CLINICAL TRIAL AGREEMENT
Agreement made this 27th day of July, 1999 ("Effective Date") between The
General Hospital Corporation, a not-for-profit corporation doing business as
Massachusetts General Hospital, having a principal place of business at Xxxxx
Xxxxxx, Xxxxxx, Xxxxxxxxxxxxx 00000 ("General"), Xxxxxxx Xxxxxx, MD, Department
of Dematology, Massachusetts General Hospital, Xxxxxx, Xxxxxxxxxxxxx 00000
("Principal Investigator") and Laser Photonics, Inc. a corporation having an
office at 0000 Xxxxxx Xxxxx, Xxxxxxxx, XX 00000 ("Company").
All of the parties to this Agreement share a common mission of improving
the public health by engaging in research for the purpose of discovering and
making available to the public new and improved medical drugs and devices. In
connection with this mission, Company desires to have further clinical research
conducted on its device described below. General and Principal Investigator,
having particular expertise and opportunity, desire to provide this research.
Accordingly, the parties agree as follows.
SECTION 1: STUDY PERFORMANCE
1.1 PROTOCOL Subject to approval of the Study pursuant to Section 1.2
below, Principal Investigator agrees to conduct to the extent funds are made
available hereunder a clinical study of a 308nm Excimer Laser manufactured by
Acculase, Inc., a subsidiary of Laser Photonics, Inc. (hereinafter referred to
as the "Study Device") in accordance with the study protocol entitled "308 nm
Excimer Laser for the Treatment of Plaque Psoriasis (High Fluence Study)", a
copy of which is attached hereto as Exhibit A (hereinafter referred to as the
"Study"). In the event of any conflict between Exhibit A and the provisions of
this Agreement, the provisions of this Agreement shall govern.
1.2 STUDY REVIEW Principal Investigator shall conduct the Study at
General with the prior approval and ongoing review of all appropriate and
necessary review authorities and in accordance with all applicable federal,
state and local laws and regulations. Principal Investigator shall provide
Company with written evidence of review and approval of this Study by General's
Institutional Review Board ("IRB") prior to the initiation of the Study and
shall inform Company of the IRB's continuing review promptly after such review
takes place, which shall be at least once per year. All volunteers shall meet
the legal age requirements of the Commonwealth of Massachusetts, the state in
which the Study is to be conducted.
1.3 STUDY DEVICE Company shall provide General, at no charge, with
quantities of the Study Device required for the Study. The General and Principal
Investigator shall safeguard such Study Device with the degree of care used for
its own property. Upon completion or termination of the Study and upon Company's
request, General shall return or otherwise dispose of any remaining Study Device
in accordance
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with Company's instructions. General and Principal Investigator shall not use
any Study Device for any purpose other than the Study, unless otherwise agreed.
SECTION 2: RESULTS OF THE STUDY
2.1 OWNERSHIP OF RECORDS, DATA AND INTELLECTUAL PROPERTY Company shall own
its case report forms and the data resulting from the Study. General shall own
its medical records, research notebooks and related documentation and any
intellectual property resulting from the Study subject to the option granted to
Company to license Inventions in Section 2.3 below. General shall have the right
to use the data for research, educational and patient care purposes as well as
to comply with any federal, state or local government laws or regulations.
Notwithstanding the above, Company shall not use any patient names, identifying
information, photographs, or other likenesses without first obtaining the
specific written informed consent of such patient for such use.
2.2 PUBLICATION The Principal Investigator shall be free to publish the
results of the Study subject only to the provisions of Section 3 regarding
Company's Proprietary Information. The Principal Investigator shall furnish
Company with a copy of any proposed publication for review and comment prior to
submission for publication, at least thirty (30) days prior to submission for
manuscripts and at least seven (7) days prior to submission for abstracts. At
the expiration of such thirty (30) day or seven (7) day period, Principal
Investigator may proceed with submission for publication provided, however, that
upon notice by Company that Company reasonably believes a patent application
claiming an Invention (as defined in Section 2.3) should be filed prior to such
publication, such publication shall be delayed for an additional thirty (30)
days or until any patent application or applications have been filed, whichever
shall first occur. In no event shall the submission of such publication of
results be delayed for more than sixty (60) days for manuscripts and for more
than thirty-seven (37) days for abstracts from the date such proposed
publication was received by Company; at the end of said sixty (60) or
thirty-seven (37) days, the Principal Investigator shall be free to publish such
results as proposed.
2.3 INVENTIONS
(a) Subject to the terms of Paragraphs 2.3 (b)-(g) below, the
Principal Investigator and any other General personnel performing the Study
under his or her direction who makes an invention which constitutes a new use of
or modification to the Study Device in the performance of the Study
("Invention") shall promptly report and assign such Invention to General.
General shall promptly disclose in writing any Inventions to Company. Within
thirty (30) days of such disclosure, Company shall notify General in writing if
it wishes General to file a patent application claiming the Invention.
(b) in the event of joint inventorship under the Study of a new use of
or modification of the Study Device between Investigators and/or personnel from
General and personnel from Company ("Joint Invention"), such Investigators
and/or personnel shall assign all of their rights, title and interest in the
Joint Invention to General and such
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personnel from Company shall assign all of their rights, title and interest in
the Joint Invention to Company, and the Joint Invention shall be deemed jointly
owned. Promptly after disclosure of the invention, the parties shall then
mutually agree as to whether an application for the Joint Invention shall be
filed.
(c) As to any patent applications prepared and/or filed under either
paragraphs (a) or (b) above, Company shall have and is hereby given by General
an exclusive option, for a period of ninety (90) days following the disclosure
of such invention, to seek either (1) a worldwide., exclusive or non-exclusive
license for inventions in which General personnel are the, sole named inventors;
or (2) a worldwide, exclusive license for General's rights in any Joint
Inventions. Exercise of Company's option shall be provided in writing to
General.
(d) In the event Company exercises its option under Paragraph 2.3(c)
above, the Parties shall have ninety (90) days from the date of Company's notice
to negotiate in good faith a license agreement containing license terms standard
for agreements between universities and industry, which may include payment of
reasonable royalties and other compensation to General, objective, time-limited
due diligence provisions for the development, commercialization and marketing of
a product embodying the invention and product liability indemnification and
insurance requirements which are acceptable to General's liability insurance
carrier. In the event the parties are unable to reach agreement on the terms of
a license under this paragraph, General shall then have the right to license its
rights to any third party, provided however, that no license to a third party
shall be agreed to by General on terms more favorable than those terms last
offered to Company.
(e) Notwithstanding the above paragraphs of this Section 2, in the
event there is an invention under the Study, either solely by General personnel
or jointly by General and Company personnel, that is: (1) directed to an optimal
dosage, protocol and/or device configuration for treating psoriasis using
ultraviolet radiation in the manner such radiation is generated by Company's
Study Device and (2) that would not come within the definition of "Patent Right"
as set forth in the License Agreement dated November 26, 1997 between the
parties, it is agreed that Company shall be given a paid up worldwide exclusive
license to such invention and that payment by Company for the Study and for all
patent preparation and filing costs for such invention shall constitute, the
consideration for the paid up license.
(f) It is agreed that for any patent application under which Company
is the licensee, Company shall pay all reasonable fees and costs associated with
the, preparation and prosecution of such application, provided however, that the
parties shall mutually select the attorneys for such application and that
General shall keep Company promptly apprised of all proceedings in connection
with the application and Company shall have the right to review and approve all
submissions made during said filing and prosecution
(g) In the event the Parties do not come to an agreement as to the
terms of a license under Paragraphs 2-3 (a) - (d), Company shall no longer have
responsibility to fund any further fees and costs associated with the filing and
prosecution of the application, and, in the event General enters into an
agreement with third party for such application, Company shall be reimbursed for
the fees and costs Company previously paid.
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2.4 USE OF NAME Except for disclosure by General of Company's support for
the Study in publications, no party to this Agreement shall use the name of any
other party or of any staff member, employee or student of any other party or
any adaptation, acronym or name by which any party is commonly known, in any
advertising, promotional or sales literature or in any publicity without the
prior written approval of the party or individual whose name is to be used. For
General, such approval shall be obtained from the Director of Public Affairs and
for Company, from Xx. Xxxxx Xxxxxxxx.
2.5 STUDY RECORDS General shall make Study records available to Company
representatives upon request for comparison with case report forms. General
shall also make such records available upon reasonable request for review by
representatives of the U.S. Food and Drug Administration. General shall retain
records of the Study including either the original or a copy of all volunteer
consent forms in conformance with applicable federal regulations. Company shall
notify Principal Investigator of the date a premarket approval application (PMA)
is approved for the Study Device; or if the application is not approved, Company
shall notify Principal Investigator when all clinical investigations have been
discontinued and the FDA notified.
SECTION 3: COMPANY PROPRIETARY INFORMATION
3.1 It is anticipated that in the performance of the Study, Company shall
provide to General, Principal Investigator and other General personnel who are
designated in writing by the Principal Investigator as being authorized to
receive Proprietary Information and who agree in writing to the following
confidentiality obligations (each such institution or person individually
referred to in this Section 3.1 as "a Recipient" and collectively as
"Recipients"), or shall give Recipients access to, certain information which
Company considers proprietary. The rights and obligations of the parties with
respect to such information are as follows:
(a) For the purposes of this Agreement, "Proprietary Information"
refers to information of any kind which is disclosed by Company to a Recipient
and which, by appropriate marking, is identified as confidential and proprietary
at the time of disclosure. In the event that proprietary information must be
provided visually or orally, obligations of confidence shall attach only to that
information which is confirmed by Company in writing within ten (10) working
days as being confidential.
(b) For a period of five (5) years after the Effective Date of this
Agreement, each Recipient agrees to use reasonable efforts, no less than the
protection given their own confidential information, to use Proprietary
Information received from Company and accepted by that Recipient only in
accordance with this Section 3.1(b).
(i) Each Recipient shall use Company's Proprietary Information
solely for the purposes of conducting the Study, obtaining any
required review of the Study or its conduct, or ensuring proper
medical treatment of any patient or subject. Each
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Recipient agrees to make Proprietary Information available only to
those employees and students of General who require access to it in
the performance of this Study and to inform them of the
confidential nature of such information.
(ii) Except as provided in subsection 3.1(b)(i), each Recipient
shall keep all Proprietary Information confidential unless Company
gives specific written consent for release.
(iii) If any Recipient becomes aware of any disclosure not
authorized hereunder, that Recipient shall notify Company and take
reasonable steps to prevent any further disclosure or unauthorized
use.
(c) No Recipient shall be required to treat any information as
Proprietary Information under this Agreement in the event: (i) it is publicly
available prior to the date of the Agreement or becomes publicly available
thereafter through no wrongful act of any Recipient; (ii) it was known to any
Recipient prior to the date of disclosure or becomes known to any Recipient
thereafter from a third party having an apparent bona fide right to disclose the
information; (iii) it is disclosed by any Recipient in accordance with the terms
of Company's prior written approval; (iv) it is disclosed by Company without
restriction on further disclosure; (v) it is independently developed by any
Recipient; or, (vi) any Recipient is obligated to produce it pursuant to an
order of a court of competent jurisdiction or a facially valid administrative,
Congressional or other subpoena, provided that the Recipient subject to the
order or subpoena (A) promptly notifies Company and (B) cooperates reasonably
with Company's efforts to contest or limit the scope of such order.
SECTION 4: BUDGET
4.1 Company agrees to support this Study with a research grant of
Sixty-three thousand, three hundred seventy-five dollars ($63,375) which
includes indirect costs in the amount of Twelve thousand, six hundred
seventy-five dollars ($12,675) computed at a rate of 25% of total direct costs,
payable to General as follows:
Thirty-one thousand, six hundred eighty-seven dollars and 50 cents
($31,687.50) upon execution of this Agreement;
Fifteen thousand, eight hundred forty-three dollars and seventy-five cents
($15,843.75) upon enrollment/ completion of ten (10) subjects; and,
Fifteen thousand, eight hundred forty-three dollars and seventy-five cents
($15,843.75) upon completion of a total of twenty (20) subjects and submission
of all completed case report forms.
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4.2 Checks should be made payable to "The General Hospital Corporation" and
sent, along with a letter indicating the name of the Principal Investigator and
the specific clinical trial agreement for which the funds are intended, to:
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Financial Control Coordinator
Research Finance
Massachusetts General Hospital
Thirteenth Street, Building 149, Suite 1115
Xxxxxxxxxxx, XX 00000
SECTION 5: TERM AND TERMINATION
5.1 The term of this Agreement shall be until the completion of the Study,
which is anticipated to be one (1) year from the Effective Date, unless
terminated in accordance with Section 5.2.
5.2. Any party hereto shall have the right to terminate the Study and this
Agreement at any time upon thirty (30) days prior written notice thereof to the
other parties, except that any party may terminate this Agreement immediately
upon written notice to the other parties if necessary to protect the health,
welfare or safety of any Study subject.
5.3 In the event of termination, the amount of the research grant by
Company to support the Study shall be appropriately prorated to allow General to
recover reasonable costs and noncancellable commitments incurred, including
without limitation, termination salary costs of any of General's employees
released as a result of such termination.
5.4 The obligations of the parties under Sections 2, 3 and 6 shall survive
the termination or expiration of this Agreement.
SECTION 6: INDEMNIFICATION AND INSURANCE
6.1 Indemnification (a) Company shall indemnify, defend and hold harmless
General and its trustees, officers, medical and professional staff, employees,
and agents and their respective successors, heirs and assigns (the
"Indemnitees"), against any liability, damage, loss or expense (including
reasonable attorney's fees and expenses of litigation) incurred by or imposed
upon the Indemnitees or any one of them in connection with any claims, suits,
actions, demands or judgments arising out of any side effect, adverse reaction,
illness, or injury occurring to any person as a result of his or her involvement
in the Study.
(b) Company's indemnification under (a) above shall not apply to any
liability, damage, loss or expense to the extent that it is directly
attributable to: (i) the negligent activities, reckless misconduct or
intentional misconduct of the Indemnitees; or (ii) failure of the Indemnitees to
adhere to the terms of the protocol for the Study.
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(c) Company agrees, at its own expense, to provide attorneys
reasonably acceptable to General to defend against any actions brought or filed
against any party indemnified hereunder with respect to the subject of the
indemnity contained herein, whether or not such actions are rightfully brought.
(d) Company also agrees to reimburse General for the costs of the care
and treatment of any illness or injury to a subject resulting from his or her
participation in the Study to the extent that such costs are not covered by the
subject's medical or hospital insurance or governmental programs providing such
coverage.
6.2 INSURANCE (a) Company shall, at its sole cost and expense, procure and
maintain commercial general liability insurance or equivalent self-insurance in
amounts not less than $2,000,000 per incident and $2,000,000 annual aggregate.
Such commercial general liability insurance or equivalent self-insurance shall
provide contractual liability coverage for Company's indemnification under
Section 6.1 of this Agreement.
(b) Company shall provide General with written evidence of such
insurance prior to the commencement of the Study. Company shall provide General
with written notice at least fifteen (15) days prior to the cancellation,
non-renewal or material change, in such insurance; if Company does not obtain
replacement insurance providing comparable coverage within such fifteen (15) day
period, General shall have the right to terminate this Agreement effective at
the end of such fifteen (15) day period without notice of any additional waiting
periods.
SECTION 7: MISCELLANEOUS
7.1 The terms of this Agreement can be modified only by a writing which is
signed by General, Principal Investigator and Company.
7.2 The provisions of this Agreement shall be interpreted under the laws
of the Commonwealth of Massachusetts, regardless of the choice of law rules of
any jurisdiction.
7.3 No party to this Agreement may assign its obligations hereunder
without the prior written consent of the other parties.
7.4 This Agreement constitutes the entire understanding between the
parties, and supersedes and replaces all prior agreements, understandings,
writings and discussions between the parties, with respect to the subject matter
of this Agreement.
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IN WITNESS WHEREOF, the parties have caused this Agreement to be duly
executed as of the day and year first above written.
LASER PHOTONICS, INC. THE GENERAL HOSPITAL CORPORATION
(Federal Tax ID No.: 042 697 983)
BY: /s/ Xxxxx Xxxxxxxx By: /s/ Xxxxx X. Xxxxx
------------------------ ---------------
Xxxxx Xxxxxxxx Xxxxx X. Xxxxx
TITLE: COO/CFO TITLE: Director, Office of Corporate Sponsored
Research and Licensing
DATE: 8/4/99 DATE: 8/9/99
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