Drug Approval Applications. NovaMedica shall be entitled to file Drug Approval Applications and seek Regulatory Approvals for the Covered Products in the Territory, provided that such filing shall be subject to the oversight of the JDC. Prior to submitting any IND or Drug Approval Application, the Parties, through the JDC, shall consult and cooperate in preparing such filings, their content and scope. NovaMedica shall own all regulatory submissions, including all INDs, Drug Approval Applications and associated government licenses, approvals, and certificates for the Covered Products in the Territory.
Appears in 2 contracts
Samples: Clinical Development and Collaboration Agreement (Neothetics, Inc.), Clinical Development and Collaboration Agreement (Neothetics, Inc.)
Drug Approval Applications. NovaMedica shall be entitled to file Drug Approval Applications and seek Regulatory Approvals for the Covered Products in the Territory, provided that such filing shall be subject to the oversight of the JDC. Prior to submitting any IND or Drug Approval Application, the Parties, through the JDC, shall consult and cooperate in preparing such filings, their content and scope. NovaMedica shall own all regulatory submissions, including all INDsINDS, Drug Approval Applications and associated government licenses, approvals, and certificates for the Covered Products and/or Compound in the Territory.
Appears in 1 contract
Drug Approval Applications. NovaMedica shall be entitled to file Drug Approval Applications and seek Regulatory Approvals for the Covered Products in the Territory, provided that such filing shall be subject to the oversight of the JDC. Prior to submitting any IND clinical trial application or Drug Approval Application, the Parties, through the JDC, shall consult and cooperate in preparing regarding the preparation of such filings, their content and scope. NovaMedica shall own all regulatory submissions, including all INDsclinical trial applications, Drug Approval Applications and associated government licenses, approvals, and certificates for the Covered Products and/or Compound in the Territory.
Appears in 1 contract
Samples: Clinical Development and Collaboration Agreement (Marinus Pharmaceuticals Inc)