CLINICAL TRIAL SPONSORED
CLINICAL TRIAL SPONSORED RESEARCH AGREEMENT (this “
Agreement ”) is made effective as of December 5, 2008
(the “ 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 (“
(A) WHEREAS, AstraZeneca and Palatin
are parties to that certain Research Collaboration and License
Agreement effective as of January 30, 2007 and amended effective as
of June 27, 2008 (collectively, the “ License
(B) WHEREAS, as part of the License
Agreement, Palatin inter alia granted to AstraZeneca a
license to the Licensed Patents and Additional Licensed Patents and
a License to certain Compounds and Additional Compounds for use
within the Licensed Field (all as capitalized terms are defined in
the License Agreement);
(C) WHEREAS, Palatin is
(D) WHEREAS, AstraZeneca has
determined that it is in its best interests to have ***;
(E) WHEREAS, the Parties, in view of
the above, wish to enter into the Agreement on the terms set forth
“***” IS OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION UNDER RULE 24b-2
THEREFORE, in consideration of the mutual covenants contained in
this Agreement, and other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the
Parties, intending to be legally bound, agree as
otherwise specifically provided in this Agreement, the following
terms shall have the following meanings:
“ Affiliate ”
means, with respect to a Person, any Person that Controls, is
Controlled by or is under common Control with such first Person.
For purposes of this definition only, “ Control
(a) to possess,
directly or indirectly, the power to direct the management or
policies of a Person, whether through ownership of voting
securities or by contract relating to voting rights or corporate
governance, or (b) to own, directly or indirectly, more than fifty
percent (50%) of the outstanding voting securities or other
ownership interest of such Person.
“ Agreement ” has
the meaning set forth in the preamble of this Agreement.
“ Applicable Law ”
means the federal state and local laws, rules and regulations (as
may be amended from time to time) applicable to the conduct of the
Study, including without limitation (i) the United States Food,
Drug and Cosmetic Act, as amended, and any rules and regulations
promulgated thereunder, (ii) Title 21 Code of Federal Regulations (
“CFR” ) Parts 50, 54, 56 and 312, and (iii) all
other applicable United States Food and Drug Administration (
“FDA” ) regulations and guidance (including
without limitation, those with respect to standards of Good
Clinical Practice (GCP) and adverse event reporting).
*** and any product in a form
suitable for applications for human use that contains the compound
as the sole active ingredient.
“ Calendar Quarter
” means each successive period of three (3) calendar months
commencing on 1st January, 1st April, 1st July and 1st
“ Calendar Year ”
means each successive period of twelve (12) calendar months
commencing on 1st January.
“ Completion Date
” means the date of acceptance of the Final Study Report by
AstraZeneca. The Final Study Report *** unless AstraZeneca prior to
such date advises Palatin in writing of specific objections to or
deficiencies in the Final Study Report, in which event
“ Effective Date ”
means the date as set forth in the preamble to this
“ Existing Clinical Data
” means pre-clinical and clinical data relating to *** the
“ Existing CMC Data
” means chemistry, manufacturing and controls protocols and
data *** the Effective Date.
“ FDA ” means the
United States Food and Drug Administration and any successor agency
“ Final Study Report
” means the final report in respect of the Study written by
or on behalf of Palatin and summarising the results of the Study as
more particularly described in Schedule
“ FTE ” means the
equivalent of one (1) professional staff member being at least a
graduate or a similarly qualified employee or contract employee of
Palatin having the requisite skills to fulfil Palatin’s
obligations under this Agreement and devoting the equivalent hours
of a full time employee. For purposes of this Agreement,
“full time” shall mean *** as determined in accordance
with Palatin’s regular project hour reporting system. An FTE
shall be ***.
“ FTE Rate ” means
the price of one (1) FTE per single Calendar Year. The FTE Rate
shall ***. The FTE Rate reflects the fully burdened costs for an
FTE. AstraZeneca shall not be responsible for any Palatin ***
incurred in pursuit of the Study and services rendered by Palatin
under this Agreement, above and beyond the FTE Rate, or for *** but
shall be responsible for ***.
“ Good Clinical Practice
” or “ GCP ” shall have the meaning
defined by the ICH Harmonised Tripartite Guideline for Good
Clinical Practice, at all times in its most recent version, and in
21 CFR Parts 50, 54, 56, and 312.
“ Good Manufacturing
Practice ” or “ GMP ” means the
principle of good manufacturing practice in respect of medicinal
products for human use and investigational medicinal products for
human use as required by Applicable Law.
“ Health Authority
” means the FDA and any applicable supra-national, federal,
national, regional, state, provincial or local regulatory agency,
department, bureau, commission, council or other government entity
regulating or otherwise exercising authority with respect to *** or
otherwise has power to regulate the conduct of the Study at a Study
site or to inspect a Study site.
“ IND ” means an
investigational new drug application filed with the FDA for
authorisation to commence human clinical trials in the U.S. as
defined in 21 CFR Part 312.
“ Indirect Taxes ”
means value added taxes, sales taxes, consumption taxes and other
“ Informed Consent
” has the meaning set forth in 21 CFR Part 56.
“ Informed Consent
Materials ” means the information to be provided to
potential Subjects in the Study to secure their Informed Consent,
including information about any compensation being provided to
Subjects for their participation in the Study, pursuant to 21 CFR
“ Institutional Review
Board ” or “ IRB ” means an
independent body, institutional, regional, national or
supranational committee or review board as defined in 21 US CFR
Part 56, whose responsibility it is to ensure the protection of
rights, safety and well-being of human subjects in a clinical study
and responsible for, among other things, reviewing and
approving/providing opinion on, the Study Protocol and amendments,
subject recruitment materials, methods and Informed Consent
Product ” means ***, which is studied or tested in the
“ Investigator ”
shall have the meaning set forth in Section 7.1.
Brochure ” means the compilation of all relevant clinical
and non-clinical information and data on the Investigational
“ JPT ” shall have
the meaning set forth in Section 5.1.
“ License Agreement
” has the meaning set forth in the recitals of this
“ Palatin Clinical Staff
” shall have the meaning set forth in Section 2.3.
“ Parties ” means
AstraZeneca and Palatin and “Party” means either of
AstraZeneca or Palatin.
“ Payments ” has
the meaning set forth in Section 10.1.
“ Person ” means
an individual, sole proprietorship, partnership, limited
partnership, limited liability partnership, corporation, limited
liability company, business trust, joint stock company, trust,
incorporated association, joint venture or similar entity or
organization, including a government or political subdivision,
department or agency of a government.
Documentation ” means all protocols, including the Study
Protocol, applications, registrations, licenses, authorisations and
approvals, all correspondence submitted to or received from FDA or
other Health Authorities (including minutes and official contact
reports relating to any communications with FDA or other Health
Authorities) and all supporting documents and all clinical results
and tests, relating to use of Investigational Product in the
“ Researchers ”
shall mean all researchers, experts and other staff engaged by
Palatin in the conduct of the Study, including the Palatin Clinical
Staff and the Investigators.
“ Results ” means
inventions, discoveries, know-how, data, documentation, reports,
materials, writings, techniques and other information, recorded in
any form, that are discovered, conceived or otherwise generated
through the Study by Palatin or any of the Researchers (other than
“ Site ” shall
have the meaning set forth in Section 7.1.
“ SMC ” shall have
the meaning set forth in Section 6.1.
“ Study ” means
***, all as described in the Study Plan.
“ Study Documentation
” means all records, accounts, notes, reports and data,
collected, generated or used in connection with the Study, whether
in written, electronic, optical or other form, including all
recorded original observations and notations of clinical activities
such as case report forms and all other reports and records
necessary for the evaluation and reconstruction of the
“ Study Efficacy Data
” means Results from the Study relating to ***.
“ Study Plan ”
means the plan attached hereto as Schedule 1.40 ,
outlining the Study and each Party’s undertakings and
obligations, including the allocation of FTEs by Palatin and Third
Party subcontracts in relation thereto as the same may be amended
from time to time in accordance with Section 6.2.
“ Study Plan Budget
” shall mean the budget for the Study attached hereto as
Schedule 1.41 , as it may be amended from time to time by
written agreement of both Parties.
“ Study Protocol ”
means the definitive protocol for the Study included within an IND
or other Regulatory Documentation (including but not limited to in
the event that the study is initiated by filing a protocol or other
Regulatory Documentation under an existing IND held by Palatin)
submitted by Palatin to the FDA to commence the Study,
provided that such submission shall be made only
following written approval of the SMC by authorized representatives
of both Parties, it being understood that Sections 6.4.1. and
6.4.2. do not apply to such approval by the SMC.
“ Study Results ”
means all Study Safety Data, all Study Efficacy Data and all other
“ Study Safety Data
” means Results from the Study relating *** or any reportable
experience pursuant to 21 CFR § 312.32 but excluding
“ Study Year ”
means each successive period of twelve (12) calendar months ending
on the last day of each successive anniversary of the Calendar
Quarter which includes the Effective Date, it being understood that
the initial Study Year may be less than twelve (12) calendar
“ Subject ” means
a person recruited to participate in the Study.
“ Term ” means the
period beginning on the Effective Date and continuing until the
Agreement terminates in accordance with Article 11
“ Third Party ”
means any Person not including the Parties or the Parties’
“ U.S. ” means the
United States of America, including its territories, possessions
and Puerto Rico.
Sponsorship. Palatin shall be
***. Any reference to “sponsor” in this Agreement or a
Schedule shall be ***.
Conduct of Study. Palatin
will conduct the Study in the U.S. in accordance with this
Agreement, the Study Plan, the Study Protocol and the
Investigator’s Brochure, in good scientific manner and in
compliance with all Applicable Law, including good laboratory
practices, Good Manufacturing Practices and Good Clinical
Practices, as well as any condition required by a Health Authority
or an IRB. Palatin shall accomplish its responsibilities under this
Agreement efficiently and expeditiously and, in particular, conduct
the Study within agreed time schedules.
Facilities and Key Personnel
. Palatin shall provide facilities, equipment and manpower
that are reasonably necessary to carry out the work undertaken by
Palatin under this Agreement at the Sites and such other facilities
as may be set out in the Study Plan. The clinical staff designated
by Palatin listed on Schedule 2.3 hereto (the “
Palatin Clinical Staff ”) shall be responsible for all
Study activities undertaken by Palatin and shall supervise the work
of all personnel and Third Party subcontractors engaged by Palatin
in the Study. The Palatin Clinical Staff shall serve as the primary
contact for AstraZeneca on all matters related to the Study, Study
Plan and Study Protocol.
Subcontracting . Palatin
shall, as between the Parties, be solely responsible for the
conduct of the Study and completion of the activities set forth in
the Study Plan. To the extent set forth in the Study Plan or
otherwise explicitly approved by AstraZeneca in writing, Palatin
will engage a Third Party contract research organization (“
CRO ”) or other Third Party subcontractors to carry
out a portion of Study activities. For the avoidance of doubt,
Palatin shall, when using such Third Party subcontractor, ensure
that such Third Party subcontractor complies with the provisions of
Articles 2 and 3, Sections 4.3., 4.4. and 4.5. and Article 7 (as
applicable) and, notwithstanding anything else set forth herein,
Palatin shall ***. Any permitted Third Party subcontract shall be
subject to the applicable terms and conditions of this Agreement.
Any fees or costs due to any Third Party subcontractor ***.
AstraZeneca shall reimburse Palatin for such fees or costs to ***.
Palatin shall invoice and AstraZeneca shall pay such reimbursement
as provided in Section 4.6.
3 Reports and
3.1 In addition
to providing AstraZeneca with the Study Results in accordance with
Section 8.1., Palatin shall submit written progress reports to
AstraZeneca *** during the conduct of the Study, which reports
shall include, but shall not be limited to, a summary of all work
done and Study Results achieved during the relevant
shall submit ***, as *** is specified in the Study Plan, upon
Palatin’s receipt thereof ***, it being understood that
Sections 6.4.1. and 6.4.2. do not apply to such approval by the
SMC. Notwithstanding anything else set forth herein, Palatin shall
diligently undertake to have *** Date, provided that such *** may
be extended by unanimous decision of the SMC, it being understood
that Sections 6.4.1. and 6.4.2. do not apply to such approval by
Palatin shall submit ***, it being
understood that Sections 6.4.1. and 6.4.2. do not apply to such
approval by the SMC.
Palatin shall submit the ***, it
being understood that Sections 6.4.1. and 6.4.2. do not apply to
such approval by the SMC.
Palatin shall, during the conduct of
the Study and for