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EXHIBIT 10.10
RESEARCH AND LICENSE AGREEMENT
THIS AGREEMENT is between RHODE ISLAND HOSPITAL CORPORATION, a
not-for-profit Rhode Island corporation having offices at 000 Xxxx Xxxxxx,
Xxxxxxxxxx, XX 00000 ("RIH") and NYMOX CORPORATION, a corporation having its
principal place of business at 0000 Xxxxxxxxx Xxxx, Xxxxx 000X, Xxxxxxxxxx, XX
00000-0000 ("NYMOX").
WHEREAS, Xxxx Xxxxx, M.D. and Xxxxxxx de la Xxxxx, M.D., of the Laboratory
of Liver Research of the RIH funded in part by the Department of Health and
Human Services are interested in the development of new diagnostic or
therapeutic strategies for Alzheimer's Disease and other neurodegenerative
diseases ("TECHNOLOGY");
WHEREAS, RIH and Drs. Wands and de la Monte desire to continue their
research pertaining to the TECHNOLOGY and are seeking additional funds to
continue such research;
WHEREAS, as a center for research and education, RIH is interested in
facilitating the use of this new TECHNOLOGY and in licensing PATENT RIGHTS and
RESEARCH INFORMATION as hereinafter defined and thus benefiting the public and
RIH by facilitating the development of healthcare products, but is without
capacity to commercially develop, manufacture, and distribute any such product;
and
WHEREAS, NYMOX has the capacity and know-how that will enhance the
usefulness of the results of the research performed by Xx. Xxxxx and Dr. de la
Monte and desires to provide RIH with funding to continue the research and to
obtain the right to use the results of this research under a license to PATENT
RIGHTS in order to commercially develop, manufacture, use and distribute
products throughout the world.
NOW THEREFORE, in consideration of the premises and of the faithful
performance of the covenants herein contained, the parties hereto agree as
follows:
SECTION 1. DEFINITIONS
1.1. The term "AFFILIATE" as applied to NYMOX shall mean NYMOX and any
company or other legal entity other than NYMOX in whatever country organized,
controlling, or controlled by NYMOX. The term "control" means possession, direct
or indirect, of the powers to direct or cause the direction of the management
and policies of a person, whether through the ownership of voting securities, by
contract or otherwise.
1.2. The term "AGREEMENT YEAR" shall mean the twelve (12) month period
beginning on the EFFECTIVE DATE and each succeeding twelve (12) month period
thereafter for the term of the Agreement. If not otherwise specified, terms
involving time periods shall be applied pro rata according to any time frame in
which less than the full specified period is involved.
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1.3. The term "EFFECTIVE DATE" shall mean March 1, 1999.
1.4. The term "FIELD OF RESEARCH" shall mean research pertaining to the use
of any form of neural thread protein, its antibodies, and any cDNAs or genes or
genomic fragments coding for neural thread protein, for diagnostic or
therapeutic purposes.
1.5. The term "FIRST COMMERCIAL SALE" shall mean in each country the first
sale of any PRODUCT by NYMOX, its AFFILIATES or SUBLICENSEES, following approval
of its marketing by the appropriate governmental agency for the country in which
the sale is to be made and when governmental approval is not required, the first
sale in that country.
1.6. The term "RIH MATERIAL" shall mean any material or substance
(including transgenic mice or cell lines) which has biological activity in the
FIELD OF RESEARCH (i) which relates to SPONSORED RESEARCH and is in the
possession of the PRINCIPAL INVESTIGATORS on the EFFECTIVE DATE and which RIH
has the right to transfer to NYMOX under the terms and conditions of this
Agreement, or (ii) which is discovered, produced or derived by an INVESTIGATOR
in the performance of SPONSORED RESEARCH.
1.7. The term "INVENTION" shall mean any new and useful process,
manufacture, or composition of matter which is in the FIELD OF RESEARCH (a)
which was conceived (i) prior to the EFFECTIVE DATE or (ii) in the performance
of SPONSORED RESEARCH; and (b) which is first reduced to practice,
constructively or actually (i) by an INVESTIGATOR in the performance of
SPONSORED RESEARCH or (ii) within one year of the termination of the SPONSORED
RESEARCH in which it was conceived by a person who had been an INVESTIGATOR; and
(c) in which RIH has rights by virtue of (i) sole or joint inventorship by an
INVESTIGATOR (or in case of an INVENTION first reduced to practice within said
one year period by a person who has been an INVESTIGATOR) or (ii) the terms of
any agreement that does not preclude granting rights to NYMOX hereunder.
1.8. The term "INVESTIGATOR" shall mean PRINCIPAL INVESTIGATORS, any other
member of RIM's Professional Staff, graduate student, undergraduate student, or
employee of RIH who shall perform SPONSORED RESEARCH.
1.9. The term "LICENSE FIELD" shall mean the manufacture, use or sale of
PRODUCTS for diagnostic or therapeutic purposes.
1.10. The term "NYMOX MATERIALS" shall mean any material or substance first
discovered, produced or derived by an employee of NYMOX prior to termination of
the SPONSORED RESEARCH which pertains to the SPONSORED RESEARCH, and in which
NYMOX has ownership or licensable rights.
1.11.
(a) The term "NET SALES PRICE" shall mean the gross billing price of any
PRODUCT received by NYMOX, its AFFILIATE or SUBLICENSEE for the sale or
distribution of any PRODUCT, less the following amounts actually paid out by
NYMOX, its AFFILIATE or SUBLICENSEE or credited against the amounts received by
them from the sale or distribution of
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PRODUCT:
(i) discounts allowed;
(ii) returns;
(iii) transportation charges or allowances;
(iv) customs, duties and charges; and
(v) sales, transfer and other excise taxes or other governmental
charges levied on or measured by the sales but no franchise or
income tax of any kind whatsoever.
(b) Transfer of a PRODUCT to an AFFILIATE for sale by the AFFILIATE shall not
be considered a sale; in the case of transfer the NET SALES PRICE shall be based
on the gross billing price of the PRODUCT by the AFFILIATE as invoiced to its
customer.
(c) Every commercial use or disposition of any PRODUCT (excluding any use for
(i) use in assuring product testing or control, (ii) promotional distribution to
physicians or (iii) distribution to researchers by or on behalf of NYMOX or any
of its AFFILIATES or SUBLICENSEES or (iv) obtaining regulatory approvals), in
addition to a bona fide sale to a bona fide customer (not to be construed as
including NYMOX or any such AFFILIATE or SUBLICENSEE) shall be considered a sale
of such PRODUCT at the NET SALES PRICE then payable in an arm's length
transaction.
(d) In the event any PRODUCT is sold as a component of a combination of active
functional elements, NET SALES PRICE for purposes of determining royalty
payments on such combination, shall be calculated by multiplying the NET SALES
PRICE of the combination by the fraction A over A+B, in which "A" is the gross
selling price of the PRODUCT portion of the combination when sold separately
during the ACCOUNTING PERIOD in which the sale was made, and "B" is the gross
selling price of the other active functional elements of the combination sold
separately during the ACCOUNTING PERIOD in question. All gross selling prices
shall be calculated as the average gross selling price of the PRODUCT for the
ACCOUNTING PERIOD as hereafter defined in the country in which the sale is made.
In the event that no separate sale of either such above-designated PRODUCT or
such above-designated active functional elements of the combination is made
during the ACCOUNTING PERIOD in which the sale was made, NET SALES shall be
calculated by multiplying NET SALES PRICE of such combination by the fraction C
over C+D, in which "C" is the standard fully-absorbed cost of the PRODUCT
portion of such combination, and "D" is the standard fully absorbed cost of the
other active functional element(s), such costs being arrived at using the
standard accounting procedures of NYMOX which will be in accord with generally
accepted accounting practices. The "ACCOUNTING PERIOD" shall be the periods for
which royalty payments are due as provided for in paragraph 7.7.
1.12. The term "PATENT RIGHT" shall mean
(a) any United States patent application which contains one or more claims
to an INVENTION; and
(b) any division or continuation and any foreign patent application or
equivalent
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corresponding to such patent applications and any Letters Patent or the
equivalent thereof issuing thereon or reissue or extension thereof.
1.13. The term "PRINCIPAL INVESTIGATORS" shall mean Xxxx Xxxxx, M.D. and
Xxxxxxx de la Monte, M.D.
1.14. The term "PRODUCT" shall mean any diagnostic article, composition,
apparatus, substance, chemical, material, method or service (a) whose
manufacture, use, or sale infringes one or more claims of any PATENT RIGHT, or
(b) which, in the absence of any PATENT RIGHT which would be infringed by such
manufacture, use or sale, (i) incorporates one or more RIH MATERIALS or (ii)
whose discovery, development, manufacture or use employs any RIH MATERIAL,
RESEARCH INFORMATION or PROCESS or unpatented INVENTION or NYMOX MATERIAL.
1.15. The term "PROCESS" shall mean any process or method for the
production, manufacture or use of any PRODUCT.
1.16. The term "RESEARCH INFORMATION" shall mean any research data,
formulas, process information or other information pertaining to the SPONSORED
RESEARCH (a) known to PRINCIPAL INVESTIGATORS on the EFFECTIVE DATE and which
PRINCIPAL INVESTIGATORS are not under obligation to any third party to maintain
in confidence, or (b) thereafter produced by an INVESTIGATOR in the performance
of SPONSORED RESEARCH.
1.17. The term "RESEARCH PROPOSAL" shall mean the written description of
SPONSORED RESEARCH attached hereto as Appendix A on the EFFECTIVE DATE or
thereafter appended hereto as Appendix A and incorporated herein pursuant to
paragraph 2.4(c) and shall include a reasonably detailed description of the
goals and scope of such research, and a budget that details the equipment,
materials, personnel, and the funds to be supplied by NYMOX to support the
research described in such proposal.
1.18. The term "SPONSORED RESEARCH" shall mean scientific research
pertaining to the FIELD OF RESEARCH funded in whole or in part by NYMOX and
performed by an INVESTIGATOR after the EFFECTIVE DATE pursuant to a RESEARCH
PROPOSAL attached as Appendix A.
1.19. The term "SUBLICENSEE" shall mean any non-AFFILIATE third party
licensed by NYMOX to make, have made, use or sell any PRODUCT or use any
PROCESS.
1.20. "VALID CLAIM" shall mean a claim of any PATENT RIGHT which has not
been finally rejected or declared invalid by a patent office or by a court of
competent jurisdiction in any unappealed and unappealable decision.
1.21. The use herein of the plural shall include the singular, and the use
of the masculine shall include the feminine.
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SECTION 2. RIH RESEARCH AND NYMOX'S SUPPORT THEREOF
2.1. Beginning on the EFFECTIVE DATE and continuing thereafter, unless
sooner terminated, for the next three (3) years, RIH shall:
(a) through the PRINCIPAL INVESTIGATORS and any other INVESTIGATOR conduct
SPONSORED RESEARCH and the grants and other amounts paid by NYMOX pursuant to
paragraphs 2.2(a) and 2.2(b) plus any additional funds paid pursuant to
paragraph 2.4(c) shall be used to support the expenses of SPONSORED RESEARCH, in
accordance with the RESEARCH PROPOSAL;
(b) promptly and systematically disclose to NYMOX RESEARCH INFORMATION
which NYMOX shall be entitled to use except to the extent such use is covered by
(i) a PATENT RIGHT under which NYMOX has elected not to be licensed under this
Agreement or (ii) any other patent, other than a PATENT RIGHT, owned by RIH and
not licensed to NYMOX
(c) promptly and systematically describe NYMOX RIH MATERIALS, and at
NYMOX'S request provide such RIH MATERIALS to NYMOX in accordance with
paragraph 3.3, which NYMOX shall be entitled to use in accordance with
paragraph 3.4 except to the extent (i) such RIH MATERIAL is covered by (A)
a PATENT RIGHT under which NYMOX has elected not to be licensed under this
Agreement or (B) any other patent, other than a PATENT RIGHT, owned by NYMOX and
not licensed to NYMOX or (ii) RIH does not have the right to grant to NYMOX the
right to use such RIH MATERIAL in accordance with paragraph 3.4;
(d) as to all SPONSORED RESEARCH:
(i) for the purpose of facilitating disclosure to NYMOX of RESEARCH
INFORMATION, INVENTIONS and RIH MATERIAL, permit duly authorized
employees of or representatives of NYMOX to visit the PRINCIPAL
INVESTIGATORS' laboratories at the RIH or other RIH facilities
where SPONSORED RESEARCH is conducted at the reasonable
convenience of PRINCIPAL INVESTIGATORS or any other pertinent
INVESTIGATOR; and
(ii) promptly advise NYMOX of any INVENTION and provide NYMOX with
adequate advance notice of the intent to file, filing allowance
and issuance of any PATENT RIGHT, except those filed by RIH at
its own expense pursuant to paragraph 5.1.
2.2. In consideration of said undertaking by PRINCIPAL INVESTIGATORS, NYMOX
shall at NYMOX's expense:
A. beginning with the EFFECTIVE DATE, make annual research grants to
RIH for the support of
SPONSORED RESEARCH in accordance with budgets that shall be supplied to NYMOX by
PRINCIPAL INVESTIGATORS (all figures in U.S. dollars) in the following amounts:
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One hundred seventy-two thousand dollars ($172,000) in the First AGREEMENT YEAR,
One hundred seventy-two thousand dollars ($172,000) in the Second AGREEMENT
YEAR,
One hundred seventy-two thousand dollars ($172,000) in the Third AGREEMENT YEAR,
or such greater amounts as shall be agreed to under paragraph 2.4(c).
B. pay to the RIH the grants set forth in the foregoing subparagraph
(a) in advance in accordance with the following:
Forty-three thousand dollars ($43,000) within ten days of the execution of this
AMENDMENT for the calendar quarter beginning on the EFFECTIVE DATE;
Forty-three thousand dollars ($43,000) on or about the first day of each
calendar quarter for the next eleven (11) consecutive quarters.
It is understood and agreed by the parties that, unless otherwise agreed,
the funds provided in advance by NYMOX shall not be expended by the PRINCIPAL
INVESTIGATORS prior to the start of the AGREEMENT YEAR for which such funds were
intended. In the event that the SPONSORED RESEARCH is terminated in accordance
with Article 10, any advance funds paid to RIH in excess of the amounts due RIH
under Article 10 and the noncancellable expenses reasonably committed to or
incurred by RIH prior to the termination shall be returned to NYMOX.
(c) provide PRINCIPAL INVESTIGATORS and INVESTIGATORS with NYMOX MATERIALS
in accordance with the terms and conditions of paragraphs 3.1 and 3.5 and in
reasonable amounts sufficient to allow PRINCIPAL INVESTIGATORS to carry out the
SPONSORED RESEARCH, and such other projects as the parties may agree to conduct,
to the extent reasonably available for distribution by NYMOX; and,
2.3.
(a) The grants paid by NYMOX pursuant to paragraphs 2.2(a), 2.2(b) or
2.4(c) shall be used to support the Total Direct Costs ("TDC"), as defined by
the U.S. Department of Health and Human Services ("DHHS"), of SPONSORED
RESEARCH, in accordance with the budgets that shall be supplied to NYMOX by
PRINCIPAL INVESTIGATORS and to pay all indirect costs ("Indirect Costs")
attendant to such TDC. The budgets shall be adjusted as necessary to allow for
payment of full Indirect Costs. The Indirect Costs shall be calculated as the
product of the Modified Total Direct Costs ("MTDC"), as defined by DHHS, of
SPONSORED RESEARCH and the RIH's research Indirect Cost Rate in effect at the
time the attendant MTDC are incurred. The Indirect Cost Rate shall be the
Hospital Research Rate on MTDC that is negotiated annually by RIH with the DHHS.
In no event shall any such adjustment require NYMOX to pay funds in excess of
those specified in paragraph 2.2 or which have been agreed to under
paragraph 2.4(c).
(b) If the research grants which NYMOX is obligated to pay RIH during any
AGREEMENT YEAR exceed the sum of the actual TDC of the SPONSORED RESEARCH
conducted during that
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AGREEMENT YEAR, and the total Indirect Costs during that AGREEMENT YEAR, the
excess shall be applied to SPONSORED RESEARCH in a future AGREEMENT YEAR. Any
interest earned by RIH on funds paid by NYMOX prior to being expended shall
belong to RIH.
2.4.
(a) Each INVESTIGATOR may conduct research outside the FIELD OF RESEARCH.
INVESTIGATORS shall be free to seek funding for such research from any source
including a commercial sponsor other than NYMOX.
(b) INVESTIGATORS shall be free at any time to seek funding for any
research in the FIELD OF RESEARCH, including additional funding for SPONSORED
RESEARCH, from any state or federal agency, private or public foundation except
foundations owned or operated by a commercial entity other than NYMOX, provided
that the terms and conditions of the funding agreement are not in conflict with
the terms and conditions of this Agreement including but not limited to NYMOX's
rights in and to SPONSORED RESEARCH.
(c) At any time during the term of this Agreement either party may propose
in writing additional research in the FIELD OF RESEARCH not previously described
in any RESEARCH PROPOSAL appended hereto as Appendix A. Each such proposal shall
include a description of the additional research proposed and a budget of the
costs to be funded by NYMOX and a schedule of payment of such costs. Unless the
parties shall otherwise agree in writing, negotiations between them over any
such proposal shall not extend beyond the sixtieth (60) day next following the
date when the proposal shall have first been so made, and whenever such
negotiations shall end without agreement between the parties to proceed with the
proposed research, the party proposing the additional research may go ahead
without the other party and seek funding from any other sponsor including but
not limited to a commercial sponsor for such proposal as set forth in
subparagraph (d). When such proposal is accepted by the RIH and NYMOX, it shall
be appended hereto as a RESEARCH PROPOSAL and shall be subject to the terms and
conditions of this Agreement unless otherwise specified, and the SPONSORED
RESEARCH described therein shall commence and budgeted amounts shall be paid as
set forth in the proposal or as otherwise agreed by the parties in writing. In
no event shall any additional research be added to SPONSORED RESEARCH nor shall
the direction of SPONSORED RESEARCH be altered without the concurrence of RIH.
(d) An INVESTIGATOR may not seek funding from another commercial sponsor
for an additional research proposal in the FIELD OF RESEARCH unless and until
such proposal has been submitted to NYMOX in accordance with the foregoing
subparagraph (c) and the parties have failed to agree in writing to append such
proposal hereto as a RESEARCH PROPOSAL within the stipulated sixty (60) days. In
the event of such failure to agree an INVESTIGATOR shall be free to seek and
accept funding from another commercial sponsor for such research proposal,
provided, that the subject matter of the proposal is not so closely related
scientifically to SPONSORED RESEARCH that sponsorship of such proposal by such
other commercial sponsor (i) would in the opinion of RIH after consultation with
NYMOX create a conflict of interest for RIH or any INVESTIGATOR performing
SPONSORED RESEARCH or (ii) would result in an agreement which is prohibited by
paragraph 6.7 of this Agreement or (iii) would conflict with the terms and
conditions of this Agreement. A "conflict of interest" for the purposes of this
paragraph 2.4 means that the sponsorship of such proposal by such other
commercial entity is likely to result in a product
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for the other commercial sponsor competitive with a PRODUCT likely to result
from the SPONSORED RESEARCH. In the event that RIH is of the opinion that there
is no "conflict of interest," NYMOX shall be notified promptly in writing of
such opinion. If NYMOX disagrees with such opinion, NYMOX shall have the right
to have the existence of a "conflict of interest" determined by alternative
dispute resolution pursuant to paragraph 11.3(b) by submitting such issue to
alternative dispute resolution within thirty (30) days of receipt of such
notice. INVESTIGATORS shall not be free to seek such funding until the later of
the expiration of such thirty (30) day period, or if an alternative dispute
resolution is initiated, a determination by alternative dispute resolution that
there is no "conflict of interest."
Section 3. TRANSMISSION OF AND RIGHTS TO USE RIH
MATERIALS AND NYMOX MATERIALS
3.1. RIH and PRINCIPAL INVESTIGATORS shall not distribute NYMOX MATERIALS
to any one other than INVESTIGATORS or use them for any purpose other than
SPONSORED RESEARCH without the prior written approval of NYMOX.
3.2. During the life of this Agreement RIH agrees not to grant to any third
party commercial or for-profit entity the right to use any RIH MATERIAL in the
LICENSE FIELD without NYMOX's written consent except where such RIH MATERIAL or
its manufacture or its use is claimed in a PATENT RIGHT (i) to which NYMOX fails
to exercise an option for a license pursuant to paragraph 6.1, or (ii) to which
NYMOX's license rights have been terminated, or (iii) which is licensed
non-exclusively in the LICENSE FIELD hereunder, or (iv) which is licensed
coexclusively in the LICENSE FIELD hereunder, provided that in the case of such
co-exclusively licensed PATENT RIGHT, RIH shall have the right to grant the
right to use such RIH MATERIAL only to the party to which such PATENT RIGHT is
co-exclusively licensed.
3.3. To the extent allowed by law and the requisite informed consent of any
person whose tissue contributes substantially to any RIH MATERIALS, PRINCIPAL
INVESTIGATORS promptly, upon NYMOX's request, shall provide NYMOX with an amount
of such RIH MATERIAL specified by NYMOX and reasonably needed for the purposes
of this Agreement including those specified in paragraph 3.4 but in no event
shall PRINCIPAL INVESTIGATORS be obligated to provide NYMOX such RIH MATERIAL in
an amount that would interfere with PRINCIPAL INVESTIGATORS' ability to conduct
SPONSORED RESEARCH.
3.4. NYMOX shall have the right to use RIH MATERIALS provided to it for
(i) any commercial purposes solely in the LICENSE FIELD including but not
limited to the development, manufacture, sale and use of any PRODUCT or practice
of any PROCESS; (ii) for research and development purposes in the FIELD OF
RESEARCH so long as such uses that may lead to publications are discussed with
the PRINCIPAL INVESTIGATORS under whose direction the RIH MATERIALS are produced
prior to the use of the transferred RIH MATERIALS for such purposes and the
INVESTIGATOR who produces the RIH MATERIALS is given the credit and recognition
customary for academic scientific publication by acknowledgment or co-authorship
as appropriate; and (iii) transfers to third parties, provided, however, that in
the case of transfer to third parties NYMOX has obtained the consent of the
PRINCIPAL INVESTIGATORS under whose direction the RIH MATERIALS are produced for
the following cases: (a) in the case of RIH
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MATERIALS that have not been described by an INVESTIGATOR in a journal that
requires dissemination of the described materials as a condition of publication,
and which are being transferred to any party allowed to publish the results of
research performed using the described materials, prior to the transfer, and (b)
in all cases, prior to depositing any RIH MATERIALS in any depository in support
of any patent application.
3.5.
(a) During the period SPONSORED RESEARCH is being performed hereunder, RIH
and PRINCIPAL INVESTIGATORS shall not, without NYMOX's prior written approval,
distribute or knowingly allow to be distributed RIH MATERIALS to for-profit
entities except for use outside the FIELD OF RESEARCH and LICENSE FIELD or to
for-profit non-exclusive licensees or co-exclusive licensees in the LICENSE
FIELD or persons known to be employed thereby or consulting or performing
research therefor in the FIELD OF RESEARCH unless, (1) a description of the RIH
MATERIAL is published in a journal that requires dissemination of the described
materials as a condition for publication, or (2) RIH and NYMOX have mutually
agreed not to seek PATENT RIGHTS claiming such RIH MATERIAL or its manufacture
or use. Under the circumstances described in (1) or (2) of this paragraph 3.5,
RIH and PRINCIPAL INVESTIGATORS shall have the right to distribute such RIH
MATERIAL, only to:
(i) scientists who agree in writing not to transfer such RIH
MATERIALS to any other person or entity or to use such RIH
MATERIALS for commercial purposes or for research for commercial
purposes; or
(ii) third persons solely for the purpose of obtaining chemical,
physical, or biological analysis or characterization of such RIH
MATERIALS, provided that such persons agree in writing not to
transfer or grant access to such RIH MATERIALS or any non-public
information regarding such RIH MATERIALS to any other person or
entity and to use such RIH MATERIALS only for the purpose of the
agreed upon analysis or characterization and not to disclose such
analysis or characterization to any third party.
(b) During the period SPONSORED RESEARCH is being performed hereunder, RIH
and PRINCIPAL INVESTIGATORS shall have the right to transfer RIH MATERIALS to
not-for-profit entities or persons known to be affiliated therewith provided
that such entities or persons agree in writing not to (i) transfer such RIH
MATERIALS to any other person or entity, (ii) use such RIH MATERIALS for
commercial purposes, and (iii) sequence or close any genetic material or
sequence in such RIH MATERIALS or products thereof.
(c) In the event that a PRINCIPAL INVESTIGATOR is no longer available to
perform SPONSORED RESEARCH at RIH but continues to be employed by a
not-for-profit entity, it is understood that at said former PRINCIPAL
INVESTIGATOR's request RIH shall make available to said former PRINCIPAL
INVESTIGATOR, RIH MATERIALS, provided that in the event that said former
PRINCIPAL INVESTIGATOR is replaced by a new PRINCIPAL INVESTIGATOR pursuant to
paragraph 10.2, the amounts of such RIH MATERIAL shall not interfere with the
ability of said new PRINCIPAL INVESTIGATOR to conduct SPONSORED RESEARCH at RIH,
and further provided that said former PRINCIPAL INVESTIGATOR agrees in writing
(i) not to
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use said RIH MATERIALS for commercial purposes or in research sponsored by any
for-profit entity and (ii) not to transfer said RIH MATERIALS to any third party
except under the same conditions set forth in paragraphs 3.5(a) and 3.5(b)
hereof.
(d) Prior to any such distribution of any such RIH MATERIALS by reason of
the conditions described in subparagraphs (a), (b) or (c) above, RIH and NYMOX
shall use reasonable efforts to consider the patentability of such RIH MATERIALS
and cooperate to file, where appropriate, PATENT RIGHTS protecting such RIH
MATERIALS prior to their distribution.
SECTION 4. CONFIDENTIALITY AND PUBLICATION RIGHTS
4.1. In the event that NYMOX discloses to any RIH personnel any information
which relates to the SPONSORED RESEARCH that NYMOX considers confidential, the
rights and obligations of the parties with respect to such information shall be
governed by the terms and conditions set forth in Appendix C.
4.2. Recognizing RIH's desire to publish previously unpublished RESEARCH
INFORMATION and NYMOX's desire to develop the results of SPONSORED RESEARCH for
the earliest introduction to the public:
(a) RIH agrees to submit to NYMOX an early draft of each document as
follows:
(i) Each manuscript first disclosing RESEARCH INFORMATION or an
INVENTION or describing a RIH MATERIAL at least thirty (30) days
prior to its submission for publication; and
(ii) Each abstract disclosing RESEARCH INFORMATION or an INVENTION or
a RIH MATERIAL at least seven (7) days prior to its submission
for publication.
NYMOX shall have the right to advise RIH as to the patentability of any
INVENTIONS disclosed therein and of NYMOX's desire to have PATENT RIGHTS
claiming such INVENTIONS filed. RIH shall use reasonable efforts to carry out
such advice in accordance with the terms of this Agreement. At the end of such
thirty (30) day or seven (7) day period, RIH shall have the right, at its
discretion, to submit such manuscript or abstract for publication.
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(b) Nothing in this Agreement shall be construed to prohibit or limit
in any way:
(i) The filing by RIH of any report required by any public authority
pertaining to SPONSORED RESEARCH;
(ii) The non-public disclosure and discussion of RESEARCH INFORMATION
between the INVESTIGATORS and their academic colleagues. RIH
shall advise the INVESTIGATORS that when making such non-public
disclosures, consideration should be given to RIH's and NYMOX's
interest in obtaining the benefits of worldwide patent coverage
of any INVENTIONS included in RESEARCH INFORMATION.
SECTION 5. PATENTS
5.1. Each INVESTIGATOR who during the course of SPONSORED RESEARCH shall
make an INVENTION, solely or jointly, ("RIH INVENTOR") shall promptly report
such INVENTION to RIH. Each RIH INVENTOR shall assign all of his rights, title
and interest in an INVENTION TO RIH. Each employee of NYMOX who makes an
INVENTION jointly with an INVESTIGATOR, shall report such INVENTION to NYMOX and
shall assign all his rights, title and interest in such INVENTION to NYMOX.
INVENTIONS made jointly by INVESTIGATOR and NYMOX employees shall be jointly
owned. NYMOX shall report such INVENTION in writing to RIH's Office of Research
Administration. RIH and NYMOX agree that for each PATENT RIGHT jointly assigned
to RIH and NYMOX, NYMOX and RIH each own a one-half undivided interest in such
PATENT RIGHT in each country in which it is filed and RIH's interest therein is
subject to the license rights granted to NYMOX under this Agreement. RIH and
NYMOX shall each be allowed to sell, license or otherwise transfer its rights to
such PATENT RIGHT without the consent of the other; however, RIH's rights in
this respect are subject to the terms and conditions of this Agreement and
NYMOX's licensing rights thereto.
Each party shall promptly advise the other in writing of each
INVENTION disclosed to it. Representatives of RIH and NYMOX shall then discuss
whether a patent application or applications pertaining to such INVENTION should
be filed and in which countries. If both parties mutually agree that patent
application(s) should be filed, applications assigned solely to RIH shall be
filed by RIH, applications assigned solely to NYMOX shall be filed by NYMOX and
jointly assigned applications shall be filed as mutually agreed upon by the
parties. The titles, serial numbers and other identifying data of any patent
applications claiming an INVENTION filed after the EFFECTIVE DATE by mutual
agreement of RIH and NYMOX shall be listed in Appendix D and shall become PATENT
RIGHTS.
Reasonable and customary patent costs incurred by RIH for PATENT
RIGHTS filed by mutual agreement ("PATENT COSTS") shall be reimbursed in full by
NYMOX upon NYMOX's receipt of RIH's notice of payment of such PATENT COSTS,
except as provided for below. Such PATENT COSTS shall include but not be limited
to the costs of preparing, filing, prosecuting (including mutually agreed upon
interferences or oppositions), issuing or maintaining and working the PATENT
RIGHTS. For PATENT COSTS not reimbursed by NYMOX within thirty (30) days after
receipt of RIH's notice of payment of such costs, NYMOX shall pay RIH interest
at the rate of
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one and one half (1.5) percent per month compounded each month that they remain
unpaid. For PATENT RIGHTS in which other commercial entities have acquired
license rights, NYMOX shall reimburse the RIH only for the same share of such
costs as reimbursed by each of the other commercial entities, but in no event
shall NYMOX be required to reimburse RIH for more than 50% of the PATENT COSTS
for such PATENT RIGHTS.
In the event NYMOX is not interested in having PATENT RIGHTS filed
with respect to a particular INVENTION made solely by RIH INVENTOR(S), NYMOX
shall advise RIH of such fact within ninety (90) days from the date on which the
INVENTION was disclosed to NYMOX by RIH or sooner as specified by RIH if
necessary to avoid the lost of PATENT RIGHTS. RIH, at its own expense may then
file and prosecute such patent application in any country where NYMOX elects not
to file, and such patent applications and patents shall not be included with the
rights licensed to NYMOX pursuant to paragraphs 6.1, 6.2 and 6.3 of this
Agreement and RIH shall be free to license such patent application or patent to
any other party.
In the event that RIH does not wish to file a patent application with respect to
a particular INVENTION, or does not wish to file patent applications with
respect to specific countries, it shall first without delay notify NYMOX, and
NYMOX shall be free, where not contrary to United States law, to file at its
expense patent applications in the name of RIH. If necessary, RIH shall render
NYMOX, at NYMOX's expense, all necessary assistance in order to facilitate such
filing. Any such application shall be considered a PATENT RIGHT for all purposes
of this Agreement.
5.2. With respect to any PATENT RIGHT filed by mutual agreement of the
parties, each patent application, office action, response to office action,
request for terminal disclaimer, and request for reissue or reexamination of any
patent issuing from such application shall be provided to NYMOX sufficiently
prior to the filing of such application, response or request to allow for review
and comment by NYMOX.
SECTION 6. LICENSES
6.1. As to each PATENT RIGHT assigned in whole or in part to RIH or in
which RIH has a licensable right, RIH shall, upon written request submitted by
NYMOX within the eighteen (18) months next following the U.S. filing date of
such PATENT RIGHT, grant to NYMOX and any AFFILIATE of NYMOX designated in
writing by NYMOX, a license as defined in the next succeeding paragraphs 6.2 and
6.3 under RIM's rights; and, in the absence of such request by NYMOX, RIH may
grant a license to said PATENT RIGHT to any other person or persons on any
terms. The option to acquire a license hereunder does not apply to any PATENT
RIGHT that NYMOX has advised RIH's Office of Research Administration in writing
that NYMOX is not interested in having filed, prosecuted or maintained.
6.2. To the extent not prohibited by the United States government or by
contractual obligations requiring RIH to license a PATENT RIGHT to any other
sponsor of research with respect to INVENTIONS made jointly by a person who is
not an INVESTIGATOR but who is a co-inventor of a PATENT RIGHT with an
INVESTIGATOR, at the written request of NYMOX or any
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AFFILIATE of NYMOX in accordance with the foregoing paragraph 6.1, RIH hereby
grants to NYMOX:
(a) an exclusive, worldwide, royalty-bearing license under PATENT RIGHTS
in the LICENSE FIELD (i) to make, have made, use, sell and have sold
PRODUCTS and (ii) to use PROCESS; and
A. the right to grant sublicenses in the LICENSE FIELD to any PATENT
RIGHTS licensed
exclusively hereunder or co-exclusively to NYMOX pursuant to paragraph 6.3
provided that any SUBLICENSEE agrees to be bound by the terms and conditions of
this Agreement applicable to SUBLICENSEES. If NYMOX has only a non-exclusive
license to any PATENT RIGHTS, RIH will, upon request of NYMOX, grant NYMOX the
right to grant sublicenses thereunder unless it has a reasonable basis for
refusing such grant.
6.3. To the extent and only to the extent that RIH is prohibited from
granting to NYMOX an exclusive license to pay PATENT RIGHT for the reasons set
forth in paragraph 6.2, the license granted to NYMOX under paragraph 6.2 shall
be co-exclusive with such other sponsor where exclusivity is prohibited by RlH's
contractual obligations to such other sponsor and nonexclusive where exclusivity
is prohibited by the United States government.
6.4. The above licenses to sell any PRODUCT includes the right to grant to
the purchaser of such PRODUCT from NYMOX, its AFFILIATES, and SUBLICENSEES the
right to use such purchased PRODUCT in a method coming within the scope of
PATENT RIGHTS.
6.5. All licenses pursuant to paragraphs 6.2, 6.3 and 6.4 above to
INVENTIONS conceived or first actually reduced to practice during the course of
research funded by a U.S. federal agency are subject to the rights, conditions
and limitations imposed by U.S. law. RIH agrees to use its best efforts to
diligently comply with the requirements of such laws and applicable regulations.
The words "exclusive license" as used herein shall mean exclusive except for the
royalty-free non-exclusive license granted to the U.S. government by RIH
pursuant to 35 USC Section 202(c)(4) for any PATENT RIGHT claiming an INVENTION
subject to 35 USC Section 201 and the rights of RIH and INVESTIGATORS as set
forth in paragraph 6.6.
6.6. All licenses granted pursuant to paragraphs 6.2, 6.3 and 6.4 above are
subject to RlH's and INVESTIGATOR's rights to use for its internal research and
patient care purposes any INVENTION claimed in the licensed PATENT RIGHT,
however, except as set forth in paragraph 2.2(c), such rights do not obligate
NYMOX to supply PRODUCT or NYMOX MATERIALS for such use.
6.7. RIH represents that on the date this agreement is signed by RIH, that
to the best of its knowledge (i) there is no agreement in effect on the
EFFECTIVE DATE between RIH or PRINCIPAL INVESTIGATORS and any party (not
including the United States Government) which prohibits RIH from granting to
NYMOX the exclusive licenses set forth in paragraphs 6.2 and 6.3 and (ii) that
all INVESTIGATORS are obligated to assign all right, title and interest in
INVENTIONS and PATENT RIGHTS to RIH.
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(a) Notwithstanding anything else to the contrary, RIH agrees during the
period SPONSORED RESEARCH is being performed not to enter into an
agreement with any third party commercial entity to fund PRINCIPAL
INVESTIGATORS or any INVESTIGATOR to conduct SPONSORED RESEARCH.
(b) RIH agrees to use reasonable care not to enter into an agreement with
a third party to acquire materials for use in SPONSORED RESEARCH under
terms that will prevent RIH from granting NYMOX sole and exclusive
rights to PATENT RIGHTS.
6.8. NYMOX, its AFFILIATES and SUBLICENSEES shall use reasonable efforts to
develop a PRODUCT as defined by paragraph 1.14(a) or 1.14(b)(i) selected by
NYMOX for commercial sales and distribution or to use PROCESSES for commercial
purposes throughout the world. Prior to the end of three (3) years from the date
each PATENT RIGHT is first filed in the United States or eighteen (18) months
from the date NYMOX is granted a license to such PATENT RIGHT pursuant to
paragraph 6.1 and 6.2, whichever shall occur first, RIH and NYMOX shall meet to
designate reasonable objectives and the time periods in which such objectives
are to be met by NYMOX, its AFFILIATES or SUBLICENSEES with respect to PRODUCT
selected by NYMOX. By way of example, such objectives may include commencement
of animal toxicity studies, submission of a Notice of Claimed Investigational
Exemption for a New Drug with the U.S. Food and Drug Administration (the "FDA"),
commencement and diligent performance of human studies and submission of a
Product License Application (a "PLA") with the FDA. If such meeting occurs prior
to the third anniversary of the first U.S. filing date of such PATENT RIGHT and
the parties agree that such objectives cannot be designated at that time, the
period to designate such objectives may be extended for up to one (1) year.
NYMOX shall exert reasonable efforts to obtain such objectives. In the event
NYMOX subsequently indicates in writing to RIH that such objectives cannot be
met or fails to meet such objectives, NYMOX and RIH shall enter into good faith
negotiations to reconsider such objectives. In the event that the parties cannot
agree to the initial objectives by the fifth anniversary or to modify objectives
within ninety (90) days after beginning good faith negotiations, the matter
shall be submitted to alternative dispute resolution pursuant to paragraph 11.3
to determine the objectives and the time periods therefor which should be met
pursuant to this paragraph 6.8. The alternative dispute resolver in setting and
determining the objectives shall consider the state of the technology; the
efforts exerted by NYMOX; the business circumstances of NYMOX, including
finances and manpower available to NYMOX; and technical and regulatory problems.
Thereafter, NYMOX shall exert reasonable efforts to achieve such objectives.
In the event that NYMOX indicates that it cannot meet the objectives
whether set by the parties or by alternative dispute resolution because of
technological or regulatory problems, RIH shall not unreasonably deny an
extension of the objectives.
If NYMOX (i) fails to meet the objectives established by agreement of
the parties for development either of diagnostic PRODUCTS or therapeutic
PRODUCTS and fails to negotiate reconsideration of such objectives or to request
alternative dispute resolution or (ii) fails to meet objectives established by
alternative dispute resolution, RIH shall have the right to terminate the
licenses to such PATENT RIGHT granted hereunder in the portion of the field,
diagnostics or therapeutics, in which the objectives have not been met or
convert such licenses to non-exclusive
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licenses in the applicable portion of the field by providing to NYMOX sixty (60)
days prior written notice. Prior to the expiration of such sixty (60) day
period, NYMOX may submit such action to alternative dispute resolution to
determine whether or not NYMOX has exerted reasonable efforts pursuant to this
paragraph 6.8, and once such action has been submitted to alternative dispute
resolution the licenses and rights may only be modified or canceled in the event
of a decision in the alternative dispute resolution that NYMOX has not exerted
such reasonable efforts. If the alternative dispute resolver decides that NYMOX
has exerted reasonable efforts, the alternative dispute resolver shall establish
new objectives.
NYMOX shall insure that, for any PRODUCT or PROCESS being developed or
commercialized by an AFFILIATE or SUBLEASEE, such AFFILIATE or SUBLICENSEE shall
assume the obligations imposed on NYMOX under this paragraph 6.8.
6.9. At the end of each AGREEMENT YEAR, after objectives are established,
NYMOX shall report in writing to RIH on the progress made toward the objectives
established pursuant to Paragraph 6.8.
6.10. In the event NYMOX or any AFFILIATE or SUBLICENSEE intends to sell any
PRODUCT whose manufacture, use or sale is not subject to one or more VALID
CLAIMS of any PATENT RIGHT licensed to NYMOX, NYMOX will notify RIH in writing
of such intent not later than sixty (60) days prior to its distribution of such
PRODUCT, and shall discuss with RIH and renegotiate as necessary a "Competitive"
royalty as provided in paragraph 7.l(d).
SECTION 7. ROYALTIES
7.1. On all sales of PRODUCTS anywhere in the world by NYMOX, its
AFFILIATES or SUBLICENSEES, NYMOX shall pay RIH royalties in accordance with the
following schedule subject to the provisions of paragraph 7.l(d), such
undertaking and schedule having been agreed to for the purpose of reflecting and
advancing the mutual convenience of the parties.
(a) For each PRODUCT sold by NYMOX or its AFFILIATES or SUBLICENSEES where
such PRODUCT, its manufacture or use shall be subject to a VALID CLAIM
of any PATENT RIGHT: licensed exclusively to NYMOX, the royalty shall
be four percent (4%) of the NET SALES PRICE; and
(b) For each PRODUCT sold by NYMOX or its AFFILIATES or SUBLICENSEES where
such PRODUCT, its manufacture or use shall be subject to a VALID CLAIM
of any PATENT RIGHT licensed non-exclusively to NYMOX, the royalty
shall be one-half of the rate specified for such PRODUCT in (a) above;
and
(c) During each of the seven (7) years next following the FIRST COMMERCIAL
SALE anywhere in the world by NYMOX, its AFFILIATES, or SUBLICENSEES
of each PRODUCT whose manufacture, use or sale shall employ or
incorporate any RIH MATERIAL, RESEARCH INFORMATION or NYMOX MATERIAL
where such RIH MATERIAL, RESEARCH
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INFORMATION or NYMOX MATERIAL is not subject to one or more VALID
CLAIMS of any PATENT RIGHT in the country in which such PRODUCT is
manufactured, used or sold, NYMOX shall pay RIH a royalty on the sale
of such PRODUCT of one (1) percent of the NET SALES PRICE of such
PRODUCT; and
(d) Notwithstanding paragraphs 7.1(a), (b) and (c) and 7.2 below, if at
the time NYMOX requests in writing a license pursuant to paragraph 6.1
or notifies RIH in writing of its intent to distribute a PRODUCT whose
manufacture, use or sale is not subject to one or more VALID CLAIMS of
any PATENT RIGHT licensed to NYMOX pursuant to paragraph 6.10, and no
royalty as specified in this paragraph 7.1 is "Competitive" as
hereinafter defined, RIH shall grant to NYMOX a license at the lowest
royalty rate that is Competitive at the time RIH receives NYMOX's
written request. A royalty rate shall be regarded as "Competitive" if
it is within the range of royalty rates that RIH would charge in an
arms length transaction with a licensee which was not and had not been
a sponsor of research at RIH, taking into account the value of the
licensed technology at the time of RIH's receipt of a written request
for a license or notice of intent to distribute a PRODUCT by NYMOX.
7.2. If NYMOX is required to pay a royalty or royalties to any third party
to practice PATENT RIGHTS licensed hereunder, NYMOX may reduce the amount paid
to RIH hereunder by one-half of the amount paid to such third party or parties,
provided, however, that the aggregate of any reduction in royalties under this
paragraph 7.2 shall not exceed fifty (50) percent of any royalty payment
otherwise due RIH under paragraph 7.1.
7.3. If and whenever RIH shall as permitted herein license any PATENT RIGHT
to another licensee for the purpose of making, using or selling PRODUCTS in the
FIELD, at a royalty or royalties more favorable to such licensee than herein
provided for NYMOX, RIH shall give written notice thereof to NYMOX and as of the
effective date of such more favorable royalty or royalties, NYMOX's obligation
hereunder to pay royalty or royalties to RIH shall be revised to the more
favorable rate.
7.4. In the event that the royalty paid to RIH is a significant factor in
the return realized by NYMOX so as to diminish NYMOX's capability to respond to
competitive pressures in the market, RIH agrees to consider a reasonable
reduction in the royalty paid to RIH as to each such PRODUCT for the period
during which such market condition exists. Factors determining the size of the
reduction will include profit margin on PRODUCT and on analogous products,
prices of competitive products, total prior sales by NYMOX, and NYMOX's
expenditures in PRODUCT development.
7.5. NYMOX shall keep, and shall cause each of its AFFILIATES and
SUBLICENSEES, if any, to keep, full and accurate books of account containing all
particulars that may be necessary for the purpose of calculating all royalties
payable to the RIH. Such books of account shall be kept at their principal place
of business and, with all necessary supporting data shall, during all reasonable
times for the three (3) years next following the end of the calendar year to
which each shall pertain, be open for inspection at reasonable times by RIH or
its designee at RIH's expense for the sole purpose of verifying royalty
statements or compliance with this Agreement.
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7.6. With each semiannual payment, NYMOX shall deliver to RIH a full and
accurate accounting to include at least the following information:
(a) Quantity of each PRODUCT sold or leased (by country) by NYMOX, and
its AFFILIATES or SUBLICENSEES;
(b) Total receipts for each PRODUCT (by country);
(c) Quantities of each PRODUCT (i) used by NYMOX and its AFFILIATES or
SUBLICENSEES unless such PRODUCT is used for the purposes excluded by
paragraph l.ll(c) or (ii) sold to the United States Government for
which the government requires a reduction in the NET SALES PRICE as a
result of its license under 35 USC Sec. 204.
(d) Names and addresses of all SUBLICENSEES of NYMOX; and
(e) Total royalties payable to RIH.
7.7. In each year the amount of royalty due shall be calculated semiannually
as of June 30 and December 31 ("ACCOUNTING PERIOD") and shall be paid
semiannually within the sixty (60) days next following such date, every such
payment shall be supported by the accounting prescribed in paragraph 7.5 and
shall be made in United States currency. Whenever for the purpose of calculating
royalties conversion from any foreign currency shall be required, such
conversion shall be at the rate of exchange thereafter published in the Wall
Street Journal for the business day closest to the last day of the applicable
ACCOUNTING PERIOD.
7.8. Only one royalty calculated at the highest applicable royalty rate
shall be due and payable to RIH by NYMOX for any PRODUCT subject to royalty
under this Agreement regardless of the number of PATENT RIGHTS covering such
PRODUCT, its manufacture and use.
7.9. If the transfer of or conversion into United States Dollar Equivalent
of any such remittance in any such instance is not lawful or possible, the
payment of such part of the royalties as is necessary shall be made by the
deposit thereof, in the currency of the country where the sale was made on which
the royalty was based, to the credit and account RIH or its nominee in any
commercial bank or trust NYMOX located in that country, prompt notice of which
shall be given to NYMOX.
7.10. Any tax required to be withheld by NYMOX under the laws of any foreign
country for the account of RIH, shall be promptly paid by NYMOX for and on
behalf of RIH to the appropriate governmental authority, and NYMOX shall use its
best efforts to furnish RIH with proof of payment of such tax. Any such tax
actually paid on RIH's behalf shall be deducted from royalty payments due RIH.
7.11. The royalty payments due under the Agreement shall, if overdue, bear
interest until payment at a per annum rate equal to one percent (1 %) above the
prime rate in effect at the Bank of Boston on the due date, not to exceed the
maximum permitted by law. The payments of such interest shall not preclude RIH
from exercising any other rights it may have as a consequence of the lateness of
any royalty payment.
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SECTION 8. INFRINGEMENT
8.1. RIH will protect its PATENT RIGHTS from infringement and prosecute
infringers when, in its sole judgment, such action may be reasonably necessary,
proper and justified.
8.2. If NYMOX shall have supplied RIH with written evidence demonstrating
to RIH's reasonable satisfaction prima facie infringement of a claim of a PATENT
RIGHT by a third party, NYMOX may by notice request RIH to take steps to protect
the PATENT RIGHT, and unless RIH shall within (3) months of the receipt of such
notice either (i) cause infringement to terminate or (ii) initiate legal
proceedings against the infringer, NYMOX may, upon notice to RIH, initiate legal
proceedings against the infringer at NYMOX's expense and in RIM's name if so
required by law. NYMOX's reasonable and customary expenses for such legal
proceedings shall be fully creditable against royalties owed to RIH hereunder,
provided that in no event shall any royalty payment to RIH be reduced by more
than 50%.
8.3. In the event one party shall initiate or carry on legal proceedings to
enforce any PATENT RIGHT against any alleged infringer, the other party shall
fully cooperate with and supply all assistance reasonably requested by the party
initiating or carrying on such proceedings. The party which institutes any suit
to protect or enforce a PATENT RIGHT shall have sole control of that suit and
shall bear the reasonable expenses (excluding legal fees) incurred by said other
party in providing such assistance and cooperation as is requested pursuant to
this paragraph. The party initiating or carrying on such legal proceedings shall
keep the other party informed of the progress of such proceedings and said other
party shall be entitled to counsel in such proceedings but at its own expense.
Any award paid by third parties as the result of such proceedings (whether by
way of settlement or otherwise) shall first be applied to reimbursement of the
unreimbursed legal fees and expenses incurred by either party and then to the
payment to RIH of the amount of royalties which were applied to the expense of
legal proceedings in accordance with paragraph 8.2 above and then the remainder
shall be divided between the parties as follows;
(a)
A. If the amount is lost profits, NYMOX shall receive an amount
equal to the damages the court determines NYMOX has suffered as a
result of the infringement less the amount of any royalties that
would have been due RIH on sales of PRODUCT lost by NYMOX as a
result of the infringement had NYMOX made such sales; and
(ii) RIH shall receive an amount equal to the royalties it would
have received if such sales had been made by NYMOX; or
(b) As to awards other than lost profits, seventy (70) percent to the
party initiating such proceedings and thirty (30) percent to the other
party.
8.4. For the purpose of the proceedings referred to in this paragraph 8,
RIH and NYMOX shall permit the use of their names and shall execute such
documents and carry out such other acts as may be necessary.
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SECTION 9. INDEMNIFICATION AND INSURANCE
9.1.
(a) NYMOX shall indemnify, defend and hold harmless RIH 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
attorneys' 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 theory of
product liability (including, but not limited to, actions in the form
of tort warranty, or strict liability) concerning any PRODUCT, PROCESS
or service made, used or sold pursuant to any right or license granted
under this Agreement or (ii) arising out of any other activities to be
carried out pursuant to this Agreement.
(b) NYMOX's indemnification under (a) above shall not apply to any
liability, damage, loss or expense that it is attributable to the
negligent activities, reckless misconduct or intentional misconduct of
the Indemnitees.
(c) NYMOX agrees, at its own expense, to provide attorneys reasonably
acceptable to RIH to defend against any actions brought or filed
against any party indemnified hereunder with respect to the subject of
indemnity contained herein, whether or not such actions are rightfully
brought.
9.2.
(a) Beginning at the time any such PRODUCT, PROCESS or service is being
commercially distributed or sold (other than for the purpose of
obtaining regulatory approvals) by NYMOX or by a SUBLICENSEE,
AFFILIATE or agent of NYMOX, NYMOX shall at its sole cost and expense,
procure and maintain policies of commercial and general RIH liability
insurance in amounts not less than $2,000,000 per incident and
$2,000,000 annual aggregate and naming the Indemnitees as additional
insureds. Such commercial general liability insurance shall provide
(i) product liability coverage and (ii) contractual liability coverage
for NYMOX indemnification under paragraph 9.1 of the Agreement. If
NYMOX elects to self-insure all or part of the limits described above
(including deductibles or retentions which are in excess of $250,000
annual aggregate) such self-insurance program must be acceptable to
the RIH and its insurer. The minimum amounts of insurance coverage
required under this paragraph 9.2 shall not be construed to create a
limit of NYMOX's liability with respect to its indemnification under
paragraph 9.1 of this Agreement.
(b) NYMOX shall provide RIH with written evidence of such insurance upon
request of RIH. NYMOX shall provide RIH with written notice at least
fifteen (15) days prior to the cancellation, non-renewal or material
change in such insurance; if NYMOX does not obtain replacement
insurance providing comparable coverage within such fifteen (15) day
period, RIH shall have the right to terminate this Agreement effective
at the end of such fifteen (15) day period without notice or any
additional waiting periods.
(c) NYMOX shall maintain such comprehensive RIH liability insurance beyond
the expiration or termination of this Agreement during (i) the period
that any PRODUCT, PROCESS, or service, relating to, or developed
pursuant to, this Agreement is being commercially distributed
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or sold (other than for the purpose of obtaining regulatory approvals)
by NYMOX or by a SUBLICENSEE, AFFILIATE or agent of NYMOX and (ii) a
reasonable period after the period referred to in (c)(i) above which
in no event shall be less than fifteen (15) years.
SECTION 10. TERMINATION
10.1. The SPONSORED RESEARCH hereunder shall have an initial term of three
(3) years.
10.2. So long as the PRINCIPAL INVESTIGATORS are available to direct the
SPONSORED RESEARCH at RIH, NYMOX may not terminate SPONSORED RESEARCH except in
accordance with paragraph 10.1 or 10.3(a). If for any reason the PRINCIPAL
INVESTIGATORS shall no longer be available at RIH, the parties agree to
negotiate in good faith the continuance of such SPONSORED RESEARCH. However, if
a new PRINCIPAL INVESTIGATOR acceptable to NYMOX cannot be agreed upon, NYMOX
may terminate such SPONSORED RESEARCH except for an obligation to continue for
up to six (6) months beyond notification of the departing PRINCIPAL
INVESTIGATOR's departure, salary support at the pretermination level of all
Ph.D. or M.D. personnel who have been committed to the SPONSORED RESEARCH on
half-time or greater basis, provided RIH uses reasonable efforts to reduce such
costs to NYMOX.
10.3. If either party shall materially default in performing any of its
obligations under this Agreement, the nondefaulting party may give notice of the
default to the defaulting party. Unless such default is corrected within sixty
(60) days after such notice, then:
(a) in the event that the default pertains to the obligations of RIH to
perform SPONSORED RESEARCH, NYMOX may immediately terminate in writing
its support of SPONSORED RESEARCH;
(b) in the event that the default pertains to the obligations of NYMOX to
support SPONSORED RESEARCH, RIH may, in writing, immediately terminate
the SPONSORED RESEARCH and may, in writing, immediately terminate any
unexercised license options to PATENT RIGHTS (and, once RIH has given
a notice that NYMOX has defaulted on such support obligations, NYMOX
shall not have the right to exercise any such options unless and until
the default is cured); and
(c) in the event that the default pertains to the obligations of NYMOX
under Articles 6, 7 or 9 with respect to any licenses granted
hereunder, RIH may, in writing, immediately terminate such license.
10.4. NYMOX may at any time terminate any or all licenses granted pursuant
to paragraphs 6.2, 6.3 and 6.4 on a patent by patent and/or country by country
basis upon thirty (30) days prior written notice.
10.5. Termination of the licenses granted NYMOX in accordance with
paragraphs 6.2, 6.3 and 6.4 shall not relieve NYMOX of the obligation to pay the
RIH any royalties due pursuant to paragraphs 7.1 or 7.2 for the sale of PRODUCT
prior to the effective date of such termination, or affect the rights of the RIH
to receive written statements accounting for royalties payable and to
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inspect NYMOX's books and records as provided for herein.
10.6. Unless sooner terminated, RIH shall have the right to terminate the
licenses and rights granted to NYMOX in any country under this Agreement in the
event that after the FIRST COMMERCIAL SALE of PRODUCT in such country there is a
continuous two (2) year period in which no PRODUCT is sold in such country,
provided that such sale is not prevented by force majeure, government regulation
or intervention, or RIH of a law suit by a third party.
10.7. Unless otherwise terminated, the royalty bearing licenses under PATENT
RIGHTS granted hereunder will continue on a country by country basis until the
last to expire of PATENT RIGHTS, the claims of which but for this Agreement
would be infringed by the manufacture, use or sale of PRODUCT in the applicable
country, at which time NYMOX shall have a fully paid up license.
10.8. Upon any termination of any license under this Agreement, for a period
of one (1) year, NYMOX shall be entitled to finish any work-in-progress and to
sell any completed inventory of a PRODUCT covered by this Agreement which
remains on hand as of the date of the termination, so long as NYMOX pays to RIH
the royalties applicable to said subsequent sales in accordance with the same
terms and conditions as set forth in this Agreement.
10.9. In the event that any license granted to NYMOX under this Agreement is
terminated, any sublicense granted prior to termination of said license shall
remain in full force and effect, provided that:
(i) the SUBLICENSEE is not then in breach of its sublicense
agreement;
(ii) the SUBLICENSEE agrees to be bound to RIH as the licensor under
the terms and conditions of this sublicense agreement, as
modified by the provisions of this paragraph 10.9;
(iii) the SUBLICENSEE, at RIH's written request, assumes in a signed
writing the same obligations to RIH as those assumed by NYMOX
under Articles 9 and 11 hereof;
(iv) RIH shall have the right to receive the greater of (a) any
payments payable to NYMOX under such sublicense agreement to the
extent that they are reasonably and equitably attributable to
such SUBLICENSEE's right under such sublicense to use and
exploit PATENT RIGHTS, RESEARCH INFORMATION and/or RIH
MATERIALS, or (b) the lowest royalty which is within the
"Competitive Range" as defined in paragraph 7.1(d) hereof, at
the time RIH's license to NYMOX is terminated;
(v) the SUBLICENSEE agrees to be bound by the due diligence
obligations of NYMOX pursuant to paragraph 6.8 hereof, (whether
set by the parties or by arbitration) in the field and territory
of the sublicense;
(vi) RIH has the right to terminate such sublicense upon fifteen (15)
days prior written notice to NYMOX and such SUBLICENSEE in the
event of any material breach by
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the obligation to make payments described in clause (iv) of this
paragraph 10.9, unless such breach is cured prior to the
expiration of such fifteen (15) day period, and shall further
have the right to terminate such sublicense in the event of
SUBLICENSEE's failure to meet its due diligence obligations
pursuant to clause (v) hereof;
(vii) RIH shall not assume, and shall not be responsible to such
SUBLICENSEE for, any representations, warranties or obligations
of NYMOX to such SUBLICENSEE, other than to permit such
SUBLICENSEE to exercise any rights to PATENT RIGHTS, RESEARCH
INFORMATION and RIH MATERIALS that are granted under such
sublicense agreement consistent with the terms of this Agreement.
(a) In the event of a termination of SPONSORED RESEARCH hereunder for any
reason, the provisions of Articles 5, 6, 7, 8, 9 and 11 and paragraphs
10.3 through 10.10 and NYMOX's right to xxx RESEARCH INFORMATION and
RIH MATERIALS under paragraph 2. l(b) and (c) shall survive such
termination.
(b) In the event of termination of any license granted hereunder, NYMOX's
right to use RIH MATERIALS, the manufacture, use or sale of which is
claimed in the PATENT RIGHTS to which NYMOX's license shall have been
terminated, shall be terminated; the obligations of the parties with
respect to SPONSORED RESEARCH shall survive, and all provisions of
this Agreement shall survive with respect to all other licenses which
have not been terminated; and the provisions of paragraphs 10.5, 10.8,
10.9 and 10.10 and Articles 9 and 11 shall survive with respect to the
terminated license(s).
SECTION 11. MISCELLANEOUS
11.1. This Agreement constitutes the entire understanding between the
parties with respect to the subject matter hereof, and supersedes and replaces
all prior agreements, understandings, writings, and discussions between the
parties relating to said subject matter.
11.2. In order to facilitate implementation of this Agreement, RIH and NYMOX
are designating the following individuals to act on their behalf with respect to
this Agreement for the matters indicated below:
(a) with respect to matters concerning the conduct of SPONSORED RESEARCH,
budgets, manuscripts for publication, written transmittal of RESEARCH
INFORMATION and MATERIALS for RIH, PRINCIPAL INVESTIGATORS; for NYMOX:
General Counsel;
(b) with respect to any RESEARCH PROPOSAL submitted pursuant to paragraph
2.4, the receipt of research payments made pursuant to paragraph 2.2
or any RESEARCH PROPOSAL appended hereto, all royalty payments, the
form of any Confidentiality Agreement to be signed by an INVESTIGATOR,
the disclosure of any INVENTION or any correspondence pertaining to
any INVENTION or PATENT RIGHT for RIH, the Office of Research
Administration; for NYMOX, General Counsel;
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(c) any amendment of or waiver under this Agreement, any written notice or
other communication pertaining to the Agreement: for RIH, the Office
of Research Administration; for NYMOX, General Counsel;
(d) the above designations may be superseded from time to time by
alternative designations made by: for RIH, the RIH Director; for
NYMOX: CEO/President.
Any notice or communication required by the foregoing 11.2(a)-(d)
shall be deemed made if mailed first class postage prepaid to the
individuals so designated, except notices pertaining to breach or
termination which shall be made by prepaid, first class, certified
mail, return receipt requested.
11.3. (a) This Agreement shall be governed by and construed and interpreted
in accordance with the substantive laws of The State of Rhode Island and the
United States of America, regardless of the choice of law rules of any
jurisdiction.
(a) For any and all claims, disputes, or controversies arising under, out
of, or in connection with this Agreement, including any dispute
relating to patent validity or infringement, which the parties shall
be unable to resolve within sixty (60) days, the party raising such
dispute shall promptly advise the other party of such claim, dispute,
or controversy in a writing which describes in reasonable detail the
nature of such dispute. By not later than five (5) business days after
the recipient has received such notice of dispute, each party shall
have selected for itself a representative who shall have the authority
to bind such party and shall additionally have advised the other party
in writing of the name and title of such representative. By not later
than ten (10) business days after the date of such notice of dispute,
such representatives shall schedule a date for engaging in an
alternative dispute resolution ("ADR") process with a party mutually
acceptable to the parties. Thereafter, the representatives of the
parties shall engage in good faith in an ADR process under the
auspices of that party. If the representatives of the parties have not
been able to resolve the dispute within thirty (30) business days
after the termination of ADR, the parties shall have the right to
pursue any other remedies legally available to resolve such dispute in
either the Courts of the State of Rhode Island or in the United States
District Court for the District of Rhode Island, to whose jurisdiction
for such purposes RIH and NYMOX each irrevocably consents and submits.
Notwithstanding the foregoing, nothing in this paragraph 11.3(b) shall
be construed to waive any rights or timely performance of any
obligations existing under this Agreement.
11.4. This Agreement may be amended and any of its terms or conditions
may be waived only by a written instrument executed by the parties or, in the
case of a waiver, by the party waiving compliance. The failure of either party
at any time or times to require performance of any provision hereof shall in no
manner affect its rights at a later time to enforce the same. No waiver by
either party of any condition or term shall be deemed as a continuing waiver
of such condition or term or another condition or term.
11.5. This Agreement shall be binding upon and inure to the benefit of and
be enforceable by the parties hereto and their respective successors and
permitted assigns.
11.6. Any delays in or failures of performance by either party under this
Agreement shall not be considered a breach of this Agreement if and to the
extent caused by occurrences beyond the
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reasonable control of the party affected including but not limited to: Acts of
God; acts, regulations or laws of any government; strikes or other concerted
acts of workers; fires; floods; explosions; riots, wars; rebellion; and
sabotage; and any time for performance hereunder shall be extended by the actual
time of delay caused by such occurrence.
11.7. Neither party shall use the name of the other or of any staff member,
employee or student or any adaptation thereof in any advertising, promotional or
sales literature or publicity without the prior written approval of, for RIH,
the Communications and Public Affairs Office and for NYMOX, CEO/President.
11.8. This Agreement shall not be assignable to the RIH without NYMOX's
written consent except for the right to receive royalties payable herein. NYMOX
may at its own discretion and without approval by the RIH transfer its interest
or any part thereof under this Agreement to a wholly-owned subsidiary or
partnership of which NYMOX is the general partner or any assignee or purchaser
of the portion of its business associated with the licenses and rights granted
under this Agreement. In the event of any such transfer, the transferee shall
assume and be bound by the provisions of this Agreement. Otherwise this
Agreement shall be assignable by NYMOX only with the consent in writing of RIH
which consent shall not be unreasonably withheld.
11.9. If any provision(s) of this Agreement are or become invalid, are ruled
illegal by any court of competent jurisdiction or are deemed unenforceable under
then current applicable law from time to time in effect during the term hereof,
it is the intention of the parties that the remainder of this Agreement shall
not be affected thereby provided that a party's rights under this Agreement are
not materially affected. It is further the intention of the parties that in lieu
of each such provision which is invalid, illegal, or unenforceable, there be
substituted or added as part of this Agreement a provision which shall be as
similar as possible in economic and business objectives as intended by the
parties to such invalid, illegal or unenforceable provision, but shall be valid,
legal and enforceable.
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IN WITNESS WHEREOF, RIH and NYMOX have caused this instrument to be executed.
NYMOX CORPORATION RHODE ISLAND HOSPITAL CORPORATION
By: /s/ Xxxx Xxxxxxxx By: /s/ Xxxx Xxxx
________________________________ ______________________________________
Title: Xxxx Xxxxxxxx, M.D. Title: Xxxx X. Xxxx, M.D.
CEO and President Senior Vice President,
Medical Affairs
Date: May 14, 1999 Date: May 14, 1999
By: /s/ Xxxx Xxxxxxx
________________________________
Title: Xxxx Xxxxxxx
General Counsel
Date: May 14, 1999
I have read the foregoing Agreement and agree to comply with the obligations of
the Principal Investigator stated therein. In addition, I have read Appendix C
and agree to comply with the obligations of RIH stated therein.
/s/ Xxxx Xxxxx /s/ Xxxxxxx de la Xxxxx
________________________________ __________________________________
Xxxx Xxxxx, M.D. Xxxxxxx de la Xxxxx, M.D.
Date: May 14, 1999 Date: May 14, 1999
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APPENDIX A
CONFIDENTIAL
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APPENDIX C
NYMOX PROPRIETARY INFORMATION
It is anticipated that in the performance of the SPONSORED RESEARCH
sponsored by NYMOX, the PRINCIPAL INVESTIGATORS and members of the research team
designated by him/her will be provided with or given access by NYMOX to certain
information which NYMOX considers proprietary. The rights and obligations of the
parties with respect to such information are as follows:
1. PROPRIETARY INFORMATION. For the purposes of this Agreement, "Proprietary
Information" refers to information of any kind which is disclosed by NYMOX to
RIH 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 NYMOX in writing within ten (10)
working days as being confidential.
2. LIMITATIONS ON USE. RIH shall use NYMOX's Proprietary Information solely
for the purposes of the Research and License Agreement between the parties. It
is agreed by NYMOX and RIH that the transfer of Proprietary Information shall
not be construed as a grant of any right or license with respect to the
information delivered except as set forth herein or in a duly executed license
agreement.
3. CARE OF PROPRIETARY INFORMATION. NYMOX and RIH agree that all Proprietary
Information communicated by NYMOX and accepted by RIH in connection with this
Agreement shall be kept confidential by RIH as provided herein unless specific
written release is obtained from NYMOX. RIH agrees to exert reasonable efforts
(no less than the protection given its own confidential information) to maintain
such Proprietary Information in confidence, to make such Proprietary Information
available only to those employees and students who require access to it in the
performance of this Agreement and to inform them of the confidential nature of
such information.
RIH shall be deemed to have discharged its obligations hereunder provided RIH
has exercised the foregoing degree of care and provided further that RIH shall
immediately, upon discovery of any disclosure not authorized hereunder, notify
NYMOX and take reasonable steps to prevent any further disclosure or
unauthorized use.
When the Proprietary Information is no longer required for the purpose of this
Agreement, RIH shall return it or dispose of it as directed by NYMOX. RIH's
obligations of confidentiality with respect to Proprietary Information provided
under this Agreement will expire five (5) years after the date of this
Agreement.
4. INFORMATION NOT COVERED. It is agreed by NYMOX and RIH that information
shall not be deemed Proprietary Information in the event:
a. it is publicly available prior to the date of the Agreement or becomes
publicly available thereafter through no wrongful act of RIH;
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b. it was known to RIH prior to the date of disclosure or becomes
known to RIH thereafter from a third party having an apparent bona
fide right to disclose the information;
c. it is disclosed by RIH in accordance with the terms of NYMOX's
prior written approval;
d. it is disclosed by NYMOX without restriction on further
disclosure;
e. it is independently developed by RIH; or
f. RIH is obligated to produce pursuant to an order of a court of
competent jurisdiction or a valid administrative or Congressional
subpoena, provided that RIH (a) promptly notifies NYMOX and (b)
cooperates reasonably with NYMOX's efforts to contest or limit the
scope of such order.
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APPENDIX D
PATENT RIGHTS
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