DocuSign Envelope ID: 825F08E0-8B8C-4025-B847-35643F5A066C
CLINICAL TRIAL AGREEMENT
This Clinical Trial Agreement (this Agreement), is made on the Effective Date (as defined below) between Forma
Therapeutics, Inc., located at 300 North Beacon Street, Suite 501, Watertown, MA 02472, USA (Forma),
Prince Mohammad Bin Naser Hospital,, located at 2034 King Abdul Aziz Rd, Jazan 82943,Saudi Arabia (the
Institution), and
Dr. Hafiz Mosa Ali Malhan located at 2034 King Abdul Aziz Rd, Jazan 82943, Saudi Arabia (the Principal
Investigator).
WHEREAS, Forma is sponsoring a clinical trial involving subjects on FT-4202 (the Product) to be entitled, An
Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral FT-4202, a Pyruvate Kinase
Agonist in Patients with Sickle Cell Disease (PRAISE), Protocol No. 4202-HEM-301 (the Trial);
WHEREAS, the Principal Investigator is an employee of the Institution and wishes to participate as a clinical
investigator in the conduct of the Trial at the Institution.
WHEREAS, by separate agreement, Forma has engaged a designee, Synteract, Inc. a contract research
organization (“CRO”), with a principal place of business at 430 Davis Drive, Morrisville, North Carolina 27560, USA,
acting as an independent contractor, to act on behalf of Forma for the purposes of transferring certain obligations
in connection to this Agreement, said obligations including but not limited to, negotiations and execution of the
Agreement and payment administration for services performed and described hereunder.
IT IS THEREFORE AGREED AS FOLLOWS:
1. Subject matter of this Agreement
Forma entrusts the Institution to conduct the Trial in accordance with the provisions as stipulated in this
Agreement and the Trial protocol governing the Trial (as may be amended from time to time and confirmed
in writing by Forma) (the Protocol).
The provisions as stipulated in the Protocol, the Trial-related documents, including the informed consent
of subjects participating in the Trial (the Subject(s)), shall be binding on the parties and thus constitute an
integral part of this Agreement. This shall apply accordingly to any amendments of the Protocol and the
resulting new versions of the Protocol and updated Trial-related documents.
2. Obligations of Forma
In its conduct of this Trial, Forma, or its designee, shall assume, among other things, the following
obligations incumbent on it as the sponsor under the Applicable Laws and Regulations (as such term is
defined in Section 3(e) below):
(a) effecting the compulsory Trial Subject insurance within the meaning of the relevant Applicable Laws
and Regulations;
(b) preparing the Subject template information documents and informed consent forms for all
participating Subjects;
(c) adhering with the regulations of Research Ethics Code on Living Creatures issued by Royal decree
number (M/59) on 14/9/1431 H;
(d) registration on [Link]; the Saudi Clinical Trials Registry (SCTR) and databases that
serve a comparable purpose;
(e) obtaining the approval of the Saudi Food and Drug Authority to perform the Trial (the Competent
Authorities); and
(f) provision of the required Products (placebos or reference products).
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DocuSign Envelope ID: 825F08E0-8B8C-4025-B847-35643F5A066C
Per Assessment
Unscheduled Visit (If required)
Completed
Remote/Telemedicine Visit - SC Fee (hourly) for
redaction, copying of Documentation - Budget XX per 107.45 16.12 123.57
hour for XX hours per day
Remote/Telemedicine Visit - PI Fee (hourly) (Budget
43.99 6.60 50.59
upto max of 1 hour per visit)
Remote/Telemedicine Visit - Data Entry Fee (hourly)
45.06 6.76 51.82
(Budget upto max of 1 hour per visit)
Telepone Contact - Dosage Adjustment (Budget upto
129.58 19.44 149.02
max of 30 minutes per call)
Home Health Visit - Data Entry Fee (hourly) (Budget
45.06 6.76 51.82
upto max of 2 hours per visit)
Site Costs Cost
Admin Study Start-Up Fee/Site Set-Up Fee 5,014.53
Record Archiving (Total) 787.89
Advertising 335.69
6,138.11
*Applicable only if a patient is prematurely discontinued from participation
in the study during the Double-Blind Treatment Period (ie, after Day 1 and
before the Week 52 visit) or during the Open-Label Extension Treatment
Period, the Investigator or designee must make every effort to perform the
assessments scheduled for the W52/EOBT or W104/EOT visit
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DocuSign Envelope ID: 825F08E0-8B8C-4025-B847-35643F5A066C
Schedule B
Principal Investigator Statement
Trial No.: 4202-HEM-301
I, the Principal Investigator in the Trial (as described in the clinical trial agreement to which this Schedule is attached
(the Clinical Trial Agreement)) hereby ensure and warrant to Forma as follows:
(a) Freedom to Perform the Trial. I am free to participate in the Trial and owe no obligations to any third
party that might prevent or restrict my performance of the obligations specified in this Clinical Trial
Agreement.
(b) Clinical Research History. I am not involved in any regulatory litigation or investigation by any Competent
Authority or other regulatory authorities. No data produced by me in any previous clinical Trial has been
rejected because of concerns as to its accuracy or because it was generated by fraud.
(c) Staff. I shall use only properly qualified and experienced personnel, to carry out the Trial, and all such
personnel shall work under my supervision and control.
(d) Insurance. I carry medical liability insurance (or the Institution carries medical liability insurance covering
me) and will provide details and evidence of my coverage to Forma upon request.
(e) Financial Interests. I certify that neither I, nor my spouse or any dependent children, have entered into
and I will not enter into any financial arrangements with Forma, nor do I hold financial interests in Forma
that are required to be disclosed pursuant to Section 21 CFR Part 54, namely: (i) the value of
compensation, if any, which I and my spouse and dependent children receive could not be affected by the
outcome of the Trial (as defined in 21 CFR 54.2(a)), (ii) I and my spouse and dependent children do not
have a proprietary interest protected by copyright in the products being tested (as defined in 21 CFR
54.2(c)), (iii) or a significant equity interest in Forma (as defined in 21 CFR 54.2(b)) and (iv) I have not,
and my spouse or dependent children have not, been the recipient of significant payments from Forma (as
defined in 21 CFR 54.2(f)). As regards subparagraphs (iii) and (iv) I understand that such prohibitions
relate to the period in the course of which I carry out the Trial and for one (1) year following completion of
the Trial. I undertake to inform Forma immediately upon learning of the existence of any such financial
arrangements or interests.
All relevant provisions of the 21 CFR 54 stated above are available on the website ([Link]):
(f) Other Interests. I have disclosed to Forma any personal direct or indirect commercial or other interests
with respect to the Product, any Material or relating to the conduct of the Trial I myself or members of my
family or any other persons depending on me may have.
I have read this Schedule B and the Clinical Trial Agreement to which it is attached and agree to be bound by the
terms and conditions of this Schedule and the relevant provisions of the Clinical Trial Agreement, including but not
limited to the obligations of nondisclosure, ownership of Inventions and publications set out in the Clinical Trial
Agreement.
[Link] MOSA ALI MALHAN
Signature Date
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DocuSign Envelope ID: 825F08E0-8B8C-4025-B847-35643F5A066C
Schedule C
Bribery and Corruption
The Institution, the Principal Investigator, the Staff and any other person contributing to the Trial (the Trial Parties)
shall at all times in the conduct of the Trial comply with the Bribery Act 2010 of the United Kingdom (Bribery Act),
the Foreign Corrupt Practices Act 1977 of the United States of America (FCPA), and any other applicable anti-
bribery and anti-corruption legislation (together the Applicable Anti-Corruption Legislation).
It is the responsibility of the Trial Parties to ensure that they are familiar with, and comply with, the provisions of the
Applicable Anti-Corruption Legislation. Nevertheless, the following is intended as a summary of the key principles
underlying the Bribery Act and the FCPA.
(A) The Trial Parties must at all times act with integrity and honesty and comply with the highest ethical
standards.
(B) The Trial Parties must not make, give, or offer any payment, gift or other benefit or advantage to any
person for the purposes of:
(i) securing any improper advantage; or
(ii) inducing the recipient or another person to do or omit to do any act in violation of their duties or
responsibilities (or for the purposes of rewarding such conduct).
This restriction applies at all times and in all contexts. For the avoidance of any doubt, it applies both to
dealings with "public officials" and to dealings with employees and agents of commercial enterprises.
(C) Nevertheless, particular care must be exercised with dealings with public officials. The Trial Parties must
not make, give or offer any payment, gift or other benefit or advantage for the purposes of influencing any
act or decision of a public official (or inducing such official to use their influence with another person, entity
or government instrumentality or to affect or influence any act or decision of such other person, entity or
government instrumentality).
(D) The term "Public Official" includes any person acting on behalf of any government department, agency
or instrumentality or any state-owned or controlled enterprise. By way of example, this includes health
care professionals employed by a state- or local municipality-run hospital or clinic, and representatives of
public international organizations.
(E) The Trial Parties must not make, give or offer any payment, gift or other benefit or advantage to any person
whilst knowing or suspecting that all or a portion of such money, gift, benefit or advantage will be used,
whether directly or indirectly, in breach of (B) or (C) above.
(F) The Trial Parties shall make and keep books, records, and accounts, which, in reasonable detail,
accurately and fairly reflect the transactions and dispositions of the assets of the Trial Parties;
(G) The Trial Parties shall devise and maintain a system of internal accounting controls sufficient to provide
reasonable assurances that –
(i) transactions are executed in accordance with management’s general or specific authorization;
(ii) transactions are recorded as necessary
(I) to permit preparation of financial statements in conformity with generally accepted
accounting principles or any other criteria applicable to such statements, and
(II) to maintain accountability for assets;
(iii) access to assets is permitted only in accordance with management’s general or specific
authorization; and
(iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals
and appropriate action is taken with respect to any differences.
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