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CLINICAL STUDY AGREEMENT

 

This Clinical Study Agreement (the "Agreement") is entered into on July 17, 2017
(the "Effective Date") by and among the Regents of the University of Michigan
with its principal office and place of business at 3003 South State Street, Ann
Arbor, MI 48109-1274 (“Lead Institution”), and Volition America, Inc., a
Delaware corporation, with its principal office and place of business at 100
Congress Avenue, Suite 2000, Austin TX 78701 (together "Laboratory") .

 

BACKGROUND

 

Laboratory has expressed an interest in participating with the National Cancer
Institute (“NCI”) Early Detection Research Network (“EDRN”) (the “Clinical
Study”) Great Lakes New England Clinical Validation Center (“GLNE CVC”) clinical
study as set forth in the grant proposal submitted by the Regents of the
University of Michigan (“Lead Institution”) to the National Cancer Institute
titled “the Great Lakes New England Clinical Validation Center,” which Lead
Institution has established with those research institutions listed on Exhibit A
attached hereto (each, a “Research Institution”) with funding provided by NCI.
Together the Lead Institution and other Research Institutions are referred to as
the “Institutions” under this Agreement. Each Research Institution has agreed to
enroll patients in accordance with the protocol attached hereto as Exhibit A (as
may be amended in accordance with this Agreement, the "Protocol"). The
Institutions together will enroll approximately 9,000 adults age 60 or older who
have not undergone a prior screening or diagnostic colonoscopy falling within
the catchment areas defined by the Protocol (the “Study Subjects,” as more
specifically defined in Section 1.5 below). Samples obtained from Study Subjects
in accordance with the Protocol (the “Samples,” as more specifically defined in
Section 4.1 below) will be tested for blood-based, cell-free circulating
biomarkers on the Laboratory’s proprietary Nu.QTM platform (“Services” as more
specifically defined in Section 2.1) at the laboratory facilities in Belgium and
other places owned or contracted by Laboratory or its affiliates at no charge to
the Lead Institution or the Research Institution, and Laboratory will provide a
copy of all test results for the Clinical Study (the “Test Results”) to Lead
Institution’s designated Data Management Coordinating Center (the “DMCC”)
following the completion of the performance of the Services by the Laboratory on
the Samples. The DMCC will collect and store all such Test Results, and shall
share Test Results with the Institutions for collaborative analysis.

 

RECITALS

 

Whereas, the Laboratory is engaged in the business of diagnostic testing,
including without limitation for clinical trials, development of new kits and
assays and reference laboratory services;

 

Whereas, the Lead Institution has the qualified personnel, experience,
facilities and resources to undertake and competently manage the Clinical Study,
and has engaged and subcontracted with the Research Institutions to participate
in the Clinical Study; and

 

Whereas, Laboratory and Lead Institution wish to perform the activities
described and in adherence to the Protocol (the “Activities”) as part of the
Clinical Study, subject to the terms and conditions set forth herein.

 

NOW, THEREFORE, the parties hereto agree as follows:

 

1LEAD INSTITUTION RESPONSIBILITIES 

 

1.1Lead Investigator. Lead Institution’s principal investigator is named on the
signature page hereto and shall be designated as the Lead Investigator under
this Agreement, and Lead Institution, including the Lead Investigator, shall be
responsible for administrative activities in the conduct of the Clinical Study,
as specified in the Protocol, including without limitation engaging and
subcontracting with the Research Institutions and the principal investigators
assigned by each Research Institution to the Clinical Study (each, a “Principal
Investigator”) and administering all payments to the Research Institutions from
the consideration paid to Lead Institution in accordance with Section 3. 

 

1.2IRB Approval. The Lead Investigator shall obtain all requisite approvals from
the Institutional Review Board ("IRB") of the Protocol, the Investigational Plan
(as such term is defined in 21 C.F.R. Section 812.25), and the informed consent
form to be used for Study Subjects ("Informed Consent"). Lead Institution will
allow Laboratory to review and comment on the Informed Consent used in the
conduct of the Clinical Study. The Lead Investigator shall provide Laboratory
with written confirmation of the IRB approval prior to Laboratory performing
Services on any Study Subject Samples (as defined below). If the IRB withdraws
approval of the Clinical Study at any time, the Lead Investigator shall
immediately notify Laboratory and the Research Institutions in writing and
concurrently provide a written explanation of the circumstances leading to such
withdrawal. In such event, Laboratory, in its absolute discretion, may terminate
this Agreement by written notice to the Lead Institution effective immediately
upon delivery. Lead Investigator shall be responsible for notifying all of the
Research Institutions and Principal Investigators of such termination. 

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1.3Protection of Human Subjects. To the extent required by Applicable Law, each
party shall promptly notify the other party of information discovered through
the course of performing the Clinical Study that could affect the safety or
medical care of participants, affect the willingness of participants to continue
participation, influence the conduct of the study, or alter the IRB approval to
continue the study. Lead Institution shall take reasonable measures to ensure
that all Research Institutions and Principal Investigators shall (a) comply with
the ethical standards used in human research; and (b) comply with the Protocol,
applicable law, and its ethical standards to protect Study Subjects. 

 

1.4Commencement and Completion. It is anticipated that the Clinical Study will
commence on the Effective Date and that Study Subject enrollment will be
completed approximately three (3) years from initiation of enrollment on the
study, unless this Agreement is otherwise terminated pursuant to its terms (the
“Enrollment Period”). The parties anticipate that the Clinical Study will be
completed within twelve (12) months thereafter (together with the Enrollment
Period, the “Study Term”). The parties agree that time is a critical element of
this Clinical Study, and the Lead Institution, including the Lead Investigator,
agrees to use diligent efforts to complete the Clinical Study by the expiration
of the Study Term.  

 

1.5Study Subject Accrual. The Clinical Study will involve a total of
approximately 9,000 new Study Subjects (within the Enrollment Period) (“New
Study Subjects”) and 4677 previous Study Subjects (“Previous Study Subjects).
New Study Subjects and Previous Study Subjects are collectively referred to as
“Study Subjects”. New Study Subjects shall be enrolled by Institutions pursuant
to Protocol eligibility criteria and before the expiration of the Enrollment
Period. Samples from each New Study Subject shall be obtained and forwarded to
GLNE CVC.  

 

1.6Study Subject Sample Access. Laboratory will perform Services on Samples
obtained from New Study Subjects (the “New Study Subject Samples”) and from
Previous Study Subjects (the “Previous Study Subject Samples”), which Lead
Institution will coordinate with NCI to provide to Laboratory, as per the
following schedule, in accordance with Section 4.2: 

 

(i)Subject to available NCI funding and EDRN approval, a serum aliquot from each
of the 4,677 Previous Study Subject Samples will be delivered to Laboratory. The
time table to delivery of these samples rests with NCI resources as these
samples are under control of the NCI at their Frederick MD repository. The Lead
Institution will make very effort to obtain release of these samples from the
Previous Study Subject Samples within one hundred eighty (180) days of the first
quarterly payment by Laboratory as per Section 3.1 below, however, the parties
acknowledge and agree that such releases, including the time required to
identify and pull these samples, are subject to NCI priorities and resources;
and 

 

(ii)all New Study Subject Samples collected in a calendar quarter will be
delivered on a schedule mutually agreed upon but at a maximum interval of ninety
(90) days (quarterly) allowing at least ninety (90) days required to pull and
ship the samples after completion of a given quarter; provided, that Laboratory
will be supplied at least four hundred (400) New Study Subject Samples in each
calendar quarter commencing January 1, 2018. 

 

Laboratory shall not be obligated to perform Services on all New Subject Study
Samples and Previous Study Subject Samples.

 

1.7Use of Samples. To the extent permitted under applicable law and regulations
and any relevant informed consent document, Laboratory shall have a perpetual,
non-terminable and fully paid-up right to use all the Samples provided under
this Agreement in connection with blood-based, cell-free circulating biomarkers
on the Laboratory’s proprietary Nu.QTM platform including as part of the
Services and for additional indications. 

 

1.8Key Personnel. The parties agree that the participation of the Principal
Investigators are important to the successful performance and completion of the
Clinical Study. If a Principal Investigator is unable to complete his or her
responsibilities in connection with the Clinical Study for any reason, or
withdraws from participation in the Clinical Study, the Lead Institution shall
coordinate with the applicable Research Institution to appoint a successor, and
the Lead Institution shall immediately notify Laboratory in writing of such
successor. 

 

1.9Laboratory Visits. Lead Investigator shall ensure Laboratory’s
representatives may conduct periodic visits of Lead Insitution, at mutually
acceptable times during normal business hours, and at Laboratory's sole
reasonable expense, as applicable, to review the progress of the Clinical Study.
Lead Institution shall cooperate with Laboratory and use reasonable efforts to
provide all information requested. 

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1.10Changes to the Protocol. In the event that modifications to the Protocol as
it pertains to Laboratory Services provided hereunder appear desirable or
necessary, such changes may be made through prior written agreement between the
Laboratory and the Lead Institution, provided, however, any requisite IRB
approval of such changes is obtained prior to implementing such changes to the
Protocol. If in the course of performing this Agreement, however, generally
accepted standards of clinical study and medical practice relating to the safety
of Study Subjects require a deviation from the Protocol, such standards will be
followed. In such case, the party aware of the need for a deviation will
promptly inform the other party in writing of the facts causing such deviation
as soon as the facts are known to that party. Lead Institution shall be
responsible for notifying all of the Research Institutions and Principal
Investigators of any such changes as they may pertain to Research Institution
activities. 

 

1.11Medical Records; HIPAA Privacy Rule; and Genetic Testing Laws. Lead
Institution, including Lead Investigator, shall comply with all applicable Laws
governing the privacy and security of Clinical Study participant information,
including without limitation HIPAA, as well as applicable U.S. Federal and State
genetic testing laws, and shall use reasonable measures to ensure that all
Research Institutions and Principal Investigators do the same, including without
limitation all applicable genetic testing laws of each Research Institution’s
jurisdiction. 

 

1.12Advertising. In the event Lead Institution elects to advertise to recruit
patients for enrollment in the Clinical Study and such advertisements include
reference to Laboratory, Lead Institution will provide a copy of any such
advertisement to Laboratory for prior written approval. The Lead Institution
will be responsible for obtaining IRB approval of all advertisements prior to
use. 

 

1.13Compliance with Law – Financial Disclosure. The Lead Institution shall
provide Laboratory with sufficient and accurate financial information, including
without limitation facilitation of the acquisition of such information from
Research Institutions, to allow the Laboratory to prepare and submit complete
and accurate certification or disclosure statements as required under 21 C.F.R.
Part 54, as amended. The Lead Institution shall also promptly update this
information if any relevant changes occur during the course of the Clinical
Study and for one (1) year following the completion of the Clinical Study.  

 

2LABORATORY RESPONSIBILITIES 

 

2.1Laboratory Services. “Laboratory Services” shall mean any clinical testing
activities that shall be performed by Laboratory in the performance of the
Clinical Study as set forth in the Protocol. Laboratory agrees to perform the
Laboratory Services at no charge to NCI, the Lead Institution, the Research
Institutions or Principal Investigators. Laboratory shall use commercially
reasonable efforts to perform the Laboratory Services in compliance with (i) the
terms and conditions of this Agreement, including without limitation, and to the
extent applicable, the terms, specifications and limitations in the Protocol and
any amendments thereto; (ii) Laboratory’s standard operating procedures for the
applicable tests to be provided; (iii) any applicable laws, regulations or
rulings governing its performance, including without limitation all applicable
health, medical privacy and safety laws and regulations, and all applicable laws
and regulations with respect to the handling and disposal of infectious or
hazardous waste.  

 

2.2Laboratory Limitations. Laboratory will not: (i) use Study Subject
information except for the purposes of the Clinical Study and as authorized by
the Study Subject in the Informed Consent Form; (ii) disclose Study
Subject-identifying information or disclose Study Subject private information to
any third party (other than as permitted by Research Institutions, NCI and Lead
Institution or the Repository) unless required to do so by Applicable Law or
government order or pursuant to a written request of the Study Subject; (iii)
remove de-identified Study Subject information from Samples; or (iv) attempt to
contact any Study Subject not previously known to Laboratory, as applicable,
unless required to protect the Study Subject’s welfare. 

 

3.CONSIDERATION 

 

3.1In consideration of its participation in the Clinical Study on the terms and
conditions of this Agreement, Laboratory shall provide direct and indirect
funding in the amount of up to Three Million United State Dollars
(US$3,000,000). Direct payments by the Laboratory for the Clinical Study will be
as follows: 

 

Starting one (1) month from the date of Institutional Review Board approval from
the Calgary, Canada Institution and 50% of participating United States
Institutions, Laboratory will make up to twelve (12) quarterly installment
payments to Lead Institution of Two Hundred Fifty Thousand United States Dollars
(US$250,000) each not to exceed three million United States Dollars
(US$3,000,000) in total payments under Section 3 during the term of this
Agreement.

 

3.2The funding amounts detailed in Section 3.1 are the sole consideration for
Laboratory’s participation in the Clinical Study, and are inclusive of all
rights provided to Laboratory herein, including without limitation pursuant to
Sections 1.5, 1.6, 1.7, 7 and 8. All of the funding amounts provided hereunder
shall be used for costs and expenses of the Clinical Study. 

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3.3The funding amounts detailed in Section 3.1 will be provided to the GLNE
Operations Office at the University of Michigan pursuant to the issuance of an
invoice to Laboratory by Lead Institution. 

 

4CLINICAL STUDY SAMPLES  

 

4.1Study Samples. The term “Samples” shall be understood to include biological
materials derived from New Study Subjects enrolled in the Clinical Study,
including but not limited to: blood plasma, serum, feces, DNA extracts and other
biological materials as may be agreed between the Parties. The term “Samples”
shall also include biological materials extracted prior to the Enrollment Period
from Previous Study Subjects meeting the eligibility criteria set forth in the
Protocol and banked for future use, solely to the extent any such Samples may be
used for such purpose, in accordance with all the requirements of this
Agreement, including without limitation Study Subject approvals and waivers, as
necessary. Without limiting the foregoing, Laboratory will receive 4 ml of serum
from each of the New Study Subject Samples and at least 2 ml of serum from each
of the Previous Study Subject Samples. To the extent that more than 2 ml of
serum from Previous Study Subject Samples is available, up to a maximum of 4 ml
will be provided to Laboratory. 

 

4.2Transfer of Study Samples. The Samples will be stored by either GLNE CVC or
NCI. Where Samples are stored by GLNE CVC, Lead Institution shall be solely
responsible for the proper delivery and transport of the Samples to Laboratory
under the terms of this Agreement in compliance with all applicable
international, federal, state and local laws, regulations, and standards for the
shipment and transportation of biological specimens from their point of origin
to Laboratory’s facility located in Belgium. Lead Institution and Laboratory
shall agree on the day and time for delivery of the Samples to Laboratory. All
Samples are considered biohazardous and should be handled, stored, and
transported according to appropriate laws, regulations, and government
guidelines, including those issued by the Occupational Safety and Health
Administration, the Centers for Disease Control and Prevention, and the
Department of Transportation. Where Samples are stored by NCI, the Samples will
be provided to Laboratory pursuant to the NCI Materials Transfer Agreement set
forth in Exhibit B and executed by Latoratory and NCI. 

 

5.STUDY RECORDS, REPORTS AND DATA 

 

5.1Study Records. Lead Institution, including Lead Investigator, shall maintain,
and Lead Institution shall cause all Research Institutions and Principal
Investigators to maintain, complete, accurate and current Clinical Study records
for its Study Subjects as set forth in the Protocol ("Study Records"). Lead
Investigator shall retain the right to audit all Study Records, including,
without limitation, source documents, signed Informed Consents, laboratory data
and summaries of financial records. All Study Records shall be retained by each
Institution for a period of two (2) years after the later of completion of the
Clinical Study or termination of this Agreement, whichever is later, or such
longer period as specified in the Protocol or as required by law. 

 

5.2Case Report Forms. Lead Institution shall obligate each Research Institution
to promptly complete full clinical evaluations and original or electronic case
report forms ("CRFs"), as appropriate, on each Study Subject in accordance with
the Protocol. 

 

5.3Annual Reports. During the term of this Agreement, Lead Institution shall
provide Laboratory with annual written reports, detailing the progress of the
Clinical Study. Such reports shall include the number of Study Subjects, the
number of Samples obtained, a summary of any adverse events, and a general
description of the Clinical Study’s progress. Lead Institution shall provide
such reports to the Laboratory within ninety (90) days after each anniversary of
the Effective Date. Lead Institution shall also provide Laboratory with
quarterly reports commencing the second quarter after the Effective Date. These
quarterly reports are only required to provide the number of Study Subjects
enrolled, on trial, completed trial, ineligible, eligible and numbers of
endpoint events for analysis and will be provided together with the invoices
issued by Lead Institution in respect of the quarterly payments detailed in
Section 3.1(c). 

 

5.4Final Report. Within ninety (90) days after completion or termination of the
Clinical Study, the Lead Institution shall provide to the Research Institutions,
Laboratory, and to the IRB a final Clinical Study report similar in content to
the annual report specified in Section 5.3.  

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6CONFIDENTIALITY 

 

6.1Confidential Information. "Confidential Information" shall mean any
information, data or material that is identified as confidential at the time of
disclosure and is disclosed by a party (“Disclosing Party”) to the other party
(“Receiving Party”) in connection with the Clinical Study or any other
activities in connection with this Agreement and, if disclosed in non-tangible
form, is confirmed as confidential in writing within twenty (20) working days of
disclosure. Confidential Information shall not include information that: (i) was
generally known and available in the public domain at the time it was disclosed,
or becomes generally known and available in the public domain through no breach
of this Agreement by the Receiving Party; (ii) was known by Receiving Party
prior to disclosure, as demonstrated by written records; (iii) was developed by
the Receiving Party independently of and without reference to the Confidential
Information, or (iv) is received by Receiving Party from a third party having no
obligation of confidentiality to the Disclosing Party. 

 

6.2Nondisclosure/Nonuse. Except as otherwise expressly provided herein, for the
term of this Agreement and for a period of five (5) years thereafter, no
Receiving Party shall disclose to any third party Confidential Information
disclosed hereunder, and shall not use for any purpose other than as expressly
provided herein any such Confidential Information, without the express written
consent of the Disclosing Party. Without limiting the foregoing, Receiving Party
shall disclose Confidential Information only to those employees or contractors
of Receiving Party who require such Confidential Information for the purposes of
this Agreement and who are bound by like obligations of confidentiality. Prior
to disclosing Confidential Information to any employee or contractors, Receiving
Party shall advise such employee or contractor of the confidential nature of the
information, and shall require them to take all necessary and reasonable
precautions to prevent the unauthorized disclosure thereof. In the event
Receiving Party is required to disclose Confidential Information pursuant to law
or the order or requirement of a court, administrative agency, or other
governmental body, Receiving Party may disclose such Confidential Information to
the minimum extent necessary provided that the Receiving Party provides the
Disclosing Party with reasonable advance written notice thereof to enable
Disclosing Party to seek a protective order or otherwise prevent such
disclosure. 

 

6.3Protection. Each Receiving Party shall maintain reasonable procedures to
prevent accidental or other loss or disclosure of any Confidential Information
of Disclosing Party, and shall use at least the same procedures and degree of
care that it uses to protect its own proprietary information, but in no case
less than reasonable care. In the event of loss, disclosure or use of any
Confidential Information in violation of this Agreement, the Receiving Party or
other party aware of such breach of this Section 6 shall immediately notify
Disclosing Party in writing, specifying all details of the circumstances. 

 

6.4Return of Confidential Information. Except as otherwise provided herein, upon
termination, cancellation or expiration of this Agreement for any reason, all
documents and other tangible items containing Confidential Information, together
with all copies or summaries, abstracts or synopsis thereof shall be promptly
returned to the applicable Disclosing Party, provided however, that one (1) copy
of Confidential Information may be retained for archival purposes. If Disclosing
Party requests, each Receiving Party shall provide written confirmation that
they have returned all such materials to Disclosing Party. 

 

7PUBLICATION 

 

7.1The parties recognize the value of disseminating research results. It is
understood that publication of results of the Clinical Study is expected. The
Lead Investigator will collaborate with the Laboratory and the Research
Institutions and Principal Investigators to publish the results of the Clinical
Study, subject to the obligations of Section 6 above and this Section 7.
Drafting of documents for publication and co-authorship shall follow the
guidelines of the International Committee of Medical Journal Editors’ “Uniform
Requirements for Manuscripts Submitted to Biomedical Journals: Writing and
Editing for Biomedical Publication (updated October 2008). Lead Institution will
register and update the Study listing on ClinicalTrials.gov. 

 

7.2The Lead Institution, including Lead Investigator shall furnish Laboratory
with a written copy of any proposed publication or disclosure, including without
limitation, disclosures at research seminars, lectures and professional meetings
and the submission of papers for publication that include Laboratory submitted
results at least sixty (60) days prior to submission for publication or
disclosure so that Laboratory may have a reasonable opportunity to review the
accuracy of the information related to the results generated by Laboratory under
this Agreement and protect its proprietary rights to information, inventions, or
products developed under the Clinical Study. Lead Institution, including Lead
Investigator shall consider Laboratory’s comments in good faith. Further, if
Laboratory indicates that such publication or disclosure contains Confidential
Information provided by Laboratory, the Lead Institution, including the Lead
Investigator, agrees to remove such Confidential Information from the proposed
publication or disclosure. Lead Institution, including Lead Investigator, when
applicable may release the draft document for publication or presentation after
the aforementioned 60-day term has elapsed; provided that if, during the 60-day
review period, Laboratory indicates that additional time is required to apply
for patents to protect proprietary rights to inventions or products developed
under the Clinical Study that are disclosed in the proposed publication, Lead
Institution, including Lead Investigator, when applicable, will delay such
publication for a period of up to ninety (90) days to enable such protection to
be obtained. 

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7.3Except as set forth in this Agreement or the Protocol, Laboratory will not
use the Institutions’ name(s) in any advertising, marketing, or sales
promotional material without the Institutions prior written approval, or in any
material that implies or suggests endorsement of a product or service of
Laboratory; provided, that, as soon as practicable following the date hereof,
Laboratory may issue a press release approved by Lead Institution announcing the
existence of this Agreement and Laboratory’s participation in the Clinical
Study. Additionally, Laboratory may make public statements in response to
questions by the press, analysts, investors or those attending industry
conferences or financial analyst calls, or issue press releases, so long as any
such public statement or press release is not inconsistent with prior public
disclosures or public statements approved by Lead Institution pursuant to this
Section 7.3 and which do not reveal non-public information about the
Instituions. 

 

8.OWNERSHIP RIGHTS 

 

8.1Data. Each Institution shall retain ownership of Study Records, which shall
be the Confidential Information of the applicable Institution. Subject to the
publication rights set forth in Section 7.2 above, any Test Results or other
data resulting from the Laboratory Services performed on samples from the Study
Subjects and provided by Laboratory (“Results”), shall be jointly owned by
Laboratory and the applicable Institution enrolling such Study Subjects. Lead
Institution acknowledges that (i) Laboratory, in accordance with such joint
ownership shall have the royalty-free right to use the Results for any purpose,
including, without limitation, incorporating some or all of the Results in its
own patient database and forwarding such Results to the DMCC as requested by
Lead Investigator, and (ii) the Institution enrolling Study Subjects, in
accordance with such joint ownership shall have the royalty-free right to use
the Results solely for research purposes and not commercialization. 

 

8.2 Inventions. Inventorship of patentable inventions shall be determined by
U.S. Patent Law and ownership shall follow inventorship.  

 

8.3 Rights of U.S. Government. All rights granted herein are subject to the
applicable rights and regulations of the U.S. Government. 

 

9REPRESENTATIONS AND WARRANTIES  

 

9.1Lead Institution. Lead Institution represents and warrants that: (i) it has
the legal authority and right to enter into this Agreement; (ii) it has no
obligation to any other party which materially impairs its ability to fulfill
its obligations under this Agreement; (iii) it will conduct its activities in
connection with the Clinical Study in accordance with the Protocol and in full
compliance with all applicable local, state and federal laws and regulations for
the protection of the rights, safety and welfare of human subjects in clinical
trials, and the conditions of the IRB; and (iv) the Clinical Study was approved
by the IRB. Lead Institution represents that it is not aware of any
circumstance, including but not limited to any restrictions placed on the use of
the Study Samples by the IRB that would prevent it from freely transferring the
Study Samples to Laboratory for the purposes described in this Agreement. 

 

Lead Institution represents to Laboratory that it will use reasonable measures
to assure that: 

 

(a)at each Research Institution, the Clinical Study will be conducted under the
supervision of the applicable Principal Investigator, and Lead Institution shall
provide Laboratory with the curriculum vitae of any Principal Investigator upon
request. 

 

(b)each Research Institution and Principal Investigator shall perform the
Clinical Study as set forth in the Protocol in compliance with: (a) generally
accepted standards of good clinical practice, (b) the Protocol, (c) written
instructions provided by the Lead Investigator, and (d) all applicable local,
state and federal laws and regulations governing the performance of clinical
investigations including but not limited to (i) the Investigational Device
Exemptions regulations (21 C.F.R. Section 812, Subpart E, et seq.); (ii) those
relating to the rights, safety and welfare of human subjects in clinical trials;
(iii) those relating to kickbacks and physician, referrals including, without
limitation, 42 U.S.C. Sec. 1320a-7b(b) et. Seq. and 42 U.S.C. Sec. 1395nn; and
(iv) the Health Insurance Portability and Accountability Act (“HIPAA”), as set
forth below (“Applicable Law”). 

 

(c)it will obligate the Research Institutions to not deviate from the Protocol
without the prior written consent of Lead Investigator, except as necessary to
ensure Clinical Study participant safety, in which case the applicable Principal
Investigator will immediately notify the Lead Investigator of such deviation in
writing.  

 

(d)each Research Institution shall provide adequate personnel to conduct the
Clinical Study, and all such personnel shall have the necessary education,
training, licensure and experience to perform their respective Clinical Study
responsibilities, including without limitation, appropriate training on the
enrollment of eligible Study Subjects, the Protocol and all other relevant
activities requested by Lead Investigator or Laboratory in performance thereof. 

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(e)each Principal Investigator shall obtain a written authorization, Informed
Consent and IRB waiver for all Study Subjects enrolled through the applicable
Research Institution prior to performance of any procedures in connection with
the Clinical Study, which authorization, consent and waivers shall include the
right for Lead Institution to disclose their information in connection with the
Clinical Study, including genetic testing information if applicable, to the
Repository and the Laboratory for their use in connection with the Clinical
Study to the extent necessary to perform the activities contemplated by the
Protocol and to comply with Applicable Laws relating to the Clinical Study. 

 

9.2Laboratory. The Laboratory represents and warrants that: (i) it has the legal
authority and right to enter into this Agreement; (ii) it has no obligation to
any other party that is in conflict with its obligations under this Agreement
and (iii) the person executing this Agreement on its behalf has been authorized
to do so. 

 

9.3No Impairment; No Conflict. During the term of this Agreement, Lead
Institution represents that it will not enter into any agreement to provide
services that would in any way materially impair its ability to complete the
Clinical Study in accordance with the Protocol and the terms of this Agreement. 

 

9.4No Action by FDA. Lead Institution represents that it has not received any
warnings or other adverse communications from the FDA relating to the conduct of
a human clinical trial that would affect its participation in the Clinical Study
or compliance with the terms of this Agreement with respect to itself, or any
Research Institution or Principal Investigator. 

 

9.5No Pending Litigation. Lead Institution represents that it is not currently
involved in, nor is it aware of, any pending claim, litigation or proceedings
relating to its role in the conduct of a human clinical trial. Lead Institution
represents that it is not aware of any such claim, litigation or proceeding with
respect to Research Institutions or Principal Investigators. 

 

9.6Full Disclosure. Lead Institution has provided written notice to Laboratory
of any (i) clinical study or trial in which the Lead Investigator or, to the
best of its knowledge, any Principal Investigator was involved that was
terminated for any reason prior to completion, (ii) receipt of Form 483 Notices
of Observation from the FDA, Notice of Adverse Findings or any regulatory
warning letter by Lead Institution or any Research Institution, and (iii)
disqualifications of such Lead Investigator or any Principal Investigator from
receiving investigational drugs or medical devices by the FDA or any comparable
foreign regulatory entity.  

 

9.7No Debarment. Lead Institution, including Lead Investigator, hereby certifies
that, to the best of its knowledge, all of the Research Institutions and their
respective Principal Investigators, have not been debarred under the provisions
of 21 U.S.C. §335a(a) or (b), as amended. In the event that the Lead
Institution: (i) becomes debarred or learns that Lead Investigator, a Research
Institution or Principal Investigator is debarred; or (ii) receives notice of
action or threat of action with respect to such debarment, during the term of
this Agreement, Lead Institution agrees to notify Laboratory in writing
immediately. In the event that Lead Institution receives notice that a Research
Institution or Principal Investigator becomes debarred as set forth in clause
(i) above, the Lead Institution shall immediately terminate its participation in
this Agreement without any further action or notice by any party hereto. In the
event that Lead Institution notifies Laboratory of action or threat of action as
set forth in clause (ii) above, the Laboratory will have the right to terminate
or suspend (in its sole discretion) provision of Laboratory Services
immediately. 

 

9.8No Services of Debarred Persons. Each party hereby certifies that they have
not and will not use in any capacity the services of any individual,
corporation, partnership or association in connection with the Clinical Study
which has been debarred under 21 U.S.C. §335a(a) or (b), as amended. In the
event that a party becomes aware of the debarment or threatened debarment of any
individual, corporation, partnership or association providing services to such
party which directly or indirectly relates to such party’s activities under this
Agreement, such party will notify the other parties in writing immediately, and
such party may immediately terminate its participation in this Agreement without
any further action or notice by any party hereto.  

 

9.9No Other Warranties. EXCEPT FOR THE LIMITED WARRANTIES GIVEN IN THIS SECTION
9, THE PARTIES HERETO MAKE AND RECEIVE NO WARRANTIES, EXPRESS, IMPLIED,
STATUTORY OR OTHERWISE WITH RESPECT TO THE SUBJECT MATTER CONTAINED HEREIN, AND
EACH EXPRESSLY DISCLAIMS ANY IMPLIED WARRANTIES OF MERCHANTABILITY,
NONINFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE. 

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9.10Healthcare Compliance Laws. Each party agrees to comply with all applicable
laws and regulations. Neither Laboratory nor Lead Institution shall engage in
any activity prohibited by anti-kickback, anti self-referral, or any other
federal, state or local law or regulation which relate to health care and/or the
performance of services under this Agreement, as those regulations now exist or
as subsequently amended, renumbered, revised or promulgated. Lead Institution
shall use reasonable measures to ensure that all Research Institutions shall
comply with all applicable laws. It is not the intent of either Laboratory or
Lead Institution, including Lead Investigator, that any payments, gift, donation
or other consideration made under this Agreement be in return for the referral
of ongoing business, if any, or in return for the purchasing, leasing, or
ordering of any services other than the specific services described in this
Agreement. All payments or transfers of value specified in this Agreement are
consistent with fair market value in an arms-length transaction for the goods or
services provided.  

 

10INDEMNIFICATION AND INSURANCE  

 

10.1Laboratory Indemnification. Laboratory shall hold harmless and indemnify
Lead Institution, its trustees, officers, medical and professional staff
(including its Lead Investigator), employees, agents, successors or assigns from
and against third party claims for personal injury (including death) to any
person or damage to property arising out of or in connection with Laboratory’s
or its employees’ acts or omissions, except to the extent such claims arise from
Lead Institution’s breach of this Agreement including without limitation failure
to follow the Protocol, negligence or willful misconduct.  

 

10.2Institution Indemnification. To the extent permitted by law, Lead
Institution shall hold harmless and indemnify the Laboratory and its directors,
officers, employees, agents, successors or assigns from and against third party
claims for personal injury (including death) to any person or damage to property
resulting from the acts or omissions of the Lead Investigator or Lead
Institution including failure of such Lead Investigator to adhere to the
Protocol, Laboratory's written instructions with respect to the Clinical Study,
or applicable FDA or other governmental requirements except when such actions
are necessary for patient safety, clinical care and treatment purposes in the
reasonable medical judgment of the Lead Investigator.  

 

10.3Procedure. Any party entitled to indemnification under this Section 10 shall
give the indemnifying party prompt notice of any covered claim, shall provide
the indemnifying party with the opportunity to defend against the claim, and
shall reasonably cooperate in such defense at the indemnifying party’s expense;
provided, however, failure of any party to do so shall not relieve the other
party of its obligation(s) to indemnify, except to the extent that the
indemnifying party can demonstrate it was actually prejudiced by such failure.
Notwithstanding anything to the contrary in this Agreement, neither party shall
enter into any settlement, consent judgment, or other voluntary final
disposition of any claim that has a material adverse effect on the rights of the
other party or admits any wrongdoing or fault by the other party or imposes on
the other party any payment or other liability, without the prior written
consent of the other party. 

 

10.4Insurance. Each party shall, at its own expense, maintain a policy or
program of insurance or self-insurance at levels sufficient to support the
indemnification obligations assumed herein. During the term of this Agreement
and upon one party's request, the other party shall provide such party with a
certificate of insurance (or the self-insured equivalent) and shall provide to
such party thirty (30) days’ prior written notice of cancellation of such
insurance. 

 

11TERM AND TERMINATION 

 

11.1Term. This Agreement shall begin on the Effective Date and remain in full
force and effect for the Study Term or until the completion of the Clinical
Study and submission of the final report pursuant to Section 5.4 above, unless
earlier terminated in accordance with this Section 11. 

 

11.2Termination at Will. Either party may terminate this Agreement upon sixty
(60) days prior written notice to the other party. 

 

11.3Partial Termination by Lead Investigator and/or Laboratory. In the event
that a Principal Investigator becomes unavailable or withdraws from the Clinical
Study, and the Research Institution is unable to appoint a successor within
thirty (30) days after Lead Investigator is so notified in writing, Laboratory
may request that Lead Investigator terminate such Research Institution’s
participation in the Clinical Study. 

 

11.4Termination for Breach. Any party to this Agreement may terminate
participation in this Agreement upon thirty (30) days' prior written notice to
the other party of such party's material breach of this Agreement if such breach
is not cured within such thirty (30) day period. 

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11.5Effect of Termination. In the event of termination of this Agreement, for
any reason (including, without limitation, completion of the Clinical Study),
the Lead Investigator shall cease providing Study Samples to Laboratory;
provided, that, to the extent permitted by applicable law and regulations and
any relevant informed consent document, Laboratory shall have the continued
right to use the Study Samples in its possession in connection with blood-based,
cell-free circulating biomarkers on the Laboratory’s proprietary Nu.QTM platform
including for additional indications. Within one hundred eighty (180) days from
the effective date of any termination (including, without limitation, completion
of the Clinical Study), the Lead Investigator and Lead Institution shall obtain
from the Research Institutions and Principal Investigators all available
unblinded patient data collected in connection with the Clinical Study including
without limitation Annual Reports and the final written report described in
Section 5.4 above, and except as otherwise provided herein, any materials and
Confidential Information provided by Laboratory or Lead Institution for the
conduct of the Clinical Study; provided, however that one (1) copy of
Confidential Information may be retained for archival purposes. If Lead
Institution or Laboratory terminates this Agreement for any reason, Lead
Institution will provide, and Laboratory will have the perpetual right to use,
all available unblinded patient data for the Study Samples already paid for and
received by Laboratory on the completion of the Clinical Study. If the Clinical
Study is terminated for any reason, Lead Institution will provide, and
Laboratory will have the perpetual right to use, all available unblinded patient
data for the Study Samples already provided to Laboratory immediately upon
termination and completion of the analysis by relevant EDRN components (e.g.
Data Management and Coordinating Center) of the Clinical Study. For avoidance of
doubt, the patient data included in the Case Report Forms to the Protocol shall
be made available to Laboratory under this Section 11.5, which shall include,
without limitation, (a) patient conditions (i.e. colorectal cancer, high risk
adenoma), (b) age, (c) sex, (d) any other history, and (e) any other diseases.
In addition, Lead Institution agrees to, and will ensure that all Research
Institutions, hold unblinded patient data for at least three (3) months after
the completion of the Clinical Study. 

 

11.6Survival. Termination of this Agreement by any party shall not affect the
rights and obligations of the parties accrued prior to the effective date of
such termination. The rights and duties under Sections 1.3, 6, 7, 8, 9, 10.1,
10.2, 10.3, 10.4, 12.1, 12.2, and 12.7, and the last sentence of Section 5.1
shall survive the expiration or termination of this Agreement for any reason. 

 

12MISCELLANEOUS 

 

12.1Use of Names. Except as permitted in Section 7 above, no party to this
Agreement shall use the name or other identifying marks of any other party in
any advertising, promotional or sales literature or in any news release or other
media publicity without the prior written consent of the party whose name or
mark is to be used. Notwithstanding the foregoing, no party shall unreasonably
withhold its consent to any use of its name, which accurately and appropriately
describes the scope and nature of the parties' participation in the Clinical
Study, and which does not imply directly or indirectly any endorsement of the
other party or its products by the party whose name is to be used. 

 

12.2Assignment. The parties agree that their rights and obligations under this
Agreement may not be delegated, transferred or assigned to a third party without
prior written consent of the other parties hereto. Notwithstanding the
foregoing, Laboratory may transfer or assign its rights and obligations under
this Agreement to a successor to all or substantially all of its business or
assets pertaining to the subject matter of this Agreement whether by sale,
merger, operation of law or otherwise.  

 

12.3Force Majeure. No party hereto will be held liable or responsible to the
other parties, nor be deemed to have defaulted under or breached this Agreement,
for failure or delay in fulfilling or performing any term of this Agreement when
such failure or delay is caused by or results from causes beyond the reasonable
control of the affected party, including, without limitation, fire, floods,
earthquakes, natural disasters, embargoes, war, acts of war (whether war be
declared or not), insurrections, riots, civil commotions, strikes, lockouts or
other labor disturbances, acts of God, or acts, omissions or delays in acting by
any governmental authority or other party hereto. 

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12.4Notices. Any notice required or permitted hereunder shall be in writing and
shall be deemed to have been delivered (i) when delivered by hand; or (ii) when
shipped by private express carrier (such as DHL), shipping charges prepaid, to
the party to whom delivery shall be made at the respective addresses as set
forth below, or such other address as the party may substitute by written
notice; or (iii) when faxed to the number set forth below with confirming letter
mailed thereafter under the conditions described in (ii). 

 

If to Laboratory:Volition American, Inc. 

Suite 2000

100 Congress Avenue

Austin, TX 78701

Attn: Jason Terrell

 

 

If to Lead Institution:Regents of the University of Michigan 

c/o Dean E. Brenner, Lead Investigator 

2150 Cancer Center 

1500 E Medical Center Drive 

Ann Arbor, MI 48109-5930 

 

Lead Investigator: Dean E. Brenner, M.D. 

2150 Cancer Center 

1500 E Medical Center Drive 

Ann Arbor, MI 48109-5930 

 

12.5Governing Law. This Agreement shall be governed and construed by the laws of
Michigan, without reference to its conflict of laws principles.  

 

12.6Limitation of Liability. IN NO EVENT SHALL ANY PARTY BE LIABLE TO ANY OTHER
PARTY FOR ANY SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF OR
RELATING TO THIS AGREEMENT, OR THE SUBJECT MATTER HEREOF, HOWEVER CAUSED AND
WHETHER SUCH CLAIM IS BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE) OR
OTHERWISE, EVEN IF AN AUTHORIZED REPRESENTATIVE OF SUCH PARTY IS ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES. THIS LIMITATION OF LIABILITY SHALL BE RESTRICTED TO
THIS CLINICAL STUDY ONLY AND SHALL NOT EXTEND TO ANY OTHER CURRENT OR FUTURE
STUDY CONTRACT AGREEMENTS BETWEEN ANY OF THE PARTIES. 

 

12.7Modification; Waiver. This Agreement may not be altered, amended or modified
in any way except in writing signed by the parties. The failure of a party to
enforce any provision of this Agreement shall not be construed to be a waiver of
the right of such party to thereafter enforce that provision or any other
provision or right. 

 

12.8Severability. In the event that any provision of this Agreement is
determined to be illegal, invalid or unenforceable by a court of competent
jurisdiction, the remainder of this Agreement shall remain in full force and
effect without said provision. The parties shall negotiate in good faith a
substitute clause for any provision declared illegal, invalid or unenforceable,
which shall most nearly approximate the original intent of the parties in
entering this Agreement. 

 

12.9Independent Contractors. The parties agree that the relationship between the
Laboratory, the Lead Institution and Lead Investigator created by this Agreement
is that of independent contractors and that neither the Lead Investigator nor
the Lead Institution may create or assume any obligations on behalf of the
Laboratory. 

 

12.10Entire Agreement. This Agreement and the Exhibits attached hereto represent
the entire understanding of the parties with respect to the subject matter of
this Agreement, and supersede all prior discussions, agreements and writings in
respect to such subject matter. In the event of any inconsistency between this
Agreement and the Exhibits, the terms of this Agreement shall govern. 

 

12.11Counterparts. This Agreement may be executed in counterparts and delivered
by fax, each of which shall be deemed an original, and all of which, together,
shall constitute one and the same instrument. 

 

12.12Headings. Headings are provided solely for the benefit of the Parties and
shall not be used to interpret or construe its provisions. 

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IN WITNESS WHEREOF, the parties hereto have caused their duly authorized
representatives to execute this Agreement.

 

LABORATORYLEAD INSTITUTION 

 

VOLITION AMERICA, INC.THE REGENTS OF THE UNIVERSITY OF MICHIGAN 

 

By: /s/ Jason Terrell                                            By: /s/ Kevin
P. Hegarty                                                      

Name: Jason Terrell MDName: Kevin P. Hegarty  

Title:   Execitive Executive OfficerTitle: Execitive Vice President & Chief
Financial Officer 

Volition America, Inc

 

Date: 7.17.2017Date: 7.12.2017 

 

 

LEAD INVESTIGATOR 

 

By: /s/ Dean E. Brenner                                                      

Name: Dean E. Brenner 

Title: Professor of Internal Medicine 

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EXHIBIT A

 

STUDY PROTOCOL

 

GLNE 010, Version 5.0 March 6, 2017

 

[EDRN to insert]

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EXHIBIT B

 

NCI MATERIAL TRANSFER AGREEMENT for

 

4.0 mLs of frozen human plasma from Study Subjects conforming to sample
collection as described in the Early Detection Research Network (“EDRN”) Study
Protocol and at least 2 mLs but upto 4 mLs, if available, of previously banked
frozen human serum samples from the same Study Subjects collected as described
in GLNE 010. These Samples are transferred under the terms of the EDRN Clinical
Study Agreement executed between the Regents of the University of Michigan and
Volition America, Inc. (the “Clinical Study Agreement”)

 

RECIPIENT: ____________________________  

RECIPIENT SCIENTIST: _________________________

 

1. The NCI agrees to transfer to the RECIPIENT the following MATERIAL, which is
the property of the original provider of the MATERIAL to the NCI:
_______________

_______________________________________________(hereinafter referred to as
“MATERIAL”) and any clinical data, results and raw data relating to the MATERIAL
that neither contains nor is associated with identifiable private information
(“DATA”).

 

2. THIS MATERIAL MAY NOT BE USED IN HUMAN SUBJECTS. The MATERIAL will not be
used for commercial purposes such as screening, production or sale, for which a
commercialization license may be required. The RECIPIENT agrees to use the
MATERIAL and DATA in compliance with all applicable statutes and regulations.
The MATERIAL is to be used solely for the research specified in Exhibit A
attached to the Clinical Study Agreement and only by the RECIPIENT SCIENTIST and
those persons under his or her direct supervision. All requests for use for
other persons should be forwarded to the EDRN Executive Committee.

 

3. The MATERIAL and DATA have been collected from human subjects in accordance
with all applicable federal regulations for the protection of human subjects,
including, as applicable, 45 CFR Part 46, “Protection of Human Subjects,” and
the Standards for Privacy of Individually Identifiable Health Information set
forth in 45 C.F.R. Part 164, and appropriate Assurances and IRB approved
protocols, which include all necessary informed consents and authorizations. NCI
provides the MATERIAL pursuant to an exemption from IRB approval (NIH Office of
Human Subjects Research Protections Exemption #____). The DATA provided by NCI
neither contains nor is associated with identifiable private information.
RECIPIENT agrees to use the MATERIAL in compliance with all applicable laws,
regulations, and policies of the National Institutes of Health relating to human
subjects and human biospecimens. The RECIPIENT agrees not to attempt to obtain
identifying information on, or otherwise seek to re-identify or contact the
human subjects associated with the MATERIAL or DATA provided under this
Agreement.

 

4. Any MATERIAL delivered pursuant to this Agreement is understood to be
experimental in nature and may have hazardous properties. THE NCI MAKES NO
REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR
IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE MATERIAL OR DATA WILL
NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS. No
indemnification for any loss, claim, damage, or liability is intended or
provided by any party under this agreement. Each party shall be liable for any
loss, claim, damage, or liability that said party incurs as a result of its
activities under this Agreement, except that the NCI, as an agency of the United
States Government, assumes liability only to the extent as provided under the
Federal Tort Claims Act, 28 USC, chapter 171.

 

5. The MATERIAL is provided at no cost.

 

6. Inventorship of any inventions arising from the RECIPIENT’s use of the
MATERIAL shall be governed by U.S. patent law. Ownership of such inventions
shall follow the laws and RECIPIENT’s institutional rules governing assignment
obligations of the inventors. No right, title or interest in any such invention
is transferred by virtue of this Agreement.

 

7. The RECIPIENT agrees to acknowledge the contributions of the NCI’s EDRN
program in all publications resulting from the use of this MATERIAL. It is
recommended that the following statement be included in the methods or
acknowledgement section of such publications: "Tissue samples were provided by
the National Cancer Institute on behalf of the Early Detection Research Network
(EDRN).” By entering into this Agreement, the NCI does not directly or
indirectly endorse any product or service that is or will be provided, whether
directly or indirectly related to this Agreement.

 

8. The NCI shall have the right to terminate this Agreement if the RECIPIENT
materially breaches any of its obligations or responsibilities under this
Agreement, and such material breach is not cured within thirty (30) days of
receipt of written notice from the NCI. Upon termination, the RECIPIENT will, at
the NCI’s discretion, either return or destroy any remaining MATERIAL and DATA
in accordance with applicable laws and regulations.

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9. The RECIPIENT and RECIPIENT SCIENTIST agree to deposit all primary data and
processed data obtained using the MATERIAL with the EDRN Data Management and
Coordinating Center (DMCC) within four (4) months after processing the MATERIAL
in accordance with the Clinical Study Agreement. The DMCC will conduct the data
analysis and results will be provided to the RECIPIENT SCIENTIST. The results
will be posted on a secure domain of the EDRN website (eCAS) three (3) months
after the results have been provided to the RECIPIENT SCIENTIST. The NCI EDRN
reserves the right to post the results to its public website upon completion of
the study.

 

10. This Agreement may be executed in one or more counterparts, each of which
together shall be deemed original but all of which together shall constitute one
and the same document. A facsimile or Portable Document Format (PDF) of the
original signature of the representative of a party shall have the same validity
as an original signature for the purpose of this Agreement.

 

The RECIPIENT and the NCI must both sign this agreement and then the NCI will
send the MATERIAL.

 

FOR THE RECIPIENT:

 

RECIPIENT Scientist:_________________________________________________

RECIPIENT Organization:_____________________________________________

___________________________________________________________________

___________________________________________________________________

 

Name of Authorized Official: ___________________________________________

Title of Authorized Official:____________________________________________

Address:____________________________________________________________

___________________________________________________________________

 

Signature of Authorized Official ________________________________________

Date: _______________________

 

 

FOR THE NCI:

 

 

Name of Authorized Official: Lisa D. Finkelstein, Ph.D. 

Title of Authorized Official:Technology Transfer Specialist 

Technology Transfer Center

National Cancer Institute 

9609 Medical Center Drive, Rm 1E530 

Rockville, MD 20852 

 

Signature of Authorized Official:_____________________ 

Date:_____________________

 

 

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