Task/Methodology

Deliverables

Time Period Due

New Concept:

1. Write New Concept; enter via website www.takeda-iisr.com
2. Prepare/update Curriculum Vitae (CV); enter into website

1. New Concept
2. CV

1. Anytime
2. At time of New Concept submission

New Protocol:

1. Write New Protocol; enter via website
2. Complete Resource(s) Request(s) for drug and/or funds
3. Provide appropriate supporting documentation

1. New Protocol
2. Completed Resource Request(s) screens
3. Listing of supporting documentation

Within four (4) months from receipt of the New Concept notification letter (informing investigator that his/her New Concept merits submission of a New Protocol), the complete protocol will be submitted

Fair Market Value:

Acceptance of documented industry fair market value for services

Budget for study reflecting fair market value

Prior to Study Agreement (contract) initiation

Study Agreement:

Review of draft Study Agreement, requested changes, and approve/sign fully negotiated Study Agreement

Executed Study Agreement

Within three (3) months of Takeda's acceptance of the New Protocol

Regulatory Documents
(if required):

1. Submit IND or request IND exemption (if required)
2. Obtain IRB or IACUC approval

1. Date of FDA Letter of Receipt for IND (if required)
2. IRB/IACUC approval date

Within four (4) months from Takeda's acceptance of the New Protocol

Clinical Registry (if required):

Register clinical study as the Sponsor on www.ClinicalTrials.gov

Please note: Takeda is NOT the sponsor

On Takeda's II-SR website, check the box indicating completed and clinicaltrials.gov number inserted into website

Prior to initial milestone payment or shipment of drug

Enrollment/Progress Report:**

1. Enter monthly enrollment status, and all applicable SAE information by the 1st of each month for the previous month on the II-SR website
2. Complete enrollment on time as projected in original Study Agreement
3. Enter study progress for outcome or pre-clinical studies

1. Number of subjects enrolled, dropped, completed into Takeda website
2. Completed subject enrollment as projected
3. Indicate if study is on target and any issues

1. First day of each month
2. Per Study Agreement

Invoicing (if applicable):

Submit appropriate payment requests through the Takeda website

Payment request

Upon completion of each milestone per the Study Agreement

Drug/Clinical Supply Accountability (if applicable):

1. Determine supplies needed and delivery dates. Request and track supplies in Takeda website
2. Enter into Takeda's II-SR website whether supplies have been returned or destroyed at completion of study

1. Completed Resource Request - Drug
2. Confirmation of destruction or return of unused supplies in II-SR website

1. According to the terms of the Study Agreement
2. Prior to study close-out

Close-out of Study:

1. Completion of study per timeline in Study Agreement
2. Prepare final documents (i.e., abstracts, presentations, manuscripts, study reports, etc.) in Microsoft Word format submitted in Takeda II-SR website

Final documents

1. According to the terms of the Study Agreement
2. According to the terms of the Study Agreement