Clinical Trial Agreement

This Clinical Trial Agreement (“Agreement”), dated and effective as of [DATE] [(the
“Effective Date”)], is by and between [SPONSOR], a [STATE OF ORGANIZATION] [TYPE
OF LEGAL ENTITY] with its principal place of business located at [ADDRESS] (“Sponsor”),
and [RESEARCH INSTITUTION], a [STATE OF ORGANIZATION] [TYPE OF LEGAL
ENTITY] with its principal place of business located at [ADDRESS] (“Institution”).
RECITALS

WHEREAS, Sponsor is engaged in the research [, /and] [development] [, /, and]

[manufacture] [, and] [sale] of [SPONSOR'S PRODUCTS] and is interested in engaging
Institution and Investigator (as defined in 11) to conduct a human clinical trial of [PRODUCT]
(“Product”); and
WHEREAS, Institution has experience in studying [CLINICAL AREA], and the
appropriate facilities and staff for conducting such a human clinical investigation; and
WHEREAS, Investigator is qualified by training and experience to conduct and supervise
such human clinical investigation; and
WHEREAS, all parties believe that the goals of each can be achieved through an
agreement between and among them and wish to define the terms and conditions of such an
agreement.
NOW, THEREFORE, in consideration of the mutual covenants, terms, and conditions set
forth herein and for other good and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, the parties agree as follows:

1. Definitions. For the purposes of this Agreement the terms have the following
meanings:

[“Affiliate” of a Person means any other Person that directly or indirectly,

through one or more intermediaries, controls, is controlled by, or is under common control
with, such Person. The term “control” (including the terms “controlled by” and “under
common control with”) means the [possession, directly or indirectly, of the power to direct
or cause the direction of the management and policies of a Person, whether through the
ownership of voting securities, by contract or otherwise/ownership, beneficially or of record,
of more than [NUMBER IN WORDS] percent ([NUMBER]%) of the voting securities of a
Person].]

“Agreement” has the meaning set forth in the preamble.

“Authorization” has the meaning set forth in 43.2.

“Business Day” means a day other than a Saturday, Sunday, or any public
holiday in the country where the applicable obligations are to be performed.

“Confidential Information” has the meaning set forth in 1110.1.

 “CRF” means the printed or electronic case report forms provided by Sponsor
to be completed by the Institution for each enrolled Study Subject.

“CV” has the meaning set forth in 44.1.

“Disclosing Party” has the meaning set forth in 1110.1.

“Effective Date” [has the meaning set forth in the preamble/means [DATE]].

[“Exclusive Negotiation Period” has the meaning set forth in Section 9.4.]

“FDA” means the United States Food and Drug Administration.

“Force Majeure” has the meaning set forth in 1714.5.

“HIPAA” means the Health Insurance Portability and Accountability Act of

1996 and its implementing regulations.

“ICF” has the meaning set forth in 43.1.

“Indemnified Claim” has the meaning set forth in 1412.4.

“Indemnified Party” means an Institution Indemnified Party set forth in

1412.1 or a Sponsor Indemnified Party set forth in 1412.3, as applicable.

“Indemnifying Party” has the meaning set forth in 1412.4.

[“Institution IP” has the meaning set forth in Section 9.2(b).]

“Intellectual Property Rights” means any and all registered and unregistered
rights granted, applied for, or otherwise now or hereafter in existence under or related to any
patent, copyright, trademark, trade secret, database protection, or other intellectual property
rights Laws, and all similar or equivalent rights or forms of protection, in any part of the
world.

“IRB” has the meaning set forth in 42.1.

“Investigator” means [INVESTIGATOR] having an office address at

[ADDRESS].

“Law” means any statute, law, ordinance, regulation, rule, code, order,
constitution, treaty, common law, judgment, decree, other requirement, or rule of law of any
federal, state, local or foreign government, or political subdivision thereof, or any arbitrator,
court or tribunal of competent jurisdiction.

“Losses” means losses, damages, liabilities, deficiencies, claims, actions,

judgments, settlements, interest, awards, penalties, fines, costs, or expenses of whatever
kind, including [reasonable] attorneys' fees, the cost of enforcing any right to
indemnification hereunder, and the cost of pursuing any insurance providers.

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 [“Option” has the meaning set forth in Section 9.3(a).

“Option Period” has the meaning set forth in Section 9.3(a).]

“Person” means an individual, corporation, partnership, joint venture, limited

liability entity, governmental authority, unincorporated organization, trust, association, or
other entity.

“Product” has the meaning set forth in the Recitals.

“Protected Health Information” has the meaning set forth in HIPAA.

“Protocol” has the meaning set forth in 42.1.

“Receiving Party” has the meaning set forth in 1110.1.

“Representative” means, with respect to a party, that party's [and its Affiliates'
respective] employees, officers[, directors][, consultants][, agents][, independent
contractors][, service providers][, sublicensees][, subcontractors], and legal advisors.
[[PARTY]'s Representatives also includes [PARTY]'s [OTHER PERSONS].]

“Sponsor Background Intellectual Property” means all Intellectual Property

Rights owned or controlled by Sponsor as of the Effective Date including, without
limitation, all Intellectual Property Rights made, invented, developed, created, conceived, or
reduced to practice by [any] Sponsor Representative[s] as of the Effective Date or
[independently of the Study and the Institution's Confidential Information/by [any] Sponsor
Representative[s] not participating in the Study or not having access to the Institution's
Confidential Information].

[“Sponsor IP” has the meaning set forth in Section 9.2(a).]

“Study” has the meaning set forth in 42.1.

“Study Budget” has the meaning set forth in 87.1.

“Study Data” has the meaning set forth in 64.7.

“Study IP” means all Intellectual Property Rights made, invented, developed,
created, conceived, or reduced to practice [after the Effective Date] relating to or arising out
of or as a result of the Product, the Protocol, or the Study.

“Study Staff” has the meaning set forth in 44.1.

“Study Subject” means an individual enrolled in the Study in accordance with

the inclusion and exclusion criteria in the Protocol.

“Third-Party Claim” has the meaning set forth in 1412.1.

“Term” has the meaning set forth in 1514.1.

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2. Conduct of the Study.

2.1 Protocol. Institution and Investigator shall carry out the clinical trial
[CLINICAL TRIAL NUMBER AND TITLE] (the “Study”) for Sponsor in accordance with
Sponsor's clinical trial protocol set forth in Exhibit A (the “Protocol”). Institution represents
that it has the facilities, resources, and personnel needed to properly conduct the Study in
accordance with the Protocol. Institution shall [not begin the Study until the Sponsor,
Institution, Investigator, the institutional review board (“IRB”) approves the
Protocol/provide Sponsor with the institutional review board's (“IRB's”) letter approving the
Protocol before beginning the Study]. Changes to the Protocol require the prior written
approval of Sponsor, Institution, and IRB. Investigator shall provide Sponsor a copy of the
IRB letter of approval concerning any Protocol changes before implementing the Protocol
changes.

2.2 Compliance with Laws. Institution and Investigator shall perform the Study in
accordance with all applicable Laws, including FDA regulations regarding electronic
records and signatures (21 C.F.R. Part 11), informed consent (21 C.F.R. Part 50), financial
disclosure (21 C.F.R. Part 54), IRBs (21 C.F.R. Part 56), Investigational New Drug
Applications (21 C.F.R. Part 312), and the Laws and regulations governing the privacy of
Study Subjects' information, including HIPAA.

2.3 IRB Review. Institution shall ensure that the IRB complies with the
requirements set out in 21 C.F.R. Part 56 and conducts the initial and continuing review and
approval of the Study. Institution shall immediately notify Sponsor if IRB is suspended,
terminated, or subject to other sanctions by the FDA or any other government agency.

3. Informed Consent and HIPAA Authorization.

3.1 Informed Consent. Sponsor shall provide Institution an informed consent form
(“ICF”) for the Study. Institution shall submit the ICF for review by the IRB. Institution
shall provide Sponsor with the IRB-approved ICF for review before enrollment of any Study
Subjects. All changes to the ICF require both Sponsor and IRB written approval.

3.2 HIPAA Authorization. Institution shall provide Sponsor a copy of the IRB
approved authorization for collection and use of protected health information for the Study,
which shall be in a format consistent with HIPAA requirements (“Authorization”). The
HIPAA authorization may be included as part of the ICF or as a stand-alone document. Both
Institution and Sponsor must approve the HIPAA authorization.

4. Institution and Investigator Obligations.

4.1 Investigator's Obligation to Personally Conduct the Study . Investigator shall

personally conduct the Study and supervise all staff involved in the Study (“Study Staff”).
Institution shall ensure that all Study Staff have the training and expertise appropriate for the
Study. Investigator shall enroll Study Subjects in accordance with the Protocol. Investigator
shall actively attempt to contact Study Subjects who discontinue and do not complete all
necessary Protocol requirements. Investigator shall sign a Statement of Investigator (“FDA
Form 1572”) and comply with the obligations set out therein. Investigator shall provide

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Investigator's curriculum vitae (“CV”) as well as the CV of all [key] Study Staff, such as
sub-investigators and Study coordinators.

4.2 Investigator and Study Staff Qualifications. [Institution/Investigator] represents

and warrants that:

(a) Investigator's medical license is in good standing;

(b) Investigator's medical license has never been suspended, revoked, or

otherwise restricted;

(c) Investigator has never been disqualified or otherwise restricted by the

FDA or the Department of Health and Human Services or similar agencies in other
countries from conducting clinical studies; and

(d) Investigator is not currently the subject of any disciplinary action by

any state or federal agency.

(e) No debarred individual will be involved in conducting the Study.

If, during the term of this Agreement, Investigator receives notice of any action
or threat of action regarding Investigator's medical license or ability to conduct clinical
studies, Institution shall immediately notify Sponsor. On receipt of such notice, or if
Sponsor otherwise becomes aware of such action or threat of action, Sponsor shall have the
right to [immediately] terminate the Agreement.

4.3 Replacement of Investigator. Institution shall not remove or replace

Investigator without the prior written consent of Sponsor. If Investigator cannot continue to
conduct the Study or notifies Institution that he intends to leave Institution, Institution shall
notify Sponsor within [NUMBER IN WORDS] ([NUMBER]) Business Days after
Institution learns of Investigator's inability to continue to conduct the Study or intent to
leave Institution. Upon Sponsor's prior written consent, Institution may appoint a
replacement investigator. If Sponsor and Institution cannot agree to a replacement
investigator within [NUMBER IN WORDS] ([NUMBER]) Business Days after Institution
learns of Investigator's inability to continue to conduct the Study or intent to leave
Institution, Sponsor may terminate this Agreement. Any replacement investigator must sign
[this Agreement,] an FDA Form 1572, and any other forms required under this Agreement
before participating in the Study. Institution shall provide Sponsor a copy of the replacement
investigator's CV.

4.4 Financial Disclosures. Investigator shall submit all relevant financial

information as required by 21 C.F.R. Part 54 in the format required by Sponsor. Investigator
shall cooperate with Sponsor to update the financial information as requested during the
Study and for one year following completion of the Study.

4.5 Informed Consent. Investigator shall obtain written informed consent from
each Study Subject in accordance with 21 C.F.R. Part 50, and any other applicable federal,
state, local, or IRB requirements. Investigator shall obtain an ICF signed and dated by each

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Study Subject (or his or her legal representative, as appropriate) before allowing such Study
Subject to participate in the Study.

4.6 IRB [and Study] Reports. Investigator shall keep IRB informed of the progress
of the Study by submitting any required reports to the IRB and shall obtain the IRB's
continuing review and approval of the Study as required by applicable Laws and the
Institution's policies. [Investigator shall provide Sponsor with routine Study status reports
and updates upon request.]

4.7 Investigator Records. Investigator shall prepare and maintain adequate and
accurate subject case histories of each Study Subject enrolled in the Study, recording all
observations and other data pertinent to the Study, including completing CRFs provided by
Sponsor, Study Subject's case histories, recorded observations, and all other data pertinent to
the Study (“Study Data”). Investigator shall collect and record Study Data within [five
(5)/NUMBER IN WORDS (NUMBER)] Business Days of a Study Subject visit.
Investigator shall review and sign the forms used for data collection in a timely manner,
including CRFs. Investigator shall resolve all data queries within [three (3)/NUMBER IN
WORDS (NUMBER)] Business Days. Sponsor shall also own all Study Data (except
Subject medical records). Sponsor has the right to use all Study Data and results for any
purpose including seeking regulatory approval from the FDA and other similar agencies in
other countries.

4.8 Adverse Event Reporting. Investigator shall contact Sponsor or Sponsor

Representative to report adverse events as required by FDA regulations and the Protocol.
Investigator shall contact Sponsor or Sponsor Representative immediately to report any
serious adverse drug event or unexpected adverse drug event, as defined at 21 C.F.R. §
312.32. Investigator shall respond promptly to all requests for follow-up information from
Sponsor or Sponsor Representative. Investigator shall inform the IRB of any adverse drug
experiences, in accordance with the policies and procedures of the IRB.

4.9 Product. Investigator shall handle, store, and administer or dispense the
Product according to the Protocol and Sponsor's written instructions. Investigator shall
implement drug accountability procedures to ensure that only Study Subjects use the
Product. Institution shall maintain accurate and complete records of the shipment, delivery,
receipt, and disposition of the Product as required by Law, including FDA regulations. The
Product remains Sponsor's sole and exclusive property at all times.

4.10 Record Retention. Investigator shall maintain all records pertaining to the
Study for a period of [NUMBER IN WORDS] ([NUMBER]) years following the date a
marketing application is approved for the Product for the indication described in the
Protocol; or if no marketing application is approved, until [NUMBER IN WORDS]
([NUMBER]) years after Sponsor notifies Investigator that the investigation of the Product
is discontinued. Investigator may not destroy Study records without Sponsor's prior written
consent. If Institution retains any records in electronic format it must ensure that the system
in which the records are retained is validated consistent with the requirements of 21 C.F.R.
Part 11 to ensure that records will be acceptable for inclusion in a marketing application to
FDA.

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 4.11 Subcontractors. Neither Institution nor Investigator shall subcontract with any
other Person for the conduct of the Study without Sponsor's prior written consent.

5. Sponsor Obligations.

5.1 Safety Reporting. In accordance with 21 C.F.R § 312.55(b), Sponsor shall

provide Investigator with up-to-date information, including safety information, necessary to
conduct the Study and keep Investigator informed of new observations discovered by or
reported to the Sponsor on the Product.

5.2 Monitoring. Sponsor shall monitor the Study at Institution to assess adequacy
of Protocol execution, Study documentation, specimen collection, data collection, and
receipt, storage, and use of the Product. Sponsor expects to conduct clinical monitoring
visits routinely during the Study, with the frequency to be determined by Sponsor. To ensure
Sponsor can meet its Study monitoring obligations:

(a) Institution shall permit Sponsor or Sponsor Representative to visit the

Institution's site at a mutually agreed on time, during normal business hours, to:

(i) review personnel, procedures, and facilities;

(ii) discuss with Investigator the general obligations regarding the

Study;

(iii) review Investigator's Study file and the forms used for data
collection for completeness and adherence to the Protocol; and

(iv) ensure compliance with all applicable requirements.

(b) Investigator shall provide necessary Study documents for inspection

and shall respond to queries that arise as part of the review. Institution shall permit
Sponsor and Sponsor Representative to perform a final review of the Study files, and
Institution shall resolve any data queries.

5.3 Protected Health Information. Sponsor shall comply with the restrictions set
out in the Authorization to maintain the confidentiality of Study Subjects' Protected Health
Information accessed during the monitoring of the Study. Sponsor shall have contracts in place with
Sponsor Representatives involved in the Study to maintain the confidentiality of Study Subjects'
Protected Health Information collected or accessed during the monitoring of the Study.

5.4 Study Registration. Sponsor shall register the Study and disclose results in
public databases in accordance with applicable Law.

6. Study Materials.

6.1 Product Supply. Either Sponsor or Sponsor Representative shall provide

Investigator with sufficient Product and other required Study materials as set out in the
Protocol to carry out the Study.

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 (a) The Product shall be shipped to Institution after:

(i) Sponsor's receipt of copies of the IRB letter approving the

Protocol, the IRB-approved informed consent form and Authorization,
financial disclosure documents as required under 21 C.F.R. Part 54;

(ii) Sponsor's receipt of all other regulatory documents as required

to conduct the Study; and

(iii) successful completion of the site initiation visit, to ensure that

the Institution is adequately prepared to conduct the Study.

6.2 Use of Product. Institution and Investigator shall use the Product solely for
conducting the Study in accordance with the Protocol. On completion of the Study, or
termination of the Agreement, Institution shall destroy or return any remaining Product as
directed by Sponsor. On request, Institution shall provide Sponsor documentation certifying
the destruction or return of Product. Institution shall not charge any Study Subject or third-
party payor for use of the Product.

6.3 Equipment. Sponsor may provide equipment for the conduct of the Study.
Institution and Investigator may use such equipment solely to conduct the Study. Institution
shall be responsible for any loss, theft of the equipment, and damage to equipment that is
beyond normal wear and tear. On completion of the Study, or termination of the Agreement,
Institution shall return the equipment in working condition as directed by Sponsor within
[NUMBER IN WORDS] ([NUMBER]) days of such completion or termination.

7. Compensation.

7.1 Compensation. In consideration for the services to be provided under the terms
of the Agreement, Sponsor shall pay Institution in accordance with Payment Schedule and
Budget attached as Exhibit B (“Study Budget”).

7.2 Fair Market Value. The Institution represents and warrants that the Study
Budget represents the fair market value of the services provided. The Study Budget is the
product of the good faith negotiations of the parties and does not in any way take into
account the volume or value of any referrals or other business otherwise conducted between
the parties for which payment may be made under any government health care program, or
in exchange for any purchase or prescription of any Sponsor product by Institution,
Investigator, or any Study Staff.

7.3 Disclosure of Payments. Institution acknowledges and agrees that:

(a) Sponsor is subject to federal and state Laws that require the disclosure
of certain types of information (for example, amounts paid and other transfers of value
to health care practitioners); and

(b) Sponsor shall be entitled to disclose such information as is required by

Law.

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8. Government Inspection and Conflict of Interest

8.1 Government Inspections. Institution shall permit any government inspection or

audit of its facilities or records in connection with the Study. Institution shall notify Sponsor
[within [NUMBER IN WORDS] ([NUMBER]) Business Days after/immediately upon] the
FDA or any other governmental or regulatory authority begins to conduct or gives notice of
its intent to conduct any such inspection. Institution shall permit Sponsor or Sponsor
Representatives to be present during the inspection or audit. Institution shall promptly
provide Sponsor with a copy of any FDA Form 483, warning letter, and all other
correspondence issued by the FDA or other governmental or regulatory authority in
connection with any such inspection. Institution shall provide Sponsor with a draft of any
proposed response to such correspondence at least [NUMBER IN WORDS] ([NUMBER])
Business Days before Institution submits the final version to the FDA or other governmental
or regulatory authority [and Institution shall accept all reasonable changes to the proposed
response suggested by Sponsor]. Institution shall use best efforts to correct any deficiencies
found during any such inspection.

8.2 Absence of Conflicts. Institution and Investigator represent by signing this

Agreement that they have no relationship with any other Person, including any government
agency, foundation, or private corporation that would in any way prevent or interfere with
the performance of their obligations under this Agreement, including the obligation to
convey the rights described in 99.

9. Study Intellectual Property.

9.1 Invention Disclosure and Record-Keeping.

(a) Institution shall, no later than [NUMBER IN WORDS] ([NUMBER])

Business Days after any [making, invention, discovery, development, creation,]
conception or reduction to practice of any Study IP, disclose to Sponsor all such Study
IP, and provide to Sponsor copies of all invention disclosures and other documents
that disclose such Study IP. Such disclosure shall contain sufficient detail to enable
Sponsor to determine whether the Study IP contains patentable subject matter.

(b) Institution shall maintain contemporaneous, complete, and accurate

[written] records of its activities concerning the Study IP that provide proof of the
conception date, diligence, and reduction to practice date of any Study IP.

(c) Institution shall ensure that Investigator and all Representatives,

including Study Staff, are bound by valid and enforceable written agreements to assign
to Institution all of their respective right, title, and interest in any Study IP [and to
cooperate with Sponsor in obtaining and maintaining any [patent rights/Intellectual
Property Rights] in the respective Study IP they invented, in whole or in part. Such
cooperation shall include the execution of all lawful papers that may be deemed
necessary or desirable by Sponsor for the filing and prosecution of patent applications
and for the assignment of the same to Sponsor, including all declarations, oaths,

9
 specifications, and instruments of assignment for filing and recordation in the US and
foreign patent offices.]

9.2 [Ownership of Study IP. Regardless of inventorship, as between the parties,

Sponsor shall own all right, title, and interest in and to Study IP. Institution, and its
Representatives, hereby assign all right, title, and interest in and to Sponsor IP to Sponsor.
Institution, its Representatives, and Investigator shall execute and deliver at Sponsor's
request all descriptions, applications, assignments, and other documents and instruments
[necessary/useful] in carrying out the provisions of this 109.2.

9.3 Ownership of Other IP. Except as otherwise expressly provided in this

Agreement, under no circumstances shall a party, as a result of this Agreement, obtain any
Intellectual Property Rights or ownership interest or other right, title, or interest in, to, or
under any Intellectual Property Rights of the other party, whether by implication, estoppel or
otherwise, including any items controlled or developed by the other party, or delivered by
the other party, at any time pursuant to this Agreement.

OR
9.4 Ownership of Study IP.

(a) Regardless of inventorship, as between the parties, Sponsor shall own

all right, title, and interest in and to Study IP that (i) relates to Sponsor's Product,
including but not limited to the use of Sponsor's Product in the Study and the conduct
of the Protocol; or (ii) incorporates or is derived from or based on any Sponsor
Background Intellectual Property or any of Sponsor's Confidential Information
(“Sponsor IP”). Institution hereby assigns all right, title, and interest in and to
Sponsor IP to Sponsor. At the request of Sponsor, Institution and Investigator shall
execute and deliver to Sponsor all descriptions, applications, assignments, and other
documents and instruments [necessary/useful] in carrying out the provisions of this
Section 9.2(a).

(b) The Institution shall own all Study IP that is not Sponsor IP
(“Institution IP”).

9.5 Institution IP Option.

(a) Institution hereby grants to Sponsor an exclusive option, exercisable by

Sponsor in its sole discretion, for a period of [NUMBER IN WORDS] ([NUMBER])
[months/[OTHER PERIOD]] from the disclosure of Institution IP pursuant to 99.1(a)
(“Option Period”) to obtain an exclusive license[, even as to [Institution],] under any
and all Institution IP to make, have made, use, offer for sale, sell, and import, with the
right to grant sublicenses [through multiple tiers], any products or processes covered
by such Institution IP (“Option”). This grant is irrevocable subject only to Institution's
termination of this Agreement pursuant to 1614.3.

(b) Sponsor in its sole discretion may extend the Option Period for up to
[NUMBER IN WORDS] ([NUMBER]) [months/[OTHER PERIOD]] by providing to

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 Institution before the end of the Option Period, written notice [and payment of $
[NUMBER IN WORDS] ([NUMBER]) for each [month/[OTHER PERIOD]] that
Sponsor wishes to extend the Option Period].

(c) During the Option Period, the Exclusive Negotiation Period, and any
extension thereof, and throughout the Term, Institution shall:

(i) neither grant to any Person (other than Sponsor) nor directly or
indirectly, solicit, initiate, facilitate, encourage, or participate in any
discussions or negotiations with any Person concerning entering into,
continuing or consummating any transaction under which any Person other
than Sponsor does or shall obtain any right, title, or interest in, to or under any
Institution IP; and

(ii) continue to maintain and hold in its own name ownership and
control of all right, title, and interest in, to, and under Institution IP.

9.6 Sponsor's Exercise of Option Right. Sponsor may exercise the Option by
delivering to Institution written notice during the Option Period of Sponsor's intent to enter
into an exclusive license agreement. Sponsor has no obligation or commitment to exercise
the Option or to enter into any patent license or other agreement relating to the subject
matter hereof. For a period of [NUMBER IN WORDS] ([NUMBER]) [Business
Days/months] after any exercise by Sponsor of the Option pursuant to Section 9.3(a)
(“Exclusive Negotiation Period”), Institution shall, in good faith and with the object of
entering into a definitive patent license agreement with Sponsor, negotiate exclusively with
Sponsor the [remaining] terms and conditions of such a patent license agreement. The
parties may extend the Exclusive Negotiation Period upon mutual written consent.]

10. Confidentiality.

10.1 Confidential Information. In connection with this Agreement, each party (as
the “Disclosing Party”) may disclose or make available Confidential Information to the other
party (as the “Receiving Party”). Subject to 1110.2 and the Institution's right to publish under
1311.3, “Confidential Information” means information in any form or medium (whether oral,
written, electronic, or other) that the Disclosing Party considers confidential or proprietary,
including information consisting of or relating to the Disclosing Party's products, research
activities, technology, trade secrets, know-how, business operations, plans, strategies,
customers, [OTHER CATEGORIES,] pricing, and information with respect to which the
Disclosing Party has contractual or other confidentiality obligations[, in each case whether or
not marked, designated or otherwise identified as “confidential”]. [Without limiting the
foregoing, the [financial] terms [and existence] of this Agreement are the Confidential
Information of [Sponsor/both parties].].

10.2 Exclusions. Confidential Information does not include information that[ the
Receiving Party can demonstrate by written or other documentary records]: (a) was
rightfully known to the Receiving Party without restriction on use or disclosure prior to such
information's being disclosed or made available to the Receiving Party in connection with

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this Agreement; (b) was or becomes generally known by the public other than by the
Receiving Party's or any of its Representatives' noncompliance with this Agreement; (c) was
or is received by the Receiving Party on a non-confidential basis from a third party that[, to
the Receiving Party's knowledge,] was not or is not, at the time of such receipt, under any
obligation to maintain its confidentiality; or (d) [the Receiving Party can demonstrate by
written or other documentary records] was or is independently developed by the Receiving
Party without reference to or use of any Confidential Information.

10.3 Protection of Confidential Information. As a condition to being provided with

any disclosure of or access to Confidential Information, the Receiving Party shall for [TIME
PERIOD]:

(a) Not access or use Confidential Information other than as necessary to

exercise its rights or perform its obligations under and in accordance with this
Agreement.

(b) Except as may be permitted by and subject to its compliance with

1210.4, not disclose or permit access to Confidential Information other than to its
Representatives who: (i) need to know such Confidential Information for purposes of
the Receiving Party's exercise of its rights or performance of its obligations under and
in accordance with this Agreement; (ii) have been informed of the confidential nature
of the Confidential Information and the Receiving Party's obligations under this
1210.3; and (iii) are bound by [written] confidentiality and restricted use obligations at
least as protective of the Confidential Information as the terms set forth in this 1210.3.

(c) Safeguard the Confidential Information from unauthorized use, access,

or disclosure using at least the degree of care it uses to protect its [most/similarly]
sensitive information and in no event less than a reasonable degree of care.

(d) Ensure its Representatives' compliance with, and be responsible and

liable for any of its Representatives' noncompliance with, the terms of this 1210.3.

10.4 Compelled Disclosures. If the Receiving Party or any of its Representatives are
compelled by applicable Law to disclose any Confidential Information then, to the extent
permitted by applicable Law, the Receiving Party shall: (a) promptly, and prior to such
disclosure, notify the Disclosing Party in writing of such requirement so that the Disclosing
Party can seek a protective order or other remedy, or waive its rights under 1210.3; and (b)
provide reasonable assistance to the Disclosing Party[, at the Disclosing Party's sole cost and
expense,] in opposing such disclosure or seeking a protective order or other limitations on
disclosure. If the Disclosing Party waives compliance or, after providing the notice and
assistance required under this 1210.4, the Receiving Party remains required by Law to
disclose any Confidential Information, the Receiving Party shall disclose only that portion of
the Confidential Information that[, on the advice of the Receiving Party's [outside] legal
counsel, ]the Receiving Party is legally required to disclose [and, upon the Disclosing Party's
request, shall use commercially reasonable efforts to obtain assurances from the applicable
court or other presiding authority that such Confidential Information shall be afforded
confidential treatment].

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11. Publication.

11.1 Publication. Investigator and Institution shall have the right to publish or
present the Study Data that does not disclose Sponsor Confidential Information subject to
the terms and conditions of this 1311.

11.2 Publication of Multicenter Study Results. If the Study is part of a multicenter

study, Sponsor shall have the first right to publish the Study Data[, which shall include
Study Data from all clinical sites participating in the Study]. If, after all clinical sites
complete the Study, Sponsor does not notify Institution that it has submitted a manuscript
for publication within [NUMBER IN WORDS] ([NUMBER]) months following completion
of the Study by the last site to complete the Study, Institution shall be free to publish its
Study Data in accordance with this 1311.

11.3 Publication Review. Institution shall provide to Sponsor copies of any intended
publication or intended public disclosure (including any presentation or oral disclosure made
with or without obligation of confidentiality) by or on behalf of the Investigator or
Institution that incorporates any information generated in the performance of the Study or
includes Confidential Information of Sponsor, at least [NUMBER IN WORDS]
([NUMBER]) Business Days before submitting for publication or publicly disclosing such
information. No later than [NUMBER IN WORDS] ([NUMBER]) Business Days after
Sponsor receives the proposed publication or public disclosure, Sponsor shall return to
Institution the intended publication or disclosure with notice of any proposed changes or
other measures aimed at ensuring [the information is fairly stated,] the confidentiality of any
Confidential Information is maintained[,] and the ability to obtain patent protection for
Sponsor IP is preserved. Upon Institution's receipt of such notice, Institution shall take all
actions [reasonably] requested by Sponsor to preserve the confidentiality of, or patent or
other Intellectual Property Rights in, such information, including by: [incorporating
Sponsor's proposed changes to the proposed publication or public disclosure][;/and]
[deleting references to Sponsor's Confidential Information][; and] [withholding all
publication and public disclosure of such information for an additional [NUMBER IN
WORDS] ([NUMBER]) Business Days to permit the Sponsor to file patent applications for
any Sponsor IP disclosed thereby]. [Sponsor acknowledges that Institution retains editorial
control of all publications and that the Institution has a right to publish the Study Data
collected at Institution, subject only to the Sponsor's time limited right to protect its
Intellectual Property Rights and prevent disclosure of Sponsor's Confidential Information.]

11.4 Attribution. Institution shall ensure that any actual or intended publication or
public disclosure, including any manuscript or presentation, incorporating any information
concerning any aspect of the Study includes recognition of Sponsor contributions according
to standard practice for assigning scientific credit, either through authorship or
acknowledgement, as may be appropriate. If the Investigator composes any material for
publication as a result of the Study, the Investigator should retain the copyright in that
material and grant the Sponsor a perpetual, irrevocable royalty-free license to make and
distribute copies.

12. Indemnification, Compensation for Injury, and Insurance.

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 12.1 Sponsor Indemnification Obligation. Sponsor shall indemnify, defend, and
hold harmless Institution and its [Affiliates and each of their respective ]officers, directors,
employees (including Investigator), agents, successors, and assigns (each, an “Institution
Indemnified Party”) from and against all Losses arising out of [or in connection with] any
third-party claim, suit, action, or proceeding (“Third-Party Claim”) relating to
administration of the Product in accordance with the Protocol and any procedures required
by the Protocol.

12.2 Exceptions to the Sponsor's Duty to Indemnify. Sponsor shall have no duty to
indemnify, defend, and hold harmless Institution in the event: (a) Institution and its
representatives (including Investigator) have not complied with the Protocol, all applicable
regulatory and legal requirements, and all instructions furnished in writing by Sponsor for
the use and administration of the Product; (b) Institution is in the breach of any
representation, warranty, covenant, or obligation under this Agreement; or (c) the Loss
results from any [action or failure to take a required action/negligence] or more culpable act
or omission (including recklessness or willful misconduct) by Institution or its
Representatives.

12.3 Institution Indemnification Obligation. Institution shall indemnify, defend, and

hold harmless Sponsor and its [Affiliates and each of their respective ]officers, directors,
employees, agents, successors, and assigns (each, a “Sponsor Indemnified Party”), from
and against all Losses arising out of [or in connection with] any Third-Party Claim relating
to: (a) a failure to comply with the Protocol; (b) any actual or alleged [material] breach of
any representation, warranty, covenant, or obligation under this Agreement by Institution or
its Representatives; or (c) any [action or failure to take a required action/negligence/gross
negligence] or more culpable act or omission (including recklessness or willful misconduct)
by Institution or any of its Representatives in connection with the Study.

12.4 Indemnification Procedure. An Indemnified Party shall promptly notify the

party from whom it is seeking indemnification (“Indemnifying Party”) upon becoming aware
of a Third-Party Claim [with respect to which the Indemnifying Party is obligated to provide
indemnification] under this 1312 (“Indemnified Claim”). The Indemnifying Party shall
promptly assume control of the defense and investigation of the Indemnified Claim, with
counsel [of its own choosing/reasonably acceptable to the Indemnified Party], and the
Indemnified Party shall [reasonably/fully] cooperate with the Indemnifying Party in connection
therewith, in each case at the Indemnifying Party's sole cost and expense. The Indemnified Party
may participate in the defense of such Indemnified Claim, with counsel of its own choosing and
at its own cost and expense. The Indemnifying Party shall not settle any Indemnified Claim [on
any terms or in any manner that adversely affects the rights of any Indemnified Party] without
[the/such] Indemnified Party's prior written consent (which consent shall not be unreasonably
withheld, conditioned, or delayed). [If the Indemnifying Party fails or refuses to assume control
of the defense of such Indemnified Claim, the Indemnified Party shall have the right, but no
obligation, to defend against such Indemnified Claim, including settling such Indemnified Claim
after giving notice to the Indemnifying Party, in each case in such manner and on such terms as
the Indemnified Party may deem appropriate.] [Neither t/T]he Indemnified Party's failure to
perform any obligation under this 1412.4 [nor any act or omission of the Indemnified Party in
the defense or settlement of any Indemnified Claim] shall [not] relieve the Indemnifying Party

14
of its obligations under this 1312, [including with respect to any Losses,] except to the extent
that the Indemnifying Party can demonstrate that it has been [materially] prejudiced as a result
thereof.

12.5 Insurance. Each party shall secure and maintain in full force and effect
throughout the performance of the Study insurance coverage of such type and in such amounts
appropriate to the conduct of their business and this Study. Each party shall provide the other a
certificate evidencing their insurance coverage on request.

12.6 [Compensation for Injury. In the event any Study Subject suffers a physical
injury caused by the Product or a procedure required by the Protocol, Sponsor shall pay for
reasonable and necessary acute medical treatment for any physical injury which is solely and
directly attributable to the Product as administered in accordance with the Protocol if:

(a) Institution and Investigator have adhered to and complied with the
Protocol, all applicable Laws, the terms of this Agreement, and all written instructions
from Sponsor.

(b) There is no negligence or willful misconduct on the part of Institution

or Investigator.

(c) A Study Subject's private medical insurance does not cover the cost of
such treatment.]

13. Compliance with Federal Fraud and Abuse Laws.

13.1 Anti-Kickback. Institution shall remain in compliance with all Laws applicable
to its operations, including the federal health care program anti-kickback provisions of the
Social Security Act, 42 U.S.C. §1320a-7b(b), the related safe harbor regulations, and the
relevant regulations at 42 C.F.R. Part 1001.

13.2 Anti-Bribery. Institution shall not, and shall ensure that neither Investigator nor
any Study Staff, make any payment, either directly or indirectly, of any money or other
consideration to any government official where such payment would violate any Law,
including the Foreign Corrupt Practices Act.

14. Term and Termination.

14.1 Term. The term of this Agreement commences on the Effective Date and,
unless terminated earlier in accordance with this Agreement's express provisions, shall
remain in force until Institution has completed all CRFs and resolved all data queries to the
satisfaction of the Sponsor (“Term”).

14.2 Termination for Convenience. Notwithstanding any provision of this

Agreement to the contrary and without Sponsor incurring any additional obligation, liability,
or penalty by reason of its termination of the Agreement pursuant to this 1514.2, Sponsor
may terminate this Agreement:

15
 (a) at any time after the [expiration of [NUMBER IN WORDS]
([NUMBER]) [years/months] following/[ORDINAL NUMBER] anniversary of] the
Effective Date, in its sole discretion, for any or no reason, by providing [NUMBER IN
WORDS] ([NUMBER]) Business Days' prior written notice to Institution.

(b) upon written notice to Institution if Institution fails to enroll any

subjects [six (6)/[NUMBER IN WORDS] ([NUMBER])] months after the site
initiation visit.

14.3 Termination for Cause. In addition to any other express termination right set
forth elsewhere in this Agreement, either party may terminate this Agreement, effective on
written notice to the other party:

(a) if the other party [materially] breaches this Agreement, and such
breach: (i) is incapable of cure; or (ii) being capable of cure, remains uncured
[NUMBER IN WORDS] ([NUMBER]) Business Days after the non-breaching party
provides the breaching party with written notice of such breach; or

(b) if the other party: (i) becomes insolvent or admits its inability to pay its
debts generally as they become due; (ii) becomes subject, voluntarily or involuntarily,
to any proceeding under any domestic or foreign bankruptcy or insolvency Law,
which is not fully stayed within [NUMBER IN WORDS] ([NUMBER]) Business
Days or is not dismissed or vacated within [NUMBER IN WORDS] ([NUMBER])
Business Days after filing; (iii) is dissolved or liquidated or takes any corporate action
for such purpose; (iv) makes a general assignment for the benefit of creditors; or (v)
has a receiver, trustee, custodian, or similar agent appointed by order of any court of
competent jurisdiction to take charge of or sell any material portion of its property or
business.

14.4 Effect of Expiration or Termination . Upon any expiration or termination of this

Agreement:

(a) If the termination is by Sponsor pursuant to 1614.2(a) or [14.2(b)/by

either party pursuant 1614.2(b)], Sponsor shall pay to Institution a prorated share of
the amounts otherwise payable to Institution under this Agreement based on the actual
work properly performed by or on behalf of Institution as of the effective date of such
termination in accordance with the terms and conditions of this Agreement, including
the applicable protocol, [Study Budget,] milestones, and payment schedule set forth in
the Payment Schedule, provided that, to the extent that any prior payments made by
Sponsor for such work exceed the amount of such prorated share, Institution shall
refund such excess to Sponsor within [NUMBER IN WORDS] ([NUMBER])
Business Days of such termination.

(b) Subject to the requirements of applicable Law, [promptly/within

[NUMBER IN WORDS] ([NUMBER]) Business Days] after the effective date of such
expiration or termination, [Institution/Receiving Party] shall: (i) return to [Sponsor/the
Disclosing Party], or at [Sponsor's/the Disclosing Party's] option, destroy, all

16
 documents and materials in its control that comprise or reflect, in whole or in part,
[Sponsor/the Disclosing Party]'s Confidential Information and[,where Sponsor is the
Disclosing Party,] any materials, and any copies, derivatives, adaptations, or other
embodiments of such Confidential Information or materials, including any Study IP
derived therefrom or based thereon; and (ii) certify to [Sponsor/the Disclosing Party]
in a writing signed by a duly authorized officer of [Institution/the Receiving Party]
that it has complied with the requirements of this 1614.4(b). [Notwithstanding the
foregoing provisions of this 1614.4(b), [Institution/the Receiving Party] may keep one
copy of [Sponsor's/the Disclosing Party's] Confidential Information solely for archival
purposes if and to the extent required by applicable Law.]

14.5 Force Majeure. If any party is delayed or is hindered in their performance by

reasons of strike, lockouts, labor troubles, restrictive government or judicial orders, or
decrees, riots, insurrection, war, Acts of God, inclement weather or other similar reason or
any cause beyond a party's control (a “Force Majeure”), then performance of that party
shall be excused during the delay. If the delay exceeds [NUMBER IN WORDS]
([NUMBER]) Business Days, the non-affected party may terminate this Agreement.

14.6 Survival. The provisions set forth in the following Sections, and any other right
or obligation of the parties in this Agreement that, by its nature, should survive termination
or expiration of this Agreement, shall survive any expiration or termination of this
Agreement: 54.4 (Financial Disclosures), 64.10 (Record Retention), 98.1 (Government
Inspections), this 1714.6, 11 (Definitions), 99 (Study Intellectual Property), 1110
(Confidentiality), 1311 (Publication), 1312 (Indemnification, Compensation for Injury, and
Insurance), , 1715 (Dispute Resolution) and 1716 (Miscellaneous).

14.7 Continuing Obligations. Any termination under this 1514 shall not relieve
Sponsor, Institution, or Investigator, of any obligation or liability accrued before such
termination. Nor shall termination relieve any party from any obligation that by its nature,
by regulation, or by the terms of this Agreement survives termination.

15. Dispute Resolution. The parties shall attempt in good faith to resolve any dispute
promptly by negotiation between [SENIOR EXECUTIVES OF EACH PARTY]. A party may
initiate this process by providing notice of the dispute in accordance with 1816.4. Within
[NUMBER IN WORDS] ([NUMBER]) Business Days of the receipt of the notice by the other
party, [SENIOR EXECUTIVES OF EACH PARTY] shall meet in person, or by teleconference,
at a mutually agreeable time and place and thereafter as often as they reasonably deem necessary,
to attempt in good faith to resolve the dispute. If the parties fail to resolve the dispute in
[NUMBER IN WORDS] ([NUMBER]) Business Days, each party is free to seek resolution in a
court of Law.

16. Miscellaneous.

16.1 Further Assurances. Upon a party's reasonable request, the other party shall, at
the requesting party's sole cost and expense, execute and deliver such documents and
instruments, and take all such further actions necessary to give full effect to this Agreement.

17
 16.2 Relationship of the Parties. The relationship between the parties is that of
independent contractors. Nothing contained in this Agreement shall be construed as creating
any agency, partnership, joint venture, or other form of joint enterprise, employment, or
fiduciary relationship between the parties and neither party shall have authority to contract
for or bind the other party in any manner whatsoever.

16.3 Public Announcements. Except as set forth in 1311 solely with respect to
Study Data, neither party shall issue or release any announcement, statement, press release,
or other publicity or marketing materials relating to this Agreement, or otherwise use the
other party's trademarks, service marks, trade names, logos, domain names, or other indicia
of source, association, or sponsorship, in each case, without the prior written consent of the
other party, which shall not be unreasonably withheld, conditioned, or delayed[./, provided,
however, that [Institution may, without requiring Sponsor's consent, identify Sponsor by
name in its lists of Institution's current or former customers in promotional and marketing
materials/[and] Sponsor may list Institution as a site participating in the Study in accordance
with applicable Law].]

16.4 Notices. [Except as otherwise expressly set forth in this Agreement, a/A]ll
notices, requests, consents, claims, demands, waivers, and other communications hereunder
shall be in writing and shall be deemed to have been given: (a) when delivered by hand
(with written confirmation of receipt); (b) when received by the addressee if sent by a
nationally recognized overnight courier (receipt requested); (c) on the date sent by facsimile
[or email] (with confirmation of transmission) if sent during normal business hours of the
recipient; and (d) on the [ORDINAL NUMBER IN WORDS] ([ORDINAL NUMBER]) day
after the date mailed, by certified or registered mail (in each case, return receipt requested,
postage prepaid). Such communications must be sent to the respective parties at the
following addresses or at such other address for a party as shall be specified in a notice
given in accordance with this Section 16.4:

If to Sponsor:
[SPONSOR ADDRESS]
Facsimile: [FAX NUMBER]
[Email: [NOTICES CONTACT'S EMAIL ADDRESS]]
Attention: [NAME AND TITLE OF OFFICER TO RECEIVE NOTICES]
If to Institution:
[INSTITUTION ADDRESS]
Facsimile: [FAX NUMBER]
[Email: [NOTICES CONTACT'S EMAIL ADDRESS]]
Attention: [NAME AND TITLE OF OFFICER TO RECEIVE NOTICES]
16.5 Interpretation. For purposes of this Agreement, (a) the words “include,”
“includes,” and “including” are deemed to be followed by the words “without limitation”;
(b) the word “or” is not exclusive; (c) the words “herein,” “hereof,” “hereby,” “hereto,” and
“hereunder” refer to this Agreement as a whole; (d) words denoting the singular have a

18
comparable meaning when used in the plural, and vice-versa; and (e) words denoting any
gender include all genders. Unless the context otherwise requires, references in this
Agreement: (x) to sections, exhibits, schedules, attachments, and appendices mean the
sections of, and exhibits, schedules, attachments, and appendices attached to, this
Agreement; (y) to an agreement, instrument, or other document means such agreement,
instrument, or other document as amended, supplemented, and modified from time to time
to the extent permitted by the provisions thereof; and (z) to a statute means such statute as
amended from time to time and includes any successor legislation thereto and any
regulations promulgated thereunder. The parties intend this Agreement to be construed
without regard to any presumption or rule requiring construction or interpretation against the
party drafting an instrument or causing any instrument to be drafted. The exhibits,
schedules, attachments, and appendices referred to herein are an integral part of this
Agreement to the same extent as if they were set forth verbatim herein.

16.6 Headings. The headings in this Agreement are for reference only and shall not
affect the interpretation of this Agreement.

16.7 Entire Agreement. This Agreement, including its Exhibits, represents the
complete and entire understanding between the parties regarding the subject matter hereof
and supersedes all prior negotiations, representations, or Agreements, either written or oral,
regarding this subject matter.

16.8 Assignment. Institution shall not assign or otherwise transfer any of its rights,
or delegate or otherwise transfer any of its obligations or performance, under this
Agreement, in each case whether voluntarily, involuntarily, by operation of Law, or
otherwise, without Sponsor's prior written consent[, which consent Sponsor [shall not
unreasonably withhold or delay/may give or withhold in Sponsor's sole discretion]]. For
purposes of the preceding sentence, and without limiting its generality, any merger,
consolidation, or reorganization involving Institution (regardless of whether Institution is a
surviving or disappearing entity) shall be deemed to be a transfer of rights, obligations, or
performance under this Agreement for which Sponsor's prior written consent is required. No
delegation or other transfer shall relieve the Institution of any of its obligations or
performance under this Agreement. Any purported assignment, delegation, or transfer in
violation of this 1916.8 is void. This Agreement is binding upon and inures to the benefit of
the parties hereto and their respective permitted successors and assigns.

16.9 No Third-Party Beneficiaries. This Agreement is for the sole benefit of the
parties hereto and their respective [permitted] successors and permitted assigns and nothing
herein, express or implied, is intended to or shall confer upon any other Person any legal or
equitable right, benefit, or remedy of any nature whatsoever, under or by reason of this
Agreement.

16.10 Amendment; Modification; Waiver. No amendment to or modification of [or

rescission, termination, or discharge of] this Agreement is effective unless it is in writing,
identified as an amendment to [or rescission, termination, or discharge of] this Agreement
and signed by [an authorized Representative of] each party. No waiver by any party of any
of the provisions hereof shall be effective unless explicitly set forth in writing and signed by

19
the party so waiving. Except as otherwise set forth in this Agreement, no failure to exercise,
or delay in exercising, any rights, remedy, power, or privilege arising from this Agreement
shall operate or be construed as a waiver thereof; nor shall any single or partial exercise of
any right, remedy, power, or privilege hereunder preclude any other or further exercise
thereof or the exercise of any other right, remedy, power, or privilege.

16.11 Severability. If any term or provision of this Agreement is invalid, illegal, or

unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability shall not
affect any other term or provision of this Agreement nor invalidate or render unenforceable
such term or provision in any other jurisdiction. Upon such determination that any term or
other provision is invalid, illegal, or unenforceable, the parties hereto shall negotiate in good
faith to modify this Agreement so as to effect the original intent of the parties as closely as
possible in a mutually acceptable manner in order that the transactions contemplated hereby
be consummated as originally contemplated to the greatest extent possible.

16.12 Governing Law; Submission to Jurisdiction. This Agreement is governed by

and construed in accordance with the internal Laws of the State of [STATE] without giving
effect to any choice or conflict of law provision or rule that would require or permit
application of the Laws of any jurisdiction other than those of the State of [STATE]. Any
legal suit or proceeding arising out of [or related to] this Agreement or the options or
licenses granted hereunder [shall/may] be instituted [exclusively] in the federal courts of the
United States or the courts of the State of [STATE] in each case located in the city of
[CITY] and County of [COUNTY], and each party irrevocably submits to the [exclusive]
jurisdiction of such courts in any such suit, action, or proceeding. Service of process,
summons, notice, or other document by mail to such party's address set forth herein shall be
effective service of process for any suit, action, or other proceeding brought in any such
court.

16.13 Equitable Relief. Institution acknowledges and agrees that a breach or

threatened breach of its obligations under this Agreement would cause Sponsor irreparable
harm, for which monetary damages would not be adequate compensation and that, in the
event of such a breach or threatened breach, Sponsor shall be entitled to equitable relief,
including a restraining order, an injunction, specific performance, and any other relief that
may be available from any court without any requirement to post a bond or other security, or
to prove actual damages or that monetary damages are not an adequate remedy. Such
remedies are not exclusive and are in addition to all other remedies that may be available at
Law or in equity or otherwise.

16.14 Counterparts. This Agreement may be executed in counterparts, each of which

shall be deemed an original, but all of which together shall be deemed the same Agreement.
[A signed copy of this Agreement delivered by facsimile, email, or other means of electronic
transmission is deemed to have the same legal effect as delivery of an original signed copy
of this Agreement.]

[SIGNATURE PAGE FOLLOWS]

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IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the date set out
above.
[SPONSOR NAME] [INSTITUTION NAME]
By_________________ By_________________
Name: Name:
Title: Title:

READ AND ACKNOWLEDGED

[INVESTIGATOR NAME]
By_________________
Name:

21
EXHIBIT A

PROTOCOL

22
 EXHIBIT B

STUDY BUDGET

23