EXHIBIT 10(a)
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LICENSE AND RESEARCH SUPPORT AGREEMENT BETWEEN THE COMPANY
AND THE ROCKEFELLER UNIVERSITY, DATED FEBRUARY 27, 1996
LICENSE AND RESEARCH SUPPORT AGREEMENT
AGREEMENT made as of the 27th day of February, 1996 by and between
VIROLOGIX CORPORATION ("Licensee"), a corporation organized and existing under
the laws of the State of Delaware, having an office at 000 Xxxxx Xxxxxx, 00xx
Xxxxx, Xxx Xxxx, Xxx Xxxx, 00000 and THE ROCKEFELLER UNIVERSITY (" University"),
a nonprofit education corporation organized and existing under the laws of the
State of New York, having an office at 0000 Xxxx Xxxxxx, Xxx Xxxx, Xxx Xxxx
00000.
W I T N E S E T H:
WHEREAS, Dr. Xxxxxxx Xxxx has developed certain technology relating
to the prevention and treatment of retroviral infections, which technology is
more fully described in Exhibit "A" of this Agreement ("Core Technology");
WHEREAS, Licensee wishes to obtain the exclusive license rights from
the University to exploit the Core Technology;
WHEREAS, Licensee further wishes to sponsor continuing research by
Xx. Xxxx and his colleagues at the University in the area of the Core
Technology;
WHEREAS, the University is willing to grant such license rights as
provided for herein in return for the research support, patent reimbursements
and Licensee's other undertakings herein provided, all in the manner described
herein; and
WHEREAS, the research support herein described is of the essence of
this Agreement and any default in the prompt and full payment thereof in
accordance with the payment schedule herein provided shall be deemed a material
breach of this Agreement;
NOW, THEREFORE, in consideration of the mutual benefits to be
derived hereunder, the parties hereto agree as follows:
1. Definitions
The following terms will have the meanings assigned to them below when
used in this Agreement:
1.1 "Affiliate" means, as to any person or entity, any other person
or entity which directly or indirectly controls, is controlled by, or is under
common control with such person or entity. For purposes of the
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preceding definition, "control" means the right to control, or actual control
of, the management of such other entity, whether by ownership of voting
securities, by agreement, or otherwise.
1.2 "Combination Product" means any product that is comprised in
part of a Product and in part of one or more other biologically active
diagnostic, preventive or therapeutic agents which are not themselves Products
(the "Other Agents"). "Other Agents" excludes diluents and vehicles of Products.
1.3 "Commercial Sale" means any transfer to another person or entity
(including a distributor, wholesaler or sales agent), for value, after which
transfer the seller has no right, power or authority to determine the
transferee's resale price, if any. A transfer by Licensee to an Affiliate or
Sublicensee, or a transfer among or between Affiliates and/or Sublicensees,
shall not constitute a Commercial Sale. "Commercial Sale" does not include
distribution of free promotional samples of any Product or Combination Product
by Licensee or any of its Affiliates or Sublicensees in amounts determined to be
commercially reasonable by Licensee in the exercise of its reasonable
discretion.
1.4 "Party" shall mean either Licensee or University and "Parties"
shall mean both Licensee and University.
1.5 "Licensed Patent Rights" shall mean
(a) the patent applications currently being prepared and based
on invention disclosures described in Exhibit "A," and all patents which may
issue thereon;
(b) any patent(s) and/or patent application(s) covering any
Invention or Improvement (as defined below) made in the course of research
sponsored by Licensee pursuant to Paragraph 5 hereof; and
(c) all patent applications and/or patents (including patents
which may be issued) which are divisionals, continuations,
continuations-in-part, reissues, renewals, reexaminations, substitutions,
foreign counterparts, extensions or additions of or to the patents and/or
applications or are based upon the invention disclosures described in (a) and
(b) of this Paragraph 1.5.
1.6 "Core Technology" shall mean the technology described in the
patent applications currently being prepared and based on invention disclosures
set forth in Exhibit "A," as the same may be expanded by
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Invention(s) or Improvement(s) added thereto by operation of this Agreement.
1.7 "Invention(s)" or "Improvement(s)" shall mean any and all
discoveries, methods, processes, compositions of matter and uses, whether or not
patentable, made by Dr. Xxxxxxx Xxxx and/or his laboratory colleagues, conceived
and reduced to practice during the one-year term of research which is sponsored
by Licensee pursuant to the provisions of Paragraph 5 of this Agreement, or any
extension of such term of research sponsored by Licensee, which is agreed to by
the Parties.
1.8 "Technical Information" shall mean any and all technical data,
information, materials, trade secrets, methods, protocols, procedures,
formulations, arts and know-how, whether or not patentable, owned by or subject
to the rights of the University relating to the Core Technology during the term
of this Agreement which are determined by Licensee to be useful in the practice
of Licensed Patent Rights.
1.9 "Product(s)" shall mean any product that is covered by a Valid
Claim of the Licensed Patent Rights. "Valid Claim", with respect to each
country, means an issued claim of any unexpired patent, or a claim of any
pending patent application that has not been held unenforceable, unpatentable or
invalid by a decision of a court or governmental body of competent jurisdiction,
unappealable or unappealed within the time allowed for appeal, which has not
been rendered unenforceable through disclaimer or otherwise, and which has not
been lost through an interference proceeding, in such country.
1.10 "Net Sales" shall mean:
(a) with respect to Products, the gross sales price actually charged
by Licensee or an Affiliate or Sublicensee in the Commercial Sale of such
Licensed Product, less:
(i) trade, prompt payment, quantity or cash discounts,
rebates, and non-affiliated brokers' or agents' commissions, each as actually
and customarily allowed and taken;
(ii) amounts actually repaid or credited to customers on
account of rejections or returns of specified products on which Royalties have
been paid hereunder or on account of retroactive price reductions affecting such
products;
(iii) customary freight and other transportation costs,
including insurance charges, and duties, tariffs, sales, use and excise
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taxes and other governmental charges based directly on sales, turnover or
delivery of the specified products and actually paid or allowed by Licensee, an
Affiliate of Licensee or a Sublicensee; and
(iv) commercially reasonable allowances for bad debts incurred
with respect to the Products during the first full year of Commercial Sales of
any such Product, provided that such bad debt reserve shall be deemed
extinguished within 180 days of the end of such first full year, and any amount
of such reserve not actually debited in accordance with commercially reasonable
practices during that period shall be deemed to be receipts of Net Sales for all
purposes of this Agreement; and
(b) with respect to Combination Products, the gross sales price
actually charged by Licensee or an Affiliate or Sublicensee in the Commercial
Sale of such Combination Product, less the deductions set forth in subsections
(a)(i) - (iv) above, multiplied by a fraction having (i) a numerator of the
gross sales price of the Product(s) included in such Combination Product as if
sold separately or, if such sales price is not available, the fair market value
of such Product(s), and (ii) a denominator of the gross sales price of such
Combination Product, or if such sales price is not available, the sum of the
fair market values of the Other Agents and the Product(s) contained in such
Combination Product. The "fair market value" for any Product or Other Agent
shall be determined for a quantity comparable to that included in the
Combination Product and of substantially comparable class, purity and potency,
and shall be mutually agreed to by University and Licensee. When no fair market
value is available, the fraction set forth above shall be changed to a fraction
having (x) a numerator of the cost to Licensee, its Affiliates or Sublicensees,
of the Product(s) included in such Combination Product, and (y) a denominator of
the sum of such cost plus the cost to Licensee, its Affiliates or Sublicensees
of the Other Agents contained in such Combination Product, provided that in no
event shall the fraction be less than (A) one-half (1/2), if only one Other
Agent is included with a Product(s) in such Combination Product, (B) one-third
(1/3), if two Other Agents are included with a Product(s) in such Combination
Product, and (C) one-quarter (1/4), if three or more Other Agents are included
with a Product(s) in such Combination Product. "Cost" as used above means the
actual cost paid by Licensee, and/or it Affiliates or Sublicensees in an arm's
length transaction, if purchased, or if not purchased but actually
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manufactured by any such entity, the sum of the direct manufacturing cost as
determined by such entity's internal cost accounting system consistently
applied.
1.11 "Royalty" means for any given fiscal year of Licensee any sum
payable to the University with respect to Net Sales in such fiscal year of
Products or Combination Products by Licensee, its Affiliates or Sublicensees,
and shall exclude without limitation any research or development support
payments, marketing or licensing fees received by Licensee or any Affiliate from
any third party, any equity investments received from any person or entity
whatsoever, and all other reimbursements, advances, prepayments or other
payments received from third parties not specifically made with respect to sales
of Products or Combination Products.
1.12 "Sublicense" means any agreement pursuant to which Licensee or
an Affiliate of Licensee expressly grants to any third party the right to
practise the Inventions or Improvements included within the Licensed Patent
Rights for the purpose of manufacturing a Product which has not been produced by
Licensee or any of its Affiliates or provided to such third party by Licensee or
any of its Affiliates, and specifically excludes any marketing, sales,
distribution or similar arrangement with a third party; "Sublicensee" means any
person or entity which is not an Affiliate of Licensee and to whom a Sublicense
has been granted.
1.13 "Territory" shall mean the entire world.
1.14 "Effective Date shall mean the day and year first above
written.
2. Licensed Rights Granted
2.1 The University hereby grants to Licensee and its Affiliates a
sole and exclusive license, including the right to grant Royalty bearing
Sublicenses under terms consistent with this Agreement, subject only to the
University's prior approval of Sublicensee selected by Licensee which approval
shall not be unreasonably withheld or delayed, under Licensed Patent Rights and
Technical Information, to make, have made, use, have used, sell, have sold and
import Products and Combination Products in the Territory, and to enter into
marketing, sales, distribution and similar agreements with third parties, except
to the extent that the University's right to do so may be limited
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(a) under the provisions of 00 Xxxxxx Xxxxxx Code, Section
201, et seq., and regulations and rules promulgated thereunder and implementing
agreements thereof.
2.2 The University agrees that any Invention(s) or Improvement(s)
made in the course of the research sponsored by Licensee, pursuant to Paragraph
5 hereof, shall be disclosed promptly to Licensee. The University agrees that
Xx. Xxxx shall provide Licensee with a quarterly research progress report within
thirty (30) days of the end of each calendar quarter after the date hereof,
which reports shall disclose any such Invention(s) or Improvement(s) to
Licensee, and a final research report containing customary detail and summaries
within sixty (60) days following the end of the research. Any such Invention(s)
or Improvement(s) shall automatically be added to Licensee's existing license
grant under Section 2.1 hereof without the payment of any additional
consideration. The existing license shall automatically be expanded to cover the
new Invention(s) or Improvement(s) without any further action by either of the
Parties hereto, and said Invention(s) or Improvement(s) shall thereupon be
deemed an addition to the Core Technology under this Agreement.
2.3 If Licensee
(a) chooses not to practice any Licensed Patent Rights
licensed to it hereunder, or
(b) notifies the University of its intent not to add a
particular new Invention or Improvement to the existing license, the University
shall be free to license the same to a third party or parties of its choosing.
Licensee agrees to give the University prompt Notice of any
decision not to practice Licensed Patent Rights or not to add a new Invention or
Improvement to the existing license.
2.4 The University shall have the right to terminate this Agreement
at any time after four (4) years of the Effective Date if, in the University's
reasonable judgment, Licensee is not demonstrably engaged in research,
development, manufacturing, marketing or licensing, as appropriate, directed
toward putting a Product toward a commercial use either directly or through a
sublicense; provided, however, that annual expenditures of at least *****
[Confidential Information omitted and filed separately with the SEC] by Licensee
toward such commercial use, including,
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but not limited to, expenditures on research, development, manufacturing,
marketing, licensing, finance and administration, shall constitute satisfaction
of this requirement. In making this determination, the University shall take
into account the normal course of such programs conducted with sound and
reasonable business practices and judgment and shall take into account the
reports provided hereunder by Licensee.
2.5 The University agrees to provide Licensee with Technical
Information developed in Xx. Xxxx'x laboratory at the University from time to
time during the term of this Agreement. Licensee shall be entitled to use (and
shall be entitled to allow its Affiliates and Sublicensees to use) such
Technical Information internally in support of development, discovery,
manufacturing and marketing efforts for sales of Licensed Products. The
University further agrees to use its good faith efforts to cause Xx. Xxxx to
promptly deliver clones or copies of the molecules, compounds, reagents or other
materials in his possession included in the Core Technology to Licensee promptly
from time to time upon Licensee's request.
3. Royalties and Other License Consideration
3.1 As further consideration for the license grant provided in
Paragraph 2.1, Licensee agrees to pay the University the following amounts in
the nature of Royalties:
(a) Royalties on Net Sales of Products, as follows:
(I) For Products or Combination Products sold, leased
or otherwise disposed of by Licensee, or any of
its Affiliates, Royalties equal to *****
[Confidential Information omitted and filed
separately with the SEC] of Net Sales.
(II) For Products or Combination Products sold, leased
or otherwise disposed of pursuant to a Sublicense
by a Sublicensee, Royalties equal to *****
[Confidential Information omitted and filed
separately with the SEC] of the above percentage.
In addition, University shall receive *****
[Confidential Information omitted and filed
separately with the SEC] of any non-royalty
consideration received by
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Licensee for sublicensing of technology
licensed hereunder.
The obligation to pay Royalties hereunder is imposed only once
with respect to the sale, lease or disposition of any Product or Combination
Product regardless of the number of Valid Claims which cover such Product or
Combination Product. Additionally, there shall be no obligation to pay Royalties
on the sale, lease or disposition of Products by Licensee or its Affiliates to
any Sublicensees for resale, but in such instances, the obligation to pay
Royalties shall arise upon the sale by any such Sublicensee to unrelated third
parties. (b) Milestone payments (which shall be paid only once per Product) as
follows:
(i) ***** [Confidential Information omitted and
filed separately with the SEC] within sixty (60)
days of the first approved submission of an IND
in any country of the Territory on a Product,
(ii) ***** [Confidential Information omitted and
filed separately with the SEC] within sixty (60)
days of the start of a Phase II clinical trial in
any country of the Territory,
(iii) ***** [Confidential Information omitted and filed
separately with the SEC] within sixty (60) days
of the first FDA approval or its equivalent in
any country of the Territory on a Product.
3.2 Upon commencement of Net Sales of Products or Combination
Products which generate a Royalty to the University pursuant to this Agreement,
Licensee shall, within sixty (60) days of the close of the calendar quarter in
which such Net Sales begin, make quarterly reports to the University indicating
the total Net Sales of Products and Combination Products in the quarter and the
calculation of Royalties due thereon. Any Royalty then due and payable shall be
included with such report.
Licensee's records shall be open to inspection by the University or
a certified public accountant designated by the University, at reasonable times,
and from time to time, for the sole purpose of verifying the accuracy of the
reports and the Royalty payments. The University shall bear the reasonable costs
of such inspection unless the inspection establishes an error in the
University's favor of *****
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[Confidential Information omitted and filed separately with the SEC] or more of
the amount payable for the period of inspection. The University shall keep all
reports, information, documents and other materials received from Licensee under
this Agreement, including the reports made pursuant to the preceding paragraph,
confidential and the use of such reports and information by the University is
strictly limited to the enforcement of the University's rights under this
Agreement.
3.3 Licensee shall provide written reports within sixty (60) days
after the University requests in writing such report, but no more frequently
than annually, which shall include the following information: reports of
progress on research and development, regulatory approvals, manufacturing and
sublicensing, including the terms of any Sublicense.
4. Patents
4.1 Future Patent Expenses: Licensee shall select qualified
independent patent counsel reasonably satisfactory to the University to file,
prosecute and maintain all patent applications included in Licensed Patent
Rights, at the expense of Licensee, including divisionals, continuations.
continuations-in-part, reissues, renewals, foreign counterparts or extensions.
Licensee shall be entitled to determine the countries in which it wishes to
obtain and maintain patent protection under this Agreement and shall be free, at
any time and at its sole option and upon Notice to the University, to abandon
patent prosecution or maintenance in any country of the Territory.
4.2 Should Licensee decide not to finance the preparation, filing,
prosecution, or maintenance of any patent application or patent licensed
hereunder, Licensee will give Notice to the University of such decision in
writing in adequate time to allow the University, at its own cost, to effectuate
such preparation, filing, prosecution, or maintenance if it desires to do so.
Nothing herein is intended or shall be construed as obligating
the University to file or maintain any U.S. or foreign patents at its own
expense, or to defend, enforce, or support any patent or patent applications
which may be included in Licensed Patents Rights to which it has granted license
rights to Licensee; provided, however, that the University will cooperate with
Licensee in its activity in applying for
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U.S. or foreign patents or in the defense or enforcement of Licensed Patent
Rights.
Nothing herein is intended or shall be construed as obligating
Licensee to maintain its license with respect to any patent or application
licensed hereunder and to finance the preparation, filing, prosecution or
maintenance of any patent application in any country or jurisdiction in which it
believes it is not in the best business interest of Licensee to do so.
4.3 Licensee, or any Affiliate or Sublicensee of Licensee, shall
have the right but not the obligation to institute patent infringement
proceedings against third parties based on any Licensed Patent Rights licensed
hereunder. The University agrees to give Notice to Licensee promptly, in
writing, of each infringement of Licensed Patent Rights of which the University
is or becomes aware during the term of this Agreement. If Licensee does not
institute infringement proceedings against such third parties, the University
shall have the right, but not the obligation, to institute such proceedings
within thirty (30) days after Notice of its intention to commence such
proceedings shall have been given to Licensee, in writing, and provided that
Licensee does not, within such thirty (30) day period, institute its own
proceedings. The expenses of such proceedings, including lawyers' fees, shall be
borne by the Party instituting suit. The Party instituting suit shall have the
right to select counsel to conduct the suit. Each Party shall execute all
necessary and proper documents and take all other appropriate action, including
but not limited to being named as a participating party, to allow the other
Party to institute and prosecute such proceedings. Any award paid by third
parties as a result of such proceedings (whether by way of settlement or
otherwise) shall first be applied toward reimbursement for the legal fees and
expenses incurred, and the excess, if any, shall be shared on a pro rata basis
based on the expenses incurred by each Party.
5. Sponsored Research
Licensee agrees to sponsor further research as described in Exhibit
"B" on the Core Technology by Dr. Xxxxxxx Xxxx and his colleagues at the
University for a minimum period of one (1) year at the budget level provided for
in Exhibit "C", attached hereto. Sponsorship at this level shall continue for a
second and subsequent years thereafter unless Licensee
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gives the University a minimum of four (4) months' notice that it does not wish
to fund research for such second or subsequent years. Xx. Xxxx will provide to
Licensee an annual budget, similar to the budget set forth in Exhibit "C", for
such second year, and for each subsequent year, at least six (6) months prior to
the beginning of each such year.
Licensee shall pay the budgeted amounts to the University
quarterly in advance over the one (1) year period of guaranteed support, the
first quarterly payment therefor, in the amount of ***** [Confidential
Information omitted and filed separately with the SEC] being payable within five
(5) business days following the execution of this Agreement.
6. Academic Freedom
The Parties recognize the traditional freedom of all
scientists to publish and present promptly the results of their research. The
Parties also recognize that patent rights can be jeopardized by public
disclosure prior to the filing of suitable patent applications. Therefore, the
University will assure that each proposed publication concerning any technology
described in Licensed Patent Rights or Technical Information or which may
constitute an Invention or Improvement hereunder, before submission to a
publisher, will be submitted to Licensee for review in connection with
preservation of patent rights. Licensee shall have thirty (30) days in which to
review the publication, which may be extended for an additional thirty (30) days
when Licensee provides substantial and reasonable need for such extension. By
mutual agreement, this period may be further extended for not more than an
additional three (3) months. Licensee will allow for simultaneous submission of
the publication to the publisher and Licensee, where appropriate. Scientists
acting on behalf of both the University and Licensee will be expected to treat
matters of authorship in a proper collaborative spirit, giving credit where it
is due and proceeding in a manner which fosters cooperation and communication.
7. Publicity
Licensee will not use the University's name or the name of any
member of its faculty or its staff for any public, commercial or advertising
purposes without the prior written approval of the University and faculty or
staff member involved; provided, however, that it is expressly agreed that
Licensee may reveal or identify the University or any
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member of its faculty or staff as the inventor, source or origin of any Core
Technology, Technical Information or any Product or Process for the purpose of
soliciting third parties to invest or enter into other commercial arrangements
with Licensee, or to acquire a Sublicense, assignment or other transfer of
rights in such Core Technology from Licensee and provided further that Licensee
may use and disclose the University's name and the name of any member of its
faculty or its staff in its internal communications or, upon prior disclosure
and consultation with the University, in making any required governmental
reports and filings.
It is recognized by the Parties that at some future date, a
public offering of securities may be contemplated by Licensee. The University
intends to cooperate with Licensee in expeditiously reviewing any Licensee
registration statements and/or prospectuses, but wishes to reserve its rights
with respect to how its name will be used.
8. Product Liability
Licensee agrees to indemnify and hold harmless the University
and its trustees, officers, agents, faculty, employees, and students from any
and all liability arising from injury or damage to person or property resulting
directly or indirectly from Licensee's use, manufacture, or sale of any product
covered by any Licensed Patent Rights or Technical Information. This obligation
may be delegated by the Licensee to assignees and/or Sublicensees of the
Licensee's rights under this Agreement and may be satisfied by the Licensee's
and/or its Sublicensees or assignees obtaining and maintaining until the
expiration of all licenses granted hereunder, appropriate and available product
liability insurance for a conventional amount of coverage generally deemed
appropriate in the biotechnology or pharmaceutical industry, under which
insurance the University is named as an additional insured.
The University shall promptly give the Licensee Notice of any
claim asserted or threatened on the basis of which the Party giving such Notice
intends to seek indemnification from Licensee as herein provided.
9. Termination
9.1 The licenses herein granted shall continue for the full term of
any patents licensed hereunder as the same or the effectiveness
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thereof may be extended by any governmental authority, rule or regulation
applicable thereto; it being understood, however, that the Licensee's right to
continue the practice of then existing Technical Information shall continue as a
fully paid, perpetual license.
9.2 The Licensee shall have the right to terminate any license
granted herein at any time upon ninety (90) days' prior written notice to the
University.
9.3 Either Party may terminate this Agreement in the event of a
material breach by the other Party, provided only that the breaching Party is
given Notice of the breach and a reasonable time, not to exceed thirty (30)
days, in which to cure such breach.
9.4 The University agrees that in the event of the termination of
this Agreement and of any option and/or license granted hereunder it will
continue any applicable Sublicense on the terms and conditions of such
Sublicense in effect at the time of any such termination.
10. Disclaimer
EXCEPT AS EXPRESSLY SET FORTH HEREIN AND WITH RESPECT TO THE
OWNERSHIP OF THE LICENSED PATENT RIGHTS, INVENTIONS, IMPROVEMENTS, AND TECHNICAL
INFORMATION, THE UNIVERSITY MAKES NO WARRANTIES, EXPRESS OR IMPLIED, IN RESPECT
OF THE CORE TECHNOLOGY, TECHNICAL INFORMATION, LICENSED PATENT RIGHT, PRODUCT OR
PROCESSES AND SPECIFICALLY DISCLAIMS ANY WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE.
11. Notices
Any Notice required to be given pursuant to this Agreement
shall be made by personal delivery or, if by mail, then by registered or
certified mail, return receipt requested, with postage and fees prepaid, by one
Party to the other Party at the addresses noted below, or to such other address
as such Party may designate in writing from time to time to the other Party.
In the case of the Licensee, Notice should be sent to:
Virologix Corporation
000 Xxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000
In the case of the University, Notice should be sent to:
The Rockefeller University
0000 Xxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
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Attention: Office of the General Counsel
12. Representation and Warranties
The University hereby represents and warrants to the Licensee
that
(i) the University has the right to grant the license herein
provided under the terms and conditions set forth herein;
(ii) there are no encumbrances or restrictions not set forth
herein on its right to grant the licenses herein provided; and
(iii) this Agreement does not conflict with or breach any
other agreement or understanding to which the University is a
party.
Licensee hereby represents and warrants to the University that
(i) Licensee is a corporation duly organized and validly
existing under the laws of the State of Delaware, and
(ii) Licensee will deliver to the University, on an on-going
confidential basis, any reports or other materials provided to
its shareholders.
13. Assignment
No Party hereto may assign any of its rights or obligations
under this Agreement to any third party, without the express prior written
consent of the other Party to this Agreement, which consent will not be
unreasonably withheld or delayed; provided, however, that no consent shall be
necessary in the event of (i) the sale, merger, acquisition or other business
combination, or sale of substantially all the assets, of Licensee or (ii) the
sale of all of Licensee's rights with respect to any Product line or lines.
14. Governing Law
This Agreement shall be governed by and construed in
accordance with the laws of the State of New York.
15. Further Action
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At any time and from time to time, each Party agrees, without
further consideration, to take such actions and to execute and deliver such
documents as may be reasonable necessary to effectuate the purposes of this
Agreement.
16. Waiver
Any Waiver by any Party of a breach of any provision of this
Agreement shall not operate as or be construed to be a waiver of any other
breach of this provision or of any breach of any other provision of this
Agreement. The failure of a Party to insist upon strict adherence to any term of
this Agreement on one or more occasions shall not be considered a waiver or
deprive that party of the right thereafter to insist upon strict adherence to
that term or any other term of this Agreement.
17. Severability
If any provision of this Agreement is invalid, illegal, or
unenforceable, the balance of this Agreement shall remain in effect, and if any
provision is inapplicable to any person or circumstance, it shall nevertheless
remain applicable to all other persons and circumstances.
18. Counterparts
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.
19. Force Majeure
The Parties shall not be liable in any manner for failure or
delay in fulfillment of all or part of this Agreement, directly or indirectly
caused by acts of God, governmental order or restrictions, war, war-like
condition, revolution, riot, looting, strike, lockout, fire, flood or other
similar or dissimilar causes or circumstances beyond the non-performing Party's
control. The non-performing Party shall promptly notify the other Party of the
cause or circumstance and shall recommence its performance of its obligations as
soon as practicable after the cause or circumstance ceases.
20. Arbitration.
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In the event of any dispute under this Agreement, such dispute
shall be submitted to arbitration in accordance with the terms of this Section.
The party who is alleging that a dispute exists shall send a notice of such
dispute to all other parties, which notice shall set forth in detail the
dispute, the parties involved and the position of such party with respect
thereto. Within ten (10) business days after the delivery of such a notice,
counsel for the parties shall mutually select as an arbitrator an attorney
practicing in New York, New York, who is experienced in commercial arbitration.
If counsel for the parties are unable to agree upon the selection of the
arbitrator, an arbitrator residing in or about New York, New York shall be
selected by the New York office of the American Arbitration Association. The
arbitrator so selected shall schedule a hearing in New York, New York on the
disputed issues within forty-five (45) days after his/her appointment and the
arbitrator shall render a decision after the hearing, in writing, as
expeditiously as is possible, which shall be delivered to the parties. The
arbitrator shall render a decision based on written materials supplied by the
parties to the arbitration in support of their respective oral presentations at
the hearing, and no party shall be entitled to discovery in such matter. The
parties shall supply a copy of any written materials to be submitted to the
arbitrator at least fifteen (15) days prior to the scheduled hearing. A default
judgment may be entered against a party who fails to appear at the arbitration
hearing. Such decision and determination shall be final and unappealable and
shall be filed as a judgment of record in any jurisdiction designated by the
successful party. The parties to this Agreement agree that this paragraph has
been included to rapidly and inexpensively resolve any disputes between them
with respect to the matters described above, and that this paragraph shall be
grounds for dismissal of any court action commenced by any party with respect to
a dispute arising out of such matters. For purposes of this Section, Licensors
may participate in any arbitration either jointly or severally, in their sole
discretion.
21. Entire Understanding
This Agreement, together with the Exhibits hereto and the
concurrently executed Agreement constitute the entire agreement between the
Parties with respect to the subject matter hereof, supersedes all prior
understanding and agreement by the Parties with respect to the subject
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matter hereof and may be modified only by written instrument duly executed by
each Party.
22. Heading
The headings contained herein are for the purpose of
convenience only and are not intended to define or limit the contents of such
sections.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be
duly executed as of the day and year first above written.
VIROLOGIX CORPORATION
By: /s/ Xxxxxx X. Xxxxxx
--------------------------------
Its:
THE ROCKEFELLER UNIVERSITY
By: /s/ Xxxxxxx Greisar
--------------------------------
Its:
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The undersigned, Xx. Xxxxxxxx Xxxxxxxxx, to the extent that he may have
rights in the attached Agreement between The Rockefeller University and the
Licensee therein named, hereby consents and joins in the license grant to the
Licensee and agrees to be bound by the terms of the license grant with respect
to its interest in the Licensed Patent Rights described in Exhibit "A" attached
to said Agreement subject only to the agreement of The Rockefeller University to
pay to the undersigned ***** [Confidential Information omitted and filed
separately with the SEC] of the net monies received by The Rockefeller
University pursuant to Paragraph 3 thereof.
/s/ Xxxxxxxx Xxxxxxxxx
--------------------------------
Xx. Xxxxxxxx Xxxxxxxxx
February 27, 1996
---------------------
Date
In consideration of Xx. Xxxxxxxxx'x joining in the license grant as above
provided, The Rockefeller University agrees to pay to Xx. Xxxxxxxxx ******
[Confidential Information omitted and filed separately with the SEC] of the net
monies received by The Rockefeller University pursuant to Paragraph 3 thereof.
THE ROCKEFELLER UNIVERSITY
By:/s/ Xxxxxxx Xxxxxxx
February 15, 1996
---------------------
Date
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EXHIBIT A
Core Technology
Patent applications directed to the following invention disclosures from
Dr. Xxxxxxx Xxxx being prepared:
1. Transgenic Animals Permissive for HIV infection
2. Inhibitor of HIV Activator of Topoisomerase/Transcription
3. High Efficiency Retrovirus-Mediated Gene Therapy
4. Vaccine for HTLV-I and II
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EXHIBIT "B"
HUMAN RETROVIROLOGY: XXXXXXX X. XXXX, M.D. Ph.D.
(A) HIV-I: Development of Mouse Models for HIV-I Replication.
Preliminary studies from our laboratory have shown that in addition to the
virus receptor (CD4 molecule) HIV replication requires specific interactions
with several cellular proteins and these interactions appear to be
species-specific. In particular the studies have shown that HIV requires the
involvement of the human enzyme topoisomerase I (topo I). Importantly the
interaction of the virus with topo I of other species is extremely inefficient.
With this information we have begun to investigate if this enzyme may be
involved in the host restriction of virus replication, and in fact this would
appear to be the case. In recent studies we have shown that HIV infection of
mouse fibroblasts is possible if both the CD4 molecule and human topo I are
expressed in these cells. As part of our plans to develop a mouse model for
HIV-replication: 1) we intend to produce transgenic mice with expression of both
of these molecules in peripheral blood mononuclear cells. If these can
successfully support HIV replication, they will be extremely useful for studies
of virus replication, drug inhibition studies and possibly tests of vaccine
efficacy. 2) To further optimize the mouse model for HIV replication we also
intend to produce chimeric or pseudotype retroviruses containing the HIV core
and the surface molecules (receptor binding molecules) of mouse retroviruses.
These will then be tested for their ability to infect transgenic mice only
expressing human topo I. Preliminary in vitro studies have indicated a high
probability of success with the latter approach.
Research Plan
1. Transgenic Mice: The studies to produce transgenic mice are underway and
this involves the introduction of human CD4 and human topo I genes. The
latter are prepared by a combination of PCR and cloning methods, and the
fidelity of the constructs are analyzed by nucleotide sequencing analysis.
It is hoped to establish a line of double transgenic males and use these
to mate normal females. The offspring are checked for double gene
expression by Southern hybridization methods. To determine if they can be
infected with HIV initial studies will involve the establishment of spleen
cell cultures in vitro and assaying the ability of virus (both laboratory
and wild type strains) to replicate in these cells and to compare the
efficiencies of replication.
If efficient replication can be demonstrated conditions will be
established for in vivo infection. It should be appreciated that this project is
extremely labor-intensive and very expensive as this will involve the
maintenance and care of a large number of animals.
As noted above to optimize virus replication in the mouse we are also
intending to prepare chimeric murine/HIV retroviruses as this will overcome what
we feel is the rate limiting step of infection, namely virus entry. Using murine
retrovirus glycoproteins to permit virus entry we will not need to include human
CD4 in our system. Chimeric virus production will require sophisticated
molecular biological manipulation of infectious clones of HIV and murine
leukemia virus and at least one year will be required to produce a chimeric
clone. This will require the expertise of an individual with extensive
experience in molecular biology. Once established this Avirus@ should be able to
repliate very effectively in vivo in the mouse and will permit an analysis of
almost all stages of HIV repliation.
(A) HTLV-I Vaccine Produciton
Previous studies in our laboratory have resulted in the successful cloning
and expression of a truncated form of the precursor glycoproteins (gp 63) of
HTLV-I and HTLV-II. Initial studies in a rabbit model have shown that when used
as a vaccine (employing complete Xxxxxx'x as adjuvant), these can effectively
prevent infection in a rabbit model. We now intend to continue these studies and
(a) analyze the effectiveness of the vaccine in rabbits using alum and other
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adjuvants which would be more suitable for human use. (b) Establish a phase I
(safety) trial of the HTLV-I vaccine in humans. This will be carried out in
Brazil where a suitable population has been identified.
The studies planned will involve vaccine production under conditions
approved by the FDA in terms of product safety and lack of toxicity. The trial
which will be carried out in Brazil should begin within one year. The rabbit
studies will take approximately 12 months to study different dosages and
adjuvant conditions. These will be also expensive due to high maintenance and
procedure cost. Immunological studies will also be carried out on certain
animals to determine the mechanisms of vaccine protection.
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EXHIBIT "C"
Budget: (Year 1)
Personnel: Two individuals (a) a postdoctoral level molecular biologist will be
hired to prepare the molecular constructs and carry out the HIV infection
studies (100 % effort) and (b) a research technician with direct responsibility
for the animal studies both transgenic and vaccine studies (75% effort) will be
required. (c) The vaccine trial will involve a 50% effort position of a
Brazilian researcher.
Salary with benefits ***** + ****** = ***** (1)
Brazilian researcher ***** = ***** (1)
TOTAL: $****** (1)
Supplies:
Animals: mice maintenance and breeding will be expensive (At LARC mouse
@*****) for 1 year will require $***** (1)
Rabbits vaccine studies $****** (1)
TOTAL $****** (1)
Molecular Biologicals: (plasmids, restriciton enzymes, DNA sequencing reagents,
PCR related products, tissue culture reagents) $****** (1)
Other Expenses: Travel to coordinate Brazilian studies $****** (1)
Equipment: (microfuge; power supply, gel drier, vacuum pump) $****** (1)
TOTAL: Direct Costs $****** (1)
Indirect Costs (30%): $****** (1)
-------
Total Costs: $****** (1)
----------
(1) Confidential Information omitted and filed separately with the SEC.
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