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CONFIDENTIAL TREATMENT
REQUEST
THIRD AMENDMENT TO
RESEARCH COLLABORATION
AND LICENSE AGREEMENT
This THIRD AMENDMENT (this
“Third Amendment”) is made effective as of 24th September 2009
(the “Third 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
A) |
WHEREAS, AstraZeneca and Palatin are parties to that certain Research
Collaboration and License Agreement effective as of 30 January 2007 and amended
through a First Amendment effective as of 27 June 2008 and a Second Amendment
effective as of 5 December 2008 (collectively the “Agreement”); |
B) |
WHEREAS, as part of the Agreement, Palatin inter alia granted to
AstraZeneca a license to the Licensed Patents and the Parties agreed to
collaborate to generate Collaboration Compounds to be owned by AstraZeneca; |
C) |
WHEREAS, the Parties entered into a Clinical Trial Sponsored Research Agreement
effective as of 5 December 2008 (the “Clinical Trial
Agreement”), whereby Palatin conducted a certain clinical trial ***; |
D) |
WHEREAS, Palatin and AstraZeneca desire to amend the Agreement to inter alia
provide for a reduction of royalties and certain milestone payments
otherwise due, *** and other good and value consideration, and in exchange
therefore, for AstraZeneca to make an additional payment to Palatin; and |
INFORMATION MARKED
"***" IS OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION
UNDER RULE 24b-2
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E) |
WHEREAS, the Parties, in view of the above, wish to amend the Agreement on the
terms set forth herein. |
Agreement
NOW, THEREFORE, in consideration of
the mutual covenants contained in this Third 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 |
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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 Third
Amendment. |
2 |
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Amendments
to Article 3 (Research Collaboration) |
2.1 |
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Section
3.6 of the Agreement is amended by adding the following new Sections 3.6.1. through
3.6.4. immediately following the text of Section 3.6 as follows: |
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“3.6.1. |
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In addition
and without prejudice to any of Palatin’s obligations in
respect of Research Records set forth elsewhere in this Agreement: |
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a) |
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Palatin
shall, *** send to AstraZeneca the originals of all Research Records including laboratory
notebooks in respect of all work done and results achieved by Palatin under the Research
Collaboration *** provided that, to the extent mutually agreed by the Parties, Palatin
shall be entitled to retain originals of such laboratory notebooks that ***. To the
extent that originals of laboratory notebooks are agreed to be withheld in accordance
with the foregoing sentence, Palatin shall, *** after the Third |
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Amendment
Effective Date, deliver to AstraZeneca scanned copies in electronic format ***. |
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b) |
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If
so requested by AstraZeneca in writing at any time following the Third Amendment
Effective Date and prior to the expiration of the third Collaboration Year, Palatin
shall, ***, send to AstraZeneca the originals of all Research Records including
laboratory notebooks in respect of all work done and results achieved by Palatin under
the Research Collaboration during the period starting on ***. |
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c) |
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Palatin
shall, ***, send to AstraZeneca the originals of all Research Records including
laboratory notebooks in respect of all work done and results achieved by Palatin under
the Research Collaboration during ***. |
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Prior
to sending the originals of laboratory notebooks to AstraZeneca under this Section 3.6.1,
Palatin shall have such laboratory notebooks scanned and saved in electronic format and
shall deliver a copy of such electronic format laboratory notebooks to AstraZeneca and
may retain a copy of such electronic format laboratory notebooks for *** |
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3.6.2. |
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On
or prior to *** scanned and saved in electronic format and shall deliver a copy of such
portions of electronic format laboratory notebooks to AstraZeneca. AstraZeneca shall ***.
Palatin shall further, if so requested by AstraZeneca in writing at any time following
the Third Amendment Effective Date, ***. |
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3.6.3. |
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On
or prior to ***, AstraZeneca shall identify ***. On or prior to ***, Palatin shall have
those portions of its laboratory notebooks disclosing ***. |
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a) |
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3.6.4.
On or prior to ***, AstraZeneca may designate any laboratory notebooks identified in
Sections 3.6.2 (not already |
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delivered
to AstraZeneca pursuant to Section 3.6.2) or 3.6.3, or for which an original was withheld
by mutual agreement as provided in Section 3.6.1, as being notebooks which AstraZeneca
***. |
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3.6.5 |
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All
originals or electronic copies of laboratory notebooks to be sent to AstraZeneca under
Sections 3.6.1 through 3.6.4 shall be sent by an internationally-recognized overnight
delivery service to AstraZeneca at the following address (or such other address as
AstraZeneca may have specified to Palatin in writing prior to shipment): |
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AstraZeneca
shall reimburse Palatin for the costs of shipment.” |
2.2 |
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Article
3 of the Agreement is amended by adding the following new Sections 3.21, 3.22 and 3.23
to the Agreement: |
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“3.21 |
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Palatin shall throughout the third Collaboration Year *** and further provided that
it shall not be a default under this Section 3.21 if Palatin ceases to perform or cause
to be performed its obligations under the Research Plan as a result of any Force Majeure
event, provided that the provisions of Article 21 of this Agreement shall otherwise apply
to any such Force Majeure event. |
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3.22 |
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Palatin
shall make available to AstraZeneca its Key Personnel and other employees, at such times
and for such periods prior to ***, provided that to the extent such activities occur at
any place other than Palatin’s facilities, AstraZeneca shall reimburse Palatin for
its reasonable travel and accommodation costs approved by AstraZeneca in advance. |
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3.23 |
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Palatin
grants AstraZeneca the right, at AstraZeneca’s expense, to inspect and copy, or
otherwise obtain from Palatin, ***.” |
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3 |
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Amendments
to Article 10 (Consideration) |
3.1 |
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The
second sentence of Section 10.1 of the Agreement, as added by Section 6.1 of the First
Amendment, is deleted in its entirety. |
3.2 |
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Section
10.1.2.1 of the Agreement is amended to read in its entirety 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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B) |
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Regulatory
Milestones for *** Licensed Products |
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i) |
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***
U.S. Dollars ***; and |
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ii) |
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***
U.S. Dollars ***: and |
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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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C) |
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Commercial
Milestones for *** on Annual Net Sales. |
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At
the end of the Calendar Quarter in which the Annual Net Sales of *** under a Health
Registration Approval exceeds for the first time each respective milestone set forth
below, AstraZeneca shall make the corresponding payment to Palatin, as follows |
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i) |
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***
U.S. Dollars ***; and |
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ii) |
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***
U.S. Dollars ***; and |
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iii) |
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***
U.S. Dollars ***. |
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For
the avoidance of doubt, in order to qualify for a payment under subsections (i) through
(iii) above, the Annual Net Sales may ***, but no milestone shall be payable more than
once no matter *** achieve such milestone.” |
3.3 |
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Section
10.1.2.2 of the Agreement is amended to read in its entirety as follows: |
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“10.1.2.2 |
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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 ***; and |
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ii) |
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***
U.S. Dollars ***; and |
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iii) |
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***
U.S. Dollars ***. |
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B) |
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Regulatory
Milestones for *** Licensed Products |
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i) |
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***
U.S. Dollars ***; and |
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ii) |
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***
U.S. Dollars ***: and |
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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 ***.” |
3.4 |
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Section
10.1.3. of the Agreement is amended to read in its entirety as follows: |
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“10.1.3. |
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Commercial Milestones on Aggregate Net Sales. At the end of the Calendar
Quarter in which the cumulative Net Sales of a Licensed Product under a Health
Registration Approval exceeds for the first time each respective milestone set forth
below, AstraZeneca shall make the corresponding payment to Palatin, as follows. |
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i) |
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***
U.S. Dollars ***; and |
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ii) |
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***
U.S. Dollars ***; and |
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iii) |
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***
U.S. Dollars ***. |
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For
the avoidance of doubt, in order to qualify for a payment under subsections (i) through
(iii) above, the Net Sales shall emanate from any Licensed Product, but no milestone is
payable more than once no matter how many Licensed Products achieve such milestone.” |
3.5 |
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The
following new Section 10.1.5 is added to the Agreement: |
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“10.1.5 |
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Additional Investment Fee. AstraZeneca shall pay to Palatin (A) two million
five hundred thousand U.S. Dollars ($2,500,000) (the “First Payment”)
*** and (B), *** an additional payment of two million five hundred thousand U.S. Dollars
($2,500,000) (the “Second Payment”), payable as provided in either of
sub-clause (iv), (v) or (vi) below in this Section 10.1.5. |
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i) |
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For
purposes of this Section 10.1.5, (a) the term “Completion Date” shall
mean ***, (b) the term “Completion Period”shall mean *** and (c) the
term “Successful Completion”shall mean ***. |
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At
a mutually agreed date ***, the CMC shall meet (either in person or by telephone- or
videoconference) to review ***. |
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ii) |
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If
Palatin is of the good faith opinion that it has achieved a Successful Completion by the
Completion Date, Palatin shall ***. |
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iii) |
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If
AstraZeneca receives a Certification of Completion from Palatin as per sub-clause (iii)
above within the prescribed time, AstraZeneca shall, ***. If AstraZeneca has provided an
acceptance of Palatin’s Certification of Completion as per (a) above, then
AstraZeneca shall pay the Second Payment ***. |
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iv) |
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If
AstraZeneca provides ***. |
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v) |
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If
(a) AstraZeneca provides *** or (b) if AstraZeneca provides ***. |
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vi) |
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For the avoidance of doubt, the procedures set forth above in this Section 10.1.5 are
***. |
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vii) |
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If
(a) Palatin fails to provide a ***, (b) Palatin fails to provide a ***, or (c) if ***.” |
3.6 |
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Section
10.2 of the Agreement is amended to read in its entirety as follows: |
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“10.2 |
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Milestone Payments. |
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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 10.1.2.2, i.e. for *** 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. |
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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. $139,250,000 for *** Agreement Compound or Licensed Product, or U.S.
$145,250,000 for *** Agreement Compound or Licensed Product (and for the avoidance of
doubt any amounts payable or due in respect of an *** Agreement Compound or Licensed
Product shall be reduced by any amounts payable or due in respect of an *** Agreement
Compound or Licensed Product pursuant to Section 10.2.1 and the aggregate maximum amount
payable under Sections 10.1.2 and 10.1.3 shall in no event exceed U.S.$145,250,000),
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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3.7 |
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Section
10.2.3, as added to the Agreement by the Second Amendment, is deleted in its entirety, on
the understanding and with the effect that milestone payments pursuant to Section 4.8 of
the Clinical Trial Agreement shall not constitute an offset against and credit for such
amounts as may be payable by AstraZeneca to Palatin pursuant to Sections 10.1.2.1 or
10.1.2.2 of the Agreement as amended by this Third Amendment. To similar effect, Section
4.10 of the Clinical Trial Agreement, to the extent that it is incorporated into or
otherwise affects this Agreement, is deleted in its entirety. It is the intent of the
Parties that such amounts as may be payable under Sections 10.1.2.1 or 10.1.2.2, as
amended by this Third Amendment, shall be paid without any offset against or credit for
any amounts paid or payable by AstraZeneca to Palatin on or before the Third Amendment
Effective Date. |
4 |
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Amendments
to Article 11 (Royalty Payments and Other Payment-Related Provisions) |
4.1 |
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Section
11.1. of the Agreement is amended to read in its entirety as follows: |
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“11.1. |
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Royalties. AstraZeneca shall pay Palatin, with respect to each Licensed
Product, the following running royalties on the Annual Net Sales of Licensed Products
(provided that calculations for the Combination Products are to be made in accordance
with the formula set out in Section 11.3 and provided further that calculations for
Sublicensee income are to be made in accordance with Section 11.4): |
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11.1.1 |
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***
on the portion of Annual Net Sales not exceeding ***; and |
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11.1.2 |
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***
on the portion of Annual Net Sales ***; and |
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11.1.3 |
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***
on the portion of Annual Net Sales ***; and |
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11.1.4 |
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***
on the portion of Annual Net Sales ***. |
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The
calculation of royalties under this Section 11.1 shall be conducted separately for each
Licensed Product. Thus, if AstraZeneca sells more than one Licensed |
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Product
in the Territory, the thresholds and ceilings in this Section 11.1 shall apply separately
to each Licensed Product.” |
4.2 |
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Section
11.12. of the Agreement is amended to read in its entirety as follows: |
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“11.12. |
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Mode of Payment. All payments set forth in Articles 10 and 11 shall be
remitted by wire transfer to the following bank account of Palatin or such other account
as Palatin may designate in writing, pursuant to Article 26, to AstraZeneca: |
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Palatin
Technologies, Inc. |
5 |
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Amendments
to Article 18 (Representation and Warranties) |
5.1 |
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The
first paragraph of Section 18.6 of the Agreement is amended to read in its entirety as
follows: |
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“18.6 |
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Palatin represents, warrants and covenants to AstraZeneca as of the Amendment
Effective Date, the Second Amendment Effective Date and the Third Amendment Effective
Date that:" |
6 |
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Amendments
to Article 20 (Term and Termination) |
6.1 |
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Section
20.2 of the Agreement is amended to read in its entirety as follows: |
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“20.2 |
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Collaboration Term. The Collaboration Term shall commence on the Effective
Date and, unless the Agreement is terminated pursuant to Sections 20.3, 20.4, 20.5, 20.6
or 20.9 or the Research Collaboration is terminated by AstraZeneca pursuant to this
Section 20.2, continue until expiration of *** Collaboration Year. |
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Notwithstanding
what is stated in the immediately preceding paragraph, AstraZeneca may extend the
Collaboration Term, on the terms corresponding to those set forth in Article 9, for ***.” |
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7 |
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New
Article 4A (Additional Clinical Trial Sponsored Research) |
7.1 |
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A
new Article 4A is added to the Agreement, to read in its entirety as follows: |
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4A. |
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Additional
Clinical Trial Sponsored Research |
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4A.1 |
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Palatin
agrees to conduct, at AstraZeneca’s request *** one or more of the following ***
studies *** (the “Additional Studies”) under the terms and conditions
set forth in this Article 4A: |
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(i) |
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***
(the “First Additional Study”). |
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(Each
of the studies referred to in sub-clause (ii) and (iii) above, a “Follow-up Study”.) |
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4A.2 |
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Terms
and Provisions of the Clinical Trial Agreement. Any such Additional Studies shall be
conducted ***. |
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4A.3 |
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Scope
of Additional Studies. The First Additional Study shall be pursuant to a Study Plan
incorporating the synopsis of the Study Protocol ***. |
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4A.4 |
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Defined
Terms in this Article 4A. As used in this Article 4A, the terms ***, SMC, IND, FDA,
Study Protocol and Study Plan have the meaning given in the Clinical Trial Agreement. |
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4A.4 |
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Not
Extension of Research Collaboration. AstraZeneca and Palatin agree that work
conducted under this Article 4A shall, for all purposes, be deemed to be work outside the
Research Collaboration, and nothing in this Article 4A shall be deemed to extend or
otherwise modify the expiration or termination of the Collaboration Term.” |
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8.1 |
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Third
Amendment Effective Date. This Third Amendment shall become effective on the Third
Amendment Effective Date. |
8.2 |
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Notices.
All notices and communications under this Third Amendment shall be as provided in
Sections 26.1 and 26.2 of the Agreement. |
8.3 |
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Governing
Law. The interpretation and construction of this Third Amendment shall be governed by
the laws of the State of New York, U.S., excluding any conflicts or choice of law rule or
principle that might otherwise refer construction or interpretation of this Third
Amendment to the substantive law of another jurisdiction. |
8.4 |
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Arbitration.
Any controversy or claim arising out of or relating to this Third Amendment shall be
settled in accordance with Section 24.2 of the Agreement. |
8.5 |
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Entire
Agreement. This Third Amendment, together with the Agreement, constitutes the entire
agreement between the Parties with respect to the subject matter of the Agreement as
amended. The Agreement together with this Third 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 Third Amendment is intended to limit or exclude any liability
for fraud. All Schedules referred to in this Third 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 Third
Amendment, all terms and conditions of the Agreement (including, for the avoidance of
doubt the First Amendment of 27 June 2008 and the Second Amendment of 5 December 2008)
shall remain in full force and effect. |
8.6 |
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Counterparts.
This Third 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. |
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_________________
[Signatures overleaf]
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Execution
IN WITNESS WHEREOF, the Parties
hereto have executed this Amendment in two original copies of which the Parties have taken
one each.
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SIGNED for and on behalf of
AstraZeneca AB (publ) |
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SIGNED for and on behalf of
Palatin Technologies, Inc. |
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Signature |
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Signature |
Name: |
Xxx X Xxxxxxxx |
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Name: |
Xxxxxxx X. Xxxxx |
Title: |
Executive Vice President
Global Discovery |
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Title: |
Executive Vice President –
Operations and Chief Financial Officer |
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Amended Schedule 3.2
Key Personnel
(including Palatin Principal Scientists)
***
Page 16 of 17
Schedule 3.22
***
Page 17 of 17
Schedule 4A.3
Synopsis of Study
Protocol
***