LICENSE AGREEMENT by and between SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD. and PALATIN TECHNOLOGIES, INC. September 6, 2017
Exhibit 10.1
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
by and
between
SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO.
LTD.
and
PALATIN TECHNOLOGIES, INC.
September 6, 2017
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND
REPLACED WITH “[…***…]”. A COMPLETE VERSION
OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS
AMENDED.
TABLE OF CONTENTS
1
|
DEFINITIONS AND INTERPRETATION.
|
2
|
1.1.
|
Defined Terms
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2
|
1.2.
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Interpretation
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2
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2
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LICENSE GRANTS AND TECHNOLOGY TRANSFER.
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2
|
2.1.
|
License from Palatin to Fosun Within the Territory
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2
|
2.2.
|
Non-Exclusive License from Palatin to Fosun Outside the
Territory
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2
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2.3.
|
Fosun Sublicensees
|
3
|
2.4.
|
No Implied Rights
|
3
|
2.5.
|
Initial Data Transfer
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3
|
2.6.
|
Continuing Disclosure and Knowledge Transfer
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3
|
3
|
PAYMENTS BY Fosun TO PALATIN.
|
3
|
3.1.
|
Upfront Payment
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3
|
3.2.
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Development Milestone Payment
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3
|
3.3.
|
Sales Milestone Payments
|
4
|
3.4.
|
Royalty Payments
|
4
|
3.5.
|
Reports and Payments
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6
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4
|
PRODUCT DEVELOPMENT AND COMMERCIALIZATION.
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8
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4.1.
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General
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8
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4.2.
|
Diligence
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9
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4.3.
|
Regulatory Approvals
|
10
|
4.4.
|
Adverse Event Reporting
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10
|
4.5.
|
Commercialization Activities
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11
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4.6.
|
Manufacturing
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12
|
4.6.1.
|
Clinical Trial Materials.
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12
|
5
|
INTELLECTUAL PROPERTY.
|
13
|
5.1.
|
Ownership of Intellectual Property
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13
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5.2.
|
Patent Rights
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14
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5.3.
|
Enforcement and Defense of Know-How
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19
|
5.4.
|
Recording
|
19
|
i
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
6
|
CONFIDENTIALITY.
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19
|
6.1.
|
Confidentiality
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19
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6.2.
|
Authorized Disclosure
|
20
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6.3.
|
SEC Filings and Other Disclosures
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21
|
6.4.
|
Public Announcements
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21
|
7
|
REPRESENTATIONS AND WARRANTIES; COVENANTS; SECURITY
INTEREST.
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21
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7.1.
|
Mutual Representations and Warranties
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21
|
7.2.
|
Mutual Covenants
|
22
|
7.3.
|
Representations and Warranties of Palatin
|
23
|
7.4.
|
Disclaimer
|
23
|
8
|
GOVERNMENT APPROVALS; REMEDY; TERM AND TERMINATION.
|
25
|
8.1.
|
Other Government Approvals
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25
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8.2.
|
Term
|
25
|
8.3.
|
Termination by Palatin
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25
|
8.4.
|
Termination by Fosun
|
25
|
8.5.
|
Effects of Termination
|
25
|
9
|
LIMITATION ON LIABILITY, INDEMNIFICATION AND
INSURANCE.
|
27
|
9.1.
|
No Consequential Damages
|
27
|
9.2.
|
Indemnification by Fosun
|
27
|
9.3.
|
Indemnification by Palatin
|
28
|
9.4.
|
Procedure
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28
|
9.5.
|
Insurance
|
30
|
10
|
MISCELLANEOUS.
|
30
|
10.1.
|
Assignment
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30
|
10.2.
|
Further Actions
|
30
|
10.3.
|
Force Majeure
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30
|
10.4.
|
Notices
|
31
|
10.5.
|
Amendment
|
32
|
10.6.
|
Waiver
|
32
|
10.7.
|
Severability
|
32
|
10.8.
|
Descriptive Headings
|
32
|
10.9.
|
Dispute Resolution
|
32
|
10.10.
|
Governing Law
|
33
|
10.11.
|
Entire Agreement
|
33
|
10.12.
|
Representation by Legal Counsel
|
33
|
10.13.
|
Independent Contractors
|
33
|
10.14.
|
Counterparts
|
33
|
10.15.
|
No Third Party Rights or Obligations
|
33
|
ii
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
EXHIBITS
Exhibit
A
Defined Terms
Exhibit
B
Palatin Patent Rights Existing as of the Effective
Date
Exhibit
C
Compounds Existing as of the Effective Date
Exhibit
D
Section 7.3.5. Representation
i
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
This
License Agreement (the “Agreement”) is entered into as
of September 6, 2017 (the “Effective Date”), by and
between Shanghai Fosun Pharmaceutical Industrial Development Co.
Ltd., a limited liability company organized and existing under the
laws of the People’s Republic of China and having a
registered principal place of business at No. 0000 Xxxxxx Xxxx
(Building A, Fosun Technology Park), Shanghai City, 200233, the
People’s Republic of China (“Fosun”) and Palatin
Technologies, Inc., a corporation organized and existing under the
laws of Delaware and having a principal place of business at 4-B
Cedar Brook Drive, Cedar Brook Corporate Center, Xxxxxxxx, XX 00000
(“Palatin”). Fosun and Palatin may each be referred to
herein individually as a “Party” and collectively as
the “Parties.”
WHEREAS, Palatin
owns or otherwise controls certain patents, patent applications,
technology, know-how, scientific and technical information and
other proprietary rights and information relating to the
identification, research and development of Compounds,
Pharmaceutical Products, Product Delivery Devices and
Products (each, as
defined below);
WHEREAS, Fosun has
experience and expertise in the development and commercialization
of pharmaceutical products, and desires to acquire an exclusive
license in the Territory (as defined below) under Palatin’s
patents, patent applications, technology, know-how, scientific and
technical information and other proprietary rights and information
relating to Compounds; and
WHEREAS, subject to
the terms of this Agreement, Palatin wishes to grant to Fosun, and
Fosun wishes to receive from Palatin, an exclusive license in the
Territory to commercialize Compounds and Products (as defined
below).
NOW
THEREFORE, in consideration of the mutual promises and covenants
set forth below and other good and valuable consideration, the
receipt and sufficiency of which is hereby acknowledged, the
Parties hereby agree as follows:
1
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
1.1. Defined
Terms. Capitalized terms not otherwise defined herein shall
have the meanings set forth in Exhibit A.
1.2. Interpretation.
Except where the context expressly requires otherwise, (a) the
use of any gender herein shall be deemed to encompass references to
either or both genders, and the use of the singular shall be deemed
to include the plural (and vice versa), (b) the words
“include”, “includes” and
“including” shall be deemed to be followed by the
phrase “without limitation”, (c) the word
“will” shall be construed to have the same meaning and
effect as the word “shall”, (d) any definition of
or reference to any agreement, instrument or other document herein
shall be construed as referring to such agreement, instrument or
other document as from time to time amended, supplemented or
otherwise modified (subject to any restrictions on such amendments,
supplements or modifications set forth herein), (e) any reference
herein to any Person shall be construed to include the
Person’s successors and assigns, (f) the words
“herein”, “hereof” and
“hereunder”, and words of similar import, shall be
construed to refer to this Agreement in its entirety and not to any
particular provision hereof, (g) all references herein to Sections,
Exhibits or Schedules shall be construed to refer to Sections,
Exhibits or Schedules of this Agreement, and references to this
Agreement include all Exhibits and Schedules hereto, (h) the word
“notice” means notice in writing (whether or not
specifically stated) and shall include notices, consents, approvals
and other written communications contemplated under this Agreement,
(i) provisions that require that a Party or the Parties
“agree,” “consent” or “approve”
or the like shall require that such agreement, consent or approval
be specific and in writing, whether by written agreement, letter,
approved minutes or otherwise (but excluding e-mail and instant
messaging), (j) references to any specific law, rule or regulation,
or article, section or other division thereof, shall be deemed to
include the then-current amendments thereto or any replacement or
successor law, rule or regulation thereof, and (k) the term
“or” shall be interpreted in the inclusive sense
commonly associated with the term
“and/or.”
2.1. License
from Palatin to Fosun Within the Territory. As of the
Effective Date, Palatin hereby grants to Fosun (a) an exclusive
license (exclusive even as to Palatin) under the Palatin
Technology, to Commercialize and have Commercialized (but not to
use, have used, Develop, have Developed, Manufacture and have
Manufactured) Compounds, Products, Pharmaceutical Products and
Product Delivery Devices, and otherwise practice and exploit the
Palatin Technology, and (b) a non-exclusive license under the
Palatin Technology, to use, have used, Develop, have Developed,
Manufacture and have Manufactured Compounds, Products,
Pharmaceutical Products and Product Delivery Devices, in each case
(a) and (b), in the Field and in the Territory.
2.2. Non-Exclusive
License from Palatin to Fosun Outside the Territory. As of
the Effective Date, Palatin hereby grants to Fosun (a) a
non-exclusive license under the Palatin Technology, to Manufacture
and have Manufactured (but not to Commercialize or have
Commercialized) Compounds, Products, Pharmaceutical Products and
Product Delivery Devices, in the Field in all countries of North
America, and (b) a non-exclusive license under the Palatin
Technology, to Develop, have Developed, Manufacture and have
Manufactured (but not to Commercialize or have Commercialized)
Compounds, Products, Pharmaceutical Products and Product Delivery
Devices, and otherwise practice and exploit the Palatin Technology,
in the Field in all countries of the world outside the Territory,
other than the countries of North America (which are governed
solely by Section 2.2(a)), in each case, solely for purposes of
Developing and Manufacturing Compounds, Products, Pharmaceutical
Products and Product Delivery Devices for Commercialization in the
Territory.
2
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
2.3. Fosun
Sublicensees. Fosun shall have the right to grant
sublicenses, directly or indirectly, to its Affiliates and Third
Parties of any and all rights granted to Fosun under this Agreement
by Palatin, including any and all rights licensed to Fosun pursuant
to Section 2.1 or Section 2.2. Each sublicense agreement shall be
in writing and provide that the applicable Sublicensee is bound by
all applicable terms and conditions of this Agreement, including
with respect to record keeping obligations and audit rights. Fosun
shall remain responsible for the payment to Palatin of all
Milestone Payments and royalties payable with respect to Net Sales
of Products made by such Sublicensees. Fosun shall be responsible
for the acts and omissions of its Sublicensees. Fosun shall deliver
to Palatin a true, accurate and complete copy of each sublicense
agreement entered into by Fosun, and any modification or
termination thereof, within […***…] after the
applicable execution, modification or termination of the sublicense
agreement.
2.4. No
Implied Rights. Except as expressly provided in this
Agreement, neither Party shall be deemed to have granted the other
Party (by implication, estoppel or otherwise) any right, title,
license or other interest in or with respect to any intellectual
property, Know-How or information Controlled by such
Party.
2.5. Initial
Data Transfer. Within a reasonable time not to exceed
[…***…] following the Initial Payment Date (as
hereafter defined), Palatin shall disclose to Fosun all Palatin
Know-How necessary or useful in connection with securing Regulatory
Approval and Commercializing Products in the Territory, together
with such additional Palatin Know-How as Fosun may reasonably
request, in each case to the extent developed by and Controlled by
Palatin on or prior to the Effective Date, in either the format in
which such Palatin Know-How then exists or in such other format as
Fosun may reasonably request (including by download of digital
files to a secure website or e-room designated by
Fosun).
2.6. Continuing
Disclosure and Knowledge Transfer. On a Calendar Quarter
basis, or more frequently at the reasonable request of Fosun during
the Term, Palatin shall disclose to Fosun any Palatin Know-How
developed or acquired by Palatin since Palatin’s most recent
disclosure, but only to the extent the same is Controlled by
Palatin. Such disclosure shall be in either the format in which
such Palatin Know-How then exists or in such other format as Fosun
may reasonably request (including by download of digital files to a
secure website or e-room designated by Fosun). Further, Palatin
shall make appropriate personnel available to Fosun at reasonable
times and upon reasonable prior notice for the purpose of assisting
Fosun to understand and use the Palatin Technology in connection
with Fosun’s Development, Manufacture, Commercialization and
use of Compounds and Products.
2.7. Palatin
Retained Rights. Notwithstanding the rights granted to Fosun
in Section 2.1 and Section 2.2, and without limiting the generality
of Section 2.4, the Parties acknowledge that Palatin retains the
right to practice the Palatin Technology in the Territory to
fulfill its obligations under this Agreement.
3.1. Upfront
Payment. Fosun shall pay to Palatin a one-time payment of
five million dollars ($5,000,000 USD), which shall be paid within
[…***…] following the Effective Date (with the date of
receipt by Palatin being the “Initial Payment
Date”).
3.2. Development
Milestone Payment. Fosun shall pay Palatin the amount set
forth below within […***…] following the first
occurrence of the event described below for the first
Product to achieve such
event (the “Development Milestone
Payment”).
Development Event
|
Development Milestone Payment
|
Regulatory
Approval in China by CFDA with respect to the Initial Indication,
provided that a clinical and commercial supply agreement has been
entered into between Palatin and AMAG and a supply agreement has
been entered into between Palatin and Fosun, or, as the case may
be, a supply agreement has been entered into among Palatin, AMAG
and Fosun as described in Section 4.6.4.
|
$7,500,000
USD
|
The
Development Milestone Payment set forth above shall be payable one
time only (regardless of the number of Products with respect to
which, or the number of times with respect to any Product, the
specified Development Event occurs).
3
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
3.3. Sales
Milestone Payments. Fosun shall pay Palatin the following
one-time payments (each, a “Sales Milestone Payment”)
when aggregate Net Sales of all Products in a Calendar Year in the
Territory (the “Total Annual Net Sales”) first reach
the respective thresholds indicated below:
Total Annual Net Sales
|
Sales Milestone Payment
|
Total
Annual Net Sales reaching […***…]
|
[…***…]
|
Total
Annual Net Sales reaching […***…]
|
[…***…]
|
Total
Annual Net Sales reaching […***…]
|
[…***…]
|
Total
Annual Net Sales reaching […***…]
|
[…***…]
|
Total
Annual Net Sales reaching […***…]
|
[…***…]
|
Fosun
shall make any Sales Milestone Payment payable with respect to a
Calendar Year within […***…] after the end of the
applicable Calendar Year. For the avoidance of doubt, each of the
Sales Milestone Payments set forth above shall be payable one time
only, regardless of the number of times the corresponding Total
Annual Net Sales levels are achieved. The maximum aggregate amount
payable by Fosun in respect of the Development Milestone Payment
and Sales Milestone Payments (but excluding the upfront payment)
shall be one hundred million dollars ($100,000,000
USD).
3.4.1.
Royalties. Subject to the
provisions of Section 3.4.3, Fosun shall pay Palatin royalties in
the amount of the Marginal Royalty Rates (set forth below) of the
aggregate Net Sales resulting from the sale of Products, on a
Product-by-Product basis, in the Territory during each Calendar
Year of the applicable Royalty Term for each Product (each, the
“Per Product Annual Net Sales”):
Per Product Annual Net Sales
|
Marginal Royalty Rate
(% of Per Product Annual Net Sales)
|
Per
Product Annual Net Sales above $0, up to and including
[…***…]
|
[…***…]
|
Per
Product Annual Net Sales above […***…]
|
[…***…]
|
Per
Product Annual Net Sales […***…]
|
[…***…]
|
Each
Marginal Royalty Rate set forth in the table above shall apply only
to that portion of the Net Sales of a given Product in the
Territory during a given Calendar Year that falls within the
indicated range.
For
illustration purposes only, if Net Sales resulting from the sale of
a Product in the Territory during a Calendar Year
[…***…]
3.4.2.
Fully Paid-Up, Royalty Free
License. Following expiration of the Royalty Term for any
Product in a given Jurisdiction in the Territory, no further
royalties shall be payable in respect of sales of such Product in
such Jurisdiction and,
thereafter the license granted to Fosun under Sections 2.1 and 2.2
with respect to such Product in such Jurisdiction shall
automatically become fully paid-up, perpetual, irrevocable and
royalty-free.
4
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
3.4.3. Royalty
Adjustments. The following adjustments shall be made, on a
Product-by-Product and Jurisdiction-by-Jurisdiction basis, to the
royalties payable pursuant to Section 3.4.1, in each case, subject
to the limitations set forth in Section 3.4.4:
(a) Third
Party Patents. If it is necessary for Fosun to license one
or more Patent Rights from one or more Third Parties in order to
Develop, Manufacture, Commercialize or use any Product, whether
directly or through any Fosun Affiliate or Sublicensee, then Fosun
may, in its sole discretion, negotiate and obtain a license under
such Patent Right(s) (each such Third Party license referred to
herein as an “Additional Third Party License”). Any
royalty otherwise payable to Palatin under this Agreement with
respect to Net Sales of any Product by Fosun, its Affiliates or
Sublicensees shall be reduced by […***…] of the amounts
payable to Third Parties pursuant to any Additional Third Party
Licenses, such reduction to continue until all such amounts have
been expended, provided
that in no event shall the total royalty payable to Palatin
for any Product be less than […***…] of the royalty
amounts otherwise payable for such Product.
(b) No
Adjustment for Palatin Third Party Agreements. As between
Palatin and Fosun, Palatin shall be solely responsible for (i) all
obligations (including any royalty or other obligations that relate
to the Palatin Technology) under its agreements with Third Parties
that are in effect as of the Effective Date or that Palatin enters
into during the Term and (ii) all payments to inventors (other than
inventors that are Representatives of Fosun) of Palatin Technology,
including payments under inventorship compensation
Laws.
(c) Generic
Entry. As used in this Section 3.4(c), “Generic
Competition” means, with respect to a given Product in a
given Jurisdiction in the Territory, that (a) one or more Generic
Products to such Product are available in such Jurisdiction and (b)
[…***…]. Notwithstanding any provision of this
Agreement to the contrary, upon the occurrence of Generic
Competition with respect to a Product in a given Jurisdiction in
the Territory, any royalty payments owed with respect to such
Product in such Jurisdiction pursuant to this Section 3.4 shall be
reduced by […***…].
3.4.4. Limitations
on Adjustments. Notwithstanding anything herein to the
contrary, in no event shall the royalties payable to Palatin for
any Product under this Agreement be less than an amount equal to
[…***…].
5
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
3.5.
Reports and
Payments.
3.5.1. Cumulative
Royalties. The obligation to pay royalties under this
Agreement shall be imposed only once with respect to any sale of
any given unit of a Product.
3.5.2.
Royalty Statements and
Payments. Within […***…] of the end of each
Calendar Quarter, Fosun shall deliver to Palatin a report setting
forth the following information for such Calendar Quarter, on a
Product-by-Product, Jurisdiction-by-Jurisdiction and Territory-wide
basis: (a) gross sales of each Product, (b) Net Sales of each
Product, (c) deductions taken from gross sales (by category as
set forth in the definition of Net Sales) to arrive at the Net
Sales calculation, (d) the basis for any adjustments to the royalty
payable for the sale of any such Product and (e) the royalty due
hereunder for the sale of each such Product. No such reports shall
be due for any such Product (i) before the First Commercial Sale of
such Product or (ii) after the Royalty Term for such Product has
expired in all Jurisdictions in the Territory. The total royalty
due for the sale of all such Products during such Calendar Quarter
shall be remitted within […***…] following the delivery
of such report and confirmation by Palatin as to the amount of
royalty due.
3.5.3. Taxes
and Withholding. To the extent any payments made by Fosun
pursuant to this Agreement become subject to withholding taxes
under the Laws or regulations of any jurisdiction or Governmental
Authority, Fosun shall deduct and withhold the amount of such taxes
for the account of Palatin to the extent required by applicable
Laws or regulations; such amounts payable to Palatin shall be
reduced by the amount of taxes deducted and withheld; and Fosun
shall pay the amounts of such taxes to the proper Governmental
Authority in a timely manner and transmit to Palatin an official
tax certificate or other evidence of such tax obligations together
with proof of payment from the relevant Governmental Authority of
all amounts deducted and withheld sufficient to enable Palatin to
claim such payment of taxes. Any such withholding taxes required
under applicable Laws or regulations to be paid or withheld shall
be an expense of, and borne solely by, Palatin. Except as provided
in this Section 3.5.3, all taxes or duties in connection with
payments made by Fosun, including any value added or similar tax or
local tax or surcharge on value added taxes and any import duty or
fees, shall be borne by Fosun.
3.5.4. Currency.
All amounts payable and calculations under this Agreement shall be
in United States dollars. As applicable, Net Sales and any
adjustments to payments under this Agreement shall be translated
into United States dollars at the exchange rate used by Fosun for
public financial accounting purposes. If, due to restrictions or
prohibitions imposed by national or international authority, a
given payment cannot be made as provided in this Section 3, Fosun
shall promptly notify Palatin and the Parties shall consult with a
view to finding a prompt and acceptable solution. If the Parties
are unable to identify a mutually acceptable solution regarding
such payment, then Fosun may elect, in its sole discretion and upon
60 days’ advance written notice to Palatin, to deposit such
payment in local currency in the relevant jurisdiction to the
credit of Palatin in a recognized banking institution designated by
Palatin or, if none is designated by Palatin, within such 60 day
period, in a recognized banking institution selected by Fosun and
identified in a written notice given to Palatin.
6
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
3.5.5. Method
of Payment. Except as permitted pursuant to Section 3.5.4,
each payment hereunder shall be made by electronic transfer in
immediately available funds via either a bank wire transfer, an ACH
(automated clearing house) mechanism, or any other means of
electronic funds transfer, at Fosun’s election, to such bank
account as Palatin shall designate in writing to Fosun at least
[…***…] before the payment is due.
3.5.6.
Record Keeping. Fosun shall
keep and shall cause its Affiliates and Sublicensees to keep books
and accounts of record in connection with the sale of Products in
sufficient detail to permit accurate determination of all figures
necessary for verification of royalties and Sales Milestone
Payments to be paid
hereunder. Fosun and its Affiliates shall maintain such records for
a period of at least […***…] after the end of the
Calendar Quarter in which they were generated.
3.5.7. Audits.
Upon
[…***…] prior notice from Palatin, Fosun shall permit
an independent certified public accounting firm of nationally
recognized standing selected by Palatin and Fosun, to examine, at
Palatin’s sole expense, the relevant books and records of
Fosun and its Affiliates as may be reasonably necessary to verify
the amounts reported by Fosun in accordance with Section 3.5.2 and
the payment of royalties and Sales Milestone Payments hereunder. An examination by
Palatin under this Section 3.5.7 shall occur not more than once in
any Calendar Year and shall be limited to the pertinent books and
records for any Calendar Year ending not more than
[…***…] before the date of the request. The accounting
firm shall be provided access to such books and records at
Fosun’s or its Affiliates’ or any Sublicensee’s
facility(ies) where such books and records are normally kept and
such examination shall be conducted during Fosun’s normal
business hours. Fosun may require the accounting firm to sign a
reasonably acceptable non-disclosure agreement before providing the
accounting firm with access to Fosun’s or its
Affiliates’ facilities or records. Upon completion of the
audit, the accounting firm shall provide both Fosun and Palatin a
written report disclosing any discrepancies in the reports
submitted by Fosun or the royalties or Sales Milestone
Payments paid by Fosun,
and, in each case, the specific details concerning any
discrepancies. Upon […***…] from Fosun, Palatin shall
permit an independent certified public accounting firm of
nationally recognized standing selected by Fosun and Palatin, to
examine, at Fosun’s sole expense, the relevant books and
records of Palatin and its Affiliates as may be reasonably
necessary to verify the amounts reported by Palatin related to COGS
and price of Product supplied by Palatin in accordance with Section
4.6.4. The accounting firm shall be provided access to such books
and records at Palatin’s or its Affiliates’
facility(ies) where such books and records are normally kept and
such examination shall be conducted during Palatin’s normal
business hours. Palatin may require the accounting firm to sign a
reasonably acceptable non-disclosure agreement before providing the
accounting firm with access to Palatin’s or its
Affiliates’ facilities or records. Upon completion of the
audit, the accounting firm shall provide both Fosun and Palatin a
written report disclosing any discrepancies in the reports
submitted by Palatin on the COGS and price of Product supplied by
Palatin in accordance with Section 4.6.4, and the specific details
concerning any discrepancies.
7
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
3.5.8. Underpayments/Overpayments.
If any audit conducted pursuant to Section 3.5.7 concludes that
additional royalties or Sales Milestone Payments were due to Palatin, then Fosun
will pay to Palatin the additional royalties or Sales Milestone
Payments, plus interest on the deficient amount, as calculated
pursuant to Section 3.5.9, within […***…] of the date
Fosun receives such accountant’s written report.
[…***…]. If any audit conducted pursuant to Section
3.5.7 concludes that the price actually paid by Fosun with respect
to Product supplied by Palatin in accordance with Section 4.6.4
exceeded the amount Fosun should pay to Palatin, then Fosun shall
have the right to deduct the gap from the next royalty or goods
payment to Palatin. […***…].
3.5.9. Late
Payments. Any payments due under this Agreement shall be due
on such date as specified in this Agreement and, in the event such
date is not a Business Day, then the next succeeding Business Day.
In the event that any payment due under this Agreement is not made
when due, except any delay caused by Force Majeure as provided in
Section 10.3 (including, for the avoidance of doubt, any
unanticipated and unusual examination by the Government Authority
controlling foreign currency in the Territory), the amount due
shall accrue interest beginning on the […***…]
following the date on which such payment was due, calculated at the
[…***…] for the due date, calculated from the due date
until paid in full. Each payment made after the due date shall be
accompanied by all interest so accrued. Notwithstanding the
foregoing, a Party shall have recourse to any other remedy
available at law or in equity with respect to any delinquent
payment, subject to the terms of this Agreement.
3.5.10.
Confidentiality.
Notwithstanding any provision of this Agreement to the contrary,
all reports and financial information of the Parties, their
Affiliates or their Sublicensees which are provided to or subject
to review by the other Party under this Section 3 shall be deemed
to be the Confidential Information of the reporting or audited
Party, as applicable, and subject to the provisions of Section
6.
4.
PRODUCT DEVELOPMENT AND
COMMERCIALIZATION.
4.1. General.
Fosun shall have sole authority over and control of the Regulatory
Approval and Commercialization of Compounds, Products,
Pharmaceutical Products and Product Delivery Devices for
Commercialization in the Territory. Palatin shall cooperate, and
take Commercially Reasonable Efforts to secure the United States
Certificate of Pharmaceutical Product holder (the “U.S. CPP
Holder”) to cooperate, with Fosun such that the application
for Regulatory Approval shall be filed in the U.S. CPP
Holder’s name as required by the Regulatory Authority in the
Territory.
8
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
4.2.1.
Regulatory Approval. Fosun
will use Commercially Reasonable Efforts to file an NDA for a
Product for the Initial Indication in the Territory and secure
Regulatory Approval of such NDA in the Territory.
(a) Without
limiting the foregoing, the Clinical Trial application submission
to the relevant Regulatory Authority for the Initial Indication
shall occur […***…].
(b) The
Clinical Trial(s) shall be initiated
[…***…].
(c) Without
limiting the foregoing, Fosun shall file an NDA,
[…***…].
4.2.2.
Commercial Diligence. Once
the NDA described in Section 4.2.1 has received Regulatory Approval
in China with respect to the Initial Indication, Fosun will use
Commercially Reasonable Efforts to Commercialize the Product
covered by such NDA in China with respect to the Initial
Indication. The First Commercial Sale in China shall be
[…***…] following Regulatory Approval in China and
[…***…].
4.2.3.
Exceptions to Diligence
Obligations. Notwithstanding any provision of this Agreement
to the contrary, Fosun will be relieved of all Fosun Diligence
Obligations to the extent that:
(a) Fosun
or Palatin receives or generates any safety, tolerability or other
data indicating or signaling that a Product has or would have an
unacceptable risk-benefit profile or is otherwise not suitable for
initiation or continuation of Clinical Trials; or
(b) Fosun
or Palatin receive any notice, information or correspondence from
an applicable Regulatory Authority, or an applicable Regulatory
Authority takes any action, that indicates that a Product is
unlikely to receive Regulatory Approval in the Territory with
respect to the Initial Indication.
4.2.4.
Assertion of Fosun Diligence
Obligation Claims. If Palatin is, becomes or reasonably
should be aware of facts that might form a reasonable basis to
allege that Fosun has failed to meet any of its obligations under
Section 4.2.1 or Section 4.2.2, then Palatin will promptly notify
Fosun in writing of such potential alleged performance failure
(each such potential alleged performance failure, a
“Diligence Issue”). Promptly upon Fosun’s
receipt of any notice of a Diligence Issue pursuant to this Section
4.2.4, Fosun will contact Palatin to discuss the specific nature of
such Diligence Issue and seek to identify an appropriate corrective
course of action. If,
[…***…], (a) the Parties have not reached consensus
regarding whether Fosun has failed to satisfy its obligations
pursuant to Section 4.2.1 or Section 4.2.2 and (b) the Parties have
not agreed upon an appropriate corrective course of action for such
Diligence Issue, then such Diligence Issue will be escalated and
resolved pursuant to the dispute resolution provisions set forth in
Section 10.9.
4.2.5.
Remedies for Breach of Fosun
Diligence Obligations. If Fosun materially breaches any
Fosun Diligence Obligation and fails to remedy such breach
[…***…] of such breach from Palatin, then Palatin may,
in its sole discretion, elect to either (a) terminate this
Agreement pursuant to the provisions of Section 8.5.1(a) on a
Product-by-Product and Jurisdiction-by-Jurisdiction basis, but only
to the extent that a Product in a given Jurisdiction in the
Territory is directly and adversely impacted by such uncured
material breach or (b) convert any exclusive license granted to
Fosun under this Agreement with respect to a Product in a given
Jurisdiction in the Territory into non-exclusive license, but only
to the extent that such Product in such Jurisdiction is directly
and adversely impacted by such uncured material
breach.
9
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
4.2.6.
No Other Covenants. Except
as expressly set forth in Section 4.2, Fosun makes no
representation, warranty or covenant, either express or implied,
that (A) it will successfully Commercialize or continue to
Commercialize any Product in any Jurisdiction, (B) if
Commercialized, that any Product will achieve any particular sales
level, whether in any individual Jurisdiction or cumulatively
throughout the Territory.
4.3. Regulatory
Approvals. Fosun or its designated Affiliate(s) or
Sublicensee(s) shall have the sole authority, at their sole
expense, to file applications for Regulatory Approval of Products,
Pharmaceutical Products and Product Delivery Devices in the Field
in the Territory, including communicating with any Regulatory
Authority both prior to and following Regulatory Approval. As
between the Parties, Fosun shall be the sole and exclusive owner of
all such Regulatory Approval applications (including NDAs) and all
regulatory correspondence and filings with respect to such
Regulatory Approval applications and Regulatory Approvals granted
thereon. Fosun shall consult and reasonably cooperate with Palatin
and its other licensees (including, without limitation, AMAG) with
respect to all applications for Regulatory Approval of any
Products, Pharmaceutical Products or Product Delivery Devices in
the Territory, including allowing Palatin and such licensees a
reasonable opportunity and reasonable time to review and comment
regarding relevant communications with applicable Regulatory
Authorities in the Territory.
4.4. Adverse
Event Reporting; Pharmacovigilance Agreement. Fosun
acknowledges that Palatin has agreed with AMAG Pharmaceuticals,
Inc., (“AMAG”) Palatin’s exclusive licensee for
North America, that AMAG shall be solely responsible for
maintaining the global safety database for Products. Fosun agrees
to negotiate in good faith and enter into such pharmacovigilance
agreements as are reasonably necessary in further of AMAG
maintaining the global safety database for Products.
[…***…]. As between the Parties: (a) Fosun shall
be responsible for the pharmacovigilance surveillance and timely
reporting of all relevant adverse drug reactions/experiences,
Product quality, Product complaints and Safety Data relating to any
Compound, Product, Pharmaceutical Product or Product Delivery
Device to the appropriate Regulatory Authorities in the Territory;
and (b) AMAG and Palatin shall be responsible for the
pharmacovigilance surveillance and timely reporting of all relevant
adverse drug reactions/experiences, Product quality, Product
complaints and Safety Data relating to any Compound, Product,
Pharmaceutical Product or Product Delivery Device to the
appropriate Regulatory Authorities outside the Territory, in each
case in accordance with applicable Laws. The Parties shall
cooperate with each other and with AMAG with respect to their
respective pharmacovigilance responsibilities, and each Party shall
be solely responsible for costs relating to its respective
pharmacovigilance responsibilities, except to the extent agreed
otherwise by the Parties in writing. […***…], Fosun and
AMAG (or, at Palatin’s option, Fosun, Palatin and AMAG) shall
enter into a pharmacovigilance agreement, pursuant to which AMAG
will maintain the global safety database for Products, on terms
that comply with ICH guidelines, including: (i) providing
detailed procedures regarding the maintenance of core safety
information and the exchange of Safety Data relating to all
Compounds, Products, Pharmaceutical Products and Product Delivery
Devices worldwide within appropriate timeframes and in an
appropriate format to enable each Party, as applicable, and AMAG to
meet both expedited and periodic regulatory reporting requirements;
and (ii) ensuring compliance with the reporting requirements
of all applicable Regulatory Authorities on a worldwide basis for
the reporting of Safety Data in accordance with standards
stipulated in the ICH guidelines, and all applicable regulatory and
legal requirements regarding the management of Safety
Data.
10
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
4.5. Commercialization
Activities.
4.5.1.
General. Fosun shall have
sole and exclusive control, at its sole expense, over all matters
relating to the Commercialization of Compounds, Products,
Pharmaceutical Products and Product Delivery Devices in the Field
in the Territory, including sole and exclusive control over (a)
pricing of Products and (b) the negotiation of Product pricing with
Regulatory Authorities and other Third Parties.
4.5.2.
Branding. Fosun and its
designated Affiliates or Sublicensees shall have the right to brand
all Products in the Territory using any one or more Trademarks
which may vary by Jurisdiction or within a Jurisdiction in the
Territory. Fosun or its designated Affiliates or Sublicensees shall
own all rights, title and interests in and to such Trademarks and
Fosun or such Affiliates or Sublicensees may file, seek
registration of and maintain such Trademarks in the countries and
regions they determine reasonably necessary. In the event that
Fosun intends to register any Trademarks in the name of Palatin in
a Jurisdiction in the Territory, Palatin shall reasonably cooperate
to provide assistance, execute and deliver to Fosun any documents
required for the registration of the Trademarks. Palatin also
agrees to grant an exclusive license (exclusive even as to Palatin)
to Fosun of any Trademarks which are applied for by Fosun in
Palatin’s name in the Territory without additional
consideration until this Agreement is terminated.
4.5.3.
Ex-Territory Sales. Subject
to applicable Law, Palatin, its Affiliates and its licensees shall
not engage in any advertising or promotional activities relating to
any Product directed primarily to customers or other buyers or
users of any Product located in the Territory, or accept orders for
Compounds, Products, Pharmaceutical Products or Product Delivery
Devices from or sell Compounds, Products, Pharmaceutical Products
or Product Delivery Devices into the Territory, and if Palatin, its
Affiliates or its licensees receive any such order it shall refer
such order to Fosun.
11
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
4.5.4.
Export Monitoring.
(a) Fosun
shall not, and shall use reasonable efforts to not permit its
Affiliates and its Sublicensees to, export Compounds, Products,
Pharmaceutical Products or Product Delivery Devices from in the
Territory for Commercialization outside the Territory, provided
that, Fosun may export Compounds, Products, Pharmaceutical Products
or Product Delivery Devices to Palatin or its designated parties.
Fosun shall promptly inform Palatin of any such exports of
Compounds, Products, Pharmaceutical Products or Product Delivery
Devices and the actions taken to prevent such exports. Fosun will
take all reasonable actions requested in writing by Palatin that
are consistent with applicable Law to prevent Third Party exports
of Compounds, Products, Pharmaceutical Products or Product Delivery
Devices from in the Territory for Commercialization outside the
Territory.
(b) Palatin
shall not, and shall use reasonable efforts to not permit its
Affiliates and its licensees to, export Compounds, Products,
Pharmaceutical Products or Product Delivery Devices from outside
the Territory for Commercialization in the Territory, and shall
promptly inform Fosun of any such exports of Compounds, Products,
Pharmaceutical Products or Product Delivery Devices and the actions
taken to prevent such exports. Palatin will take all reasonable
actions requested in writing by Fosun that are consistent with
applicable Law to prevent Third Party exports of Compounds,
Products, Pharmaceutical Products or Product Delivery Devices from
outside the Territory for Commercialization in the
Territory.
4.6. Manufacturing.
4.6.1.
Clinical Trial Materials.
Palatin will supply to Fosun up to […***…] following
the scheduled manufacture of the same, for Development of the
Product by Fosun in the Territory. The units of bremelanotide will
be provided as part of a scheduled production run, which run is
currently planned for […***…]. Fosun shall pay the
[…***…].
4.6.2.
Manufacturing Technology
Transfer. Without limiting Palatin’s obligations under
Section 2.5, within […***…] following the Initial
Payment Date, Palatin shall disclose to Fosun all Know-How and
physical embodiments thereof then Controlled by Palatin or its
Affiliates that are necessary or useful to enable Fosun to
Manufacture Compounds, Products, Pharmaceutical Products and
Product Delivery Devices for clinical or commercial use in
accordance with all applicable product specifications, requirement
of applicable regulatory filings, and current Good Manufacturing
Practices and equivalent Laws outside the United States
(“cGMP”) (such Know-How collectively referred to herein
as “Manufacturing Know-How”). For the avoidance of
doubt, and without limitation, Manufacturing Know-How shall include
copies or samples, as applicable, of all relevant documentation,
regulatory filings, specifications, processes, materials and other
embodiments of such Know-How, all to the extent that such
documentation and materials are within the Control of Palatin.
Thereafter, throughout the Term and at Fosun’s request,
Palatin will make available to Fosun Palatin’s qualified
technical personnel to assist Fosun in understanding and applying
the Manufacturing Know-How to enable Fosun to Manufacture
Compounds, Products, Pharmaceutical Products and Product Delivery
Devices for clinical or commercial use (including qualification of
facilities used to Manufacture Compounds, Products, Pharmaceutical
Products or Product Delivery Devices).
12
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
4.6.3.
General. Fosun shall have
the non-exclusive right in the Territory, and the non-exclusive
right outside the Territory (subject to the limitations in Section
2.1), to Manufacture Compounds, Products, Pharmaceutical Products
and Product Delivery Devices itself or through one or more
Affiliates or Third Parties selected by Fosun in its sole
discretion solely for use in the Territory. Fosun shall not use for
any Clinical Trial or Commercialize any Compounds, Products,
Pharmaceutical Products and Product Delivery Devices until and
unless (a) […***…], and (b)(i) […***…]
and (ii) […***…]. Palatin shall have the right to
[…***…] However, in the event that […***…],
Palatin shall not […***…]. No inspection or
authorization by Palatin pursuant to this Section 4.6.3 shall
relieve Fosun of its obligations under this Agreement, including,
without limitation, Fosun’s indemnification obligations
pursuant to Section 9.2.
4.6.4.
Supply to Fosun. Upon the
request of Fosun, […***…] will negotiate in good faith
the terms of a supply agreement, pursuant to which
[…***…]. Fosun will pay costs and expenses incurred by
[…***…] relating to packaging, shipping costs or fees,
customs or duty expenses and any taxes, including excise and value
added taxes. For the avoidance of doubt, in the event that any
costs and expenses are already included in […***…], any
such costs and expenses shall not be separately payable by Fosun
pursuant to the preceding sentence. The Parties recognize that
there is […***…].
4.6.5.
Second Source Supply
[…***…]. Upon Palatin’s request and following the
transfer of Manufacturing Know-How, the Parties will
[…***…]. […***…] is conditioned upon
negotiation of terms and conditions that are mutually acceptable to
[…***…].
5.1. Ownership
of Intellectual Property.
5.1.1.
Ownership of Inventions.
Subject to the grant of licenses to Fosun under Section 2 and the
Parties’ other rights and obligations under this Agreement,
each Party shall own all rights, title and interests in and to: (a)
any and all Know-How, Compounds and Products (i) owned by such
Party prior to the Effective Date or (ii) made solely by or on
behalf of such Party or its Representatives in connection with
their activities under this Agreement and (b) any and all Patent
Rights claiming any such Know-How, Compounds or Products described
in clause (a) of this Section 5.1.1. Jointly made inventions, with
inventorship determined in accordance with United States or Chinese
patent laws, shall be jointly owned.
13
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
5.1.2.
Improvements in Know-How, Compounds
and Products After Effective Date. Any improvements made by
Palatin in Know-How, Compounds and Products made after the
Effective Date by a Party shall be and hereby is subject to the
licenses granted to Fosun pursuant to Sections 2.1 and 2.2, without
any additional consideration, for the term of this Agreement, with
the right to grant sublicenses, directly or indirectly. Any
improvements made by Fosun in Know-How, Compounds and Products made
after the Effective Date shall be solely owned by
Fosun.
5.2. Patent
Rights.
5.2.1.
Filing, Prosecution and Maintenance
of Palatin Patent Rights. Palatin shall be responsible, at
its sole cost and expense, for preparing, filing, prosecuting and
maintaining (including conducting any interferences,
re-examinations, reissues and oppositions) the Palatin Patent
Rights in the Territory, by itself or with Third Parties. Palatin
shall consult and reasonably cooperate with Fosun with respect to
the preparation, filing, prosecution and maintenance of the Palatin
Patent Rights, including: (i) allowing Fosun a reasonable
opportunity and reasonable time to review and comment regarding
relevant communications to Palatin and drafts of any responses or
other proposed filings by Palatin before any applicable filings are
submitted to any relevant patent office or Governmental Authority
and (ii) considering in good faith any reasonable comments offered
by Fosun with respect to any final filings submitted by Palatin to
any relevant patent office or Governmental Authority. If Palatin
elects not to file a patent application for an invention or
application included in the Palatin Patent Rights in a given
Jurisdiction in the Territory or elects to cease the prosecution or
maintenance of any Palatin Patent Right in a given Jurisdiction in
the Territory, then Palatin shall provide Fosun with written notice
promptly, but not less than […***…] before any action
is required or any Palatin Patent Rights becomes patentable in the
Territory, upon the decision to not file or continue the
prosecution of such patent application or maintenance of such
patent. In such event, Fosun shall have the right, but not the
obligation, to file the patent application or continue prosecution
or maintenance of any such Palatin Patent Right in such
Jurisdiction and at Palatin’s expense. Fosun shall not, and
shall not permit any of its Affiliates or sublicensees to, take any
action with respect to the filing, prosecution, maintenance or
enforcement of any Palatin Patent Right in the Territory that may
reasonably be expected to adversely impact the rights of Palatin or
its other licensees. Without limiting the foregoing, Fosun shall
consult and reasonably cooperate with Palatin and, at
Palatin’s request, Palatin’s other licensees
(including, without limitation, AMAG) with respect to the
preparation, filing, prosecution and maintenance of the Palatin
Patent Rights in the Territory, including: (A) allowing Palatin and
such licensees a reasonable opportunity and reasonable time to
review and comment regarding relevant communications to Fosun and
drafts of any responses or other proposed filings by Fosun before
any applicable filings are submitted to any relevant patent office
or Governmental Authority and (B) considering in good faith
any reasonable comments offered by Palatin and such licensees with
respect to any final filings submitted by Fosun to any relevant
patent office or Governmental Authority.
14
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
5.2.2.
Filing, Prosecution and Maintenance
of Fosun Patent Rights. Fosun shall have the sole right, but
no obligation, to file, prosecute and maintain the Patent Rights
that it owns or to which it otherwise has Control of prosecution
rights, including the Fosun Patent Rights, in its sole
discretion.
5.2.3.
Filing, Prosecution and Maintenance
of Joint Patent Rights. In the event that any joint
invention is made and it is determined by the Parties to file,
prosecute and maintain a patent application on such Patent Rights,
the Parties shall meet and determine responsibility for such
filing, prosecution and maintenance, provided that Palatin shall be
responsible for any such filing, prosecution and maintenance
outside of the Territory, and Fosun may, in its discretion, elect
to be responsible for any such filing, prosecution and maintenance
within the Territory.
(a) Enforcement
of Palatin Patent Rights. Each Party will promptly notify
the other in the event of any actual, potential or suspected
infringement of a patent under the Palatin Patent Rights in the
Territory. As between Fosun and Palatin, Palatin shall have the
first right, except as otherwise provided in this Section 5.2.4,
but not the obligation, to institute litigation or take other steps to remedy
infringement in
connection therewith, and any such litigation or steps […***…].
Palatin shall not, without the prior written consent of Fosun,
enter into any compromise or settlement relating to such litigation
that (i) admits the invalidity or unenforceability of any Palatin
Patent Right in the Territory or (ii) requires Fosun or Palatin to
abandon or relinquish any Palatin Patent Right in the Territory. If
Palatin fails to institute such litigation or otherwise take steps
to remedy the actual, potential or suspected infringement of a
Palatin Patent Right in the Territory within […***…] of
its receipt of notice thereof, then Fosun shall have the right, but
not the obligation, upon […***…] prior notice to
Palatin, at […***…]
expense, to institute any such litigation, however
[…***…]. Fosun will have the right to consult with
Palatin about such litigation and to participate in and be
represented by independent counsel in such litigation at Fosun's
own expense. Except in the case of a breach of a term of this
Agreement, neither Party shall incur any liability to the other
Party as a consequent of any litigation initiated or pursued
pursuant to this Section 5.2.4(a) or any unfavorable decision
resulting therefrom, including any decision holding any Palatin
Patent Right.
(b) Enforcement
of Fosun Patent Rights. Fosun shall have the sole right, but
no obligation, to take action to obtain a discontinuance of
infringement or bring suit against a Third Party infringing or
challenging the validity or enforceability of any Fosun Patent
Right.
15
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
(c) Enforcement
of Palatin Patent Rights Outside the Territory. Palatin
shall have the sole right, but no obligation, to take action to
obtain a discontinuance of infringement or bring suit against a
Third Party infringing or challenging the validity or
enforceability of any Palatin Patent Right outside the
Territory.
5.2.5.
Allegations of Infringement and
Right to Seek Third Party Licenses.
(a) Notice.
If the Development, Manufacture, Commercialization or use of any
Compound, Product, Pharmaceutical Product or Product Delivery
Device, the practice of any Palatin Technology, or the exercise of
any other right granted by Palatin to Fosun hereunder
(collectively, the “Licensed Activities”) by Fosun or
any of its Affiliates or Sublicensees is alleged by a Third Party
to infringe, misappropriate or otherwise violate such Third
Party’s Patent Rights or other intellectual property rights,
then the Party discovering the same shall, promptly upon becoming
aware of such allegation, notify the other Party in writing.
Additionally, if either Party determines that, based upon the
review of any Third Party Patent Right or other Third Party
intellectual property rights, it may be desirable to obtain a
license from such Third Party with respect thereto so as to avoid
any potential claim of infringement by such Third Party against
either Party or their respective Affiliates or Sublicensees, then
such Party shall promptly notify the other Party of such
determination.
(b) Fosun
Option to Negotiate. If Fosun determines, in its sole
discretion, that, in order for Fosun, its Affiliates or
Sublicensees to engage in the Licensed Activities, it is necessary
or desirable to obtain a license under one or more Patent Rights or
other intellectual property rights Controlled by a Third Party,
then Fosun shall have the sole right, but not the obligation, to
negotiate and enter into a license or other agreement with such
Third Party. All amounts payable under any such license or
agreement with a Third Party shall reduce Fosun’s royalty
obligations under this Agreement as and to the extent provided in
Section 3.4.3(a).
16
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
5.2.6.
Third Party Infringement
Suits. Each of the Parties shall promptly notify the other
in the event that any Third Party files any suit or brings any
other action alleging patent infringement by Fosun or Palatin or
any of their respective Affiliates or Sublicensees with respect to
the Development,
Manufacture, Commercialization or use of any Compound, Product,
Pharmaceutical Product or Product Delivery Device or the practice
of any Palatin Technology in the Territory (any such suit or other
action referred to herein as an “Infringement Claim”)
or outside the Territory. In the case of any Infringement Claim
against Fosun (including its Affiliates or Sublicensees) alone or
against both Fosun and Palatin (including its Affiliates), Fosun
shall have the right, but not the obligation, at Fosun’s sole
cost and expense subject to the provisions of this Section 5.2.6,
to control the defense of such Infringement Claim, including
control over any related litigation, settlement, appeal or other
disposition arising in connection therewith. Palatin, upon request
of Fosun, agrees to join in any litigation associated with any
Infringement Claim at Palatin’s expense and in any event to
reasonably cooperate with Fosun at Palatin’s expense (in all
cases subject to Palatin’s indemnification obligations under
Section 9.3). Palatin will have the right to consult with Fosun
concerning any Infringement Claim and to participate in and be
represented by independent counsel in any associated litigation in
which Palatin is a party at Palatin’s own expense. Fosun
shall not, without the prior written consent of Palatin, enter into
any compromise or settlement relating to such litigation that (i)
admits the invalidity or unenforceability of any Palatin Patent
Right in the Territory or (ii) requires Fosun or Palatin to abandon
or relinquish any Palatin Patent Right in the Territory. If Fosun
elects to control the defense of any Infringement Claim and Palatin
is obligated under Section 9.3 to indemnify Fosun (including any
Fosun Indemnified Party) with respect to such Infringement Claim,
then (a) […***…] and (b) Palatin will otherwise
indemnify Fosun and any applicable Fosun Indemnified Parties to the
full extent provided for under Section 9.3. In the case of any
Infringement Claim against Palatin (including Palatin’s
Affiliates) alone, Palatin shall have the right, but not the
obligation, at Palatin’s sole cost and expense, to control
the defense of such Infringement Claim, including control over any
related litigation, settlement, appeal or other disposition arising
in connection therewith; provided that Palatin shall not,
without the prior written consent of Fosun, enter into any
compromise or settlement relating to such litigation that (i)
admits the invalidity or unenforceability of any Palatin Patent
Right in the Territory or (ii) requires Fosun or Palatin to abandon
or relinquish any Palatin Patent Right in the Territory. Fosun
shall have the right to consult with Palatin concerning such
Infringement Claim and Fosun, upon request of Palatin, will
reasonably cooperate with Palatin at Palatin’s expense (but
Fosun shall have no obligation to join any Infringement Claim or
associated litigation).
5.2.7.
Other Actions by Third
Parties. Each Party shall promptly notify the other Party in
the event of any legal or administrative action by any Third Party
involving any Palatin Patent Right in the Territory of which it
becomes aware, including any nullity, revocation, interference,
reexamination or compulsory license proceeding. Fosun shall have
the first right, but no obligation, to defend against any such
action involving any Palatin Patent Right in the Territory, in its
own name (to the extent permitted by applicable Law), and any such
defense shall be at Fosun’s reasonable expense, subject to
Palatin’s indemnification obligations under Section 9.
Palatin, upon Fosun’s request, agrees to join in any such
action at Fosun’s expense and in any event to cooperate with
Fosun at Fosun’s expense. If Fosun fails to defend against
any such action involving a Palatin Patent Right, then Palatin
shall have the right to defend such action, in its own name, and
any such defense shall be at Palatin’s expense. In such
event, Fosun, upon Palatin’s request, shall reasonably
cooperate with Palatin in any such action at Palatin’s
expense.
5.2.8.
Orange Book Information.
Fosun shall have the sole right, but not the obligation, to submit
to all applicable Governmental Authorities patent information
pertaining to each Product pursuant to any statutory or regulatory
requirement similar to 21 U.S.C. § 355(b)(1)(G) in any
Jurisdiction or regulatory jurisdiction in the
Territory.
17
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
5.2.9.
Paragraph IV Type Notices.
Notwithstanding any provision of this Agreement to the contrary,
each Party shall immediately (but in no event later than two (2)
Business Days following receipt or discovery, whichever occurs
first) give written notice to the other of any certification of
which it becomes aware filed pursuant to any statutory or
regulatory requirement in any Jurisdiction in the Territory similar
to 21 U.S.C. § 355(b)(2)(A)(iv) or §
355(j)(2)(A)(vii)(IV) (or any amendment or successor statute
thereto) claiming that any Palatin Patent Right in the Territory
covering any Compound, Product or Pharmaceutical Product is invalid
or that infringement will not arise from the Development,
Manufacture, use or Commercialization of such Compound, Product or
Pharmaceutical Product by a Third Party. Upon the giving or receipt
of such notice, Fosun shall have the sole right, but not the
obligation, to bring an infringement action against such Third
Party at Fosun’s sole cost and expense. If necessary in order
to establish standing in connection with any action brought by
Fosun under this Section 5.2.9, Palatin, upon Fosun’s
request, shall reasonably cooperate with Fosun in any such action
at Fosun’s expense and shall timely commence or join in any
such action at Fosun’s request and expense. In the event of
any conflict between the terms of this Section 5.2.9 and the terms
of Section 5.2.4(a), the terms of this Section 5.2.9 shall control
and govern.
5.2.10. Patent Term Restoration and Extension.
Fosun shall have the exclusive right, but not the obligation, to
seek, in Palatin’s name if so required, patent term
extensions, and supplemental protection certificates and the like
available under Law, in any Jurisdiction in the Territory in
relation to the Palatin Patent Rights. Any costs or expenses
associated with the above shall be shared by Fosun and Palatin
equally. Palatin and Fosun shall cooperate in connection with all
such activities. Fosun, its agents and attorneys will give due
consideration to all suggestions and comments of Palatin regarding
any such activities, but in the event of a disagreement between the
Parties, Fosun will have the final decision-making authority;
provided, however, that Fosun shall seek (or allow Palatin to seek)
to extend any Palatin Patent Right at Palatin’s request,
including through the use of supplemental protection certificates
and the like, unless in Fosun’s reasonable legal
determination such Palatin Patent Right may not be extended under
Law without limiting Fosun’s right to extend any other Patent
Right.
18
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
5.3.1.
Misappropriation Actions Relating
to Palatin Know-How. Each Party will promptly notify the
other in the event of any actual, potential or suspected
misappropriation of any Palatin Know-How by any Third Party. As
between Fosun and Palatin, Fosun shall have the first right, except
as otherwise provided in this Section 5.3.1, but not the
obligation, to institute litigation or take other steps to remedy
misappropriation of the Palatin Know-How in the Territory in
connection therewith. If […***…]. If
[…***…]. If […***…]. Fosun shall not,
without the prior written consent of Palatin, enter into any
compromise or settlement relating to such litigation that (a)
admits that all or any portion of the Palatin Know-How is not
protectable under relevant trade secret Laws or (b) requires Fosun
or Palatin to abandon or relinquish trade secret protection for any
Palatin Know-How. If necessary in order to establish standing for
Fosun, Palatin, upon request of Fosun, agrees to timely commence or
to join in any such litigation, provided that any costs or expenses
associated with the above shall be shared by Fosun and Palatin
equally. Palatin will have the right to consult with Fosun about
such litigation and to participate in and be represented by
independent counsel in such litigation at Palatin’s own
expense. If Fosun fails to institute such litigation or otherwise
take steps to remedy the actual, potential or suspected
misappropriation of any Palatin Know-How in the Territory
[…***…] of its receipt of notice thereof, then Palatin
shall have the right, but not the obligation, upon
[…***…] to Fosun, at Palatin’s expense, to
institute any such litigation. If necessary in order to establish
standing for Palatin, Fosun, upon request of Palatin, agrees to
timely commence or to join in any such litigation, and in any event
to cooperate with Palatin in such litigation or steps at
Palatin’s expense. Fosun will have the right to consult with
Palatin about such litigation and to participate in and be
represented by independent counsel in such litigation at Fosun's
own expense. Palatin shall not, without the prior written consent
of Fosun, enter into any compromise or settlement relating to such
litigation that (a) admits that all or any portion of the Palatin
Know-How is not protectable under relevant trade secret Laws or (b)
requires Fosun or Palatin to abandon or relinquish trade secret
protection for any Palatin Know-How. Palatin shall have the sole
right, but not the obligation, to institute litigation or take
other steps to remedy misappropriation of the Palatin Know-How
outside the Territory.
5.3.2.
Misappropriation Actions Relating
to Fosun Know-How. Fosun shall have the sole right, but no
obligation, to take action to obtain a discontinuance of
misappropriation or bring suit against a Third Party that is
misappropriating, or that is suspected of misappropriating, any
Fosun Know-How.
5.4.
Recording. If registration
or recordation is required by applicable Law, of if Fosun otherwise
deems it necessary or desirable to register or record this
Agreement or evidence of this Agreement with any patent office or
other appropriate Governmental Authority(ies) in one or more
jurisdictions in the Territory, Palatin shall reasonably cooperate
to provide assistance, execute and deliver to Fosun any documents
accurately reflecting or evidencing this Agreement that are
necessary or desirable, in Fosun’s reasonable judgment, to
complete such registration or recordation. Upon successful
registration of this Agreement with each applicable Governmental
Authority in the Territory, Fosun shall promptly forward to Palatin
copies of any registration certificates as well as any other
documentation received by Fosun in connection therewith. Fosun
shall reimburse Palatin for all reasonable out-of-pocket expenses,
including attorneys’ fees, incurred by Palatin in complying
with the provisions of this Section 5.4.
6.1. Confidentiality. Except to the extent
expressly authorized by this Agreement, the Parties agree that,
during the Term and for […***…], each Party (the
“Receiving Party”) receiving any Confidential
Information of the other Party (the “Disclosing Party”)
hereunder shall: (a) keep the Disclosing Party’s Confidential
Information confidential; (b) not disclose, or permit the
disclosure of, the Disclosing Party’s Confidential
Information; and (c) not use, or permit to be used, the Disclosing
Party’s Confidential Information for any purpose other than
as expressly permitted under the terms of this Agreement. For the
avoidance of doubt, the Confidential Information Disclosure
Agreement dated […***…] between Palatin and Fosun shall
be terminated as of the Effective Date of this
Agreement.
19
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
6.2.1. Disclosure to Party Representatives.
Notwithstanding the foregoing provisions of Section 6.1, the
Receiving Party may disclose Confidential Information belonging to
the Disclosing Party to the Receiving Party’s Representatives
who (a) have a need to know such Confidential Information in
connection with the performance of the Receiving Party’s
obligations or the exercise of the Receiving Party’s rights
under this Agreement and (b) have agreed in writing to
non-disclosure and non-use provisions with respect to such
Confidential Information that are at least as restrictive as those
set forth in this Section 6.
6.2.2. Disclosure to Third Parties.
Notwithstanding the foregoing provisions of Section 6.1, each
Party may disclose Confidential Information belonging to the other
Party to the extent such disclosure is reasonably
necessary:
(a) to
Governmental Authorities (i) to the extent desirable to obtain or
maintain INDs or Regulatory Approvals for any Compound, Product,
Pharmaceutical Product or Product Delivery Device within the
Territory, and (ii) in order to respond to inquiries, requests or
investigations relating to Compounds or Products in the Territory
or this Agreement;
(b) in
connection with filing or prosecuting Palatin Patent Rights as
permitted by this Agreement;
(c) in
connection with prosecuting or defending litigation as permitted by
this Agreement;
(d) to
the extent necessary or desirable in order to enforce its rights
under this Agreement; or
(e) to
the extent required by relevant laws, regulations, or stock
exchanges rules.
If the
Receiving Party deems it reasonably necessary to disclose
Confidential Information belonging to the Disclosing Party pursuant
to this Section 6.2.2, then the Receiving Party shall to the extent
possible give reasonable advance written notice of such disclosure
to the Disclosing Party and take such measures to ensure
confidential treatment of such information as is reasonably
requested by the Disclosing Party, at the Disclosing Party’s
expense.
20
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
6.3.
SEC Filings and Other
Disclosures. Either Party may disclose Confidential
Information, or the terms of this Agreement, to the extent
required, in the reasonable opinion of such Party’s legal
counsel, to comply with applicable Law, including the rules and
regulations promulgated by the United States Securities and
Exchange Commission (“SEC”), stock exchanges, or any
equivalent governmental agency in any Jurisdiction in the
Territory. Before disclosing this Agreement or any of the terms
hereof pursuant to this Section 6.3, the Parties will consult with
one another on the terms of this Agreement to be redacted in making
any such disclosure (which, at a minimum, shall include redaction
of all financial terms), with the disclosing Party providing as
much advanced notice as is feasible under the circumstances, and
giving consideration to the comments of the other Party. Further,
if a Party discloses this Agreement or any of the terms hereof in
accordance with this Section 6.3, the other Party may, at its own
expense, seek such confidential treatment of confidential portions
of this Agreement and such other terms.
6.4.
Public Announcements. Except
as may be expressly permitted under Section 6.2, neither Party
will make any public announcement regarding this Agreement without
the prior written approval of the other Party. For the sake of
clarity, nothing in this Agreement shall prevent Fosun from making
any scientific publication or public announcement with respect to
any product under this Agreement; provided, however, that, except as
permitted under Section 6.2, Fosun shall not disclose any of
Palatin’s Confidential Information in any such publication or
announcement without obtaining Palatin’s prior written
consent to do so. Notwithstanding the foregoing, without prior
consent of the other Party, each Party may disseminate material
substantially similar to material included in a press release or
other document previously approved for external distribution by the
other Party. The Parties agree to coordinate timing of any public
announcement regarding this Agreement, and to exchange proposed
public announcements prior to making such
announcements.
7.
REPRESENTATIONS AND WARRANTIES; COVENANTS;
SECURITY INTEREST.
7.1. Mutual
Representations and Warranties. Each of Palatin and Fosun
hereby represents and warrants to the other Party
that:
7.1.1.
it is duly organized, validly existing and in good standing under
the laws of the jurisdiction of its organization;
7.1.2.
the execution, delivery and performance of this Agreement by such
Party has been duly authorized by all requisite action under the
provisions of its charter, bylaws and other organizational
documents, and does not require any action or approval by any of
its shareholders or other holders of its voting securities or
voting interests;
7.1.3.
it has the power and authority to execute and deliver this
Agreement and to perform its obligations hereunder;
21
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
7.1.4.
this Agreement has been duly executed and is a legal, valid and
binding obligation on each Party, enforceable against such Party in
accordance with its terms; and
7.1.5. the
execution, delivery and performance by such Party of this Agreement
and its compliance with the terms and provisions hereof does not
and will not conflict with or result in a breach of or default
under any Binding Obligation existing as of the Effective
Date.
7.2. Mutual
Covenants. Each of Palatin and Fosun hereby covenants to the
other Party that, from the Effective Date until expiration or
termination of this Agreement, it will:
7.2.1.
perform its obligations under this Agreement in compliance with
applicable Laws;
7.2.2.
comply with all applicable laws, including any U.S. laws and
regulations including, but without limitation, U.S. export
controls, U.S. economic sanctions, and anti-bribery laws (e.g., the
U.S. Foreign Corrupt Practices Act, the UK Bribery
Act);
7.2.3.
not take any actions that would cause the other Party to be in
violation of any of any applicable laws, including, but without
limitation, U.S. export controls, U.S. economic sanctions, and
anti-bribery laws;
7.2.4.
not, directly or indirectly, offer, pay, give, promise to pay or
give, or authorize the payment or giving of, money, benefit or
anything else of value to any foreign official or private
individual, while knowing or having reason to know that all or a
portion of such money, benefit or thing of value will be
used:
(a) to
seek, obtain, or retain business for the a Party, or
(b) to
induce or seek to induce consideration or action by any individual,
or any employee or officer of a customer or prospective customer,
public or private, on any basis other than the merits of Products
or other Palatin Technology.
As used
in Section 7.2.4, the term “foreign official” means:
(i) any officer or employee of any government or any department,
agency, or instrumentality of a government, including entities
owned or controlled by a government; (ii) any person acting in an
official capacity for or on behalf of such government or
department, agency or instrumentality; (iii) any member of a
foreign political party or international organization; or (iv) any
person related to or affiliated with the above.
22
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
7.3. Representations
and Warranties of Palatin. Palatin hereby represents and
warrants to Fosun that:
7.3.1.
Palatin is the sole and exclusive owner of the Palatin Technology,
all of which is free and clear of any claims, liens, charges or
encumbrances other than the North American license agreement with
AMAG and agreements incidental thereto, including without
limitation any agreement relating to a global safety database for
Products;
7.3.2.
Palatin has and will have the full right, power and authority to
grant all of the rights, title and interests in and to the licenses
and other rights granted or to be granted to Fosun, Fosun’s
Affiliates or Fosun’s Sublicensees under this
Agreement;
7.3.3.
Exhibit C sets forth a true and complete list of all
Compounds discovered or developed by Palatin or its Affiliates on
or prior to the Effective Date;
7.3.4.
as of the Effective Date (a) Exhibit B sets forth a true and
complete list of all Patent Rights owned or otherwise Controlled by
Palatin or its Affiliates that relate to the Compounds or Products,
(b) each such Patent Right remains in full force and effect and (c)
Palatin or its Affiliates have timely paid all filing and renewal
fees payable with respect to such Patent Rights;
7.3.5.
Except as disclosed in Exhibit D, there are no settled, unsettled,
pending or threatened claims or lawsuits or legal proceedings by a
third party against Palatin alleging that Palatin Technology
infringes, uses without authorization, misappropriates or otherwise
violates in part or in whole the intellectual property or
intellectual property rights of such third party;
7.3.6.
Palatin has no knowledge that any claims of any Palatin Technology
or any claims directed to any Compound, Product, Pharmaceutical
Product or Product Delivery Device covered in such patents are
unpatentable, invalid or unenforceable;
7.3.7.
the Products supplied by Palatin or AMAG under this Agreement
and/or the supply agreement as provided in section 4.6.4 will be in
full compliance with applicable Laws; and
7.3.8.
Palatin has not granted any exclusive or non-exclusive license in
the Territory under the Palatin Technology, to Commercialize and
have Commercialized (but not to use, have used, Develop, have
Developed, Manufacture and have Manufactured) Compounds, Products,
Pharmaceutical Products and Product Delivery Devices, and otherwise
practice and exploit the Palatin Technology.
7.4.
Disclaimer. THE FOREGOING
REPRESENTATIONS AND WARRANTIES OF EACH PARTY ARE IN LIEU OF ALL
OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING
ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR ANY IMPLIED WARRANTIES
OF FITNESS FOR A PARTICULAR PURPOSE, ALL OF WHICH ARE HEREBY
SPECIFICALLY EXCLUDED AND DISCLAIMED.
23
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
8.1.
Other Government Approvals.
Each of Palatin and Fosun shall cooperate with the other Party and
use Commercially Reasonable Efforts to make all registrations,
filings and applications, to give all notices and to obtain as soon
as practicable all governmental or other consents, transfers,
approvals, orders, qualifications authorizations, permits and
waivers, if any, and to do all other things necessary or desirable
for the consummation of the transactions as contemplated
hereby.
8.2.
Term. The term of this
Agreement (the “Term”) will commence on the Effective
Date and extend on a Jurisdiction-by-Jurisdiction basis (in the
Territory), unless this Agreement is terminated earlier in
accordance with this Section 8, until the last to expire of any
Royalty Term for any Product in such Jurisdiction in the Territory;
provided, however, that the
Agreement shall be automatically extended for successive
[…***…] unless and until either Party gives at least
[…***…] prior written notice to terminate the
Agreement.
8.3.
Termination by Palatin.
Palatin may terminate this Agreement for cause, at any time during
the Term, by giving written notice to Fosun in the event that Fosun
commits a material breach of its obligations under this Agreement
and such material breach remains uncured for […***…],
measured from the date written notice of such material breach is
given to Fosun; provided,
however, that if any breach is not reasonably curable within
[…***…] and if Fosun is making a bona fide effort to
cure such breach, such termination shall be delayed for a time
period to be agreed by both Parties in order to permit Fosun a
reasonable period of time to cure such breach. If the alleged
material breach relates to non-payment of any amount due under this
Agreement, the cure period shall be tolled pending resolution of
any bona fide dispute between the Parties as to whether such
payment is due.
8.4.
Termination by
Fosun.
8.4.1. Termination for Convenience. Upon at
least […***…] written notice to Palatin, Fosun may
terminate this Agreement on a Product-by-Product and
Jurisdiction-by-Jurisdiction basis, or in its entirety, without
cause, for any or no reason.
8.4.2. Termination for Cause. Fosun may
terminate this Agreement for cause with respect to one or more
Products in one or more Jurisdictions in the Territory or may
terminate this Agreement in its entirety, at any time during the
Term, by giving written notice to Palatin in the event that Palatin
commits a material breach of its obligations under this Agreement
and such material breach remains uncured […***…],
measured from the date written notice of such material breach is
given to Palatin; provided,
however, that if any breach is not reasonably curable within
[…***…] and if Palatin is making a bona fide effort to
cure such breach, such termination shall be delayed for a time
period to be agreed by both Parties in order to permit Palatin a
reasonable period of time to cure such breach.
24
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
8.5.1. Effect of Termination.
(a) Termination
for Cause by Palatin. In the event that Palatin terminates
this Agreement for cause pursuant to Section 8.3, the following
will apply (with respect to the terminated Jurisdictions in the
Territory, in the event of partial termination, and with respect to
the entire Territory, in the event of termination of the Agreement
in its entirety):
(i) Except
as otherwise expressly provided herein, all rights and obligations
of each Party hereunder shall cease (including all rights and
licenses granted by either Party to the other Party hereunder) in
the relevant Jurisdiction or Territory, as applicable;
(ii) To
the extent permitted by applicable law, Fosun will assign and
transfer to Palatin all Regulatory Approvals owned by Fosun or its
Affiliates with respect to all Continuation Products in the
relevant Jurisdiction (or the Territory in the event of termination
of this Agreement in its entirety);
(iii) To
the extent permitted by applicable law, Fosun will assign all
applications and registrations for the Product Brands that are
Controlled by Fosun or its Affiliates in the relevant Jurisdiction
(or the Territory in the event of termination of this Agreement in
its entirety) to Palatin;
(iv) Fosun
will transfer to Palatin all development data and regulatory
filings specifically relating to such Continuation Product in the
relevant Jurisdiction (or the Territory in the event of termination
of this Agreement in its entirety) and grant to Palatin rights of
reference with respect to such data and filings in each other
Jurisdiction in the Territory (if any); and
(v) On
Palatin’s written notice to Fosun, which notice may only be
delivered within […***…] following the effective date
of termination, the Parties will negotiate in good faith mutually
agreeable terms regarding (A) the grant by Fosun to Palatin of a
license under the Applicable Fosun Technology for Palatin to
continue to Develop, Commercialize and Manufacture any Product (in
the relevant Jurisdiction or Territory, as applicable) that is
under Development or Commercialization by Fosun under this
Agreement at the time of termination, in the form in which such
Product then exists (a “Continuation Product”), and (B)
the provision of transitional supplies of such Continuation Product
to Palatin. Neither Party will be obligated to enter into any
transaction described in this Section 8.5.1(a)(v), and neither
Party will have any liability to the other for failure to do
so.
25
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
(b) Termination
for Convenience by Fosun. In the event that Fosun terminates
this Agreement without cause pursuant to Section 8.4.1, the
following will apply (with respect to the terminated Jurisdictions
in the Territory, in the event of partial termination, and with
respect to the entire Territory, in the event of termination of the
Agreement in its entirety):
(i) Except
as otherwise expressly provided herein, all rights and obligations
of each Party hereunder shall cease (including all rights and
licenses granted by either Party to the other Party hereunder) in
the relevant Jurisdiction or Territory, as applicable;
(ii) To
the extent permitted by applicable law, Fosun will assign and
transfer to Palatin all Regulatory Approvals owned by Fosun or its
Affiliates with respect to all Continuation Products in the
relevant Jurisdiction (or the Territory in the event of termination
of this Agreement in its entirety);
(iii)
To the extent permitted by applicable law, Fosun will assign all
applications and registrations for the Product Brands that are
Controlled by Fosun or its Affiliates in the relevant Jurisdiction
(or the Territory in the event of termination of this Agreement in
its entirety) to Palatin; and
(iv)
Fosun will grant to Palatin a royalty-free, non-exclusive license
under the Applicable Fosun Technology, with the right to
sublicense, to Develop, Commercialize, Manufacture and use the
Continuation Products (in the relevant Jurisdiction or Territory,
as applicable).
(c) Termination
for Cause by Fosun; Alternative Remedy for
Breach.
(i) Partial
Termination. In the event that Fosun terminates this
Agreement pursuant to Section 8.4.2 with respect to any Product in
any Jurisdiction in the Territory, except as otherwise expressly
provided herein, all rights and obligations of each Party hereunder
with respect to such Product in such Jurisdiction shall cease
(including all relevant rights and licenses granted by either Party
to the other Party hereunder);
(ii)
Complete Termination. In
the event that Fosun terminates this Agreement in its entirety
pursuant to Section 8.4.2, except as otherwise expressly provided
herein, all rights and obligations of each Party hereunder shall
cease (including all rights and licenses granted by either Party to
the other Party hereunder); and
26
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
(iii)
For a period of […***…] after any such termination for
cause by Fosun, Palatin shall not grant development and
commercialization rights as to the Product in any Jurisdiction in
the Territory to any Third Party (including Palatin itself and its
affiliates) […***…]. After this
[…***…].
8.5.2.
Accrued Rights. Expiration
or termination of this Agreement for any reason shall be without
prejudice to any right which shall have accrued to the benefit of
either Party prior to such termination, including damages arising
from any breach under this Agreement and shall not preclude either
Party from pursuing any remedies it may have hereunder or at law or
in equity which accrued or are based upon any event occurring prior
to such termination or expiration. Expiration or termination of
this Agreement shall not relieve either Party from any obligation
which is expressly indicated to survive such expiration or
termination.
8.5.3.
Survival Period. The
following sections, together with any sections that expressly
survive (including any perpetual licenses granted hereunder), shall
survive expiration or termination of this Agreement for any reason:
Sections 1.1 (together with Exhibit A); 1.2; 3.4.2 (with respect to
any licenses that accrue thereunder on or prior to the end of the
Term); 3.5.6 […***…]; 3.5.7 […***…]; 3.5.8
[…***…]; 3.5.10; 6 […***…]; 8.5; 9.1; 9.2;
9.3; 9.4 and 10.
9.1. No
Consequential Damages. […***…], in
no event will either Party or its Representatives be liable under
this Agreement for any special, indirect, incidental, consequential
or punitive damages, whether in contract, warranty, tort,
negligence, strict liability or otherwise, including loss of
profits or revenue suffered by either Party or any of its
Representatives. Without limiting the generality of the foregoing,
“consequential damages” will be deemed to include, and
neither Party will be liable to the other Party or any of such
other Party’s Representatives or stockholders for any damages
based on or measured by loss of projected or speculative future
sales of the Products, any Development Milestone Payment due upon
any unachieved Development Event under Section 3.2, any Sales
Milestone Payment due upon any unachieved Total Annual Net Sales
level under Section 3.3, any unearned royalties under Section 3.4
or any other unearned, speculative or otherwise contingent payments
provided for in this Agreement.
9.2. Indemnification
by Fosun. Fosun will indemnify, defend and hold harmless
Palatin, each of its Affiliates, and each of its and its
Affiliates’ employees, officers, directors and agents (each,
a “Palatin Indemnified Party”) from and against any and
all liability, loss, damage, expense (including reasonable
attorneys’ fees and expenses) and cost (collectively, a
“Liability”) that the Palatin Indemnified Party may be
required to pay to one or more Third Parties (other than
shareholders of Palatin or its Affiliates) resulting from or
arising out of:
27
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
(a)
Development, Manufacture, Commercialization or use of any Product
by, on behalf of, or under the authority of, Fosun (other than by
any Palatin Indemnified Party), other than (i) claims by Third
Parties relating to patent infringement arising out of the exercise
of rights under the Palatin Patent Rights, (ii) claims by Third
Parties relating misappropriation of trade secrets arising out of
the exercise of rights under the Palatin Know-How, or (iii) claims
for which Palatin is required to indemnify Fosun pursuant to
Section 9.3; or
(b) the
material breach by Fosun of any of its representations, warranties
or covenants set forth in Section 7.1;
except,
in each case, to the extent caused by the negligence, recklessness
or intentional acts of Palatin or any Palatin Indemnified
Party.
9.3. Indemnification by Palatin. Palatin will
indemnify, defend and hold harmless Fosun, its Affiliates,
Sublicensees, contractors, distributors and each of its and
their respective employees, officers, directors and agents (each, a
“Fosun Indemnified Party”) from and against any and all
Liabilities that the Fosun Indemnified Party may be required to pay
to one or more Third Parties resulting from or arising out
of:
(a)
gross negligence in the manufacture and quality control of any
Product supplied by Palatin; or
(b) the
material breach by Palatin of any of its representations,
warranties or covenants, obligations and other provisions
hereof;
except,
in each case, to the extent caused by the negligence, recklessness
or intentional acts of Fosun or any Fosun Indemnified
Party.
9.4.1. Notice. Each Party will notify the other
Party in writing in the event it becomes aware of a claim for which
indemnification may be sought hereunder. In the event that any
Third Party asserts a claim or other proceeding (including any
governmental investigation) with respect to any matter for which a
Party (the “Indemnified Party”) is entitled to
indemnification hereunder (a “Third Party Claim”), then
the Indemnified Party shall promptly notify the Party obligated to
indemnify the Indemnified Party (the “Indemnifying
Party”) thereof; provided,
however, that no delay on the part of the Indemnified Party
in notifying the Indemnifying Party shall relieve the Indemnifying
Party from any obligation hereunder unless (and then only to the
extent that) the Indemnifying Party is prejudiced
thereby.
28
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
9.4.2. Control. Subject to Fosun’s right
to control any actions described in Sections 5.2.2, 5.2.6, 5.2.7,
5.2.9 or 5.3 (even where Palatin is the Indemnifying Party), the
Indemnifying Party shall have the right, exercisable by notice to
the Indemnified Party within […***…] after receipt of
notice from the Indemnified Party of the commencement of or
assertion of any Third Party Claim, to assume direction and control
of the defense, litigation, settlement, appeal or other disposition
of the Third Party Claim (including the right to settle the claim
solely for monetary consideration) with counsel selected by the
Indemnifying Party and reasonably acceptable to the Indemnified
Party; provided that (a) the Indemnifying Party has sufficient
financial resources, in the reasonable judgment of the Indemnified
Party, to satisfy the amount of any adverse monetary judgment that
is sought, (b) the Third Party Claim seeks solely monetary damages
and (c) the Indemnifying Party expressly agrees in writing that as
between the Indemnifying Party and the Indemnified Party, the
Indemnifying Party shall be solely obligated to satisfy and
discharge the Third Party Claim in full (the conditions set forth
in clauses (a), (b) and (c) above are collectively referred to as
the “Litigation Conditions”). Within
[…***…] after the Indemnifying Party has given
notice to the Indemnified Party of its exercise of its right to
defend a Third Party Claim, the Indemnified Party shall give notice
to the Indemnifying Party of any objection thereto based upon the
Litigation Conditions. If the Indemnified Party reasonably so
objects, the Indemnified Party shall continue to defend the Third
Party Claim, at the expense of the Indemnifying Party, until such
time as such objection is withdrawn. If no such notice is given, or
if any such objection is withdrawn, the Indemnifying Party shall be
entitled, at its sole cost and expense, to assume direction and
control of such defense, with counsel selected by the Indemnifying
Party and reasonably acceptable to the Indemnified Party. During
such time as the Indemnifying Party is controlling the defense of
such Third Party Claim, the Indemnified Party shall cooperate, and
shall cause its Affiliates and agents to cooperate upon request of
the Indemnifying Party, in the defense or prosecution of the Third
Party Claim, including by furnishing such records, information and
testimony and attending such conferences, discovery proceedings,
hearings, trials or appeals as may reasonably be requested by the
Indemnifying Party. In the event that the Indemnifying Party does
not satisfy the Litigation Conditions or does not notify the
Indemnified Party of the Indemnifying Party’s intent to
defend any Third Party Claim within […***…] after
notice thereof, the Indemnified Party may (without further notice
to the Indemnifying Party) undertake the defense thereof with
counsel of its choice and at the Indemnifying Party’s expense
(including reasonable, out-of-pocket attorneys’ fees and
costs and expenses of enforcement or defense). The Indemnifying
Party or the Indemnified Party, as the case may be, shall have the
right to join in (including the right to conduct discovery,
interview and examine witnesses and participate in all settlement
conferences), but not control, at its own expense, the defense of
any Third Party Claim that the other party is defending as provided
in this Agreement.
29
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
9.4.3. Settlement. The Indemnifying Party shall
not, without the prior written consent of the Indemnified Party,
enter into any compromise or settlement that commits the
Indemnified Party to take, or to forbear to take, any action. The
Indemnified Party shall have the sole and exclusive right to settle
any Third Party Claim, on such terms and conditions as it deems
reasonably appropriate, to the extent such Third Party Claim
involves equitable or other non-monetary relief, but shall not have
the right to settle such Third Party Claim to the extent such Third
Party Claim involves monetary damages without the prior written
consent of the Indemnifying Party. Each of the Indemnifying Party
and the Indemnified Party shall not make any admission of liability
in respect of any Third Party Claim without the prior written
consent of the other party, and the Indemnified Party shall use
reasonable efforts to mitigate liabilities arising from such Third
Party Claim.
9.5.
Insurance. Each Party shall
purchase insurance at its own expense with respect to its potential
liability under this Agreement. Such insurance shall be in
reasonable amounts to meet its indemnity obligations under this
Agreement and on reasonable terms in the circumstances in
accordance with common practice and applicable laws and regulations
regarding the development and sales of the Product.
10.1.
Assignment. Neither this
Agreement nor any interest hereunder shall be assignable by a Party
without the prior written consent of the other Party, except as
follows: a Party may assign its rights and obligations under this
Agreement by way of sale of itself or the sale of the portion of
its business to which this Agreement relates, through merger, sale
of assets or sale of stock or ownership interest, provided that the assignee shall
expressly agree to be bound by such Party’s obligations under
this Agreement and that such sale is not primarily for the benefit
of its creditors, (b) such Party may assign its rights and
obligations under this Agreement to any of its Affiliates,
provided that the assignee
shall expressly agree to be bound by such Party’s obligations
under this Agreement and that such Party shall remain liable for
all of its rights and obligations under this Agreement. Each Party
shall promptly notify the other Party of any assignment or transfer
under the provisions of this Section 10.1. This Agreement shall be
binding upon the successors and permitted assigns of the Parties
and the name of a Party appearing herein shall be deemed to include
the names of such Party’s successors and permitted assigns to
the extent necessary to carry out the intent of this Agreement. Any
assignment not in accordance with this Section 10.1 shall be
void.
10.2. Further Actions. Each Party agrees to
execute, acknowledge and deliver such further instruments, and to
do all such other acts, as may be necessary or appropriate in order
to carry out the purposes and intent of the Agreement.
10.3.
Force Majeure. Each Party
shall be excused from the performance of its obligations under this
Agreement to the extent that such performance is prevented by force
majeure (defined below) and the nonperforming Party promptly
provides notice of the prevention to the other Party. Such excuse
shall be continued so long as the condition constituting force
majeure continues and the nonperforming Party takes Commercially
Reasonable Efforts to remove the condition. For purposes of this
Agreement, “force majeure” shall include conditions
beyond the control of the Parties, including an act of God,
voluntary or involuntary compliance with any regulation, Law or
order of any government, war, act of terror, civil commotion, labor
strike or lock-out, epidemic, failure or default of public
utilities or common carriers, destruction of production facilities
or materials by fire, earthquake, storm or like
catastrophe.
30
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
10.4. Notices. Any notice or notification
required or permitted to be provided pursuant to the terms and
conditions of this Agreement (including any notice of force
majeure, breach, termination, change of address, etc.) shall be in
writing and shall be deemed given upon receipt if delivered
personally, on the next Business Day if sent by facsimile
transmission (receipt verified) or email, five(5) days after
deposited in the mail if mailed by registered or certified mail
(return receipt requested) postage prepaid, or on the next Business
Day if sent by overnight delivery using an internationally
recognized express courier service and specifying next Business Day
delivery (receipt verified), to the Parties at the following
addresses, email addresses or facsimile numbers (or at such other
address or facsimile number for a Party as shall be specified by
like notice, provided,
however, that notices of a change of address shall be
effective only upon receipt thereof):
All
correspondence to Fosun shall be addressed as follows:
Strategic Product
Development Center
Shanghai Fosun
Pharmaceutical Industrial Development Co., Ltd
Building A, 0000
Xxxxxx Xxxx
Xxxxxxx
Xxxxxxxx, Xxxxxxxx 000000
P.R.China
[…***…]
[…***…]
[…***…]
with a
copy to:
Legal
Department
Shanghai Fosun
Pharmaceutical (Group) Co., Ltd
Building A, 0000
Xxxxxx Xxxx
Xxxxxxx
Xxxxxxxx, Xxxxxxxx 000000
P.R.China
[…***…]
[…***…]
[…***…]
All
correspondence to Palatin shall be addressed as
follows:
Palatin
Technologies, Inc.
0-X
Xxxxx Xxxxx Xxxxx
Xxxxxxxx, XX
00000
[…***…]
[…***…]
[…***…]
with a
copy to:
Xxxxxxxx Xxxx
LLP
000
Xxxxxxx Xxxxxx, 00xx Xxxxx
Xxx
Xxxx, XX 00000
[…***…]
[…***…]
[…***…]
31
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
10.5. Amendment.
No amendment, modification or supplement of any provision of this
Agreement shall be valid or effective unless made in writing and
signed by a duly authorized officer of each Party.
10.6. Waiver.
No provision of this Agreement shall be waived by any act, omission
or knowledge of a Party or its agents or employees except by an
instrument in writing expressly waiving such provision and signed
by a duly authorized officer of the waiving Party. The waiver by
either of the Parties of any breach of any provision hereof by the
other Party shall not be construed to be a waiver of any succeeding
breach of such provision or a waiver of the provision
itself.
10.7. Severability.
If any clause or portion thereof in this Agreement is for any
reason held to be invalid, illegal or unenforceable, the same shall
not affect any other portion of this Agreement, as it is the intent
of the Parties that this Agreement shall be construed in such
fashion as to maintain its existence, validity and enforceability
to the greatest extent possible. In any such event, this Agreement
shall be construed as if such clause of portion thereof had never
been contained in this Agreement, and there shall be deemed
substituted therefor such provision as will most nearly carry out
the intent of the Parties as expressed in this Agreement to the
fullest extent permitted by applicable Law.
10.8. Descriptive
Headings. The descriptive headings of this Agreement are for
convenience only and shall be of no force or effect in construing
or interpreting any of the provisions of this
Agreement.
10.9. Dispute
Resolution. If any dispute or disagreement arises between
Fosun and Palatin in respect of this Agreement, they shall follow
the following procedures in an attempt to resolve the dispute or
disagreement:
10.9.1.
The Party claiming that such a dispute exists shall give notice in
writing (“Notice of Dispute”) to the other Party of the
nature of the dispute.
10.9.2.
Within […***…] of receipt of a Notice of
Dispute, the CEO (or his or her designee) of Fosun and the CEO (or
his or her designee) of Palatin shall meet at a mutually
agreed-upon time and location for the purpose of resolving such
dispute.
32
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
10.9.3.
If, within a further period of […***…], or if in any
event within […***…] of initial receipt of the Notice
of Dispute, the dispute has not been resolved, or if, for any
reason, the meeting described in Section 10.9.2 has not been held
within […***…] of initial receipt of the Notice of
Dispute, then the Parties agree that either Party may initiate
arbitration under the rules of Conciliation and Arbitration of the
International Chamber of Commerce to resolve the dispute. Such
Arbitration shall be held in the English language, and shall be
conducted in New York City if arbitration is demanded by Fosun and
in Hong Kong if arbitration is demanded by Palatin. The award
rendered by the arbitrator(s) shall be final and binding upon the
Parties hereto.
10.10. Governing
Law. This Agreement, and all claims arising under or in
connection therewith, shall be governed by and interpreted in
accordance with the substantive laws of the State of New York,
U.S.A., without regard to conflict of law principles thereof and
without regard to the United Nations Convention on Contracts for
the International Sale of Goods.
10.11. Entire
Agreement. This Agreement constitutes and contains the
complete, final and exclusive understanding and agreement of the
Parties and cancels and supersedes any and all prior negotiations,
correspondence, understandings and agreements, whether oral or
written, between the Parties respecting the subject matter hereof
and thereof.
10.12.
Representation by Legal
Counsel. Each Party hereto represents that it has been
represented by legal counsel in connection with this Agreement and
acknowledges that it has participated in the drafting hereof. In
interpreting and applying the terms and provisions of this
Agreement, the Parties agree that no presumption shall exist or be
implied against the Party which drafted such terms and
provisions.
10.13. Independent
Contractors. Both Parties are independent contractors under
this Agreement. Nothing herein contained shall be deemed to create
an employment, agency, joint venture or partnership relationship
between the Parties hereto or any of their agents or employees, or
any other legal arrangement that would impose liability upon one
Party for the act or failure to act of the other Party. Neither
Party shall have any express or implied power to enter into any
contracts or commitments or to incur any liabilities in the name
of, or on behalf of, the other Party, or to bind the other Party in
any respect whatsoever.
10.14. Counterparts.
This Agreement may be executed in two counterparts, each of which
shall be an original and both of which shall constitute together
the same document. Counterparts may be signed and delivered by
facsimile or PDF file, each of which shall be binding when received
by the applicable Party.
10.15. No
Third Party Rights or Obligations. No provision of this
Agreement shall be deemed or construed in any way to result in the
creation of any rights or obligation in any Person not a Party to
this Agreement. However, Fosun may decide, in its sole discretion,
to use one or more of its Affiliates to perform its obligations and
duties hereunder, provided
that Fosun shall remain liable hereunder for the performance
by any such Affiliates of any such obligations.
(Signature page follows.)
33
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
IN
WITNESS WHEREOF, authorized representatives of the Parties have
duly executed this Agreement as of the Effective Date to be
effective as of the Effective Date.
SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO.
LTD.
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|
PALATIN TECHNOLOGIES, INC.
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By
/s/ Xxxxxx
Xx
|
|
By
/s/ Xxxxxxx X.
Xxxxx
|
Name:
Xxxxxx Xx
Title:
President
|
|
Name:
Xxxxxxx X. Xxxxx
Title:
Chief Financial Officer, Chief Operating Officer and Executive Vice
President
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CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
Exhibit A
Defined Terms
“Affiliate”
means, as of any point in time and for so long as such relationship
continues to exist with respect to any Person, any other Person
that controls, is controlled by or is under common control with
such Person. A Person shall be regarded as in control of another
Person if it (a) owns or controls at least fifty percent (50%) of
the equity securities of the subject Person entitled to vote in the
election of directors or (b) possesses, directly or indirectly, the
power to direct or cause the direction of the management or
policies of any such Person (whether through ownership of
securities or other ownership interests, by contract or
otherwise).
“Applicable
Fosun Technology” means any (a) Know-How Controlled by Fosun
or its Affiliates that was invented, discovered or developed during
the Term and in connection with Fosun’s or its
Affiliates’ activities under the Agreement and (b) Patent
Right Controlled by Fosun or its Affiliates, to the extent that
such Patent Right claims any Know-How described in clause (a),
above.
“Bankruptcy
Code” means Section 101(35A) of Title 11 of the United
States Code, as amended.
“Binding
Obligation” means, with respect to a Party (a) any oral or
written agreement, arrangement or settlement that binds or affects
such Party’s operations or property, including any
assignment, license agreement, loan agreement, guaranty, or
financing agreement, (b) the provisions of such Party’s
charter, bylaws or other organizational documents or (c) any order,
writ, injunction, decree or judgment of any court or Governmental
Authority entered against such Party or by which any of such
Party’s operations or property are bound.
“Business
Day” means a day other than a Saturday, Sunday or bank or
other public national holiday in the United States and the
People’s Republic of China.
“Calendar
Quarter” means the respective periods of three consecutive
calendar months ending on March 31, June 30, September 30 and
December 31.
“Calendar
Year” means each successive period of twelve (12) months
commencing on January 1 and ending on December 31; provided that
the first Calendar Year of the Term shall begin on the Effective
Date and end on the first December 31 thereafter and the last
Calendar Year of the Term shall end on the last day of the
Term.
“CDE”
means the Chinese Center for Drug Evaluation.
“CFDA”
means the China Food and Drug Administration, or any successor
agency with a similar scope of responsibility regarding the
regulation of human pharmaceutical products in China.
Exhibits-1
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
“China”
means the People’s Republic of China, for the purpose of this
Agreement excluding Taiwan, Hong Kong S.A.R. and Macau
S.A.R...
“Clinical
Trial” means a human clinical study conducted on sufficient
numbers of human subjects that is designed to (a) establish that a
pharmaceutical product is reasonably safe for continued testing,
(b) investigate the safety and efficacy of the pharmaceutical
product for its intended use, and to define warnings, precautions
and adverse reactions that may be associated with the
pharmaceutical product in the dosage range to be prescribed or (c)
support Regulatory Approval of such pharmaceutical product or label
expansion of such pharmaceutical product.
“Commercialize”
or “Commercializing” means to market, promote,
distribute, offer for sale, sell, have sold, import, have imported,
export, have exported or otherwise commercialize a compound or
product. When used as a noun, “Commercialization” means
any and all activities involved in Commercializing.
“Commercially
Reasonable Efforts” means, with respect to the efforts to be
expended by a Party with respect to any objective, those
reasonable, good faith efforts to accomplish such objective
[…***…]. With respect to any efforts relating to the
Development, Regulatory Approval or Commercialization of a
Compound, Product, Pharmaceutical Product or Product Delivery
Device by a Party, generally or with respect to any particular
Jurisdiction in the Territory, a Party will be deemed to have
exercised Commercially Reasonable Efforts […***…] as
applicable (a) of similar modality Controlled by such Party, or (b)
(i) to which such Party has similar rights, (ii) which is of
similar market potential in such Jurisdiction, and (iii) which is
at a similar stage in its development or product life cycle, as the
Compound, Product, Pharmaceutical Product or Product Delivery
Device, in each case, taking into account all Relevant Factors in
effect at the time such efforts are to be expended. Further, to the
extent that the performance of a Party’s obligations
hereunder is adversely affected by the other Party’s failure
to perform its obligations hereunder, the impact of such
performance failure will be taken into account in determining
whether such Party has used its Commercially Reasonable Efforts to
perform any such affected obligations.
“Compound”
means bremelanotide, a generic name adopted and defined by the
United States Adopted Name (USAN) Council, including any and all
[…***…]. Those Compounds known to be existing as of the
Effective Date are listed in Exhibit C.
Exhibits-2
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
“Confidential
Information” means, with
respect to each Party, all Know-How or other information, including
proprietary information and materials (whether or not patentable)
regarding or embodying such Party’s technology, products,
business information or objectives, that is communicated by or on
behalf of the Disclosing Party to the Receiving Party or its
permitted recipients, on or after the Effective Date, but only to
the extent that such Know-How or other information in written form
is marked or otherwise designated in writing as
“confidential” at the time of disclosure or within
[…***…] thereafter, and such Know-How or other
information disclosed orally or in non-tangible form is (a)
identified by the Disclosing Party as “confidential” at
the time of disclosure and (b) within […***…]
thereafter, the Disclosing Party provides a written summary of such
Know-How or other information marked or otherwise designated in
writing as “confidential.” Confidential Information
does not include any Know-How or other information that (a) was
already known by the Receiving Party (other than under an
obligation of confidentiality to the Disclosing Party) at the time
of disclosure by or on behalf of the Disclosing Party, as evidenced
by written records in the possession of the Receiving Party, (b)
was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the Receiving Party,
(c) became generally available to the public or otherwise part of
the public domain after its disclosure to the Receiving Party,
other than through any act or omission of the Receiving Party in
breach of its obligations under this Agreement, (d) was disclosed
to the Receiving Party, other than under an obligation of
confidentiality, by a Third Party who had no obligation to the
Disclosing Party not to disclose such information to the Receiving
Party, as evidenced by written records in the possession of the
Receiving Party, or (e) was independently discovered or developed
by or on behalf of the Receiving Party without the use of any
Confidential Information belonging to the Disclosing Party, as
evidenced by written records in the possession of the Receiving
Party. The terms and conditions of this Agreement shall be
considered Confidential Information of both Parties.
“Control”
or “Controlled” means with respect to any intellectual
property right or material (including any Patent Right, Know-How or
other data, information or material), the ability (whether by sole,
joint or other ownership interest, license or otherwise, other than
pursuant to this Agreement) to, without violating the terms of any
agreement with a Third Party, grant a license or sublicense or
provide or provide access or other right in, to or under such
intellectual property right or material.
“Cover,”
“Covering” or “Covers” means, as to a
Product and Patent Rights, that, in the absence of a license
granted under, or ownership of, such Patent Rights, the
manufacture, use, offer for sale, sale or importation of such
Product would infringe such Patent Rights assuming the validity and
enforceability thereof.
“Data”
means any and all scientific, technical, test, marketing or sales
data pertaining to a Compound, Product, Pharmaceutical Product or
Product Delivery Device that is generated by or on behalf of Fosun
or its Affiliates or Sublicensees or by or on behalf of Palatin or
its Affiliates or sublicensees, including research data, clinical
pharmacology data, CMC data (including analytical and quality
control data and stability data), pre-clinical data, clinical data
or submissions made in association with any regulatory filings
(including any IND or NDA) with respect to any Compound, Product,
Pharmaceutical Product or Product Delivery Device.
“Derivatives”
means […***…].
“Develop”
or “Developing” means to discover, research or
otherwise develop a process, compound or product, including
conducting non-clinical and clinical research and development
activities. When used as a noun, “Development” means
any and all activities involved in Developing.
“Development
Event” means each Development event listed in the table that
appears in Section 3.2.
“FD&C
Act” means the United States Federal Food, Drug, and Cosmetic
Act, as amended, and the rules and regulations promulgated
thereunder.
Exhibits-3
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
“FDA”
means the United States Food and Drug Administration or any
successor agency thereto.
“Field”
means the treatment or prevention of human diseases. For clarity,
and without limiting the foregoing, Field includes female sexual
dysfunction and hypoactive sexual desire disorder in humans, and
any indication or use as monotherapy or in combination with other
marketed or to be marketed product.
“First
Commercial Sale” means, with respect to any Product and with
respect to any Jurisdiction of the Territory, the first sale of
such Product by Fosun or an Affiliate or Sublicensee of Fosun to a
Third Party in such Jurisdiction after such Product has been
granted Regulatory Approval by the appropriate Regulatory
Authority(ies) for such Jurisdiction.
“Fosun
Diligence Obligations” means Fosun’s Regulatory
Approval diligence obligations under Section 4.2.1 and
Fosun’s Commercialization diligence obligations under Section
4.2.2.
“Fosun
Know-How” means any Know-How that (a) is Controlled by Fosun
on the Effective Date or that comes into the Control of Fosun
during the Term (other than through the grant of a license by
Palatin) and (b) relates to the Development, Manufacture,
Commercialization or use of one or more Compounds or
Products.
“Fosun Patent
Right” means any Patent Right that (a) is Controlled by Fosun
on the Effective Date or that comes into the Control of Fosun
during the Term (other than through the grant of a license by
Palatin) and (b) claims any (a) Compound or Product (including the
composition of matter thereof), (b) method of making any Compound
or Product or (c) method of using any Compound or
Product.
“Fosun
Technology” means any and all Fosun Patent Rights and Fosun
Know-How.
“GAAP”
means United States generally accepted accounting principles,
consistently applied.
“Generic
Product” means any pharmaceutical product that (a) is sold by
a Third Party that is not an Affiliate or Sublicensee of Fosun
under a marketing authorization granted by a Regulatory Authority
to a Third Party, (b) contains the same Compound as a Product and
(c) for purposes of the United States, is approved in reliance on a
prior Regulatory Approval of a Product granted to Fosun or an Fosun
Affiliate or Sublicensee by the FDA or, for purposes of a country
or regulatory jurisdiction outside the United States, is approved
in reliance on a prior Regulatory Approval of a Product granted to
Fosun or an Fosun Affiliate or Sublicensee by the applicable
Regulatory Authority.
“Governmental
Authority” means any court, agency, legislative body,
department, authority or other instrumentality of any national,
multinational, supranational, federal, state, provincial, county,
city or other political subdivision.
Exhibits-4
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
“ICH”
means the International Conference on Harmonization (of Technical
Requirements for Registration of Pharmaceuticals for Human
Use).
“IND”
means an Investigational New Drug Application submitted under the
FD&C Act, or an analogous application or submission with any
analogous agency or Regulatory Authority outside of the United
States for the purposes of obtaining permission to conduct Clinical
Trials.
“Initial
Indication” shall mean the treatment of hypoactive sexual
desire disorder in premenopausal women.
“Jurisdictions”
means China, Taiwan, Hong Kong or Macau, and
“Jurisdiction” means any of the foregoing.
“Know-How”
means any invention, discovery, development, Data, information,
process, method, technique, material (including any chemical or
biological material), technology, result, cell line, compounds,
probe, sequence, regulatory correspondence or other know-how,
whether or not patentable, and any physical embodiments of any of
the foregoing.
“Law”
means any law, statute, rule, regulation, pronouncement having the
effect of law, order, judgment or ordinance of any Governmental
Authority.
“Manufacture”
or “Manufacturing” means to make, produce, manufacture,
process, fill, finish, package, label, perform quality assurance
testing, release, ship or store a compound or product or any
component thereof. When used as a noun, “Manufacture”
or “Manufacturing” means any and all activities
involved in Manufacturing a compound or product or any component
thereof.
“NDA”
means a new drug application or marketing authorization application
filed with the applicable Regulatory Authority in a Jurisdiction,
including without limitation an imported drug license application,
which application is required for marketing approval for a
pharmaceutical product.
“Net
Sales” means: (a) with respect to a Product, the gross
amounts invoiced or otherwise billed by Fosun and its Affiliates
and Sublicensees with respect to sales of such Product to Third
Parties in the Territory, less in each (i) case sales returns and
allowances actually paid or granted in the ordinary course of
business, including trade, quantity and cash discounts, adjustments
granted on account of rejected goods, damaged or defective goods,
recalls, returns, rebates, chargeback rebates, (ii) customs or
excise duties, sales tax, consumption tax, value added tax, and
other taxes (except income taxes) or duties relating to sales, to
the extent paid or allowed by the selling party, (iii) any payment
in respect of sales to the United States government, any state
government or any foreign government, or to any other Governmental
Authority, or with respect to any government-subsidized program or
managed care organization, and (iv) freight and insurance (to the
extent that Fosun, its Affiliates or its Sublicensees bear the cost
of freight and insurance for the Product). Net Sales shall be
determined from books and records maintained in accordance with
GAAP, as consistently applied by Fosun with respect to sales of the
Product.
Exhibits-5
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
“Palatin
Know-How” means any and all Know-How that (a) is Controlled
by Palatin or any of its Affiliates as of the Effective Date or
that comes into the Control of Palatin or any of its Affiliates
during the Term (other than through the grant of a license by
Fosun), (b) relates to any Compound, Product, Pharmaceutical
Product or Product Delivery Device or to the Development,
Manufacture, Commercialization or use of any of the foregoing and
(c) is necessary or useful in connection with the Development,
Manufacture, use or Commercialization of any Compound, Product,
Pharmaceutical Product or Product Delivery Device.
“Palatin
Patent Right” means any Patent Right that (a) is Controlled
by Palatin or any of its Affiliates as of the Effective Date or
comes into the Control of Palatin or any of its Affiliates during
the Term (other than through the grant of a license by Fosun) and
(b) claims any (i) Compound,
Product, Pharmaceutical Product or Product Delivery Device
(including the composition of matter thereof), (ii) method of
making any Compound, Product, Pharmaceutical Product or Product
Delivery Device, (iii) methods of using any Compound, Product,
Pharmaceutical Product or Product Delivery Device, or (iv) Palatin
Know-How. For the avoidance of doubt, and without limiting the
foregoing, Palatin Patent Rights include the Patent Rights listed
in Exhibit B.
“Palatin
Technology” means any and all Palatin Patent Rights and
Palatin Know-How.
“Patent
Rights” means any and all (a) issued patents,
(b) pending patent applications, including all provisional
applications, substitutions, continuations, continuations-in-part,
divisions and renewals, and all patents granted thereon, (c)
patents-of-addition, reissues, reexaminations and extensions or
restorations by existing or future extension or restoration
mechanisms, including patent term adjustments, patent term
extensions, supplementary protection certificates or the equivalent
thereof, (d) inventor’s certificates, (e) other forms of
government-issued rights substantially similar to any of the
foregoing, including utility model patents in the Territory, and
(f) United States and foreign counterparts of any of the
foregoing.
“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 or
department or agency of a government.
“Pharmaceutical
Product” means any pharmaceutical product containing one or
more Compounds, whether as sole active ingredients or in
combination with other active ingredients.
“Pivotal
Study” means a Clinical Trial designed to confirm the
preliminary evidence that an investigational product is safe and
effective for use in the intended indication and recipient
population and intended to support Regulatory Approval by a
Regulatory Authority.
Exhibits-6
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
“Price
Approval” means, in any country or regulatory jurisdiction
where a Governmental Authority authorizes reimbursement for, or
approves or determines pricing for, pharmaceutical products,
receipt (or, if required to make such authorization, approval or
determination effective, publication) of such reimbursement
authorization or pricing approval or determination (as the case may
be).
“Product”
means any combination of (a) any Pharmaceutical Product and (b) any
Product Delivery Device.
“Product
Delivery Device” means any device for delivery or
administration of a Pharmaceutical Product.
“Regulatory
Approval” means all technical, medical and scientific
licenses, registrations, authorizations and approvals (including
approvals of NDAs, supplements and amendments, pre- and post-
approvals, Price Approvals, and labeling approvals) of any
Regulatory Authority, necessary for the use, Development,
Manufacture, and Commercialization of a pharmaceutical product in a
regulatory jurisdiction. For the sake of clarity, Regulatory
Approval shall not be achieved for a Product in a Jurisdiction
until all applicable Price Approvals have also been obtained by
Fosun or its designee for such Product in such
Jurisdiction.
“Regulatory
Authority” means, with respect to a Jurisdiction in the
Territory, any national (e.g., the FDA), supra-national, regional,
state or local regulatory agency, department, bureau, commission,
council or other Governmental Authority involved in the granting of
a Regulatory Approval or, to the extent required in such
Jurisdiction, Price Approval, for pharmaceutical products in such
Jurisdiction, including, without limitation, the CDE and the
CFDA.
“Regulatory
Exclusivity Period” means with respect to any particular
Product in any particular Jurisdiction in the Territory, the period
of time during which the data and information submitted by Fosun or
any of its Affiliates or Sublicensees to the relevant Regulatory
Authority in such Jurisdiction for purposes of obtaining Regulatory
Approval may not be disclosed, referenced or relied upon in any way
by such Regulatory Authority (including by relying upon the
Regulatory Authority’s previous findings regarding the safety
or effectiveness of the Product) to support the Regulatory Approval
or Commercialization of any product by a Third Party in such
Jurisdiction.
Exhibits-7
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
“Relevant
Factors” means all relevant factors that may affect the
Development, Regulatory Approval or Commercialization of a
Compound, Product, Pharmaceutical Product or Product Delivery
Device, including (as applicable): actual and potential issues of
safety, efficacy or stability; product profile (including product
modality, category and mechanism of action); stage of development
or life cycle status; actual and projected Development, Regulatory
Approval, Manufacturing, and Commercialization costs; any issues
regarding the ability to Manufacture or have Manufactured any
Compound, Product, Pharmaceutical Product or Product Delivery
Device; the likelihood of obtaining Regulatory Approvals (including
satisfactory Price Approvals); the timing of such approvals; the
current guidance and requirements for Regulatory Approval for the
Product and similar products and the current and projected
regulatory status; labeling or anticipated labeling; the
then-current competitive environment and the likely competitive
environment at the time of projected entry into the market; past
performance of the Product or similar products; present and future
market potential; existing or projected pricing, sales,
reimbursement and profitability; pricing or reimbursement changes
in relevant countries; proprietary position, strength and duration
of patent protection and anticipated exclusivity; and other
relevant scientific, technical, operational and commercial
factors.
“Representatives”
means (a) with respect to Fosun, Fosun, its Affiliates, its
Sublicensees and each of their respective officers, directors,
employees, consultants, contractors and agents and (b) with respect
to Palatin, Palatin, its Affiliates and each of their respective
officers, directors, employees, consultants, contractors and
agents.
“Royalty
Term” means, with respect to any particular Product in any
particular Jurisdiction in the Territory, the period commencing
with the First Commercial Sale of such Product in such Jurisdiction
and continuing until the latest of (a) expiration or termination of
all regulatory approvals for the Product in any Jurisdiction,
including any renewal thereof, (b) the earliest date on which there
are no Valid Claims of Palatin Patent Rights Covering such Product
in such Jurisdiction, (c) the last day of the Regulatory
Exclusivity Period for such Product in such Jurisdiction and (d)
the tenth (10th) anniversary of the
First Commercial Sale of the Product in such Jurisdiction. For the
avoidance of doubt, the Royalty Term for a given Product in a given
Jurisdiction in the Territory (i) will not begin until the First
Commercial Sale of such Product in such Jurisdiction and (ii) if
not previously expired, will expire immediately upon expiration or
termination of this Agreement.
“Safety
Data” means Data related solely to any adverse drug
experiences and serious adverse drug experience as such information
is reportable to Regulatory Authorities in or outside the
Territory. Safety Data also includes “adverse events”,
“adverse drug reactions” and “unexpected adverse
drug reactions” as defined in the ICH Harmonised Tripartite
Guideline for Clinical Safety Data Management: Definitions and
Standards for Expedited Reporting.
“Sublicensee”
means any Person to whom Fosun grants or has granted, directly or
indirectly, a sublicense of rights licensed by Palatin to Fosun
under this Agreement.
“Territory”
means, collectively, the Jurisdictions.
“Third
Party” means any Person other than Fosun, Palatin or their
respective Affiliates.
“Trademark”
means any trademark, trade name, service xxxx, service name, brand,
domain name, trade dress, logo, slogan or other indicia of origin
or ownership, including the goodwill and activities associated with
each of the foregoing.
Exhibits-8
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
“Valid
Claim” means, with respect to a particular Jurisdiction, a
claim of an issued and unexpired Palatin Patent Right that (a) has
not been held permanently revoked, unenforceable or invalid by a
decision of a court or other Governmental Authority of competent
jurisdiction, which decision is unappealed or unappealable within
the time allowed for appeal and (b) has not been cancelled,
withdrawn, abandoned, disclaimed or admitted to be invalid or
unenforceable through reissue, disclaimer or
otherwise.
The
following terms are defined in the section of this Agreement listed
opposite each term:
Defined Term
|
Section in Agreement
|
Additional
Third Party License
|
3.4.3(a)
|
Agreement
|
Preamble
|
cGMP
|
4.6.2
|
Continuation
Product
|
8.5.1(a)(v)(A)
|
Development
Milestone Payment
|
3.2
|
Diligence
Issue
|
4.2.4
|
Disclosing
Party
|
6.1
|
Effective
Date
|
Preamble
|
Fosun
|
Preamble
|
Fosun
Indemnified Party
|
9.3
|
Gross
Sales
|
3.4.3(c)
|
Indemnified
Party
|
9.4.1
|
Indemnifying
Party
|
9.4.1
|
Infringement
Claim
|
5.2.6
|
Initial
Payment Date
|
3.1
|
Liability
|
9.2
|
Licensed
Activities
|
5.2.5(a)
|
Litigation
Conditions
|
9.4.2
|
Manufacturing
Know-How
|
4.6.2
|
Marginal
Royalty Rate
|
3.4.1
|
Notice
of Dispute
|
10.9.1
|
Party
or Parties
|
Preamble
|
Palatin
|
Preamble
|
Palatin
Indemnified Party
|
9.2
|
Per
Product Annual Net Sales
|
3.4.1
|
Product
Brands
|
4.5.2
|
Receiving
Party
|
6.1
|
[…***…]
|
[…***…]
|
Sales
Milestone Payment
|
3.3
|
SEC
|
6.3
|
Term
|
8.2
|
Third
Party Claim
|
9.4.1
|
Total
Annual Net Sales
|
3.3
|
U.S.
CPP Holder
|
4.1
|
|
|
Exhibits-9
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
Exhibit B
Palatin Patent Rights Existing as of the Effective
Date
[…***…]
Exhibits-10
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “[…***…]”. A COMPLETE VERSION OF THIS
EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED
UNDER THE SECURITIES ACT OF 1934, AS AMENDED.
Exhibit C
Compounds Existing as of the Effective Date
[…***…]
Exhibit D
Section 7.3.5. Representation
As
disclosed in Palatin’s quarterly report on Form 10-Q for the
quarter ended March 31, 2008, as filed on May 13, 2008, on January
21, 2008, Palatin entered into a settlement agreement and release
with Competitive Technologies, Inc. (“CTI”), resolving
all outstanding disputes between Palatin and CTI. The arbitration
proceeding and the Connecticut Superior Court proceeding were
dismissed with prejudice. The existing license agreement between
CTI and Palatin was terminated. CTI retains all rights to a peptide
called variously MT-II or PT-14, which peptide was developed at the
University of Arizona, and Palatin expressly relinquished all
claims to any contractual or intellectual property rights to that
peptide or any patents licensed under the terminated license
agreement. Palatin retained all rights to bremelanotide, and CTI
expressly relinquished all claims to any contractual or
intellectual property rights to bremelanotide, including any claim
that making, using or selling bremelanotide infringes any patents
licensed under the terminated license agreement. The settlement
agreement and release also includes mutual covenants not to xxx and
releases of all claims by either party against the other based on,
arising out of or in any way involving the subject matter of the
license agreement, the arbitration or the Connecticut Superior
Court proceeding.
Exhibits-11