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EXHIBIT 10.15
EXCLUSIVE LICENSE AGREEMENT
BETWEEN
CHILDREN'S MEDICAL CENTER CORPORATION
AND
GMP|DIAGNOSTIC|PROGNOSTIC MARKERS, INC.
FOR THE ZETTER LABORATORY
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TABLE OF CONTENTS
Articles Page
I. Definitions 1
II. Grant 5
III. Due Diligence 6
IV. Royalties and Other Payments 8
V. Reports and Records 10
VI. Patent Prosecution 11
VII. Infringement 12
VIII. Uniform Indemnification and Insurance Provisions 13
IX. Export Controls 14
X. Non-Use of Names 15
XI. Assignment 15
XII. Dispute Resolution and Arbitration 15
XIII. Term and Termination 16
XIV. Payments, Notices and Other Communications 17
XV. General Provisions 18
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EXCLUSIVE LICENSE AGREEMENT
This Agreement is made and entered into as of the date last written
below (the Effective Date), by and between CHILDREN'S MEDICAL CENTER
CORPORATION, a charitable corporation duly organized and existing under the laws
of the Commonwealth of Massachusetts and having its principal office at 000
Xxxxxxxx Xxxxxx, Xxxxxx, Xxxxxxxxxxxxx, 00000, X.X.X. (hereinafter referred to
as "CMCC"), and GMP|Diagnostic|Prognostic Markers, Inc., a business corporation
organized and existing under the laws of the State of Delaware and having its
principal office at One East Broward Boulevard, Suite 1701, Xxxx Xxxxxxxxxx, XX,
00000 (hereinafter referred to as "Licensee").
WHEREAS, CMCC is the owner of certain Patent Rights (as that term shall
be defined hereafter) and has the right to grant exclusive licenses under said
Patent Rights, subject only to a royalty-free, nonexclusive license heretofore
granted to the United States Government for those patents developed with U.S.
Government funding;
WHEREAS, CMCC desires to have the Patent Rights utilized in the public
interest and is willing to grant a license thereunder on the terms and
conditions described herein;
WHEREAS, Licensee has represented to CMCC that Licensee is ready,
willing and able to engage in the commercial development, production,
manufacture, marketing and sale of Marker Panel Products (as that term shall be
defined hereafter) and/or the use of Marker Panel Processes (as that term shall
be defined hereafter) and that it shall commit itself to a thorough, vigorous
and diligent program of exploiting the Patent Rights in accordance with the
terms and conditions described herein so that public utilization shall result
therefrom; and
WHEREAS, the Xxxxxxx Institute and CMCC have agreed to (i) work
together and pool the efforts of their respective inventors in the research and
development of Marker Panel Products and Marker Panel Processes and (ii) share
in the proceeds resulting from these joint efforts regardless of which
institution's patent rights are required for commercialization of the Marker
Panel Products and Marker Panel Processes;
WHEREAS, Licensee desires to obtain an exclusive license under the
Patent Rights on the terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the premises and the mutual
covenants contained herein, the parties hereto agree as follows:
ARTICLE I. DEFINITIONS
For the purpose of this Agreement, the following words and phrases
shall have the meanings set forth below:
A. "Affiliate" shall mean any company or other legal entity
controlling, controlled by or under common control with Licensee. For purposes
of the definition of "Affiliate" the term "control" shall mean: (i) in the case
of a corporate entity, the direct or indirect ownership of at least a majority
of the stock or participating shares entitled to vote for the election of
directors of that entity; (ii) in the case of a partnership, the power
customarily held by a general partner to direct the management and policies of
such partnership; or (iii) in the case of a joint venture,
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whether in corporate, partnership or other legal form, a more than nominal
economic interest and managerial role.
B. "Xxxxxxx License" shall mean the License Agreement between the
Xxxxxxx Institute and Licensee of even date pertaining to the patent rights
identified in Appendix 1.
C. "Combination Product(s) or Process(es)" shall mean a product
or process that includes a Marker Panel Product or Marker Panel Process (the
"Licensed Components") sold in combination with another component(s) whose
manufacture, use or sale by an unlicensed party would not constitute an
infringement of the Patent Rights under this Agreement or the Xxxxxxx License
(the "Unlicensed Components").
D. "Field of Use" shall mean the diagnosis or prognosis of any
disease or condition in humans or animals.
E. "First Commercial Sale" shall mean: (i) the first sale of any
Marker Panel Product or Marker Panel Process by Licensee or a Sublicensee,
following approval of such Marker Panel Product's or Marker Panel Process's
marketing by the appropriate governmental agency, if any such approval is
necessary, for the country in which the sale is to be made; or (ii) when
governmental approval is not required, the first sale of that Marker Panel
Product or Marker Panel Process.
F. "Know-how" shall mean any and all manufacturing information,
technical information, testing and analytic methods and specifications which
CMCC owns or has sufficient rights to include in the license grant in Article II
hereof, necessary for research, development or manufacture of any Marker Panel
Product or Marker Panel Process in the Field(s) of Use, deriving from the
activities of the Principal Investigator and/or any other Research Program
personnel in the performance of the Sponsored Research Agreement.
G. "Licensed Product" shall mean any product or part thereof:
1. The manufacture, use or sale of which would infringe
any one of the issued, valid, enforceable, unexpired
claim(s) or any one of the pending claim(s) contained
in the Patent Rights in any country.
2. The manufacture of which uses a "Licensed Process" as
that term shall be defined hereafter.
H. "Licensed Process " shall mean any process that would infringe
any one of the issued, valid, enforceable, unexpired claim(s) or any one of the
pending claim(s) contained in the Patent Rights in any country.
I. "Licensee" shall mean Licensee and/or its successor(s) or
assignee(s) and/or its Affiliates.
J. "Marker Panel Product" shall mean any product or part thereof:
1. The manufacture, use or sale of which in any country
would infringe any one of the issued, valid,
enforceable, unexpired claim(s) or any one of the
pending claim(s) contained in any of the patent
rights under the Xxxxxxx
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License or the License Agreement of even date
pertaining to patent rights identified in Appendix 2
from the Zetter laboratory or Patent Rights under
this Agreement.
2. The manufacture of which uses a "Marker Panel
Process" as that term shall be defined hereafter.
K. "Marker Panel Process" shall mean any process that would
infringe any one of the issued, valid, enforceable, unexpired claim(s) or any
one of the pending claim(s) contained in the patent rights under the Xxxxxxx
License or or the License Agreement of even date pertaining to patent rights
identified in Appendix 2 from the Zetter laboratory or Patent Rights under this
Agreement.
L. "Net Sales" shall mean gross receipts received by Licensee, or
Licensee's Affiliates for Marker Panel Products and Marker Panel Processes
produced hereunder, less the sum of the following:
1. Trade, quantity or cash discounts (including refunds,
rebates, chargebacks and retroactive price
adjustments) allowed in amounts customary in the
trade.
2. Sales taxes, tariff duties and/or use taxes directly
imposed and with reference to particular sales.
3. Freight, storage and delivery charges (including
insurance premiums related to transportation and
delivery) prepaid or allowed to the extent reflected
on the customer's invoice.
4. Amounts allowed or credited on returns.
No deductions shall be made for commissions paid to individuals whether they are
with independent sales agencies or regularly employed by Licensee and on its
payroll or for the cost of collections. Marker Panel Products and Marker Panel
Processes shall be considered "sold" when billed out or invoiced. For purposes
of this Agreement, the sale or use of a Marker Panel Product or Marker Panel
Process by a Sublicensee shall not be included in the calculation of Net Sales.
Notwithstanding anything herein to the contrary, the following shall not be
considered a sale of a Marker Panel Product or Marker Panel Process under this
Agreement: (i) the transfer of a Marker Panel Product or Marker Panel Process to
an Affiliate for sale by the Affiliate in a transaction that will be royalty
bearing; (ii) the transfer of a Marker Panel Product or Marker Panel Process to
a third party without consideration to Licensee in connection with the
development or testing of that Marker Panel Product or Marker Panel Process; or
(iii) the transfer of a Marker Panel Product or Marker Panel Process to a third
party without consideration in connection with the marketing or promotion of the
Marker Panel Product or Marker Panel Process.
M. "Patent Rights" shall mean all of the following intellectual
property that CMCC owns or has rights to during the term of this Agreement:
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1. The United States and foreign patents and/or patent
applications listed in Appendix 3 attached hereto and
incorporated herein by reference and divisionals and
continuations thereof.
2. The United States and foreign patents issued from the
applications listed in Appendix 3 and from
divisionals and continuations of those applications.
3. Claims of United States and foreign
continuation-in-part, improvement or enhancement
applications, and of the resulting patents, which
relate to the subject matter specifically described
in the United States and foreign patent applications
described in Appendix 3.
4. Claims of all later filed foreign patent
applications, and of the resulting patents, which
relate to subject matter specifically described in
the United States patent and/or patent applications
described in subparagraphs 1, 2 or 3 of this Article
I, Paragraph M.
5. Any reissues, divisions, amendments or extensions of
the United States or foreign patents described in
subparagraphs 1, 2, 3 or 4 of this Article I,
Paragraph M.
6. Claims of all United States and foreign patent
applications and patents resulting from the Sponsored
Research Agreement and licensed by Licensee in
accordance with the terms of the Zetter Sponsored
Research Agreement.
N. "Research Program" shall mean the research program between
Licensee and Children's Hospital Boston which is sponsored by Licensee pursuant
to the Zetter Sponsored Research Agreement.
O. "Sublicensee" shall mean a person or entity unaffiliated with
Licensee to whom Licensee has granted an arm's length sublicense under this
Agreement.
P. "Sublicense Consideration" shall mean consideration of any
kind received by the Licensee from a sublicense for sales of Marker Panel
Products or Marker Panel Processes or fees received, in whatever form
(including, without limitation, cash, securities or in kind consideration), such
as upfront fees or milestone fees and including any premium paid by the
Sublicensee over Fair Market Value for stock of the Licensee received in
consideration for such sublicense. However, not included in Sublicense
Consideration are amounts paid to the Licensee by the Sublicensee for Marker
Panel Product development, research work, clinical studies and regulatory
approvals performed by or for the Licensee, or third parties on their behalf
pursuant to a specific agreement including a performance plan and commensurate
budget related to the Marker Panel Product. The term "Fair Market Value for
stock" as used in this Paragraph shall mean the average of the closing prices of
the stock on all securities exchanges on which the stock may at the time be
listed or, if there have been no sales on any such exchange on the date the
value is being determined (the "Valuation Date"), the average of the highest bid
and lowest asked prices on all such exchanges at the end of the Valuation Date,
or, if the stock is not so listed, the average of the representative bid and
asked prices quoted in the NASDAQ System as of 4:00 p.m., New York time, on the
Valuation Date or, if on such day
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the stock is not quoted in the NASDAQ System, the average of the highest bid and
lowest asked prices on the Valuation Date in the domestic over-the-counter
market as reported by the National Quotation Bureau Incorporated, or any similar
successor organization, in each such case averaged over a period of twenty (20)
days consisting of the Valuation Date and the nineteen (19) consecutive business
days prior to such day. If on the Valuation Date the stock is not listed on any
securities exchange or quoted in the NASDAQ System or the over-the-counter
market, the Fair Market Value of each share of such stock shall be the fair
market value of a share of the stock as of the Valuation Date, as reasonably
determined by the Board.
Q. "Zetter Sponsored Research Agreement" shall mean that certain
Sponsored Research Agreement between the parties, of even date including any
extensions and renewals of the same pertaining to Research Program in the
laboratory of Xx. Xxxxx Xxxxxx.
ARTICLE II. GRANT
A. CMCC hereby grants to Licensee the worldwide right and
exclusive license to make, have made, use, lease and sell the Licensed Products
and to practice the Licensed Processes for the Field of Use to the end of the
term for which the Patent Rights are granted, unless sooner terminated as
provided in this Agreement.
B. Notwithstanding anything above to the contrary, CMCC shall
retain a royalty-free, nonexclusive, irrevocable license to practice, and to
sublicense other non-profit research organizations to practice, the Patent
Rights for noncommercial research purposes only. For purposes of this paragraph,
noncommercial research purposes shall exclude the practice of the Patent Rights
to perform clinical research for a for-profit organization, to produce or
manufacture Marker Panel Products for general sale, or to perform diagnostic or
prognostic services for a fee.
C. The license granted hereunder shall be subject to the rights
of the United States government, if any, under Public Laws 96-517, 97-226, and
98-620, codified at 35 U.S.C. sec. 200-212 and any regulations promulgated
thereunder.
D. CMCC hereby grants to Licensee the worldwide, irrevocable,
perpetual right and non-exclusive license to practice Know-How to develop, test,
make, have made, use, sell, have sold, offer for sale and import for use or
resale the Marker Panel Products and Marker Panel Processes.
E. Licensee agrees that Marker Panel Products leased or sold in
the United States shall be manufactured substantially in the United States.
F. In order to establish exclusivity for Licensee, CMCC hereby
agrees that it shall not, without Licensee's prior written consent, grant to any
other commercial party a license to make, have made, use, lease and/or sell
Licensed Products or to use the Licensed Processes in the Field of Use during
the period of time in which this Agreement is in effect, except as otherwise
specified in this Agreement or as required by law to grant rights to the United
States Government.
G. Licensee shall have the right to enter into sublicensing
agreements with respect to any of the rights, privileges, and licenses granted
hereunder, subject to the terms and
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conditions hereof. Such sublicenses will terminate upon the termination of
Licensee's rights granted herein unless events of default are cured by Licensee
or Sublicensee within thirty (30) days of notification by CMCC of default and/or
as provided by the terms of this Agreement.
H. Licensee agrees that any sublicense granted by it shall
provide that the obligations to CMCC of Articles II (Grant), V (Reports and
Records), VII (Infringement), VIII (Insurance and Indemnification), IX (Export
Controls), X (Non-Use of Names), XI (Assignment), XII (Dispute Resolution), XIII
(Term and Termination) and XV (Miscellaneous Provisions) of this Agreement shall
be binding upon the Sublicensee as if it were a party to this Agreement.
Licensee further agrees to attach a copy of this Agreement to all sublicense
agreements, deleting economic terms when and as appropriate.
I. Licensee agrees to provide to CMCC notice of any sublicense
granted hereunder and to forward to CMCC a copy of any and all fully executed
sublicense agreements. Licensee further agrees to forward to CMCC annually a
copy of such reports received by Licensee from its Sublicensees during the
preceding twelve (12) month period as shall be pertinent to a royalty accounting
under the applicable sublicense.
J. Licensee shall notify CMCC in writing of any Sublicensee
Consideration.
K. CMCC agrees that if Licensee has provided to CMCC notice that
Licensee has granted a sublicense to a Sublicensee under this Agreement, then in
the event CMCC terminates this Agreement for any reason provided hereafter, CMCC
shall provide to such Sublicensee no less than thirty (30) days prior to the
effective date of said termination, written notice of said termination at the
address specified by Licensee to CMCC in Licensee's notice to CMCC under
Paragraph I of this Article II. CMCC agrees that upon the Sublicensee's notice
as described below and provided the Sublicensee is not in breach of its
sublicense, CMCC shall grant to such Sublicensee license rights and terms
equivalent to the sublicense rights and terms which the Licensee shall have
granted to said Sublicensee; provided that the Sublicensee shall remain a
Sublicensee under this Agreement for a period of at least sixty (60) days
following receipt of notice from CMCC. Sublicensee shall during said sixty (60)
day period provide to CMCC notice wherein the Sublicensee: (i) reaffirms the
terms and conditions of this Agreement as it relates to the rights the
Sublicensee has been granted under the sublicense; (ii) agrees to abide by all
of the terms and conditions of this Agreement applicable to Sublicensees and to
discharge directly all pertinent obligations of Licensee which Licensee is
obligated hereunder to discharge; and (iii) acknowledges that CMCC shall have no
obligations to the Sublicensee other than its obligations set forth in this
Agreement with regard to Licensee.
L. The license granted hereunder shall not be construed to confer
any rights upon Licensee by implication, estoppel or otherwise as to any
technology not described in the Patent Rights.
ARTICLE III. DUE DILIGENCE
A. In the event Licensee decides not to exploit a licensed Patent
Right or expend the resources required to meet the Development Plan milestones,
it shall promptly inform CMCC in writing and shall surrender to CMCC its license
to that Patent Right for the specific field(s) of use or territory not being
exploited. Licensee shall use Commercially Reasonable Efforts to develop and
commercialize one or more Marker Panel Products directly or through its
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Sublicensees; and shall continue to use Commercially Reasonable Efforts to
develop and commercialize one or more Marker Panel Products throughout the term
of this Agreement. "Commercially Reasonable Efforts" for purposes of this
Article III shall mean efforts and resources commonly used in the research-based
prognostic or diagnostic industries for a product at a similar stage in its
product life of similar market potential taking into account efficacy, the
competitiveness of alternative products in the marketplace, the patent and other
proprietary position of the product, the likelihood of regulatory approval given
the regulatory structure involved, the profitability of the product and
alternative products and other relevant factors.
B. The parties acknowledge that Licensee has provided to CMCC
prior to the date of execution of this Agreement a written commercialization
development plan ("Development Plan") setting forth the initial indications and
markets for Marker Panel Products and Marker Panel Processes, including to the
extent practicable: (i) time-delimited targets for pre-clinical development,
clinical trials, regulatory approval, manufacturing and marketing that represent
Commercially Reasonable Efforts to bring Marker Panel Products and Marker Panel
Processes to the marketplace; and (ii) actual or projected financial resources
and/or strategic alliances that will be required to implement the Development
Plan. The Development Plan is attached hereto as Appendix 4.
C. Licensee shall use Commercially Reasonable Efforts to
accomplish the milestones set forth in the Development Plan and to manufacture
and distribute Marker Panel Products and Marker Panel Processes. Licensee shall
be deemed to have used such Commercially Reasonable Efforts for the first three
years of this Agreement so long as it has or has caused third parties to timely
fund the Zetter Sponsored Research Agreement.
D. Notwithstanding anything above to the contrary, CMCC shall not
unreasonably withhold its assent to any revision of the objective(s) set forth
in the Development Plan when requested in writing by Licensee and supported by
evidence reasonably acceptable to CMCC: (i) of technical difficulties or delays
in the clinical studies or regulatory process that Licensee could not have
reasonably avoided; or (ii) that Licensee, its Affiliates and/or Sublicensees
have expended good faith and diligent efforts and adequate resources to meet
said objective.
E. In the event CMCC reasonably believes that Licensee is not
diligently seeking to achieve the objectives set forth in the Development Plan
in a timely manner, CMCC shall so notify Licensee in writing. Licensee shall
have the option, exercisable by written notice to CMCC provided within ten (10)
days after receipt of any such notice, to either: (i) receive a three (3) months
grace period to establish to CMCC's reasonable satisfaction that Licensee is
expending sufficient resources to achieve said objectives; or (ii) agree to
CMCC's termination of this Agreement as provided hereafter. In the event
Licensee agrees to termination of this Agreement, CMCC shall immediately
terminate the license granted to Licensee under this Agreement. In the event
Licensee fails to establish its diligence to CMCC's reasonable satisfaction as
provided above prior to expiration of the three (3) months grace period, CMCC
shall have the right to terminate the license granted to Licensee under this
Agreement or to convert the license to a non-exclusive license as to any Patent
Rights for which the development obligation has not been met on financial terms
and conditions mutually agreed to by CMCC and Licensee. Pursuant to Article XII,
Licensee is entitled to arbitration regarding the factual issue of whether any
determination by CMCC that Licensee failed to diligently seek to achieve the
objectives set forth in the Development Plan was reasonable.
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*** CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
F. In the event Licensee fails to meet the objective(s) set forth
in the Development Plan in a timely manner, CMCC shall notify Licensee thereof
in writing, and Licensee shall have thirty (30) days following such notification
to establish to the reasonable satisfaction of CMCC that (i) it has met such
objective(s); or (ii) a revision to the Development Plan is necessary and
appropriate as contemplated above. In the event Licensee fails to establish the
same to CMCC's reasonable satisfaction, CMCC shall have the right in its
discretion to terminate the license granted to Licensee under this Agreement or
to convert the license granted to Licensee hereunder to a non-exclusive license
as to any Patent Rights for which the development obligation has not been met on
financial terms and conditions mutually agreed to by CMCC and Licensee.
ARTICLE IV. ROYALTIES AND OTHER PAYMENTS
A. For the rights, privileges and exclusive licenses granted
hereunder, Licensee shall pay to CMCC the following amounts in the manner
hereinafter provided until the end of the term of the last to expire Patent
Right, unless this Agreement shall be sooner terminated as hereinafter provided:
1. A license issue fee of [***], which license issue fee
shall be deemed earned and due immediately upon the execution
of this Agreement.
2. Licensee shall reimburse CMCC for expended patent
costs to date in the amount of [***] due immediately upon
receipt of an invoice and supporting documentation.
3. Licensee shall make the following one-time milestone
payment to CMCC upon the occurrence of the following event
("Milestone"):
[***] upon the First Commercial Sale of the first
Marker Panel Product or Marker Panel Process in any
country.
4. A License Maintenance Fee of [***] which shall be
payable on January 1, 2001, and on January 1 of each
subsequent year thereafter during the exclusive license period
of this Agreement. Notwithstanding anything herein to the
contrary, any Running Royalties (defined below) subsequently
due to CMCC on Net Sales of Marker Panel Products and Marker
Panel Processes, if any, for each such year shall be
creditable against the License Maintenance Fee for said year.
License Maintenance Fees paid in excess of Running Royalties
shall not be creditable against Running Royalties due in
future years. In addition, no License Maintenance Fee shall be
due in any year in which Licensee is funding the Research
Program.
5. Running Royalties in an amount equal to [***] of the
first [***] cumulative of Net Sales of Marker Panel Products
or Marker Panel Processes used, leased or sold by and/or for
Licensee and/or its Affiliates and [***] of Net Sales over
that amount.
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*** CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
6. In the event Licensee has granted sublicenses under
this Agreement, [***] of Sublicense Consideration.
B. No multiple royalties shall be payable because any Marker
Panel Product or Marker Panel Process, its manufacture, use, lease or sale are
or shall be covered by more than one Patent Rights patent application or Patent
Rights patent licensed under this Agreement.
C. To the extent that Licensee obtains subsequent to the date of
this Agreement licenses to third party (other than the Xxxxxxx Institute)
patents or other intellectual property that are necessary to produce or sell the
specific markers covered by the patent rights under the Xxxxxxx License, the
patent rights identified in Appendix 2 from the Moses laboratory, or the Patent
Rights under this Agreement for Marker Panel Products or Marker Panel Processes,
Licensee may deduct from the royalty due to CMCC fifteen percent (15%) of the
royalties due on such third party patents or intellectual property up to an
amount equal to fifty percent (50%) of royalties hereunder.
D. For purposes of calculating royalties for a Combination
Product or Process one of the following methods will be used:
1. By multiplying the Net Sales of the Combination
Product or Combination Process during the applicable
royalty accounting period ("accounting period") by a
fraction, the numerator of which is the aggregate
gross selling price of the Licensed Component(s)
contained in the Combination Product or Combination
Process if sold separately, and the denominator of
which is the sum of the gross selling price of the
Licensed Component(s), and the Unlicensed
Component(s) contained in the Combination Product or
Combination Process if sold separately; or
2. In the event that no such separate sales are made of
the Licensed Component(s) or the Unlicensed
Components during the applicable accounting period,
Net Sales for purposes of determining royalties
payable hereunder shall be calculated by multiplying
the Net Sales of the Combination Product or
Combination Process by a fraction, the numerator of
which is the fair market value of the Licensed
Component(s) and the denominator of which is the sum
of the fair market value of the Licensed Component(s)
and the Unlicensed Component(s) contained in the
Combination Product or Combination Process.
E. Royalty payments shall be paid in United States dollars in
Boston, Massachusetts, or at such other place as CMCC may reasonably designate
consistent with the laws and regulations controlling in any foreign country. If
the currency conversion shall be required in connection with the payments of
royalties or other amounts hereunder, the conversion shall be made by using the
exchange rate prevailing at the Fleet Bank on the last business day of the
calendar quarterly reporting period to which such royalty payments relate.
F. The royalty payments set forth in this Agreement shall, if
overdue, bear interest until payment at a per annum rate of four percent (4%)
above the prime rate in effect at the Fleet Bank on the due date. The payment of
such interest shall not foreclose CMCC from
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*** CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
exercising any other rights it may have under this Agreement as a consequence of
the lateness of any payment.
G. In consideration of the issuance of the license of the Patent
Rights as contained in this Agreement, Licensee shall issue a total of [***]
shares of Common Stock of Licensee, $.001 par value per share, (the "Shares") in
the name of CMCC. Licensee represents to CCMC that, as of the Effective Date,
the aggregate number of Shares equals no less than [***] of the Licensee's
issued and outstanding Common Stock calculated on a "Fully Diluted Basis." For
purposes of this Paragraph, "Fully Diluted Basis" shall mean that the total
number of issued and outstanding shares of the Licensee's Common Stock shall be
calculated to include conversion of all issued and outstanding securities then
convertible into common stock, the exercise of all then outstanding options and
warrants to purchase shares of common stock, whether or not then exercisable,
and shall assume the issuance or grant of all securities reserved for issuance
pursuant to any Licensee stock or stock option plan in effect on the date of the
calculation.
H. The equity interest held by CMCC would not be diluted below
[***] on a fully diluted basis until the earlier of (i) an initial public
offering of securities by Licensee, or (ii) the funding of Licensee by GMP
Companies or other entity has reached [***].
ARTICLE V. REPORTS AND RECORDS
A. Licensee shall keep, and shall require its Affiliates and
Sublicensees to keep, full, true and accurate books of account in accordance
with generally accepted accounting principles and containing sufficient detail
to enable CMCC to determine the royalty and other amounts payable to CMCC under
this Agreement. Said books of account shall be kept at Licensee's principal
place of business or the principal place of business of the appropriate division
of Licensee to which this Agreement relates. Said books and the supporting data
shall be retained for at least five (5) years following the end of the calendar
year to which they pertain.
B. CMCC shall have the right to audit the books of account
described above from time to time to the extent necessary to verify the reports
provided for herein or compliance in other respects with this Agreement. CMCC or
its agents shall perform these audits at CMCC's expense during Licensee's
regular business hours.
C. Licensee shall deliver to CMCC true and accurate reports by
March 31, for the period July 1 through December 31 of the previous year, and on
September 30, for the period January 1 through June 30 of the current year,
giving such particulars of the business conducted by Licensee, its Affiliates
and its Sublicensees under this Agreement as shall be pertinent to a royalty
accounting hereunder and to verify Licensee's activities with respect to
achieving the objectives of the Development Plan described in Article III above.
These reports shall include at least the following:
1. Number of Marker Panel Products and Marker Panel
Processes manufactured and sold.
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2. Aggregate xxxxxxxx for Marker Panel Products and
Marker Panel Processes sold.
3. Accounting for all Marker Panel Products and Marker
Panel Processes sold.
4. Applicable deductions.
5. Total royalties due.
6. Names and addresses of all Sublicensees of Licensee.
7. Payments received by Licensee from Affiliates and
Sublicensees.
8. Marker Panel Products manufactured and sold to the
U.S. Government. No royalty obligations shall arise
from sales or use by, for or on behalf of the U.S.
Government in view of a royalty-free, nonexclusive
license that may heretofore have been granted to the
U.S. Government.
9. Consideration (e.g. Royalties and Fees) received from
Sublicensees.
D. Until the First Commercial Sale of a Marker Panel Product or
Marker Panel Process, Licensee shall provide to CMCC at least annually
reasonable detail regarding the activities of Licensee and Licensee's Affiliates
and Sublicensees relative to achieving the objectives set forth in the
Development Plan in a timely manner, including but not limited to, reports of
financial expenditures to achieve said objectives, research and development
activities, regulatory approvals, strategic alliances and manufacturing,
sublicensing and marketing efforts.
E. With each such report submitted, Licensee shall pay to CMCC
the royalties due and payable under this Agreement. If no royalties shall be
due, Licensee shall so report.
F. On or before the ninetieth (90th) day following the close of
Licensee's fiscal year, Licensee shall provide CMCC with Licensee's certified
financial statements for the preceding fiscal year, including at a minimum a
balance sheet and an operating statement.
ARTICLE VI. PATENT PROSECUTION
A. CMCC shall apply for, seek prompt issuance of, and maintain
during the term of this Agreement the Patent Rights set forth in Appendix 3. The
prosecution, filing and maintenance of all Patent Rights applications and
patents shall be the primary responsibility of CMCC. Licensee shall have
reasonable opportunities to advise CMCC, including the selection of counsel, and
shall cooperate with CMCC in the prosecution, filing and maintenance of the
Patent Rights.
B. Licensee shall reimburse to CMCC the amount of all fees and
costs relating to the filing, prosecution and maintenance of the Patent Rights
incurred after the date of this Agreement. CMCC shall provide to Licensee an
itemized invoice of all such fees and Licensee
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shall pay to CMCC all amounts due under said invoice within ten (10) days of the
date of said invoice. If the Patent Rights are licensed to third parties for
other fields of use, such patent costs shall be equitably apportioned.
C. In the event CMCC elects not to pursue, maintain or retain a
particular Patent Right licensed to Licensee hereunder, CMCC shall so notify
Licensee in sufficient time for Licensee to assume the filing, prosecution
and/or maintenance of such application or patent at Licensee's expense. In such
event, CMCC shall provide to Licensee any authorization necessary to permit
Licensee to pursue and/or maintain such Patent Right. Licensee shall have no
further royalty obligations under this Agreement with respect to any such Patent
Right.
ARTICLE VII. INFRINGEMENT
A. Licensee and CMCC shall each inform the other promptly in
writing of any alleged infringement by a third party of the Patent Rights in the
Field of Use and of any available evidence thereof.
B. During the term of this Agreement, CMCC shall have the right,
but shall not be obligated, to prosecute at its own expense any infringement of
the Patent Rights and, in furtherance of such right, Licensee hereby agrees that
CMCC may include Licensee as a party plaintiff in any such suit, without expense
to Licensee and shall keep Licensee informed as to the status of such suit. The
total cost of any such infringement action commenced or defended solely by CMCC
shall be borne by CMCC. CMCC shall keep any recovery or damages for past
infringement derived therefrom except that CMCC shall pay Licensee the
equivalent amount as if royalties were calculated on Net Sales by Licensee. CMCC
shall indemnify Licensee against any order for costs that may be made against
Licensee in such proceedings.
C. If within six (6) months after having been notified of any
alleged infringement, CMCC shall have been unsuccessful in persuading the
alleged infringer to desist and shall not have brought and shall not be
diligently prosecuting an infringement action, or if CMCC shall notify Licensee
at any time prior thereto of its intention not to bring suit against any alleged
infringer then, and in those events only, Licensee shall have the right, but
shall not be obligated, to prosecute at its own expense any infringement of the
Patent Rights, and Licensee may, for such purposes, use the name of CMCC as
party plaintiff; provided, however, that such right to bring such an
infringement action shall remain in effect only for so long as the license
granted hereunder remains exclusive. No settlement, consent judgment or other
voluntary final disposition of the suit may be entered into without the consent
of CMCC, which consent shall not be unreasonably withheld. Licensee shall
indemnify CMCC against any order for costs that may be made against CMCC in such
proceedings.
D. In the event Licensee shall undertake the enforcement and/or
defense of the Patent Rights by litigation, Licensee may withhold up to fifty
percent (50%) of the payments otherwise thereafter due to CMCC under Article IV
above and apply the same toward reimbursement of up to fifty percent (50%) of
Licensee's expenses, including reasonable attorney's fees, in connection
therewith. Any recovery of damages by Licensee for each such suit shall be
applied first in satisfaction of any unreimbursed expenses and legal fees of
Licensee relating to such suit and next toward reimbursement of CMCC for any
payments under Article IV past due or withheld and applied pursuant to this
Article VII. Licensee shall
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keep any remaining balance except that Licensee shall pay CMCC the equivalent
amount as if royalties were calculated on Net Sales by Licensee.
E. In the event that a declaratory judgment action alleging
invalidity or noninfringement of any of the Patent Rights shall be brought
against Licensee, CMCC, at its option, shall have the right, within thirty (30)
days after commencement of such action, to intervene and participate in the
defense of the action at its own expense.
F. In any infringement suit which either party may institute to
enforce the Patent Rights pursuant to this Agreement, the other party hereto
shall, at the request and the expense of the party initiating such suit,
cooperate in all reasonable respects and, to the extent reasonably possible,
have its employees testify when requested and make available relevant records,
papers, information, samples, specimens, and the like.
G. Licensee shall during the exclusive period of this Agreement
have the sole right subject to the terms and conditions hereof to sublicense any
alleged infringer for future use of the Patent Rights. Any upfront fees paid to
Licensee as part of such a sublicense shall be Sublicense Consideration.
ARTICLE VIII. UNIFORM INDEMNIFICATION
AND INSURANCE PROVISIONS
A. Licensee shall indemnify, defend and hold harmless CMCC, its
corporate affiliates, current or future directors, trustees, officers, faculty,
medical and professional staff, employees, students and agents and their
respective successors, heirs and assigns (the "Indemnitees"), against any
liability, damage, loss or expense (including reasonable attorney's fees and
expenses of litigation) incurred by or imposed upon the Indemnitees or any one
of them in connection with any claims, suits, actions, demands or judgments
arising out of any theory of product liability (including, but not limited to,
actions in the form of tort, warranty, or strict liability) concerning any
product, process or service made, used or sold by Licensee or any Sublicensee
pursuant to any right or license granted to Licensee under this Agreement.
B. Licensee agrees, at its own expense, to provide attorneys
reasonably acceptable to CMCC to defend against any actions brought or filed
against any party indemnified by Licensee hereunder with respect to the subject
of indemnity contained herein, whether or not such actions are rightfully
brought.
C. Licensee's indemnification under Article VIII, Paragraph A and
duty to defend under Article VIII, Paragraph B above shall not apply to any
liability, damage, loss or expense to the extent that it is directly
attributable to the negligent activities, reckless misconduct or intentional
misconduct of the Indemnitees.
D. Beginning at the time as any product, process or service
relating to, or developed pursuant to, this Agreement is being commercially
distributed or sold (other than for the purpose of obtaining regulatory
approvals) by Licensee or by a Sublicensee, Affiliate or agent of Licensee,
Licensee shall, at its sole cost and expense, procure and maintain policies of
commercial general liability and products liability insurance in amounts not
less than $2,000,000 per incident and $2,000,000 annual aggregate and naming the
Indemnitees as additional
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insureds. Such commercial general liability insurance shall provide (i) product
liability coverage and (ii) contractual liability coverage for Licensee's
indemnification under Article VIII, Paragraphs A through C of this Agreement. If
Licensee elects to self-insure all or part of the limits described above
(including deductibles or retentions which are in excess of $250,000 annual
aggregate), such self-insurance program must be acceptable to CMCC and the Risk
Management Foundation of the Harvard Medical Institutions, Inc. The minimum
amount of insurance coverage required under this Article VIII, Paragraph D.
shall not be construed to create a limit of Licensee's liability with respect to
its indemnification under Article VIII, Paragraphs A through C of this
Agreement.
E. Licensee shall provide CMCC with written evidence of such
insurance upon request of CMCC. Licensee shall provide CMCC with written notice
at least thirty (30) days prior to the cancellation, non-renewal or material
change in such insurance. If Licensee does not obtain replacement insurance
providing comparable coverage within such thirty (30) day period, CMCC shall
have the right to terminate this Agreement effective at the end of such thirty
(30) day period without notice of any additional waiting periods. In such an
event, Licensee shall have thirty (30) days to reinstate this Agreement by
providing written evidence of replacement insurance providing comparable
coverage.
F. Licensee shall maintain such commercial general liability
insurance during (i) the period that any such product, process or service is
being commercially distributed or sold (other than for the purpose of obtaining
regulatory approvals) by Licensee or by a Sublicensee, Affiliate or agent of
Licensee and (ii) a reasonable period after the period referred to above, which
in no event shall be less than fifteen (15) years unless tail insurance that
affords equivalent coverage is obtained.
H. Children's represents and warrants that: (i) it has the right
and ability to grant the license set forth in Article II herein and (ii) that
the execution and delivery of this Agreement and the grant of the licenses to
Licensee hereunder do not conflict with the rights of any third party under any
other agreement to which CMCC is a party.
I. OTHER THAN WARRANTIES SET FORTH HEREIN, CMCC MAKES NO
WARRANTY, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR ANY IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE WITH RESPECT TO ANY PATENT, TRADEMARK, SOFTWARE, TRADE SECRET, TANGIBLE
RESEARCH PROPERTY, INFORMATION OR DATA LICENSED OR OTHERWISE PROVIDED TO
LICENSEE HEREUNDER AND HEREBY DISCLAIMS THE SAME.
J. Article VIII, Paragraphs A through I shall survive expiration
or termination of this Agreement.
ARTICLE IX. EXPORT CONTROLS
It is understood that CMCC is subject to United States laws and
regulations controlling the export of technical data, computer software,
laboratory prototypes and other commodities (including the Arms Export Control
Act, as amended and the Export Administration Act of 1979), and that its
obligations hereunder are contingent on compliance with applicable United States
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export laws and regulations. The transfer of certain technical data and
commodities may require a license from the cognizant agency of the United States
Government and/or written assurances by Licensee that Licensee shall not export
data or commodities to certain foreign countries without prior approval of such
agency. CMCC neither represents that a license shall not be required, nor that
if required, it shall be issued.
ARTICLE X. NON-USE OF NAMES
Licensee shall not use the name of Children's Medical Center
Corporation nor the name of any of its corporate affiliates or employees, nor
any adaptation thereof, in any advertising, promotional or sales literature
without prior written consent obtained from CMCC in each case, which consent
shall not be unreasonably withheld. CMCC shall respond, in writing, to any
request within five (5) business days. Notwithstanding the foregoing
restrictions, Licensee may state that it is licensed by CMCC under one or more
of the patents and/or applications comprising the Patent Rights, and Licensee
may comply with disclosure requirements, as reasonably interpreted by its
counsel, of all applicable laws and regulations relating to its business,
including United States and state security laws.
ARTICLE XI. ASSIGNMENT
A. Except as otherwise provided herein, this Agreement is not
assignable in whole or in part, and any attempt to do so shall be void and of no
effect.
B. CMCC may assign this Agreement at any time to any corporate
affiliate of CMCC without the prior consent of Licensee.
C. Except as provided in Article XI, Paragraph D below, Licensee
may assign this Agreement to another entity only with the prior written consent
of CMCC, which consent shall not be unreasonably withheld or delayed.
D. Notwithstanding anything herein to the contrary, in the event
Licensee merges with another entity, is acquired by another entity, or sells all
or substantially all of its assets to another entity, Licensee may assign its
rights and obligations hereunder to, in the event of a merger or acquisition,
the surviving entity, and in the event of a sale, the acquiring entity, without
CMCC's consent so long as: (i) Licensee is not then in breach of this Agreement;
(ii) the proposed assignee has a net worth at least equivalent to the net worth
Licensee had as of the date of this Agreement; (iii) the proposed assignee has
available resources and sufficient scientific, business and other expertise
comparable to Licensee in order to satisfy its obligations hereunder; (iv)
Licensee provides written notice of the assignment to CMCC, together with
documentation sufficient to demonstrate the requirements set forth in
subparagraphs (i) through (iii) above, at least thirty (30) days prior to the
effective date of the assignment; and (v) CMCC receives from the assignee, in
writing, at least thirty (30) days prior to the effective date of the
assignment: (a) reaffirmation of the terms of this Agreement; (b) an agreement
to be bound by the terms of this Agreement; and (c) an agreement to perform the
obligations of Licensee under this Agreement.
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ARTICLE XII. DISPUTE RESOLUTION AND ARBITRATION
A. Except for the right of either party to apply to a court of
competent jurisdiction for a temporary restraining order, a preliminary
injunction, or other equitable relief to preserve the status quo or prevent
irreparable harm, any and all claims, disputes or controversies arising under,
out of, or in connection with the Agreement, including any dispute relating to
patent validity or infringement, which the parties shall be unable to resolve
within sixty (60) days shall be mediated in good faith. The party raising such
dispute shall promptly advise the other of such claim, dispute or controversy in
writing, describing the dispute in reasonable detail. By no later than five (5)
business says after the recipient has received such notice of dispute, each
party shall have selected a representative who shall have the authority to bind
such party and shall have advised the other party in writing of the name and
title of such representative.
B. Within fifteen (15) days of receipt of a request for mediation
as described above, the parties agree to commence mediation in the City of
Boston, Commonwealth of Massachusetts in accordance with the policies and
procedures of Endispute, Inc. ("Endispute"), or in the event that Endispute is
no longer in operation, in accordance with the policies and procedures of the
American Arbitration Association (the "AAA"). The parties shall select a
mediator acceptable to both of them from a list provided by Endispute. The
parties agree to cooperate in good faith in said mediator's efforts to assist
the parties to resolve the dispute. Each party agrees to pay fifty percent (50%)
of the costs of said mediation. If the matter has not been resolved within
thirty (30) days of the commencement of mediation, either party may request in
writing that the matter be submitted to arbitration in accordance with the
following subparagraph.
C. Any and all claims, disputes or controversies arising under,
out of, or in connection with this Agreement, which have not been resolved by
good faith negotiations between the parties or by mediation shall be resolved by
final and binding arbitration in Boston, Massachusetts, in accordance with the
rules of the AAA then obtaining and all expenses, in connection therewith, will
be shared equally, except for the expense of the parties' respective legal
counsels. A single arbitrator shall be mutually agreed upon and if the parties
are unable to agree on a mutually acceptable arbitrator, an arbitrator shall be
chosen in accordance with AAA rules. Any award rendered in such arbitration
shall be final and may be enforced by either party.
D. Notwithstanding the foregoing, nothing in this Article shall
be construed to waive any rights or timely performance of any obligations
existing under this Agreement.
ARTICLE XIII. TERM AND TERMINATION
A. The term of this Agreement shall be not less than fifteen (15)
years or the life of the last expiring Patent Right, whichever period is the
longer term.
B. CMCC may terminate this Agreement immediately upon the
bankruptcy, insolvency, liquidation, dissolution or cessation of operations of
Licensee; or the filing of any voluntary petition for bankruptcy, dissolution,
liquidation or winding-up of the affairs of Licensee; or any assignment by
Licensee for the benefit of creditors; or the filing of any involuntary petition
for bankruptcy, dissolution, liquidation or winding-up of the affairs of
Licensee which is not dismissed within ninety (90) days of the date on which it
is filed or commenced.
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C. CMCC may terminate this Agreement upon thirty (30) days prior
written notice in the event of Licensee's failure to pay to CMCC royalties due
and payable hereunder in a timely manner, unless Licensee shall make all such
payments to CMCC within said thirty (30) day period. Upon the expiration of the
thirty (30) day period, if Licensee shall not have made all such payments to
CMCC, the rights, privileges and licenses granted hereunder shall terminate.
D. Except as otherwise provided in Paragraph C above, either
party may terminate this Agreement upon sixty (60) days prior written notice in
the event of the other party's breach or default of any material term or
condition or warranty contained in this Agreement, unless breaching party shall
cure such breach to the nonbreaching party's reasonable satisfaction within said
sixty (60) day period. Upon the expiration of the sixty (60) day period, if the
breaching party shall not have cured said breach to the reasonable satisfaction
of the nonbreaching party, the rights, privileges and license granted hereunder
shall terminate.
E. Licensee shall have the right to terminate this Agreement at
any time upon six (6) months' prior written notice to CMCC, and upon payment by
Licensee of all amounts due CMCC through the effective date of termination.
F. Upon termination of this Agreement for any reason, nothing
herein shall be construed to release either party from any obligation that
matured prior to the effective date of such termination. Licensee and any
Sublicensee thereof may, however, after the effective date of such termination,
sell all Marker Panel Products and complete Marker Panel Products in the process
of manufacture at the time of such termination and sell the same, provided that
Licensee shall pay to CMCC the royalties thereon as required under this
Agreement and shall submit the reports required under this Agreement on the
sales of Marker Panel Products.
ARTICLE XIV. PAYMENTS, NOTICES, AND OTHER COMMUNICATIONS
A. All payments, notices, reports and/or other communications
made in accordance with this Agreement, shall be sufficiently made or given on
the date of the mailing if delivered by hand, by facsimile or sent by first
class mail postage prepaid and addressed as follows:
In the case of CMCC:
Director, Intellectual Property Office
Children's Hospital
000 Xxxxxxxx Xxxxxx
Xxxxxx, XX 00000
In the case of Licensee:
Xxxx Xxxxxxx, M.D. President
GMP|Diagnostic|Prognostic Markers
Xxx Xxxx Xxxxxxx Xxxxxxxxx, Xxxxx 0000
Xxxx Xxxxxxxxxx, XX 00000
or such other address as either party shall notify the other in writing.
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ARTICLE XV. GENERAL PROVISIONS
A. All rights and remedies hereunder will be cumulative and not
alternative.
B. This Agreement may be amended only by written agreement signed
by the parties.
C. It is expressly agreed by the parties hereto that CMCC and
Licensee are independent contractors and nothing in this Agreement is intended
to create an employer relationship, joint venture, or partnership between the
parties. No party has the authority to bind the other.
D. This Agreement constitutes the entire agreement between the
parties with respect to the subject matter hereof and supersedes all proposals,
negotiations and other communications between the parties, whether written or
oral, with respect to the subject matter hereof.
E. If any provisions of this Agreement shall be held to be
invalid, illegal or unenforceable, the validity, legality and enforceability of
the remaining provisions of this Agreement shall not be impaired thereby.
F. CMCC agrees to promptly issue, from time to time, upon written
request, estoppel certificates in favor of the Licensee, Sublicensees or
potential Sublicensees setting forth the status of this Agreement and, if in
default, the conditions required to cure the same.
G. This Agreement may be executed in any number of counterparts,
each of which shall be deemed an original as against the party whose signature
appears thereon, but all of which taken together shall constitute but one and
the same instrument.
H. The failure of either party to assert a right to which it is
entitled or to insist upon compliance with any term or condition of this
Agreement shall not constitute a waiver of that right or excuse a similar
subsequent failure to perform any such term or condition by the other party.
I. Licensee agrees to xxxx any Marker Panel Products sold in the
United States with all applicable United States patent numbers. All Marker Panel
Products shipped to or sold in other countries shall be marked in such a manner
as to conform with the patent laws and practices of the country of manufacture
or sale.
J. Each party hereto agrees to execute, acknowledge and deliver
such further instruments and do all such further acts as may be necessary or
appropriate to carry out the purposes and intent of this Agreement.
K. The paragraph headings contained in this Agreement are for
reference purposes only and shall not in any way affect the meaning or
interpretation of this Agreement.
L. This Agreement shall be governed by the laws of the
Commonwealth of Massachusetts, without regard to conflict of law rules.
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IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date last written below.
CHILDREN'S MEDICAL CENTER CORPORATION LICENSEE
By: By:
--------------------------------- ------------------------------
Name: Xxxxxxx New Name: Xxxxxxx X. Xxxxx
Title: VP of Research Administration Title: Secretary, GMP|Diagnostic|
Prognostics Markers, Inc.
Date: May 25, 2000 Date: May 25, 2000
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APPENDIX 1
Patent Rights for the Xxxxxxx License Agreement
Patent Family U.S. Patent Nos., Application Nos. or
------------------------ -------------------------------------
Application Names
-----------------
1. BAP-1 Family i. 5,539,094
ii. 5,650,491
iii. 5,641,866
iv. 5,686,595
2. BCL-G Family i. Patent application(1) filed 12/14/99
3. BAG Family i. Patent application filed 9/9/98 (5 novel
genes)
ii. Patent application filed 7/9/99 (method
claims)
4. BAX Inhibitor Protein i. 5,837,838
5. Traf Family Novel Traf Family Proteins
--------
(1) Application Serial Nos. not available
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APPENDIX 2
Patent Rights for the Moses License Agreement
6,037,138 (breast cancer associated MMP)
09/469,637 (urine assay, etc.)
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APPENDIX 3
Patent Rights for the Zetter License Agreement
5,663,071 (nucleic acids, vectors, host cell)
5,721,337 (protein)
5,831,033 (antibody)
CMCC 737 (TB 16)
5,858,681 (method of prognosis)
09/135,599 (method of diagnosis)
6,017,717
PCT/US98/21671
ID CMCC 737
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*** CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
APPENDIX 4
DEVELOPMENT PLAN
GMP|Diagnostic|Prognostic Markers, Inc. agrees to fund up to an
aggregate of [***] to fund the research and development and the
commercialization of the Marker Panel Products and Marker Panel Processes, and
shall attempt to develop a Marker Panel Product or Marker Panel Process pursuant
to the following schedule:
June 1, 2000 through May 31, 2003 - GMP agrees to fund or cause third parties to
timely fund the Sponsored Research Agreement at [***] per year for three years.
Third quarter 2003 - Start clinical trials, if necessary, for FDA approval.
June 1, 2003 through May 31, 2005 - Obtain FDA approval and develop boxed assays
in commercial form.
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