CLINICAL TRIAL AGREEMENT
Agreement made this 17th day of 1998, ("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"), R. Rox Xxxxxxxx, M.D.,
Department of Dermatology, Massachusetts General Hospital, Xxxxxx, Xxxxxxxxxxxxx
00000 ("Principal Investigator") and Laser Photonics, Inc. a corporation having
an office at 0000 Xxxxxxxx Xxxxx, Xxxxx X, Xxx Xxxxx, 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 "308nm
Excimer Laser for the Treatment of Psoriasis," 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
no more than three Study Devices 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 other-wise dispose of any remaining Study
Device in accordance 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 governments 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 Paragraph 2.3 (b)(g) below, the
Principal Investigator and any other General personnel performing the Study
under his direction who makes an invention which constitutes a new use of or
modification of 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, whether it
elects to have General 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 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 further 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.
2.4 USE OF NAME. Except for disclosure by General of Company's support-t
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 Devices; 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 with the (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 the 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 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)(1), 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: (1) 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) i 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 One
Hundred Fifty Nine Thousand Six Hundred Twenty Five Dollars ($159,625.00) with
includes indirect costs in the amount of Thirty One Thousand Nine Hundred Twenty
Five Dollars ($31,925.00) computed at a rate of 25% of total direct costs,
payable to General as follows:
Fifty Thousand Dollars ($50,000.00) upon execution of this Agreement;
Sixty Thousand Dollars ($60,000.00) upon enrollment/completion of eight (8)
subjects; and,
Forty Nine Thousand Six Hundred Twenty Five Dollars ($49,625.00) upon
completion of no less than twelve (12) fully available subjects and submission
of all completed case report forms.
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:
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 by Company, the amount of the research
grant by Company to support the Study shall be appropriately prorated to allow
General to recover reasonable costs and noricancellable 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 the 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 intention
misconduct of the Indemnitees; or (ii) failure of the Indemnities to adhere to
the terms of the protocol for the Study.
(c) Company agrees, at its own expense, to provide attorneys
reasonably acceptable to General to defend against any action 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 I 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 or equivalent self insurance in amounts
not less than $1,000,000 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.
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
/s/ Xxxxx Xxxxxxxx /s/ R. Rox Xxxxxxxx, M.D.
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Xxxxx Xxxxxxxx, R. Rox Xxxxxxxx, M.D.
Chief Operating Officer, Administrative Officer
Chief Financial Officer of Technology Affairs
