Exhibit 10.13
CLINICAL RESEARCH AGREEMENT
BETWEEN
GEORGETOWN UNIVERSITY AND
MARCO HI-TECH JV, LTD.
PREAMBLE
This Agreement is between Georgetown University (UNIVERSITY), an
educational institution located at 00xx & 0 Xxxxxxx, XX, Xxxxxxxxxx, XX and
Marco Hi-Tech JV, Ltd. (SPONSOR) a for-profit corporation organized under the
laws of New York with its principal place of business at Xxx Xxxx Xxxxx, Xxx
Xxxx, XX 00000.
The research program contemplated by this Agreement is established
pursuant to the Memorandum of Agreement of March 1 2002 signed by the parties
and partially funded under NIH grant in the amount of $ 1,300,000 RO1-AG19268 is
of mutual interest and benefit to the UNIVERSITY and to the SPONSOR and will
further the UNIVERSITY'S instructional and research objectives in a manner
consistent with its status as an educational institution.
In consideration of the promises and mutual covenants contained in this
Agreement, and in order to be legally bound, the UNIVERSITY and the SPONSOR
agree to the terms and conditions set forth below.
1. STATEMENT OF WORK, TERM AND AMOUNT OF CONTRACT
1.1. Statement of Work
The University shall carry out this Phase II research (Research) set forth
in the Protocol entitled Phase II Study of Huperzine A in Alzheimer's
Disease which is appended to this Agreement as ATTACHMENT A (Protocol).
The research shall be performed in accordance with the Protocol and in
accordance with the terms and conditions of this Agreement. As of the date
of execution of this Agreement, the Protocol consists of 27 pages and is
dated October, 2003. University shall have the right to hire the
University of California at San Diego who shall be bound by the terms and
conditions of this agreement, as a subcontractor.
1.2. Principal Investigator
The UNIVERSITY'S Principal Investigator for the Research is Xxxx Xxxxx,
M.D.(Principal Investigator), who will be responsible for the direction of
the Research in accordance with the applicable policies of the UNIVERSITY,
which the UNIVERSITY represents and warrants are not inconsistent with the
(1) terms of this Agreement; (2) the Protocol; (3) generally accepted
standards of good clinical practice, (4) all applicable local, state, and
federal laws and regulations governing the performance of clinical
investigations. If for any reason Xx. Xxxxx is unwilling or unable to
serve as Principal Investigator, Xx. Xxxxx and University, in consultation
with The Alzheimer's Disease Cooperative Study will use their best efforts
to assist SPONSOR in finding a replacement. If a successor acceptable to
both the UNIVERSITY and the SPONSOR is not available, this Agreement shall
be terminated in accordance with Article 9.
1.3. Contract Amount
The amount of this contract is $1,846,667 and is payable in installments
according to the schedule contained in Attachment B and ATTACHMENT C (SEE
PARAGRAPH 1.4 BELOW)
1.4. Period of Performance
The effective period of this Agreement shall be from December 19, 2003
through March 31, 2006 unless otherwise terminated in accordance with
Article 9. A schedule entitled "Huperzine II Protocol Timeline" shall be
appended to this Agreement as Attachment C (Timeline). The University
recognizes that the meeting of these timelines is critical to the
commercial success of SPONSOR'S program to develop Huperzine A as an FDA
approved Drug and that SPONSOR may suffer financial damages should such
milestones not be met. The effective period may be altered by mutual
agreement of the parties in accordance with Article 11.1
1.5. Notices
UNIVERSITY ADMINISTRATIVE CONTACT:
Name: Xxxxxxx X. Xxxxxxx
Associate Vice President,
Research & Technology Development Services
000 Xxxxxxxx X, Xxx 000000
Xxxxxxxxxx, XX 00000-0000
Telephone: (000) 000-0000
Fax: (000) 000-0000
Email:xxxxxxxx@xxxxxxxxxx.xxx
SPONSOR ADMINISTRATIVE CONTACT:
Name: Xxxxxx Xxxxxxx
Title: President
Address: Xxx Xxxx Xxxxx
Xxx Xxxx, XX 00000
Telephone.- 000 0 00 0000
Fax: 000 000 0000
1.6. Anything contained in the PROTOCOL which is in conflict with anything in
this Agreement will be reconciled by mutual agreement of both parties.
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2. CONFIDENTIALITY AND PROPRIETARY DATA
2.1. SPONSOR may provide UNIVERSITY and INVESTIGATORS with proprietary
information (INFORMATION) relevant to the work under this Agreement.
UNIVERSITY'S and INVESTIGATORS' acceptance and use of INFORMATION shall be
subject to the following:
(a) SPONSOR must xxxx or designate in writing any such INFORMATION as
proprietary or confidential.
(b) Where UNIVERSITY and INVESTIGATORS accept such INFORMATION, they shall
not publish or otherwise reveal the INFORMATION to any third party
without the written permission of the SPONSOR, unless the INFORMATION
has already been published or disclosed publicly by third parties or is
required to be disclosed by order of a court of law, or the INFORMATION
is already known to UNIVERSITY or INVESTIGATORS prior to its receipt
from SPONSOR, or is developed independently by UNIVERSITY as evidenced
by its written records. UNIVERSITY and INVESTIGATORS shall not use
such Information for any purpose except as contemplated under this
Agreement.
(c) INFORMATION may be revealed to employees of UNIVERSITY but only on a need
to know basis. All persons receiving such INFORMATION must assume the same
confidentiality and non-use obligation as are set forth in this Agreement.
2.2. All commercial data and commercial and regulatory information developed
under this Agreement shall remain the property of SPONSOR. The UNIVERSITY shall
be entitled to retain copies of this information and it shall not be disclosed
to third parties. Data disclosed under the provisions of Article 4 shall be
available for disclosure to third parties.
2.3. All data obtained on study patients will be furnished to SPONSOR in a coded
format that protects patient identities. SPONSOR will not have access to patient
names or other material that allows the identification of patient. SPONSOR'S
ability to review a patient's medical record shall be subject to reasonable
safeguards for the protection of patient confidentiality.
2.4. UNIVERSITY retains a non-exclusive royalty-free right without the right to
sublicense to use INFORMATION in connection with its own research, education and
clinical programs subject to Section 2.1. In the event that any INFORMATION
needs patent protection, UNIVERSITY will give written notice to SPONSOR and upon
a subsequent written request from SPONSOR the UNIVERSITY shall delay the use of
such INFORMATION for a maximum of one hundred and twenty (120) days to allow for
the filing of patent applications, after such notice.
3. INVENTIONS, DISCOVERIES AND PATENTS
3.1.a All inventions made in direct performance of and contemplated by the
protocol shall be the property of the SPONSOR. In the event SPONSOR desires to
secure patent of such invention, UNIVERSITY shall cooperate, at SPONSOR'S
expense for all out-of-pocket costs, for the purpose of filing and prosecuting
such patent applications.
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3.1.b All data compiled from the clinical studies conducted under such
protocol shall be the property of the SPONSOR.
3.2. To the extent that Principal Investigator or other UNIVERSITY employees
conceive and/or first reduce to practice an invention other than in the direct
or indirect performance of the protocol, such invention shall be the sole
property of the UNIVERSITY.
3.3. Except as expressly stated herein, neither party claims by virtue of this
agreement any right, title, or interest in any issued or pending patents owned
or controlled by the other party or any invention, process, or product arising
out of the other party's previous research or development, whether or not
patented or patentable.
4. PUBLICATION
4.1. The SPONSOR recognizes that consistent with the UNIVERSITY'S status as an
educational institution and the principles of academic freedom, the UNIVERSITY
requires that its researchers be free to publish the results of their research
activities. The SPONSOR agrees that researchers engaged in this Research shall
be permitted to publish in journals, theses, dissertations, or other format of
their own -choosing, and to present at symposia and national or regional
professional meetings, the methods and results of this Research, subject,
however, to paragraph 2 concerning confidentiality and proprietary data and
provided that the Sponsor shall have been furnished copies of any proposed
publication or presentation to a journal, editor, or other third party.
4.2. Sponsor shall have one hundred and twenty (120) days after receipt of the
copies to file the necessary patent protection. directed to the patentable
subject matter contained in the proposed publication or presentation.
4.3. SPONSOR shall have the right to trademark the Huperzine Study drug.
5. USE OF NAME
5.1. SPONSOR will not use UNIVERSITY'S names without prior written approval
except to identify UNIVERSITY as the Study site when required to do so by law.
5.2. UNIVERSITY shall not use, expressly or by implication, any trademark, trade
name, or any contraction, abbreviation, simulation, or adaptation thereof of
SPONSOR; or the name of any of SPONSOR staff in any news, publicity release,
policy recommendation, advertising or any commercial communication without the
express written approval of SPONSOR.
6. INDEMNIFICATION
6.1. SPONSOR agrees to indemnify, defend and hold harmless UNIVERSITY, its
trustees officers, employees and agents from (1) any claims, loss, damage,
arising from SPONSOR'S use of the research performed under this agreement and
(2) any liability and expenses (including attorney's fees) arising out of an
injury or condition allegedly caused by the administration of the Study drug
being tested or procedure required by the PROTOCOL. Notwithstanding the above,
SPONSOR shall not be responsible for indemnifying UNIVERSITY, its trustees,
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officers, employees or agents for any liability to the extent such liability
arises from UNIVERSITY'S (1) failure to adhere to the terms of the Protocol or
Sponsor's written instructions concerning use of the Study drug, (2) failure to
comply with applicable FDA or other government requirements, or (3) negligence,
willful misconduct or research contrary to the PROTOCOL. In the event that
SPONSOR defends UNIVERSITY and proof of the foregoing is established, UNIVERSITY
shall reimburse SPONSOR for all costs and expenses incurred by SPONSOR in such
defense. SPONSOR agrees not to compromise or settle any claim against UNIVERSITY
or its trustees, officers, employees, or agents without the prior written
approval of UNIVERSITY.
6.2. UNIVERSITY shall indemnify and hold SPONSOR, it's affiliates, officers,
directors, employees and agents harmless from any liability and expenses
including attorneys fees ) resulting from the negligent acts or omissions of the
UNIVERSITY, Principal Investigator or its employees pertaining to the activities
to be carried out under this Agreement, including but not limited to
UNIVERSITY's (1) failure to adhere to the terms of the Protocol or Sponsor's
written instructions concerning use of the Study drug, (2) failure to comply
with applicable FDA or other government requirements, or (3) negligence, willful
misconduct or research contrary to the PROTOCOL or SPONSOR'S patents.
6.3. UNIVERSITY makes no representations or warranties, expressed or implied,
regarding its performance under this Agreement, including but not limited to,
the marketability, use or fitness for any particular purpose of the research
results developed under this work, or that such results do not infringe upon any
third party property rights but will disclose in writing any knowledge of such
issues within thirty (30) days of receiving such knowledge.
6.4. Should a subject suffer any adverse effect caused by the study drug, the
study procedures, or laboratory work required by the PROTOCOL, SPONSOR will pay
for all reasonable medical and hospital costs required for the diagnosis and
treatment of such adverse effect except in the event that such adverse effect be
the result of negligence, misconduct or malpractice.
7. FISCAL MANAGEMENT
7.1. UNIVERSITY shall maintain complete and accurate accounting records in
accordance with accepted accounting practices. University shall make such
accounting records pertaining to the Huperzine research program available to
Sponsor periodically. UNIVERSITY agrees to invoice SPONSOR according to the
payment plan set forth in Attachment B and to provide reasonable documentation
to support such invoices upon request by SPONSOR. The NIH grant shall be funded
in the same proportion to the Sponsor's scheduled payments in accordance with
Attachment C.
7.2. Sponsor shall retain title to equipment and all other items purchased with
funds provided by SPONSOR.
8. INSURANCE
8.1. UNIVERSITY agrees to maintain a self-Insurance program with adequate
liability insurance, such protection being applicable to officers, employees and
agents of UNIVERSITY
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8.2. SPONSOR shall maintain a policy or program of insurance or self insurance
at levels sufficient to support the indemnification obligations assumed under
this Agreement. Upon request, SPONSOR shall provide evidence of its insurance or
self-insurance. In the event SPONSOR'S insurance is cancelled, SPONSOR shall
notify UNIVERSITY thirty days in advance of such cancellation and provide
University with evidence that the cancelled policy has been replaced.
9. TERMINATION
9.1. Articles 3, 4, 5 and 6 shall survive indefinitely the termination of this
Agreement and Article 2 shall survive for a period of seven (7) years following
the date of termination of the Agreement.
9.2. If for any reason the INVESTIGATORS become unavailable to direct the
performance of the work under this Agreement, UNIVERSITY shall notify SPONSOR.
If the parties are unable to identify a mutually acceptable successor, this
Agreement may be terminated by either party upon thirty (30) days written notice
as per section 9.3.
9.3. This Agreement may be terminated by either party giving to the other a
minimum of thirty (30) days prior written notice. UNIVERSITY and INVESTIGATORS
will take all efforts necessary to minimize further costs upon issuing or
receiving such notice. UNIVERSITY will be entitled to payment for documented
non-cancelable contracted obligations (Obligations) and amortized indirect,
overhead and. oversight project costs (Costs) pre-approved by Sponsor and
incurred through the termination date. Any unexpended funds paid by SPONSOR and
held by UNIVERSITY after satisfying the Obligations set forth in this paragraph
and the Costs amortized in accordance with Attachment C shall be returned to
SPONSOR.
9.4. The parties will safely withdrawal subjects from the Study over a mutually
agreeable period if thirty (30) days notice is insufficient, based upon
evaluation of risks to subjects.
10. AMENDMENT
10.1. This Agreement represents the entire understanding of the parties with
respect to the subject matter. Any modification of this Agreement must be in
writing and signed by the parries.
11. GENERAL
11.1. This Agreement may be amended only by the written agreement of the
parties.
11.2. This Agreement may not be assigned by UNIVERSITY or SPONSOR without the
prior written consent of the other, which shall not be unreasonably withheld.
11.3. The captions and headings used in this Agreement are for convenience and
reference only and are not a part of this Agreement.
11.4. All notices shall be in writing and sent to the respective administrative
contacts set forth in paragraph 1.1 of this Agreement. Notices shall be deemed
to have been given when delivered if personally delivered, on the business day
after dispatch if sent by air courier, on the third business day following the
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date of mailing if sent by mail, and on the date of telefax if sent by telefax
transmission.
11.5. This Agreement and its effects are subject to and shall be construed and
enforced in accordance with the laws of the state of New York.
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The parties have executed this Agreement in duplicate by persons authorized to
contractually bind them.
FOR SPONSOR FOR UNIVERSITY
/s/ /s/ Xxxxxxx Xxxxxxx
------------------------------------ --------------------------------------
Signature Signature
Xxxxxxx Xxxxxxx
------------------------------------ --------------------------------------
Printed Name Printed Name
President Assoc. VP, R&TDS
------------------------------------ --------------------------------------
Title Title
12/19/03 12/17/03
------------------------------------ --------------------------------------
Date Date
PRINCIPAL INVESTIGATOR
/s/
------------------------------------
Signature
12/18/03
------------------------------------
Date
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MODIFICATION NO. 1 TO THE
CLINICAL RESEARCH AGREEMENT
BETWEEN
GEORGETOWN UNIVERSITY
AND
MARCO HI-TECH JV, LTD.
Due to a mutual desire on the part of the parties to modify the clinical
research agreement that was fully-executed as of December 19, 2003, the
modifications detailed below are made to the existing Agreement.
1. STATEMENT OF WORK, TERM AND AMOUNT OF CONTRACT
The effective period of the Agreement is extended by one year and five months
therefore 1.4 Period of Performance is changed to read:
THE EFFECTIVE PERIOD OF THIS AGREEMENT SHALL BE FROM DECEMBER 19, 2003 THROUGH
AUGUST 31, 2007 UNLESS OTHERWISE TERMINATED IN ACCORDANCE WITH ARTICLE. 9. A
SCHEDULE ENTITLED "HUPERZINE II PROTOCOL TIMELINE " SHALL BE APPENDED TO THIS
AGREEMENT AS ATTACHMENT C (TIMELINE). THE UNIVERSITY RECOGNIZES THAT THE MEETING
OF THESE TIMELINES IS CRITICAL TO THE COMMERCIAL SUCCESS OF SPONSOR'S PROGRAM
TO DEVELOP HUPERZINE A AS AN FDA APPROVED DRUG AND THAT SPONSOR MAY SUFFER
FINANCIAL DAMAGES SHOULD SUCH MILESTONES NOT BE MET. THE EFFECTIVE PERIOD MAY BE
ALTERED BY MUTUAL AGREEMENT OF THE PARTIES IN ACCORDANCE WITH ARTICLE 11.1.*
ALL OTHER TERMS AND CONDITIONS OF THIS AGREEMENT REMAIN IN FULL FORCE AND
EFFECT.
THE PARTIES HAVE EXECUTED THIS MODIFICATION NUMBER 1 IN TRIPLICATE BY PERSONS
AUTHORIZED TO CONTRACTUALLY BIND THEM.
FOR MARCO HI-TECH JV, LTD.: FOR GEORGETOWN UNIVERSITY:
/s/ Xxxxxx Xxxxxxx /s/ Xxxxx Xxxxxx
------------------------------------ --------------------------------------
Signature Signature
Xxxxxx Xxxxxxx Xxxxx Xxxxxx
------------------------------------ --------------------------------------
Printed Name Assistant Director, Office of
Sponsored Research, Georgetown
University Medical Center
------------------------------------ --------------------------------------
Title Title
11/18/05 8/18/05
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Date Date
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* Subject to NIH no cost extension through August 31, 2007.
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