SAMARITAN PHARMACEUTICALS IRELAND INC. LIMITED PATENT AND TRADEMARK LICENSE AGREEMENT
Exhibit
10.24
SAMARITAN
PHARMACEUTICALS IRELAND INC. LIMITED
This
Patent License Agreement, hereinafter referred to as the “Agreement”, consists
of the following Agreement, a Signature Page, Appendix A (List of Patent(s) or
Patent Application(s)and Trademark(s)), Appendix B (Fields of Use and
Territory), Appendix C (Royalties), Appendix D ((Benchmarks and Performance),
Appendix E (Commercial Development Plan), Appendix F (Example Royalty Report),
Appendix G (Royalty Payment Options), and Appendix H (Model Use
Sublicense). The Parties to this Agreement are:
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1)
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Samaritan
Pharmaceuticals Ireland Inc. Limited, having offices at the address
indicated on the Signature Page, hereinafter referred to as “Samaritan”;
and
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2)
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Taconic
Farms, Inc., having offices at the address indicated on the Signature
Page, hereinafter referred to as
“Taconic.”
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Samaritan
and Taconic agree as follows:
1.
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BACKGROUND
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1.1
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In
the course of conducting biomedical research, Georgetown University and
Samaritan Pharmaceuticals Inc.’s investigators invented a Rat Model
Simulating Neurologic Disease, which has commercial
applicability.
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1.2
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Samaritan
Pharmaceuticals, Inc., having offices at 000 Xxxxxxxxxx Xxxxxx Xxxxx,
Xxxxx 000, Xxx Xxxxx, Xxxxxx 00000, owns intellectual property rights
claimed in any United States or foreign patent applications or patents and
trademarks corresponding to the assigned
inventions.
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1.3
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Samaritan
has the authority to enter into this Agreement for the licensing of rights
to this invention.
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1.4
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Samaritan
desires to transfer this invention through a license to facilitate the
commercial development of this
product.
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1.5
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Taconic
desires to acquire commercialization rights to this invention in order to
make and distribute The Samaritan Alzheimer’s Rat Model for public use and
benefit.
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2.
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DEFINITIONS
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2.1
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“Active
Compound” means such pharmaceutically active materials that arise from or
out of the Patent Rights.
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2.2
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“Affiliate”
means any person or entity that directly or indirectly through one or more
intermediate controls, or is controlled by, or is under common control
with any other entity or person. For this purpose “control”
means the ownership or control of 55% or more of the outstanding voting
securities of a person or entity, or in the case of a partnership, the
power to appoint or elect 55% or more of the members of the board or
management or executive committee (or similar governing body) of the
partnership, or the power to otherwise direct or cause the direction of
the management and policies of such person or entity, whether through the
ownership of voting stock or similar rights or the holding of offices in
such person or entity, by contract or
otherwise.
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2.3
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“Benchmarks”
mean the performance milestones that are set forth in Appendix
D.
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2.4
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“Customer”
means a person or entity that uses or intends to use, but not to make or
distribute Licensed Product.
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2.5
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“Commercial
Development Plan” means the written commercialization plan attached as
Appendix E.
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2.6
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“First
Commercial Sale” means the initial transfer by or on behalf of Taconic of
Licensed Product or the initial practice of a Licensed Process by or on
behalf of Taconic in exchange for cash or some equivalent to which value
can be assigned for the purpose of determining Net
Sales.
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2.7
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“Intellectual
Property Rights” shall mean Licensed Patent Rights and
Trademarks.
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2.8
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“Licensed
Fields of Use” means the fields of use identified in Appendix
B.
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2.9
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“Licensed
Patent Rights” shall mean:
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(a)
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Patent
applications (including provisional patent applications and PCT patent
applications) or patents listed in Appendix A, all divisions and
continuations of these applications, all patents issuing from these
applications, divisions, and continuations, and any reissues,
reexaminations, and extensions of all these
patents;
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(b)
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to
the extent that the following contain one or more claims directed to the
invention or inventions disclosed in the patents and patent applications
listed in 2.9(a):
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(i)
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continuations-in-part
of 2.9(a);
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(ii)
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all
divisions and continuations of these
continuations-in-part;
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(iii)
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all
patents issuing from these continuations-in-part, divisions, and
continuations;
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(iv)
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priority
patent application(s) of 2.9(a);
and
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(v)
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any
reissues, reexaminations, and extensions of all these
patents;
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(c)
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to
the extent that the following contain one or more claims directed to the
invention or inventions disclosed in 2.9(a): all counterpart foreign and
U.S. patent applications and patents to 2.9(a) and 2.9(b), including those
listed in Appendix A; and
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(d)
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Licensed
Patent Rights shall not include 2.9(b) or
2.9(c) to the extent that they contain one or more claims directed to new
matter which is not the subject matter disclosed in
2.9(a).
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2.10
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“Licensed
Processes” means processes, which in the course of being practiced, would
be within the scope of one or more claims of the Licensed Patent Rights
that have not expired or been held unpatentable, invalid or unenforceable
by an unappealed or unappealable judgment of a court of competent
jurisdiction.
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2.11
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“Licensed
Products” means tangible materials, which in the course of manufacture,
use, sale, or importation, would be within the scope of one or more claims
of the Licensed Patent Rights that have not expired or been held
unpatentable, invalid or unenforceable by an unappealed or unappealable
judgment of a court of competent
jurisdiction.
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2.12
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“Licensed
Territory” means the geographical area identified in
Appendix B.
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2.13
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“Net
Sales” means the total gross receipts for sales of Licensed Products or
practice of Licensed Processes by or on behalf of Taconic, and from
leasing, renting, or otherwise making Licensed Products available to
others without sale or other dispositions, whether invoiced or not, less
returns and allowances, packing costs, insurance costs, freight out, taxes
or excise duties imposed on the transaction (if separately invoiced), and
wholesaler and cash discounts in amounts customary in the trade to the
extent actually granted. No deductions shall be made for
commissions paid to individuals, whether they are with independent sales
agencies or regularly employed by Taconic, and on its payroll, or for the
cost of collections. The cost of Taconic’s Long Xxxxx Rats
shall not be included in the calculations of Net Sales (if separately
invoiced or if invoiced as a separate line
item.)
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2.14
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“Practical
Application” means to manufacture in the case of a composition or product,
to practice in the case of a process or method, or to operate in the case
of a machine or system; and in each case, under these conditions as to
establish that the invention is being utilized and that its benefits are
to the extent permitted by law or Government regulations available to the
public on reasonable terms.
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2.15
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“Third
Parties” means all persons who are not parties to this
agreement.
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2.16
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“Trademarks”
means the trademarks identified in Appendix
A.
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3.
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GRANT OF
RIGHTS
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3.1
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Samaritan
grants Taconic, subject to the terms and conditions of this Agreement, an
exclusive license under the Licensed Patent Rights in the Licensed
Territory to sell the Licensed Products in the Licensed Fields of Use
only.
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3.2
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Samaritan
grants Taconic, subject to the terms and conditions of this Agreement, a
nonexclusive license under the Licensed Patent Rights in the Licensed
Territory to make the Licensed Products and to make and use Licensed
Processes in the Licensed Fields of Use
only.
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3.3
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Samaritan
retains the right to grant licenses under the Licensed Patent Rights in
the Licensed Territory to make and to use, but not to sell the Licensed
Products and Licensed Processes in the Licensed Fields of
Use.
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3.4
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Samaritan
hereby authorizes Taconic to use the Trademarks of Samaritan in the
Licensed Territory on or in relation to Licensed Product for the purpose
only of exercising its rights and performing its obligations under this
Agreement provided that Taconic shall ensure that each reference to and
use of any of the Trademarks is in a manner from time to time approved by
Samaritan and where appropriate is accompanied by an acknowledgement, in a
form approved by Samaritan that the same is a registered Trademark of
Samaritan.
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3.5
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This
Agreement confers no license or rights by implication, estoppel, or
otherwise under any patent applications or patents of Samaritan other than
the Licensed Patent Rights regardless of whether these patents are
dominant or subordinate to the Licensed Patent
Rights. Samaritan covenants that it will not assert against
Taconic any patents of Samaritan that would be infringed by Taconic’s
exercise of the rights granted to it under this Agreement, including
without limitation, the use Licensed Process or the making and sale of the
Licensed Product.
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4.
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SUBLICENSING
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4.1
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Taconic
has the right to sublicense to Affiliates provided that the terms and
conditions of any sublicense do not conflict with the terms and conditions
of this Agreement in any material respect. With each
sublicense, Samaritan must first receive written notice, signed on behalf
of both Taconic and the Affiliate: (1) stating that the
Affiliate intends to exercise such rights, and (2) agreeing that the
Affiliate and Taconic shall be jointly and severally liable for all
obligations to Samaritan under the sublicense arising from the activities
of that Affiliate. The activities of the Affiliate under the
sublicense shall then be deemed to be the activities of
Taconic. The rights of an Affiliate under the sublicense shall
terminate if Taconic’s rights under the Agreement terminate. An
Affiliate may not sublicense, assign or otherwise transfer any rights
under the sublicense.
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4.2
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Taconic
has the right to sublicense to Customer, the right to use the Licensed
Products in the Licensed Fields of Use as set forth in Appendix
H.
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5.
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STATUTORY AND
SAMARITAN REQUIREMENTS AND RESERVED GOVERNMENT
RIGHTS
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5.1
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Taconic
agrees to provide Samaritan with Long Xxxxx Rats and shall charge the
amount of ____ off of Taconic’s list price for each
rat. Taconic agrees to provide Samaritan with Licensed Product
for Samaritan research use and shall charge the amount of ___ off
Taconic’s list price for the conduct of the Licensed Process on each
Licensed Product. Samaritan shall not resell or transfer any
Long Xxxxx Rats or any Licensed Product obtained from Taconic to any
entity that is not an Affiliate of
Samaritan.
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5.2
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Taconic
agrees that Licensed Product made, used or sold throughout the United
States shall be substantially manufactured in the United States, unless a
written waiver is obtained in advance from
Samaritan.
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6.
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ROYALTIES AND
REIMBURSEMENT
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6.1
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Taconic
agrees to pay Samaritan a noncreditable, nonrefundable license issue
royalty as set forth in Appendix C.
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6.2
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Taconic
agrees to pay Samaritan earned royalties on a country-by-country basis in
the amount set forth in Appendix C. Notwithstanding the
forgoing, in the event that Samaritan has not been granted a patent in one
or more countries on or before December 31, 2014, then upon written
request of Taconic, Samaritan agrees to renegotiate in good
faith the royalties to be paid by
Taconic.
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6.3
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A
patent or patent application licensed under this Agreement shall cease to
fall within the Licensed Patent Rights for the purpose of computing earned
royalty payments in any given country on the earliest of the dates
that:
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(a)
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the
application has been abandoned and not
continued;
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(b)
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the
patent expires or irrevocably lapses;
or
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(c)
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the
claim has been held to be invalid or unenforceable by an unappealed or
unappealable decision of a court of competent jurisdiction or
administrative agency.
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6.4
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No
multiple royalties shall be payable because any Licensed Product or
Licensed Processes are covered by more than one of the Licensed Patent
Rights.
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6.5
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On
sales of Licensed Product by Taconic made in other than an arms-length
transaction, the value of the Net Sales attributed under this Article 6 to
this transaction shall be that which would have been received in an
arms-length transaction, based on sales of like quantity and quality
products on or about the time of this
transaction.
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7.
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TRADEMARK AND PATENT
FILING, PROSECUTION, AND
MAINTENANCE
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7.1
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Samaritan
agrees to take responsibility for the preparation, filing, prosecution,
and maintenance of any and all patent applications or patents included in
the Licensed Patent Rights. Samaritan shall keep Taconic reasonably
informed of the status of any patent application and patent included in
the Licensed Patent Rights and shall promptly notify Taconic of the filing
of any additional patent applications and of the issuance of any patent
within the Licensed Patent Rights.
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7.2
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In
order to maintain the integrity of Samaritan’s Patents and Trademarks,
Taconic shall not: 1) make any modification to the Licensed Product or
it’s Trademark; 2) alter, obscure, remove or tamper with any trademarks,
markings, numbers, labels, indication of the source of origin, or other
means of identification used on or in relation to the Licensed Product; 3)
use the Trademarks in any way which might prejudice their distinctiveness
or validity or the goodwill of Samaritan therein; 4) use in relation to
the Licensed Product any trademarks other than the Trademarks without
obtaining the written consent of Samaritan; or 5) use or make any
application for registration in the Licensed Territory of any trademarks
or trade names so resembling any Trademark or trade name of Samaritan as
to be likely to cause confusion or
deception.
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7.3
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With
regard to expenses associated with the preparation, filing, prosecution,
and maintenance of all patent applications and patents included within the
Licensed Patent Rights and incurred by Samaritan prior to the effective
date of this Agreement, Taconic shall not owe any amount to Samaritan,
either as an additional royalty or as a license issue
fee.
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7.4
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With
regard to expenses associated with the preparation, filing, prosecution,
and maintenance of all patent applications and patents included within the
Licensed Patent Rights and incurred by Samaritan on or after the effective
date of this Agreement, Taconic shall not owe any amount to
Samaritan.
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8.
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RECORD
KEEPING
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8.1
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Taconic
agrees to keep accurate and correct records of Licensed Products made,
used, sold, or imported and Licensed Processes practiced under this
Agreement appropriate to determine the amount of royalties due
Samaritan. These records shall be retained for at least five
(5) years following a given reporting period and shall be, upon reasonable
prior written request by Samaritan which request shall be no more frequent
than once each calendar year, available during normal business hours for
inspection by an independent accountant or other designated independent
auditor of Samaritan for the sole purpose of verifying reports and royalty
payments hereunder. The independent accountant or auditor shall
only disclose to Samaritan information relating to the accuracy of reports
and royalty payments made under this Agreement. If an
inspection shows an underreporting or underpayment in excess of _____
percent (____%) for any twelve (12) month period, then Taconic shall
reimburse Samaritan for the cost of the inspection at the time Taconic
pays the unreported royalties, including any additional
royalties. All royalty payments required under this Paragraph
shall be due within sixty (60) days of the date Samaritan provides Taconic
notice of the payment due.
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8.2
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Taconic
agrees to have an audit of sales and royalties conducted by an independent
auditor at least every year if annual sales of the Licensed Products or
Licensed Processes are over ________ dollars_____. The audit
shall address, at a minimum, the amount of gross sales of Licensed Product
or Licensed Process by or on behalf of Taconic during the audit period,
terms of the license as to percentage or fixed royalty to be remitted to
Samaritan, the amount of royalties owed to Samaritan under this Agreement,
and whether the royalties owed have been paid to Samaritan and is
reflected in the records of the Taconic. The audit shall also
indicate Samaritan license number and the time period being
audited. A report certified by the auditor shall be submitted
promptly by the auditor directly to Samaritan on
completion. Taconic shall pay for the entire cost of the
audit.
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9.
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REPORTS ON PROGRESS,
BENCHMARKS, SALES, AND
PAYMENTS
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9.1
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Prior
to signing this Agreement, Taconic has provided Samaritan with the
Commercial Development Plan in Appendix E, under which Taconic intends to
bring the subject matter of the Licensed Patent Rights to the point of
Practical Application. This Commercial Development Plan is
hereby incorporated by reference into this Agreement. Based on
this plan, performance Benchmarks are determined as specified in Appendix
D.
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9.2
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Taconic
shall provide written annual reports on its product development progress
or efforts to commercialize under the Commercial Development Plan for each
of the Licensed Fields of Use within fifteen (15) days after December 31
of each calendar year. These progress reports shall include,
but not be limited to: production, marketing, importing, exporting and
sales during the preceding calendar year, as well as, plans for the
present calendar year. Samaritan also encourages these reports
to include information on any of Taconic’s public service activities that
relate to the Licensed Patent Rights. If reported progress
differs from that projected in the Commercial Development Plan and
Benchmarks, Taconic shall explain the reasons for such
differences. In any annual report, Taconic may propose
amendments to the Commercial Development Plan, acceptance of which by
Samaritan may not be denied unreasonably. Taconic agrees to
provide any additional information reasonably required by Samaritan to
evaluate Taconic’s performance under this Agreement. Taconic
may amend the Benchmarks at any time upon written approval by
Samaritan. Samaritan shall not unreasonably withhold approval
of any request of Taconic to extend the time periods of this schedule if
the request is supported by a reasonable showing by Taconic of diligence
in its performance under the Commercial Development Plan and toward
bringing the Licensed Products to the point of Practical
Application.
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9.3
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Taconic
shall report to Samaritan the dates for achieving Benchmarks specified in
Appendix D and the First Commercial Sale in the Licensed Territory within
thirty (30) days of such
occurrences.
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9.4
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Taconic
shall submit within ten (10) days after each calendar quarter ending March
31, June 30, September 30 and December 31 to Samaritan, for the purpose of
reporting financial numbers into Samaritan’s Securities and Exchange
filings, an internal report, setting forth for the preceding quarter
period the amount of the Licensed Products sold or Licensed Processes
practiced by or on behalf of Taconic in each country within the Licensed
Territory, the Net Sales, and the amount of royalty accordingly
due. Within sixty (60) days of each calendar quarter ending,
Taconic shall submit a royalty report, as described in the example in
Appendix F and a payment of earned royalties due. If no earned
royalties are due to Samaritan for any reporting period, the written
report shall so state. The royalty report shall be certified as
correct by an authorized officer of Taconic and shall include a detailed
listing of all deductions made under Paragraph 2.10 to determine Net Sales
made under Article 6 to determine royalties
due.
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9.5
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Royalties
due under Article 6 shall be paid in U.S. dollars and payment options are
listed in Appendix G. For conversion of foreign currency to
U.S. dollars, the conversion rate shall be the New York foreign exchange
rate quoted in The Wall
Street Journal on the day that the payment is due, and any loss of
exchange, value, taxes, or other expenses incurred in the transfer or
conversion to U.S. dollars shall be paid entirely by
Taconic. The royalty report required by Paragraph 9.4 shall be
mailed to Samaritan at its address for Agreement Notices indicated on the
Signature Page.
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9.6
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Taconic
shall be solely responsible for determining if any tax on royalty income
is owed outside the United States and shall pay this tax and be
responsible for all filings with appropriate agencies of foreign
governments.
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9.7
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A
penalty may be assessed by Samaritan on any payment that is more than
thirty (30) days overdue at the rate of ____ percent (___) per month on
the amount overdue. This interest rate may be applied
retroactively from the original due date until the date of receipt by
Samaritan of the overdue payment and the penalty payment. The
payment of any penalty shall not prevent Samaritan from exercising any
other rights it may have as a consequence of the lateness of any
payment.
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10.
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PERFORMANCE
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10.1
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Taconic
shall use its reasonable commercial efforts to bring the Licensed Products
and Licensed Processes to Practical Application. “Reasonable
commercial efforts” for the purposes of this provision shall include
adherence to the Commercial Development Plan in Appendix E and performance
of the Benchmarks in Appendix D.
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10.2
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Upon
the First Commercial Sale, until the expiration or termination of this
Agreement, Taconic shall use its reasonable commercial efforts to make
Licensed Products reasonably available to the United States
public.
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10.3
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Taconic
agrees, within 60 days, and as part of its marketing and product
promotion, to develop educational materials (e.g., brochures, website,
etc.) directed to researchers detailing the Licensed Product and uses of
the Licensed Products.
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10.4
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Taconic
agrees to supply, to the Mailing Address for Agreement Notices indicated
on the Signature Page, with one copy of Taconic’s packaging, artwork, and
promotional material in electronic and hardcopy format for educational and
display purposes on Samaritan website and Samaritan’s other promotional
materials.
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11.
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INFRINGEMENT AND
PATENT ENFORCEMENT
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11.1
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Samaritan
and Taconic agree to notify each other promptly of each infringement or
possible infringement of the Intellectual Property Rights, as well as, any
facts which may affect the validity, scope, or enforceability of the
Intellectual Property Rights of which either Party becomes
aware.
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11.2
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Samaritan
has the first right to defend Intellectual Property Rights against any
infringers which Samaritan, in its sole discretion, decides is reasonable
and necessary for it to undertake. Samaritan shall bring or
defend or may settle any such actions; provided, however, that Taconic
shall be entitled in each instance to participate through counsel of its
own selection and its own expense. Samaritan shall have no
right to join Taconic in any such actions. Subject to approval
by Taconic’s counsel, Taconic shall execute legal documents necessary for
the prosecution of any infringement suit brought by
Samaritan. Any and all costs and expenses including legal fees
incurred by Samaritan in connection with Samaritan bringing any action for
infringement or defending any counterclaim of invalidity or action of a
third party for declaratory judgment of non-infringement shall be paid by
Samaritan. In the event that Samaritan receives any settlement
or recovers any compensation from any person or entity for infringement or
alleged infringement of the Intellectual Property Rights, after Samaritan
recovers any and all costs and expenses including legal fees incurred by
Samaritan in connection therewith, Samaritan shall be entitled to retain
_____ percent (____) of aggregate amount of any recovery or
settlement.
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11.3
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If
within ninety (90) days of such notice from Taconic, Samaritan fails to
reasonably act to defend such Intellectual Property Rights against any
infringers, Taconic shall have the right to defend the Intellectual
Property Rights against any infringers at Taconic’s own
cost. In the event that Taconic receives any settlement or
recovers any compensation from any person or entity for infringement or
alleged infringement of the Intellectual Property Rights, Taconic shall be
entitled to retain the amount of any such recovery or settlement minus
payment of royalties due to
Samaritan.
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11.4
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In
the event that a declaratory judgment action alleging invalidity of any of
the Intellectual Property Rights shall be brought against Samaritan,
Samaritan agrees to notify Taconic that an action alleging invalidity has
been brought. Samaritan does not represent that it shall
commence legal action to defend against a declaratory action alleging
invalidity. Taconic shall take no action to compel Samaritan
either to initiate or to join in any declaratory judgment
action. Should Samaritan be made a party to any suit by motion
or any other action of Taconic, Taconic shall reimburse Samaritan for any
costs, expenses, or fees, which Samaritan incurs as a result of the motion
or other action. Upon Taconic's payment of all costs incurred
by Samaritan as a result of Taconic's joinder motion or other action,
these actions by Taconic shall not be considered a default in the
performance of any material obligation under this
Agreement.
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12.
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WARRANTIES AND
INDEMNIFICATION
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12.1
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Samaritan
represents and warrants that (i) it has the full right, power and
authority to enter into this Agreement and to grant the licenses granted
to Taconic pursuant to this Agreement, (ii) that the Licensed Patent
Rights have been properly filed naming all true inventors, and (iii) as of
the Effective Date there are no pending or threatened lawsuits which
include a claim that the Licensed Product or Licensed Process infringe a
third party’s intellectual property
rights.
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12.2
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Samaritan
does not warrant the validity of the Licensed Patent Rights and makes no
representations whatsoever with regard to the scope of the Licensed Patent
Rights, or that the Licensed Patent Rights may be exploited without
infringing other patents or other intellectual property rights of third
parties.
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12.3
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Samaritan
makes no warranties, expressed or implied, of merchantability or fitness
for a particular purpose of any subject matter defined by the claims of
the Licensed Patent Rights or tangible materials related
thereto.
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12.4
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Samaritan
does not represent that it shall commence legal actions against third
parties infringing the Licensed Patent
Rights.
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12.5
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Taconic
shall indemnify and hold Samaritan, Samaritan Pharmaceuticals, Inc. and
Georgetown University, its employees, students, fellows, agents, and
consultants (the “Samaritan Indemnities”) harmless from and against all
liability, demands, damages, expenses, and losses of third parties,
including but not limited to death, personal injury, illness, or property
damage, imposed upon the Samaritan Indemnities arising out of or in
connection with any third party claim
regarding:
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(a)
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the
use by or on behalf of Taconic, its directors, employees, or third parties
of any Licensed Patent Rights; or
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(b)
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the
design, manufacture, distribution, or use of any Licensed Products,
Licensed Processes or materials by Taconic, or other products or processes
developed in connection with or arising out of the Licensed Patent
Rights.
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(c)
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Provided,
however that Taconic’s indemnification obligations under (a) and (b) shall
not apply to any liability, damage, loss or expense to the extent that it
is directly attributable to the negligent activities, reckless misconduct
or intentional misconduct of the Samaritan Indemnities or to any claims
that the Licensed Product or Licensed Process infringe the intellectual
property rights of a third party.
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12.6
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Samaritan
shall indemnify and hold harmless Taconic, its Affiliates, directors,
employees, agents and consultants against all liability, demands, damages,
expenses and losses arising out of any breach by Samaritan of the
representations and warranties set forth in Section 12.1 of this
Agreement.
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12.7
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Taconic
agrees to maintain a liability insurance program consistent with sound
business practice.
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13.
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TERM, TERMINATION, AND
MODIFICATION OF RIGHTS
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13.1
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This
Agreement is effective when signed by all parties, is subject to
termination in accordance with all other relevant provisions hereof, shall
continue in force for an initial period of _____ (____) years, and
thereafter the agreement will automatically extend for consequent periods
of ____ (____) years unless terminated by one of the parties with _____
(____) months written notice of
termination.
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13.2
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In
the event that Taconic is in default in the performance of any material
obligations under this Agreement, and if the default has not been remedied
within thirty (30) days after the date of notice in writing of the
default, Samaritan may terminate this Agreement by written
notice.
|
13.3
|
In
the event that Taconic becomes insolvent, files a petition in bankruptcy,
has such a petition filed against it, determines to file a petition in
bankruptcy, or receives notice of a third party’s intention to file an
involuntary petition in bankruptcy, Taconic shall immediately notify
Samaritan in writing. Furthermore, Samaritan shall have the
right to terminate this Agreement immediately upon Taconic’s receipt of
written notice.
|
13.4
|
Taconic
shall have a unilateral right to terminate this Agreement in any country
or territory by giving Samaritan ninety (90) days written notice to that
effect, provided Taconic has paid all royalties owed to
Samaritan.
|
13.5
|
Within
ninety (90) days of expiration or termination of this Agreement under this
Article 13, a final report shall be submitted by Taconic. Any
royalty payments, including those incurred but not yet paid (such as the
full minimum annual royalty), and those related to patent expense, due to
Samaritan shall become immediately due and payable upon termination or
expiration. Unless otherwise specifically provided for under
this Agreement, upon termination or expiration of this Agreement, Taconic
shall return all Licensed Products or other materials included within the
Licensed Patent Rights to Samaritan or provide Samaritan with written
certification of the destruction
thereof.
|
13.6
|
Samaritan
shall have the right to terminate this agreement after 60 days notice to
Taconic after the second anniversary of the Effective Date in any year
that Taconic does not reach minimum annual revenues of USD
________.
|
14.
|
GENERAL
PROVISIONS
|
14.1
|
Neither
party may waive or release any of its rights or interests in this
Agreement except in writing. The failure of Samaritan to assert
a right hereunder or to insist upon compliance with any term or condition
of this Agreement shall not constitute a waiver of that right by Samaritan
or excuse a similar subsequent failure to perform any of these terms or
conditions by Taconic.
|
14.2
|
This
Agreement constitutes the entire agreement between the Parties relating to
the subject matter of the Licensed Patent Rights, Licensed Products and
Licensed Processes, and all prior negotiations, representations,
agreements, and understandings are merged into, extinguished by, and
completely expressed by this
Agreement.
|
14.3
|
The
provisions of this Agreement are severable, and in the event that any
provision of this Agreement shall be determined to be invalid or
unenforceable under any controlling body of law, this determination shall
not in any way affect the validity or enforceability of the remaining
provisions of this Agreement.
|
14.4
|
If
either party desires a modification to this Agreement, the parties shall,
upon reasonable notice of the proposed modification by the party desiring
the change, confer in good faith to determine the desirability of the
modification. No modification shall be effective until a
written amendment is signed by the signatories to this Agreement or their
designees.
|
Page 9 of
21
14.5
|
This
agreement shall be governed by and be construed in accordance with the
laws of the Republic of Ireland. The Courts within the City of
Dublin shall have exclusive jurisdiction over any dispute arising out from
or in connection with this
Agreement.
|
14.6
|
The
subject matter of this Agreement shall be governed by and construed in
accordance with the laws of the country of Ireland (without reference to
its choice of law principles), and to the exclusion of the law of any
other forum, without regard to the jurisdiction in which any action or
special proceeding may be instituted. Each party hereto agrees
to submit to the personal jurisdiction and venue of the state and/or
federal courts located in Dublin, Ireland for resolution of all disputes
arising out of, in connection with, or by reason of the interpretation,
construction, and enforcement of this agreement, and hereby waives the
claim or defense therein that such courts constitute an inconvenient
forum. As a material inducement for this agreement, each party
specifically waives the right to trial by jury of any issues so
triable. If it becomes necessary for any party to institute
legal action to enforce the terms and conditions of this Agreement, the
prevailing party may be awarded reasonable attorneys fees, expenses, and
costs.
|
14.7
|
All
Agreement notices required or permitted by this Agreement shall be given
by prepaid, first class, registered or certified mail or by an
express/overnight delivery service provided by a commercial carrier,
properly addressed to the other party at the address designated on the
Signature Page, or to any other address as may be designated in writing by
such other party. Agreement notices shall be considered timely
if such notices are received on or before the established deadline date or
sent on or before the deadline date as verifiable by U.S. Postal Service
postmark or dated receipt from a commercial carrier. Parties
should request a legibly dated U.S. Postal Service postmark or obtain a
dated receipt from a commercial carrier or the U.S. Postal
Service. Private metered postmarks shall not be acceptable as
proof of timely mailing.
|
14.8
|
This
Agreement shall not be assigned by Taconic
except:
|
|
(a)
|
with
the prior written consent of Samaritan, this consent shall not to be
withheld unreasonably; or
|
|
(b)
|
as
part of a sale or transfer of substantially the entire business of Taconic
relating to operations which concern this Agreement;
and
|
|
(c)
|
Taconic
shall notify Samaritan within ten (10) days of any assignment of this
Agreement by Taconic, and Taconic shall pay Samaritan, as an additional
royalty, three (3) percent of the fair market value of any consideration
received for any assignment of this Agreement within thirty (30) days of
the assignment.
|
14.9
|
Taconic
acknowledges that it is subject to and agrees to abide by local laws and
regulations.
|
14.10
|
Taconic
agrees to xxxx the Licensed Products or their packaging sold in the United
States with all applicable U.S. patent numbers and similarly to indicate
“Patent Pending” status. All Licensed Products manufactured in,
shipped to, or sold in other countries shall be marked in a manner to
preserve Samaritan Licensed Patent Rights in those
countries.
|
14.11
|
TACONIC
WILL NOT BE LIABLE TO SAMARITAN FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL,
EXEMPLARY, PUNITIVE, MULTIPLE OR OTHER INDIRECT DAMAGES ARISING OUT OF
THIS AGREEMENT OR THE EXERCISE OF TACONIC’S RIGHTS HEREUNDER, OR FOR LOSS
OF PROFITS, LOSS OF DATA OR LOSS OF USE DAMAGES ARISING FROM OR RELATING
TO ANY BREACH OF THIS AGREEMENT WHETHER BASED XXXX XXXXXXXX, XXXXXXXX,
XXXX, XXXXXX LIABILITY OR OTHERWISE, REGARDLESS OF ANY NOTICE OF SUCH
DAMAGES.
|
Page 10
of 21
14.12
|
By
entering into this Agreement, Samaritan does not directly or indirectly
endorse any product or service provided, or to be provided, by Taconic
whether directly or indirectly related to this
Agreement. Taconic shall not state or imply that this Agreement
is an endorsement by Georgetown University, Samaritan Pharmaceuticals,
Inc., or Samaritan. Additionally, except for the use of the
Trademarks, Taconic shall not use the names of Samaritan, Samaritan
Pharmaceuticals, Inc. or Georgetown University or their employees in any
advertising, promotional, or sales literature without the prior written
approval of Samaritan. Samaritan shall not use the names of
Taconic or its Affiliates or their employees in any advertising,
promotional, or sales literature without the prior written approval of
Taconic.
|
14.13
|
The
Parties agree to attempt to settle amicably any controversy or claim
arising under this Agreement or a breach of this Agreement, except for
appeals of modifications or termination decisions provided for in Article
13. Taconic agrees first to appeal any unsettled claims or
controversies to the designated Samaritan official, or designee, whose
decision shall be considered the final agency
decision. Thereafter, Taconic may exercise any administrative
or judicial remedies that may be available
within.
|
14.14
|
Nothing
relating to the grant of a license, nor the grant itself, shall be
construed to confer upon any person any immunity from or defenses under
the antitrust laws or from a charge of patent misuse, and the acquisition
and use of rights pursuant to 37 CFR Part 404 shall not be immunized from
the operation of state or Federal law by reason of the source of the
grant.
|
14.15
|
The
provisions of this Agreement shall survive the Agreement’s termination for
so long as may be necessary to give efficacy
thereto.
|
14.16
|
The
terms and conditions of this Agreement shall, at Samaritan’s sole option,
be considered by Samaritan to be withdrawn from Taconic’s consideration
and the terms and conditions of this Agreement, and the Agreement itself
to be null and void, unless this Agreement is executed by the Taconic and
a fully executed original is received by Samaritan within sixty (60) days
from the date of Samaritan signature found at the Signature
Page.
|
15.
|
FURTHER
RESEARCH
|
15.1
|
TRINITY
COLLEGE DUBLIN. Either party may propose that Taconic fund
additional research at Trinity College Dublin related to Licensed Product
or to Licensed Know-How, entitled “Induction of an Alzheimer’s-Like
Phenotype in Rats” and under the general direction of Xx. Xxxxxx Xxxxx, as
principal investigator, under terms to be mutually
agreed. Neither party shall have any obligation to enter into
such an agreement if mutually acceptable terms cannot be found. While the
terms of any such agreement would be negotiated by the parties, it is the
parties’ expectation that the agreement would be generally along the lines
of Trinity College Dublin’s standard sponsored research agreement
template, a copy of which has been provided to Taconic. In particular,
rights under any patents or patent applications resulting from such
research would be owned by Samaritan and governed by the terms of the
research agreement, and would not necessarily be governed by the
provisions of the present Agreement. It is the parties’ expectation that
such a research agreement may provide, however, that any unpatented
Know-How resulting from the research would be governed by the provisions
of the present Agreement concerning Licensed Know-How. Before Samaritan
may seek funding from a private, non-governmental entity other than
Taconic to conduct research related to Licensed Products or Licensed
Know-How, research for which Xx. Xxxxx would be principal investigator or
co-principal investigator, Samaritan shall first present a formal or
informal proposal to Taconic, inquiring whether Taconic might have an
interest in funding the research. If Taconic expresses an interest within
thirty days, then for an additional thirty days Taconic and Samaritan
shall discuss whether mutually agreeable terms can be found for an
agreement under which Taconic would support the research, as otherwise
discussed above. Neither party shall have any obligation to enter into
such an agreement if mutually acceptable terms cannot be found. Following
the initial thirty-day period, or following the additional thirty-day
period if applicable, Samaritan shall be free to discuss the proposed
sponsored research project with other private sponsors, and to enter into
an agreement concerning the sponsored research project with another
private sponsor, upon such terms as Samaritan and the other party may find
mutually agreeable, terms that may or may not be the same as those that
had been discussed by Samaritan and Taconic. Taconic’s right of first
review, as provided above, does not apply where funding is sought from a
state or federal agency, only where funding is sought from a private,
non-governmental entity. Except as expressly provided in this Paragraph,
nothing in this Agreement shall be construed to limit the freedom of
Samaritan from engaging in research in the same field that is covered by
this Agreement.
|
Page 11
of 21
15.2
|
_______
COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT
“_______”. Either party may propose that Taconic fund
additional research through an ________ related to Licensed Product or to
Licensed Know-How, under the general direction of _________, as principal
investigator under terms to be mutually agreed. Neither party
shall have any obligation to enter into such an agreement if mutually
acceptable terms cannot be found. While the terms of any such agreement
would be negotiated by the parties, it is the parties’ expectation that
the agreement would be generally along the lines of the ______’s standard
sponsored research agreement template, a copy of which has been provided
to Taconic. In particular, rights under any patents or patent applications
resulting from such research would be owned by Samaritan and governed by
the terms of the research agreement, and would not necessarily be governed
by the provisions of the present Agreement. It is the parties’ expectation
that such a research agreement may provide, however, that any unpatented
Know-How resulting from the research would be governed by the provisions
of the present Agreement concerning Licensed Know-How. Before Samaritan
may seek funding from a governmental entity to conduct research related to
Licensed Products or Licensed Know-How, research for which _____________
would be principal investigator or co-principal investigator, Samaritan
shall first present a formal or informal proposal to Taconic, inquiring
whether Taconic might have an interest in funding the research. If Taconic
expresses an interest within thirty days, then for an additional thirty
days Taconic and Samaritan shall discuss whether mutually agreeable terms
can be found for an agreement under which Taconic would support the
research, as otherwise discussed above. Neither party shall have any
obligation to enter into such an agreement if mutually acceptable terms
cannot be found. Following the initial thirty-day period, or following the
additional thirty-day period if applicable, Samaritan shall be free to
discuss the proposed sponsored research project with other private
sponsors, and to enter into an agreement concerning the sponsored research
project with another private sponsor, upon such terms as Samaritan and the
other party may find mutually agreeable, terms that may or may not be the
same as those that had been discussed by Samaritan and
Taconic. Except as expressly provided in this Paragraph,
nothing in this Agreement shall be construed to limit the freedom of
Samaritan from engaging in research in the same field that is covered by
this Agreement.
|
SIGNATURES
BEGIN ON NEXT PAGE
Page 12
of 21
SAMARITAN
PATENT LICENSE
AGREEMENT
SIGNATURE
PAGE
For
Samaritan Pharmaceuticals Ireland Inc. Limited:
___________________________________________
|
___________________ |
Xx.
Xxxxx Xxxxxxx
|
Date
|
Chief
Executive Officer
Mailing
Address for Agreement notices:
Samaritan
Pharmaceuticals Ireland Inc. Limited
C/O
Samaritan Pharmaceuticals, Inc.
000
Xxxxxxxxxx Xxxxxx Xxxxx, Xxxxx 000
Xxx
Xxxxx, Xxxxxx 00000
For
Taconic Farms, Inc.:
___________________________________________
|
___________________ |
Printed
Name
|
Date
|
Title
Official
and Mailing Address for Agreement notices:
Taconic
Farms, Inc.
0 Xxxxxx
Xxxx Xxxxxx
Xxxxxx,
XX 00000
Page 13
of 21
APPENDIX A – PATENT(S) OR
PATENT APPLICATION(S) AND TRADEMARK(S)
Trademark
(s)
|
a)
|
Samaritan
Alzheimer’s Rat Model
|
|
b)
|
Samaritan
FAB Rat Model
|
Patent(s)
or Patent Application(s):
Title
|
Country
|
Application
Serial Number
|
Patent
Grant Number
|
Priority
Date
|
Filing
Date
|
Animal
Model Simulating Neurologic Disease
|
Australia
|
2004220522
|
Pending
|
March
12, 2003
|
March
11, 2004
|
Animal
Model Simulating Neurologic Disease
|
Canada
|
2,518,407
|
Pending
|
March
12, 2003
|
March
11, 2004
|
Animal
Model Simulating Neurologic Disease
|
China
|
200480006554.7
|
Pending
|
March
12, 2003
|
March
11, 2004
|
Animal
Model Simulating Neurologic Disease
|
European
Patent Office
|
04719774.4
|
Pending
|
March
12, 2003
|
March
11, 2004
|
Animal
Model Simulating Neurologic Disease
|
Japan
|
2006507086
|
Pending
|
March
12, 2003
|
March
11, 2004
|
Animal
Model Simulating Neurologic Disease
|
United
States of America
|
10/798,081
|
Pending
|
March
12, 2003
|
March
11, 2004
|
Animal
Model Simulating Neurologic Disease
|
PCT
|
PCT/US2004/007457
|
N/A
|
March
12, 2003
|
March
11, 2004
|
Page 14
of 00
XXXXXXXX X – LICENSED FIELDS
OF USE AND TERRITORY
I.
|
Licensed Fields of
Use:
|
(a)
|
Long
Xxxxx Rats with the Active Compound in the indication of
Alzheimer’s
|
II.
|
Licensed
Territory:
|
(a)
|
United States
|
(b)
|
Canada
|
(c)
|
Europe
|
(d)
|
Australia
|
(e)
|
China
|
(f)
|
Japan
|
Page 15
of 21
APPENDIX C –
ROYALTIES
Page 16
of 21
APPENDIX D – BENCHMARKS AND
PERFORMANCE
Page 17
of 21
APPENDIX E –
COMMERCIAL DEVELOPMENT PLAN
Page 18
of 21
APPENDIX F – EXAMPLE ROYALTY
REPORT
Page 19
of 21
APPENDIX G – ROYALTY
PAYMENTS
Page 20
of 21
APPENDIX H – MODEL USE
AGREEMENT FOR CUSTOMERS
The
following statement will be prominently noted in Taconic’s webpage for the
Samaritan Alzheimer’s Rat Model and any printed marketing material such as sales
catalogs. Additionally a copy will be sent with any order
confirmation for the Samaritan Alzheimer’s Rat Model .
The
Samaritan Alzheimer’s Rat Model (Taconic model # ) is produced and distributed
under rights to patents and intellectual property licensed from Samaritan
Pharmaceuticals Ireland Limited. Purchasers agree and acknowledge the
following terms of use:
|
·
|
Title
to the Rat Model and biological materials derived from them remains with
TACONIC FARMS, INC.
|
|
·
|
The
Rat Model will be used only for research purposes at Purchasers’
location.
|
|
·
|
The
Rat Model will not be produced or manufactured for internal use or general
sale.
|
|
·
|
The
Rat Model and biological materials derived from them will not be
distributed to third parties or used for commercial
purposes.
|
|
·
|
Any
publication, presentation, or public release of the results of the
research using the Rat Models will duly acknowledge Taconic Farms, Inc.
and Samaritan Pharmaceuticals, Inc. as the source of the Rat Model,
referencing the Rat Model with the Taconic nomenclature and reference
number and Recipient shall maintain the name designation, “The Samaritan
Alzheimer’s Rat Model,” in all publications, presentations, or public
release of the library name, and any clone derived
therefrom.
|
Page 21 of
21