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CONFIDENTIAL TREATMENT REQUEST
FIRST AMENDMENT
TO
RESEARCH
COLLABORATION AND LICENSE AGREEMENT
This FIRST AMENDMENT (this “ Amendment ”) is
made effective as of 27 June 2008 (the “ Amendment
Effective Date ”), by and between PALATIN TECHNOLOGIES,
INC., a Delaware corporation having an address of Cedar Brook
Corporate Center, 4C Cedar Brook Drive, Cranbury, New Jersey 08512
(“ Palatin ”) and ASTRAZENECA AB, a company
incorporated in Sweden under no. 556011-7482 with offices at S-151
85 Södertälje, Sweden (“ AstraZeneca
”).
Recitals
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A)
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WHEREAS, AstraZeneca and Palatin are parties to that certain
Research Collaboration and License Agreement effective as of
January 30, 2007 (the “ Agreement ”);
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B)
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WHEREAS, as part of the Agreement, Palatin inter alia
granted to AstraZeneca a license to the Licensed Patents (as
defined in the Agreement) and the Parties agreed to collaborate to
generate Collaboration Compounds (as defined in the Agreement) to
be owned by AstraZeneca;
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C)
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WHEREAS, Palatin and AstraZeneca have concluded that there are
additional compounds developed by Palatin, not covered or claimed
by the Licensed Patents, which the Parties may desire to utilize
for the purposes of the Agreement;
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D)
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WHEREAS, Palatin and AstraZeneca have further concluded that
AstraZeneca has an interest in certain AZ Compounds (as defined
below in this Amendment), *** ; and
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E)
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WHEREAS, the Parties, in view of the above, wish to amend the
Agreement on the terms set forth herein.
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INFORMATION MARKED "***" IS OMITTED AND FILED
SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION UNDER RULE 24b-2
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Agreement
NOW, THEREFORE, in consideration of the mutual covenants
contained in this Amendment, and other good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties, intending to be legally bound, agree as
follows:
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1
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Definitions and Construction
.
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Capitalized terms used but not defined herein
shall have the meanings set forth in the Agreement. Unless the
context otherwise requires, reference to “the
Agreement” or “this Agreement” shall be construed
to mean the Agreement as amended by this Amendment.
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2
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Amendments to Article 1
(Definitions)
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2.1
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Sections 1.5, 1.67, 1.71, 1.73 and 1.74 of the
Agreement are amended to read in their entirety as follows:
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“1.5
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“Agreement Compounds” means
the Compound, the Collaboration Compound, the Additional Compound
and, *** .
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1.67
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“ License ” shall include
the Additional Licence, with both License and Additional License
having the meaning set forth in Section 7.5.
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1.71
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“ Licensed Know-How ” means
(i) the Information set out and described in *** and *** , but
excluding any Information to the extent covered or claimed by the
Licensed Patents and (ii) the Additional Know How.
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1.73
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“Licensed Patents” means
the *** Patents, *** and any Patents claiming or covering any
Licensed Improvement.
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1.74
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“Licensed Products” means
*** .”
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2.2
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The following new Sections 1.104 - 1.115 are
added to the Agreement:
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“1.104
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“Additional Compound” means
*** .
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1.105
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"Additional Know-How" means any
Information which *** .
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Page 3 of 21
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1.106
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"Additional License" has the meaning
set forth in Section 7.5.4.
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1.107
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“Additional Licensed
Patents” means *** .
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1.108
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“ Additional Product
” means any product in a form suitable for applications for
human, veterinary or agricultural use that contains an Additional
Compound as the sole active ingredient.
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1.109
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“Amendment Effective Date”
shall mean 27 June 2008.
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1.110
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"AstraZeneca Notice" shall have the
meaning set forth in Section 3.10.
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1.111
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“AZ Chemical Space” means
*** .
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1.112
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"AZ Compound" means any compound - ***.
Notwithstanding the foregoing, the compounds *** .
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1.113
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"AZ Compound Patent" means a Patent
that cover or claim one or more AZ Compound, *** .
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1.114
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"Designated Compound" shall have the
meaning set forth in Section 3.9.
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1.115
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“ IPC ” or “ IP
Steering Committee ” means the joint committee
established by the Parties pursuant to Section 4.5.
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1.116
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"JEC Designation" shall have the
meaning set forth in Section 3.9."
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2.3
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The Research Plan, Schedule 1.92 to the
Agreement, is amended as set forth in Schedule 1.92 to this
Amendment.
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2.4
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The term “Collaboration Compounds”
shall, *** .
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3
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Amendments to Article 3 (Research
Collaboration)
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3.1
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The following new Sections 3.9 – 3.12
are added to the Agreement:
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“3.9
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The chemical structure of any compound
referred to in Section 7 of the Research Plan, *** .
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3.10
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AstraZeneca may, at its sole discretion,
select one or more of any Designated Compound for licensing
hereunder by ***
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3.11
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During the Evaluation Period for a certain
Designated Compound, *** .
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3.12
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Should AstraZeneca (i) during the Evaluation
Period for a certain Designated Compound notify Palatin *** ."
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3.2
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The following new sentence is inserted
immediately after the second sentence in Section 3.4.1 of the
Agreement:
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“3.4.1
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Without prejudice to the foregoing, Palatin
shall, and shall cause its Affiliates, without additional
compensation and at Palatin’s sole expense, to provide to
AstraZeneca copies of any Additional Know-How which could be
reasonably considered material to the Research Collaboration, not
previously provided to AstraZeneca, *** .”
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4
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Amendments to Article 4 (Management
of the Research Collaboration)
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4.1
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The following new Section 4.5 is added to the
Agreement:
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“4.5
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IP Steering Committee
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4.5.1
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Responsibilities of the IPC. The
Parties shall establish an IP Steering Committee consisting of
Palatin and AstraZeneca representatives to *** review and resolve
any other specific issues relating to IP Protection Rights brought
before it by either Party. This Section 4.5 shall be without
prejudice to the provisions set forth elsewhere in this Agreement
regarding the filing, prosecution, maintenance, defence or
enforcement of any Patents, any potential infringement of any
Intellectual Property Right of any Third Party and the cooperation
between the Parties in relation to the foregoing.
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4.5.2
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Modifications of the AZ Chemical Space.
The Parties *** .
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4.5.3
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Review of Patent Filings. The Parties
will provide *** .
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4.5.4
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Formation of the IPC. The IPC
shall consist of four (4) members, one patent expert and one
chemist appointed by each Party. Each Party shall have the right to
replace its IPC representatives upon written notice to the other
Party, provided that any such substitute representative shall have
substantially the equivalent position and experience as the
representative that such person replaces.
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4.5.5
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Disputes . The IPC shall
endeavour to reach consensus on all matters brought before it with
each Party having a single vote, irrespective of the number of
representatives actually in attendance at a meeting; provided,
however, that in the event the IPC is unable to resolve an
outstanding matter before it, such matter shall be resolved by the
CMC or, if the CMC is unable to resolve the matter, by the JEC,
***.
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4.5.6
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Meetings and Quorum . The IPC
shall meet at least quarterly and more frequently when required, at
such dates and times as will be mutually agreed upon by the IPC.
The meetings shall be held by means of teleconference or
videoconference or, when held in person, at AstraZeneca AB’s
facilities in Mölndal, Sweden, or at Palatin’s
facilities in New Jersey, USA or such other locations as may be
mutually agreed upon by the Parties. A quorum of the IPC shall
require the presence of all four members of the IPC. In addition,
the IPC may act without a formal meeting by a written memorandum
signed by all of the members of the IPC.
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4.5.7
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Expenses . Palatin and
AstraZeneca each shall bear all expenses of its respective IPC
members related to such members’ participation on the IPC and
attendance at IPC meetings.
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4.5.8
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Minutes . The IPC shall keep
accurate minutes of its deliberations, which minutes shall record
all proposed decisions and all actions recommended or taken. Drafts
of minutes shall be delivered to the members of the IPC within
twenty (20) days after the respective meeting. The Parties, on an
alternating basis, shall prepare and circulate the draft minutes.
Draft minutes shall be issued
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in final form only with the approval and
agreement of all of the members of IPC, such issuance not subject
to final determination by the CMC or the JEC in the event of a
dispute.
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4.5.9
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Dissolution of the IPC . The IPC shall
be dissolved *** unless extended or earlier dissolved by mutual
agreement of the Parties.
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5
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Amendments to Article 7 (Ownership and
Grant of Rights)
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5.1
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The following new Sections 7.1(a) –
7.1(d) are inserted immediately following Section 7.1 of the
Agreement:
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“7.1(a)
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AstraZeneca shall ***. Palatin shall promptly
disclose to AstraZeneca in writing the development, making,
conception or reduction to practice *** and shall, and does hereby,
assign, and shall cause its Affiliates and its and their employees
and agents, as applicable, ***. For the avoidance of doubt,
compounds ***. The aforesaid shall, for the avoidance of doubt, ***
pursuant to this Agreement.
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7.1(b)
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AstraZeneca shall ***.
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7.1(c)
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The term “ Agreement Compound
” (and, consequently and for the avoidance of doubt, the term
“ Collaboration Compound ” as well as the
reference to “Agreement Compound” in the definition of
“ Product ” and (indirectly) in the definition
of “ Licensed Product ”) shall, *** . Any such
*** , i.e. meeting the requirements set forth in the preceding
sentence, shall include any of *** .
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7.1(d)
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AstraZeneca will not at any time ***
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5.2
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The following new Sections 7.5.4 - 7.5.6 are
added to the Agreement:
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"7.5.4
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Upon the AstraZeneca Notice, Palatin grants,
*** (the "Additional License"). For the avoidance of doubt, any
reference in this Agreement to the rights and exclusive position
granted to AstraZeneca under *** .
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7.5.5
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Subject to Section 7.5.6, Palatin may conduct
any research or development program outside the Licensed Field in
which any Compound, *** , will be
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utilized, provided, however, that *** . This
Section 7.5.5 shall, in respect of any Compound which is covered or
claimed by the *** .
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7.5.6
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Notwithstanding any other provision in this
Agreement, Palatin will not, directly or through any Third Party,
use or otherwise Exploit any Additional Compound or Additional
Product used or useful in the Licensed Field other than in carrying
out its obligations under the Research Collaboration. This Section
7.5.6 shall, in respect of any Additional Compound and Additional
Product, apply in lieu of Section 7.5.3.”
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5.3
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The first sentence in Section 7.10 of the
Agreement is amended to read as follows:
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“7.10
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Covenant Not to Sue . Neither Palatin
nor any of its Affiliates shall ever, anywhere in the world,
institute or prosecute (or in any way aid any Third Party in
instituting or prosecuting), at law or in equity, any claim,
demand, action or cause of action for damages, costs, expenses or
compensation, or for an enjoinment, injunction, or any other
equitable remedy, against AstraZeneca, its Affiliates,
Sublicensees, suppliers, Distributors, vendors or customers
alleging the infringement by AstraZeneca in its Exploitation of the
Compounds, the Licensed Patents, the Licensed Know-How, the
Licensed Improvements, the Collaboration Compounds, the
Collaboration Patents, the AZ Compounds, the AZ Compound Patents or
the Licensed Products or of any Patent that claims an invention
that is based on, derived from or otherwise relates to the Results
and is Controlled by Palatin or its Affiliates, so long as such
Exploitation is in accordance with this Agreement.”
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6
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Amendments to Article 10
(Consideration)
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6.1
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The following new sentence is inserted
immediately after the first sentence in Section 10.1 of the
Agreement:
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“For the sole purpose of determining the
milestone payments payable by AstraZeneca to Palatin pursuant to
this Article 10, (i) any Additional Compound shall, regardless of
the
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actual route of administration thereof, be
regarded *** and (ii) any Additional Product shall, regardless of
the actual route of administration thereof, be regarded ***
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6.2
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The initial passages of Section 10.1.2.1 of
the Agreement are amended to read as follows:
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“10.1.2.1
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*** Agreement Compounds or Licensed
Product
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A)
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Development Milestones for *** Agreement
Compounds
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i)
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*** U.S. Dollars ***; or
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ii)
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*** U.S. Dollars ***; or
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iii)
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*** U.S. Dollars ***; and
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iv)
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*** U.S. Dollars ***; and
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v)
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*** U.S. Dollars ***; and
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vi)
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*** U.S. Dollars ***.
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For the sake of clarity, with respect to the
milestones set forth in clauses (i), (ii) and (iii) above, payment
shall be made only upon the achievement of the first one of those
three milestones.
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6.3
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The first sentence in Section 10.2.1 of the
Agreement is amended to read as follows:
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“10.2.1
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If a milestone payment set forth under Section
10.1.2.1 (A) or (B), i.e. for *** Agreement Compounds or Licensed
Products, has been made or is due by AstraZeneca, the corresponding
milestone payment set forth under Section *** Agreement Compounds
or Licensed Products, shall be reduced with the sum already paid or
due to be paid for such *** Agreement Compound or Licensed Product,
whichever is applicable, with the exception, however,
***.”
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6.4
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Section 10.2.2 of the Agreement is amended to
read as follows:
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“10.2.2
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Each of the payments set forth in Sections
10.1.2 and 10.1.3 shall be made by AstraZeneca no more than once
under this Agreement, collectively amounting to an aggregate
maximum amount of U.S. $300,000,000 for an *** Agreement Compound
or Licensed Product, or, in case the payment under Section
10.1.2.1(A)(ii) or Section 10.1.2.1(A)(iii) becomes payable, U.S.
$2,500,000 less, or U.S.$ 300,000,000 for an *** Agreement Compound
or Licensed Product, irrespective of the number of CDs, Agreement
Compounds and Licensed Products that have achieved the milestone
events set forth in Section 10.1, or the number of countries or
Major Markets in which such milestone events have been
achieved.”
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6.5
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The following new Section 10.4 is added to the
Agreement:
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“10.4
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Should AstraZeneca propose to Palatin other
milestones or royalties than those set forth in this Article 10,
excluding, *** to apply in respect of any Additional Compound or
Additional Product having ***, then, upon receipt of such proposal,
Palatin agrees to negotiate in good faith with AstraZeneca to agree
on such other milestones or royalties (but for the avoidance of
doubt, excluding ***, taking into account inter alia the ***
of such Additional Compound or Additional Product having ***. For
the avoidance of doubt, no such agreement on other milestones or
royalties shall be valid and binding unless in writing and signed
by authorised representatives of both Parties.”
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7
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Amendments to Article 15 (Patent
Prosecution and Defence)
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7.1
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The following new Sections 15.8 - 15.12 are
added to the Agreement:
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“15.8
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Prosecution of the Additional Licensed
Patents . Subject to Section 15.9, ***, using legal counsel at
its sole discretion, diligently file, prosecute (including any
interferences, reissue proceedings and re-examinations) and
maintain the Additional Licensed Patents in the Territory, all such
filing, prosecution and maintaining within *** reasonable
discretion, and *** shall bear all costs and
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expenses of such activities, incl
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