Kit Component definition
Examples of Kit Component in a sentence
Exhibits: Exhibit 1 Existing Countries Exhibit 2 Planned/targeted countries Exhibit 3 Prices Exhibit 4: Sample Development Order Exhibit 5: Kit Component Aging Studies Exhibit 6: Format for Status of Yearly Review [signature page follows] ▇▇▇▇▇: ▇▇▇▇▇▇ ▇▇▇▇▇: Berlin Date: 23-12-2015 Date: 22-12-2015 for and on behalf of Shire Pharmaceuticals Ireland Ltd.
CLIENT further warrants that the Bulk Conjugated Antibody and other CLIENT Supplied Components provided to ▇▇▇▇▇▇ hereunder will (1) conform to the applicable Kit Component Specifications and/or Kit Specifications and (2) not be adulterated or misbranded within the meaning of the FD&C Act.
BAXTER shall control packaging materials listed in the Product Master Plan and shall assist CLIENT with evaluation and purchase of modified materials in the event that CLIENT requests, pursuant to Section 2.2, a packaging change in the Kit Specifications and/or Kit Component Specifications.
If any reprocessing, rework, or reproduction is required in order to meet the Kit Component Specifications and/or Kit Specifications, BAXTER shall conduct such reprocessing, rework, or reproduction in compliance with cGMPs and the BLA.
BAXTER shall be permitted to store Kit Components and Kits [CONFIDENTIAL TREATMENT REQUESTED] in third party storage facilities only to the extent permitted in the applicable Project Plans, provided in each case that (a) such third 3.9.3 party shall have been previously approved in writing by CLIENT and (b) CLIENT shall have the right to visit, inspect and audit such third party's facilitates and records used in or that otherwise directly affect the storage of any Kit Component or Kit.
For each Kit and Kit Component delivered by Spectrum, MMCO agrees to pay the price set forth in Exhibit E, as may be amended from time to time by the Parties.
In the event of any modification(s) to the Kit Component Specifications, Kit Specifications, the Shipping Instructions, the list of countries where Products will be sold and/or the Regulatory Authorities that result in an increase/decrease in the cost to BAXTER to Produce a Kit Component or Kit, then the parties shall negotiate in good faith an adjustment to the Purchase Price for such Kit Component or Kit to reflect such increased/decreased cost.
The price to be paid by CLIENT for process development, validation, regulatory and other services (which price shall exclude the Purchase Price for each Kit Component or Kit that is Produced under this Agreement and released by ▇▇▇▇▇▇'▇ quality assurance department in accordance with the Quality Agreement) shall be set forth in Part B of Exhibit 7, as amended, supplemented or restated from time to time in accordance with Section 2.2.2 or as the parties otherwise mutually agree in writing.
The price to be paid by CLIENT for each Kit Component or Kit that is Produced under this Agreement and released by ▇▇▇▇▇▇'▇ quality assurance department in accordance with the Quality Agreement shall be the applicable Purchase Price therefor, as set forth in Part A of Exhibit 7, as amended, supplemented or restated from time to time in accordance with Section 2.2.2 or as the parties otherwise mutually agree in writing.
In no event shall BAXTER be required to store any Kit Component or Kit for more than [CONFIDENTIAL TREATMENT REQUESTED] after such Kit Component or Kit is released by ▇▇▇▇▇▇'▇ quality assurance department, without ▇▇▇▇▇▇'▇ prior written consent and CLIENT's agreement to reimburse BAXTER for at the rate set forth in Part B of Exhibit 7, as amended, supplemented or restated from time to time in accordance with Section 2.2.2 or as the parties otherwise mutually agree in writing.