EXCLUSIVE LICENSE AGREEMENT
Between
XENOGENICS
CORPORATION
And
RUTGERS,
THE STATE UNIVERSITY OF NEW JERSEY
Xenogenics_________
Rutgers_________
1
THIS
LICENSE AGREEMENT (the “Agreement”) is made and is effective as of September 30,
2010, (the “Effective Date”) by and between RUTGERS, THE STATE UNIVERSITY,
having its statewide Office of Technology Commercialization at 0 Xxxxxxx Xxxxx,
Xxx Xxxxxxxxx, Xxx Xxxxxx 00000, (hereinafter referred to as “Rutgers”), and
Xenogenics Corporation, a Nevada Corporation, a having a principal place of
business at 00 Xxxxxxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxxxx, XX 00000 (hereinafter
referred to as “Licensee”).
RECITALS
WHEREAS,
certain inventions disclosed under Rutgers Docket numbers listed in Exhibit A
and Exhibit B attached hereto, hereinafter collectively referred to as the
“Invention” were made in the course of research at Rutgers, The State
University, under the direction of Xxxx. Xxxxxxx Xxxxxx and any other inventors
of Rutgers Patent Rights (hereinafter, collectively “Inventors”);
WHEREAS,
Licensee is a “small business firm” as defined in 15 U.S.C. 632;
WHEREAS,
Licensee wishes to obtain certain rights from Rutgers for the commercial
development, manufacture, use, and sale of the Invention, and Rutgers is willing
to grant such rights on the terms and conditions set forth in this Agreement;
and,
WHEREAS,
Rutgers desires that the Invention be developed and utilized to the fullest
extent so that the benefits can be enjoyed by the general public.
NOW
THEREFORE, the parties agree as follows:
1.
DEFINITIONS
1.1. “Affiliate”
shall mean, with respect to any Person, any Entity, in whatever country
organized, that controls, is controlled by or is under common control with such
Person. The term “control” means possession, direct or indirect, of
the power to direct or cause the direction of the management and policies of an
Entity, whether through the ownership of voting securities, by contract or
otherwise.
1.2. “Confidential
Information” shall mean all data, information, and tangible material owned or
controlled by Rutgers and acquired by Licensee, its Affiliates or its
sublicensees directly or indirectly from or through Rutgers, its units, its
employees, the Inventor, or its consultants relating to the Invention, Licensed
Products, or this Agreement, including but not limited to, all patent
prosecution documents and all information received from Inventors as well as all
Rutgers Technology.
1.3. “Entity”
shall mean any corporation, partnership, limited liability company, association,
stock company, trust, joint venture, unincorporated organization, governmental
entity, any department, agency or political subdivision thereof, or any other
legal entity.
1.4. “Good
Faith Reasonable Efforts” shall mean those efforts that are similar to the
efforts used by medical device companies generally in relation to other products
under similar commercial circumstances that have similar commercial value,
status and potential to a bioabsorbable stent.
1.5. “Licensed
Field” shall mean bioabsorbable stent for interventional cardiology and
peripheral vascular applications.
1.6. “Licensed
Intellectual Property” shall mean such intellectual property as is listed in
Exhibit A attached hereto including all issues, reissues, amendments, divisions,
continuations, continuations-in-part, and corresponding foreign counterparts
thereof.
Xenogenics_________
Rutgers_________
2
1.7. “Licensed
Method” shall mean any process, method, or use or practice of which would
constitute, but for the license granted to Licensee pursuant to this Agreement,
an infringement of any issued patent claim within Rutgers Patent
Rights.
1.8. “Licensed
Products” shall mean products made, made for, used or sold by Licensee or its
Affiliates or sublicensees and that would infringe on at least one Valid Patent
Claim of Rutgers Patent Rights or Rutgers Optional Patent Rights in the absence
of a license, or that use a process, material or machine covered by a Valid
Patent Claim of Rutgers Patent Rights or Rutgers Optional Patent Rights in the
absence of the License.
1.9. “Major
Market Countries” shall mean Canada, the European Union Member States, Japan,
and the United States of America.
1.10. “Net
Sales” shall mean the total of the gross consideration charged for Licensed
Products made, used, leased, transferred, distributed, sold or otherwise
disposed of by Licensee, its Subsidiaries, Affiliates, and its sublicensees,
less the sum of the following actual and customary deductions (net of rebates or
allowances of such deductions received) included on the invoice and actually
paid: cash, trade, or quantity discounts; sales or use taxes imposed upon
particular sales; import/export duties; and transportation
charges. In the event Licensee or any of its Affiliates or
sublicensees makes a transfer of a Licensed Product to a third party for other
than monetary consideration, or for less than fair market value, such transfer
shall be considered a sale hereunder to be calculated at a fair market value for
accounting and royalty purposes. Furthermore if Licensee, its
Affiliates or sublicensees commercially use Licensed Product with no expectation
of subsequent royalty bearing transfer of such Licensed Product to an
unaffiliated third party, such commercial use shall be considered a sale
hereunder to be calculated at a fair market value for royalty and accounting
purposes. For the avoidance of doubt, any disposal of Licensed
Products for or use of Licensed Products in clinical or pre-clinical trials, or
as free samples (such samples to be in quantities common in the industry for
this type of product) shall not give rise to any deemed sale under this
Agreement.
1.11. “Optional
Rutgers Patent Rights” shall mean the intellectual property listed on Exhibit B,
including all issues, reissues, amendments, divisions, continuations,
continuations-in-part, and corresponding foreign counterparts
thereof.
1.12. “Patent
Pending” shall mean any patent or patent application including all issues,
reissues, amendments, divisions, continuations, continuations-in-part, and
corresponding foreign counterparts thereof that has been filed and not yet
rejected without the possibility of appealing by a competent patent authority
anywhere in the world.
1.13. “Person”
shall mean any individual or entity.
1.14. “Term”
shall mean the earlier of (a) the expiration of all Valid Patent Claims in a
country, or (b) ten (10) years from the date of the first commercial sale in a
country.
1.15. “Territory”
shall mean all countries of the world.
1.16. “Valid
Patent Claims” shall mean any claim of any unexpired patent or Patent Pending of
Licensed Intellectual Property that has not been revoked, or held to be
unenforceable or invalid ay a decision of a court or other government agency,
unappealable, or unappealed within the time allowed for the appeal.
2.
GRANT
2.1. Subject
to the limitations set forth in this Agreement, Rutgers hereby grants to
Licensee an exclusive license to Licensed Intellectual Property in the Licensed
Field to make, have made, use, import, put into use, distribute, sell and have
sold Licensed Products and to practice Licensed Method in the Territory during
the term of this Agreement.
Xenogenics_________
Rutgers_________
3
2.2. Rutgers
further grants to Licensee an Option, the term of which shall be six (6) months
from the Effective Date (“Option Period”), for Licensee to decide whether it
wants to add any patents or patent applications designated in Exhibit B as
Rutgers Optional Patent Rights to the list of patents and patent applications
designated in Exhibit A as Licensed Intellectual Property. Upon
expiration of the Option Period, Licensee shall have no rights whatsoever to any
Rutgers Optional Patent Rights that it has not opted to include as Licensed
Intellectual Property.
2.3. If
the Invention was funded by the U.S. Government, the license granted hereunder
shall be subject to the overriding obligations to the U.S. Government set forth
in 35 U.S.C. 200-212, and any future amendments thereto, and applicable
governmental implementing regulations, as well as any other applicable
governmental restrictions, if any, including, without limitation (i) to the
obligation to manufacture in the United States Licensed Product intended for
consumption in the United States unless a waiver is obtained, and (ii) to the
royalty free non-exclusive license thereunder to which the U.S. Government is
entitled.
2.4. Rutgers
expressly reserves the right to have the Invention and associated intellectual
property rights licensed hereunder used for educational, research and other
non-business purposes, and to publish the rights thereof.
2.5. To
the extent Rutgers, principally through the Inventors, has provided Rutgers
Technology to Licensee, it is understood that at the time of disclosure to the
Licensee some of the Rutgers Technology may have been made available to the
public without restrictions.
3.
SUBLICENSES
3.1. Rutgers
grants to Licensee the right to grant sublicenses to third parties under any or
all of the licenses granted in Article 2, provided Licensee has current
exclusive rights thereto under this Agreement at the time it exercises a right
of sublicense. To the extent applicable, such sublicense shall
include all of the rights of and obligations due to Rutgers (and to the United
States Government) that are contained in this Agreement.
3.2. Within
thirty (30) days after execution thereof, Licensee shall provide Rutgers with a
copy of each sublicense issued hereunder, and shall thereafter collect and
guarantee payment of all royalties and other obligations due Rutgers relating to
the sublicensees and summarize and deliver all reports due Rutgers relating to
the sublicensees. Licensee shall pay Rutgers a twenty-five percent
(25%) sublicensing fee on any non-royalty consideration received from any
sublicense.
4.
LICENSE ISSUE FEE, LICENSE
MAINTENANCE FEES AND MILESTONE AND OTHER PAYMENTS
4.1. Licensee
shall pay to Rutgers a license issue fee of Fifty Thousand Dollars ($50,000) no
later than five (5) business days from the Effective Date of this
Agreement.
4.2.
Licensee shall pay Rutgers a License Maintenance Fee according to the following
schedule:
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4.2.1.
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$0
on the first anniversary of the Effective
Date
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4.2.2.
|
$0
on the second anniversary of the Effective
Date
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4.2.3.
|
$25,000
on the third anniversary of the Effective
Date
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Xenogenics_________
Rutgers_________
4
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4.2.4.
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$50,000
on the fourth anniversary of the Effective Date and annually thereafter
until the first commercial sale.
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4.2.5.
|
The
License Maintenance Fee is non-refundable, and shall not be off-set
against future royalty payments.
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4.3. Licensee
shall pay Rutgers the following Milestone Payments:
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4.3.1.
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$50,000
upon initiation of first-in-human clinical studies anywhere in the world
for Licensed Product.
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4.3.2.
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$200,000
upon initiation of pivotal human clinical trial in preparation for
submission of an application for market approval to a regulatory authority
anywhere in the world for Licensed
Product.
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4.3.3.
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$300,000
upon submission of application for market approval to a regulatory
authority anywhere in the world for Licensed
Product.
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4.3.4.
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$1,000,000
upon market approval by a regulatory authority anywhere in the world for
Licensed Product.
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4.3.5.
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Fifty
percent (50%) of the Milestone Payments actually received by Rutgers shall
be off-set against future royalty
payments.
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4.3.6.
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Each
Milestone Payment that is owed shall be made only one time with respect to
Licensed Products, regardless of how many times such Licensed Products
achieves each of the indicated milestones and, no payment shall be owed
for a milestone which is not
reached.
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5.
ROYALTIES
5.1. Except
as otherwise required by law, Licensee shall pay to Rutgers a royalty of three
percent (3%) of annual Net Sales of Licensed Product. Other transfers
among Licensee, its Affiliates and sublicensees which would otherwise be royalty
bearing under this Agreement shall be disregarded for purposes of computing
royalties to the extent that Licensed Product subject to such sale or transfer
is subsequently sold or transferred to a third party where a payment of royalty
by such third party pursuant to the terms of this Agreement with respect to such
sale or transfer will be required.
5.2. Royalties
payable to Rutgers shall be paid quarterly no later than forty-five (45) days
after the following dates of each calendar year:
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5.2.1.
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March
31st
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5.2.2.
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June
30th
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5.2.3.
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September
30th
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5.2.4.
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December
31st
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5.3. Each
such royalty payment shall be for unpaid royalties that accrued within
Licensee's most recently completed calendar quarter plus any other unpaid
royalties due, but not previously paid for any reason.
Xenogenics_________
Rutgers_________
5
5.4. A
Licensed Product shall be deemed made, used, leased, transferred, sold, or
otherwise disposed of at the time Licensee bills, invoices, ships, or receives
payment for such Licensed Product or commercially uses product, whichever occurs
first.
5.5. Starting
upon the first commercial sale of a Licensed Product, and annually thereafter,
Licensee shall pay Rutgers a minimum annual royalty on the anniversary of the
date of such sale as laid out below:
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5.5.1.
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Upon
first commercial
sale: $100,000
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5.5.2.
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First
anniversary of first commercial
sale: $150,000
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5.5.3.
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Second
anniversary of first commercial
sale: $200,000
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5.5.4.
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Third
anniversary of first commercial
sale: $250,000
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5.5.5.
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Fourth
anniversary of first commercial sale and annually
thereafter: $300,000
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5.6. The
minimum annual royalty shall be credited against the earned royalty due and
owing for the calendar year in which the minimum annual royalty is
paid.
5.7. All
amounts due Rutgers shall be payable in United States Dollars in New Brunswick,
New Jersey. When Licensed Products are sold for monies other than
United States Dollars, the earned royalties will first be determined in the
foreign currency of the country in which such Licensed Products were sold and
then converted into equivalent United States Dollars. The exchange
rate will be the United States Dollar buying rate quoted in the Wall Street
Journal on the last day of the reporting period.
5.8. Licensee
shall be responsible for any and all taxes, fees, or other charges imposed by
the government of any country outside the United States on the remittance of
royalty income for sales occurring in any such country. Licensee
shall also be responsible for all bank transfer charges.
5.9. If
at any time legal restrictions prevent the acquisition or prompt remittance of
United States Dollars by Licensee with respect to any country where a Licensed
Product is sold, Licensee shall pay royalties due to Rutgers from Licensee's
other sources of United States Dollars.
5.10. In
the event that any patent or any claim thereof of Licensed Intellectual Property
shall be held invalid in a final decision by a court of competent jurisdiction
and last resort in any country and from which no appeal has or can be taken, all
obligation to pay royalties based on such patent or claim or any claim
patentably indistinct therefrom shall cease as of the date of such final
decision with respect to such country. Licensee shall not, however,
be relieved from paying any royalties that accrued before such decision or that
are based on another patent or claim not involved in such decision.
5.11. Licensee
its affiliates and its sublicensees, and Rutgers shall work cooperatively to
resolve any such issue without resorting to litigation or a request for
reexamination of the subject Licensed Intellectual Property by the U.S. Patent
and Trademark Office or another competent jurisdictional patent
agency.
6.
DILIGENCE
6.1. Licensee,
upon and after execution of this Agreement, shall use Good Faith Reasonable
Efforts to develop, test, obtain any required governmental approvals,
manufacture, market and sell Licensed Products in all countries of the Territory
within a reasonable time after execution of this Agreement and in quantities
sufficient to meet the market demands.
6.2. Licensee
shall be entitled to exercise prudent and reasonable business judgment in
meeting its diligence obligations in this Section 6.1.
Xenogenics_________
Rutgers_________
6
6.3. In
addition to 6.1 above, Licensee will make Good Faith Reasonable Efforts to
achieve the following development milestones:
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6.3.1.
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raise
at least five (5) million dollars in equity funding within six (6) months
from the Effective Date;
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6.3.2.
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restart
manufacturing and produce a device within twelve (12) months from the
Effective Date;
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6.3.3.
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initiate
an animal study within eighteen (18) months from the Effective
Date;
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6.3.4.
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make
a regulatory submission to support a human use clinical trial within
twenty-four (24) months of the Effective
Date;
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6.3.5.
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initiate
a human use clinical trial within thirty-six (36) months of the Effective
Date; and,
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6.3.6.
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make
a regulatory submission or equivalent for marketing approval for use in
humans within forty-eight (48) months from the Effective Date in at least
one Major Market Country.
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7.
PROGRESS AND PAYMENT
REPORTS
7.1. Beginning
six (6) months after the Effective Date, and semi-annually thereafter, Licensee
shall submit to Rutgers a progress report covering Licensee's activities related
to the research, development and testing of all Licensed Products, and obtaining
of governmental approvals necessary for marketing Licensed Products in each
country of the Territory.
7.2. The
progress reports submitted under Section 7.1 shall include sufficient
information to enable Rutgers to determine Licensee's progress in fulfilling its
obligations under Article 6, including, but not limited to, the following
topics:
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7.2.1.
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summary
of work completed, including key scientific results, market
analysis;
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7.2.2.
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summary
of work in progress, including product development and testing and
progress in obtaining government
approvals;
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7.2.3.
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current
schedule of anticipated events or
milestones;
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7.2.4.
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market
plans for introduction of Licensed Products in the
Territory;
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7.2.5.
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summary
of resources (dollar value) spent in the reporting period for research,
development, and marketing of Licensed
Products;
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7.2.6.
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activities
in obtaining sublicensees and activities of
sublicensees;
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7.2.7.
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certified
financial statements as of the end of the previous calendar quarter;
and,
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7.2.8.
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statement
showing how amounts due were
calculated.
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7.3. Licensee
shall have a continuing responsibility to keep Rutgers informed of the
large/small entity status (as defined by the United States Patent and Trademark
Office) of itself and its sublicensees.
7.4. Licensee
shall report to Rutgers in its immediately subsequent progress and payment
report the date of first commercial sale of each Licensed Product in each
country within the Territory.
Xenogenics_________
Rutgers_________
7
7.5. After
the first commercial sale of a Licensed Product in the Territory, Licensee will
make quarterly royalty reports to Rutgers no later than forty-five (45) days
after the following dates of each calendar year: March
31st, June
30th,
September 30th, and
December 31st. Each
such royalty report will cover Licensee's most recently completed calendar
quarter and will show (i) the units and gross sales and Net Sales of each type
of Licensed Product sold by Licensee, its Affiliates and sublicenses on which
royalties have not been paid, including a clear indication of how Net Sales were
calculated; (ii) the royalties and fees, in U.S. dollars, payable hereunder,
including a breakdown, where more than one patent is licensed hereunder, of how
royalty income is allocated among the patents; (iii) the method used to
calculate the royalty; (iv) the exchange rates used, if any; and (v) any other
information relating to the foregoing reasonably requested by
Rutgers.
7.6. If
no sales of Licensed Products have been made during any reporting period, a
statement to this effect shall be made by Licensee.
7.7. Licensee
shall include a written statement with any additional payment or other
consideration made to Rutgers pursuant to the terms of this Agreement setting
forth in reasonable detail the basis for the payment and the manner in which the
payment was calculated.
8.
BOOKS AND
RECORDS
8.1. Licensee
shall keep and cause its Affiliates and sublicensees to keep books and records
in accordance with generally accepted accounting principles accurately showing
all transactions and information relating to this Agreement. Such
books and records shall be preserved for at least five (5) years from the date
of the entry to which they pertain and shall be open to inspection by
representatives or agents of Rutgers at reasonable times upon reasonable
notice.
8.2. The
fees and expenses of Rutgers' representatives performing such an examination
shall be borne by Rutgers. However, if an error in any payment of
more than five percent (5%) of such payment due is discovered, or if as a result
of the examination it is determined that Licensee is in material breach of its
other obligations under this Agreement, then the fees and expenses of these
representatives shall be borne by Licensee, and Licensee shall promptly
reimburse Rutgers for reasonably documented audit expenses as well as all
overdue payment and late interest payments.
9.
TERM OF THE
AGREEMENT
9.1. Unless
otherwise terminated by operation of law or by acts of the parties in accordance
with the provisions of this Agreement, the Term of this Agreement shall be as
defined in Section 1.14.
9.2. Any
termination or expiration of this Agreement shall not affect the rights and
obligations set forth in the following Sections or Articles: Article
1, Sections 2.4 and 2.5 of Article 2, Section 7.5 of Article 7, Article 8, this
Section 9.2, Article 10, Article 12, Article 13, Article 14, Article 18, Article
23, Article 27 and Article 28.
9.3. Any
termination under this agreement shall not relieve Licensee of any obligation or
liability accrued hereunder prior to such termination or rescind anything done
by Licensee or any payments made to Rutgers hereunder prior to the time such
termination becomes effective, and such termination shall not affect in any
manner any rights of Rutgers arising under this Agreement prior to such
termination.
10.
TERMINATION FOR CAUSE BY
EITHER PARTY
10.1. If
one party should breach or fail to perform any provision of this Agreement, then
the other party may give written notice of such default (Notice of Default) to
the breaching party. If the breaching party should fail to cure such
default within ninety (90) days of notice thereof, the non-breaching party shall
have the right to terminate this Agreement and the licenses herein by a second
written notice (Notice of Termination) to the breaching party. If a
Notice of Termination is sent to breaching party, this Agreement shall
automatically terminate on the effective date of such
notice. Termination shall not relieve breaching party of its
obligation to pay all amounts due to the non-breaching party as of the effective
date of termination and shall not impair any accrued rights of the non-breaching
party.
Xenogenics_________
Rutgers_________
8
11.
VOLUNTARY TERMINATION BY
LICENSEE
11.1. Licensee
shall have the right at any time to terminate this Agreement in its entirety by
giving one hindered and twenty (120) days advance notice thereof in writing to
Rutgers.
12.
DISPOSITION OF LICENSED
PRODUCTS AND INFORMATION ON HAND UPON TERMINATION
12.1. Upon
termination of this Agreement by either party (i) Licensee shall have the
privilege of disposing of all previously made or partially made Licensed
Products (Licensee may complete partially made Licensed Products), but no more,
within a period of one hundred and eighty (180) days after the initial notice of
termination given pursuant to Section 10.1 or Section 11.1 hereunder, provided,
however, that the disposition of such Licensed Products shall be subject to the
terms of this Agreement including, but not limited to, the payment of royalties
at the rate and at the time provided herein and the rendering of reports
thereon; and, (ii) Licensee shall promptly return, and shall cause its
Affiliates and sublicensees to return, to Rutgers all property belonging to
Rutgers including without limitation, if any, that has been provided to Licensee
or its Affiliates or sublicensees hereunder, and all copies and facsimiles
thereof and derivatives therefrom (except that Licensee may retain one copy of
written material for record purposes only, provided such material is not used by
Licensee for any other purpose and is not disclosed to others).
13.
USE OF NAMES, TRADEMARKS,
AND CONFIDENTIAL INFORMATION
13.1. Nothing
contained in this Agreement shall be construed as granting any right to
Licensee, its Affiliates or sublicensees to use in advertising, publicity, or
other promotional activities or otherwise any name, trade name, trademark, or
other designation of Rutgers or any of its units (including contraction,
abbreviation or simulation of any of the foregoing). Unless required
by law or consented to in advance in writing by an authorized representative of
Rutgers, the use by Licensee of the name, “Rutgers, The State University” or any
campus or unit of Rutgers is expressly prohibited.
14.
LIMITED
WARRANTY
14.1. Rutgers
warrants to Licensee that it has the lawful right to grant this
license.
14.2. This
license and the associated Invention are provided WITHOUT WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY,
EXPRESS OR IMPLIED. RUTGERS MAKES NO REPRESENTATION OR WARRANTY THAT THE
LICENSED PRODUCTS OR LICENSED METHODS WILL NOT INFRINGE ANY PATENT OR OTHER
PROPRIETARY RIGHT. IN NO EVENT WILL RUTGERS BE LIABLE FOR ANY
INCIDENTAL, DIRECT, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES, INCLUDING
WITHOUT LIMITATION, LOST PROFITS, RESULTING FROM EXERCISE OF THIS LICENSE BY OR
ON BEHALF OF LICENSEE, ITS AFFILIATES OR SUBLICENSEES OR MANUFACTURE, SALE, OR
USE OF THE INVENTION OR LICENSED PRODUCTS OR RUTGERS INTELLECTUAL PROPERTY
LICENSED HEREUNDER.
14.3. Nothing
in this Agreement shall be construed as:
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14.3.1.
|
a
warranty or representation by Rutgers as to the validity or scope of any
Rutgers Patent Rights; or
|
Xenogenics_________
Rutgers_________
9
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14.3.2.
|
a
warranty or representation that anything made, used, sold or otherwise
disposed of under any license granted in this Agreement is or will be free
from infringement of patents or other intellectual property rights of
third parties; or
|
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14.3.3.
|
an
obligation to bring or prosecute actions or suits against third parties
except as provided in Article 17;
or
|
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14.3.4.
|
conferring
by implication, estoppel or otherwise any license or rights under any
patents or other intellectual property of Rutgers other than Rutgers
Patent Rights and Rutgers Technology, regardless of whether such patents
are dominant or subordinate to Rutgers Patent Rights;
or
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14.3.5.
|
an
obligation to furnish any know-how not provided in Rutgers intellectual
property licensed hereunder.
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15.
PATENT PROSECUTION AND
MAINTENANCE
15.1. Rutgers
shall diligently prosecute and maintain the United States patent applications
and patents comprising Licensed Intellectual Property. Licensee and
Rutgers shall agree in advance with respect to the retaining of patent counsel
to manage the Licensed Intellectual Property. Rutgers shall keep
Licensee informed and apprised of the continuing prosecution of Licensed
Intellectual Property. Licensee agrees to keep this documentation
confidential.
15.2. Rutgers
shall give due consideration to amending any patent application to include
claims reasonably requested by Licensee to protect Licensed
Products.
15.3. All costs
incurred by Rutgers after the Effective Date for preparing, filing, prosecuting,
defending, and maintaining all United States patent applications and patents,
including but not limited to declaratory judgments, interferences, oppositions,
reexaminations, reissues, and all corresponding foreign patent applications and
patents covered by Licensed Intellectual Property shall be borne by
Licensee. Future costs shall be payable by Licensee within thirty
(30) days of the billing date. If Licensee fails to pay patent costs
in a timely manner as required in this Section, Rutgers may, at its discretion,
require Licensee to pay estimated patent costs in
advance. Notwithstanding the foregoing, Licensee shall not pay patent
costs on Rutgers Optional Patent Rights unless and until it exercises its
option. Should Licensee exercise its option with regard to any or all
of the Rutgers Optional Patent Rights then those patents shall be included under
Licensed Intellectual Property, and Licensee shall pay all patent fees related
thereto as set forth in this Section 15.3.
15.4. Licensee
shall pay Rutgers for any unpaid costs incurred by Rutgers prior to the
Effective Date for preparing, filing, prosecuting, defending, and maintaining
all United States patent applications and patents, including but not limited to
declaratory judgments, interferences, oppositions, reexaminations, reissues, and
all corresponding foreign patent applications and patents covered by Licensed
Intellectual Property. Said unpaid costs incurred by Rutgers prior to
the Effective Date shall not exceed One Hundred Thirty-six Thousand dollars
($136,000), and shall be payable by Licensee the earlier of (a)
within six (6) months of the Effective Date, or (b) upon the closing of an
equity financing with gross proceeds equal to or greater than Five Million
dollars ($5,000,000).
15.5. Only
at the request of Licensee, shall Rutgers file, prosecute, and maintain patent
applications and patents covered by Licensed Intellectual Property in foreign
countries. Licensee consents to the filing of all PCT and foreign
patent applications that have already been filed as of the Effective
Date. Licensee shall notify Rutgers within six (6) months of the
filing of the corresponding United States application of its decision to obtain
any foreign patents. This notice shall be in writing, and shall
identify the countries desired. The absence of such a notice from
Licensee shall be considered by Rutgers to be an election not to request foreign
rights.
Xenogenics_________
Rutgers_________
10
15.6. Licensee's
obligation to underwrite and to pay patent prosecution costs shall continue for
so long as this Agreement remains in effect, provided, however, that Licensee
may terminate its obligations with respect to any given patent application or
patent upon three (3) months prior written notice to Rutgers. Rutgers
shall use reasonable efforts to curtail future patent costs when such a notice
is received from Licensee. Licensee shall promptly pay patent costs
which cannot be so curtailed. Commencing on the effective date of
such notice, Rutgers may continue prosecution or maintenance of such
application(s) or patent(s) at its sole discretion and expense, and Licensee
shall have no further right or licenses thereunder.
15.7. Rutgers
shall have the right to file patent applications at its own expense in any
country or countries in which Licensee has not elected to secure patent rights
or in which Licensee's patent rights hereunder have terminated, and such
applications and resultant patents shall not be subject to this Agreement and
may be freely licensed by Rutgers to third parties.
15.8. In
the event Rutgers licenses a party other than Licensee rights under Licensed
Intellectual Property in a field other than the Licensed Field, the cost of
prosecuting and maintain Licensed Intellectual Property shall be borne equally
between said third party and Licensee.
16.
PATENT
MARKING
16.1. Licensee
shall xxxx all Licensed Products made, used, sold imported, exported, or
otherwise disposed of under the terms of this Agreement, in accordance with the
applicable patent marking laws.
17.
PATENT
INFRINGEMENT
17.1. In
the event that Licensee shall learn of the infringement of any patent licensed
under this Agreement, Licensee shall notify Rutgers in writing and shall provide
Rutgers with reasonable evidence of such infringement. Both parties
to this Agreement agree that during the period and in a jurisdiction where
Licensee has exclusive rights under this Agreement, neither will notify a third
party of the infringement of any of Rutgers Patent Rights without first
obtaining consent of the other Party, which consent shall not be unreasonably
denied. Both parties shall use their best efforts in cooperation with
each other to terminate such infringement without litigation.
17.2. Licensee
may request that Rutgers take legal action against the infringement of Licensed
Intellectual Property. Such request shall be made in writing, and
shall include reasonable evidence of such infringement and damages to
Licensee. If the infringing activity has not been abated within
ninety (90) days following the effective date of such request, Rutgers shall
have the right to commence suite on its own account or refuse to commence such
suit. Rutgers shall give notice of its election in writing to
Licensee within one hundred (100) days after receiving notice of such request
from Licensee. Licensee may thereafter bring suit for patent
infringement if and only if Rutgers refuses to commence suite, and if the
infringement occurred during the period and in jurisdiction where Licensee had
exclusive rights under this Agreement. However, in the event Licensee
elects to bring suit in accordance with this paragraph, Rutgers may thereafter
join such suit at its own expense. Such legal action as is decided
upon shall be at the expense of the party on account of whom suit is
brought.
17.3. Each
party agrees to cooperate with the other in litigation proceedings instituted
hereunder but at the expense of the party on account of whom suit is brought for
out-of-pocket expenses. Such litigation shall be controlled by the
party bringing the suit. Each party may be represented by counsel of
its choice at its own expense.
17.4. All
recoveries, damages and awards in any infringement suit after reimbursement of
any litigation expenses of Rutgers and Licensee not previously reimbursed from a
lawsuit regarding Licensed Intellectual Property shall be divided equally
between Rutgers and Licensee.
Xenogenics_________
Rutgers_________
11
18.
INDEMNIFICATION AND
INSURANCE
18.1. To
the maximum extent permitted by law, Licensee shall indemnify, hold harmless and
defend Rutgers, its governors, trustees, officers, employees, students, agents
and the Inventors against any and all claims, suits, losses, liabilities,
damages, costs, fees and expenses (including reasonable attorneys' fees)
resulting from or arising out of the exercise of the rights granted under this
license or any sublicense by Licensee, its Affiliates and
sublicensees. This indemnification shall include, but is not limited
to, any and all claims alleging products liability.
18.2. Throughout
the term of this Agreement, and to the extent applicable from and after the date
of first commercial sale of a Licensed Product, Licensee shall maintain
commercially issued policies of insurance, or a program of self-insurance if
such program is approved in advance in writing by an authorized representative
of Rutgers, which provide coverage and limits as required by statute or as
necessary to prudently insure the activities and operations of
Licensee. The commercial general liability insurance policy, or
liability self-insurance program, shall include the interests of Rutgers as an
additional insured and provide coverage limits of not less than $2,000,000
combined single limits as respects premises, operations, contractual liability
and, if applicable, liability arising out of products and/or completed
operations. Licensee shall provide Rutgers with certificates of
insurance for commercially insured policies, or a letter from Licensee’s
independent auditors stating its opinion as to the adequacy of any
self-insurance program.
18.3. It
is expressly agreed that the insurance or self-insurance are minimum
requirements which shall not in any way limit the liability of Licensee and
shall be primary coverage. Any insurance or self-insurance program
maintained by Rutgers shall be excess and noncontributory.
18.4. Rutgers
shall promptly notify Licensee in writing of any claim or suit brought against
Rutgers in respect of which Rutgers intends to invoke the provisions of Article
18. Licensee shall keep Rutgers informed on a current basis of its
defense of any claims pursuant to Article 18.
19.
NOTICES
19.1. Any
notice or payment required to be given to either party shall be deemed to have
been properly given and to be effective (a) on the date of delivery if delivered
in person, (b) five (5) days after mailing if mailed by first-class certified
mail, postage paid and deposited in the United States mail, to the respective
addresses given below, or to such other address as it shall designate by written
notice given to the other party, (c) on the date of delivery if delivered by
express delivery service such as Federal Express or DHL or (d) or as otherwise
agreed upon in writing by the parties.
In the
case of
Licensee: Xenogenics
Corporation
00 Xxxxxxxxxx Xxxxxx, Xxxxx
000
Xxxxxxxxxx, XX 00000
Tel.: (000)
000-0000
FAX: (000)
000-0000
Attention: W. Xxxxxx
Xxxxxx, Chairman & CEO
In the
case of
Rutgers: Rutgers,
The State University
Office of Technology
Commercialization
ASB III, 0 Xxxxxxx Xxxxx
Xxx Xxxxxxxxx, XX 00000
Attention: Director
Xenogenics_________
Rutgers_________
12
20.
ASSIGNABILITY
20.1. This
Agreement is binding upon and shall inure to the benefit of Rutgers, its
successors and assigns, but shall be personal to Licensee and assignable by
Licensee only upon the transfer or sale of all or substantially all of the
assets relating to this Agreement.
21.
LATE
PAYMENTS
21.1. In
the event any amounts due Rutgers hereunder, including but not limited to
royalty payments, fees and patent cost reimbursements, are not received when
due, Licensee shall pay to Rutgers interest charges at a rate of ten percent
(10%) per annum, compounded monthly. Such interest shall be
calculated from the date payment was due until actually received by
Rutgers.
22.
WAIVER
22.1. It
is agreed that failure to enforce any provisions of this Agreement by a party
shall not be deemed a waiver of any breach or default hereunder by the other
party. It is further agreed that no express waiver by either party
hereto of any breach or default of any of the covenants or agreements herein set
forth shall be deemed a waiver as to any subsequent and/or similar breach or
default.
23.
FAILURE TO
PERFORM
23.1. In
the event of a failure of performance due under the terms of this Agreement, and
if it becomes necessary for either party to undertake legal action against the
other on account thereof, then the prevailing party shall be entitled to
reasonable attorney's fees in addition to costs and necessary
disbursements.
24.
GOVERNING
LAWS
24.1. THIS
AGREEMENT SHALL BE INTERPRETED AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE
STATE OF NEW JERSEY WITHOUT REGARD TO ITS CONFLICTS OF LAW PROVISIONS, but the
scope and validity of any patent or patent application shall be governed by the
applicable laws of the country of such patent or patent
application.
25.
FOREIGN GOVERNMENT APPROVAL
OR REGISTRATION
25.1. If
this Agreement or any associated transaction is required by the law of any
nation to be either approved or registered with any governmental agency,
Licensee shall assume all legal obligations to do so and the costs in connection
therewith.
26.
EXPORT CONTROL
LAWS
26.1. Licensee
shall observe all applicable United States and foreign laws with respect to the
transfer of Licensed Products and related technical data to foreign countries,
including, without limitation, the International Traffic in Arms Regulations
(ITAR) and the Export Administration Regulations.
27.
CONFIDENTIALITY
27.1. Licensee
(i) shall not use any Confidential Information except for the sole purpose of
performing this Agreement, (ii) shall safeguard the same against disclosure to
others with the same degree of care as it exercises with its own information of
a similar nature, and (iii) shall not disclose or permit the disclosure of
Confidential Information to others (except to its employees, agents or
consultants who are bound to Licensee and Rutgers by a like obligation of
confidentiality) without the express written permission of Rutgers, except that
Licensee shall not be prevented from using or disclosing any Confidential
Information:
Xenogenics_________
Rutgers_________
13
|
27.1.1.
|
which
Licensee can demonstrate by written records was previously known to it;
or
|
|
27.1.2.
|
which
is now, or becomes in the future, information generally available to the
public in the form supplied, other than through acts or omissions of
Licensee; or
|
|
27.1.3.
|
which
is lawfully obtained by Licensee from sources independent of Rutgers who
were entitled to provide such information to Licensee;
or
|
|
27.1.4.
|
which
is required by law to be disclosed.
|
27.2. The
obligations of Licensee under this section 27.1 shall remain in effect during
the term of this Agreement and for five (5) years from the date of termination
or expiration of this Agreement.
28.
MISCELLANEOUS
28.1. The
headings of the several articles are inserted for convenience of reference only
and are not intended to be a part of or to affect the meaning or interpretation
of this Agreement.
28.2. This
Agreement will not be binding upon the parties until it has been signed below on
behalf of each party by a duly authorized representative.
28.3. No
amendment or modification hereof shall be valid or binding upon the parties
unless made in writing and signed on behalf of each party by a duly authorized
representative.
28.4. This
Agreement embodies the entire understanding of the parties and shall supersede
all previous and contemporaneous communications, representations or
understandings, either oral or written, between the parties relating to the
subject matter hereof.
28.5. Licensee
shall not enter into any agreements relating to this Agreement with Inventor or
other Rutgers employees or students in contravention of the legal rights or
policies of Rutgers.
28.6. In
case any of the provisions contained in this Agreement shall be held to be
invalid, illegal or unenforceable in any respect, (i) such invalidity,
illegality or unenforceability shall not affect any other provisions hereof,
(ii) the particular provision, to the extent permitted by law, shall be
reasonably construed and equitably reformed to be valid and enforceable and if
the provision at issue is a commercial term, it shall be equitably reformed so
as to maintain the overall economic benefits of the Agreement as originally
agreed upon by the parties. and (iii) this Agreement shall be construed as if
such invalid or illegal or unenforceable provisions had never been contained
herein.
28.7. Rutgers
shall have the right to terminate this Agreement forthwith by giving written
notice of termination to Licensee at any time upon or after the filing by
Licensee of a petition in bankruptcy or insolvency, or upon or after any
adjudication that Licensee is bankrupt or insolvent, or upon or after the filing
by Licensee of any petition or answer seeking judicial reorganization,
readjustment or arrangement of the business of Licensee under any law relating
to bankruptcy or insolvency, or upon or after the appointment of a receiver for
all or substantially all of the property of Licensee, or upon or after the
making of any assignment or attempted assignment for the benefit of creditors,
or upon or after the institution of any proceeding or passage of any resolution
for the liquidation or winding up of Licensee’s business or for termination of
its corporate life.
28.8. Neither
Licensee nor its Affiliates shall originate any publicity, news release or other
public announcement, written or oral, relating to this Agreement or the
existence of an arrangement between the parties, except as required by law,
without the prior written approval of Rutgers, which approval shall not be
unreasonably withheld. Notwithstanding the foregoing, Rutgers
acknowledges (i) Licensee is the majority owned subsidiary of MultiCell
Technologies, Inc., a publicly traded company subject to U.S. security laws and
regulation by the U.S. Security and Exchange Commission (“SEC”), and (ii)
MultiCell Technologies will be required to issue a press release and file a Form
8K with the SEC announcing the consummation of this Agreement between Licensee
and Rutgers.
Xenogenics_________
Rutgers_________
14
28.9. This
Agreement may be executed in any number of counterparts, each of which shall be
deemed an original, but all of which together shall constitute one and the same
instrument.
28.10. Nothing
herein shall be deemed to constitute one party as the agent or representative of
the other party or both parties as joint ventures or partners. Each
party as an independent contractor.
[This
Portion of the Page Intentionally Left Blank]
Xenogenics_________
Rutgers_________
15
SIGNATURE
PAGE
IN
WITNESS WHEREOF, both Rutgers and Licensee have executed this Agreement by their
duly authorized representatives.
FOR
XENOGENICS CORPORATION:
|
FOR
RUTGERS, THE STATE UNIVERSITY:
|
|
W.
Xxxxxx Xxxxxx
|
Xxxxxxxx
Xxx, Ph.D., MBA, CLP
|
|
Chairman
& Chief Executive Officer
|
Executive
Director, Office of Technology Commercialization
|
|
Title
|
Title
|
|
Date
|
Date
|
Xenogenics_________
Rutgers_________
16
EXHIBIT
A
Licensed
Intellectual Property
TITLE
|
Rutgers Docket
|
Attorney Docket
|
Application No./Patent
No.
|
|||
Medical
Devices Employing Novel Polymers
|
PMX-018
|
01435.062US1
|
10/716,577
|
|||
Polyanhydrides
with Therapeutically
|
97-0049
|
01435.008US1
|
7,122,615
|
|||
Useful
Degradation Products
|
01435.008US2
|
7,534,852
|
||||
01435.008US3
|
12/428,088
|
|||||
Polyanhydride
Linkers for Production of
|
04-028
|
01435.012US1
|
6,486,214
|
|||
Drug
Polymers and Drug Polymer
|
01435.012US3
|
7,666,398
|
||||
Compositions
Produced Thereby
|
||||||
Synthesis
of Salicylate-based
|
02-052
|
01435.023US1
|
7,411,031
|
|||
Polyanhydrides
|
|
|
01435.023US2
|
|
12/026,925
|
Xenogenics_________
Rutgers_________
17
EXHIBIT
B
Optional
Intellectual Property
Attorney Docket
|
Country
|
Application Number
|
Application Status
|
Patent Number
|
||||
1435.006
|
Mexico
|
2001/010752
|
Granted
|
235839
|
||||
1435.006
|
USA
|
09/298729
|
Granted
|
6365146
|
||||
1435.007
|
USA
|
09/422295
|
Granted
|
6328988
|
||||
1435.010US1
|
USA
|
09/917595
|
Granted
|
6602915
|
||||
1435.013
|
Canada
|
2393676
|
Pending
|
|||||
1435.013
|
EPC
|
00982544.9-2112
|
Published
|
|||||
0000.000
|
Xxxxx
|
2001-543098
|
Pending
|
|||||
1435.013
|
Mexico
|
2002/05769
|
Granted
|
268990
|
||||
1435.013
|
USA
|
11/524664
|
Published
|
|||||
1435.014
|
Canada
|
2387558
|
Pending
|
|||||
1435.014
|
Hong
Kong
|
5102868
|
Published
|
|||||
0000.000
|
Xxxxx
|
2001-531088
|
Pending
|
|||||
1435.014
|
Mexico
|
2002/003890
|
Granted
|
232176
|
||||
1435.014
|
USA
|
09/422294
|
Granted
|
6685928
|
||||
1435.017
|
Canada
|
2417389
|
Pending
|
|||||
1435.017
|
EPC
|
1956013.5
|
Published
|
|||||
0000.000
|
Xxxxx
|
2002-515320
|
Granted
|
245201
|
||||
1435.017
|
USA
|
11/956189
|
Pending
|
|||||
1435.017
|
USA
|
09/917194
|
Granted
|
6689350
|
||||
1435.017
|
USA
|
11/956202
|
Pending
|
|||||
1435.021
|
Australia
|
20011278052
|
Granted
|
245201
|
||||
1435.021
|
Canada
|
2417388
|
Pending
|
|||||
1435.021
|
EPC
|
1956010.0
|
Published
|
|||||
1435.021
|
Hong
Kong
|
3108039.3
|
Published
|
|||||
0000.000
|
Xxxxx
|
2002-515319
|
Pending
|
|||||
1435.021
|
USA
|
09/917231
|
Granted
|
6613807
|
||||
1435.021
|
USA
|
11/732653
|
Published
|
|||||
1435.022
|
USA
|
10/754900
|
Granted
|
7262221
|
||||
1435.025
|
USA
|
10/913289
|
Granted
|
7396527
|
||||
1435.029
|
Canada
|
2488121
|
Pending
|
|||||
1435.029
|
EPC
|
3734450.4
|
Published
|
|||||
0000.000
|
Xxxxx
|
2004-510715
|
Granted
|
4422018
|
||||
1435.029
|
Mexico
|
2004-012290
|
Granted
|
268987
|
||||
1435.029
|
USA
1
|
11/006506
|
Granted
|
7470802
|
||||
1435.029
|
USA
2
|
10/949955
|
Pending
|
|||||
1435.035
|
EPC
|
5712364.8
|
Published
|
|||||
1435.035
|
USA
|
10/587678
|
Published
|
|||||
1435.040
|
EPC
|
6770908.9
|
||||||
1435.040US
|
USA
|
11/915284
|
||||||
1435.042
|
PCT
|
PCT/US2007/070531
|
Published
|
|||||
PMEX
Cases:
|
||||||||
13640-00002
|
USA
|
10/503838
|
Pending.060US1
|
|||||
13640-00003
|
USA
|
10/504121
|
Pending.061US1
|
|||||
13640-00020
|
USA
|
10/716577
|
Pending.062US1
|
|||||
00000-00000
|
Canada
|
2506319
|
Pending.062CA1
|
|||||
13640-00025
|
EPC
|
3786836.1
|
Published.062EP1
|
|||||
00000-00000
|
Xxxxx
|
2004/553918
|
Published.062JP1
|
|||||
13640-00030
|
USA
|
10/532703
|
Published.063US1
|
|||||
00000-00000
|
Canada
|
2527495
|
Pending.064CA1
|
|||||
EPC
|
4816742.3
|
Published.064EP1
|
||||||
|
USA
|
|
10/861881
|
|
Granted
|
|
7662864
|
Xenogenics_________
Rutgers_________
18