EXHIBIT 10.1
RESEARCH AGREEMENT
THIS RESEARCH AGREEMENT ("Agreement") is made effective as of October 1,
1998 by and between Photogen, Inc., a Tennessee corporation with offices in
Knoxville, Tennessee (hereinafter referred to as "Sponsor"), and the Center for
Imaging and Pharmaceutical Research ("CIPR") of The General Hospital
Corporation, a Massachusetts corporation (doing business as "Massachusetts
General Hospital"), with offices on Fruit St. in Xxxxxx, Xxxxxxxxxxxxx 00000
(hereinafter collectively referred to as "General") and joined into by each
person engaged by General as an Investigator to the extent indicated in Section
20 of this Agreement. Sponsor and General are collectively referred to as the
"Parties."
WITNESSETH:
WHEREAS, the research project contemplated by this Agreement is of mutual
interest and benefit to the Sponsor and General, and will further the
instructional, medical, and research objectives of General and the research and
development objectives of the Sponsor.
NOW THEREFORE, in consideration of the mutual covenants contained herein,
the Parties hereto agree as follows:
1. THE PROJECT. General, through the Principal Investigator (as defined
below) agrees to use its best efforts to perform in a timely and
expeditious manner one or more research projects pursuant and limited to
one or more protocols agreed to between the Parties (the "Project"). The
first phase of the Project will consist of research pursuant to the terms
of the protocol dated October 1, 1998 entitled "Combination of Two-Photon
Excitation Photodynamic Therapy (TPE-PDT) with Advanced Tumor Imaging
Technology for the Treatment of Lung and Prostate Cancer" between the
Sponsor and General which has been separately delivered and acknowledged by
the Parties ("Protocol-1"). Additional phases of the Project will be
conducted pursuant to mutually agreed upon protocols which shall be subject
in all respects to this Agreement and shall be designated by consecutive
numbers (e.g., Protocol-2, Protocol-3, etc.). Revised budgets shall be
mutually agreed for such additional protocols and shall form the basis for
an amendment to this Agreement The Project will be conducted under the
direction of Xxxxxx X. Xxxx, Ph.D., M.D. ("Principal Investigator").
General shall provide personnel, working under the Principal Investigator's
supervision, (who, together with the
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Principal Investigator, are referred to as the "Investigators"),
facilities, and resources as required to accomplish the work necessary
to complete the Project in accordance with Protocol-1 and any subsequent
protocols agreed to between the Parties.
2. TERM. The term of this Agreement and the Project shall be from October 1,
1998 through September 30, 2003, unless sooner terminated in accordance
with the terms hereof.
3. PAYMENT. The total cost to the Sponsor for the work described in
Protocol-1 will not exceed $225,000. The cost for subsequent work pursuant
to other protocols will be agreed upon by the Parties. Payments during the
first year shall be made to General by the Sponsor according to the
following schedule:
Amount Date
------ ----
$50,000 October 1, 1998
$50,000 By December 1, 1998
$50,000 By March 1, 1999
$74,008 By June 1, 1999
Checks shall be made payable to "The General Hospital Corporation" and
shall be mailed to the following address:
Financial Director, Grants and Contracts
Research Finance
Massachusetts General Hospital
Thirteenth Street, Building 149, Suite 1115
Xxxxxxxxxxx, XX 00000
All funds provided by Sponsor under this Agreement may be used at the
discretion of General in support of the work for the Project. Any changes
to the above payment schedule must be agreed to in writing by the Parties.
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4. TERMINATION. This Agreement and the Project may be terminated as set forth
below, in which case Sponsor's payment obligations will be adjusted through
the date of termination:
a. In the event that either Party defaults in the due performance of its
respective obligations under this Agreement, or in the event that any
representation or warranty by either Party in this Agreement or in the
documentation or data produced through the Project proves to be
materially false or misleading, and such default or breach is not
cured within thirty (30) days after written notice by the other Party,
then the non-defaulting Party may elect to terminate the Project and
this Agreement by giving written notice to the defaulting Party, and
this Agreement shall terminate upon the defaulting Party's receipt of
said notice.
b. General shall promptly advise Sponsor if for any reason Xx. Xxxx
cannot be available as the Principal Investigator. If the Parties
cannot agree on a qualified scientist as a replacement, Sponsor may
terminate the Project and this Agreement on the 30th day after
delivery of written notice to General.
c. Notwithstanding anything in this Agreement to the contrary, either
Party may terminate this Agreement, with or without cause and without
liability, on 90 days' prior written notice to the other Party; in
which event this Agreement and the Project shall terminate on the 90th
day after delivery of such notice. In the event of such termination,
Sponsor shall have an obligation to continue for up to four (4) months
beyond such written notification, salary support at the pretermination
level of all Ph.D. or M.D. personnel who have been committed to the
Project on half-time or greater basis, provided General uses
reasonable efforts to reduce such costs to Sponsor.
d. The Parties recognize that the results of any particular research
project cannot be guaranteed even through the use of General's best
efforts; therefore, it is specifically agreed that the failure of
General to achieve specific research results or to reach specific
research milestones shall not constitute a default or breach of this
Agreement. Further, the Parties agree that obligations under Sections
5, 6, 7, 9, 10, 12, 13, 14 and 19 survive any termination of this
Agreement or the Project.
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5. EQUIPMENT. Title to any equipment purchased or manufactured by General in
the course of the research conducted under this Agreement or with the use
of funds provided by Sponsor shall vest in General.
6. PROPRIETARY INFORMATION OF THE PARTIES.
a. General and Sponsor recognize that the conduct of the Project may
involve the exchange and/or development or discovery of proprietary
information, including Inventions (as defined in Section 13.a below)
and other confidential business, technical and scientific information
or Trade Secrets (defined below). Accordingly, it is agreed that each
Party shall use reasonable efforts, no less than those used for its
own information of similar nature, to retain in confidence all
proprietary information of the other Party identified as confidential
at the time of disclosure and not disclose such information to any
other person or entity, nor use such information without written
permission of the Party owning such information, except in accordance
with the terms of this Agreement. The obligations of this paragraph
shall be binding upon the parties for a period of 5 years from the
Effective Date of this Agreement.
b. The term "proprietary information" as used herein shall not include
any information which the recipient clearly shows by appropriate
documentation:
(1) Was at the time of receipt both lawfully and independently known
to the receiving Party, its agents, or employees;
(2) Without breach of this Agreement by the receiving Party has been
published or is otherwise within the public knowledge or is
generally known to the public at the time of disclosure;
(3) Becomes known or available to the receiving Party without
restriction from a source other than the disclosing Party,
provided that such source has an unqualified right to disclose
such information without restriction;
(4) Becomes a part of the public domain after disclosure without
breach of this Agreement by the receiving Party; or
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(5) Is required by law to be disclosed, in which case the receiving
Party will give the disclosing Party prompt written notice of the
required disclosure. The disclosing Party may, in good faith and
at its own expense, contest disclosure or seek confidential
treatment and the receiving Party shall cooperate with the
disclosing Party in all reasonable respects.
7. PUBLICATION.
a. The Project studies may be worthy of written or oral publication in
scholarly journals or at meetings. Such presentation or publication
shall be jointly authored by the Principal Investigator and Sponsor's
scientists in accordance with their respective scientific
contributions to the Project, if applicable (otherwise, by the
originating person). Prior to publication, each Party will give the
other the opportunity to review and comment on any intended public
disclosure covering the Project, but in no event shall publication be
permitted without the express written approval of the Party from which
the results originated in accordance with prevailing academic
practice.
b. In order to give Sponsor an opportunity to protect against loss of
confidentiality or patent rights as a result of publication, the
Principal Investigator and/or General shall submit copies of drafts of
any article, abstract or presentation on the research conducted in the
Project written by any Investigator to Sponsor for review and comment
at least thirty (30) days prior to the anticipated date of submission
for publication or presentation. In the absence of Sponsor's notice
to the contrary, General shall be free to submit such drafts for
publication or presentation. If Sponsor notifies General in writing
within such 30 day period that it needs additional time to seek patent
protection for the information, then General and the Investigators, as
the case may be, agree to defer the submission for publication until
such patent application has been filed, or an additional 60 days,
whichever is sooner. The person seeking to publish the material shall
make appropriate changes in such material to reflect the Parties'
reasonable comments concerning patent protection and non-disclosure of
Sponsor's Trade Secrets (defined below).
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8. INDEPENDENT CONTRACTOR. The Parties' relationship to one another in the
performance of this Agreement is that of independent contractors. The
Parties are not employees or agents of one another. Neither Party shall
have the authority to bind or incur liability for the other except as may
be expressly authorized in writing.
9. INDEMNIFICATION.
a. Sponsor shall be responsible and shall hold General harmless for any
injury to persons or damage to property to the extent that such injury
or damage is caused by the negligence or willful misconduct of
Sponsor, its employees or staff in carrying out the Project. Sponsor
will defend, indemnify, and hold harmless General and its trustees,
employees and staff against any and all actions, suits, claims,
demands or prosecutions that may be brought or instituted against
General and/or its trustees, employees and staff based on or arising
out of the manufacture, use, sale or other distribution of any product
of Sponsor (or its affiliates or licensees) resulting from the
Project, except to the extent any such action, suit, claim, demand or
prosecution is based on the negligence or willful misconduct of
General and/or its trustees, employees or staff.
b. General will defend, indemnify and hold harmless Sponsor and its
directors, employees and representatives from and against all actions,
suits, claims, demands or prosecutions that may be brought or
instituted against any of them to the extent based on the negligence
or willful misconduct of General and/or its trustees, employees or
staff.
10. NEGATION OF WARRANTIES BY GENERAL. Although General will use its best
efforts in connection with the Project as set forth in Section 1 of this
Agreement, General makes no warranties, either expressed or implied, as to
the result of such research or the merchantability or fitness for a
particular purpose of the research or any product arising out of the
Project. General shall not be liable for any direct, consequential, or
other damages suffered by the Sponsor or others which may result from the
use of any product arising out of the Project (except to the extent set
forth in Section 9, above).
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11. KEY PERSONNEL. Xxxxxx X. Xxxx, Ph.D., M.D., Principal Investigator, is
considered to be essential to the Project. Substitutions for or
substantial changes in his level effort or participation will not be made
without the prior written approval of Sponsor. Each Party will obtain
agreements from those of its employees, independent contractors,
consultants and similar persons involved in the Project (in the case of
General, all Investigators) causing such third parties to be bound by the
provisions of Sections 6, 7, 12 and 13 hereof.
12. INTELLECTUAL PROPERTY RIGHTS OF THE PARTIES. Neither Party shall have any
claim by virtue of this Agreement or the Project to any right, title or
interest in any Invention, Trade Secret or Patent Rights (defined below) or
any other intellectual property rights (a) issued to, owned or controlled
by the other Party prior to the date hereof, or (b) after the date hereof
except any new Inventions, Trade Secrets or Patent Rights conceived and
reduced to practice, constructively or actually in the performance of the
Project and as specifically set forth in Section 13 below.
13. INVENTIONS AND PATENT RIGHTS.
a. The term "Invention" means a patentable discovery or invention
conceived and reduced to practice, constructively or actually in the
performance of the Project, including any novel process, method,
formula, machine, manufacture, composition of matter and technology.
The term "Sponsor Trade Secret" means non-patented know-how,
compositions, protocols, formulas, processes and techniques,
discoveries, machines, ideas, compilations of information, computer
programs (including software and data used in all such programs),
drawings, specifications and technical information owned or developed
by Sponsor or its employees. The term "Patent Rights" means patent
applications and patent disclosures claiming an Invention, together
with all letters patent, reissuances, continuations, divisionals,
those claims in any continuations-in-part of any patent application
which claim an Invention described in said patent application,
revisions, extensions, and reexaminations thereof.
b. Inventions, Patent Rights and Sponsor Trade Secrets arising out of
the Project during the term of this Agreement and for a period of 12
months thereafter shall be owned as follows:
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(1) General will own all such Inventions it, the Principal
Investigator or any other General Investigator independently
conceives (a "General Invention") and all corresponding Patent
Rights, subject to the license if Sponsor exercises its option
described in paragraph 13.f below;
(2) General and Sponsor will jointly own all such Inventions jointly
conceived by General, the Principal Investigator or any other
Investigator together with Sponsor (a "Joint Invention") and all
corresponding Patent Rights, subject to the license if Sponsor
exercises its option described in paragraph 13.f below; and
(3) Sponsor will own all Inventions and Sponsor Trade Secrets Sponsor
independently conceives or owns and all corresponding Patent
Rights.
c. With respect to General Inventions, General will use reasonable
efforts, consistent with the practices of the Office of Technology
Affairs to cause all Investigators to report such Invention and assign
all of their right, title and interest therein to General; and with
respect to Joint Inventions, the Sponsor will cause its personnel and
General will use reasonable efforts to cause each Investigator to
report such Invention and assign all of their right, title and
interest therein to Sponsor and General jointly. Sponsor and General
shall promptly advise the other in writing of each General Invention
or Joint Invention and shall cause their Investigators and personnel,
as applicable, to maintain current and reasonably detailed records (in
accordance with customary academic research practice) as to possible
General and Joint Inventions, which shall be open to inspection by the
other Party with reasonable advance notice. The Parties shall discuss
for up to 90 days after the date an Invention is disclosed by one
Party to the other Party whether patent applications pertaining to
such General or Joint Invention should be filed and in which
countries. All of the foregoing shall constitute proprietary
information subject to Section 6, above.
d. If both Parties agree that patent applications should be filed, patent
applications relating to General Inventions shall be filed by General
and patent applications relating to Joint Inventions shall be filed as
agreed by the Parties. If within such 90-day period one Party states
in writing that it
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is not interested in filing patent applications on either a General
Invention or a Joint Invention (a "declining Party") and the other
Party (a "prosecuting Party") is interested in filing such
applications, the prosecuting Party shall be free, at its own
expense, to file such applications in the name(s) of the parties to
whom the Inventors would be obliged to assign and the declining
Party shall render the prosecuting party, at the prosecuting
Party's expense, all necessary assistance in order to facilitate
filing of such Joint Inventions.. All prosecution costs pertaining
to patent applications covering a General or Joint Invention that
are filed by mutual agreement of the Parties (including
preparation, filing, prosecution, issuance and maintenance costs)
shall be borne by Sponsor. General shall select counsel for such
General or Joint Inventions, subject to the approval of the
Sponsor, which approval shall not be unreasonably withheld. General
agrees to cause Patent counsel selected by it to promptly provide
Sponsor with copies of all documents relating to the patent
application, to be available to Sponsor for consultation and
suggestions and for Sponsor to be otherwise fully informed
regarding all matters relating to the patent application and its
prosecution.
e. The Parties agree to cooperate and work together in good faith to
effect the provisions of this Section 13. Each Party agrees to
execute and deliver (or cause to be executed and delivered) all
assignments and other instruments of transfer necessary to effect the
provisions of this Section 13.
f. As to all Patent Rights relating to a General Invention or a Joint
Invention, General hereby grants Sponsor for the twelve (12) months
next following the first filing of patent applications in any
jurisdiction relating to such Invention the irrevocable first option
to obtain a license granting Sponsor the following rights and
containing the following terms:
(1) Sponsor shall for the life of all patent rights, unless sooner
terminated by either party in accordance with the terms of such a
license agreement, have a world-wide, exclusive (subject only to
paragraph (h) below), royalty-bearing license granting Sponsor
the right to use the Invention, to design, make, have made,
market lease, offer for sale, sell and/or distribute products
embodying or produced through the use of the Invention, itself or
through third parties by way of sublicense, and in all other
respects to use, sublicense, and commercialize the Invention and
any such product
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under all Patent Rights. Pursuant to such license, Sponsor
shall use reasonable efforts to commercialize such products in
accordance with time limits and objectives consistent with the
market potential of the Invention and the capacity and
resources of the Sponsor. Sponsor will be free to design the
products, and select pricing and marketing methods in its
discretion.
(2) Sponsor shall pay General a reasonable royalty of an amount
equal to the greater of $10,000 per year or up to 5% of
Sponsor's annual net sales revenues for such Invention (gross
revenues actually received by Sponsor from sales of the specific
product which results from the General or Joint Invention, net of
customary cash and trade discounts, returns and allowances);
provided, that Sponsor will pay the minimum $10,000 annual
royalty beginning in the fifth year after the license is executed
or sooner if Sponsor has net sales revenues before the fifth
year. The applicable royalty rate shall be agreed upon by the
parties within 30 days of Sponsor's exercise of the option.
(3) Sponsor will use all reasonable efforts to defend all challenges
to Patent Rights, including alleged infringements, and General
will cooperate with Sponsor in that regard.
(4) Sponsor may abandon the license at any time by express written
notice to General, in which case all rights will revert back to
General and all license and royalty obligations on Sponsor shall
terminate.
(5) Product liability indemnification and insurance requirements
which are reasonably acceptable to General's liability insurance
carrier.
(6) In addition to the foregoing, any other commercially reasonable
terms standard for agreements between universities and industry
not inconsistent with the foregoing.
Sponsor may exercise this option by giving written notice of exercise
to General during said twelve-month period. Thereafter, General and
Sponsor each agree to negotiate in good faith and to enter into a
license agreement incorporating the foregoing terms within six (6)
months after
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notice of exercise. If Sponsor elects not to give written notice
of exercise during such 12-month period, General may grant a
license to such Invention and Patent Rights to any other person or
entity.
g. General represents and warrants to Sponsor that, to the best of its
knowledge, based on a diligent review of its documents, as of the
effective date hereof, General is not prohibited or prevented from
granting such a license to Sponsor. General agrees, during the term
of the Project hereunder, not to enter into an agreement with any
third party to fund Principal Investigator to conduct the Project and
to use reasonable care not to enter into an agreement with a third
party under terms that will prevent General from granting to the
Sponsor the license contemplated under subsection (f) above. General
will monitor the activities of the Principal Investigator in order to
avoid conflicting activities that would prevent General from granting
such a License.
h. It is understood that General will reserve the right to use any
General Invention or Joint Invention only for research, clinical and
educational purposes, and that if federal funding supports the
Invention, Sponsor's license will be subject to the rights, conditions
and limitations imposed by U.S. law including without limitation the
royalty-free non-exclusive license granted to the U.S. government (see
35 USC sec. 202 et. seq. and regulations pertaining thereto). General
represents, warrants and agrees with Sponsor that no federal funds
will be used to support the Project as of the date of this Agreement
and, if any such funds will be used in the future, General will give
Sponsor at least 120 days' prior written notice of General's
acceptance of federal funds..
14. DATA. The original data generated as a result of the Project shall be
provided to Sponsor promptly, and Sponsor may use such data as it deems
advisable, including for purposes of publication, presentation to the
scientific community, seeking regulatory approvals or for any other
purposes, except to the extent that such use infringes a patent owned or
controlled by General not licensed to Sponsor. However, this provision
shall not be interpreted to restrict General's publication rights under
Section 7 of this Agreement. The Principal Investigator shall report to
the Sponsor every 90 days on the status and results of the Project. The
Principal Investigator shall keep reasonable and customary records of the
Project and related data sufficient for Sponsor's regulatory approval
activities and shall make such records available to Sponsor on reasonable
request.
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15. PUBLICITY. Neither Party shall use the name of the other Party or of any
Investigator in any advertising or promotional material without the prior
written approval of the other Party. The foregoing notwithstanding, (a)
General and the Principal Investigator shall acknowledge Sponsor's support
of the Project in their respective reports and publications, (b) Sponsor
may disclose the existence and describe the terms of, and may file a copy
of this Agreement (redacted to the extent Sponsor deems appropriate to
ensure confidentiality) as an exhibit to its press releases, reports and
governmental filings, including reports and filings with the U.S.
Securities and Exchange Commission and relevant foreign government
authorities; and (c) Sponsor may make reference to technical publications
by the Principal Investigator or his co-authors. Any publicity or
governmental filings of this Agreement pursuant to this Section 15 shall
describe the relationship of the Parties accurately and appropriately,
including the fact that CIPR is a division of Massachusetts General
Hospital and the same are affiliated with Harvard Medical School.
16. APPROVALS. General represents and warrants to Sponsor that this Agreement
and the Project have received the required approvals within Massachusetts
General Hospital and that no other approvals are required to authorize the
execution and effectiveness of this Agreement. Sponsor represents and
warrants to General that this Agreement and the Project have been approved
by its Board of Directors.
17. MODIFICATION. This Agreement and the Protocol constitute the sole, full,
and complete agreement by and between the Parties concerning the subject
matter hereof and supersedes and replaces all prior agreements, discussions
and representations (including the July 9, 1998 and July 10, 1998
correspondence between the Parties and the Memorandum of Understanding
referred to therein). No amendments of any provision of this Agreement
shall be valid unless reduced in writing and signed by the Parties and all
waivers must be in writing and signed by the Party against which the waiver
is to be enforced.
18. NOTICES AND OTHER COMMUNICATIONS. With the exception of Sponsor's payments
under Section 3, all notices and other communications between the Parties
in connection with this Agreement shall be in writing and deemed
sufficiently given when delivered by messenger or overnight courier
providing for receipted delivery, transmitted by fax with confirmation of
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transmission or sent by prepaid United States mail or other recognized
carrier, addressed as follows:
a. If to Sponsor:
Xxxx Xxxxxx
President, CEO
Photogen, Inc.
0000 Xxx Xxxxx xxxxxxx
Xxxxxxxxx, XX 00000
Fax number: (000) 000-0000
b. If to General:
Director, Office of Technology Affairs
Massachusetts General Hospital
13th Street, Building 149
Suite 1101
Xxxxxxxxxx, XX 00000
Fax number: (000) 000-0000
Either Party may change its address by written notice given to the other
Party. It is specifically provided that this notice provision shall not be
construed in such a manner as to abrogate the provisions of Section 16
regarding modification of this Agreement.
19. GOVERNING LAW; CHOICE OF FORUM. This Agreement is made and entered into the
State of Massachusetts and its validity and interpretation and the legal
relations of the Parties shall be governed by the internal laws of the
State of Massachusetts without regard to its provisions on conflict of
laws. Each Party submits to the exclusive jurisdiction of any state or
federal court sitting in Chicago, Illinois in any action or proceeding
relating to this Agreement and each Party agrees that all claims in respect
of the action or proceeding may be heard and determined only in any such
court. Each of such Parties waives any defense of inconvenient forum to
the maintenance of any action or proceeding so brought and waives any bond,
surety, or other security that might be required of any other Party with
respect thereto.
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20. INVESTIGATORS JOIN INTO AGREEMENT. Each person engaged by General as an
Investigator hereby joins into this Agreement and agrees to become bound to
all terms applicable to him or her and in particular, Sections as 1, 7(b)
and 13.
THIS AGREEMENT shall not be considered accepted, approved, or otherwise
effective until the signature of each Party is affixed in the space provided
below.
IN WITNESS WHEREOF, signifying their acceptance of and agreement to be bound by
the terms and conditions of this Agreement, the signatures of the Parties are
affixed hereto:
PHOTOGEN, INC. THE GENERAL HOSPITAL CORPORATION,
doing business as MASSACHUSETTS
GENERAL HOSPITAL
By: /s/Xxxx Xxxxxx By: /s/Xxxxx X. Xxxxx
---------------------- ---------------------
Xxxx Xxxxxx Xxxxx X. Xxxxx, Ph.D.
President, CEO Associate Director for Patents
Photogen, Inc. Office of Technology Affairs
Date: 10/12/98 Date: 10/6/98
-------------------- --------------------
JOINED INTO BY THE FOLLOWING INVESTIGATORS:
Name(s)
Date: 10/7/98 Xxxxxx X. Xxxx
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Date:
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Date:
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