Examples of Galapagos Product in a sentence
Unless otherwise agreed by the Parties in writing, Galapagos shall be solely responsible for all regulatory matters relating to any Pre-Program Activities or Galapagos Product.
The Existing Galapagos Patents in Section 11.2(c) of the Galapagos Schedule of Exceptions represent all Patents within Galapagos’ or its Affiliates’ ownership or control (by license or otherwise) that Galapagos reasonably believes include claims covering the making, using or composition of matter of the Galapagos Molecules or Galapagos Products, or the Exploitation of any such Galapagos Molecule or Galapagos Product.
Galapagos has provided a true, complete and correct list of each Galapagos Molecule and Galapagos Product in the Subject Program that has received IND approval from the FDA.
The rights and obligations of both Parties with respect to any Patents that disclose the use of any active pharmaceutical ingredient that is owned or controlled by Gilead or any of its Affiliates with any Galapagos Molecule, Galapagos Product, Optioned Molecule or Optioned Product (including, for clarity, any Gilead Combination Product) shall be governed by the applicable Combination Product Activities Agreement.
No later than […***…] days after the Completion Date of any Phase 2 Clinical Trial or Phase 3 Clinical Trial for a Galapagos Product, Galapagos shall notify the JDC of such Completion Date.
In the case of a termination of this Agreement with respect to any Galapagos Program, Galapagos Molecule or Galapagos Product, all rights and licenses granted to Gilead under this Agreement with respect to such Galapagos Program, Galapagos Molecule or Galapagos Product, as applicable, shall terminate.
At least […***…] days prior to Initiating any Phase 2 Clinical Trial or Phase 3 Clinical Trial for a Galapagos Product, Galapagos shall provide to the JDC for review the […***…] any Regulatory Materials Controlled by Galapagos or its Affiliates with respect to such Clinical Trial.
Neither Party, nor any of its Affiliates, shall Exploit or grant any (sub)licenses to any Third Party to Exploit any Galapagos Product or Optioned Product for Veterinary Use without the prior written consent of the other Party.
Galapagos has provided a true, complete and correct list of each Galapagos Molecule and Galapagos Product that has received IND approval from the FDA (i) for the ADAMTS-5 Program and (ii) for the Autotaxin Program.
For each Galapagos Program, if either Party becomes aware of any potential claim, or claim, of infringement or misappropriation of Third Party intellectual property rights in connection with the Exploitation of any applicable Galapagos Molecule or Galapagos Product (“Infringing Activity”), then such Party shall promptly notify the other Party thereof.