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Letter of Intent for Clinical Trials

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Letter of Intent for Clinical Trials - attorney-drafted template. Party names and deal-specific details have been replaced with neutral placeholders. Review before use.

[DATE]

[INDIVIDUAL]

Clinical Trial Leader & Medical Advisor / Clinical Studies

[COMPANY]

[ADDRESS]

[ADDRESS]

Phone: [PHONE]

Re: Letter of Intent for Clinical Trial Services to be provided by [COMPANY] (“[COMPANY]”) to [COMPANY] Health, Inc. (“[COMPANY]”)

Dear [INDIVIDUAL]:[COMPANY] and [COMPANY] are parties to that certain Clinical Trial Services Agreement dated as of the [DATE] (the “CTS Agreement”) and a certain Work Statement [COMPANY]-1 under the CTS Agreement. Pursuant to Section 2.1 of the CTS Agreement, we have been negotiating the definitive terms of a certain Work Statement [COMPANY]-2 under the CTS Agreement for the performance of a“[PROJECT]”(the “Study”). Work Statement [COMPANY]-2 provides for payment by [COMPANY] to [COMPANY] of both cash and equity compensation in consideration of the services provided by [COMPANY] pursuant to such Work Statement [COMPANY]-2, with the equity portion of such compensation to be made pursuant to an Amendment No. 1 to the Amended and Restated Stock Issuance Agreement entered into by the parties as of [DATE]. [COMPANY] has determined that it is required to take certain actions to comply with its Certificate of Incorporation and applicable securities laws before issuing to [COMPANY] the equity compensation contemplated by Work Statement [COMPANY]-2. Compliance with these requirements will cause a delay in the execution and delivery of the Work Statement [COMPANY]-2 and Amendment No. 1 to the Amended and Restated Stock Issuance Agreement.

In order to have [COMPANY] perform certain work in respect of the Study while [COMPANY] undertakes the actions necessary for it to enter into Work Statement [COMPANY]-2 under the CTS Agreement and Amendment No. 1 to the Amended and Restated Stock Issuance Agreement (collectively, the “Definitive Documents”), [COMPANY] wishes to enter into this Letter of Intent (“LOI”) to provide funding for [COMPANY]’s performance of the work described or referred to herein and in Attachment A1, which work is directed towards the Study. A copy of the Study Protocol is attached as Attachment A2.

1. [COMPANY] hereby authorizes [COMPANY] and [COMPANY] accepts to commence the following work to facilitate initiation of the Study: (a) assuming the role of legal representative of [COMPANY] in all local regulatory interactions; (b) preparing, compiling, translating and submitting the Study regulatory and ethics dossiers to the competent authorities; (c) providing continuing support of submitted documents to ensure their successful and timely approval; (d) identifying and qualifying all proposed Study centers; and (e)  prepare any third party vendor qualifications and agreements (collectively, the “Activities”).

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Letter of Intent for Clinical Trials

Healthcare Agreements -- US - General