Common use of Adverse Drug Events Clause in Contracts

Adverse Drug Events. The Parties recognize that as the holder of a Drug Approval Application, ALTUS will be required to submit information and file reports to various governmental agencies on compounds under clinical investigation, compounds proposed for marketing, or marketed drugs. Information must be submitted at the time of initial filing for investigational use in humans and at the time of a request for market approval of a new drug. In addition, supplemental information must be provided on compounds at periodic intervals and adverse drug experiences must be reported at more frequent intervals depending on the severity of the experience. The specific obligations of each Party with respect to adverse drug experiences will be governed by the safety and adverse event reporting agreement(s) described in Section 13.1 above.

Appears in 3 contracts

Samples: And Marketing Agreement (Altus Pharmaceuticals Inc.), And Marketing Agreement (Altus Pharmaceuticals Inc.), And Marketing Agreement (Altus Pharmaceuticals Inc.)

AutoNDA by SimpleDocs

Adverse Drug Events. The Parties recognize that as the Party that is the holder of an IND and a Drug Approval Application, ALTUS Application will be required to submit information and file reports to various governmental agencies on compounds under clinical investigation, compounds proposed for marketing, or marketed drugs. Information must be submitted at the time of initial filing for investigational use in humans and at the time of a request for market approval of a new drug. In addition, supplemental information must be provided on compounds at periodic intervals and adverse drug experiences must be reported at more frequent intervals depending on the severity of the experience. The specific obligations of each Party with respect to adverse drug experiences will be governed by the safety and adverse event reporting agreement(s) described in Section 13.1 above.

Appears in 1 contract

Samples: Collaboration and Licensing Agreement (Osi Pharmaceuticals Inc)

AutoNDA by SimpleDocs
Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!