Common use of Process Development Clause in Contracts

Process Development. Each Party shall be responsible, at its expense, for manufacturing process development in accordance with the applicable Development Plan. The Development Plan for each HemOnc Product shall set forth the timeline and the Parties’ respective activities for the development of the manufacturing process for each such HemOnc Product, to be generally assigned to each Party consistent with the table below for each such HemOnc Product. In addition, manufacturing process development activities shall include technology transfer to Third Party manufacturers or Third Party research organizations for scale up and production of materials for clinical trials, and all other such activities related to development and validation of a commercial manufacturing process. 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”). Each Party shall provide periodic written reports on its Development of the applicable manufacturing process. [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]

Appears in 2 contracts

Sources: License and Option Agreement (Jazz Pharmaceuticals PLC), License and Option Agreement (Pfenex Inc.)

Process Development. Each Party shall be responsible, at its expense, for manufacturing process development in accordance with the applicable Development Plan. The Development Plan for each HemOnc Product shall set forth the timeline and the Parties’ respective activities for the development of the manufacturing process for each such HemOnc Product, to be generally assigned to each Party consistent with the table below for each such HemOnc Product. In addition, manufacturing process development activities shall include technology transfer to Third Party manufacturers or Third Party research organizations for scale up and production of materials for clinical trials, and all other such activities related to development and validation of a commercial manufacturing process. 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”). Each Party shall provide periodic written reports on its Development of the applicable manufacturing process. [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Appears in 2 contracts

Sources: License Agreement (Pfenex Inc.), License Agreement (Pfenex Inc.)

Process Development. Each Party shall be responsible, at its expense, for manufacturing process development in accordance with the applicable Development Plan. The Development Plan for each HemOnc Product shall set forth the timeline and the Parties’ respective activities for the development of the manufacturing process for each such HemOnc Product, to be generally assigned to each Party consistent with the table below for each such HemOnc Product. In addition, manufacturing process development activities shall include technology transfer to Third Party manufacturers or Third Party research organizations for scale up and production of materials for clinical trials, and all other such activities related to development and validation of a commercial manufacturing process. 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”). Each Party shall provide periodic written reports on its Development of the applicable manufacturing process. [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]] [***] Subject to Section 6.2(b)(ii), with respect to HemOnc-NextGen, at any time after achievement of [***] as set forth on Exhibit 6.3 and irrespective of whether Jazz has conducted any Jazz Assessment Activities, Jazz may request in writing that Pfenex begin, and Pfenex shall so begin, [***] in accordance with the applicable Development Plan.

Appears in 1 contract

Sources: License Agreement (Jazz Pharmaceuticals PLC)