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IMPLEMENTATION OF CORRECTIVE ACTION PLANS

IMPLEMENTATION OF CORRECTIVE ACTION PLANS. Karen Lowney Senior Director, Global Compliance Cephalon Elizabeth A. Lewis Vice President, Deputy General Counsel Millennium Pharmaceuticals, the Takeda Oncology Company Wendy C. Goldstein (Moderator) Shareholder

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IMPLEMENTATION OF CORRECTIVE ACTION PLANS

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  1. IMPLEMENTATION OF CORRECTIVE ACTION PLANS Karen Lowney Senior Director, Global Compliance Cephalon Elizabeth A. Lewis Vice President, Deputy General Counsel Millennium Pharmaceuticals, the Takeda Oncology Company Wendy C. Goldstein (Moderator) Shareholder Epstein Becker & Green, P.C. OCTOBER 2008

  2. DISCLAIMER The Statements Made By the Panelists during this Session Represent His/Her Individual Views and Should Not Be Construed to Represent those of his/her organization.

  3. 1 IMPLEMENTATION Audience Polling Question Fill in the Blank: In your opinion, ________ is the biggest challenge when implementing a corrective action plan approved as part of the resolution of an investigation.

  4. 2 IMPLEMENTATION Audience Polling Question In your opinion, _______ of the CAPs that are approved as part of the resolutions of investigations are completed in their entirety. All More than 75% Between 50% - 75% Less than 50%

  5. 3 IMPLEMENTATION Audience Polling Question In your opinion, who should be responsible for ensuring that the CAP approved as part of the resolution of an investigation is completed? Compliance department Legal department Human Resources Business

  6. 4 IMPLEMENTATION Audience Polling Question True or False: There are never attorney-client privilege considerations when implementing a CAP. True False

  7. 5 IMPLEMENTATION Audience Polling Question In your opinion, in which location(s) should records relating to the implementation and completion of the CAP be maintained? Compliance department Legal department Human Resources Business Other

  8. IMPLEMENTATION OF CORRECTIVE ACTION PLANS Karen Lowney Senior Director, Global Compliance Cephalon Elizabeth A. Lewis Vice President, Deputy General Counsel Millennium Pharmaceuticals, the Takeda Oncology Company Wendy C. Goldstein (Moderator) Shareholder Epstein Becker & Green, P.C. OCTOBER 2008

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