EXHIBIT 10(d)
EXCLUSIVE LICENSE AGREEMENT
BETWEEN
MARC PHARMACEUTICALS, INC.
(MARC)
AND
CORNELL RESEARCH FOUNDATION, INC.
(FOUNDATION)
EXCLUSIVE LICENSE AGREEMENT
This License Agreement ("AGREEMENT") is made as of the _________ day of
June 2002 (the "EFFECTIVE DATE"), by and between Cornell Research Foundation,
Inc. (the "FOUNDATION"), a nonprofit corporation of the State of New York, with
offices located at 00 Xxxxxxxxx Xxxxx, Xxxxx 000, Xxxxxx, Xxx Xxxx 00000, and
Marc Pharmaceuticals, Inc. ("MARC"), a corporation organized under the laws of
the State of Delaware, with offices located at Xxx Xxxxxxxxxx Xxxxx, 0xx Xxxxx,
Xxxxxxxx, XX 00000.
WHEREAS, MARC is funding research at Cornell University's Weill Medical
College ("WMC") under a separate sponsored research agreement (the "SPONSORED
RESEARCH AGREEMENT", attached hereto as Attachment 1); and
WHEREAS, Xx. Xxxx X. Xxxxxx, has developed certain TECHNOLOGY (as
hereinafter defined) relating to the preparation of betulinol derivatives
directed towards the treatment of cancer and described in Attachment 2 attached
hereto; and
WHEREAS, FOUNDATION is a wholly owned subsidiary of Cornell University
("CORNELL"), and holds the ownership interests in certain intellectual property
developed by Xx. Xxxx X. Xxxxxx and others of WMC and administers licenses in a
manner consistent with the policies of CORNELL; and
WHEREAS, MARC desires to obtain the exclusive right and license to use,
develop, exploit and commercialize the TECHNOLOGY, and any intellectual property
developed under the SPONSORED RESEARCH AGREEMENT; and
WHEREAS, FOUNDATION has determined that the exploitation of the
intellectual property developed by Xx. Xxxxxx, et al. is in the best interest of
FOUNDATION and is consistent with its educational and research missions and
goals; and
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WHEREAS, FOUNDATION and MARC agree to the following terms and
conditions in order to develop the TECHNOLOGY for commercial purposes, and
utilize it in the public interest.
NOW, THEREFORE, in consideration of the promises and covenants
contained in this AGREEMENT and intending to be legally bound, the parties agree
as follows:
1. DEFINITIONS
1.1 ADDITIONAL PAYMENT means any payment to MARC by a third party
sublicensee other than (i) a research payment, (ii) an advance
against royalty payments; (iii) a guaranteed minimum royalty
payment or (iv) royalty payments.
1.2 AFFILIATE means any legal entity directly or indirectly
controlling, controlled by or under common control with MARC. For
purposes of this AGREEMENT, "control" means the direct or indirect
ownership of more than fifty percent (50%) of the outstanding
voting securities of a legal entity, or the right to receive more
than fifty percent (50%) of the profits or earnings of a legal
entity, or the right to control the policy decisions of a legal
entity.
1.3 CALENDAR QUARTER means each three-month period that this AGREEMENT
is in force, or any portion thereof, beginning on January 1, April
1, July 1 and October 1 of each year.
1.4 COMPLETE TRANSFER means the transfer by MARC to a third party of
all of its rights, title and interest with respect to the
FOUNDATION LICENSED PRODUCT(S) and the FOUNDATION PATENT RIGHTS.
1.5 CONTRACT YEAR means each twelve (12) month period ending on
December 31.
1.6 FOUNDATION LICENSED PRODUCT(S) means products or methods which are
made, made for, used, offered for sale, sold or imported by or on
behalf of MARC, its
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AFFILIATE, or any sublicensee and which: (1) in the absence of
this AGREEMENT would infringe at least one VALID CLAIM in the
jurisdiction in which said product or method is made, made for,
used, offered for sale, sold or imported by or on behalf of MARC,
its AFFILIATE, or a sublicensee, or (2) use, at least in part,
FOUNDATION TECHNICAL INFORMATION.
1.7 FOUNDATION PATENT RIGHTS means (a) all patents and patent
applications listed in Attachment 2 and their foreign counterparts
and extensions, including continuation, divisional and re-issue
applications and re-examinations; (b) all patents issuing from
those United States patent applications listed in Attachment 2 and
their foreign counterparts and extensions, including continuation,
divisional and re-issue applications and re-examinations; and (c)
all invention disclosures listed in Attachment 2, all patents and
patent applications arising from such disclosures, all patents
issuing from such patent applications, and foreign counterparts
and extensions, including continuation, divisional and re-issue
applications and any re-examinations of any of the foregoing in
this subparagraph (c).
1.8 FOUNDATION TECHNICAL INFORMATION means all the FOUNDATION
Confidential Information pertaining to manufacture and use of
FOUNDATION LICENSED PRODUCTS that is disclosed to MARC by
FOUNDATION and that is not disclosed in any patent within the
FOUNDATION PATENT RIGHTS.
1.9 FIELD OF USE means oncology.
1.10 NET SALES, for purposes of this AGREEMENT, means the consideration
attributable to the SALE of any FOUNDATION LICENSED PRODUCT(S) to
a third party received by MARC, its AFFILIATES, or its
sublicensees, less qualifying costs directly attributable to such
SALE and borne by MARC, its AFFILIATES, or its sublicensees. Such
qualifying costs shall include: (a) discounts for quantity
purchases, prompt payments and for wholesalers and distributors;
(b) credits or refunds, not exceeding the original invoice amount,
for claims or returns; outbound transportation expenses and
transportation insurance premiums; (c) sales and use taxes and
other fees imposed by a
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governmental agency; (d) commissions actually paid to brokers and
salesmen; and (e) any other costs customarily incurred with
respect to sales of similar products.
1.11 SALE means any bona fide transaction for which consideration is
received by MARC or its AFFILIATE(S) or an authorized sublicensee
of MARC under this AGREEMENT for the sale, use, lease, transfer or
other disposition of FOUNDATION LICENSED PRODUCT(S). A SALE of
FOUNDATION LICENSED PRODUCT(S) shall be deemed completed at the
time MARC, its AFFILIATE(S), or its sublicensee receives payment
for such FOUNDATION LICENSED PRODUCT(S).
1.12 SPONSORED RESEARCH AGREEMENT means the Sponsored Research
Agreement between MARC and the FOUNDATION.
1.13 TECHNOLOGY means the novel inventions, designs, discoveries,
improvements, principles, concepts, systems, formulas, algorithms,
methodologies, techniques, processes, procedures, results,
software, plans, specifications, guidelines, instructions,
training, instructor guides, student materials compositions,
biological materials, devices, or other ideas or expressions
claimed in FOUNDATION PATENT RIGHTS.
1.14 UNACCEPTABLE PARTY means any entity with respect to which, in the
three (3) years preceding the date of determination, there has
been (i) a regulatory determination of material violations of the
laws and regulations of the Food and Drug Administration or a
comparable agency in another jurisdiction or (ii) a material
criminal conviction relating to the manufacturing or distributing
of a pharmaceutical product or which, at the date of
determination, is insolvent and unable to pay its debts as
incurred.
1.15 UNRECOUPED COSTS means costs and expenses incurred by MARC from
the date of this AGREEMENT until the date of determination in
connection with the FOUNDATION LICENSED PRODUCT(S), including,
without limitation, the cost incurred in connection with the
SPONSORED RESEARCH AGREEMENT.
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1.16 VALID CLAIM means either (i) an issued and/or granted claim of an
in force patent within the FOUNDATION PATENT RIGHTS, or (ii) a
pending claim contained in a patent application included in the
FOUNDATION PATENT RIGHTS which is being diligently prosecuted by
or on behalf of FOUNDATION and has not been pending for more than
three (3) years from the filing of the first application in which
such claim or any obvious variation thereof was presented.
2. LICENSE GRANT
2.1 Subject to the terms and conditions of this AGREEMENT, FOUNDATION
hereby grants and MARC hereby accepts for the term of this AGREEMENT an
exclusive, world-wide right and license, including the right to grant
sublicenses, under the FOUNDATION PATENT RIGHTS, to make, have made, use,
import, sell and offer for sale FOUNDATION LICENSED PRODUCT(S) in the FIELD OF
USE, and a non-exclusive right and license to use the FOUNDATION TECHNICAL
INFORMATION, to make, have made, use, import, sell and offer for sale FOUNDATION
LICENSED PRODUCT(S) in the FIELD OF USE.
2.2 This license grant is exclusive except that FOUNDATION and CORNELL
may use the FOUNDATION PATENT RIGHTS for educational and research purposes only.
However, neither FOUNDATION nor CORNELL shall, under any circumstances, use or
permit others to use the FOUNDATION PATENT RIGHTS to commercialize any product
or service or to import, make, have made, offer, use or sell any product or
service in return for payment.
2.3 MARC acknowledges that pursuant to Public Laws 96-517, 97-256 and
98-620, codified at 35 U.S.C. 200-212, the United States government retains
certain rights in intellectual property funded in whole or part under any
contract, grant or similar agreement with a Federal agency. Pursuant to these
laws, the government may impose certain requirements regarding such intellectual
property, including but not limited to the requirement that products resulting
from such intellectual property sold in the United States must be substantially
manufactured in the United States. This license grant is expressly subject to
all applicable United States government rights as provided in the
above-mentioned laws and any regulations issued under those laws, as those laws
or regulations may be amended from time to time.
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2.4 MARC shall have the right to grant sublicenses under this AGREEMENT
with prior written approval by FOUNDATION, not to be unreasonably withheld or
delayed, which may be withheld only if the intended sublicensee is an
UNACCEPTABLE PARTY. If the intended sublicensee shall not be an UNACCEPTABLE
PARTY, FOUNDATION's failure to approve such sublicense agreement shall be
without effect and MARC shall not be in breach of this AGREEMENT for entering
into such sublicense. If MARC fails to obtain the prior written consent of
FOUNDATION to a sublicense agreement to an UNACCEPTABLE PARTY, FOUNDATION shall
have the right to require that the sublicense be terminated and, if the
sublicense shall not be terminated within thirty (30) days after notice to that
effect from FOUNDATION, that shall be deemed to be a breach of this AGREEMENT.
Any sublicenses granted by MARC under this AGREEMENT shall contain all the
provisions of this AGREEMENT which are protective of and beneficial to
FOUNDATION and shall comply with the following:
2.4.1 In each such sublicense, MARC shall require that the
sublicensee be subject to the terms and conditions of the license granted to
MARC under this AGREEMENT. MARC shall be responsible to FOUNDATION for the
payment of royalties on SALES made by sublicensees as though they were SALES by
MARC.
2.4.2 In addition to the royalties due pursuant to Paragraph 3.1.2,
if any sublicensee shall make an ADDITIONAL PAYMENT to MARC, then MARC shall pay
FOUNDATION an amount equal to ten percent (10%) of such ADDITIONAL PAYMENT.
2.4.3 Within thirty (30) days after MARC enters into any
sublicense, MARC shall send to FOUNDATION a complete copy of the sublicense.
2.4.4 Even if MARC enters into sublicenses, MARC remains primarily
liable to FOUNDATION for all of MARC's duties and obligations contained in this
AGREEMENT, and any act or omission of a sublicensee which would be a breach of
this AGREEMENT if performed by MARC shall be deemed to be a breach by MARC of
this AGREEMENT, but only after MARC receives actual notice of such breach in
writing.
2.5 In the event MARC makes a COMPLETE TRANSFER, MARC agrees to pay
FOUNDATION fifty percent (50%) of the consideration received by MARC in
connection with such COMPLETE TRANSFER, after the deduction by MARC of (i) all
costs incurred in connection with such
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COMPLETE TRANSFER, and (ii) all UNRECOUPED COSTS. Notwithstanding any other
provision of this AGREEMENT, such payment shall be in lieu of and in
substitution for any other amounts which are or may be payable to FOUNDATION
under any provision of this AGREEMENT by MARC or the transferee from and after
such COMPLETE TRANSFER.
2.6 MARC shall use its diligent efforts consistent with sound and
reasonable business practices and judgment, to effect commercialization of
FOUNDATION LICENSED PRODUCT(S) and agrees to satisfy the following milestones:
2.6.1 MARC agrees to fund research either at WMC under the
SPONSORED RESEARCH AGREEMENT or otherwise, in the amount of
at least one million dollars ($1,000,000) over a period of
three (3) CONTRACT YEARS.
2.6.2 Within one year from the date the SPONSORED RESEARCH
AGREEMENT shall terminate, MARC agrees to invest one
million dollars ($1,000,000) in the development of the
FOUNDATION LICENSED PRODUCT(S).
2.6.3 MARC agrees to invest an aggregate of ten million dollars
($10,000,000) (which shall include the amounts set forth in
Paragraphs 2.6.1 and 2.6.2 of this AGREEMENT) in the
development of the FOUNDATION LICENSED PRODUCT(S) by
December 31, 2008.
In the event that MARC shall not satisfy any of the provisions of this
Section 2.6, FOUNDATION's sole remedy shall be to terminate this AGREEMENT,
pursuant to Article 5.
2.7 Within sixty (60) days after the start of each CONTRACT YEAR after
the first CONTRACT YEAR, until MARC has a FOUNDATION LICENSED PRODUCT available
for commercial sale, MARC shall make a written annual report to FOUNDATION
covering the preceding CONTRACT YEAR, regarding the progress of MARC toward
commercial use of FOUNDATION LICENSED PRODUCT. Such report shall include, at a
minimum, information sufficient to enable FOUNDATION to satisfy reporting
requirements of the U.S. Government and for FOUNDATION to ascertain progress by
MARC toward meeting the diligence requirements of this Article 2.
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3. FEES AND ROYALTIES
3.1 LICENSE INITIATION FEE AND ROYALTIES
3.1.1 In partial consideration of the exclusive license granted to
MARC, MARC shall pay FOUNDATION within thirty (30) days of the EFFECTIVE DATE, a
non-refundable license initiation fee of fifty thousand dollars ($50,000).
3.1.2 In further consideration of the exclusive license granted to
MARC, MARC shall pay FOUNDATION a royalty of seven percent (7%) on the NET SALES
of FOUNDATION LICENSED PRODUCT(S), in countries in which there is a VALID CLAIM
under the FOUNDATION PATENT RIGHTS, less fifty percent (50%) of any royalties
paid by MARC to a third party with respect to the SALES of the FOUNDATION
LICENSED PRODUCT(S) with respect to which such NET SALES shall have been earned,
provided, however, that in no event shall the royalty payable to FOUNDATION be
less than four percent (4%).
3.1.3 In further consideration of the exclusive license granted to
MARC, MARC shall pay FOUNDATION within thirty (30) days following the occurrence
of each of the events set forth below, the following developmental milestone
payments:
Submission of an IND $US 50,000
Initiation of Phase I Clinical Trial $US 62,500
Initiation of Phase II Clinical Trial $US 125,000
Initiation of Phase III Clinical Trial $US 200,000
FDA (or equivalent) Approval $US 1,000,000
1 Year Anniversary from FDA (or equivalent) Approval $US 750,000
3.1.4 Beginning with the CONTRACT YEAR following the CONTRACT YEAR
in which the first sale of FOUNDATION LICENSED PRODUCTS occurs under this
AGREEMENT, and in each CONTRACT YEAR thereafter in which this AGREEMENT is in
force, MARC shall pay FOUNDATION a minimum annual royalty for the CONTRACT YEAR.
Payment shall be due on the
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anniversary of the EFFECTIVE DATE and will be considered as an advance against
the royalties otherwise due to FOUNDATION from MARC for that CONTRACT YEAR.
Minimum annual royalties are not refundable or applicable to succeeding CONTRACT
YEARS. The minimum annual royalty payment shall be one hundred thousand dollars
($100,000) for each CONTRACT YEAR to which the minimum annual royalty applies.
3.1.5 NET SALES of any FOUNDATION LICENSED PRODUCT shall not be
subject to more than one royalty payable to FOUNDATION under any agreement
between FOUNDATION and MARC; such royalty shall be the highest applicable
royalty under this AGREEMENT.
3.2 REPORTS AND RECORDS
3.2.1 MARC shall deliver to FOUNDATION within sixty (60) days after
the end of each CALENDAR QUARTER a true and correct report, certified by an
officer of MARC, setting forth the calculation of the royalties due to
FOUNDATION for such CALENDAR QUARTER, including, without limitation:
3.2.1.1 Number of FOUNDATION LICENSED PRODUCTS involved in
SALES, listed by country in which such SALES were
made.
3.2.1.2 NET SALES.
3.2.1.3 Qualifying costs, as defined in Paragraph 1.10 listed
by category of cost.
3.2.1.4 NET SALES listed by country in which such sales were
made.
3.2.1.5 Royalties owed to FOUNDATION, listed by category,
including without limitation earned,
sublicensee-derived, and minimum royalty categories.
3.2.1.6 Minimum royalty payments credited against earned
royalty amounts.
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3.2.2 MARC shall pay the royalties due under Paragraph 3.1 within
sixty (60) days following the last day of the CALENDAR QUARTER in which the
royalties accrue, and together with the report described in Paragraph 3.2.1,
such report shall be submitted regardless of whether or not royalties are owed.
3.2.3 MARC shall maintain and cause its AFFILIATES, and
sublicensees, to maintain, complete and accurate books and records which enable
the royalties, fees, and payments payable under this AGREEMENT to be verified.
The records for each CALENDAR QUARTER must be maintained for five (5) years
after the submission of each report under this Article 3. Upon not less than
thirty (30) days prior written notice to MARC, MARC shall provide an independent
auditor selected by FOUNDATION and subject to the approval of MARC, which
approval shall not be unreasonably withheld or delayed, with access to all books
and records relating to the SALES of FOUNDATION LICENSED PRODUCTS by MARC and
its AFFILIATES, and sublicensees, to conduct a review or audit of those books
and records. Access to these books and records pertaining to NET SALES must be
made available no more than once each calendar year, during normal business
hours, and once each year during each of the five (5) years after expiration or
termination of this AGREEMENT. This paragraph shall survive termination of this
AGREEMENT.
3.3 CURRENCY, PLACE OF PAYMENT, INTEREST
3.3.1 All dollar amounts referred to in this AGREEMENT are
expressed in United States dollars. All payments to FOUNDATION under this
AGREEMENT must be made in United States dollars by check payable to "Cornell
Research Foundation, Inc." and sent to the address specified in Paragraph 10.4.
For electronic transfer, all payments should be sent to the following address:
Xxxxxxxx Trust Company
Xxx Xxxxxxx
Xxxxxx, XX 00000
ABA# 000000000
ACCOUNT NUMBER: 00-000-000000
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3.3.2 If MARC receives revenues from SALES of FOUNDATION LICENSED
PRODUCTS in currency other than United States dollars, such revenues shall be
converted into United States dollars at the conversion rate for the foreign
currency as published in the eastern edition of The Wall Street Journal as of
the last business day of the CALENDAR QUARTER in which such royalties were
earned.
3.3.3 Amounts that are not paid when due shall accrue interest from
the due date until paid, at a rate equal to one percent (1%) per month, or the
maximum allowed by law, whichever is less.
4. CONFIDENTIALITY.
4.1 CONFIDENTIAL INFORMATION means and includes all technical
information, inventions, developments, discoveries, software, know-how, methods,
techniques, formulae, data, processes and other proprietary ideas, whether or
not patentable or copyrightable, that the disclosing party identifies in writing
as confidential or proprietary at the time it is delivered or communicated to
the receiving party.
4.2 The receiving party agrees to maintain in confidence and not to
disclose to any third party any CONFIDENTIAL INFORMATION of the disclosing party
except the receiving party shall be permitted to disclose CONFIDENTIAL
INFORMATION to third parties and employees engaged by the receiving party
provided such third parties agree to be bound by the confidentiality provisions
of this AGREEMENT as set forth in Paragraphs 4.2 and 4.3. The receiving party
agrees to ensure that its employees have access to CONFIDENTIAL INFORMATION only
on a need-to-know basis and are obligated in writing to abide by the receiving
party's obligations under this AGREEMENT. The foregoing obligations of
confidentiality shall not apply to:
4.2.1 information that is in the public domain through publication
or otherwise prior to disclosure hereunder;
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4.2.2 information that is known to the receiving party or
independently developed by the receiving party prior to the time of disclosure
hereunder, in each case, to the extent evidenced by written records;
4.2.3 information disclosed to the receiving party by a third party
that has a legal right to make such disclosure;
4.2.4 information that becomes patented, published or otherwise
part of the public domain through no act or fault of the receiving party; or
4.2.5 information that is required to be disclosed by law or by
order of United States governmental authority or a court of competent
jurisdiction; provided that the receiving party must use reasonably diligent
efforts to obtain confidential treatment of such information by the agency or
court.
4.3 MARC shall not be obligated to accept any CONFIDENTIAL INFORMATION
from FOUNDATION.
5. TERM AND TERMINATION
5.1 This AGREEMENT, unless sooner terminated as provided in this
AGREEMENT, shall expire when the last of the FOUNDATION PATENT RIGHTS (a)
expires, (b) is finally adjudged or declared invalid or unenforceable by a
non-appealable decision of a court or agency of competent jurisdiction or, (c)
becomes abandoned or unenforceable, whichever shall occur first.
5.1.1 MARC may, upon sixty (60) days written notice to FOUNDATION,
terminate this AGREEMENT by doing all of the following:
5.1.1.1 ceasing to make, have made, use, import, sell and offer
for SALE all FOUNDATION LICENSED PRODUCTS; and
5.1.1.2 terminating all sublicenses and causing all AFFILIATES,
and sublicensees,
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to cease making, having made, using, importing, selling and
offering for SALE all FOUNDATION LICENSED PRODUCTS; and
5.1.1.3 paying all monies then owed to FOUNDATION under this
AGREEMENT.
5.1.2 FOUNDATION may terminate this AGREEMENT by giving MARC ten
(10) days written notice of intention to terminate if any of the following
occur:
5.1.2.1 MARC is in default in payment of license fees,
milestone payments, royalties, cost reimbursements or
in providing any report;
5.1.2.2 MARC breaches any provision of this AGREEMENT;
and MARC does not cure any such default within sixty (60) days after receipt by
MARC of written notice thereof.
5.1.3 Upon termination of this AGREEMENT pursuant to Paragraph 5.1
by either party prior to expiration, MARC and its AFFILIATES, and sublicensees
shall have the right to sell thereafter for one hundred eighty (180) days only
(a) FOUNDATION LICENSED PRODUCTS in inventory on the termination date, (b)
FOUNDATION LICENSED PRODUCTS then in the process of manufacture, and (c)
FOUNDATION LICENSED PRODUCTS with respect to which firm commitments for
manufacture have been made at the time of termination by reason of either of (i)
any contract for the purchase of materials or services to be used in the
manufacture of FOUNDATION LICENSED PRODUCTS, or (ii) any contract for the sale
of FOUNDATION LICENSED PRODUCTS. All such SALES shall be subject to the terms
and conditions of this AGREEMENT relating to reporting and royalty payments.
5.1.4 Upon expiration of this AGREEMENT as set forth in Paragraph
5.1 (a), (b), and (c) MARC shall have a paid-up license under the FOUNDATION
PATENT RIGHTS and shall be free to use and disclose FOUNDATION CONFIDENTIAL
INFORMATION.
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6. PATENT MAINTENANCE AND REIMBURSEMENT
FOUNDATION shall be solely responsible for and shall control the
preparation, prosecution and maintenance of FOUNDATION PATENT RIGHTS during the
term of this AGREEMENT. MARC shall reimburse FOUNDATION for all documented
reasonable attorneys fees and expenses (including out-of-pocket expenses),
official fees and other charges incident to the preparation, prosecution, and/or
maintenance of FOUNDATION PATENT RIGHTS (for which FOUNDATION has not previously
received reimbursement). MARC shall make such reimbursement to FOUNDATION within
thirty (30) days after receipt by MARC of invoices for such unreimbursed fees,
expenses and charges; provided however, that no payment under this Article 6
shall be due before sixty (60) days after the EFFECTIVE DATE.
7. INFRINGEMENT AND LITIGATION
7.1 FOUNDATION and MARC are responsible for notifying each other
promptly of any infringement of FOUNDATION PATENT RIGHTS which may come to their
attention. FOUNDATION and MARC shall consult one another in a timely manner
concerning any appropriate response to the infringement.
7.2 (a) MARC may initiate and prosecute a claim or suit for
infringement of FOUNDATION PATENT RIGHTS at its own expense and in its own name
and using counsel selected by MARC. If MARC initiates a suit for infringement of
any FOUNDATION PATENT RIGHTS and such suit is dismissed or otherwise cannot
proceed because FOUNDATION is not a party in such suit, then, at MARC's request,
FOUNDATION shall join the action as a party plaintiff provided that MARC has
provided FOUNDATION with pleadings and information relevant to the claim or suit
for infringement that is not reasonably believed by or on behalf of MARC to be
privileged or attorney work product. If FOUNDATION joins such suit at MARC'S
request, MARC shall bear all expenses FOUNDATION incurs in connection with such
action (including FOUNDATION's reasonable attorney's fees). If FOUNDATION is
joined in such suit involuntarily, MARC shall bear all expenses FOUNDATION
incurs in connection with such action from and after the date of joinder
(including FOUNDATION's reasonable attorney's fees). FOUNDATION shall cooperate
with MARC in
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prosecuting any claim for infringement at no expense to MARC, except for
reasonable out of pocket expenses. In either case, MARC shall indemnify
FOUNDATION for any and all loss, damage, or liability incurred by FOUNDATION as
a result of such action (including loss, damage or liability as a result of any
counterclaim asserted against FOUNDATION), provided, however, that in the event
the action results in a final determination that any patent under FOUNDATION
PATENT RIGHTS is unenforceable due to fraud on the Patent and Trademark Office
committed by FOUNDATION, then MARC shall have no duty to indemnify FOUNDATION
for any loss, damage, or liability FOUNDATION incurs as a direct consequence of
the unenforceability of such patent.
(b) MARC shall have the right to control prosecution of any claim or
suit for infringement of the FOUNDATION PATENT RIGHTS, but shall seek the advice
of FOUNDATION in conjunction with such claim or suit, and shall keep FOUNDATION
informed regarding the progress of the claim or suit. MARC may not settle or
compromise any claim contesting the validity of the FOUNDATION PATENT RIGHTS in
a manner that imposes any obligations or restrictions on FOUNDATION or that
grants rights in FOUNDATION PATENT RIGHTS or that concedes the invalidity of any
of the FOUNDATION PATENT RIGHTS without first receiving the prior written
permission of FOUNDATION, which shall not be unreasonably withheld or delayed;
provided, however, that MARC shall have the right to settle any such claim or
suit by granting sublicenses that it is otherwise permitted to grant under this
AGREEMENT without first receiving the prior written consent of FOUNDATION.
(c) FOUNDATION may not settle or compromise any infringement claim or
suit or any suit contesting the validity of the FOUNDATION PATENT RIGHTS in a
manner that imposes any obligations or restrictions on MARC or that grants
rights in FOUNDATION PATENT RIGHTS to any third party that are inconsistent with
the rights licensed to MARC under this Agreement without first receiving the
prior written permission of MARC. Financial recoveries from any litigation
prosecuted by MARC under this Article 7 will first be applied to reimburse MARC
for its litigation expenditures (including reasonable attorneys fees) with any
remaining recovery being paid to MARC, subject to payment of any royalty due
FOUNDATION based on the provisions of Article 3.
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7.3 MARC's rights under Paragraph 7.2 are subject to the continuing
right of FOUNDATION to intervene at the sole expense of FOUNDATION and join MARC
in any claim or suit for infringement of the FOUNDATION PATENT RIGHTS. In
addition, MARC shall have the right to request FOUNDATION to participate in and
share the expense of any claim or suit for infringement of the FOUNDATION PATENT
RIGHTS apart from those arising under Paragraph 7.2. If FOUNDATION voluntarily
intervenes or accepts a request under this Paragraph by MARC to join in a claim
or suit, then any consideration received by MARC after settlement or entry of a
final judgment of such claim or suit shall be shared between FOUNDATION and MARC
in proportion with their respective litigation expenses in such claim or suit,
after first being applied to reimburse MARC and FOUNDATION for their expenses
(including reasonable attorneys fees). Any consideration received by MARC as a
result of such settlement or damage award after apportionment and reimbursement
of the parties' attorneys fees shall also be subject to any royalty due to
FOUNDATION pursuant to the provisions of Article 3.
7.4 If MARC fails to prosecute any infringement, FOUNDATION may
prosecute such infringement at its own expense, provided that it gives MARC at
least sixty (60) days prior notice of its intention to file suit. In such event,
FOUNDATION shall be entitled to retain from any recovery, the full amount of any
settlement or award of damages or attorneys' fees. If MARC for legitimate
business reasons requests during the notice period that FOUNDATION refrain from
initiating suit and demonstrates to the satisfaction of FOUNDATION that
refraining from instituting suit will not adversely affect the development or
utilization of FOUNDATION LICENSED PRODUCTS or the amount of royalties and fees
FOUNDATION would otherwise receive under this AGREEMENT, then FOUNDATION shall
refrain from initiating such suit.
7.5 In any action to enforce any of the FOUNDATION PATENT RIGHTS,
either party, at the request and expense of the other party shall cooperate to
the fullest extent reasonably possible. This provision shall not be construed to
require either party to undertake any activities, including legal discovery, at
the request of any third party except as may be required by lawful process of a
court of competent jurisdiction.
7.6 Regardless of which party controls a suit brought against an
infringer, both parties shall participate in any settlement discussions and each
will be a signatory to any settlement agreement.
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8. DISCLAIMER OF WARRANTIES; INDEMNIFICATION
8.1 THE FOUNDATION PATENT RIGHTS, FOUNDATION TECHNICAL INFORMATION,
FOUNDATION LICENSED PRODUCTS, AND ALL OTHER TECHNOLOGY LICENSED UNDER THIS
AGREEMENT ARE PROVIDED ON AN "AS IS" BASIS AND FOUNDATION MAKES NO
REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT THERETO. BY WAY
OF EXAMPLE BUT NOT OF LIMITATION, FOUNDATION MAKES NO REPRESENTATIONS OR
WARRANTIES (i) OF COMMERCIAL UTILITY; (ii) OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE; OR (iii) THAT THE USE OF THE FOUNDATION PATENT RIGHTS,
FOUNDATION TECHNICAL INFORMATION, FOUNDATION LICENSED PRODUCTS, AND/OR ANY OTHER
TECHNOLOGY LICENSED UNDER THIS AGREEMENT WILL NOT INFRINGE ANY PATENT, COPYRIGHT
OR TRADEMARK OR OTHER PROPRIETARY RIGHTS OF OTHERS. FOUNDATION SHALL NOT BE
LIABLE TO MARC, MARC'S SUCCESSORS OR ASSIGNS OR ANY THIRD PARTY WITH RESPECT TO:
ANY CLAIM ARISING FROM MARC'S USE OF THE FOUNDATION PATENT RIGHTS, FOUNDATION
TECHNICAL INFORMATION, FOUNDATION LICENSED PRODUCTS, AND/OR ANY OTHER TECHNOLOGY
LICENSED UNDER THIS AGREEMENT OR FROM THE MANUFACTURE, USE OR SALE OF FOUNDATION
LICENSED PRODUCTS; OR ANY CLAIM FOR LOSS OF PROFITS, LOSS OR INTERRUPTION OF
BUSINESS, OR FOR INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES OF ANY KIND.
8.2 FOUNDATION states that, as of the EFFECTIVE DATE, FOUNDATION does
not have actual knowledge, without investigation, that the manufacture, use,
offer for sale, sale, or importation of any FOUNDATION LICENSED PRODUCT would
infringe any claim of an in-force patent owned by a third party.
8.3 MARC shall defend, indemnify and hold harmless FOUNDATION and
CORNELL and their respective trustees, officers, agents, personnel, students,
and employees (individually, an "Indemnified Party", and collectively, the
"Indemnified Parties"), from and against any and all liability, loss, damage,
action, claim or expense suffered or incurred by the Indemnified Parties
(including
17
reasonable attorney's fees) (individually, a "Liability", and collectively, the
"Liabilities") that results from or arises out of: (a) the development, use,
manufacture, promotion, sale or other disposition of any FOUNDATION TECHNICAL
INFORMATION, FOUNDATION PATENT RIGHTS, or FOUNDATION LICENSED PRODUCTS, by or on
behalf of MARC, its AFFILIATES, its assignees, or sublicensees, vendors or other
third parties; (b) any breach of this AGREEMENT by MARC, its AFFILIATES, its
assignees, or sublicensees , vendors or other third parties; and (c) the
enforcement by an Indemnified Party of this Paragraph. Without limiting the
foregoing, MARC shall defend, indemnify and hold harmless the Indemnified
Parties from and against any Liabilities resulting from:
8.3.1 any product liability or other claim of any kind related
to the use by a third party of a FOUNDATION LICENSED PRODUCT, that was
manufactured or sold by MARC, its AFFILIATES, its assignees, or sublicensees,
vendors or other third parties;
8.3.2 a claim by a third party that the design, composition,
manufacture, use, sale or other disposition of any FOUNDATION LICENSED PRODUCT
that was manufactured or sold by MARC, its AFFILIATES, its assignees, or
sublicensees, or vendors, infringes or violates any patent, copyright, trademark
or other intellectual property rights of such third party; and
8.3.3 clinical trials or studies conducted by or on behalf of
MARC relating to the FOUNDATION PATENT RIGHTS, FOUNDATION TECHNICAL INFORMATION,
or FOUNDATION LICENSED PRODUCTS, that were manufactured or sold by MARC, its
AFFILIATES, its assignees, or sublicensees vendors, including, without
limitation, any claim by or on behalf of a human subject of any such clinical
trial or study.
8.4 MARC shall not be liable under any of the foregoing indemnities nor
shall MARC have any obligation to indemnify or defend FOUNDATION unless MARC
shall have been promptly notified in writing by FOUNDATION of the date that
FOUNDATION received actual notice of the claim or suit for which indemnity or
defense is being sought by FOUNDATION.
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8.4.1 MARC shall not be required to defend, indemnify or hold
FOUNDATION harmless for any liability arising out of the sole gross negligence
of FOUNDATION, any intentional acts of FOUNDATION or the willful malfeasance of
FOUNDATION.
8.5 MARC may not settle or compromise any claim or action giving rise
to Liabilities in a manner that imposes any restrictions or obligations on
FOUNDATION or grants any rights to FOUNDATION TECHNICAL INFORMATION, FOUNDATION
PATENT RIGHTS, or FOUNDATION LICENSED PRODUCTS, without FOUNDATION's prior
written consent, which shall not be unreasonably withheld or delayed; provided
however, that MARC may settle any such claim or action without FOUNDATION's
consent by granting a sublicense. MARC shall be entitled to assume and control
the defense of any such claim or action involving a Liability or the
Liabilities, using counsel selected by MARC. If MARC fails or declines to assume
and control the defense of any such claim or action within thirty (30) days
after receipt by MARC of written notice thereof, FOUNDATION may assume the
defense of such claim or action for the account and at the risk of MARC, and any
Liabilities related thereto shall be conclusively deemed a liability of MARC.
The indemnification rights of FOUNDATION or other Indemnified Party contained
herein are in addition to all other rights which such Indemnified Party may have
at law or in equity or otherwise.
8.6 INSURANCE
8.6.1 MARC shall procure and maintain and cause its
AFFILIATES, and sublicensees, to procure and maintain a policy or policies of
comprehensive general liability insurance, including broad form and contractual
liability, in a minimum amount of $1,000,000 per incident and $10,000,000 annual
aggregate as respects personal injury, bodily injury and property damage arising
out of MARC's performance of this AGREEMENT.
8.6.2 MARC shall, upon commencement of clinical trials
involving FOUNDATION LICENSED PRODUCTS, procure and maintain and cause its
AFFILIATES, and sublicensees, to procure and maintain a policy or policies of
product liability insurance in amounts consistent with industry standards for
the development of other cancer therapies with respect to bodily injury and
property damage arising out of MARC's performance of this AGREEMENT.
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8.6.3 The policy or policies of insurance described in this
Paragraph 8.6 must be issued by an insurance carrier with an A.M. Best rating of
"A" or better and must name FOUNDATION and CORNELL as additional insureds with
respect to MARC's performance of this AGREEMENT. MARC shall provide FOUNDATION
with certificates evidencing the insurance coverage required herein and all
subsequent renewals thereof. Such certificates must provide that MARC's
insurance carrier(s) will notify FOUNDATION in writing at least 30 days prior to
cancellation or material change in coverage.
8.6.4 FOUNDATION may periodically review the adequacy of the
minimum limits of liability insurance specified in this Paragraph and FOUNDATION
reserves the right to require MARC to adjust the liability insurance coverage(s)
to levels considered reasonable and customary in the industry for similar types
of risk at that time. Such levels of liability insurance coverage for MARC will
be comparable to other similarly situated or comparable biopharmaceutical
licensees of FOUNDATION. The specified minimum insurance amounts do not
constitute a limitation on MARC's obligation to indemnify FOUNDATION under this
AGREEMENT
9. USE OF FOUNDATION AND MARC NAMES
9.1 MARC and its employees and agents may not use and MARC may not
permit its sublicensees to use FOUNDATION's or CORNELL's name or any adaptation
thereof, or any FOUNDATION or CORNELL seal, logotype, trademark, or service
xxxx, or the name, xxxx, or logotype of any FOUNDATION or CORNELL representative
or organization in any way without the prior written consent of the FOUNDATION
or CORNELL, as appropriate, which shall not be unreasonably withheld or delayed.
However, MARC shall be permitted to use the name of FOUNDATION or CORNELL in any
manner that may be required as a matter of law. MARC shall submit to FOUNDATION
prior to the release and FOUNDATION shall have the right to review and comment
on that portion of any press releases or any other communication which shall
contain reference to FOUNDATION or CORNELL, intended to be released in the
public domain that may be prepared by MARC from time to time.
9.2 FOUNDATION and its employees and agents may not use and FOUNDATION
may not permit any third party to use the name of MARC, or any adaptation
thereof, or any XXXX xxxx, logotype,
20
trademark or search xxxx, or the name, xxxx, or logotype of any MARC
representative, affiliate, subsidiary or licensee in any way without the prior
written consent of MARC, which shall not be unreasonably withheld or delayed.
10. PUBLICATION
It is the policy of FOUNDATION and CORNELL to promote and safeguard
free and open inquiry by faculty, students and others. To further this policy,
FOUNDATION and CORNELL shall retain the right to publish the TECHNOLOGY
described in FOUNDATION PATENT RIGHTS. However, FOUNDATION shall provide MARC
with a copy of manuscripts concerning the TECHNOLOGY no less than sixty (60)
days prior to publication for the purpose of review, comment, and to allow time
for filing patent applications.
11. ADDITIONAL PROVISIONS
11.1 Nothing in this AGREEMENT shall be deemed to establish a
relationship of principal and agent between FOUNDATION and MARC, nor any of
their agents or employees for any purpose whatsoever, nor shall this AGREEMENT
be construed as creating any other form of legal association or arrangement
which would impose liability upon one party for the act or failure to act of the
other party.
11.2 MARC may not assign this AGREEMENT or any part of it, either
directly or by merger or other operation of law, without the prior written
consent of FOUNDATION, which shall not be unreasonably withheld or delayed,
except that MARC shall have the unfettered right to transfer or assign its
rights under this AGREEMENT or any part thereof, without prior written consent
of FOUNDATION, as part of the sale, transfer or restructuring of MARC; provided,
however, that at the time of such unfettered assignment or transfer, the
proposed assignee or transferee is financially capable of fulfilling the
relevant obligations of MARC under this AGREEMENT. Any such permitted assignee
shall be required to assume the relevant obligations of MARC hereunder. Any
prohibited assignment of this AGREEMENT or the rights hereunder shall be null
and void. No assignment relieves MARC of responsibility for the performance of
any accrued obligations, which it has actually incurred prior to such
assignment.
21
11.3 A waiver by either party of a breach of any provision of this
AGREEMENT will not constitute a waiver of any subsequent breach of that
provision or a waiver of any breach of any other provision of this AGREEMENT.
11.4 Notices, payments, statements, reports and other communications
under this AGREEMENT shall be in writing and shall be deemed to have been
received as of the date dispatched if personally delivered, or as of the date of
actual receipt if sent by public overnight courier (e.g. FedEx) or registered
mail, postage prepaid, return receipt requested, and addressed as follows, or at
such other address as a party shall have given notice of pursuant hereto:
If to FOUNDATION:
Payments and royalty reports to FOUNDATION shall be sent to:
Cornell Research Foundation, Inc.
00 Xxxxxxxxx Xxxxx, Xxxxx 000
Xxxxxx, XX 00000
Attention: Accounting
Phone #: (000) 000-0000
Fax #: (000) 000-0000
All other communications to FOUNDATION shall be sent to:
Cornell Research Foundation, Inc.
000 X. 00xx Xxxxxx, Xxxxx 00
Xxx Xxxx, XX 00000
Attention: Xxxxx X. Xxxxx, Vice President
Phone #: (000) 000-0000
Fax #: (000) 000-0000
If to MARC:
Marc Pharmaceuticals, Inc.
Xxx Xxxxxxxxxx Xxxxx, 0xx Xxxxx
Xxxxxxxx, XX 00000
Attention: Xxxx San Xxxxxxx
Phone #: (000) 000-0000
Fax #: (000) 000-0000
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with a copy to:
Xxxxxxxxxx Helpern Syracuse & Hirschtritt LLP
000 Xxxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attention: Xxxxxxx Xxxxxxxxx, Esq.
Phone #: (000) 000-0000
Fax #: (000) 000-0000
11.5 This AGREEMENT shall be construed and governed in accordance with
the laws of the State of New York, without giving effect to conflict of law
provisions. In the event that a party to this AGREEMENT perceives the existence
of a dispute with the other party concerning any right or duty provided for
herein, the parties will, as soon as practicable, confer in an attempt to
resolve the dispute. If the parties are unable to resolve such dispute amicably,
then the parties hereby submit to the exclusive jurisdiction of and venue in the
courts located in the State of New York with respect to any and all disputes
concerning the subject of this AGREEMENT.
11.6 FOUNDATION and MARC shall not discriminate against any employee or
applicant for employment because of race, color, sex, sexual or affectional
preference, age, religion, national or ethnic origin, or handicap.
11.7 MARC shall comply with all prevailing laws, rules and regulations
that apply to its activities or obligations under this AGREEMENT. Without
limiting the foregoing, it is understood that this AGREEMENT may be subject to
United States laws and regulations controlling the export of technical data,
computer software, laboratory prototypes and other commodities, articles and
information, including the Arms Export Control Act as amended in the Export
Administration Act of 1979, and that the parties' obligations are contingent
upon compliance with applicable United States export laws and regulations. The
transfer of certain technical data and commodities may require a license from
the cognizant agency of the United States Government and/or written assurances
by MARC that MARC shall not export data or commodities to certain foreign
countries without prior approval of such agency. FOUNDATION neither represents
that a license is not required nor that, if required, it will issue.
23
11.8 Any modification of this AGREEMENT must be in writing and signed
by an authorized representative of each party.
11.9 This AGREEMENT and the SPONSORED RESEARCH AGREEMENT constitutes
the entire agreement between the parties and no variation, modification or
waiver of any of the terms or conditions of the AGREEMENT or the SPONSORED
RESEARCH AGREEMENT shall be deemed valid unless made in writing and signed by
both parties. In the event of a conflict between this AGREEMENT and the
SPONSORED RESEARCH AGREEMENT, each agreement shall governed in accordance with
its terms. This AGREEMENT supersedes any and all prior agreements or
understandings whether oral or written between FOUNDATION and MARC.
24
IN WITNESS WHEREOF, the parties, intending to be legally bound, have
caused this AGREEMENT to be executed by their duly authorized representatives as
of the EFFECTIVE DATE.
CORNELL RESEARCH FOUNDATION, INC. MARC PHARMACEUTICALS, INC.
By:________________________ By:________________________
Name: Xxxxx X. Xxxxx Name: Xxxx San Antonio
Title: Vice President Title: Chief Executive Officer
Date:______________________ Date:________________________
25
ATTACHMENT 1
SPONSORED RESEARCH AGREEMENT
BETWEEN MARC PHARMACEUTICALS, INC.
AND CORNELL UNIVERSITY
FOR ITS WEILL MEDICAL COLLEGE
ATTACHMENT 2
FOUNDATION PATENT RIGHTS AND TECHNOLOGY
1. PCT APPLICATION NUMBER PCT/US/98/11456 (PCT Publication No. WO 98/55497)
2. UNITED STATES PATENT APPLICATION NUMBER 09/089,894
3. EUROPEAN PATENT APPLICATION NUMBER 98926258.9 (EP Publication No. 988,311)
4. CANADIAN PATENT APPLICATION NUMBER 2,293,502
2
