Examples of Xxxxxx SOPs in a sentence
Such testing shall be performed in accordance with the procedures set out in the Product specific Xxxxxx SOPs for the stability protocol and Product Master Plan.
In accord with Xxxxxx SOPs, Xxxxxx shall properly use, store, handle and maintain all Celator property, including but not limited to Celator-supplied Components, equipment and Product, in Xxxxxx’x custody or control.
Xxxxxx agrees to inform Client within [***] of the result of any regulatory development or changes to Client Product-specific Xxxxxx SOPs that materially affect the Production of Client Product.
In the case of a force majeure event, Xxxxxx shall use commercially reasonable efforts to arrange for the Production of Client Product through subcontracting or other means as appropriate, subject to Client’s prior written consent, to provide Conforming Client Product meeting Specifications and produced in substantial compliance with the Xxxxxx SOPs. The responsibility for any differential in the cost for such Production will be [***].
Client shall comply with all Xxxxxx SOPs while on Althea’s premises.
Such testing shall be performed in accordance with the procedures set out in the product-specific Xxxxxx SOPs for the stability protocol and Product Master Plan.
Client shall have the right to audit Xxxxxx’x facilities to determine compliance with (i) cGMP, (ii) the Project Plan, (iii) Xxxxxx SOPs, and (iv) applicable laws and regulations.
PORTIONS DENOTED WITH [***] HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT MONITORING: Assumes that source document verification will be handled according to Xxxxxx SOPs.
While in attendance at the Facility, Client agrees to comply with all Xxxxxx policies and Xxxxxx SOPs applicable to visitation of the Facility as provided by Xxxxxx to Client prior to or during such attendance.
In addition, Dynavax shall audit Xxxxxx SOPs. If Dynavax chooses to audit more than one (1) time in a calendar year, unless such additional audit is for cause, Dynavax will reimburse Xxxxxx for its reasonable expenses incurred in hosting the audit.