Communications with Regulatory Authorities. During the Collaboration Term, Xencor shall provide MorphoSys with reasonable advance notice of any meeting or substantive telephone conference with any Regulatory Authority relating to any Licensed Antibody and/or Licensed Product. MorphoSys shall have the right to attend and observe (but not participate actively in) any material meeting or material conference call with any Regulatory Authority regarding any of MorphoSys (or its Affiliate’s or Sublicensee’s) Licensed Antibody and/or Licensed Products. In addition, Xencor shall promptly furnish to MorphoSys copies of all correspondence that Xencor (or its Affiliate) receives from, or submits to, any Regulatory Authority (including contact reports concerning conversations or substantive meetings) relating to any Licensed Antibody and/or Licensed Product. Xencor shall also provide to MorphoSys any meeting minutes that reflect material communications with any Regulatory Authority regarding a Licensed Antibody and/or Licensed Product. Subject to the provisions of Section 2.2(c)(ii), MorphoSys shall provide in its MorphoSys Annual Development Reports to Xencor, and through JDC discussion, information regarding its (or its Affiliate’s or, to the extent permitted by the Sublicense, Sublicensee’s) interactions with Regulatory Authorities with respect to all Licensed Antibodies and/or Licensed Products in its respective Territory. In addition, to the extent permitted by law and subject to Section 3.6, Xencor may participate in communications and meetings with any Regulatory Authority to the extent the name and/or then-current Xencor logo is used on the drug product label and such labeling is being discussed in such communication or meeting. Notwithstanding MorphoSys’ obligations under this Article 3, MorphoSys shall not be required to share with Xencor any information which MorphoSys is not permitted to share with Xencor under the applicable laws or regulations of the Securities & Exchange Commission or other regulatory body of the US or elsewhere.
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 Pro...
Communications with Regulatory Authorities. Novartis will provide Surface, through the JDC, as part of the [***] updates regarding Development activities described in Section 5.3.6.1, with a brief description in English, of the principal issues raised in any material communication with any Regulatory Authority in the Novartis Territory with respect to any Global Licensed Product during the preceding Calendar Quarter. For purposes of this Section 7.3.1.3, “material communication” with Regulatory Authorities include meetings with Regulatory Authorities and Regulatory Authority questions or concerns regarding significant issues, including any of the following: key product quality attributes (e.g., purity), safety findings affecting the platform (e.g., Serious Adverse Events, emerging safety signals), clinical or nonclinical findings affecting patient safety, or lack of efficacy.
Communications with Regulatory Authorities. From and after the Effective Date, except as otherwise set forth in this Agreement, Maruishi shall be responsible for all contacts with Regulatory Authorities with respect to Licensed Products in the Territory within the Field of Use. Maruishi shall have the responsibility, subject to the terms of this Agreement, to prepare and submit (a) all regulatory filings with Regulatory Authorities in the Territory as needed to conduct its clinical development of Licensed Products in the Territory in the Field of Use, and (b) all applications to obtain Regulatory Approvals in the Territory. All such regulatory submissions shall be in compliance with all Applicable Laws. Maruishi shall keep Cara fully informed regarding all such regulatory activities, shall provide to Cara copies of all regulatory submissions (including applications for Regulatory Approval) in the Territory and of all responses from Regulatory Authorities, shall provide Cara reasonable advance notice of any meetings or scheduled discussions with Regulatory Authorities in the Territory regarding Licensed Products, and shall update Cara as requested as to all progress and results of all such regulatory filings and meetings. Cara shall have the right to comment on all draft regulatory submissions, and Maruishi shall use reasonable efforts to accommodate all such comments. Maruishi shall use Commercially Reasonable Efforts, including conducting all such activities as needed, to obtain Regulatory Approvals in the Territory as soon as reasonably practicable and feasible. Cara will use reasonable efforts to provide a reasonable level of assistance to Maruishi in its efforts to prepare and to make regulatory submissions leading to Regulatory Approvals in the Territory. Cara shall have the right to use any such regulatory submissions for any of its (or its Affiliates’ or other licensees’) activities involving Licensed Products outside the Territory except upon termination of this Agreement pursuant to Section12.2 At Maruishi’s request, and subject to Cara personnel being available, Cara shall use reasonable efforts to assist and participate in such regulatory discussions, such participation to be paid for by Maruishi at Cara’s standard FTE rate for the applicable personnel (and including payment of all of Cara’s reasonable external expenses, including travel, per diem and lodging, incurred in performing such requested participation). In addition, Cara shall have the right to attend, at its own initiative and ...
Communications with Regulatory Authorities. From and after the Effective Date, MirnaRx shall be solely responsible for all contacts with all Regulatory Authorities with respect to Licensed Products within the Field of Use in the Territory. At MirnaRx’s request, Marina Bio shall participate in such regulatory discussions, to the extent reasonably needed with respect to the Marina Bio Technology components of a Licensed Product, provided that Marina Bio’s participation shall be limited to those matters for which MirnaRx expressly requests Marina Bio’s comment or other involvement in such discussions. MirnaRx shall reimburse Marina Bio for its reasonable expenses at reasonable, agreed rates that reflect the actual internal costs and Marina Bio’s reasonable external expenses regarding travel, per diem and lodging, with respect to such requested participation.
Communications with Regulatory Authorities. As between the Parties, EYEFITE shall be responsible for all communications with any Regulatory Authority relating to the Licensed Product or Licensed Compound in the Territory during the term of this Agreement. As relating to the Licensed Product or Licensed Compound, EYEFITE (or its Affiliates or Sublicensees) shall promptly provide CANFITE with copies of all (i) material written communications to or from any Regulatory Authority, and (ii) written meeting minutes or summaries of material meetings, conferences and discussions with Regulatory Authorities. Except as necessary to comply with the Laws, CANFITE shall not initiate any communications with any Regulatory Authority concerning the Licensed Compound or the Licensed Product without first obtaining EYEFITE’s approval.
(a) EYEFITE shall promptly inform CANFITE of any action, correspondence or reports to or from governmental authorities (other than Regulatory Authorities) that would reasonably be expected to materially affect the current or anticipated development or commercialization of the Licensed Product or Licensed Compound, and shall furnish CANFITE with copies of any relevant documents relating thereto.
Communications with Regulatory Authorities. 6.3.1 For purposes of this Article 6.3, “material” shall mean any ***. Servier shall be responsible for all submissions to, and communications and interactions with, Regulatory Authorities in the Servier Territory with respect to Program DARTs and Licensed Products (unless otherwise agreed by the JRDC on the basis of Section 4.2), and MacroGenics shall be responsible for submissions to, and communications and interactions with, Regulatory Authorities in the MacroGenics Territory with respect to Program DARTs and Licensed Products (unless otherwise agreed by the JRDC on the basis of Section 4.1). In connection therewith:
(a) On a Licensed Program by Licensed Program basis Servier shall keep MacroGenics reasonably informed regarding Servier’s (or its Affiliate’s or Sublicensee’s) regulatory strategy, planned regulatory submissions and material communications with the Regulatory Authorities in the Servier Territory with respect to the Program DARTs and Licensed Products for each Licensed Program, including any material changes to such strategy, submissions or communications. Servier shall provide MacroGenics with copies of material regulatory submissions to, and material communications with the *** relating to the Program DARTs and Licensed Products. To the extent permitted by Regulatory Authorities, MacroGenics shall have the right to have a senior, experienced employee participate as an observer in meetings with the *** or their agents, as well as participate in internal meetings or discussions of Servier occurring immediately before or after, and related to, such meetings, and shall be provided with advance access to Servier’s materials prepared for such meetings. MacroGenics shall also have the right to review and comment upon any correspondence with the *** or their agents related to such meetings. Servier shall provide MacroGenics regularly prepared minutes of material meetings with the *** regarding Program DARTs and Licensed Products in the Field in the Servier Territory and available material teleconference reports with the *** pertaining to Program DARTs and Licensed Products in the Field in the Servier Territory.
(b) On a Licensed Program by Licensed Program basis MacroGenics shall keep Servier reasonably informed regarding MacroGenics’ (or its Affiliate’s or Sublicensee’s) regulatory strategy, planned regulatory submissions and material communications with the *** with respect to the Program DARTs and Licensed Products for each Licensed Program, i...
Communications with Regulatory Authorities. Each Party will notify the JDC, including a brief description in English, of the principal issues raised in each material communication with Regulatory Authorities with respect to such Regional Licensed Product within [***] after receipt thereof. Upon request, each Party will provide to the other Party: (a) at the requesting Party’s expense, a summary translation of such material communications in English, (b) at the requesting Party’s expense, complete copies of the original correspondence in their native language, or (c) at the requesting Party’s expense, a full translation of such material communications in English, in each case of (a) through (c) within a reasonable period of time following such request. For the purposes of this Section 7.2, “material communications” with Regulatory Authorities include meetings with Regulatory Authorities and Regulatory Authority questions or concerns with respect to significant issues, including any of the following: key product quality attributes (e.g., purity), safety findings affecting the platform (e.g., Serious Adverse Events, emerging safety signals), clinical or nonclinical findings affecting patient safety, lack of efficacy or receipt or denial of Regulatory Approval.
Communications with Regulatory Authorities. Within [***] after receipt of any Material Communication from a Regulatory Authority with respect to any Collaboration Product, Voyager will provide Genzyme, through its Alliance Manager, with a brief written description of the principal issues raised in such Material Communication. Voyager will allow Genzyme a reasonable opportunity to review and comment on Voyager’s proposed response to any Material Communications with any Regulatory Authority with respect to any Collaboration Product in advance of the transmission of such response, and Voyager will reasonably consider all comments timely provided by Genzyme in connection therewith.
Communications with Regulatory Authorities. The Technical Agreement contains provisions relating to reporting and filing obligations to Regulatory Authorities with respect to manufacture of Bulk Product. As more fully set forth in the Technical Agreement, both Parties will promptly provide to each other copies of correspondence to and from any Regulatory Authority relating to or impacting the manufacture of any Bulk Product, including correspondence to, from or among [***], any Third Party Contractors and any Regulatory Authority with respect to the Bulk Product.
