Master Alliance Provisions Guide (MAPGuide)

FIND Sample Funding Terms and Conditions

  • Business model | Regulatory strategy

Provision Language

2. PROJECT: SCOPE OF PROJECT, FINANCIAL AND OPERATIONAL

2.2 Project Implementation

[…]

(b) Quality Management Systems (“QMS”) (if applicable). XYZ shall ensure compliance at all times with the following;

– Ensure an appropriate QMS covering in vitro diagnostic products, is in place and compliant with SRA and/or WHO Pre-qualification (“PQ”) requirements; and

– Ensure any Product obtains and maintains appropriate SRA and/or WHO PQ authorization or approval, as appropriate, for the duration of this Agreement or its market availability in LMICs, whichever is longest.

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