Common use of TRANSFER OF DATA, INFORMATION AND REGULATORY FILINGS Clause in Contracts

TRANSFER OF DATA, INFORMATION AND REGULATORY FILINGS. Vanda shall promptly assign to BMS all rights, title and interests in any INDs, Marketing Authorizations, and Approvals that it shall have filed in the Remaining Countries with respect to the Product and the Compound contained in the Product and all data generated by it with respect to the Product and the Compound contained in the Product in the Remaining Countries, and will promptly transfer to BMS originals or copies of all pertinent documents relating to same as requested by BMS. In the event that Vanda fails to effectuate the transfer of the foregoing within thirty (30) days after the date that BMS exercises its BMS Option, then, in addition to any other recourse or remedy that BMS may be entitled to at law or in equity, BMS shall be entitled to specific performance of the foregoing obligation and the Parties acknowledge and agree that BMS may obtain an order for same from any court of competent jurisdiction without posting of bond. BMS will reimburse Vanda for any out-of-pocket expenses incurred in connection with such assignment. Within ninety (90) days following any such assignment to BMS, the Parties will finalize and enter into a Data Safety Exchange covering such matters as adverse event reporting, data safety exchange and response to physician inquiries so that BMS may fulfill its reporting responsibilities on a timely basis to Regulatory Authorities;

Appears in 1 contract

Sources: License, Development and Commercialization Agreement (Vanda Pharmaceuticals Inc.)

TRANSFER OF DATA, INFORMATION AND REGULATORY FILINGS. Vanda shall promptly assign to BMS all rights, title and interests in any INDs, Marketing Authorizations, and Approvals that it shall have filed in the Remaining Countries with respect to the Product and the Compound contained in the Product and all data generated by it with respect to the Product and the Compound contained in the Product in the Remaining Countries, and will promptly transfer to BMS originals or copies of all pertinent documents relating to same as requested by BMS. In the event that Vanda fails to effectuate the transfer of the foregoing within thirty (30) days [*] after the date that BMS exercises its BMS Option, then, in addition to any other recourse or remedy that BMS may be entitled to at law or in equity, BMS shall be entitled to specific performance of the foregoing obligation and the Parties acknowledge and agree that BMS may obtain an order for same from any court of competent jurisdiction without posting of bond[*]. BMS will reimburse Vanda for any out-of-pocket expenses incurred in connection with such assignment. Within ninety (90) days [*] following any such assignment to BMS, the Parties will finalize and enter into a Data Safety Exchange covering such matters as adverse event reporting, data safety exchange and response to physician inquiries so that BMS may fulfill its reporting responsibilities on a timely basis to Regulatory Authorities;

Appears in 1 contract

Sources: License, Development and Commercialization Agreement (Vanda Pharmaceuticals Inc.)