***
INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.
SECOND AMENDMENT TO THE
COLLABORATION AGREEMENT
This Second
Amendment (“ Second Amendment ”) to the
Collaboration Agreement is effective as of the Second Amendment
Effective Date (as set forth in Section 4 of this Second
Amendment), by and between UCYCLYD PHARMA, INC. , a Maryland
corporation, with its principal place of business at 7720 North
Dobson Road, Scottsdale, AZ 85256 (“ Ucyclyd ”)
and HYPERION THERAPEUTICS, INC. , a Delaware corporation,
with its principal place of business at 601 Gateway Blvd.,
Suite 200, South San Francisco, CA 94080 (hereunder referred
to as “ Hyperion ”). Ucyclyd and Hyperion are
sometimes referred to herein individually as a “ Party
” and collectively as the “ Parties
.”
WHEREAS ,
Ucyclyd and Hyperion entered into that certain Collaboration
Agreement dated August 23, 2007 (the “ Collaboration
Agreement ”), as amended by the First Amendment on
November 24, 2008;
WHEREAS ,
Ucyclyd and Hyperion desire to amend the Collaboration Agreement as
more fully set forth in this Second Amendment; and
WHEREAS ,
in partial consideration of Ucyclyd agreeing to the modifications
set forth in this Second Amendment, Hyperion has agreed to sell
five percent (5%) of its common stock to Ucyclyd and concurrent
with the signing of this Second Amendment, the Parties have entered
into a Common Stock Purchase Agreement (the “ Transaction
Document ”).
NOW,
THEREFORE , in consideration of the foregoing recitals (which
are incorporated by reference into this Second Amendment), and for
other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, the Parties hereto agree as
follows:
1.
Capitalized Terms . All capitalized terms not otherwise
defined in this Second Amendment shall have the meanings ascribed
to them as set forth in the Collaboration Agreement.
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a)
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Article 1 is hereby amended to
include the following defined terms:
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“ Note ”
means that certain Note to be issued by Hyperion in favor of
Ucyclyd in accordance with Section 3.3, the form of which is
attached hereto as Exhibit 9 (Note) .
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“ Security
Agreement ” means that certain Security Agreement to
be entered into between Hyperion and Ucyclyd in accordance with
Section 3.3, the form of which is attached hereto as
Exhibit 10 (Security Agreement) .
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b)
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Section 1.15 is hereby amended
and restated in its entirety as follows:
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“ Change in
Control ” means the consummation of: (a) any
merger, consolidation, business combination or sale of shares of
stock other than in a direct issuance of shares of stock by a Party
for fair value, that, if completed, will result in the stockholders
of such Party prior to such transaction not having voting control
of the surviving entity immediately after the transaction such that
they, acting in concert with one another, could not elect a
majority of the board of directors of the surviving entity; or
(b) the sale, transfer, exchange or other disposition of all
or substantially all of a Party’s assets or business relating
to this Agreement (whether alone or in connection with a sale,
transfer, exchange or other disposition of other assets or
businesses of such Party). Notwithstanding the foregoing, Change in
Control shall not include a financing transaction, either in the
form of a private equity financing or public offering.
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c)
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Section 1.24 is hereby amended
and restated in its entirety as follows:
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“
Development Field ” means the treatment of any human
disease, disorder or condition, including but not limited to UCD,
HE or Hyperammonemia.
Notwithstanding
the amendment set forth above, Hyperion acknowledges and affirms:
(i) its obligations under Section 2.2 of the Agreement
including Hyperion’s agreement that the primary focus of its
efforts under the Development and Regulatory Program is to obtain
Regulatory Approval first in the United States for GT4P in UCD and
HE; and (ii) Hyperion does not have any rights to further develop
Ammonul HE during the Development Term.
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d)
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Section 2.2.2 is hereby amended
and restated in its entirety as follows:
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“
2.2.2 R&D Rights of Third Parties .
(a) Hyperion
acknowledges that, prior to the Second Amendment Effective Date,
Ucyclyd has granted Third Parties certain rights under the
Distribution Agreements (as such term has been amended based on
changes to Schedule 1.30 pursuant to this Second Amendment)
with respect to research and development of the Products for uses
within the Development Field (the “ Pre-existing
Rights ”) and that Hyperion’s exclusive license
in Section 8.2 is subject to such Pre-existing
Rights.
(b) From the
Second Amendment Effective Date until the termination or expiration
of the Development Term, Ucyclyd agrees not to grant (i) such
Third Parties or any new Third Parties any further rights with
respect to GT4P for uses within the Development Field; and
(ii) distribution rights to the Marketed Products in the
United States to a Third Party which will extend past the Closing
Date. The Parties acknowledge and agree that because the Closing
Date is based on the occurrence of certain events described in
Section 3.1 (Purchase Rights) , the exact date cannot
be determined accurately and the Parties can rely only upon the
dates on which the Closing is anticipated to occur based on the
Development Plan in effect as of the Second Amendment Effective
Date. Based on such Development Plan, the Closing Date is
anticipated to be ***, which shall be the date relied upon with
respect to the foregoing limitation; provided, however, that the
date will be adjusted automatically if the events on which it is
based change in the Development Plan or the events have not
occurred by such date (as may be adjusted based on the foregoing)
and the Parties agree to extend the date for a Closing under the
Agreement.
(c) During the
Development Term, Ucyclyd reserves the right to grant Third Parties
that currently or in the future distribute the Marketed Products
the right to conduct research and development with respect to the
Marketed Products for purposes of (i) obtaining Regulatory
Approval for the Marketed Products in the applicable country or
region, (ii) conducting post-marketing approval studies, and
(iii) conducting any other studies or activities required by
the applicable Regulatory Agency.
(d) During the
Development Term, Ucyclyd shall have the right to support
investigator-sponsored activities or investigator-sponsored use of
the Marketed Products for uses within the Development Field and
will keep Hyperion apprised of such activities through the JSC
meetings.
(e) During the
Development Term, Ucyclyd may support investigator-sponsored
activities or investigator-sponsored use of GT4P only after
allowing Hyperion to review such activities in advance and
obtaining Hyperion’s approval of such
activities.”
Second
Amendment to Collaboration Agreement
2
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e)
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Section 2.2.3 is hereby amended
and restated in its entirety as follows:
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“
R&D Rights Outside of the United States .
(a) During the
Development Term, Hyperion shall have the right to conduct research
and development activities outside of the United States in support
of Hyperion’s efforts to obtain Regulatory Approval in the
United States, except in those jurisdictions where such research
and development efforts would conflict with the rights granted to
Third Parties pursuant to the Pre-existing Rights.
(b) Subject to any
Pre-existing Rights, during the Development Term, Hyperion shall
have the right to propose to the JSC research and development
activities outside of the United States in connection with
obtaining Regulatory Approval for the Development Products outside
of the United States. Ucyclyd shall advise Hyperion whether the
conduct of any such activities would conflict with any rights
granted to Third Parties that are in addition to the Pre-existing
Rights. To the extent such proposed activities do not conflict with
any Third Party rights, Hyperion shall have the right to perform
such proposed activities. In the event that Hyperion conducts any
research and development activities outside of the United States as
permitted in this Section, Hyperion shall coordinate all such
activities with Ucyclyd through the JSC during the Development
Term.”
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f)
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Schedule 1.30 (Distribution
Agreements) is hereby amended and restated in its entirety in the
new Schedule 1.30 attached to this Second
Amendment.
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g)
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Section 3.3.2 is hereby amended
and restated in its entirety as follows:
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“
Closing . The Parties will mutually agree upon a closing
date (the “ Closing Date ”), which shall
occur not later than *** following, as applicable: (a) the GT4P
Approval Date, (b) Hyperion’s exercise of the Purchase
Option #1 or (c) the Purchase Option #2 End Date.
(a) On
the Closing Date, Hyperion shall become obligated to pay Ucyclyd
the Purchase Price, Purchase Option Price #1 or Purchase Option
Price #2, as applicable (the “ Purchase Price
Amount ”) in accordance with
Section 3.3.3.
(b) On
the Closing Date the Parties shall execute and deliver all
documents set forth below (the “ Purchase Transaction
Documents ”), under which Ucyclyd shall sell,
transfer, assign and convey all Assets to Hyperion:
(i) a Bill of Sale
in the form attached to the Agreement as Exhibit 4 (Bill of
Sale) , under which Ucyclyd transfers the ownership of certain
Assets (including all Inventories) to Hyperion, which shall be
signed by both Ucyclyd and Hyperion;
(ii) a Technology
Assignment Agreement in the form attached to the Agreement as
Exhibit 5 (Technology Assignment Agreement) , under
which Ucyclyd shall assign all Product Technology and Developed
Technology, which shall be signed by Ucyclyd;
(iii) an
Assignment and Assumption Agreement of all Assigned Agreements in
the form attached to the Agreement as Exhibit 6 (Assignment
and Assumption Agreement) , which shall be countersigned by
Ucyclyd and accompanied by all consents required from the
applicable Third Parties to such Assigned Agreements to Hyperion as
attachments to such Assignment and Assumption Agreement;
Second
Amendment to Collaboration Agreement
3
(iv) a Note in the
form attached to the Agreement as Exhibit 9 (Note) ;
and
(v) a Security
Agreement in the form attached to the Agreement as
Exhibit 10 (Security Agreement) .”
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h)
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Section 3.3.3 is hereby amended
and restated in its entirety as follows:
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“
Payment of Purchase Price Amount .
(a) The Purchase
Price Amount shall be due and payable *** commencing on the first
Business Day of the *** following the Closing Date and continuing
on the first Business Day of *** thereafter in accordance with the
terms and conditions of the Note. Hyperion’s obligations
under the Note shall be secured by a first priority lien in and to
the Collateral (as defined in the Security Agreement) in accordance
with the terms and conditions of the Security Agreement.
(b) From and after
the Closing Date, Hyperion shall keep the Collateral in good order,
and shall have sole responsibility for taking such steps as may be
necessary, from time to time, to preserve all rights of Hyperion
and Ucyclyd in the Collateral against Third Parties. Hyperion, at
its place of business, shall keep accurate and complete books and
records related to the Collateral in accordance with sound and
generally accepted accounting principles applied on a basis
consistent with prior years. Ucyclyd shall have the right at all
times during business hours to inspect said books and records and
make extracts therefrom.
(c) Effective as
of and after the Closing, Hyperion hereby covenants with and
warrants to Ucyclyd that: (i) Hyperion is the sole owner of
the Collateral free from any lien, security interest or encumbrance
of any kind; (ii) Hyperion will not sell, lease or grant any
further security interest in the Collateral or any part thereof,
and will not part with possession of the same, except in the usual
and ordinary course of Hyperion ‘s business; and (iii )
Hyperion will not use or permit the Collateral to be used in
violation of any law or ordinance. Hyperion covenants, warrants and
represents to Ucyclyd that all representations and warranties of
Hyperion contained in this Section 3.3 shall be true at the
time of the Closing Date and shall survive the execution, delivery
and acceptance thereof by the Parties hereto and the closing of the
transactions described herein or related hereto.”
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i)
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Section 4.1.1 is hereby amended
and restated in its entirety as follows:
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“
Exclusive Commercialization Rights . Subject to the terms
and conditions of this Agreement (including rights of Third Parties
under the Distribution Agreements), on and following Closing,
Hyperion shall have the sole and exclusive worldwide rights (even
as to Ucyclyd) to Commercialize all Products for any and all
indications (including any and all indications in the field of
Hyperammonemia) which rights shall include the worldwide
manufacture and supply of Products for use in all such
Commercialization activities, provided that Hyperion complies with
the terms and conditions set forth in Section 8.2.2
(Manufacturing Technology; Drug Master Files) regarding the
manufacture and supply of Products. Hyperion shall be solely
responsible for all costs and expenses in the Commercialization of
Products including the supply and manufacture
thereof.”
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j)
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Section 8.2.1 is hereby amended
and restated in its entirety as follows:
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Product Technology and Developed Technology . Subject to the
terms and conditions of the Agreement, Ucyclyd hereby grants to
Hyperion an exclusive (except as to Ucyclyd
Second
Amendment to Collaboration Agreement
4
as set forth in
Section 2.2.6(a) (Transition of Development and Regulatory
Program to Hyperion) ), non-transferable (except as permitted
by Section 16.14 (Assignment) ), non-sublicenseable
(except as necessary to conduct research and development activities
outside of the United States in accordance with in
Section 2.2.3 (R&D Rights Outside of the United
States) ), license under the Product Technology and the
Developed Technology to research, develop, make, have made, import
and use the Development Products to: (a) perform the
activities under the Development and Regulatory Program in the
Development Field in the Development Territory; and
(b) perform research and development activities of such
Development Products outside the Development Territory only
pursuant to Section 2.2.3 (R&D Rights Outside of the
United States) , in each case for the duration of the
Development Term. For clarity, the license granted under this
Section 8.2.1 (Product Technology and Developed
Technology) does not grant Hyperion the right to Commercialize,
promote, market or sell the Development Products, and any rights to
Commercialize, promote market or sell the Development Products in
the Development Field arise only on and following
Closing.”
For clarity,
references to Ammonul HE have been removed since Hyperion no longer
has rights to Ammonul HE prior to the Closing and any references to
Development Products only refer to GT4P.
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k)
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Section 10.3(b)(i) is hereby
amended and restated in its entirety as follows:
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“(b) the
Developed Technology developed, conceived, reduced to practice,
originated, prepared, learned, generated, obtained or made by or on
behalf of Hyperion, its Affiliates or their respective
subcontractors in connection with the Agreement: (i) shall be
performed, developed or manufactured in conformity with the
Development Plan and all Legal Requirements, including current Good
Laboratory Practices, Good Manufacturing Practices, and Good
Clinical Practices, and all applicable FDA regulations,
(ii) does not, to Hyperion’s actual knowledge as of the
Second Amendment Effective Date, infringe upon the patents of a
Third Party actually known to Hyperion; and (iii) does not, to
Hyperion’s actual knowledge as of the Second Amendment
Effective Date, infringe upon, or result from the misappropriation
of, any other intellectual property rights of a Third
Party.”
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l)
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Section 12.2(f) is hereby
amended and restated in its entirety as follows:
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“(f)
Ucyclyd shall have the right to terminate the Term of this
Agreement immediately upon prior written notice to Hyperion, as a
result of one or more of the following violations, if Hyperion
fails to remedy such violation within thirty (30) days
following receipt of written notice of such violation from Ucyclyd,
or if Hyperion is unable to cure such violation using reasonably
diligence efforts within such thirty day period, such additional
time as is reasonably necessary to cure such violation, but in any
event not to exceed ninety (90) days following receipt of
written notice from Ucyclyd:
(i) ***
violation of any of the Compliance Requirements by Hyperion or any
of its officers, directors or employees including a violation
manifesting a wanton and reckless disregard for
compliance;
(ii) ***
violation of any of the Compliance Requirements by a subcontractor
of Hyperion that manifests a wanton and reckless disregard by
Hyperion to require compliance by its subcontractors;
(iii) ***
violations of any particular obligation under the Compliance
Requirements by Hyperion or any Hyperion Personnel that in the
aggregate manifest a wanton and reckless disregard by Hyperion for
compliance; or
Second
Amendment to Collaboration Agreement
5
(iv) ***
violation of any of the Compliance Requirements by Hyperion or any
Hyperion Personnel that results in an enforcement action or
proceeding, whether, criminal, civil or administrative, by a
Governmental Authority or Regulatory Agency (including the OIG)
against any of Hyperion, Ucyclyd, Medicis or their respective
Affiliates. For avoidance of doubt, the initial receipt of a
Form 483, and efforts undertaken in
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