to any Collaboration Compound or Licensed Product. SANOFI-AVENTIS shall also provide MERRIMACK with any meeting minutes that SANOFI-AVENTIS prepares that reflect material communications with any Regulatory Authorities in the Major Territories regarding any Collaboration Compound or Licensed Product.

Communications with Regulatory Authorities. (a) Following the Effective Date, SANOFI-AVENTIS subject to Section 5.3, MERRIMACK shall be responsible for all submissions to, and communications and interactions with, Regulatory Authorities in outside the PEI Territory with respect to Collaboration Compounds the Licensed Compound and the Licensed ProductsProduct, providedand PEI shall, thatunder the direction of the JDC, be responsible for submissions to, and communications and interactions with, Regulatory Authorities in the PEI Territory with respect to the Licensed Compound and the Licensed Product. In connection therewith: (i) SANOFI-AVENTIS MERRIMACK shall keep MERRIMACK promptly PEI reasonably informed regarding SANOFI-AVENTISMERRIMACK’s (or its Affiliate’s or sublicensee’s) regulatory strategy, planned regulatory submissions and material communications with Regulatory Authorities in the United States, the Major Territories EU Countries and the Major Asian Countries with respect to all Collaboration Compounds the Licensed Compound and the Licensed ProductsProduct, including any material changes to such strategy, submissions or communications;. MERRIMACK shall, to the extent (A) relevant to Development of the Licensed Compound and the Licensed Product in the PEI Territory and (B) Controlled by MERRIMACK, provide PEI with copies of material regulatory submissions to, and material communications with, any Regulatory Authorities in the United States, the MERRIMACK Europe Territory and the MERRIMACK Asia Territory relating to the Licensed Compound and the Licensed Product. (ii) SANOFI-AVENTIS Subject to the direction of the JDC, to the extent relevant to the Development of the Licensed Compound and Licensed Product and Commercialization of the Licensed Compound and Licensed Product outside the PEI Territory, PEI shall conduct regulatory activities in the PEI Territory in accordance with the regulatory strategy set forth in the Development Plan. PEI shall keep MERRIMACK reasonably informed regarding PEI’s (or its Affiliate’s or sublicensee’s) planned regulatory submissions and material communications with Regulatory Authorities in the PEI Territory with respect to the Licensed Compound and the Licensed Product, including any material changes to such submissions or communications, PEI shall, to the extent (A) relevant to Development of the Licensed Compound and the Licensed Product outside the PEI Territory and (B) Controlled by PEI, provide MERRIMACK with copies, for information, copies of regulatory submissions to, and material communications with, any Regulatory Authorities in the Major Territories PEI Territory relating to Collaboration Compounds the Licensed Compound and the Licensed Products and MERRIMACK shall have an opportunity to review and comment on all planned regulatory submissions to, and material communications with, Regulatory Authorities relating to clinical trials referenced in clause (iii) below; and (iii) As to any human clinical trial for a particular Collaboration Compound or Licensed Product for a given indication conducted or to be conducted by MERRIMACK under the Global Development Plan, SANOFI-AVENTIS shall give due consideration in good faith to incorporating any and all comments provided by MERRIMACK on any planned regulatory submissions to, or material communications with, any Regulatory Authorities in the Major Territories with respect to such clinical trial (or the results thereof) or the Collaboration Compound or Licensed Product used in such clinical trial, unless such comments are unreasonableProduct. (b) In addition to each Party’s rights and obligations under clause (a): (i) SANOFI-AVENTIS shall provide MERRIMACK, if feasible, with reasonable advance notice of any material meeting or substantive telephone conference with the FDA, MHLW or EMEA relating to Collaboration Compounds or Licensed Products; and (ii) As to any human clinical trial for a particular Collaboration Compound or Licensed Product for a given indication conducted or to be conducted by MERRIMACK under the Global Development Plan, MERRIMACK shall have the right to attend and participate in any such material meeting or material conference call with such Regulatory Authorities relating to such clinical trial (or the results thereof) or the Collaboration Compound or Licensed Product used in such clinical trial. (c) Without limiting the generality of any of the foregoing in this Section 4.25.4, (i) To the extent relevant to the Development or Commercialization of the Licensed Compound and the Licensed Product in the PEI Territory, SANOFI-AVENTIS MERRIMACK shall also promptly provide MERRIMACK PEI with a copy of all material correspondence that SANOFI-AVENTIS MERRIMACK (or its Affiliate or sublicensee) receives from, or submits to, any Regulatory Authorities in the United States, the Major TerritoriesEU Countries and the Major Asian Countries, including (to the extent relevant and requested) contact reports concerning conversations or substantive meetings, contact reports of all Regulatory Authority interactions concerning conversations or substantive meetings, all IND annual reports (including any equivalent filings outside the USUnited States), and cover letters of all agency submissions (it being understood that PEI may request, and shall then receive, copies of all attachments to any such cover letters) relating to the Licensed Compound or the Licensed Product. To the extent relevant to the Development or Commercialization of the Licensed Compound and the Licensed Product in the PEI Territory and requested by PEI, MERRIMACK shall also provide PEI with any meeting minutes that MERRIMACK prepares that reflect material communications with any Regulatory Authorities in the United States, the Major EU Countries and the Major Asian Countries regarding the Licensed Compound or the Licensed Product. PEI shall use the information and materials provided by MERRIMACK pursuant to this Section 5.4(b)(i) solely in the Development and Commercialization of the Licensed Compound and the Licensed Product in the PEI Territory and in accordance with the provisions of Article XI. (ii) To the extent relevant to the Development or Commercialization of the Licensed Compound and the Licensed Product outside the PEI Territory, PEI shall also promptly provide MERRIMACK with a copy of all material correspondence that PEI (or its Affiliate or sublicensee) receives from, or submits to, the DOH, including (to the extent relevant and requested) contact reports concerning conversations or substantive meetings, contact reports of all DOH interactions concerning conversations or substantive meetings, all IND annual reports (or the equivalent filing in Taiwan), and cover letters of all agency submissions (it being understood that MERRIMACK may request, and shall then receive, copies of all attachments to any such cover letters) relating to any Collaboration the Licensed Compound or the Licensed Product. SANOFI-AVENTIS To the extent relevant to the Development or Commercialization of the Licensed Compound and the Licensed Product outside the PEI Territory and requested by MERRIMACK, PEI shall also provide MERRIMACK with any meeting minutes that SANOFI-AVENTIS PEI prepares that reflect material communications with any Regulatory Authorities the DOH regarding the Licensed Compound or the Licensed Product. MERRIMACK shall use the information and materials provided by PEI pursuant to this Section 5.4(b)(ii) solely in the Major Territories regarding any Collaboration Development and Commercialization of the Licensed Compound or and the Licensed ProductProduct outside the PEI Territory and in accordance with the provisions of Article XI.

Communications with Regulatory Authorities. (a) Following the Effective Datetransfer of Regulatory Approvals and regulatory filings to Ipsen in accordance with Section 4.1, SANOFI-AVENTIS Ipsen shall be responsible for all submissions to, and communications and interactions with, Regulatory Authorities in the Licensed Territory with respect to Collaboration Compounds the Compound and all Licensed Products, provided, that: (i) SANOFI-AVENTIS Lexicon shall be responsible for all submissions to, and communications and interactions with, Regulatory Authorities in the Licensed Territory with respect to INDs relating to clinical trials conducted by Lexicon pursuant to the Development Plan; (ii) Ipsen shall keep MERRIMACK Lexicon promptly informed informed, through the JSC, JDC and JCC and Xxxxx’x reports pursuant to Section 6.2, regarding SANOFI-AVENTIS’s Xxxxx’x (or its Affiliate’s or sublicensee’s) regulatory strategy, planned regulatory submissions and material communications with Regulatory Authorities in the Major Territories Licensed Territory with respect to the Compound and all Collaboration Compounds and Licensed Products, including any changes to such strategy, submissions or communications; (iiiii) SANOFI-AVENTIS Lexicon shall provide MERRIMACK Ipsen with copies, for information, of regulatory submissions to, and material communications with, any Regulatory Authorities in the Major Territories Lexicon Territory relating to Collaboration Compounds the Compound and all Licensed Products and MERRIMACK as to clinical trials conducted by Lexicon in the Licensed Territory pursuant to the Development Plan; and (iv) Ipsen shall have an opportunity to review and comment on all planned provide Lexicon with copies, for information, of regulatory submissions to, and material communications with, Regulatory Authorities relating to clinical trials referenced in clause (iii) below; and (iii) As to any human clinical trial for a particular Collaboration Compound or Licensed Product for a given indication conducted or to be conducted by MERRIMACK under the Global Development Plan, SANOFI-AVENTIS shall give due consideration in good faith to incorporating any and all comments provided by MERRIMACK on any planned regulatory submissions to, or material communications with, any Regulatory Authorities in the Major Territories with respect Licensed Territory relating to such clinical trial (or the results thereof) or the Collaboration Compound or and all Licensed Product used in such clinical trial, unless such comments are unreasonableProducts. (b) In addition to each Party’s rights and obligations under clause (a): (i) SANOFI-AVENTIS Ipsen shall provide MERRIMACKLexicon, if feasible, with reasonable advance notice of any material meeting or substantive telephone conference with the FDA, MHLW or EMEA EMA relating to Collaboration Compounds the Compound or Licensed Products; and (ii) As to any human clinical trial for the Compound or a particular Collaboration Compound or Licensed Product for a given indication conducted or to be conducted by MERRIMACK Lexicon under the Global Development Plan, MERRIMACK Ipsen shall have the right to attend and participate in any such material meeting or material conference call with such Regulatory Authorities relating to such clinical trial (or the results thereof) or the Collaboration Compound or Licensed Product used in such clinical trial. (c) Without limiting the generality of any of the foregoing in this Section 4.2, SANOFI-AVENTIS each Party shall also promptly provide MERRIMACK the other Party with a copy of all material correspondence that SANOFI-AVENTIS such Party (or its Affiliate or sublicensee) receives from, or submits to, any Regulatory Authorities Authorities, in the Major TerritoriesLexicon Territory (and as to clinical trials conducted by Lexicon in the Licensed Territory pursuant to the Development Plan) in the case of Lexicon and in the Licensed Territory in the case of Ipsen, including including: (A) contact reports concerning substantive conversations or substantive meetings, contact reports of meetings with all Regulatory Authority interactions concerning conversations or substantive meetingsAuthorities, (B) documents related to regulatory milestone events and dates (e.g., filing and submission, validation, agency review questions, CHMP opinion and FDA complete response letter and their equivalent), (C) all IND annual reports (including any equivalent filings outside the US), and cover letters of all agency submissions (it being understood that MERRIMACK the other Party may request, and shall then receive, copies of all attachments to any such cover letters) relating to any Collaboration the Compound or any Licensed Product. SANOFI-AVENTIS Each Party shall also provide MERRIMACK the other Party with any meeting minutes that SANOFI-AVENTIS such Party prepares that reflect material communications with any Regulatory Authorities in the Major Territories Lexicon Territory (and as to clinical trials conducted by Lexicon in the Licensed Territory pursuant to the Development Plan) in the case of Lexicon and in the Licensed Territory in the case of Ipsen regarding any Collaboration the Compound or any Licensed Product.

Communications with Regulatory Authorities. (a) Following the Effective Date, SANOFI-AVENTIS subject to Section 4.1(c)(i) and Section 4.1(h), XXXXXX shall be responsible for all submissions to, and communications and interactions with, Regulatory Authorities in the Licensed Territory with respect to Collaboration Compounds the Licensed Compound and Licensed ProductsProduct, provided, provided that: (i) SANOFI-AVENTIS XXXXXX shall keep MERRIMACK promptly informed regarding SANOFI-AVENTIS’s XXXXXX’x (or its Affiliate’s or sublicensee’s) regulatory strategy, planned regulatory submissions and material communications with Regulatory Authorities in the Major Licensed Territories with respect to the Licensed Compound and all Collaboration Compounds and Licensed Products, including any changes to such strategy, submissions or communications; (ii) SANOFI-AVENTIS XXXXXX shall provide MERRIMACK with copies, for information, of material regulatory submissions to, and material communications with, any Regulatory Authorities in the Major Licensed Territories relating to Collaboration Compounds the Licensed Compound and Licensed Products and MERRIMACK shall have an opportunity to review in advance and comment on all such planned regulatory submissions to, and material communications with, Regulatory Authorities relating to clinical trials referenced in clause (iii) belowsubmissions; and (iii) As to any human clinical trial for a particular Collaboration Compound or Licensed Product for a given indication conducted or to be conducted by MERRIMACK under the Global Development Plan, SANOFI-AVENTIS XXXXXX shall give due consideration in good faith to incorporating any and all comments provided by MERRIMACK on any planned regulatory submissions to, or material communications with, any Regulatory Authorities in the Major Territories Licensed Territory with respect to such clinical trial (or the results thereof) or the Collaboration Licensed Compound or Licensed Product used in such clinical trial, unless such comments are unreasonable. (b) In addition Following the Effective Date, MERRIMACK shall be responsible for all submissions to, and communications and interactions with, Regulatory Authorities in the MERRIMACK Territory with respect to each Party’s rights the Licensed Compound and obligations under clause (a): (i) SANOFI-AVENTIS shall provide MERRIMACKLicensed Product, if feasible, with reasonable advance notice of any material meeting or substantive telephone conference with the FDA, MHLW or EMEA relating to Collaboration Compounds or Licensed Products; and (ii) As provided that as to any human clinical trial for a particular Collaboration the Licensed Compound or Licensed Product for a given indication conducted or to be conducted by MERRIMACK under the Global Development Plan, MERRIMACK shall have the right give due consideration in good faith to attend incorporating any and participate in all comments provided by XXXXXX on any such material meeting planned regulatory submissions to, or material conference call with such Regulatory Authorities relating to such clinical trial (or the results thereof) or the Collaboration Compound or Licensed Product used in such clinical trial. (c) Without limiting the generality of any of the foregoing in this Section 4.2, SANOFI-AVENTIS shall also promptly provide MERRIMACK with a copy of all material correspondence that SANOFI-AVENTIS (or its Affiliate or sublicensee) receives from, or submits tocommunications with, any Regulatory Authorities in the Major TerritoriesMERRIMACK Territory with respect to such clinical trial, including contact reports concerning conversations or substantive meetings, contact reports of all Regulatory Authority interactions concerning conversations or substantive meetings, all IND annual reports (including any equivalent filings outside the US), and cover letters of all agency submissions (it being understood that MERRIMACK may request, and shall then receive, copies of all attachments to any unless such cover letters) relating to any Collaboration Compound or Licensed Product. SANOFI-AVENTIS shall also provide MERRIMACK with any meeting minutes that SANOFI-AVENTIS prepares that reflect material communications with any Regulatory Authorities in the Major Territories regarding any Collaboration Compound or Licensed Productcomments are unreasonable.