Common use of Supplier Qualification Clause in Contracts

Supplier Qualification. ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇ shall be responsible for the qualification of the suppliers of components, containers, labeling and packaging materials provided by ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇. Auxilium shall be responsible for the qualification of the suppliers of any material(s) supplied to ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇ by Auxilium. Upon request, ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇ or Auxilium, as the case may be, shall provide the requesting party with documented evidence describing the qualifications of applicable suppliers and contractors used to provide components, containers, testing services, labeling and packaging materials used for Auxilium products. ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇ shall provide this information to Auxilium for regulatory filings (e.g., BLA filing). ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇ shall provide a list of approved suppliers associated with Auxilium’s product(s) and process. ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇ shall ensure that any component vendors and third party subcontract manufacturers/packagers or testing laboratories used by ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇ are qualified and in compliance with current GMPs or equivalent standards defined in regulatory submissions for Worldwide Marketing Authorizations. Auxilium has the right to request the use of a vendor or subcontractor that is not currently qualified by ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇. Upon such requests, Auxilium will be responsible for qualifying and approving the new entity. Likewise, Auxilium and ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇ may work together to qualify the new entity in order to add them to ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇’▇ approved vendor/subcontractor list. Upon Auxilium’s request, ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇ shall provide Auxilium with documented evidence describing the qualifications of third party subcontractors used by ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇ for performing outsourced testing.