Process Transfer definition
Examples of Process Transfer in a sentence
Further, the Development Plan for each HemOnc Product shall set forth the criteria with respect to the manufacturing process for such HemOnc Product that must be satisfied prior to the transfer of such manufacturing process pursuant to Section 4.7(b) (with respect to such HemOnc Product, the “Manufacturing Process Transfer Criteria”).
For clarity, after completion of the applicable Manufacturing Process Transfer, Sections 7.1(a) and 7.1(b) shall govern ownership of Inventions that constitute a process, or an improvement, modification, or enhancement of a process, used in the manufacture of proteins following the primary recovery of such proteins.
In connection with such request, SutroVax shall provide to Sutro a description of the desired Process Transfer and/or Capacity, including timing and other requirements thereof.
It is understood that SutroVax may request that the Process Transfer and establishment of Capacity be undertaken in separate steps, for example by undertaking an initial Process Transfer to demonstrate the CMO’s ability to Manufacture Extract, and then later establishing Capacity for Phase 3 and commercial supply, as requested by SutroVax in accordance with Section 2.15.1(a) (i.e., in separate requests).
Translate Bio shall use Commercially Reasonable Efforts to deliver to Sanofi the tangible items of the Licensed Technology listed within Technology and Process Transfer Plan within the timeframes prescribed therein.
Translate Bio’s personnel that are transferring Licensed Technology under the Technology and Process Transfer Plan shall have actual knowledge of the Licensed Technology and Licensed Improvements, if any, they are transferring.
The parties acknowledge that Sandoz’s ability to conduct the Pilot Phase in accordance with this timetable is dependent on timely delivery by Unigene in accordance with the Technology Transfer Plan of agreed-upon Process Transfer Information.
Prior to Manufacturing Process Transfer under Section 4.7(b) (if applicable), Pfenex shall use reasonable efforts to manufacture and supply to Jazz all non-GMP HemOnc Products reasonably required for pre-clinical and process development studies in accordance with the specifications, quantities and timeline set forth in the applicable Development Plan.
Notwithstanding the foregoing, Pfenex shall perform a Manufacturing Process Transfer for an applicable Product at Jazz’s request (A) not later than the applicable time set forth in the Development Plan and/or (B) if after good faith discussions with Pfenex with an opportunity for Pfenex to take corrective action, Jazz reasonably determines that Pfenex will be unable achieve the Manufacturing Process Transfer Criteria by the applicable time set forth in the Development Plan.
Upon SutroVax’s request (which request, for clarity, may be before a request to negotiate a Transfer Addendum), Sutro shall seek quotations from one or more Third Party CMO(s) for such a Process Transfer and/or establishment of such Capacity, in each case as requested by SutroVax, and the Parties shall reasonably cooperate to establish requests for quotations for such purposes.