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.
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 [***].
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.
Client shall comply with all Xxxxxx SOPs while on Althea’s premises.
This is important in cooperative com- position where providers have pairwise service agreements between them.
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.
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.
The Contractor shall provide all the construction equipment, tools, tackle and scaffoldings required for construction, erection and commissioning of the33 KV EOI-18/P&D/2020power line covered under the contract.
Omeros has the right to perform one audit of Xxxxxx facilities, laboratories and warehouses each year for the purposes of confirming Althea’s compliance with cGMP, applicable guidelines and Xxxxxx SOPs in the manufacture, testing and validation of the Product.