Common use of Development and Regulatory Reporting Clause in Contracts

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.

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 Shionogi 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.

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 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.

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: E389DDA3-3EA0-4C1B-801D-93CD35BC54C2 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.

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 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.

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 thereafterdaysthereafter.