Submission of a New Protocol (NP)

Upon notification from Takeda that the New Concept merits submission of a New Protocol the investigator must finalize the full protocol by completing the New Protocol (NP) and the Resource Request(s) screens in the Takeda website. The Resource Request screens describe the type of support (i.e., funding and/or drug) requested from Takeda.

The completed New Protocol (NP), Resource Request(s), and any supporting documentation are submitted to Takeda via the website.

Documentation required for submission of a New Protocol to Takeda:

• Completed NP
• Completed Resource Request Template (funding and/or drug)

Once Takeda receives the completed NP and resource requests for funding and/or drug, it is forwarded to Takeda's External Research Review (ERR) members for consideration. *Subject to a Fair Market Value (FMV) analysis.

New Protocol Review

The External Research Review (ERR) members are responsible for reviewing an investigator's New Protocol. The ERR is comprised of Takeda employees (physicians and scientific personnel) who are experts in scientific and clinical development programs. The ERR usually meets once a month to review New Protocols.

Based on scientific merit and therapeutic strategies and objectives the ERR members determine if the New Protocol is:

• Acceptable: Information submitted meets applicable requirements.
• Conditionally Acceptable: Information submitted generally meets applicable requirements and will move to the next stage. Investigator may be asked via the notification letter to provide additional information or clarification.
• Deferred: Information submitted does not generally meet applicable requirements and the ERR will seek additional information or clarification prior to moving to the next stage in the review process level.
• Rejected: Information submitted does not meet applicable requirements. A rejected New Protocol may not be resubmitted.

Takeda will inform the Investigator of the ERR members decision via email.