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.
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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. (ii) JDS shall be responsible, with Banner’s full cooperation, to prepare FDA approvable label copy, proposed samples of packaging and artwork for Products, and shall use reasonable commercial efforts to provide such label copy and artwork to Banner in sufficient time to prevent any delay in obtaining Regulatory Approval due to the label copy, proposed samples of packaging or artwork; provided however, that in the case of the Valproic Acid EnteriCare™ Product, such proposed label copy and artwork (but not samples of packaging) shall be provided by JDS to Banner no later than ***. All such JDS label copy and final packaging specifications shall be subject to Banner’s prior approval to the extent it contains information subject to Regulatory Approval. (iii) Upon request by Banner, JDS shall cooperate with Banner in, and shall provide Banner with, all other information with respect to JDS or its activities hereunder reasonably necessary for filing in connection with obtaining or maintaining the Regulatory Approval of the Product(s) and/or in responding to any questions or requests for additional information by the FDA.
Sample 1
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. (b) Notwithstanding Subsection (a), for [***] clinical trials initiated by [***] will be the sponsor of any required RA and will carry out the responsibilities assigned to [***] under Subsection (a) unless otherwise provided in the applicable Project Agreement. (c) The COG may appoint a Regulatory Affairs Committee to carry out its responsibilities with respect to RAs including its responsibilities under this Section 3.11 and Section 7.
Sample 1
Responsibility for Regulatory Submissions. [***] 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 (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 RA and will be responsible for satisfying all sponsor obligations and other requirements of applicable governmental authorities except for sponsor obligations that are [***] 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.
Sample 1

Related to Responsibility for Regulatory Submissions

  • Regulatory Submissions With respect to the Governmental Approvals of the Agreement Products in the Territory: (a) Unless otherwise required by Applicable Law, any Governmental Approvals and any Regulatory Submissions relating to Agreement Products in the Territory shall be filed, owned and held in the name of EVOLUS or its Affiliates. (b) EVOLUS shall be solely responsible, at its expense, and shall use commercially reasonable efforts to timely prepare, file, prosecute, and maintain all Regulatory Submissions relating to Agreement Products in the Territory, including any reports or amendments necessary to maintain Governmental Approvals, and for seeking any revisions of the conditions of each Governmental Approval. (c) EVOLUS shall have sole authority and responsibility and shall use commercially reasonable efforts to develop, modify, seek and/or obtain any necessary Governmental Approvals of any Labeling, packaging, advertising or other promotional or informational materials used in connection with Agreement Products in the Territory, and Promotional Materials and for determining whether the same requires Regulatory Approval. (d) EVOLUS will be the primary contact with the Regulatory Authorities in the Territory and shall be solely responsible for all communications with such Regulatory Authorities that relate to any Regulatory Submission relating to Agreement Products in the Territory prior to and after any Governmental Approval. (e) Subject to the terms and conditions of this Agreement, EVOLUS may file any submissions that are intended to change or modify Labeling or prescribing information approved by Health Canada for the Agreement Products in the field for the Territory; provided that, except as required by Applicable Laws, EVOLUS will provide to the DISTRIBUTOR a draft of such submission at least ten (10) business days prior to a planned submission to the applicable Regulatory Authority and EVOLUS will give reasonable consideration to any comments the DISTRIBUTOR may have. For greater certainty it is acknowledged and agreed that the labeling with respect to Products for distribution in Canada will be different than labeling for Products for distribution in the United States, as a result of among other things, the requirement in Canada to have the label in both English and French languages.

  • 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 Content Vendor is solely responsible for administration, content, intellectual property rights, and all materials at Vendor’s website. DIR reserves the right to require a change of listed content if, in the opinion of DIR, it does not adequately represent the Contract.

  • Responsibility for Filing Tax Returns (a) Sellers shall prepare, or cause to be prepared, in a timely manner, all income Tax Returns of each Acquired Company that are due after the Closing with respect to any taxable period ending prior to or ending on and including the Closing Date; provided, however, that any such Tax Return shall be prepared by treating items on that Tax Return in a manner consistent with the prior Tax Returns of each Acquired Company. Sellers shall deliver to Buyer draft copies of each such Tax Return prior to the date for filing that Tax Return. Sellers shall make all changes in each such Tax Return reasonably requested by Buyer. Buyer shall cause each such Tax Return to be appropriately signed and filed, and Sellers shall pay to each Acquired Company any Taxes due from such Acquired Company on that Tax Return. (b) Buyer shall after the Closing prepare and file, or cause to be prepared and filed, Tax Returns of each Acquired Company for any period beginning prior to the Closing Date and ending after the Closing Date (a “Straddle Period”). Any such Tax Return shall be prepared by treating items on that Tax Return in a manner consistent with the prior Tax Returns of each Acquired Company. Buyer shall deliver to Sellers draft copies of each such Tax Return at least thirty (30) days prior to the date for filing that Tax Return. Buyer shall make all changes in each such Tax Return reasonably requested by Sellers. Sellers shall pay to each Acquired Company the Taxes due for the period prior to and including the Closing Date from such Acquired Company on that Tax Return.

  • 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).

  • Responsibility For Use (a) The Company alone will be responsible for furnishing, or arranging for a third party to furnish, all data and information required by the Documentation and the specifications therein for the Licensed System to function and perform in accordance with the Documentation, other than the data and information residing in the Licensed System in connection with BNYM’s performance of the Core Services. BNYM shall have no liability or responsibility for any Loss caused in whole or in part by the Company’s or a Permitted User’s exercise of the Licensed Rights or use of the Licensed System or by data or information of any nature inputted into the Licensed System by or under the direction or authorization of Company or a Permitted User; provided, however, this Section 2.5 shall not relieve BNYM of its obligation to act in accordance with its obligations under the Main Agreement. Company shall be responsible and solely liable for the cost or expense of regenerating any output or other remedial action if the Company, a Permitted User or an agent of either shall have failed to transmit properly and in the correct format any data or information, shall have transmitted erroneous or incorrect information or data, or shall have failed to timely verify or reconcile any such data or information when it is generated by the Licensed System (“Data Faults”).

  • Regulatory Filing In the event that this Interconnection Service Agreement contains any terms that deviate materially from the form included in Attachment O of the Tariff, Transmission Provider shall file the Interconnection Service Agreement on behalf of itself and the Interconnected Transmission Owner with FERC as a service schedule under the Tariff within thirty days after execution. Interconnection Customer may request that any information so provided be subject to the confidentiality provisions of Section 17 of this Appendix 2. An Interconnection Customer shall have the right, with respect to any Interconnection Service Agreement tendered to it, to request (a) dispute resolution under Section 12 of the Tariff or, if concerning the Regional Transmission Expansion Plan, consistent with Schedule 5 of the Operating Agreement, or (b) that Transmission Provider file the agreement unexecuted with the Commission. With the filing of any unexecuted Interconnection Service Agreement, Transmission Provider may, in its discretion, propose to FERC a resolution of any or all of the issues in dispute between or among the Interconnection Parties.

  • 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).

  • Responsibility for documentation None of the Security Agent, any Receiver nor any Delegate is responsible or liable for: (a) the adequacy, accuracy or completeness of any information (whether oral or written) supplied by the Security Agent, an Obligor or any other person in or in connection with any Finance Document or the transactions contemplated in the Finance Documents or any other agreement, arrangement or document entered into, made or executed in anticipation of, under or in connection with any Finance Document; (b) the legality, validity, effectiveness, adequacy or enforceability of any Finance Document, the Transaction Security or any other agreement, arrangement or document entered into, made or executed in anticipation of, under or in connection with any Finance Document or the Transaction Security; or (c) any determination as to whether any information provided or to be provided to any Secured Party is non-public information the use of which may be regulated or prohibited by applicable law or regulation relating to insider dealing or otherwise.

  • Responsibility for Evaluation Within each school the Principal will be responsible for the evaluation of employees assigned to that school. Evaluation will be made by the Principal or a qualified administrator. An employee assigned to more than one school will be evaluated by the Principal of the school in which the employee is assigned for the greater amount of time, with input provided by the Principal of the other school. Any Principal or person charged with the responsibility of evaluation of employees may involve other staff and students in the process if acceptable to the certificated teacher being evaluated.

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