Common use of Notice of Certain Events; Pharmacovigilance Clause in Contracts

Notice of Certain Events; Pharmacovigilance. In addition to the progress reports required pursuant to Section 3.3 above, Ophthotech shall provide Archemix with written notice within [***] days of the occurrence of (a) the [***] in each country, (b) the Completion of each [***], [***] and [***] of a Licensed Product, and the final reports thereof, (c) each milestone set forth in Section 4.4 below, (d) any Regulatory Approval in any country, and (e) any other material event other than as set forth in the foregoing clauses (a)-(d) related to the Development or commercialization of Licensed Products. Ophthotech and, to the extent Archemix Develops and/or commercializes any Licensed Product, Archemix, shall notify one another in writing of all information coming to their attention regarding Adverse Events, Serious Adverse Events and/or Unexpected Adverse Events related to, or reasonably likely to be related to, any Licensed Product, regardless of the origin of such information and, for the avoidance of doubt, including such information coming to their attention through journal publications and other media. Notifications of Serious Adverse Events and Unexpected Adverse Events shall be given contemporaneously with notifications of such Serious Adverse Events or Unexpected Adverse Events to any regulatory authority, including the FDA or any Foreign Regulatory Authority. In addition, Ophthotech shall provide Archemix with periodic (not more frequently than [***] per [***]) telephone updates as to Adverse Events, Serious Adverse Events and/or Unexpected Adverse Events related to any Licensed Product, to the extent reasonably requested by Archemix. Notifications of all other Adverse Events shall be provided [***], with the information provided in each [***] notification to be current to within [***] days prior to the Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 17 date of such notification.

Appears in 2 contracts

Samples: Exclusive License Agreement (Nitromed Inc), Exclusive License Agreement (Archemix Corp.)

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Notice of Certain Events; Pharmacovigilance. In addition to the progress reports required pursuant to Section 3.3 3.2 above, Ophthotech shall provide Archemix with written notice within [***] days of after the occurrence of (a) the [***] First Commercial Sale in each country, (b) the Completion of each [***]Phase I Clinical Trial, [***] Phase II Clinical Trial and [***] Phase III Clinical Trial of a Licensed Product, and the final reports thereof, (c) each milestone set forth in Section 4.4 below, (d) any Regulatory Approval in any country, and (e) any other material event other than as set forth in the foregoing clauses (a)-(d) related to the Development or commercialization of Licensed Products. Ophthotech and, to the extent Archemix Develops and/or commercializes any Licensed Product, Archemix, shall notify one another in writing of all information coming to their attention regarding Adverse Events, Serious Adverse Events and/or Unexpected Adverse Events related to, or reasonably likely to be related to, any Licensed Product, regardless of the origin of such information and, for the avoidance of doubt, including such information coming to their attention through journal publications and other media. Notifications of Serious Adverse Events and Unexpected Adverse Events shall be given contemporaneously with notifications of such Serious Adverse Events or Unexpected Adverse Events to any regulatory authority, including the FDA or any Foreign Regulatory Authority. In addition, Ophthotech shall provide Archemix with periodic (not more frequently than [***] per [***]) telephone updates as to Adverse Events, Serious Adverse Events and/or Unexpected Adverse Events related to any Licensed Product, to the extent reasonably requested by Archemix. Notifications of all other Adverse Events shall be provided [***], with the information provided in each [***] notification to be current to within [***] days prior to the Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 17 date of such notification.

Appears in 1 contract

Samples: Exclusive License Agreement (Ophthotech Corp.)

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Notice of Certain Events; Pharmacovigilance. In addition to the progress reports required pursuant to Section 3.3 3.2 above, Ophthotech shall provide Archemix with written notice within [***] days of after the occurrence of (a) the [***] First Commercial Sale in each country, (b) the Completion of each [***]Phase I Clinical Trial, [***] Phase II Clinical Trial and [***] Phase III Clinical Trial of a Licensed Product, and the final reports thereof, (c) each milestone set forth in Section 4.4 4.3 below, (d) any Regulatory Approval in any country, and (e) any other material event other than as set forth in the foregoing clauses (a)-(d) related to the Development or commercialization of Licensed Products. Ophthotech and, to the extent Archemix Develops and/or commercializes any Licensed Product, Archemix, shall notify one another in writing of all information coming to their attention regarding Adverse Events, Serious Adverse Events and/or Unexpected Adverse Events related to, or reasonably likely to be related to, any Licensed Product, regardless of the origin of such information and, for the avoidance of doubt, including such information coming to their attention through journal publications and other media. Notifications of Serious Adverse Events and Unexpected Adverse Events shall be given contemporaneously with notifications of such Serious Adverse Events or Unexpected Adverse Events to any regulatory authority, including the FDA or any Foreign Regulatory Authority. In addition, Ophthotech shall provide Archemix with periodic (not more frequently than [***] per [***]) telephone updates as to Adverse Events, Serious Adverse Events and/or Unexpected Adverse Events related to any Licensed Product, to the extent reasonably requested by Archemix. Notifications of all other Adverse Events shall be provided [***], with the information provided in each [***] notification to be current to within [***] days prior to the Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 17 date of such notification.

Appears in 1 contract

Samples: Exclusive License Agreement (Ophthotech Corp.)

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