Common use of Withdrawals and Recalls Clause in Contracts

Withdrawals and Recalls. Talecris GmbH shall make all contacts with the relevant Regulatory Authorities and shall be responsible, at its sole cost and expense (except where the recall is due to the negligence or willful default of ▇▇▇▇▇), for coordinating all activities in connection with any recall or withdrawal of any Contractual or Finished Product. In the event that ▇▇▇▇▇ believes a recall or withdrawal of a Contractual or Finished Product may be necessary or appropriate, ▇▇▇▇▇ shall immediately notify Talecris GmbH in writing. In the event that Talecris GmbH initiates a recall or withdrawal of a Contracutal or Finished Product, Talecris GmbH shall so notify ▇▇▇▇▇. Notwithstanding the above, while ▇▇▇▇▇ remains the releaser of Finished Product: (a) if ▇▇▇▇▇ makes a determination that a recall of a Contractual or Finished Product is necessary but Talecris GmbH disagrees with such determination, ▇▇▇▇▇ may initiate a joint discussion by the Parties of such issue with a mutually agreeable independent consultant and if such consultant advises the Parties that it believes there should be a recall, the Parties shall voluntarily implement a recall of the Contractual or Finished Product; (b) if ▇▇▇▇▇ makes a determination that a withdrawal of a Contractual or Finished Product is necessary for reasons of safety and efficacy but Talecris GmbH disagrees with such determination, ▇▇▇▇▇ shall have the right to discontinue its performance hereunder with respect to such Contractual or Finished Product and all rights with respect to such product, including, without limitation, under the licenses granted to ▇▇▇▇▇ under this Agreement with respect to such product shall terminate and permanently revert to Talecris GmbH.

Appears in 2 contracts

Sources: European Product Sales Agreement (Talecris Biotherapeutics Holdings Corp.), European Product Sales Agreement (Talecris Biotherapeutics Holdings Corp.)