Blueprint





 









 



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.


 


LICENSE
AGREEMENT


 


by and
between


 



AMAG PHARMACEUTICALS, INC.


 


and


 



PALATIN TECHNOLOGIES, INC.


 



January 8, 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.

	

EFFECTIVENESS;
DEFINITIONS AND INTERPRETATION 



	
 1


	
 

	

1.1.

	

Effectiveness

	

1


	
 

	

1.2.

	

Defined
Terms

	

2


	
 

	

1.3.

	

Interpretation

	

2


	

2.

	

LICENSE GRANTS AND
TECHNOLOGY TRANSFER 



	
 3


	
 

	

2.1.

	

Exclusive License
from Palatin to AMAG

	

3


	
 

	

2.2.

	

Non-Exclusive
License from Palatin to AMAG

	

3


	
 

	

2.3.

	

AMAG
Sublicensees

	

3


	
 

	

2.4

	

[...***...]

	

4


	
 

	

2.5.

	

Right
of Reference

	

4


	
 

	

2.6.

	

No
Implied Rights

	

4


	
 

	

2.7

	

Assignment of
Existing Regulatory Filings

	

4


	
 

	

2.8.

	

Initial
Data Transfer

	

4


	
 

	

2.9.

	

Continuing
Disclosure and Knowledge Transfer

	

5


	

3.

	

PAYMENTS BY AMAG
TO PALATIN 



	
 5


	
 

	

3.1.

	

Initial
Research Payment

	

5


	
 

	

3.2.

	

Ongoing
Program Expenses

	

5


	
 

	

3.3.

	

Development
Payments

	

6


	
 

	

3.4.

	

Sales
Milestone Payments

	

6


	
 

	

3.5.

	

Royalty
Payments

	

7


	
 

	

3.6.

	

Reports
and Payments

	

8


	
 

	

3.7.

	

No
Guarantee of Success

	

11


	

4.

	

PALATIN
DEVELOPMENT OBLIGATIONS 



	
 11


	
 

	

4.1.

	

Overview

	

11


	
 

	

4.2.

	

Governance

	

12


	

5.

	

PRODUCT
DEVELOPMENT AND COMMERCIALIZATION 



	
 13







 




 

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.


 


	
 

	

5.1.

	

General

	

13


	
 

	

5.2.

	

Diligence

	

13


	
 

	

5.3.

	

Regulatory
Approvals

	

15


	
 

	

5.4.

	

Adverse
Event Reporting

	

15


	
 

	

5.5.

	

Commercialization
Activities

	

16


	
 

	

5.6.

	

Manufacturing

	

17


	
 

	

5.7.

	

Other
AMAG Programs

	

19


	

6.

	

INTELLECTUAL
PROPERTY 



	
 19


	
 

	

6.1.

	

Ownership
of Intellectual Property

	

19


	
 

	

6.2.

	

Patent
Rights

	

20


	
 

	

6.3.

	

Enforcement
and Defense of Know-How

	

25


	
 

	

6.4.

	

Recording

	

26


	

7.

	

CONFIDENTIALITY

	




	
 26


	
 

	

7.1.

	

Confidentiality

	

26


	
 

	

7.2.

	

Authorized
Disclosure

	

26


	
 

	

7.3.

	

SEC
Filings and Other Disclosures

	

27


	
 

	

7.4.

	

Public
Announcements; Publications

	

28


	
 

	

7.5.

	

Obligations
in Connection with Change of Control

	

28


	

8.

	

REPRESENTATIONS
AND WARRANTIES; COVENANTS; SECURITY INTEREST 



	
 28







 




 

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.


 


	
 

	

8.1.

	

Mutual
Representations and Warranties

	

28


	
 

	

8.2.

	

Mutual
Covenants

	

29


	
 

	

8.3.

	

Representations
and Warranties of Palatin

	

29


	
 

	

8.4.

	

Palatin
Covenants

	

32


	
 

	

8.5.

	

Disclaimer

	

34


	

9.

	

GOVERNMENT
APPROVALS; REMEDY; TERM AND TERMINATION 



	
 34


	
 

	

9.1.

	

HSR
Filing

	

34


	
 

	

9.2.

	

Intentionally
Omitted

	

34


	
 

	

9.3.

	

Other
Government Approvals

	

34


	
 

	

9.4.

	

Term

	

34


	
 

	

9.5.

	

Termination
by Palatin

	

34


	
 

	

9.6.

	

Termination
by AMAG

	

35


	
 

	

9.7.

	

Effects
of Termination

	

35


	
 

	

9.8.

	

Provisions
for Insolvency

	

38


	

10.

	

LIMITATION ON
LIABILITY, INDEMNIFICATION AND INSURANCE 



	
 39


	
 

	

10.1.

	

No
Consequential Damages

	

39


	
 

	

10.2.

	

Indemnification
by AMAG

	

40


	
 

	

10.3.

	

Indemnification
by Palatin

	

40


	
 

	

10.4.

	

Procedure

	

40


	
 

	

10.5.

	

Insurance

	

42


	

11.

	

MISCELLANEOUS




	
 42


	
 

	

11.1.

	

Assignment

	

42


	
 

	

11.2.

	

Change
of Control of Palatin

	

43


	
 

	

11.3.

	

Further
Actions

	

43


	
 

	

11.4.

	

Force
Majeure

	

43


	
 

	

11.5.

	

Notices

	

43







 




 

iii








 






 


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.


 


	
 

	

11.6.

	

Amendment

	

44


	
 

	

11.7.

	

Waiver

	

44


	
 

	

11.8.

	

Severability

	

44


	
 

	

11.9.

	

Descriptive
Headings

	

45


	
 

	

11.10.

	

Dispute
Resolution

	

45


	
 

	

11.11.

	

Governing
Law

	

45


	
 

	

11.12.

	

Consent
to Jurisdiction

	

45


	
 

	

11.13.

	

Entire
Agreement

	

46


	
 

	

11.14.

	

Representation
by Legal Counsel

	

46


	
 

	

11.15.

	

Independent
Contractors

	

46


	
 

	

11.16.

	

Counterparts

	

46


	
 

	

11.17.

	

No
Third Party Rights or Obligations

	

46







 




 

iv








 






 


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 Execution Date


	
 

	
 


	

Exhibit C

	

Compounds
Existing as of the Execution Date







 




 

v








 






 


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.


 



SCHEDULES


 


	

Schedule
2.11

	

Assigned
Contracts


	
 

	
 


	

Schedule
3.5.1

	

Marginal
Royalty Rate Calculation Example


	
 

	
 


	

Schedule
4.1(a)

	

Palatin
Development Obligations — Activities Necessary to File
NDA


	
 

	
 


	

Schedule
4.1(b)

	

Palatin
Development Obligations — Assistance Necessary to Secure
Regulatory Approval


	
 

	
 


	

Schedule
5.5.2(b)

	

Product
Brands


	
 

	
 


	

Schedule
7.4.1

	

Public
Announcement


	
 

	
 


	

Schedule
8.3.1

	

Exceptions
to Palatin’s Exclusive Ownership of Palatin
Technology


	
 

	
 


	

Schedule
8.3.6

	

Known
Infringement of Palatin Patent Rights


	
 

	
 


	

Schedule
8.3.8

	

Exceptions
to Palatin’s Rights under Palatin Know-How


	
 

	
 


	

Schedule
8.3.12

	

Disclosed
Third Party Agreements







 




 

vi








 






 


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.


 



LICENSE AGREEMENT


 


This
License Agreement (the “Agreement”) is entered into as
of January 8, 2017 (the “Execution Date”), by and
between AMAG Pharmaceuticals, Inc., a corporation organized
and existing under the laws of Delaware and having a principal
place of business at 1100 Winter Street, Waltham, MA 02451
(“AMAG”) 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, Cranbury, NJ 08512
(“Palatin”). AMAG 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, AMAG 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 AMAG, and
AMAG wishes to receive from Palatin, (a) an exclusive license
in the Territory to use, research, develop, manufacture and
commercialize Compounds and Products (as defined below) and
(b) a non-exclusive license to research, develop and
manufacture (but not commercialize) Compounds and Products in all
countries outside of the Territory.


 


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. 

EFFECTIVENESS; DEFINITIONS AND
INTERPRETATION.






 


1.1.           Effectiveness.
The provisions of Sections 2, 3, 4, 5 and 6 of this Agreement
(collectively, the “Contemplated Transactions”) shall
be effective and binding on the Parties as of 9:00
a.m. (United States Eastern time) on a date to be specified by
the Parties, such date to be no later than the second (2nd)
Business Day after satisfaction or waiver of all of the conditions
set forth in this Section 1.1 (the “Effective
Date”), unless another date is agreed to in writing by the
Parties. The remaining provisions of this Agreement shall be
effective and binding on the Parties as of the Execution
Date.


 


1.1.1.           The
obligations of each Party to consummate the Contemplated
Transactions are subject to the fulfillment, or to the extent
permitted by applicable Law, waiver by the applicable Party, of the
following condition (the “Mutual
Condition”):


 


(a)           (1) a
determination by AMAG that the SEC Financial Statements are not
required to be filed by AMAG pursuant to Section 8.4.9 or
(2) if AMAG


 




 

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.


 


determines that the
SEC Financial Statements are required to be filed by AMAG pursuant
to Section 8.4.9, Palatin has delivered the SEC Financial
Statements to AMAG pursuant to, and in compliance with, the terms
of Section 8.4.9.


 


1.1.2.           The
obligations of AMAG to consummate the Contemplated Transactions are
subject to the fulfillment, or to the extent permitted by
applicable Law, waiver by AMAG, in its sole discretion, of the
following conditions (the “AMAG Conditions” and
together with the Mutual Condition, the “Effectiveness
Conditions”):


 


(a)           Palatin
shall have obtained the prior written consent and acknowledgement
of the Horizon Lenders that the Contemplated Transactions
constitute a “Permitted License” as defined under the
Horizon Agreement and shall not constitute an event of default or
other breach by Palatin under the Horizon Agreement;


 


(b)           Palatin
shall have obtained the prior written consent and acknowledgment of
Catalent Belgium S.A. (“Catalent”) that the
Contemplated Transactions do not constitute a “Change of
Control” under either of the Catalent Agreements, and that
the only amounts payable to Catalent in connection with the
Contemplated Transactions are those set forth under
Section 3.3 of the Catalent Services Agreement;
and


 


(c)           Palatin
shall have obtained the prior written consent and acknowledgement
of Catalent to the assignment of each of the Catalent Agreements to
AMAG, which consent and acknowledgement shall further state that
Catalent (i) acknowledges that the Catalent Agreements are and
shall continue to be in full force and effect following the
Effective Date, (ii) waives any right of termination Catalent
may have under the Catalent Agreements as a result of the
Contemplated Transactions and (iii) confirms that there is
currently no default existing under the Catalent Agreements that
has not been cured and that Catalent is not aware of any event or
condition, which with the passage of time or the giving of notice,
or both, would constitute a default under the Catalent
Agreements.


 


1.2.           Defined
Terms. Capitalized terms not otherwise defined herein shall
have the meanings set forth in Exhibit A.


 


1.3.           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”,


 








 

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.


 


“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, the Parties or any committee hereunder “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. 

LICENSE GRANTS AND TECHNOLOGY
TRANSFER.






 


2.1.           Exclusive
License from Palatin to AMAG. As of the Effective Date,
Palatin hereby grants to AMAG (a) an exclusive license
(exclusive even as to Palatin) under the Palatin Technology and
Palatin’s interest in the Joint Technology, to use, have
used, Develop, have Developed, Commercialize and have
Commercialized (but not to Manufacture or have Manufactured)
Compounds, Products, Pharmaceutical Products and Product Delivery
Devices, and otherwise practice and exploit the Palatin Technology
and Palatin’s interest in the Joint Technology, and
(b) a non-exclusive license under the Palatin Technology and
Palatin’s interest in the Joint Technology, to 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 AMAG. As of the Effective Date,
Palatin hereby grants to AMAG a non-exclusive license under the
Palatin Technology and Palatin’s interest in the Joint
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
and Palatin’s interest in the Joint Technology, in the Field
in all countries of the world outside the Territory, solely for
purposes of Developing and Manufacturing Compounds, Products,
Pharmaceutical Products and Product Delivery Devices for
Commercialization in the Territory.


 


2.3.           AMAG
Sublicensees. AMAG shall have the right to grant
sublicenses, directly or indirectly, to its Affiliates and Third
Parties of any and all rights granted to AMAG under this Agreement
by Palatin, including any and all rights licensed to AMAG 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. AMAG 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. AMAG shall be
responsible for the acts and omissions of its Sublicensees. AMAG
shall deliver to Palatin a true, accurate and complete copy of
each


 








 

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.


 


sublicense
agreement entered into by AMAG, and any modification or termination
thereof, within [...***...] after the applicable execution,
modification or termination of the sublicense agreement;
provided, however, that AMAG may make appropriate
redactions to such sublicense agreements prior to delivery to
Palatin.


 


2.4.           [...***...]


 


2.4.1.           [...***...]


 


2.4.2.           [...***...]


 


2.4.3.           Confidentiality.
Notwithstanding any provision of this Agreement to the contrary,
all information of the Parties, their Affiliates or their licensees
or sublicensees that is disclosed to the other Party under this
Section 2.4 shall be deemed to be the Confidential Information
of the disclosing Party and subject to the provisions of
Section 7.


 


2.5.           Right
of Reference. Palatin hereby grants to AMAG a “Right
of Reference,” as that term is defined in 21 C.F.R. §
314.3(b) (or any analogous Law recognized outside of the
United States), to all Data Controlled by Palatin or its Affiliates
that relate to any Compound, Product, Pharmaceutical Product or
Product Delivery Device, and Palatin shall provide a signed
statement to this effect, if requested by AMAG, in accordance with
21 C.F.R. § 314.50(g)(3) (or any analogous Law outside of
the United States).


 


2.6.           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.


 


2.7.           Assignment
of Existing Regulatory Filings. Within a reasonable time not
to exceed [...***...] following the Effective Date, Palatin
shall (a) transfer title and assign to AMAG all Regulatory
Approval applications and other filings with Regulatory Authorities
(including INDs) owned or Controlled by Palatin or its Affiliates
with respect to any Compound, Product, Pharmaceutical Product or
Product Delivery Device in the Territory in the field of female
sexual dysfunction (including the Initial Indication) and
(b) deliver to AMAG true and complete copies of (i) each
of the foregoing applications and filings and (ii) all
correspondence with any Regulatory Authority(ies) relating to any
of the foregoing. Within a reasonable time not to exceed
[...***...] following the Effective Date, Palatin shall
(1) transfer title and assign to AMAG all other Regulatory
Approval applications and other filings with Regulatory Authorities
(including INDs) owned or Controlled by Palatin or its Affiliates
with respect to any Compound, Product, Pharmaceutical Product or
Product Delivery Device in the Territory and (2) deliver to
AMAG true and complete copies of (A) each of the foregoing
applications and filings and (B) all correspondence with any
Regulatory Authority(ies) relating to any of the
foregoing.


 


2.8.           Initial
Data Transfer. Within a reasonable time not to exceed
[...***...] following the Effective Date, Palatin shall
disclose to AMAG all Palatin Know-How necessary or useful in
connection with securing Regulatory Approval and Commercializing
Products in the


 




 

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.


 


Territory,
together with such additional Palatin Know-How as AMAG may
reasonably request, in each case to the extent developed 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 AMAG
may reasonably request (including by download of digital files to a
secure website or e-room designated and controlled by
AMAG).


 


2.9.           Continuing
Disclosure and Knowledge Transfer. On a Calendar Quarter
basis, or more frequently at the reasonable request of AMAG during
the Term, Palatin shall disclose to AMAG any Palatin Know-How
developed by Palatin since Palatin’s most recent disclosure.
Such disclosure shall be in either the format in which such Palatin
Know-How then exists or in such other format as AMAG may reasonably
request (including by download of digital files to a secure website
or e-room designated and controlled by AMAG). Further, Palatin
shall make appropriate personnel available to AMAG at reasonable
times and places and upon reasonable prior notice for the purpose
of assisting AMAG to understand and use the Palatin Technology in
connection with AMAG’s Development, Manufacture,
Commercialization and use of Compounds and Products.


 


2.10.           Palatin
Non-Competition Obligations. During the Term, Palatin shall
not, directly or indirectly, itself or through any Affiliate,
licensee or Third Party, Commercialize in the Territory any product
in the field of female sexual dysfunction (including the Initial
Indication). For the avoidance of doubt, Palatin may, during the
Term, Commercialize melanocortin agonists, including melanocortin
receptor-4 agonists but excluding Compounds, in the Territory for
indications other than in the field of female sexual
dysfunction.


 


2.11.           Assignment
of Contracts. On the Effective Date, Palatin will assign,
and will cause its Affiliates to assign, to AMAG all contracts
listed on Schedule 2.11 (the “Assigned
Contracts”).


 


2.12.           Palatin
Retained Rights. Notwithstanding the rights granted to AMAG
in Section 2.1 and Section 2.2, and without limiting the
generality of Section 2.6, the Parties acknowledge that
Palatin retains the right to practice the Palatin Technology in the
Territory to fulfill its obligations under this Agreement,
including the Palatin Development Activities.


 



3. 

PAYMENTS BY AMAG TO
PALATIN.






 


3.1.           Initial
Research Payment. AMAG shall pay to Palatin (a) a
one-time payment of sixty million dollars ($60,000,000) minus the
Holdback Amount, within five (5) days following the Effective
Date, and (b) a one-time payment equal to the Holdback Amount,
within [...***...] following the later of the Effective Date and
the date of AMAG’s receipt of written confirmation from
Catalent that it has received all amounts payable to Catalent
arising from or in connection with the Contemplated Transactions.
The “Holdback Amount” shall be equal to
[...***...].


 


3.2.           Ongoing
Program Expenses. AMAG shall reimburse Palatin for all
reasonable, documented, direct out-of-pocket costs (with no markup)
incurred by Palatin following the Effective Date in the performance
of Palatin’s obligations pursuant to Section 4.1 (such
costs, the “Ongoing Program Expenses”) up to an
aggregate amount of twenty-five million dollars


 




 

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.


 


($25,000,000)
(the “Program Expense Cap”). Unless otherwise approved
by the JSC, such direct out-of-pocket costs shall not exceed to any
material extent the budgeted costs approved by the JSC pursuant to
Section 4.2.3. Palatin shall invoice AMAG for Ongoing Program
Expenses on a monthly basis within [...***...] following
the end of each calendar month, and each such invoice shall be
accompanied by reasonable supporting documentation evidencing the
amounts reflected in such invoice. Absent AMAG contesting, in good
faith, the amounts reflected in an invoice, payment shall be due
within [...***...] following AMAG’s receipt of each
such properly documented invoice. Notwithstanding any provision of
this Agreement to the contrary, the
[...***...].


 


3.3.           Development
Payments. In consideration of Palatin’s performance
under Section 4.1, AMAG shall pay Palatin the amounts set
forth below within [...***...] following the first
occurrence of each event described below for the first Product to
achieve such event (each, a “Development
Payment”).


 


	
 

	
 

	


Development Event

	
 

	


Development Payment


	

(i)

	
 

	

Acceptance
of an NDA by the FDA with respect to the Initial
Indication

	
 

	

[...***...]


	

(ii)

	
 

	

Regulatory
Approval in the United States with respect to the Initial
Indication

	
 

	

[...***...]







 


Each of
the Development Payments 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). No Development Payments shall be payable
for any subsequent Product regardless of the number of Products
Developed. The maximum aggregate amount payable by AMAG in respect
of Development Payments if all Development Events occur on or prior
to [...***...] shall be eighty million dollars
($80,000,000).


 


3.4.           Sales
Milestone Payments. AMAG 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 exceeding $250 million

	
 

	

$25,000,000


	

Total
Annual Net Sales exceeding [...***...]

	
 

	

[...***...]


	

Total
Annual Net Sales exceeding [...***...]

	
 

	

[...***...]


	

Total
Annual Net Sales exceeding [...***...]

	
 

	

[...***...]







 




 

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.


 


AMAG
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 AMAG in respect of Sales Milestone Payments shall be
three hundred million dollars ($300,000,000).


 


3.5.           Royalty
Payments.


 


3.5.1.           Royalties.
Subject to the provisions of Section 3.5.3, AMAG 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 [...***...]

	
 

	

[...***...]


	

Per
Product Annual Net Sales above [...***...]

	
 

	

[...***...]


	

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. An example calculation of royalties under this
Section 3.5.1 is set forth in Schedule 3.5.1.


 


3.5.2.           Fully
Paid-Up, Royalty Free License. Following expiration of the
Royalty Term for any Product in a given country, no further
royalties shall be payable in respect of sales of such Product in
such country and, thereafter the license granted to AMAG under
Sections 2.1 and 2.2 with respect to such Product in such country
shall automatically become fully paid-up, perpetual, irrevocable
and royalty-free.


 


3.5.3.           Royalty
Adjustments. The following adjustments shall be made, on a
Product-by-Product and country-by-country basis, to the royalties
payable pursuant to Section 3.5.1, in each case, subject to
the limitations set forth in Section 3.5.4:


 


(a)           Third
Party Patents. If it is necessary or desirable for AMAG 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 AMAG Affiliate or Sublicensee, then
AMAG may, in its sole


 




 

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.


 


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 AMAG, its Affiliates or Sublicensees
shall be reduced by [...***...], 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. 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, in
each case, other than the Assigned Contracts, and (ii) all
payments to inventors (other than inventors that are
Representatives of AMAG) of Palatin Technology or Joint Technology,
including payments under inventorship compensation
Laws.


 


(c)           Generic
Entry. As used in this Section 3.5(c), “Generic
Competition” means, with respect to a given Product in a
given country in the Territory, that (a) one or more Generic
Products to such Product are available in such country 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 country in the
Territory, any royalty payments owed with respect to such Product
in such country pursuant to this Section 3.5 shall be reduced
by [...***...].


 


3.5.4.           Limitations
on Adjustments. Notwithstanding anything herein to the
contrary, in no event shall the royalties payable to Palatin for
any Product under this Agreement [...***...].


 


3.6.           Reports
and Payments.


 


3.6.1.           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.


 


3.6.2.           Royalty
Statements and Payments. Within [...***...] of the
end of each Calendar Quarter, AMAG shall deliver to Palatin a
report setting forth the following information for such Calendar
Quarter, on a Product-by-Product, country-by-country 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 countries 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.


 




 

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.


 


3.6.3.           Taxes
and Withholding. It is understood and agreed between the
Parties that any payments made by AMAG under this Agreement are
inclusive of any value added or similar tax imposed upon such
payments. In addition, in the event any payments made by AMAG
pursuant to this Agreement become subject to withholding taxes
under the Laws or regulations of any jurisdiction or Governmental
Authority, AMAG 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 AMAG
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. AMAG will provide
Palatin with reasonable assistance to enable Palatin to recover
such taxes as permitted by applicable Laws or
regulations.


 


3.6.4.           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 AMAG 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,
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 AMAG may
elect, in its sole discretion, to deliver such payment in the
relevant jurisdiction and in the local currency of the relevant
jurisdiction.


 


3.6.5.           Method
of Payment. Except as permitted pursuant to
Section 3.6.4, 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 AMAG’s
election, to such bank account as Palatin shall designate in
writing to AMAG at least [...***...] before the payment is
due.


 


3.6.6.           Record
Keeping. AMAG shall keep and shall cause its Affiliates 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. AMAG 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.


 


3.6.7.           Audits.


 


(a)           Palatin
Audit Rights. Upon [...***...] prior notice from
Palatin, AMAG shall permit an independent certified public
accounting firm of nationally recognized standing selected by
Palatin and reasonably acceptable to AMAG, to examine, at
Palatin’s sole expense, the relevant books and records of
AMAG and


 




 

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.


 


its
Affiliates as may be reasonably necessary to verify the amounts
reported by AMAG in accordance with Section 3.6.2 and the
payment of royalties and Sales Milestone Payments hereunder. An
examination by Palatin under this Section 3.6.7(a) 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 AMAG’s or its Affiliates’ facility(ies) where such
books and records are normally kept and such examination shall be
conducted during AMAG’s normal business hours. AMAG may
require the accounting firm to sign a reasonably acceptable
non-disclosure agreement before providing the accounting firm with
access to AMAG’s or its Affiliates’ facilities or
records. Upon completion of the audit, the accounting firm shall
provide both AMAG and Palatin a written report disclosing any
discrepancies in the reports submitted by AMAG or the royalties or
Sales Milestone Payments paid by AMAG, and, in each case, the
specific details concerning any discrepancies.


 


(b)           AMAG
Audit Rights. Upon [...***...] prior notice from
AMAG, Palatin shall permit AMAG or an independent certified public
accounting firm of nationally recognized standing selected by AMAG
and reasonably acceptable to Palatin, to examine, at AMAG’s
sole expense, the relevant books and records of Palatin and its
Affiliates as may be reasonably necessary to verify Ongoing Program
Expenses invoiced to AMAG pursuant to Section 3.2. An
examination by AMAG under this Section 3.6.7(b) 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 three (3) years before the date of the request. AMAG
or the accounting firm, as applicable, 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, AMAG or the accounting firm, as applicable, shall provide
Palatin a written report disclosing any discrepancies in the
Ongoing Program Expenses reported by Palatin or the corresponding
reimbursements paid by AMAG, and, in each case, the specific
details concerning any discrepancies.


 


3.6.8.           Underpayments/Overpayments.
If any audit conducted pursuant to
Section 3.6.7(a) concludes that additional royalties or
Sales Milestone Payments were due to Palatin, then AMAG will pay to
Palatin the additional royalties or Sales Milestone Payments, plus
interest on the deficient amount, as calculated pursuant to
Section 3.6.9, within [...***...] of the date AMAG
receives such accountant’s written report.
[...***...]. If any audit conducted pursuant to
Section 3.6.7(a) concludes that AMAG overpaid royalties
or Sales Milestone Payments to Palatin, or if any audit conducted
pursuant to Section 3.6.7(b) concludes that Palatin
overcharged AMAG reimbursements for Ongoing Program Expenses to
Palatin, then Palatin will refund such overcharges or


 




 

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.


 


overpayments to
AMAG, plus interest as calculated pursuant to Section 3.6.9,
within [...***...] of the date Palatin receives the
applicable audit report. [...***...]


 


3.6.9.           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, 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, or, if
lower, the maximum rate permitted by law, 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.


 


3.6.10.                      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 7.


 


3.7.           No
Guarantee of Success. AMAG and Palatin acknowledge and agree
that payments to Palatin pursuant to Section 3.3,
Section 3.4 and Section 3.5: (a) have been included
in this Agreement on the basis that they are only payable or
otherwise relevant if a Product is successfully Developed or
Commercialized, as applicable; and (b) are not intended to be
used and will not be used as a measure of damages if this Agreement
is terminated for any reason, including pursuant to AMAG’s
right to terminate for convenience, before any such success is
achieved and such amounts become due.


 



4. 

PALATIN
DEVELOPMENT OBLIGATIONS






 


4.1.           Overview.
Palatin shall (a) use diligent efforts to conduct all
development and regulatory activities, including clinical and CMC
activities, necessary to file an NDA for a Product for the Initial
Indication in the United States (including without limitation all
activities set forth in Schedule 4.1(a)), and (b) upon
AMAG’s request, provide AMAG with reasonable assistance
necessary for AMAG to secure Regulatory Approval for such NDA
(including without limitation all assistance set forth in Schedule
4.1(b)) (clauses (a) and (b), collectively the “Palatin
Development Activities”). For the avoidance of doubt, Palatin
Development Activities shall not include marketing, market
research, commercialization plans or activities, pre-launch support
or production of inventory in anticipation of launch.
Palatin’s obligations under this Section 4.1 shall
endure until they are successfully completed, regardless of whether
Palatin’s costs of performing such obligations exceed the
Program Expense Cap. Notwithstanding any provision of this
Agreement to the contrary, AMAG may elect to perform one or more
Palatin Development Activities itself, through its Affiliates or
using Third Party contractors selected by AMAG.


 




 

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.


 


4.2.           Governance.


 


4.2.1.           Joint
Steering Committee. The Parties hereby establish a joint
steering committee (the “JSC”) as of the Effective Date
to review, approve and oversee the Palatin Development Activities
as described below.


 


(a)           Composition
of the Joint Steering Committee. The JSC shall be comprised
of [...***...]. Each Party shall appoint its respective
representatives to the JSC and may substitute any of its
representatives, in its sole discretion, effective upon notice to
the other Party of such change. Additional representatives or
consultants may from time to time, by mutual consent of the
Parties, be invited to attend JSC meetings, subject to such
representatives and consultants undertaking confidentiality
obligations, whether in a written agreement or by operation of law,
no less stringent than the confidentiality provisions of this
Agreement.


 


(b)           JSC
Chairperson. The JSC Chairperson shall be a representative
of AMAG.


 


4.2.2.           Meetings.
During the Development Term, the JSC shall meet in accordance with
a schedule established by mutual written agreement of the Parties,
but no less frequently than (a) once per month until the
filing of an NDA for a Product for the Initial Indication in the
United States and (b) once per Calendar Quarter thereafter, at
a location mutually agreed by the Parties. Alternatively, the JSC
may meet by means of teleconference, videoconference or other
similar means of communication. Each Party shall bear its own
expenses relating to attendance at such meetings by its
representatives.


 


4.2.3.           JSC
Responsibilities. The JSC shall have the following
responsibilities:


 


(a) reviewing,
approving, monitoring and overseeing all Palatin Development
Activities, including ensuring AMAG’s ability to review and
comment on all materials, discussions and strategies related to,
and to attend, as applicable, (i) clinical studies (including
related protocols and final study reports) to be conducted by
Palatin pursuant to the Palatin Development Activities,
(ii) any meetings or discussions with any Regulatory
Authorities with respect thereto, including any pre-NDA meetings
and (iii) interactions with scientific advisors and key
opinion leaders with respect thereto;


 


(b) establishing
procedures for maintaining and recording the costs incurred in
conducting the Palatin Development Activities, and establish and
update as required approved budgets for Palatin Development
Activities;


 


(c) 
establishing procedures to allow AMAG to audit Palatin’s
Third Party vendors with respect to the Palatin Development
Activities;


 


(d) forming
such other committees and sub-committees as the JSC may deem
appropriate, provided that such committees and sub-committees
may


 




 

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.


 


make
recommendations to the JSC but may not be delegated JSC
decision-making authority; and


 


(e) 
performing such other activities as the Parties agree in writing
shall be the responsibility of the JSC.


 


4.2.4.           Action
by Consensus; Final Decision Making Authority. In spite of
the number of AMAG JSC representatives or Palatin JSC
representatives, each Party shall have one vote, and the JSC shall
make decisions by consensus. If the JSC is unable to reach
consensus with respect to a given matter, then the JSC
representatives of either Party may submit such matter to the Chief
Executive Officers of the Parties, or their designees (any such
designee to be a senior member of the designating Chief Executive
Officer’s management team) for resolution. If such matter is
not resolved within [...***...] following such escalation,
then [...***...] shall have final decision-making authority
with respect to such matter.


 


4.2.5.           Limits
on JSC Authority. Notwithstanding any provision of this
Agreement to the contrary, (a) each Party shall retain the
rights, powers and discretion granted to it under this Agreement
and no such rights, powers, or discretion shall be delegated to or
vested in the JSC unless such delegation or vesting of rights is
expressly provided for in this Agreement or the Parties expressly
so agree in writing and (b) the JSC shall not have the power
to amend this Agreement or otherwise modify or waive compliance
with this Agreement in any manner.


 


4.2.6.           Term.
The JSC shall be dissolved immediately upon expiration of the
Development Term unless the Parties otherwise agree in
writing.


 



5. 

PRODUCT DEVELOPMENT AND
COMMERCIALIZATION.






 


5.1.           General.
Subject to the provisions of Section 4, AMAG shall have sole
authority over and control of the Development, Manufacture,
Regulatory Approval and Commercialization of Compounds, Products,
Pharmaceutical Products and Product Delivery Devices in the
Territory.


 


5.2.           Diligence.


 


5.2.1.           Regulatory
Approval. Once Palatin has successfully completed all
Palatin Development Activities necessary to file an NDA for a
Product for the Initial Indication in the United States, and
subject to Palatin’s continuing performance of its
obligations under Section 4.1, AMAG will use Commercially
Reasonable Efforts to secure Regulatory Approval of such NDA in the
United States.


 


5.2.2.           Commercial
Diligence. Once the NDA described in Section 5.2.1 has
received Regulatory Approval in the United States with respect to
the Initial Indication, AMAG will use Commercially Reasonable
Efforts to Commercialize the Product covered by such NDA in the
United States with respect to the Initial Indication.


 




 

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.


 


5.2.3.           Exceptions
to Diligence Obligations. Notwithstanding any provision of
this Agreement to the contrary, AMAG will be relieved of all AMAG
Diligence Obligations to the extent that:


 


(a)           AMAG
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;


 


(b)           AMAG
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 with respect to the Initial
Indication; or


 


(c)           Palatin
fails to satisfactorily perform the Palatin Development Activities
or other obligations under this Agreement and such failure prevents
AMAG from fulfilling the AMAG Diligence Obligations.


 


5.2.4.           Assertion
of AMAG Diligence Obligation Claims. If Palatin is, becomes
or reasonably should be aware of facts that might form a reasonable
basis to allege that AMAG has failed to meet any of its obligations
under Section 5.2.1 or Section 5.2.2, then Palatin will
promptly notify AMAG in writing of such potential alleged
performance failure (each such potential alleged performance
failure, a “Diligence Issue”). Promptly upon
AMAG’s receipt of any notice of a Diligence Issue pursuant to
this Section 5.2.4, AMAG will contact Palatin to discuss the
specific nature of such Diligence Issue and seek to identify an
appropriate corrective course of action. If, no later than
[...***...] after AMAG’s receipt of such a notice,
(a) the Parties have not reached consensus regarding whether
AMAG has failed to satisfy its obligations pursuant to
Section 5.2.1 or Section 5.2.2 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 11.10.


 


5.2.5.           Remedies
for Breach of AMAG Diligence Obligations. If AMAG materially
breaches any AMAG Diligence Obligation and fails to remedy such
breach within [...***...] of AMAG’s receipt of notice
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 9.7.1(a) on a
Product-by-Product and country-by-country basis, but only to the
extent that a Product in a given country in the Territory is
directly and adversely impacted by such uncured material breach or
(b) convert any exclusive license granted to AMAG under this
Agreement with respect to a Product in a given country in the
Territory into non-exclusive license, but only to the extent that
such Product in such country is directly and adversely impacted by
such uncured material breach. Palatin acknowledges and agrees that
the elections set forth in this Section 5.2.5: (i) have
been negotiated by the Parties to fully address any harm that
Palatin may incur as a result of AMAG’s material breach of
the AMAG Diligence Obligations and (ii) constitute
Palatin’s sole and exclusive remedies with respect to any
breach by AMAG of any AMAG Diligence Obligation.


 




 

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.


 


5.2.6.           No
Other Covenants. Except as expressly set forth in
Section 5.2, AMAG makes no representation, warranty or
covenant, either express or implied, that (A) it will
successfully Develop, Manufacture, Commercialize or continue to
Develop, Manufacture or Commercialize any Product in any country,
(B) if Commercialized, that any Product will achieve any
particular sales level, whether in any individual country or
cumulatively throughout the Territory or (C) AMAG will devote,
or cause to be devoted, any level of diligence or resources to
Developing, Manufacturing or Commercializing any Product in any
country, or in the Territory in general.


 


5.3.           Regulatory
Approvals. AMAG or its designated Affiliate(s) or
Sublicensee(s) shall have the sole authority, at their sole
expense except as otherwise set forth in this Agreement, 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, AMAG 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. Palatin shall, and shall require its Affiliates and
sublicensees to, consult and reasonably cooperate with AMAG with
respect to applications for Regulatory Approval of any Products,
Pharmaceutical Products or Product Delivery Devices outside the
Territory, including allowing AMAG a reasonable opportunity and
reasonable time to review and comment regarding relevant
communications with applicable Regulatory Authorities outside the
Territory.


 


5.4.           Adverse
Event Reporting; Pharmacovigilance Agreement. AMAG shall be
solely responsible for maintaining the global safety database for
Products. [...***...]. As between the Parties:
(a) AMAG 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) Palatin or its
licensee(s) 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 with
respect to their respective pharmacovigilance responsibilities, and
each Party shall be solely responsible for costs relating to its
respective pharmacovigilance responsibilities, unless agreed
otherwise by the Parties in writing. Within [...***...]
after the Effective Date, the Parties shall enter into a
pharmacovigilance agreement 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 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.


 




 

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.


 


5.5.           Commercialization
Activities.


 


5.5.1.           General.
AMAG 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.


 


5.5.2.           Branding.


 


(a)           General.
AMAG and its designated Affiliates or Sublicensees shall have the
right to brand all Products in the Territory using any one or more
Trademarks, including any Product Brand, that it determines
appropriate for a Product, which may vary by country or within a
country. AMAG or its designated Affiliates or Sublicensees shall
own all rights, title and interests in and to such Trademarks and
AMAG or such Affiliates or Sublicensees may file, seek registration
of and maintain such Trademarks in the countries and regions they
determine reasonably necessary.


 


(b)           Product
Brands. Promptly upon AMAG’s written request, Palatin
shall assign to, and shall cause its Affiliates to assign to, AMAG
all rights, title and interests in and to all Trademarks owned or
Controlled by Palatin or its Affiliates in the Territory and
intended for use in connection with the Commercialization of any
Product in the Territory (the “Product Brands”).
Without limiting the foregoing, Product Brands includes the
Trademarks and associated registrations and applications listed in
Schedule 5.5.2(b).


 


(c)           License
Prior to Assignment. Effective as of the Effective Date,
Palatin hereby grants to AMAG an exclusive (exclusive even as to
Palatin), sublicensable, royalty-free, fully paid-up, perpetual
license to use the Product Brands in connection with the
Development, Manufacture and Commercialization of Compounds,
Products, Pharmaceutical Products and Product Delivery Devices in
the Territory. For so long as AMAG uses the Product Brands pursuant
to the license set forth in this Section 5.5.2(c), AMAG shall,
and shall cause its Affiliates and Sublicensees to, ensure that the
quality of the Compounds, Products, Pharmaceutical Products and
Product Delivery Devices, and the Manufacture and Commercialization
thereof, marketed under the Product Brands shall be consistent with
the standards of quality customary in the pharmaceuticals industry.
If, during such time, Palatin reasonably objects to a proposed
usage of a Product Brand by AMAG, then it shall give written notice
of such objection to AMAG specifying the way in which such usage of
the Product Brand fails to meet the quality or quality control
standards for such Product Brand, and the Parties shall work in
good faith to ensure that such usage is modified to meet all
applicable quality and quality control standards.


 


(d)           Quiet
Enjoyment. Palatin shall not, and shall ensure that its
Affiliates and sublicensees shall not, contest, oppose or challenge
AMAG’s


 




 

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.


 


license
under, or ownership of, the Product Brands. Neither Palatin nor its
Affiliates or sublicensees shall use or seek to register, anywhere
in the world, any Trademark (other than the registration of Product
Brands outside the Territory) which is confusingly similar to any
Trademark used by or on behalf of AMAG, its Affiliates or
Sublicensees in connection with any Product, or otherwise do or
suffer to be done any act or thing that will in any way impair
AMAG’s ownership of or rights in and to any such Trademark or
that may depreciate the value of such Trademark.


 


5.5.3.           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 receives any such order it shall
refer such order to AMAG.


 


5.5.4.           Export
Monitoring. 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 AMAG 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 AMAG 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.


 


5.6.           Manufacturing.


 


5.6.1.           General.
AMAG shall have the non-exclusive right in the Territory, and the
non-exclusive right outside the Territory, to Manufacture
Compounds, Products, Pharmaceutical Products and Product Delivery
Devices itself or through one or more Affiliates or Third Parties
selected by AMAG in its sole discretion. For clarity, AMAG shall
have no diligence obligations with respect to the Manufacture of
Compounds, Products, Pharmaceutical Products or Product Delivery
Devices except to the extent necessary to fulfill its obligations
under Section 5.2.1 or Section 5.2.2.


 


5.6.2.           Assignment
of Existing Supply Agreements. On the Effective Date,
Palatin will assign, and will cause its Affiliates to assign, to
AMAG or its designee all contracts to which Palatin or any of its
Affiliates are a party that relate to the manufacture or supply of
any Compound, Product, Pharmaceutical Product or Product Delivery
Device, including those contracts listed in Schedule
2.11.


 


5.6.3.           Cooperation.
Without limiting the foregoing Section 4.1, Palatin shall
provide all reasonable cooperation to AMAG for AMAG to
(a) continue, assume and direct the negotiation of all
contracts that are under negotiation by Palatin or its Affiliates
as of the Execution Date and relate to the manufacture or supply of
any Compound,


 




 

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.


 


Product,
Pharmaceutical Product or Product Delivery Device, including
without limitation (i) the contract that is under negotiation
between Palatin and Ypsomed AG as of the Execution Date and
(ii) the contract that is under negotiation between Palatin
and Lonza Ltd as of the Execution Date and (b) perform its
obligations under the Catalent Agreements, including without
limitation delivering or causing the delivery of raw materials in
Palatin’s possession or control to Catalent on a timely basis
and without additional charge to AMAG.


 


5.6.4.           Transfer
of Compound Inventories. Palatin agrees to transfer title
and assign, and does hereby transfer title and assign, to AMAG,
effective as of the date on which an NDA with respect to the
Initial Indication is accepted by the FDA, all inventories that are
owned or Controlled by Palatin with respect to any Compound,
Product, Pharmaceutical Product or Product Delivery Device,
including without limitation all bulk drug substance, finished drug
products, APIs, manufacturing equipment, raw materials,
auto-injector devices and tooling, in all cases in totality as of
the date of transfer. Palatin shall, upon AMAG’s request and
at AMAG’s expense, ship such inventory to addresses provided
by AMAG.


 


5.6.5.           Manufacturing
Technology Transfer. Without limiting Palatin’s
obligations under Section 2.7, within [...***...]
following the Effective Date, Palatin shall transfer to AMAG all
Know-How and physical embodiments thereof then Controlled by
Palatin or its Affiliates that are necessary or useful to enable
AMAG to Manufacture Compounds, Products, Pharmaceutical Products
and Product Delivery Devices for clinical or commercial use,
including bulk drug substance, finished drug products, placebos,
tooling, prototypes, manufacturing equipment, raw materials,
auto-injector devices, analytical methods and batch records, 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, master drug files,
materials and other embodiments of such Know-How. Thereafter,
throughout the Term and at AMAG’s request, Palatin will
(a) transfer to AMAG any and all updated, improved and
subsequently developed Manufacturing Know-How and (b) make
available to AMAG Palatin’s qualified technical personnel to
assist AMAG in understanding and applying the Manufacturing
Know-How to enable AMAG 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).


 


5.6.6.           Supply
Among the Parties. Upon Palatin’s request and
following Palatin’s fulfillment of its obligations under this
Section 5.6, the Parties will negotiate in good faith the
terms of a clinical and commercial supply agreement, pursuant to
which AMAG or its designees will supply Products to Palatin or its
designees (solely to the extent that AMAG is manufacturing such
Products for its own use) for use outside the


 




 

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.


 


Territory. The
Parties’ entry into any such supply agreement is conditioned
upon negotiation of terms and conditions that are mutually
acceptable to both Parties.


 


5.7.           Other
AMAG Programs. Palatin understands and acknowledges that
AMAG may have present or future initiatives or opportunities,
including initiatives or opportunities with its Affiliates or Third
Parties, involving products, programs, technologies or processes
that are similar to, and in some instances may compete with, a
Product, program, technology or process covered by this Agreement.
Palatin acknowledges and agrees that nothing in this Agreement will
be construed as a representation, warranty, covenant or inference
that AMAG will not itself Develop, Manufacture or Commercialize or
enter into business relationships with one or more of its
Affiliates or Third Parties to Develop, Manufacture or
Commercialize products, programs, technologies or processes that
are similar to or that may compete with any product, program,
technology or process covered by this Agreement, provided that, for clarity, AMAG will
not use Palatin’s Confidential Information in breach of this
Agreement.


 



6. 

INTELLECTUAL
PROPERTY.






 


6.1.           Ownership
of Intellectual Property.


 


6.1.1.           Ownership
of Inventions. Subject to the grant of licenses to AMAG
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 6.1.1. Inventorship shall be
determined in accordance with United States patent
laws.


 


6.1.2.           Ownership
of Sponsored Technology. Notwithstanding any provision of
Section 6.1.1 to the contrary, AMAG shall own all rights,
title and interests in and to: (a) any and all Know-How,
whether or not patentable and including all pharmacological,
toxicological, pre-clinical, clinical, analytical, quality control
and other data, discovered, developed or made solely by or on
behalf of Palatin or its Representatives in connection with the
Palatin Development Activities or made jointly by or on behalf of
(i) Palatin or its Representatives and (ii) AMAG or its
Representatives in connection with the Palatin Development
Activities (“Sponsored Know-How”) and (b) any and
all Patent Rights claiming any invention included in Sponsored
Know-How (“Sponsored Patent Rights,” and, together with
Sponsored Know-How, “Sponsored Technology”). Palatin
agrees to assign and hereby perpetually and irrevocably assigns,
and shall cause its Representatives to assign, to AMAG all rights,
title and interests throughout the world in and to any and all
Sponsored Technology. Further, Palatin shall, and shall cause its
Representatives to (a) deliver all physical embodiments of
Sponsored Technology to AMAG and (b) execute any and all
assignments, applications for domestic and foreign patents and
other documents and to do such other acts (including the execution
and delivery of instruments of further assurance or confirmation)
reasonably requested by AMAG to assign the Sponsored Technology to
AMAG and to permit AMAG or its designees to practice and enforce
the Sponsored Technology. The Parties shall discuss in good faith
the terms


 




 

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.


 


pursuant
to which AMAG may grant Palatin a license under the Sponsored
Technology to use, have used, Develop, have Developed, Manufacture,
have Manufactured, Commercialize and have Commercialized Compounds
and Products in the Field outside the Territory.


 


6.1.3.           Ownership
of Joint Technology. The Parties shall jointly own any Joint
Technology. Subject to the grant of licenses to AMAG under
Section 2 and the Parties’ other rights and obligations
under this Agreement, each Party shall be free to exploit, either
itself or through the grant of licenses to Third Parties (which
Third Party licenses may be further sublicensed), Joint Patent
Rights and Joint Know-How throughout the world without restriction,
without the need to obtain further consent from or provide notice
to the other Party, and without any duty to account or otherwise
make any payment of any compensation to the other
Party.


 


6.2.           Patent
Rights.


 


6.2.1.           Filing,
Prosecution and Maintenance of Palatin Patent Rights and Joint
Patent Rights. AMAG shall have the first right with respect
to the Palatin Patent Rights in the Territory and the Joint Patent
Rights (collectively, the “Program Patent Rights”), but
not the obligation, to prepare, file, prosecute and maintain the
Program Patent Rights at AMAG’s sole cost and expense. AMAG
shall consult and reasonably cooperate with Palatin with respect to
the preparation, filing, prosecution and maintenance of the Program
Patent Rights, including: (i) allowing Palatin a reasonable
opportunity and reasonable time to review and comment regarding
relevant communications to AMAG and drafts of any responses or
other proposed filings by AMAG 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 Palatin with respect to any final filings submitted by
AMAG to any relevant patent office or Governmental Authority.
Palatin shall promptly execute such documents and perform such acts
as may be reasonably necessary for AMAG to prepare, file, prosecute
and maintain the Program Patent Rights, including making available
to AMAG its authorized attorneys, agents or representatives, or
such of its employees, in each case, as are reasonably necessary to
assist AMAG in obtaining and maintaining the patent protection
described in this Section 6.2.1. If AMAG elects not to file a
patent application for an invention or application included in the
Program Patent Rights in a given country or elects to cease the
prosecution or maintenance of any Program Patent Right in a given
country, then AMAG shall provide Palatin with written notice
promptly, but not less than [...***...] before any action
is required, upon the decision to not file or continue the
prosecution of such patent application or maintenance of such
patent. In such event, Palatin shall have the right, but not the
obligation, to file or continue prosecution or maintenance of any
such Program Patent Right in such country and at Palatin’s
expense. Further, in such event AMAG shall promptly execute such
documents and perform such acts as may be reasonably necessary for
Palatin to prepare, file, prosecute and maintain the Program Patent
Rights, including making available to Palatin its authorized
attorneys, agents or representatives, or such of its employees, in
each case, as are reasonably necessary to assist Palatin in
obtaining and maintaining the patent protection described in this
Section 6.2.1. Further, Palatin shall not, and shall not
permit any of its Affiliates or


 




 

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.


 


sublicensees to,
take any action with respect to the filing, prosecution,
maintenance or enforcement of any Palatin Patent Right outside the
Territory that may reasonably be expected to adversely impact the
rights granted to AMAG under this Agreement, including AMAG’s
exclusive rights in the Palatin Patent Rights within the Territory.
Without limiting the foregoing, Palatin shall consult and
reasonably cooperate with AMAG with respect to the preparation,
filing, prosecution and maintenance of the Palatin Patent Rights
outside the Territory, including: (A) allowing AMAG 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 (B) considering in good faith any
reasonable comments offered by AMAG with respect to any final
filings submitted by Palatin to any relevant patent office or
Governmental Authority.


 


6.2.2.           Filing,
Prosecution and Maintenance of AMAG Patent Rights and Sponsored
Patent Rights. AMAG 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 AMAG Patent Rights and Sponsored Patent Rights, in
its sole discretion.


 


6.2.3.           Enforcement
and Defense of Patent Rights.


 


(a)           Enforcement
of Palatin Patent Rights and Joint 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 or the Joint Patent Rights anywhere
in the world by any Third Party. As between AMAG and Palatin, AMAG
shall have the first right, except as otherwise provided in this
Section 6.2.3, but not the obligation, to institute litigation
or take other steps to remedy infringement in connection therewith,
and any such litigation or steps [...***...]. AMAG 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 Joint Patent Right anywhere in the
world or (ii) requires AMAG or Palatin to abandon or
relinquish any Palatin Patent Right in the Territory or Joint
Patent Right anywhere in the world. If necessary in order to
establish standing for AMAG, Palatin, upon request of AMAG, agrees
to timely commence or to join in any such litigation, and in any
event to cooperate with AMAG in such litigation or steps, all at
AMAG’s expense. Palatin will have the right to consult with
AMAG about such litigation and to participate in and be represented
by independent counsel in such litigation at Palatin’s own
expense. If AMAG 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 or Joint
Patent Right anywhere in the world (A) within
[...***...] of its receipt of notice thereof in the case of
a Palatin Patent Right, or (B) within [...***...] of
its receipt of notice thereof in the case of a Joint Patent Right,
then Palatin shall have the right, but not the obligation, upon
[...***...] prior notice to AMAG, at Palatin’s
expense, to institute any such litigation and Palatin will solely
retain any


 




 

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.


 


recoveries
resulting from such litigation or steps. If necessary in order to
establish standing for Palatin, AMAG, 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. AMAG 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
AMAG’s own expense. Palatin shall not, without the prior
written consent of AMAG, 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
Joint Patent Right anywhere in the world or (ii) requires AMAG
or Palatin to abandon or relinquish any Palatin Patent Right in the
Territory or Joint Patent Right anywhere in the world. 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 6.2.3(a) or any unfavorable decision resulting
therefrom, including any decision holding any Palatin Patent Right
or Joint Patent Right invalid or unenforceable.


 


(b)           Enforcement
of AMAG Patent Rights and Sponsored Patent Rights. AMAG
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 AMAG Patent Right or Sponsored Patent
Right.


 


(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.


 


6.2.4.           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 Joint Technology,
or the exercise of any other right granted by Palatin to AMAG
hereunder (collectively, the “Licensed Activities”) by
AMAG 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.


 




 

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.


 


 


(b)           AMAG
Option to Negotiate. If AMAG determines, in its sole
discretion, that, in order for AMAG, 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
(collectively, “Third Party IP Rights”), then AMAG
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 AMAG’s royalty obligations under this
Agreement as and to the extent provided in
Section 3.5.3(a).


 


6.2.5.           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 AMAG 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 or Joint
Technology (any such suit or other action referred to herein as an
“Infringement Claim”). In the case of any Infringement
Claim against AMAG (including its Affiliates or Sublicensees) alone
or against both AMAG and Palatin (including its Affiliates), AMAG
shall have the right, but not the obligation, at AMAG’s sole
cost and expense subject to the provisions of this
Section 6.2.5, 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 AMAG, agrees to join in any litigation
associated with any Infringement Claim at AMAG’s expense and
in any event to reasonably cooperate with AMAG at AMAG’s
expense (in all cases subject to Palatin’s indemnification
obligations under Section 10.3). Palatin will have the right
to consult with AMAG 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. AMAG 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
Joint Patent Right anywhere in the world or (ii) requires AMAG
or Palatin to abandon or relinquish any Palatin Patent Right in the
Territory or Joint Patent Right anywhere in the world. If AMAG
elects to control the defense of any Infringement Claim and Palatin
is obligated under Section 10.3 to indemnify AMAG (including
any AMAG Indemnified Party) with respect to such Infringement
Claim, then (a) [...***...] and (b) Palatin will
otherwise indemnify AMAG and any applicable AMAG Indemnified
Parties to the full extent provided for under Section 10.3. 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 AMAG, 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 Joint Patent Right anywhere in the
world or (ii) requires AMAG or Palatin to abandon or
relinquish any Palatin Patent Right in the Territory or Joint
Patent Right anywhere in the world.


 




 

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.


 


AMAG
shall have the right to consult with Palatin concerning such
Infringement Claim and AMAG, upon request of Palatin, will
reasonably cooperate with Palatin at Palatin’s expense (but
AMAG shall have no obligation to join any Infringement Claim or
associated litigation).


 


6.2.6.           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 or Joint Patent Right anywhere in the world of which it
becomes aware, including any nullity, revocation, interference,
reexamination or compulsory license proceeding. AMAG shall have the
first right, but no obligation, to defend against any such action
involving any Palatin Patent Right in the Territory or Joint Patent
Right anywhere in the world, in its own name (to the extent
permitted by applicable Law), and any such defense shall be at
AMAG’s reasonable expense, subject to Palatin’s
indemnification obligations under Section 10. Palatin, upon
AMAG’s request, agrees to join in any such action at
AMAG’s expense and in any event to cooperate with AMAG at
AMAG’s expense. If AMAG fails to defend against any such
action involving a Palatin Patent Right or Joint 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, AMAG, upon Palatin’s request, shall reasonably
cooperate with Palatin in any such action at Palatin’s
expense.


 


6.2.7.           Orange
Book Information. AMAG shall have the sole right, but not
the obligation, to submit to all applicable Governmental
Authorities patent information pertaining to each Product pursuant
to 21 U.S.C. § 355(b)(1)(G) (or any amendment or
successor statute thereto), or any similar statutory or regulatory
requirement in any non-U.S. country or other regulatory
jurisdiction in the Territory.


 


6.2.8.           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 country 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 or Joint Patent Right anywhere in the world 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, AMAG shall have the sole right, but not the obligation, to
bring an infringement action against such Third Party at
AMAG’s sole cost and expense. If necessary in order to
establish standing in connection with any action brought by AMAG
under this Section 6.2.8, Palatin, upon AMAG’s request,
shall reasonably cooperate with AMAG in any such action at
AMAG’s expense and shall timely commence or join in any such
action at AMAG’s request and expense. In the event of any
conflict between the terms of this Section 6.2.8 and the terms
of Section 6.2.3(a), the terms of this Section 6.2.8
shall control and govern.


 




 

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.


 


6.2.9.           Patent
Term Restoration and Extension. AMAG 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, including 35 U.S.C. § 156 and applicable foreign
counterparts, in any country in the Territory in relation to the
Palatin Patent Rights and in any country in the world in relation
to the Joint Patent Rights at AMAG’s sole cost and expense.
Palatin and AMAG shall cooperate in connection with all such
activities. AMAG, 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, AMAG will have the final decision-making authority;
provided, however, that AMAG 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 AMAG’s reasonable legal determination
such Palatin Patent Right may not be extended under Law without
limiting AMAG’s right to extend any other Patent
Right.


 


6.3.           Enforcement
and Defense of Know-How.


 


6.3.1.           Misappropriation
Actions Relating to Palatin Know-How and Joint Know-How.
Each Party will promptly notify the other in the event of any
actual, potential or suspected misappropriation of any Palatin
Know-How or Joint Know-How by any Third Party. As between AMAG and
Palatin, AMAG shall have the first right, except as otherwise
provided in this Section 6.3.1, but not the obligation, to
institute litigation or take other steps to remedy misappropriation
of the Palatin Know-How in the Territory or of the Joint Know-How
in connection therewith, and any such litigation or steps shall be
at AMAG’s expense, subject to Palatin’s obligation to
indemnify AMAG for such expenses pursuant to Section 10;
provided that any
recoveries resulting from such litigation or steps after deducting
AMAG’s out of pocket expenses (including counsel fees and
expenses and any amounts paid to Palatin for its cooperation with
such litigation) in pursuing such claim, will be
[...***...]. AMAG 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 or Joint Know-How is not
protectable under relevant trade secret Laws or (b) requires
AMAG or Palatin to abandon or relinquish trade secret protection
for any Palatin Know-How or Joint Know-How. If necessary in order
to establish standing for AMAG, Palatin, upon request of AMAG,
agrees to timely commence or to join in any such litigation, at
AMAG’s expense, and in any event to cooperate with AMAG in
such litigation or steps at AMAG’s expense. Palatin will have
the right to consult with AMAG about such litigation and to
participate in and be represented by independent counsel in such
litigation at Palatin’s own expense. If AMAG 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 or Joint Know-How anywhere in the world
(i) within [...***...] of its receipt of notice
thereof in the case of any Palatin Know-How, or (ii) within
[...***...] of its receipt or notice thereof in the case of
any Joint Know-How, then Palatin shall have the right, but not the
obligation, upon [...***...] prior notice to AMAG, at
Palatin’s expense, to institute any such litigation. If
necessary in order to establish standing for Palatin, AMAG, upon
request of Palatin, agrees to timely commence or to join in
any


 




 

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.


 


such
litigation, and in any event to cooperate with Palatin in such
litigation or steps at Palatin’s expense. AMAG 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 AMAG’s own expense. Palatin shall not, without
the prior written consent of AMAG, enter into any compromise or
settlement relating to such litigation that (a) admits that
all or any portion of the Palatin Know-How or Joint Know-How is not
protectable under relevant trade secret Laws or (b) requires
AMAG or Palatin to abandon or relinquish trade secret protection
for any Palatin Know-How or Joint 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.


 


6.3.2.           Misappropriation
Actions Relating to AMAG Know-How and Sponsored Know-How.
AMAG 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 AMAG Know-How or Sponsored
Know-How.


 


6.4.           Recording.
If AMAG 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 execute and deliver to AMAG any documents accurately reflecting
or evidencing this Agreement that are necessary or desirable, in
AMAG’s reasonable judgment, to complete such registration or
recordation. AMAG shall reimburse Palatin for all reasonable
out-of-pocket expenses, including attorneys’ fees, incurred
by Palatin in complying with the provisions of this
Section 6.4.


 



7. 

CONFIDENTIALITY.






 


7.1.           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.


 


7.2.           Authorized
Disclosure.


 


7.2.1.           Disclosure
to Party Representatives. Notwithstanding the foregoing
provisions of Section 7.1, 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 7.


 




 

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.


 


7.2.2.           Disclosure
to Third Parties. Notwithstanding the foregoing provisions
of Section 7.1, 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 Program Patent Rights as
permitted by this Agreement;


 


(c)           in
connection with prosecuting or defending litigation as permitted by
this Agreement; or


 


(d)           to
the extent necessary or desirable in order to enforce its rights
under this Agreement.


 


If the
Receiving Party deems it reasonably necessary to disclose
Confidential Information belonging to the Disclosing Party pursuant
to this Section 7.2.2, 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.


 


7.2.3.           Business
Transaction Disclosure. Nothing in this Agreement,
(a) shall prevent AMAG from using information to formulate a
proposal for a business transaction with Palatin or communicating
with Palatin’s CEO or board of directors, on a confidential
basis, regarding such a transaction or (b) shall restrict AMAG
from seeking to acquire Palatin in the event that Palatin announces
an agreement contemplating a Change of Control, the consummation of
a Change of Control. or the exploration of strategic
alternatives.


 


7.3.           SEC
Filings and Other Disclosures. Either Party may disclose 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”) or any equivalent governmental agency in any
country in the Territory. Before disclosing this Agreement or any
of the terms hereof pursuant to this Section 7.3, 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 7.3, such
Party shall, at its own expense, seek such confidential treatment
of confidential portions of this Agreement and such other terms, as
may be reasonably requested by the other Party.


 




 

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.


 


7.4.           Public
Announcements; Publications.


 


7.4.1.           Announcements.
Except as may be expressly permitted under Section 7.2,
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
AMAG from making any scientific publication or public announcement
with respect to any product under this Agreement; provided, however, that, except as
permitted under Section 7.2, AMAG 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 that each Party may release the
announcement attached hereto as Schedule 7.4.1 regarding the
signing of this Agreement following the Effective
Date.


 


7.5.           Obligations
in Connection with Change of Control. If Palatin is subject
to a Change of Control, Palatin will, and it will cause its
Representatives to, ensure that no Confidential Information of AMAG
is released to (a) any Affiliate of Palatin that becomes an
Affiliate as a result of the Change of Control or (b) any
other Representatives of Palatin (or of the relevant surviving
entity of such Change of Control) who become Palatin
Representatives as a result of the Change of Control, unless such
Affiliate or other Representatives, as applicable, have signed
individual confidentiality agreements which include equivalent
obligations to those set out in this Section 7. If any Change
of Control of Palatin occurs, Palatin shall promptly notify
AMAG.


 



8. 

REPRESENTATIONS AND WARRANTIES; COVENANTS;
SECURITY INTEREST.






 


8.1.           Mutual
Representations and Warranties. Each of Palatin and AMAG
hereby represents and warrants to the other Party
that:


 


8.1.1.           it
is duly organized, validly existing and in good standing under the
laws of the jurisdiction of its organization;


 


8.1.2.           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;


 


8.1.3.           it
has the power and authority to execute and deliver this Agreement
and to perform its obligations hereunder


 


8.1.4.           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


 




 

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.


 


8.1.5.           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 Execution
Date.


 


8.2.           Mutual
Covenants. Each of Palatin and AMAG hereby covenants to the
other Party that, from the Execution Date until expiration or
termination of this Agreement, it will perform its obligations
under this Agreement in compliance with applicable
Laws.


 


8.3.           Representations
and Warranties of Palatin. Palatin hereby represents and
warrants to AMAG that:


 


8.3.1.           except
as expressly disclosed in Schedule 8.3.1, 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;


 


8.3.2.           it
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 AMAG, AMAG’s Affiliates or
AMAG’s Sublicensees under this Agreement;


 


8.3.3.           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 Execution
Date;


 


8.3.4.           as
of the Execution 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;


 


8.3.5.           as
of the Execution Date, Palatin has made available to AMAG all
material scientific and technical information and all information
relating to safety and efficacy known to it or its Affiliates with
respect to the Compounds and Products;


 


8.3.6.           to
its best knowledge, the Palatin Patent Rights, are, or, upon
issuance, will be, valid and enforceable patents and, as of the
Execution Date, no Third Party (a) is infringing any Palatin
Patent Right except as set forth in Schedule 8.3.6 or (b) has
challenged or threatened to challenge the scope, validity or
enforceability of any Palatin Patent Right (including, by way of
example, through the institution or written threat of institution
of interference, nullity or similar invalidity proceedings before
the United States Patent and Trademark Office or any analogous
foreign Governmental Authority);


 


8.3.7.           it
has complied in all material respects with all applicable Laws,
including any disclosure requirements, in connection with the
filing, prosecution and maintenance of the Palatin Patent
Rights;


 


8.3.8.           except
as expressly disclosed in Schedule 8.3.8, Palatin has independently
developed all Palatin Know-How or otherwise has a valid right to
use, and to permit


 




 

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.


 


AMAG,
AMAG’s Affiliates and AMAG’s Sublicensees to use, the
Palatin Know-How for all permitted purposes under this
Agreement;


 


8.3.9.           it
has obtained from all inventors of Palatin Technology existing as
of the Execution Date, valid and enforceable agreements assigning
to Palatin each such inventor’s entire right, title and
interest in and to all such Palatin Technology;


 


8.3.10.                      no
Palatin Technology existing as of the Effective Date is subject to
any funding agreement with any government or Governmental
Authority;


 


8.3.11.                      neither
Palatin nor any of its Affiliates are party to or otherwise subject
to any agreement, arrangement or settlement which limits the
ownership or licensed rights of AMAG or its Affiliates with respect
to, or limits the ability of AMAG or its Affiliates to grant a
license, sublicense or access, or provide or provide access or
other rights in, to or under, any intellectual property right or
material (including any Patent Right, Know-How or other data or
information), in each case, that would, but for such agreement,
arrangement or settlement, be included in the rights licensed or
assigned to AMAG or its Affiliates pursuant to this
Agreement;


 


8.3.12.                      (a) there
are no Palatin Third Party Agreements, other than
(i) agreements with employees or consultants substantially
similar to the form of Consulting Services Agreement or form of
Employee Agreement on Confidentiality, Intellectual Property,
Debarment Certification and Conflict of Interest provided by
Palatin to AMAG, (ii) contract research agreements entered
into in the ordinary course of business that do not assign or grant
to any Third Party any right, title or interest in or to, or any
license under, any Patent Rights or Know-How and (iii) the
Palatin Third Party Agreements expressly disclosed in Schedule
8.3.12 (each, a “Disclosed Third Party Agreement”),
true and complete copies of which have been provided to AMAG,
(b) except as provided in the Disclosed Third Party
Agreements, no Third Party has any right, title or interest in or
to, or any license under, any Palatin Technology in the Territory,
(c) no rights granted by or to Palatin or its Affiliates under
any Disclosed Third Party Agreement conflict with any right or
license granted to AMAG or its Affiliates hereunder and
(d) Palatin and its Affiliates are in compliance in all
material respects with all Disclosed Third Party
Agreements;


 


8.3.13.                      to
its best knowledge, the use, Development, Manufacture or
Commercialization by Palatin or AMAG (or their respective
Affiliates or Sublicensees) of any Compound, Product,
Pharmaceutical Product or Product Delivery Device (a) does not
and will not infringe any issued patent of any Third Party or
(b) will not infringe the claims of any published Third Party
patent application when and if such claims issue;


 


8.3.14.                      there
is no (a) claim, demand, suit, proceeding, arbitration,
inquiry, investigation or other legal action of any nature, civil,
criminal, regulatory or otherwise, pending or, to the best
knowledge of Palatin, threatened against Palatin or any of its
Affiliates or (b) judgment or settlement against or owed by
Palatin or any of its Affiliates, in each case in connection with
the Palatin Technology, any Compound, Product,


 




 

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.


 


Pharmaceutical
Product or Product Delivery Device or relating to the transactions
contemplated by this Agreement.


 


8.3.15.                      neither
Palatin nor any of its Affiliates, nor any of their respective
employees, officers, directors, or agents, has been debarred by the
FDA, is the subject of a conviction described in 21 U.S.C.
§335a, or is subject to any similar sanction;


 


8.3.16.                      Palatin,
and each of its Affiliates that are or will be involved in the
conduct of activities under this Agreement, is in compliance with
all applicable Laws with respect to the conduct of such
activities;


 


8.3.17.                      Palatin
(a) is not excluded from, and has not been convicted of any
crime or engaged in any conduct that could result in exclusion
from, participation in any state or federal healthcare program, as
defined in 42 U.S.C. §1320a-7b(f), for the provision of items
or services for which payment may be made by a federal healthcare
program, (b) to its best knowledge has not contracted with any
Person to conduct activities under this Agreement who is excluded
from participation in any state or federal healthcare program and
(c) is not subject to a final adverse action, as defined in 42
U.S.C.§ 1320a-7a(e) and 42 U.S.C. § 1320a-7a(g), and
has no adverse action pending or threatened against
it;


 


8.3.18.                      Palatin
is not entering into the transactions contemplated by this
Agreement with the intent to hinder, delay or defraud either
present or future creditors. Palatin is not, and will not be
rendered by consummation of the transactions contemplated by this
Agreement, insolvent (either because its financial condition is
such that the sum of its debts is greater than the fair value of
its assets or because the fair saleable value of its assets is less
than the amount required to pay its probable liability on its
existing debts and liabilities as they mature);


 


8.3.19.                      Palatin,
including Palatin’s Ultimate Parent Entity
(“UPE”) as that term is defined in 16 C.F.R.
Part 801.1(a)(3), (a) is not engaged in manufacturing as
defined in 16 C.F.R. Part 801.1(j) and (b) has total
assets of less than $10 million (as adjusted), as determined in
accordance with 16 C.F.R. Part 801.11; and


 


8.3.20.                      On
the Effective Date after giving effect to the transactions
contemplated by this Agreement: (i) Palatin will be able to
pay its liabilities as they become due in the ordinary course of
its business; (ii) Palatin will have assets (calculated at
fair market value) that exceed its liabilities; (iii) Palatin
will not have unreasonably small capital with which to conduct its
present or proposed business; (iv) Palatin will not have
incurred debts (and does not immediately plan to incur debt) beyond
its ability to pay as they become due; and (v) taking into
account all pending and threatened litigation, final judgments
against Palatin in actions for money damages are not reasonably
anticipated to be rendered at a time when, or in amounts such that,
Palatin will be unable to satisfy any such judgments promptly in
accordance with their terms (taking into account the maximum
probable amount of such judgments in any such actions and the
earliest reasonable time at which such judgments might be rendered)
as well as all of Palatin’s other obligations and
liabilities. The cash available to Palatin, after receipt of the
payment set forth in Section 3.1 and taking into account all
other anticipated uses of the cash, will


 




 

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.


 


be
sufficient to pay all such debts and judgments promptly in
accordance with their terms.


 


8.4.           Palatin
Covenants. In addition to the covenants made by Palatin
elsewhere in this Agreement, Palatin hereby covenants to AMAG that,
from the Execution Date until expiration or termination of this
Agreement, as set forth in this Section 8.4:


 


8.4.1.           Palatin
shall not, and shall cause its Affiliates not to (a) sell,
assign, license or otherwise transfer to any Person (other than
AMAG or its Affiliates or Sublicensees pursuant to the terms of
this Agreement) any Palatin Technology in the Territory or Joint
Technology in the Territory (or agree to do any of the foregoing)
or (b) incur or permit to exist, with respect to any Palatin
Technology or Joint Technology, any lien, encumbrance, charge,
security interest, mortgage, liability, assignment, grant of
license or other Binding Obligation that is or would be
inconsistent with the licenses and other rights granted (or to be
granted) to AMAG or its Affiliates or Sublicensees under this
Agreement.


 


8.4.2.           Palatin
will not take any action that diminishes the rights under the
Palatin Technology or Joint Technology granted (or to be granted)
to AMAG or AMAG’s Affiliates under this
Agreement.


 


8.4.3.           Palatin
will (a) not enter into any Palatin Third Party Agreement that
adversely affects (i) the rights granted (or to be granted) to
AMAG, AMAG’s Affiliates or Sublicensees hereunder or
(ii) Palatin’s ability to fully perform its obligations
hereunder; (b) not amend or otherwise modify any Palatin Third
Party Agreement (including any Disclosed Third Party Agreement) or
consent or waive rights with respect thereto in any manner that
(i) adversely affects the rights granted (or to be granted) to
AMAG or AMAG’s Affiliates or Sublicensees hereunder or
(ii) Palatin’s ability to fully perform its obligations
hereunder; (c) promptly furnish AMAG with true and complete
copies of all (i) amendments to the Disclosed Third Party
Agreements and (ii) Palatin Third Party Agreements and related
amendments executed following the Execution Date, provided that
financial terms may be redacted; (d) remain, and cause its
Affiliates to remain, in compliance in all material respects with
all Palatin Third Party Agreements (including Disclosed Third Party
Agreements); and (e) furnish AMAG with copies of all notices
received by Palatin or its Affiliates relating to any alleged
breach or default by Palatin or its Affiliates under any Palatin
Third Party Agreement (including any Disclosed Third Party
Agreement) within five (5) Business Days after receipt
thereof.


 


8.4.4.           Palatin
will not enter into or otherwise allow itself or its Affiliates to
be subject to any agreement, arrangement or settlement which limits
the ownership or licensed rights of AMAG or its Affiliates with
respect to, or limits the ability of AMAG or its Affiliates to
grant a license, sublicense or access, or provide or provide access
or other rights in, to or under, any intellectual property right or
material (including any Patent Right, Know-How or other data or
information), in each case, that would, but for such agreement,
arrangement or settlement, be included in the rights licensed or
assigned to AMAG or its Affiliates pursuant to this
Agreement.


 




 

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.


 


8.4.5.           Palatin
will maintain valid and enforceable agreements with all Persons
acting by or on behalf of Palatin or its Affiliates under this
Agreement which require such Persons to assign to Palatin their
entire rights, title and interests in and to all Palatin Technology
and Joint Technology.


 


8.4.6.           Except
to the extent included in any budget approved by the JSC under
Section 4.2.3, without the prior written consent of AMAG,
Palatin shall not incur any expense (or related series of expenses)
greater than [...***...] in connection with its Development
of any Compound, Product, Pharmaceutical Product, or Product
Delivery Device (in each case, including any expense in connection
with any Palatin Development Activity).


 


8.4.7.           Palatin
shall pay or otherwise satisfy in the ordinary course of business
all of is liabilities and obligations existing on the Effective
Date, including without limitation all payments under the Catalent
Agreements, whether arising out of or in connection with the
Contemplated Transactions or otherwise, such payments to include
payments required as a result of a “Change of Control”
(as defined in the Catalent Agreements) or payments arising from a
license of Palatin’s rights as set forth in Section 3 of
the Catalent Services Agreement.


 


8.4.8.           From
the Effective Date until the acceptance of an NDA by the FDA with
respect to the Initial Indication, Palatin shall not (i) make
any declaration or payment of, or set aside funds for, any dividend
or other distribution with respect to any of its capital stock or
other equity interests; or (ii) repurchase, redeem, or
otherwise acquire or cancel any of its capital stock or other
equity interests unless and until each of the following has
occurred:


 


(a) Palatin’s
payment of any and all taxes due and payable by it in connection
with the transactions contemplated by this Agreement;
and


 


(b) Palatin’s
payment, or adequate provision for the payment, in full of all of
its liabilities and debts existing on the Effective Date, including
without limitation payment in full of all liabilities and
obligations under the Catalent Agreements and the Horizon
Agreement.


 


8.4.9.           If
AMAG determines in good faith that it would be required to file
with the Securities and Exchange Commission (“SEC”)
pursuant to Rule 3-05 of Regulation S-X audited annual
financial statements of the business related to the Compound,
Product, Pharmaceutical Product or Product Delivery Device (the
“Audited Financial Statements”) and unaudited quarterly
financial statements of the business related to the Compound,
Product, Pharmaceutical Product or Product Delivery Device (the
“Unaudited Financial Statements”) for the periods
specified by Rule 3-05 of Regulation S-X (any Audited
Financial Statements together with any Unaudited Financial
Statements, the “SEC Financial Statements”), then
Palatin will deliver to AMAG as soon as reasonably practicable, but
in any event no later than forty-five (45) days after notice from
AMAG, the SEC Financial Statements. The SEC Financial Statements
will be (a) prepared in accordance with the books and records
of the business related to the


 




 

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.


 


Compound, Product,
Pharmaceutical Product or Product Delivery Device,
(b) prepared in accordance with Regulation S-X and U.S. GAAP
and (c) in the case of the Audited Financial Statements,
accompanied by an opinion (the “Audit Opinion”) of KPMG
LLP (the “Independent Auditor”), which opinion complies
with Regulation S-X. Palatin will use its commercially reasonable
efforts to cause the Independent Auditor to provide to AMAG the
consents requested by AMAG no later than three (3) Business
Days prior to the required filing date of the SEC Financial
Statements to permit the inclusion of the Audit Opinion with
respect to the Audited Financial Statements in AMAG’s reports
and registration statements filed with the SEC for periods required
under applicable Law. AMAG will reimburse Palatin for the
reasonable costs incurred by Palatin supported by reasonable
documentation for Palatin’s activities pursuant to this
Section 8.4.9.


 


8.5.           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.


 



9. 

GOVERNMENT APPROVALS; REMEDY; TERM AND
TERMINATION.






 


9.1.           HSR
Filing. Each of Palatin and AMAG has determined that no HSR
Filing is required of it under the HSR Act with respect to the
transactions contemplated hereby.


 


9.2.           Intentionally
Omitted.


 


9.3.           Other
Government Approvals. Each of Palatin and AMAG 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.


 


9.4.           Term.
The term of this Agreement (the “Term”) will commence
on the Execution Date and extend on a country-by-country basis (in
the Territory), unless this Agreement is terminated earlier in
accordance with this Section 9, until the last to expire of
any Royalty Term for any Product in such country in the
Territory.


 


9.5.           Termination
by Palatin. Palatin may terminate this Agreement for cause,
at any time during the Term, by giving written notice to AMAG in
the event that AMAG commits a material breach of its obligations
under this Agreement and such material breach remains uncured for
ninety (90) days, measured from the date written notice of such
material breach is given to AMAG; provided, however, that if any breach
is not reasonably curable within ninety (90) days and if AMAG 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 AMAG a reasonable period of time to cure such
breach. If the alleged material breach relates to non-payment of
any amount due under


 




 

34








 






 


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
Agreement, the cure period shall be tolled pending resolution of
any bona fide dispute between the Parties as to whether such
payment is due.


 


9.6.           Termination
by AMAG.


 


9.6.1.           Failure
of Closing Conditions. AMAG may terminate this Agreement in
its entirety upon ten (10) days prior written notice to Palatin if
any of the Effectiveness Conditions have not been satisfied within
one hundred twenty (120) days following the Execution
Date.


 


9.6.2.           Termination
for Convenience. Upon at least one hundred eighty (180) days
written notice to Palatin, AMAG may terminate this Agreement on a
Product-by-Product and country-by-country basis, or in its
entirety, without cause, for any or no reason.


 


9.6.3.           Termination
for Cause. AMAG may terminate this Agreement for cause with
respect to one or more Products in one or more countries 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 for
ninety (90) days, 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 ninety (90) days 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. For the avoidance of doubt, any breach by Palatin of its
obligations under Section 8.4.9 shall be deemed a material
breach of Palatin’s obligations under this Agreement, and
shall not be curable by Palatin.


 


9.7.           Effects
of Termination.


 


9.7.1.           Effect
of Termination.


 


(a)           Termination
for Cause by Palatin. In the event that Palatin terminates
this Agreement for cause pursuant to Section 9.5, the
following will apply (with respect to the terminated countries 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 country or Territory, as applicable;


 


(ii)           AMAG
will assign and transfer to Palatin all Regulatory Approvals owned
by AMAG or its Affiliates with respect to all Continuation Products
in the relevant country (or the Territory in the event of
termination of this Agreement in its entirety);


 


(iii)           AMAG
will assign all applications and registrations for the Product
Brands that are Controlled by AMAG or its Affiliates in
the


 




 

35








 






 


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 country
(or the Territory in the event of termination of this Agreement in
its entirety) to Palatin;


 


(iv)           AMAG
will grant to Palatin a royalty-free, non-exclusive license under
the Sponsored Technology, with the right to sublicense, to Develop,
Commercialize, Manufacture and use the Continuation Products (in
the relevant country or Territory, as applicable);


 


(v)           AMAG
will transfer to Palatin all development data and regulatory
filings specifically relating to such Continuation Product in the
relevant country (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
country in the Territory (if any); and


 


 (vi)          
On Palatin’s written notice to AMAG, 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 AMAG to Palatin of a
license under the Applicable AMAG Technology for Palatin to
continue to Develop, Commercialize and Manufacture any Product (in
the relevant country or Territory, as applicable) that is under
Development or Commercialization by AMAG 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 9.7.1(a)(vi), and neither
Party will have any liability to the other for failure to do
so.



 


(b)           Termination
for Failure of Closing Conditions. In the event that AMAG
terminates this Agreement pursuant to Section 9.6.1, except as
otherwise expressly provided herein, all rights and obligations of
each Party hereunder shall cease.


 


(c)           Termination
for Convenience by AMAG. In the event that AMAG terminates
this Agreement without cause pursuant to Section 9.6.2, the
following will apply (with respect to the terminated countries 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 country or Territory, as applicable;


 


(ii)           AMAG
will assign and transfer to Palatin all Regulatory Approvals owned
by AMAG or its Affiliates with respect to all


 




 

36








 






 


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.


 


Continuation
Products in the relevant country (or the Territory in the event of
termination of this Agreement in its entirety);


 


(iii)           AMAG
will assign all applications and registrations for the Product
Brands that are Controlled by AMAG or its Affiliates in the
relevant country (or the Territory in the event of termination of
this Agreement in its entirety) to Palatin; and


 


(iv)           AMAG
will grant to Palatin a royalty-free, non-exclusive license under
the Applicable AMAG Technology and Sponsored Technology, with the
right to sublicense, to Develop, Commercialize, Manufacture and use
the Continuation Products (in the relevant country or Territory, as
applicable).


 


(d)           Termination
for Cause by AMAG; Alternative Remedy for
Breach.


 


(i)           Partial
Termination. In the event that AMAG terminates this
Agreement pursuant to Section 9.6.3 with respect to any
Product in any country in the Territory, except as otherwise
expressly provided herein, all rights and obligations of each Party
hereunder with respect to such Product in such country shall cease
(including all relevant rights and licenses granted by either Party
to the other Party hereunder).


 


(ii)           Complete
Termination. In the event that AMAG terminates this
Agreement in its entirety pursuant to Section 9.6.3, 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).


 


(iii)           Alternative
Remedy for Breach by Palatin. If Palatin commits a material
breach of its obligations under this Agreement that would entitle
AMAG to terminate this Agreement (in whole or in part) pursuant to
Section 9.6.3 and AMAG elects, in its sole discretion, not to
terminate this Agreement (in whole or in part) as a result of such
breach, then, notwithstanding any provision of this Agreement to
the contrary, all payments due to Palatin under Section 3.3,
Section 3.4 and Section 3.5 following the date of such
material breach will [...***...]. If Palatin undergoes a
Change of Control during the Development Term without the prior
written consent of AMAG in contravention of Section 11.2,
then, notwithstanding any provision of this Agreement to the
contrary, all payments due to Palatin under Section 3.3 will
[...***...]. Notwithstanding the foregoing, AMAG shall have
recourse to any other remedy available at law or in equity with
respect to such material breach, including an action for specific
performance of this Agreement, subject to the terms of this
Agreement.


 




 

37








 






 


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.


 


9.7.2.           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.
Expiration or termination of this Agreement shall not relieve
either Party from any obligation which is expressly indicated to
survive such expiration or termination.


 


9.7.3.           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 1.2 (together with
Exhibit A); 1.3; 2.4.3; 3.5.2 (with respect to any licenses
that accrue thereunder on or prior to the end of the Term); 3.6.6
([...***...] following such expiration or termination);
3.6.7 ([...***...] following such expiration or
termination); 3.6.8 ([...***...] following such expiration
or termination); 3.6.10; 6.1; 7 ([...***...] following such
expiration or termination); 9.7; 9.8; 10.1; 10.2; 10.3; 10.4 and 11
(other than Section 11.2).


 


9.8.           Provisions
for Insolvency.


 


9.8.1.           Termination
Right. Palatin shall be deemed a “Debtor” under
this Agreement if, at any time during the Term (a) a case is
commenced by or against Palatin under the Bankruptcy Code,
(b) Palatin files for or is subject to the institution of
bankruptcy, reorganization, liquidation or receivership proceedings
(other than a case under the Bankruptcy Code), (c) Palatin
assigns all or a substantial portion of its assets for the benefit
of creditors, (d) a receiver or custodian is appointed for
Palatin’s business or (e) a substantial portion of
Palatin’s business is subject to attachment or similar
process; provided, however,
that in the case of any involuntary case under the Bankruptcy Code,
Palatin shall not be deemed a Debtor if the case is dismissed
within sixty (60) days after the commencement thereof. If Palatin
is deemed a Debtor, then AMAG may terminate this Agreement by
providing written notice to Palatin. If AMAG terminates this
Agreement pursuant this Section 9.8.1, then: (i) all
licenses granted to AMAG under this Agreement shall become
irrevocable and perpetual, and AMAG shall have no further
obligations to Palatin under this Agreement other than
(A) those obligations that expressly survive termination in
accordance with Section 9.7.3 and (B) an obligation to
pay royalties with respect to Net Sales of Products in accordance
with and subject to the other terms of this Agreement governing the
payment of royalties; (ii) such termination shall not be
construed to limit Palatin’s right to receive payments that
accrued before the effective date of such termination;
(iii) AMAG shall have the right to offset, against any payment
owing to Palatin as provided for under clause (i), above, any
damages found or agreed by the Parties to be owed by Palatin to
AMAG; and (iv) nothing in this Section 9.8.1 shall limit
any other remedy AMAG may have for any breach by Palatin of this
Agreement.


 


9.8.2.           Rights
to Intellectual Property. All rights and licenses now or
hereafter granted by Palatin to AMAG under or pursuant to any
Section of this Agreement, including Sections 2.1, 2.2, 2.3,
2.5, 2.7, 2.8 and 2.9 hereof, are rights to “intellectual
property” (as defined in the Bankruptcy Code). The Parties
hereto acknowledge and


 




 

38








 






 


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.


 


agree
that the payments provided for under Sections 3.1, 3.2, 3.3 and 3.4
and all other payments by AMAG to Palatin hereunder, other than
royalty payments pursuant to Section 3.5, do not constitute
royalties within the meaning of Section 365(n) of the
Bankruptcy Code or relate to licenses of intellectual property
hereunder. If (a) a case under the Bankruptcy Code is
commenced by or against Palatin, (b) this Agreement is
rejected as provided in the Bankruptcy Code and (c) AMAG
elects to retain its rights hereunder as provided in
Section 365(n) of the Bankruptcy Code, then Palatin (in
any capacity, including debtor-in-possession) and its successors
and assigns (including any trustee) shall provide to AMAG all
intellectual property licensed hereunder, and agrees to grant and
hereby grants to AMAG and its Affiliates a right to access and to
obtain possession of and to benefit from and, in the case of any
chemical or biological material or other tangible item of which
there is a fixed or limited quantity, to obtain a pro rata portion
of, each of the following to the extent related to any Compound,
Product, Pharmaceutical Product or Product Delivery Device, or
otherwise related to any right or license granted under or pursuant
to this Agreement: (i) copies of pre-clinical and clinical
research data and results; (ii) Product samples;
(iii) Palatin Technology, (iv) laboratory notes and
notebooks; (v) Product data or filings, and (vi) Rights
of Reference in respect of regulatory filings and approvals, all of
which constitute “embodiments” of intellectual property
pursuant to Section 365(n) of the Bankruptcy Code, and
(vii) all other embodiments of such intellectual property,
whether any of the foregoing are in Palatin’s possession or
control or in the possession and control of any Third Party but
which Palatin has the right to access or benefit from and to make
available to AMAG. Palatin shall not interfere with the exercise by
AMAG or its Affiliates of rights and licenses to intellectual
property licensed hereunder and embodiments thereof in accordance
with this Agreement and agrees to use Commercially Reasonable
Efforts to assist AMAG and its Affiliates to obtain such
intellectual property and embodiments thereof in the possession or
control of Third Parties as reasonably necessary or desirable for
AMAG or its Affiliates or Sublicensees to exercise such rights and
licenses in accordance with this Agreement.


 


9.8.3.           No
Limitation of Rights. All rights, powers and remedies of
AMAG provided in this Section 9.8 are in addition to and not
in substitution for any and all other rights, powers and remedies
now or hereafter existing at Law or in equity (including the
Bankruptcy Code) in the event of the commencement of a case under
the Bankruptcy Code involving Palatin.


 



10. 

LIMITATION
ON LIABILITY, INDEMNIFICATION AND INSURANCE.






 


10.1.           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 Payment due upon any unachieved
Development Event under Section 3.3, any Sales Milestone
Payment due upon any


 




 

39








 






 


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.


 


unachieved
Total Annual Net Sales level under Section 3.4, any unearned
royalties under Section 3.5 or any other unearned, speculative
or otherwise contingent payments provided for in this
Agreement.


 


10.2.           Indemnification
by AMAG. AMAG 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:


 


(a) Development,
Manufacture, Commercialization or use of any Product by, on behalf
of, or under the authority of, AMAG (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 AMAG
pursuant to Section 10.3; or


 


(b) the
material breach by AMAG of any of its representations, warranties
or covenants set forth in Section 8.1;


 


except,
in each case, to the extent caused by the negligence, recklessness
or intentional acts of Palatin or any Palatin Indemnified
Party.


 


10.3.           Indemnification
by Palatin. Palatin will indemnify, defend and hold harmless
AMAG, its Affiliates, Sublicensees, contractors, distributors and
each of its and their respective employees, officers, directors and
agents (each, a “AMAG Indemnified Party”) from and
against any and all Liabilities that the AMAG Indemnified Party may
be required to pay to one or more Third Parties resulting from or
arising out of:


 


(a) the
material breach by Palatin of any of its representations,
warranties or covenants set forth in Section 8.1,
Section 8.2, Section 8.3 or Section 8.4 except to
the extent caused by the negligence, recklessness or intentional
acts of AMAG or any AMAG Indemnified Party;


 


(b) any claim
that the practice of the Palatin Technology to Develop,
Manufacture, Commercialize or use any Compound, Product,
Pharmaceutical Product or Product Delivery Device infringes or
misappropriates any issued patent or other proprietary right owned
or possessed by any Third Party; or


 


(c) the
negligence or willful misconduct of Palatin in the conduct of the
Palatin Development Activities by or on behalf of
Palatin.


 


10.4.           Procedure.


 


10.4.1.                      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


 




 

40








 






 


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.


 


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.


 


10.4.2.                      Control.
Subject to AMAG’s right to control any actions described in
Sections 6.2.2, 6.2.5, 6.2.6, 6.2.8 or 6.3 (even where Palatin is
the Indemnifying Party), the Indemnifying Party shall have the
right, exercisable by notice to the Indemnified Party within ten
Business Days 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 ten
(10) Business Days 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 ten Business Days 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


 




 

41








 






 


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.


 


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.


 


10.4.3.                      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.


 


10.5.           Insurance.
Each Party further agrees to obtain and maintain, during the Term,
commercial general liability insurance, including products
liability insurance, with reputable and financially secure
insurance carriers (or pursuant to a program of self-insurance
reasonably satisfactory to the other Party) to cover its
indemnification obligations under Section 10.2 or
Section 10.3, as applicable, in each case with limits of not
less than [...***...] per occurrence and in the aggregate.
Insurance shall be procured with carriers having an A.M. Best
Rating of A-VII or better.


 



11. 

MISCELLANEOUS.






 


11.1.           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) subject to the provisions
of Section 11.2, as applicable, 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. In addition, AMAG may assign its rights and
obligations under this Agreement to a Third Party where AMAG or its
Affiliate is required, or makes a good faith determination based on
advice of counsel, to divest a Compound, Product, Pharmaceutical
Product or Product Delivery Device in order to comply with Law or
the order of any Governmental Authority as a result of a merger or
acquisition, provided that
the assignee shall expressly agree to be bound by AMAG’s
obligations under this Agreement. Each Party shall promptly notify
the other Party of any assignment or transfer under the provisions
of this Section 11.1. 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


 




 

42








 






 


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.


 


accordance
with this Section 11.1 shall be void. Conditioned upon
satisfaction of the requirements of §365(b) of the
Bankruptcy Code, Palatin hereby consents to assumption of this
Agreement in any case filed by or against AMAG under the Bankruptcy
Code.


 


11.2.           Change
of Control of Palatin. Palatin shall notify AMAG in writing
promptly (and in any event within five Business Days) following the
entering into of a definitive agreement with respect to a Change of
Control of Palatin. If Palatin undergoes a Change of Control
without AMAG’s prior written consent prior to the acceptance
of an NDA by the FDA for a Product with respect to the Initial
Indication, then the reductions in payment set forth in
Section 9.7.1(d)(iii) shall automatically apply to all
subsequent amounts payable by AMAG pursuant to this
Agreement.


 


11.3.           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.


 


11.4.           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.


 


11.5.           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 or by facsimile transmission
(receipt verified), five 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 a nationally recognized express courier service and
specifying next Business Day delivery (receipt verified), to the
Parties at the following 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 AMAG shall be addressed as follows:


 


	
 

	

AMAG
Pharmaceuticals, Inc.


	
 

	

1100
Winter Street


	
 

	

Waltham, MA
02451


	
 

	

Attn:
General Counsel


	
 

	

Email:
jvittiglio@amagpharma.com







 


	

with a
copy to:







 




 

43








 






 


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.


 


	
 

	

Ropes &
Gray LLP


	
 

	

Prudential
Tower


	
 

	

800
Boylston Street


	
 

	

Boston,
MA 02199


	
 

	

Attn:
Mark W. Bellomy


	
 

	

Email:
mark.bellomy@ropesgray.com







 


	

All
correspondence to Palatin shall be addressed as
follows:

	
 


	
 

	
 


	
 

	

Palatin
Technologies, Inc.


	
 

	

4-B
Cedar Brook Drive


	
 

	

Cranbury, NJ
08512


	
 

	

Attn:
Carl Spana, Ph.D.


	
 

	

Fax:
(609) 495-2202


	
 

	

Email:
cspana@palatin.com







 


	

with a
copy to:

	
 


	
 

	
 


	
 

	

Thompson Hine
LLP


	
 

	

335
Madison Avenue, 12th Floor


	
 

	

New
York, NY 10017


	
 

	

Attn:
Faith L. Charles, Esq.


	
 

	

Fax:
(212) 344-6101


	
 

	

Email:
Faith.Charles@ThompsonHine.com







 


11.6.           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.


 


11.7.           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.


 


11.8.           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.


 




 

44








 






 


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.


 


11.9.           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.


 


11.10.                      Dispute
Resolution. If any dispute or disagreement arises between
AMAG and Palatin in respect of this Agreement, they shall follow
the following procedures in an attempt to resolve the dispute or
disagreement:


 


11.10.1.                  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.


 


11.10.2.                  Within
[...***...] of receipt of a Notice of Dispute, the CEO (or
his or her designee) of AMAG 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.


 


11.10.3.                  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 11.10.2 has not been held
within [...***...] of initial receipt of the Notice of
Dispute, then the Parties agree that either Party may initiate
litigation to resolve the dispute.


 


Notwithstanding
any provision of this Agreement to the contrary, either Party may
immediately initiate litigation in any court of competent
jurisdiction seeking any remedy at law or in equity, including the
issuance of a preliminary, temporary or permanent injunction, to
preserve or enforce its rights under this Agreement. The provisions
of this Section 11.10 will survive termination or expiration
of this Agreement.


 


11.11.                      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,
without regard to conflict of law principles thereof.


 


11.12.                      Consent
to Jurisdiction. Each Party to this Agreement hereby
(a) irrevocably submits to the exclusive jurisdiction of the
state courts of the State of New York or the United States District
Court for the Southern District of New York for the purpose of any
and all actions, suits or proceedings arising in whole or in part
out of, related to, based upon or in connection with this Agreement
or the subject matter hereof, (b) waives to the extent not
prohibited by applicable Law, and agrees not to assert, by way of
motion, as a defense or otherwise, in any such action, any claim
that it is not subject personally to the jurisdiction of the
above-named courts, that its property is exempt or immune from
attachment or execution, that any such action brought in one of the
above-named courts should be dismissed on grounds of forum non conveniens, should be
transferred to any court other than one of the above-named courts,
or should be stayed by reason of the pendency of some other
proceeding in any other court other than one of the above-named
courts, or that this Agreement or the subject matter hereof may not
be enforced in or by such court, and (c) agrees not to
commence any such action other than before one of the above-named
courts nor to make any motion or take any other action seeking or
intending to cause the transfer or removal of any such action to
any court other than one of the above-named courts whether on the
grounds of inconvenient forum or otherwise.


 




 

45








 






 


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.


 


11.13.                      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.


 


11.14.                      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.


 


11.15.                      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.


 


11.16.                      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.


 


11.17.                      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, AMAG may decide, in its sole discretion,
to use one or more of its Affiliates to perform its obligations and
duties hereunder, provided
that AMAG shall remain liable hereunder for the performance
by any such Affiliates of any such obligations.


 



(Signature page follows.)


 




 

46








 






 


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 Execution Date to be
effective as of the Execution Date.


 


	


AMAG PHARMACEUTICALS, INC.


	
 

	



PALATIN TECHNOLOGIES, INC.  


	
 

	
 

	
 

	
 

	
 


	
 

	
 

	
 

	
 

	
 


	

By

	

/s/
William K. Heiden

	
 

	

By

	

/s/
Carl Spana


	

Name:

	

William
K. Heiden

	
 

	

Name:

	

Carl
Spana


	

Title:

	

Chief
Executive Officer

	




	



Title:	
President and Chief
Executive Officer







 


Signature
Page to Research Collaboration and License
Agreement


 


 




 

47








 






 


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).


 


“AMAG
Diligence Obligations” means AMAG’s Regulatory Approval
diligence obligations under Section 5.2.1 and AMAG’s
Commercialization diligence obligations under
Section 5.2.2.


 


“AMAG
Know-How” means any Know-How, excluding all Joint Know-How,
that (a) is Controlled by AMAG on the Execution Date or that
comes into the Control of AMAG 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.


 


“AMAG Patent
Right” means any Patent Right, excluding all Joint Patent
Rights, that (a) is Controlled by AMAG on the Execution Date
or that comes into the Control of AMAG 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.


 


“AMAG
Technology” means any and all AMAG Patent Rights and AMAG
Know-How.


 


“Applicable
AMAG Technology” means any (a) Know-How Controlled by
AMAG or its Affiliates that was invented, discovered or developed
during the Term and in connection with AMAG’s or its
Affiliates’ activities under the Agreement and
(b) Patent Right Controlled by AMAG 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 holiday in New York, New York.


 






 




 

A-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.


 


“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.


 


“Catalent
Agreements” means (i) the Commercial Supply Agreement,
dated June 20, 2016, by and between Catalent Belgium S.A. and
Palatin and (ii) the Manufacturing Preparation and Services
Agreement, dated June 20, 2016, by and between Catalent
Belgium S.A. and Palatin (the “Catalent Services
Agreement”).


 


“Change of
Control” means, with respect to a Party (a) the
acquisition of beneficial ownership, directly or indirectly, by any
Person (other than such Party or an Affiliate of such Party, and
other than by virtue of obtaining irrevocable proxies) of
securities or other voting interest of such Party representing a
majority or more of the combined voting power of such Party’s
then outstanding securities or other voting interests, (b) any
merger, reorganization, consolidation or business combination
involving such Party with a Third Party that results in the holders
of beneficial ownership (other than by virtue of obtaining
irrevocable proxies) of the voting securities or other voting
interests of such Party (or, if applicable, the ultimate parent of
such Party) immediately prior to such merger, reorganization,
consolidation or business combination ceasing to hold beneficial
ownership of at least fifty percent (50%) of the combined voting
power of the surviving entity immediately after such merger,
reorganization, consolidation or business combination, (c) any
sale, lease, exchange, contribution or other transfer (in one
transaction or a series of related transactions) of all or
substantially all of the assets of such Party to which this
Agreement relates, other than a sale or disposition of such assets
to an Affiliate of such Party or (d) the approval of any plan
or proposal for the liquidation or dissolution of such Party (other
than in circumstances where such Party is deemed a Debtor pursuant
to Section 9.8).


 


“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.


 


“Combination
Product” means a Product containing a Compound and one or
more other therapeutically active ingredients.


 


“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.


 






 




 

A-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.


 


“Commercially
Reasonable Efforts” means, with respect to the efforts to be
expended by a Party with respect to any 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
country 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 country, 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
Execution Date are listed in Exhibit C.


 


“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 Execution 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


 






 




 

A-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.


 


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 AMAG
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 3.3.


 


“Development
Term” means the period beginning on the Effective Date and
ending upon the earlier of (a) Regulatory Approval in the
United States for the first Product for the Initial Indication and
(b) the date that the Parties agree in writing to end all
Palatin Development Activities.


 


“FD&C
Act” means the United States Federal Food, Drug, and Cosmetic
Act, as amended, and the rules and regulations promulgated
thereunder.


 


“FDA”
means the United States Food and Drug Administration or any
successor agency thereto.


 


“Field”
means the treatment, prevention or diagnosis of any and all
diseases and medical conditions in humans. For clarity, and without
limiting the foregoing, with respect to Compounds and Products,
Field includes all fields of use, all indications, and all
formulations (whether injectable, oral, or otherwise).


 


“First
Commercial Sale” means, with respect to any Product and with
respect to any country of the Territory, the first sale of such
Product by AMAG or an Affiliate or Sublicensee of AMAG to a Third
Party in such country after such Product has been granted
Regulatory Approval by the appropriate Regulatory Authority(ies)
for such country.


 






 




 

A-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.


 


“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
AMAG 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 AMAG or an AMAG Affiliate or Sublicensee by the FDA or,
for purposes of a country outside the United States, is approved in
reliance on a prior Regulatory Approval of a Product granted to
AMAG or an AMAG Affiliate or Sublicensee by the applicable
Regulatory Authority.


 


“Governmental
Authority” means any court, agency, department, authority or
other instrumentality of any national, state, county, city or other
political subdivision.


 


“Horizon
Agreement” means the Amended and Restated Venture Loan and
Security Agreement, dated July 2, 2015, by and between Palatin
and the Horizon Lenders.


 


“Horizon
Lenders” means Horizon Technology Finance Corporation,
Fortress Credit Co LLC, Horizon Credit II LLC and Fortress Credit
Opportunities V CLO Limited.


 


“HSR
Act” means the Hart-Scott-Rodino Antitrust Improvements Act
of 1976, as amended, and the rules and regulations promulgated
thereunder.


 


“HSR
Filing” means a filing by AMAG and Palatin with the United
States Federal Trade Commission and the Antitrust Division of the
United States Department of Justice of a Notification and Report
Form for Certain Mergers and Acquisitions (as that term is
defined in the HSR Act) with respect to the matters set forth in
this Agreement, together with all required documentary attachments
thereto.


 


“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.


 


“Joint
Know-How” means any Know-How (excluding Sponsored Know-How),
whether or not patentable, made or created during the Term jointly
by (a) Palatin or any of its Representatives and (b) AMAG
or any of its Representatives.


 


“Joint Patent
Right” means any Patent Right that claims or discloses any
invention included in Joint Know-How.


 


“Joint
Technology” means the Joint Know-How and the Joint Patent
Rights.


 






 




 

A-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.


 


“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, 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 submitted to the FDA in the United
States in accordance with the FD&C Act with respect to a
pharmaceutical product or any analogous application or submission
with any Regulatory Authority outside of the United
States.


 


“Net
Sales” shall be determined from books and records maintained
in accordance with United States GAAP, as consistently applied by
AMAG with respect to sales of the Product.


 


“Palatin
Know-How” means any and all Know-How, other than Joint
Know-How, that (a) is Controlled by Palatin or any of its
Affiliates as of the Execution 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 AMAG), (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, other than a Joint
Patent Right, that (a) is Controlled by Palatin or any of its
Affiliates as of the Execution 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 AMAG) 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.


 


“Palatin
Third Party Agreement” means any agreement between Palatin
(or any of its Affiliates) and any Third Party that relates to any
of the Palatin Technology or Joint Technology.


 


“Patent
Rights” means any and all (a) issued patents,
(b) pending patent applications, including all provisional
applications, substitutions, continuations,
continuations-in-part,


 






 




 

A-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.


 


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 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.


 


“Price
Approval” means, in any country 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 country until all
applicable Price Approvals have also been obtained by AMAG or its
designee for such Product in such country.


 


“Regulatory
Authority” means, with respect to a country 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 country,
Price Approval, for pharmaceutical products in such
country.


 


“Regulatory
Exclusivity Period” means with respect to any particular
Product in any particular country in the Territory, the period of
time during which the data and information submitted by AMAG or any
of its Affiliates or Sublicensees to the relevant Regulatory
Authority in such country 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


 






 




 

A-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.


 


support
the Regulatory Approval or Commercialization of any product by a
Third Party in such country.


 


“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 AMAG, AMAG, 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 country in the Territory, the period commencing with the
First Commercial Sale of such Product in such country and
continuing until the latest of (a) the earliest date on which there
are no Valid Claims of Palatin Patent Rights Covering such Product
in such country [...***...], (b) the last day of the Regulatory
Exclusivity Period for such Product in such country and (c) the
tenth (10th) anniversary of the First Commercial Sale of the
Product in such country. For the avoidance of doubt, the Royalty
Term for a given Product in a given country in the Territory (i)
will not begin until the First Commercial Sale of such Product in
such country 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 AMAG grants or has granted, directly or
indirectly, a sublicense of rights licensed by Palatin to AMAG
under this Agreement.


 


“Territory”
means all countries of North America. For the avoidance of doubt,
and without limiting the foregoing, Territory includes the United
States, Canada, Mexico and their respective territories and
possessions.


 


“Third
Party” means any Person other than AMAG, Palatin or their
respective Affiliates.


 


“Trademark”
means any trademark, trade name, service mark, 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.


 






 




 

A-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 country, a claim
of an issued and unexpired Palatin Patent Right or Joint 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

	
 

	

3.5.3(a)


	

Agreement

	
 

	

Preamble


	

AMAG

	
 

	

Preamble


	

AMAG
Conditions

	
 

	

1.1.2


	

AMAG
Indemnified Party

	
 

	

10.3


	

[...***...]

	
 

	

[...***...]


	

[...***...]

	
 

	

[...***...]


	

[...***...]

	
 

	

[...***...]


	

[...***...]

	
 

	

[...***...]


	

Assigned
Contracts

	
 

	

2.11


	

Audit
Opinion

	
 

	

8.4.9


	

Audited
Financial Statements

	
 

	

8.4.9


	

Catalent

	
 

	

1.1.2


	

cGMP

	
 

	

5.6.5


	

Contemplated
Transactions

	
 

	

1.1


	

Continuation
Product

	
 

	

9.7.1(a)(vi)(A)


	

Debtor

	
 

	

9.8.1


	

Development
Payment

	
 

	

3.3


	

Diligence
Issue

	
 

	

5.2.4


	

Disclosed
Third Party Agreement

	
 

	

8.3.12


	

Disclosing
Party

	
 

	

7.1


	

Effective
Date

	
 

	

1.1


	

Effectiveness
Conditions

	
 

	

1.1.2


	

Execution
Date

	
 

	

Preamble


	

Generic
Competition

	
 

	

3.5.3(c)


	

Gross
Receipts

	
 

	

3.5.3(c)


	

Holdback
Amount

	
 

	

3.1


	

Indemnified
Party

	
 

	

10.4.1


	

Indemnifying
Party

	
 

	

10.4.1


	

Independent
Auditor

	
 

	

8.4.9


	

Infringement
Claim

	
 

	

6.2.5


	

JSC

	
 

	

4.2.1


	

Liability

	
 

	

10.2


	

Licensed
Activities

	
 

	

6.2.4(a)


	

Litigation
Conditions

	
 

	

10.4.2







 






 




 

A-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.


 


	

Manufacturing
Know-How

	
 

	

5.6.5


	

Marginal
Royalty Rate

	
 

	

3.5.1


	

Mutual
Condition

	
 

	

1.1.1


	

Notice
of Dispute

	
 

	

11.10.1


	

Ongoing
Program Expenses

	
 

	

3.2


	

Party
or Parties

	
 

	

Preamble


	

Palatin

	
 

	

Preamble


	

Palatin
Development Activities

	
 

	

4.1


	

Palatin
Indemnified Party

	
 

	

10.2


	

[...***...]

	
 

	

[...***...]


	

[...***...]

	
 

	

[...***...]


	

[...***...]

	
 

	

[...***...]


	

[...***...]

	
 

	

[...***...]


	

[...***...]

	
 

	

[...***...]


	

Per
Product Annual Net Sales

	
 

	

3.5.1


	

Product
Brands

	
 

	

5.5.2


	

Program
Expenses

	
 

	

2.4


	

Program
Expense Cap

	
 

	

3.2


	

Program
Patent Rights

	
 

	

6.2.1


	

Receiving
Party

	
 

	

7.1


	

[...***...]

	
 

	

[...***...]


	

Sales
Milestone Payment

	
 

	

3.4


	

SEC

	
 

	

7.3


	

SEC
Financial Statements

	
 

	

8.4.9


	

Sponsored
Know-How

	
 

	

6.1.2


	

Sponsored
Patent Rights

	
 

	

6.1.2


	

Sponsored
Technology

	
 

	

6.1.2


	

Term

	
 

	

9.4


	

Third
Party Claim

	
 

	

10.4.1


	

Third
Party IP Rights

	
 

	

6.2.4(b)


	

Total
Annual Net Sales

	
 

	

3.4


	

Unaudited
Financial Statements

	
 

	

8.4.9







 






 




 

A-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 B



Palatin Patent Rights Existing as of the Execution
Date


 


[...***...]


 






 




 

B-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.


 



Exhibit C



Compounds Existing as of the Execution Date


 


[...***...]







 




 

C-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.


 



Schedule 2.11


 



Assigned Contracts


 



1. 

Commercial Supply
Agreement, dated June 20, 2016, by and between Catalent
Belgium S.A. and Palatin






 



2. 

Manufacturing
Preparation and Services Agreement, dated June 20, 2016, by
and between Catalent Belgium S.A. and Palatin






 






 




 








 






 


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.


 



Schedule 3.5.1


 



Marginal Royalty Rate Calculation Example


 


By way
of example only, if (a) AMAG, its Affiliates or its
Sublicensees sell two Products in the Territory during a given
Calendar Year, (b) Net Sales of the first Product in the
Territory during such Calendar Year are [...***...] and
(c) Net Sales of the second Product in the Territory during
such Calendar Year are [...***...], then the royalties
payable by AMAG under Section 3.5.1 during such Calendar Year
would be calculated as follows:


 


Royalty
for first Product


[...***...]


 


Royalty
for second Product


[...***...]


 


Total
royalty payable for applicable Calendar Year


[...***...]


 






 




 








 






 


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.


 



Schedule 4.1(a)


 



Palatin Development Obligations — Activities Necessary to
File NDA


 


Finalize
CSRs for both pivotal phase 3 trials (BMT-301,
BMT-302).


 


Continue
work and finalize protocol development, study start-up, trial
conduct/oversight, completion of CSRs for all required studies to
support filing including [...***...]


 


Conduct
and complete all study close out activities on all clinical trials
required for NDA.


 


Complete
briefing package and participate actively in pre-NDA meeting with
FDA.


 


Continue
design, conduct and completion to final report the formative and
summative studies for the drug/device combination.


 


Complete
all required CMC work for filing and commercialization of
product.



1. 

Process
validation






 


Complete
and finalize Non-clinical studies


[...***...]


 


Draft
and finalize all reports (including pre-clinical, PK, CMC, clinical
reports) required for NDA submission.


 


Finalize
ISS (Integrated Safety Summary), ISE (Integrated Summary
Efficacy), and DIP (Data Integration Plan) and all other required
sections of the NDA.


 


Prepare
all data reports for 120 day safety update amendment to NDA
filing.


 


Continue
to generate and submit all necessary regulatory submissions to the
IND (annual reports, responses to information
requests, etc.).


 






 




 








 






 


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.


 



Schedule 4.1(b)


 



Palatin Development Obligations — Assistance Necessary to
Secure Regulatory Approval


 


Assist
in advisory panel preparations and participation in advisory panel
as requested.


 


Assist
with any post-NDA filing regulatory interactions with FDA as
requested.


 






 




 








 






 


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.


 



Schedule 5.5.2(b)


 



Product Brands


 


[...***...]


 






 




 








 






 


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.


 



Schedule 7.4.1


 



Public Announcement


 


See
attached.


 


[Attached
as Exhibit 99.3 to AMAG’s Current Report on Form 8-K filed on
January 9, 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.


 



Schedule 8.3.1


 



Exceptions to Palatin’s Exclusive Ownership of Palatin
Technology


 



1. 

“Ypsomed
Intellectual Property Rights” as defined in each of the
Customization Proposal, dated June 8, 2012, by and between
Ypsomed AG and Palatin and the Industrialization Proposal, dated
January 30, 2014, by and between Ypsomed AG and
Palatin






 



2. 

“Catalent
IP,” “Catalent Inventions” and the “Auto
Injector Assembly Line,” each as defined in the Commercial
Supply Agreement, dated June 20, 2016, by and between Catalent
Belgium S.A. and Palatin






 



3. 

“Manufacturing
Preparation” as defined in the Manufacturing Preparation and
Services Agreement, dated June 20, 2016, by and between
Catalent Belgium S.A. and Palatin






 



4. 

“New General
Application Intellectual Property” and Lonza Ltd’s
“Background Intellectual Property,” each as defined in
the Service Agreement, dated October 11, 2015, by and between
Palatin and Lonza Ltd, including any improvements and direct
derivatives made to Lonza Ltd’s Background Intellectual
Property during the services conducted by Lonza Ltd under such
agreement






 






 




 








 






 


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.


 



Schedule 8.3.6


 



Known Infringement of Palatin Patent Rights


 


Palatin
is aware of internet sites advertising or purporting to advertise
bremelanotide for sale, but does not have knowledge of whether the
purported seller is in the Territory or outside the Territory.
[...***...]


 






 




 








 






 


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.


 



Schedule 8.3.8


 



Exceptions to Palatin’s Rights under Palatin
Know-How


 


None.


 






 




 








 






 


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.


 



Schedule 8.3.12


 



Disclosed Third Party Agreements


 



1. 

Commercial Supply
Agreement, dated June 20, 2016, by and between Catalent
Belgium S.A. and Palatin






 



2. 

Manufacturing
Preparation and Services Agreement, dated June 20, 2016, by
and between Catalent Belgium S.A. and Palatin






 



3. 

Purchase orders and agreed quotations for services by and between Lonza Ltd and Palatin Technologies, Inc., including [...***...]






 



4. 

The
[...***...], by and between Ypsomed AG and Palatin
Technologies, Inc.