Welcome!

Takeda Pharmaceuticals North America, Inc, ("Takeda") is pleased that you are interested in conducting an Investigator Initiated-Sponsored Research (II-SR) study. Takeda has created this Informational Guide to assist investigators in working with Takeda throughout the entire II-SR process.

The Takeda II-SR Informational Guide for Investigators is also available online, at www.takeda-iisr.com.

What is Investigator Initiated-Sponsored Research (II-SR)?

Investigator initiated-sponsored research (II-SR) is unsolicited pre/non-clinical, clinical, outcomes, or disease state research related to a Takeda compound or therapeutic area in which the investigator independently generates a research protocol and for which Takeda provides financial and/or in-kind support in the form of an II-SR Grant. Either the individual investigator or the institution with which the investigator is affiliated serves as the Sponsor. The investigator is responsible for initiating and conducting the study, as well as directing the administration or dispensing of study drug (if applicable).

II-SR is also commonly referred to throughout the pharmaceutical industry as Investigator Initiated Research ("IIR"), Investigator Initiated Studies ("IIS"), Investigator Sponsored Research ("ISR") and Investigator Initiated Trials ("IIT").

Why Does Takeda Support II-SR?

Takeda's objective in supporting II-SR studies is to obtain valuable scientific, clinical and outcomes information relating to Takeda products or disease states of interest and to enhance patient care. Takeda may support legitimate programs in a manner consistent with all applicable regulatory requirements and ethical standards.

The vision of Takeda's II-SR program:

• II-SR supports robust scientific research that helps us answer pertinent questions about its products and therapeutic areas of focus.
• II-SR activities are conducted using an efficient and systematic process that is understandable and easy to execute by all involved.
• Investigators who collaborate with us to conduct II-SR studies are accountable for meeting agreed upon goals and working toward the end result of manuscript development.

The mission of Takeda's II-SR program:

• Foster scientific exchange through clinical research collaborations by:
• Uncovering emerging research trends and fulfill unmet needs for new scientific data to help advance knowledge of a specified therapeutic area, and
• Exploring the feasibility and viability of new scientific ideas of interest (often pilot/hypothesis-generating studies).

Takeda II-SR Online Website System

Takeda provides an online system for the management of II-SR projects. The system is accessible through the following website: www.takeda-iisr.com. This online system enables investigators to view real-time information and perform tasks related to their particular II-SR study such as:

• Completing new concept and new protocol submissions;
• Receiving responses to the above submissions;
• Tracking study enrollment/progress;
• Monitoring payment history;
• Managing clinical supplies; and
• Closing out the study.

To access Takeda's II-SR system, an investigator (and any co- or sub-investigator) must register for a user ID and password through Takeda's website www.takeda-iisr.com. The investigator receives an ID and password within one business day of registering and may then proceed to the first step.

The Takeda II-SR Program is comprised of five (5) steps:

• Step One: New Concept submission (NC);
• Step Two: New Protocol submission (NP);
• Step Three: Acceptable Protocol submission (AP);
• Step Four: Study Management/Progress; and
• Step Five: Study Close-out.

An investigator's access to each area of the system is granted on a step-by-step basis throughout the study's duration. For example: If Takeda has reviewed the New Concept and determined that it merits submission of a full protocol, the investigator will be granted access to the next level (i.e., New Protocol submission). A confirmation email is sent to the investigator each time Takeda receives any submission from the investigator.

Definitions

Clinical Science Liaison (CSL): Takeda field-based medical/research liaison team member who conducts scientific exchange with academic and clinical experts in therapeutic areas of interest to Takeda. The CSL team will serve as an educational and research resource for investigators and serve as the investigator's liaison with the Takeda home office.

Investigator: An individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. "Sub-investigator" includes any other individual member of that team.

Sponsor: A person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators. Takeda is not the Sponsor in II-SR studies because the company does not assume legal and regulatory sponsorship of the study.

Sponsor-Investigator: An individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual. The requirements applicable to a sponsor-investigator under this part include both those applicable to an investigator and a sponsor.