Introduction to the Due Diligence Process iii
Contents
A General Introduction to Due Diligence: Look Before You Leap. ..........vii
1: Transaction Types and Gauging the Extent of Due Diligence............ 1
2: Forming Due Diligence Teams. .........................................................11
3: Initial Interactions with the Target (Requesting Materials,
Teleconferences and the Data Room). ...............................................17
4: The Target’s Role in Due Diligence. .................................................25
5: Role of the Regulatory Professional or Regulatory Legal Counsel
in Due Diligence................................................................................29
6: Regulatory Diligence Review.............................................................37
7: Supplemental Requests and Diligence Calls. .....................................67
8: Chemistry, Manufacturing and Controls and Supply Chain
Diligence............................................................................................73
9: Nonclinical and Clinical Expert Due Diligence Roles.......................83
10: Other Due Diligence Roles...............................................................99
11: Creating and Negotiating Milestones. .............................................117
12: Outputs of Due Diligence and the Final Diligence Report.............123
List of Abbreviations................................................................................129
Index........................................................................................................133
Figures
Figure 10-1. Generic Illustration of a “Treatment Tree” Format for
Understanding Patient Population Flow...........................102
Figure 10-2. Generic Example of Patient Leakage From Using a
Treatment Decision Tree...................................................103
Contents
A General Introduction to Due Diligence: Look Before You Leap. ..........vii
1: Transaction Types and Gauging the Extent of Due Diligence............ 1
2: Forming Due Diligence Teams. .........................................................11
3: Initial Interactions with the Target (Requesting Materials,
Teleconferences and the Data Room). ...............................................17
4: The Target’s Role in Due Diligence. .................................................25
5: Role of the Regulatory Professional or Regulatory Legal Counsel
in Due Diligence................................................................................29
6: Regulatory Diligence Review.............................................................37
7: Supplemental Requests and Diligence Calls. .....................................67
8: Chemistry, Manufacturing and Controls and Supply Chain
Diligence............................................................................................73
9: Nonclinical and Clinical Expert Due Diligence Roles.......................83
10: Other Due Diligence Roles...............................................................99
11: Creating and Negotiating Milestones. .............................................117
12: Outputs of Due Diligence and the Final Diligence Report.............123
List of Abbreviations................................................................................129
Index........................................................................................................133
Figures
Figure 10-1. Generic Illustration of a “Treatment Tree” Format for
Understanding Patient Population Flow...........................102
Figure 10-2. Generic Example of Patient Leakage From Using a
Treatment Decision Tree...................................................103