EXHIBIT 10.2
EXCLUSIVE
LICENSE AGREEMENT
1. Consideration and Effective Date
1.1 The effective date of this agreement shall be ,199 .
1.2 The parties enter into this agreement in consideration of the mutual
covenants and terms expressed herein and hereby acknowledge receipt of said
consideration.
2. Parties
2.1 The University of North Carolina at Chapel Hill is a non-profit
organization having its principal place of business at Chapel Hill, North
Carolina 27599-4100 (hereinafter referred to as the "University").
2.2 BTRL Contracts and Services, Inc., is a corporation organized under the
laws of Massachusetts and has its principal place of business at 1600 E. Gude
Drive, Rockville, Maryland 20850 (hereinafter referred to as "the Company").
3. [RESERVED]
4. Definitions
4.1 RELATED COMPANY shall mean any corporation or other business entity
which directly or indirectly controls, is controlled by, or is under common
control with Company. Control means ownership or other beneficial interest in
40% or more of the voting stock or other voting interest of a corporation or
other business entity. Boston Biomedica, Inc. is presently a RELATED COMPANY.
CORPORATE FAMILY shall mean the COMPANY and all RELATED COMPANIES.
4.2 "SUBJECT INVENTIONS" shall mean:
(a) any invention disclosed in
(i) UNC Invention Disclosure ORS 93-16, entitled "Anti-AIDS
Agents: Suksdorfin (1)";
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(ii)
[Language Deleted due to Confidential Treatment Request]
(iii) U.S. patent application (LEE33) serial number 08/142,992,
filed October 29, 1993; and/or
(iv) U.S. patent application (LEE33A) serial number 08/235,852,
filed April 29, 1994;
(b) any invention arising out of NIH Grant No. AI-33066 and any
continuations, extensions or amendments thereof which relate to one of the
compounds set forth in Appendix 1 or to a derivative or analogue thereof; and/or
These inventions may be compounds, methods of purifying or synthesizing
such compound, compositions comprising such compounds, and/or the use of such
compounds in the FIELD OF USE, whether or not patentable, and whether or not
conceived or made prior to the execution of this Agreement.
4.3 (a) "LICENSED PRODUCT" is a product which is covered by a claim of a
patent or pending patent application, in at least one country included in
LICENSED RIGHTS, or is manufactured by a method covered by such a claim, or is
used or intended to be used in FIELD OF USE, by a method covered by such a
claim, or is manufactured, or used or intended to be used in FIELD OF USE, in
accordance with PROPRIETARY TECHNOLOGY.
(b) A LICENSED ARTICLE is an article of a LICENSED PRODUCT.
(c) A LICENSED TRANSACTION is a transaction whereby a LICENSED
ARTICLE is made, used in FIELD OF USE, leased or sold, and, in the country where
such act occurs (i) such act would, but for this license, and but for any
license implied as a result of assignment of any title in any of LICENSED RIGHTS
to the Company, infringe one or more claims of a patent included in LICENSED
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RIGHTS, or, if issued, of a patent application included in LICENSED RIGHTS, or
(ii) such act occurred during the period set forth in Section 6.1(c) in which
the University is entitled to royalties for PROPRIETARY TECHNOLOGY.
4.4 "CONFIDENTIAL INFORMATION" means information, not generally known in
the relevant trade or industry, whether or not used by the disclosing party,
including information relating to research, development, patent solicitation,
manufacture, purchasing, accounting, engineering, marketing, merchandising or
selling, which is considered by the party which possesses or controls it to be
proprietary to it.
4.5 An ARTICLE REPRESENTING CONFIDENTIAL INFORMATION is any object, device,
machine, material, substance or copy thereof, including any writing, recording,
drawing, sample, specimen, prototype, model, photograph, organism, culture,
tissue, organ, antibody, virus, or DNA or RNA molecule, which completely or
partially describes, depicts, embodies, contains, constitutes, reflects or
records CONFIDENTIAL INFORMATION.
4.6 "LICENSED RIGHTS" shall include all pending patent applications and all
patents-in-force in any country which are owned or controlled in whole or in
part by the University, now or during the term of this Agreement, and which
relate to, SUBJECT INVENTIONS, including, but not limited to (i) the patents and
applications listed in Appendix 3, and any division, continuation, continuation-
in-part, substitute, renewal, reissue, extension or reexamination thereof, (ii)
any rights of priority based on the foregoing, (iii) any patent applications
claiming priority from or otherwise related to the applications of (i) above,
and (iv) U.S. and foreign patents issued on (i) and (iii) above. It shall also
include the University's PROPRIETARY TECHNOLOGY.
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4.7 (a) "LICENSED TECHNOLOGY" shall mean "PATENTED TECHNOLOGY", "PATENT
PENDING TECHNOLOGY", and "PROPRIETARY TECHNOLOGY".
(b) PATENTED TECHNOLOGY shall mean any method or product the
manufacture, use, sale, rental or lease of which is covered by a claim of a
patent included in LICENSED RIGHTS which has not expired, lapsed, or been
declared invalid or unenforceable by a court from which no appeal has or can be
taken.
(c) PATENT PENDING TECHNOLOGY shall mean any method or product,
other than PATENTED TECHNOLOGY, the manufacture, use, sale, rental or lease of
which is covered by a claim of a pending patent application included in LICENSED
RIGHTS.
(d) PROPRIETARY TECHNOLOGY means an invention, whether or not
patentable, which is not PATENTED TECHNOLOGY or PATENT PENDING TECHNOLOGY, and
which utilizes CONFIDENTIAL INFORMATION owned by UNIVERSITY and disclosed by the
UNIVERSITY to Company, which relates to a SUBJECT INVENTION. However, it shall
not include information which
(i) was in Company's possession at the time of the disclosure and
was not previously acquired, directly or indirectly from the
University, or which is subsequently developed by Company by
persons not privy to the disclosure;
(ii) has since been acquired by Company from others who have no
confidential commitment to the University with respect to same,
or
(iii) is now or becomes, through no fault of Company, a part of the
public domain by publication (including publication or issuance
of Patent applications) or otherwise.
4.8 (a) "Net Sales" shall mean payments received by a CORPORATE FAMILY
member as part of a LICENSED TRANSACTION with respect to LICENSED ARTICLES, less
returns and customary trade
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discounts actually taken, outbound freight, value added, sales or use taxes and
custom duties.
(b) However, a transaction between members of the CORPORATE FAMILY
shall only be included in "Net Sales" if the article paid for is used, and such
use is other than in research or development, quality assurance or the
development of data for regulatory approval. A LICENSED TRANSACTION may,
however, occur when the LICENSED ARTICLE is resold, rented or leased to one not
a member of the CORPORATE FAMILY, in accordance with 4.8(a).
(c) (i) In the event any LICENSED PRODUCT 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 fully allocated costs
of the licensed active ingredients and "D" that of the unlicensed active
ingredients. The fully allocated cost of a component shall be determined in
accordance with conventional cost accounting principles. (iii) Notwithstanding
the above, in no event shall the Net 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.
4.9 FIELD OF USE shall mean (a) use for the inhibition of retroviruses, or
of pathogens of diseases related to those caused
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by retroviruses, and (b) uses for compounds included in SUBJECT INVENTIONS,
discovered in whole or in part by the Company, a Related Company, or a
Sublicense.
5. License Grant
5.1 The University grants to Biotech Research Labs, upon and subject to all
the terms and conditions of this Agreement, a worldwide license, exclusive
except for any license to a Federal agency to practice the invention which that
agency has acquired by operation of Public Law 96-517, under LICENSED RIGHTS to
use LICENSED TECHNOLOGY and to make, use, sell, have made, rent or lease
LICENSED PRODUCTS in FIELD OF USE for the term provided under Section 14 hereof.
This license specifically includes a right of sublicense.
5.2 Company is further granted the right to disclose and use any
information pertaining to a SUBJECT INVENTION, or a product incorporating or
embodying same, in any submission to a local, state, federal or foreign
governmental agency or instrumentality, including, but not limited to, the U.S.
Food and Drug Administration and the U.S. Patent and Trademark Office. This
right shall survive the termination of this Agreement under 14.2, but not the
uncured material breach by Company of its obligations hereunder.
5.3 To the extent that the Company cannot practicably make or use a
LICENSED ARTICLE without infringing a patent, other than one included in
LICENSED RIGHTS, which is owned by the University and not exclusively licensed
to a third party, pursuant to this Agreement, the Company pays University a
royalty on said article, the University agrees not to assert said patent against
the manufacture, use or sale of said article by the Company or those in privity
therewith. Where such alternative manufacture or use is practicable, but not
commercially desirable, the University agrees
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to negotiate in good faith terms under which it will grant COMPANY a license
under such patent which would permit such manufacture and use, if said patent is
not already exclusively licensed to a third party.
6. Compensation
6.1 In consideration of the license granted under Section 5.1 of this
Agreement, Company shall pay the University a royalty on NET SALES by Company or
a RELATED COMPANY.
(a) During each calendar year, such royalties shall be, on NET SALES of any
PATENTED TECHNOLOGY, [Language Deleted due to Confidential Treatment Request] on
the first fifty million dollars of sales for that year, [Language Deleted due to
Confidential Treatment Request] on sales in excess of fifty million dollars, up
through the hundred millionth dollar of sales for that year, and [Language
Deleted due to Confidential Treatment Request] on sales in excess of one hundred
million dollars for that year.
(b) Also during each calendar year, such royalties shall be, on NET SALES
of any PATENT PENDING TECHNOLOGY, [Language Deleted due to Confidential
Treatment Request] on the first fifty million dollars of sales of PATENT PENDING
TECHNOLOGY for that year, [Language Deleted due to Confidential Treatment
Request] on sales in excess of fifty million dollars up through the hundred
millionth dollar of sales for that year, and [Language Deleted due to
Confidential Treatment Request] on sales in excess of one hundred million
dollars for that year.
(c) Also during each calendar year, such royalties shall be, on NET SALES
of any PROPRIETARY TECHNOLOGY for that year, [Language Deleted due to
Confidential Treatment Request] on the first fifty million dollars of sales of
PROPRIETARY TECHNOLOGY, [Language Deleted due to Confidential Treatment Request]
on sales in excess of fifty million dollars up through the hundred millionth
dollar sales for that year, and [Language Deleted due to Confidential Treatment
Request] on sales in excess one hundred million dollars for that year. However,
no royalty will be due on NET SALES of articles covered solely by PROPRIETARY
TECHNOLOGY more than [Language Deleted due to Confidential Treatment Request]
years after the first sale of an article representing such technology, or
[Language Deleted due to Confidential Treatment Request] years after the
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disclosure of such technology to the Company, whichever comes earlier.
(d) On any particular article, only one PATENTED, PATENT PENDING, or
PROPRIETARY TECHNOLOGY royalty will be paid, whichever is the highest royalty
applicable.
6.2 Nothing in this Agreement shall be construed to require the payment of
more than one royalty with regard to the manufacture, use, lease, or sale of a
particular article.
6.3 In the case of income derived by Company through sublicensing (other
than to a RELATED COMPANY), Company will pay the University a share of such
sublicensing income, which share will be computed as follows:
(i) if there is no IND filed on
the sublicensed product.....................[Language Deleted due to Confidential Treatment Request]
(ii) if an IND was filed, but phase II clinical
studies have not been completed.............[Language Deleted due to Confidential Treatment Request]
(iii) if phase II clinical studies have
been completed, but an NDA has not
yet been filed..............................[Language Deleted due to Confidential Treatment Request]
(iv) if an NDA has been filed....................[Language Deleted due to Confidential Treatment Request]
6.4 (a) Company will also make the following milestone payments for each
distinct LICENSED PRODUCT, subject to the limitations of ss. 6.4(b) and (c):
(i) on filing its first IND for the LICENSED
PRODUCT..................................[Language Deleted due to Confidential Treatment Request]
(ii) on first completing a phase II clinical study
for the LICENSED PRODUCT.................[Language Deleted due to Confidential Treatment Request]
(iii) on first filing an NDA (but not an
ANDA) for the LICENSED PRODUCT...........[Language Deleted due to Confidential Treatment Request]
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(iv) on the first commercial sale outside the
CORPORATE FAMILY, of the LICENSED PRODUCT, based
on an approved NDA (but not an
ANDA).................................. [Language Deleted due to Confidential Treatment Request]
(b) The parties recognize that different LICENSED PRODUCTS may contain the
same active ingredients. A milestone payment is due for a LICENSED PRODUCT only
if it contains an active ingredient (which is the subject of a SUBJECT
INVENTION) which is distinct from the active ingredients of all LICENSED
PRODUCTS for which that level of milestone payment has previously been paid. A
chemical, and its salts, complexes and esters, are considered the same active
ingredient for the purpose of this provision. Moreover, the active ingredient is
not considered distinct if it differs from prior active ingredients solely by
one or more of the following structural differences: substitution of one halogen
atom for another; substitution of one chalcogen (oxygen or sulfur) atom for
another; or lengthening or shortening of a hydrocarbon chain (i.e., the two
compounds are members of a homologous series).
Each of the compounds set forth in Appendix 1 is considered distinct from
the others so listed.
(c) Milestone payments will not apply to products covered solely by
PROPRIETARY TECHNOLOGY.
6.5 If a properly instructed court would be more likely than not to hold
that Company, or a Related Company, or their customers, require a license from a
third party in order to practice a Subject Invention and Company or a Related
Company acquires such a license, Company shall receive a credit equal to the
sums paid by Company or a Related Company to said third party for practicing
said Subject Invention.
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Prior to obtaining said license, the Company shall supply the University
with a reasoned opinion of outside patent counsel supporting its conclusion that
a license is so required.
No such reduction shall be made, notwithstanding the foregoing, if the
University supplies the Company with a reasoned opinion of outside patent
counsel to the effect that the license is not so required, and the University
agrees to indemnify and hold harmless the Company (or, as the case may be, the
Related Company, or their customers) for liability for infringement with respect
to said inventions or uses if the Company (or the Related Company) refuses or
terminates said third party license.
6.6 The credits granted to the Company pursuant to 6.5, 10.2 and 11.5 may
be applied against the payments due under 6.1, 6.3 and 6.4 above, with the
proviso that the total credits outstanding cannot be used to offset more than
50% of the total payments due in any given period under 7.1, any excess being
carried forward to later periods.
7. Reports and Payments
7.1 For each semiannual period in which this Agreement is in force, Company
shall submit to the University a written semiannual report (the "Payment
Report") within two months of the close of each semiannual period. Such Reports
shall state:
(i) NET SALES made by Company and any RELATED COMPANIES during
such period for LICENSED TECHNOLOGY;
(ii) Payments received by the Company or a Related Company which
are excluded from Net Sales pursuant to 4.8(b).
(iii) NET SALES made by unrelated sublicensees during such period;
(iv) sublicensing income under 6.3 for such period, and the
University's share thereof; and
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(v) milestones achieved, for which payments are due under 6.4, for
such period; and
(vi) A calculation under Section 6 of the amounts due to the
University, making reference to each subsection. Said calculation shall include
an itemization of any credits to which the Company is entitled, itemized by the
section under which said credit is granted, and indicating any excess credits
carried into the reported period from a prior period, any new credits, the
amount of the accrued credits which can be used to offset the payment otherwise
due for the reported period, and any excess credit to be carried forward to the
next period.
7.2 Simultaneously with the submission of each Payment Report, Company
shall make payments to the University of the amounts due for the period covered
by the Payment Report.
7.3 Company shall maintain at its principal office the usual books of
accounts and records showing its actions under this Agreement. Upon reasonable
notice, such books and records shall be made available for inspection and
copying, during usual business hours, by University auditors, or by the State
Auditor, or by an independent certified public accountant retained by the
University at its own expense to whom Company has no reasonable objection, for
three years after the calendar quarter for which such books and records pertain,
solely for purposes of verifying the accuracy of the amounts paid by Company
under this Agreement, and the contents of Company's books and records shall be
held in confidence by the University and its accountant. In the event of the
discovery by an independent certified public accountant hired by the University
of an error in Company's favor which is more than $1,000, and more than 10% of
the payment actually due, Company will reimburse the University for the
University's actual and reasonable out of pocket
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expenses for such audit. The amount of said reimbursement shall not, however,
exceed the amount of the error.
Nothing herein shall be construed to limit the authority of the State
Auditor of North Carolina.
8. Patent Prosecution and Maintenance
8.1 As to any Subject Invention which is not fully disclosed in an
application previously filed, the University shall diligently provide the
Company with a written disclosure thereof. The University shall in a timely
manner provide a disclosure sufficiently detailed to permit the Company to
determine the patentability of the Subject Invention, and to permit the drafting
of a patent application with a specification reasonably likely to be deemed
adequate to support one or more patentable and commercially meaningful claims.
The University shall disclose to the Company any information in its possession
or control which is material to patentability of the Subject Invention, and give
the Company timely notice of any activities known to it which could limit the
time available for filing a patent application without loss of rights in the
U.S. or abroad.
8.2 (a) The Company shall give the University timely notice of the deadline
for filing a U.S. application abroad with the benefit of priority, and timely
notice of the deadline for entering the national stage in the case of a PCT
application. The University shall give the Company a timely response indicating
the foreign countries in which it is interested in pursuing patent protection.
(b) The Company shall give the University timely notice of its intent not
to file for patent protection, or to continue to prosecute a pending application
for patent protection, or to maintain a patent, in the United States or any
foreign country, with respect to any Subject Invention.
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8.3 If, after receiving notice under 8.2, the University decides to file,
prosecute or maintain the noticed application or patent, the effect will be that
the Company's exclusive license, with respect to the noticed Subject Invention,
will terminate insofar as the countries in which the University exercises its
right of intervention under this section are concerned. This will not affect the
Company's exclusive license under patents and applications included in Licensed
Rights which the Company continues to file, prosecute, and maintain.
8.4 At the University's discretion, which shall not be unreasonably
refused, the Company may reestablish rights lost pursuant to 8.3 if (a) it
reimburses the University for its reasonable legal expenses in filing or
prosecuting such applications or maintaining such patents, and pays compensation
pursuant to Article 6, for any transactions which would have been LICENSED
TRANSACTIONS if the Company had not terminated the license rights it now seeks
to reestablish, and (b) at the time of the request for reinstatement, the
Company is still an exclusive licensee under this Agreement with respect to at
least one pending application or patent-in-force in at least one country.
8.5 Unless it has given suitable notice under 8.2 above, the Company shall
file for patent protection, and prosecute and maintain Licensed Rights, in such
countries as the University has indicated are of interest to it insofar as the
Subject Invention in question is concerned.
8.6 Until it has given suitable notice under 8.2 above, the Company shall
pay all expenses relating to the filing, prosecution and maintenance of Licensed
Rights. After notice is given under 8.2 above, the University will be
responsible for payment of all expenses incurred after said notice with respect
to the noticed
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applications or patents. The Company will remain responsible for expenses
incurred prior to notice, even if billed subsequently.
8.7 Except for the cases as to which the Company has relinquished rights
pursuant to 8.3, the U.S. and foreign prosecution conducted under this Article 8
shall be performed by one or more patent attorneys or agents selected by
Company. The University shall provide said one or more selected patent attorneys
or agents with any necessary Power of Attorney as required to authorize the
patent attorney or agent to prosecute the applications for patent rights.
8.8 The University will timely provide Company with all information in its
possession or control which might be material to patentability of LICENSED
TECHNOLOGY. The University will promptly provide Company's patent counsel with a
copy of any legal opinion it receives or has received regarding the
patentability, validity, enforceability, scope or third party infringement of
any of LICENSED RIGHTS.
8.9 The Company will provide the University with the opportunity to have
draft applications and responses reviewed by patent counsel of the University's
choice, and the Company will reimburse the University for its reasonable
expenses for such review. The Company will give good faith consideration to
suggestions made by the reviewing counsel chosen by the University.
8.10 The University will on a timely basis provide COMPANY with all
information in its possession or control, or readily obtainable by it, which is
reasonably requested by the Company to aid in drafting and prosecuting
applications, and defending patents, within Licensed Rights.
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9. Commercialization
9.1 Company shall use its best efforts to develop and market drugs
embodying LICENSED TECHNOLOGY for the treatment of retroviral infections
throughout the world. Specifically, in the case of a drug embodying LICENSED
TECHNOLOGY, Company shall use its best efforts to, for at least one drug which
is a LICENSED PRODUCT (hereafter, LICENSED DRUG), (a) file an IND within
[Language Deleted due to Confidential Treatment Request] years of first
receiving a sample of the drug for testing or executing this Agreement,
whichever comes later, (b) file a new drug application (NDA) within [Language
Deleted due to Confidential Treatment Request] years after its IND for a
LICENSED DRUG becomes effective, (c) obtain NDA approval for a LICENSED DRUG
within [Language Deleted due to Confidential Treatment Request] years after its
NDA for that drug is filed, and (d) commercialize a LICENSED DRUG within
[Language Deleted due to Confidential Treatment Request] year after the NDA for
that drug is approved.
9.2 After [Language Deleted due to Confidential Treatment Request] years
have elapsed from the execution of this Agreement, the University may in writing
notify the Company that it desires that an IND be filed for a LICENSED DRUG for
which the Company has not yet filed an IND, which LICENSED DRUG has been
supplied to the Company for testing, and the Company will then have six months
from such notice to file an IND or have its license terminated as to the noticed
LICENSED DRUG. The University cannot so designate more than three LICENSED DRUGS
within a six month period.
9.3 In the event that Section 9.1 is not complied with in one or more
countries for one or more LICENSED DRUGS, and there is no excuse pursuant to
14.4, the Company shall forfeit its exclusive license in such countries under
this Agreement as to such LICENSED DRUGS as were not developed and marketed in
accordance with 9.1 above, but its license as to other LICENSED DRUGS, or as to
the same LICENSED DRUG in other countries, shall not be affected.
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9.4 To the extent required by law, it is agreed that any LICENSED PRODUCTS
sold in the United States shall be substantially manufactured in the United
States.
10. Infringement
10.1 The University will protect its licensed Patents from infringement
and prosecute infringers at its own expense when in its sole reasonable judgment
such action may be reasonably necessary, proper, and justified.
10.2 If Company shall have supplied the University with written evidence
reasonably demonstrating prima facie infringement of a claim of a Licensed
Patent by a third party selling products in competition with Company or any of
its AFFILIATES, Company may, by written notice, request The University to take
steps to protect the Licensed Patent. Unless the University shall within three
months of the receipt of such notice either (i) cause such infringement to
terminate or (ii) initiate legal proceedings against the infringer, Company may
upon notice to the University initiate legal proceedings against the infringer
at the expense of Company. In such event Company may deduct from shall receive a
credit equal to its reasonable costs and legal fees incurred to conduct such
proceedings.
10.3 In the event one party shall initiate or carry on legal proceedings
to enforce any Licensed Patent against an alleged infringer, the other party
shall use its best efforts to fully cooperate with and shall supply all
assistance reasonably requested by the party initiating or carrying on such
proceedings. The party which institutes any proceeding to protect or enforce a
Licensed Patent shall have sole control of that proceeding and shall bear the
reasonable expenses incurred by said other party in providing
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such assistance and cooperation as is requested pursuant to this paragraph.
10.4 The litigating party shall not settle, or abandon a legal proceeding
without the consent of the other party, which consent shall not be unreasonably
withheld. If consent is withheld, the nonconsenting party shall assume control
of the proceeding and shall reimburse the prior litigating party for all legal
expenses incurred prior to such assumption of control.
10.5 Any recovery, whether by settlement or judgment, shall be first
applied, in the following order:
(a) to reimburse the parties for their previously unreimbursed costs
and legal fees in connection with the proceedings;
(b) to pay any royalties or milestone payments withheld from the
University by Company under ss. 10.2; and
(c) to pay the University its proper share of that portion of the
recovery which the Company would have expected to receive as
income from sublicensing had the third party been granted a
sublicense on the royalty terms set forth in ss. 6.1.
The remainder of the recovery shall go to the Company.
As a term of any settlement, the settling party shall use best
efforts to require the third party to account for its prior sales in such manner
as to facilitate the calculation of the University's share of the recovery.
10.6 Nothing in this Agreement shall be construed to limit the authority
of the Attorney General of North Carolina.
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11. Representations and Related Obligations by the University
11.1 The University represents, and covenants, as follows:
(a) It has the full right, power, and authority to enter into this
Agreement and to perform all of its obligations hereunder.
(b) 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 the University activities.
(c) 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.
(d) To the best of the knowledge and belief of the University, no
employee, agent, or consultant of the University who has performed any work in
connection with the LICENSED TECHNOLOGY is, or is now expected to be, 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 present employer relating to the
right of any such employee, agent, or consultant to be employed or engaged by
the University in connection with the work to be performed hereunder.
(e) 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 Company, the University is the owner of all right, title and
interest in and to the patents,
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License Agreement between UNC and Biotech Research Labs
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December 6, 1994
patent rights, and patentable inventions, comprising the LICENSED TECHNOLOGY.
Also subject to the aforementioned rights of the U.S. Government, the University
has the sole and complete authority to issue and grant to Company the exclusive
license granted hereunder, free and clear of any claims, liens, encumbrances or
charges of any third party.
(f) The University has no knowledge of any potential infringement
action or claim relating to the LICENSED TECHNOLOGY 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 LICENSED TECHNOLOGY or Company's license to the LICENSED
TECHNOLOGY.
(g) The University has taken all steps within its power which
under Public Law 96-517, 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 LICENSED TECHNOLOGY.
11.2 To the extent that rights granted by the University to Company 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 LICENSED TECHNOLOGY in the United States and in any foreign country
designated by Company for the duration of this license and to avoid exercise by
any federal agency of "march-in" rights under such law.
11.3 The University will promptly disclose to the designated Patent
Counsel of Company all information which is or could be
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License Agreement between UNC and Biotech Research Labs
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December 6, 1994
material to the patentability, enforceability or validity of any application or
patent included in LICENSED RIGHTS.
11.4 The University will promptly disclose to the designated Patent
Counsel of Company any information pertaining to the likelihood or merits of a
third party claim of infringement arising from Company use of LICENSED
TECHNOLOGY.
11.5 In the event that the University discovers that an interest in an
Invention is not held by either the University or by Company (or its employees),
it shall promptly notify the Company. The University may, at its option, acquire
such interest at its own expense, or invite the Company to acquire said
interest. In the latter case, the cost to the Company of acquiring said interest
may be applied as a credit.
11.6 The University represents that all representations made in this
Article 11 were made only after using best efforts to diligently investigate the
underlying circumstances.
12. Disclosure and Confidentiality
12.1 The University shall disclose each SUBJECT INVENTION to
Company:
(a) within two months after the inventor discloses it to
University personnel or agents responsible for patent matters,
(b) at least two months prior to any intended public disclosure of
all or part of the SUBJECT INVENTION, and
(c) prior to submission for publication of any manuscript or
abstract which discloses all or part of the SUBJECT INVENTION.
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License Agreement between UNC and Biotech Research Labs
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December 6, 1994
12.2 The disclosure under 12.1 shall be in writing and shall be
sufficiently complete in technical detail to convey a clear understanding to the
extent known at the time of the disclosure, of the nature, purpose, operation
and the physical, chemical, biological or electrical characteristics of the
invention, such that a patent application may be drafted with a specification
reasonably likely to be deemed adequate to support one or more patentable and
commercially meaningful claims. It should also indicate the earliest expected
date of public disclosure of the SUBJECT INVENTION.
12.3 The University will promptly inform Company of the submission of any
abstract or manuscript for publication and of the acceptance thereof.
12.4 The University will not permit public disclosure of the SUBJECT
INVENTION until 60 days after the disclosure under 12.1 (complying with 12.2),
or until after the filing of a patent application adequately disclosing the
SUBJECT INVENTION, whichever is earlier. If within 60 days of the disclosure
under 12.1, Company advises the University that it would be beneficial to have
more time to prepare and file a patent application thereon, and such advice is
reasonably made, the University will defer the public disclosure of the SUBJECT
INVENTION for up to an additional 30 days, and will not unreasonably deny a
request for further deferral.
12.5 Any information which is to be treated as Confidential Information
hereunder must be clearly marked as "confidential" prior to transmittal to the
other party. If such Confidential Information is disclosed orally, it shall be
identified as being confidential at the time of disclosure, and shall thereafter
be reduced to writing within 30 days, marked as confidential, and transmitted to
the receiving party. Specifically excluded from such
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License Agreement between UNC and Biotech Research Labs
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December 6, 1994
confidential treatment shall be information which: (i) as of the date of
disclosure, is already known to the party receiving such information; (ii) is or
becomes part of the public domain, through no fault of the receiving party;
(iii) is lawfully disclosed to the receiving party by a third party who is not
obligated to retain such information in confidence; or (iv) is independently
developed at the receiving party by personnel not privy to the confidential
information.
12.6 Confidential Information shall not be disclosed by the receiving
party without written consent of the other party. Confidential Information will
be used by the receiving party only by its authorized personnel and only for the
purposes contemplated under this Agreement. The receiving party shall advise its
employees, agents, and consultants who have access to the disclosing party
premises or to any proprietary information or trade secrets of the disclosing
party, including any LICENSED TECHNOLOGY not previously released to the public
pursuant the terms of this Article 12, of the responsibility under this
Agreement to be bound by the confidentiality obligations to not disclose,
publicly use, or offer for sale any of said proprietary information or trade
secrets or LICENSED TECHNOLOGY not previously released to the public or any
information that is confidential and proprietary to the disclosing party.
12.7 The obligation pursuant to Section 12.6 shall terminate three years
after the first sale of an article represent-ing such information, or ten years
after the disclosure of the information, whichever comes earlier (compare ss.
6.1(c)).
13. Breach and Cure
13.1 In addition to applicable legal standards, Company shall be
considered to be in material breach of this Agreement for failure
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License Agreement between UNC and Biotech Research Labs
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December 6, 1994
to pay fully and promptly amounts due pursuant to Article 6 and payable pursuant
to Article 7; in addition, failure to meet the obligations of Article 9 shall
also be deemed a material breach of this Agreement.
13.2 In addition to applicable legal standards, the University shall be
considered in material breach of this Agreement for making a knowing or
negligent material misrepresentation of a matter as to which UNIVERSITY has made
a representation under Article 11, or breaching its obligations under Article 5,
Section 8.4, Article 11 or Article 12.
13.3 Either party shall have the right to cure its material breach. The
cure shall be effected within a reasonable period of time, but in no event later
than thirty days after written notice of any breach given by the non-breaching
party.
If the breach is not cured within the thirty day period, the non-breaching
party may, in addition to any other rights it may have at law or in equity,
terminate this Agreement.
13.4 In the event of a material breach by University, which is not cured
pursuant to Section 13.3, in lieu of termination, Company may pay into escrow
such compensation as is due under Article 6 as to any articles embodying
Inventions to which the breach pertains, until such breach is cured, while
still, however, paying directly expenses pursuant to Article 8.
13.5 The Parties shall not be liable for any failure to perform as
required by this Agreement, to the extent such failure to perform is caused by
any reason beyond the party's control, or by reason of any of the following:
labor disturbances or disputes of any kind, accidents, failure of any required
governmental approval, civil disorders, acts of aggression, acts of God, energy
or other conservation measures, failure of utilities, mechanical breakdowns,
material shortage, disease, or similar occurrences.
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License Agreement between UNC and Biotech Research Labs
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14. Term of Agreement
14.1 This Agreement shall be effective as of the date first set forth
above and shall continue in full force and effect until its expiration or
termination in accordance with this Article 14.
14.2 Unless terminated earlier under any provision of this Agreement, the
term of the exclusive license granted under the LICENSED RIGHTS shall extend
until the expiration, lapse, invalidation, declaration of unenforceability, or
abandonment of the last of the patents and applications included in LICENSED
RIGHTS and the lapse of the period of compensation for PROPRIETARY TECHNOLOGY
pursuant to subsection 6.1(c).
14.3 In the event any term or provision of this Agreement shall for any
reason be held to be invalid, illegal, or unenforceable in any respect, then,
unless such term or provision goes to the root of the Agreement and subject as
otherwise agreed, this Agreement shall continue in full force and effect save
that the term or provision shall be deemed to be excised therefrom and shall be
interpreted and construed as if such term or provision, to the extent the same
shall have been held to be valid, illegal, or unenforceable, had never been
contained herein.
14.4 Each party shall be excused from any nonperformance of this Agreement
which is proximately caused by government regulation, war, strike, act of God,
or other similar circumstances normally deemed outside the control of well
managed businesses.
15. Notices
15.1 Any notice required or permitted to be given under this Agreement
shall be sufficient if sent by first class mail, postage prepaid, if to the
University, to:
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License Agreement between UNC and Biotech Research Labs
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December 6, 1994
David M. Parker, Esq.
Associate Director, Technology Development
and Associate University Counsel
Office of Research Services
CB# 4100, 302 Bynum Hall
The University of North Carolina at
Chapel Hill
Chapel Hill, North Carolina 27599-4100
if to Company, to:
Richard T. Schumacher
President and CEO
Boston Biomedica, Inc.
375 West Street
West Bridgewater, Massachusetts 02379
or to such other or additional address as a party may specify by
notice hereunder.
16. Complete Agreement
16.1 It is understood and agreed between University and Company that this
license, together with Appendix 1, and the invention disclosures and patent
applications referred to in subsection 4.2(a), constitutes the entire Agreement,
both written and oral, between the parties, and that all prior agreements
respecting the subject matter hereof, either written or oral, expressed or
implied, shall be abrogated, canceled, and are null and void and of no effect.
17. Governing Law
17.1 This Agreement shall be governed by North Carolina law applicable to
agreements made and to be performed in North Carolina.
18. Indemnity
18.1 Licensee agrees to indemnify, hold harmless and defend
University, its officers, employees, and agents, against any and
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License Agreement between UNC and Biotech Research Labs
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December 6, 1994
all claims, suits losses, damage, cost, fees, and expenses asserted by third
parties, both government and private, resulting from or arising out of the
exercise of this license, except to the extent that such claims, suits, losses,
damages, costs, fees or expenses arise in whole or in material part from
circumstances related to a breach by the University of a representation or
agreement given under Article 11.
19. Insurance
19.1 Licensee is required to maintain in force at its sole cost and
expense, with reputable insurance companies, to the extent that such coverage is
reasonably available for biotech companies manufacturing or selling drugs for
the inhibition of human retroviruses, general liability insurance and, to the
extent available to Licensee, products liability insurance coverage, in an
amount reasonably sufficient to protect against liability under paragraph 18,
above. The University shall have the right to ascertain from to time that such
coverage exists, such right to be exercised in a reasonable manner, and, if the
University is of the opinion that Licensee's coverage is inadequate, Licensee
will be given a reasonable opportunity to obtain additional coverage or to
explain why its present coverage is sufficient, or why additional coverage is
not reasonably available.
20. Use of University's Name
20.1 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. The University consents to use
of its name to the extent such is required to prosecute patent applications
pursuant
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License Agreement between UNC and Biotech Research Labs
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to this Agreement and to the extent such is required to secure governmental
approval to test and sell Licensed Technology.
21. Disposition of Licensed Products on Hand Upon Cancellation or
Termination
21.1 Upon cancellation of this Agreement or upon termination in whole or
in part, other than natural termination pursuant to Section 14.2:
(a) Company shall provide University with a written inventory of all
Licensed Technology and Licensed Products in process of manufacture, in use or
in stock.
(b) Except with respect to termination pursuant to Section 13.2, Company
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 Company can reasonably obtain.
(c) Company will also have the right to complete performance of all
contracts requiring use of the Licensed Technology (except in the case of
termination pursuant to Paragraph 13.2) or Licensed Products within and beyond
said 180-day period provided that the remaining term of any such contract does
not exceed one year, and
(d) 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 Company's sole expense.
22. University Use
22.1 It is expressly agreed that, notwithstanding any provisions herein,
University is free to use Subject Invention, Licensed Technology, patent rights
and Licensed Products for its own research (not supported by any "for profit"
entity), public
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License Agreement between UNC and Biotech Research Labs
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December 6, 1994
service, clinical, teaching and educational purposes without payment of
royalties.
23. Waiver
23.1 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.
24. Assignments
24.1 This Agreement is binding upon and shall inure to benefit of the
University, its successors and assigns. However, this Agreement shall be
personal to Company and it not assignable by Company to any other entity, except
as part of the sale or transfer of all assets of Company to another entity,
without the written consent of the University, which consent shall not be
withheld unreasonably.
25. Late Payments
25.1 In the event royalty payments or other financial consideration are
not received by the University when due, or within a grace period of 30 days,
Company shall pay to University on said indebtedness, interest running from said
due date to the date of payment, at an interest rate calculated, on the first
business day of each month, at six percentage points above the six month T-bill
rate then applicable, as published in the Wall Street Journal.
26. Compliance with Laws
26.1 In exercising its rights under this license, Company shall use best
efforts to comply with the requirements of any and all
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License Agreement between UNC and Biotech Research Labs
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applicable laws, regulations, rules and orders of any governmental body having
jurisdiction over the exercise of rights under this license. Such compliance
includes, but is not limited to, manufacturing articles in the United States to
the extent required by Public Law 96-517, as amended, and the implementing
regulations. Company 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.
27. Survival of Terms
27.1 The following shall survive the termination of this
Agreement:
(a) the right of each party to sue the other party for breach
of any term of this Agreement, subject to Article 17
("Governing Law");
(b) the obligation of the Company to compensate the
University, pursuant to Article 6, for its licensed acts;
(c) the obligation of the Company to indemnify the University
pursuant to Articles 18 and 26;
(d) the obligation of the Company to refrain from use of the
University's name, pursuant to Article 20;
(e) the obligation of the receiving party with respect to
Confidential Information, pursuant to Section 12.6, but
subject to Section 12.7;
(f) the right of the Company to dispose of Licensed Products,
pursuant to Article 21, except as limited by said
Article, and subject to the obligations of Article 26;
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License Agreement between UNC and Biotech Research Labs
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(g) the Company's right of use of data pursuant to Section
5.2, except as limited thereby, and
(h) the University's right of use pursuant to Article 22.
IN WITNESS THEREOF, the University and the COMPANY, have caused this
Agreement to be executed by their duly authorized representatives as of the day
and year first written above.
UNIVERSITY OF NORTH CAROLINA BRL CONTRACTS AND SERVICES,
AT CHAPEL HILL (UNIVERSITY) INC.
By __________________________ By __________________________
Wayne Jones
Title _______________________ Title _______________________
Vice Chancellor, Business &
Finance
Agreed to:
- --------------------------------
K.H. Lee
30
APPENDIX I
UNC-CH/BTRL EXCLUSIVE LICENSE AGREEMENT
DECEMBER 12, 1994 LIST OF COMPOUNDS:
1. Suksdorfin
2. Xie-Br-24
3. Xie-Br-25
4. DCK
5. KHL-FH-2(also referred to as FH11309)
6. KHL-FH-1A