AMENDMENT NO. 2 TO LICENSE, DEVELOPMENT AND COOPERATION AGREEMENT
EXHIBIT 10.99
***Text Omitted and Filed Separately
with the Securities and Exchange Commission.
Confidential Treatment Requested
Under 17 C.F.R. Sections 200.80(b)(4)
and 240.24b-2.
with the Securities and Exchange Commission.
Confidential Treatment Requested
Under 17 C.F.R. Sections 200.80(b)(4)
and 240.24b-2.
AMENDMENT NO. 2 TO
LICENSE, DEVELOPMENT AND COOPERATION AGREEMENT
LICENSE, DEVELOPMENT AND COOPERATION AGREEMENT
This Amendment No. 2 (“Amendment No. 2”) is entered into effective as of April 28, 2009 (the
“Amendment Effective Date”), pursuant to and amending that certain License, Development and
Cooperation Agreement (the “Agreement”) between Gen-Probe Incorporated, a Delaware corporation
(“Gen-Probe”) and DiagnoCure, Inc., a company organized under the laws of the Province of Quebec,
Canada (“DiagnoCure”). Capitalized terms used but not defined herein shall have the meanings set
forth in the Agreement.
Recitals
A. The parties entered into the Agreement as of November 19, 2003 pursuant to which, among
other things, the parties described their respective rights and obligations with respect to the
development, manufacture, marketing and distribution of Licensed Products for the detection and
measurement of PCA3 as a marker for prostate cancer. The Agreement was previously amended on May
24, 2006 (“Amendment No. 1”).
B. Pursuant to the Agreement, Gen-Probe has commenced development of an in vitro diagnostic
test kit for the detection and measurement of PCA3 as a marker for prostate cancer.
C. The parties desire to clarify and/or modify certain aspects of their relationship pursuant
to the Agreement, in the manner set forth in this Amendment No. 2.
Agreement
NOW, THEREFORE, for and in consideration of the mutual covenants and agreements set forth in
this Amendment No. 2, the parties hereby agree to amend the Agreement as follows:
1. Unless otherwise stated herein, all capitalized terms shall have the meaning set forth in
the Agreement.
2. Section 1.31 of the Agreement shall be deleted and replaced in its entirety by the
following:
1.31 “Net Sales” shall mean the aggregate amount of revenue in U.S.
Dollars (converted as necessary for sales made in a currency other than U.S. Dollars
into U.S. Dollars at the applicable Exchange Rate) realized by Gen-Probe or its
Affiliates or its or their respective sublicensees or distributors from End Users
for any Licensed Product sold or otherwise disposed of, or Licensed
Methods practiced, for consideration less only the allowable deductions set forth in
subsections (a) through (c) below (and Gen-Probe shall ensure that all sales and
other dispositions of the Licensed Products in any country shall be by Gen-Probe or
its Affiliates or its or their respective sublicensees or distributors directly to
End Users); provided, however, in any country of the world that is not a
Major Country (as defined below in this Section) where it is not commercially
feasible
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for Gen-Probe to have a direct sales force or a sublicensee and where Gen-Probe has
a contract with a distributor for the sale of Licensed Product in such non-Major
Country as specified in such contract (such distributor, an “Authorized
Distributor,” such country, a “Distributor Country” and such contract, a
“Distributor Contract”), “Net Sales” shall mean the aggregate amount of revenue in
U.S. Dollars (converted as necessary for sales made in a currency other than U.S.
Dollars into U.S. Dollars at the applicable Exchange Rate) realized by Gen-Probe or
its Affiliates for any Licensed Product sold or otherwise disposed of, or any
Licensed Methods practiced, in such Distributor Country (less only the allowable
deductions set forth in subsections (a) through (c) below), and shall not mean
revenue based upon End User pricing for such Licensed Product (unless such
Licensed Product was not sold or otherwise disposed of by the Authorized Distributor
for such Distributor Country under the applicable Distributor Contract, in which
event, this proviso shall not apply and the sale or other disposition of such
Licensed Product in such Distributor Country shall be treated in the same manner as
it would be treated in any country that is not a Distributor Country and mean
revenue based upon End User pricing). For purposes of this Section, “Major Country”
shall mean (i) [...***...], and/or (ii) [...***...] (A) in which any Licensed
Product is sold or otherwise disposed of, or any Licensed Methods are practiced, by
or though Gen-Probe or any of its Affiliates, or any of its or their respective
sublicensees or distributors and which sublicensee or distributor (or any of their
respective Affiliates) has its primary place of business in [...***...], and/or (B)
from which any Licensed Product is distributed, sold or otherwise disposed of by
Gen-Probe or any of its Affiliates or any of its or their respective sublicensees or
distributors into [...***...].
For any Licensed Product sold or otherwise disposed of, or Licensed Methods
practiced, for consideration other than cash, the revenue from each such Licensed
Product shall be deemed to be the average price charged for identical or similar
(after reasonable adjustments) Licensed Products sold or Licensed Methods practiced
by Gen-Probe or its Affiliates during the same royalty period in “arms-length”
transactions.
The following deductions shall be permitted to the extent customary and actually
taken and allowed in the applicable country, and, in each case, as determined and
allocated in accordance with U.S. generally accepted accounting principles,
consistently applied (GAAP) (and, in each case, solely to the extent such deduction
is directly related to a sale of a Licensed Product in the applicable country where
such sale was made):
(a) customary credits and allowances granted by Gen-Probe and its Affiliates
(if any) for such Licensed Products on account of refunds, price
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reductions, price discounts or rebates, whether arising out of recalls, rejections,
returns or otherwise relating to Licensed Products sold during or prior to such
royalty period (and for which royalties were previously paid to DiagnoCure
hereunder);
(b) excise taxes, sales taxes, value added taxes, consumption taxes, customs
duties and other taxes or duties (excluding income taxes or franchise taxes) imposed
with respect to such Licensed Products; and
(c) transportation charges (including packing, insurance, and freight costs)
actually incurred by Gen-Probe or its Affiliate in connection with the sales of such
Licensed Products.
3. A new Section 3.2.5 shall be added to the Agreement as follows:
3.2.5 Gen-Probe shall supply Gen-Probe’s current TMA PCA3 ASR product to
DiagnoCure until the date on which the FDA approves a Gen-Probe in vitro diagnostic
test for PCA3. Gen-Probe shall supply the current TMA PCA3 ASR product to
DiagnoCure on commercial terms [...***...]. Gen-Probe hereby grants DiagnoCure an
option to a sublicense to develop, make, have made, use, sell, offer for sale and
import Licensed Products intended for use as laboratory developed tests within
DiagnoCure’s or its Affiliate’s laboratories in the United States. Such option to a
sublicense shall only be exercisable by DiagnoCure if [...***...] and, as a result,
[...***...] (in which event, upon exercise of the option by DiagnoCure upon written
notice to Gen-Probe, DiagnoCure would have the right under the sublicense to develop
and commercialize the laboratory developed test and Gen-Probe would use its best
efforts to promptly grant such sublicense to DiagnoCure). The parties acknowledge
that, unless otherwise agreed by the parties, such option shall not include the
right for DiagnoCure to sell Licensed Products in the United States to Third Parties
for use in laboratories other than those laboratories owned by DiagnoCure and/or its
Affiliates.
4. A new Section 4.1.6 shall be added to the Agreement as follows:
4.1.6 Gen-Probe shall pay DiagnoCure Five Hundred Thousand U.S. Dollars
(US$500,000) on an annual basis, which payment shall be non-refundable and
non-cancelable and due and payable within ten (10) days of the Amendment Effective
Date for 2009, and shall be due and payable by [...***...] of each subsequent
calendar year. Subject to, and without limiting, Section 10.2.5, Gen-Probe shall
continue to pay this annual payment to DiagnoCure (A) until the earlier of (i) two
(2) years after Gen-Probe’s filing of an application with the FDA for regulatory
approval of a Licensed Product that is a TMA PCA3 assay
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in the United States, (ii) FDA approval of a Licensed Product that is a PCA3 assay
in the United States, or (iii) the date on which DiagnoCure obtains co-exclusive
rights pursuant to Section 10.2.4; and (B) if applicable, as set forth in Section
10.2.5. Fifty percent (50%) of each such annual payment (e.g., US$250,000) (each, a
“Permitted Deduction Amount”) may be deducted by Gen-Probe against future royalties
due and payable to DiagnoCure by Gen-Probe pursuant to Section 4.2. Solely during
the period that Gen-Probe is deducting the Permitted Deduction Amounts, the royalty
payment thresholds shall be as set forth in the table below instead of as set forth
in Section 4.2(a). For the avoidance of doubt, upon Gen-Probe’s recoupment of the
Permitted Deduction Amounts as set forth herein, the provisions set out in the table
below shall no longer have any force or effect and the applicable royalty payment
thresholds shall again be those set forth in Section 4.2(a).
| Permitted Deduction Amounts | Royalty thresholds | Royalty thresholds for | ||
| deductible from future | for 8% annual | 16% annual royalties on | ||
| royalties | royalties on Net Sales | Net Sales of Licensed | ||
| (by way of example) | of Licensed Products | Products | ||
| If there is one Permitted Deduction Amount equal to US$250,000 | Up to US$53.125 million in cumulative Net Sales | In excess of US$53.125 million in cumulative Net Sales | ||
| If there are two Permitted Deduction Amounts, each equal to US$250,000 | Up to US$56.25 million in cumulative Net Sales | In excess of US$56.25 million in cumulative Net Sales | ||
| If there are three Permitted Deduction Amounts, each equal to US$250,000 | Up to US$59.375 million in cumulative Net Sales | In excess of US$59.375 million in cumulative Net Sales |
5. A new Section 4.5 shall be added to the Agreement as follows:
4.5 Preferred Stock.
(a) Issuance of Shares. Within fifteen (15) days after the Amendment
Effective Date (the “Closing Date”), Gen-Probe shall purchase Four Million Nine
Hundred Thousand (4,900,000) shares of DiagnoCure Series A convertible preferred
shares of DiagnoCure for an aggregate purchase price of Five Million U.S. Dollars
(US$5,000,000) (the “Original Purchase Price”), no par value (the “Series A
Preferred”).
(b) Conversion. Each share of the Series A Preferred shall initially
be convertible into one share of DiagnoCure’s common stock (the “Common Shares”).
The conversion rate will be subject to adjustment for dilutive issuances as provided
below. The Series A Preferred shares may be converted in whole or in part, at
Gen-Probe’s option.
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(c) Conversion Price. The conversion price of the Series A Preferred
shall be subject to proportional adjustment for stock splits, stock dividends and
the like.
(d) Protective Provisions. For so long as any shares of Series A
Preferred remain outstanding, consent of the holders of a majority of the Series A
Preferred shall be required for any action (by merger, reclassification or
otherwise) that (i) alters or changes the rights, preferences or privileges of the
Series A Preferred, or (ii) amends or waives any provision of the Company’s
Certificate of Incorporation or Bylaws in a manner adverse to the holders of the
Series A Preferred.
(e) Dividends. The holders of the Series A Preferred shall be entitled
to receive non-cumulative dividends in preference to any dividend on the Common
Shares at the rate of six percent (6%) of the sum of the Original Purchase Price
plus any declared but unpaid dividends, when, as and if declared by DiagnoCure’s
Board of Directors.
(f) Liquidation Preference. In the event of any liquidation or winding
up of DiagnoCure, DiagnoCure shall pay to the holders of the Series A Preferred
shares a per share amount equal to the sum of the Original Purchase Price per share
then outstanding plus any declared but unpaid dividends (the “Liquidation
Preference”). The Liquidation Preference shall be paid to Gen-Probe in preference
to any payments to the holders of the Common Shares (and any other preferred shares
that may be issued after the Closing Date). DiagnoCure’s Certificate of
Incorporation or Certificate of Designation for the Series A Preferred shall provide
that in the event of any liquidation or winding up of DiagnoCure, the holders of the
Series A Preferred shares shall be entitled to receive at least twenty (20) days
prior written notice of such event in order that the holders may elect to receive
the Liquidation Preference or, alternatively, convert the Series A Preferred shares
into Common Shares prior to or upon such event. A merger, acquisition, sale of
voting control or sale or other disposition of substantially all of the assets of
DiagnoCure in which the shareholders of DiagnoCure do not own a majority of the
outstanding shares of the surviving corporation shall be treated as a liquidation.
(g) Registered Shares. The Common Shares issued upon conversion of the
Series A Preferred shares will be freely tradable upon issuance. In the event any
applicable law requires registration, DiagnoCure shall use diligent efforts to
provide such registration.
(h) Automatic Conversion. After the twelve (12) month anniversary of
the Closing Date, if DiagnoCure’s Common Shares trade at CAD $2.50 or more per share
for a minimum consecutive trading period of thirty (30) days (the “Minimum Trading
Period”), then DiagnoCure shall have the right to require a conversion of the Series
A Preferred shares into Common Shares at the then applicable Conversion Rate, upon
delivery of a written notice to Gen-Probe at least five (5) business days prior to
the intended consummation date of such conversion.
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(i) Redemption Right. Prior to receipt by DiagnoCure of a notice from
Gen-Probe (or a subsequent holder of the Series A Preferred shares) that Gen-Probe
(or such subsequent holder) has exercised its right of conversion, DiagnoCure shall
have the right to redeem any or all of the then-outstanding Series A Preferred
shares, by paying to the holder the greater of (i) the Original Purchase Price of
such shares plus interest at six percent (6%) per annum from the date of issue, or
(ii) the fair market value of the Common Shares that would be issued upon immediate
conversion.
(j) Share Purchase Agreement. The investment shall be made pursuant to
a Share Purchase Agreement governed by Quebec law and which is reasonably acceptable
to DiagnoCure and Gen-Probe and which shall contain, among other things, appropriate
representations and warranties of DiagnoCure, reflecting the provisions set forth in
this Section 4.5 summary of terms and appropriate closing conditions, including an
opinion of counsel for DiagnoCure under Quebec law.
6. A new Section 4.6 shall be added to the Agreement as follows:
4.6 Security Interest. In consideration of Gen-Probe entering into and
continuing its performance under this Agreement and agreeing to purchase the Series
A Preferred shares, DiagnoCure shall enter into a movable hypothec agreement (the
“Movable Hypothec Agreement”) pursuant to the laws of the Province of Quebec,
substantially in the form attached hereto as Schedule 4, and an intellectual
property security agreement (the “Intellectual Property Security Agreement”),
substantially in the form attached hereto as Schedule 5, to provide Gen-Probe with a
first ranking movable hypothec and security interest, respectively, in all of
DiagnoCure’s right, title and interest in the Collateral (as defined in the Movable
Hypothec Agreement) to secure the payment of the Liquidation Preference pursuant to
Section 4.5(f) of this Agreement, subject to and as set forth in the Movable
Hypothec Agreement and the Intellectual Property Security Agreement. DiagnoCure
shall file or cause to be filed such Movable Hypothec Agreement, Intellectual
Property Security Agreement, financing statements and/or other appropriate
documents, with the appropriate filing offices in the United States and Canada,
including the Register of Personal and Movable Real Rights (Quebec), the Canadian
Intellectual Property Office, the United States Patent and Trademark Office, and the
District of Columbia Recorder of Deeds, as applicable, in order to register or
record such movable hypothec and security interest promptly after the execution of,
and as set forth in, such Movable Hypothec Agreement and Intellectual Property
Security Agreement, respectively. In the event DiagnoCure fails to do so, and to
the extent necessary, DiagnoCure appoints Gen-Probe its attorney in fact to make
such filings and authorizes Gen-Probe to make such filings. The Collateral shall at
all times be free and clear of all hypothecs, pledges, assignments, security
interests and other liens or similar types of encumbrances save and except for
security created pursuant to the Movable Hypothec Agreement and the Intellectual
Property Security Agreement. The hypothecary rights and other remedies Gen-Probe
may have as secured
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creditor against the Collateral pursuant to the Movable Hypothec Agreement and the
Intellectual Property Security Agreement or under applicable laws, shall become
enforceable only upon the occurrence of an Event of Default (as defined in the
Movable Hypothec Agreement).
The movable hypothec and security interest granted in the Collateral by the Movable
Hypothec Agreement and the Intellectual Property Security Agreement shall
automatically and immediately terminate, and Gen-Probe shall sign such documents and
take such actions as may be reasonably requested by DiagnoCure to evidence,
implement, effect and record the termination and release of the movable hypothec and
security interest, (i) upon DiagnoCure obtaining a co-exclusive license right under
Sections 10.2.4 or 10.2.5, or (ii) upon Gen-Probe having received, in consideration
for the sale, transfer or other disposition of any Series A Preferred shares or
Common Shares acquired hereunder, at least [...***...] of the sum of the Original
Purchase Price plus any declared but unpaid dividends (including, without
limitation, pursuant to DiagnoCure’s exercise of its redemption rights pursuant to
Section 4.5(i) or through a sale to any other person or entity), or (iii) if
Gen-Probe receives, in consideration for the sale, transfer or other disposition of
any Series A Preferred shares or Common Shares acquired hereunder, an amount that is
less than [...***...] of the sum of the Original Purchase Price plus any declared
but unpaid dividends (the “Actual Amount”), upon DiagnoCure’s payment to Gen-Probe
of (A) if such sale, transfer or other disposition was to a Third Party pursuant to
an “arms-length” transaction, an amount equal to the difference between (x) the
Actual Amount received by Gen-Probe in consideration for such sale, transfer or
other disposition of such Series A Preferred shares or Common Shares acquired
hereunder, and (y) [...***...] of the sum of the Original Purchase Price plus any
declared but unpaid dividends, or (B) if such sale, transfer or other disposition
was not to a Third Party pursuant to an “arms-length” transaction, an amount equal
to the difference between (x) the amount Gen-Probe would have received in
consideration for such sale, transfer or other disposition of such Series A
Preferred shares or Common Shares acquired hereunder to a Third Party pursuant to an
“arms-length” transaction, and (y) [...***...] of the sum of the Original Purchase
Price plus any declared but unpaid dividends.
Upon request by Gen-Probe, DiagnoCure shall use its reasonable commercial efforts to
obtain consent to DiagnoCure’s execution of the Movable Hypothec Agreement and the
Intellectual Property Security Agreement by the licensors of the Patent Licenses
included within the Collateral; provided that the parties acknowledge and
agree that DiagnoCure may not be able to obtain such consent(s) from such licensors.
7. Section 6.1.1 of the Agreement shall be amended to add the following sentence
immediately after the first sentence of Section 6.1.1:
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At least one of the three representatives of each party shall be the
Chief Financial Officer of such party or such person’s designee.
8. A new Section 6.1.2 shall be added to the Agreement, providing as follows:
6.1.2 Each quarterly meeting of the Marketing and Clinical Trial Subcommittee
of the Joint Advisory Committee shall include a presentation by Gen-Probe of current
information regarding: (i) Gen-Probe’s strategy concerning [...***...]; and (ii)
Gen-Probe’s current research and development activities concerning [...***...].
9. Section 10.2 of the Agreement shall be deleted and replaced in its entirety by the
following:
10.2 Gen-Probe Diligence Obligations. Gen-Probe shall, at its own
cost, comply with each of the following:
10.2.1 Gen-Probe shall use its commercially reasonable efforts to obtain FDA
approval of the Licensed Product that is the current end-point TMA assay for PCA3
and prostate specific antigen (PSA) (and Gen-Probe shall create a commercially
reasonable development plan therefor and shall provide at least quarterly updates to
DiagnoCure with respect thereto (and as may be reasonably requested by DiagnoCure
from time to time));
10.2.2 Gen-Probe shall use its commercially reasonable efforts to obtain FDA
approval of a Licensed Product that is the real-time TMA PCA3 assay which shall run
on the Panther instrument (and Gen-Probe shall create a commercially reasonable
development plan therefor and shall provide at least quarterly updates to DiagnoCure
with respect thereto (and as may be reasonably requested by DiagnoCure from time to
time)); and
10.2.3 In any event, Gen-Probe shall file an application with the FDA for
regulatory approval of a Licensed Product that is a TMA PCA3 assay in the United
States by [...***...] (the “Milestone Date”).
10.2.4 If Gen-Probe (A) fails to comply with its obligations under Sections
10.2.1 through 10.2.3, or (B) fails to notify DiagnoCure of its election pursuant to
Section 10.2.5 within the time period specified therein, or (C) fails to pay
DiagnoCure the minimum annual payments of Five Hundred Thousand U.S. Dollars
(US$500,000) as set forth in Section 4.1.6 and/or Section 10.2.5 (and fails to cure
any such failure within [...***...] after receipt of written notice thereof from
DiagnoCure) (notwithstanding anything contained herein, the foregoing shall be in
addition to, and shall not limit, DiagnoCure’s rights and
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remedies under this Agreement for any late payment), or (D) elects pursuant to
Section 10.2.5 for DiagnoCure to obtain a co-exclusive license in the United States,
then, as DiagnoCure’s sole remedy, Gen-Probe’s license under this Agreement shall
automatically and immediately convert to a co-exclusive (with DiagnoCure) license in
the United States. DiagnoCure shall not have the right to grant a sublicense to any
Third Party under such co-exclusive sublicense (but may grant a sublicense to an
Affiliate that is directly or indirectly wholly owned by DiagnoCure) nor to serve as
a foundry for a Third Party (i.e., manufacture products in bulk on an OEM basis for
sale by the Third Party under the trademarks of the Third Party). Without
Gen-Probe’s prior written consent (such consent not to be unreasonably withheld or
delayed), DiagnoCure shall not have the right to assign its license (other than in
connection with an assignment of this Agreement as permitted under Section 17.3).
10.2.5 If Gen-Probe has not obtained FDA approval of a Licensed Product that is
a TMA PCA3 assay in the United States by [...***...], then Gen-Probe shall, within
[...***...], elect one of the following and so notify DiagnoCure in writing of its
election: (A) to continue the minimum annual payments of Five Hundred Thousand U.S.
Dollars (US$500,000) (which Gen-Probe shall pay to DiagnoCure in the same manner as
set out in Section 4.1.6 (i.e., on an annual basis, by [...***...] of each calendar
year) until the earlier of the date on which (i) FDA approval of a Licensed Product
that is a PCA3 assay in the United States, or (ii) the DiagnoCure Patent Rights have
fully expired in the United States; or (B) that DiagnoCure shall obtain a
co-exclusive license in the United States on the terms set forth in Section 10.2.4.
10. Section 17.3 of the Agreement shall be deleted and replaced in its entirety by the
following:
17.3 Assignment. Neither party shall assign its rights or obligations
under this Agreement, and DiagnoCure shall not transfer or assign the DiagnoCure
Patent Rights, without the prior written consent of the other party;
provided, however, that (A) DiagnoCure may, without the consent of
Gen-Probe, assign this Agreement and its rights and obligations hereunder, and/or
any of the DiagnoCure Patent Rights, to any Affiliate that is directly or indirectly
wholly owned by DiagnoCure, and/or (B) either party may, without such consent,
assign this Agreement and its rights and obligations hereunder, and DiagnoCure may
transfer or assign the DiagnoCure Patent Rights, in connection with the transfer or
sale of all or substantially all of its business related to this Agreement, or in
the event of its merger, consolidation, change in control or similar transaction.
Any permitted assignee shall assume all obligations of its assignor under this
Agreement.
11. The Agreement is hereby amended to add a Schedule 4 to the Agreement, which is attached
hereto as Exhibit A.
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12. The Agreement is hereby amended to add a Schedule 5 to the Agreement, which is attached
hereto as Exhibit B.
13. For the avoidance of doubt, Paragraphs 8 through 10 of Amendment No. 1 shall have no
further force or effect and are superseded by this Amendment No. 2.
14. Except as is expressly set forth in this Amendment No. 2, all other terms and conditions
of the Agreement shall continue in full force and effect.
15. This Amendment No. 2 may be executed in counterparts, each of which shall be an original,
and all of which together shall constitute one and the same instrument.
* * * * *
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IN WITNESS WHEREOF, the parties have caused this Amendment No. 2 to be executed and the
persons signing below warrant that they are duly authorized to sign for and on behalf of the
respective parties.
| GEN-PROBE INCORPORATED | DIAGNOCURE, INC. | |||||||||||||
| By: | /s/ Xxxxx X. Xxxxxxxx | By: | /s/ Xxxx-Xxxxxxxx Bureau | |||||||||||
| Name: | Xxxxx X. Xxxxxxxx | Name: | Xxxx-Xxxxxxxx Bureau | |||||||||||
| Title: | Chief Executive Officer | Title: | Senior Vice President &
Chief Financial Officer |
|||||||||||
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EXHIBIT A to Amendment No. 2
SCHEDULE 4
Form of Movable Hypothec Agreement
[Intentionally Omitted]
12
SCHEDULE 5
Form of Intellectual Property Security Agreement
[Intentionally Omitted]
13
