Correspondence with Regulatory Authorities Sample Clauses

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Correspondence with Regulatory Authorities. Unless otherwise agreed in writing by the parties, BioAlliance, subject to Section 4.2(d), shall be responsible, using Commercially Reasonable Efforts, for preparing and filing ▇▇▇▇ and seeking and maintaining Regulatory Approvals for Licensed Products in the Territory in accordance with the Development Plan, including preparing all reports necessary as part of a MAA. BioAlliance shall provide NovaDel with drafts of any material documents or correspondence to be submitted to any Regulatory Authority in the Territory that pertains to Licensed Product, including ▇▇▇▇. BioAlliance will consult in advance with NovaDel with respect to any substantive or material filings to be made by BioAlliance in accordance with the terms of this Section 4.2(b), including ▇▇▇▇, and shall consider in good faith any comments NovaDel may have with respect to any such filings.
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Correspondence with Regulatory Authorities. The Party responsible for regulatory matters related to a particular Licensed Compound or Licensed Product with respect to a particular country of the Territory shall keep the other Party reasonably informed as to all material correspondence, meetings, notices, reports or submissions to any Regulatory Authorities regarding the Licensed Compounds and Licensed Products as follows: (i) the responsible Party shall promptly provide to the other Party a copy of any material documents and correspondence submitted to or received from a Regulatory Authority regarding a Licensed Compound or Licensed Product; and (ii) the responsible Party shall promptly provide to the other Party a draft of the responsible Party’s response to such inquiries, or of any material submission regarding the Licensed Compounds and Licensed Products by the responsible [***] Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Confidential treatment has been requested with respect to this information. Party to a Regulatory Authority, for such other Party to review and comment. Such other Party shall provide its comments to the responsible Party within a reasonable amount of time from the date such other Party receives such inquiries from the responsible Party, but no later than such date as may be required to not adversely impact the timeliness of the response to the Regulatory Authority, or of such submission. The responsible Party shall reasonably consider in good faith the comments of the other Party provided in accordance with this clause in the final submission of its response to the Regulatory Authority. Unless correspondence with a Regulatory Authority is related to safety, the obligations set forth in this Section 5.6 shall be limited to correspondence with Regulatory Authorities in the Co-Promotion Territory, European Union, the United Kingdom (if no longer included in the European Union) and Japan.
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Correspondence with Regulatory Authorities. Except as otherwise set forth in this Agreement, and without limiting Section 3.2 (Preparation of the Initial U.S. MAA and the Initial E.U. MAA) or Section 3.3 (Other Regulatory Submissions), promptly following the Regulatory Responsible Party’s receipt, forwarding, or production thereof, the Regulatory Responsible Party will provide the other Party with (a) access to or copies of all material written or electronic correspondence and communications (other than Regulatory Submissions) received by the Regulatory ​ ​ Responsible Party or its Affiliates or Sublicensees from, or forwarded by the Regulatory Responsible Party or its Affiliates or Sublicensees to, the Regulatory Authorities in the Territory related to the Licensed Product, and (b) copies of all meeting minutes and summaries of all meetings, conferences, and discussions held by the Regulatory Responsible Party or its Affiliates or Sublicensees with the Regulatory Authorities related to the Licensed Products in the Territory, provided that, when Partner is the Regulatory Responsible Party, Partner is only obligated to provide uniQure with access to or copies of the correspondence and information in clause (a) or clause (b) pertaining to (i) uniQure’s Manufacture of the Licensed Products if uniQure is then Manufacturing the Licensed Products, (ii) safety changes, or (iii) material changes to a Licensed Product’s Product Labeling that pertain to new efficacy claims or patient populations, provided that Partner will only be obligated to provide the information in sub-clause (iii) for [*] after the date of receipt of the first Regulatory Approval in the United States. Partner, in its sole discretion, may provide uniQure with access to or copies of the correspondence and information in clause (a) or clause (b) if such correspondence or information requires uniQure’s support, including information to be provided by uniQure or support with respect to any Regulatory Submission, Regulatory Approval, Reimbursement Approval, or uniQure’s Manufacturing or chemistry, manufacturing, and control activities. If such written or electronic correspondence received from any such Regulatory Authority relates to the prohibition or suspension of the supply of the Licensed Product, or the initiation of any investigation, review, or inquiry by such Regulatory Authority concerning the safety of the Licensed Product, then, if uniQure is the Regulatory Responsible Party, the Regulatory Responsible Party will notify the other P...
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Correspondence with Regulatory Authorities. Each Party will provide the other Party with (a) copies of any material written correspondence submitted to or received from any Regulatory Authority, and (b) summaries of any material oral communications with any Regulatory Authority, in each case ((a) and (b)), relating to Regulatory Submissions for the Licensed Products, reasonably promptly after receipt or delivery by such Party of such correspondence or communication with any Regulatory Authority [***].
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Correspondence with Regulatory Authorities. The Regulatory Responsible Party will provide the other Party with (a) copies of any material written correspondence submitted to or received from Regulatory Authorities in the Thera Territory, and (b) summaries of any material oral communications with Regulatory Authorities in the Thera Territory, in each case ((a) and (b)), relating to Regulatory Submissions for the Licensed Products in such jurisdiction, reasonably promptly after receipt or delivery by such Regulatory Responsible Party of such correspondence or communication, as the case may be (but in any event, no later than [Redacted: Time Period] after receipt or delivery). If the non-Regulatory Responsible Party receives any correspondence or communication from a Regulatory Authority in the Thera Territory regarding the Licensed Products, such Party shall promptly inform the Regulatory Responsible Party and forward copies of all such correspondence as soon as practically possible. Furthermore, Ionis will keep Thera reasonably apprised of all material correspondence or communications with Regulatory Authorities in the Ionis Territory that may reasonably be expected to have an impact on the Development or Commercialization of a Licensed Product in the Thera Territory by Thera under this Agreement.
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Correspondence with Regulatory Authorities. Unless otherwise agreed in writing by the parties, Rechon, subject to Section 3.2(d), shall be responsible for preparing and filing ▇▇▇▇ and seeking and maintaining Regulatory Approvals for Licensed Products in the Territory in accordance with the Development Plan, including preparing all reports necessary as part of a MAA. Rechon shall upon request provide NovaDel with drafts of any material documents or correspondence to be submitted to any Regulatory Authority in the Territory that pertains to Licensed Product, including ▇▇▇▇. Rechon will inform NovaDel before submission of any substantive or material filings to be made by Rechon in accordance with the terms of this Section 3.2(b), including ▇▇▇▇, and shall consider in good faith any comments NovaDel may have with respect to any such filings.
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Related to Correspondence with Regulatory Authorities

  • Regulatory Authorities Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, the Company and its subsidiaries: (i) are in compliance in all material respects with all statutes, rules, regulations, ordinances, orders and decrees applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, price reporting, reimbursement, storage, import, export or disposal of any product manufactured or distributed by or for the Company or any of its subsidiaries (“Applicable Laws”), except where the failure to so comply would not, individually or in the aggregate, result in a Material Adverse Effect; (ii) to the knowledge of Company and its subsidiaries, have not, either voluntarily or involuntarily, disclosed to any governmental authority any violations of Applicable Laws, except such as would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) have not received any Food and Drug Administration (“FDA”) Form 483 or any foreign counterpart thereof, warning letter, clinical hold notice or untitled letter from the FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section 56.102(g)) or any other governmental authority alleging or asserting noncompliance with any Applicable Laws or any licenses, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except such as would not, individually or in the aggregate, result in a Material Adverse Effect; (iv) have not received notification of nor have reason to believe that any audits by a governmental authority have resulted in a determination that any of their respective products have been improperly reimbursed, except such audits and determinations as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (v) possess all Authorizations (including, without limitation, exemptions under any Investigational Device Exemption or Investigational New Drug Application, as described at 21 CFR Sections 312 and 812, and approvals of any Institutional Review Board), which are in full force and effect, required for the conduct of their respective businesses (and such Authorizations are valid and in full force and effect) and are not in violation of any term of any such Authorizations, except where the failure to possess such Authorization or the violation of such Authorization would not, individually or in the aggregate, result in a Material Adverse Effect; (vi) have not received written notice of any pending or threatened claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, suspension, debarment or exclusion from any governmental authority or Institutional Review Board alleging that any of their respective operations or activities is in violation of any Applicable Laws or Authorizations and the Company has no knowledge or reason to believe that any such governmental authority, Institutional Review Board or other non-governmental authority is considering any such claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, suspension, debarment or exclusion except for any such claims, suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations, suspensions, debarments or exclusions that would not, individually or in the aggregate, result in a Material Adverse Effect; (vii) have not received written notice that any governmental authority or Institutional Review Board has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and the Company has no knowledge or reason to believe that any such governmental authority is considering such action, except for any such actions that would not, individually or in the aggregate, result in a Material Adverse Effect; (viii) have, or have had on their behalf, filed, declared, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any Applicable Laws or Authorizations, except where the failure to so file, declare, obtain, maintain or submit would not, individually or in the aggregate, result in a Material Adverse Effect and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (ix) have not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, warning, “dear doctor” letter or investigator notice relating to an alleged lack of safety or efficacy of any product or product candidate, any alleged product defect, or violation of any material Applicable Laws or Authorizations and the Company is not aware of any facts that would cause the Company or any of its subsidiaries to initiate any such notice or action and the Company has no knowledge or reason to believe that any governmental authority, Institutional Review Board or other non-governmental authority intends to initiate any such notice or action, except for any such notices or actions that would not, individually or in the aggregate, result in a Material Adverse Effect. Any clinical trials conducted by or on behalf of the Company or any of its subsidiaries that are described in the Registration Statement, the General Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable federal, state, local and foreign laws, rules and regulations, including, but not limited to, the Federal Food, Drug, and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312. Any descriptions of studies, tests and preclinical and clinical trials, including any related results and regulatory status, contained in the Registration Statement, the General Disclosure Package or the Prospectus are, and will be, accurate and complete in all material respects. The Company is not aware of any studies, tests or trials the results of which reasonably call into question in any material respect the clinical trial results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus. Neither the Company nor any of its subsidiaries has received any written notices or other correspondence from the FDA, an Institutional Review Board or other governmental agency requiring or recommending the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company or any of its subsidiaries or in which the Company or any of its subsidiaries has participated.

  • 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.

  • Regulatory Authorizations Each Party represents and warrants that it has, or applied for, all regulatory authorizations necessary for it to perform its obligations under this Agreement.

  • Other Regulatory Approvals All necessary approvals, authorizations and consents of any governmental or regulatory entity required to consummate the Merger shall have been obtained and remain in full force and effect, and all waiting periods relating to such approvals, authorizations and consents shall have expired or been terminated.

  • Cooperation with supervisory authorities 1. The data exporter agrees to deposit a copy of this contract with the supervisory authority if it so requests or if such deposit is required under the applicable data protection law. 2. The parties agree that the supervisory authority has the right to conduct an audit of the data importer, and of any subprocessor, which has the same scope and is subject to the same conditions as would apply to an audit of the data exporter under the applicable data protection law. 3. The data importer shall promptly inform the data exporter about the existence of legislation applicable to it or any subprocessor preventing the conduct of an audit of the data importer, or any subprocessor, pursuant to paragraph 2. In such a case the data exporter shall be entitled to take the measures foreseen in Clause 5 (b).