THERACOUR-NANOVIRICIDES ADDITIONAL LICENSE AGREEMENT
Exhibit 10.1
THERACOUR-NANOVIRICIDES
ADDITIONAL LICENSE AGREEMENT
This
License Agreement (the "Agreement") is made between TheraCour Pharma, Inc. a
Connecticut corporation (collectively referred to as "TheraCour" or “Theracour”)
and NanoViricides, Inc., a Nevada corporation ("Nano").
BACKGROUND
1. TheraCour
is engaged in a long-term effort for the research, development and
commercialization of certain proprietary drug delivery and targeting
technologies, including but not limited to the type falling within the scope of
its patent applications, patents, and proprietary products licensed under this
Agreement. TheraCour is entering into this Agreement, in furtherance of such
research, development, and commercialization of its drug delivery and targeting
technologies.
2. Nano
desires to obtain a license for specific products, to be developed, under such
patents, and patent applications and/or proprietary technologies, to make, have
made, use and sell pharmaceuticals for certain viral diseases, and subject to
certain field, format and other limitations more specifically set forth below,
and TheraCour is willing to grant such a license pursuant to the terms and
conditions set forth herein.
AGREEMENT
NOW,
THEREFORE, in consideration of the above provisions and the mutual covenants
contained herein, the parties agree as follows:
1.
Definitions
The
following defined terms shall have the meanings set forth below (with derivative
forms being interpreted accordingly):
1.1 "Affiliate"
shall mean:
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1.1.1
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any
entity that directly or indirectly controls, is controlled by, or is under
common control with another entity, and for such purpose "control" shall
mean (a) the possession, direct or indirect, of more than 50 percent of
the voting power or beneficial interest in the entity, whether through
ownership of voting securities, by contract or otherwise, or (b) having
the power to govern the financial or operating policies or to appoint the
management of the controlled organization, or by (c) contractual or other
means, the right to participate with, control, direct or otherwise act in
concert or derive any benefit from the activities of such
entity.
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1.1.2
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any
entity that directly or indirectly has a minority stock interest in the
other entity .
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1.2
"Calendar Year" shall mean the twelve (12) month period beginning January
1 and ending December 31 in the same year.
1.3 "Effective
Date" shall mean the date this Agreement is executed by the latest signing
party.
1.4 ''End
User" shall mean a person or entity whose use of Licensed Product results in its
consumption, destruction, or loss of activity (in each case, whether whole or
partial).
1.5 "FDA"
shall mean the U.S. Food and Drug Administration and any successor .thereto.
1.6 "Licensed
Product" shall mean any product the manufacture, use or sale of which product
would, in the absence of the license granted to Nano hereunder, infringe a Valid
Patent Claim, Patent Application or a Proprietary Claim covering such
manufacture, use or sale in any of the countries of manufacture, use or sale for
the following viral diseases set forth in the License Grant below.
1.7 "Licensed
Patent" shall mean a claim in a patent or patent application listed in
Exhibit A or that is entitled to the priority of a patent, patent
application, or provisional patent application listed in Exhibit A, or that is
entitled as a claim in a subsequent patent application derived from subject
matter that is further refinement of or substantially inherited from or
disclosed in a patent or patent application or provisional patent application
listed in Exhibit A, including claims in any divisions, extensions,
renewals, reissues, re-examination certificates and continuations of such
patents, patent applications, and provisional patent applications. If a priority
claim is abandoned or lost for any reason including applicable regulatory or
legal time limitations, nevertheless the patent or patent claim that would be
eligible for (i) claiming priority without consideration of any such time
limitations imposed by law, or (ii) exhibiting dependence as derivative from a
patent or patent application or provisional patent application listed in Exhibit
A shall be considered a “Licensed Patent” in this Agreement.
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1.8 "Ship",
"Shipped" or "Shipment" shall mean the delivery of any unit of Licensed Product
by Nano to a third party for any commercial purpose, except (i) any unit of
Licensed Product for which said third party receives an actual credit for goods
damaged during transit, warranty replacement (excluding expired goods) and
product recalls, (ii) any unit delivered without charge solely for purposes of
preclinical or clinical trials that are required for regulatory approval in that
country and that are conducted prior to the first regulatory approval of the
affected product in that country, and (iii) any unit delivered as free samples
for customer evaluation, up to the maximum number of units permitted for such
purpose.
1.9 "Territory"
shall mean all countries of the world.
1.10 "Third
Party" shall mean any person or entity other than TheraCour and Nano or any of
their respective Affiliates.
1.11 "Valid
Patent Claim" shall mean a claim in any issued or granted, unexpired patent, or
in any patent application or provisional patent application, that is included in
Licensed Products, which claim has not been held unpatentable, invalid or
unenforceable by a non-appealed or unappealable decision by a court or other
appropriate body of competent jurisdiction, or lapsed, become abandoned or
expired. If a pending Valid Patent Claim ceases to be a Valid Patent Claim
because it has gone abandoned, but such pending claim is later revived, then
once it ceases to be abandoned, it shall again qualify as a Valid Patent Claim.
Where elsewhere in this Agreement the phrase "would infringe a Valid Claim" or
similar terminology is used, pending Valid Patent Claims shall be evaluated as
if issued in the country in which such pending Valid Patent Claims are
pending.
1.12 “Proprietary
Claim" shall mean a claim regarding proprietary technologies or confidential
information owned by TheraCour, that is included in or used in the. research,
development, manufacture, packaging, or use of Licensed Products.
1.13 "Claim"
shall mean a Valid Patent Claim or a Proprietary Claim as defined
above.
2.
License
Grant. TheraCour hereby grants to Nano a limited, non-transferable.
exclusive license for the use, sale. or offer of sale of the Licensed Product(s)
in the Territory.
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2.1 Licensed
Products. The products herein licensed shall include all drugs
developed by TheraCour, for payment by Nano of Costs, Development Fees,
Royalties and other consideration as outlined below, for the treatment of the
following human viral diseases: Dengue Fever type I,II,III & IV; Japanese
Encephalitis; West Nile Virus; Ebola/Marburg; Adenoviral
Conjuntivitis/Keratitis; and Ocular Indications of Herpes Simplex Type 1 & 2
.. The term "virus" shall include all currently medically recognized human viral
strains identified for the specified viruses.
2.2 Additional
Licensed Products: TheraCour may, but has no obligation
to, license additional developmental products for treatment of additional viral
diseases to Nano, after Nano has developed and commercialized at least one drug
candidate.
2.3 TheraCour
retains the exclusive right to develop and manufacture the aforesaid drugs. As
to any Licensed Product, TheraCour agrees that it will manufacture such drug
exclusively for Nano, and unless such license is terminated, will not
manufacture such product for its own sake or for others. Nano agrees that
TheraCour shall automatically have a license to employ Nano’s proprietary or
patented technologies or other know how for the purpose of manufacturing the
drug as may be required without payment of any consideration therefore, whether
cash or non-cash considerations, irrespective of whether such consideration is
with or without monetary value.
3.
Licensing
Fees. Development Fees and Royalties.
In
consideration of TheraCour granting Nano the license herein, Nano agrees to pay
TheraCour the following licensing fees, development fees and
royalties.
3.1 Upon
execution, a licensing fee of 7 million shares of NanoViricides, Inc. Series A
convertible Preferred Stock, the rights of which are set forth in the
Certificate of Designation attached hereto.
3.2 Development
Fee. TheraCour shall be the sole developer of all Licensed Products.
TheraCour shall charge all of its costs, direct costs (as hereinafter defined),
as well as indirect costs, plus a fee equal to thirty (30%) percent of such
direct costs. To the extent not paid pursuant to prior license agreements, Nano
shall further pay to TheraCour a monthly laboratory facilities fee of
$25,000.00. In consideration of such fee, TheraCour shall use all the
nano-materials and chemicals in its existing inventory in the development of the
licensed product(s) as required. The above shall constitute the Development Fee
to be paid to TheraCour.
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3.2.1 Advance
Payments. TheraCour may request, and Nano agrees to provide, an advance
payment equal to two months of estimated future development costs, as pursuant
to prior agreements.
3.3 Direct
Costs. Direct Costs shall include all salaries and wages including all
payroll taxes, Workers Compensation premiums, employee benefits, consultants
providing services directly related to the development of the licensed
product(s), lab supplies and chemicals, and reasonable and customary charges for
items such as future hazardous materials disposal according to local law and
regulations. The costs may also include the costs for protection of all
intellectual property rights related to the development. Any other costs
incurred during the conduct of the development project will also be charged as
development costs. In addition, to the extent not paid pursuant to prior
agreements, the following monthly amounts of expenses may be billed with no need
for a voucher: Office Supplies ($500); Travel and Entertainment ($500); External
Consultants ($500); and Miscellaneous Expenses ($500) as pursuant to prior
agreement and not in addition. Such Development fees shall be due and payable in
periodic installments as billed, along with advance payments as requested.
Salaries paid to Xx. Xxxx Xxxxx and Xx. Xxxxxx Xxxxxx shall not be included as
Development Costs, but such salaries, benefits and other payments shall be
reimbursed in full by Nano.
3.4 Royalties.
Nano shall pay to TheraCour a royalty of 15% on its net sales and other revenue
proceeds of Licensed Products. Net sales are defined as Sales at gross invoice
amounts less any adjustments for returns, allowances, or discounts taken against
the sales and no other adjustments. Other Revenue Proceeds include all revenues
or consideration generated as a result of the development of Licensed Products
or from further licensing by Nano of any rights resulting from the Licensed
Products or Technologies. Both Net Sales and Other Revenue Proceeds shall
include cash as well as non-cash considerations, irrespective of whether such
consideration is with or without monetary value.
3.4 Nano
shall make its best efforts to market and commercialize any Licensed Product
that is approved for marketing or sales in a region of the
Territory.
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(i).
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If
Nano determines not to proceed to do so, then Nano shall promptly notify
TheraCour as such and TheraCour subsequently shall have all rights to such
Product including right to market the product or license it to other
parties provided that TheraCour arranges to pay back the amounts financed
by Nano for the said product.
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(ii).
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If
Nano fails to market an approved product within a reasonable period of
time, then TheraCour shall have the right to buy back the rights to the
said product by arranging to repay the costs financed by Nano for the said
product.
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3.5 If
Nano decides to terminate the development of any Licensed Product at any stage,
all rights provided to Nano for said product shall reinvest in TheraCour.
TheraCour may declare that Nano has terminated the development of a Licensed
Product by giving a 90 days notice cure (the "Cure period") to Nano if Nano
fails to or refuses to (a) pay the licensing fees in a timely manner, (b) pay
the development costs (including advance payments as specified above) of any
Licensed Product in a timely manner, (c) pay royalties and development costs
when due, or (d) market, sell and/or commercialize the licensed product(s) as
agreed to. Upon the expiration of the cure period the licenses granted herein
for such licensed product are cancelled and void.
3.6 Records:
Reports. Nano shall keep complete and accurate records of the Shipment of
Licensed Products hereunder and other revenue proceeds related to the Licensed
Products hereunder for no less than five (5) years after the time period to
which they relate. Nano shall within 60 days following the end of each calendar
quarter deliver to TheraCour a written report for such period setting forth the
product Shipped, the number of units delivered for preclinical or clinical study
purposes or provided as free samples pursuant to this Agreement and setting
forth the royalties accrued during such period, (specifying with respect to the
quantity of each Licensed Product for sale and other revenue
proceeds).
3.7 Audits.
TheraCour shall have the right to have an independent certified public
accounting firm reasonably acceptable to Nano (such acceptance not to be
unreasonably withheld, delayed or conditioned) audit Nano's Licensed
Product-related records. Nano shall permit such firm access to Nano's records
during reasonable business hours for the purpose of verifying the royalties as
provided for in this Agreement, but no more frequently than once per year. Such
firm shall agree to keep all information received strictly confidential and will
provide to TheraCour only the information necessary to verify
the royalty calculations. If any
such audit results in a change upward in any royalty payment Nano shall
pay such additional amount, with compound interest. If such additional amount
exceeds 5%, Nano shall additionally pay the costs of such audit
promptly.
3.8 Upon
termination of this agreement for any cause, Nano shall duly account to
TheraCour and shall transfer to TheraCour all rights that it may possess in
contracts, sub-licenses, letters patent, inventions, trade names, and
trademarks, relating to the Licensed Product(s).
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4.
Payment.
4.1 Currency:
Payment Timing. Except to the extent provided under Paragraph 3.1,
payment of royalties under this Agreement shall be in U.S. Dollars and made
within 30 days following the end of each calendar quarter for royalties accrued
during such period in accordance with Article 3.
4.2 Transfers.
All payments of cash value under this Agreement shall be made by bank wire
transfer to the bank account designated, in writing, by TheraCour and which
shall be authorized to accept payment on behalf of TheraCour. Any late payments
shall bear interest monthly at the lesser of (i) two percent (2%) more than the
prime rate then in effect of Chase Manhattan Bank, New York, New York (or any
successor to Chase, or if Chase ceases to quote such rate and does not have a
successor entity a comparable bank), or (ii) the maximum rate permitted by
applicable law.
5.
Representations
and Warranties
5.1 Representations
and Warranties. Theracour and Nano each represent and warrant to the
other that they have the full right and power to enter into this Agreement and
grant the licenses that such parties are granting as set forth in this
Agreement.
5.2. Disclaimer.
EXCEPT AS SPECIFICALLY SET FORTH IN PARAGRAPH 5.1 HEREIN, NO PARTY MAKES ANY
REPRESENTATION OR WARRANTY, EITHER EXPRESS OR IMPLIED, ARISING BY LAW OR
OTHERWISE, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT WILL ANY PARTY LICENSING
TECHNOLOGY TO THE OTHER PARTY HAVE, AS A RESULT OF SUCH LICENSE, ANY OBLIGATION
OR LIABILITY ARISING FROM TORT, OR FOR LOSS OF REVENUE OR PROFIT, OR FOR
INCIDENTAL OR CONSEQUENTIAL DAMAGES.
In
particular, with no limitation implied, nothing in this Agreement will be
construed as:
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1)
A warranty or representation as to the validity or scope of any of the
Licensed Products, Patents or Patent
Applications;
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2)
A warranty or representation that anything made, used, sold, or otherwise
disposed of under the licenses granted in this Agreement is or will be
free from infringement of patents of third
parties;
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3)
An obligation to or for the licensing parties to bring or prosecute
actions or suits against third parties for Licensed Patent infringement or
a right for the Licensed Party to do
so;
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4)
Conferring the right to use in advertising, publicity, or otherwise any
trademark, trade name, or any contraction, abbreviation, simulation, or
adaptation thereof, of another party except to the extent of the licenses
herein granted; or
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5)
Except as otherwise provided herein, conferring by implication, estoppel,
or otherwise, any license or rights under any patents other than as to the
Licensed Products, or any license under any other property rights, such as
know-how, clinical data, trademarks or trade
names.
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6.
Term.
Termination
6.1 Term.
This Agreement is in force and effect on and as of the Effective Date, and shall
continue in effect until the expiration of the last to expire of the Patents
underlying the Licensed Products ("last expiration date"), unless earlier
terminated as provided herein. If at said last expiration date, Nano continues
to use any proprietary technologies developed by TheraCour for any of the
Licensed Products, then this agreement will continue to remain in force as long
as Nano continues to use such proprietary technologies of
TheraCour.
6.2 Termination.
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6.2.1
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The
licenses granted to Nano hereunder may be terminated by TheraCour upon
written notice to Nano in case of (a) the institution by or against Nano
of insolvency, receivership or bankruptcy proceedings or any other
proceedings for the settlement of Nano's debts; (b) Nano's making a
general assignment for the benefit of its creditors; (c) Nano's
dissolution; (d) Nano's cessation of business for a period of ninety (90)
days or more; or (e) Nano or any of its Affiliates voluntarily acting or
assisting others to challenge or invalidate the Licensed Patents in any
opposition, declaratory judgment or other
proceedings.
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6.2.2
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Nano
may terminate this Agreement on 90 days notice to TheraCour, providing it
pays to said parties all monies due and owing as of the date of such
notice to terminate, and further providing that it ceases all sales of
Licensed Products and destroys all stocks of product not otherwise shipped
and transfers all related documentation to
TheraCour.
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6.2.3
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All
rights to the Licensed Products and technologies shall revert to TheraCour
upon termination of the Agreement.
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6.3 Non-Waiver.
Failure to terminate this Agreement following a material breach or failure to
comply with this Agreement shall not constitute a waiver of a party's defenses,
rights or causes of action arising from such or any future breach or
noncompliance.
6.4 Survival.
Articles 7 and 8 shall survive any and all expirations and terminations of this
Agreement.
7.
Confidential
Information
From time
to time during the term of this Agreement, TheraCour, on the one hand, and Nano,
on the other, may provide to each other information concerning patents, patent
applications, license agreements and other confidential or proprietary
information related to this Agreement and the Licensed Products (the
"Information"). Each party receiving such Information (the ''Receiving Party")
shall during the term of this Agreement and for a period of ten (10) years after
termination hereof: (i) maintain the Information in confidence; (ii) not
disclose the Information or any portion or copy of it to any third party; and
(iii) not use the Information or any portion or copy of it for any purpose not
directly related to performance of its obligations under this Agreement. The
obligations of this Section shall not apply to any Information which is at the
time of disclosure or thereafter becomes generally known to the public by means
other than a breach of a duty by the Receiving Party or a breach of this
Agreement. The Receiving Party shall disclose the Information only to those
officers, employees and agents bound by similar terms of confidentiality to
those imposed on the Receiving Party hereunder. Upon termination of this
Agreement for any reason, the Receiving Party shall return all Information and
copies thereof. The Receiving Party may disclose Information if required to
comply with law or court order; provided, however, that it provides the
Disclosing Party with advance notice of the required disclosure and all
reasonable assistance to seek confidential treatment or a protective
order.
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8.
Miscellaneous
8.1 Severability:
Compliance with Law. In performing this Agreement, the parties shall
comply with all applicable laws. Nothing in this Agreement shall be construed so
as to require the violation of any law, and wherever there is any conflict
between any provision of this Agreement and any law, the law shall prevail and
the provision shall be appropriately adjusted, but in such event the affected
provision of this Agreement shall be adjusted only to the extent necessary to
bring it within the applicable law and accomplish the intent of the
parties.
8.2 Notices.
Any notice, report, demand or other communication required or permitted to be
given by this Agreement shall be in writing in English, and shall be given by
facsimile and by postpaid, first class, registered or certified mail addressed
as set forth below unless changed by notice so given:
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For
TheraCour:
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For
Nano:
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TheraCour
Pharma, Inc.
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000
Xxxx Xxxxxx, Xxx. 000
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000
Xxxx Xxxxxx, Xxx. 000
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Xxxx
Xxxxx, XX 00000, X.X.X.
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Xxxx
Xxxxx, XX 00000, X.X.X.
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Attn:
Chief Executive Officer
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Attn:
Chief Executive Officer
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cc:
General Counsel
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cc:
General Counsel.
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8.3 Force
Majeure. No party to this Agreement shall be liable for delay or failure
in the performance of any of its obligations hereunder if such delay or failure
is due to causes beyond its reasonable control or ability to plan for,
including, without limitation, acts of God, fires, earthquakes, strikes and
labor disputes, acts of war, civil unrest or intervention of any governmental
authority, but any such delay or failure shall be remedied by such party as soon
as is reasonably possible, and if such delay or failure last for more than
ninety (90) days, the other party or parties shall be entitled to terminate this
Agreement.
8.4 Assignments.
Nano may not assign its rights and obligations under this Agreement without the
written consent of the other parties hereto. Without limiting the generality of
the foregoing, this Agreement shall inure to the benefit of and be binding on
the permitted assigns, Affiliates and subsidiaries of the parties.
8.5 No
Third Party Beneficiaries. This Agreement is entered into solely for the
benefit of the parties hereto, and the provisions of this Agreement shall be for
the sole and exclusive benefit of such parties. Nothing herein contained will be
deemed to create any third party beneficiaries or confer any benefit or rights
on or to any person not a party hereto, and no person not a party hereto shall
be entitled to enforce any provisions hereof or exercise any rights
hereunder.
8.6 Waivers
and Modifications. The failure of any party to insist on the performance
of any obligation hereunder shall not act as a waiver of such obligation. No
waiver, modification, release or amendment of any obligation under this
Agreement shall be valid or effective unless in writing and signed by duly
authorized officers of each party hereto.
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8.7 Choice
of Law. This Agreement is subject to and shall be construed and enforced
in accordance with the laws of the state of New York, with giving effect to any
conflict of law principles that would apply the law of another
jurisdiction.
8.8 Dispute
Resolution.
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8.8.1
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Any
controversy or claim arising out of or relating to this Agreement or the
validity, inducement, or breach thereof, shall be settled by arbitration
before a single arbitrator in accordance with the commercial Arbitration
Rules of the American Arbitration Association ("AAA") then pertaining,
except where those rules conflict with this provision, in which case this
provision controls. The parties hereby consent to the personal
jurisdiction of the Federal District Court for the Southern District of
New York (and to the extent that federal subject matter jurisdiction is
lacking, to New York state courts within such Southern District) for the
enforcement of these provisions and the entry of judgment on any award
rendered hereunder. Should such court for any reason lack jurisdiction,
any court with jurisdiction shall enforce this clause and enter judgment
on any award. The arbitrator shall be an attorney specializing in business
litigation who has at least 15 years of experience with a law firm of over
25 lawyers or was a judge of a court of general jurisdiction. The
arbitration shall be held in Manhattan and the arbitrator shall apply the
substantive law of the State of New York, except that the interpretation
and enforcement of this arbitration provision shall be governed by the
Federal Arbitration Act. Within 30 days of initiation of arbitration, the
parties shall reach agreement upon and thereafter follow procedures
assuring that the arbitration will be concluded and the award rendered
within no more than six months from the selection of the arbitrator.
Failing such agreement, the AAA will design and the parties will follow
such procedures. Each party has the right before or during the arbitration
to seek and obtain from the appropriate court provisional remedies such as
attachment, preliminary injunction, replevin, etc, to avoid irreparable
harm, maintain the status quo or preserve the subject matter of the
arbitration. THE ARBITRATOR SHALL NOT AWARD ANY PARTY PUNITIVE, EXEMPLARY
OR CONSEQUENTIAL DAMAGES, AND EACH PARTY HEREBY IRREVOCABLY WAIVES ANY
RIGHT TO SEEK. SUCH DAMAGES.
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8.8.2
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Nothing
in this Section 8.8 shall be deemed to preclude a party from bringing suit
against the other party in a court of competent jurisdiction to enforce,
or enjoin infringement of, such party's intellectual property
rights.
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8.9 Headings.
The headings of the sections of this Agreement have been inserted for
convenience of reference only and do not constitute a part of this
Agreement.
8.10 Entire
Agreement. This Agreement constitutes the entire agreement between the
parties as to the subject matter hereof, and all prior negotiations,
representations, agreements and understandings are merged into, extinguished by
and completely expressed by this Agreement.
8.11 Draftsmanship.
This Agreement has been jointly prepared by the parties and shall not be
strictly construed against any of them.
8.12 Counterparts.
This Agreement may be executed in any number of counterparts with the same
effect as if all parties had signed the same document. All such counterparts
shall be deemed an original, shall be construed together and shall constitute
one and the same instrument.
IN
WITNESS WHEREOF, the parties have duly executed this Agreement on the date(s)
written below.
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TheraCour
Pharma, Inc.
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By:
/s/
Xxxx Xxxxx
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By:
/s/
Xxxxxx Xxxxxxx
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Name:
Xxxx X. Xxxxx. Ph.D.
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Name:
Xxxxxx Xxxxxxx, M.D.
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Title:
Chief Executive Officer
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Title:
Chief Executive Officer
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Date: February
15, 2010
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Date:
February 15, 2010
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EXHIBIT
A
LICENSED
PATENTS AND PATENT APPLICATIONS
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1.
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"SOLUBILIZATION
AND TARGETED DELIVERY OF DRUGS WITH SELF-ASSEMBLING AMPHIPHILIC
POLYMERS," as
described in an Application for Letters Patent of the Unites States of
America, Application No. PCT/US2006/001820, filed January 19,
2006.
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2.
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"AMPHIPHILIC
POLYMERIC MATERIALS," as described in Letters Patent of the United States
of America, Serial No. US 6,521,736, filed February 18,
2003.
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3.
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“SELF-ASSEMBLING
AMPHIPHILIC POLYMERS AS ANTIVIRAL AGENTS,” as described in an Application
for Letters Patent of the Unites States of America, Application No.
PCT/US07/01607, filed January 19,
2007.
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EXHIBIT
B
CERTIFICATE
OF DESIGNATION
Page 14 of
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