Exhibit 10.7


 


[ **** ]
indicates confidential portions have been redacted and submitted separately
pursuant to confidentiality request with the Commission


 


CLINICAL
TRIAL RESEARCH AGREEMENT


 


This Agreement is
entered into as of the last date on the signature page hereof (“Effective
Date”), by and between DUKE UNIVERSITY,
a nonprofit educational and health care institution located at Office of Grants
and Contracts, DUMC Box 3001, 107 Seeley G. Mudd Building, Durham, NC 27710,
hereinafter called “Institution,” and MEDAREX, INC.,
a New Jersey corporation with its principal place of business located at 707
State Road, Suite 206, Princeton, New Jersey 08540-1437, hereinafter
called “Medarex”.


 


RECITALS


 


WHEREAS,
Medarex desires Institution to study the safety and/or efficacy of [ **** ]
(the “Study Drug”); and


 


WHEREAS,
Institution is willing to perform certain clinical trial research with the
Study Drug pursuant to the terms of this Agreement (the “Study”);


 


WHEREAS,
the Study contemplated by this Agreement is of mutual interest and benefit to
Institution and Medarex, and will further the instructional and research
objectives of Institution in a manner consistent with its status as a nonprofit
educational and health care institution,


 


NOW
THEREFORE, based upon the promises and mutual covenants set
forth herein, the parties hereto agree as follows:


 


AGREEMENT


 


1.                                      SCOPE OF
WORK


 


Institution and
Principal Investigator (defined in Article 2 below) agree to perform the
Study under this Agreement strictly in accordance with the terms of the final
protocol, including as it may be amended in accordance with the terms of
this Agreement, for the Study entitled “A Phase I Open-Label, Dose-Escalation,
Multi-Dose Study of [ **** ]” which is attached as Exhibit A (the “Protocol”)
and which is incorporated into this Agreement by reference. Institution
represents and warrants that, to its best knowledge, its facilities and
population are adequate to perform the Study contemplated by this
Agreement and the Protocol. Institution and Principal Investigator agree that
all aspects of the Study shall be conducted in conformity with all applicable
supranational, national, state and other local laws and regulations, including
any applicable requirements of the Health Insurance Portability and
Accountability Act of 1996 and the United States Food and Drug Administration (“FDA”)
(collectively, “Applicable Law”).


 

















 


2.                                      PRINCIPAL
INVESTIGATOR


 


A.                                    Appointment and Substitution of
Principal Investigator.


 


(i)                                    Institution’s principal
investigator is Michael Morse, M.D., (who with any sub-investigators shall be
collectively referred to as “Principal Investigator”). Principal Investigator
shall direct and supervise the performance of the Study in accordance with
applicable Institution policies, the Protocol and this Agreement.


 


(ii)                                In the event that the Principal
Investigator who signs either the Protocol and/or this Agreement leaves or is
removed from the Institution or otherwise becomes unavailable to direct and
supervise the performance of the Study, then Institution shall, within ten (10) days
of such event, provide written notice thereof to Medarex and propose a
replacement for the Principal Investigator with appropriate qualifications. Any
successor to Principal Investigator must be approved, in writing, by Medarex
and such successor shall be required to agree to all the terms and conditions
of the Protocol and this Agreement and to sign each such document as evidence
of such agreement (although failure to so sign shall not relieve such successor
from abiding with all the terms and conditions of the Protocol and this
Agreement). If Institution does not identify a qualified successor to Principal
Investigator as provided above, or if the Medarex does not approve the
successor proposed by the Institution, Medarex shall have the right to
terminate this Agreement as provided in Section 6. A.


 


B.                                    No Debarment.


 


(i)                                    Institution and Principal
Investigator represent that they shall not use in any capacity, in connection
with any services to be performed under this Agreement, any individual who has
been debarred pursuant to § 306(a) or § 306(b) of the
Federal Food, Drug and Cosmetic Act, or excluded from a federal healthcare
program (“Debarred”).


 


(ii)                                Institution and Principal
Investigator agree to immediately inform Medarex in writing if any person
who is performing services hereunder is Debarred or if any action, suit, claim,
investigation or legal or administrative proceeding is pending, or, to the best
of Institution’s knowledge, is threatened, that could result in Institution or
any person performing services hereunder becoming Debarred.


 


(iii)                            Principal Investigator
represents that s/he is not Debarred and that no action, suit, claim
investigation or legal or administrative proceeding is pending or threatened
that could result in Principal Investigator becoming Debarred, and Principal
Investigator agrees to immediately inform Medarex in writing if any such
action, suit, claim, investigation or legal or administrative proceeding is
threatened or commenced.


 


C.                                    Disclosure of Financial Interest.


 


(i)                                    Institution shall ensure that
the Principal Investigator and other researchers engaged in a Study
individually complete the form for the disclosure of financial interests
and arrangements as attached at Appendix B as updated from time to time by
Medarex to conform with applicable laws and regulations (the “Disclosure”)
and return it to Medarex. If circumstances change during the Study, and the
Disclosure submitted by Principal Investigator is 


 


2

















 


no longer truthful
and accurate, then Principal Investigator will promptly submit to Medarex an
updated Disclosure reflecting the new circumstances.


 


(ii)                                Medarex will hold any
Disclosures in confidence and will only use such Disclosure in meeting FDA
regulatory requirements under 21 C.F.R. Part 54. By completing the
Disclosure, Principal Investigator certifies that the Disclosure supplied is
truthful and accurate. Failure to return a completed Disclosure to Medarex
shall be a material breach of this Agreement that may result in Medarex
terminating this Agreement.


 


3.                                      PROJECT
MONITOR AND INSPECTION RIGHTS


 


A.                                    Medarex may designate from
time to time certain of its employees, consultants or contractors as project
monitors (“Project Monitor(s)”). During the Study and for a reasonable time
after completion or early termination of the Study, the Project Monitor(s) may,
with reasonable advance notice and during regular business hours:


 


(i)                                    examine and inspect Institution
facilities used in the performance of the Study; and


 


(ii)                                inspect, audit, and copy or have
copied, all data and work product generated in the performance of the Study
conducted under this Agreement, and all other data necessary for Medarex to
confirm that the Study is being conducted in conformance with the Protocol and
in compliance with all Applicable Law.


 


B.                                    Institution agrees to cooperate
with and assist Medarex, to the extent deemed reasonable by Medarex, in order
to facilitate the Project Monitor’s examination, inspection, auditing and
copying of materials relating to the Study and in order to enforce the rights
granted to Medarex in this Article 3.


 


C.                                    Principal Investigator and
Institution agree to take any action necessary, as reasonably requested by
Medarex, to properly correct or address any deficiencies noted by the Project
Monitors during any audit and agree to cooperate with Medarex with respect to
any action taken to address any such deficiencies.


 


4.                                      CLINICAL
TRIAL APPROVALS


 


A.                                    Institution shall be responsible
for obtaining the following:


 


(i)                                    approval of the Protocol, any
informed consent relating to the Study and advertisement, if any, pertaining to
the enrollment of subjects in the Study by the appropriate Institutional Review
Board (“IRB”) prior to beginning any Study on human subjects; and


 


(ii)                                an informed consent which
complies with all Applicable Law signed by or on behalf of each human subject
prior to the subject’s participating in the Study.


 


B.                                    In the event the IRB requires
changes in the Protocol or form of informed consent, Institution shall
advise Medarex in advance of such changes and all modifications to the
Protocol, and Medarex must approve all such changes in advance. Institution and
Principal 


 


3

















 


Investigator shall not modify the Protocol or
the informed consent as approved by the IRB without the prior written approval
of Medarex.


 


5.                                      TERM OF
AGREEMENT


 


A.                                    The term of this Agreement shall
commence on the Effective Date and shall expire upon the completion of the
Study and the receipt and acceptance by Medarex of the final Study
documentation required to be provided under the Protocol.


 


B.                                    It is anticipated that the Study
shall begin on March 2004, and shall be completed on March 2005. If
at any time Institution or Principal Investigator have reason to believe that
the Study shall not be initiated or completed as per the above schedule, they
shall advise Medarex in writing of the reason(s) and length of additional
time required to commence or complete work, and if such delay is due to the
negligence or willful misconduct of Institution or Principal Investigator, then
Medarex may terminate this Agreement as provided in Article 6.


 


6.                                      TERMINATION
AND ENROLLMENT CAP


 


A.                                    Medarex may terminate this
Agreement by giving thirty (30) days written notice to Institution. In the
event thirty (30) days is determined by Institution to be insufficient notice
based upon evaluation of risks to enrolled research subject(s) then
receiving the Study Drug, the parties shall cooperate to safely withdraw
subjects from drug treatment as soon as reasonably possible. Notwithstanding
the foregoing, in the event Medarex believes that immediate termination is
necessary due to its evaluation of risks to enrolled research subject(s),
Medarex may terminate this Agreement immediately.


 


B.                                    Notwithstanding any other
provision hereof, Medarex shall be entitled to terminate this Agreement for any
Material Breach which shall be defined as Institution’s failure to comply with (a) its
obligations and responsibilities hereunder and the terms and conditions of this
Agreement (b) the Protocol; or (c) Applicable Law relevant to the
Study.


 


C.                                    In the event of any termination:


 


(i)                                    Institution and Principal
Investigator shall return to Medarex all unused materials, including but not
limited to, Study Drug and clinical supplies (unless written authorization to
retain or destroy them is given by Medarex, in which case Institution and
Principal Investigator shall comply with the applicable provisions of Article 12
hereof);


 


(ii)                                except in the event of
termination because of a Material Breach by Institution or Principal
Investigator, and unless otherwise specified in writing between the parties,
the total sums payable by Medarex pursuant to this Agreement shall be pro-rated
for actual work performed and non-cancelable expenses incurred in accordance
with the Protocol to date of termination with any unexpended portion of funds
previously paid by Medarex to Institution being refunded to Medarex;


 


(iii)                            in the event of termination as a
result of a Material Breach, the parties agree to make a good faith effort to
reach agreement to compensate Institution for actual work performed and
non-cancelable expenses incurred in accordance with the Protocol to date of 


 


4

















 


termination to the extent that such work can
be used in the further development of the Study Drug, but in no event more than
the pro-rated amounts as provided in subsection (ii) above; and


 


(iv)                               Institution and Principal
Investigator shall return to Medarex all Confidential Information provided by
Medarex (as defined in Article 9 hereof) in the possession of Institution
and Principal Investigator.


 


D.                                    The termination of this
Agreement shall not relieve either party of its obligation to the other in
respect of:


 


(i)                                    retaining in confidence all
Confidential Information (as defined in Article 9 hereof);


 


(ii)                                complying with record keeping
and reporting obligations (as set forth in Article 7 hereof);


 


(iii)                            providing prior review for any
publications (as set forth in Article II hereof) and obtaining written
approval and consents for publicity and promotional purposes (as set forth in Article 18
hereof);


 


(iv)                               compensation by Medarex for
services performed by Institution to date of termination, except as set forth
in Article 6.C(iii) hereof;


 


(v)                                   complying with obligations
relating to clinical supplies (as set forth in Article 12 hereof);


 


(vi)                               indemnification and insurance
(as set forth in Article 13 hereof);


 


(vii)                           inspection rights (as set forth
in Article 3 hereof); and


 


(viii)                       obligation to assist in
obtaining patent protection (as set forth in Article 14 hereof), if
applicable


 


all of which
obligations are binding on the appropriate party and shall survive any
termination and remain in full force and effect as set forth in this Agreement.


 


E.                                      Institution and Principal
Investigator agree that during the term of this Agreement and for a period of
six (6) months thereafter, they shall neither directly nor indirectly
solicit for employment, or otherwise retain employees of Medarex, whom
Institution and Principal Investigator have encountered as a result of
performance of the Study(ies) for Medarex.


 


F.                                      Institution shall neither
disclose to Medarex nor induce Medarex to use any secret or confidential
information or material belonging to third parties, including other sponsors of
other clinical trials.


 


G.                                    Medarex reserves the right to
limit enrollment in the Study by giving written notice, or by giving notice by
telephone followed by written notice, to Institution and Principal Investigator
to cease further enrollment in the Study beyond the number of patients set
forth in 


 


5

















 


such notice (the “Enrollment Cap”). Upon
receipt of such notice, Institution and Principal Investigator agree to enroll
no further patients in the Study. Unless otherwise specified in writing between
the parties, in the event of such a notice to cease further enrollment, the
total sums payable by Medarex pursuant to this Agreement shall be pro-rated for
the number of patients enrolled to the date of such notice, with any funds for
patients beyond the Enrollment Cap previously paid by Medarex to Institution
being refunded to Medarex.


 


7.                                      RECORDS AND
REPORTS


 


A.                                    Principal Investigator and
Institution shall have the following record keeping and reporting obligations:


 


(i)                                    preparation and maintenance of
complete, accurate written records, accounts, notes, reports and data relating
to the Study under this Agreement; and


 


(ii)                                preparation of and submission to
Medarex (in a periodic and timely manner during the term of this Agreement) all
raw data and other material as required in the Protocol in the form of
properly completed patient case report forms (“Case Report Forms”) or into an
electronic database (i.e., remote data entry) made available by Medarex for
each patient as provided in the Protocol. Case Report Forms and the electronic
database shall be the exclusive property of Medarex.


 


B.                                    Principal Investigator and
Institution agree to notify Medarex within twenty-four (24) hours after
learning of any serious and/or unexpected adverse drug reaction affecting any
patient in the Study. Principal Investigator and Institution further agree to
follow up such notification of adverse drug reaction with appropriate reports
to Medarex and, as appropriate, regulatory authorities in compliance with the
Protocol and Applicable Law.


 


C.                                    Principal Investigator and
Institution further agree to maintain records and data during and after the
term or early termination of this Agreement in compliance with Applicable Law.


 


D.                                    Principal Investigator and
Institution agree to notify Medarex within twenty-four (24) hours in the event
that the FDA or any other regulatory authority notifies the Study site of a
pending inspection/audit. In addition, Principal Investigator and Institution
shall forward to Medarex any written communication received as a result of the
inspection/audit within twenty-four (24) hours of receipt of such communication
and Institution agrees to allow Medarex to assist in responding to any such
communication that requires a response. Such responses by Institution shall be
made within two (2) weeks of issuance of any such communication or within
any earlier deadline set by the issuing regulatory authority or Applicable Law.
Principal Investigator and Institution shall also provide to Medarex copies of
any documents related to the Study provided to any inspector or auditor. If the
FDA or other regulatory authority requests or requires any action to be taken
to address any such communication, Principal Investigator and Institution
agree, after consultation with Medarex, to take such action as necessary to
address such communication, and agree to cooperate with Medarex with respect to
any such communication and/or action taken with respect thereto.


 


6

















 


8.                                      COST
AND PAYMENT


 


Medarex shall pay
Institution for the performance of the Study as provided in the budget for the
Study that is attached as Exhibit C (the “Budget”) and which is
incorporated into this Agreement by reference. The parties acknowledge that the
payment(s) set forth in the Budget are adequate consideration for the work
undertaken hereunder. Unless otherwise agreed in writing by a duly authorized
officer of Medarex, Medarex shall have no obligation to make any payments to
Institution or Principal Investigator in addition to those contained in the
Budget.


 


9.                                      CONFIDENTIAL
INFORMATION


 


A.                                    “Confidential Information” shall
mean any and all confidential or proprietary information obtained from Medarex,
or generated, created or learned by Institution or Principal Investigator as a
result of performing the Study under this Agreement, including without limitation
commercial, scientific, medical and technical information and data relating to
Medarex, the Study Drug or any Study, any information derived therefrom, the
Protocol, the investigator’s brochure, interim results and any other
information or material disclosed under secrecy agreements previously entered
into between the parties. During and for a period of five (5) years after
the term or early termination of this Agreement, Institution and Principal
Investigator shall retain in confidence all Confidential Information. Confidential
Information shall not include information:


 


(i)                                    which is or becomes public
knowledge through no fault of Institution or Principal Investigator; or


 


(ii)                                which is lawfully made available
to Institution or Principal Investigator by an independent third party owing no
obligation of confidentiality to Medarex with regard thereto (and such lawful
right can be properly demonstrated by Institution or Principal Investigator);
or


 


(iii)                            which is already in Institution’s
or Principal Investigator’s possession at the time of receipt from Medarex (and
such prior possession can be properly demonstrated by contemporaneous written
records belonging to Institution or Principal Investigator); or


 


(iv)                               which is independently developed
by Institution personnel without access to or reliance upon Confidential
Information provided by Medarex hereunder (and such independent development can
be properly demonstrated by contemporaneous written records belonging to
Institution or Principal Investigator).


 


B.                                    Subject to applicable federal,
state or local legal and regulatory requirements, Institution and Principal
Investigator agree to promptly return to Medarex, upon its request, all
Confidential Information obtained from Medarex pursuant to this Agreement; provided,
however, that Institution’s legal counsel may retain one copy of such
Confidential Information in a secure location for purposes of identifying
Institution’s obligations under these confidentiality provisions, and provided
further, that Principal Investigator may retain a copy of the Study
results for use in accordance with the terms of this Agreement.


 


C.                                    Institution and Principal
Investigator shall not use Confidential Information for any purpose other than
performance in accordance with this Agreement. Institution and Principal
Investigator shall limit disclosure of Confidential Information received
hereunder to only those of their representatives, agents, officers and
employees (collectively, “Agents”) who are directly 


 


7

















 


involved with the Study and only if such
Agents are subject to binding obligations of confidentiality at least as
protective as those agreed upon in this Agreement. Institution and Principal
Investigator shall protect the confidentiality of Confidential Information
using at least the same level of effort as it uses to protect their own
confidential or proprietary information, but in no event shall Institution and
Principal Investigator use less than commercially reasonable efforts.


 


D.                                    Institution and Principal
Investigator acknowledge and expressly agree that any disclosure of
Confidential Information in violation of this Agreement may be detrimental
to Medarex’s business and may cause it irreparable harm and damage. In
accordance with Applicable Law and in addition to any other rights and remedies
provided herein, Medarex shall be entitled to seek equitable relief by way of
injunction or otherwise.


 


10.                               PERMITTED
DISCLOSURES


 


Notwithstanding
anything to the contrary in this Agreement, Institution may disclose
Confidential Information to the extent, and to the persons and/or entities,
required by governmental law, rule, regulation or order; provided, however,
that if possible, Institution both (i) gives prompt notice to Medarex of
the disclosure requirement in order to allow to Medarex to obtain any available
limitation on or exemptions from such disclosure requirement, and (ii) reasonably
cooperates in such efforts by Medarex.


 


11.                               DATA,
PUBLICATIONS AND OTHER RIGHTS


 


In recognition of
the importance of disseminating information relating to any novel or important
observations or results arising from the Study and understanding that such need
must be balanced with Medarex’s obligations to maintain control over
Confidential Information as well as to comply with appropriate rules and
regulations of the FDA, the parties hereby agree to the following:


 


A.                                    All research data and results
generated during the course of the Study shall be the property of Medarex, and
Medarex shall have the right to use such data and results for any purpose in
accordance with applicable law; provided, however that Medarex agrees to
collect, use and disclose data from the Study with respect to any Study subject
only in accordance with the authorization contained in the informed consent(s) obtained
from such Study subject as part of the Study, unless otherwise required by
law. Institution shall be free to use the results of the Study for its own
internal, non-commercial research, educational, clinical and publication purposes
without the payment of royalties or other fees. Principal Investigator and
Institution further agree to execute any documents or under take any further
actions if requested by Medarex to assign and transfer title to such data.


 


B.                                    Subject to the terms and
conditions of this Agreement, Institution and. Principal Investigator have the
right to publish or publicly present the results of the Study. Principal
Investigator and Institution agree not to publish or publicly present any
interim results of the Study without the prior written consent of Medarex, as
provided below. Principal Investigator and Institution further agree to provide
thirty (30) days written notice to Medarex prior to submission for publication
or presentation to permit Medarex to review drafts of abstracts and 


 


8

















 


manuscripts for publication (including,
without limitation, slides and texts of oral or other public presentations and
texts of any transmission through any electronic media, e.g., any computer
access system such as the Internet, World Wide Web, etc., collectively or
individually a “Public Presentation”) which contain any results arising out of
the Study. Medarex shall have the right to review and comment, with respect to
a Public Presentation, including but not limited to, the data analysis and
presentation.


 


If the parties
disagree concerning the accuracy and appropriateness of the data analysis and
presentation, and/or presence of Medarex’s Confidential Information, Institution
agrees to meet with Medarex’s representatives at the Study site or as otherwise
agreed, prior to submission or performance of a Public Presentation, for the
purpose of making good faith efforts to discuss and resolve any such
disagreement.


 


C.                                    If the Study is part of a
multi-center study, Institution and Principal Investigator agree that an
initial Public Presentation of the Study results shall occur only as a
multi-center publication of the results obtained by all the sites participating
in that study, unless specific written permission is obtained in advance from
Medarex for separate Public Presentation of that site’s results. The Public
Presentation review procedures set forth in Article 11.B and E shall apply
to the Public Presentation of the Study results as part of such
multi-center publication.


 


D.                                    A Public Presentation shall not
contain any Confidential Information provided by Medarex other than Study
results and information necessary for the accurate presentation, interpretation
and validation of the Study results. At Medarex’s request, Medarex shall be
acknowledged as one of several or as the sole financial sponsor, as the case may be,
of the Study reported in the Public Presentation.


 


E.                                      If Medarex believes there is
patentable subject matter contained in any Public Presentation submitted for
review, Medarex shall promptly identify such subject matter to Institution, and
Institution shall delay any Public Presentation for up to an additional sixty
(60) days to allow Medarex to obtain patent protection or take other measures,
as Medarex deems necessary. At Medarex’s request and expense, Institution shall
use its best efforts to assist Medarex to file a patent application covering
such subject matter with the United States Patent and Trademark Office or
through the Patent Cooperation Treaty prior to any Public Presentation.


 


F.                                      Medarex grants Institution the
right, subject to the provisions of this Agreement, to use the results of the
Study, including but not limited to, the results of tests and any raw data and
statistical data generated therefrom, in accordance with the provisions of Article 11A
above.


 


12.                               CLINICAL
SUPPLIES


 


A.                                    Institution and Principal
Investigator shall use the Study Drug and clinical supplies solely for the
purpose of conducting the Study according to the Protocol and not for purposes
that are contrary to the provisions of the Protocol or outside the scope of the
Protocol. Medarex shall make available to Institution and Principal
Investigator sufficient quantities of Study Drug to carry out the Study.


 


B.                                    Institution and Principal
Investigator shall take responsibility for and reasonable steps to maintain
appropriate records and assure appropriate supply, handling, storage,


 


9

















 


distribution and usage of these materials in
accordance with the Protocol and Applicable Law.


 


C.                                    All unused Study Drug will be
returned to Medarex at Medarex’s expense by Institution at the conclusion of
the Study, or upon earlier termination of this Agreement, unless Medarex gives
Institution or Principal Investigator written authorization to destroy or
retain Study Drug. If Medarex authorizes Institution or Principal Investigator
to destroy unused Study Drug, then Institution or Principal Investigator shall
provide Medarex with certification of the Study Drug’s destruction according to
Applicable Law.


 


13.                               INDEMNIFICATION
AND INSURANCE


 


A.                                    Medarex shall indemnify, defend
and hold harmless Institution, its trustees, officers, agents, employees and
Principal Investigator, (and any named co-investigator) (collectively, “Institution
Indemnitees”) from and against any and all losses, settlements, damages,
judgments, expenses and costs (including reasonable attorneys’ fees and court
costs) (“Losses”) resulting from any third-party claim, action or suit (“Third-Party
Claim”) arising from an Institution Indemnitee’s performance of the Study in
strict accordance with this Agreement.


 


B.                                    Notwithstanding the foregoing,
Medarex shall have no indemnification obligation or liability, and Institution
shall indemnify, defend and hold harmless Medarex, its parent corporation,
subsidiaries, affiliates, officers, directors, agents, and employees for Losses
resulting from any Third-Party Claim that arose from:


 


(i)                                    failure of an Institution
Indemnitee to adhere to the terms and provisions of the Protocol or agreed
amendments thereto or Medarex’s written recommendations and instructions
relative to the administration and use of any drug substances involved in the
Study, including, but not limited to, the Study Drug, any comparative drug and
any placebo;


 


(ii)                                failure of an Institution
Indemnitee to comply with any Applicable Law relevant to the performance of an
Institution Indemnitee’s obligations under this Agreement;


 


(iii)                            failure of an Institution
Indemnitee to render services in a professional manner or to conduct the Study
in a normal, prudent manner; or


 


(iv)                               negligence, recklessness or
willful misconduct or omission by an Institution Indemnitee related to the
performance of services under this Agreement.


 


C.                                    A condition of Medarex’s
indemnity obligation is that, whenever Principal Investigator and/or
Institution has information from which it may reasonably conclude a
Third-Party Claim has occurred, Institution shall immediately give notice to
Medarex of all pertinent data surrounding such Third-Party Claim. In addition,
Principal Investigator and Institution shall comply with all of their
obligations with regard to adverse event reporting procedures as set forth in
this Agreement and the Protocol and any appendix or attachment thereto. In the
event a Third-Party Claim is made or suit is brought, Institution and Principal
Investigator shall assist Medarex and cooperate in the gathering of information
with respect to the time, place, and circumstances and in obtaining the names
and addresses of the injured parties and available witnesses. Principal
Investigator and Institution agree to cooperate with and to authorize Medarex
to carry out sole management and defense of such claim or action. Neither
Principal Investigator nor 


 


10

















 


Institution, its trustees, officers, a gents
or employees shall compromise or settle any claim or action without the prior
written approval of Medarex.


 


D.                                    Medarex will reimburse
Institution and/or the Study subject for the reasonable costs and expenses
incurred in diagnosing and treating unanticipated adverse effects, injuries,
illnesses, or reactions that result from the use or application of Medarex`s
investigational drug or device in the course of this Study.


 


E.                                      Institution shall secure and
maintain in full force and effect through the performance of the Study (and
following termination or early termination of the Study to cover any claims
arising from the Study) insurance coverage for:


 


(i)                                    medical professional and/or
medical malpractice liability (including coverage of Principal Investigator);


 


(ii)                                general liability (including
coverage for the Study site); and


 


(iii)                            worker’s compensation, each such
insurance coverage in amounts required by Applicable Law and appropriate to the
conduct of Institution’s business activities and the services contemplated by
the Study.


 


Upon request of
Medarex, copies of certificates evidencing such insurance coverage will be made
available to Medarex, and Institution shall provide thirty (30) days’ prior
written notice to Medarex in the event of cancellation or any material change
in such insurance.


 


F.                                      Medarex represents that it
carries insurance coverage to protect against liability under this provision in
amounts equal to at least three million dollars ($3,000,000) per occurrence
combined single limit and ten million dollars ($10,000,000) annual aggregate,
and Medarex agrees to furnish to Institution a certificate of insurance acceptable
to Institution indicating the required coverage.


 


14.                               INVENTIONS
AND PATENTS


 


A.                                    Neither anything contained in
this Agreement nor the delivery of any Confidential Information to or by
Institution or Principal Investigator shall be deemed to grant Institution or
Principal Investigator any right or licenses under any ideas, know-how, trade
secrets, technologies, discoveries, inventions, improvements, modifications or
works of authorship, whether patentable, copyrightable or not, and all patent,
copyright, trade secret or other intellectual property rights arising therefrom
in any country of the world (“Inventions”) of Medarex (“Medarex Inventions”).


 


B.                                    Inventorship or authorship of
Inventions that are made, conceived, reduced to practice, authored or otherwise
developed or generated either solely by personnel of one Party or jointly by
personnel of both Parties, in whole or in part, in the course of activities in
connection with this Agreement (“Study Inventions”) shall be determined in
accordance with United States patent or copyright laws, respectively, or by
mutual agreement if the Study Invention is not patentable. Institution and
Principal Investigator will disclose to Medarex in writing any and all Study
Inventions within forty-five (45) working days of the earliest of such Study
Invention’s 


 


11

















 


conception, reduction to practice, invention,
fixation in a tangible medium of expression or development. All such Study
Inventions and any information with respect thereto, shall be deemed to be
confidential, and shall be held in confidence by both parties subject to the
provisions in Article 9.


 


C.                                    Medarex shall exclusively own
all right, title and interest in and to all Medarex Inventions and all intellectual
property rights appurtenant thereto. Title to Study Inventions shall reside
with Medarex if Medarex personnel are the sole inventors, with Institution if
Institution personnel are the sole inventors, and will be held jointly if both
Institution and Medarex personnel are inventors. To the extent that Institution
owns the rights of sole or joint inventorship of a Study Invention, Medarex is
hereby granted, without option fee other than the consideration of the research
sponsored herein and the reimbursement of Institution for a 11 patent expenses
incurred prior to and during the option period related to the Study Invention,
an option to acquire an exclusive, worldwide, fee and royalty-bearing license
of Institution’s rights to any Study Invention, which option shall extend for
ninety (90) days after Medarex’s receipt of a Study Invention disclosure. If
Medarex notifies Institution in writing of its exercise of the option within
the option period, then the parties will proceed in good faith to negotiate a license
agreement within sixty (60) days after notification of exercise; and if Medarex
does not exercise this option, or notifies Institution that it will not
exercise this option, or the parties fail to sign a license agreement within
said sixty (60) day negotiation period, then Medarex shall no longer own any
rights in the subject Study Invention.


 


15.                               NOTICE


 


Whenever any
notice is to be given hereunder, it shall be in writing and mailed postage
prepaid by certified or registered mail, return receipt requested, or
personally delivered to the appropriate party at the address indicated below,
or at such other place or places as either party may designate in a
written notice to the other:


 


	
  To
  Institution:

  	
  Office of
  Grants and Contracts

  
	
   

  	
  Duke
  University Medical Center. Box 3001

  
	
   

  	
  107 Seeley
  G. Mudd Building

  
	
   

  	
  Durham, NC
  27710

  
	
   

  	
  Attn.: Holly
  Snair, Interim Director

  
	
   

  	
   

  
	
  With a copy
  to:

  	
  Duke
  University

  
	
   

  	
  Office of
  University Counsel

  
	
   

  	
  2400 Pratt
  Street, Suite 4000

  
	
   

  	
  Durham, NC
  27705

  
	
   

  	
   

  
	
  To Medarex:

  	
  Medarex, Inc.

  
	
   

  	
  519 Route
  173 W

  
	
   

  	
  Bloomsbury,
  NJ 08801

  
	
   

  	
  Attn.:
  Richard Romasz

  
	
   

  	
   

  
	
  With a copy
  to:

  	
  Medarex, Inc.

  
	
   

  	
  707 State
  Road

  



 


12

















 


	
   

  	
  Suite 206

  
	
   

  	
  Princeton,
  NJ 08540

  
	
   

  	
  Attn.:
  General Counsel

  



 


Notice shall be
deemed to have been received at the earlier of receipt or five (5) days
from the date of mailing (in the case of a letter).


 


16.                               ASSIGNMENT


 


This Agreement is
not assignable or delegable by Institution and any attempted assignment or
delegation in violation hereof shall be null and void. Medarex may assign
this Agreement, without the prior consent of Institution, to an affiliated
company or to a successor of substantially all of Medarex’s business interests
by a merger, acquisition or transfer of assets. Notwithstanding such
assignment, Medarex shall remain liable for all of its obligations under this
Agreement.


 


17.                               APPLICABLE
LAW


 


This Agreement
shall be governed by the laws of the State of North Carolina as applied to
agreements executed and performed entirely within the State of North Carolina
by North Carolina residents. If either party engages attorneys to enforce any
rights arising out of or relating to this Agreement, the prevailing party shall
be entitled to recover its fees expended in engaging such attorneys.


 


18.                               PUBLICITY


 


Neither party
shall use the name of the other party nor the name of any division or
affiliated companies of Medarex for promotional purposes without the prior
written consent of the party whose name is proposed to be used. Subject to the
publication rights of Institution, no news release, publicity or other public
announcement, either written or oral, regarding this Agreement or performance
hereunder or results arising from the Study, shall be made by Institution
without the prior written approval of Medarex.


 


19.                               INDEPENDENT
CONTRACTOR


 


Institution and
Principal Investigator are acting in the capacity of independent contractors
hereunder and not as employees, agents or joint venturers of or with Medarex. Neither
Institution nor Principal Investigator shall have any authority to represent,
bind or act on behalf of Medarex.


 


20.                               AGREEMENT
MODIFICATIONS


 


Neither this
Agreement nor the Protocol may be altered, amended or modified except by
written document signed by duly authorized representatives of both parties.


 


21.                               SEVERABILITY


 


If any term or
condition of this Agreement, the deletion of which would not adversely 


 


13

















 


affect the receipt
of any material benefit by either party hereunder, shall be held illegal,
invalid or unenforceable, the remaining terms and conditions of this Agreement
shall not be affected thereby and such terms and conditions shall be valid and
enforceable to the fullest extent permitted by law.


 


22.                               NO WAIVER


 


Failure on the part of
Medarex to exercise or enforce any right conferred upon it hereunder shall not
be deemed to be a waiver of any such right nor operate to bar the exercise or
enforcement thereof at any time or times thereafter.


 


23.                               FORCE
MAJEURE


 


Noncompliance by
either party with the obligations of this Agreement due to force majeure, (laws
or regulations of any government, war, civil commotion, destruction of
production facilities and materials, fire, flood, earthquake or storm, labor
disturbances, shortage of materials, failure of public utilities or common
carriers), or any other causes beyond the reasonable control of the applicable
party, shall not constitute breach of this Agreement and such party shall be
excused from performance hereunder to the extent and for the duration of such
prevention, provided it first notifies the other party in writing of such
prevention and that it uses its best efforts to cause the event of the force
majeure to terminate, be cured or otherwise ended.


 


24.                               ENTIRE
UNDERSTANDING


 


This Agreement,
including any exhibits and schedules hereto, constitutes the entire agreement
between the parties with respect to the subject matter hereof. This Agreement
supersedes and cancels all previous agreements among the parties, written and
oral in respect of the subject matter hereof. In the event of any inconsistency
between this Agreement and the attached Protocol, the terms of this Agreement
shall govern except with regard to adverse event reporting procedures which
shall be governed by the Protocol and any appendix or attachment thereto.


 


IN
WITNESS WHEREOF, the parties have caused this Agreement to be
executed, by duly authorized representatives, as of the last date written
below.


 


	
  DUKE UNIVERSITY

  	
  MEDAREX, INC.

  
	
   

  	
   

  
	
  BY

  	
  /s/ R.
  Sanders Williams, M.D.

  	
   

  	
  BY

  	
  /s/ Geoff
  Nichol

  	
   

  
	
   

  	
   

  
	
  NAME 

  	
  R. Sanders
  Williams, M.D.

  	
   

  	
  NAME 

  	
  Geoff Nichol

  	
   

  
	
   

  	
   

  
	
  TITLE 

  	
  Dean of
  School of Medicine

  	
   

  	
  TITLE

  	
  Senior VP of
  Product Development

  	
   

  
	
   

  	
   

  
	
  DATE

  	
  3/29/04

  	
   

  	
  DATE 

  	
  4/5/04

  	
   

  
	
   

  	
   

  
	
  AGREED AND
  ACCEPTED:

  	
   

  
	
   

  	
   

  
	
  /s/ Michael
  Morse

  	
   

  	
   

  
											



 


14

















 


	
  Michael Morse, MD

  	
   

  
	
  Principal
  Investigator

  	
   

  
	
  DATE

  	
     3/11/04

  	
   

  	
   

  
				



 


15

















 


EXHIBIT A


 


PROTOCOL


 


16














 


EXHIBIT B


 


DISCLOSURE OF FINANCIAL INTERESTS AND ARRANGEMENTS

OF INVESTIGATOR OR OTHER RESEARCHER


 


As a condition of
participating as a clinical investigator (“Investigator”) in the protocol
entitled, “                                                                                ”
(the “Study”) which is sponsored by Medarex, Inc., a New Jersey
corporation (“Sponsor”), please provide the appropriate information and
responses to the following statements.


 


	
  Investigator’s
  Name:

  	
   

  	
   

  
	
   

  
	
  Title:

  	
   

  	
   

  
	
   

  
	
  Organization/Institution:

  	
   

  	
  Date:

  	
   

  	
   

  
								



 


Please mark the
applicable checkboxes.


 


	
  ·

  	
   

  	
  I have financial
  arrangement(s) with Sponsor in which the value of the compensation for
  conducting the Study could be influenced by the outcome of the Study.

  
	
   

  	
   

  	
   

  
	
  ·

  	
   

  	
  I have received
  or will receive from Sponsor, since February 2, 1999 and during the time
  of the Study and for one year after its completion, payment(s) of other
  sorts (e.g., grants to fund other ongoing research, compensation in the form
  of equipment not for the Study, retainer for ongoing consultation, or
  honoraria) that have a monetary value of more than $25,000. Such payments)
  exclude the costs of conducting the Study or other clinical studies.

  
	
   

  	
   

  	
   

  
	
  ·

  	
   

  	
  I have any
  proprietary interest(s) in the product tested in the Study.

  
	
   

  	
   

  	
   

  
	
  ·

  	
   

  	
  During the time
  of the Study and for one year after its completion, I will hold significant
  equity interest in Sponsor. “Significant equity interest” means any
  (l) ownership interest, stock options or other financial interest whose
  value cannot be readily determined through reference to public prices; or
  (2) equity interest in a publicly traded corporation that exceeds
  $50,000.

  



 


For those
statements I have checked, details of the individuals financial arrangements
and interests are attached, along with a description of steps taken to minimize
the potential bias of Study results by any of the disclosed arrangements or
interests.


 


Sponsor agrees to
treat as confidential all financial arrangements and interests attached to this
Exhibit and to use such disclosure to meet the requirements placed on
Sponsor under 21 C.F.R. Part 54. 
Investigator acknowledges and agrees that Sponsor may use such
disclosure for this purpose.  During the
time of the Study and for one year after its completion, Investigator shall notify
Sponsor in writing of any change to the information provided in this Exhibit.


 


	
  Investigator’s
  signature:

  	
   

  	
  Date:

  	
   

  	
   

  



 


17

















 


EXHIBIT C


 


BUDGET


 


18

















 


DUKE
UNIVERSITY BUDGET DEVELOPMENT WORKSHEET


	
  Sponsor:

  	
  Medarex, Inc.

  
	
  Study:

  	
  MDX-1307

  
	
  PI:

  	
  Michael
  Morse. M.D.

  



 


Budget
for One (1) Patient


 


	
  Screening

  	
   

  	
  No. of Units

  (if applicable)

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total Price

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [ **** ]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


19

















 


DUKE
UNIVERSITY PAYMENT SCHEDULE


	
  Sponsor:

  	
  Medarex

  
	
  Study:

  	
  MDX1307-01

  
	
  PI:

  	
  Michael
  Morse, M.D.

  



 


PAYMENT SCHEDULE


 


EXHIBIT A


 


Payments
shall be made to Duke University (Institution) by the Medarex (Sponsor) according
to the following schedule:


 


[
**** ]


 


20

















 


CONTRACT COVER SHEET


 


Date:  4/04


 


Contract
Title:  Duke University


 


Primary
Medarex Business or Scientific Contact:


 


(Printed)
Name:     CRA: Andrea Kelly


 


       Contact:  Carol Craig


 


Department:    Clinical Operations


 


Responsible
Medarex Attorney:


 


(Printed)
Name:     Brian Stalter


 


Notes:  Clinical Trial Research Agreement


 


21

















 


FIRST ADDENDUM

TO

CLINICAL TRIAL RESEARCH AGREEMENT


 


This First Addendum to Clinical
Trial Research Agreement (the “Addendum”) is entered into as of the last date
on the signature page hereof (the “Effective Date”), by and between DUKE UNIVERSITY, a non-profit educational and healthcare
institution located at Office of Research Administration, 2424 Erwin Road, Suite 1103,
Durham, NC 27705, hereinafter called the “Institution” and CELLDEX
THERAPEUTICS, INC., a Delaware corporation with its principal place
of business located at 222 Cameron Drive, Suite 400, Phillipsburg, NJ
08865, hereinafter called “Celldex.”


 


WHEREAS,
the Institution had previously entered into that certain Clinical Trial
Research Agreement (the “Agreement”) dated as of April 5, 2004 with
Medarex, Inc. (“Medarex”); and


 


WHEREAS,
on April 6, 2004 Medarex and Celldex entered into that certain Assignment
and License Agreement (the “Assignment”), pursuant to which Medarex assigned
the Agreement to Celldex in accordance with the terms of Section 16 of the
Agreement; and


 


WHEREAS,
as of the date of the Assignment, Celldex was a wholly-owned subsidiary and an
affiliate of Medarex; and


 


WHEREAS,
as of the Effective Date of this Addendum, Celldex is a majority-owned
subsidiary and an affiliate of Medarex; and


 


WHEREAS,
the Institution and Celldex desire to make certain modifications to the terms
of the Agreement;


 


NOW,
THEREFORE, based upon the promises and mutual
covenants set forth herein, the parties agree as follows:


 


1.             NAME REFERENCES.  The parties agree that all references in the
Agreement to Medarex, Inc. shall be amended to read Celldex Therapeutics, Inc.
and all references to Medarex shall be amended to read Celldex.  In addition, except as set forth in the
immediately succeeding sentence, all references in the Agreement to [ **** ]
shall be amended to read [ **** ]. 
Similarly, all references in the Study title to [ **** ] shall be
amended to read [ **** ].


 


2.             TERM OF AGREEMENT.  The first sentence of Section 5B shall
be amended to read as follows:


 


“It is anticipated that the
Study shall begin in March 2004 and shall be completed on or before June 30,
2009.”


 


22

















 


3.             INDEMNIFICATION AND INSURANCE.  Section 13D shall be amended to read in
its entirety as follows:


 


“D.     Celldex agrees to pay any
reasonable medical expenses for treatment of research related injuries which
are a direct result of the investigational drug or device properly administered
in accordance with the Study Protocol to the extent the expenses for such
treatment are not covered by the injured Study subject’s commercial medical
insurance.  However, it is understood and
agreed that neither Institution nor Study subject will be required to seek
reimbursement from Medicare, Medicaid or Tricare.”


 


4.             BUDGET.   Patients enrolled in the fourth cohort of
Protocol [ **** ], as provided for in the 6th Amendment to the Clinical Study
Protocol, will be reimbursed according to Exhibit A (the “Budget”), dated September 25th,
2006, attached hereto, the terms of which Exhibit A are incorporated in
full into this Addendum by reference.


 


5.             NOTICE.  Section 15 shall be amended to read the
Institution’s address and the address for the copy as follows:


 


	
  “To Institution:

  	
   

  	
  Office of Research Administration

  
	
   

  	
   

  	
  2424 Erwin Road, Suite 1103

  
	
   

  	
   

  	
  Durham, NC 27705

  
	
  With a copy to:

  	
   

  	
  Michael Morse, M.D.

  
	
   

  	
   

  	
  Box 3233 Med Ctr

  
	
   

  	
   

  	
  Durham, NC 27710”

  



 


5.             COST AND PAYMENT.  Section 8 shall be amended to read the
Institution’s new mailing address for payments as follows:


 


	
  Payee:

  	
   

  	
  Duke University

  
	
  Mailing address:

  	
   

  	
  Clinical Research Office Support

  
	
   

  	
   

  	
  2424 Erwin Road, Suite 504

  
	
   

  	
   

  	
  Durham, NC 27705

  
	
   

  	
   

  	
  ATTN: Post-Award Division

  



 


IN WITNESS
WHEREOF, the parties have caused this Addendum to be
executed, by duly authorized representatives, as of the last date written
below.


 


	
  DUKE UNIVERSITY

  	
   

  	
  CELLDEX THERAPEUTICS, INC.

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
      /s/ R. Sanders
  Williams

  	
   

  	
  By:

  	
      /s/ Thomas Davis

  	
   

  	
   

  
	
  Name:

  	
  R. Sanders Williams, M.D.

  	
  Name: 

  	
  Thomas Davis, MD

  
	
  Title:

  	
  Dean, Schoo1 of Medicine

  	
  Title:

  	
  CMO

  
	
  Date:

  	
  11/14/06

  	
  Date:

  	
  11/20/06

  
									



 


23

















 


EXHIBIT A


 


Budget for One (1) Patient (Cohort 4; Patients treated at 2.5 mg [
**** ] with GM-CSF)


 


	
  Screening

  	
   

  	
  No. of Units

  (if applicable)

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total Price

  	
   

  
	
  Study
  Coordinator

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protocol
  Review/Initiation visit with sponsor

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Obtain
  informed consent

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Inclusion/Exclusion
  Criteria-review patient chart

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Collect demographic
  data

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Patient
  setup (study calendar, supplies, scheduling visits, blood work, patient
  assistance)

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  ECOG
  Performance Status

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Tumor
  Archived

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Medical
  History

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Chest X-ray
  and EKG

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Vital signs,
  body weight and height

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Record
  Concomintant Medication

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  AE/Toxicity
  Assessment

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Pull scans,
  film, retrieve tissue, blood sample

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Schedule lab
  tests, cardiology and radiology procedures

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Kit
  preparation, form completion and shipping

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Query case
  report forms (per visit)

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Record in
  case report forms (per visit)

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Phlebotomist:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sample
  collection

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Principal
  Investigator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protocol
  Review

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  PI Fee

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Data
  Manager:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Case Report
  Review/Training

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Case Report
  Form database setup-patient entry

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Clinical
  Procedures and Tests:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CT Scans
  (Abd., chest, pelvis)

  	
   

  	
  soc

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Total
  Screening Fee:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  



 


24

















 


	
  Treatment (Visit 2, 7 and 8)

  	
   

  	
  No. of Units

  (if applicable)

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total Price

  	
   

  
	
  Study
  Coordinator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Vital Signs

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  ECOG
  Performance Status

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Record
  Concomintant Medication

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  CDX 1307
  Vaccination

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  AE/Toxicity
  Assessment

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Kit
  preparation, form completion and shipping

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  GM-CSF

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  500 mcg vial

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Dispensing
  Fee

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Phlebotomist:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sample
  Collection

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Principal
  Investigator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PI Fee

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  NA

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Data
  Manager:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Case Report
  Form Entry

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Clinical
  Procedures and Tests:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Leukapheresis

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Other
  Facility Fee Charges (Room Use at Duke Clinic)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NA

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Pharmacy:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Dispense

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Total
  Visit 2, 7 and 8 Fees:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  



 


	
  Treatment (Visit 3, 4 and 6)

  	
   

  	
  No. of Units

  (if applicable)

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total Price

  	
   

  
	
  Study
  Coordinator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Vital Signs

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Record
  Concomintant Medication

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  AE/Toxicity
  Assessment

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Kit
  Preparation, form completion and shipping

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Phlebotomist:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sample
  Collection

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Principal
  Investigator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PI Fee

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Data
  Manager:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Case Report
  Form Entry

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Clinical
  Procedures and Tests:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Physical
  Exam (visit 3 & 4)

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Leukapheresis

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Other
  Facility Fee Charges (Room Use at Duke Clinic)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NA

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Pharmacy:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Dispense

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Total
  Visit 3, 4 and 6 Fees:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  



 


25

















 


	
  Treatment (Visit 5)

  	
   

  	
  No. of Units

  (if applicable)

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total Price

  	
   

  
	
  Study
  Coordinator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Vital Signs

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Record
  Concomintant Medication

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  CDX-1307
  Vaccination

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  AE/Toxicity
  Assessment

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Kit
  Preparation, form completion and shipping

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  GM-CSF

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  500 mcg vial

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Dispensing
  Fee

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Phlebotomist:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sample
  Collection

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Principal
  Investigator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PI Fee

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Data
  Manager:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Case Report
  Form Entry

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Clinical
  Procedures and Tests:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NA

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Other
  Facility Fee Charges (Room Use at Duke Clinic)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Nurse
  Room (nurse visit only)

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Pharmacy:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Dispense

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Total
  Visit 5 Fee:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  



 


	
  Treatment (Treatment Visit 9)

  	
   

  	
  No. of
  Units

  (if applicable)

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total
  Price

  	
   

  
	
  Study
  Coordinator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Vital Signs

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Record
  Concomintant Medication

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  AE/Toxicity
  Assessment

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Kit
  preparation, form completion and shipping

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Principal
  Investigator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PI Fee

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Phlebotomist:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sample
  Collection

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Data
  Manager:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Case Report
  Form Entry

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Clinical
  Procedures and Tests:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Leukapheresis

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Pharmacy:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Dispense

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Total
  Visit 9 Fee:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  



 


26

















 


	
  Treatment (Visit 10, 11 and 12)

  	
   

  	
  No. of
  Units

  (if applicable)

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total
  Price

  	
   

  
	
  Study
  Coordinator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Vital Signs

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  ECOG
  Performance Status

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Chest X-ray
  and EKG

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Record
  Concomintant Medication

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  AE/Toxicity
  Assessment

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Kit
  preparation, form completion and shipping

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Phlebotomist:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sample
  Collection

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Principal
  Investigator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PI Fee

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  NA

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Data
  Manager:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Case Report
  Form Entry

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Clinical
  Procedures and Tests:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NA

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Other
  Facility Fee Charges (Room Use at Duke Clinic)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NA

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Pharmacy:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NA

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Total
  Visit 10, 11 and 12 Fees:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  



 


27

















 


	
  Treatment (Treatment Visit 9)

  	
   

  	
  No. of
  Units

  (if applicable)

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total
  Price

  	
   

  
	
  Study
  Coordinator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Vital Signs

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  ECOG
  Performance Status

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Record
  Concomintant Medication

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  AE/Toxicity
  Assessment

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Kit
  preparation, form completion and shipping

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Phlebotomist:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sample
  Collection

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Principal
  Investigator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PI Fee

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  NA

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Data
  Manager:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Case Report
  Form Entry

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Total
  Fee For Each Follow-up Visit Per Patient

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  



 


	
  OTHER COSTS-For items to be
  invoiced

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total
  Price

  	
   

  
	
  CT chest
  w/wo enhancement ([ **** ]); CT abdomen w/wo enhancement ([ **** ]); CT
  pelvis w/wo enhancement ([ **** ]) [ **** ]per scan

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  IRB Protocol
  Amendment review (each new amendment reviewed by full board)

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  IRB Protocol
  Renewal (yearly)

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Hotel Stays
  (per night) if requested for patients living beyond 35 miles from Duke

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Meals-if
  requested for patients living beyond 35 miles from Duke-per day

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Parking-per
  day (only for patients staying overnight to receive treatment living 35 miles
  beyond Duke)(per day)

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Tumor hCG-B
  Immunohistochemistry

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Screen
  Failure Visits (1 enrolled for every 3 screened) (Note, Sponsor will be
  billed for every required test by protocol completed for screening
  separately; [ **** ]will be used to offset nursing time.)

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  



 


Note: For Items and services that are
provided solely to satisfy data collection and analysis needs and are not used
in the direct clinical management of the patient.


 


28

















 


Payment Schedule


Exhibit A


 


Payments shall be made to Duke University (Institution)
by Celldex (Sponsor) according to the following schedule:


 


I.  Payment Schedule:  Sponsor agrees to make payment to institution
on a quarterly basis.  Payments will be
based on the number of patients enrolled, each visit completed, and CRF’s and
study materials receiving during the quarter.


 


The Institution will be paid according to the following milestones
visits below to institution:


 


	
  Screening/BL

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 2

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 3

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 4

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 5

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 6

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 7

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 8

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 9

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 10

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 11

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 12

  	
   

  	
  [ **** ]

  	
   

  
	
  Total

  	
   

  	
  [ **** ]

  	
   

  



 


Follow-up (see note below)


Each patient follow-up visit (every 3 months or until progression of
disease up to 3 years at $637.50 per patient/per visit to be invoiced
separately.)


 


	
  II. OTHER COSTS-For items to be invoiced

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total Price

  	
   

  
	
  CT chest
  w/wo enhancement [ **** ]); CT abdomen w/wo enhancement ([ **** ]); CT pelvis
  w/wo enhancement [ **** ])

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  IRB Protocol
  Amendment review (each new amendment reviewed by full board)

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  IRB Protocol
  Renewal (yearly)

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Hotel Stays
  (per night) if requested for patients living beyond 35 miles from Duke

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Meals-if
  requested for patients living beyond 35 miles from Duke-per day

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Parking-per
  day (only for patients staying overnight to receive treatment living 35 miles
  beyond Duke)(per day)

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Tumor hCG-B
  Immunohistochemistry

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Screen
  Failure Visits (1 enrolled for every 3 screened) (Note, Sponsor will be
  billed for every required test by protocol completed for screening
  separately; [ **** ] will be used to offset nursing time.)

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  



 


Note: For Items and services that are
provided solely to satisfy data collection and analysis needs and are not used
in the direct clinical management of the patient.


 


III.  Materials


Sponsor agrees to supply any materials associated with the performance
on this study.  Materials include but are
not limited to:


Test tubes and storage devices for specimens to be shipped


Packing materials for shipment of research specimens


Mail Express Account Numbers for lab shipments


 


29