Exhibit 10.4
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
NORTH CAROLINA UNIVERSITY
LICENSE AGREEMENT
This Agreement is made by and between North Carolina State University
(hereinafter referred to as "NCSU"), a constituent institution of the University
of North Carolina and an educational institution organized under the laws of
North Carolina, and having its principal office at ▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇,
▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇, and LipoMed, Inc. ("hereinafter referred to
as "LICENSEE"), a corporation organized under the laws of North Carolina and
having its principal place of business at ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇, ▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇.
WHEREAS, ▇▇. ▇▇▇▇▇ ▇▇▇▇▇ has discovered an invention titled "Method and
Apparatus for Measuring Blood Lipoprotein Levels by NMR Spectroscopy" (NCSU File
No. 91-02), and NCSU owns all rights, title, and interest in and to the Patent
Rights (as hereinafter defined) pertaining to such invention; and
WHEREAS, NCSU has the right to grant licenses to the foregoing invention,
and wishes to have the invention utilized in the public interest; and
WHEREAS, NCSU is willing to grant a license to LICENSEE to the invention
and related Patent Rights subject to the terms and conditions set forth herein;
NOW, THEREFORE, in consideration of the premises and the mutual covenants
set forth herein, and for good and valuable consideration, the receipt and
sufficiency of which is acknowledged, the parties hereto, intending to be
legally bound, agree as follows:
ARTICLE 1- DEFINITIONS
----------------------
1.01 "Patent Rights" shall mean:
U.S. Patent No. 5,343,389 "Method and Apparatus for Measuring Classes
and Subclasses of Lipoproteins" (filed June 17, 1993; issued August
30, 1994)
1.02 "Field" or "Field of Use" shall mean the use of the Patent Rights for
NMR testing of blood.
1.03 "Licensed Product" shall mean any product; (a) which is covered by an
unexpired claim contained in the Patent Rights in the country in which
the
1
Licensed Product(s) is made, used, sold or transferred; or (b) the use
of which is covered in an unexpired claim contained in the Patent
Rights in the country in which the License Product(s) are made, used,
sold or transferred.
1.04 "Licensed Test" shall mean any process or use thereof (a) which is
covered by an unexpired claim contained in the Patent Rights in the
country in which the Licensed Test is made, used, sold or transferred;
or (b) the use of which is covered in an unexpired claim contained in
the Patent Rights in the country in which the Licensed Test is made,
used, sold or transferred.
1.05 "Net Sales" shall mean LICENSEE's ▇▇▇▇▇▇▇▇ for the Licensed Products
produced and Licensed Tests performed hereunder, less the sum of the
following:
(a) Discounts allowed in amounts customary in the trade;
(b) Sales, tariff duties and/or use taxes directly imposed and with
reference to particular sales;
(c) Outbound transportation prepaid or allowed; and
(d) Amounts allowed or credited on returns.
No deductions shall be made for commissions paid to individuals whether they be
independent sales agents or regularly employed by LICENSEE and on its payroll,
nor for the cost of collections. Licensed Products and Licensed Tests shall be
considered "sold" when ▇▇▇▇ out or invoiced. Net Sales in the case of Licensed
Products and Licensed Tests used or transferred by LICENSEE shall mean the fair
market value of Licensed Products and Licensed Tests as if they were sold to an
unrelated third party in similar quantities.
1.06 "Affiliate" or "Affiliates" shall mean (i) any corporation, company or
other entity in which LICENSEE owns or controls at least fifty percent
(50%) of the stock entitled to vote in election of members of the
Board of Directors; or (ii) any corporation, company or other entity
which owns or controls at least (50%) of the stock of LICENSEE.
1.07 "Effective Date" shall mean May 12, 1997.
2
ARTICLE 2- LICENSE
------------------
2.01 NCSU hereby grants to LICENSEE and LICENSEE hereby accepts from NCSU,
upon the terms and conditions herein specified, an exclusive license
to make, have made, use and sell Licensed Products and perform
Licensed Tests, with the right to sub-license. Such license is
worldwide and shall remain in effect, on a country by country basis,
until the full end of the term or terms for which Patent Rights are
issued, unless sooner terminated as hereinafter provided. The
foregoing notwithstanding, LICENSEE's rights and license shall be
subject to the rights of the U.S. Government pursuant to any funding
agreement between NCSU and the Government.
2.02 LICENSEE shall have the right to grant sub-licenses and to extend any
license granted to LICENSEE to its Affiliates. Any such sub-licenses
or extensions shall be subject to the terms of this Agreement and
shall be no less favorable to NCSU than is this license. A copy of
each sub-license shall be provided to NCSU. LICENSEE agrees to be
responsible for the performance hereunder by its Affiliates and
sub-licenses, if any. Should this Agreement be terminated for any
reason, LICENSEE agrees to assign all such sub-licenses directly to
NCSU.
2.03 The license granted hereunder shall not be construed to confer any
rights upon LICENSEE by implication, estoppel or otherwise as to any
technology not part of the Patent Rights licensed hereunder.
2.04 LICENSEE agrees that any products constituting Licensed Products will
be manufactured substantially in the United States to the extent
required by 35 U.S.C. Sec. 204, if such statute shall be applicable
ARTICLE 3- DUE DILIGENCE
------------------------
3.01 LICENSEE agrees to diligently pursue the development of the Patent
Rights. This will include manufacturing or producing a Licensed
Product utilizing the Patent Rights for testing, development, and
sale, and also using best efforts in seeking required governmental
approvals of such Licensed Product. In addition to this general
commitment to diligence, LICENSEE agrees to the following diligence
requirements:
(a) LICENSEE agrees to raise sufficient funds to support LICENSEE'S
business operations and promote development and commercialization of
3
the Patent Rights. If LICENSEE fails to raise $[**] within [**] ([**])
months of the Effective Date, all rights granted herein shall
terminate.
(b) LICENSEE shall support a program of collaborative research in an
amount of not less than [**] dollars ($[**]) for at least [**] under
the direction of ▇▇▇▇▇ ▇. ▇▇▇▇▇, Ph.D. This program shall be governed
by a separate Research Agreement between the parties, said agreement
to be entered into within thirty days after the closing date of the
first [**] dollars ($[**]) raised by LICENSEE.
(c) Within [**] from the Effective Date of this Agreement, LICENSEE shall
deliver to NCSU a report showing LICENSEE'S plans for commercializing
the Patent Rights and shall provide a similar report on [**] of [**]
until first commercial sale under the Patent Rights.
(d) LICENSEE agrees to commercialize the Patent Rights according to the
following schedule:
(1) [**] Licensed Test within [**] after the latest date of the
regulatory approvals required to engage in U.S. intrastate
and interstate commerce.
(2) [**] Licensed Tests within [**] after the latest date in (1)
above.
(3) [**] Licensed Tests within [**] after the latest date in (2)
above.
3.02 LICENSEE agrees to use its best efforts to have the Patent Rights
cleared for marketing in those countries in which LICENSEE intends to
sell or use Licensed Products or Licensed Tests by the responsible
government agencies requiring such clearance. To accomplish such
clearances at the earliest possible date, LICENSEE agrees to file,
according to the usual practice of LICENSEE, any necessary data with
such government agencies. Should LICENSEE terminate this Agreement,
LICENSEE agrees to assign its full interest and title in such market
clearance application, including all data relating thereto, to NCSU at
no cost to NCSU.
3.03 Failure by LICENSEE to comply with the provisions of this Article 3
shall result in NCSU having the right, at its option, to convert any
exclusive license to a non-exclusive license, or to cancel the license
upon sixty (60) days notice, and to require a reversion of rights to
all relevant materials, research information and technology, including
Patent Rights, transferred to LICENSEE by NCSU.
4
ARTICLE 4- LICENSE FEE, ROYALTIES, RECORDS, AND REPORTS
-------------------------------------------------------
4.01 LICENSEE shall pay to NCSU, as a license fee for this Agreement,
the sum of [**] dollars ($[**]); said fee to be paid within
thirty days after the closing date of the first [**] ($[**])
raised by LICENSEE.
4.02 For as long as this license is in effect, LICENSEE shall pay to
NCSU royalties as follows:
(1) Except in the case of minimum annual royalties, as set forth
in 4.03 below, [**] shall be due or payable on the [**]
$[**] of LICENSEE'S cumulative Net Sales of Licensed
Products and Net Sales from Licensed Tests.
(2) For cumulative Net Sales greater than $[**] and less than
$[**] of Licensed Products and Licensed Tests, whether sold
by LICENSEE or LICENSEE'S sub-licensee(s), LICENSEE shall
pay to NCSU a royalty of [**] percent ([**]%) of Net Sales;
(3) For cumulative Net Sales greater than $[**] of Licensed
Products and Licensed Tests, whether sold by LICENSEE or
LICENSEE'S sub-licensee(s), LICENSEE shall pay to NCSU a
royalty of [**] percent ([**]%) of Net Sales.
4.03 LICENSEE will pay to NCSU $[**] as a minimum annual royalty.
Payment of the first specified minimum annual royalty payments shall be made on
the [**] of the [**] after the [**] of the [**] required to engage in [**] and
[**]. Each subsequent minimum annual royalty payment shall be made on the annual
anniversary date of the first minimum annual royalty payment, consistent with
the [**] and [**] set forth in 4.05 hereof. Once commercial sales of Licensed
Products have commenced, the minimum annual royalty payments required herein
shall be considered advance payments against earned running royalties for the
year in which each minimum annual royalty payment is made. In no event shall the
payment of the minimum annual royalty payment excuse LICENSEE from its
obligations to meet the reporting, development and/or payment requirements
otherwise specified and applicable.
4.04 LICENSEE shall render to NCSU on a quarterly basis a written
account of the Net Sales of Licensed Products as of July 1, October 1, January
1, and April 1 of each calendar year. The reports of Net Sales and the royalty
payment due NCSU thereon shall be due and payable within sixty (60) days
following the applicable date. LICENSEE shall make such reports even if there
have been no Net Sales or if no royalties are due to NCSU for a particular
quarter. LICENSEE'S report shall include at least the following:
(a) All Licensed Products manufactured and sold.
5
(b) Total ▇▇▇▇▇▇▇▇ for Licensed Products sold.
(c) Accounting for all sub-licensing proceeds received by LICENSEE from
LICENSEE'S sub-licensees.
(d) Deductions applicable as provided in section 1.04.
(e) Total sales made to U.S. Government Agencies which require no royalty
payment.
(f) Total royalties due to NCSU.
(g) Names and addresses of all sub-licensees of LICENSEE.
4.05 LICENSEE and its Affiliates shall keep full, true, and accurate books
of accounts and other records containing all particulars which may be necessary
to ascertain and verify properly such Net Sales. Upon NCSU's request, LICENSEE
and its Affiliates shall permit an independent Certified Public Accountant
selected by NCSU (except one to whom LICENSEE has some reasonable objection) to
have access during ordinary business hours to such of LICENSEE'S or its
Affiliates' records as may be necessary to determine, in respect of any three
(3) month period ending not more than five (5) years prior to the date of such
request, the correctness of any report made under this Agreement. Nothing herein
shall be construed to limit the authority of the State Auditor of North
Carolina.
4.06 In the event this Agreement is assigned or transferred by LICENSEE to
a third party, in accordance with Article 11 hereunder, LICENSEE shall pay to
NCSU [**] percent ([**]%) of the gross proceeds received by LICENSEE as the
result of any such assignment or transfer.
4.07 All payments made as a result of this Agreement shall be paid in
United States dollars in Raleigh, North Carolina, or at such other place as NCSU
may reasonably designate consistent with the laws and regulations controlling in
any foreign country. If any currency conversion shall be required in connection
with the payment of royalties hereunder, such conversion shall be made by using
the exchange rate prevailing at the Chase Manhattan Bank (N.A.) on the last
business day of the calendar quarterly reporting period to which such royalty
payments relate.
4.08 The royalty payments set forth in this Agreement, if overdue, shall
bear interest until payment at a per annum rate of four percent (4%) above the
prime rate in effect at the Chase Manhattan Bank (N.A) on the due date. However,
in no event shall any penalties hereunder exceed eighteen percent (18%) per
annum (or 1.5% per month).
6
ARTICLE 5- PATENTS
------------------
5.01 NCSU shall select patent counsel and shall have sole responsibility for
filing, prosecuting and maintaining appropriate U.S. and foreign patent
application(s) on the Patent Rights in the name of NCSU, and all expenses of
such protection shall be paid by LICENSEE. LICENSEE also agrees to reimburse
NCSU for unreimbursed out-of-pocket patent costs incurred through the Effective
Date. NCSU shall keep LICENSEE advised as to the prosecution of such
applications by forwarding to LICENSEE copies of all official correspondence
relating thereto. LICENSEE agrees to cooperate with NCSU in the prosecution of
patent application(s) to insure that such applications reflect, to the best of
NCSU's and LICENSEE'S knowledge, all items of commercial, scientific and
technical interest and importance. All final decisions with respect to the
prosecution of said patent application(s) are reserved to NCSU.
5.02 LICENSEE shall designate the foreign countries, if any, in which
LICENSEE desires patent protection, and NCSU agrees to file, prosecute and
maintain appropriate applications in such countries. LICENSEE shall pay all
expenses with regard to such foreign patent protection. NCSU may elect to seek
patent protection in countries not so designated by LICENSEE, in which case NCSU
shall be responsible for all expenses attendant thereto; however, in such
instances, LICENSEE shall forfeit its rights under this license agreement as to
such countries.
5.03 For each country in which Licensed Products will be sold, LICENSEE
agrees to ▇▇▇▇ all Licensed Products it commercializes with the applicable
patent number.
ARTICLE 6- GOVERNMENT CLEARANCE, PUBLICATION, OTHER USE,
--------------------------------------------------------
EXPORT, DUTIES
--------------
6.01 LICENSEE agrees that the right of publication of any and all information
related to the Patent Rights shall reside in the inventor and other staff of
NCSU. NCSU shall use its best efforts to provide a copy of each publication at
the time of submission for pre-publication review, or in any event not less than
thirty (30) days prior to the expected date of publication. Such review will be
in no way construed as a right to restrict such publication.
6.02 It is agreed that, notwithstanding any provisions herein, NCSU is free
to use the Patent Rights for its own educational, teaching, and research
purposes without restriction and without payment of royalties or other fees.
6.03 This Agreement is subject to, and LICENSEE will comply with, all of the
United States laws and regulations controlling the export of technical data,
computer software, laboratory prototypes, and other commodities and technology
which may be applicable.
7
6.04 LICENSEE shall be solely responsible for the payment and discharge of
any taxes or duties relating to any transaction of LICENSEE, its employees,
contractors, agents, or sub-licensees, in connection with the manufacture, use,
or sale in any country of Licensed Product(s).
ARTICLE 7- DURATION AND TERMINATION
-----------------------------------
7.01 This Agreement shall become effective upon the Effective Date and,
unless sooner terminated in accordance with any of the provisions herein, shall
remain in full force and effect for the life of the last-to-expire of the
patents included in the Patent Rights.
7.02 In the event an order for relief is entered against LICENSEE under the
Federal Bankruptcy Code, or an order appointing a receiver for substantially all
of LICENSEE'S assets is entered by a court of competent jurisdiction, or
LICENSEE makes an assignment for the benefit of creditors, or a levy of
execution is made upon substantially all of the assets of LICENSEE and such levy
is not quashed or dismissed within thirty (30) days, this Agreement shall
automatically terminate effective on the date of such order or assignment or, in
the case of such levy, the expiration of such thirty (30) day period; provided,
however, that such termination shall not impair or prejudice any right of remedy
that NCSU might have under this Agreement.
7.03 LICENSEE may terminate this Agreement by giving NCSU written notice at
least ninety (90) days prior to such termination, and thereupon terminate the
manufacture, use, or sale of Licensed Products.
7.04 Should LICENSEE fail to pay NCSU royalties due and payable hereunder,
NCSU shall have the right to terminate this Agreement on sixty (60) days'
notice, unless LICENSEE shall pay NCSU, within the sixty (60) day period, all
such royalties and interest due and payable. Upon the expiration of the sixty
(60) day period, if LICENSEE shall not have paid all such royalties and interest
due and payable, the rights, privileges and license granted hereunder shall
terminate.
7.05 Either party may immediately terminate this Agreement for fraud, willful
misconduct, or illegal conduct of the other party upon written notice of same to
that other party. Except as provided above, if either party fails to fulfill any
of its obligations under this Agreement, the non-breaching party may terminate
this Agreement by providing written notice to the breaching party, as provided
below. Such notice must contain a full description of the event or occurrence
constituting a breach of the Agreement. The party receiving notice of the breach
will have the opportunity to cure that breach within forty-five (45) days of
receipt of notice. If the breach is not cured within that time, the termination
will be effective as of the forty-five (45/th/) day after receipt of notice. A
party's ability to cure a breach will apply only to the first two (2) breaches
properly noticed under the terms of this Agreement, regardless of the nature of
those breaches.
8
Any subsequent breach by that party will entitle the other party to terminate
this Agreement upon proper notice, with no opportunity to cure.
7.06 If at any time prior to the first commercial sale of a Licensed Product
under this Agreement LICENSEE shall cease to pursue commercial development of
the Patent Rights as contemplated herein, LICENSEE shall be obligated to so
notify NCSU, and this Agreement shall automatically terminate without obligation
on the part of NCSU to refund any of the fees or royalties which may have been
paid by LICENSEE prior to such termination.
7.07 Upon the termination of this Agreement pursuant to Article 7.03,
LICENSEE may notify NCSU of the amount of Licensed Products that LICENSEE has on
hand and LICENSEE shall then have a license to sell that amount of Licensed
Products, but no more; provided, however, that LICENSEE shall pay NCSU a royalty
thereon at the rate and at the time provided for.
7.08 In the event LICENSEE'S license rights to U.S. Patent No. 4,933,844,
"Measurement of Blood Lipoprotein Constituents by Analysis of Data Acquired from
an NMR Spectrometer", are terminated for any reason, prior to expiration, then
all license rights granted herein shall terminate immediately.
7.09 Within thirty (30) days of the termination of this Agreement under
Sections 7.02, 7.03, 7.04, or 7.06, or for LICENSEE'S breach under 7.05,
LICENSEE shall duly account to NCSU and transfer to NCSU all rights which
LICENSEE may have in or to all trade names and trademarks used to identify
Licensed Products.
ARTICLE 8- INFRINGEMENT OF THIRD-PARTY RIGHTS
---------------------------------------------
8.01 In the event that NCSU or LICENSEE is charged with infringement of a
patent by a third party or is made a party in a civil action as a result of
LICENSEE'S or a sub-licensee's practice of the Patent Rights under this
Agreement, LICENSEE shall:
(a) defend and/or settle any such claim of infringement or civil
action;
(b) assume all cost, expenses, damages, and other obligations for
payments incurred as a consequence of such charges of
infringement and/or civil action;
(c) indemnify and hold NCSU harmless from any and all damages,
losses, liability, and costs resulting from a charge of
infringement or civil action which shall be brought against NCSU
and attributable to technology added to, incorporated into or
sold with a Licensed Product by LICENSEE or a sub-licensee or to
manufacturing processes utilized by LICENSEE or a sub-licensee;
and
9
(d) if such claim of infringement or civil action shall be based on
patent claims contained in any pending or issued patent included
in the Patent Rights, LICENSEE may terminate this Agreement
effective immediately upon NCSU's receipt of written notice of
termination, and LICENSEE shall have no further liability for
claims and/or damages arising subsequent to said date of
termination except to the extent such claims and/or damages
arising subsequent to said date of termination arise as a
consequence of or in connection with the sale of Licensed
Products under Section 7.07.
8.02 NCSU shall give LICENSEE assistance, at LICENSEE'S expense, in the
defense of any such infringement charge or lawsuit, as may be reasonably
required.
ARTICLE 9- INFRINGEMENT OF NCSU's PATENT RIGHTS BY THIRD
--------------------------------------------------------
PARTIES
-------
9.01 Each party to this Agreement shall be obligated to inform the other
promptly in writing of any alleged infringement of which it becomes aware and of
any available evidence of infringement by a third party of any patents within
the Patent Rights.
9.02 If during the term of this Agreement LICENSEE becomes aware of any
alleged infringement by a third pary, LICENSEE shall have the right, but not the
obligation, to either:
(a) settle the infringement suit by sub-licensing the alleged
infringer or by other means; or
(b) prosecute at its own expense any infringement of the Patent
Rights. In the event LICENSEE prosecutes such infringement,
LICENSEE may, for such purposes, request to use the name of NCSU
as party plaintiff. Subject to the approval of the Board of
Governors of the University of North Carolina, NCSU may agree to
become a party plaintiff, and costs associated therewith shall be
borne by LICENSEE.
9.03 In the event that LICENSEE undertakes the enforcement and/or defense of
the Patent Rights by litigation, including any declaratory judgment action, the
total cost of any such action commenced or defended solely by LICENSEE shall be
borne by LICENSEE. Any recovery of damages by LICENSEE as a result of such
action shall be applied first in satisfaction of any unreimbursed expenses and
attorneys' fees of LICENSEE relating to the action, and second in satisfaction
of unreimbursed legal expenses and attorneys' fees of NCSU, if any, relating to
the action. The balance remaining from any such recovery shall be distributed to
LICENSEE, provided that LICENSEE shall pay to NCSU such royalties as would
otherwise be applicable under
10
Article 4 hereof for that portion of LICENSEE'S recovery attributable to lost
sales. LICENSEE shall be entitled to settle any such litigation by agreement,
consent, judgment, voluntary dismissal, or otherwise, with the consent of NCSU,
which consent shall not be withheld unreasonably.
9.04 In the event LICENSEE does not undertake action to prevent the
infringing activity within three (3) months of having been made aware and
notified thereof, NCSU shall have the right, but shall not be obligated, to
prosecute at its own expense any such infringements of the Patent Rights and, in
furtherance of such right, NCSU may use the name of LICENSEE as a party
plaintiff in any such suit without expense to LICENSEE. The total cost of any
such infringement action commenced or defended solely by NCSU shall be borne by
NCSU. Any recovery of damages by NCSU for any infringement shall be applied
first in satisfaction of any unreimbursed expenses and attorneys' fees of NCSU
relating to the suit, and second toward reimbursement of LICENSEE'S reasonable
expenses, including reasonable attorneys' fees, relating to the suit. The
balance remaining from any such recovery shall be distributed to NCSU.
9.05 In any infringment suit instituted by either party to enforce the Patent
Rights pursuant to this Agreement, the other party hereto shall, at the request
and expense of the party initiating such suit, cooperate in all respects and, to
the extent possible, have its employees testify when requested and make
available relevant records, papers, information, samples, specimens, and the
like.
9.06 LICENSEE shall have the sole right in accordance with the terms and
conditions herein to sub-license any alleged infringer under the Patent Rights
for future infringements.
9.07 Any of the foregoing notwithstanding, if at any time during the term of
this Agreement any of the Patent Rights are held invalid or unenforceable in a
decision which is not appealable or is not appealed within the time allowed,
LICENSEE shall have no further obligations to NCSU with respect to its future
use or sale of any product or process covered solely by such Patent Rights,
including the obligation of paying royalties. Nevertheless, LICENSEE shall not
have a damage claim or a claim for refund or reimbursement against NCSU.
ARTICLE 10- INDEMNITY, INSURANCE, REPRESENTATIONS
-------------------------------------------------
10.01 LICENSEE shall indemnify, defend and hold NCSU, its trustees, officers,
employees and affiliates, harmless against all claims and expenses, including
legal expenses and reasonable attorneys' fees, arising out of the death or
injury to any person or persons or out of any damage to property and against any
other claim, proceeding, demand, expense and liability of any kind whatsoever
resulting from utilization of the Patent Rights in the production, manufacture,
sales, use, lease, consumption or advertisement of the Licensed Products by
LICENSEE and its sub-licensees or arising from any obligations of LICENSEE
hereunder, except for any claim or expenses arising
11
out of the negligence or willful misconduct of NCSU or its officers, agents or
employees. The parties acknowledge that NCSU's liability under this paragraph
shall be subject to the limitations of the North Carolina Tort Claims Act (N.C.
General Statutes Section 143-291).
10.02 LICENSEE shall maintain reasonable levels of product liability insurance
as soon as it has commercialized Licensed Products. NCSU shall have the right to
require such insurance policies or certificates of insurance, at NCSU's
discretion, to be made available for NCSU's inspection.
10.03 NCSU MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND,
EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND VALIDITY OF PATENT
RIGHTS CLAIMS ISSUED OR PENDING.
10.04 Nothing in this Agreement shall be deemed to be a representation or
warranty by NCSU of the validity of any of the patents or the accuracy, safety,
efficacy, or usefulness for any purpose, of any Patent Rights. NCSU shall have
no obligation, express or implied, to supervise, monitor, review, or otherwise
assume responsibility for the production, manufacture, testing, marketing, or
sale of any Licensed Product, and NCSU shall have no liability whatsoever to
LICENSEE or any third parties for or on account of any injury, loss, or damage,
of any kind or nature, sustained by, or any damage assessed or asserted against,
or any other liability incurred by or imposed upon LICENSEE or any other person
or entity, arising out of or in connection with or resulting from:
(a) the production, use, or sale of any Licensed Product;
(b) the use of any Patent Rights; or
(c) any advertising or other promotional activities with respect to any
of the foregoing.
ARTICLE 11- GOVERNING LAW
-------------------------
11.01 This Agreement shall be construed as having been entered into in the
State of North Carolina and shall be interpreted in accordance with and its
performance governed by the laws of the State of North Carolina.
ARTICLE 12- NON-ASSIGNABILITY
-----------------------------
12.01 This Agreement may not be assigned by LICENSEE except in connection with
the sale or other transfer of LICENSEE'S entire business or that part of
12
LICENSEE'S business to which this license relates. LICENSEE shall give NCSU
thirty (30) days prior written notice of such assignment or transfer. Any other
assignment of this Agreement without the prior written consent of NCSU shall be
void.
ARTICLE 13-NOTICES
------------------
13.01 It shall be a sufficient giving of any notice, payment, request,
report, statement, disclosure or other communication hereunder, if the party
giving the same shall deposit a copy thereof in the Post Office in certified
mail, postage prepaid, addressed to the other party at its address hereinafter
set forth or at such other address as the other party shall have theretofore in
writing designated:
NCSU LICENSEE
---- --------
Director ▇▇▇▇▇ ▇. ▇▇▇▇▇, Ph.D.
Office of Technology Administration LipoMed, Inc.
and Development ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ University ▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇ ▇▇▇▇
▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
The date of giving any such notice, request, report, statement, disclosure or
other communication, and the date of making any payment hereunder required
(provided such payment is received), shall be the date of the U.S. postmark of
such envelope if marked or actual date of receipt if delivered otherwise.
ARTICLE 14- NON-USE OF NAMES
----------------------------
14.01 LICENSEE shall not use the name of NCSU, or any trademark, trade
device, service ▇▇▇▇, symbol, or any abbreviation, contraction, or simulation
thereof, owned by NCSU, nor the names of any of its employees, or any adaptation
thereof, in any advertising, promotional, or sales literature without prior
written consent obtained from an authorized officer of NCSU in each case, except
that LICENSEE may state that it is licensed by NCSU under one or more of the
patents and/or patent applications comprising the Patent Rights. Failure by
LICENSEE to comply with this restriction shall be deemed a material breach of
this Agreement pursuant to section 7.05. Such material breach shall be deemed
cured if the offending use is terminated within ninety (90) days of LICENSEE's
receipt of a written notice from NCSU.
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ARTICLE 15-SEVERANCE
--------------------
15.01 Each clause of this Agreement is a distinct and severable clause and
if any clause is deemed illegal, void, or unenforceable, the validity, legality,
or enforceability of any other clause or portion of this Agreement will not be
affected thereby.
ARTICLE 16-ENTIRE AGREEMENT
---------------------------
16.01 This Agreement, including any schedules or other attachments which
are incorporated herein by reference, contain the entire agreement between the
parties as to its subject matter. This Agreement merges all prior discussions
between the parties and neither party shall be bound by conditions, definitions,
warranties, understanding, or representations concerning such subject matter
except as provided in this Agreement or as may be specified later in writing and
signed by the properly authorized representatives of the parties. This Agreement
can be modified or amended only by written agreement duly signed by persons
authorized to sign agreements on behalf of the parties.
ARTICLE 17-WAIVER
-----------------
17.01 The failure of a party in any instance to insist upon the strict
performance of the terms of this Agreement shall not be construed to be a waiver
or relinquishment of any of the terms of this Agreement, either at the time of
the party's failure to insist upon strict performance or at any time in the
future, and such term or terms shall continue in full force and effect.
ARTICLE 18-TITLES
-----------------
18.01 All titles and article headings contained in this Agreement are
inserted only as a matter of convenience and reference. They do not define,
limit, extend, or describe the scope of this Agreement or the intent of any of
its provisions.
ARTICLE 19-SURVIVAL OF TERMS
----------------------------
19.01 The provisions of Articles 1,4,8,10,11,13,and 14 shall survive the
expiration or termination of this Agreement.
14
IN WITNESS WHEREOF, the parties hereto have executed this Agreement on the dates
set forth below.
NORTH CAROLINA STATE UNIVERSITY
By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
---------------------------------------
▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
Vice Chancellor for Research, Outreach,
Extension and Economic Development
Date: 5/9/97
---------------------------------------
ATTEST:
By:______________________
SEAL
LICENSEE
By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇
---------------------------------------
Title: President, LipoMed, Inc.
---------------------------------------
Date: 5/8/97
---------------------------------------
ATTEST:
By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
SEAL
[Revised April 29, 1997]
15
AMENDMENT
This AMENDMENT is made and entered into this 10/th/ day of January, 2001, and
amends the License Agreement entered into by and between North Carolina State
University ("NCSU"), an educational institution organized under the laws of the
State of North Carolina, and LipoMed, Inc. ("LICENSEE"), a North Carolina
corporation. The License Agreement was executed by the parties on May 9, 1997
and May 8, 1997 respectively.
The parties agree to amend the License Agreement as hereinafter set forth.
1. The first (1/st/) recital is deleted in its entirely and the following
substituted in lieu thereof:
WHEREAS, ▇▇. ▇▇▇▇▇ ▇▇▇▇▇ has discovered an inventions entitled "Methods
and Apparatus for Measuring Blood Lipoprotein Levels by NMR Spectroscopy" (NCSU
File No. 91-02), and NCSU owns all rights, title, and interest in and to the
Patent Rights (as defined below) pertaining to such invention; and
WHEREAS, ▇▇. ▇▇▇▇▇ ▇▇▇▇▇ has discovered certain other invention entitled
"Method and Computer Program Products for Determining Risk of Developing Type 2
Diabetes and Other Insulin Resistance Related Disorders" (Serial Nos. 09/550,359
and PCT/US00/10463), and "Methods, Systems, and Computer Program Products for
Analyzing and Presenting NMR Lipoprotein-Based Risk Assessment Results" (Serial
No. 09/258,740 and 09/291,736), and NCSU and LICENSEE jointly own all rights,
title, and interest in and to the Patent Rights (as defined below) pertaining to
such other inventions; and
2. The second (2/nd/) and third (3/rd/) recitals are amended to change, in all
instances, the word "invention" to "inventions".
3. Article 1.01 shall be deleted in its entirety and the following
substituted in lieu thereof:
1.01 "Patent Rights" shall mean:
(a) U.S. Patent No. 5,343,389 "Method and Apparatus for Measuring
Classes and Subclasses of Lipoproteins" (filed June 17, 1993;
issued August 30, 1994) (the "Issued Patent").
(b) U.S. Patent Application No. [**] "Methods and Computer Program
Products for Determining Risk of Developing Type 2 Diabetes and
Other Insulin Resistance Related Disorders" (filed [**]); and
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(c) [**] "Methods and Computer Program Products for Determining Risk of
Developing Type 2 Diabetes and Other Insulin Resistance Related
Disorders" (filed [**]); and
(d) U.S. Patent Application No. [**] "Methods, Systems, and Computer
Program Products for Analyzing and Presenting NMR Lipoprotein-Based
Risk Assessment Results" (filed [**]); and
(e) U.S. Patent Application No. [**] "Methods Systems, and Computer
Program Products for Analyzing and Presenting NMR Lipoprotein-Based
Risk Assessment Results" (filed [**]) (collectively, the inventions
listed as subitems (b) through (e) are referred to as the "Patent
Applications").
The term "Patent Rights" shall further include: letters patents, utility
models, allowances and applications therefor in all countries of the world,
including re-issues, re-examinations, continuations, continuations-in-part,
divisionals and all corresponding foreign patents (as presently or hereafter
comprised) relating to the Patent Applications.
4. Article 1.03 is amended to add the following immediately following the
last sentence of such Article:
As used in this Article 1.03, "unexpired claims" shall not include those
claims of Patent Applications that are canceled during patent prosecution.
5. Article 1.04 shall be appended to add the following sentence to
immediately follow the last sentence of such Article:
As used in this Article 1.04, "unexpired claims" shall not include those
claims of Patent Applications that are canceled during patent prosection.
6. Article 5 is deleted and the following substituted in lieu thereof:
5.01 NCSU shall select patent counsel and shall have sole responsibility
for filing, prosecuting and maintaining appropriate U.S. and foreign
patent application(s) on the Issued Patent in the name of NCSU, and all
expenses of such protection shall be paid by LICENSEE. NCSU shall keep
LICENSEE advised as to the prosecution of such application by forwarding
to LICENSEE copies of all official correspondence relating thereto.
LICENSEE agrees to cooperate with NCSU in the prosecution of such Issued
Patent to insure that such Issued Patent reflects, to the best of NCSU's
and LICENSEE'S knowledge, all items of commercial, scientific and
technical interest and importance. All final decisions with respect to
the prosecution of said patent application are reserved to NCSU.
5.02 With respect to the Issued Patent, LICENSEE shall designate the
foreign countries, if any, in which LICENSEE desires patent protection,
and NCSU agrees to file, prosecute and maintain appropriate applications
in such countries.
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LICENSEE shall pay all expenses with regard to such foreign patent
protection. NCSU may elect to seek patent protection in countries not so
designated by LICENSEE, in which case NCSU shall be responsible for all
expenses attendant thereto; however, in such instances, LICENSEE shall
forfeit its rights under this license agreement as to such countries.
5.03 LICENSEE shall select patent counsel of its choice and shall have
sole responsibility for filing, prosecuting and maintaining appropriate
U.S. and foreign patent application(s) on the Patent Applications in the
joint name of LICENSEE and NCSU, and all expenses of such protection of
Patent Rights shall be paid by LICENSEE. LICENSEE must keep NCSU advised
as to the prosecution of such application by forwarding to NCSU copies of
all official correspondence relating thereto. Further, LICENSEE will give
full consideration to any suggestions and comments from NCSU regarding
the prosecution of the Patent Applications. NCSU agrees to cooperate with
LICENSEE in the prosecution of the patent application(s) on the Patent
Applications to ensure that such applications reflect, to the best of
LICENSEE'S and NCSU's knowledge, all items of commercial, scientific, and
technical interest and importance. All final decisions with respect to
the prosecution of the Patent Application(s) are reserved to LICENSEE.
Should LICENSEE elect not to file a foreign application related to a
Patent Application, NCSU may elect to file at its sole discretion and
expense. Should NCSU make such election, then LICENSEE forfeits all
rights to the Patent Applications in the affected country and will assign
the Patent Rights in that country to NCSU.
Article 5.04 For each country in which Licensed Products will be sold,
Licensee agrees to ▇▇▇▇ all Licensed Products it commercializes with the
applicable patent number.
Except to the extent provided above, the terms and conditions of the original
License Agreement remain in full force and effect as originally executed.
IN WITNESS WHEREOF, the parties have executed this AMENDMENT on the dates set
forth below.
NORTH CAROLINA STATE UNIVERSITY LIPOMED, INC.
/s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
------------------------------------ -------------------------------------
By: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ By: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
Title: Vice Chancellor, Research Title: CEO
and Graduate Studies
Date: 1/10/01 Date: 1/10/01
------------------------------ -------------------------------------
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