DDTC Posts Revised Agreement Guidelines

If you prepare Technical Assistance Agreements (TAAs), Manufacturing License Agreements (MLAs) or Warehouse and Distribution Agreements (WDAs), you know that DDTC’s Guidelines for Preparing Agreements are a trusted source when it comes to preparing them properly. The Guidelines contain all the information you need for agreements, transmittal letters, amendments, supporting documents and more.

The document was updated this morning when DDTC posted a revised version of the Guidelines (Revision 4.3) on its home page. A draft of the revised Guidelines was published for comment some months ago, but now they are final and apply to new filings.

  • You can download the revised Guidelines by clicking here.
  • You can also download DDTC’s responses to comments received on the draft revised Guidelines by clicking here. 

The responses to the comments help explain DDTC’s thinking but can cause confusion in understanding proper compliance practices.

For help with matters about DDTC Agreements or ITAR in general, please contact us at contactus@orchidadvisors.com