Development Events. In connection with the Discovery and Development of Licensed Products that are Covered by a Valid Claim of Licensed Patent Rights, or the Manufacture of which Licensed Products is Covered by a Valid Claim of a Licensed Patent Right, and directed against a given Target hereunder, Licensee shall pay, or cause to be paid, to Alnylam the following payments upon the achievement of the events set forth below: Development Event: (in [**]): Initiation of GLP Toxicology Studies $ [**] Initiation of the first Phase I Study $ [**] Initiation of the first Phase II Study $ [**] Initiation of the first Phase III Study for the first Indication $ [**] Initiation of first Phase III Study for a second Indication $ [**] First filing of an NDA in the U.S. for the first Indication $ [**] First filing of an NDA in the EU for the first Indication $ [**] First filing of an NDA in Japan for the first Indication $ [**] First filing of an NDA in the U.S. or EU for a second Indication $ [**] Regulatory Approval in the U.S. for the first Indication $ [**] Regulatory Approval in the EU for the first Indication $ [**] Regulatory Approval in Japan for the first Indication $ [**] Regulatory Approval in the U.S. or EU for a second Indication $ [**]
Appears in 2 contracts
Sources: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.), License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)
Development Events. In connection with the Discovery and Development of Licensed Products that are Covered by a Valid Claim of Licensed Patent Rights, or the Manufacture of which Licensed Products is Covered by a Valid Claim of a Licensed Patent Right, and directed against a given Target hereunder, Licensee shall pay, or cause to be paid, to Alnylam the following payments upon the achievement of the events set forth below: Development Event: Payment for Licensed Products (in [**]): Initiation of GLP Toxicology Studies $ [**] Initiation of the first Phase I Study $ [**] Initiation of the first Phase II Study $ [**] [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Initiation of the first Phase III Study for the first Indication $ [**] Initiation of first Phase III Study for a second Indication $ [**] First filing of an NDA in the U.S. for the first Indication $ [**] First filing of an NDA in the EU for the first Indication $ [**] First filing of an NDA in Japan for the first Indication $ [**] First filing of an NDA in the U.S. or EU for a second Indication $ [**] Regulatory Approval in the U.S. for the first Indication $ [**] Regulatory Approval in the EU for the first Indication $ [**] Regulatory Approval in Japan for the first Indication $ [**] Regulatory Approval in the U.S. or EU for a second Indication $ [**]Indication
Appears in 1 contract
Sources: License and Collaboration Agreement (Arrowhead Research Corp)