Regulatory Filings in the Territory. With respect to regulatory filings filed by or on behalf of Company (or NovaMedica, as the case may be) in the Territory, the party designated by Company and NovaMedica to report to Regulatory Authorities in the Territory shall be responsible for reporting to such Regulatory Authorities any Adverse Event required to be reported, whether in non-clinical or clinical studies for or during Development or Commercialization of any Covered Product. The filing party shall promptly provide the other party with a complete and true copy of any Adverse Event report filed with a Regulatory Authority within the Territory.
Appears in 3 contracts
Samples: Technology Transfer Agreement (Neothetics, Inc.), Technology Transfer Agreement (Regado Biosciences Inc), Technology Transfer Agreement (Regado Biosciences Inc)
Regulatory Filings in the Territory. With respect to regulatory filings filed by or on behalf of Company Marinus (or NovaMedica, as the case may be) in the Territory, the party designated by Company Marinus and NovaMedica to report to Regulatory Authorities in the Territory shall be responsible for reporting to such Regulatory Authorities any Adverse Event required to be reported, whether in non-clinical or clinical studies for or during Development or Commercialization of any Covered Product. The filing party shall promptly provide the other party with a complete and true copy of any Adverse Event report filed with a Regulatory Authority within the Territory.
Appears in 1 contract
Samples: Technology Transfer Agreement (Marinus Pharmaceuticals Inc)