AMENDMENT TO CONTRIBUTION AGREEMENT
Exhibit 10.2
AMENDMENT TO CONTRIBUTION
AGREEMENT
This
Amendment (the “Amendment”), dated as of October 6, 2009, to that certain
Contribution Agreement (the “Agreement”) executed as of July 28, 2006 by the
parties hereto, is entered into by and between SHIVA BIOMEDICAL, LLC, a
limited liability company duly organized under the laws of New Jersey having a
place of business at 10810 Executive Center Drive, Xxxxxxxx Xxxxxxxx, Xxxxx 000,
Xxxxxx Xxxx, XX 00000 (“Shiva”), and CORMEDIX, INC., formerly PICTON HOLDING COMPANY, INC.
and successor in interest to PICTON PHARMACEUTICALS, INC.,
a corporation duly organized and existing under the laws of the State of
Delaware having a place of business at 00 Xxxxxx Xxxxxx, Xxxxx 000, Xxxxxx,
XX 00000 (the “Company”).
WHEREAS, the parties hereto
desire to amend and restate certain provisions of the Agreement as set forth
herein;
NOW, THEREFORE, in
consideration of the premises and the mutual covenants contained herein and
other good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the parties hereto, intending to be legally bound, agree as
follows:
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1.
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Capitalized
terms used herein and not otherwise defined shall have the meanings given
to them in the Agreement. All references to an Article shall
refer to an Article of the Agreement unless otherwise
indicated.
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2.
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Article
1.14 is hereby amended and restated in its entirety as
follows:
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“Licensed
Product(s)” shall mean (i) any product that cannot be manufactured, used
or sold, in whole or in part, in the country in which the product is made,
used, leased, imported, exported, offered for sale or sold, without
infringing one or more claims included within an existing issued patent or
pending patent application included in the Patent Rights as of the date of
the execution of this Agreement or (ii) any Contributed Product that
cannot be manufactured, used or sold, in whole or in part, in the country
in which the product is made, used, leased, imported, exported, offered
for sale or sold, without (x) infringing one or more claims otherwise
included at any time during the term of this Agreement within the Patent
Rights or (y) the use or incorporation of
Know-how.
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3.
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Article
1.18 is hereby amended and restated in its entirety as
follows:
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“Non-Royalty
Sublicensing Income” means any and all consideration received from a
Sublicensee in connection with the grant of a Sublicense under the Patent
Rights or Know-how, including without limitation sublicense issue fees,
sublicense maintenance fees and sales and non-sales related milestone
payments, but excluding (a) consideration received for the sale, issuance
or exchange of debt or equity securities of the Company; (b) payments
received by the Company as reimbursement or advance payment for expenses
actually incurred by the Company in the research or development of the
Technology or any Licensed Product; and (c) royalty payments based on the
sales of Licensed Products (as such sales will be subject to payment under
Article 6.3.1).
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[*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
1
4.
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Article
1.23 is hereby amended and restated in its entirety as
follows:
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“Technology”
means deferiprone, otherwise known as Shiva 102, and a diagnostic test to
predict renal disease, otherwise known as Shiva 101, and any other compound,
device or technology, the use of which is covered by the Patent
Rights.
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5.
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A
new Article 1.28 shall be added, which shall read in its entirety as
follows:
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“Company
Technology Know-how” means all non-public tangible or intangible
information whether patentable or not (but which has not been patented)
related to the Technology, any Licensed Product or any Improvement,
including but not limited to: formulations, in vitro, preclinical or
clinical design, information or results, other proprietary materials,
processes, including but not limited to manufacturing processes, data,
drawings and sketches, designs, testing and test results, and regulatory
information of a like nature.
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6.
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A
new Article 1.29 shall be added, which shall read in its entirety as
follows:
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“Equity
Adjustment Shares” shall mean a number of shares of Series A Common Stock that,
when aggregated with the number of shares of Series A Common Stock held by Shiva
prior to an Equity Adjustment Event, results in Shiva owning at least the
Minimum Equity Percentage.
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7.
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A
new Article 1.30 shall be added, which shall read in its entirety as
follows:
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“Equity
Adjustment Event” shall mean (i) the issuance of Equity Securities (other than
Exempted Securities), (ii) a Sale (as defined in the Restated Certificate) or
(iii) a Reverse Merger.
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8.
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A
new Article 1.31 shall be added, which shall read in its entirety as
follows:
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“Equity
Securities” shall mean (i) any common stock, preferred stock or other security
of the Company, (ii) any security convertible into or exercisable or
exchangeable for, with or without consideration, any common stock, preferred
stock or other security (including any option to purchase such a convertible
security), (iii) any security carrying any warrant or right to subscribe to or
purchase any common stock, preferred stock or other security or (iv) any such
warrant or right.
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9.
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A
new Article 1.32 shall be added, which shall read in its entirety as
follows:
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“Exempted Securities” shall
mean:
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(i)
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all
shares of Series A Common Stock and/or options, warrants or other Series A
Common Stock purchase rights and the Series A Common Stock issued pursuant
to such options, warrants or other rights (as adjusted for any stock
dividends, combinations, splits, recapitalizations and the like after the
date hereof) issued or to be issued after the date hereof to employees,
officers or directors of, or consultants or advisors to the Company
pursuant to stock purchase or stock option plans or other compensatory
arrangements that are approved by the Board of Directors of the Company,
not to exceed at any time, in the aggregate, more than fifteen percent
(15%) of the outstanding shares of Series A Common Stock (after giving
effect to (a) the assumed conversion of all then-outstanding securities
convertible by their terms into shares of Series A Common Stock on the
date of determination and (b) the assumed exercise of all then-outstanding
securities exercisable by their terms for shares of Series A Common Stock
on the date of determination);
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[*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
2
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(ii)
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stock
issued or issuable pursuant to those rights or agreements, options,
warrants or convertible securities outstanding and determinable as of the
date of this Amendment, all of which are fully and accurately described in
Exhibit 1.32 attached hereto;
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(iii)
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any
Equity Securities issued pro rata in connection with any stock split,
stock dividend or recapitalization by the
Company;
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(iv)
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any
Equity Securities issued for consideration other than cash pursuant to a
merger, consolidation, acquisition or similar business combination with an
unaffiliated Third Party;
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(v)
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any
Equity Securities issued pursuant to any equipment loan or leasing
arrangement, real property leasing arrangement, or debt financing from a
bank or similar financial or lending
institution;
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(vi)
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any
Equity Securities that are issued by the Company pursuant to a
registration statement filed under the Securities Act of 1933, as
amended;
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(vii)
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any
Equity Securities issued in connection with strategic transactions
involving the Company and other entities, including, without limitation,
(a) joint ventures, strategic alliances, or research and development
collaborations and (b) technology transfer, licensing or development
arrangements; provided, that such transaction is not primarily for equity
financing purposes; and
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(viii)
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any
Equity Securities issued to Shiva.
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10.
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A
new Article 1.33 shall be added, which shall read in its entirety as
follows:
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“Minimum
Equity Percentage” shall mean seven percent (7%) of the outstanding shares of
Series A Common Stock on the date of determination (after giving effect to (i)
the assumed conversion of all then-outstanding securities convertible by their
terms into shares of Series A Common Stock on the date of determination and (ii)
the assumed exercise of all then-outstanding securities exercisable by their
terms for shares of Series A Common Stock on the date of
determination).
[*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
3
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11.
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A
new Article 1.34 shall be added, which shall read in its entirety as
follows:
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“Reverse
Merger” shall mean a merger, share exchange, or other transaction (or series of
related transactions), in which (i) the Company merges into or otherwise becomes
a wholly-owned subsidiary of a company subject to the public company reporting
requirements of the Securities Exchange Act of 1934, as amended, and (ii) the
aggregate consideration payable to the Company or its stockholders in such
transaction(s) is greater than or equal to $10,000,000.
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12.
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A
new Article 1.35 shall be added, which shall read in its entirety as
follows:
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“Qualifying
Financing Amount” shall mean an aggregate of $25,000,000 in gross proceeds
received by the Company after the date of this Amendment from the issuance and
sale, to parties other than Shiva, of Equity Securities in one or a series of
transactions.
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13.
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Article
2.2.4 is hereby amended and restated in its entirety as
follows:
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Except
as expressly agreed in writing by Shiva in its sole discretion or as set
forth in this Article 2.2.4, no Sublicense shall survive termination of
this Agreement. Notwithstanding the foregoing, with respect to
any Sublicense granted after such time that the Company has raised ten
million dollars ($10,000,000) in Additional Financing (as defined in
Article 10.4.2(b)) (the “Financing Benchmark”), in the event that Shiva
terminates this Agreement pursuant to Section 10.3 (non-payment) or
Section 10.4 (termination for cause) or this Agreement terminates pursuant
to Section 10.2 (Company bankruptcy), such Sublicense shall survive such
termination of this Agreement and such Sublicensee shall have a direct
grant from Shiva of the same rights Sublicensed to Sublicensee under the
Sublicense, subject to Sublicensee assuming all obligations of the Company
to Shiva under this Agreement and providing directly to Shiva, rather than
to the Company, any additional consideration payable by Sublicensee to the
Company under the Sublicense. Upon request of the Company at
the time it enters into any sublicense agreement after achievement of the
Financing Benchmark, Shiva agrees to directly contract with each such
Sublicensee in writing with respect to the foregoing
conditions.
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14.
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Article
6.2 is hereby amended and restated in its entirety as
follows:
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Equity to
be Issued
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6.2.1
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On
the date of this Amendment, the Company and Shiva shall enter into a
common stock exchange agreement, in the form attached hereto as Exhibit
6.2.1, pursuant to which Shiva shall exchange all shares of Series B
Common Stock, Series C Common Stock, Series D Common Stock, Series E
Common Stock and Series F Common Stock currently held by Shiva
(collectively, the “Exchanged Shares”) for an aggregate of 773,717 shares
of Series A Common Stock (as more particularly described in the Company’s
Amended and Restated Certificate of Incorporation described in Article
6.2.2 below) (the “New Shares”). The New Shares shall represent
no less than seven percent (7%) of the outstanding shares of Series A
Common Stock on the date hereof (after giving effect to (i) the surrender
of the Exchanged Shares and the issuance of the New Shares, (ii) the
assumed conversion of all outstanding securities convertible by their
terms into shares of Series A Common Stock on the date hereof and (iii)
the assumed exercise of all outstanding securities exercisable by their
terms for shares of Series A Common Stock on the date
hereof).
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[*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
4
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6.2.2
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In
conjunction with the execution of this Amendment, the Company shall file
an Amended and Restated Certificate of Incorporation, in the form attached
hereto as Exhibit 6.2.2 (the “Restated Certificate”), with the Secretary
of State of the State of Delaware, which Restated Certificate shall set
forth the rights, preferences and privileges of the Series A Common Stock
representing the New Shares and shall remove all references to the several
series of common stock that comprised the Exchanged
Shares.
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6.2.3
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In
addition to the shares of Series A Common Stock to be issued pursuant to
Article 6.2.1, upon any proposed Equity Adjustment Event, the Company
shall, if necessary to achieve the Minimum Equity Percentage upon the
consummation of such Equity Adjustment Event, cause to be issued to Shiva
the applicable number of Equity Adjustment Shares as a condition to or
concurrently with the consummation of the proposed Equity Adjustment
Event.
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6.2.4
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The
Company’s obligations set forth in Article 6.2.3 shall terminate following
the earlier of (i) the consummation of one or more equity financings
following which the Qualifying Financing Amount has been received by the
Company, provided that Shiva’s rights under Article 6.2.3 shall apply to
the sale of Equity Securities up to and including the Qualifying Financing
Amount; (ii) any Sale (as defined in the Restated Certificate), provided
that Shiva’s rights under Article 6.2.3 shall apply up to and including
such Sale; (iii) any Reverse Merger, provided that Shiva’s rights under
Article 6.2.3 shall apply up to and including such Reverse Merger; or (iv)
the Company’s first firm commitment underwritten public offering of its
Series A Common Stock (or similar equity security for which the Series A
Common Stock may be exchanged or recapitalized after the date hereof)
registered under the Securities Act of 1933, as
amended.
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6.2.5
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The
Company shall not take any action that would have the effect of denying to
Shiva the intended benefits of the equity consideration provided for in
this Article 6.2.
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15.
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Article
6.3.1 is hereby amended and restated in its entirety as
follows:
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Unless
this Agreement shall be terminated as hereinafter provided, during the
applicable Royalty Term for each Licensed Product, the Company shall pay
Shiva royalties on such Licensed Product on a country-by-country basis
equal to [*] of Net Sales.
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[*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
5
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16.
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Article
6.3.2 is hereby amended and restated in its entirety as
follows:
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The Company shall also make the
following one time payments to Shiva:
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(a)
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[*];
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(b)
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[*];
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(c)
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[*];
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(d)
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[*];
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(e)
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[*];
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(f)
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[*];
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(g)
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[*];
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(h)
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[*];
and
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(i)
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[*].
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[*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
6
17.
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Article
6.4 is hereby amended and restated in its entirety as
follows:
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The
Company shall remit to Shiva [*] of all Non-Royalty Sublicensing Income received
by the Company, within [*] of the Company’s receipt of any such Non-Royalty
Sublicensing Income; provided,
however, if the Company receives any Non-Royalty Sublicensing Income in
the form of a milestone payment upon achievement of an event requiring the
Company to pay Shiva a milestone payment pursuant to Article 6.3.2, then the
Company shall remit to Shiva [*] of the net amount of such Non-Royalty
Sublicensing Income after deducting the applicable cash payment to
Shiva. By way of example, if the Company receives [*] from a
Sublicensee in the form of a milestone payment upon achievement of a certain
event, and the Company is obligated to pay Shiva a milestone payment of [*]
pursuant to Article 6.3.2 upon achievement of that same event, then the Company
shall remit to Shiva [*], which is equal to the [*] milestone payment plus [*]
of the [*] of such Non-Royalty Sublicensing Income that remains after
subtracting such milestone payment to Shiva.
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18.
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A
new Article 6.12 shall be added, which shall read in its entirety as
follows:
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Restrictions
on Transfer of Shares
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6.12.1
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Any
shares issued to Shiva pursuant to Article 6.2 (collectively, the “Shiva
Shares”) shall not be sold, pledged, or otherwise transferred, and the
Company shall not recognize and shall issue stop-transfer instructions to
its transfer agent with respect to any such sale, pledge, or transfer,
except upon the conditions specified in this Agreement, which conditions
are intended to ensure compliance with the provisions of the Securities
Act of 1933, as amended (the “Securities Act”). Shiva shall
cause any proposed purchaser, pledgee, or transferee of the Shiva Shares
to agree to take and hold such securities subject to the provisions and
upon the conditions specified in this
Agreement.
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6.12.2
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Each
certificate or instrument representing the Shiva Shares and any other
securities issued in respect of the Shiva Shares upon any stock split,
stock dividend, recapitalization, merger, consolidation, or similar event,
shall (unless otherwise permitted by the provisions of Article 6.12.3
below) be stamped or otherwise imprinted with a legend substantially in
the following form:
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THE
SECURITIES REPRESENTED HEREBY HAVE BEEN ACQUIRED FOR INVESTMENT AND HAVE NOT
BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933. SUCH SHARES MAY NOT
BE SOLD, PLEDGED, OR TRANSFERRED IN THE ABSENCE OF SUCH REGISTRATION OR A VALID
EXEMPTION FROM THE REGISTRATION AND PROSPECTUS DELIVERY REQUIREMENTS OF SAID
ACT.
[*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
7
THE
SECURITIES REPRESENTED HEREBY MAY BE TRANSFERRED ONLY IN ACCORDANCE WITH THE
TERMS OF AN AGREEMENT BETWEEN THE COMPANY AND THE STOCKHOLDER, A COPY OF WHICH
IS ON FILE WITH THE SECRETARY OF THE COMPANY.
Shiva
consents to the Company making a notation in its records and giving instructions
to any transfer agent of the Shiva Shares in order to implement the restrictions
on transfer set forth in this Article 6.12.
6.12.3
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Shiva,
by its acceptance of the Shiva Shares, agrees to comply in all respects
with the provisions of this Article 6.12. Before any proposed
sale, pledge, or transfer of any Shiva Shares, unless there is in effect a
registration statement under the Securities Act covering the proposed
transaction, Shiva shall give notice to the Company of its intention to
effect such sale, pledge, or transfer. Each such notice shall
name the proposed transferee and state the number of Shiva Shares to be
sold, pledged or transferred, the proposed consideration, and all other
terms and conditions of the proposed sale, pledge or transfer in
sufficient detail. If reasonably requested by the Company, such
notice shall be accompanied at Shiva’s expense by either (i) a written
opinion of legal counsel who shall, and whose legal opinion shall, be
reasonably satisfactory to the Company, addressed to the Company, to the
effect that the proposed transaction may be effected without registration
under the Securities Act; (ii) a “no action” letter from the SEC to the
effect that the proposed sale, pledge, or transfer of such Shiva Shares
without registration will not result in a recommendation by the staff of
the SEC that action be taken with respect thereto; or (iii) any other
evidence reasonably satisfactory to counsel to the Company to the effect
that the proposed sale, pledge, or transfer of the Shiva Shares may be
effected without registration under the Securities Act, whereupon Shiva
shall be entitled to sell, pledge, or transfer such Shiva Shares in
accordance with the terms of the notice given by Shiva to the Company,
subject to the terms of Article 6.12.4 below. The Company will
not require such a legal opinion or “no action” letter (x) in any
transaction in compliance with SEC Rule 144 or (y) in any transaction in
which Shiva distributes Shiva Shares to an Affiliate of Shiva for no
consideration; provided that each transferee agrees in writing to be
subject to the terms of this Article 6.12. Each certificate or
instrument evidencing the Shiva Shares transferred as above provided shall
bear, except if such transfer is made pursuant to SEC Rule 144, the
appropriate restrictive legend set forth in Article 6.12.2, except that
such certificate shall not bear such restrictive legend if, in the opinion
of counsel for Shiva and the Company, such legend is not required in order
to establish compliance with any provisions of the Securities
Act.
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[*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
8
6.12.4
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Shiva
hereby agrees that it shall not sell, transfer, make any short sale of,
grant any option for the purchase of, or enter into any hedging or similar
transaction with the same economic effect as a sale, the Shiva Shares or
any other securities of the Company held by Shiva (other than those
included in the registration) (i) during the 180-day period following the
effective date of the Company’s first firm commitment underwritten public
offering of its common stock registered under the Securities Act (or such
longer period as the underwriters or the Company shall request in order to
facilitate compliance with FINRA Rule 2711 or NYSE Member Rule 472 or any
successor or similar rule or regulation), and (ii) the 90-day period
following the effective date of a subsequent registration statement of the
Company filed under the Securities Act (or such longer period as the
underwriters or the Company shall request in order to facilitate
compliance with FINRA Rule 2711 or NYSE Member Rule 472 or any successor
or similar rule or regulation); provided, that, with respect to (i) and
(ii) above, all executive officers and directors of the Company and all
holders of greater than three percent (3%) of the Company’s outstanding
Series A Common Stock are bound by and have entered into similar
agreements. The obligations described in this Article 6.12.4 shall not
apply to a registration relating solely to employee benefit plans on Form
S-1 or Form S-8 or similar forms that may be promulgated in the future, or
a registration relating solely to a transaction on Form S-4 or similar
forms that may be promulgated in the
future.
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19.
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The
heading for Article 10.2 is hereby amended to “Termination for Bankruptcy”
and all references to Article 10.2 shall be amended to reflect “Company
bankruptcy.”
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20.
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The
heading for Article 10.4 is hereby amended to “Termination for Cause”, and
Article 10.4 is hereby amended and restated in its entirety as
follows:
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10.4.1
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Subject
to Article 9 and the provisions of this Article 10.4.1, upon any material
breach or default of this Agreement by the Company, other than as set
forth in Article 10.2 and 10.3 above or as set forth in Article 10.4.2
below, Shiva shall have the right to terminate this Agreement and the
rights, privileges and license granted hereunder by giving ninety (90)
days prior written notice to the Company. Upon the expiration
of the ninety (90) day period, if the Company shall have failed to cure
such breach or default, this Agreement shall, at the option of Shiva,
terminate upon written notice of Shiva. Notwithstanding
anything herein to the contrary, if the nature of the breach is such that
additional time is reasonably needed to cure such breach, and Company has
commenced with good faith efforts to cure such breach, then Shiva shall
provide Company with additional time (but in no event more than a total of
180 days) in which to cure such breach. If a dispute regarding
termination is addressed according to Article 9, this Agreement shall
remain in full force and effect until such dispute is settled or
determined in accordance with Article
9.
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[*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
9
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10.4.2
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Shiva
shall have the right to terminate this Agreement within fifteen (15) days
after giving written notice of termination to the Company if any of the
following occurs:
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(a)
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the
Company has not raised at least one million five hundred thousand dollars
($1,500,000) on or before November 30,
2009;
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(b)
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the
Company has not, on or before March 31, 2010, either (i) obtained at least
ten million dollars ($10,000,000) in financing that is additional to the
capital raise described in Article 10.4.2(a) (“Additional Financing”) or
(ii) filed a registration statement for an initial public offering with
the United States Securities and Exchange
Commission;
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(c)
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the
Company has not, on or before June 30, 2010, obtained at least ten million
dollars ($10,000,000) in Additional
Financing;
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(d)
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the
Company has not initiated patient dosing in a “Proof of Concept Trial” for
a Licensed Product on or before April 30, 2010, where a “Proof of Concept
Trial” is a Phase II clinical study as and to the extent defined for the
United States in 21 C.F.R. § 312.21(b), or its successor regulation, or
the equivalent regulation in any other country;
or
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(e)
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the
Company has not initiated patient dosing in a “Pivotal Trial” for a
Licensed Product on or before September 30, 2011, where “Pivotal Trial”
means (i) a Phase III clinical study (as such term is defined in 21
C.F.R.§ 312.21(c) or its successor regulation or the equivalent regulation
in any other country), or (ii) if it has been determined at the time of
first dosing that the data generated in such study, if successful, will be
sufficient, without data from further studies, to support the filing of an
NDA, a Phase II clinical study (as described above) or a combination Phase
II clinical study and Phase III clinical
study.
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21.
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Article
10.5 is hereby amended and restated in its entirety as
follows:
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Upon
expiry of the Royalty Term in each country in the Territory, provided that this Agreement is still
in effect immediately prior to such expiration, the Company will have an
irrevocable, paid up, royalty-free license under the Patent Rights and Know-how
to make, have made, use, import, offer for sale and sell the Licensed Products
in such country.
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22.
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The
heading for Article 10.6 is hereby amended to “Termination by the
Company”, and Article 10.6 is hereby amended and restated in its entirety
as follows:
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10.6.1
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The
Company shall have the right at any time to terminate this Agreement in
its entirety, for any reason or no reason, by giving thirty (30) days
notice thereof in writing to Shiva.
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[*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
10
10.6.2
|
Without
limiting the generality of the foregoing Article 10.6.1 or the right of
the Company to terminate this Agreement at will as provided therein,
subject to Article 9 and the provisions of this Article 10.6.2, the
Company shall have the right to terminate this Agreement for cause as
provided in this Article 10.6.2. Upon any material breach or default of
this Agreement by Shiva, the Company shall have the right to terminate
this Agreement by giving ninety (90) days prior written notice to Shiva.
Upon the expiration of the ninety (90) day period, if Shiva shall have
failed to cure such breach or default, this Agreement shall, at the option
of the Company, terminate upon written notice of the Company.
Notwithstanding anything herein to the contrary, if the nature of the
breach is such that additional time is reasonably needed to cure such
breach, and Shiva has commenced with good faith efforts to cure such
breach, then the Company shall provide Shiva with additional time (but in
no event more than a total of 180 days) in which to cure such breach. If a
dispute regarding termination is addressed according to Article 9, this
Agreement shall remain in full force and effect until such dispute is
settled or determined in accordance with Article
9.
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23.
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A
new Article 10.7.3 shall be added, which shall read in its entirety as
follows:
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Without
limiting the provisions of Article 10.7.1 and 10.7.2, upon early
termination of this Agreement by either party for any reason other than
termination by the Company for cause pursuant to Article
10.6.2, as of the effective date of such termination the following
provisions shall apply:
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(a)
|
The
Company shall reassign to Shiva all Know-how and other intellectual
property that Shiva assigned to the Company pursuant to Article
3.1.
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|
(b)
|
Unless
otherwise prohibited by law, the Company shall transfer and assign to
Shiva all Company Technology Know-how Controlled by the Company, including
as applicable: (i) copies of all regulatory submissions; (ii)
all data and reports from pre-clinical and clinical studies; (iii) any
prototypes, designs or models of Shiva 101 and/or Shiva 102; (iii) any
communications with the FDA and the minutes of any meetings with the FDA
relating to any Licensed Product; (iv) trial master files relating to any
Licensed Product, including copies of all case report forms; (v) copies of
all listings and tables of results from the clinical trials relating to
any Licensed Product; (vi) copies of all treatment-related serious adverse
event reports from the clinical trials relating to any Licensed Product;
(vii) any retained samples of materials used in clinical trials relating
to any Licensed Product; (viii) rights of access to CROs involved in the
clinical trials relating to any Licensed Product; (ix) the data, files and
results of any CMC related activities regarding any Licensed Product; and
(x) all other information that Shiva may reasonably request regarding the
manufacturing of any Licensed Product, clinical trials with respect to any
Licensed Product, and the commercial sale of any Licensed
Product.
|
[*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
11
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(c)
|
The
Company shall use commercially reasonable efforts to arrange (i) for the
assignment to Shiva of any manufacturing, supply, or similar commercial
contract related to any Licensed Product or ingredient thereof and
necessary or desirable for the manufacture, development, and
commercialization of any Licensed Product or ingredient thereof by Shiva
after the effective date of termination, subject to the assumption of such
contract by Shiva or (ii) for any Third Party who is (as of the effective
date of termination) a party with the Company to any such contract to
enter into a similar contract with Shiva, on a basis acceptable to Shiva,
provided that the Company shall not be required to make any payment or
provide any other consideration in order to arrange for any such
assignment or similar contract.
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|
(d)
|
The
Company shall grant to Shiva a free-of-charge right to reference and use
and have full access to all Governmental Approvals and all other
regulatory documents relating to any Licensed Product, including any IND,
any NDA and any DMF (whether as an independent document or as part of any
NDA, and all chemistry, manufacturing and controls information), and any
supplements, amendments or updates to the foregoing, where such regulatory
documents are owned or sufficiently Controlled by the Company, directly or
indirectly, to permit such grant (for the purposes of this Article, the
“Right of Reference”). Shiva may sublicense the Right of Reference to
Affiliates and to Third Parties, in Shiva’s sole
discretion.
|
|
(e)
|
Upon
Shiva’s request, the Company shall transfer to Shiva any Governmental
Approvals or other applicable regulatory filings related to Licensed
Products, which are owned and held by the Company as of the effective date
of termination.
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|
(f)
|
The
Company shall transfer to Shiva at Shiva’s request all or any part of the
Company’s inventory of (i) Licensed Products and (ii) GMP and non-GMP
Compound.
|
|
24.
|
Article
10.8 is hereby amended and restated in its entirety as
follows:
|
Upon
termination or expiration 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 or obligations under Article 6, Article
7, Article 9, Article 10.5, Article 10.7, this Article 10.8, Article 13, Article
15 and Article 17.
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25.
|
Article
15.1 is hereby amended and restated in its entirety as
follows:
|
Any and
all information relating to the Patent Rights, Know-how (including but not
limited to patent prosecution documents relating to Patent Rights) and reports
and records under Article 7 collectively constitute the “Confidential
Information.” Neither party will use the Confidential Information for
any purpose other than the development and commercialization of the Licensed
Products under this Agreement (or as otherwise permitted by this Article 15.1),
and will hold it in confidence during the Term and for a period of five (5)
years after the termination or expiration date of this Agreement (except for
permitted disclosures authorized by this Article 15.1). Each party
shall exercise with respect to such Confidential Information the same degree of
care as the party exercises with respect to its own confidential or proprietary
information of a similar nature, but in any event no less than reasonable care,
and shall not disclose it or permit its disclosure to any Third Party (except to
those of its employees, consultants, or agents who are bound by substantially
similar obligations of confidentiality and non-use as set forth in this
Agreement). However, such undertaking of confidentiality shall not
apply to any information or data which:
[*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
12
|
15.1.1
|
the
party using or disclosing such Confidential Information receives at any
time from a Third Party lawfully in possession of such Confidential
Information and having a right to disclose the
same;
|
|
15.1.2
|
is,
as of the date of this Agreement, in the public domain, or subsequently
enters the public domain through no fault of the party disclosing or using
such Confidential Information; or
|
|
15.1.3
|
is
disclosed or used pursuant to the prior written consent of the other
party.
|
Notwithstanding
the obligations set forth in this Article 15.1, a party may disclose
Confidential Information and the terms of this Agreement to the
extent:
i.
|
15.1.4
such
disclosure: (a) is reasonably necessary for filing, prosecuting,
defending or asserting Patent Rights as contemplated by this Agreement;
(b) is reasonably necessary in connection with any regulatory filings
for any Licensed Product; or (c) is made to any Third Party bound by
written obligations of confidentiality and non-use similar to those set
forth under this Article 15.1, to the extent otherwise necessary or
appropriate in connection with the exercise of its rights or the
performance of its obligations
hereunder;
|
ii.
|
15.1.5
such disclosure is reasonably necessary: (a) to such party’s directors,
attorneys, independent accountants or financial advisors for the sole
purpose of enabling such directors, attorneys, independent accountants or
financial advisors to provide advice to the party making such disclosure,
provided that in each such case disclosure is on the condition that such
directors, attorneys, independent accountants and financial advisors are
bound by confidentiality and non-use obligations substantially similar
with those contained in this Agreement; or (b) to actual or potential
investors and/or acquirors solely for the purpose of evaluating an actual
or potential investment or acquisition; provided that in each such case
disclosure is on the condition that such actual or potential investors
and/or acquirers are bound by confidentiality and non-use obligations
substantially consistent with those contained in the Agreement;
or
|
[*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
13
iii.
|
15.1.6
such
disclosure is required by judicial or administrative process, provided
that in such event such party shall promptly inform the other party of
such required disclosure and provide the other party an opportunity to
challenge or limit the disclosure obligations. Confidential
Information that is disclosed by judicial or administrative process shall
remain otherwise subject to the confidentiality and non-use provisions of
this Article 15.1, and the party disclosing Confidential Information
pursuant to law or court order shall take all steps reasonably necessary,
including seeking of confidential treatment or a protective order, to
ensure the continued confidential treatment of such Confidential
Information.
|
26.
|
A
new Exhibit 1.32 shall be added, which shall read in its entirety as
provided in the Exhibit
attached to this Amendment.
|
|
27.
|
This
Amendment shall be in full force and effect from and after the date
hereof. Except as amended hereby, the Agreement shall remain in
full force and effect.
|
|
28.
|
This
Amendment may be executed in two or more counterparts, each of which shall
be deemed an original, but all of which together shall constitute one and
the same instrument. This Amendment may be signed and delivered to the
other parties by facsimile signature; such transmission will be deemed a
valid signature.
|
[SIGNATURE
PAGE FOLLOWS]
[*] Certain information in
this document has been omitted and filed separately with the Securities and
Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
14
IN WITNESS WHEREOF, the
parties hereto have executed this Assignment, in triplicate by proper persons
thereunto duly authorized.
CORMEDIX,
INC.
|
SHIVA
BIOMEDICAL, LLC
|
|||
By:
|
/s/ Xxxx X. Xxxxxxxx
|
By:
|
/s/ Xxxxxxxx Xxxxx
|
|
Name:
|
Xxxx X. Xxxxxxxx
|
Name:
|
Xxxxxxxx Xxxxx
|
|
Title:
|
President and CEO
|
Title:
|
Vice President
|
|
Date:
|
9/28/09
|
Date:
|
9/30/09
|
[*] Certain information in
this document has been omitted and filed separately with the Securities and
Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.