External Sponsored Research (ESR) Investigator Initiated Studies (IIS) and Collaborative Research (CR)

Daiichi Sankyo may support IIS and CR that aligns with the company defined strategic areas of interest (AOl)

Types of studies eligible for support:

• Clinical studies of approved and investigational uses, involving marketed Daiichi Sankyo products or those still in development (interventional studies phase I to IV)
• Observational studies, real-world evidence
• Translational, non-clinical and preclinical studies

The following submissions are out of scope:

• Requests for compassionate use such as Expanded Access/Compassionate Use and/or Named Patient Programs, which should be submitted to the Daiichi Sankyo affiliate in your country
• Requests for products of American Regent, Inc. and Plexxikon Inc. (both marketed and investigational products)
• Company sponsored research

The sponsor/qualified investigator has to fulfill (or agree to) the following requirements:

• Have the scientific, technical, and operational capabilities (i.e., submit CV, medical licenses, if applicable) to conduct a study as a sponsor; including adequately trained staff to execute a study (under GCP, GLP, etc.)
• Have the infrastructure and access to target patient group in case of a clinical study
• Have expert statistical support, if needed
• Have ability to deliver to agreed timelines
• Submit scientifically well-designed and well-written study concept and protocol
• Submit a detailed study budget per protocol design if applicable
• Fulfill all regional/local regulatory requirements (including for example submitting an Investigational New Drug Application (IND), Study Agreement, Confidentiality Agreement (CDA), Quality Assurance Agreement (QAA), activate clinicaltrials.gov, General Data Protection Regulation (GDPR) link, writing of final study report and manuscripts, etc.)
• Provide a written report of the final study results to Daiichi Sankyo
• Willing to publish the study in a scientific journal and/or medical congress
• Agree to submit safety reports to health authorities and Daiichi Sankyo
• Agree to provide study updates to Daiichi Sankyo periodically

Qualified external investigators should submit investigator-initiated study (IIS) concepts or collaborative research (CR) concepts through Daiichi Sankyo's mailbox IIS@dsi.com and for non-oncology submissions please use our online submission portal https://daiichisankyo-iis.com/. Concept submission will be reviewed by the Daiichi Sankyo Global Review Committee based on scientific merit, alignment with strategic areas of interests and budget availability. The qualified external investigator will be informed about the outcome and interest of Daiichi Sankyo in the concept submitted. If a concept is endorsed, a formal notification will be sent, and the qualified external investigator will be requested to submit a protocol. Concept endorsement is not a guarantee of protocol endorsement. Notification regarding the status of your protocol application will be sent once a decision is reached by the Global Review Committee. If the protocol is endorsed, the next step would be execution of a study agreement.

Daiichi Sankyo requires that the following documents are in place before the support can be initiated:

• A fully executed confidential/non-disclosure agreement (CDA/NDA)
• A fully executed study agreement between the sponsor (qualified external investigator) and Daiichi Sankyo
• A fully executed study safety data exchange agreement between the sponsor (qualified external investigator) and Daiichi Sankyo, if applicable
• A fully executed quality assurance agreement (preclinical studies excluded), if applicable
• An Ethics Committee/Institutional Review Board and/or health authority approval, if applicable
• A final approved protocol (Ethics committee approved protocol and informed consent, if applicable and Health authority approved protocol if required by local law)

All funding requests will be assessed to ensure that they do not exceed local fair market value. Funding requests for expenses not associated with the conduct of the study are strictly prohibited.

For general questions and inquiries, please send an email to IIS@dsi.com.