Regulatory Data and Regulatory Materials Sample Clauses

Regulatory Data and Regulatory Materials. As soon as reasonably practicable, but in any event within [***] of the Effective Date and in accordance with a plan to be reasonably agreed to by the Parties, Lilly shall provide Licensee with copies of all Regulatory Materials and Regulatory Data that are in Lilly’s possession and that are necessary for Licensee to perform its obligations hereunder. During the Term, Lilly and Licensee shall each promptly provide to the other copies of any further Regulatory Materials and Regulatory Data that either may generate or otherwise acquire that is necessary for such other Party to Develop, Manufacture or Commercialize its respective products (i.e., Products in the case of Licensee, and Lilly Products in the case of Lilly). Lilly shall make such data and information available in electronic common technical document (“eCTD”) format as is currently in such eCTD format, it being understood that Lilly shall provide all other data and information not in eCTD format in its current electronic and/or paper format. For clarity, Licensee shall have the right to use and reference all such data and information made available under this Section 4.1 in connection with its Development and Commercialization of Products in accordance with this Agreement. Each Party may use the Regulatory Materials and Regulatory Data provided by the other Party hereunder only in accordance with the rights granted to, or retained by, such other Party hereunder.
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Regulatory Data and Regulatory Materials. Lilly shall use [***] to provide Licensee with such Regulatory Materials and Regulatory Data as set forth on Schedule C in the current “as-is” form and format [***]after the Effective Date. Licensee may only use the Regulatory Materials and Regulatory Data provided by Lxxxx xxxxxxxxx in accordance with the rights granted to Licensee under Section 2.1.
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Regulatory Data and Regulatory Materials. At Licensee’s election by written notice, Agenus will either (a) within [**] after the Effective Date, deliver to Licensee all Regulatory Materials and Regulatory Data for AGEN1777, or (b) continue to hold all such Regulatory Materials and Regulatory Data and complete the filing of the first IND for AGEN1777. In either scenario (a) or (b) in the preceding sentence, Agenus will make available to Licensee all [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Exhibit 10.1 Regulatory Materials and Regulatory Data [**] after the Effective Date. Subject to the foregoing and Section 5.2.2 (Initial IND for AGEN1777), Agenus will and hereby does assign to Licensee all of its rights, title, and interest in and to such Regulatory Materials and Regulatory Data. Licensee may only use the Regulatory Materials and Regulatory Data provided by Agenus to Exploit the Licensed Antibodies and Licensed Products in the Field in the Territory.
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Regulatory Data and Regulatory Materials. Subject to the terms of Section 4.8 above, any Regulatory Materials and Regulatory Data that AKP may generate or otherwise acquire (including any Regulatory Materials and Regulatory Data that its Affiliates or Sublicensees may generate or otherwise acquire, but excluding any Regulatory Materials or Regulatory Data Controlled by VectivBio (other than pursuant to any licenses granted by AKP to VectivBio under this Agreement), and excluding the global safety database maintained by VectivBio for the Product) shall be owned solely and exclusively by AKP. On a quarterly basis throughout the Term or upon VectivBio’s reasonable request, AKP shall provide to VectivBio copies of any Regulatory Materials and Regulatory Data that AKP may generate or otherwise acquire (including any Regulatory Materials and Regulatory Data that its Affiliates or Sublicensees may generate or otherwise acquire), that are reasonably necessary or useful for Developing or Commercializing the Product or for obtaining or maintaining Regulatory Approvals for the Product, in each case in the Field and outside the Territory (or within the Territory) as contemplated under Section 2.2. Unless otherwise agreed by the Parties, all Regulatory Materials and Regulatory Data to be provided hereunder by AKP (including without limitation all submissions made to Regulatory Authorities) shall be in original language and if English translation thereof are in its possession, with English translation thereof, and where practical, a summary thereof in English, and in computer readable format.
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Regulatory Data and Regulatory Materials 
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Related to Regulatory Data and Regulatory Materials

  • Regulatory Materials (a) Alvogen shall have the sole right to control filing or submission of Regulatory Materials with the Regulatory Agencies in the Territory with respect to Product including the MAA Approval for Product and Regulatory Approvals in the Territory, subject to Section 3.2 and the oversight of and in consultation with the Executive Steering Committee, and [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. shall be responsible for managing all communications and interactions with the Regulatory Agencies in the Territory with respect to Product in the Territory. In all cases, prior to the filing of any Regulatory Materials (including the MAA for Product) for Product with the applicable Regulatory Agency, Alvogen shall provide a copy thereof to Pfenex (through the Executive Steering Committee) for its review and comment. Pfenex shall have fifteen (15) Business Days from the date it receives a copy of any Regulatory Materials with respect to the Product to provide Alvogen with comments regarding such Regulatory Materials, unless the Regulatory Agencies in the Territory or Applicable Law requires that such Regulatory Material(s) be filed on a timeline that does not reasonably permit such advanced notice, in which case Pfenex shall have as much time as is reasonably practicable to provide Alvogen with comments. Alvogen shall consider all such comments in good faith. Alvogen shall, to the extent permitted by Applicable Law, provide Pfenex with (i) reasonable advanced notice (and in no event less than fifteen (15) Business Days’ advance notice whenever feasible) of substantive meetings with any Regulatory Agency in the Territory that are either scheduled with or initiated by or on behalf of Alvogen or its Affiliates, (ii) an opportunity to have a reasonable number (but at least two (2)) representatives participate in all substantive meetings with the Regulatory Agencies in the Territory with respect to Product, and in any case keep Pfenex informed as to all material interactions with the Regulatory Agencies in the Territory with respect to Product, and (iii) a copy of any material documents, information and correspondence submitted to or received from the Regulatory Agencies in the Territory with respect to Product as soon as reasonably practicable.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

  • Regulatory Filing In the event that this Interconnection Construction Service Agreement contains any terms that deviate materially from the form included in Attachment P or from the standard terms and conditions in this Appendix 2, the Transmission Provider shall file the executed Interconnection Construction Service Agreement on behalf of itself and the Interconnected Transmission Owner with FERC as a service schedule under the Tariff. Interconnection Customer may request that any information so provided be subject to the confidentiality provisions of Section 17 of this Appendix

  • 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.

  • Product Data Illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by Developer to illustrate a material, product, or system for some portion of the Work.

  • SHOP DRAWINGS, PRODUCT DATA AND SAMPLES 4.12.1 Shop Drawings are drawings, diagrams, schedules and other, data specially prepared for the Work by the Contractor or any Subcontractor, manufacturer, supplier or distributor to illustrate some portion of the Work.

  • Third Party Materials The Application may display, include, or make available third-party content (including data, information, applications, and other products, services, and/or materials) or provide links to third-party websites or services, including through third- party advertising ("Third-Party Materials"). You acknowledge and agree that Company is not responsible for Third-Party Materials, including their accuracy, completeness, timeliness, validity, copyright compliance, legality, decency, quality, or any other aspect thereof. Company does not assume and will not have any liability or responsibility to you or any other person or entity for any Third-Party Materials. Third-Party Materials and links thereto are provided solely as a convenience to you, and you access and use them entirely at your own risk and subject to such third parties' terms and conditions.

  • Regulatory Applications (a) Sky and Metropolitan and their respective Subsidiaries shall cooperate and use their respective reasonable best efforts to prepare, within 45 days of the execution of this Agreement, all documentation and requests for regulatory approval, to timely effect all filings and to obtain all permits, consents, approvals and authorizations of all third parties and Governmental Authorities and Regulatory Authorities necessary to consummate the transactions contemplated by this Agreement. Each of Sky and Metropolitan shall have the right to review in advance, and to the extent practicable each will consult with the other, in each case subject to applicable laws relating to the exchange of information, with respect to, and shall be provided in advance so as to reasonably exercise its right to review in advance, all material written information submitted to any third party or any Governmental Authority or Regulatory Authority in connection with the transactions contemplated by this Agreement. In exercising the foregoing right, each of the parties hereto agrees to act reasonably and as promptly as practicable. Each party hereto agrees that it will consult with the other party hereto with respect to the obtaining of all material permits, consents, approvals and authorizations of all third parties and Governmental Authorities or Regulatory Authorities necessary or advisable to consummate the transactions contemplated by this Agreement and each party will keep the other party apprised of the status of material matters relating to completion of the transactions contemplated hereby.

  • Licensed Materials The materials that are the subject of this Agreement are set forth in Appendix A ("Licensed Materials").

  • Promotional Materials In the event that the Fund or the Adviser makes available any promotional materials related to the Securities or the transactions contemplated hereby intended for use only by registered broker-dealers and registered representatives thereof by means of an Internet web site or similar electronic means, the Adviser will install and maintain, or will cause to be installed and maintained, pre-qualification and password-protection or similar procedures which are reasonably designed to effectively prohibit access to such promotional materials by persons other than registered broker-dealers and registered representatives thereof.

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