Responsibility for Regulatory Submissions Sample Clauses

Responsibility for Regulatory Submissions. For [***] Clinical Studies conducted by MSKCC, [***] will be have primary responsibility, subject to Section 2.2, for preparing investigational new drug applications and other filings required by the FDA and any other in-country regulatory submissions and approvals (each an “RA”) required to conduct a Clinical Study, and shall initially be the sponsor of and own any such RAs. For [***] Clinical Studies, [***] will be responsible for preparing all RAs required to conduct [***] clinical trials, and shall be the sponsor of and own such RAs. The owner of a RA will be responsible for satisfying all sponsor obligations and other requirements of any applicable governmental authority relating thereto. Prior to commencement of any Clinical Study, [***], will be responsible for preparing and submitting to the appropriate governmental authorities any RAs required, as necessary, under the laws of each jurisdiction where such Clinical Study will be conducted. Following the completion of a [***] Clinical Study for any Study Product, at the request of Sponsor, MSKCC shall assign to Sponsor, without charge, any and all RAs held by MSKCC with respect to the applicable Study Product. MSKCC agrees to cooperate with Sponsor in the development of any RA, and at Sponsor’s request to provide Sponsor any other documents and information required by applicable laws and regulations or that Sponsor reasonably requests in connection with the preparation, filing and maintenance of any RA. [***] 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.
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Responsibility for Regulatory Submissions. (a) [***] will be responsible for all investigational new drug applications and other filings required by the FDA and any other in-country regulatory submissions and approvals (including an investigational new drug application (“IND”) under 21 Code of Federal Regulation, Part 312) (each an “RA”) required to conduct a Collaboration Project. Prior to commencement of any clinical trial that is part of a Collaboration Project, [***] will prepare and submit to the appropriate governmental authorities any RAs required under the laws of each jurisdiction where the clinical trial will be conducted. [***] will be the sponsor of any such RA and will be responsible for satisfying all sponsor obligations and other requirements of applicable governmental authorities except for sponsor obligations that are specifically transferred to [***] under the terms of this Agreement or the applicable Project Agreement. [***] agrees to cooperate with [***] and to provide [***] any other documents and information required by applicable laws and regulations or that [***] reasonably requests in connection with the preparation, filing and maintenance of any RA as more fully described in Section 7.
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Responsibility for Regulatory Submissions. (i) Banner shall be responsible for interacting with the FDA and shall diligently act to complete any requirements for obtaining Regulatory Approval of the Product(s). Banner may discharge its responsibility under this Section 2.1(a)(i) directly or through a third party. Banner shall consult with JDS prior to selection of any such third party, Banner shall be responsible to maintain all Regulatory Approvals or other FDA-filings or applications for Regulatory Approval as long as required for use in connection with either party’s activities under this Agreement.
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Related to Responsibility for Regulatory Submissions

  • Regulatory Submissions From and after the Effective Date, NVS will[***] be responsible for (a) preparing, filing, and submitting, directly or through its Affiliates and permitted Sublicensees, all Regulatory Submissions for all Products in the Territory, and each material amendment or update thereto, in its name other than Jointly-Agreed Regulatory Submissions; and (b) interfacing, corresponding and meeting with Regulatory Authorities relating to Regulatory Submissions in the Territory for such Products; provided, that Regulatory Submissions and correspondence made to, and meetings held with, the FDA and EMA with respect to (i) [***] or (ii) [***] in each of (i) and (ii), will be prepared or conducted, as applicable, in collaboration with a representative from HMI’s regulatory team in accordance with this Article 7 (Regulatory Affairs); provided further that in all cases, such rights shall expressly exclude and not apply with Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by Homology Medicines, Inc. respect to any data in Regulatory Submissions, correspondence, or meetings relating to any Other Components. Subject to Section 7.6 (Transfer of U.S. BLA for In-Vivo [***] Products), all Regulatory Approvals and Pricing Approvals for Products will be [***] owned by [***]. For all Products, NVS will timely inform HMI regarding the submission, receipt or denial of Regulatory Approval for such Product obtained or denied; provided, however, that NVS will inform HMI of such event prior to public disclosure of such event by NVS.

  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

  • Responsibility for Filing Tax Returns (i) The Parties acknowledge that the income and operations of Company and its Subsidiaries shall be included in the consolidated, unitary or combined Tax Returns of the Xxxxxxx US Affiliated Group (each a “Combined Tax Return” and collectively the “Combined Tax Returns”) for Tax periods of Company and its Subsidiaries ending on or prior to the Closing Date, and Seller or their Affiliates shall pay any and all Taxes due with respect to such Combined Tax Returns. Acquiror shall have no rights to prepare, review or comment on any such Combined Tax Returns in which Company and its Subsidiaries are included. Seller shall prepare or cause to be prepared and shall timely file or cause to be filed all (A) Tax Returns of Company and its Subsidiaries (other than Combined Tax Returns) which are required to be filed (taking into account any extensions of time to file) on or prior to the Closing Date and (B) income and franchise (in lieu of income) Tax Returns of Company and its Subsidiaries (other than Combined Tax Returns) for Tax periods ending on or before the Closing Date which are required to be filed (taking into account any extensions of time to file) after the Closing Date, and shall pay or cause to be paid any and all Taxes due (taking into account any extensions of time to pay) with respect to such Tax Returns described in this sentence; provided, however, that Acquiror shall promptly reimburse Seller for the payment of any such Taxes to the extent such Taxes were included in any reserve or liability for Taxes reflected in the calculation of Net Working Capital. All Tax Returns described in the preceding sentence (such Tax Returns, excluding, for the avoidance of doubt, Combined Tax Returns, “Pre-Closing Tax Returns”) shall be prepared in a manner consistent with prior practice of Company and its Subsidiaries unless a past practice has been finally determined to be incorrect by the applicable Governmental Authority or a contrary treatment is required by applicable Law. Seller shall deliver all such Pre-Closing Tax Returns (other than, for the avoidance of doubt, Combined Tax Returns) to Acquiror at least twenty (20) days before the due date thereof. Seller shall permit Acquiror to review and comment on each such Tax Return prior to filing, which comments Seller shall consider in good faith. If applicable, Acquiror and Company or any of its Subsidiaries shall be responsible for signing and timely filing any Tax Returns described in this Section 7.4(c)(i).

  • Litigation and Regulatory Cooperation During and after the Executive’s employment, the Executive shall cooperate fully with the Company in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company which relate to events or occurrences that transpired while the Executive was employed by the Company. The Executive’s full cooperation in connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as a witness on behalf of the Company at mutually convenient times. During and after the Executive’s employment, the Executive also shall cooperate fully with the Company in connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrences that transpired while the Executive was employed by the Company. The Company shall reimburse the Executive for any reasonable out-of-pocket expenses incurred in connection with the Executive’s performance of obligations pursuant to this Section 7(f).

  • Other Regulatory Matters The Investment Adviser represents and warrants that (1) it and each Fund is and will remain: (a) an “eligible contract participant” under 7 U.S.C. Section 1A, as amended, and 17 CFR Section 1.3(m), and (b) a “qualified eligible person” under CFTC Rule 4.7; (2) that it is registered as a commodity pool operator and is a member of the NFA, where applicable, or it is not required to be registered with the CFTC or to be a member of the NFA; and (3) that it will provide Subadviser reasonable advance notification (in no event less than 30 days) of any decision to: (a) alter its operation of any Fund for which the Investment Adviser has claimed an exclusion or exemption from registration as a commodity pool operator on behalf of a Fund, to then register and operate as a commodity pool operator on behalf of the Fund, or (b) if the investment adviser is registered as a commodity pool operator on behalf of the Fund, to operate such Fund under an exclusion or exemption from registration with the CFTC.

  • Regulatory Cooperation In connection with any foreclosure, collection, sale or other enforcement of Liens granted to the Administrative Agent in the Collateral Documents, Parent will, and will cause its Restricted Subsidiaries to, reasonably cooperate in good faith with the Administrative Agent or its designee in obtaining all regulatory licenses, consents and other governmental approvals necessary or (in the reasonable opinion of the Administrative Agent or its designee) reasonably advisable to conduct all aviation operations with respect to the Collateral and will, at the reasonable request of the Administrative Agent and in good faith, continue to operate and manage the Collateral and maintain all applicable regulatory licenses with respect to the Collateral until such time as the Administrative Agent or its designee obtain such licenses, consents and approvals, and at such time Parent will, and will cause its Restricted Subsidiaries to, cooperate in good faith with the transition of the aviation operations with respect to the Collateral to any new aviation operator (including, without limitation, the Administrative Agent or its designee).

  • Regulatory Compliance Cooperation (a) CIT/VC agrees to use commercially reasonable best efforts to avoid the occurrence of a Regulatory Problem. In the event that CIT/VC determines that it has a Regulatory Problem, the Company agrees to use commercially reasonable efforts to take all such actions as are reasonably requested by CIT/VC in order (A) to effectuate and facilitate any transfer by CIT/VC of any Securities of the Company then held by CIT/VC to any Person designated by CIT/VC (subject, however, to compliance with Section 3 of this Agreement), (B) to permit CIT/VC (or any Affiliate of CIT/VC) to exchange all or any portion of the voting Securities of the Company then held by such Person on a share-for-share basis for shares of a class of non-voting Securities of the Company, which non-voting Securities shall be identical in all respects to such voting Securities, except that such new Securities shall be non-voting and shall be convertible into voting Securities on such terms as are requested by CIT/VC in light of regulatory considerations then prevailing, and (C) to continue and preserve the respective allocation of the voting interests with respect to the Company arising out of CIT/VC's ownership of voting Securities of the Company and/or provided for in this Agreement before the transfers and amendments referred to above (including entering into such additional agreements as are requested by CIT/VC to permit any Person(s) designated by CIT/VC to exercise any voting power which is relinquished by CIT/VC upon any exchange of voting Securities for nonvoting Securities of the Company); and the Company shall enter into such additional agreements, adopt such amendments to this Agreement, the Company's Charter and the Company's By-laws and other relevant agreements and taking such additional actions, in each case as are reasonably requested by CIT/VC in order to effectuate the intent of the foregoing. If CIT/VC elects to transfer Securities of the Company to a Regulated Holder in order to avoid a Regulatory Problem, the Company shall enter into such agreements with such Regulated Holder as it may reasonably request in order to assist such Regulated Holder in complying with applicable laws, and regulations to which it is subject. Such agreements may include restrictions on the 39. redemption, repurchase or retirement of Securities of the Company that would result or be reasonably expected to result in such Regulated Holder holding more voting securities or total securities (equity and debt) than it is permitted to hold under such laws and regulations.

  • Responsibility for documentation Neither the Agent nor the Arranger:

  • Regulatory Filings NYISO and Connecting Transmission Owner shall file this Agreement (and any amendment hereto) with the appropriate Governmental Authority, if required. Any information related to studies for interconnection asserted by Developer to contain Confidential Information shall be treated in accordance with Article 22 of this Agreement and Attachment F to the ISO OATT. If the Developer has executed this Agreement, or any amendment thereto, the Developer shall reasonably cooperate with NYISO and Connecting Transmission Owner with respect to such filing and to provide any information reasonably requested by NYISO and Connecting Transmission Owner needed to comply with Applicable Laws and Regulations.

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