EXECUTION ORIGINAL
MAMMASTATIN SUBLICENSE AGREEMENT
This Mammastatin Sublicense Agreement (this "Agreement") is made as of
November 30, 2001, by and between Biotherapies Incorporated, a Michigan
corporation ("BIOTHERAPIES"), and Genesis BioVentures, Inc., a New York
corporation ("GBI").
W I T N E S S E T H:
WHEREAS, BIOTHERAPIES is the licensee under an exclusive, world-wide
license agreement with The Regents of The University of Michigan, a
constitutional corporation of the State of Michigan (hereafter "Michigan"),
dated March 29, 1996 (the "Michigan License"), relating to: (i) the human
mammary cell growth inhibitor protein known as Mammastatin (the "Protein"); and
(ii) the 3C6 and 7G6 monoclonal antibodies directed against the Protein, and
making and using the same (the "Antibodies"); both as described in the Michigan
License (Protein and Antibodies collectively, the "Michigan Technology") which
is attached to this Agreement as EXHIBIT A; and
WHEREAS, through its use and practice of the Michigan Technology,
BIOTHERAPIES has developed a dot blot diagnostic assay related to the detection
and measurement of the Protein in human blood samples which is more fully
described in EXHIBIT B attached to this Agreement (the "Mammastatin Serum
Assay");
WHEREAS, GBI and BIOTHERAPIES were members of Biomedical Diagnostics, LLC
(the "LLC") and BIOTHERAPIES has granted certain rights to the Michigan
Technology and the Mammastatin Serum Assay to the LLC pursuant to the terms of
an Amended and Restated Limited Liability Company Operating Agreement, dated as
of November 4, 1998, and executed on August 6, 1999 (the "Operating Agreement"),
which license is superceded by this Agreement;
WHEREAS, pursuant to the terms of a Purchase Agreement dated even date
herewith, GBI acquired all of BIOTHERAPIES' membership interest in the LLC (the
"Purchase Agreement"); and
WHEREAS, GBI desires to receive a sublicense to use the Protein and
Antibodies in the practice of the Mammastatin Serum Assay and in the research
and development of other diagnostic assays related to breast cancer, and to
receive a license to make, use and sell the Mammastatin Serum Assay, and
BIOTHERAPIES is willing to grant such sublicense and license under the terms and
conditions hereinafter set forth;
NOW, THEREFORE, in consideration of the mutual promises and undertakings
hereinafter set forth, the parties hereto agree as follows.
ARTICLE I
DEFINITIONS
As used herein, the following terms shall have the following meanings:
1.1 "ADDITIONAL PRODUCTS" has the meaning set forth in Section 2.3 of
this Agreement.
1
EXECUTION ORIGINAL
1.2 "AFFILIATE" shall mean any individual, corporation, partnership,
proprietorship or other entity controlled by, controlling, or under common
control with a party through equity ownership, ability to elect directors, or by
virtue of a majority of overlapping directors, and shall include any individual,
corporation, partnership, proprietorship or other entity directly or indirectly
owning, owned by or under common ownership with such party to the extent of
fifty percent (50%) or more of the voting shares, including shares owned
beneficially by such party. For purposes of this Agreement, GBI shall not be
deemed to be an Affiliate of BIOTHERAPIES, and BIOTHERAPIES shall not be deemed
to be an Affiliate of GBI.
1.3 "ANTIBODIES" has the meaning set forth in the recitals of this
Agreement.
1.4 "GROSS SALES" shall mean the sum of all amounts received and all other
consideration received (or, if in a form other than cash or cash equivalents,
the fair market value of the consideration when received) by GBI or its
Affiliates and sublicensees from persons or entities due to or by reason of the
sale, distribution or use of Licensed Products, Licensed Technology, Additional
Products and/or Improvements, including without limitation from the
administration of diagnostic tests and the provision of related services.
1.5 "IMPROVEMENTS" shall mean (i) any alteration, modification or
enhancement to an invention which changes or improves the effectiveness,
efficiency, performance or other attribute of, or related to, an invention, or
any element thereof, and (ii) any new product or material which performs
substantially the same function as the invention, but does so through a
different method or process, regardless of whether the new product or material
is independently patentable or was created based on the invention.
1.6 "KNOW-HOW" means all technical information, experimental data and
other expert knowledge possessed by BIOTHERAPIES regarding the formulation,
manufacture and/or use of, or required to implement, the Protein, Antibodies
and/or Mammastatin Serum Assay, to the extent BIOTHERAPIES has control or
access as of the date of this Agreement.
1.7 "LICENSED PRODUCTS" shall mean any article, composition, apparatus,
substance, chemical, or any other material that utilizes the Licensed
Technology.
1.8 "LICENSED TECHNOLOGY" means the Michigan Technology, Mammastatin
Serum Assay, Know How and/or any one or more of the Patents.
1.9 "MAMMASTATIN SERUM ASSAY" has the meaning set forth in the recitals
hereto.
1.10 "MICHIGAN LICENSE" has the meaning set forth in the recitals hereto.
1.11 "MICHIGAN TECHNOLOGY" has the meaning set forth in the recitals of
this Agreement.
1.12 "NET REVENUES" shall mean Net Sales less the four percent (4%) royalty
paid to Michigan pursuant to the terms of Section 3.1(a).
2
EXECUTION ORIGINAL
1.13 "NET SALES" shall mean Gross Sales, less
(a) the following deductions and offsets, but only to the extent such
sums were first included in the computation of Gross Sales, or are paid by GBI
and not otherwise reimbursed: refunds, rebates, replacements or credits actually
allowed and taken by purchasers for return of Licensed Products, the Licensed
Technology or the Additional Products; customary trade, quantity and cash
discounts actually allowed and taken;
(b) the following items, but only to the extent such sums were
actually paid by GBI, its Affiliates or sublicensees and not otherwise
reimbursed: excise, value-added, and sales taxes actually paid by GBI, its
Affiliates or sublicencees for Licensed Products or Licensed Technology; and
shipping and handling charges actually paid by GBI, its Affiliates or
sublicensees for Licensed Products or Licensed Technology.
1.14 "OPERATING AGREEMENT" has the meaning set forth in the recitals
hereto.
1.15 "PATENTS" shall mean all patents and patent applications, as well as
all foreign equivalent patent applications and Patent Cooperation Treaty
filings, and all patents issuing therefrom, in which Michigan and/or
BIOTHERAPIES has or acquires a property interest, (i) which cover an invention
included in the Licensed Technology, and (ii) which BIOTHERAPIES has the right
to sublicense and/or license.
1.16 "P&O LICENSE" shall mean that certain exclusive license to prostate
and ovarian technology by and between GBI and BIOTHERAPIES of even date
herewith.
1.17 "PROTEIN" has the meaning set forth in the recitals hereto.
1.18 "PURCHASE AGREEMENT" has the meaning set forth in the recitals hereto.
1.19 "ROYALTY QUARTER" shall mean the three-month periods ending on the
last day of March, June, September and December of each year.
1.20 "SUPPLY AGREEMENT" shall mean that certain supply agreement by and
between GBI and BIOTHERAPIES of even date herewith.
1.21 "TERM" shall have the meaning set forth in Section 13.6.
1.22 "VALID CLAIM" shall mean any claim in an unexpired patent or pending
in a patent application included within the Patents which has not been held
unenforceable, unpatentable, or invalid by a decision of a court or other
governmental agency of competent jurisdiction, unappealable or unappealed within
the time allowed for appeal, and which has not bee admitted to be invalid or
unenforceable through the reissue or disclaimer. If in any country there should
be two or more such decisions conflicting with respect to the validity of the
same claim, the decision of the higher or highest tribunal shall thereafter
control; however, should the tribunals be of equal rank, then the decision or
decisions upholding the claim shall prevail when the conflicting decisions are
equal in number, and the majority of decisions shall prevail when the
conflicting decisions are unequal in number.
3
EXECUTION ORIGINAL
ARTICLE II
GRANTS
2.1 EXCLUSIVE SUBLICENSE GRANT. BIOTHERAPIES grants, subject to the
terms of this Agreement, to GBI a worldwide, perpetual and exclusive
sublicense to make, use and sell the Protein and Antibodies solely for use
with the Mammastatin Serum Assay.
2.2 EXCLUSIVE LICENSE GRANT FOR MAMMASTATIN SERUM ASSAY. BIOTHERAPIES
grants, subject to the terms of this Agreement, to GBI a worldwide, perpetual
and exclusive license to make, have made, use and sell the Mammastatin Serum
Assay and Improvements thereto.
2.3 NON-EXCLUSIVE SUBLICENSE GRANT. BIOTHERAPIES grants, subject to the
terms of this Agreement, to GBI a worldwide, perpetual and non-exclusive
sublicense to make, use and create Improvements to Proteins and Antibodies
solely in the research, development and sale of additional antibodies and/or
diagnostic assays solely for the diagnosis of breast, prostate and/or ovarian
cancers ("Additional Products").
2.4 NON-EXCLUSIVE LICENSE GRANT. BIOTHERAPIES grants, subject to the terms
of this Agreement, to GBI a worldwide, perpetual and non-exclusive license to
make, have made, use and create Improvements to the Mammastatin Serum Assay and
the Know-How solely in the research, development and sale of Additional
Products.
2.5 OPERATING AGREEMENT MAMMASTATIN LICENSE. The license granted by
BIOTHERAPIES to the LLC for certain rights to the Michigan Technology and the
Mammastatin Serum Assay under the Operating Agreement is hereby replaced in its
entirety by the license granted under this Agreement, and all licenses granted
by BIOTHERAPIES to the LLC under the Operating Agreement are hereby made void
and are of no effect from and after the date of this Agreement. In its capacity
as the sole member of the LLC, GBI hereby amends the Operating Agreement to give
full effect to this Section 2.5.
2.6 SUBLICENSES.
(a) GBI shall have the exclusive right to grant sublicenses under the
sublicense and licenses granted herein. GBI shall notify BIOTHERAPIES of every
sublicense agreement and each amendment thereto within thirty (30) days after
their execution and shall provide to BIOTHERAPIES a copy of each such agreement
and amendment (subject to the redaction of confidential information of GBI or
its sublicensees, which redaction shall not include financial terms, the name of
the sublicensee, the territory of the sublicense or the scope of the
sublicense).
(b) Any sublicense granted by GBI shall provide for its termination
upon termination of the Michigan License and/or this Agreement; PROVIDED,
HOWEVER, that a sublicensee may, by written notice to BIOTHERAPIES within sixty
(60) days of the sublicensee's receipt of written notice of such termination,
elect to continue the sublicense from Biotherapies. No such election will be
valid unless (1) the sublicense conforms to the requirements of this Section 2,
and (2) the sublicensee agrees in writing at the time of election to assume in
respect to BIOTHERAPIES all of the obligations (including obligations for
payment) contained in its sublicense agreement with GBI.
4
EXECUTION ORIGINAL
(c) All sublicenses shall be consistent with the terms and conditions
of this Agreement, and shall contain acknowledgements by the sublicensee of
Michigan's and BIOTHERAPIES rights in the Michigan Technology, Mammastatin Serum
Assay and Know How, and the disclaimer of warranty and limitation on Michigan's
and BIOTHERAPIES' liability as provided in this Agreement. All sublicenses shall
also contain provisions under which the sublicensee accepts duties to keep
records; to avoid improper representations and responsibilities; to defend, hold
harmless, and indemnify Michigan and BIOTHERAPIES consistent with the
indemnification obligations of GBI hereunder; to control export; to restrict the
use of Michigan's and BIOTHERAPIES' names; and to properly ▇▇▇▇ the Michigan
Technology, Mammastatin Serum Assay and Know How with copyright and/or patent
notices; which duties shall be at least equivalent to those set forth in this
Agreement.
(d) All sublicenses shall provide for each sublicensee to pay taxes
due, if any, in the same manner as set forth in this Agreement, or shall provide
that the sublicensee will be responsible for such taxes should the sublicense be
assigned to BIOTHERAPIES.
(e) All sublicenses shall provide the right for GBI to assign its
rights under the sublicense to BIOTHERAPIES.
2.7 COMMERCIALIZATION EFFORTS.
(a) GBI shall have the responsibility to do all that is necessary
after the date hereof for any governmental approvals to manufacture and/or sell
the Licensed Products or the Licensed Technology, except as otherwise
specifically provided herein with regard to the Patents. GBI agrees to use its
best efforts to manufacture and sell the Licensed Products and the Licensed
Technology, to obtain any government approvals necessary therefor, and to
exploit, market and manufacture the Licensed Products in sufficient quantities
to meet GBI's reasonably anticipated customer demand and to make the benefits of
the Licensed Technology reasonably available to the public.
(b) GBI agrees to manufacture or have manufactured substantially all
of the Licensed Products in the United States.
(c) Subject to the foregoing, GBI shall have the sole discretion for
making all decisions as to how to develop, commercialize, market and sell the
Licensed Products.
2.8 PUBLICATIONS. BIOTHERAPIES shall not, and shall not permit its
employees and investigators to, submit for publication, or publicly present, any
information regarding the Licensed Technology, or the use thereof, unless such
proposed publication or presentation has been reviewed by GBI to allow GBI to
identify and protect its proprietary and confidential information. BIOTHERAPIES
shall provide GBI a copy of such proposed publication or presentation thirty
(30) days prior to its submission for publication or it presentation. In the
event GBI determines that a delay in publication or presentation is necessary
for GBI to protect or perfect its proprietary rights, BIOTHERAPIES shall delay
such publication or presentation for a period of up to three (3) months in order
to allow such protection to be put in place.
5
EXECUTION ORIGINAL
2.9 RESERVATION OF RIGHTS. All rights not expressly granted to GBI are
reserved by BIOTHERAPIES and Michigan, and GBI may not use the Michigan
Technology, the Mammastatin Serum Assay and/or the Know How except as expressly
authorized herein. GBI acknowledges that Michigan and BIOTHERAPIES reserve the
right to practice the Michigan Technology and Patents solely for research and
education purposes, and that Michigan reserves the right to grant to the U.S.
Government a nonexclusive, irrevocable, royalty-free license or licenses, with
the right to sublicense, to all patent applications and resulting patents
included in the Michigan Technology and the Patents, to the extent that such
grant of license(s) is or may be required by research funding agreements between
Michigan and the U.S. Government relating to the Michigan Technology or the
Patents.
2.10 PRODUCT MARKING. GBI shall ▇▇▇▇, and require its Affiliates and
sublicensees to ▇▇▇▇ the Licensed Products or the Licensed Technology with the
appropriate patent and copyright notices as approved by Michigan and
BIOTHERAPIES (when appropriate), such approval not to be unreasonably withheld.
2.11 TRANSFER. Within fifteen (15) days of the date hereof, BIOTHERAPIES
shall provide GBI with the information and materials in its possession listed in
Exhibit C, relating to the Licensed Technology reasonably necessary or useful to
enable GBI to develop, design, manufacture, have manufactured, use and sell the
Licensed Technology in accordance with this Agreement. Thereafter, BIOTHERAPIES
shall supply such assistance as is reasonably requested by GBI, subject to the
parties' agreement regarding payment therefor; GBI shall not pay BIOTHERAPIES
for remedial work relating to errors or omissions in the transfer of technology
described herein.
ARTICLE III
ROYALTY AND OTHER PAYMENT OBLIGATIONS
3.1 ROYALTY.
(a) During the Term, GBI shall pay Michigan, with respect to each
Royalty Quarter, a royalty equal to four percent (4%) of Net Sales of GBI, its
Affiliates and its sublicensees for all Licensed Technology and/or Improvements.
Such payments shall be made in accordance with the terms of Section 6 of the
Michigan License, with copies of all reports and checks to BIOTHERAPIES.
(b) In addition to the royalties payable to Michigan pursuant to
Section 3.1(a) above, GBI shall pay to BIOTHERAPIES during the Term and subject
to the terms and conditions of this Agreement, a royalty equal to the percentage
set forth below of the Net Revenues of GBI, its Affiliates and its sublicensees
during such calendar year. This royalty shall be calculated quarterly.
CALENDAR YEAR - CUMULATIVE NET SALES ROYALTY
------------------------------------- -------
Up to $100 million 10%
$100 million to $300 million 15%
Greater than $300 million 20%
6
EXECUTION ORIGINAL
(c) The amount of the royalties payable to BIOTHERAPIES for each
calendar year of the Term will in no event be less than eight percent (8%) of
Gross Sales during a calendar year. If at the end of a calendar year, the amount
of royalties payable to BIOTHERAPIES pursuant to Section 3.1(b) is less than
eight percent (8%) of Gross Sales, GBI shall pay to BIOTHERAPIES the amount
equal to eight percent (8%) of Gross Sales, minus the amount of total royalties
already paid for such calendar year.
3.2 MONTHLY MINIMUM ROYALTY. Commencing one (1) year from the date
hereof, GBI shall make a non-refundable minimum royalty payment of Fifty
Thousand Dollars ($50,000) per calendar month, which payment shall be due on
the first business day of each month beginning on the thirteenth month after
the Closing Date. Such minimum monthly payments shall be credited against the
royalty payments set forth in Section 3.1 for the calendar year in which such
payment is made in accordance with Article IV.
3.3 PENALTY PAYMENT. In the event that GBI fails to make a scheduled
royalty payment when due under this Section 3 and does not cure such default
within sixty (60) days, GBI shall pay penalty interest at a rate equal to twenty
percent (20%) per annum on any such past due royalty due to BIOTHERAPIES under
Section 3.1(b) (such interest to accrue and be payable without written notice of
any kind to GBI). GBI shall pay interest to Michigan for any late payments in
accordance with the terms of Section 6 of the Michigan License.
3.4 CURRENCY OF PAYMENTS. All payments under this Agreement shall be made
in U.S. Dollars by wire transfer to such bank account as BIOTHERAPIES may
designate from time to time. Any payments due hereunder on Net Sales outside of
the United States shall be payable in U.S. Dollars at the average of the rate of
exchange of the currency of the country in which the Net Sales are made as
reported in the New York edition of THE WALL STREET JOURNAL, for the last three
(3) business days of the quarter for which the royalties are payable.
Notwithstanding the foregoing, all payments to Michigan made pursuant to Section
3.1 above shall be made in accordance with the terms of Section 6 of the
Michigan License.
3.5 TAX WITHHOLDING. If laws or regulations require the withholding of
income taxes owed by BIOTHERAPIES on account of royalties accruing under this
Agreement, such taxes shall be deducted on a country-by-country basis by GBI
from such remittable royalty and will be paid by it to the proper taxing
authority. Proof of payment shall be secured and sent to BIOTHERAPIES as
evidence of such payment.
3.6 OBLIGATION TO PAY ROYALTIES. The obligation to pay a royalty under
this Section 3 is imposed only once with respect to the same unit of Licensed
Products or Licensed Technology. However, for purposes of determination of
payments due hereunder, whenever the term Licensed Products or Licensed
Technology may apply to a property during various stages of manufacture, use
or sale, Net Sales, as otherwise defined, shall be derived from the sale,
distribution or use of such Licensed Products or Licensed Technology and/or
Improvements by GBI, its Affiliates and/or sublicensees at the stage of its
highest invoiced value to unrelated third parties.
7
EXECUTION ORIGINAL
ARTICLE IV
RECORDS, REPORTS, PAYMENTS
4.1 REPORTS AND PAYMENTS. Within thirty (30) days after the close of each
Royalty Quarter during the term of this Agreement (including the close of any
Royalty Quarter immediately following any termination of this Agreement), GBI
shall report to BIOTHERAPIES all royalties accruing to BIOTHERAPIES during such
Royalty Quarter. On or before February 15 of each calendar year, GBI shall
submit a final report to BIOTHERAPIES detailing the royalties payable to
BIOTHERAPIES for the prior year, and include therewith payment of all royalties
owed to BIOTHERAPIES in accordance with Section 3.1(b) and 3.1(c), less the
total of any monthly minimum royalty payments actually received by BIOTHERAPIES
during the applicable calendar year in accordance with Section 3.2.
4.2 INFORMATION. Each quarterly report, and the final report, shall
indicate for each Royalty Quarter all Gross Sales during such Royalty Quarter,
the Net Sales during the Royalty Quarter and the Net Revenue during the Royalty
Quarter, and the amount of the corresponding royalty payments to be made, as
well as the various calculations used to arrive at said amounts, including the
quantity, description of item sold or services provided, country of manufacture
and country of sale. In case no royalty has accrued for any Royalty Quarter, GBI
shall so report.
4.3 NOMENCLATURE. GBI covenants that it will promptly establish and
consistently employ a system of specific nomenclature and type designations for
the Licensed Products and Licensed Technology and/or Improvements so that
various types can be identified and segregated, where necessary. GBI, its
Affiliates and sublicensees shall consistently employ such system when rendering
invoices thereon and henceforth agree to inform BIOTHERAPIES, or its auditors,
when requested as to the details concerning such nomenclature system as well as
to all additional thereto and changes therein.
4.4 BOOKS AND RECORDS. GBI shall keep, and shall require its Affiliates
and sublicensees to keep, true and accurate records and books of account
containing data reasonably required for the computation and verification of
payments to be made as provided by this Agreement, which records and books
shall be open for inspection upon reasonable notice during business hours by
either BIOTHERAPIES, Michigan and/or either's auditor(s) or an independent
certified accountant selected by BIOTHERAPIES or Michigan, for the purpose of
verifying the amount of payments due and payable. Said right of inspection
will exist for six (6) years from the date of filing of the report for the
Royalty Quarter to which such records and books of account relate in support
thereof, and this requirement and right of inspection shall survive any
termination of this Agreement. BIOTHERAPIES and/or Michigan shall be
responsible for all expenses of such inspection, except that if such
inspection reveals an underpayment of royalties to BIOTHERAPIES in excess of
ten percent (10%), then said inspection shall be at GBI's expense and such
underpayment shall become immediately due and payable to BIOTHERAPIES.
4.5 CERTIFICATION. The reports provided for hereunder shall be
certified by an authorized representative of GBI to be correct to the best of
GBI's knowledge and information.
8
EXECUTION ORIGINAL
ARTICLE V
PATENT PROSECUTION
5.1 PATENT PROSECUTION. The prosecution, filing and maintenance of all
Patents shall be the right and responsibility of BIOTHERAPIES, subject to the
terms and provisions of Section 10 of the Michigan License. Payment of all fees
and costs relating to the filing, prosecution, and maintenance, including
re-examinations, interferences, and inter-parties proceedings of the Patents
shall be the responsibility of BIOTHERAPIES.
5.2 ABANDONMENT. In the event that, pursuant to the terms of Section 10.2
of the Michigan License, BIOTHERAPIES, and thereafter Michigan, determine to
refrain from or to cease prosecuting or maintaining any of the Patents,
BIOTHERAPIES will notify GBI and the parties will discuss the terms under which
GBI shall receive the rights to prosecute and/or maintain such Patents;
PROVIDED, HOWEVER, that the granting of such rights will be solely within the
discretion of BIOTHERAPIES and Michigan.
ARTICLE VI
INFRINGEMENT/ENFORCEMENT
6.1 INFRINGEMENT BY THIRD PARTIES. If, during the Term, the Licensed
Technology, or any item thereof, is or appears to be infringed by a third party,
then the party having knowledge thereof shall notify the other party and the two
parties shall consult to consider what, if any, action should be taken. GBI
acknowledges and agrees that BIOTHERAPIES and Michigan shall have the first and
second right to police the Licensed Technology against infringement by third
parties pursuant to the terms of Section 11 of the Michigan License.
6.2 GBI'S RIGHTS OF ENFORCEMENT. In the event that neither BIOTHERAPIES
nor Michigan takes any action pursuant to Section 11 of the Michigan License
within one hundred twenty (120) days of a written request by GBI to do, then
GBI shall have the right to take such action at its expense and BIOTHERAPIES
shall use reasonable efforts to cooperate in such action at GBI's expense.
GBI shall have and retain control of such action, but may not settle any such
action without the prior express written consent of BIOTHERAPIES and
Michigan, which shall not be unreasonably withheld.
6.3 EXPENSES AND AWARDS. If legal proceedings are commenced pursuant to
Sections 6.1 or 6.2 above, all fees and costs incurred therein shall be borne by
the prosecuting party(ies). Such parties shall be reimbursed for such costs and
expenses from any damages and awards recovered. The remaining damages and awards
shall be deemed Net Sales to GBI and shall be included in the royalty
calculation under Section 3.1.
9
EXECUTION ORIGINAL
ARTICLE VII
PRODUCT LIABILITY
7.1 GBI INDEMNIFICATION.
(a) GBI shall defend, indemnify and hold harmless and shall require
its Affiliates and sublicensees to defend, indemnify and hold harmless
BIOTHERAPIES, its Affiliates, Michigan, its fellows, officers, employees and
agents, for and against any and all claims, demands, damages, losses, and
expenses of any nature (including reasonable attorneys' fees and other
litigation expenses), resulting directly or indirectly from, but not limited to,
death, personal injury, illness, property damage, economic loss or products
liability arising from or in connection with, any of the following:
(i) any manufacture, use, sale or other disposition by GBI, its
Affiliates and/or sublicensees or transferees of any Licensed Products or
Licensed Technology and/or Improvements;
(ii) the direct or indirect use by any person of Licensed
Products or Licensed Technology and/or Improvements made, used, sold or
otherwise distributed by GBI, its Affiliates or sublicensees;
(iii) the use by GBI, its Affiliates or its sublicensees of any
invention or computer software related to the Licensed Products, Licensed
Technology, Improvements or Patents.
(b) BIOTHERAPIES and/or Michigan shall be entitled to participate at
its option and expense through counsel of its own selection, and may join in any
legal actions related to any such claims, demands, damages, losses and expenses
under Section 7.1(a) above.
7.2 DISCLAIMERS. IN ADDITION TO THE DISCLAIMERS CONTAINED IN SECTION
11.4 BELOW, NEITHER MICHIGAN, BIOTHERAPIES, THEIR AFFILIATES, FELLOWS,
DIRECTORS, OFFICERS, STAFF, EMPLOYEES OF ALL TYPES, NOR AGENTS, OF ANY AND
ALL OF THOSE ENTITIES MAKE ANY REPRESENTATION OR WARRANTY OF ANY KIND WITH
RESPECT TO THE LICENSED TECHNOLOGY AND THEY EXPRESSLY DISCLAIM ANY WARRANTIES
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AND ANY OTHER IMPLIED
WARRANTIES WITH RESPECT TO THE VALIDITY, CAPABILITIES, SAFETY, UTILITY, OR
COMMERCIAL APPLICATION OF THE LICENSED TECHNOLOGY.
7.3 BIOTHERAPIES INDEMNIFICATION.
(a) BIOTHERAPIES agrees to defend GBI and its Affiliates against any
third party claims, demands or suits ("Claim") alleging that such parties'
authorized use of the Licensed Technology, or any element thereof, infringes a
third party's U.S. copyright, trade secret, patent or other intellectual
property rights. BIOTHERAPIES shall indemnify and hold GBI and its Affiliates
harmless from any and all damages, fines, penalties, costs, expenses and fees
(including reasonable attorneys' fees) awarded or assessed against them as a
result of such Claim, or reached through a negotiated settlement of the Claim.
10
EXECUTION ORIGINAL
(b) This indemnification extends only to the Licensed Technology
delivered by BIOTHERAPIES and does not extend (i) to any modifications or
Improvements created by or at the direction of GBI and its Affiliates; or (ii)
to any Claim arising out of the combination of the Licensed Technology and any
other code, software, hardware or any other products, provided that such
infringement would not have occurred but for such combination.
(c) In order to receive the indemnification in this Section, the Claim
must take place in the United States or in any country where BIOTHERAPIES is
conducting business and in which BIOTHERAPIES has obtained an issued patent
covering the Licensed Technology; GBI must promptly notify BIOTHERAPIES of the
assertion of the Claim; allow BIOTHERAPIES to retain sole and exclusive control
over the defense and/or settlement of the Claim; and cooperate with
BIOTHERAPIES, at BIOTHERAPIES' expense, in the defense and/or settlement of the
Claim.
(d) This Section sets forth BIOTHERAPIES' sole and exclusive
obligations, and GBI's sole and exclusive remedies, with respect to
indemnification of GBI and any liability, under any other theory, arising out of
a Claim described above.
ARTICLE VIII
EXPORT CONTROLS
This Agreement shall be subject to all United States laws and regulations
now or hereafter applicable to the subject matter of this Agreement. GBI shall
comply, and shall require all of its Affiliates and sublicensees to comply, with
all provisions of any applicable laws, regulations, rules and orders relating to
the license herein granted and to the testing, production, transportation,
export, packaging, labeling, sale or use of the Licensed Technology and/or
Additional Products, or otherwise applicable to GBI's or its Affiliates' or
sublicensees' activities hereunder. GBI shall obtain, and shall require its
Affiliates and sublicensees to obtain, such written assurances regarding export
and re-export of technical data (including products made by use of technical
data) as may be required by the Office of Export Administration Regulations, and
GBI hereby gives such written assurances as may be required under those
regulations to BIOTHERAPIES.
ARTICLE IX
NON-USE OF NAMES
GBI agrees to refrain from using, and to require its Affiliates and
sublicensees to refrain from using, the name of Michigan and/or BIOTHERAPIES in
publicity or advertising without the prior written approval of Michigan and/or
BIOTHERAPIES, as applicable. Reports in scientific literature and presentations
of joint research and development work are not considered publicity. In
addition, each party agrees that it shall not use the names of the other party
or such other party's Affiliates or any of their employees, or any adaptation
thereof, in any advertising, promotional or sales literature without written
consent of such other party, except that GBI may state that it is licensed by
BIOTHERAPIES under one or more Patents.
11
EXECUTION ORIGINAL
ARTICLE X
ASSIGNMENT
Due to the unique relationship between the parties, this Agreement shall
not be assignable by either party without the prior express written consent of
the other party. Any attempt to assign this Agreement without such consent shall
be void from the beginning. Neither party shall unreasonably withhold consent
for the other party to assign this Agreement to a purchaser of all or
substantially all of that party's assets or business. No assignment shall be
effective unless and until the intended assignee agrees in writing to accept all
of the terms and conditions of this Agreement. Further, GBI shall refrain from
pledging any of the license rights granted in this Agreement as security for any
creditor.
ARTICLE XI
REPRESENTATIONS, WARRANTIES AND RELATED COVENANTS; ADDITIONAL
DISCLAIMERS AND LIMITATIONS ON LIABILITY
11.1 MAMMASTATIN LICENSE MILESTONES. BIOTHERAPIES warrants that all
milestones set forth under Section 7.3 of the Michigan License have been met in
regard to the diagnostic applications of the technology and that it will obtain
agreement that such milestones have been met from the University of Michigan
within sixty (60) days of the date hereof. Such agreement by Michigan shall be
appended to this Agreement as EXHIBIT D.
11.2 BIOTHERAPIES INTELLECTUAL PROPERTY.
BIOTHERAPIES represents and warrants that as of the date of this Agreement:
(a) it owns or has the exclusive license to the Licensed Technology
free and clear of all liens or claims;
(b) it has the rights to grant the licenses and sublicense hereunder;
(c) no other sublicenses have been granted to the Licensed Technology
under any Patent; and
(d) to BIOTHERAPIES' actual knowledge, the Licensed Technology does
not infringe on the intellectual property rights of any third party.
Additionally, BIOTHERAPIES covenants not to grant any other sublicense(s) and/or
licenses under the Licensed Technology in violation of the sublicenses and
licenses granted to GBI herein.
11.3 MICHIGAN LICENSE. BIOTHERAPIES shall not terminate nor breach the
Michigan License during the Term; PROVIDED, HOWEVER, that BIOTHERAPIES shall not
be liable for any breach of an obligation of BIOTHERAPIES under the Michigan
License that is to be performed by GBI pursuant to the terms hereof.
11.4 BIOTHERAPIES DISCLAIMERS AND LIMITATIONS. Nothing in this Agreement
shall be construed as:
12
EXECUTION ORIGINAL
(a) a warranty or representation that anything made, used, sold or
otherwise disposed of under any license granted in this Agreement is or will be
free from infringement of patents of third parties (except as provided in
Section 11.2 above);
(b) an obligation to bring or prosecute actions or suits against third
parties for patent infringement (except as provided in Section 6.1 above); or
(c) conferring by implication, estoppel or otherwise any license or
rights under any patents of BIOTHERAPIES other than Patents as defined herein,
regardless of whether such patents are dominant or subordinate to the Patents.
(d) EXCEPT AS OTHERWISE PROVIDED HEREIN, THE LICENSED TECHNOLOGY IS
LICENSED UNDER THIS AGREEMENT "AS IS" WITHOUT ANY REPRESENTATIONS OR WARRANTIES
OF ANY KIND OR NATURE. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING,
BIOTHERAPIES DOES NOT WARRANT THE PERFORMANCE, COMPLETENESS OR ACCURACY OF THE
LICENSED TECHNOLOGY, OR ANY RESULTS OR SUCCESS TO BE ACHIEVED THROUGH THE
MANUFACTURE, SALE, DISTRIBUTION OR USE OF THE LICENSED TECHNOLOGY. BIOTHERAPIES
DISCLAIMS, AND GBI EXPRESSLY WAIVES, ALL WARRANTIES, WHETHER EXPRESS, IMPLIED
AND/OR STATUTORY, INCLUDING, WITHOUT LIMITATION ANY WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
11.5 MICHIGAN DISCLAIMERS AND LIMITATIONS.
(a) Michigan, including its fellows, officers, employees and agents,
makes no representations or warranties that any Patents is or will be held
valid, or that the manufacture, use, sale or other distribution of the Michigan
Technology and/or Improvements will not infringe upon any patent or other rights
not vested in Michigan.
(b) Michigan, including its fellows, officers, employees and agents,
makes no representations, extends no warranties of any kind, either express or
implied, including but not limited to the implied warranties of merchantability
or fitness for a particular purpose, and assumes no responsibilities whatever
with respect to design, development, manufacture, use, sale or other disposition
by BIOTHERAPIES, GBI and their Affiliates and/or sublicensees of Michigan
Technology and/or Improvements.
(c) The entire risk as to performance of the Michigan Technology is
assumed by BIOTHERAPIES, GBI and their Affiliates and/or sublicensees. In no
event shall Michigan, including its fellows, officers, employees and agents, be
responsible or liable for any direct, indirect, special, incidental, or
consequential damages, or lost profits or other economic loss or damage, to
BIOTHERAPIES, GBI, and/or their Affiliates and/or sublicensees or any other
individual or entity regardless of legal theory. The above limitations on
liability apply even through Michigan, its fellows, officers, employees or
agents may have been advised of the possibility of such damage.
(d) GBI shall not, and shall require that its Affiliates and
sublicensees do not, make any statements, representations or warranties or
accept any liabilities or responsibilities whatsoever to or with regard to any
person or entity which are inconsistent with any disclaimer or limitation
included in this Section 11.5.
13
EXECUTION ORIGINAL
11.6 BIOTHERAPIES LIMITATION OF LIABILITY. Except as in association with
BIOTHERAPIES' indemnification obligations under this Agreement, in no event
shall BIOTHERAPIES be liable or responsible to GBI, its Affiliates and/or
sublicensees, regardless of the form of action or theory of recovery, in
association with this Agreement and/or the Licensed Technology, for any (a)
indirect, special, exemplary, consequential, incidental or punitive damages,
even if BIOTHERAPIES has been advised of the possibility of such damages; (b)
lost profits, lost revenue, lost business expectancy, benefit of the bargain
damages, business interruption losses or loss of data; or (c) direct damages in
an amount in excess of all of the royalty fees paid to BIOTHERAPIES under this
Agreement preceding the event giving rise to the claim against BIOTHERAPIES.
ARTICLE XII
INSURANCE
Prior to any distribution of any Licensed Products or Licensed Technology
and/or Improvements by GBI or any Affiliate, GBI shall purchase and maintain in
effect a policy of product liability insurance. Prior to any distribution of any
Licensed Products or Licensed Technology and/or Improvements by a sublicensee of
GBI, GBI shall require that the sublicensee shall purchase and maintain in
effect a policy of product liability insurance. Each such insurance policy shall
provide reasonable coverage for all claims with respect to any Licensed Products
or Licensed Technology and/or Improvements manufactured, sold, licensed or
otherwise distributed by GBI and its Affiliates --- or, in the case of a
sublicensee's policy, by said sublicensee --- and shall specify BIOTHERAPIES,
its Affiliates, MICHIGAN, including its fellows, officers and employees, as an
additional insured. GBI shall furnish certificates of such insurance to
BIOTHERAPIES upon request.
ARTICLE XIII
TERMINATION
13.1 TERMINATION BY BIOTHERAPIES. IF GBI SHALL:
(a) fail to meet its funding obligation under Section 5.15 of the
Purchase Agreement;
(b) fail to make any royalty payment when due pursuant to Section 3.1,
and such payment default shall not be cured within sixty (60) days from the date
the royalty payment is due;
(c) materially breach this Agreement;
(d) fail to achieve aggregate Gross Sales of Licensed Technology and
Additional Products hereunder and under the P&O License of $7,500,000 within
twenty four (24) months of the date of this Agreement; or
(e) fail to achieve aggregate Gross Sales of Licensed Technology and
Additional Products hereunder and under the P&O License of $20,000,000 within
thirty six (36) months of the date of this Agreement;
14
EXECUTION ORIGINAL
then BIOTHERAPIES shall have the right to declare this Agreement in default by
written notice to GBI. GBI may cure such default if: (i) GBI rectifies the
default condition, and (ii) pays a twenty percent (20%) penalty on any royalty
or payments due to BIOTHERAPIES under this Agreement. If the default is not so
cured within six (6) months of the date of the above described default notice,
then, other then as provided below, this Agreement may be terminated at the
option of BIOTHERAPIES by written notice to that effect. During the period
between the event of a default described above and the expiration of the
applicable cure period, GBI shall have the right to continue to sell and
otherwise use the Licensed Technology, but shall not be permitted to assign or
sublicense the Licensed Technology. Notwithstanding the provisions of this
Section 13.1 above, in case of an event default described in Subsection 13.1(d)
or 13.1(e) above, GBI may, at its discretion, may pay to BIOTHERAPIES cash
sufficient to satisfy the royalty obligation of GBI that would have accrued had
GBI met the Gross Sales targets set forth in subsections. If GBI makes the
royalty payments set forth in the previous sentence within six months of the
date of the last royalty installment for the related initial Gross Sales
milestone period would have been due, the event of default which would otherwise
be deemed to have occurred under subsection 13.1(d) or 13.1(e) as applicable,
shall be deemed cured and this Agreement shall continue in full force and effect
for an additional period of 1 year after such cure payment has been made, at
which point GBI will again be obligated to met the Gross Sales milestone
specified in subsections 13.1(d) and 13.1(e).
13.2 TERMINATION BY MICHIGAN. This Agreement shall terminate simultaneously
with the termination of the Michigan License unless (i) BIOTHERAPIES agrees to
assign this Agreement to Michigan with Michigan's prior express written consent,
or (ii) Michigan and BIOTHERAPIES otherwise agree in writing to preserve the
rights and obligations under this Agreement with GBI.
13.3 TERMINATION BY GBI. GBI shall have the right to terminate this
Agreement at any time by giving notice in writing to BIOTHERAPIES of its intent
to do so at least sixty (60) days prior to a termination date designated in said
notice.
13.4 BANKRUPTCY. If, at any time, either party shall file in any court
pursuant to any statute of any individual state or country, a petition in
bankruptcy, insolvency or for reorganization or for an agreement among creditors
or for the appointment of a receiver or trustee of the party or of its assets,
or if either party proposes a written agreement of composition or extension of
its debts, or if either party shall be served with an involuntary petition
against it filed in any insolvency proceeding, and such petition shall not be
dismissed within sixty (60) days after the filing thereof, or if either party
shall make an assignment for the benefit of creditors, then, in the event of any
of the above, the other party shall have the right to terminate this Agreement
upon written notice to the other.
13.5 GBI'S SUBLICENSES. In the event of any termination under this Article,
GBI shall assign its rights under any further sublicense agreement hereunder to
BIOTHERAPIES, and BIOTHERAPIES shall accept such sublicense, subject to Section
2.5 above. For the purposes of any such sublicensee assuming the position of GBI
in the event of termination of this Agreement, the date of this Agreement for
computation of obligations of the sublicensee shall be the date of this
Agreement.
13.6 TERM. Unless otherwise terminated as provided herein, this Agreement
shall remain in full force and effect for twenty (20) years from the date of
this Agreement.
15
EXECUTION ORIGINAL
13.7 OBLIGATIONS UPON TERMINATION. Upon the expiration or termination of
this Agreement for any reason: (a) all of GBI's license rights shall immediately
cease and neither GBI, its Affiliates or sublicensees shall have any right to
continue making, having made, using, selling and/or creating Improvements to the
Licensed Technology; (b) GBI shall return to BIOTHERAPIES all Licensed
Technology in its possession, and all copies thereof; (c) GBI shall pay to
BIOTHERAPIES all royalties and other amounts that have accrued through the
effective date of any such expiration and termination (and shall timely pay all
royalties and other amounts accruing or discovered after the effective date of
any such expiration and termination); (d) each party shall return the other
party's Confidential Information (defined below), and all copies thereof; and
(e) except in the event of early termination by GBI pursuant to Section 13.3 or
Section 13.4, GBI shall provide and assign to BIOTHERAPIES all GBI Technology
and Additional Products relating to the Licensed Technology, including all of
GBI's rights, title and interests relating thereto.
13.8 SURVIVAL. In addition to any provisions of this Agreement which
specifically provide for survival, the following provisions shall survive any
termination of this Agreement: Articles I, III, IV, VII, VIII, IX, XI, XIII,
XIV, XV, XVI, XVII and XVIII.
ARTICLE XIV
OWNERSHIP
14.1 MICHIGAN TECHNOLOGY. GBI acknowledges and agrees that Michigan has and
shall retain all rights, title and interests, including all intellectual
property rights, in and to all Michigan Technology. Nothing in this Agreement
shall be deemed to transfer any such interests, in whole or in part, to GBI,
except for the sublicense granted herein.
14.2 BIOTHERAPIES TECHNOLOGY. GBI acknowledges and agrees that BIOTHERAPIES
has and shall retain all rights, title and interests, including all intellectual
property rights, in and to the Mammastatin Serum Assay, the Know How, the
Improvements made by BIOTHERAPIES and all other materials provided by
BIOTHERAPIES to GBI under this Agreement (collectively, the "BIOTHERAPIES
Technology"). Nothing in this Agreement shall be deemed to transfer any such
interests, in whole or in part, to GBI, except for the licenses granted herein.
14.3 LLC TECHNOLOGY. The LLC shall have and retain all rights, title and
interests, including all intellectual property rights, in and to all
Improvements to the Licensed Technology made by the LLC prior to the date of
this Agreement. The LLC's rights in the Improvements to the Licensed Technology
are exclusive of Michigan's and BIOTHERAPIES' rights in their respective
technology.
14.4 GBI TECHNOLOGY. GBI shall have and retain all rights, title and
interests, including all intellectual property rights, in and to all Licensed
Products and/or Improvements to the Licensed Technology made by or on behalf of
GBI during the term of this Agreement. GBI's rights in the Licensed Products
and/or Improvements to the Licensed Technology are exclusive of Michigan's and
BIOTHERAPIES' rights in their respective technology.
16
EXECUTION ORIGINAL
ARTICLE XV
CONFIDENTIALITY
15.1 CONFIDENTIAL INFORMATION. During this Agreement, each party may have
access to information that is considered confidential by the other. This
information includes, but is not limited to, the Licensed Technology, technical
know-how, technical specifications, software object code and source code,
protocols, strategic business plans, results of testing, systems, financial
information, product information, methods of operation, customer information,
supplier information, and compilations of data ("Confidential Information").
15.2 USE. Each party shall use the other party's Confidential Information
only for the purposes of this Agreement. Each party shall maintain the
confidentiality of the other party's Confidential Information in the same manner
in which it protects its own Confidential Information of like kind, but in no
event shall either party take less than reasonable precautions to prevent the
unauthorized disclosure or use of the other party's Confidential Information.
15.3 DISCLOSURE. Each party is permitted to disclose the other party's
Confidential Information to its employees and contractors on a need to know
basis only, PROVIDED, that such employees and contractors have written
confidentiality obligations to that party no less stringent than those contained
in this Agreement.
15.4 EXCEPTIONS. The confidentiality provisions of this Agreement do not
apply to information that is or becomes entirely in the public domain through no
fault of the receiving party; was received lawfully from a third party through
no breach of any obligation of confidentiality owed to the disclosing party; or
created by a party independently of its access to or use of the other party's
Confidential Information. In addition, nothing contained in this Agreement shall
be construed to prevent GBI from complying with its disclosure obligations
pursuant to U.S. securities laws.
15.5 TERMINATION AND SURVIVAL. Upon termination or expiration of this
Agreement, each party shall return the other party's Confidential Information
and shall not use the other party's Confidential Information for its own, or any
third party's, benefit. The provisions of this Section shall survive termination
of this Agreement for so long as the Confidential Information remains
confidential.
ARTICLE XVI
NOTICES AND OTHER COMMUNICATIONS
Any notice, request, instruction or other document to be given hereunder by
any party to another party will be in writing and will be deemed given when
delivered personally, upon receipt of a transmission confirmation (with a
confirming copy sent by overnight courier) if sent by facsimile or like
transmission, and on the next business day when sent by Federal Express, United
Parcel Service, Express Mail, or other reputable overnight courier. All notices
will be sent to the following addresses:
17
EXECUTION ORIGINAL
If to GBI, then to:
Genesis BioVentures, Inc.
▇▇▇▇▇ ▇▇
▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇ ▇▇▇
Telephone No.: (▇▇▇) ▇▇▇-▇▇▇▇
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: E. ▇▇▇▇ ▇▇▇▇▇▇▇▇▇, Chairman, President and
Chief Executive Officer
with a copy to:
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ & ▇▇▇▇▇
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Telephone No.: (▇▇▇) ▇▇▇-▇▇▇▇
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
Attn: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇, Esq.
If to BIOTHERAPIES, then to:
Biotherapies Incorporated
▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Telephone No.: (▇▇▇) ▇▇▇-▇▇▇▇
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: ▇▇. ▇▇▇▇ ▇. ▇▇▇▇▇, ▇▇., Chief Executive Officer
with a copy to:
▇▇▇▇▇▇, ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇ LLP
▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Telephone No.: (▇▇▇) ▇▇▇-▇▇▇▇
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
Attn: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇, Esq.
or to such other persons or addresses as may be designated in writing by the
party to receive such notice. Nothing in this section will be deemed to
constitute consent to the manner and address for service of process in
connection with any legal proceeding (including litigation arising out of or in
connection with this Agreement), which service will be effected as required by
applicable law.
18
EXECUTION ORIGINAL
ARTICLE XVII
REGISTRATION AND RECORDATION
17.1 REGISTRATION. If the terms of this Agreement, or any assignment or
license under this Agreement are or become such as to require that the Agreement
or license or any part thereof be registered with or reported to a national or
supranational agency of any area in which GBI, its Affiliates or sublicensees
would do business, GBI will, at its expense, undertake such registration or
report. Prompt notice and appropriate verification of the act of registration or
report or any agency ruling resulting from it will be supplied by GBI to
BIOTHERAPIES.
17.2 RECORDATION. Any formal recordation of this Agreement or any license
herein granted which is required by the law of any country, as a prerequisite to
enforceability of the Agreement or license in the courts of any such country or
for other reasons, shall also be carried out by GBI at its expense, and
appropriately verified proof of recordation shall be promptly furnished to
BIOTHERAPIES.
ARTICLE XVIII
MISCELLANEOUS
18.1 WAIVER. Any waiver by a party of a right or remedy under this
Agreement must be in writing and signed by that party to be effective. No waiver
shall be implied by a failure of a party to enforce a right or remedy. 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.
18.2 ENTIRE AGREEMENT. This Agreement and all Exhibits hereto contain the
entire understanding of the parties with respect to the subject matter contained
herein, and replaces and supercedes all prior agreements, understandings and
promises related thereto, including, without limitation, all licenses contained
in the Operating Agreement.
18.3 ATTORNEYS' FEES. In the event of a failure of performance due under
the terms of this Agreement and if it becomes necessary for either party to
undertake legal action against the other on account thereof, then the prevailing
party shall be entitled to reasonable attorney's fees in addition to costs and
necessary disbursements.
18.4 HEADINGS. The headings of the several sections are inserted for
convenience of reference only and are not intended to be a part of or to affect
the meaning or interpretation of this Agreement.
18.5 AMENDMENTS. Neither this Agreement nor any term hereof may be changed
or amended except through a writing signed by both parties.
18.6 SEVERABILITY. In the event that any term, provision, or covenant of
this Agreement shall be determined by a court of competent jurisdiction to be
invalid, illegal or unenforceable, that term will be curtailed, limited or
deleted, but only to the extent necessary to remove such invalidity, illegality
or unenforceability, and the remaining terms, provisions and covenants shall not
in any way be affected or impaired thereby.
19
EXECUTION ORIGINAL
18.7 COUNTERPARTS. For the convenience of the parties hereto, this
Agreement may be executed in any number of counterparts, each such counterpart
being deemed to be an original instrument, and all such counterparts together
constituting the same agreement.
18.8 GOVERNING LAW. This Agreement and the relationships between the
parties shall be governed in all respects by the law of the State of Michigan
(notwithstanding any provisions governing conflict of laws under such Michigan
law to the contrary), except that questions affecting the construction and
effect of any patent shall be determined by the law of the country in which the
patent has been granted.
18.9 JURISDICTION AND FORUM. The parties hereby consent to the jurisdiction
of the courts of the State of Michigan over any dispute concerning this
Agreement or the relationship between the parties. Should GBI bring any claim,
demand or other action against Michigan, its fellows, officers, employees or
agents, arising out of this Agreement, the Michigan License and/or the Michigan
Technology, GBI agrees to bring said action only in the Michigan Court of
Claims.
END OF AGREEMENT - SIGNATURE PAGE APPEARS ON NEXT PAGE.
20
EXECUTION ORIGINAL
SIGNATURE PAGE TO THE MAMMASTATIN SUBLICENSE AGREEMENT,
DATED NOVEMBER 30, 2001, BETWEEN BIOTHERAPIES INCORPORATED
AND GENESIS BIOVENTURES, INC.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
duly executed as of the date first written above.
GBI:
GENESIS BIOVENTURES, INC.
By: _______________________________________________
E. ▇▇▇▇ ▇▇▇▇▇▇▇▇▇
Chairman, President and Chief Executive Officer
BIOTHERAPIES:
BIOTHERAPIES INCORPORATED
By: _______________________________________________
▇▇. ▇▇▇▇ ▇. ▇▇▇▇▇, ▇▇.
Chief Executive Officer
21
EXHIBIT A
MAMMASTATIN LICENSE
EXHIBIT B
MAMMASTATIN SERUM ASSAY
DESCRIPTION OF MAMMASTATIN SERUM ASSAY
The Mammastatin Serum Assay is a test to measure Mammastatin levels in the serum
of healthy women and breast cancer patients. This assay has been performed in
two different formats with different antibody formats.
The original Mammastatin Serum Assay was developed at the University of Michigan
as an ELISA assay that used two anti-Mammastatin monoclonal antibodies, 3C6 and
6B8. The 6B8 antibody was typically used to coat 96 well microtiter plates.
Coated plates were exposed to Mammastatin standard or patient samples. Unbound
antibody was washed from the plate. The plate was blocked with non-specific
protein and then exposed to a biotin labeled 3C6 antibody. The plates were
washed to remove unbound antibody and were then incubated with alkaline
phosphatase conjugated strept-avidin. This solution was removed from the plate
and the plate was developed with a para-nitro-phenyl phosphate substrate and
density was read by microtiter plate reader.
A later development by Biotherapies and the Mammastatin Research Institute was
the development of a dot-blot assay to measure serum Mammastatin. For this assay
protein samples (standard and patient samples) are drawn onto nitrocellulose by
vacuum, typically in a 96 well format. The filter is then blocked with a
non-specific protein and exposed to anti-Mammastatin monoclonal antibody 7G6.
Filters are washed and exposed to anti-mouse antibody which is conjugated to
alkaline phosphatase (second antibody). Filters are then washed and developed
with Nitro-blue-tetrazolium substrate system. Intensity of signal is then
interpreted visually or by scanning and digitizing the image.
An improvement that has been implemented by Biomedical Diagnostics LLC to this
dot-blot assay is the use of a peroxidase conjugated second antibody and a DAB
substrate system.
These are the currently investigated formats that constitute the Mammastatin
diagnostic technology. Additional ELISA formats using different antibodies are
an obvious planned improvement. Although the 6B8 antibody is not currently used
for any Mammastatin detecting assays, the 6B8, 3C6 and 7G6 anti-Mammastatin
monoclonal antibodies and the hybridomas that produce these antibodies are the
intellectual property of the University of Michigan and are protected, along
with diagnostic methods that use these antibodies, under US and foreign patents.
