Regulatory Documentation and Technical Data Packages Sample Clauses

Regulatory Documentation and Technical Data Packages. The Awardee shall work in consultation with the Government Regulatory and Quality Affairs staff for the development of all regulatory submission packages to the FDA and include Government Regulatory and Quality Affairs staff in all formal discussions with the FDA. The Awardee shall provide the Government copies of all technical data generated by the Awardee prior to and during performance of the project, necessary to pursue FDA approval and notify the Government of FDA decisions as these take place. If applicable, the Awardee shall prepare an IND/BLA in the Electronic Common Technical Document (eCTD) format for submission to the FDA and the Government. The awardee shall submit all pre-IND, IND, pre-EUA, and/or BLA report submissions to the AOR for review. The Awardee will take into consideration the comments provided by the AOR and provide the final document being sent to FDA to the AOR. The Awardee shall provide all written communications to and/or from the FDA to the Government as it takes place. The Awardee shall courtesy copy the AOR on all email traffic to the FDA and will forward all emails received from the FDA to the AOR. The Awardee will allow a minimum of 2 government representatives to any meeting with the FDA. Meeting minutes will be forwarded to the AOR within seven (7) calendar days of the meeting or teleconference. All documentation submitted to the government must have quality oversight from an independent quality group not reporting to the executing management group (for example; clinical trials group, data management group, etc).
Sample 1
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Regulatory Documentation and Technical Data Packages. The Awardee shall work in consultation with the Government Regulatory and Quality Affairs staff for the development of all regulatory submission packages to the FDA and include Government Regulatory and Quality Affairs staff in all formal discussions with the FDA. The Awardee shall provide the Government copies of all technical data generated by the Awardee prior to and during performance of the project, necessary to pursue FDA approval and notify the Government of FDA decisions as these take place. If applicable, the Awardee shall prepare an IND/BLA in the Electronic Common Technical Document (eCTD) format for submission to the FDA and the Government. The awardee shall submit all pre-IND, IND, pre-EUA, and/or BLA report submissions to the AOR. The Awardee shall provide all written communications to and/or from the FDA to the Government as it takes place. The Awardee shall courtesy copy the AOR on all email traffic to the FDA and will forward all emails received from the FDA to the AOR. Meeting minutes will be forwarded to the AOR within seven (7) calendar days of the meeting or teleconference. Miscellaneous Data Submissions Awardee must submit to the Government all Point Papers, Briefings, Technical Performance Plans (TPP), Program Development Plans (PDP), Regulatory Strategy, Technology Transfer Report and Gap Analysis, Formulation Development, Feasibility and Optimization Reports, United States Army Medical Research and Material Command Animal Care and Use Review Office (USAMRMC ACURO) Approvals, Human Resources Operations Branch (HROB) Approvals, Technical Presentations and Publications, and any formal technical reports that have been prepared for eventual submission to FDA or other regulatory agencies. Examples include the following reports related to: pharmaceutical development, manufacturing development, manufacturing validation, completed batch records, certificates of analysis, analytical development and validation, drug substance and product stability, nonclinical testing, and clinical testing. Work Breakdown Structure Three-level WBS with costs and schedule (top level is program, level two (2) is phase, level three (3) are major tasks). For WBS level two (2), show breakdown for labor, material, and other indirect costs. WBS shall be updated annually or thirty (30) calendar days after a Statement of Work modification. Government review/approval is fifteen (15) calendar days after receipt of first submittal. Provide changes to draft within ten (10...
Sample 1

Related to Regulatory Documentation and Technical Data Packages

  • Regulatory Materials (a) On a Program-by-Program basis, commencing on the Effective Date until the Regulatory Transfer Date, Prothena shall have the right, in consultation with Celgene, to prepare, file and maintain all Regulatory Materials (including any Regulatory Approvals) necessary for the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program (collectively, the “Program Regulatory Materials”), and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategy. In addition, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. (b) If Celgene exercises its Phase 1 Portion Participation Right for a given Program, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, and maintain such Program Regulatory Materials, and to interact with Regulatory Authorities in connection with the Development and, as applicable, Manufacture of such Collaboration Candidates and Collaboration Products for such Program in accordance with the terms and conditions of Section 2.5. Additionally, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, if the Regulatory Transfer Date does not occur prior to the expiration of the Option Term for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall apply.

  • Manufacturing Technology Transfer Upon AbbVie’s written request with respect to a given Collaboration CAR-T Product and Licensed Product, Caribou shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party Provider) of all Materials and Know-How Controlled by Caribou relating to the then-current process for the Manufacture of such Collaboration CAR-T Product and any corresponding Licensed Products (each, a “Manufacturing Process”). Caribou shall provide, shall cause its Affiliates to provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to provide, all reasonable assistance requested by AbbVie to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to implement each Manufacturing Process at the facilities designated by AbbVie. If requested by AbbVie, such assistance shall include facilitating the entering into of agreements with applicable Third Party suppliers relating to such Collaboration CAR-T Product and any corresponding Licensed Products. Without limitation of the foregoing, in connection with the Manufacturing Process and related transfer: (a) Caribou shall, and shall cause its Affiliates to, make available to AbbVie (or its Affiliate or designated Third Party Provider, as applicable), and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to make available to AbbVie, from time to time as AbbVie may request, all Materials and Manufacturing-related Know-How Controlled by Caribou relating to each Manufacturing Process, including methods, reagents and processes and testing/characterization Know-How, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to Materials to be used, and control methods, that are necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice such Manufacturing Process; (b) Caribou shall cause all appropriate employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of each Manufacturing Process and with the training of the personnel of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to the extent necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice such Manufacturing Process; (c) Without limiting the generality of this Section 4.4.2, Caribou shall cause all appropriate analytical and quality control laboratory employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate analytical and quality control laboratory employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the provision of all applicable analytical methods and the validation thereof (including all applicable Know-How, Information and Materials Controlled by Caribou, and sufficient supplies of all primary and other reference standards); (d) Caribou shall, and shall cause its Affiliates to, take such steps, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers take such steps, as are necessary or reasonably useful to assist AbbVie (or its Affiliate or designated Third Party Provider, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacture of the applicable Collaboration CAR-T Products and corresponding Licensed Products at the applicable facilities; and (e) Caribou shall, and shall cause its Affiliates to, provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party Provider, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice each Manufacturing Process and otherwise to Manufacture the applicable Collaboration CAR-T Products and corresponding Licensed Products.

  • Background Technology List here prior contracts to assign Inventions that are now in existence between any other person or entity and you.

  • Technical Information The Employer agrees to provide to the Union such information that is available relating to employees in the bargaining unit, as may be required by the Union for collective bargaining purposes.

  • 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.

  • 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.

  • Technical Documentation Prior to commencement of the Tests on Completion, the Contractor shall supply to the Engineer the technical documentation as specified in the Employer’s Requirements. The Works or Section shall not be considered to be completed for the purposes of taking- over under sub-clause 10.1 [Taking Over of the Works and Sections] until the Engineer has received the technical documentation as defined in this sub-clause 5.7, the "history file" including design calculations and certain certification as well as any other documents required to meet the CE Marking requirements.

  • Licensed Technology (a) LICENSOR is not aware of any interference, infringement, misappropriation, or other conflict with any intellectual property rights of third parties, and LICENSOR has never received any charge, complaint, claim, demand, or notice alleging any such interference, infringement, misappropriation, or violation (including any claim that LICENSOR must license or refrain from using any intellectual property rights of any third party). To the knowledge of LICENSOR, no third party has interfered with, infringed upon, misappropriated, or otherwise come into conflict with any of the LICENSED TECHNOLOGY. (b) Exhibit A identifies each patent or registration which has been issued to LICENSOR with respect to any of the LICENSED TECHNOLOGY and identifies each pending patent application or application for registration which LICENSOR has made with respect to any of the LICENSED TECHNOLOGY. LICENSEE acknowledges that LICENSOR has previously made available to LICENSEE correct and complete copies of all such patents, registrations and applications (as amended to-date) in LICENSOR’s possession and has made available to LICENSEE correct and complete copies of all other written documentation in LICENSOR’s possession evidencing ownership and prosecution (if applicable) of each such item. (c) Exhibit A identifies each item of LICENSED TECHNOLOGY that is assigned to LICENSOR or that LICENSOR uses pursuant to license, sublicense, agreement, or permission. LICENSOR has made available to LICENSEE correct and complete copies of all such licenses, sublicenses, agreements, patent prosecution files and permissions (as amended to-date) in LICENSOR’s possession. With respect to each item of LICENSED TECHNOLOGY required to be identified in Exhibit A and to the knowledge of LICENSOR: (i) the license, sublicense, agreement, or permission covering the item is legal, valid, binding, enforceable, and in full force and effect; (ii) the license, sublicense, agreement, or permission will continue to be legal, valid, binding, enforceable, and in full force and effect on identical terms following the consummation of the transactions contemplated hereby; (iii) no Party to the license, sublicense, agreement, or permission is in breach or default, and no event has occurred which with notice or lapse of time would constitute a breach or default or permit termination, modification, or acceleration thereunder; (iv) no party to the license, sublicense, agreement, or permission has repudiated any provision thereof; (v) the underlying item of LICENSED TECHNOLOGY is not subject to any outstanding lien or encumbrance, injunction, judgment, order, decree, ruling, or charge; (vi) no action, suit, proceeding, hearing, investigation, charge, complaint, claim, or demand is pending or is threatened which challenges the legality, validity, or enforceability of the underlying item of LICENSED TECHNOLOGY; and (vii) except as provided in Exhibit A, LICENSOR has not granted any license or similar right to the LICENSED TECHNOLOGY within the GENERAL FIELD or PARTHENOGENESIS FIELD.

  • Background Data The Disclosing Party's Background Data, if any, will be identified in a separate technical document.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

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