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







 


 








 

31