Exhibit 10.2
LICENSE AGREEMENT
THIS LICENSE AGREEMENT, effective on the date of last signature below is between
THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL having an address at CB #4105,
308 Bynum Hall, Chapel Hill, NC (hereinafter referred to as "University") and
Boston Biomedica, Inc., a corporation organized and existing under the laws of
Massachusetts and having an address at 375 West Street, West Bridgewater, MA
02379, (hereinafter referred to as "Licensee").
WITNESSETH
WHEREAS, University owns and controls its share of the ownership
interest in the inventions listed in Appendix A (hereinafter "Inventions",
developed by the persons also listed in Appendix A [hereinafter "Inventors"] of
the University; and
WHEREAS, Licensee is desirous of producing, using and selling products
which include the use of Inventions and is willing to expend its best efforts
and resources to do so if it can obtain a license to use the Invention under the
terms and conditions set forth herein; and
WHEREAS, University and Licensee have already entered into a previous
license agreement, effective 14 December 1994, and wish for the present
Agreement to supersede the prior agreement in its entirety; and
WHEREAS, University desires to facilitate a timely transfer of its
information and technology concerning the Invention for the ultimate benefit of
the public and this transfer is best accomplished by the grant of this license;
and
WHEREAS, in the opinion of the University, this transfer can best be
accomplished consistent with its mission by affiliation with Licensee;
NOW, THEREFORE, for and in consideration of the covenants, conditions,
and undertakings hereinafter set forth, it is agreed by and between the parties
as follows:
I. DEFINITIONS
a. "University Technology" means any unpublished research and
development information, unpatented inventions, and technical data
in the possession of the University prior to the effective date of
the attached Sponsored Research Agreement or which comes into the
possession of University during the term of this Agreement, is not
covered under the Sponsored Research Agreement, and which relates
to and is necessary for the practice of the Invention and which
University has the right to provide to Licensee.
b. "Inventions" mean any process, machine, manufacture, composition
of matter or improvement thereof, which comes within the scope of
any unexpired claim of any of the Patents.
c. "Licensed Products" means any method, procedure, or component part
thereof whose manufacture, use, or sale includes any University
Technology, Patents, or Licensed Compounds in an individual
Licensed Field.
d. "Licensed Compounds" means any individual compounds included in
Inventions, University Technology, or Patents, or whose method,
procedure, or uses included in Licensed Products.
e. "Patents" means any US patents and/or patent applications covering
Inventions owned or controlled in whole or in part by University
prior to or during the term of this Agreement and which University
has the right to provide its share to Licensee, as well as ay
continuations, continuations in part, divisionals, provisionals,
continued prosecution applications, extensions, or reissues
thereof, and any foreign counterpart of any of the foregoing. A
summary of current Patents is included as Appendix A herein.
f. "New Sales Price" means the invoiced sales price, less any charges
for (a) sales taxes or other taxes separately stated on the
invoice and (b) shipping and insurance charges.
g. "Net Sales" means the total New Sales Price of Licensed Products,
after deduction actual allowances for returned or defective goods,
less trade discounts, but before cash discounts. Licensed Products
will be considered sold when billed out, or when delivered or paid
for before delivery, whichever first occurs.
h. "Licensed Territory" means any countries which Licensee,
Affiliate, or Sublicensee practice or otherwise utilize the
Invention(s), University Technology, Licensed Products, or Patents
in a Licensed Field.
i. "Licensed Field" means, and is limited to, the practice of the
Inventions, University Technology, and Patents for the inhibition
of Human Immunodeficiency Virus (HIV) or other human exogenous
retroviruses, and one (1) additional virus or disease to be
selected by Licensee within two years after the effective date of
the Agreement. Additional Licensed Fields may be acquired by
Licensee pursuant to Article 3.3.
j. "Sublicensee" means an organization, which is not an Affiliate of
Licensee, to which Licensee has granted a sublicense to the
Inventions(s), University Technology, Licensed Products, or
Patents for the purpose of commercialization in an individual
Licensed Field.
k. "Affiliate" means any corporation or other business entity which
directly or indirectly controls, or is under common control of
Licensee. Control shall mean ownership or other beneficial
interest in 40% or more of the voting stock or other voting
interest of a corporation or other business entity.
l. "Patent Counsel" shall mean the patent law firm of Sterne,
Kessler, Goldstein, and Fox, LLC.
m. "Confidential Information" shall mean information considered
proprietary to the Party disclosing the information, and may
include information relating to: research, development, patent
prosecution and maintenance, manufacturing, purchasing,
accounting, engineering, marketing, merchandising or selling.
n. "Sublicense Income" shall mean all royalties, other payments, and
equity Licensee receives from Sublicensees, of which University is
owed a percentage. Sublicense Income shall specifically exclude
research funding.
o. "IND" shall mean in Investigational New Drug Application when in
the United States, or any foreign equivalent document that allows
the initiation of human clinical trials.
II. GRANT OF LICENSE AND TERM
a. University grants to Licensee, to the extent of the Licensed
Territory, a non-exclusive right and license to use University
Technology in each individual Licensed Field, subject to all the
terms and conditions of this Agreement.
b. University grants to Licensee, to the extent of the Licensed
Territory, an exclusive license under the Patents to make, have
made, use and sell Licensed Products and Licensed Compounds
embodying the Inventions thereof in the Licensed Field, upon the
terms and conditions set forth herein.
c. University grants to Licensee, to the extent of the Licensed
Territory, the right to sublicense. Sublicensees shall be subject
to all the terms and conditions of this Agreement.
d. Any license granted herein excluding the grant in Article 2/1
above, is exclusive for a term beginning on the date of execution
of this Agreement and, unless terminated sooner as herein
provided, for the lives of such Patents.
e. Licensee shall not disclose any unpublished University Technology
furnished by University pursuant to Article 2.1 above to third
parties during the term of this agreement or any time thereafter;
provided, however, that disclosure may be made of any such
University Technology at any time; (1) with the prior written
consent of University, or (2) pursuant to Article 6.3 herein.
f. Licensee is further granted the right to disclose and use any
information pertaining to Inventions, University Technology,
Patents, Licensed Products, or Licensed Compounds in any
submission to local, state, federal or foreign governmental
agency, including, but not limited to, the US Food and Drug
Administration and the US Patent and Trademark Office.
g. Affiliate(s) shall, for the purposes of this Agreement, have the
same rights and responsibility to University Technology, Patents,
Licensed Compounds and Licensed Products as the Licensee. Use of
Licensed Products or sales of Licensed Compounds by Affiliates and
subsequent payments due University pursuant to Article III herein
shall be treated as if they were made by Licensee.
h. Notwithstanding the foregoing, any and all licenses granted
hereunder are subject to the rights of the United States
Government which arise out of its sponsorship of the research
which led to the Invention.
III. LICENSE FEE AND ROYALTIES
a. Licensee will pay a license fee in the form of payment of the
costs (including attorney's fees) arising out of the patenting of
the Inventions pursuant to Article XI of this Agreement. Payment
of Patenting costs shall be non-refundable and shall not be a
credit against any other amounts due hereunder.
b. Beginning on the effective date of this Agreement and continuing
for the life of this Agreement, Licensee will pay University a
running royalty on all of Licensee's Net Sales of the Licensed
Compound(s) or use of Licensed Products in each Licensed Field in
accordance with the chart below:
--------------------------------------------------------------
NET SALES OF LICENSED ROYALTY RATE
COMPOUND(S)
--------------------------------------------------------------
Less Than $50 million 4.0%
--------------------------------------------------------------
$50 million - $100 million 4.5%
--------------------------------------------------------------
Greater Than $100 million 5.0%
--------------------------------------------------------------
a. Licensee may also select additional Licensed Fields in which to
practice University Technology, Licensed Products, Licensed
Compounds, or Patents. Selection of such Licensed Field must be
requested in writing and agreed upon by University. Licensee will
pay University a one-time fee of $20,000 for each additional
Licensed Field. For each new Licensed Field that Licensee funds
under Article 4.1 of the Sponsored Research Agreement, Licensee
shall instead pay University a one-time fee of $3,000. Such
payments shall be non-refundable and shall not be a credit against
any other amounts due hereunder.
b. (i) In the event any Licensed Compound in an individual Licensed
Field is sold as a component of a combination of two or more
active ingredients, where a license hereunder was not required for
all said active ingredients, Net Sales Price for purposes of
determining royalty payments on such combination shall be
calculated by multiplying the net sales price of the combination
by the fraction A/(A+B) in which "A" is the total of the gross
selling prices of the licensed active ingredients when sold
separately and "B" is the total of the gross selling prices of the
unlicensed active ingredients.
(ii) In the event that it is not possible to determine the gross
selling price for each ingredient, Net Sales Price shall be
calculated by multiplying the net sales price of the combination
by the fraction C/(C+D), in which "C" is the total of the direct
costs plus the direct overhead of the licensed active ingredients
and "D" that of the unlicensed active ingredients. The direct
costs plus the direct overhead of a component shall be determined
in accordance with generally acceptable cost accounting
principles.
(iii) Notwithstanding the above, in no event shall the New Sales
Price be adjusted to be less than forty percent (40%) of the net
sales price of any combination product prior to adjustment
pursuant to (i) and (ii) above, unless mutually agreed upon in
writing.
c. Beginning with the date of first commercial use of Licensed
Products or sales of Licensed Compounds in a Licensed Field,
Licensee agrees to make quarterly written reports to University
within 30 days after the first days of each January, April, July,
and October during the life of this Agreement and as of such
dates, stating in each such report the number, description, and
aggregate net Selling Prices of Licensed Compounds or use of
Licensed Products sold, used, or otherwise disposed of during the
preceding three calendar months and upon which royalty is payable
as provided in Article 3.2 or 4.2 hereof, as appropriate. The
first such report shall include all such use of Licensed Products
or sales of Licensed Compounds so sold, used, or otherwise
disposed of prior to the date of such report. Until Licensee has
achieved a first commercial use of Licensed Products or sales of
Licensed Compounds a report shall be submitted by Licensee at the
end of each January after the effective date of this Agreement and
will include a full written report describing Licensee's technical
and other efforts made towards such first commercial use of
Licensed Products or sales of Licensed Compounds under
development.
d. Concurrently with the making of each such report, Licensee shall
pay to the University royalties at the rate specified in Article
3.2 or 4.2, as appropriate, and any milestone payments as
specified in Article 3.7 or 4.2, as appropriate, of this Agreement
on each use of Licensed Products or sales of Licensed Compounds in
each individual Licensed Field included therein.
-------------------------------------------------------------------------
STAGE OF DEVELOPMENT MINIMUM PAYMENT DUE
-------------------------------------------------------------------------
Upon filing the first IND for each Licensed $15,000
Product in an individual Licensed Field
-------------------------------------------------------------------------
Completion of a Phase II clinical trial for $15,000
each Licensed Product in an individual
Licensed Field
-------------------------------------------------------------------------
Upon filing an NDA (but not an ANDA) for each $50,000
Licensed Product in an individual Licensed
Field
-------------------------------------------------------------------------
Upon the first commercial sale for each $50,000
Licensed Product based on an approved NDA
(but not an ANDA) in an individual Licensed
Field
-------------------------------------------------------------------------
a. Licensee will make milestone payments upon reaching the designated
sages of development listed in the table below. Payment shall be
the greater of the compensation due University pursuant to Article
4.2, or the amount listed in the table below.
b. In the event of default in payment of any payment owing to
University under the terms of this Agreement, and if it becomes
necessary for University to undertake legal action to collect said
payment, Licensee shall pay all legal fees and costs incurred by
University in connection therewith.
c. University may, by written notice to Licensee, terminate this
agreement during any April subsequent to the year 2002, if
Licensee has not performed good-faith development efforts towards
commercializing the Invention, and met the first Performance
Milestone as listed in Appendix B.
d. The Parties recognize that different Licensed Compounds may
contain the same active ingredients. A milestone payment is due
for a Licensed Compounds or Licensed Products in an individual
Licensed Field only if it contains an active ingredient which is
the subject of a separate independent claim in any patent
application in the Patents. For example, substitution of halogens,
chalcogens, or differing lengths of a hydrocarbon backbone shall
not be considered differentiated products.
e. Nothing in this Agreement shall be construed to require the
payment of more than one royalty with regard to the manufacture,
use, or sale of an individual Licensed Compounds or Licensed
Products in an individual Licensed Field.
IV. SUBLICENSES
a. Sublicensee may not further sublicense any rights it obtains
herein.
b. In the case of income derived by licensee from Sublinensee,
Licensee shall pay University a share of such sublicensing income,
whose share shall be in accordance with the following table:
-------------------------------------------------------------------------------
STAGE OF DEVELOPMENT AT THE TIME % OF SUBLICENSING INCOME TO
OF SUBLICENSING UNIVERSITY
-------------------------------------------------------------------------------
IND not filed on Licensed Product in an 50%
individual Licensed Field
-------------------------------------------------------------------------------
IND filed on Licensed Product in an 40%
individual Licensed Field, but Phase II
clinical trials are incomplete
-------------------------------------------------------------------------------
Phase II clinical trials completed, but 30%
before filing an NDA in an individual
Licensed Field
-------------------------------------------------------------------------------
NDA filed in an individual Licensed Field 25%
-------------------------------------------------------------------------------
V. BEST EFFORTS
a. Licensee shall use its best efforts to proceed diligently with the
development, manufacture and sale of Licensed Compounds and use of
Licensed Products either directly or through a Sublicensee and
shall earnestly and diligently offer and continue to offer for
sale such use of Licensed Products or sales of Licensed Compounds,
both under reasonable conditions, during the period of this
Agreement.
b. In particular, Licensee will use its best efforts to meet the
performance milestones set forth in Appendix B, which is attached
hereto. In the event that Licensee fails to meet these Performance
Milestones for a Licensed Product or Licensed Compound, Licensee
shall, following written notice from the University, have six
months to designate a related Licensed Product or Licensed
Compound for development. Development of this related Licensed
Product or Licensed Compound will be subject to the original time
constraints and performance Milestones of the original Licensed
Product or Licensed Compound.
Example: A Licensed Product or Licensed Compound is
being developed by Licensee who, according
to Appendix B, is required to file an IND by
January 1, 2002. IF the original Licensed
Product or Licensed Compound is replaced
during the development cycle by a related
Licensed Product or Licensed Compound, that
related compound must be the subject of an
IND filed by January 1, 2002 to meet the
Performance Milestone.
If Licensee does not so designate, this Agreement shall terminate
in accordance with Article VII herein only for that Licensed
Compound or Licensed Product which is no longer being developed by
Licensee.
c. After two years have elapsed from the effective date of this
Agreement, University may notify Licensee, in writing, that it
desires an IND to be filed for a Licensed Product or Licensed
Compound which University has provided to Licensee for testing.
Licensee will have six months from such notice to file an IND or
have its license terminated as to the designated Licensed Product
or Licensed Compound. University cannot designate more than three
Licensed Products or Licensed Compounds for IND filing within a
six month period. When the Licensed Products or Licensed Compounds
are in the Licensed Field of "an additional virus or disease" or a
new Licensed Field as defined under Article 1.9 herein, such
notification may be no earlier than two years after the date of
written selection of the new Licensed Field(s) by Licensee.
d. In the event that the Performance Milestones in Appendix B are not
met in one or more countries or if Licensee does not proceed
diligently with the development, manufacture, and sale of Licensed
Compounds and Licensed Products, Licensee may extend any
individual deadline for a period of six months upon payment of
$20,000 to University. Up to two (2) extensions, each requiring
payment, may be obtained for any individual milestone, however,
only three (3) total extensions may be obtained under Appendix B
in its entirety.
e. If Licensee exhausts all extensions as set forth in Article 5.4
above, and still cannot meet the obligations outlined in Appendix
B, University may terminate this agreement pursuant to Article VII
of this Agreement.
VI. DISCLOSURE AND CONFIDENTIALITY
a. Information disclosed by one Party ("Disclosing Party") to the
other Party ("Receiving Party") to be considered Confidential
Information shall be clearly marked "CONFIDENTIAL" on the first
page of such written disclosure.
b. Receiving Party agrees that all Confidential Information received
under this Agreement shall be maintained in confidence for a
period of five (5) years from the termination date of this
Agreement, and further agrees not to use such Confidential
Information for any purpose other than upholding the obligations
of this Agreement without the prior written consent of Disclosing
Party. Receiving Party shall use the same standard of care to
protect the confidentiality of information received under this
Agreement as it uses to protect its own Confidential Information,
and shall limit disclosure of such information to those of its
employees who have an actual need to know and who have a written
obligation, or are subject to applicable University policies, to
protect the confidentiality of such information which is
substantially the same as the agreement contained herein.
c. Notwithstanding Article 6.2, the obligations of the Receiving
Party regarding confidentiality and use of Confidential
Information disclosed hereunder shall not include:
XXVIII. information which, at the time of disclosure, was
published, known publicly, or otherwise in the
public domain;
XXIX. information which, after disclosure, is
published, becomes known publicly, or otherwise
becomes part of the public domain through no
fault of the Receiving Party of Affiliates;
XXX. information which the Receiving Party can
establish was in its possession prior to the time
of disclosure;
XXXI. information which, after disclosure, is made
available to Receiving Party in good faith by a
third party under no obligation in
confidentiality to university; or;
XXXII. information which either party is required by law
to disclose.
VII. CANCELLATION OR TERMINATION BY UNIVERSITY
a. It is expressly agreed that, notwithstanding the provisions of any
other Article of this contract, if Licensee should fail to deliver
to University ay payment, royalty, or equity at the time or times
that the same should be due to University or if Licensee should in
any material respect violate of fail to keep or perform any
covenant, condition, or undertaking of this Agreement on its part
to be kept or performed hereunder, then the University, by written
notice to Licensee, shall have the right to cancel and terminate
the license granted to Licensee under Article II herein. Licensee
shall have the opportunity to cure any such breach described in
University's written notice with 30 days of receipt. Licensee's
right to cure a breach will apply only to the first two breaches
properly noticed under terms of this Agreement,
regardless of the nature of those breaches. Any subsequent breach
by Licensee will entitle University to terminate this Agreement
upon proper notice at University's sole discretion.
b. Alternatively, should Licensee be in breach or default as set
forth above, and should University be in a position where it could
rightfully terminate this Agreement, then in its sole discretion,
University may convert this exclusive license to a non-exclusive
license upon giving notice of such decision to Licensee.
c. If Licensee should be adjudged bankrupt or enter into a
composition with or assignment to its creditors, then in such
event University shall have the right to cancel and terminate this
Agreement, and the license herein provided for, by written notice
to Licensee.
d. Any termination or cancellation under any provision of this
Agreement shall not relieve Licensee of its obligation to pay any
royalty or other fees (including attorney's fees pursuant to
Article 3.1 hereof) due or owing at the time of such cancellation
or termination.
VIII. DISPOSITION OF LICENSED PRODUCTS ON HAND UPON CANCELLATION OR
TERMINATION
Upon cancellation of this Agreement or upon termination in whole
or in part, Licensee shall provide University with a written
inventory of all University Technology and Licensed Products in
process of manufacture, in use or in stock. Except with respect to
termination pursuant to Article 5.1, Licensee shall have the
privilege of disposing of the inventory of such Licensed Products
within a period of one hundred and eighty (180) days of such
termination upon conditions most favorable to University that
Licensee can reasonable obtain. Licensee will also have the right
to complete performance of all contracts requiring use of the
University Technology, Patents (except in the case of termination
pursuant to Article 5.1) or Licensed Products within and beyond
said 180-day period provided that the remaining term of any such
contract does not exceed one year. All Licensed Products which are
not disposed of as provided above shall be delivered to University
or otherwise disposed of, in University's sole discretion, and at
Licensee's sole expense.
VIII. USE OF UNIVERSITY'S NAME
The use of the name of University, or any contraction thereof, in
any manner in connection with the exercise of this license is
expressly prohibited except with prior written consent of
University.
IX. UNIVERSITY USE
It is expressly agreed that, notwithstanding any provisions
herein, University is free to use University Technology, Patents,
Licensed Compounds and Licensed Products for its own research,
public service, clinical, teaching and educational purposes
without payment of royalties. Furthermore, University shall be
free to publish University Technology, as it sees fit.
X. PATENTS AND INFRINGEMENTS
a. Patent Counsel may be changed by University or Licensee at any
time at the sole discretion of either Party. If a party suggests
changing Patent Counsel, the other Party shall have thirty (30)
days to accept or reject this change. In the event that a party
disagrees with a decision by the other party to change Patent
Counsel, the Parties agree to search for new, mutually acceptable
counsel.
b. Licensee shall bear the cost of filing, prosecuting, and
maintaining all United States and foreign patent applications and
issued patents included within the Patents, and any interferences
related to the Patents. Such filings and prosecution shall be by
mutually agreed upon counsel. Where they are based on joint
inventions, the filings shall be in the name of the University and
Licensee. In the case of joint ownership, Licensee shall obtain a
letter from Patent Counsel stating the University is the assignee
of its share in such Patents, and such letter will state that both
University and Licensee have equal ownership rights in the
Patents. Patent Counsel will keep University and Licensee advised
of the prosecution of such applications by forwarding copies of
all official correspondence, (including, but not limited to,
Applications, Office Actions, responses, etc.) relating thereto.
University shall have the right to have all draft applications and
responses to Office Actions reviewed by patent counsel of the
University's choosing any may make reasonable requests and
suggestions as to the conduct of such prosecution.
c. As regards filing of foreign patent applications corresponding to
the US applications described in Article 11.2 above, Licensee
shall designate that country or those countries, if any, in which
Licensee shall pay all costs and legal fees associated with the
preparation, filing, and maintenance of such designated foreign
patent applications and, where they are based on joint inventions,
such applications shall be in the name of both the University and
Licensee. University may elect to file corresponding patent
applications in countries other than those designated by Licensee,
but in that event University shall be responsible for all costs
associated with such non-designated filings. In such event,
Licensee shall forfeit its rights under this license, and assign
all rights in joint inventions to the University, in the
country(ies) (hereinafter "Alternate Country") where University
exercises its option to file such corresponding patent
applications.
Royalty income University receives from use of Licensed Products
or sales of Licensed Compounds in Alternate Countries shall be
shared with Licensee in accordance with the table in Article 4.2
herein. Licensee may regain its rights in Alternate Countries by
reimbursing University for all costs and legal fees associated
with patent prosecution in said countries. In addition, Licensee
must pay University compensation as described below, to regain its
rights in any Alternate Country provided University has not
exclusively licensed its rights in these countries to a third
party.
--------------------------------------------------------------------
COUNTRY COMPENSATION
--------------------------------------------------------------------
United States $50,000
--------------------------------------------------------------------
EPO member countries, Canada, Japan $20,000
--------------------------------------------------------------------
Any other country $10,000
--------------------------------------------------------------------
a. University will provide Licensee, in a timely manner, all
information in its possession or control which might effect the
Inventions, University Technology, or Patents. University will
promptly provide Patent Counsel with a copy of any legal opinion
it receives or has received regarding the patentability of any
Invention, University Technology, or Patents, and agrees to
cooperate with Licensee and patent Counsel to whatever extent is
reasonable and necessary to obtain patent protection of any
rights, including agreeing to execute any and all documents to
provide licensee the benefits of the licenses granted herein.
b. If the production, sale or use of Licensed Products under this
Agreement by Licensee results in any claim for patent infringement
against Licensee, Licensee shall promptly notify the University
thereof in writing, setting forth the facts of such claim in
reasonable detail. As between the parties to this Agreement,
Licensee shall have the first and primary right and responsibility
at its own expense to defend and control the defense of any such
claim against Licensee, by counsel of its own choice. It is
understood that any settlement of such actions must be approved by
University. Such approval shall not be unreasonably withheld.
University agrees to cooperate with Licensee in any reasonable
manner deemed by Licensee to be necessary in defending any such
action. Licensee shall reimburse University for any out of pocket
expenses incurred in providing such assistance.
c. In the event that any Patents licensed to Licensee are infringed
by a third party, Licensee shall have the primary right, but not
the obligation, to institute, prosecute and control any action or
proceeding with respect to such infringement, by counsel of its
choice, including any declaratory judgment action arising from
such infringement. Proceeds from any settlement, after deduction
for Licensee's or University's legal fees actually incurred, shall
be treated as sales of Licensed Compounds.
d. Notwithstanding the foregoing, and in University's sold
discretion, University shall be entitled to participate through
counsel of its own choosing in any legal action involving the
Invention. Nothing in the foregoing sections shall be construed in
any way which would limit the authority of the Attorney General of
North Carolina.
XII. WAIVER
e. The University represents, and covenants, as follows:
i. It has the full right, power, and authority to
enter into this Agreement and to perform all of
its obligations hereunder.
ii. The execution and delivery of this Agreement and
the consummation of the transaction contemplated
by this Agreement do not violate, conflict with,
or constitute a default under the University's
Charter or the terms and provisions of any
material or other instrument to which the
University is a party or by which it is bound, or
any material order, award, judgment or decree to
which the University is a party or by which it is
bound, or any state or federal law governing
University activities.
iii. Upon execution and delivery, this Agreement will
constitute the legal, valid and binding
obligation of the University enforceable against
the University in accordance with its terms.
iv. To the best of the knowledge and belief of the
University and Dr. Kuo-Hsiung Lee, no employee o
the University who has performed any work in
connection with the University Technology,
Patents, Licensed Compounds, and Licensed
Products is in violation of any term of any
employment or consulting contract or agreement,
non-disclosure or confidentiality agreement,
non-competitive agreement, or any other common
law obligation to a former or preformed
hereunder.
v. Subject to the rights held by the U.S. Government
under Public Law 96-517, as amended, and the
implementing regulations, and to such rights as
may be held by Licensee, the University is the
owner of all rights to the University Technology,
and its share of the title and interest in
Patents, Licensed Compounds, and Licensed
Products. Also subject to the aforementioned
rights of the U.S. Government, the University has
the sole and complete authority to issue and
grant to Licensee the exclusive license granted
hereunder, free and clear of any claims, liens,
encumbrances or charges of any third party.
vi. The University has no knowledge of any potential
infringement action or claim relating to the
University Technology, Patents, Licensed
Compounds and Licensed Products and has no
knowledge of any infringement, or breach of any
agreement or of any facts that might reasonably
lead to any claim of infringement or breach of
any agreement relating to any patent, patent
right, patentable invention, patent application,
trade secret or other proprietary right of any
third party relating to the University's use or
ownership of the University Technology, Patents,
Licensed Compounds, and Licensed Products or
Licensee's license to the University Technology,
Patents, Licensed Compounds, and Licensed
Products. However, University has done no
searching regarding possible pr potential
infringement actions or claims.
vii. The University has taken all steps within its
power which under Public Law96-517, as amended,
were necessary as of the date of execution of
this Agreement, for the University to retain
title to the fullest extent permitted by law in
any of University Technology, Patents, Licensed
Compounds and Licensed Products.
f. To the extent that rights granted by the University to Licensee
under this Agreement, are subject to the requirements of Public
Law 96-517, as amended, and its implementing regulations, the
University agrees that it will take all steps within its power to
retain title, to the fullest extent permitted by law, to the
University Technology, Patents, Licensed Compounds, and Licensed
Products in the United States and in any foreign country
designated by licensee for the duration of this license.
g. The University and its Inventor(s) will promptly disclose to the
designated Patent Counsel of Licensee all information which is or
could be material to the patentability, enforceability or validity
of any application of patent included in University Technology,
Patents, Licensed Compounds, and Licensed Products.
h. In the event that the University discovers that an interesting an
Invention is not held by either the University or by Licensee (or
its employees), it shall promptly notify the Licensee. The
University may, at its option, acquire such interest at its own
expense, or invite the Licensee to acquire said interest. In the
latter case, the cost to the Licensee of acquiring said interest
may be applied as a credit.
i. It is agreed that no waiver by either Party hereto of any breach
or default of any of the covenants or agreements herein set forth
shall be deemed a waiver as to any subsequent and/or similar
breach or default.
XIII. LICENSE RESTRICTIONS
It is agreed that the rights and privileges granted to Licensee
are each and all expressly conditioned upon the faithful
performance on the part of the Licensee of every requirement
herein contained, and that each of such conditions and
requirements may be and the same are specific license
restrictions.
XIV. ASSIGNMENTS
This Agreement is binding upon and shall inure to the benefit of
the University, its successors and assigns. This Agreement may be
assigned by the Licensee to a company formed by the Licensee in
part for the purpose of developing products within the Licensed
Field(s) of this Agreement (hereinafter, "New Company" and in
which the licensee has at least 40%
ownership at the time of assignment or another percent ownership
interest agreed upon in writing by the Parties. However, this
Agreement shall not be assignable by Licensee to any entity other
than the new Company without the written consent of University,
which consent shall not be withheld unreasonably.
XV. INDEMNITY
Licensee agrees to indemnify, hold harmless and defend University,
its officers, employees, and agents, against any and all claims,
suits, losses, damage, costs, fees, and expenses asserted by third
parties, both government and private, resulting from or arising
out of the exercise of this license.
XVI. INSURANCE
Licensee is required to maintain in force at its sole cost and
expense, with reputable insurance companies, general liability
insurance and products liability insurance coverage in an amount
reasonably sufficient to protect against liability under Article
XV, above. The University shall have the right to ascertain from
time to time that such coverage exists, such right to be exercised
in a reasonable manner.
XVII. INDEPENDENT CONTRACTOR STATUS
Neither Party hereto is an agent of the other for any purpose.
XVIII. LATE PAYMENTS
In the event that any payment due hereunder is not made when due,
the payment shall accrue interest beginning on the tenth day
following the due date thereof, calculated at the annual rate of
the sum of (a) five percent (5%) plus (b) the prime interest rate
quoted by The Wall Street Journal [Midwest Edition] on the date
said payment was due. The interest shall be compounded on the last
day of each calendar quarter provided, however, that in no event
shall said annual interest rate exceed the maximum legal interest
rate for corporations. Each such royalty payment, when paid, shall
be accompanied by all accrued interest.
XIX. WARRANTIES
University makes no warranties that any patent will issue on
University Technology or Inventions. University Further makes no
warranties, express or implied as to any matter whatsoever,
including, without limitation, the condition of any Inventions,
Patents, Licensed Compounds or Licensed Products that are the
subject of this Agreement; or the merchantability or fitness for a
particular purpose of any such Inventions, Licensed Compounds or
Licensed Products. University shall not be liable for any direct,
consequential, or other damages suffered by Licensee or any others
resulting from the use of the Inventions, Licensed Compounds,
Licensed Products, or Patents.
XX. ACCOUNTING AND RECORDS
j. Licensee will keep complete, true and accurate books of account
and records for the purpose of showing the derivation of amounts
payable to University under this Agreement. Such books and records
will be kept at Licensee's principal place of business for at
least three (3) years following the end of the calendar quarter to
which they pertain, and will be open at all reasonable times for
inspection by a representative of University for the purpose of
verifying Licensee's royalty statements, or Licensee's compliance
in other respects with this Agreement. The representative will be
obliged to treat as confidential all relevant matters.
k. Such inspections shall be at the expense of University, unless a
variation or error resulting from an underpayment to University
and exceeding US $1,000, or the equivalent, is discovered in the
course of any such inspection, whereupon all costs relating
thereto would be paid by Licensee.
l. Licensee will promptly pay to University the full amount of any
underpayment, along with interest calculated at the annual rate of
the sum of (a) five percent (5%) plus (b) the prime interest rate
quoted by The Wall State Journal [Midwest Edition] on the date
said payment was due. The interest shall be compounded on the last
day of each calendar quarter provided, however, that in no event
shall said annual interest rate exceed the maximum legal interest
rate for corporations.
XXI. COMPLIANCE WITH LAWS
In exercising its rights under this license, Licensee shall fully
comply with the requirements of any and all applicable laws,
regulations, rules and orders of any governmental body having
jurisdiction over the exercise of rights under this license.
Licensee further agrees to indemnify and hold University harmless
from and against any costs, expenses, attorney's fees, citation,
fine, penalty and liability of every kind and nature which might
be imposed by reason of any asserted or established violation of
any such laws, order, rules and/or regulations.
XXII. US MANUFACTURE
It is agreed that any Licensed Products sold in the United Sates
shall be substantially manufactured in the United States.
XXIII. NOTICES
Any notice required or permitted to be given to the parties hereto
shall be deemed to have been properly given if delivered in person
or mailed by first class certified mail to the other Party at the
appropriate address as set forth below or to such other addresses
as may be designated in writing by the parties from time to time
during the term of this Agreement.
-----------------------------------------------------------------------------------
UNIVERSITY LICENSEE
-----------------------------------------------------------------------------------
Francis J. Meyer, Ph.D Richard T. Schumacher
-----------------------------------------------------------------------------------
Associate Vice Provost President and CEO
-----------------------------------------------------------------------------------
Office of Technology Development Boston Biomedica, Inc.
-----------------------------------------------------------------------------------
The University of North Carolina at Chapel Hill 375 West Street
-----------------------------------------------------------------------------------
CB #4105, 308 Bynum Hall West Bridgewater, MA 02379
-----------------------------------------------------------------------------------
Chapel Hill, NC 27599-4105
-----------------------------------------------------------------------------------
XXIV. SEVERABILITY
In the event that a court of competent jurisdiction holds any
provision of this Agreement to be invalid, such holding shall have
o effect on the remaining provisions of this Agreement, and they
shall continue in full force and effect.
XXVII. SURVIVAL OF TERMS
The provisions of Articles 6,7,8,9,13,14,17,18,19,21,22, and 23
shall survive the expiration or termination of this Agreement.
IN WITNESS WHEREOF, both University and Licensee have executed this
Agreement, in duplicate originals, by their respective officers hereunto
duly authorized, the day and year of last signature below. Inventor has
likewise indicated his acceptance of the terms hereof by signing below.
THE UNIVERSITY OF NORTH CAROLINA BOSTON BIOMEDICA, INC.
AT CHAPEL HILL
-------------------------------- --------------------------------
Francis J. Meyer, Ph.D. Richard T. Schumacher
Associate Vice Provost President and CEO
Technology Development
Date: _________________________ Date: _________________________
INVENTOR
--------------------------------
Dr. Kuo-Hsiung Lee
Date: _________________________
Appendix A
Inventions, Inventors, and Patent Rights
----------------------------------------
Status of Patent Portfolio for BBI/K.H. Lee Collaboration
April 1999
------------------------------------------------------------------------------------------------------------------------------
SKG7F Ref. Serial No./ Filing Continuation Named Inventors Subject Matter / Status
UNC Ref. Patent No. Date/ Date [affiliation]
Issue Date
------------------------------------------------------------------------------------------------------------------------------
1589.0030000 Appl. No. 10/29/93 Lee, Kuo-Hsiung [UNC] SUKSDORFIN ANALOGS,
ORS 93-16 08-142,992 Cosentino, Mark [BBI] COMPOSITIONS THEREOF AND METHODS FOR
Manak, Mark [BBI MAKING AND USING THEREOF INCLUDING
Snider, Jim [BBI] TREATMENT OF RETRO VIRAL RELATED
Li, Huang [UNC] PATHOLOGIES
Thomas, Lee [UNC]
Kashiwada, Yoshiki * Abandoned in favor of 1589.0030001
[UNC]
------------------------------------------------------------------------------------------------------------------------------
1589.0030001 Appl. No. 4/24/94 CIP of Same as the .0030000 SUKSDORGIN ANALOGS, COMPOSITIONS
ORS 93-16 08/235,852 08/142,992 THEREOF AND METHODS FOR MAKING AND
USING THEREOF INCLUDING TREATMENT OF
RETRO VIRAL RELATED PATHOLOGIES
* Abandoned (claims prosecuted in
1589.0030003)
* Stat. Bar 11/21/95 missed.
(Response to Restriction Requirement)
------------------------------------------------------------------------------------------------------------------------------
1589-003PC01 Appl. No. 11/1/94 Related to Same as the .0030000 KHELLACTONE DERIVATIVES AND RELATED
ORS 93-16 PCT/US94/12630 08/235,852 COMPOUNDS, PROCESS FOR THEIR
WO 95/29920 PREPARATION AND THEIR USE AS
ANTIVIRAL AND IMMUNOSTIMULATING AGENTS
* Abandoned, did enter national Phase
------------------------------------------------------------------------------------------------------------------------------
Appendix A
Inventions, Inventors, and Patent Rights
----------------------------------------
Status of Patent Portfolio for BBI/K.H. Lee Collaboration
April 1999
------------------------------------------------------------------------------------------------------------------------------
SKG7F Ref. Serial No./ Filing Date/ Continuation Named Inventors Subject Matter / Status
UNC Ref. Patent No. Issue Date Date [affiliation]
------------------------------------------------------------------------------------------------------------------------------
1589.0030002 Appl. No. 02/21/95 CIP of Lee, Kuo-Hsiung SUKSDORFIN ANALOGS,
ORS 93-16 08/392,558 08/235,852; Cosentino, Mark COMPOSITIONS THEREOF AND METHODS FOR
Patent No. 06/10/97 which is a CIP Snider, Jim MAKING AND USING THEREOF
5,637,589 of 08/142,992 Li, Huang
Thomas, Lee * Claims to lactam derivatives,
Kashiwada, Yoshiki Formula III,
where X is NH.
* Maintenance Fees Due:
1st - 12/10/00
2nd - 12/10/04
3rd - 12/10/08
------------------------------------------------------------------------------------------------------------------------------
1589-0030003 Appl. No. 06/05/95 CON of Xie, Lan [UNC] SUKSDORGIN ANALOGS, COMPOSITIONS
ORS 93-16 08/462,280 03/10/98 08/392,558; Snider, Jim THEREOF AND METHODS FOR MAKING AND
Patent No. which is a Li, Huang USING THEREOF
5,726,204. CIP of Thomas, Lee
08/235,852; Kashiwada, Yoshiki * Claims to lactone derivatives,
which is a Lee, Kuo-Hsiung Formula I and Formula III, where X is
CIP of Cosentino, Mark NH.
08/142,992 * Maintenance Fees Due:
1st - 09/10/01
2nd - 09/10/05
3rd - 09/10/09
------------------------------------------------------------------------------------------------------------------------------
Appendix A
Inventions, Inventors, and Patent Rights
----------------------------------------
Status of Patent Portfolio for BBI/K.H. Lee Collaboration
April 1999
------------------------------------------------------------------------------------------------------------------------------
SKG7F Ref. Serial No./ Filing Date/ Continuation Named Inventors Subject Matter / Status
UNC Ref. Patent No. Issue Date Date [affiliation]
------------------------------------------------------------------------------------------------------------------------------
1589.0030004 Appl. No. 02/21/96 CON of Lee, Kuo-Hsiung SUKSDORFIN ANALOGS,
ORS 93-16 08/604,305 08/462,280 Cosentino, Mark COMPOSITIONS THEREOF AND METHODS FOR
12/08/98 which is CON Xie, Lan MAKING AND USING THEREOF
of 08/392,558 Manak, Mark
* Claims to asymmetric synthesis of
suksdorfin analogs.
* Maintenance Fees Due:
1st - 12/10/01
2nd - 12/08/05
3rd - 12/08/09
------------------------------------------------------------------------------------------------------------------------------
1589.0030005 Appl. No. 12/08/98 CON of Lee, Kuo-Hsiung SUKSDORGIN ANALOGS, COMPOSITIONS
ORS 93-16 09/207,500 08/604,305, Cosentino, Mark THEREOF AND METHODS FOR MAKING AND
which is CON Xie, Lan USING THEREOF
of 08/462,280, Manak, Mark
which is CON Snider, Jim * Declaration Filed 02/28/99
of 08/392,558 Li, Huang * Notice to File Missing Parts filed
Thomas, Lee 02/28/99
Kashiwada, Yoshiki * Information Disclosure Statement
03/08/99
* Stat bar 7/30/99
------------------------------------------------------------------------------------------------------------------------------
Appendix A
Inventions, Inventors, and Patent Rights
Status of Patent Portfolio for BBI/K.H. Lee Collaboration
April 1999
------------------------------------------------------------------------------------------------------------------------------
SKG7F Ref. Serial No./ Filing Date/ Continuation Named Inventors Subject Matter / Status
UNC Ref. Patent No. Issue Date Date [affiliation]
------------------------------------------------------------------------------------------------------------------------------
1589.003PC04 Appl. No. 02/21/96 Claims benefit Same as the .0030005 SUKSDORFIN ANALOGS, COMPOSITIONS
OTD 93-16 PCT/US96/02441 of Appl. No. THEREOF, AND METHODS FOR MAKING AND
08/392,558 USING THEREOF
* National Phase entered in Canada
and Europe
* Petition for examination due
02/21/03
------------------------------------------------------------------------------------------------------------------------------
1589-003CA04 Appl. No. 02/21/96 National Phase SUKSDORFIN ANALOGS, COMPOSITIONS
ORS 93-16 2,213,519 of THEREOF, AND METHODS FOR MAKING AND
PCT/US96/2441 USING THEROF
* national application filed 08/21/97
* petition for examination due 2/21/03
------------------------------------------------------------------------------------------------------------------------------
1589.003EP04 Appl. No. 02/21/96 National Phase SUKSDORFIN ANALOGS, COMPOSITIONS
ORS 93-16 96906599.4 of THEREOF, AND METHODS FOR MAKING AND
PCT/US96/02441 USING THEREOF
* National application filed and
examination requested 09/19/97
------------------------------------------------------------------------------------------------------------------------------
Appendix A
Inventions, Inventors, and Patent Rights
----------------------------------------
Status of Patent Portfolio for BBI/K.H. Lee Collaboration
April 1999
------------------------------------------------------------------------------------------------------------------------------
SKG7F Ref. Serial No./ Filing Date/ Continuation Named Inventors Subject Matter / Status
UNC Ref. Patent No. Issue Date Date [affiliation]
------------------------------------------------------------------------------------------------------------------------------
1589.0040000 Appl. No. 06/05/95 Cosentino, Louis BETULINIC ACID AND DIHYDROBETULINIC
ORS 95-25 08/463,071 10/21/97 Lee,Kuo-Hsiung ACID DERIVATIVES AND USES THEREFOR
Patent No. Manak, Mark
5,679,828 Kashiwada, Yoshiki * Maintenance Fees Due:
Fumio, Hashimoto 1st - 04/21/01
[UNC] 2nd - 04/21/05
3rd - 04/21/09
------------------------------------------------------------------------------------------------------------------------------
1589.004PC00 Appl. No. 06/05/96 Priority to Same as the .0040000 BETULINIC ACID AND DIHYDROBETULINIC
ORS 95-25 PCT/US96/09485 U.S. ACID DERIVATIVES AND USES THEREFOR
08/463,071
* national Phase entered in Canada
and EPO
------------------------------------------------------------------------------------------------------------------------------
1589.004CA00 Appl. No. 06/05/96 National Phase Same as the .0040000 BETULINIC ACID AND DIHYDROBETULINIC
ORS 95-25 2,223,513 of ACID DERIVATIVES AND USES THEREFOR
PCT/US96/09485
* National application filed 11/20/97
* Petition for examination due 06/05/03
------------------------------------------------------------------------------------------------------------------------------
Appendix A
Inventions, Inventors, and Patent Rights
----------------------------------------
Status of Patent Portfolio for BBI/K.H. Lee Collaboration
April 1999
------------------------------------------------------------------------------------------------------------------------------
SKG7F Ref. Serial No./ Filing Date/ Continuation Named Inventors Subject Matter / Status
UNC Ref. Patent No. Issue Date Date [affiliation]
------------------------------------------------------------------------------------------------------------------------------
1589-004EP00 Appl. No. 06/05/96 National Phase Same as the .0040000 BETULINIC ACID AND DIHYDROBETULINIC
OTD 95-25 96922408.8 of ACID DERIVATIVES AND USES THEREFOR
PCT/US96/09485
* national application filed and
examination requested - 12/08/97
* Not filing in Hong Kong - 02/12/99
------------------------------------------------------------------------------------------------------------------------------
1589-0050000 Appl. No. 06/0795 Claims Manak, Mark BROMINATED HEXAHYDROXYBIPHENYL
ORS 92-34 08/477,939 03/18/97 Priority to Kashiwada, Yoshiki DERIVATIVES
Patent No. U.S. 08/477,939 Cosentino. Louis
5,612,341 Lee, Kuo-Hsiung * Maintenance Fees Due:
Xie, Lan 1st - 09/18/00
Yung-Chi, Cheng [UNC] 2nd - 09/18/04
Xie, Jing-Xi [UNC] 3rd - 09/18/08
Kilkulskie, Robert
[UNC]
------------------------------------------------------------------------------------------------------------------------------
1589-005PC01 Appl. No. 06/07/96 National Phase Same as the .0050000 BROMINATED DEXAHYDROXYBIPHENYL
PCT/US96/10080 of DERIVATIVES
PCT/US96/10080
* National Phase entered in Canada
and Europe
------------------------------------------------------------------------------------------------------------------------------
1589.05CA01 Appl. No. 06/07/96 National Phase Same as the .0050000 BROMINATED HEXAHYDROXYBIPHENYL
2,223,898 of DERIVATIVES
PCT/US96/10080
* National application filed 11/21/97
* petition for examination due 6/7/03
------------------------------------------------------------------------------------------------------------------------------
Appendix A
Inventions, Inventors, and Patent Rights
----------------------------------------
Status of Patent Portfolio for BBI/K.H. Lee Collaboration
April 1999
------------------------------------------------------------------------------------------------------------------------------
SKG7F Ref. Serial No./ Filing Date/ Continuation Named Inventors Subject Matter / Status
UNC Ref. Patent No. Issue Date Date [affiliation]
------------------------------------------------------------------------------------------------------------------------------
1589.005EP00 Appl. No. 06/07/96 Same as the .0050000 BROMINATED HEXAHYDROXYBIPHENYL
96921528.4 DERIVATIVES
* national application filed and
examination requested - 12/05/97
------------------------------------------------------------------------------------------------------------------------------
1589.0110000 Appl. No. 03/02/98 Provisional Cosentino, Louis ACYLATED BETULIN AND DIHYDROBETULIN
OTD 99-95 60/076,449 Application Lee, Kuo-Hsiung DERIVATIVES, PREPARATION THEREOF AND
Sun, I-Chen [UNC] USE THEREOF
Wang, Hui-Kang [UNC]
* filed non-provisional and foreign
(PCT) on 03/02/99
------------------------------------------------------------------------------------------------------------------------------
1589.0110001 TBA 03/02/99 Claims Same as the .0110000 ACYLATED BETULIN AND DIHYDROBETULIN
Priority to DERIVATIVES, PREPARATION THEREOF AND
Appl. No. USE THEREOF
60/076,449
------------------------------------------------------------------------------------------------------------------------------
1589.011PC01 TBA 03/02/99 Claims Same as the .0110000 ACYLATED BETULIN AND DIHYDROBETULIN
Priority to DERIVATIVES, PREPARATION THEREOF AND
Appl. No. USE THEREOF
60/076,449
------------------------------------------------------------------------------------------------------------------------------
Appendix B
PERFORMANCE MILESTONES FOR EACH LICENSED COMOUNDS
-------------------------------------------------
BEING DEVELOPED IN AN INDIVIDUAL LICENSED FIELD
-----------------------------------------------
-----------------------------------------------------------------------
MILESTONE TIMEFRAME
-----------------------------------------------------------------------
IND Filed Two years
after the
Effective Date of
this Agreement, or
designation by
Licensee in
accordance with
Article 1.9 herein
-----------------------------------------------------------------------
NDA filed Seven years after filing an IND
-----------------------------------------------------------------------
NDA approval Two years after filing an NDA
-----------------------------------------------------------------------
First sale of Licensed Product One year after NDA approval
-----------------------------------------------------------------------