Development and Regulatory Reporting Sample Clauses

Development and Regulatory Reporting. For the period beginning from the Effective Date, within ten (10) Business Days following the end of each Calendar Quarter, Licensee shall provide MPP with a quarterly written report covering all its activities related to the development and testing of all Licensed Products and/or Compound (as permitted and to the extent applicable) and the obtaining of necessary governmental approvals, including, but not limited to (and to the extent applicable and permitted) its (a) Licensed Products, Product, and/or Compound in its development pipeline, (b) status of development of each Licensed Product, Product and/or Compound in development, (c) regulatory filing plan for WHO Prequalification Programme and/or an SRA, and where applicable any local regulatory filings, for each Licensed Product, (d) a list of Agencies, including as applicable the FDA, WHO and authorities in the countries within the Territory for which such Key Approvals or other local approvals or authorizations have been filed and/or obtained for any Licensed Product, (e) summary of work completed and in progress, (f) current schedule of anticipated events and milestones, (g) anticipated market introduction dates, (h) all bioequivalence data generated by or on behalf of Licensee related to Licensed Product, and (i) other activities, if applicable. Licensee will also report to MPP and Pfizer the date of first commercial sale of each Licensed Product, whether such sale is to a Public Purchaser, Governmental Authority or private entity or person and whether such sale is made under an emergency use authorization (“EUA”) or Key Approval within five (5) business days thereafter.
Sample 1Sample 2Sample 3See All (29)
AutoNDA by SimpleDocs
Development and Regulatory Reporting. For the period beginning from the Effective Date, within ten (10) Business Days following the end of each Calendar Quarter, Licensee shall provide MPP with a quarterly written report covering all DocuSign Envelope ID: 20ED8EAA-71E5-4C18-B49D-62DBEC763D25 its activities related to the development and testing of all Licensed Products and/or Compound (as permitted and to the extent applicable) and the obtaining of necessary governmental approvals, including, but not limited to (and to the extent applicable and permitted) its (a) Licensed Products, Product, and/or Compound in its development pipeline, (b) status of development of each Licensed Product, Product and/or Compound in development, (c) regulatory filing plan for WHO Prequalification Programme and/or an SRA, and where applicable any local regulatory filings, for each Licensed Product, (d) a list of Agencies, including as applicable the FDA, WHO and authorities in the countries within the Territory for which such Key Approvals or other local approvals or authorizations have been filed and/or obtained for any Licensed Product, (e) summary of work completed and in progress, (f) current schedule of anticipated events and milestones, (g) anticipated market introduction dates, (h) all bioequivalence data generated by or on behalf of Licensee related to Licensed Product, and (i) other activities, if applicable. Licensee will also report to MPP and Pfizer the date of first commercial sale of each Licensed Product, whether such sale is to a Public Purchaser, Governmental Authority or private entity or person and whether such sale is made under an emergency use authorization (“EUA”) or Key Approval within five (5) business days thereafter.
Sample 1See All (7)

Related to Development and Regulatory Reporting

  • Regulatory Reporting Ultimus agrees to provide reports to the federal and applicable state authorities, including the SEC, and to the Funds’ Auditors. Applicable state authorities are those governmental agencies located in states in which the Fund is registered to sell shares.

  • Research Use Reporting To assure adherence to NIH GDS Policy, the PI agrees to provide annual Progress Updates as part of the annual Project Renewal or Project Close-out processes, prior to the expiration of the one (1) year data access period. The PI who is seeking Renewal or Close-out of a project agree to complete the appropriate online forms and provide specific information such as how the data have been used, including publications or presentations that resulted from the use of the requested dataset(s), a summary of any plans for future research use (if the PI is seeking renewal), any violations of the terms of access described within this Agreement and the implemented remediation, and information on any downstream intellectual property generated from the data. The PI also may include general comments regarding suggestions for improving the data access process in general. Information provided in the progress updates helps NIH evaluate program activities and may be considered by the NIH GDS governance committees as part of NIH’s effort to provide ongoing stewardship of data sharing activities subject to the NIH GDS Policy.

  • REGULATORY FILINGS AND CAISO TARIFF COMPLIANCE 3.1 Filing

  • Program Reporting Contractor shall provide such data as may be required by the Board, in the form required by the Board to fulfill its obligations as a public school district, as well as academic, financial and other program records and reports as requested by the Board for program accreditation, monitoring, payment, and auditing. Such data and reports shall include, but not be limited to, all of the following:

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Progress Reporting 5. The IP will submit to UNICEF narrative progress reports against the planned activities contained in the Programme Document, using the PDPR. Unless otherwise agreed between the Parties in writing, these reports will be submitted at the end of every Quarter. The final report will be submitted no later than thirty (30) calendar days after the end the Programme and will be provided together with the FACE form.

  • Legal and Regulatory Compliance The Consultant shall perform all services and prepare documents in compliance with the applicable requirements of laws, codes, rules, regulations, ordinances, and standards.

  • Development cooperation 1. The Parties recognise that development cooperation is a crucial element of their Partnership and an essential factor in the realisation of the objectives of this Agreement as laid down in Article 1. This cooperation can take financial and non-financial forms.

  • Additional Information for Product Development Projects Outcome of product development efforts, such copyrights and license agreements. • Units sold or projected to be sold in California and outside of California. • Total annual sales or projected annual sales (in dollars) of products developed under the Agreement. • Investment dollars/follow-on private funding as a result of Energy Commission funding. • Patent numbers and applications, along with dates and brief descriptions.  Additional Information for Product Demonstrations: • Outcome of demonstrations and status of technology. • Number of similar installations. • Jobs created/retained as a result of the Agreement.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

Time is Money Join Law Insider Premium to draft better contracts faster.