Correspondence with Regulatory Authorities Sample Clauses

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.
Sample 1
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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...
Sample 1
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 XXXx 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 XXXx. 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 XXXx, and shall consider in good faith any comments NovaDel may have with respect to any such filings.
Sample 1
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 XXXx 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 XXXx. 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 XXXx, and shall consider in good faith any comments NovaDel may have with respect to any such filings.
Sample 1

Related to Correspondence with Regulatory Authorities

  • Regulatory Authorities Except as described in the Registration Statement, the General Disclosure Package or the Prospectus, each of the Company and its subsidiaries: (a) is and at all times has been in material compliance with all statutes, rules or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”); (b) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (c) possesses all Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (d) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (e) has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge that any such Governmental Authority is considering such action; and (f) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that 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). The studies, tests and preclinical and clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each of its subsidiaries, were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, including, without limitation, the Federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package or the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its subsidiaries has received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or any of its subsidiaries that are material to the Company and its subsidiaries taken as a whole.

  • 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).

  • COOPERATION WITH REGULATORY AUTHORITIES OR OTHER ACTIONS The parties to this Agreement each agree to cooperate in a reasonable manner with each other in the event that any of them should become involved in a legal, administrative, judicial or regulatory action, claim, or suit as a result of performing its obligations under this Agreement.

  • Agreements with Regulatory Agencies Except as set forth on Schedule E, neither the Company nor any Company Subsidiary is subject to any material cease-and-desist or other similar order or enforcement action issued by, or is a party to any material written agreement, consent agreement or memorandum of understanding with, or is a party to any commitment letter or similar undertaking to, or is subject to any capital directive by, or since December 31, 2006, has adopted any board resolutions at the request of, any Governmental Entity (other than the Appropriate Federal Banking Agencies with jurisdiction over the Company and the Company Subsidiaries) that currently restricts in any material respect the conduct of its business or that in any material manner relates to its capital adequacy, its liquidity and funding policies and practices, its ability to pay dividends, its credit, risk management or compliance policies or procedures, its internal controls, its management or its operations or business (each item in this sentence, a “Regulatory Agreement”), nor has the Company or any Company Subsidiary been advised since December 31, 2006 by any such Governmental Entity that it is considering issuing, initiating, ordering, or requesting any such Regulatory Agreement. The Company and each Company Subsidiary are in compliance in all material respects with each Regulatory Agreement to which it is party or subject, and neither the Company nor any Company Subsidiary has received any notice from any Governmental Entity indicating that either the Company or any Company Subsidiary is not in compliance in all material respects with any such Regulatory Agreement. "Appropriate Federal Banking Agency" means the “appropriate Federal banking agency” with respect to the Company or such Company Subsidiaries, as applicable, as defined in Section 3(q) of the Federal Deposit Insurance Act (12 U.S.C. Section 1813(q)).

  • Regulatory Authority If any regulatory authority having jurisdiction (or any successor boards or agencies), a court of competent jurisdiction or other Governmental Authority with the appropriate jurisdiction (collectively, the ''Regulatory Body'') issues a rule, regulation, law or order that has the effect of cancelling, changing or superseding any term or provision of this Agreement (the ''Regulatory Requirement''), then this Agreement will be deemed modified to the extent necessary to comply with the Regulatory Requirement. Notwithstanding the foregoing, if a Regulatory Body materially modifies the terms and conditions of this Agreement and such modification(s) materially affect the benefits flowing to one or both of the Parties, as determined by either of the Parties within twenty (20) business days of the receipt of the Agreement as materially modified, the Parties agree to attempt in good faith to negotiate an amendment or amendments to this Agreement or take other appropriate action(s) so as to put each Party in effectively the same position in which the Parties would have been had such modification not been made. In the event that, within sixty (60) days or some other time period mutually agreed upon by the Parties after such modification has been made, the Parties are unable to reach agreement as to what, if any, amendments are necessary and fail to take other appropriate action to put each Party in effectively the same position in which the Parties would have been had such modification not been made, then either Party shall have the right to unilaterally terminate this Agreement forthwith.

  • Cooperation with Authorities Each party hereto shall cooperate with the other party and all appropriate governmental authorities (including without limitation the SEC) and shall permit such authorities reasonable access to its books and records in connection with any investigation or inquiry relating to this agreement or the transactions contemplated hereby.

  • Governmental Authorities From the date of this Agreement and until the End Date, the Company shall duly observe and conform in all material respects to all valid requirements of governmental authorities relating to the conduct of its business or to its properties or assets.

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