Additional Phase definition
Examples of Additional Phase in a sentence
Following completion of the Development Plan Study, AbbVie shall continue to perform the CMC Services with respect to chemistry, manufacturing and controls with respect to Drug Substance and Drug Product and in support of any associated filings with applicable Regulatory Authorities until the expiration or termination of its obligations to perform the Additional Phase III Supply Services.
AbbVie will provide CMC Services, Additional Phase III Supply Services and Technology Transfer Services pursuant to the terms and conditions set forth in Schedule 2.5 of the Development License and Option Agreement.
Pfizer shall be responsible for the manufacture and supply of (i) clinical materials for an Additional Phase II Clinical Trial initiated after the Completion of the Ongoing Clinical Trial and any Phase III Clinical Trial for each Licensed Product and (ii) for the commercial supply of each Compound and each Licensed Product in the Territory.
Except as expressly provided in this Schedule 2.5, AbbVie shall not contract out to any Third Party any part of AbbVie’s Development Plan Supply Services, CMC Services and Additional Phase III Supply Services and associated Manufacturing obligations without the prior written approval of Receptos.
AbbVie will supply all Drug Substance and Drug Product to Receptos in the course of the Development Plan Supply Services, Additional Phase III Supply Services and any Technology Transfer Services for a purchase price equal to *** which shall be paid by Receptos upon quarterly invoice; ***.
The CMC Services, Additional Phase III Supply Services and Technology Transfer Services not otherwise covered pursuant to Section 4.1 will be provided at *** which shall be paid by Receptos upon quarterly invoice.
Notwithstanding the foregoing: (i) any CMC Services or Additional Phase III Supply Services by AbbVie not otherwise covered pursuant to Section 4.1 provided during the term of the Collaboration Agreement (if executed) shall be charged ***; provided, however, that Technology Transfer Services provided during the term of the Collaboration Agreement (if executed) shall be addressed as set forth in Schedule 3.3.2 (e.g..
On the Transfer Date, ▇▇▇▇▇ and Developer shall each execute and deliver to the other a non-exclusive Common Facilities Easement in the form attached hereto as Exhibit B-2, which shall provide Developer the right to use the easements of ▇▇▇▇▇ on which the Common Facilities and the Additional Phase are anticipated to be located, for the purposes of ingress and egress to and from, and operation, maintenance and inspection of, the Common Facilities and the Additional Phase.
On the Effective Date, ▇▇▇▇▇ and Developer shall each execute and deliver to the other a non-exclusive Common Facilities Easement in the form attached hereto as Exhibit B-2, which shall provide Developer the right to use the easements of ▇▇▇▇▇ on which the Common Facilities and the Additional Phase are anticipated to be located, for the purposes of the connection of the Additional Phase with the Common Facilities.
If Relay does not agree to the addition of the Optional Additional Phase Ia Study to the Relay Phase Ia Plan, then Licensee may conduct such Optional Additional Phase Ia Study at its own expense outside of the Relay Phase Ia Plan.