Document:

ptn_ex1030

 

Exhibit 10.30

 

 

Portions of this Exhibit have been redacted because they are both
(i) not material and (ii) would be competitively harmful if
publicly disclosed. Information that was omitted has been noted in
this document with a placeholder identified by the mark
“[***]”.

 

Manufacturing Services Agreement

 

(the
“Agreement”)

 

 

 

by and
between

 

 

 

 

Lonza Ltd

Münchensteinerstrasse
38 

CH-4002
Basel 

Switzerland

 

-
hereinafter “Lonza” -

 

 

 

and

 

 

 

AMAG Pharmaceuticals, Inc.

1100
Winter St, Waltham,

MA
02451         

                  

-
hereinafter “Customer” –

 

 

 

 

 

 

 

 

Effective
as of 1 June, 2018 (the “Effective Date”)

 

 

1

 

 

 

Table of Contents

 

1    Definitions
and Interpretation    

2    Commitments
and Performance of Services    

3    Project
Management / Steering
Committee    

4    Quality    

5    Insurance    

6    Forecasting,
Ordering and Cancellation    

7    Delivery
and Acceptance    

8    Price
and Payment    

9    Intellectual
Property    

10    Warranties    

11    Indemnification
and Liability    

12    Confidentiality    

13    Term
and Termination    

14    Force
Majeure    

15    Miscellaneous    

 

Appendix
A

    

Appendix
B

 

Appendix
C

 

Appendix
D

 

Appendix
E

 

 

2

 

 

 

Recitals

WHEREAS,
Customer is engaged in the development and research of certain
products and requires assistance in the development and manufacture
of product;

WHEREAS,
Lonza and its Affiliates have expertise in the evaluation,
development and manufacture of products;

WHEREAS,
Lonza and Palatin Technologies, Inc. (“Palatin”)
entered into a Service Agreement dated as of November 11, 2015, as
amended on January 19, 2016 and November 11, 2017 (the
“Palatin Service Agreement”);

WHEREAS,
pursuant to a License Agreement entered into as of January 8, 2017,
by and between Customer and Palatin (the “Palatin License
Agreement”), Palatin was obligated to assign to Customer
agreements that relate to the manufacture or supply of the Product,
as defined herein, including specifically the Palatin Service
Agreement;

WHEREAS,
on December 27, 2017, Palatin assigned to Customer the Palatin
Service Agreement;

WHEREAS,
Customer wishes to engage Lonza for Services relating to the
manufacture of the Product as described in this Agreement;
and

WHEREAS,
Lonza, or its Affiliate, is prepared to perform such Services for
Customer on the terms and subject to the conditions set out
herein.

NOW,
THEREFORE, in consideration of the mutual promises contained
herein, and for other good and valuable consideration, the parties
intending to be legally bound, agree as follows:

1Definitions and Interpretation

	
 

	
 

	

“Affiliate”

	

means
any company, partnership or other entity which directly or
indirectly Controls, is Controlled by or is under common Control
with the relevant Party. “Control” means the ownership
of more than fifty percent (50%) of the issued share capital or the
power to direct or cause the direction of the general management
and policies of the relevant Party.

	
 

	
 

	

“Agreement”

	

means
this agreement incorporating all Appendices, as amended from time
to time by written agreement of the Parties.

	
 

	
 

	

“Applicable
Laws”

	

means
all relevant federal, state and local laws, statutes, rules, and
regulations in the Territory which are applicable to a
Party’s activities hereunder, including, without limitation,
the applicable regulations and guidelines of any Governmental
Authority and all applicable cGMP together with amendments
thereto.

 

 

3

 

 

 

	
 

	
 

	

“Approval”

	

means
the first marketing approval by the FDA or EMA of Product from the
Facility for commercial supply.

	
 

	
 

	

“Background
Intellectual Property”

	

means
any Intellectual Property either (i) owned or controlled by a Party
prior to the Effective Date or (ii) developed or acquired by a
Party (a) independently from the performance of the Services
hereunder during the Term of this Agreement and (b) that does not
claim or otherwise expressly incorporate the other Party’s
Intellectual Property.

	
 

	
 

	

“Batch”

	

means
the Product derived from a single run of the Manufacturing Process,
yielding approximately 
[***] of Product.

	
 

	
 

	

"Batch
Price"

	

means
the Price of each Batch.

	
 

	
 

	

“Binding
Forecast”

	

has the
meaning given in Section 6.1.

	
 

	
 

	

“Campaign”

	

means a
series of cGMP Batches manufactured consecutively.

	
 

	
 

	

“Cancellation
Fee”

	

has the
meaning given in Section 6.7.

	
 

	
 

	

“Capacity
Reservation”

	

has the
meaning given in Section 6.5.

	
 

	
 

	

“Certificate
of Analysis”

	

means a
document prepared by Lonza listing tests performed by Lonza or
approved External Laboratories, the Specifications and test
results.

	
 

	
 

	

“cGMP”

	

means
those laws and regulations applicable in the Territory, relating to
the manufacture of medicinal products for human use, including,
without limitation, current good manufacturing practices as
specified in the ICH guidelines, including without limitation, ICH
Q7A “ICH Good Manufacturing Practice Guide for Active
Pharmaceutical Ingredients”, US Federal Food Drug and
Cosmetic Act at 21CFR (Chapters 210, 211, 600 and 610) and the
Guide to Good Manufacturing Practices for Medicinal Products as
promulgated under European Directive 91/356/EEC, each as may be
amended from time to time. For the avoidance of doubt,
Lonza’s operational quality standards are defined in internal
cGMP policy documents.

	
 

	
 

	

“cGMP
Batches”

	

means
any Batches which are required under the Project Plan to be
manufactured in accordance with cGMP.

 

 

4

 

 

 

	
 

	
 

	

“Change”

	

means
any change to the Services, Specifications, pricing or Scope of
Work incorporated into a written amendment to the Agreement in
accordance with clause 15.2 or effected in accordance with the
Quality Agreement.

	
 

	
 

	

“Change
Order”

	

means a
document in the format provided in Appendix E provided by Lonza to Customer
outlining a proposed adjustment (increase or decrease) to the Price
and the reasons for such adjustment, such document to be reviewed
and signed by both parties to enable such adjustment to take
effect.

	
 

	
 

	

“Commencement
Date”

	

means
the date of commencement of manufacturing activities for a Campaign
or Batch hereunder.

	
 

	
 

	

“Confidential
Information”

	

means
Customer Information and Lonza Information, as the context
requires.

	
 

	
 

	

“Customer
Indemnitees”

	

has the
meaning given in Section 11.1.

	
 

	
 

	

“Customer
Information”

	

means
all information that is proprietary to Customer or any Affiliate of
Customer and that is maintained in confidence by Customer or any
Affiliate of Customer and that is disclosed by Customer or any
Affiliate of Customer to Lonza under or in connection with this
Agreement, including without limitation, the Manufacturing Process,
any and all Customer know-how and trade secrets, and any materials
supplied by Customer to Lonza in accordance with this
Agreement.

	
 

	
 

	

“Delivery
Date”

	

means
the delivery date of a Batch as set forth in a Purchase Order and
confirmed by Lonza in accordance with Section 6.3.

	
 

	
 

	

“Disclosing
Party”

	

has the
meaning given in Section 12.1.

	
 

	
 

	

“EMA”

	

means
the European Medicines Agency, or any successor agency
thereto.

	
 

	
 

	

“External
Laboratories”

	

means
any Third Party instructed by Lonza, with Customer’s prior
consent, which is to conduct activities required to complete the
Services.

	
 

	
 

	

“Facility”

	

means
Lonza’s manufacturing facilities in 
[***] or such
other Lonza facility as may be agreed upon by the
Parties.

	
 

	
 

	

“Failure
to Supply”

	

has the
meaning given in Section 7.4.1.

 

 

5

 

 

 

	
 

	
 

	

“FDA”

	

means
the United States Food and Drug Administration, or any successor
agency thereto.

	
 

	
 

	

“Forecast”

	

has the
meaning given in Section 6.1.

	
 

	
 

	

“Governmental
Authority”

	

means
any Regulatory Authority and any national, multi-national,
regional, state or local regulatory agency, department, bureau, or
other governmental entity in the Territory.

	
 

	
 

	

“Intellectual
Property”

	

means
(i) inventions (whether or not patentable), patents, trade secrets,
copyrights, trademarks, trade names and domain names, rights in
designs, rights in computer software, database rights, rights in
confidential information (including know-how) and any other
intellectual property rights, in each case whether registered or
unregistered, and (ii) all applications (or rights to apply) for,
and renewals or extensions of, any of the rights described in the
foregoing clause (i) in each case, which exist now or which come to
exist in the future, anywhere in the world.

	
 

	
 

	

“LOI”

	

has the
meaning given in Section 2.4.

	
 

	
 

	

“LOI
Batch”

	

has the
meaning given in Section 2.4.

	
 

	
 

	

“Lonza
Indemnitees”

	

has the
meaning given in Section11.2.

	
 

	
 

	

“Lonza
Information”

	

means
all information that is proprietary to Lonza or any Affiliate of
Lonza and that is maintained in confidence by Lonza or any
Affiliate of Lonza and that is disclosed by Lonza or any Affiliate
of Lonza to Customer under or in connection with this Agreement,
including without limitation, any and all Lonza know-how and trade
secrets.

	
 

	
 

	

“Lonza
Manufacturing-related IP”

	

has the
meaning given in Section 9.7.

	
 

	
 

	

“Lonza
Release”

	

has the
meaning given in Section 7.1.

	
 

	
 

	

“Manufacturing
Process”

	

means
the production process provided by Customer for the manufacture of Product, as
such process may be improved or modified from time to time by
agreement of the Parties in writing.

	
 

	
 

	

“Master
Batch Record”

	

means
the document, proposed by Lonza and approved by Customer, which
defines the manufacturing methods, test methods and other
procedures, directions and controls associated with the manufacture
and testing of Product.

	
 

	
 

	

“Minimum
Quantity”

	

has the
meaning given in Section 6.4.

 

 

6

 

 

 

	
 

	
 

	

“Minimum
Quantity Penalty”

	

has the
meaning given in Section 6.4.

	
 

	
 

	

“Necessary
Consumables”

	

has the
meaning given in Section 2.8.

	
 

	
 

	

“New
Customer Intellectual Property”

	

has the
meaning given in Section 9.2.

	
 

	
 

	

"New
General Application Intellectual Property”

	

has the
meaning given in Section 9.3.

	
 

	
 

	

“Party”

	

means
each of Lonza and Customer and, together, the
“Parties”.

	
 

	
 

	

“Price”

	

means
the price for the Services and Products as set out in Appendix
A.

	
 

	
 

	

“Process
Validation Batch”

	

means a
Batch that is produced with the intent to show reproducibility of
the Manufacturing Process and is required to complete process
validation studies.

	
 

	
 

	

“Product”

	

means
the proprietary molecule identified by Customer as PI-001
(Bremelanotide), to be manufactured using the Manufacturing Process
by Lonza for Customer as specified in the Project
Plan.

	
 

	
 

	

“Project
Plan”

	

means
the plan(s) describing the Services to be performed by Lonza under
this Agreement, including any update and amendment of the Project
Plan to which the Parties may agree from time to time. The initial
Project Plan is attached hereto as Appendix B.

	
 

	
 

	

“Purchase
Order”

	

has the
meaning set forth in Section 6.2.

	
 

	
 

	

“Quality
Agreement”

	

means
the quality agreement, attached hereto as Appendix C, setting out the
responsibilities of the Parties in relation to quality as required
for compliance with the Manufacturing Process, Specifications and
cGMP.

	
 

	
 

	

“Raw
Materials”

	

means
all general ingredients, solvents, amino acids, and other
components of the Product required to perform the Manufacturing
Process or Services set forth in the bill of materials detailing
the same (excluding 
[***], which is defined as “Specialty Material”
herein).

	
 

	
 

	

“Receiving
Party”

	

has the
meaning given in Section 12.1.

	
 

	
 

	

“Specialty
Material”

	

means

[***].

	
 

	
 

	

"Specialty
Material Fee"

	

means a
procurement and handling fee of 
[***] of the acquisition cost of Specialty Material
by

 

 

7

 

 

 

Lonza
that is charged to the Customer in accordance with Section 2.9. In
the event that Specialty Material will be used less than

[***] times,
the handling fee for the next purchase of Specialty Materials shall
be reduced to 
[***].

	
 

	
 

	

“Regulatory
Authority”

	

means
the FDA, EMA and any other similar regulatory authorities in the
Territory.

	
 

	
 

	

“Release
for Delivery”

	

has the
meaning given in Clause 7.1.

	
 

	
 

	

“Services”

	

means
all or any part of the services to be performed by Lonza under this
Agreement (including, without limitation, process and analytical
method transfer, process development, process optimization,
validation, clinical and commercial manufacturing, as well as
quality control and quality assurance activities), particulars of
which are set out in a Project Plan and the Quality
Agreement.

	
 

	
 

	

“Specifications”

	

means
the specifications of the Product as specified in Appendix D, which may be amended from
time to time in accordance with this Agreement.

	
 

	
 

	

“Term”

	

has the
meaning given in Section 13.1.

	
 

	
 

	

“Territory”

	

means
the United States, European Union and such other countries as may
be agreed upon by the Parties.

	
 

	
 

	

“Third
Party”

	

means
any party other than Customer, Lonza and their respective
Affiliates.

	
 

	
 

	

“Up-Front
Payment”

	

has the
meaning set forth in Appendix
A.

 

In this
Agreement references to the Parties are to the Parties to this
Agreement, headings are used for convenience only and do not affect
its interpretation, references to a statutory provision include
references to the statutory provision as modified or re-enacted or
both from time to time and to any subordinate legislation made
under the statutory provision, references to the singular include
the plural and vice versa, and references to the word
“including” are to be construed without
limitation.

 

2    Commitments
and Performance of Services

	
 

	
 

	

2.1

	

Performance of Services. Lonza shall itself and through its
Affiliates, diligently carry out the Services as provided in the
Project Plan. Lonza shall retain appropriately qualified and
trained personnel with the requisite knowledge and experience to
perform the Services in accordance with this Agreement. Lonza may
subcontract or delegate any of its rights or obligations under this
Agreement to an External Laboratory to perform the Services only
with prior written consent from Customer; provided, that any
External Laboratories shall be subject to the same obligations and
other provisions contained in this Agreement or any applicable
Project Plan. In the event that Customer requests

 

 

8

 

 

 

Lonza
to outsource certain services to an External Laboratory appointed
by Customer, Lonza shall not be responsible for analytical lab
services performed by External Laboratories.

	
 

	
 

	

2.2

	

cGMP
Batch(es). Lonza will, in accordance with the terms of this
Agreement and Quality Agreement, manufacture at the Facility and
deliver to Customer, cGMP Batches that comply with the
Manufacturing Process, cGMP and the Specifications, together with a
Certificate of Analysis and all other documentation as set forth in
the Quality Agreement. Prior to commencement of cGMP manufacturing
in 2018, Lonza shall review the process assumptions. In the event
that there is a material difference in the process assumptions as
compared with the process results demonstrated during previous
manufacturing campaigns, the Parties shall meet to discuss in good
faith to resolve the matter.

 

	
 

	
 

	

2.2.1

	

Notwithstanding
anything herein to the contrary or in the Quality Agreement, except
as otherwise agreed to by Customer in writing or as may be required
to comply with Applicable Laws (including cGMPs), Lonza shall not
amend, change, or supplement any of the following without
Customer’s prior written consent: (1) the Specifications; (2)
the specifications for or the source of Raw Materials or Specialty
Materials that have regulatory impact; (3) the equipment and
machinery, other than in-kind replacements, used in the manufacture
of Product that have a direct impact on the quality of the Product;
(4) the test methods used in connection with manufacturing Product
that have regulatory impact; or (5) the Manufacturing
Process.

	
 

	
 

	

2.2.2

	

In the
event that Lonza is required to change any of the foregoing in
order to comply with a change in an Applicable Law (including
cGMPs) or such change is otherwise agreed to by Customer in
writing, Lonza shall: (i) immediately notify Customer of such
change and use commercially reasonable efforts to implement such
change as soon as reasonably practicable; (ii) be responsible for
ensuring that all Product manufactured following such change meets
the Specifications; and (iii) provide Customer with all information
with respect to the manufacture of the Product in connection with
such change needed to amend any regulatory filings maintained with
respect to the Product. 
[***].

	
 

	
 

	

2.2.3

	

In the
event that Customer desires to propose a discretionary change
(i.e., changes which are not required by cGMPs or other Applicable
Laws) under Section 2.2.1 during the Term, the Parties shall
discuss such discretionary changes and any manufacturing issues
identified by either Party in connection with implementing such
change. In all cases, such discretionary changes shall be made in
accordance with any change control procedures in the Quality
Agreement to the extent applicable. 
[***].

	
 

	
 

	

2.2.4

	

In the
event that Lonza desires to propose a discretionary change (i.e.,
changes which are not required by cGMPs or other Applicable Laws)
under Section 2.2.1 during the Term, the Parties shall discuss such
discretionary changes and any manufacturing issues identified by
either Party in connection with implementing such change. In all
cases, such discretionary changes shall be made in accordance with
any change control procedures in the Quality Agreement to the
extent applicable. 
[***].

	
 

	
 

	

2.2.5

	

Lonza
acknowledges that any such change(s) under this Section 2.2 shall,
in each case, comply with cGMP, this Agreement and the Quality
Agreement. Any

 

 

9

 

 

 

such
amended Specifications shall be reflected in and attached hereto as
an amended and restated Appendix
D.

	
 

	
 

	

2.3

	

Process Validation Batches. Customer may request Lonza to
manufacture and deliver Process Validation Batches as mutually
agreed by Parties sufficient to document the operability and
reproducibility of the Manufacturing Process and permit the Parties
to complete and file the necessary regulatory documents. Any and
all validation effort shall be additional and outside the scope of
this Project Plan. No Validation effort is currently anticipated as
part of the current Project Plan.

	
 

	
 

	

2.3.1

	

Upon
request of Customer, Lonza and Customer shall further discuss and
agree to a process validation plan identifying the validation
requirements of the Manufacturing Process. Any and all process
validation activities are not considered as part of the Project
Plan and are excluded from the Prices within this Agreement. Any
such future Process Validation or Process Validation Batches shall
be approved by the Customer in advance and shall be paid for by the
Customer at a Price to be determined in a separate Project
Plan.

	
 

	
 

	

2.4

	

Letter of Intent. The Parties entered into a Letter of
Intent dated 
[***] (the “LOI”) 
[***] (the “LOI

[***]”). In accordance with Sections 6(c) and 11 of
the LOI, the terms covenants and conditions of this Agreement
govern the supply of the LOI 
[***] and such LOI 
[***] is deemed to be Product manufactured by Lonza and
supplied to AMAG under this Agreement. In the event of a conflict
between this Agreement and the LOI, this Agreement shall
control.

	
 

	
 

	

2.5

	

Regulatory Support Activities. Any regulatory support
documentation (including, without limitation, documentation related
to pre-Approval inspection and provision of any data and
information (in English) relating to Lonza’s performance
under this Agreement) required and agreed to by Customer to support
and maintain the Approval of the Product from the Facility shall be
performed and supported by Lonza as reasonably requested by
Customer. 
[***]. If required, additional regulatory support activities
shall be approved by the Customer in advance, 
[***] at a price set out in a separate Project
Plan.

	
 

	
 

	

2.6

	

Commercial manufacturing and supply. Customer shall purchase
Product from Lonza during the Term at the Price outlined in
Attachment A. Lonza shall
manufacture all Product as ordered and accepted per Section 6,
under this Agreement at the Facility and pursuant to the terms
hereof and the Quality Agreement. Manufacturing of Product may not
be relocated from the Facility without Customer’s prior
written consent.

	
 

	
 

	

2.7

	

Supply of Customer Information. Customer shall supply to
Lonza all Customer Information and other information or materials
that may be reasonably required by Lonza to perform the Services.
Lonza shall not be responsible for any delays arising out of
Customer’s failure to provide such Customer Information or
other information or materials reasonably required to perform the
Services to Lonza.

	
 

	
 

	

2.8

	

Raw Materials. Lonza shall procure all required Raw
Materials as well as consumables necessary to perform the Services
(the “Necessary
Consumables”). In order to fulfil its obligations
under this Agreement, Lonza may purchase and hold a minimum of

[***] extra Batch’s requirements of Raw Materials to
serve as safety stock.

	
 

	
 

	

2.9

	

Specialty Material and Specialty Material Fee. Specialty
Material is not considered part of the Raw Materials and shall be
ordered and invoiced separately from Raw Materials. Specialty
Material shall be ordered and stocked by Lonza only upon reasonable
notice

 

 

10

 

 

 

to and
approval by Customer, such notice not to be unreasonably withheld.
The Specialty Material Fee is intended compensate Lonza for the
procurement and handling of the Specialty Material, any development
or validation efforts Lonza performs in order to prepare, use,
clean and/or store Specialty Material (including any
experimentation to determine the number of times Specialty Material
may be reused), and Lonza’s preparation, use, cleaning and/or
storage of Specialty Material. Lonza shall submit an invoice to
Customer, together with sufficient substantiating documentation,
for the cost of Specialty Material and the associated Specialty
Material Fee. Customer shall pay invoices under this Section in
accordance with Section 8.

 

3    Project
Management / Steering Committee

	
 

	
 

	

3.1

	

Project Plan. With respect to the Services to be governed by
this Agreement, a Project Plan shall be added by agreement in a
writing signed by the Parties and appended to Appendix B. The
Project Plan shall include a description of the Services to be
provided and such other information as is necessary for performance
of the Services. In the event of a conflict between the terms of a
Project Plan and this Agreement, the terms of this Agreement will
govern unless the terms of the Project Plan expressly override the
terms of the Agreement set forth herein.

	
 

	
 

	

3.2

	

Project Management. Each party will appoint a project
manager who will be the party responsible for overseeing the
Project Plan.

	
 

	
 

	

3.3

	

Steering Committee. Each Party shall name a mutually agreed
upon equal number of representatives for the Steering Committee,
which shall meet twice per calendar year, or as otherwise mutually
agreed by the Parties. In the event that a Steering Committee
dispute cannot be resolved, such dispute shall be escalated to a
senior executive of each of Customer and Lonza.

 

The
primary function of the Steering Committee is to ensure the ongoing
communication between the Parties and discuss and resolve any
issues arising under this Agreement. In addition to the primary
function described above, the Steering Committee shall also take on
the following responsibilities:

	
 

	
 

	

3.3.1

	

discuss
and seek resolution of issues around management of the
Services;

	
 

	
 

	

3.3.2

	

agree
and monitor deadlines and milestones for the Services;
and

	
 

	
 

	

3.3.3

	

discuss
and recommend any changes to the Services (although such changes
will not take effect until they have been incorporated into a
written amendment to the Project Plan which has been signed by the
Parties).

	
 

	
 

	

3.4

	

Person in Plant. In addition to the inspection and audit
rights set forth in Section 4.2 and the Quality Agreement, Customer
shall be permitted to have, at no additional cost, 
[***] at the
Facility as reasonably requested by Customer, 
[***] the Manufacturing Process for the purpose of
observing, reporting on, and consulting as to the performance of
the Services. Such 
[***] shall be subject to and agree to abide by
confidentiality obligations of this Agreement and Lonza’s
customary practices and operating procedures regarding persons in
plant, and such 
[***] agrees to comply with all instructions of
Lonza’s employees at the Facility.

 

4    Quality

 

 

11

 

 

 

	
 

	
 

	

4.1

	

Responsibility
for quality assurance and quality control of Product shall be
allocated between Customer and Lonza as set forth in the Quality
Agreement. If there is a conflict between the terms and conditions
of this Agreement and the Quality Agreement, the terms and
conditions of this Agreement shall prevail except on quality
matters where the Quality Agreement shall prevail. Lonza and
Customer commit to enter into the Quality Agreement in a timely
manner, but in no event later than the commencement of cGMP
manufacturing.

	
 

	
 

	

4.2

	

Inspections
by Regulatory Authorities and audits shall be in accordance with
the Quality Agreement.

 

5    Insurance

	
 

	
 

	

5.1

	

Each
Party shall, during the Term and for 
[***] years
after delivery of the last Product manufactured or Services
provided under this Agreement, obtain and maintain 
[***] from a qualified insurance company, comprehensive
general liability insurance including, but not limited to product
liability coverage in the amount of at least 
[***] per claim. Each Party shall provide the respective
other Party with a copy of the certificate of such insurance upon
reasonable request.

 

6    Forecasting,
Ordering and Cancellation

	
 

	
 

	

6.1

	

Forecast and Binding Forecast. No later than the first (1st)
day of each calendar quarter, Customer shall supply Lonza with a
written forecast showing Customer’s good faith estimated
quarterly requirements for Batches for the following 
[***] period (the “Forecast”). No later than

[***] following Lonza’s receipt of a Forecast, Lonza
shall provide written notice to Customer of whether it has (as of
the date of receipt of the Forecast) capacity available to
manufacture the number of Batches forecasted therein and shall
provide Customer with an estimated production schedule showing the
estimated Commencement Date and delivery date of each Batch. In the
event Customer disputes all or a portion of such production
schedule provided by Lonza, the Parties agree to negotiate in good
faith the disputed portion(s) of such production schedule. Upon
agreement between the Parties regarding the production schedule set
forth in the Forecast, the first 
[***] of such Forecast shall be binding on both Parties (the
“Binding
Forecast”). For the sake of clarity, such Binding
Forecast shall include at least the Minimum Quantity as set forth
in Section 6.4. If the Binding Forecast exceeds the Capacity
Reservation as set forth in Section 6.5, Lonza will use
commercially reasonable efforts to include such excess Batch(es) in
its production schedule.

	
 

	
 

	

6.2

	

Purchase Order. Customer shall provide Lonza with a binding
purchase order in writing (the “Purchase Order”) a minimum of

[***] prior to the scheduled Commencement Date of each Batch
consistent with the Binding Forecast under Section
6.1.

	
 

	
 

	

6.3

	

Purchase Order Confirmation. Lonza shall confirm the
delivery date as set out in each Purchase Order within 
[***] business days of receipt from Customer of the relevant
Purchase Order (the “Delivery
Date”). Upon confirmation, each Purchase Order will be
regarded by the Parties as a binding commitment by Lonza to
manufacture and to deliver to Customer the Batch according to the
requirements set out in such Purchase Order. Lonza will make
commercially reasonable efforts to effect delivery as close as
possible to the Delivery Date set forth in the Purchase Order
confirmation, provided that in no event shall actual delivery be
greater than 
[***] before or after such Delivery Date. 
[***]. Any additional or inconsistent terms or conditions of
any Purchase Order, acknowledgement or similar standardized form
given or received pursuant to this

 

 

12

 

 

 

Section
shall have no effect and such additional or inconsistent terms or
conditions are hereby rejected.

	
 

	
 

	

6.4

	

Minimum Quantity. Customer undertakes to purchase from Lonza
a minimum of 
[***] per calendar year during the Term of the Agreement
(“Minimum
Quantity”). For the purposes of this section, a Batch
is considered “purchased” as of the Commencement Date
in the Purchase Order confirmed by Lonza in accordance with Section
6.3. If Customer fails to purchase the Minimum Quantities in any
calendar year, Lonza shall submit an invoice to Customer in January
of the next calendar year and Customer shall pay the 
[***] ("Minimum Quantity
Penalty"), within 
[***] after receipt of such invoice.

	
 

	
 

	

6.5

	

Capacity Reservation.
Lonza shall reserve capacity to manufacture the Minimum Quantity
agreed between the Parties plus 
[***] per applicable calendar year during the Term of the
Agreement, starting in 2019 (“Capacity
Reservation”).

	
 

	
 

	

6.6

	

First Commercial Batch. Lonza agrees to manufacture

[***]. This commercial 
[***] will be manufactured in accordance with the
Specifications. The Parties agreed upon the pricing of 
[***] in the Letter of Intent entered into as 
[***].

	
 

	
 

	

6.7

	

Cancellation Fee. Customer may cancel a Purchase Order upon
written notice to Lonza, subject to the payment of a cancellation
fee equal to 
[***] with supplier, of each such Batch cancelled under the
Purchase Order (the "Cancellation
Fee"). Any Up-Front Payment paid by Customer to Lonza in
accordance with Appendix A
shall be deducted from such Cancellation Fee; provided, however, to
the extent that such Up-Front Payment was used by Lonza to purchase
Raw Materials in reliance on such cancelled Purchase Order, (i) the
cost of such Raw Materials, as substantiated by sufficient
documentation, shall not be deducted from the Cancellation Fee, and
(ii) such Raw Materials shall be used by Lonza in the preparation
of a subsequent Batch (and the cost of such Raw Materials shall be
deducted from the Batch Price for such subsequent Batch) or
otherwise disposed of at Customer’s direction. Any
Cancellation Fee shall be payable in accordance with Section 8
herein. For the purpose of calculating whether Customer has
purchased the Minimum Quantity in accordance with Section 6.4, any
Batch in a Purchase Order that is cancelled under this Section 6.7
and for which the applicable Cancellation Fee has been paid by
Customer will be considered a Batch “purchased” as of
the Commencement Date in such cancelled Purchase
Order.

	
 

	
 

	

6.8

	

Rescheduling. Lonza shall have the right to reschedule a
Commencement Date of any Batch or Campaign once upon 
[***] prior written notice to Customer, provided that the
resulting rescheduled Delivery Date is targeted not to exceed

[***] later than the confirmed Delivery Date and for the
purpose of calculating whether Customer has purchased the Minimum
Quantity in accordance with Section 6.4, such rescheduled Batch
will be considered “purchased” as of the original
Commencement Date in the confirmed Purchase Order. If the Customer
requests to change the Commencement Date, Lonza will make all
reasonable attempts to accommodate the request; provided, however,
in the event that this change would impact other projects scheduled
for occupancy in the designated suite or suites, manufacture of the
Customer’s Batch or Campaign may be delayed until an adequate
time period is available in the Facility schedule. Parties shall
discuss in good faith the impact such rescheduling request has. Any
delay requested by Customer of more than 
[***] shall be considered a cancellation of the Purchase
Order and shall be subject to the Cancellation Fee set forth in
Section 6.7.

 

 

13

 

 

 

	
 

	
 

	

6.9

	

Product
Quantities. A Batch of 
[***] of Product (the “Target Quantity”), up to
a maximum of 
[***] above or below, will be invoiced according to the
Batch Price as set forth in Appendix A.

 

In case
of quantities below 
[***] of the Target Quantity), Lonza shall invoice and
Customer shall pay (i) the Batch Price minus (ii) the Batch Price
multiplied by the number of kilograms produced less than

[***] divided by the Target Quantity. For example: In case
the quantity is 
[***]))).

 

In case
of quantities above 
[***] of the Target Quantity) Lonza shall invoice and
Customer shall pay (i) the Batch Price plus (ii) the Batch Price
multiplied by the number of kilograms produced in excess of

[***] divided by the Target Quantity. For example: In case
the quantity is 
[***]))).

 

The
Purchase Order shall be fulfilled if at least 
[***] of the Target Quantity is delivered. In the event that

[***] or less
of the Target Quantity for any Batch is delivered, (a) the Parties
will negotiate in good faith the scheduling of the manufacture of a
subsequent Batch, and Lonza will use its best efforts to prioritize
the scheduling of such subsequent Batch so as to minimize
disruption of Customer’s supply of Product, and (b) at
Customer’s discretion, such subsequent Batch shall be
considered a Batch “purchased” in the next calendar
year for purposes of calculating whether Company has purchased the
Minimum Quantity in accordance with Section 6.4.

 

7    Delivery
and Acceptance

	
 

	
 

	

7.1

	

Delivery. Lonza shall deliver to Customer all documentation
as set forth in the Quality Agreement and as is reasonably required
to meet all applicable regulatory requirements of the Governmental
Authorities, including without limitation Master Batch Records,
Certificates of Analysis, deviations, and Batch records in
accordance with the Quality Agreement (the “Lonza Release”). After the Lonza
Release, 
[***] in accordance with Appendix A and Section 8. Customer shall
be responsible for reviewing such documentation and for final
release for delivery of the Product to Customer within 
[***] after Lonza Release in accordance with the Quality
Agreement, and upon approval of such documentation by Customer,
Lonza shall deliver the Product 
[***] on a date mutually agreed to by the Parties in
accordance with Section 7.2 (the “Release for Delivery”) and title
and risk of loss shall transfer to Customer 
[***].

	
 

	
 

	

7.2

	

Storage. Customer shall arrange for shipment and take
delivery of such Batch from the Facility, at 
[***] expense, within 
[***] after Lonza Release or 
[***]. Lonza shall provide storage in accordance with the
requirements set forth in the Quality Agreement on a bill and hold
basis for such Batch(es) at 
[***] for up to 
[***]; provided that any additional storage beyond

[***]. In addition to Section 8.2, below, 
[***] shall be responsible for all value added tax (VAT) and
any other applicable taxes, levies, import, duties and fees of
whatever nature imposed as a result of any storage. Notwithstanding
anything to the contrary contained in this Agreement, in no event
shall Lonza be required to store any Batch for more than

[***] after Release for Delivery. Within 
[***] following a written request from Lonza, Customer shall
provide Lonza with a letter in form satisfactory to Lonza
confirming the bill and hold status of each stored
Batch.

	
 

	
 

	

7.3

	

Acceptance/Rejection
of Product.

	
 

	
 

	

7.3.1

	

Promptly
following Lonza Release of a Batch, Customer shall inspect such
Batch and shall have the right to test such Batch to determine
compliance with the

 

 

14

 

 

 

Product
Specifications. Customer shall notify Lonza in writing of any
rejection of a Batch based on any claim that it fails to meet
Specifications within 
[***] of Release for Delivery, after which time all
unrejected Batches shall be deemed accepted. Customer shall inform
Lonza in writing in case of concealed or latent defects (i.e. not
discovered by routine quality control means), promptly upon
discovery of such defects but no later than 
[***] after delivery of the Product.

	
 

	
 

	

7.3.2

	

In the
event that Lonza believes that a Batch has been incorrectly
rejected, Lonza may require that Customer provide to it Batch
samples for testing. Lonza may retain and test the samples of such
Batch. In the event of a discrepancy between Customer’s and
Lonza’s test results such that Lonza’s test results
fall within relevant Specifications, or there exists a dispute
between the Parties over the extent to which such failure is
attributable to a given Party, the Parties shall cause an
independent laboratory promptly to review records, test data and
perform comparative tests and analyses on samples of the Product
that allegedly fails to conform to Specifications. Such independent
laboratory shall be mutually agreed upon by the Parties. The
independent laboratory’s results shall be in writing and
shall be final and binding save for manifest error. Unless
otherwise agreed to by the Parties in writing, the costs associated
with such testing and review shall be borne by the Party against
whom the independent laboratory rules.

	
 

	
 

	

7.3.3

	

Lonza
shall Reprocess or Rework any Batch, as defined in the Quality
Agreement, or, if Reprocessing or Reworking is not possible,
replace any Batch that fails to conform with the Specifications (a
“Failed Batch”).
In the event that such failure of the Failed Batch is determined by
the Parties or the independent laboratory in accordance with
Section 7.3.2 to be attributable to the Manufacturing Process
supplied to Lonza by Customer (“AMAG Failed Batch”), then such
Reprocessing, Reworking or replacement will be at 
[***] cost, including the cost of Raw Materials and
Necessary Consumables, according to a schedule mutually agreed to
by the Parties, which shall in any event be as promptly as
practicable.

 

In the
event that it is determined by the Parties or the independent
laboratory in accordance with Section 7.3.2 that such failure of
the Failed Batch is not attributable to the Manufacturing Process
supplied to Lonza by Customer (“Lonza Failed Batch”), then such
Reprocessing, Reworking or replacement will be at 
[***] cost, including the cost of Raw Materials and
Necessary Consumables, and according to a schedule mutually agreed
to by the Parties, which shall in any event be as promptly as
practicable. If Lonza is or will be unable to (i) Reprocess or
Rework such Lonza Failed Batch and deliver the resulting Product
within 
[***] of the Delivery Date, or (ii) replace such Lonza
Failed Batch and deliver the resulting Product within 
[***] of the Delivery Date, then in either case Lonza shall
instead, at Customer’s discretion, refund the Batch Price of
the Lonza Failed Batch to Customer. In the event that 
[***] or more consecutive Lonza Failed Batches occur during
the Term, Customer may, at its discretion, terminate this
Agreement.

 

Regardless of the
remedy elected by Customer under this Section 7.3.3, for the
purpose of calculating whether Customer has purchased the Minimum
Quantity in accordance with Section 6.4, a Failed Batch shall be
considered a Batch “purchased” on the Commencement Date
of such Batch as specified in the Purchase Order.

 

 

15

 

 

 

Except
for Lonza’s indemnification obligations set forth in Section
11.1, Customer acknowledges and agrees that its sole remedy with
respect to a Lonza Failed Batch is as set forth in this Section,
and in furtherance thereof, Customer hereby waives all other
remedies at law or in equity regarding the foregoing
claims.

	
 

	
 

	

7.4

	

Failure to Supply

	
 

	
 

	

7.4.1

	

If
Lonza is or will be unable, for any reason (not including an event
of Force Majeure under Section 14 hereof) to supply a Batch in
accordance with the quantity and/or on the Delivery Date specified
in a Purchase Order confirmed by Lonza in accordance with Section
6.3 or as rescheduled in accordance with Section 6.8
(“Failure to
Supply”), Lonza shall immediately upon discovery
notify Customer in writing of such circumstance. Within

[***] of discovery of such Failure to Supply, Lonza shall
notify Customer of the cause of such failure and shall propose a
plan of remediation.

	
 

	
 

	

7.4.2

	

If
Lonza is unable to remedy the Failure to Supply within 
[***] after the Delivery Date specified in the Purchase
Order confirmed by Lonza in accordance with Section 6.3, then
Customer may, at its discretion, cancel such Purchase Order,
provided that in the event of such a cancellation, (i) the
Cancellation Fee set forth in Section 6.7 shall not apply to such
canceled Purchase Order, (ii) the Batch set forth in such canceled
Purchase Order shall be considered a Batch “purchased”
on the Commencement Date of such Batch as specified in the Purchase
Order for purposes of calculating whether Company has purchased the
Minimum Quantity in accordance with Section 6.4, and (iii) any
Up-Front Payment paid by Customer to Lonza according to
Appendix A shall be, at
Customer’s discretion, fully refunded to Customer or applied
to the Batch Price for a subsequent Batch.

	
 

	
 

	

7.4.3

	

Lonza
shall promptly notify Customer when Lonza can resume supply of
Product in accordance with this Agreement and provide Customer with
a date for Delivery of the Product in accordance with
Customer’s needs.

	
 

	
 

	

7.4.4

	

In the
event that 
[***] or more consecutive Supply Failures occur during the
Term, Customer may, at its discretion, terminate this
Agreement.

 

8    Price
and Payment

	
 

	
 

	

8.1

	

Pricing
for the Services provided by Lonza are set out in, and based on the
assumptions and information set out in Appendix A.

	
 

	
 

	

8.2

	

Unless
otherwise indicated in writing by Lonza, all Prices and charges are
exclusive of value added tax (VAT) and of any other applicable
taxes, levies, import, duties and fees of whatever nature imposed
by or under the authority of any government or public authority and
all such charges applicable to the Services shall be paid by
Customer.

	
 

	
 

	

8.3

	

All
invoices are strictly net of any deduction and payment must be made
within 
[***] of date of receipt of invoice. Customer will inform
Lonza in writing if it disputes any invoice or amounts specified
therein within 
[***] of its receipt thereof.

	
 

	
 

	

8.4

	

Any
payments due hereunder which are not made within 
[***] after the due date of such payments shall be subject
to default interest at the lesser of (i) rate of 
[***] per month or (ii) the 
[***], such interest to accrue on a day to day basis until
full payment, provided that if any portion of an invoice is
disputed by Customer on justified grounds,

 

 

16

 

 

 

Customer
shall pay the undisputed amounts in accordance with the terms
above, and the Parties shall use good faith efforts to resolve
differences or discrepancies with regard to any disputed amount as
soon as practicable.

	
 

	
 

	

8.5

	

Price adjustments. Not more than once per calendar year,
Lonza may adjust the Batch Price in accordance with 
[***] increase for the previous calendar year, such increase
not to exceed 
[***] in any calendar year, provided that Lonza provides
Customer with sufficient documentation to substantiate such
proposed increase. The new Batch Price reflecting any such
adjustment shall be effective for any Batch for which the
Commencement Date is on or after the date of Lonza’s notice
to Customer of the Price adjustment. In the event of an adjustment
to the Batch Price under this Section 8.5, Lonza will submit a
Change Order to the pricing to substantiate the change at least

[***] prior to the proposed change, to be signed by both
Parties.

	
 

	
 

	

8.6

	

Capital Equipment. Any capital equipment required for the
performance of the Services shall be acquired on terms to be agreed
by the Parties prior to commencement of the relevant
Services.

 

9    Intellectual
Property

	
 

	
 

	

9.1

	

Except
as expressly otherwise provided herein, neither Party will, as a
result of this Agreement, acquire any right, title, or interest in
any Background Intellectual Property of the other Party, including
any improvements made thereto during the Services under this
Agreement.

	
 

	
 

	

9.2

	

Subject
to Section 9.3, Customer shall own all right, title, and interest
in and to 
[***] (collectively, the “New Customer Intellectual
Property”). For avoidance of doubt, New Customer
Intellectual Property shall include 
[***].

	
 

	
 

	

9.3

	

Subject
to Section 9.2, and subject to the license granted in Section 9.5,
Lonza shall own all right, title and interest in 
[***] (“New General
Application Intellectual Property”). For avoidance of
doubt, New General Application Intellectual Property shall include

[***].

	
 

	
 

	

9.4

	

Lonza
agrees to assign and hereby assigns to Customer all of its right,
title and interest in any New Customer Intellectual Property. Lonza
shall execute, and shall require its personnel as well as its
Affiliates, External Laboratories or other contractors or agents
and their personnel involved in the performance of the Services to
execute, any documents reasonably required to confirm
Customer’s ownership of the New Customer Intellectual
Property, and any documents required to apply for, maintain and
enforce any patent or other right in the New Customer Intellectual
Property. Customer agrees to assign and hereby assigns to Lonza all
of its right, title and interest in any New General Application
Intellectual Property. Customer shall execute, and shall require
its personnel as well as its Affiliates, or other contractors or
agents and their personnel involved in the performance of the
Services to execute, any documents reasonably required to confirm
Lonza’s ownership of the New General Application Intellectual
Property, and any documents required to apply for, maintain and
enforce any patent or other right in the New General Application
Intellectual Property.

	
 

	
 

	

9.5

	

Subject
to the terms and conditions set forth herein (including the payment
of the Price as required above), Lonza hereby grants to Customer a
non-exclusive, world-wide, fully paid-up, irrevocable, transferable
license, including the right to grant sublicenses, under the Lonza
Background Intellectual Property and the New General Application
Intellectual

 

 

17

 

 

 

Property
to use, offer for sale, sell, export and import the Product
manufactured under this Agreement.

	
 

	
 

	

9.6

	

Subject
to the terms and conditions set forth herein, Customer hereby
grants Lonza the non-exclusive right to use the Customer
Information, Customer Background Intellectual Property and New
Customer Intellectual Property during the Term solely for the
purpose of fulfilling its obligations under this
Agreement.

	
 

	
 

	

9.7

	

Customer
has the right to transfer the Manufacturing Process to itself and
any Third Party. Lonza shall provide reasonably necessary documents
to complete such technology transfer and 
[***] (based on a full-time employee rate for such support)
and expenses that are substantiated by sufficient documentation. If
any Lonza Confidential Information, Lonza Background Intellectual
Property, or New General Application Intellectual Property is
useful in manufacturing the Product (“Lonza Manufacturing-related IP”),
the Parties shall negotiate in good faith the terms and conditions
of a 
[***] license under such Lonza Manufacturing-related IP for
the manufacture of the Product, provided, additionally, that any
such license shall be 
[***].

 

10    Representations
and Warranties

	
 

	
 

	

10.1

	

Lonza
represents and warrants that:

	
 

	
 

	

10.1.1

	

the
Services shall be performed in accordance with all Applicable
Laws;

	
 

	
 

	

10.1.2

	

except
with respect to any development services and preparation batches as
needed, the manufacture of Product shall be performed in accordance
with cGMP and the Quality Agreement and will, at the date of
delivery, meet the Specifications at the date of delivery and not
be adulterated or misbranded within the meaning of the U.S. Federal
Food, Drug and Cosmetic Act, or any similar Applicable
Laws;

	
 

	
 

	

10.1.3

	

it or
its Affiliate holds, and shall maintain during the Term, all
necessary permits, approvals, consents and licenses to enable it to
perform the Services at the Facility in accordance with Applicable
Laws, the Quality Agreement and this Agreement;

	
 

	
 

	

10.1.4

	

it is
under no contractual or other obligation or restriction that is
inconsistent with its execution or performance of this Agreement,
and it will not enter into any agreement, either written or oral,
that would conflict with its responsibilities under this
Agreement;

	
 

	
 

	

10.1.5

	

at the
Effective Date of this Agreement and to the best of its knowledge,
the performance and provision of Services will not infringe or
misappropriate any patent, trade secret or other proprietary or
Intellectual Property rights of any Third Party;

	
 

	
 

	

10.1.6

	

it will
promptly notify Customer in writing if it becomes aware of a claim
from a Third Party that its performance of the Services or the use,
offer for sale, sale, import or export by the Customer of the
Product manufactured under this Agreement infringes any
Intellectual Property or other rights of any Third
Party;

	
 

	
 

	

10.1.7

	

as of
the Effective Date of this Agreement and to the best of its
knowledge, any Third Party property that is either (i) used in
Lonza’s performance of the Services or (ii) incorporated into
the Services or the Product manufactured under this

 

 

18

 

 

 

Agreement
or (iii) subject to a sub-license from Lonza to Customer under the
terms of this Agreement is under a valid license, with the right to
sublicense, from the Third Party;

	
 

	
 

	

10.1.8

	

Lonza,
its employees, affiliates, contractors, and agents used to perform
Services under this Agreement, and any of their respective officers
or directors, as applicable: (i) have not been debarred and are not
subject to a pending debarment, (ii) are not disqualified and are
not subject to a pending disqualification proceeding by any
government or regulatory agency from performing the Services, and
(iii) have not been convicted of a crime for which a person can be
debarred under Section 335(a) or 335(b) of the Federal Food, Drug,
and Cosmetic Act or under any analogous law or regulation under
Applicable Laws, and are not subject to any such pending action
upon execution of this Agreement; and Lonza will notify Customer
immediately if Lonza, its employees, affiliates, contractors, and
agents, or any person used to perform Services under this
Agreement, or any of their respective officers or directors, as
applicable, is subject to the foregoing, or if any action, suit,
claim, investigation, or proceeding relating to the foregoing is
pending, or to the best of Lonza’s knowledge, is threatened;
and

	
 

	
 

	

10.1.9

	

it has
the necessary corporate authorizations to enter into and perform
this Agreement.

	
 

	
 

	

10.2

	

Customer
warrants that:

	
 

	
 

	

10.2.1

	

at the
Effective Date of this Agreement and to the best of its knowledge,
Lonza’s use of the Customer Information and Customer
Intellectual Property in connection with the performance of the
Services shall not infringe any Third Party Intellectual Property
rights;

	
 

	
 

	

10.2.2

	

Customer
will promptly notify Lonza in writing if it becomes aware of a
claim from a Third Party that Customer Information and Customer
Intellectual Property or that the use by Lonza thereof for the
provision of the Services infringes any Intellectual Property or
other rights of any Third Party;

	
 

	
 

	

10.2.3

	

Customer
has the necessary corporate authorizations to enter into this
Agreement;

	
 

	
 

	

10.2.4

	

Customer,
its employees, affiliates, contractors, and agents used to perform
Services under this Agreement, and any of their respective officers
or directors, as applicable: (i) have not been debarred and are not
subject to a pending debarment, (ii) are not disqualified and are
not subject to a pending disqualification proceeding by any
government or regulatory agency from performing the Services, and
(iii) have not been convicted of a crime for which a person can be
debarred under Section 335(a) or 335(b) of the Federal Food, Drug,
and Cosmetic Act or under any analogous law or regulation under
Applicable Laws, and are not subject to any such pending action
upon execution of this Agreement upon execution of this Agreement;
and Customer will notify Lonza immediately if Lonza, its employees,
affiliates, contractors, and agents, or any person used to perform
Services under this Agreement, or any of their respective officers
or directors, as applicable, is subject to the foregoing, or if any
action, suit, claim, investigation, or proceeding relating to the
foregoing is pending, or to the best of Customer’s knowledge,
is threatened.

 

 

19

 

 

 

	
 

	
 

	

10.3

	

The
Parties hereby acknowledge that Customer is publicly traded on the
NASDAQ National Market System under the symbol "AMAG".
 Further, each party is aware and will advise its employees,
consultants and representatives who are informed of matters that
are the subject of this Agreement, of the restrictions imposed by
certain federal and state securities laws on the purchase or sale
of securities by any person who has received or had access to
material, nonpublic information concerning a company and on the
communication of such information to any other person when it is
 reasonably foreseeable that such person is likely to purchase
or sell such securities in reliance on such
information.

	
 

	
 

	

10.4

	

DISCLAIMER: THE WARRANTIES EXPRESSLY SET FORTH IN THIS
AGREEMENT ARE IN LIEU OF ALL OTHER WARRANTIES, AND ALL OTHER
WARRANTIES, BOTH EXPRESS AND IMPLIED, ARE EXPRESSLY DISCLAIMED,
INCLUDING WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.

 

11    Indemnification
and Liability

	
 

	
 

	

11.1

	

Indemnification by Lonza. Lonza shall indemnify the
Customer, its Affiliates, and their respective officers, employees
and agents (“Customer
Indemnitees”) for any loss, damage, costs and expenses
(including reasonable attorney fees) that Customer Indemnitees may
suffer as a result of any Third Party claim arising directly out of
(i) any material breach of the warranties given by Lonza in this
Agreement, or (ii) Lonza’s or Lonza’s
Indemnitees’ negligence or intentional misconduct in
performing any obligations under this Agreement, or (iii) any
claims alleging that the Services (excluding use by Lonza of
Customer Information and Customer Background Intellectual Property)
infringe any Intellectual Property rights of a Third Party except,
in each case, to the extent that such claims resulted from the
negligence, intentional misconduct or breach of this Agreement by
any Customer Indemnitees.

	
 

	
 

	

11.2

	

Indemnification by Customer. Customer shall indemnify Lonza,
its Affiliates, and their respective officers, employees and agents
(“Lonza
Indemnitees”) from and against any loss, damage, costs
and expenses (including reasonable attorney fees) that Lonza
Indemnitees may suffer as a result of any Third Party claim arising
directly out of (i) any material breach of the warranties
given by Customer in this Agreement, or (ii) any claims alleging
that Lonza’s use of the Customer Intellectual Property or
Customer Information in the performance of Services infringes any
Intellectual Property rights of Third Parties, or (iii)
Customer’s or Customer’s Indemnitees’ negligence
or intentional misconduct in performing any obligations under this
Agreement, or (iv) the manufacture (except pursuant to this
Agreement), use, sale, or distribution of any Product, including
any claims of product liability; except, in each case, to the
extent that such claims (A) resulted from the negligence,
intentional misconduct or breach of this Agreement by any Lonza
Indemnitees, or (B) resulted in any loss, damage, costs and
expenses (including reasonable attorney fees) for which Lonza is
liable pursuant to Clause 11.1 above.

	
 

	
 

	

11.3

	

Indemnification Procedure. If the Party to be indemnified
intends to claim indemnification under this Clause 11, it shall
promptly notify the indemnifying Party in writing of such claim.
The indemnitor shall have the right to control the defense and
settlement thereof; provided, however, that any indemnitee shall
have the right to retain its own counsel at its own expense. The
indemnitee, its employees and agents, shall reasonably cooperate
with the indemnitor in the investigation of any liability covered
by this Clause 11. The failure to deliver prompt written notice to
the indemnitor of any claim, to the extent prejudicial to its
ability to defend such claim, shall relieve the indemnitor of its
obligation

 

 

20

 

 

 

to the
indemnitee under this Clause 11 to the extent so prejudiced. The
indemnitor shall not settle or compromise any claim in any manner
that could have an adverse effect upon any indemnitee without such
indemnitee’s consent, which shall not be unreasonably
withheld or delayed.  The indemnitor shall not make any
admission of liability in respect of any claim without the prior
written consent of the indemnitee(s).

	
 

	
 

	

11.4

	

DISCLAIMER OF CONSEQUENTIAL DAMAGES. IN NO EVENT SHALL
EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR 
[***] ARISING FROM OR RELATED TO THIS AGREEMENT, EXCEPT TO
THE EXTENT RESULTING FROM FRAUD, NEGLIGENCE OR INTENTIONAL
MISCONDUCT, OR A BREACH OF SECTION 12.

	
 

	
 

	

11.5

	

LIMITATION OF LIABILITY. LONZA’S LIABILITY FOR DAMAGES
UNDER THIS AGREEMENT SHALL IN NO EVENT EXCEED, 
[***] UNDER THIS AGREEMENT IN THE 
[***] (OR IN THE CASE OF RELATED CAUSES OF ACTION,

[***]), EXCEPT TO THE EXTENT RESULTING FROM INDEMNIFIABLE
THIRD PARTY CLAIM UNDER CLAUSE 11.1 (i) OR (ii) ABOVE,
LONZA’S FRAUD,
NEGLIGENCE OR INTENTIONAL MISCONDUCT, OR A BREACH OF SECTION
12.

 

12    Confidentiality

	
 

	
 

	

12.1

	

Except
as expressly permitted otherwise herein, the Party receiving
Confidential Information (the “Receiving Party”) agrees to
strictly keep secret any and all Confidential Information received
during the Term from or on behalf of the other Party (the
“Disclosing
Party”) using at least the same level of measures as
it uses to protect its own Confidential Information, but in any
case at least commercially reasonable and customary efforts.
Confidential Information shall include information disclosed in any
form including but not limited to in writing, orally, graphically
or in electronic or other form to the Receiving Party, observed by
the Receiving Party or its employees, agents, consultants, or
representatives, or otherwise learned by the Receiving Party under
this Agreement, which the Receiving Party knows or reasonably
should know is confidential or proprietary.

	
 

	
 

	

12.2

	

Notwithstanding
the foregoing, Receiving Party may disclose to any courts and/or
other authorities Confidential Information which is required to be
disclosed pursuant to applicable governmental or administrative or
public law, rule, regulation or order. In such case the Receiving
Party will, to the extent legally permitted, (i) inform the other
Party promptly in writing, (ii) cooperate with the Disclosing Party
to secure confidential treatment for such Confidential Information,
and (iii) seek to minimize the extent of Confidential Information
which is required to be disclosed to the courts and/or
authorities.

	
 

	
 

	

12.3

	

The
obligation to maintain confidentiality under this Agreement does
not apply to Confidential Information, which:

	
 

	
 

	

12.3.1

	

at the
time of disclosure was publicly available; or

	
 

	
 

	

12.3.2

	

is or
becomes publicly available other than as a result of a breach of
this Agreement by the Receiving Party; or

	
 

	
 

	

12.3.3

	

as the
Receiving Party can establish by contemporaneous written records,
was rightfully in its possession at the time of disclosure by the
Disclosing Party and had not been received from or on behalf of
Disclosing Party; or

 

 

21

 

 

 

	
 

	
 

	

12.3.4

	

is
supplied to a Party by a Third Party which was not in breach of an
obligation of confidentiality to Disclosing Party or any other
party, as evidenced by contemporaneous written records;
or

	
 

	
 

	

12.3.5

	

is
developed by the Receiving Party independently from and without use
of the Confidential Information, as evidenced by contemporaneous
written records.

	
 

	
 

	

12.4

	

The
Receiving Party will use Confidential Information only for the
purposes of this Agreement and will not make any use of the
Confidential Information for its own separate benefit or the
benefit of any Third Party including, without limitation, with
respect to research or product development or any reverse
engineering or similar testing. The Receiving Party agrees to
return or destroy promptly (and certify such destruction) on
Disclosing Party’s request all written or tangible
Confidential Information of the Disclosing Party, except that one
copy of such Confidential Information may be kept by the Receiving
Party in its confidential files for record keeping purposes
only.

	
 

	
 

	

12.5

	

Each
Party will restrict the disclosure of Confidential Information to
such officers, employees, consultants and representatives of itself
and its Affiliates who have been informed of the confidential
nature of the Confidential Information and who have a need to know
such Confidential Information for the purpose of this Agreement.
Prior to disclosure to such persons, the Receiving Party shall bind
its and its Affiliates’ officers, employees, consultants and
representatives to confidentiality and non-use obligations no less
stringent than those set forth herein. The Receiving Party shall
notify the Disclosing Party as promptly as practicable of any
unauthorized use or disclosure of the Confidential
Information.

	
 

	
 

	

12.6

	

The
Receiving Party shall be fully liable for any and all breaches of
the confidentiality obligations in this Clause 13 by any of its
Affiliates or the officers, employees, consultants and
representatives of itself or its Affiliates.

	
 

	
 

	

12.7

	

Each
Party hereto expressly agrees that any breach or threatened breach
of the undertakings of confidentiality provided under this Clause
12 by a Party may cause irreparable harm to the other Party and
that money damages may not provide a sufficient remedy to the
non-breaching Party for any breach or threatened breach. In the
event of any breach and/or threatened breach, then, in addition to
all other remedies available at law or in equity, the non-breaching
Party shall be entitled to seek injunctive relief.

	
 

	
 

	

12.8

	

The
confidentiality and non-use obligations imposed by this Agreement
shall expire with respect to any particular item of a Disclosing
Party's Confidential Information on the 
[***] anniversary of the date of disclosure of such
Confidential Information (and in the case of trade secrets, until
such time as such trade secrets are no longer accorded trade secret
status under 
[***] law).

 

13    Term
and Termination

	
 

	
 

	

13.1

	

Term. This Agreement shall commence on the Effective Date
and shall be in effect until 
[***] (the "Term”). In order to avoid
interruptions in the supply of Product to Customer, at least

[***] prior
to the expiration of
the Term, the Parties shall meet (in person or telephonically) to
discuss whether or not to extend the Term of this Agreement or to
agree in good faith on a new agreement, which may include revisions
to the following terms:

 

 

22

 

 

 

	
 

	
 

	

13.1.1

	

an
annual minimum supply quantity (kilograms or Batches) Customer
undertakes to purchase from Lonza;

	
 

	
 

	

13.1.2

	

a
minimum % of Customer's annual demand that Customer undertakes to
purchase from Lonza; and

	
 

	
 

	

13.1.3

	

the
option for Lonza to produce the Product in a dedicated
manufacturing asset.

	
 

	
 

	

13.2

	

Termination. This Agreement may be terminated as
follows:

	
 

	
 

	

13.2.1

	

by
either Party if the other Party breaches a material provision of
this Agreement and fails to cure such breach within 
[***] for non-payment) following written notification of
such breach from the non-breaching party to the breaching party;
provided, however, that such 
[***] (or 
[***] for non-payment) period may be extended only if
mutually agreed to by the Parties if the identified breach is
incapable of cure within 
[***] (or 
[***] for non-payment) and if the breaching Party promptly
provides a plan and timeline to cure the breach, promptly commences
efforts to cure the breach and diligently prosecutes such
cure;

	
 

	
 

	

13.2.2

	

by
Customer, if the Product does not receive FDA approval and if
Customer notifies Lonza in writing, within 
[***] that it wishes to terminate the Agreement for that
reason;

	
 

	
 

	

13.2.3

	

by
Customer, if Customer is required to withdraw the Product from the
market for regulatory or health and safety reasons, on 
[***] prior written notice to Lonza;

	
 

	
 

	

13.2.4

	

by
either Party, immediately, if the other Party becomes insolvent, is
dissolved or liquidated, makes a general assignment for the benefit
of its creditors, or files or has filed against it, a petition in
bankruptcy or has a receiver appointed for a substantial part of
its assets, provided that, in the case of an involuntary
proceeding, such other Party may not terminate this Agreement if
the petition is dismissed within 
[***] of filing; or

	
 

	
 

	

13.2.5

	

by
Customer pursuant to Section 7.3.3, 7.4.4 or 14.

	
 

	
 

	

13.3

	

Consequences of
Termination.

	
 

	
 

	

13.3.1

	

In the
event of termination hereunder by Lonza under Section 13.2.1, or
13.2.4 Lonza shall submit to Customer an invoice, together with
sufficient substantiating documentation, for (i) any applicable

[***] and (ii) any applicable 
[***]. Customer shall pay such invoice in accordance with
Section 8. At Customer’s direction, with regard to any

[***].

	
 

	
 

	

13.3.2

	

In the
event of termination hereunder by Customer under Clause 13.2.2, or
13.2.3, (i) any Purchase Order(s) issued prior to the termination
date that have not been fulfilled will be cancelled and such
cancelled Purchase Orders shall not be subject to the Cancellation
Fee set forth in Section 6.7, and (ii) Lonza shall submit to
Customer an invoice, together with sufficient substantiating
documentation, for (a) the 
[***], and (b) 
[***] as set
forth in Section 6.4, if applicable. Customer shall pay such
invoice in accordance with Section 8. At Customer’s
direction, with regard to any 
[***].

 

 

23

 

 

 

	
 

	
 

	

13.3.3

	

In the
event of termination hereunder by Customer under Clause 13.2.1,
13.2.4 or 13.2.5, (i) any Purchase Order(s) issued prior to the
termination date that have not been fulfilled will be cancelled and
such cancelled Purchase Orders shall not be subject to the
Cancellation Fee set forth in Section 6.8, (ii) any 
[***], and (iii) 
[***]. In such event, Customer shall compensate Lonza only
for 
[***].

	
 

	
 

	

13.3.4

	

In the
event of termination by either Party, each Party agrees to return
or destroy the other Party’s Confidential Information in
accordance with Clause 12.4.

	
 

	
 

	

13.4

	

Survival. Sections 2.5, 4, 5, 8, 9, 10, 11, 12, 13.3, 13.4,
15.1, 15.3, 15.4, 15.5 and 15.6 shall survive the termination or
expiration of this Agreement.

 

14    Force
Majeure

	
 

	
 

	

14.1

	

If
either Party is prevented or delayed in the performance of any of
its obligations under the Agreement by Force Majeure and gives
written notice thereof to the other Party specifying the matters
constituting Force Majeure together with such evidence as the
affected Party reasonably can give and specifying the period for
which it is estimated that such prevention or delay will continue,
the affected Party shall be excused from the performance or the
punctual performance of such obligations as the case may be from
the date of such notice for so long as such cause of prevention or
delay shall continue, provided that such Party is obligated to
mitigate damages and to use best efforts to resume the fulfilment
of its contractual obligations as soon as reasonably possible.
Provided that, if such Force Majeure persists for a period of

[***] or more, the Party not affected by such force majeure
may terminate this Agreement by delivering written notice to the
affected Party, with immediate effect.

	
 

	
 

	

14.2

	

“Force
Majeure” shall be deemed to include any reason or cause
beyond a Party’s reasonable control affecting the performance
by the Party of its obligations under the Agreement, including, but
not limited to, acts of God, strike, lockouts, labor troubles,
restrictive governmental orders or decrees, riots, insurrection,
war, or terrorists acts.

	
 

	
 

	

14.3

	

Force
Majeure affecting services or production at Lonza’s
Affiliates shall be regarded as an event of Force
Majeure.

 

15    Miscellaneous

	
 

	
 

	

15.1

	

Severability. If any provision hereof is or becomes at any
time illegal, invalid or unenforceable in any respect, neither the
legality, validity nor enforceability of the remaining provisions
hereof shall in any way be affected or impaired thereby. The
Parties hereto undertake to substitute any illegal, invalid or
unenforceable provision by a provision which is as far as possible
commercially equivalent considering the legal interests and the
Purpose. Any provision of this Agreement held invalid or
unenforceable only in part or degree will remain in full force and
effect to the extent not held invalid or
unenforceable.

	
 

	
 

	

15.2

	

Amendments/Assignment. Modifications and/or amendments of
this Agreement must be in writing and signed by the Parties. Lonza
may instruct one or more of its Affiliates to perform any of
Lonza’s obligations contained in this Agreement only with
prior written consent from Customer, but Lonza shall remain fully
responsible in respect of those obligations. Subject thereto,
neither Party may assign its interest under this Agreement without
the prior written consent of the other Party, such consent not to
be unreasonably withheld, conditioned or delayed, provided, however
that (a) either Party may assign

 

 

24

 

 

this
Agreement to (i) any Affiliate of such Party or (ii) any third
party in connection with the sale or transfer (by whatever method,
including merger, consolidation, acquisition or other form of
business combination) of all or substantially all of the assets of
the business related to the Facility or providing the Services in
the case of Lonza, or all or substantially all of the assets
related to the Product in the case of Customer, and (b) Lonza shall be entitled to sell,
assign and/or transfer its trade receivables resulting from this
Agreement without the consent of the Customer. For purposes of this
Clause 15.2, the terms “assign” and
“assignment” shall include, without limitation
(i) the sale or transfer or other assignment of all or
substantially all of the assets of the Party or the line of
business or Product to which this Agreement relates, and (ii) a
merger, consolidation, acquisition or other form of business
combination. Any purported assignment without a required consent
shall be void. No assignment shall relieve any Party of
responsibility for the performance of any obligation that accrued
prior to the effective date of such assignment.

	
 

	
 

	

15.3

	

Notice. All
notices must be written and sent to the address of the Party first
set forth above. All notices must be given (a) by personal
delivery, with receipt acknowledged, (b) by facsimile or electronic
mail, (c) by prepaid certified or registered mail, return receipt
requested, or (d) by prepaid recognized next business day delivery
service. Notices will be effective upon receipt or at a later date
stated in the notice.

	
 

	
 

	

15.4

	

Public Disclosures. It is understood that each Party may
desire or be required to issue press releases or disclosures to the
SEC or other applicable agency relating to this Agreement or
activities hereunder. The Parties shall consult with each other
reasonably and in good faith with respect to text and timing of
such press releases and disclosures prior to the issuance thereof,
provided that (i) neither Party may unreasonably withhold,
condition or delay consent to such press releases or such
disclosures to the SEC or other applicable agency, and (ii) either
Party may issue such press releases or make such disclosures to the
SEC or other applicable agency as it determines, based on advice of
counsel, are reasonably necessary to comply with laws or
regulations or for appropriate market disclosure. Each Party shall
provide the other Party with advance notice of legally required
disclosures to the extent practicable. The Parties will consult
with each other on the provisions of this Agreement to be redacted
in any filings made by a Party with the SEC or as otherwise
required by applicable laws or regulations, provided that each
Party may make any such filing it reasonably determines necessary
under such applicable laws and regulations. After any initial press
releases related to this Agreement, either Party may disclose,
without the other Party’s consent, the existence of this
Agreement, the identity of the other Party, and the terms of the
Agreement which have already been publicly disclosed in accordance
herewith. Notwithstanding the foregoing, Lonza shall not use the
name of Customer, its Affiliates, or the names of their employees
or representatives in any advertising materials without prior
written consent of Customer, and Customer shall not use the name of
Lonza, its Affiliates, or the names of their employees or
representatives in any advertising materials without prior written
consent of Lonza.

	
 

	
 

	

15.5

	

Authorized Disclosures. Customer may disclose the terms of
this Agreement to any actual or potential acquiror or licensee to
the Product, provided that: (i) such disclosure is solely for the
purpose of such Third Party evaluating such acquisition or license
opportunity with Customer; (ii) Customer redacts the financial
terms of this Agreement (but Customer shall have the right to
disclose the Batch Prices to any bona fide potential or actual
acquirer or licensee who would bear and/or share the Batch Prices
for the Product). Any party to whom such disclosure is made shall
be under written obligations of confidentiality and non-use at
least as stringent as those herein.

 

 

25

 

 

 

	
 

	
 

	

15.6

	

Governing Law/Jurisdiction. This Agreement is governed in
all respects by the laws of 
[***]. The Parties agree to submit to the jurisdiction of
the courts of 
[***].

	
 

	
 

	

15.7

	

Entire Agreement. This Agreement and its Appendices contain
the entire agreement between the Parties as to the subject matter
hereof and supersedes all prior and contemporaneous agreements with
respect to the subject matter hereof. This Agreement may be
executed in any number of counterparts, each of which shall be
deemed to be an original, and all of which together shall
constitute one and the same document. Each party acknowledges that
an original signature or a copy thereof transmitted by facsimile or
by .pdf shall constitute an original signature for purposes of this
Agreement.

 

IN WITNESS WHEREOF, each of the Parties
hereto has caused this Manufacturing Services Agreement to be
executed by its duly authorized representative effective as of the
date written above.

 

 

LONZA LTD 

 

By:
/s/ Bart A. M. Van
Aarnhem

Name
Bart A. M. Van Aarnhem

Title
Senior Legal Counsel

 

By:
/s/ Cordula
Altekruger

Name
Cordula Altekruger

Title
Senior Legal Counsel

 

AMAG
PHARMACEUTICALS, INC

By:
/s/ William K.
Heiden

Name
William K. Heiden

Title
CEO

 

 

26

 

 

APPENDIX A

 

 

Product Pricing

 

 

Parties
agree that the Batch Price shall be:

 

 

Product Volume                        Price
per Batch ([***])

[***] Batches
per
Campaign                    [***] per
Batch

Additional Batches: 
[***] (or more) per
Campaign        [***]
per Batch

 

 

Payment
terms:

	
 

	
 

	

●

	

Lonza
shall invoice and Customer shall pay 
[***] of the Batch Price upon confirmation of the binding
Purchase Order in accordance with Section 6.3, for facility
reservation, Raw Materials procurement, manufacturing and
preparation (the “Up-Front
Payment”).

	
 

	
 

	

●

	

Lonza
shall invoice and Customer shall pay 
[***] of the Batch Price upon delivery of the
Batch.

	
 

	
 

	

●

	

Invoicing
and payment shall be in accordance with Section 8.

 

[***], as defined in this
Agreement.

 

[***] as
defined in Section 1. Lonza will submit an invoice to Customer for
the Specialty Material and Specialty Material Fee in accordance
with Section 2.9, and Customer will pay such invoice in accordance
with Section 8.

 

Additional Work Scope:

Any
additional project needs that are not specifically called out
within this Agreement or the Quality Agreement shall be invoiced
and billed under a separate work order. 

 

 

 

27

 

 

 

APPENDIX
B

Project Plan

 

 

 

 

28

 

 

 

APPENDIX C

Quality Agreement

[Attached]

 

 

 

29

 

 

 

APPENDIX D

Specifications

[Attached]

 

 

30

 

 

 

 

APPENDIX E

Change Order

 

Change Order – [insert
number]

                

Dated:
[insert
date]

 

This is
a Change Order of the purposes of Manufacturing Services Agreement
between Lonza Ltd. and
AMAG Pharmaceuticals, Inc. dated
_________________[insert
date] (the “Agreement”).

 

Terms
used but not defined in this Change Order shall have the meaning
given to them in the Agreement.

 

Effective
Date:    Day, Month, Year

End
Date:    Day, Month, Year

 

Current
Price: 
[***]

 

Revised
Price: 
[***]

 

New
Total Cost (if applicable): 
[***]

 

The
following reasons have caused the Price to change (increase or
decrease):

 

	
 

	
 

	

1.

	
 

 

 

    

 

 

 

EXECUTED as an AGREEMENT

 

	
 

	
 

	
 

	

Signed
by

LONZA LTD.

 

___________________________

Signature

 

___________________________

Name

 

___________________________

Title

 

___________________________

Date

	

Signed
for and on behalf of

AMAG PHARMACEUTICALS, INC.

 

___________________________

Signature

 

___________________________

Name

 

___________________________

Title

 

___________________________

Date

 

 

 

31ptn_ex1031

 

Exhibit 10.31

 

Portions of this Exhibit have been redacted because they are both
(i) not material and (ii) would be competitively harmful if
publicly disclosed. Information that was omitted has been noted in
this document with a placeholder identified by the mark
“[***]”.

 

SUPPLY AGREEMENT

effective
as of 20 December 2018 ("Effective
Date")

between

AMAG Pharmaceuticals, Inc., 1100 Winter Street, Waltham, MA
02451, USA

-
"AMAG" -

and

Ypsomed AG, Brunnmattstrasse 6, CH-3401 Burgdorf,
Switzerland

-
"Ypsomed"
–

 

 

For Autoinjectors for the Administration of
Bremelanotide

Preamble

	
 

	
 

	

a)

	

Palatin
Technologies, Inc., 4-B Cedar Brook Drive, Cranbury, New Jersey
08512, USA (“Palatin”) developed a subcutaneous
injection formulation of Bremelanotide (as defined below) for use
in female sexual dysfunction;

 

	

b)

	

Palatin
licensed to AMAG the rights to develop and commercialize
Bremelanotide in North America and to manufacture Bremelanotide
worldwide;

 

	

c)

	

AMAG,
Palatin and Ypsomed have entered into a three way Confidentiality
and Non-Use Agreement, effective as of 6 March 2017 (hereinafter
“Confidentiality
Agreement”), and, under such Confidentiality
Agreement, have discussed the potential use of a customized version
of the YpsoMate (as defined below) for the injection of
Bremelanotide;

 

	

d)

	

Palatin
and Ypsomed entered into an agreement, dated as of 8 June 2012,
with respect to the variant specific customization of the YpsoMate
for the administration of pre-filled Bremelanotide syringes
(“Customization
Proposal”);

 

	

e)

	

Palatin
and Ypsomed entered into an agreement, dated as of 30 January 2015,
with respect to an industrialization project for the initializing
of the commercial supply of the customized autoinjectors
(“Industrialization
Proposal”);

 

 

 

 

 

 

	

f)

	

AMAG
and Ypsomed entered into Terms and Conditions dated 14 June 2017
governing the purchase of Component Sets (as defined therein)
pursuant to AMAG purchase order numbers 71635 and 71636 (the
“Terms and
Conditions”) and it is intended that the terms and
conditions of this Agreement will govern the supply of such
Component Sets to AMAG; and

 

	

g)

	

AMAG
and Ypsomed now wish to agree on the terms and conditions of the
commercial supply of the Components (as defined hereunder) used to
assemble the customized YpsoMate injection
device.

 

Now,
therefore, in consideration of the above, AMAG and Ypsomed agree as
follows:

 

1.    Definitions    

	
 

	
 

	

"Affiliate"

	

shall
mean any corporation or other entity that directly or indirectly
controls, is controlled by, or is under common control with AMAG or
Ypsomed, as applicable. For the purpose of this Agreement,
"control" shall mean the direct or indirect ownership of fifty
percent (50%) or more of the outstanding shares or other voting
rights of the subject entity for the election of
directors.

	

"Agreement"

	

shall
mean this Supply Agreement, together with all Appendices, as
amended or modified from time to time in accordance with the terms
hereof.

	

“Annual Minimum Quantity”

	

shall
have the meaning set forth in Appendix 3.

	

"Appendix", "Appendices"

	

shall
mean the addenda, exhibits, schedules and/or supplements to this
Agreement, as amended or modified from time to time in accordance
with the terms hereof.

	

"Applicable Laws"

	

as of
the Effective Date, Applicable Laws shall mean applicable statutes,
laws and regulations of the United States, the European Union,
Switzerland, Canada, Mexico, China, and South Korea relevant to the
services under this Agreement and the manufacture of the Components
in the Territory, and shall include, without limitation, cGMP; FDA
21 CFR Part 820; European Council Directive 93/42/EEC; ISO
13485:2003; ISO 14971:2007 and any additional, successor or
replacement statutes, laws and regulations thereto, which come into
effect during the Term of this Agreement. The statutes, laws and
regulations of additional countries or jurisdictions in the
Territory may be added to the Applicable Laws upon mutual agreement
of the Parties in accordance with Section 4.9.

	

"Authority"

	

shall
mean the Food and Drug Administration (“FDA”) (or any
successor agency thereto) in the United States, the European
Medicines Agency EMA (or any successor agency thereto) in Europe,
Health Canada in Canada, and/or the applicable equivalent
regulatory agency or entity, governmental or non-governmental,
having the responsibility, jurisdiction and authority for the grant
of Authorizations in Mexico, China, South Korea, and any other
country or jurisdiction in the Territory as mutually agreed to by
the Parties in accordance with Section 4.9.

	

"Authorizations"

	

shall
mean the authorizations for the manufacture, labeling, packaging,
importation, promotion, marketing, offer to sell, sale,
distribution and use of the Bremelanotide Devices in the Territory,
and any amendments or modifications thereto.

	

“Binding Forecast”

	

shall
have the meaning set forth in Section 7.2.

	

"Bremelanotide"

	

shall
mean Palatin’s injectable drug substance licensed to AMAG in
which the active pharmaceutical ingredient is the peptide
Ac-Nle-cyclo(-Asp-His-D-Phe-Arg-Trp-Lys)-OH.

 

 

 

 

 

	
 

	
 

	
 

	
 

	

"Bremelanotide Device"

	

shall
mean the customized YpsoMate for the injection of Bremelanotide
consisting of the Components, a syringe containing Bremelanotide
and accessories, if any, as such Bremelanotide Device is further
defined in the Specifications.

	

“Price Change Order”

	

shall
mean a document in the format provided in Appendix 5 provided by Ypsomed to AMAG
outlining a proposed adjustment (increase or decrease) to the
Purchase Price and the reasons for such adjustment, such document
to be reviewed and signed by both parties to enable such adjustment
to take effect.

	

"cGMP"

	

shall
mean the current Good Manufacturing Practice requirements related
to the methods used in, and the facilities and controls used for,
developing, customizing, manufacturing, testing, processing,
packaging, labeling, storing, installing, and servicing of the
Components as specified in the Medical Device Directive 93/42/EEC
and ISO 13485, as amended or modified from time to
time.

	

"Components"

	

shall
mean the individual parts and subassemblies of Ypsomed’s
customized YpsoMate, as they are described in the Specifications.
For the avoidance of doubt, Components shall not include the
syringe containing Bremelanotide.

	

"Component Set"

	

shall
mean a complete set of all Components for use by AMAG or its
designee to assemble of one Bremelanotide Device.

	

"Delivery"

	

shall
have the meaning set forth in Section 8.1.

	

“Delivery Date”

	

shall
have the meaning set forth in Section 7.4.

	

"Hidden Defect"

	

shall
mean any Component's failure (i) to have been manufactured in
accordance with this Agreement, including, without limitation, cGMP
in effect at the time of manufacture, or (ii) to conform in all
material respects to the Specifications in effect at the time of
manufacture, to the exclusion of any failure which was or could
have been identified through commercially reasonable and adequate
inspection and testing based on mutually agreed inspection criteria
as set out in the Specifications and according to Section
9.1.

	

“Initial Inspection”

	

shall
have the meaning set forth in Section 9.1.

	

"Initial Term"

	

shall
have the meaning set out in Section 21.1.

	

"Intellectual Property Rights"

	

shall
mean any and all rights in or to inventions, discoveries, know-how,
trade secrets, trade names, confidential information (including
know-how), domain names, works of authorship reduced to a tangible
medium of expression, including, without limitation, technical data
and software, industrial and other design rights, patents,
trademarks, copyrights, database rights, and any other intellectual
property, in each case, whether registered or unregistered or
patentable or not, including rights to applications or
registrations for any of the foregoing.

	

"Party", "Parties"

	

shall
mean AMAG and/or Ypsomed, as applicable.

	

“Pricing Tier”

	

shall
have the meaning set forth in Appendix 3.

	

“Purchase Order”

	

shall
have the meaning set forth in Section 7.3.

	

"Purchase Price"

	

shall
mean the prices per Component Set according to the price list as
set out in Appendix
3.

	

"Quality Agreement"

	

shall
mean the quality agreement set out in Appendix 2, as amended or modified from
time to time in accordance with the terms hereof.

	

“Rolling Forecast”

	

shall
have the meaning set forth in Section 7.2.

	

"Subsequent Term"

	

shall
have the meaning set out in Section 21.1.

 

 

 

 

 

	
 

	
 

	
 

	
 

	

"Specifications"

	

shall
mean the specifications for the Components and Component Sets, as
well as certain requirements regarding the assembly of the
Bremelanotide Device, all as further described in Appendix 1, as amended from time to
time in accordance with the terms hereof.

	

"Territory"

	

shall -
for the purpose of this Agreement - include the countries
enumerated in the definition of Applicable Laws and Authority
hereinabove; provided however that Ypsomed acknowledges that AMAG
has the right to use, register, and market the Bremelanotide Device
worldwide. Accordingly, statutes, laws and regulations of
additional countries or jurisdictions may be added to the
Applicable Laws and the respective further countries will be
included to the definition of Territory pursuant to Section
4.9.

	

" YpsoMate"

	

shall
mean the technical platform of a two-step disposable autoinjector
developed by Ypsomed for use with various drug substances contained
in a syringe.

 

	

2.

	

Appendices

 

	

2.1

	

The
following Appendices are incorporated into this Agreement by this
reference:

 

	
 

	
 

	
 

	
 

	
 

	
 

	

No.

	

Appendix

	

Subject/Content (inter alia)

	

1

	

Specifications

	

Specifications
for Component and Component Sets

	

2

	

Quality
Agreement

	

Quality
Agreement for Component Sets: change control, complaint handling,
audits, regulatory issues

	

3

	

Commercial
Terms

	

Pre-commercial
supply & capacity reservation, forecast and ordering procedure,
Purchase Prices, minimum purchase quantities

	

4

	

Price
Change Order

	

Form to
be used in the event of a change to the Purchase Price based on the
template format set out in Appendix 4.

 

	

2.2

	

Order of Precedence. The following interpretation rule shall
apply: (a) any amendments or modifications to this Agreement or the
Appendices shall prevail over this Agreement or the Appendices
themselves, (b) this Agreement shall prevail over the Appendices,
except with respect to matters relating to the quality of the
Components, the Quality Agreement shall prevail over this
Agreement, and (c) this Agreement shall prevail over the Terms and
Conditions.

 

3.    Amendments and/or
Modifications

	
 

	
 

	

3.1

	

Either
Party may at any time recommend an amendment and/or modification to
this Agreement or the Appendices, including the Specifications.
Amendments and/or modifications to this Agreement or the Appendices
shall only be effective upon a signed written agreement between the
Parties. The Appendices shall be subject to version control to
document any changes made to them. Amendments and/or modifications
to the Specifications shall be made in accordance with the change
control provisions of the Quality Agreement.

 

	

3.2

	

Neither
Party shall unreasonably withhold, condition or delay its consent
to any amendments and/or modifications recommended in good faith by
the other Party in relation to compliance with changes in
Applicable Laws, including, without limitation, cGMP, or changes in
the regulatory environment. In the event Ypsomed modifies the
YpsoMate and determines in good faith that corresponding
modifications to any Component is necessary or beneficial, then
AMAG shall approve such modifications,

 

 

 

 

 

provided
that such modifications are made in accordance with the change
control provisions of the Quality Agreement. Notwithstanding the
foregoing, with respect to each proposed amendment and/or
modification to the Agreement or the Appendices, the Parties shall
discuss in good faith the cost and time implications associated
therewith. The requirements and the procedure for change control
are set out in the Quality Agreement.

	
 

	
 

	

3.3

	

In the
event that the Parties agree to change the Specifications in
accordance with the change control provisions of the Quality
Agreement, Ypsomed shall: (x) use commercially reasonable efforts
to implement such change as soon as reasonably practicable; (y) be
responsible for ensuring that all Components manufactured following
such change meets the Specifications as amended; and (z) provide
AMAG with all information and reasonable assistance with respect to
the manufacture of the Components in connection with such change
needed to amend any regulatory filings maintained with respect to
the Bremelanotide Device. To the extent such change is a result of
a change in Applicable Law or a discretionary change requested by

[***], AMAG shall 
[***] of implementing the changes, otherwise, Ypsomed shall

[***].

	
 

	
 

	

3.4

	

The
Specifications are not physically attached to this Agreement, since
they are kept in the Design History File (DHF) which is maintained
at Ypsomed's premises. Ypsomed shall provide AMAG with a copy of
the Specifications.

 

4.    Commercial Supply

	
 

	
 

	

4.1

	

Ypsomed
shall manufacture the Component Sets in accordance with the terms
of this Agreement and the Specifications attached as Appendix
1.    

	
 

	
 

	

4.2

	

Subject
to the terms of this Agreement, AMAG shall purchase Component Sets
from Ypsomed and Ypsomed shall supply AMAG with Component
Sets.

	
 

	
 

	

4.3

	

In the
event AMAG decides during the Term of this Agreement to develop
(directly or indirectly) a new injection device for the
administration of Bremelanotide, AMAG shall give Ypsomed notice
thereof prior to issuing an invitation to tender or commencing
negotiations with any third party in respect of developing such
injection device. If, within 
[***] after AMAG gives such notice to Ypsomed, Ypsomed
requests, in writing, an opportunity to submit a proposal with
respect to the development, customization, manufacture and supply
of such injection device, AMAG shall provide Ypsomed with the
desired specifications on a confidential basis and negotiate in
good faith with Ypsomed regarding any such proposal by Ypsomed. For
the avoidance of doubt, AMAG shall be free to engage in parallel
good faith negotiations, and to enter into a definitive agreement,
with any third party with respect to the development,
customization, manufacture and supply of the new injection
device.

	
 

	
 

	

4.4

	

Ypsomed
retains all rights to promotion, import, advertisement,
distribution, offering for sale and sale in the Territory of the
YpsoMate and/or
customized variations thereof as well as other disposable injection
systems, other than the Component Sets being supplied to AMAG
pursuant to this agreement, to itself, its customers or
distributors.

	
 

	
 

	

4.5

	

The
commercial terms for the supply of Component Sets are set out in
Appendix 3.

	
 

	
 

	

4.6

	

[***] at the Purchase Price set out in Appendix 3. The Purchase Price is firm
until 
[***]. Thereafter, the Purchase Price is subject to
adjustments, however no more than on 
[***] basis, to reflect increases or decreases in raw
material prices and other related cost influencing factors that are
not under Ypsomed’s control; provided, however, that
notwithstanding the foregoing, the percentage increase or decrease
in

 

 

 

 

 

the
Purchase Price shall not exceed the lesser of (i) the percentage
increase in the 
[***] since the then-current Purchase Price was established
and (ii) 
[***]. In the event of a proposed adjustment to the Purchase
Price under this Section 4.6, Ypsomed will in good faith submit a
Price Change Order to AMAG to substantiate the adjustment, and such
adjustment shall not take effect until the Price Change Order is
signed by both Parties.

	
 

	
 

	

4.7

	

Throughout
the Term, Ypsomed agrees to use its commercially reasonable efforts
to identify and target all potential areas of cost improvement.

[***]. In the event of a proposed adjustment to the Purchase
Price under this Section 4.7, Ypsomed will in good faith submit a
Price Change Order to AMAG to substantiate the adjustment, and such
adjustment shall not take effect until the Price Change Order is
signed by both Parties.

	
 

	
 

	

4.8

	

Beginning
in 
[***], AMAG shall purchase at least the Minimum Annual
Quantity of Component Sets in each remaining calendar year during
the Initial Term as set out in Appendix 3. For the purpose of
determining whether AMAG is in compliance with this Section 4.8, a
Component Set is considered “purchased” as of the
agreed Delivery Date in the respective Purchase Order, provided
however that such ordered Component Sets will have been duly paid
by AMAG (during such calendar year or, as applicable, at a later
stage in accordance with the terms of this Agreement). If AMAG does
not purchase the Annual Minimum Quantity in a calendar year in
accordance with this Section 4.8, AMAG shall pay Ypsomed at the end
of such calendar year, upon receipt of an invoice and reasonable
supporting documentation in accordance with Section 6, an amount
equal to (a) the difference between (i) the Annual Minimum
Quantity for such calendar year and (ii) the aggregate number
of Component Sets purchased by AMAG (or its Affiliates or
licensees) during such calendar year (such amount, the
“Shortfall”),
multiplied by

[***] of the Unit Price per Component Set as set forth in
Appendix 3 (the
“Shortfall
Fee”). In the event that AMAG disputes the amount of
the Shortfall Fee due under this Section 4.8, AMAG shall provide
Ypsomed with written notice of such dispute within 
[***] of receipt of such invoice. If no written notice is
provided by AMAG within 
[***] of receipt of such invoice AMAG shall be deemed to
have given its approval to the Shortfall Fee.

	
 

	
 

	

4.9

	

The
Parties - each for its obligations under this Agreement - shall
comply with all Applicable Laws. The Parties acknowledge that AMAG
has the right to market, sell and distribute the Bremelanotide
Device in further countries than those enumerated in the definition
of Applicable Laws and Authority in Section 1 subject to and in
accordance with the terms of this Agreement. Accordingly, AMAG has
the right to reasonably request Ypsomed to comply with any
applicable laws other than the Applicable Laws as such laws are
identified and deviate from the Applicable Laws and their
requirements communicated in writing by AMAG to Ypsomed and to
adjust the term Territory under Section 1 accordingly. In the event
of any additional, successor or replacement applicable laws
affecting Ypsomed's performance under this Agreement (including,
without limitation, in respect of costs, timelines, facilities,
equipment, processes, materials or systems), Ypsomed shall have the
right to request and the Parties shall negotiate in good faith an
amendment and/or modification pursuant to Section 3. For
clarity, in the event that any additional, successor or replacement
applicable laws that AMAG wishes Ypsomed to comply with, does not
affect Ypsomed's performance under this Agreement, such additional
applicable laws shall become automatically part of the Applicable
Laws without any need for an amendment and/or modification pursuant
to Section 3.

 

 

 

 

 

	
 

	
 

	

4.10

	

The
Parties agree that the terms and conditions of this Agreement will
govern the manufacture and supply of Component Sets pursuant to
AMAG purchase order numbers 71635 and 71636, and such Component
Sets are deemed to be Component Sets manufactured by Ypsomed and
supplied to AMAG under this Agreement. In the event of a conflict
between this Agreement and the Terms and Conditions, this Agreement
shall control.

 

5.    Engagement of Subcontractors and
Designees, Final Assembly & Packaging

	
 

	
 

	

5.1

	

Ypsomed
shall be entitled to engage subcontractors in accordance with the
Quality Agreement, including (i) such subcontractors involved in
the development and manufacture of the YpsoMate platform
(“YpsoMate
Subcontractor”), and (ii) such other subcontractors
which are solely and specifically involved in the manufacture of
Component Sets under this Agreement, not being YpsoMate
Subcontractors (“Specific
Subcontractor”). The engagement of a Specific
Subcontractor by Ypsomed requires AMAG’s prior written
approval, such approval not to be unreasonably withheld,
conditioned or delayed. Ypsomed shall not be relieved from its
obligations hereunder and assumes full liability for the
performance and all acts and/or omissions of its subcontractors as
if they were its own performance and acts and/or omissions. Ypsomed
shall ensure that each subcontractor is aware of and bound by the
applicable provisions of this Agreement.

	
 

	
 

	

5.2

	

Ypsomed
shall deliver the Component Sets in bulk packaging as set out in
the Specifications (Appendix
1). AMAG shall be responsible for the final assembly and
packaging of the Bremelanotide Device. AMAG shall be entitled to
engage designees for final assembly and/or packaging of the
Bremelanotide Device, provided that AMAG shall not be relieved from
its obligations hereunder and that it assumes full liability for
the performance and all acts and/or omissions of its designees as
if they were its own performance and acts and/or
omissions.

	
 

	
 

	

5.3

	

The
Parties agree that Ypsomed and its subcontractors, and AMAG and its
designees, as applicable, may need to discuss aspects of this
Agreement with each other, (e.g., in respect of AMAG’s
designee's final assembly of the Component Set into the
Bremelanotide Device). For such purpose, Ypsomed and its
subcontractors, as applicable, on the one hand, and AMAG and its
designees, as applicable, on the other hand, may directly disclose
to, and receive from, each other confidential information of the
other Party. Each Party shall ensure that its designees or its
subcontractors, as applicable, are bound by appropriate
confidentiality obligations no less stringent than the
confidentiality obligations set out in this Agreement.

 

6.    Payment

	
 

	
 

	

6.1

	

All
costs and prices invoiced under this Agreement are specified in

[***]. All payments due to Ypsomed by AMAG under this
Agreement are expressed as net amounts and AMAG shall be liable to
pay any applicable sales taxes, value added taxes and
duties.

	
 

	
 

	

6.2

	

With
respect to each undisputed invoice under this Agreement, AMAG shall
make payments to Ypsomed under this Agreement in immediately
available funds to the bank account designated by Ypsomed from time
to time, within 
[***] after the date of the invoice.

	
 

	
 

	

6.3

	

Any
payments due hereunder which are not made within 
[***] after
the due date of such payments shall be subject to default interest
of 
[***] per 
[***] period on the unpaid amount until paid in full.
Notwithstanding any right to terminate this Agreement

 

 

 

 

 

for
AMAG's material breach as set out in Section 21.2, if any payment
due hereunder is not made within 
[***] after the date on which such payment is due, Ypsomed
shall provide written notice to AMAG, and AMAG shall use
commercially reasonable efforts to remedy such failure. If any
portion of an invoice is disputed by AMAG on justified grounds,
AMAG shall pay the undisputed amounts in accordance with the terms
above, and the Parties shall use good faith efforts to resolve
differences or discrepancies with regard to any disputed amount as
soon as practicable.

 

7.    Forecasts and Purchase
Orders

	
 

	
 

	

7.1

	

On the
Effective Date and before January 1 of each year thereafter, AMAG
shall provide Ypsomed with a written forecast for 
[***] of AMAG’s estimated requirements for Component
Sets (the "Long Range
Forecast"). Such Long Range Forecasts shall only be used for
capacity planning and determination purposes as set out
herein.

	
 

	
 

	

7.2

	

On the
Effective Date and on or before of each January 1, April 1, July 1
and October 1 during the Term, AMAG shall provide Ypsomed with a
written 
[***] rolling forecast of AMAG’s estimated
requirements for Component Sets (the "Rolling Forecast"). Such Rolling
Forecasts shall include binding and non-binding periods,

[***] (the “Binding
Forecast”). The non-binding portion of each Rolling
Forecast shall only be used for capacity planning and determination
purposes as set out herein. In its Rolling Forecast, AMAG shall, to
the extent practicable, level out potential variations in the
forecasted amounts for consecutive quarters (in any case for at
least the first 
[***] covered by the Rolling Forecast) to enable continuous
manufacture and resource planning at Ypsomed.

	
 

	
 

	

7.3

	

On or
before each January 1, April 1, July 1 and October 1 during the
Term, AMAG shall submit to Ypsomed a purchase order specifying the
number of Component Sets and the requested delivery date(s) for the
second quarter thereafter in accordance with the Binding Forecast
(“Purchase
Order”), and in each case no later than 
[***] prior to the requested delivery date(s) specified in
the Purchase Order.

	
 

	
 

	

7.3

	

In the
event of any conflict between a Purchase Order submitted by AMAG
and this Agreement, this Agreement shall prevail, unless Ypsomed
expressly approves such conflict or accepts such Purchase Order in
writing.

	
 

	
 

	

7.4

	

Ypsomed
shall acknowledge and confirm each Purchase Order in writing within

[***] of receipt, provided that AMAG has submitted the
Purchase Order in accordance with the terms of this Agreement.
However, (a) in no event shall Ypsomed be required to supply
quantities of Component Sets in excess of the Applicable Capacity
unless otherwise agreed by the Parties, and (b) if the quantity of
ordered Component Sets in a Purchase Order exceeds the quantity set
out in the Rolling Forecast by more than 
[***] for the
respective quarter, the Parties will agree on the delivery date for
such excess quantities on a case-by-case basis. If Ypsomed is
unable to deliver all of the Component Sets by the requested date
of Delivery in the Purchase Order, Ypsomed shall so notify AMAG
within 
[***] of receipt of the Purchase Order, and the Parties
shall negotiate in good faith an alternate date of Delivery as
close to the requested date of Delivery as is commercially
reasonable, provided that in no event shall such alternate date be
more than 
[***] after the requested date of Delivery in the Purchase
Order. Upon confirmation by Ypsomed, each Purchase Order will be
regarded by the Parties as a binding commitment by Ypsomed to
manufacture and Deliver to AMAG the relevant number of Component
Sets on the delivery date (such agreed upon delivery date being the
“Delivery
Date”).

 

 

 

 

 

8.    Delivery

	
 

	
 

	

8.1

	

Ypsomed
shall deliver the number of Component Sets set out in the relevant
Purchase Order by the Delivery Date (“Delivery”), provided that
over-delivery or under-delivery of up to 
[***] of the ordered amount shall be allowed. Component Sets
shall be delivered to AMAG FCA Ypsomed's manufacturing facility
indicated in the Quality Agreement (Incoterms 2010) and title shall
pass upon Delivery at such facility.

	
 

	
 

	

8.2

	

Ypsomed
shall notify AMAG of any expected delay in Delivery and will make
commercially reasonable efforts to effect Delivery as quickly as
possible. The Parties shall, if requested by AMAG, renegotiate the
date(s) of Delivery of all placed Purchase Orders following a
delayed Delivery. Ypsomed may, upon AMAG’s prior written
consent, make partial deliveries to maintain continuous supply. In
case Ypsomed anticipates that it may not be able or is unable to
Deliver all Components Sets by more than 
[***] after the Delivery Date set forth in a Purchase Order,
Ypsomed shall notify AMAG in writing immediately and provide an
explanation thereof. Ypsomed shall discuss with AMAG potential
remedies and propose as soon as reasonably possible a mitigation
plan to AMAG’s reasonable satisfaction, which will include
concrete measures in line with Ypsomed’s business continuity
plan, such as the introduction or increase of shift work, an
internal second source option, or safety stock provisions; as well
as any other measures in order to provide a fast and secure
recovery of the supply of Component Sets. Notwithstanding the
foregoing, if Ypsomed is or will be unable for any reason to
deliver all Component Sets within 
[***] of the Delivery Date in the respective Purchase Order,
then AMAG may, at its sole discretion, (i) cancel such Purchase
Order without penalty to AMAG and the number of Component Sets in
such cancelled Purchase Order shall be counted toward the Annual
Minimum Quantity for the calendar year in which the cancelled
Purchase Order was submitted, or (ii) accept Delivery of the
Component Sets on a delivery date mutually agreed to by the
Parties.

	
 

	
 

	

8.3

	

Ypsomed
will convey good title to the Component Sets to AMAG on the date of
Delivery, free and clear of any lien or encumbrance.

 

9.    Inspection, Notification of
Defects

	
 

	
 

	

9.1

	

Upon
receipt of a lot of Component Sets and all release documentation at
AMAG or its designee’s premises, AMAG or its designee acting
on behalf of AMAG shall carry out commercially reasonable and
adequate inspection and testing of the lot of Component Sets based
on mutually agreed inspection criteria as set out in the
Specifications (the “Initial
Inspection”). If any Component Sets fail Initial
Inspection, then AMAG shall notify Ypsomed within 
[***] after the arrival of such Component Sets at AMAG's or
its designee’s premises (such notice, a “Failure Notice”). If AMAG does not
so notify Ypsomed, then such Component Sets shall be deemed
accepted by AMAG. In the event AMAG rejects any Component Sets
under this Section 9.1, AMAG shall identify such Component Sets and
their date of Delivery and provide Ypsomed with a report (including
photos if applicable) on the nature of the alleged defect. AMAG
shall hold any such Component Sets for inspection by Ypsomed or,
upon Ypsomed’s written request and at 
[***] sole cost, shall return such Component Sets to
Ypsomed, whereas 
[***] shall reimburse the cost of returning such Component
Sets to Ypsomed in the event the respective Component Sets are
determined not to have failed Initial Inspection.

 

 

 

 

 

	
 

	
 

	

9.2

	

If at
any time within a period of 
[***] after Delivery of a Component Set to AMAG or its
designee AMAG discovers an alleged Hidden Defect, AMAG shall notify
Ypsomed within 
[***] after the discovery of such Hidden Defect. AMAG shall
identify the relevant Component Sets and their date of Delivery and
provide Ypsomed with a report (including photos if applicable)
describing the nature of the alleged Hidden Defect. AMAG shall hold
any such Component Set for inspection by Ypsomed or, upon
Ypsomed’s written request and at 
[***] sole cost, shall return such Component Sets to
Ypsomed, whereas 
[***] shall reimburse the cost of returning such Component
Sets to Ypsomed in the event the respective Component Sets are
determined to comply with the product warranty set out in Section
11.1. Except to the extent AMAG provides the notice of an alleged
Hidden Defect to Ypsomed in accordance with this Section 9.2, the
Delivered Component Sets shall be deemed to be accepted by
AMAG.

 

10.    Remedy and Liability for
Defects

	
 

	
 

	

10.1

	

In the
event one or more Component Sets fails Initial Inspection under
Section 9.1, has a Hidden Defect under Section 9.2, or is
determined not to comply with the product warranty set out in
Section 11.1, provided that AMAG provided proper notice to Ypsomed
within the agreed time period under Section 9.1 or Section 9.2, as
applicable, and subject to Section 11.2, as applicable, Ypsomed
shall, upon the Parties good faith decision, either (a)

[***] or, (b) 
[***]. In either case, 
[***] shall reimburse 
[***] for any applicable delivery charges. AMAG shall not
request an 
[***] as set
out under option (a) above, if the amount of defective Components
is 
[***] as set forth in Appendix 4.

	
 

	
 

	

10.2

	

In the
event the Parties are unable to agree as to whether or not a
Component Set fails Initial Inspection under Section 9.1, has a
Hidden Defect under Section 9.2, or complies with the product
warranty set out in Section 11.1, the Parties shall select an
independent laboratory which shall test such Component Set lot or
Component Sets to determine
whether such Component Set(s) fails Initial Inspection under
Section 9.1, has a Hidden Defect under Section 9.2, or complies
with the product warranty set out in Section 11.1. The findings of
such laboratory shall be binding. 
[***] upon such laboratory testing shall pay the costs
invoiced by such laboratory. During any period that the Parties are
in dispute regarding the conformity of the Component Sets, Ypsomed
shall, if requested by AMAG, replace such quantity of Component
Sets. If the laboratory determines the Component Set(s) fail
Initial Inspection under Section 9.1, has a Hidden Defect under
Section 9.2, or does not comply with the product warranty set out
in Section 11.1, then AMAG shall be entitled to the remedies set
out in Section 10.1. If the laboratory determines the Component
Set(s) passes Initial Inspection under Section 9.1, does not have a
Hidden Defect under Section 9.2, or complies with the product
warranty set out in Section 11.1, then AMAG shall pay for both the
original shipment of Component Sets and the replacement shipment of
Component Sets following such determination.

 

11.    Representations and Warranties by
Ypsomed

	
 

	
 

	

11.1

	

Product Warranty. Subject to Section 11.2, Ypsomed hereby
represents and warrants to AMAG that the Component Sets delivered
by Ypsomed to AMAG hereunder (a) will have been manufactured in
accordance with this Agreement, the Quality Agreement and
Applicable Laws, including, without limitation, cGMP in effect at
the time of manufacture, (b) will, as of the date of Delivery,
conform to the Specifications in effect at the time of manufacture,
and (c) will not be adulterated

 

 

 

 

 

within
the meaning of the U.S. Federal Food, Drug and Cosmetic Act, or any
other law in the Territory.

	
 

	
 

	

11.2

	

Warranty Limitation. The warranty under Section 11.1 and
AMAG’s remedies under Section 10 shall not apply to, and
shall be void in respect to (a) Components that have been modified
or altered in any manner by anyone other than Ypsomed or its
Affiliates or designees or authorized by Ypsomed, except that
activities carried out by AMAG or its designees in the final
assembly of a Component Set into a Bremelanotide Device in
accordance with the applicable specification, including the
Specifications, shall not be considered modified or altered under
this Section 11.2(a), or (b) defects caused by anyone other than
Ypsomed or its Affiliates or designees or authorized by Ypsomed
(i) by the use or operation of the Component Sets in an
application or environment other than that intended or recommended
for the Component Sets and/or the Bremelanotide Devices (as further
detailed in the Specifications or other separate documents such as
the Bremelanotide Device IFU); ii) by accident, negligence,
misuse or other causes other than the uses covered by this
Agreement; or (iii) by packaging, transport, warehousing,
storage or handling of the Component Sets, in any manner
inconsistent with this Agreement, including, without limitation,
the Specifications. Ypsomed expressly excludes any liability for
instructions for use for the Component Sets or Bremelanotide
Devices respectively.

	
 

	
 

	

11.
3

	

Authority & Approvals. Ypsomed represent and warrants
that (a) it has full power and authority, and has taken all
necessary actions and has obtained all necessary statutory
authorizations, licenses and approvals required, to execute and
perform this Agreement; and (b) its entry into this Agreement and
its performance of its obligations under this Agreement do not, and
will not, breach any agreements (to which it is party) with any
third party.

	
 

	
 

	

11.4

	

Regulatory Violations. Ypsomed represents and warrants that
it and its employees, agents, officers and directors have not been
debarred, disqualified or convicted of a crime for which one can be
debarred under Article 306 of the FDCA, 21 U.S.C. §335a(a) or
(b), or any equivalent foreign or local law, rule or regulation. In
the event that Ypsomed or any of its employees, agents, officers
and directors becomes so debarred, disqualified or convicted,
Ypsomed agrees to notify AMAG thereof immediately, and AMAG shall
have the right to terminate this Agreement pursuant to Section
21.2. Ypsomed further represents and warrants that it has not and
shall not knowingly use or employ in any capacity related to any
activities under this Agreement any individual, corporation,
partnership, or association which has been debarred, disqualified
or convicted of a crime for which one can be debarred under Article
306 of the FDCA, 21 U.S.C. §335a(a) or (b), or any equivalent
foreign or local law, rule or regulation. In the event that Ypsomed
becomes aware of or receives notice of the debarment,
disqualification or conviction of any such individual, corporation,
partnership, or association providing services to it which relate
to any activities under this Agreement, Ypsomed agrees to notify
AMAG immediately thereof, and AMAG shall have the right to
terminate this Agreement pursuant to Section 21.2.

 

12.    Representations and Warranties by
AMAG

	
 

	
 

	

12.1

	

AMAG
warrants that, following Delivery to AMAG or its designee, all
Component Sets shall be transported, warehoused, stored, processed,
handled and marketed by AMAG or its designees in accordance with
this Agreement, including the Specifications, and all Applicable
Laws. AMAG further warrants that it will not knowingly put on the
market any Component Sets or Bremelanotide Device with known
defects nor shall AMAG knowingly put on the market any Component
Sets or

 

 

 

 

 

Bremelanotide
Device except subject to and in accordance with the applicable
specifications, including the Specifications and
Authorizations.

	
 

	
 

	

12.2

	

AMAG
warrants that all advertising and promotional materials as well as
user manuals and other information, instructions and directions of
use relating to safety and risk issues, use, transport, handling,
and storage of the Bremelanotide Device shall comply with the
applicable specifications, and all applicable laws, rules, and
regulations in the Territory.12.3    AMAG
warrants that it will not market, offer to sell or sell any
Bremelanotide Device in any country unless and until it has all the
necessary Authorizations from the relevant regulatory agency in
such country that are required to market, offer to sell and sell
the Bremelanotide Device. Ypsomed will support AMAG in obtaining
such Authorizations in accordance with Section 14 and as set out in
the Quality Agreement.

	
 

	
 

	

12.4

	

Authority & Approvals. AMAG represent and warrants that
(a) it has full power and authority, and has taken all necessary
actions and has obtained all necessary statutory authorizations,
licenses and approvals required, to execute and perform this
Agreement; and (b) its entry into this Agreement and its
performance of its obligations under this Agreement do not, and
will not, breach any agreements (to which it is party) with any
third party.

 

	
 

	
 

	

12.5

	

Regulatory Violations. AMAG represents and warrants that is
has not been debarred under Article 306 of the FDCA, 21 U.S.C.
§335a(a) or (b), or any equivalent foreign or local law, rule
or regulation. In the event that AMAG becomes debarred, AMAG agrees
to notify Ypsomed thereof immediately, and Ypsomed shall have the
right to terminate this Agreement pursuant to Section 21.2. AMAG
further represents and warrants that it has not and shall not
knowingly use or employ in any capacity related to any activities
under this Agreement any individual, corporation, partnership, or
association which has been debarred under Article 306 of the FDCA,
21 U.S.C. §335a(a) or (b), or any equivalent foreign or local
law, rule or regulation. In the event that Ypsomed becomes aware of
or receives notice of the debarment of any such individual,
corporation, partnership, or association providing services to it
which relate to any activities under this Agreement, AMAG agrees to
notify the Ypsomed immediately thereof, and Ypsomed shall have the
right to terminate this Agreement pursuant to Section
21.2.

 

13.    Quality Management System

	
 

	
 

	

13.1

	

On or
about the date hereof the Parties shall enter into a Quality
Agreement covering the Components and Component Sets. The Parties
shall review the Quality Agreement and shall modify same from time
to time as detailed in the Quality Agreement as necessary through a
written amendment to the Quality Agreement signed by an authorized
representative on behalf of each of the Parties. The Parties shall
perform the quality control and quality assurance testing specified
in this Section 13, the Quality Agreement, the Specifications and Applicable
Laws.

	
 

	
 

	

13.2

	

Ypsomed
shall (i) maintain a quality management system, (ii) manufacture
the Component Sets and (iii) generate and maintain the compilation
of records of the manufacturing, testing, processing, packaging,
labeling, and storage of the Component Sets in accordance with the
Quality Agreement. Reference is made to Section 24.7 for the
language of such records.

	
 

	
 

	

13.3

	

Ypsomed
will participate in and support AMAG in all required actions in
respect of AMAG’s medical device vigilance systems,
including, without limitation, support in

 

 

 

 

 

respect
of initial reporting and corrective action, as set out in the
Quality Agreement or required by Applicable Law.

	
 

	
 

	

13.4

	

In
accordance with the Quality Agreement, Ypsomed shall allow AMAG
(and, if requested by AMAG, its notified body) to audit
Ypsomed’s manufacturing facilities in order to assure
compliance with this Agreement and the Quality
Agreement.

	
 

	
 

	

13.5

	

Unless
otherwise indicated, 
[***] incurred in respect of Audits pursuant to Section
13.4. All information obtained by AMAG in any Audit (including,
without limitation, the findings and results related thereto but
excluding all Confidential Information of AMAG) shall be deemed to
be Ypsomed’s Confidential Information that may not be shared
with any third parties, except as otherwise permitted under this
Agreement (which permitted uses include, for clarity, use in
regulatory filings for Authorizations, provided however that AMAG
shall not be authorized to list patents of Ypsomed in the FDA
publication entitled Approved Drug Products with Therapeutic
Equivalence Evaluations (Orange Book) without the prior written
consent of Ypsomed) or unless compulsory under Applicable
Law.

 

14.    Authorizations

	
 

	
 

	

14.1

	

AMAG
shall obtain and maintain all Authorizations for the Bremelanotide
Device and shall be the sole owner of such Authorizations in the
Territory. The costs for such applications and Authorizations shall
be borne by 
[***]. Subject to Section 14.3, as between the Parties, AMAG
shall be responsible for all communications with Authorities
regarding such Authorizations.

	
 

	
 

	

14.2

	

For the
purposes of Sections 14.3 and 14.4, AMAG shall use reasonable
efforts to notify Ypsomed in a timely manner about its application
schedule for Authorizations and any updates thereto. AMAG shall use
reasonable efforts to regularly inform Ypsomed about the expected
times for obtaining the Authorizations and notify Ypsomed in
writing about any Authorizations obtained.

	
 

	
 

	

14.3

	

Ypsomed
shall use reasonable efforts to provide AMAG or, at AMAG's request,
Authorities in the Territory with any data and information (in
English) relating to Ypsomed's performance under this Agreement,
which is necessary to apply for and/or maintain Authorizations in
the Territory.

	
 

	
 

	

14.4

	

Ypsomed
agrees to cooperate with any inspection of Ypsomed's facilities by
Authorities, including any regulatory inspection required for AMAG
to apply for and/or maintain Authorizations, in accordance with the
Quality Agreement. 

	
 

	
 

	

14.5

	

Any
provision in this Agreement, including, without limitation, in the
Quality Agreement, giving AMAG the right to access, control, check
or receive documents from Ypsomed or to visit or audit
Ypsomed’s premises, shall be interpreted as covering all
documents and information relevant to the Components but excluding
trade, operating and/or business secrets of Ypsomed and/or its
subcontractors. If documents or information containing such trade,
operating and business secrets are required for (i) AMAG's
certification by an Authority, (ii) applying for and/or maintaining
Authorizations in the Territory, (iii) risk evaluation by an
Authority or (iv) market surveillance by an Authority, the document
or information will be disclosed only to the relevant Authority.
Ypsomed shall inform AMAG of any information directly submitted to
Authorities, and Ypsomed shall be responsible for any updates and
annual reports required by such Authorities in respect of such
information.

 

 

 

 

 

	
 

	
 

	

14.6

	

[***] shall 
[***] in respect of Ypsomed's activities of providing data
and information as set out in Section 14.3, Section 14.4 and
Section 14.5, provided such costs are administrative costs of
Ypsomed. To the extent such costs relate to the Authorizations and
are not administrative costs (e.g., costs for the undertaking of
further technical studies, tests or experiments, costs for
translation of or costs for compiling additional documents),

[***] shall pay the respective costs, provided 
[***] supplies reasonable documentation substantiating such
costs, except as otherwise agreed upon in writing. For one (1)
regulatory inspection related to the Authorizations every

[***] pursuant to Section 14.4, 
[***] shall bear its own costs. 
[***] shall pay the reasonable costs incurred by

[***] for regulatory inspections in excess of one (1) every

[***] related to the Authorizations, provided 
[***] supplies reasonable documentation substantiating such
costs, except if such inspection is for-cause.

 

15.    Patient Complaints and
Recalls

	
 

	
 

	

15.1

	

The
process for resolving complaints, adverse events, and inquiries
related to the Bremelanotide Device shall be in accordance with the
Quality Agreement. As between the Parties, AMAG shall have the sole
responsibility for resolving patient questions or complaints
related to the Bremelanotide Device. Ypsomed shall refer any
patient questions and complaints (including safety and efficacy
inquiries, quality complaints and adverse event reports) that it
receives concerning the Bremelanotide Device to AMAG (together with
all available evidence and other information relating thereto) in
accordance with the Quality Agreement. Ypsomed shall not take any
further action in connection with any such patient questions or
complaints without the consent of AMAG, but shall cooperate in the
investigation and closure of any such questions or complaints at
the request of AMAG. Such assistance shall include follow-up
investigations, including testing according to Ypsomed’s SOP
and complaint handling proceedings. In addition, Ypsomed shall
provide AMAG with all information to enable AMAG to respond
properly to patient questions or complaints relating to the
Components Sets as provided in the Quality Agreement.

	
 

	
 

	

15.2

	

As
between the Parties, AMAG shall have the sole responsibility as to
whether to institute a recall or withdrawal of Bremelanotide
Devices (whether required by an Authority or instituted by AMAG for
any reason). Ypsomed shall support AMAG as set out in the Quality
Agreement. If AMAG plans a recall or withdrawal of the
Bremelanotide Device, AMAG shall notify Ypsomed promptly of the
details regarding such recall or withdrawal, including, without
limitation, providing copies of all relevant documentation
concerning such recall or withdrawal. As far as the Components are
concerned, Ypsomed shall cooperate with AMAG in any such recall and
AMAG shall reasonably consider Ypsomed’s input in respect to
the Components. Ypsomed shall provide such information in respect
of Ypsomed's performance under this Agreement as AMAG reasonably
requests or which is necessary according to Applicable Laws. All
regulatory contacts that are made and all activities concerning
such recall will be initiated and coordinated by AMAG with
Ypsomed’s involvement and assistance, as such involvement and
assistance is reasonably requested by AMAG. .

	
 

	
 

	

15.3

	

Ypsomed
shall indemnify AMAG and bear the expense and costs, including
replacements costs but not including loss of profit, resulting from
a recall or withdrawal of Bremelanotide Device to the extent caused
by a failure of the Components to comply with the product warranty
set out in Section 11.1.

 

 

 

 

 

16.    Intellectual Property
Rights

	
 

	
 

	

16.1

	

Any and
all Intellectual Property Rights in existence prior to the
Effective Date or developed during the period of this Agreement but
otherwise than in the course of performance of obligations under
this Agreement shall, as between the Parties, remain the sole and
exclusive property of the Party that brings such rights to this
Agreement.

	
 

	
 

	

16.2

	

Ypsomed
shall be the sole and exclusive owner of 
[***] (“New Ypsomed Intellectual Property
Rights”). AMAG agrees to assign and hereby assigns all of its
rights, including all patent rights, to such New Ypsomed
Intellectual Property Rights to Ypsomed, and such New Ypsomed
Intellectual Property Rights shall be included in the license in
Section 16.4. Ypsomed shall be solely entitled to legally protect
any such New Ypsomed Intellectual Property Rights and shall bear
all related costs.

	
 

	
 

	

16.3

	

AMAG
shall be the sole and exclusive owner of 
[***] (“New AMAG Intellectual Property Rights”).
Ypsomed agrees to assign and hereby assigns all of its rights,
including all patent rights, to such New AMAG Intellectual Property
Rights to AMAG. AMAG shall be solely entitled to legally protect
any such New AMAG Intellectual Property Rights and shall bear all
related costs.

	
 

	
 

	

16.4

	

Ypsomed
grants to AMAG a royalty-free, fully paid-up, irrevocable (during
the term of this Agreement), sublicensable and non-exclusive
license in respect of the Ypsomed Intellectual Property Rights and
New Ypsomed Intellectual Property Rights to the extent required for
AMAG to final assemble and pack, use, sell, offer for sale,
distribute, import and export the Components, Component Sets and
Bremelanotide Device. This limited license shall only survive an
expiration or termination of this Agreement to the extent that a
permitted use set out hereunder outlasts the expiration or
termination of this Agreements. For the avoidance of doubt, the
license shall survive expiration or termination of this Agreement
with respect to any and all Component Sets ordered or purchased as
of the date of expiration or termination until such time as the
resulting Bremelanotide Devices have been sold or have expired. The
license shall not include the right to manufacture or have
manufactured the Components.

	
 

	
 

	

16.5

	

Each
Party shall cooperate with the other in completing any patent
applications or obtaining any other patent rights relating to
Intellectual Property Rights created or developed under this
Agreement, including executing and delivering any instrument
required to assign or transfer such Intellectual Property Rights to
the other Party in accordance with Sections 16.2 or
16.3.

	
 

	
 

	

16.6

	

Ypsomed
has established a continuous standard patent surveillance in the
EU, USA and Switzerland concerning the YpsoMate. Under this
Agreement Ypsomed shall continue to undertake its continuous
standard patent surveillance concerning the YpsoMate.

 

In the
event that Ypsomed becomes aware of any third party patent rights
(granted patents) that may reasonably adversely impact AMAG’s
use of the Components in accordance with this Agreement, Ypsomed
shall notify AMAG thereof in writing without delay.

 

Ypsomed
represents and warrants that 
[***] it has
not received any claims from a third party that the YpsoMate or the
performance of the activities under this Agreement infringe or
misappropriate the rights of any third party Intellectual Property
Rights and according to Ypsomed’s assessment (of infringement
and validity) and good faith belief, 
[***], the use of the Components and Component Sets
in accordance with
this Agreement does not infringe or misappropriate any valid and
enforceable issued third party patent. If Ypsomed becomes aware of
any third party claims of patent infringement or misappropriation
(e.g., by receiving a cease and desist letter) after the Effective
Date, Ypsomed shall promptly notify AMAG thereof in
writing.

 

 

 

 

 

	
 

	
 

	

16.7

	

If
either Party becomes aware of any claim or action by a third party
claiming that the YpsoMate or the Component Sets infringes or
misappropriates a third party patent (in particular upon receipt of
a corresponding letter from such third party) (each a "Third Party Action"), such Party shall
promptly inform the other Party of such Third Party
Action.

	
 

	
 

	

16.8

	

The
defense against a Third Party Action shall be ruled as
follows:

	
 

	
 

	

a)

	

If the
Third Party Action is directed against Ypsomed for alleged
infringement of a third party patent by the YpsoMate, Ypsomed shall
defend at its sole cost the Third Party Action directed against the
YpsoMate through counsel of its choice. Ypsomed shall reasonably
update and inform AMAG on its defense strategy and the status of
any Third Party Action under this Section 16.8(a).

	
 

	
 

	

b)

	

If the
Third Party Action is 
[***] then AMAG shall have the right to defend such Third
Party Action 
[***]. The Party defending such Third Party Action shall
have the sole and exclusive right to select counsel for such Third
Party Action. The non-controlling Party shall have a reasonable
opportunity for meaningful participation in decision-making and
formulation of defense strategy. The Parties shall reasonably
cooperate with each other in all such actions or proceedings. In
the event that AMAG is enjoined from selling the Bremelanotide
Device as a result of such Third Party Action, 
[***].

	
 

	
 

	

c)

	

For
Third Party Actions under Section 16.8 (b), the Party conducting
the defense to such Third Party Action shall (i) take all
reasonable steps to prevent judgment by fault or by default being
granted in favor of the third party; (ii) ensure that the other
Party is given the right to conduct proper consultations with the
third party in relation to the claim or potential claim; (iii) if
appropriate and practicable, allow the other party to join in the
defense (including, without limitation, settlement, litigation or
appeal) of any claim; and (iv) not, without the prior written
consent of the other Party, settle or compromise any claim or
consent to the entry of any judgment that imposes any liability or
obligation upon such Party.

	
 

	
 

	

16.9

	

In the
event it is established that the Components infringe a third party
patent or if the Parties agree to settle any claim or consent to
the entry of any judgment that prevents Ypsomed to continue to
manufacture and supply the Components to AMAG, the Parties shall
mutually agree on the strategy to be followed which may contain one
of the following actions: (i) Ypsomed at its own cost shall
redesign the Components to avoid the infringement, or (ii) Ypsomed
at its own cost shall procure to obtain a license from such third
party, 
[***]. If the Parties cannot agree on either of such
actions, or if such actions are not possible or successful, the
Parties agree to discuss in good faith alternative solutions,
whereas in case such alternative solutions are not possible or
successful, the Parties agree to consensually terminate this
Agreement.

	
 

	
 

	

16.10

	

If any
Ypsomed Intellectual Property Right licensed to AMAG under this
Agreement is infringed and/or misappropriated by a third party (the
“Infringed Intellectual
Property”) the Party first having knowledge of such
infringement/misappropriation shall promptly notify the other Party
in writing.

 

 

 

 

 

17.    Disclaimer

 

Except
as expressly set out in this Agreement, neither Party makes any
warranties in respect of its activities under this Agreement,
express or implied, including, without limitation, any implied
warranty of merchantability or fitness for a particular
purpose.

 

18.    Indemnity and Insurance

	
 

	
 

	

18.1

	

Ypsomed
agrees to indemnify, defend and hold harmless AMAG, its Affiliates
and its and their respective officers, directors, employees,
subcontractors, and agents (collectively, the “AMAG Indemnitees”) against any and
all losses, damages, liabilities or expenses (including reasonable
attorney’s fees and other costs of defense) (collectively,
“Losses”) in
connection with any and all actions, suits, claims or demands that
are brought or instituted against any AMAG Indemnitee by any third
party to the extent they arise out of (a) any breach of
Ypsomed’s representations, warranties or obligations set out
in this Agreement, including but not limited to the ones set out in
Sections 11, 16.6 and 16.7, (b) any Ypsomed Indemnitees’
gross negligence or willful misconduct in performing obligations
under this Agreement, (c) a recall or withdrawal of Bremelanotide
Device in accordance with Section 15.3, or (d) 
[***] except, in each case, to the extent that such Losses
result from an action for which AMAG has an obligation to indemnify
Ypsomed under Section 18.2(a), (b) or (c).

[***].

	
 

	
 

	

18.2

	

AMAG
agrees to indemnify, defend and hold harmless Ypsomed, its
Affiliates and its and their respective officers, directors,
employees, subcontractors, and agents (collectively, the
“Ypsomed
Indemnitees”) against any and all Losses in connection
with any and all actions, suits, claims or demands that are brought
or instituted against any Ypsomed Indemnitee by any third party to
the extent they arise out of (a) the use of the Component Sets, (b)
any breach of AMAG’s representations, warranties or
obligations set out in this Agreement, (c) any AMAG
Indemnitee’s gross negligence or willful misconduct in
performing obligations under this Agreement, or (d) any claim
alleging that the manufacture, use, offer for sale, sale, import or
export of Bremelanotide infringes any Intellectual Property Rights
of a third party, except, in each case, to the extent that such
Losses result from an action for which Ypsomed has an obligation to
indemnify AMAG under Section 18.1(a), (b) or (c).

	
 

	
 

	

18.3

	

Each
Party agrees that if it is notified by a third party of any claim
or potential claim that may give rise to a right of indemnification
pursuant to Section 18.1 or Section 18.2, it shall

	
 

	
 

	

a)

	

forthwith
inform the other Party of such claim or potential
claim;

	
 

	
 

	

b)

	

take
all reasonable steps to prevent judgment by fault or by default
being granted in favor of the third party;

	
 

	
 

	

c)

	

ensure
that the other Party is given the right to conduct proper
consultations with the third party in relation to the claim or
potential claim;

	
 

	
 

	

d)

	

if
appropriate, allow the other party to join in the defense
(including, without limitation, settlement, litigation or appeal)
of any claim; and

 

 

 

 

 

 

 

	
 

	
 

	

e)

	

not,
without the prior written consent of the other Party, settle or
compromise any claim, or consent to the entry of any judgment that
imposes any liability or obligation upon such Party.

	
 

	
 

	

18.4

	

Both
Parties shall obtain and maintain for the duration of this
Agreement and a period of 
[***] thereafter
comprehensive liability insurance and other insurance all in
amounts and with coverage as required by the jurisdictions in which
they operate or as necessary to cover their obligations pursuant to
this Agreement. Each Party shall, within 
[***] of any request from the other Party, provide a copy or
extract of its certificate of insurance to the other Party
evidencing compliance with this Section.

 

19.    Limitation of Liability

	
 

	
 

	

19.1

	

To the
extent permitted by the applicable law, neither Party shall be
liable to the other Party or to any third party, under this
Agreement, in contract, tort (including negligence) or otherwise
howsoever, and whatever the cause thereof, for lost profits,
goodwill, the cost of procurement of substitute goods, the cost of
Bremelanotide or for any consequential or indirect damages,
provided, however that
such limitation shall not apply with respect to any claim arising
from (a) the gross negligence or willful misconduct of either
Party, or (b) a breach of the confidentiality provisions of Section
20. This limitation shall apply even where a Party has been
advised of the possibility of such damage and notwithstanding the
failure of the essential purpose of any limited remedy stated
herein.

	
 

	
 

	

19.2

	

To the
extent permitted by applicable laws and subject to the provisions
of this Section 19.2, either Party’s liability under this
Agreement in any calendar year shall be limited to the greater of
(a) 
[***]) and (b) the total charges paid by AMAG to Ypsomed
under this Agreement during the 
[***] period preceding the event that gave rise to the
liability, provided, however that Ypsomed’s liability over
such calendar year shall in any event be limited to 
[***]. Such limitation shall not apply with respect to any
claim arising from (a) the gross negligence or willful misconduct
of either Party, or (b) a breach of the confidentiality provisions
of Section 20.

 

It is
hereby clarified that 
[***] own costs for defending a Third Party Action pursuant
to Section 16.8 (a) or 16.8 (b) 
[***], shall not be considered as "liability" for the
purpose of calculating 
[***] liability limit pursuant to this Section
19.2.

	
 

	
 

	

19.3

	

Each
Party shall be obliged to mitigate damages.

 

20.    Confidentiality

	
 

	
 

	

20.1

	

It is
understood between the Parties that the existing secrecy
undertakings as stipulated in the Confidentiality Agreement have
been and shall remain in force with respect to information
exchanged thereunder.

	
 

	
 

	

20.2

	

For
purposes of this Agreement, “Confidential Information” includes
all information furnished by or on behalf of a Party (the
“Disclosing
Party”), its Affiliates or any of its or their
respective Representatives (as defined below), to the other Party
(the “Receiving
Party”), its Affiliates or any of its or their
respective Representatives, in respect of this Agreement or any
performance hereunder, whether furnished before, on or after the
Effective Date and furnished in any form, including written,
verbal, visual, electronic or in any other media or manner and
information acquired by observation or otherwise during any site
visit at the other Party’s facility. Confidential Information
includes all proprietary technologies, know-how, trade secrets,
discoveries, ideas, processes, formulas, samples, compounds,
extracts, inventions and any other intellectual property (whether
or not patented), analyses and compilations,
business, technical and financial information and other materials
prepared by either Party, their respective Affiliates, or any of
its or their respective representatives, containing or based in
whole or in part on any information furnished by the Discloser, its
Affiliates or any of its or their respective Representatives.
Confidential Information also includes the existence of this
Agreement and its terms.

 

 

 

 

	
 

	
 

	

20.3

	

The
Receiving Party shall maintain all Confidential Information in
trust and confidence and shall not disclose or divulge or use any
Confidential Information for any purpose other than the performance
of its obligations under this Agreement without the prior written
consent of the Disclosing Party.

	
 

	
 

	

20.4

	

The
Receiving Party may disclose Confidential Information to its
officers, directors, employees, agents, independent, consultants,
attorneys or accountants (collectively “Representatives”) only on a need
to know basis; provided that (a) such Representatives are bound by
written agreements to maintain in confidence and not use the
Confidential Information under terms at least as restrictive as the
terms of this Agreement, and (b) the Receiving Party shall be
liable for any breach by its Representatives of any obligations
hereunder.

	
 

	
 

	

20.5

	

The
foregoing obligations of confidentiality shall not apply to
Confidential Information that the Receiving Party can prove by
competent written proof:

	
 

	
 

	

a)

	

was
known to the Receiving Party prior to its receipt from the
Disclosing Party, or

	
 

	
 

	

b)

	

is
publicly available prior to receipt from the Disclosing Party or
subsequently becomes publicly available through no fault of the
Receiving Party, or

	
 

	
 

	

c)

	

is
obtained by the Receiving Party from a third party who is not under
an obligation of confidentiality and has a lawful right to make
such disclosures, or

	
 

	
 

	

d)

	

is
independently developed by or for the Receiving Party without use
of the Disclosing Party’s confidential
information.

	
 

	
 

	

20.6

	

The
Receiving Party may make disclosures required by an order of a
governmental agency, legislative body or court of competent
jurisdiction, provided that the Receiving Party: (i) provides the
Disclosing Party with immediate written notice of such requirement,
(ii) cooperates with the Disclosing Party at the Disclosing
Party’s expense in connection with the Disclosing
Party’s reasonable and lawful actions to obtain confidential
treatment for such Confidential Information, and (iii) limits such
disclosure of Confidential Information to the fullest extent
permitted under applicable law.

	
 

	
 

	

20.7

	

The
confidentiality and non-use obligations imposed by this Agreement
shall expire with respect to any particular item of a Disclosing
Party's Confidential Information on the 
[***] anniversary of the date of disclosure of such
Confidential Information.

 

21.    Term and Termination

	
 

	
 

	

21.1

	

The
term of this Agreement shall commence on the Effective Date and,
unless terminated under Sections 21.2 through 21.6, this Agreement
shall continue in full force and effect until 
[***] ("Initial
Term"). This Agreement shall be automatically renewed for
successive 
[***] year
periods (each a "Subsequent
Term" and, with the Initial Term, the “Term”) unless either Party
terminates this Agreement by 
[***] written
notice to the other Party prior to the expiration of the Initial
Term or any Subsequent

 

 

 

 

 

Term,
as applicable. 
[***] before expiration of this Agreement, the Parties shall
undertake to facilitate the phase out and wind down of the
supply.

	
 

	
 

	

21.2

	

This
Agreement may be terminated by either Party effective upon

[***] written notice to the other Party in the event of
material breach of this Agreement by the other Party, provided it
has previously given written notice of such material breach and the
breaching Party has failed to remedy such breach within

[***] of
receipt of such notice.

	
 

	
 

	

21.3

	

This
Agreement may be terminated by either Party effective immediately
upon written notice to the other Party (i) upon the institution by
or against the other Party of insolvency, receivership or
bankruptcy proceedings or any other proceedings for the settlement
of the other Party’s debts, unless such other Party timely
contests such proceedings, (ii) upon the other Party’s
making an arrangement for the benefit of creditors, or
(iii) upon the other Party’s dissolution or cessation of
business.

	
 

	
 

	

21.4

	

This
Agreement may be terminated by either Party effective upon

[***] written notice to the other Party in the event of a
change of control of the other Party if such controlling party is a
competitor of the terminating Party. For the purposes of this
Section 21.4, the term “control” shall have the same
meaning as set out in Section 1 in respect of
Affiliates.

	
 

	
 

	

21.5

	

This
Agreement may be terminated by AMAG if the Bremelanotide Device
does not receive FDA approval, provided AMAG notifies Ypsomed in
writing with 
[***] notice
that it wishes to terminate the Agreement.

	
 

	
 

	

21.6

	

This
Agreement may be terminated by AMAG if AMAG is required to withdraw
the Bremelanotide Device from the market for regulatory or health
and safety reasons, provided AMAG notifies Ypsomed in writing with

[***] notice that is wishes to terminate the
Agreement.

 

22.    Effects of Termination or
Expiration

	
 

	
 

	

22.1

	

Upon
termination by Ypsomed or receipt of notice of termination from
AMAG, Ypsomed will as soon as reasonably practicable cease
performance of the applicable activities in respect to the
Component Sets and will take reasonable steps to mitigate the
out-of-pocket expenses incurred in connection
therewith.

	
 

	
 

	

22.2

	

Each
Party shall return all documents and materials in its possession
which contain confidential information of the other Party within

[***] after termination or expiration of this Agreement,
except for copies of information that may be routinely and
automatically stored in the Party’s computer backup and
electronic communications systems. The receiving Party may retain
one copy of documents and materials which contain the disclosing
Party's confidential information for the purpose of verifying the
receiving Party's compliance with its obligations under this
Agreement or as required by Applicable Laws, but for no other
purpose whatsoever.

	
 

	
 

	

22.3

	

Sections
1, 2, 4.4, 6, 9, 10, 11, 12, 13.2(iii), 13.3, 14.3, 14.4, 14.5,
14.6, 15, 16, 17, 18, 19, 20, 22, 24.1, 24.2, 24.4, 24.5, 24.6,
24.7, 25 and 26 shall survive termination or expiration of this
Agreement.

	
 

	
 

	

22.4

	

In the
event of termination of this Agreement by Ypsomed according to
Section 21.2, 21.3 or 21.4, 
[***] shall (i) 
[***].

 

 

 

 

 

	
 

	
 

	

22.5

	

In the
event of termination of this Agreement by AMAG according to 21.5 or
21.6, 
[***] shall (i) 
[***].

	
 

	
 

	

22.6

	

In the
event of termination of this Agreement by 
[***] according to Sections 16.9, 21.2, 21.3 or 21.4,

[***].

 

23.    Force Majeure

 

Neither
Party shall lose any rights hereunder or be liable to the other
Party for damages or losses (except for payment obligations) on
account of failure of performance by the defaulting Party if the
failure is occasioned by war, strike, acts of terrorism, fire, acts
of god, earthquake, flood, lockout, embargo, governmental acts or
orders or restrictions or any other similar reason where failure to
perform is beyond the reasonable control of and could not
reasonably have been expected to occur by the defaulting Party and
such Party has exerted all reasonable efforts to avoid or remedy
such force majeure. Failure to obtain, or revocation of, one or
more Authorizations shall not be considered an event of force
majeure.

 

24.    Miscellaneous

	
 

	
 

	

24.1

	

Entire Agreement. This Agreement, including its Appendices,
together with the Confidentiality Agreement, set forth the entire
agreement and understanding of the Parties in respect of the
subject matter hereof, and supersedes all prior discussions,
agreements and writings relating thereto.

	
 

	
 

	

24.2

	

Independent Contractors. The relationship of the Parties
hereto is that of independent contractors. The Parties are not
deemed to be agents or partners nor are they engaged in a joint
venture for any purpose as a result of this Agreement or the
transactions contemplated herein.

	
 

	
 

	

24.3

	

Assignment. Except as otherwise expressly provided herein,
the Parties agree that their rights and obligations under this
Agreement shall not be delegated, transferred or assigned to a
third party without the prior written consent of the other Party;
provided either Party may assign this Agreement or parts thereof to
its Affiliates, without the other Party's consent. Subject to
Section 21.4, either Party may assign this Agreement in its
entirety, without the other Party’s consent, to a successor
to substantially all of the business or assets of the assigning
Party. This Agreement shall be binding upon and inure to the
benefit of the Parties and their successors and permitted
assigns.

	
 

	
 

	

24.4

	

Severability, Waiver. In the event that any provisions of
this Agreement are determined to be invalid or unenforceable by a
court of competent jurisdiction, the remainder of this Agreement
shall remain in full force and effect without said provision. The
Parties shall in good faith negotiate a substitute clause for any
provision declared invalid or unenforceable, which shall most
nearly approximate the intent of the Parties in entering this
Agreement, or will leave the provision unreplaced by mutual
consent. Any provision of this Agreement held invalid or
unenforceable only in part or degree will remain in full force and
effect to the extent not held invalid or unenforceable. The failure
of a Party to enforce any provision of this Agreement shall not be
construed to be a waiver of the right of such Party to thereafter
enforce that provision or any other provision or
right.

	
 

	
 

	

24.5

	

Notices. Any required notices hereunder shall be given in
writing and sent by (a) facsimile or electronic mail
transmission (receipt verified), (b) recognized overnight courier,
freight prepaid, specifying next-day delivery, with written
verification of receipt

 

 

 

 

or (c)
priority mail, postage prepaid, with written verification of
receipt, in each case, to the address of the applicable Party
below, or to such other address as such Party may substitute by
written notice.

 

If to
AMAG:

AMAG
Pharmaceuticals, Inc.

1100
Winter Street

Waltham,
MA 02451

USA

 

Attention:
VP, Technical Operations

Fax:

 

with a
copy to:

Attention:
General Counsel

Fax:

 

 

If to
Ypsomed:

 

Ypsomed
AG

Brunnmattstrasse
6

CH-3401
Burgdorf

Switzerland

 

Attention:
General Counsel

Fax:
+41 (34) 424 41 55

 

With a
copy to:

Attention:
Product and Account Manager AMAG 

 

Either
Party may change its address for communications by a notice to the
other Party in accordance with the terms of this Section
24.5.

	
 

	
 

	

24.6

	

No Use of Name. Neither AMAG nor Ypsomed shall be permitted
to use the name of the other Party in any publicity, advertising or
public announcement concerning this Agreement or the subject matter
hereof without the prior express written consent of the other Party
except to the extent required by law. As soon as the Bremelanotide
Device is in the market, Ypsomed shall be allowed to mention AMAG
in its clients list and to show the Component Set (assembled with a
syringe of placebo) in trade fairs, exhibitions and
publications.

	
 

	
 

	

24.7

	

English Language. This Agreement has been prepared in the
English language and the English language shall control its
interpretation. All notices required or permitted to be given
hereunder, and all written or other communications between the
Parties regarding this Agreement or pursuant to this Agreement,
shall be in the English language, unless otherwise stated herein.
AMAG acknowledges that parts of the technical and quality
documentation for the Component Sets and the documentation of
Ypsomed's business activities are in the German
language.

 

 

 

 

 

25.    Arbitration and Governing
Law

 

	
 

	
 

	

25.1

	

Disputes. The Parties will try to settle their differences
amicably between themselves. If any claim, dispute, or controversy
of whatever nature arising out of or relating to this Agreement,
including the performance or alleged nonperformance of a Party of
its obligations under this Agreement arises between the Parties
(each a “Dispute”), a Party will, before
initiating any proceedings pursuant to Section 6(c), notify the
other Party in writing of such Dispute. If the Parties are unable
to resolve the Dispute within 
[***] of receipt of the written notice by the other Party,
such dispute will be referred to an executive officer of AMAG and
an executive officer of Ypsomed, or their designees, who will meet
in person at least once and use their good faith efforts to resolve
the Dispute within 
[***] after such referral.

	
 

	
 

	

25.2

	

Arbitration. If a Dispute is not resolved as provided in
Section 25.1, whether before or after expiration or termination of
these Terms and Conditions, the Parties hereby agree that such
Dispute will be resolved by final and binding arbitration conducted
in accordance with the 
[***]. The arbitration will be held in 
[***]. The governing law of this Agreement will govern any
such proceedings. The arbitration will be conducted by a panel of
three (3) arbitrators with significant experience in the
pharmaceutical manufacturing industry, unless otherwise agreed by
the Parties, appointed in accordance with applicable 
[***]. Any arbitration herewith will be conducted in the
English language to the maximum extent possible. The arbitrators
will be instructed not to award any punitive or special damages and
will render a written decision no later than 
[***] following the selection of the arbitrators, including
a basis for any damages awarded and a statement of how the damages
were calculated. Any award will be promptly paid in U.S. dollars
free of any tax, deduction or offset. Each Party agrees to abide by
the award rendered in any arbitration conducted pursuant to this
Section 6. With respect to money damages, nothing contained herein
will be construed to permit the arbitrator or any court or any
other forum to award punitive or exemplary damages. By entering
into this agreement to arbitrate, the Parties expressly waive any
claim for punitive or exemplary damages. Each Party will pay its
legal fees and costs related to the arbitration (including witness
and expert fees). Judgment on the award so rendered will be final
and may be entered in any court having jurisdiction
thereof.

	
 

	
 

	

25.3

	

Governing
Law. This Agreement and any dispute arising therefrom shall be
governed by and construed in accordance with the laws of

[***], regardless of the conflict of laws principles of that
or any other jurisdiction. The UN Convention on Contracts for the
International Sale of Goods is not applicable to this
Agreement.

	
 

	
 

	

25.4

	

Nothing
in this Section 25 will preclude either Party from seeking
equitable relief or interim or provisional relief from a court of
competent jurisdiction, including a temporary restraining order,
preliminary injunction, specific performance or other interim
equitable relief, concerning a Dispute either prior to or during
any arbitration if necessary to protect the interests of such Party
or to preserve the status quo pending the arbitration
proceeding.

	
 

	
 

	

26.

	

Securities Laws. The parties hereby acknowledge that AMAG is
publicly traded on the NASDAQ National Market System under the
symbol "AMAG" and Ypsomed is publicly traded on the Swiss
Performance Index (SPI) of SIX Swiss Exchange.  Further, each
party is aware and will advise its Representatives who are informed
of matters that are the subject of this Agreement, of the
restrictions imposed by certain applicable securities laws on the
purchase or sale of securities by any person who has received or
had access material, nonpublic information concerning a company and
on the communication of such information to any other person when
it is  reasonably
foreseeable that such person is likely to purchase or sell such
securities in reliance on such information.

 

 

 

 

 

 

In
witness whereof, AMAG and Ypsomed have executed this Agreement in
two originals, one for each Party, by their respective duly
authorized representatives.

 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	

AMAG
Pharmaceuticals, Inc.  

	
	

Ypsomed
AG  

	

Date:

	

December
21, 2018

	
 

	

Date:

	

January
25, 2019

	

By:

	

/s/
William K. Heiden

	
 

	

By:

	

/s/
Ulrike Bauer

	

Print
Name:

	

William
K. Heiden

	
 

	

Print
Name:

	

Ulrike
Bauer

	

Title:

	

President
and CEO

	
 

	

Title:

	

SVP
Marketing and Sales Delivery Systems

	
 

	
 

	
 

	

By:

	

/s/
Frank Mengis

	
 

	
 

	
 

	

Print
Name:

	

Frank
Mengis

	
 

	
 

	
 

	

Title:

	

COO

 

 

 

 

 

 

 

Appendix
1

Specifications
for Components

 

The
Specifications for the Components are kept in the Design History
File (DHF), which is maintained at Ypsomed's premises.

 

 

 

 

 

 

 

 

Appendix
2

Quality
Agreement

 

Separate
Document.

 

 

 

 

 

 

 

 

Appendix
3

Commercial
Terms

 

	
 

	
 

	

1.

	

Applicable
Capacity & Contribution

	
 

	
 

	

1.1

	

Ypsomed
will invest in the entire production infrastructure required to
produce the Components, including high-cavity tooling and fully
automatic assembly equipment.

 

Pursuant
to the terms of the Industrialization Proposal, 
[***] partially financed the manufacturing capacity build-up
through upfront payments as set out in the Industrialization
Proposal.

	
 

	
 

	

1.2

	

AMAG
and Ypsomed will determine the required manufacturing capacity that
Ypsomed will reserve for AMAG based on AMAG’s Long Range
Forecast delivered by AMAG to Ypsomed in accordance with Section
7.1 of the Supply Agreement. It is agreed between the Parties that
the applicable manufacturing capacity per calendar year
(“Applicable
Capacity”) will be determined in accordance with this
Section 1.2. The initial Applicable Capacity is 
[***] Component Sets. The Applicable Capacity may be
adjusted, from time to time upon either Party’s written
request, based on the Long Range Forecast. In the event AMAG
requests an increase in the Applicable Capacity that requires
Ypsomed to invest in additional production infrastructure, such
change shall be possible provided AMAG notifies Ypsomed at least

[***] prior
to such requested increase. In the event AMAG or Ypsomed in good
faith requests a decrease in the Applicable Capacity, such change
shall be possible provided that the Party requesting such decrease
notifies the other Party at least 
[***] prior to such requested decrease. Each change of the
Applicable Capacity shall be agreed upon by the Parties in good
faith. In the event AMAG’s capacity demand according to the
Long Range Forecast exceeds 
[***] Component
Sets per calendar year, the parties shall negotiate in good faith
the terms upon which Ypsomed will expand its manufacturing capacity
to accommodate AMAG’s increased capacity demand. In the event
AMAG’s capacity demand according to the Long Range Forecast
exceeds 
[***] Component Sets per calendar year (i.e., a commitment
for Applicable Capacity above 
[***] but not
more than 
[***] Component Sets) AMAG shall pay Ypsomed a capacity
contribution fee of 
[***]) as follows upon receipt of an invoice from
Ypsomed:

 

	
 

	
 

	
 

	
 

	

Payment Milestones (Contribution for Applicable Capacity
from [***] to [***] Component
Sets) 

	

Amount in [***]

	

[***] prior
to the planned change of Applicable Capacity (i.e. date of request
for additional capacity above 
[***] Component Sets per calendar year)

	

[***]

	

[***] prior
to the planned change of Applicable Capacity (i.e. 
[***] after
date of request for additional capacity above 
[***] Component
Sets per calendar year)

	

[***]

	

[***] prior
to the planned change of Applicable Capacity (i.e. 
[***] after
date of request for additional capacity above 
[***] Component Sets per calendar year)

	

[***]

	

Total

	

[***]

	
 

	
 

	

2.

	

Minimum
Purchase Quantity

 

In
accordance with Section 4.8 of the Supply Agreement, beginning in
2019 AMAG shall purchase at least the Annual Minimum Quantity of
Component Sets in each calendar year during the Term as
set forth below. For the purpose of determining whether AMAG is in
compliance with Section 4.8 of the Agreement, a Component Set is
considered “purchased” as of the agreed Delivery Date
in the respective Purchase Order, provided however that such
ordered Component Sets will have been duly purchased and paid by
AMAG (during such calendar year or, as applicable, at a later stage
in accordance with the terms of this Agreement).

 

 

 

 

	
 

	
 

	
 

	
 

	

Units

	

Minimum
Purchase Quantity

	

Per
Purchase Order

	

[***] (the “Minimum Batch Size”)

	

Initial
Term

	

[***] Component Sets per each calendar year during the
Initial Term beginning in 
[***] (the “Annual Minimum
Quantity”)

	

Subsequent
Term(s)

	

The
Annual Minimum Quantity for the Subsequent Term(s) shall be
determined and mutually agreed upon by the Parties prior to the end
of the Initial Term or of each Subsequent Term, as applicable. If
the Parties cannot agree on the Annual Minimum Quantity for a
Subsequent Term prior to beginning of such Subsequent Term, AMAG
shall be obligated to purchase, in each calendar year during the
Subsequent Term, no less than the Annual Minimum Quantity for the
last full calendar year

 

	

3.

	

Purchase
Price

 

The
invoiced Purchase Price for Component Sets applied to all invoices
during a calendar year will be determined based on number of
Component Sets for the respective calendar year as set forth in the
Binding Forecast and as determined according to the following
Pricing Tiers:

 

Pricing Tiers

	
 

	
 

	
 

	
 

	

Annual Quantity of Component Sets

	

Unit Price per Component Set in 
[***]

	

[***]

	

[***]

	

[***]

	

[***]

	

[***]

	

[***]

	

[***]

	

[***]

	

[***]

	

[***]

	

[***]

	

[***]

 

The
Purchase Price includes the costs for bulk packaging (bulk
packaging as set out in Appendix
2).

 

The
effective Unit Price per Component Set shall be determined based on
the total number of Component Sets ordered by AMAG for the
respective calendar year accordance with Section 7.3, provided
however that such ordered Component Sets will have been duly
purchased and paid by AMAG (during such calendar year or, as
applicable, at a later stage in accordance with the terms of this
Agreement).

 

Accordingly,
within 
[***] after the end of each calendar year during the Term,
Ypsomed shall calculate the total amount of ordered Component Sets
duly purchased and paid by AMAG and shall perform a
“True-Up”
reconciliation and shall provide AMAG with a written report of such
reconciliation. If the True-Up report shows that a difference in
the number of Component Sets purchased by AMAG compared to the
pricing tier serving as basis for the invoiced Purchase Price in
such calendar year results in either an underpayment or an
overpayment between
the Parties, the Party owing payment to the other Party shall pay
the amount of the difference to the other Party within 
[***] of the
date of delivery of such True-Up report.

 

 

 

 

 

	
 

	
 

	

4.

	

Invoicing

 

Ypsomed
shall submit an invoice to AMAG upon each Delivery of Component
Sets. The term of payment is 
[***] from
the date of invoice.

	
 

	
 

	

5.

	

Delivery

	
 

	
 

	

5.1

	

Ypsomed
shall deliver the Component Sets in accordance with Section 8 of
the Agreement and the shipping procedures set out in the
Specifications.

	
 

	
 

	

5.2

	

All
Component Sets shall be delivered to AMAG FCA Ypsomed's
manufacturing facility (Incoterms 2010).

 

 

 

 

Appendix 4

Price Change Order

 

Price Change Order – [insert
number]

                

Dated:
[insert
date]

 

This is
a Price Change Order of the purposes of Supply Agreement between
Ypsomed AG and AMAG Pharmaceuticals, Inc. dated
_________________[insert
date] (the “Agreement”).

 

Terms
used but not defined in this Price Change Order shall have the
meaning given to them in the Agreement.

 

Effective
Date:    Day, Month, Year

End
Date:    Day, Month, Year

 

Current
Purchase Price: $

 

Revised
Purchase Price: $

 

New
Total Cost (if applicable): $

 

The
following reasons have caused the Purchase Price to change
(increase or decrease):

 

	
 

	
 

	

1.

	
 

EXECUTED as an AGREEMENT

 

	
 

	
 

	
 

	
 

	

Signed
by

YPSOMED AG

 

___________________________

Signature

 

___________________________

Name

 

___________________________

Title

 

___________________________

Date

	

Signed
for and on behalf of

AMAG PHARMACEUTICALS, INC.

 

___________________________

Signature

 

___________________________

Name

 

___________________________

Title

 

___________________________

Date

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