Page 1 of 21
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, 0X Xxxxx Xxxxx Xxxxx,
Xxxxxxxx, Xxx Xxxxxx 00000 (“Palatin”) and ASTRAZENECA AB, a company
incorporated in Sweden under no. 556011-7482 with offices at X-000 00
Xxxxxxxxxx, Xxxxxx (“AstraZeneca”).
Recitals
| B) |
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; |
| C) |
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; |
| D) |
WHEREAS, Palatin and AstraZeneca have further concluded that AstraZeneca has an
interest in certain AZ Compounds (as defined below in this Amendment), *** ; and |
| E) |
WHEREAS, the Parties, in view of the above, wish to amend the Agreement on the
terms set forth herein. |
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:
| 1 |
|
Definitions
and Construction. |
| |
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. |
| 2 |
|
Amendments
to Article 1 (Definitions) |
| 2.1 |
|
Sections
1.5, 1.67, 1.71, 1.73 and 1.74 of the Agreement are amended to read in their entirety as
follows: |
| |
“1.5 |
|
“Agreement
Compounds” means the Compound, the Collaboration Compound, the Additional Compound and,
*** . |
| |
1.67 |
|
“License” shall
include the Additional Licence, with both License and Additional License having the
meaning set forth in Section 7.5. |
| |
1.71 |
|
“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. |
| |
1.73 |
|
“Licensed
Patents” means the *** Patents, *** and any Patents claiming or covering any Licensed
Improvement. |
| |
1.74 |
|
“Licensed
Products” means *** .” |
| 2.2 |
|
The
following new Sections 1.104 - 1.115 are added to the Agreement: |
| |
“1.104 |
|
“Additional Compound”means *** . |
| |
1.105 |
|
"Additional
Know-How" means any Information which *** . |
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| |
1.106 |
|
"Additional
License" has the meaning set forth in Section 7.5.4. |
| |
1.107 |
|
“Additional
Licensed Patents” means *** . |
| |
1.108 |
|
“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. |
| |
1.109 |
|
“Amendment
Effective Date” shall mean 27 June 2008. |
| |
1.110 |
|
"AstraZeneca
Notice" shall have the meaning set forth in Section 3.10. |
| |
1.111 |
|
“AZ
Chemical Space” means *** . |
| |
1.112 |
|
"AZ
Compound" means any compound - ***. Notwithstanding the foregoing, the compounds *** . |
| |
1.113 |
|
"AZ
Compound Patent" means a Patent that cover or claim one or more AZ Compound, *** . |
| |
1.114 |
|
"Designated
Compound" shall have the meaning set forth in Section 3.9. |
| |
1.115 |
|
“IPC” or
“IP Steering Committee” means the joint committee established by the
Parties pursuant to Section 4.5. |
| |
1.116 |
|
"JEC
Designation" shall have the meaning set forth in Section 3.9." |
| 2.3 |
|
The
Research Plan, Schedule 1.92 to the Agreement, is amended as set forth in Schedule 1.92 to this Amendment. |
| 2.4 |
|
The
term “Collaboration Compounds” shall, *** . |
| 3 |
|
Amendments
to Article 3 (Research Collaboration) |
| 3.1 |
|
The
following new Sections 3.9 – 3.12 are added to the Agreement: |
| |
“3.9 |
|
The chemical structure of any compound referred to in Section 7 of the Research
Plan, *** . |
Page 4 of 21
| |
3.10 |
|
AstraZeneca
may, at its sole discretion, select one or more of any Designated Compound for licensing
hereunder by *** |
| |
3.11 |
|
During
the Evaluation Period for a certain Designated Compound, *** . |
| |
3.12 |
|
Should
AstraZeneca (i) during the Evaluation Period for a certain Designated Compound notify
Palatin *** ." |
| 3.2 |
|
The
following new sentence is inserted immediately after the second sentence in Section 3.4.1
of the Agreement: |
| |
“3.4.1 |
|
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, *** .” |
| 4 |
|
Amendments
to Article 4 (Management of the Research Collaboration) |
| 4.1 |
|
The
following new Section 4.5 is added to the Agreement: |
| |
“4.5 |
|
IP Steering Committee |
| |
4.5.1 |
|
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. |
| |
4.5.2 |
|
Modifications
of the AZ Chemical Space. The Parties *** . |
| |
4.5.3 |
|
Review
of Patent Filings. The Parties will provide *** . |
Page 5 of 21
| |
4.5.4 |
|
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. |
| |
4.5.5 |
|
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, ***. |
| |
4.5.6 |
|
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. |
| |
4.5.7 |
|
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. |
| |
4.5.8 |
|
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 |
Page 6 of 21
| |
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. |
| |
4.5.9 |
|
Dissolution
of the IPC. The IPC shall be dissolved *** unless extended or earlier dissolved by
mutual agreement of the Parties. |
| 5 |
|
Amendments
to Article 7 (Ownership and Grant of Rights) |
| 5.1 |
|
The
following new Sections 7.1(a) – 7.1(d) are inserted immediately following Section
7.1 of the Agreement: |
| |
“7.1(a) |
|
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. |
| |
7.1(b) |
|
AstraZeneca
shall ***. |
| |
7.1(c) |
|
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 ***
.. |
| |
7.1(d) |
|
AstraZeneca
will not at any time *** .” |
| 5.2 |
|
The
following new Sections 7.5.4 - 7.5.6 are added to the Agreement: |
| |
"7.5.4 |
|
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 *** . |
| |
7.5.5 |
|
Subject
to Section 7.5.6, Palatin may conduct any research or development program outside the
Licensed Field in which any Compound, *** , will be |
Page 7 of 21
| |
utilized,
provided, however, that *** . This Section 7.5.5 shall, in respect of any Compound which
is covered or claimed by the *** . |
| |
7.5.6 |
|
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.” |
| 5.3 |
|
The
first sentence in Section 7.10 of the Agreement is amended to read as follows: |
| |
“7.10 |
|
Covenant Not to Xxx. 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.” |
| 6 |
|
Amendments
to Article 10 (Consideration) |
| 6.1 |
|
The
following new sentence is inserted immediately after the first sentence in Section 10.1
of the Agreement: |
| |
“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 |
Page 8 of 21
| |
actual
route of administration thereof, be regarded *** and (ii) any Additional Product shall,
regardless of the actual route of administration thereof, be regarded *** .” |
| 6.2 |
|
The
initial passages of Section 10.1.2.1 of the Agreement are amended to read as follows: |
| |
“10.1.2.1 |
|
*** Agreement Compounds or Licensed Product |
| |
|
A) |
|
Development
Milestones for *** Agreement Compounds |
| |
|
i) |
|
***
U.S. Dollars ***; or |
| |
|
ii) |
|
***
U.S. Dollars ***; or |
| |
|
iii) |
|
***
U.S. Dollars ***; and |
| |
|
iv) |
|
***
U.S. Dollars ***; and |
| |
|
v) |
|
***
U.S. Dollars ***; and |
| |
|
vi) |
|
***
U.S. Dollars ***. |
| |
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. |
| 6.3 |
|
The
first sentence in Section 10.2.1 of the Agreement is amended to read as follows: |
| |
“10.2.1 |
|
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, ***.” |
| 6.4 |
|
Section
10.2.2 of the Agreement is amended to read as follows: |
Page 9 of 21
| |
“10.2.2 |
|
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.” |
| 6.5 |
|
The
following new Section 10.4 is added to the Agreement: |
| |
“10.4 |
|
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 aliathe
*** 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.” |
| 7 |
|
Amendments
to Article 15 (Patent Prosecution and Defence) |
| 7.1 |
|
The
following new Sections 15.8 - 15.12 are added to the Agreement: |
| |
“15.8 |
|
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 |
Page 10 of 21
| |
expenses
of such activities, including fees and expenses paid to outside legal counsel and
experts, direct costs of in-house counsel and filing, prosecution and maintenance
expenses associated therewith. Without prejudice to the foregoing, *** shall (a) file and
prosecute Patent applications to secure Patent rights for subject matters within the
Licensed Field disclosed in the Additional Licensed Patents and for such other patentable
Additional Know-How within the Licensed Field as *** may from time to time reasonably
designate in writing, in each case in the United States or any of the other countries
***; provided, however that, in each such case, such *** and *** shall not have the
obligation to file or prosecute such *** designated Patent application, if *** has a
reasonable belief that the filing or prosecution of such Patent application mentioned in
this sub-clause (a) might *** patent strategies regarding the Agreement Compounds or the
Licensed Products or on the utilisation of the Agreement Compounds, the Licensed Products
or the Licensed Patents hereunder, including the filing or prosecution of a claim ***
under any of the Licensed Patents in the Licensed Field, or would otherwise in ***
reasonable judgement have *** on the Licensed Patents in the Licensed Field; and (b) upon
issuance, maintain such Patents described under (a) in full force in such countries. This
Section 15.8 shall apply in respect of the Additional Licensed Patents and the Additional
Know-How in lieu of Section 15.1 of the RCL Agreement. |
| |
15.9 |
|
Cooperation
regarding the Additional Licensed Patents. *** shall consult with *** to the strategy
and prosecution of Patent applications and the maintenance or extension of the Additional
Licensed Patents, and in the case where an Additional Licensed Patent covers two or more
Compounds or Candidate Drugs, *** may, at its sole discretion, apply for coverage of such
Compounds or Candidate Drugs by separate patents in the countries or territories in which
the patent application has been filed (by way of example; through the use of divisional
patent applications). *** shall cause its patent attorneys/agents to consult with *** (so
far as practicable) on all important issues relating to the filing, prosecution
(including any interferences, reissue proceedings and re- |
Page 11 of 21
| |
examinations)
and maintenance of the Additional Licensed Patents. *** shall provide *** with sufficient
opportunity to review and comment on the nature and text of new or pending applications,
amendments, registrations, filing, submissions, pleadings, responses or correspondence
with any patent authorities with respect to the Additional Licensed Patents and should
any comment refer to a matter that *** in its reasonable judgment considers to be of
significant importance for the filing, registration and prosecution of the Additional
Licensed Patents for use outside of the Licensed Field then *** reasonable opinion ***;
provided, however that, in each such case, *** opinion shall not be decisive, and ***
shall ***, if *** has a reasonable belief that the requested action might *** patent
strategies regarding the Agreement Compounds or the Licensed Products or on the
utilisation of the Agreement Compounds, the Licensed Products or the Licensed Patents
hereunder, including the filing or prosecution of a claim *** under the Licensed Patents
in the Licensed Field, or would otherwise in *** reasonable judgement have a *** on the
Licensed Patents in the Licensed Field. The Parties will co-operate in gaining patent
term extension(s), restoration(s) or the like that may be available during the Term to
the Additional Licensed Patents in any part of the Territory, for example under a
supplementary protection certificate in European countries. Should in any country any
decision have to be made as to what product or claim or otherwise to apply for a patent
term extension(s), restoration(s) or the like regarding which decision ***, in its
reasonable judgment, considers *** which the Additional Licensed Patents are intended to
provide in the Licensed Field, then ***. *** shall (a) notify *** as early as reasonably
practicable in advance of all meetings and significant communications with any patent
authorities concerning the Additional Licensed Patents and shall permit *** to
participate in such meetings, (b) promptly prepare and deliver to *** complete and
accurate minutes of any such meeting or communications, and (c) promptly forward to ***
copies of all office actions and material written communications received from any patent
authorities with respect to the Additional Licensed Patents upon receipt therefrom. This
Section |
Page 12 of 21
| |
15.9
shall, in respect of Additional Licensed Patents, apply in lieu of Section 15.2. |
| |
15.10 |
|
Election
not to Prosecute the Additional Licensed Patents. If *** elects not (a) to pursue or
continue the filing, prosecution (including any interferences, reissue proceedings and
re-examinations) or maintenance of an Additional Licensed Patent in a particular country,
or (b) to take any other action with respect to an Additional Licensed Patent in a
particular country that is necessary or useful to establish, preserve or extend rights
thereto, including by seeking any Patent term extension, restoration or the like that may
be available now or in the future, then in each such case *** shall so notify *** in
writing not less than two (2) months before any deadlines by which an action must be
taken to establish or preserve any such rights in such Additional Licensed Patent in such
country. Upon receipt of each such notice by *** or if, at any time, *** fails to
initiate any such action within *** days after a request by *** that it do so (or, if
after initiating any requested action, *** at any time thereafter fails to diligently
pursue such action), *** shall have the right, but not the obligation, through counsel of
its choosing, to pursue the filing or registration, or support the continued prosecution
(including any interferences, reissue proceedings and re-examinations) or maintenance, of
such Additional Licensed Patent at its expense in such country. If *** elects to pursue
such filing or registration, as the case may be, or continue such support, then *** shall
notify *** of such election. This Section 15.10 shall, in respect of Additional Licensed
Patents, apply in lieu of Section 15.3. |
| |
15.11 |
|
Prosecution
of the *** Patents. *** shall have the sole and exclusive worldwide right, at its
sole cost, expense and discretion, through counsel of its choosing and in its own name
(or any Person designated by it) to prepare, file, obtain, prosecute (including any
interferences, reissue proceedings and re-examinations) and maintain any and all Patents
or other IP Protection Rights in relation to all ***. *** shall have the sole right to
determine in which countries to file, obtain, |
Page 13 of 21
| |
prosecute
and maintain ***. To the extent that *** is filing, obtaining, prosecuting or maintaining
an *** or otherwise exercising its rights under this Article 15, neither *** nor any of
its employees, agents or representatives shall be liable to *** in respect of any act,
omission, default or neglect on the part of any such employee, agent or representative in
connection with such activities. |
| |
15.12 |
|
Cooperation
regarding the *** . At *** reasonable request and at *** sole cost, *** shall, and
shall cause its Affiliates to, assist and cooperate with *** in filing, obtaining,
prosecuting and maintaining *** .” |
| 8 |
|
Amendments
to Article 16 (Enforcement of Patents) |
| 8.1 |
|
The
following new Section 16.2.7 - 16.2.9 are added to the Agreement: |
| |
“16.2.7 |
|
*** shall have the sole right, but only after notifying *** through counsel of its
choosing, to take any measures it deems appropriate to stop infringement of the
Additional Licensed Patents for uses in the Licensed Field pursuant to the Additional
License, by any Third Party or Sublicensee in the Territory or to grant to the infringing
Third Party or Sublicensee adequate rights and licenses necessary for continuing such
activities. This Section 16.2.7 shall, in respect of the Additional Licensed Patents,
apply in lieu of Section 16.2.1. |
| |
16.2.8 |
|
Notwithstanding
what is stated in Section 16.2.7, if any Additional Licensed Patent is infringed by a
Third Party in any country, *** shall have the right to commence an action for
infringement, the right to enforce any judgment thereon and shall have full control over
the conduct of the litigation, including, subject to what is stated below in this Section
16.2.8, settlement of it, provided, however, that *** or a *** may join the proceedings
voluntarily, at *** cost and expense, and shall have the right to be heard in such
proceedings and to defend the validity of the Additional Licensed Patent and *** shall
give due regard to ***. Notwithstanding the foregoing, *** shall not have the right to,
and shall not permit any of its Sublicensees and shall procure such Sublicensees not to,
enter into any settlement or consent to any claim to the effect that any claim under, or |
Page 14 of 21
| |
the
patent protection otherwise offered under, any part of the Additional Licensed Patents
outside the Licensed Field would be materially negatively affected, without the prior
written consent of ***, such consent not to be unreasonably withheld. This Section 16.2.8
shall, in respect of the Additional Licensed Patents, apply in lieu of Section 16.2.2. |
| |
16.2.9 |
|
Upon
the reasonable request by either Party, each Party, at the requesting Party’s cost
and expense, shall give the other Party all information and assistance reasonably
necessary or useful for the requesting Party’s actions or measures permitted under
Section 16.2.7 or 16.2.8 above. In the event *** fails within *** following notice of an
infringement described in Section 16.2.7 above to take action permitted under Section
16.2.7 or 16.2.8, or notifies *** in writing of its intent not to take such action, ***,
shall have the right to do so at *** cost and expense; provided, however, that if *** has
commenced negotiations with an alleged infringer for discontinuance of such infringement
within such *** period, *** shall have an additional *** to conclude its negotiations
before Palatin, or a ***, may bring suit for such infringement. Should *** bring suit for
infringement in accordance with this Section 16.2.9, *** may contribute to the
proceedings or join such proceedings voluntary, at its own cost and expense, and shall
have the right to be heard and *** shall, and shall ***, give due regard to *** views. In
no event shall *** have the right to, and shall not permit any of its other licensees and
shall procure such licensees not to, enter into any settlement or consent to any claim to
the effect that any claim under, or the patent protection otherwise offered under, any
part of ***, without the prior written consent of ***, such consent not to be
unreasonably withheld. This Section 16.2.9 shall, in respect of the Additional Licensed
Patents, apply in lieu of Section 16.2.3.” |
| 8.2 |
|
The
following new Section 16.5 is added to the Agreement: |
| |
“16.5 |
|
Infringement of the *** . |
Page 15 of 21
| |
16.5.1 |
|
In
the event that *** supposes that a Third Party may be infringing any ***, Palatin shall
promptly notify *** thereof in writing, identifying the alleged infringer and the alleged
infringement complained of and furnishing the information upon which such determination
is based. |
| |
16.5.2 |
|
***
shall have the sole right, through counsel of its choosing and at its sole cost and
expense, to take any measures it deems appropriate to stop infringement of the *** by any
Third Party or Sublicensee in the Territory or to grant to the infringing Third Party or
Sublicensee adequate rights and licenses necessary for continuing such activities. At the
reasonable request by *** and at *** cost, *** shall give *** all reasonable information
and assistance, including allowing *** access to *** and to *** personnel, including the
inventors, who may have possession of relevant information and, if necessary for *** to
prosecute any legal action, joining in the legal action as a party. |
| |
16.5.3 |
|
Any
amounts recovered by *** pursuant to this Section 16.5, whether by settlement or
judgment, shall be ***. *** will, when pursuing any action under Section 16.5.2 above,
bear all payments awarded against or agreed to be paid by *** pursuant to such action,
including any costs or expenses incurred that exceed the amounts recovered by ***.” |
| 9 |
|
Amendments
to Article 17 (Potential Third Party Rights) |
| 9.1 |
|
The
following new Sections 17.7 – 17.10 are added to the Agreement: |
| |
“17.7 |
|
Third Party Licenses and *** . If, in the opinion of ***, the Exploitation
of ***, its Affiliates or *** infringes or misappropriates any Patent or any Intellectual
Property Right of a Third Party in any country, such that *** cannot Exploit the *** in
such country without infringing the Patent or Intellectual Property Right of such Third
Party, then, *** shall have the right, but not the obligation, through counsel of its
choosing and at its sole cost and expense, to negotiate and obtain a license from such
Third Party as necessary for *** to Exploit the *** in such country. |
Page 16 of 21
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17.8 |
|
Invalidity
or Unenforceability Defences or Actions and *** . In the event that a Third Party or
Sublicensee asserts, as a defence or as a counterclaim in any infringement action under
either of Sections 16.2.7 – 16.2.9 or Section 16.5 above, that any of the *** is
invalid or unenforceable, then *** shall have the right, but not the obligation, through
counsel of its choosing and at its cost and expense, to respond to such defence or defend
against such counterclaim (as applicable), including, the right to settle or otherwise
compromise such claim. Similarly, if a Third Party or Sublicensee asserts, in a
declaratory judgment action or similar action or claim filed by such Third Party or
Sublicensee, that any of the *** is invalid or unenforceable, then *** shall have the
right, but not the obligation, through counsel of its choosing and at its cost and
expense, to defend against such action or claim, including the right to settle or
otherwise compromise such claim. This Section 17.8 shall, in respect of ***, apply in
lieu of Section 17.2.1. |
| |
17.9 |
|
Third
Party Litigation and *** . In the event of any actual or threatened suit against
Palatin, *** alleging that the Exploitation of *** by or on behalf of ***, infringes the
Patent or other intellectual property rights of any Person (an “Infringement Suit”),
the Party first becoming aware of such Infringement Suit shall promptly give written
notice to the other Party. *** shall have the first right, but not the obligation,
through counsel of its choosing and at its cost and expense, to assume direction and
control of the defence of claims arising therefrom, including the right to settle such
claims at its sole discretion. |
| |
17.10 |
|
***
will provide to *** all reasonable assistance requested by *** in connection with any
action, claim or suit under Section 17.8 or 17.9 above, including allowing AstraZeneca
access to *** and to ***, who may have possession of relevant information. In particular
*** will promptly make available to ***, all information in its possession or control
that it is aware will assist *** in responding to any such action, claim or suit under
Section 17.8 or 17.9 above.” |
Page 17 of 21
| 10 |
|
Amendments
to Article 18 (Representations and Warranties) |
| 10.1 |
|
The
following new Section 18.6 is added to the Agreement: |
| |
“18.6 |
|
Palatin
represents, warrants and covenants to AstraZeneca as of the Amendment Effective Date that: |
| |
18.6.1 |
|
The
execution, delivery and performance of this Agreement, insofar as it relates to the
Additional Compounds, Additional Licensed Patents, Additional Products, Additional
Know-How, *** , will not result in a violation of, or be in conflict with, or constitute
a default, under any agreement between Palatin and Third Parties and Palatin is not party
to any other agreements that limit AstraZeneca’s rights and licenses in relation to
the foregoing under this Agreement and Palatin will not enter into any agreement, whether
written or oral, inconsistent with such rights and licenses. |
| |
18.6.2 |
|
Palatin
is the sole and exclusive owner of the entire right, title and interest in the Additional
Licensed Patents and, to its Knowledge, the Additional Know-How, and is entitled to grant
the licenses and the rights herein. Palatin has not placed, and to its Knowledge there
does not exist, upon the Additional Licensed Patents or Additional Know-How any
encumbrance or lien and no claim has been made to Palatin of ownership by any Third Party
of any right or interest in or to the Additional Licensed Patents or Additional Know-How.
The granting of the Additional License does not violate any right known to Palatin of any
Third Party and, to its Knowledge, Palatin has obtained all necessary consents from Third
Parties in order to allow it to enter into its obligations under the Agreement insofar as
it relates to the Additional Compounds, Additional Licensed Patents, Additional Products,
Additional Know-How, *** . |
| |
18.6.3 |
|
To
Palatin’s and its Affiliates’ Knowledge, the Additional Licensed Patents are
being diligently procured from the respective patent offices in accordance with all
Applicable Laws. The Additional Licensed Patents have been filed and |
Page 18 of 21
| |
maintained
properly and correctly and all applicable fees have been paid on or before the due date
for payment. |
| |
18.6.4 |
|
As
of the Amendment Effective Date, to Palatin’s and its Affiliates’ Knowledge,
there is no actual infringement or threatened infringement of the Additional Licensed
Patents or the Additional Know-How by any Person. |
| |
18.6.5 |
|
To
the Knowledge of Palatin and its Affiliates, the disclosing, copying, making, assigning,
licensing or the Exploitation pursuant to this Agreement of the Additional Compounds,
Additional Licensed Patents or Additional Know-How hereunder will not infringe or
conflict with any Patent or other IP Protection Right of any Person. To the Knowledge of
Palatin and its Affiliates, the conception, development and reduction to practice of the
Additional Licensed Patents and Additional Know-How have not constituted or involved the
misappropriation of trade secrets or other rights or property of any Person. |
| |
18.6.6 |
|
Palatin
shall not grant to any Third Party any right under the Additional Licensed Patents or the
Additional Licensed Know-How which would mean or have as a consequence that *** in
accordance with this Agreement. |
| |
18.6.7 |
|
No
claim or litigation has been brought or threatened by any Person alleging that (a) the
Additional Licensed Patents or the Additional Know-How are invalid or unenforceable or
(b) the Additional Licensed Patents or the Additional Know-How or the disclosing,
copying, making, assigning, licensing or Exploiting of the Additional Licensed Patents or
the Additional Know-How, or products and services embodying the Additional Compounds or
Additional Products violates, infringes or otherwise conflicts or interferes with any
intellectual property or proprietary right of any Person. |
| |
18.6.8 |
|
All
Patents within Palatin’s Control claiming or covering the *** will be disclosed to
AstraZeneca as *** . |
Page 19 of 21
| |
18.6.9 |
|
Palatin
has not been involved in any governmentally-funded research and development project
relating to the Additional Compounds or Additional Licensed Patents. |
| |
18.6.10 |
|
Except
as explicitly disclosed to AstraZeneca in writing prior to the date of the AstraZeneca
Notice, Palatin will not have prior to such date entered into any agreement, whether
written or oral, with respect to, or otherwise assigned, transferred, licensed, conveyed
or otherwise encumbered its right, title or interest in or to, the Additional Licensed
Patents, Additional Know-How, Additional Compounds or the Additional Products (including
by granting any covenant not to xxx with respect thereto) and it will not enter into any
such agreements or grant any such right, title or interest to any Person that is
inconsistent with the rights and licenses granted to AstraZeneca under the Agreement. |
| |
18.7 |
|
The
representations, covenants and warranties set forth in Sections 18.6.1 through 18.6.10
shall, save to the extent otherwise explicitly disclosed by *** in writing within ***
(the ” *** “) following an ***, be deemed made also as of the date of the
AstraZeneca Notice. AstraZeneca may within *** following a ***, at its sole discretion,
cancel the *** in respect of one or more of the ***, whereupon *** . For the purpose of
this Section 18.7 the term “Business Day” shall mean any day (other than
a Saturday or a Sunday) on which banks are open for business in Sweden and the USA.” |
| 11.1 |
|
Amendment
Effective Date. This Amendment shall become effective on the Amendment Effective Date. |
| 11.2 |
|
Notices.
All notices and communications under this Amendment shall be as provided in Sections
26.1 and 26.2 of the Agreement. |
| 11.3 |
|
Governing
Law. The interpretation and construction of this Amendment shall be governed by the laws
of the State of New York, U.S., excluding any conflicts or choice of |
Page 20 of 21
| |
law
rule or principle that might otherwise refer construction or interpretation of this
Amendment to the substantive law of another jurisdiction. |
| 11.4 |
|
Arbitration.
Any controversy or claim arising out of or relating to this Amendment shall be settled
in accordance with Section 24.2 of the Agreement. |
| 11.5 |
|
Entire
Agreement. This Amendment, together with the Agreement, constitutes the entire
agreement between the Parties with respect to the subject matter of the Agreement as
hereby amended. The Agreement together with this Amendment supersedes all prior
agreements, whether written or oral, with respect to the subject matter of the Agreement,
as amended. Each Party confirms that it is not relying on any representations, warranties
or covenants of the other Party except as specifically set out in the Agreement as
amended. Nothing in this Amendment is intended to limit or exclude any liability for
fraud. All Schedules referred to in this Amendment are intended to be and are hereby
specifically incorporated into and made a part of the Agreement. The Parties hereby agree
that subject to the modifications specifically stated in this Amendment, all terms and
conditions of the Agreement shall remain in full force and effect. |
| 11.6 |
|
Counterparts.
This Amendment may be executed in any number of counterparts, each of which shall be
deemed an original and all of which taken together shall be deemed to constitute one and
the same instrument. |
Execution
IN WITNESS WHEREOF, the Parties
hereto have executed this Amendment in two original copies of which the Parties have taken
one each.
Page 21 of 21
|
|
|
|
| SIGNED for and on behalf of |
SIGNED for and on behalf of |
| AstraZeneca AB (publ) |
Palatin Technologies, Inc. |
| /S/Xxx X Xxxxxxxx |
/S/Xxxxxxx X. Xxxxx |
| Signature |
Signature |
| Name: |
Xxx X Xxxxxxxx |
Name: |
Xxxxxxx X. Xxxxx |
| Title: |
Executive Vice President Global Discovery |
Title: |
EVP – Operations & CFO |
| |
Global Discovery |
|
|
Schedule 1.92
The following new Section 7 is
inserted into the Research Plan:
***
Schedule 1.111
***
Schedule 1.112
***
Schedule 4.5.3
***
Schedule 15.8
***
