Orange Book Listing. The Party that is the NDA holder for the applicable Product shall be responsible for listing and maintaining all applicable Patents in the Orange Book, including payment of all costs and expenses related to such maintenance incurred after the Effective Date. The listing and maintaining Party shall provide the other Party with its planned listings in advance of their submission with sufficient time for the other Party to review and provide comments. The listing and maintaining Party shall consider any such comments in good faith. Upon request of the listing and maintaining Party, the other Party shall cooperate in the filing of appropriate information with the FDA listing such Patents in the Orange Book.
Appears in 4 contracts
Samples: License and Collaboration Agreement (Ultragenyx Pharmaceutical Inc.), Common Stock Purchase Agreement (Ultragenyx Pharmaceutical Inc.), License and Collaboration Agreement (Ultragenyx Pharmaceutical Inc.)
Orange Book Listing. The Parties agree that, upon the filing of an NDA covering a Licensed Product, the Parties will designate which Party that is the NDA holder for the applicable Product shall be responsible for listing and maintaining all applicable Patents the Patent Rights covering the Licensed Product in the Orange BookBook and, including payment of all costs and expenses related subject to such maintenance incurred after the Effective Date. The listing and maintaining Party shall provide the other Party with its planned listings in advance of their submission with sufficient time for the other Party to review and provide comments. The listing and maintaining Party shall consider any such comments in good faith. Upon request of the listing and maintaining Partyforegoing, the other Party so designated shall cooperate in the filing of appropriate information with the FDA listing promptly list such Patents Patent Rights in the Orange Book.
Appears in 2 contracts
Samples: Collaborative Development and License Agreement (Immunogen Inc), Collaborative Development and License Agreement (Immunogen Inc)