Master Manufacturing Services Agreement
Confidential Materials Omitted, Designated Herein as [***], and Filed Separately
with the Securities and Exchange Commission
Master Manufacturing Services Agreement
September 27, 2016
Table of Contents
ARTICLE 14
STRUCTURE OF AGREEMENT AND INTERPRETATION4
1.1MASTER AGREEMENT.
4
1.2PRODUCT AGREEMENTS.
4
1.3DEFINITIONS.
5
1.4CURRENCY.
10
1.5SECTIONS AND HEADINGS.
10
1.6SINGULAR TERMS.
10
1.7APPENDIX 1, SCHEDULES AND EXHIBITS.
10
ARTICLE 211
PATHEON'S MANUFACTURING SERVICES11
2.1MANUFACTURING SERVICES.
11
2.2ACTIVE MATERIAL YIELD.
13
ARTICLE 315
CLIENT'S OBLIGATIONS15
3.1PAYMENT.
15
3.2ACTIVE MATERIALS AND QUALIFICATION OF ADDITIONAL SOURCES OF SUPPLY.
15
ARTICLE 416
CONVERSION FEES AND COMPONENT COSTS16
4.1FIRST YEAR PRICING.
16
4.2PRICE ADJUSTMENTS - SUBSEQUENT YEARS' PRICING.
16
4.3PRICE ADJUSTMENTS - CURRENT YEAR PRICING.
18
4.4ADJUSTMENTS DUE TO TECHNICAL CHANGES OR REGULATORY AUTHORITY
REQUIREMENTS.
18
4.5MULTI-COUNTRY PACKAGING REQUIREMENTS.
19
ARTICLE 519
ORDERS, SHIPMENT, INVOICING, PAYMENT19
5.1ORDERS AND FORECASTS.
19
5.2RELIANCE BY PATHEON.
21
5.3MINIMUM ORDERS.
22
5.4DELIVERY AND SHIPPING.
22
5.5INVOICES AND PAYMENT.
22
ARTICLE 623
PRODUCT CLAIMS AND RECALLS23
6.1PRODUCT CLAIMS.
23
6.2PRODUCT RECALLS AND RETURNS.
24
6.3PATHEON'S RESPONSIBILITY FOR DEFECTIVE AND RECALLED PRODUCTS.
24
6.4DISPOSITION OF DEFECTIVE OR RECALLED PRODUCTS.
25
6.5HEALTHCARE PROVIDER OR PATIENT QUESTIONS AND COMPLAINTS.
25
6.6SOLE REMEDY.
25
ARTICLE 725
CO-OPERATION26
7.1QUARTERLY REVIEW.
26
7.2GOVERNMENTAL AGENCIES.
26
7.3RECORDS AND ACCOUNTING BY PATHEON.
26
7.4INSPECTION.
23
7.5ACCESS.
27
7.6NOTIFICATION OF REGULATORY INSPECTIONS.
27
7.7REPORTS.
27
7.8REGULATORY FILINGS.
27
ARTICLE 828
TERM AND TERMINATION28
8.1INITIAL TERM.
28
8.2TERMINATION FOR CAUSE.
29
8.3PRODUCT DISCONTINUATION.
29
8.4OBLIGATIONS ON TERMINATION.
29
ARTICLE 931
REPRESENTATIONS, WARRANTIES AND COVENANTS31
9.1AUTHORITY.
31
9.2CLIENT WARRANTIES.
31
9.3PATHEON WARRANTIES.
32
9.4DEBARRED PERSONS.
33
9.5PERMITS.
33
9.6NO WARRANTY.
33
ARTICLE 1033
REMEDIES AND INDEMNITIES33
10.1CONSEQUENTIAL DAMAGES.
33
10.2LIMITATION OF LIABILITY.
34
10.3PATHEON INDEMNITY.
34
10.4CLIENT INDEMNITY.
35
10.5REASONABLE ALLOCATION OF RISK.
35
ARTICLE 1135
CONFIDENTIALITY35
11.1CONFIDENTIAL INFORMATION.
35
11.2
USE OF CONFIDENTIAL INFORMATION.
40
11.3
EXCLUSIONS.
403
11.4
PHOTOGRAPHS AND RECORDINGS.
39
11.5PERMITTED DISCOSURE.
40
11.6
MARKING.
40
11.7
RETURN OF CONFIDENTIAL INFORMATION.
404
11.8
REMEDIES.
395
ARTICLE 1238
DISPUTE RESOLUTION38
12.1COMMERCIAL DISPUTES.
38
12.2TECHNICAL DISPUTE RESOLUTION.
38
ARTICLE 1339
MISCELLANEOUS39
13.1INVENTIONS.
39
13.2INTELLECTUAL PROPERTY.
40
13.3INSURANCE.
40
13.4INDEPENDENT CONTRACTORS.
40
13.5NO WAIVER.
40
13.6ASSIGNMENT.
40
13.7FORCE MAJEURE.
41
13.8ADDITIONAL PRODUCT.
41
13.9NOTICES.
41
13.10SEVERABILITY.
42
13.11ENTIRE AGREEMENT.
42
13.12OTHER TERMS.
42
13.13NO THIRD PARTY BENEFIT OR RIGHT.
43
13.14EXECUTION IN COUNTERPARTS.
43
13.15USE OF CLIENT NAME.
43
13.16TAXES.
43
13.17GOVERNING LAW.
44
MASTER MANUFACTURING SERVICES AGREEMENT
THIS MASTER MANUFACTURING SERVICES AGREEMENT (the "Agreement") is made as of
September 27, 2016 (the "Effective Date")
B E T W E E N:
PATHEON MANUFACTURING SERVICES LLC,
a limited liability company existing under the laws of the State of Delaware
("Patheon"),
- and -
KERYX BIOPHARMACEUTICALS, INC.
a corporation existing under the laws of the State of Delaware
("Client").
THIS AGREEMENT WITNESSES THAT in consideration of the rights conferred and the
obligations assumed herein, and for other good and valuable consideration (the
receipt and sufficiency of which are acknowledged by each party), and intending
to be legally bound the parties agree as follows:
ARTICLE 1
STRUCTURE OF AGREEMENT