Regulatory Activities and Submissions Generally Sample Clauses

Regulatory Activities and Submissions Generally. The Company and AbPro will confer and cooperate with one another with respect to all dealings with Regulatory Authorities concerning the Product and will jointly prepare a strategy concerning any applications for Regulatory Approvals, including without limitation, discussions regarding the regulatory documentation to be filed, the decision as to whether to make such filings and the timing of such filings. Company will periodically report to Licensor the status of any pending or proposed applications for Regulatory Approval for the Product in the License Territory and will keep Licensor fully informed on an ongoing basis regarding the schedule and process for the preparation of such applications for Regulatory Approval for any given Product.
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Regulatory Activities and Submissions Generally. MRK will actively cooperate with ArcherDX in the regulatory process for the development and global Regulatory Approval of a Product. The regulatory process includes the development of regulatory strategy, the sharing of regulatory information and data and the Regulatory Submission and liaison with global Regulatory Authorities. ArcherDX will, subject to Section 7.3, be the applicant of any Regulatory Submission(s) for a Product in the MRK Markets to the applicable Regulatory Authority, and therefore will be ultimately responsible for the submission of such required documentation per the jointly agreed timelines. The preparation, including strategy, for such Regulatory Submissions for a Product will be done in cooperation and consultation with MRK, provided, however, that ArcherDX will have ultimate decision-making authority in relation to the content and timing of such Regulatory Submissions. For avoidance of doubt, ArcherDX shall be the sole owner of any Product design history file, PMA and CE technical file, however, subject to any MRK rights to Outcome Data and Compound Foreground IP under this Agreement. MRK shall be solely responsible Page 32 for Regulatory Submissions for the Drug. Activities included in the regulatory process that are subject to this regulatory plan include the following:
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Regulatory Activities and Submissions Generally. The Parties will confer and cooperate with one another through the JDC (or, as directed by the JDC, through a Subcommittee) and in accordance with this Article 7.3 with respect to all dealings with Regulatory Authorities and with all aspects of Approval for each Product as applicable, including discussions regarding the regulatory documentation to be filed, the decision as to whether to make such filings and the timing of such filings. LBS will report to the JDC regarding the status of each pending or proposed Regulatory Submission for the Product and will provide the JDC with copies of all correspondence LBS receives from the Regulatory Authorities relating to the clinical validation part of the Regulatory Submission for any given Product (or other correspondence that references any given Drug or that concerns the Labeling of any given Product), and will keep the JDC informed on an ongoing basis regarding the schedule and process for the preparation of Regulatory Submissions for any given Product, and will provide working drafts of proposed Regulatory Submissions related to the clinical validation part of the Regulatory Submission for any given Product (or other parts of the Regulatory Submission that reference any given Drug or that concerns the Labeling of any given Product) to the JDC to provide ARNO an opportunity to review and comment on such drafts. Likewise, ARNO shall provide working drafts of proposed labeling for any given Drug that references any given Product to the JDC to provide LBS an opportunity to review and comment on such drafts. The purpose of such interaction is to identify and resolve any potential concerns in advance of the proposed filing of such Regulatory Submission. In accordance with the foregoing, LBS will not be obliged to provide to ARNO copies of such correspondence and drafts that pertain to the manufacturing or preclinical sections of the Regulatory Submissions (that do not include information with respect to the clinical validation or Labeling of any given Product and/or references to any given Drug), as ARNO acknowledges that the manufacturing and preclinical part of the Regulatory Submission may contain proprietary information (for example, manufacturing methods) that may not be necessary to share for the purpose of this Agreement. All references to any given Drug in Regulatory Submissions and other correspondence with Regulatory Authorities by LBS for the corresponding Product will be subject to the prior written appr...
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Regulatory Activities and Submissions Generally. The Parties will confer and cooperate with one another through the JDC (or, as directed by the JDC, through a Subcommittee) and in accordance with this Section 7 with respect to all substantive dealings with regulatory authorities including, but not limited to, [*].
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Regulatory Activities and Submissions Generally. The Parties will confer and cooperate with one another with respect to all dealings with Regulatory Authorities in the Territory concerning the Products through the Steering Committee. The Parties through the Steering Committee will jointly prepare a strategy concerning any filings or applications for Regulatory Approvals relating thereto, including without limitation, discussions regarding the regulatory documentation to be filed, the decision as to whether to make such filings and the timing of such filings. Celltrion, in consultation with Abpro and in accordance with the strategy approved by the Steering Committee, will be responsible for all dealings with Regulatory Authorities concerning the Product in the Territory and will prepare a strategy concerning any applications for Regulatory Approvals, including without limitation, discussions regarding the regulatory documentation to be filed, the decision as to whether to make such filings and the timing of such filings. Celltrion will periodically report to Abpro through the Steering Committee the status of any pending or proposed applications for Regulatory Approval for the Product in the Territory and will keep Abpro fully informed on an ongoing basis regarding the schedule and process for the preparation of such applications for Regulatory Approval for any given Product.
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Regulatory Activities and Submissions Generally. The Parties will confer and cooperate with one another with respect to all dealings with Regulatory Authorities in the License Territory concerning the Products and will jointly prepare a strategy concerning any filings or applications for Regulatory Approvals relating thereto, including without limitation, discussions regarding the regulatory documentation to be filed, the decision as to whether to make such filings and the timing of such filings. The Company, in consultation with Licensor, will be responsible for all dealings with Regulatory Authorities concerning the Product in the License Territory and will prepare a strategy concerning any applications for Regulatory Approvals, including without limitation, discussions regarding the regulatory documentation to be filed, the decision as to whether to make such filings and the timing of such filings. Company will periodically report to Licensor the status of any pending or proposed applications for Regulatory Approval for the Product in the License Territory and will keep Licensor fully informed on an ongoing basis regarding the schedule and process for the preparation of such applications for Regulatory Approval for any given Product.
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Related to Regulatory Activities and Submissions Generally

  • Regulatory Activities Beginning on the Effective Date and to the extent UGNX remains the Lead Development Party with respect to a particular territory, subject to and in accordance with the terms and conditions of this Agreement and the requirements of Applicable Laws, UGNX, shall: (a) use Commercially Reasonable Efforts to file (or have filed) all Regulatory Filings with respect to the Licensed Products in the Field in order to obtain Marketing Approvals in each country in the Territory and the European Territory (or to obtain the European Centralized Approval in the European Core Territory) and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in a timely fashion to requests for data and information from Regulatory Authorities with respect to the Licensed Products in the Field in the Territory and the European Territory; and (c) meet with officials of the Regulatory Authorities at such times as may be requested by such Regulatory Authorities with respect to the Core Development Activities (“Regulatory Activities”), provided that KHK will have primary responsibility for obtaining, and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX in connection with such activities will be shared equally (50/50). All such Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions and meetings with Regulatory Authorities in the Territory and the European Territory relating to the Licensed Products in the Field.

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • Regulatory Matters and Approvals Each of the Parties will give any notices to, make any filings with, and use its reasonable best efforts to obtain any necessary authorizations, consents, and approvals of governments and governmental agencies in connection with the transactions contemplated by this Agreement. Without limiting the generality of the foregoing:

  • Reports; Regulatory Matters (a) The Company and each Company Subsidiary has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2004 with (i) the Federal Reserve Board, (ii) the FDIC, (iii) the Office of the Comptroller of the Currency, (iv) the NASD, (v) any state banking agency, insurance commission or other state regulatory authority, (vi) the SEC, (vii) any foreign regulatory authority and (viii) any SRO (collectively, “Regulatory Agencies”) and with each other applicable Governmental Entity, and all other reports and statements required to be filed by them since January 1, 2004, including any report or statement required to be filed pursuant to the laws, rules or regulations of the United States, any state, any foreign entity, or any Regulatory Agency or Governmental Entity, and have paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by a Regulatory Agency or Governmental Entity in the ordinary course of the business of the Company and its Subsidiaries, no Regulatory Agency or Governmental Entity has initiated since January 1, 2004 or has pending any proceeding, enforcement action or, to the knowledge of the Company, investigation into the business, disclosures or operations of the Company or any Company Subsidiary. Since January 1, 2004, no Regulatory Agency or Governmental Entity has resolved any proceeding, enforcement action or, to the knowledge of the Company, investigation into the business, disclosures or operations of the Company or any Company Subsidiary. There is no unresolved violation, criticism or exception by any Regulatory Agency or Governmental Entity with respect to any report or statement relating to any examinations or inspections of the Company or any Company Subsidiary. Since January 1, 2004, there has been no formal or informal inquiries by, or disagreements or disputes with, any Regulatory Agency or Governmental Entity with respect to the business, operations, policies or procedures of the Company or any Company Subsidiary.

  • 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 Matters The parties will negotiate in good faith to resolve regulatory criticisms or concerns expressed by the Office of the Comptroller of the Currency or other U.S. federal or state banking Regulators that can reasonably be addressed through a modification of the Agreement or adoption of mutually agreeable policies or procedures to prevent or resolve a Material Default described by clause (iii) of such definition, subject to applicable legal requirements including restrictions on disclosing confidential supervisory information.

  • Regulatory Approvals and Related Matters (a) Each party shall use reasonable best efforts to file, as soon as practicable after the date of this Agreement, all notices, reports and other documents required to be filed by such party with any Governmental Body with respect to the Merger and the other Contemplated Transactions, and to submit promptly any additional information requested by any such Governmental Body. Without limiting the generality of the foregoing, the Company and Parent shall, promptly (and in any event within 10 days) after the date of this Agreement, prepare and file the notifications required under any Legal Requirement that is designed to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade (collectively, “Antitrust Laws”) in connection with the Merger. The Company and Parent each shall promptly (i) supply the other party with any information which may be required in order to effectuate notices, reports, documents or other filings with any Governmental Body required to be made pursuant to any Antitrust Laws (including the HSR Act) (the “Antitrust Filings”); and (ii) supply any additional information which reasonably may be required by any Governmental Body in connection with Antitrust Filings or which the parties may reasonably deem appropriate. Each of the Company and Parent will notify the other party promptly upon the receipt of (A) any comments from any Governmental Bodies in connection with any Antitrust Filings made pursuant hereto; and (B) any request by any Governmental Bodies for amendments or supplements to any Antitrust Filings made pursuant to, or information provided to comply in all material respects with, any Legal Requirements, including the requirements of the HSR Act. Whenever any event occurs that is required to be set forth in an amendment or supplement to any Antitrust Filings, the Company or Parent, as the case may be, will promptly inform the other party of such occurrence and cooperate in filing with the applicable Governmental Body such amendment or supplement. Each of the Company and Parent shall give the other party prompt notice of the commencement or known threat of commencement of any Legal Proceeding by or before any Governmental Body with respect to the Merger or any of the other Contemplated Transactions, keep the other party reasonably informed as to the status of any such Legal Proceeding or threat, and in connection with any such Legal Proceeding, each of the Company or Parent will permit authorized representatives of the other party to be present at each meeting or conference relating to any such Legal Proceeding and to have access to and be consulted in connection with any document, opinion or proposal made or submitted to any Governmental Body in connection with any such Proceeding.

  • Regulatory Actions The following provisions shall be applicable to the parties to the extent that they are required to be included in employment agreements between a savings bank and its employees pursuant to Section 563.39(b) of the Office of Thrift Supervision (“OTS”) Rules and Regulations, 12 C.F.R. §563.39(b), or any successor thereto, and shall be controlling in the event of a conflict with any other provision of this Agreement, including without limitation Section 5 hereof.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • 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.

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