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.
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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: E68F63E3-D274-4CA3-9C96-ECE5CBD30F63 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.
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Related to Development and Regulatory Reporting

  • 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.

  • 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.

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