Exhibit 10.1

 

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

EXECUTION COPY

 

SUPPLY AGREEMENT

 

by and among

 

AstraZeneca AB

 

and

 

Aralez Pharmaceuticals Trading DAC

 

Dated October 31, 2016

 

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

TABLE OF CONTENTS

 

1.

DEFINITIONS AND INTERPRETATION

1

 

 

 

2.

MANUFACTURE AND SUPPLY OF PRODUCT

7

 

 

 

 

2.1

Requirements

7

 

2.2

Specifications; Change Control

7

 

2.3

Compliance with Applicable Laws

9

 

2.4

TAA Compliant

9

 

2.5

[***]

9

 

 

 

 

3.

PACKAGING TRANSFER; LICENSE GRANT

9

 

 

 

 

3.1

[***]

9

 

3.2

Intellectual Property

9

 

 

 

 

4.

FORECASTS

10

 

 

 

 

4.1

Monthly Forecast

10

 

 

 

 

5.

PURCHASE ORDERS

11

 

 

 

 

5.1

Purchase Orders

11

 

5.2

AstraZeneca’s Fulfillment of Purchase Orders

12

 

5.3

Minimum Order Quantities

13

 

5.4

Terms and Conditions

13

 

5.5

Accuracy

13

 

 

 

 

6.

DELIVERY

13

 

 

 

 

6.1

Delivery

13

 

6.2

Delivery Date

13

 

6.3

Documentation

14

 

6.4

Packaging

14

 

 

 

 

7.

RISK AND TITLE

14

 

 

 

 

7.1

Risk and Title

14

 

 

 

 

8.

PRICE

14

 

 

 

 

8.1

Supplied Product Price

14

 

8.2

Price Changes

14

 

8.3

Currency

15

 

2

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

 

8.4

Financial Audits

15

 

 

 

 

9.

INVOICING AND PAYMENT

16

 

 

 

 

9.1

Invoicing

16

 

9.2

Payment

16

 

9.3

Failure to Timely Pay

16

 

9.4

Withholding Taxes

16

 

 

 

 

10.

WARRANTIES

17

 

 

 

 

10.1

Warranty by AstraZeneca

17

 

10.2

Warranty by Buyer

17

 

 

 

 

11.

SHORTAGE OR NON-CONFORMING PRODUCT

17

 

 

 

 

11.1

Shortage or Non-Conforming Product

17

 

11.2

Remedies for Shortage or Non-Conformance

17

 

11.3

Return or Destruction of Non-Confirming Products

17

 

11.4

Disagreement

18

 

11.5

Referral to Independent Expert

18

 

11.6

[***]

18

 

 

 

 

12.

REGULATORY MATTERS

18

 

 

 

 

12.1

Quality Agreement

18

 

12.2

Records

18

 

12.3

Regulatory Inspections

18

 

12.4

Quality Audits

19

 

12.5

Product Recall

20

 

12.6

Adverse Event Reporting

20

 

 

 

 

13.

CONFIDENTIALITY

20

 

 

 

 

13.1

Confidentiality

20

 

13.6

Press Releases; Public Announcements

22

 

13.7

Injunctive Relief

22

 

13.8

Return or Destruction of Confidential Information

22

 

13.9

Permitted Retention of Confidential Information

22

 

 

 

 

14.

INDEMNIFICATION

23

 

 

 

 

14.1

Indemnification of AstraZeneca

23

 

14.2

Indemnification of Buyer

23

 

3

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

 

14.3

Indemnification Claim Procedure

23

 

14.4

No Limitation on Direct Claims

23

 

 

 

 

15.

LIABILITY

23

 

 

 

 

15.1

Disclaimer

23

 

15.2

Limitation of Liability

24

 

15.3

Maximum Liability

24

 

15.4

Recovery of Damages

24

 

 

 

 

16.

INSURANCE

24

 

 

 

 

16.1

Insurance

24

 

 

 

 

17.

FORCE MAJEURE

25

 

 

 

 

17.1

Force Majeure

25

 

 

 

 

18.

TERM AND TERMINATION

25

 

 

 

 

18.1

Term

25

 

18.2

Termination by AstraZeneca

25

 

18.3

Termination by Buyer

25

 

18.4

Termination by Either Party

25

 

 

 

 

19.

EFFECT OF TERMINATION

27

 

 

 

 

19.1

Effect of Termination

27

 

19.2

Effect of Termination by AstraZeneca

27

 

19.3

Effect of Termination by Buyer

29

 

19.4

Effect of Mutual Termination

29

 

19.5

[***]

29

 

19.6

[***]

30

 

19.7

Manufacturing Technology Transfer

31

 

19.8

Technology Transfer Limitations

31

 

19.9

Survival

31

 

 

 

 

20.

INDEPENDENT CONTRACTORS

32

 

 

 

 

20.1

Independent Contractors

32

 

 

 

 

21.

NOTICES

32

 

 

 

 

21.1

Notice Requirements

32

 

21.2

Day-to-day Communications

33

 

4

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

22.

MISCELLANEOUS

33

 

 

 

 

22.1

Setoff Rights

33

 

22.2

Amendment and Waiver

33

 

22.3

Counterparts

34

 

22.4

Severability

34

 

22.5

Headings

34

 

22.6

Assignment

34

 

22.7

Intentionally Omitted

34

 

22.8

No Benefit to Third Parties

34

 

22.9

Entire Agreement

35

 

22.10

Governing Law, Jurisdiction and Venue

35

 

22.11

Delivery of Agreement

35

 

 

SCHEDULE 1

SUPPLY PRICE

I

 

 

 

SCHEDULE 2

DOCUMENTATION TO ACCOMPANY DELIVERIES

II

 

 

 

SCHEDULE 3

SPECIFICATION

III

 

 

 

SCHEDULE 4

MINIMUM ORDER QUANTITIES

IV

 

5

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

THIS SUPPLY AGREEMENT (this “Supply Agreement” or this “Agreement”) is dated
October 31, 2016 (the “Effective Date”)

 

BETWEEN:

 

(1)                                 ASTRAZENECA AB, a Swedish corporation and a
member of the AstraZeneca group of companies (“AstraZeneca”); and

 

(2)                                 ARALEZ PHARMACEUTICALS TRADING DAC, an Irish
designated activity company (“Buyer”);

 

(each a “Party”, collectively the “Parties”).

 

BACKGROUND:

 

(A)                               AstraZeneca, Buyer and Aralez Pharmaceuticals
Inc. (solely for purposes of Section 9.16 thereof) entered into that certain
Asset Purchase Agreement, dated as of October 3, 2016 (the “Purchase
Agreement”), pursuant to which Buyer agreed to purchase and AstraZeneca agreed
to sell certain assets and rights associated with the Product in the Territory
(each, as defined in the Purchase Agreement).

 

(B)                               In accordance with the terms and conditions of
the Purchase Agreement, AstraZeneca and Buyer have agreed to enter into an
agreement pursuant to which AstraZeneca will supply to Buyer, and Buyer will
purchase from AstraZeneca, Buyer’s entire requirements, subject to certain
limitations described herein, of Supplied Products for distribution and sale in
the Territory.

 

(C)                               For the avoidance of doubt, this Supply
Agreement is the Supply Agreement defined and referred to in the Purchase
Agreement.

 

(D)                               Pursuant to the terms and subject to the
conditions of the Purchase Agreement, AstraZeneca and Buyer have also agreed to
enter into a Quality Agreement, which shall include provisions with respect to
release testing, change control procedures with respect to the specifications
and the manufacturing processes for the Supplied Products, stability testing and
record retention requirements with respect to recalls.

 

NOW, THEREFORE, in consideration of the mutual benefits to be derived from this
Supply Agreement, the representations, warranties, conditions, agreements and
promises contained herein and other good and valuable consideration, the receipt
and sufficiency of which are hereby acknowledged, the Parties, intending to be
legally bound, hereby agree as follows:

 

1.                                      DEFINITIONS AND INTERPRETATION

 

1.1                               Unless otherwise defined in this Supply
Agreement, capitalized terms used in this Supply Agreement have the meanings
ascribed to them in the Purchase Agreement.

 

1.2                               In this Supply Agreement, the following words
and expressions shall have the following meanings:

 

“AG Finished Product” means the Authorized Generic Product packaged with primary
packaging, secondary packaging and patient information leaflet, or otherwise
packaged with items set forth in the Specification, in a commercially presented
outer carton Labeled for the purpose of sale to an end-user in the Territory;

 

“Apparent Defects” has the meaning given in Clause 11.1(a);

 

1

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

“Assignment” has the meaning given in Clause 22.6;

 

“AstraZeneca” has the meaning given in the introductory paragraph hereto;

 

“AstraZeneca Confidential Information” has the meaning given in Clause 13.3;

 

“AstraZeneca Indemnitee” has the meaning given in Clause 14.1;

 

“AstraZeneca Permitted Purpose” has the meaning given in Clause 13.2;

 

“Branded Product” means the Product packaged with primary packaging, secondary
packaging and patient information leaflet, or otherwise packaged with items set
forth in the Specification, in a commercially presented outer carton Labeled for
the purpose of sale to an end-user in the Territory;

 

“Breaching Party” has the meaning given in Clause 18.4(a);

 

“Buyer” has the meaning given in the introductory paragraph hereto;

 

“Buyer Confidential Information” has the meaning given in Clause 13.2;

 

“Buyer Indemnitees” has the meaning given in Clause 14.2;

 

“Buyer IP” means all Purchased Regulatory Approvals, Purchased Regulatory
Documentation, Purchased Product Records, trademarks, trade names, logos, trade
dress, copyrights and data, information, patents, other intellectual property
rights and know-how, in each case, Controlled by Buyer or its Affiliates as of
the Effective Date or at any time during or after the Supply Term;

 

“Buyer Permitted Purpose” has the meaning given in Clause 13.3;

 

“Buyer Requested Changes” has the meaning given in Clause 2.2(g);

 

“Certificate of Analysis” means the certificate of analysis to accompany each
Delivery of Supplied Product delivered to Buyer, which certifies that such
Supplied Product has been Manufactured and tested in compliance with its
Specification and which is in the form set out in the Quality Agreement;

 

“Commercially Reasonable Efforts” means, with respect to the Manufacture and
supply of Supplied Products provided hereunder, the carrying out of such
activities in a diligent manner using efforts and resources comparable to the
efforts and resources commonly used in the contract manufacturing industry for
pharmaceutical products;

 

“Confidential Information” has the meaning given in Clause 13.1;

 

“Confidentiality Period” has the meaning given in Clause 13.2;

 

“Controlled” means, with respect to any Purchased Regulatory Approval, Purchased
Regulatory Documentation, Purchased Product Record or intellectual property
right, possession of the right, whether directly or indirectly, and whether by
ownership, license or otherwise, to assign or grant a license, sublicense or
other right to or under such Purchased Regulatory Approvals Purchased Regulatory
Documentation, Purchased Product Record or intellectual property right, as
provided for herein, the Purchase Agreement or in any Ancillary Agreement
without violating the terms of any Contract or other arrangement with any Third
Party or without the need to secure any Third Party consent for use as permitted
herein.

 

2

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

“Credit Note” shall mean a credit memo issued by AstraZeneca to Buyer and usable
by Buyer as an offset against amounts payable to AstraZeneca by Buyer or, if no
such amounts are outstanding at the time of termination or expiration of this
Supply Agreement, for a refund from AstraZeneca to Buyer which AstraZeneca shall
pay to Buyer no later than [***] days after any such termination or expiration;

 

“Deliver” or “Delivery” has the meaning given in Clause 6.1;

 

“Delivery Location” means the location for delivery of a Supplied Product,
which, prior to a Packaging Transfer, shall be AstraZeneca’s facility located at
587 S. Old Baltimore Pike, Newark, DE 19702, United States of America and
following a Packaging Transfer shall be the selected Third Party packager’s
facility in the United States designated by AstraZeneca in writing;

 

“Disclosing Party” has the meaning given in Clause 13.1;

 

“Effective Date” has the meaning given in the introductory paragraph hereto;

 

“Excess Volume” has the meaning given in Clause 4.1(c);

 

“Excess Volume Month” has the meaning given in Clause 4.1(c);

 

“Facility” means the AstraZeneca facility where the bulk form of the Supplied
Product is Manufactured, which is currently at Gärtunavägen, SE-151 85,
Södertälje, Sweden;

 

“Firm Orders” has the meaning given in Clause 4.1(b);

 

“Force Majeure Event” means any event beyond a Party’s reasonable control that
is in the nature of fires, floods, earthquakes, hurricanes, embargoes, epidemics
or pandemics, quarantines, war, acts of war (whether war be declared or not),
terrorist acts, insurrections, riots, civil commotion, strikes or similar labor
disturbances (whether involving the workforce of the non-performing Party or of
any other Person), acts of God or acts, or omissions or delays in acting by any
Governmental Authority;

 

“Forecast” has the meaning given in Clause 4.1;

 

“Independent Expert” has the meaning given in Clause 11.4;

 

“Indirect Taxes” has the meaning given to such term in the Purchase Agreement;

 

“Initial Average Volume” has the meaning given in Clause 4.1(d);

 

“Initial Excess Volume” has the meaning given in Clause 4.1(d);

 

“Initial Term” has the meaning given in Clause 18.1;

 

[***];

 

“IT Media” has the meaning given in Clause 13.9;

 

“Labeling” means all labels, package inserts, carton imprints and all other
markings on packaging for the Supplied Products that are defined as labels or
labeling under any relevant Regulatory Approval (excluding, for the avoidance of
doubt, any transportation packaging);

 

[***];

 

3

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

“Manufacturing Know-How” means all data, information and know-how that (a) is
not generally known, (b) is Controlled by AstraZeneca or any of its Affiliates
as of the Effective Date or at any time thereafter and (c) is used by or on
behalf of AstraZeneca or its Affiliates for the Manufacture or supply of
Supplied Product as of the Effective Date or at any time thereafter;

 

“Manufacturing Process” has the meaning set forth in Clause 2.2(d);

 

“Minimum Order Quantity” or “Minimum Order Quantities” means the minimum order
quantity for each SKU as set forth in Schedule 4; [***].

 

“Non-Conforming Product” means any Supplied Product which, at the time of
delivery to the Delivery Location, does not conform with the requirements of
Clause 11.1;

 

“Notice Period” has the meaning given in Clause 18.4(a);

 

“Packaging Transfer” has the meaning given in Clause 3.1;

 

“Party” has the meaning given in the introductory paragraph hereto;

 

“Personnel” means the employees, officers, agents and contractors of a Party or
(where, the context requires) those of a Party’s Affiliates;

 

“PO Quarter” has the meaning given in Clause 5.1(b);

 

“Preference Period” has the meaning given in Clause 5.2(b);

 

“Price” means the price as applicable under Clause 8.1;

 

[***];

 

“Proportional Amount” has the meaning given in Clause 19.6;

 

“Purchase Agreement” has the meaning given in the Background section hereto;

 

“Purchase Order” has the meaning given in Clause 5.1;

 

“Quality Agreement” means the quality assurance agreement agreed between the
Parties in relation to the Supplied Products, as such agreement may be amended
or replaced by agreement between the Parties in writing from time to time;

 

“Receiving Party” has the meaning given in Clause 13.1;

 

“Remaining Term” has the meaning given in Clause 18.1;

 

“Required Change” has the meaning given in Clause 2.2(e);

 

“RoW Product” has the meaning given in Clause 19.4;

 

“SKU” means, with respect to the Branded Product or the AG Finished Product, a
stock keeping unit designated for such product;

 

“Shortage” means the quantity of any SKU of Supplied Product actually delivered
to Buyer that is less than the quantity for such SKU set out in the Purchase
Order unless the actual

 

4

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

quantity of such SKU delivered is only [***] (or a smaller percentage) less than
the amount of such SKU ordered in such Purchase Order;

 

“Six Month Average Volume” has the meaning given in Clause 4.1(c);

 

“SOTC Period” means the Service Period (as defined in the Transitional Services
Agreement) for the SOTC Services (as defined in the Transitional Services
Agreement) set forth in Schedule 2.1 to the Transitional Services Agreement;

 

“Specification” means, on a Supplied Product-by-Supplied Product basis, the
written specifications for the characteristics, quality and processing of such
Supplied Product as set forth on Schedule 3, as such specification may be
amended or replaced from time to time in accordance with the Quality Agreement
(or, prior to the effectiveness of the Quality Agreement, Clause 2.2(e));

 

“Start-Up Month” has the meaning given in Clause 4.1(d);

 

“Supplied Product” means the Branded Product and the AG Finished Product;

 

“Supply Agreement” has the meaning given in the introductory paragraph hereto;

 

“Supply Term” has the meaning given in Clause 18.1;

 

“Technology Recipient” has the meaning given in Clause 19.7;

 

“Technology Transfer” has the meaning given in Clause 19.7;

 

“Third Party” means any Person other than AstraZeneca, Buyer and their
respective Affiliates and permitted successors and assigns; and

 

“Third Party Claims” has the meaning given in Clause 14.1.

 

1.3                               In this Supply Agreement, except to the extent
expressly provided otherwise herein:

 

(a)                                 when a reference is made in this Supply
Agreement to a Clause or Schedule, such reference is to a Clause of or a
Schedule to this Supply Agreement respectively, and all Schedules to this Supply
Agreement form a part hereof for all purposes;

 

(b)                                 the contents page and headings are included
for convenience only and shall not affect the interpretation or construction of
this Supply Agreement;

 

(c)                                  any reference to a Party or the Parties is
to a Party or the Parties (as the case may be) to this Supply Agreement and
shall include any permitted assignees of a Party;

 

(d)                                 any use of the masculine, feminine or neuter
gender respectively includes the other genders and any reference to the singular
includes the plural (and vice versa);

 

(e)                                  the words including, includes or include,
whenever used in this Supply Agreement, are deemed to be followed by the words
“without limitation”; in particular means “in particular but without
limitation”, “such as” means “such as without limitation” and other general
words shall not be given a restrictive interpretation by reason of their being
preceded or followed by words indicating a particular class of acts, matters or
things;

 

(f)                                   any reference to “US Dollars” or “$” is to
the lawful currency from time to time of the United States of America;

 

5

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

(g)                                  references to a Law include any amendment
or modification to such Law and any rules or regulations issued thereunder, in
each case, as in effect at the relevant time of reference thereto;

 

(h)                                 the word “or” is used in the inclusive
sense, as in “and/or”;

 

(i)                                     the words “hereof,” “hereto,” “hereby,”
“herein” and “hereunder” and words of similar import when used in this Supply
Agreement refer to this Supply Agreement as a whole and not to any particular
provision of this Supply Agreement;

 

(j)                                    the word “extent” in the phrase “to the
extent” means the degree to which a subject or other thing extends, and such
phrase does not mean simply “if”;

 

(k)                                 all terms defined in this Supply Agreement
shall have the defined meanings when used in any certificate or other document
made or delivered pursuant hereto, unless otherwise defined in such certificate
or other document, and all definitions contained herein apply both to the
singular and plural forms of such terms;

 

(l)                                     any reference to writing shall include
any modes of reproducing words in a legible and non-transitory form (excluding
short-message-service (SMS), e-mail and other electronic communications, save
that e-mail may be used as a means of delivering written notice for the purposes
of Clause 21 (for example, where a PDF copy of a written notice is sent as an
attachment to an e-mail)) and as provided in Clause 21.2; and

 

(m)                             reference to any date or time is a reference to
such date or time in New York, New York.

 

2.                                      MANUFACTURE AND SUPPLY OF PRODUCT

 

2.1                               Requirements. Pursuant to the terms and
subject to the conditions of this Supply Agreement, during the Supply Term,
Buyer shall purchase, and AstraZeneca shall Manufacture and supply, all of
Buyer’s requirements of Supplied Products pursuant to this Supply Agreement, and
Buyer shall use the Supplied Product supplied hereunder solely for Exploitation
of the Product and the Authorized Generic Product in the Territory; provided,
however, that if (a) AstraZeneca shall fail to Manufacture and supply at least
[***], or (b) the Parties have agreed that neither Buyer nor any Affiliate,
transferee, licensee or assignee of Buyer is required to make any Royalty
Payments under the Purchase Agreement, then Buyer shall be permitted, without
limiting the obligations and rights of the Parties hereunder, to source supply
and Manufacture of the Supplied Products or any portion thereof from any Third
Party.  [***], neither AstraZeneca nor any Affiliate thereof will supply or
Manufacture any Supplied Product or any other product approved for the same
indication as the Supplied Product containing the API as an active
pharmaceutical ingredient to any Person (other than Buyer or its Affiliates) for
distribution, marketing, promotion, offering for sale, sale or commercialization
in the Territory.

 

2.2                               Specifications; Change Control .

 

(a)                                 AstraZeneca shall Manufacture the Supplied
Products in accordance with the Specifications.

 

(b)                                 AstraZeneca shall retain samples of each
batch of Supplied Products supplied to Buyer pursuant to this Supply Agreement
as described in the Quality Agreement and manage any stability programs required
by regulatory requirements including storage, testing and reporting, as
necessary.

 

6

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

(c)                                  AstraZeneca shall perform, or cause to be
performed, the tests required to be performed by AstraZeneca as set forth in the
applicable Specification and the Quality Agreement on each lot of Supplied
Product Manufactured pursuant to this Supply Agreement before Delivery thereof
to Buyer, and upon the reasonable request of Buyer, AstraZeneca shall make the
results of such tests available to Buyer, its agents, representatives or
applicable regulators.

 

(d)                                 The procedures governing changes to any
applicable Specification or the process or procedures used to Manufacture the
Supplied Product (the “Manufacturing Process”) shall be set forth in the Quality
Agreement; provided that such procedures shall not be inconsistent with this
Clause 2.2.  If, in accordance with the Quality Agreement or this Clause 2.2, a
change is made to any Specification or the Manufacturing Process, then prior to
AstraZeneca implementing any such change, Buyer shall (i) submit all
supplemental applications or reports to Governmental Authorities with respect to
the Supplied Products, if required, to reflect such change, (ii) use
commercially reasonable efforts to obtain all approvals required by Governmental
Authorities with respect to such change, provided, however, that such change
shall not be made until all such approvals have been obtained and (c) promptly
provide copies of the materials referenced in clauses (i) and (ii) to
AstraZeneca.  Any costs or expenses incurred by Buyer in connection with
complying with its obligations pursuant to the preceding sentence shall be paid
by Buyer unless the applicable change is effected at the request of AstraZeneca
or its Affiliates (and does not constitute a Required Change or Buyer Requested
Change), in which case all such costs and expenses shall be paid by AstraZeneca
(or, if paid by Buyer, promptly reimbursed to Buyer by AstraZeneca promptly
following receipt of a request therefor from Buyer).

 

(e)                                  If any change to any Specification or the
Manufacturing Process are required due to regulatory requirements in the
Territory or the country of Manufacture (each a “Required Change”), then
AstraZeneca will use Commercially Reasonable Efforts to implement such change as
promptly as practicable following receipt of notice of such Required Change and
in any event within any deadline for implementation required by applicable Law
or the relevant Governmental Authority.  With regard to any one-time
implementation costs associated with the Required Change (including costs of
obsolete materials that cannot otherwise reasonably be used by AstraZeneca, work
in process and Supplied Product that has been Manufactured but not yet
delivered), Buyer will bear such one-time implementation costs (or, if such
change affects other lines or products, a reasonable and proportionate share
thereof), unless such Required Change is due to events both inside and outside
the Territory, in which case the Parties will reasonably determine an equitable
apportionment of such one-time implementation costs, taking into account, among
other things, (i) anticipated volumes of Supplied Product to be Manufactured for
sale in the Territory compared to anticipated volumes of product to be
Manufactured for sale outside of the Territory and (ii) affected products other
than Supplied Product.  If either Party receives notice, or is otherwise
informed of, any Required Change, such Party will deliver notice thereof to the
other Party as promptly as practicable.  AstraZeneca shall provide to Buyer such
information as Buyer may reasonably request in respect of any one-time
implementation costs that Buyer is required to pay, in whole or in part,
pursuant to this Clause 2.2(e), including such information as Buyer may
reasonably request in respect of the allocation of such one-time implementation
as contemplated hereby.

 

(f)                                   AstraZeneca may amend, modify or
supplement the Manufacturing Process or any source of materials with respect to
Supplied Product upon [***] prior written notice to Buyer (or such shorter
period as may be practicable under the circumstances), provided that no such
change may take effect if it would cause Buyer to be in

 

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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

violation of applicable Law or require Buyer to cease the Exploitation of the
Product in the Territory, it being agreed that, if required in connection with
any such amendment, modification or supplement, Buyer shall comply with the
terms set forth in Clause 2.2(d) in connection therewith.  If AstraZeneca shall
deliver any such written notice in respect of any such amendment, modification
or supplement, then it shall thereafter provide to Buyer such additional
information with respect thereto as Buyer may reasonably request.  AstraZeneca
may also amend, modify or supplement any Specifications with respect to Supplied
Product with the prior written consent of Buyer, provided that Buyer shall not
unreasonably withhold, delay or condition such consent.  The costs of
implementing any such amendment, modification, supplement or changes will be
borne by AstraZeneca.

 

(g)                                  AstraZeneca will implement any changes to
any Specification or the Manufacturing Process reasonably requested by Buyer
(“Buyer Requested Changes”), provided that (i) such changes do not require
material capital expenditures by AstraZeneca to implement unless Buyer agrees to
bear the entire cost and expense of such material capital expenditures, (ii) any
costs and expenses (including costs of obsolete materials that cannot otherwise
reasonably be used by AstraZeneca, work in process and Supplied Product that has
been Manufactured but not yet delivered) associated with such changes requested
by Buyer are paid by Buyer (other than the costs associated with initially
changing over to Buyer’s label for the Branded Product, which shall be borne by
AstraZeneca), and (iii) such changes do not impact the Manufacture, distribution
or sale of the Supplied Product outside of the Territory unless, in the case of
(iii), such changes are necessary to enable Buyer to continue to sell the
Supplied Product in the Territory.

 

2.3                               Compliance with Applicable Laws. In performing
their respective obligations under this Supply Agreement and the Quality
Agreement, each Party shall comply in all material respects with applicable
Laws.

 

2.4                               TAA Compliant.  At all times during the
Initial Term, AstraZeneca shall ensure that the Facility and the Manufacture and
supply of the Supplied Product pursuant to the terms hereof remains compliant
with the Trade Agreements Act (19 U.S.C. & 2501-2581) or any successor act or
Law.

 

2.5                               [***].

 

3.                                      PACKAGING TRANSFER; LICENSE GRANT

 

3.1                               [***].

 

3.2                               Intellectual Property.

 

(a)                                 AstraZeneca will retain all right, title and
interest in and to any intellectual property used in connection with the
Manufacture of the Supplied Product, other than the Buyer IP, which will be
retained by Buyer or its Affiliates.

 

(b)                                 Buyer, on behalf of itself and its
Affiliates, hereby grants to AstraZeneca and its Affiliates a worldwide,
irrevocable, non-exclusive, royalty-free, fully paid-up, non-transferable (other
than to a Third Party packager in connection with a Packaging Transfer under
Clause 3.1 or a Third Party manufacturer in connection with a Technology
Transfer under Clause 19.7) license and a right of reference and use under the
Buyer IP that is necessary for the performance of AstraZeneca’s obligations
hereunder, with the right to grant further licenses and sublicenses or rights of

 

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CONFIDENTIAL TREATMENT REQUEST.

 

reference and use, in each case solely to the extent necessary for AstraZeneca
and its Affiliates to perform their obligations hereunder.

 

(c)                                  AstraZeneca, on behalf of itself and its
Affiliates, hereby grants to Buyer and its Affiliates a worldwide, irrevocable,
non-exclusive, royalty-free, fully paid-up, non-transferable license and right
of use to the Manufacturing Know-How, with the right to grant further licenses
and sublicenses or rights of use, to the extent necessary for Buyer and its
Affiliates to supply and Manufacture, or have supplied and Manufactured on their
behalf, the Product and the Authorized Generic Product solely for Exploitation
in the Territory.  The license granted under this Clause 3.2(c) may only be
exercised by Buyer (a) to effect a Technology Transfer or (b) following notice
of the termination of this Supply Agreement.

 

4.                                      FORECASTS

 

4.1                               Monthly Forecast.

 

(a)                                 Beginning on December 7, 2016, Buyer shall
provide AstraZeneca, on or before the fifth Business Day of each calendar month
during the Supply Term, with a written rolling, non-binding (except as set forth
in Clause 4.1(b)) forecast of its anticipated requirements, in whole multiples
of the Minimum Order Quantities, for Supplied Product in the Territory broken
out on a month-by-month basis by SKU and indicating for each calendar month
whether the anticipated requirements are for Branded Product or AG Finished
Product, for the subsequent [***] period (each, a “Forecast”).

 

(b)                                 The forecasted quantities of Supplied
Product for the calendar month in which the SOTC Period ends or any calendar
month prior to such calendar month in which the SOTC Period ends shall be
non-binding.  Subject to the preceding sentence, forecasted quantities for the
first [***] of each Forecast shall be binding on Buyer.  The forecasted
quantities of Supplied Product that are binding on Buyer pursuant to this Clause
4.1(b) are referred to as “Firm Orders” and may not be changed without
AstraZeneca’s written consent (which may be withheld in its sole discretion),
but without limitation of the terms and obligations set forth in Clause 5.1(a).

 

(c)                                  [***].

 

(d)                                 [***].

 

(e)                                  Buyer shall reasonably cooperate with and
inform AstraZeneca as far in advance as reasonably practicable of any
significant expected or known changes to Forecasts (including with respect to
forecasted quantities of Supplied Product and allocation of such Supplied
Product between SKUs).

 

5.                                      PURCHASE ORDERS

 

5.1                               Purchase Orders.

 

(a)                                 Buyer shall deliver to AstraZeneca a written
purchase order (“Purchase Order”) in respect of each Firm Order for which Buyer
has not previously submitted a Purchase Order in accordance with this Clause
5.1.  Each Purchase Order shall be binding on Buyer and shall specify the
Supplied Products ordered on an SKU-by-SKU basis and indicating whether the
Supplied Product ordered is Branded Product or AG Finished Product, the
quantities of SKU of Supplied Product ordered, and the requested calendar month
of Delivery.  The quantity of an SKU specified in any Purchase Order

 

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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

submitted by Buyer to AstraZeneca for Delivery in the applicable calendar month
shall be, in the case of any SKU of AG Finished Product, no more than [***] and
no less than [***] of, and in the case any SKU of the Branded Product, equal to,
the quantity of such SKU forecasted by Buyer in the Firm Order for such calendar
month and shall be the applicable Minimum Order Quantity for such SKU, or whole
multiples thereof.  [***].  AstraZeneca shall use its Commercially Reasonable
Efforts to supply the quantities of each such SKU specified in Buyer’s proposed
reallocation notice, but shall not have any liability for its failure to do so
(without limitation of its obligations to supply and Manufacture Supplied
Product as set forth in this Agreement without giving effect to such proposed
reallocation).  All Purchase Orders for Supplied Product submitted by Buyer to
Supplier shall reference this Supply Agreement and shall be governed exclusively
by the terms contained herein and the Quality Agreement.

 

(b)                                 On or prior to the fifth Business Day of
each Calendar Quarter of the Supply Term (each such Calendar Quarter, a “PO
Quarter”), commencing with the Calendar Quarter in which the SOTC Period will
terminate (or, if the SOTC Period will terminate on a day that is not the last
day of a Calendar Quarter, on or prior to the fifth Business Day of the Calendar
Quarter prior to the Calendar Quarter in which the SOTC Period terminates),
Buyer shall deliver to AstraZeneca a Purchase Order that complies with this
Clause 5.1 specifying the quantities of Supplied Product to be delivered in each
calendar month in the Calendar Quarter immediately following the PO Quarter (or,
if the SOTC Period will terminate on a day that is not the last day of a
Calendar Quarter, the quantities of Supplied Product to be delivered in each
calendar month in the Calendar Quarter in which the SOTC Period terminates that
follows the termination of the SOTC Period).

 

(c)                                  In the event that the quantity of any SKU
of Supplied Product Delivered by AstraZeneca differs from the quantity for such
SKU ordered in the applicable Purchase Order, Buyer shall pay AstraZeneca for
the quantity of such SKU of Supplied Product Delivered, rather than the quantity
ordered, to the extent that the quantity of such SKU Delivered is not more than
[***] of the quantity of such SKU required in the Purchase Order, but if such
quantify is less than the quantity required by the applicable Purchase Order,
subject to Clause 6.2, such payment shall not affect the rights or obligations
of the Parties hereunder in respect thereof.

 

5.2                               AstraZeneca’s Fulfillment of Purchase Orders.

 

(a)                                 For a given Purchase Order, AstraZeneca
shall promptly (and, in any event, within three Business Days) notify Buyer in
writing if it becomes aware or believes that it will not be able to satisfy a
particular Purchase Order on time, in full or at all, which notice shall include
an explanation in reasonable detail of the reason for AstraZeneca’s failure to
comply with a particular Purchase Order and its proposed course of action for
remedying such failure. In such case the Parties shall meet to discuss in good
faith the potential interruption of supply to resolve such issues and
appropriate steps to maintain continuity of supply.  If AstraZeneca fails to
supply the quantities required pursuant to a given Purchase Order, subject to
Clause 11, [***], AstraZeneca shall replace the shortfall as soon as reasonably
possible, and the Parties shall cooperate in good faith to agree upon an
appropriate number of replacement batches of Supplied Products.

 

(b)                                 [***].

 

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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

5.3                               Minimum Order Quantities. All quantities of
Supplied Product ordered by Buyer pursuant to Purchase Orders submitted
hereunder shall be in the applicable Minimum Order Quantities set forth on
Schedule 4, or whole multiples thereof.

 

5.4                               Terms and Conditions. Each Purchase Order
shall be the subject of a separate contract of sale between AstraZeneca and
Buyer. All Purchase Orders shall be on the terms and conditions set out in this
Supply Agreement and in the Quality Agreement. All other terms and conditions
(including any terms and conditions which Buyer or AstraZeneca purports to apply
under any purchase order, specification or other document attached to any
Purchase Order) are hereby excluded.

 

5.5                               Accuracy. Buyer shall be responsible for
ensuring that its Forecasts and Purchase Orders comply with the requirements of
this Supply Agreement.

 

6.                                      DELIVERY

 

6.1                               Delivery. AstraZeneca shall deliver to Buyer
the Supplied Products ordered pursuant to a given Purchase Order at the Delivery
Location FCA (Incoterms® 2010) (a “Delivery” or, as a verb, “Deliver”).

 

6.2                               Delivery Date. Subject to the last two
sentences of this Clause 6.2, AstraZeneca will Deliver all Supplied Product
ordered by Buyer for a calendar month by the last Business Day of such calendar
month, and may make multiple Deliveries during a calendar month that in total,
supply all of the Supplied Product ordered by Buyer for such calendar month;
provided, that (a) without limiting the terms of the last sentence of this
Clause 6.2, unless otherwise requested by Buyer, AstraZeneca shall use its
Commercially Reasonable Efforts to minimize the number of Deliveries each
calendar month, and (b) if the quantity of Supplied Product for any SKU
delivered by AstraZeneca for such calendar month is less than or equal to [***]
and greater than or equal to [***] of the quantity of Supplied Product for such
SKU set forth in the applicable Purchase Order, then AstraZeneca shall be deemed
to have delivered the quantity of Supplied Product for such SKU in accordance
with such Purchase Order.  Subject to the terms of this Agreement, Buyer shall
arrange for its nominated carrier to be at the Delivery Location (ready for the
Product to be loaded on to the Buyer’s carrier) within five Business Days after
AstraZeneca gives Buyer written notice that the Supplied Product is ready for
loading.  If for any reason Buyer fails to arrange for its carrier to arrive at
the Delivery Location for pickup within this timeframe, then AstraZeneca may at
its option either: (a) acting as agent for Buyer and at the Buyer’s expense,
arrange for a delivery company to collect the Supplied Product from the Delivery
Location for Delivery to any premises of Buyer designated by Buyer; or (b) store
the Supplied Product until Buyer collects them and Buyer shall be liable for all
related reasonable costs and expenses incurred by AstraZeneca in connection
therewith (including, reasonable storage and insurance costs and expenses
incurred in respect thereof).  All Deliveries of Supplied Product hereunder
shall be in substantially full truck load quantities, except as otherwise
requested by Buyer.  Notwithstanding anything in this Supply Agreement to the
contrary, AstraZeneca shall not be deemed in breach of its obligation to Deliver
any Supplied Product in the calendar month specified for Delivery in the
applicable Purchase Order if the sole reason for the failure to make such
Delivery is that AstraZeneca holds such Supplied Product after such calendar
month in order for the Delivery to be a substantially full truck load quantity,
provided that if AstraZeneca intends to delay Delivery because there is not a
substantially full truck load quantity of Supplied Product, prior to delaying,
AstraZeneca shall provide prior notice (which may be oral) thereof to Buyer to
afford Buyer the opportunity to waive the terms set forth in the immediately
preceding sentence if Buyer determines to provide such waiver or otherwise
elects to have less than a substantially full truck load of Supplied Product
delivered hereunder, AstraZeneca shall be required to make Deliveries in
accordance with the terms hereof and taking into account such waiver or
election, as applicable.

 

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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

6.3                               Documentation. All Deliveries must be
accompanied by the documentation required to comply with applicable Law or as
otherwise specified in Schedule 2.

 

6.4                               Packaging. AstraZeneca shall package and label
the Supplied Products in accordance with this Agreement and its customary
practices, including its customary primary packaging and an appropriate shipping
container, or such other containers or packaging as the Parties may agree from
time to time, and prior to shipment, AstraZeneca shall perform release testing
for the Supplied Product pursuant to and in accordance with applicable Law, the
applicable Specifications, cGMP and the Quality Agreement.

 

7.                                      RISK AND TITLE

 

7.1                               Risk and Title. Title and risk of loss or
damage to Supplied Products shall pass to Buyer upon Delivery of the Supplied
Products to Buyer in accordance with the terms of this Agreement.

 

8.                                      PRICE

 

8.1                               Supplied Product Price.  The Price payable by
Buyer to AstraZeneca or its Affiliates, as of the Effective Date, for Supplied
Product Delivered hereunder shall be as set forth on Schedule 1, and is subject
to adjustment in accordance with this Clause 8.

 

8.2                               Price Changes.

 

(a)                                 [***].

 

(b)                                 [***].

 

(c)                                  [***].

 

(d)                                 Buyer and Seller agree that any increase or
decrease in the Price for an SKU arising from this Clause 8 shall be reflected
in the Prices for the SKUs in any unfilled Purchase Orders (or portion thereof)
at the time of such increase or decrease, and for any Purchase Orders submitted
thereafter.

 

(e)                                  AstraZeneca shall use Commercially
Reasonable Efforts to provide as much advance notice as possible to Buyer in
respect of any proposed Price increase (or decrease) as contemplated hereby. 
[***].

 

8.3                               Currency. All amounts to be paid by Buyer
under this Supply Agreement shall be payable in US Dollars.

 

8.4                               Financial Audits.

 

(a)                                 Each Party shall keep and maintain complete
and accurate records and books of account necessary for the calculation of the
amounts payable under this Agreement and, with respect to AstraZeneca,
Manufacturing Costs, consistent with its standard procedures and policies in the
ordinary course of business and shall maintain such records and books for a
period of [***] Calendar Years after the Calendar Year to which such records and
books relate, unless a longer retention period is required by Law.

 

(b)                                 Upon either Party’s request, the other Party
shall permit an independent certified public accountant selected by the
requesting Party to inspect and audit the records and books maintained by it
pursuant to this Clause 8.4 in order to confirm the accuracy and completeness of
such records and books of account and all payments hereunder;

 

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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

provided, that neither Party shall be entitled to exercise its inspection and
audit rights under this Clause 8.4 more than once per Calendar Year, unless, in
any case, any prior audit resulted in an adjustment to amounts due hereunder. 
The selected independent certified public accountant only shall provide to the
Party that requested the audit its summary findings of such audit and not any
specific information obtained in the course of such audit (and the engagement
letter for such independent certified public accountant shall expressly provide
for the same).  The Party requesting the audit shall bear all out-of-pocket
costs and expenses incurred in connection with any inspection or audit performed
pursuant to this Clause 8.4; provided, however, that the audited Party shall
reimburse the Party requesting the audit for all reasonable costs and expenses
incurred by such Party in connection with such inspection or audit if any such
audit identifies an underpayment to the auditing Party or an overpayment to the
audited Party hereunder in excess of [***] of the amount subject to the audit. 
In any case, the full amount of any underpayment or overpayment as applicable
shall be payable to the applicable Party [***].  All information disclosed
pursuant to this Clause 8.4 shall be subject to the non-disclosure and non-use
provisions set forth in Clause 13.

 

9.                                      INVOICING AND PAYMENT

 

9.1                               Invoicing. All orders under this Supply
Agreement shall be invoiced following Delivery of the Supplied Product. Any
other costs, expenses or other sums which may be chargeable by AstraZeneca under
this Supply Agreement shall be invoiced by AstraZeneca in arrears, on a monthly
or a less frequent basis as AstraZeneca may (in its sole discretion) decide.  If
requested by Buyer, AstraZeneca will provide Buyer with a reasonable level of
supporting documentation for the amounts subject to any invoice. 
Notwithstanding the foregoing, Buyer agrees that invoices may be issued by
AstraZeneca or any of its U.S. Affiliates so long as the identity of the
invoicing party does not increase the amount of such invoice, including any
Indirect Taxes payable thereon, relative to the amount of such invoice if
AstraZeneca is the invoicing party.

 

9.2                               Payment. Buyer shall pay each undisputed
invoice submitted in accordance this Supply Agreement within [***] days after
Buyer’s receipt of the invoice. All payments due to AstraZeneca under this
Supply Agreement are exclusive of any Indirect Taxes which may be chargeable,
which Buyer shall pay in addition at the rate and in the manner for the time
being prescribed by applicable Law, but the Parties shall work reasonably
together in an effort to minimize or eliminate, if permitted by applicable Law,
any such Indirect Taxes.

 

9.3                               Failure to Timely Pay. If Buyer fails to pay
any undisputed amount payable under this Supply Agreement within [***] days
after the due date for payment, then without prejudice to any other rights or
remedies that AstraZeneca may have:

 

(a)                                 [***]; and

 

(b)                                 without prejudice to Clause 9.3(a) and
subject to giving Buyer 10 Business Days prior written notice of its intention
to do so, AstraZeneca shall be entitled to suspend any of its obligations under
this Supply Agreement until such time as any unpaid and undisputed amounts have
been paid in full.

 

9.4                               Withholding Taxes.  Section 5.9.1 (Withholding
Taxes) of the Purchase Agreement shall apply to payments made under this Supply
Agreement as if set forth herein mutatis mutandis.

 

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WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

10.                               WARRANTIES

 

10.1                        Warranty by AstraZeneca.  AstraZeneca hereby
warrants to Buyer that, at the time of Delivery and subject to the accuracy of
Buyer’s warranty in Clause 10.2, the Supplied Product (a) shall conform to the
applicable Specification at the time of release and shall be in accordance with
the Quality Agreement, (b) shall have been Manufactured in compliance with cGMP
and other requirements of applicable Laws in the Territory and in the country of
Manufacture, (c) shall have a minimum remaining shelf life of [***], (d) shall
be free and clear of Encumbrances and (e) shall not be adulterated or
misbranded. This warranty is exclusive and is in lieu of all other warranties,
whether written or oral express, implied or statutory. EXCEPT WITH RESPECT TO
THE FOREGOING WARRANTY, THERE IS NO WARRANTY OF MERCHANTABILITY, SATISFACTORY
QUALITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR OTHERWISE GIVEN BY ASTRAZENECA
WITH RESPECT TO SUPPLIED PRODUCTS.

 

10.2                        Warranty by Buyer. Buyer hereby warrants to
AstraZeneca that any change to the Specifications, Labeling or Manufacturing
Process for any Supplied Product made or requested by Buyer will comply with all
applicable Laws and the Regulatory Approval for such Supplied Product.

 

11.                               SHORTAGE OR NON-CONFORMING PRODUCT

 

11.1                        Shortage or Non-Conforming Product. Buyer shall
promptly notify AstraZeneca of any Shortage or Non-Conforming Product in any
Delivery of Supplied Products, and shall provide AstraZeneca with a reasonably
detailed written report of the alleged Shortage or Non-Conformance, not later
than:

 

(a)                                 [***] days after the Delivery of the
applicable Supplied Product for any Shortage or any Non-Conformance that, in
each case, would reasonably be likely to be discovered through a reasonable
visual inspection of such Supplied Product by Buyer (“Apparent Defects”); or

 

(b)                                 [***] days after the Shortage or
Non-Conformance has become apparent, but in any event no later than the actual
date of expiry of the shelf-life of the Supplied Product in question, for any
Shortage or Non-Conformance which is not an Apparent Defect.

 

11.2                        Remedies for Shortage or Non-Conformance. Provided
Buyer has duly notified AstraZeneca of a Shortage or a Non-Conforming Product in
accordance with Clause 11.1, AstraZeneca shall at Buyer’s option either and
without limitation of any other rights or remedies of Buyer under this Supply
Agreement arising as a result thereof (with such other rights or remedies being
subject to the terms set forth in Clause 15 hereof):

 

(a)                                 in the case of any Shortage, make up the
Shortage as soon as reasonably practicable, at AstraZeneca’s cost and expense
(including shipping costs); and

 

(b)                                 in the case of any Non-Conforming Product,
(i) replace the Non-Conforming Product as soon as reasonably practicable given
the nature of the non-conformance, at AstraZeneca’s cost and expense (including
shipping costs) or (ii) only in the case of AG Finished Product, provide Buyer
with a Credit Note equal to the quantity of such Non-Conforming Product
multiplied by the Price applicable to such Non-Conforming Product at the time of
purchase.

 

11.3                        Return or Destruction of Non-Conforming Products. 
Buyer shall, at AstraZeneca’s option and expense (including shipping costs),
return to AstraZeneca or destroy in an environmentally acceptable manner, in
accordance with applicable Law (and certify

 

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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

destruction of) any Non-Conforming Product and provide evidence of such
destruction to AstraZeneca for purposes of reimbursement, which reimbursement
shall be made within [***] days after the provision of such evidence.

 

11.4                        Disagreement. If a dispute arises between the
Parties as to whether or not a Supplied Product is a Non-Conforming Product
which cannot be resolved by the Parties within [***] days of a claim being
notified by Buyer to AstraZeneca, either Party may require that the matter in
dispute be referred to an independent testing laboratory or other appropriate
independent expert mutually agreed upon by the Parties or, failing agreement,
appointed by the ICC International Centre for Expertise at the request of either
Party (the “Independent Expert”).

 

11.5                        Referral to Independent Expert. The referral of any
matter to the Independent Expert pursuant to Clause 11.4 shall be solely for the
purpose of establishing whether or not there has been a supply of Non-Conforming
Product. Except in the case of fraud or manifest error on the part of the
Independent Expert, the decision of the Independent Expert will be final and
binding upon the Parties. If the Independent Expert decides that the relevant
Supplied Product is a Non-Conforming Product, the costs of the Independent
Expert will be borne by AstraZeneca. If the Independent Expert decides that the
relevant Supplied Product is not a Non-Conforming Product, the costs of the
Independent Expert will be borne by Buyer.

 

11.6                        [***].

 

12.                               REGULATORY MATTERS

 

12.1                        Quality Agreement. The Parties shall enter into a
Quality Agreement within [***] days following the date hereof.  In the event of
a discrepancy between the Quality Agreement and this Supply Agreement, the terms
of the Quality Agreement shall govern solely in relation to quality-related
matters, and this Supply Agreement shall govern all other matters.

 

12.2                        Records. AstraZeneca shall, and shall cause its
Affiliates and any subcontractors to, keep appropriate records of the work
performed under this Supply Agreement, including records pertaining to the
methods and facilities used by it for the Manufacture, storage, and testing of
Supplied Products. AstraZeneca shall maintain all records and reports with
respect to the Manufacture and supply of Supplied Products (and in relation to
the provision of any other services) under this Supply Agreement as required by
applicable Laws or by the terms of any Regulatory Approval.

 

12.3                        Regulatory Inspections. If, during or, to the extent
related to the Supplied Product, at any time following the Supply Term, any
Regulatory Authority contacts a Party or its Affiliates in connection with any
regulatory purpose (including, but not limited to, inspections, inquiries and
notices) with respect to (a) the Supplied Products or (b) the Facility or other
location at which any portion of the Manufacturing activities hereunder are
undertaken (but in the case of this clause (b), only to the extent such contact
is with respect to the supply or Manufacture of the Supplied Products or
otherwise could reasonably be expected to have a material impact on or otherwise
materially affect the Supplied Product or the ability of AstraZeneca to
Manufacture or supply the same pursuant to the terms hereof), then (to the
extent permitted by applicable Laws) that Party shall promptly (and, in any
event, within three Business Days) notify the other Party thereof, which
notification shall contain a reasonable description of the nature of such
contact, including as to the substance thereof.  Thereafter, to the extent
permitted by applicable Law, the Parties shall keep each other reasonably
informed in respect of any communications with, documentation provided to, or
interactions with, any such Regulatory Authority and shall provide to the other
Party such additional information with respect thereto as such other Party may
reasonably request.  Without limitation of the foregoing, to the extent any
communications, documentation or interaction relates to (i) the Supplied
Products or (ii) the Facility or other location at which any portion of the

 

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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

Manufacturing activities hereunder are undertaken (but in the case of this
clause (ii), only to the extent the foregoing is with respect to the supply or
Manufacture of the Supplied Products or otherwise could reasonably be expected
to have a material impact on or otherwise materially affect the Supplied Product
or the ability of AstraZeneca to Manufacture or supply the same pursuant to the
terms hereof), the Party not receiving or making, providing or participating in
such communications, documentation or interaction shall have the right to review
and provide to the Party making, providing or participating in such
communications, documentation or interaction comments to such communications,
documentation or interactions, to the extent permitted by applicable Law, and
the Parties shall cooperate in good faith with respect thereto, including by
considering any such comments in good faith.  The Party contacted by the
Regulatory Authority shall, subject to the terms hereof, be solely responsible
for coordinating with the Regulatory Authority with respect to any such visit or
inspection, including in developing any response to observations made by the
Regulatory Authority, provided that if the Party contacted by the Regulatory
Authority shall be the Buyer and the nature of the contact relates to the
Manufacturing and supply of the Supplied Product hereunder, then AstraZeneca
shall provide such reasonable assistance as the Buyer may require in connection
therewith, without limitation of the other terms of this Agreement, including
Clause 12.4.

 

12.4                        Quality Audits. During the Supply Term, upon Buyer’s
reasonable request (but no more than once in any Calendar Year except such
limitation shall not apply for “cause” based audits under the Quality
Agreement), AstraZeneca shall allow Buyer or its authorized representatives or
any Regulatory Authority with jurisdiction in the Territory (or that otherwise
regulates Buyer with respect to the Supplied Product and makes an inspection
request) to audit the records and inspect the premises of AstraZeneca and its
Affiliates in which the Supplied Products are Manufactured, stored, or tested,
as applicable during normal business hours and at a date and time mutually
agreed by the Parties for the purposes of verifying AstraZeneca’s compliance
with: (i) the Specifications; (ii) applicable Laws (including verifying that
Manufacture of each Supplied Product complies with applicable Laws); (iii) this
Agreement; and (iv) the requirements of any Regulatory Approvals in connection
with this Supply Agreement; subject in each case to any reasonable conditions
stipulated by AstraZeneca. Any such audit or inspection shall be at Buyer’s
expense, except to the extent that such an audit or inspection reveals that
AstraZeneca has materially failed to comply with such requirements or this
Agreement, in which case AstraZeneca will not charge Buyer any expenses and will
reimburse Buyer for its reasonable out-of-pocket expenses incurred in performing
such audit or inspection, including no charge for and reimbursement of
reasonable out-of-pocket expenses regarding a follow-up audit relating to the
same material failure. AstraZeneca shall promptly resolve using Commercially
Reasonable Efforts any quality issues raised by any inspections of its own
facilities and those of its Affiliates and its permitted subcontractors as
provided in the Quality Agreement, and to the extent AstraZeneca or its
Affiliates identifies any such quality issues, AstraZeneca shall, and shall
cause its Affiliates to, provide notice thereof to Buyer.  Buyer shall use
commercially reasonable efforts to limit the duration and number of individuals
that participate in any such audit or inspection pursuant to this Clause 12.4,
provided that in no event shall such audit or inspection be longer than two days
in duration or conducted by more than two individuals representing Buyer. 
Unless otherwise agreed by the Parties, each Party shall, at its sole cost and
expense, maintain in full force and effect all necessary licenses, approvals,
permits and other authorizations required by applicable Law to carry out its
duties and obligations under this Supply Agreement and the Quality Agreement. 
For clarity, neither Buyer nor its representatives shall have a right to access
any Manufacturing Know-How that constitutes trade secrets relating to the
Manufacturing process of the Supplied Product during an audit or inspection
conducted pursuant to this Clause 12.4 unless Buyer is required by applicable
Law to make available or cause to be made available such information to the
applicable Regulatory Authority, in which case, AstraZeneca shall make such
information available directly to the applicable Regulatory Authority.

 

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WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

12.5                        Product Recall.  The procedures governing recall or
market withdrawal of Supplied Product supplied to Buyer hereunder shall be set
forth in the Quality Agreement.  Subject to the Purchase Agreement, the
Transitional Services Agreement and the Quality Agreement, Buyer will be
responsible for all costs of each recall or market withdrawal of the Supplied
Product in the Territory that is sold by or on behalf of Buyer following the
Closing Date, including reasonable documented costs incurred by or on behalf of
AstraZeneca and its Affiliates, except to the extent that such recall or market
withdrawal results from a breach of this Supply Agreement or the Quality
Agreement by, or negligence on the part of, AstraZeneca or any of its Affiliates
or permitted sub-contractors or any of their respective Personnel in connection
with the performance of AstraZeneca’s obligations hereunder, in which event
AstraZeneca will, [***], be responsible for: (a) the reasonable documented costs
and expenses incurred by Buyer and its Affiliates in respect of such recall or
market withdrawal; (b) replacing, at AstraZeneca’s expense, the Supplied Product
which has to be recalled and (c) the shipping and distribution costs and
expenses of such replacement Supplied Product.

 

12.6                        Adverse Event Reporting. The reporting of adverse
events in relation to any Supplied Product supplied to Buyer under this Supply
Agreement will be governed by the pharmacovigilance agreement to be entered by
the parties pursuant to Section 5.7 of the Purchase Agreement.

 

13.                               CONFIDENTIALITY

 

13.1                        Confidentiality.  From and after the Effective Date,
all Confidential Information provided by one Party (or its Representatives or
Affiliates) (collectively, the “Disclosing Party”) to the other Party (or its
Representatives or Affiliates) (collectively, the “Receiving Party”) shall be
subject to and treated in accordance with the terms of this Clause 13.  As used
in this Clause 13, “Confidential Information” means (a) all information
disclosed to the Receiving Party by the Disclosing Party in connection with this
Supply Agreement, the Manufacturing Know-How (which shall be deemed to be
AstraZeneca Confidential Information) or any Technology Transfer and (b) all
memoranda, notes, analyses, compilations, studies and other materials prepared
by or for the Receiving Party to the extent containing or reflecting the
information in the preceding clause (a).  Notwithstanding the foregoing,
Confidential Information shall not include information that, in each case:

 

(i)                                     was already known to the Receiving Party
other than under an obligation of confidentiality (other than Confidential
Information known to AstraZeneca or its Representatives or Affiliates due to the
prior ownership of the Product and the other assets acquired by the Buyer
pursuant to the Purchase Agreement), at the time of disclosure by the Disclosing
Party;

 

(ii)                                  was generally available to the public or
otherwise part of the public domain at the time of its disclosure to the
Receiving Party;

 

(iii)                               became generally available to the public or
otherwise part of the public domain after its disclosure to the Receiving Party
other than through any act or omission of the Receiving Party in breach of this
Supply Agreement;

 

(iv)                              is subsequently disclosed to the Receiving
Party by a Third Party without obligations of confidentiality with respect
thereto; or

 

(v)                                 is subsequently independently discovered or
developed by the Receiving Party without the aid, application or use of
Confidential Information.

 

13.2                        During the Supply Term and the until the fifth
anniversary of the date on which this Supply Agreement terminates (the
“Confidentiality Period”), all Confidential Information obtained by AstraZeneca
(or its Affiliates or Representatives) from Buyer (or its Affiliates or

 

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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

Representatives) (the “Buyer Confidential Information”) shall be used solely by
AstraZeneca or its Affiliates or Representatives solely as required to
(a) perform its obligations or exercise or enforce their respective rights and
remedies under this Supply Agreement, the Purchase Agreement or any other
Ancillary Agreement or (b) comply with applicable Law or its or its Affiliates’
respective regulatory, stock exchange, Tax or financing reporting requirements
(each of (a) and (b), a “AstraZeneca Permitted Purpose”), and for no other
purpose.  During the Confidentiality Period, AstraZeneca shall (i) not disclose,
or permit the disclosure of, any of the Buyer Confidential Information to any
Person except those Persons to whom such disclosure is necessary in connection
with any AstraZeneca Permitted Purpose and who are advised of the confidential
nature of the Confidential Information and directed to comply with the
confidentiality and non-use obligations under this Clause 13; and (ii) treat,
and will cause its Affiliates and their respective Representatives to treat, the
Buyer Confidential Information as confidential, using the same degree of care as
AstraZeneca normally employs to safeguard its own confidential information from
unauthorized use or disclosure, but in no event less than a reasonable degree of
care.  AstraZeneca shall be responsible for any use or disclosure of Buyer
Confidential Information by any of AstraZeneca’s Affiliates or Representatives
that would breach this Clause 13 if such Affiliate or Representative was a party
hereto.

 

13.3                        During the Confidentiality Period, all Confidential
Information obtained by Buyer (or its Affiliates or Representatives) from
AstraZeneca (or its Affiliates or Representatives) (the “AstraZeneca
Confidential Information”) shall be used by Buyer solely as required to
(a) perform its obligations or exercise or enforce its rights and remedies under
this Supply Agreement, the Purchase Agreement or any other Ancillary Agreement
or (b) comply with applicable Law or its or its Affiliates’ respective
regulatory, stock exchange, Tax or financing reporting requirements (each of
(a) and (b), a “Buyer Permitted Purpose”), and for no other purpose.  During the
Confidentiality Period, Buyer shall (i) not disclose, or permit the disclosure
of, any of AstraZeneca Confidential Information to any Person except those
Persons to whom such disclosure is necessary in connection with a Buyer
Permitted Purpose and who are advised of the confidential nature of the
Confidential Information and directed to comply with the confidentiality and
non-use obligations under this Clause 13; and (ii) treat, and will cause its
Affiliates and the Representatives of Buyer or any of its Affiliates to treat,
AstraZeneca Confidential Information as confidential, using the same degree of
care as Buyer normally employs to safeguard its own confidential information
from unauthorized use or disclosure, but in no event less than a reasonable
degree of care.  Buyer shall be responsible for any use or disclosure of
AstraZeneca Confidential Information by any of Buyer’s Affiliates or
Representatives that would breach this Clause 13 if such Affiliate or
Representative was a party hereto.

 

13.4                        In the event either Party is requested pursuant to,
or required by, applicable Law to disclose any of the other Party’s Confidential
Information (i.e., AstraZeneca Confidential Information or Buyer Confidential
Information, as applicable), it will notify the other Party in a timely manner
so that such Party may seek a protective order or other appropriate remedy at
such Party’s expense or, in such Party’s sole discretion, waive compliance with
the confidentiality provisions of this Supply Agreement.  Each Party will
cooperate in all reasonable respects in connection with any reasonable actions
to be taken for the foregoing purpose.  In any event, the Party requested or
required to disclose such Confidential Information may furnish it as requested
or required pursuant to applicable Law (subject to any such protective order or
other appropriate remedy) without liability hereunder, provided that such Party
furnishes only that portion of the Confidential Information which such Party is
advised by counsel is legally required, and such Party exercises reasonable
efforts to obtain reliable assurances that confidential treatment will be
accorded such Confidential Information.

 

13.5                        Nothing in this Clause 13 shall be construed as
preventing or in any way inhibiting either Party from (i) complying with
applicable Law, including any applicable Law governing

 

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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

activities and obligations undertaken pursuant to this Supply Agreement, the
Purchase Agreement or any Ancillary Agreement in any manner which it reasonably
deems appropriate, or (ii) making disclosures to lenders, investors or potential
purchasers of any Party or any Affiliate thereof so long the as person receiving
any Confidential Information agrees to keep the same confidential pursuant to a
written agreement with such Party or an Affiliate thereof.

 

13.6                        Press Releases; Public Announcements. Except to the
extent permitted by the Purchase Agreement, Buyer and AstraZeneca agree not to
issue any press releases or public announcements concerning this Supply
Agreement (and to ensure that their respective Affiliates do not do so) without
the prior written consent of the other Party to the form, timing and content of
any such release or announcement, except (i) as required by applicable Laws,
including disclosure required by any securities exchange, or (ii) in connection
with the enforcement of any rights or remedies pursuant to this Supply
Agreement, the Purchase Agreement or any Ancillary Agreement.  The Parties
acknowledge that Buyer or an Affiliate thereof intends to file a copy of this
Agreement with the U.S. Securities and Exchange Commission and to seek
confidential treatment of portions hereof to the extent permitted by applicable
Law.  Prior to making any such filing, Buyer shall provide AstraZeneca and its
counsel with a redacted version of this Agreement that it intends to file, and
will consider in good faith any comments provided by AstraZeneca or its counsel
and use commercially reasonable efforts to ensure the confidential treatment by
such Governmental Authority of those sections that Buyer deems reasonably
appropriate taking into account any such sections specified by AstraZeneca or
its counsel for redaction and confidentiality.

 

13.7                        Injunctive Relief. Each Party acknowledges that
damages resulting from disclosure of Confidential Information not permitted
hereby shall be an insufficient remedy and that in the event of any such
disclosure or any indication of an intent to disclose such information, the
other Party shall be entitled, by way of private litigation, injunctive relief
or other equitable relief in addition to any and all remedies available at law
or in equity.  Each Party hereby waives (a) any requirement that the other Party
post a bond or other security as a condition for obtaining any such relief, and
(b) any defenses in any action for injunctive relief, including the defense that
a remedy at law would be adequate.

 

13.8                        Return or Destruction of Confidential Information.
Subject to Clause 13.9, on expiry or termination of this Supply Agreement, the
Receiving Party shall return to the Disclosing Party all copies containing
Confidential Information of the Disclosing Party or, at the Disclosing Party’s
option, destroy all copies of such Confidential Information. The return or
destruction of the Confidential Information of the Disclosing Party will not
affect the receiving Party’s obligation to observe the confidentiality and
non-use restrictions in respect of that Confidential Information set out in this
Supply Agreement.

 

13.9                        Permitted Retention of Confidential Information.
Each Party may keep one copy of Confidential Information for evidence purposes
at a secure place subject to the confidentiality and non-use obligations
provided in this Clause 13. The aforementioned return and destruction obligation
shall not apply to electronic copies of Confidential Information which are
rightfully contained in computers, word processors, communication systems and
system-backup media (collectively “IT Media”) which do not need to be destroyed
or returned, provided that such IT Media are: (a) overwritten in the ordinary
course of their reuse; or (b) at all times maintained in confidence and not
readily accessible and the receiving Party shall treat such copies as
confidential in accordance with this Clause 13.

 

14.                               INDEMNIFICATION

 

14.1                        Indemnification of AstraZeneca.  Subject to this
Clause 14, Buyer shall indemnify and hold harmless AstraZeneca and its
Affiliates, and their respective officers, directors, employees

 

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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

and agents (collectively, “AstraZeneca Indemnitees”) from and against, and
compensate and reimburse the AstraZeneca Indemnitees for, any and all Losses
suffered by them in connection with any and all Litigation by Third Parties
(collectively, “Third Party Claims”) arising from or occurring as a result of:
(a) any breach by Buyer of any term of this Supply Agreement, (b) the fraud or
willful misconduct on the part of any Buyer Indemnitee in the performance of
Buyer’s obligations under this Supply Agreement or (c) the Exploitation of the
Supplied Product by or on behalf of Buyer, its Affiliates, licensees,
sublicensees or distributors, except, in each case ((a), (b) and (c)), to the
extent of those Losses for which AstraZeneca has an obligation to indemnify any
Buyer Indemnitees pursuant to Clause 14.2, as to which Losses each Party shall
indemnify the other Party and the AstraZeneca Indemnitees or Buyer Indemnitees,
as applicable, to the extent of its liability for such Losses.

 

14.2                        Indemnification of Buyer. Subject to this Clause 14,
AstraZeneca shall indemnify and hold harmless Buyer and its Affiliates, and
their respective officers, directors, employees and agents (collectively, “Buyer
Indemnitees”) from and against, and compensate and reimburse Buyer Indemnitees
for, any and all Losses suffered by them in connection with any and all Third
Party Claims arising from or occurring as a result of (a) any breach by
AstraZeneca of any term of this Supply Agreement, or (b) the fraud or willful
misconduct on the part of any AstraZeneca Indemnitee in the performance of
AstraZeneca’s obligations under this Supply Agreement, except to the extent of
those Losses for which Buyer has an obligation to indemnify any AstraZeneca
Indemnitee pursuant to Clause 14.1, as to which Losses each Party shall
indemnify the other Party and the AstraZeneca Indemnitees or Buyer Indemnitees,
as applicable, to the extent of its liability for such Losses.

 

14.3                        Indemnification Claim Procedure.  All
indemnification claims in respect of Buyer or any Buyer Indemnitee shall be made
solely by Buyer and all indemnification claims in respect of AstraZeneca or any
AstraZeneca Indemnitee shall be made solely by AstraZeneca and, in each case,
shall be governed by Section 7.2 of the Purchase Agreement, which shall apply
mutatis mutandis, including as to control of proceedings and settlement. 
Notwithstanding the foregoing, in the event of a Third Party Claim for which
AstraZeneca is entitled to control the defense under this Supply Agreement and
the Distributor (as defined in the AG Agreement) is entitled to control the
defense under the AG Agreement, the Distributor shall be entitled to control the
defense of such Third Party Claim.  In such case, Buyer shall (a) keep
AstraZeneca reasonably informed with respect to such Third Party Claim
(including with respect to all material proceedings), (b) to the extent Buyer is
able to provide input to the Distributor with respect to the defense of such
Third Party Claim, provide AstraZeneca a reasonable opportunity to provide its
input, and (c) provide AstraZeneca with copies of material pleadings and filings
with respect to such Third Party Claim.

 

14.4                        No Limitation on Direct Claims.  Subject to the
terms of Clause 15 of this Supply Agreement, this Clause 14 shall not preclude a
Party from exercising any rights or remedies available to it under this
Agreement, at law or in equity in respect of any claim (other than a Third Party
Claim, which shall be subject to the terms of this Clause 14) for Losses
incurred by such Party arising from the breach by the other Party of, or other
non-compliance, negligence or other actions or omission by such other Party, in
each case under the terms of this Supply Agreement or in respect of the
transactions contemplated hereby.

 

15.                               LIABILITY

 

15.1                        Disclaimer. Except to the extent set out expressly
in this Supply Agreement, the Purchase Agreement or the other Ancillary
Agreements, all conditions, warranties or other terms which might have effect
between the Parties or be implied or incorporated into this Supply Agreement,
the Purchase Agreement or the other Ancillary Agreements (whether by statute,
common law or otherwise) are hereby excluded to the fullest extent permitted by
applicable Laws. Without prejudice to the general nature of the previous
sentence, unless this Supply

 

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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

Agreement, the Purchase Agreement or the other Ancillary Agreements specifically
state otherwise, neither AstraZeneca nor Buyer makes any representations or
warranties with respect to any Supplied Product, including any representations
or warranties as to non-infringement or fitness for a particular purpose.

 

15.2                        Limitation of Liability. TO THE MAXIMUM EXTENT
PERMITTED BY LAW, NOTWITHSTANDING ANY OTHER PROVISION CONTAINED HEREIN, UNLESS
RESULTING FROM A PARTY’S OR ITS AFFILIATES OR PERMITTED SUB-CONTRACTORS WILLFUL
MISCONDUCT OR FRAUD, A BREACH OF CLAUSE 13 HEREOF OR ARISING FROM
INDEMNIFICATION OBLIGATIONS UNDER CLAUSE 14 WITH RESPECT TO THIRD PARTY
CLAIMS, IN NO EVENT SHALL ASTRAZENECA, ON THE ONE HAND, OR BUYER, ON THE OTHER
HAND, BE LIABLE TO THE OTHER OR THEIR AFFILIATES FOR ANY FOR ANY CLAIMS, DEMANDS
OR SUITS FOR CONSEQUENTIAL, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, INDIRECT
OR MULTIPLE DAMAGES, FOR LOSS OF PROFITS, REVENUE OR INCOME, DIMINUTION IN VALUE
OR LOSS OF BUSINESS OPPORTUNITY (WHETHER OR NOT FORESEEABLE AT THE EFFECTIVE
DATE), CONNECTED WITH OR RESULTING FROM ANY BREACH OF THIS AGREEMENT, OR ANY
ACTIONS UNDERTAKEN IN CONNECTION HEREWITH, OR RELATED HERETO, INCLUDING ANY SUCH
DAMAGES WHICH ARE BASED UPON BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE AND
MISREPRESENTATION), BREACH OF WARRANTY, STRICT LIABILITY, STATUTE, OPERATION OF
LAW OR ANY OTHER THEORY OF RECOVERY.

 

15.3                        Maximum Liability. TO THE MAXIMUM EXTENT PERMITTED
BY LAW, NOTWITHSTANDING ANY OTHER PROVISION CONTAINED HEREIN, UNLESS RESULTING
FROM A PARTY’S OR ITS AFFILIATES’ OR ITS PERMITTED SUB-CONTRACTOR’S WILLFUL
MISCONDUCT OR FRAUD, A BREACH OF CLAUSE 13 HEREOF OR ARISING FROM
INDEMNIFICATION OBLIGATIONS UNDER CLAUSE 14 WITH RESPECT TO THIRD PARTY CLAIMS,
THE AGGREGATE LIABILITY OF ASTRAZENECA UNDER OR IN CONNECTION WITH THIS SUPPLY
AGREEMENT SHALL NOT EXCEED [***].

 

15.4                        Recovery of Damages. Neither Party shall be entitled
under any provision of this Supply Agreement to recover damages, or obtain
payment, reimbursement, restitution or indemnity more than once in respect of
the same loss, shortfall, damage, deficiency, breach or other event or
circumstance.

 

16.                               INSURANCE

 

16.1                        Insurance. Each Party shall, and shall ensure that
their respective Affiliates shall, take out and maintain such types and amounts
of liability insurance or, if applicable, self-insurance to cover liabilities
related to its activities under this Supply Agreement as is normal and customary
in the pharmaceutical industry generally for Persons similarly situated, and
shall upon request provide to the other Party evidence of such insurance
coverage. Such insurance coverage shall remain in effect throughout the Supply
Term and for a period of three years thereafter.

 

17.                               FORCE MAJEURE

 

17.1                        Force Majeure.  Except for the obligation to pay
monies due and owing, neither Party shall be liable for any failure to perform
or any delays in performance, and no such Party shall be deemed to be in breach
or default of its obligations set forth in this Supply Agreement, if, to the
extent and for so long as, such failure or delay is due to any Force Majeure
Event.  In the event of a Force Majeure Event, the Party prevented from or
delayed in performing shall

 

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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

promptly give notice to the other Party and shall use Commercially Reasonable
Efforts to avoid or minimize the delay.  In the event that the delay continues
for a period of at least 30 days, the Party affected by the other Party’s delay
may elect to suspend performance and extend the time for performance for the
duration of the Force Majeure Event.

 

18.                               TERM AND TERMINATION

 

18.1                        Term. This Supply Agreement commences on the
Effective Date and has an initial term of 10 years ending on the 10 year
anniversary of the Effective Date (“Initial Term”).  Effective on and following
the 10th anniversary of the Effective Date, AstraZeneca will continue to
Manufacture and supply Supplied Product and this Agreement shall remain in full
force and effect (such period during which this Agreement remains in effect
following such 10th anniversary being referred to herein as the “Remaining
Term”, and together with the Initial Term, the “Supply Term”) unless earlier
terminated pursuant to Clause 18.2 (Termination by AstraZeneca), Clause 18.3
(Termination by Buyer), or Clause 18.4 (Termination by Either Party), but
subject always to terms set forth in Clause 19.5 (AstraZeneca Obligation to
Supply until Technology Transfer).

 

18.2                        Termination by AstraZeneca.  Subject to Clause 19.2
(Effect of Termination by AstraZeneca) and Clause 19.5 [***], following the
Initial Term, AstraZeneca may, upon providing Buyer 12 calendar months’ prior
written notice, inform Buyer that it wishes to discontinue the Manufacture and
supply of the Supplied Product and terminate this Supply Agreement, provided
that, for the avoidance of doubt, the delivery of such written notice (with or
without the passage of such time) shall not result in the termination of, or
have any impact on the rights and obligations of the Parties under, this
Agreement, it being agreed that following the delivery of such notice, this
Agreement shall only terminate (if at all) in accordance with the terms set
forth in Clause 19.2(a) (Effect of Termination or Notice of Intent to Terminate
by AstraZeneca with Identified Third Party) or Clause 19.2(b) (Effect of
Termination or Notice of Intent to Terminate by AstraZeneca without Identified
Third Party).

 

18.3                        Termination by Buyer.  Subject to Clause 19.3
(Effect of Termination by Buyer) and Clause 19.5 [***]:

 

(a)                                 following the [***] anniversary of the
Effective Date, Buyer may terminate this Supply Agreement without cause on 12
calendar months’ prior written notice to AstraZeneca; and

 

(b)                                 following the Initial Term, Buyer may, upon
providing AstraZeneca 12 calendar months’ prior written notice, terminate this
Supply Agreement without cause.

 

18.4                        Termination by Either Party.

 

(a)                                 In the event that either Party (the
“Breaching Party”) breaches any of its material obligations under this Supply
Agreement, subject (as applicable) to the terms set forth in Clause 19.5 [***],
the other Party may terminate this Supply Agreement upon [***] days’ prior
written notice (such 90-day period, the “Notice Period”) to the Breaching Party,
specifying the breach and its claim of right to terminate; provided, that,
without limitation of the terms set forth in Clause 19.5 [***], the termination
of this Supply Agreement shall not become effective at the end of the Notice
Period if (i) the Breaching Party cures such breach during the Notice Period or
(ii) such breach cannot be cured during the Notice Period and the Breaching
Party commences and diligently pursues actions to cure such breach within the
Notice Period, in which case the Breaching Party shall have an additional
[***]-day period to cure such breach before such termination shall become
effective; provided, further, that the Notice Period for any breach of an
undisputed payment obligation hereunder shall be [***]

 

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WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

days and such [***]-day period shall not be subject to extension in accordance
with the preceding proviso.  [***].

 

(b)                                 Subject (as applicable) to the terms set
forth in Clause 19.5 [***], either Party may terminate this Supply Agreement
immediately upon written notice to the other Party if the other Party (i) files
in any court or with any other Governmental Authority, pursuant to any Law of
any state or country, a petition in bankruptcy or insolvency or for
reorganization or for an arrangement or for the appointment of a receiver or
trustee of that Party or of its assets; (ii) enters into a written agreement of
composition or extension of its debts (other than extension of debts in the
ordinary course of business); (iii) is served with an involuntary petition
against it, filed in any insolvency proceeding, and such petition is not
dismissed within 60 days after the filing thereof; (iv) consents to the
appointment or taking possession by a receiver, liquidator, assignee, custodian,
trustee, sequestrator (or similar official) of such Party or for any substantial
part of its property or makes any assignment for the benefit of creditors;
(v) admits in writing its inability to pay its debts generally as they become
due; or (vi) has issued or levied against its property any judgment, writ,
warrant of attachment or execution or similar process that represents a
substantial portion of its property.

 

(c)                                  Subject to the terms set forth in Clause
19.5 [***], this Supply Agreement may be terminated upon the mutual written
agreement of Buyer and AstraZeneca at any time.

 

19.                               EFFECT OF TERMINATION

 

19.1                        Effect of Termination.  Except as otherwise set
forth herein, the termination of this Supply Agreement for any reason shall be
without prejudice to either Party’s other rights and remedies or to any accrued
rights and liabilities as the date of such termination.  Upon termination of
this Supply Agreement for any reason:

 

(a)                                 except where this Supply Agreement is
terminated by AstraZeneca under Clause 18.4(a) (Termination by AstraZeneca for
Buyer Material Breach) or Clause 18.4(b) (Termination by AstraZeneca for Buyer
Insolvency), in which case, all unfilled Purchase Orders may, at AstraZeneca’s
option, be cancelled, AstraZeneca will continue to process and fulfill any
Purchase Orders for Supplied Product which have been placed prior to the date of
such termination and Buyer will buy such Supplied Product in accordance with the
terms hereof, provided that all Purchase Orders, other than the foregoing, will
be cancelled;

 

(b)                                 Buyer shall pay all undisputed sums owed to
AstraZeneca pursuant to this Supply Agreement within [***] days after receiving
an invoice for the same;

 

(c)                                  Except where this Supply Agreement is
terminated by AstraZeneca under Clause 18.2 (Termination by AstraZeneca), by
Buyer under Clause 18.4(a) (Termination by Buyer for AstraZeneca Material
Breach) or by Buyer under Clause 18.4(b) (Termination by Buyer for AstraZeneca
Insolvency) and subject to mutual agreement of the Parties if this Agreement is
terminated by the Parties pursuant to Section 18.4(c) (Termination by Mutual
Agreement), Buyer shall reimburse AstraZeneca for:

 

(i)                                     any commitments or obligations that were
made by AstraZeneca or its Affiliates to Third Parties for the sole purpose of
performing its obligations under this Supply Agreement, which cannot be
cancelled by AstraZeneca or its Affiliates or refunded or credited by such Third
Party or which relate to materials that were purchased by AstraZeneca or its
Affiliates from Third Parties for the sole purpose of performing its obligations
under this Supply

 

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WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

Agreement and which cannot reasonably be used by AstraZeneca or its Affiliates
in the ordinary course of business; and

 

(ii)                                  any write-off costs (including waste
disposal costs) for inventories of the Supplied Product or materials that were
purchased by AstraZeneca or its Affiliates from Third Parties for the sole
purpose of performing its obligations under this Supply Agreement and which
AstraZeneca or its Affiliates are not reasonably able to re-utilize elsewhere in
their respective businesses;

 

in each case (i) and (ii), to the extent such commitments, obligations and
inventories were reasonable in light of Buyer’s most recent Forecast, provided
that in no event shall the payment obligations of Buyer pursuant to this Clause
19.1(c) exceed an amount equal to [***].

 

19.2                        Effect of Termination or Notice of Intent to
Terminate by AstraZeneca.

 

(a)                                 If (i) AstraZeneca informs Buyer in writing
in accordance with Clause 18.2 (Termination by AstraZeneca) of its desire to
discontinue the supply and Manufacture of the Supplied Product following the
10th anniversary of the Effective Date, and (ii) in connection therewith,
AstraZeneca has identified a Third Party that proposes to supply and Manufacture
the Supplied Product on behalf of AstraZeneca (either following a Technology
Transfer to such Third Party or after the Third Party acquires the Facility),
then AstraZeneca will (A) provide for the continued supply and Manufacture of
the Supplied Product to Buyer on the same terms and conditions as set forth in
this Supply Agreement pursuant to a written agreement that is entered into by
Buyer and such Third Party (the “Replacement Supply Agreement”), (B) use
reasonable efforts to effectuate a Technology Transfer pursuant to Clause 19.7
to such Third Party manufacturer and (C) pay for [***] in connection with such
Technology Transfer.  Buyer shall execute any such Replacement Supply
Agreement.  Notwithstanding the foregoing, this Agreement shall not terminate
pursuant to Clause 18.2 (Termination by AstraZeneca) unless and until all of the
following conditions are satisfied (and, if this Agreement shall terminate upon
the satisfaction of such conditions, such termination shall be deemed to have
been effected pursuant to Clause 18.2 (Termination by AstraZeneca)): (1) the
Technology Transfer shall have been completed to the reasonable satisfaction of
the Parties; (2) Buyer and the Third Party manufacturer shall have entered into
the Replacement Supply Agreement, and such Third Party manufacturer shall
commence the Manufacturing and supply of Supplied Product to Buyer pursuant to
the terms thereof; and (3) AstraZeneca shall have paid all amounts required to
be paid by it pursuant to clause (C) of the immediately preceding sentence.

 

(b)                                 If (i) AstraZeneca informs Buyer in writing
in accordance with Clause 18.2 (Termination by AstraZeneca) of its desire to
discontinue the supply and Manufacture of the Supplied Product following the
10th anniversary of the Effective Date, and (ii) AstraZeneca has not identified
a Third Party that proposes to Manufacture the Supplied Product, then
AstraZeneca will (A) provide written thereof to Buyer stating its desire to
terminate this Agreement two years following the delivery thereof, (B) use
reasonable efforts to identify a Third Party that could Manufacture and supply
the Supplied Product, (C) use reasonable efforts to effectuate a Technology
Transfer pursuant to Clause 19.7 to a Third Party manufacturer that may
thereafter be identified by AstraZeneca or Buyer, and (D) pay for [***] in
connection with such Technology Transfer.  Notwithstanding the foregoing, this
Agreement shall not terminate pursuant to Clause 18.2 (Termination by
AstraZeneca) unless and until all of the following conditions are satisfied
(and, if this Agreement shall terminate upon

 

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WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

the satisfaction of such conditions, such termination shall be deemed to have
been effected pursuant to Clause 18.2 (Termination by AstraZeneca): (1) the
Technology Transfer shall have been completed to the reasonable satisfaction of
the Parties; (2) Buyer and the Third Party manufacturer shall have entered into
a supply agreement for the supply of the Supplied Product on terms reasonably
acceptable to Buyer (and Buyer shall negotiate in good faith and use its
commercially reasonable efforts to promptly enter into such supply agreement),
and such Third Party manufacturer shall commence the Manufacturing and supply of
Supplied Product to Buyer pursuant to the terms thereof; and (3) AstraZeneca
shall have paid all amounts required to be paid by it pursuant to clause (D) of
the immediately preceding sentence.

 

(c)                                  AstraZeneca will use reasonable efforts to
effect a Technology Transfer pursuant to Clause 19.7 in connection with any
termination by AstraZeneca pursuant to Clause 18.4(a) (Termination by
AstraZeneca for Buyer Material Breach) or a termination by AstraZeneca pursuant
to Section 18.4(b) (Termination by AstraZeneca for Buyer Insolvency), provided
that (i) all reasonable costs and expenses incurred by AstraZeneca, Buyer or
their respective Affiliates in connection therewith shall be paid by Buyer, and
(ii) AstraZeneca shall not have any responsibility with respect to a Technology
Transfer if such termination is based on Buyer’s breach of any undisputed
payment obligation or a termination pursuant to Clause 18.4(b) (Termination by
AstraZeneca for Buyer Insolvency), unless (in the case of this clause (ii)) all
undisputed amounts are paid in full and adequate assurance of payment is
delivered to AstraZeneca and is reasonably acceptable thereto.

 

19.3                        Effect of Termination by Buyer.

 

(a)                                 AstraZeneca will not have any responsibility
with respect to a Technology Transfer in connection with any termination by
Buyer pursuant to Clause 18.3(a) (Termination by Buyer following the [***]
Anniversary).

 

(b)                                 If Buyer elects to terminate this Supply
Agreement pursuant to Clause 18.3(b) (Termination by Buyer following the Initial
Term) (other than (i) any time at which Buyer is entitled to terminate this
Supply Agreement pursuant to Clause 18.4(a) (Termination by Buyer for
AstraZeneca Material Breach), (ii) any time following delivery by AstraZeneca of
notice informing Buyer in accordance with Clause 18.2 (Termination by
AstraZeneca) of its desire to discontinue the supply and Manufacture of the
Supplied Product following the 10th anniversary of the Effective Date), or
(iii) at any time at which Buyer is entitled to terminate this Supply Agreement
pursuant to Clause 18.4(b) (Termination by Buyer for AstraZeneca Insolvency)),
AstraZeneca will provide such cooperation in connection with a Technology
Transfer as Buyer may reasonably request, [***].

 

(c)                                  If Buyer elects to terminate this Supply
Agreement pursuant to Clause 18.4(a) (Termination by Buyer for AstraZeneca
Material Breach), Clause 18.4(b) (Termination by Buyer for AstraZeneca
Insolvency) or Clause 18.3(b) (Termination by Buyer following the Initial Term)
(if, solely in the case of a termination pursuant to Clause 18.3(b) (Termination
by Buyer following Initial Term), at the time of Buyer’s notice of termination,
(x) Buyer is entitled to terminate this Supply Agreement pursuant to Clause
18.4(a) (Termination by Buyer for AstraZeneca Material Breach), (y) Buyer is
entitled to terminate this Supply Agreement pursuant to Clause 18.4(b)
(Termination by Buyer for AstraZeneca Insolvency) or (z) subject to Clause 19.6,
if AstraZeneca has notified Buyer of its election to discontinue the supply
Manufacture of the Supplied Product), then AstraZeneca will (i) use reasonable
efforts to effectuate a Technology Transfer

 

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WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

pursuant to Clause 19.7 and (ii) pay for [***] in connection with such
Technology Transfer.

 

19.4                        Effect of Mutual Termination.  If this Supply
Agreement is terminated by the Parties pursuant to Clause 18.4(c) (Mutual
Termination), AstraZeneca will provide such cooperation in connection with a
Technology Transfer as Buyer may reasonably request and the allocation the costs
and expenses incurred in connection therewith shall be as agreed by the Parties
in connection with such termination of this Supply Agreement.

 

19.5                        [***].

 

19.6                        [***].

 

19.7                        Manufacturing Technology Transfer.  Other than in
connection with a termination by AstraZeneca pursuant to Clause 18.4(a)
(Termination by AstraZeneca for Material Breach by Buyer) or Clause
18.4(b) (Termination by AstraZeneca for Buyer Insolvency), as a result of which
AstraZeneca is not required to take the actions described in this Clause 19.7
pursuant to the terms set forth in Clause 19.2(c), or a termination by Buyer
pursuant to Clause 18.3(a) (Termination by Buyer following the [***]
Anniversary), promptly following notice of termination of this Supply Agreement
in accordance with any of the terms hereof, or if required pursuant to Clause
19.6 [***], or if Buyer has the right to source alternative sources of supply
and Manufacture of the Supplied Product pursuant to Clause 2.1, and subject to
the limitations of Clause 19.8 (Technology Transfer Limitations) and the other
terms of this Agreement, the Parties shall work together to agree to a plan for
transitioning the Manufacturing Know-How (a “Technology Transfer”) to Buyer or
its Third Party manufacturer (Buyer or such Third Party, the “Technology
Recipient”), including a targeted completion date for such Technology Transfer,
and the Parties shall, and shall otherwise cause their Affiliates to, use
commercially reasonable efforts to assist and cooperate in respect of any
Technology Transfer.  Such assistance shall include AstraZeneca providing such
information, data and documentation in respect of the Supplied Products, the
materials and the Manufacturing process in respect thereof as Buyer may
reasonably request, supplier information with respect to the Supplied Product,
batch records in respect of any Supplied Product and artwork, logos and the like
in respect thereof) and such other information and data as may be reasonably
necessary to qualify the Technology Recipient with any Regulatory Authority for
purposes of Manufacturing and supplying the Supplied Product (including as to
any information, data or documentation that such Technology Recipient may be
required to provide to, or include in any filing or application made to, any
Regulatory Authority in respect of the qualification of such Technology
Recipient for the Manufacturing and supply of Supplied Products).  Each Party
shall, and Buyer shall use Commercially Reasonable Efforts to cause any selected
Third Party manufacturer to use Commercially Reasonable Efforts to perform its
obligations under such plan in accordance with the timelines set out therein. 
All documents transmitted to the Technology Recipient in connection with a
Technology Transfer shall be transmitted electronically unless otherwise
required by applicable Law in order to effect the Technology Transfer.  Neither
AstraZeneca nor its Affiliates will be required to transfer to the Technology
Recipient any data, information or documents not in the possession of
AstraZeneca or its Affiliates or that cannot be reasonably obtained thereby.

 

19.8                        Technology Transfer Limitations.  In no event shall
AstraZeneca be required to transfer the Manufacturing Know-How to more than one
Technology Recipient at the request of Buyer.  Buyer (or a Third Party
Technology Recipient at Buyer’s direction) shall obtain and make available such
information, personnel, products, materials, services, facilities and other
resources, and take such other actions, as are reasonably necessary to enable
AstraZeneca to transition the Manufacturing Know-How to the Technology
Recipient, including those set forth in the technology transfer plan(s) to be
agreed to by the Parties.  Buyer acknowledges

 

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WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

that the timely and successful transfer of the Manufacturing Know-How to the
Technology Recipient depends on the cooperation of and availability of
information, personnel, products, materials, services, facilities and other
resources by or on behalf of Buyer or the taking of certain actions by or on
behalf of Buyer.  Buyer acknowledges and agrees that AstraZeneca provides no
assurances or guarantee that the Manufacturing Know-How shall be successfully
transferred to the Technology Recipient.

 

19.9                        Survival. Any provision of this Supply Agreement
which expressly or by implication is intended to come into or continue in force
on termination or expiry of this Supply Agreement, including Clauses 1, 8 (to
the extent that payments to AstraZeneca are due or still owing), 9 (to the
extent that payments to AstraZeneca are due or still owing), 11, 12.2, 13, 14,
15, 16, 18, 19 and 22 shall remain in full force and effect.

 

20.                               INDEPENDENT CONTRACTORS

 

20.1                        Independent Contractors. AstraZeneca is acting as an
independent contractor under this Supply Agreement. Nothing in this Supply
Agreement or any circumstances associated with it or its performance give rise
to any relationship of agency, partnership or employer and employee between
Buyer and (i) AstraZeneca, (ii) AstraZeneca’s Affiliates and (iii) AstraZeneca’s
and its Affiliates’ respective Personnel directly and effectively involved, if
any, in the performance of this Supply Agreement, nor authorize either Party to
make or enter into any commitments for or on behalf of the other Party.

 

21.                               NOTICES

 

21.1                        Notice Requirements. Any notice, request, demand,
waiver, consent, approval or other communication permitted or required under
this Supply Agreement (each, a “Notice”) shall be in writing, shall refer
specifically to this Supply Agreement and shall be deemed given only if
delivered by hand or sent by facsimile transmission or by email of a PDF
attachment (with transmission confirmed) or by internationally recognized
overnight delivery service that maintains records of delivery, addressed to the
Parties at their respective addresses specified below or to such other address
as the Party to whom notice is to be given may have provided to the other Party
at least 10 days prior to such address taking effect in accordance with this
Clause 21.1.  Such Notice shall be deemed to have been given as of the date
delivered by hand or internationally recognized overnight delivery service or
confirmed that it was received by facsimile or email (with receipt confirmed by
telephone or, solely in the case of facsimile, by email or by delivery (in
addition to such facsimile) of such communication by internationally recognized
overnight delivery service that maintains records of delivery).  Any Notice
delivered by facsimile or email shall be confirmed by a hard copy delivered as
soon as practicable thereafter.

 

For notices to AstraZeneca:

 

Address:                         AstraZeneca AB

 

151 85 Södertälje, Sweden

 

Attention:                 Deputy General Counsel, Corporate

 

with a copy to (which shall not constitute effective notice):

 

Address:                         AstraZeneca Pharmaceuticals LP

 

1800 Concord Pike

 

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WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

Wilmington, DE 19086

 

E-mail:                                Richard.Kenny@astrazeneca.com

 

Attention:                 Richard Kenny

 

For notices to Buyer:

 

Address:                         Aralez Pharmaceuticals Trading DAC

 

56 Fitzwilliam Square

 

Dublin 2, Ireland

 

Fax:                                               +353 61 363 682

 

Attention:                 Andrew I. Koven, Director

 

with a copy to (which shall not constitute effective notice):

 

Address:                         Aralez Pharmaceuticals Inc.

 

7100 West Credit Avenue, Suite 101

 

Mississauga, Ontario L5N 0E4, Canada

 

Fax:                                               +1 (347) 983-6777

 

Attention:                 Eric L. Trachtenberg

 

21.2                        Day-to-day Communications. Day-to-day communications
relating to the operation of this Supply Agreement, including Forecasts and
Purchase Orders shall be in writing (which for this purpose may include e-mail)
and shall be delivered by e-mail to the Account Managers appointed by the
Parties or to such other persons as those Account Managers may agree and shall
be deemed to be delivered when the e-mail is sent or if outside normal business
hours in the country where the recipient is generally located, the following
working day in such country.

 

22.                               MISCELLANEOUS

 

22.1                        Setoff Rights.  Neither Party shall have any right
of setoff of any amounts due and payable, or any Liabilities arising, under this
Supply Agreement against any other amounts due and payable under this Supply
Agreement or any amounts due and payable, or any Liabilities arising, under the
Purchase Agreement or any other Ancillary Agreement.  The payment obligations
under each of this Supply Agreement and the Purchase Agreement and Ancillary
Agreements remain independent obligations of each Party, irrespective of any
amounts owed to any other Party under this Supply Agreement or the respective
Purchase Agreement or Ancillary Agreements.

 

22.2                        Amendment and Waiver.

 

(a)                                 This Agreement may not be modified, amended,
altered or supplemented except upon the execution and delivery of a written
agreement executed by both Parties.

 

(b)                                 Any term or condition of this Supply
Agreement may be waived at any time by the Party that is entitled to the benefit
thereof, but no such waiver shall be effective

 

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WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

unless set forth in a written instrument duly executed by or on behalf of the
Party waiving such term or condition.  The waiver by either Party of any right
hereunder or of the failure to perform or of a breach by the other Party shall
not be deemed a waiver of any other right hereunder or of any other breach or
failure by said other Party whether of a similar nature or otherwise.  The
rights and remedies provided herein are cumulative and do not exclude any other
right or remedy provided by applicable Law or otherwise available except as
expressly set forth herein.

 

22.3                        Counterparts.  This Agreement may be executed in any
number of counterparts, and each such counterpart hereof shall be deemed to be
an original instrument, but all such counterparts together shall constitute but
one agreement.  Delivery of an executed counterpart of a signature page of this
Supply Agreement by facsimile or other electronic transmission (including in
portable document format (.pdf), as a joint photographic experts group (.jpg)
file, or otherwise) shall be effective as delivery of a manually executed
original counterpart of this Supply Agreement.

 

22.4                        Severability. If any provision of this Supply
Agreement is held by a court of competent jurisdiction to be illegal, invalid or
unenforceable under any present or future Law, and if the rights or obligations
of either Party under this Supply Agreement will not be materially and adversely
affected thereby, (a) such provision shall be fully severable, (b) this Supply
Agreement shall be construed and enforced as if such illegal, invalid or
unenforceable provision had never comprised a part hereof, (c) the remaining
provisions of this Supply Agreement shall remain in full force and effect and
shall not be affected by the illegal, invalid or unenforceable provision or by
its severance herefrom and (d) in lieu of such illegal, invalid or unenforceable
provision, there shall be added automatically as a part of this Supply Agreement
a legal, valid and enforceable provision as similar in terms to such illegal,
invalid or unenforceable provision as may be possible and reasonably acceptable
to the Parties.

 

22.5                        Headings. The headings used in this Supply Agreement
have been inserted for convenience of reference only and do not define or limit
the provisions hereof.

 

22.6                        Assignment.  Subject to AstraZeneca’s right under
Clause 3.1 to effect a Packaging Transfer and retain a Third Party packager,
neither this Supply Agreement nor either Party’s rights or obligations hereunder
may be assigned or delegated by such Party without the prior written consent of
the other Party, and any attempted assignment or delegation of this Supply
Agreement or any of such rights or obligations by either Party without the prior
written consent of the other Party shall be void and of no effect; provided,
however, that either Party may assign or delegate any or all of its rights or
obligations hereunder to an Affiliate without prior written consent (but subject
to providing prior written notice), and Buyer may collaterally assign this
Supply Agreement to any Financing Source (or other lender of Buyer or any
Affiliate thereof), pursuant to the Credit Agreement (or any other lending
facility under which Buyer or any of its Affiliates obtains funding), without
the prior written consent of Seller, but, in each case, the assigning Party
shall remain responsible for all of its obligations hereunder notwithstanding
any such assignment.  Subject to the preceding sentence, this Supply Agreement
shall be binding upon, inure to the benefit of, and be enforceable by, the
Parties and their respective successors and permitted assigns.  Notwithstanding
the foregoing, in the event a Party assigns its rights or obligations under this
Supply Agreement or otherwise makes or receives payments from a jurisdiction
other than the jurisdiction in which such party is organized (each, an
“Assignment”), and immediately after such Assignment the amount of Tax required
to be withheld or paid on any payment pursuant to this Supply Agreement is
greater than the amount of such Tax that would have been required to have been
withheld absent such Assignment, then such increased withholding tax shall be
borne by the Party making such Assignment.  Notwithstanding anything contained
in this Agreement to the contrary, the purchase by any Person of the Facility or
all or substantially all of the assets thereof or of AstraZeneca or its
Affiliates that are utilized at the Facility or in connection with

 

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WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

the supply and Manufacture of Supplied Product shall have no effect on this
Agreement, which shall remain in full force and effect unless otherwise
terminated in accordance with Clause 18 (and then subject to Clause 19).

 

22.7                        Intentionally Omitted.

 

22.8                        No Benefit to Third Parties.  The covenants and
agreements set forth in this Supply Agreement are for the sole benefit of the
Parties and their successors and permitted assigns, and, except for the rights
of any indemnified Person under Clause 14, they shall not be construed as
conferring any rights on any other Persons.

 

22.9                        Entire Agreement. This Supply Agreement, together
with the Purchase Agreement, the Schedules and Exhibits expressly contemplated
hereby and attached hereto, the Disclosure Schedules, the other Ancillary
Agreements and the other agreements, certificates and documents delivered in
connection with the Purchase Agreement or otherwise in connection with the
transactions contemplated hereby and thereby, contain the entire agreement
between the Parties with respect to the transactions contemplated hereby or
thereby and supersede all prior agreements, understandings, promises and
representations, whether written or oral, between the Parties with respect to
the subject matter hereof and thereof.  In the event of any inconsistency
between any such Schedules and Exhibits and this Supply Agreement, the terms of
this Supply Agreement shall govern.  In the event of any inconsistency between
this Supply Agreement and the Purchase Agreement, the terms of the Purchase
Agreement shall govern.

 

22.10                 Governing Law, Jurisdiction and Venue.

 

(a)                                 Governing Law.  This Agreement shall be
governed by and construed in accordance with the Laws of the State of New York,
excluding any conflicts or choice of Law rule or principle that might otherwise
refer construction or interpretation of this Supply Agreement to the substantive
Law of another jurisdiction.

 

(b)                                 Jurisdiction.  The Parties hereby
irrevocably and unconditionally consent to the exclusive jurisdiction of the
courts of the State of New York and the United States District Court for the
Southern District of New York for any action, suit or proceeding (other than
appeals therefrom) arising out of or relating to this Supply Agreement, and
agree not to commence any action, suit or proceeding (other than appeals
therefrom) related thereto except in such courts.  The Parties irrevocably and
unconditionally waive their right to a jury trial in connection with any
Litigation arising out of or relating to this Supply Agreement or the
transactions contemplated hereby.

 

(c)                                  Venue.  The Parties further hereby
irrevocably and unconditionally waive any objection to the laying of venue of
any action, suit or proceeding (other than appeals therefrom) arising out of or
relating to this Supply Agreement in the courts of the State of New York or in
the United States District Court for the Southern District of New York, and
hereby further irrevocably and unconditionally waive and agree not to plead or
claim in any such court that any such action, suit or proceeding brought in any
such court has been brought in an inconvenient forum.

 

(d)                                 Service.  Each Party further agrees that
service of any process, summons, notice or document by registered mail to its
address set forth in Clause 21 shall be effective service of process for any
action, suit or proceeding brought against it under this Supply Agreement in any
such court.

 

29

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

22.11                 Delivery of Agreement. The Parties do not intend this
Supply Agreement to be delivered by, or to become legally binding on, any of
them until the date of this Supply Agreement is written at its head,
notwithstanding that one or more of them may have executed this Supply Agreement
prior to that date being inserted.

 

[Signature pages follow]

 

30

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

IN WITNESS WHEREOF, the Parties have executed this Supply Agreement as of the
date first written above.

 

 

ASTRAZENECA AB

 

 

 

 

 

 

 

By:

 

 

 

Name:

 

 

Title:

 

 

 

 

 

 

 

ARALEZ PHARMACEUTICALS TRADING DAC

 

 

 

 

 

 

 

By:

 

 

 

Name:

 

 

Title:

 

[SIGNATURE PAGE TO SUPPLY AGREEMENT]

 

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

SCHEDULE 1

 

SUPPLY PRICE

 

Supply Price per Tablet for Supplied Product (by SKU)

 

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i

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

SCHEDULE 2

 

DOCUMENTATION TO ACCOMPANY DELIVERIES

 

·                  Pack list

 

·                  Bill of Lading (truck shipment) or AWB (airway bill for air
shipment)

 

·                  Certificate of Analysis (and where relevant, Certificate of
Origin)

 

·                  Or as otherwise specified in the Quality Agreement or as
mutually agreed

 

ii

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

SCHEDULE 3

 

SPECIFICATION

 

See attached.

 

iii

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH
CONFIDENTIAL TREATMENT REQUEST.

 

SCHEDULE 4

 

MINIMUM ORDER QUANTITIES

 

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iv

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