Master Manufacturing Services Agreement July 28, 2017
EXHIBIT 10.12
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
CONFIDENTIAL
Master Manufacturing Services Agreement
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
ARTICLE 1 STRUCTURE OF AGREEMENT AND INTERPRETATION |
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1.1 |
Master Agreement. |
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1.2 |
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1.3 |
Definitions. |
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1.4 |
Currency. |
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1.5 |
Sections and Headings. |
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1.6 |
Singular Terms. |
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1.7 |
Appendix 1, Schedules and Exhibits. |
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ARTICLE 2 PATHEON'S MANUFACTURING SERVICES |
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2.1 |
Manufacturing Services. |
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2.2 |
Active Material Yield. |
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ARTICLE 3 CLIENT'S OBLIGATIONS |
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3.1 |
Payment. |
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3.2 |
Active Materials and Qualification of Additional Sources of Supply. |
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ARTICLE 4 [* * *] COMPONENT COSTS |
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4.1 |
First Year Pricing. |
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4.2 |
Price Adjustments – Subsequent Years’ Pricing. |
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4.3 |
[* * *]. |
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4.4 |
Price Adjustments – Current Year Pricing. |
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4.5 |
Adjustments Due to Technical Changes or Regulatory Authority Requirements. |
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4.6 |
Multi-Country Packaging Requirements. |
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ARTICLE 5 ORDERS, SHIPMENT, INVOICING, PAYMENT |
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5.1 |
Orders and Forecasts. |
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5.2 |
Reliance by Patheon. |
19 |
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5.3 |
Minimum Orders. |
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5.4 |
Delivery and Shipping. |
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5.5 |
Invoices and Payment. |
20 |
ARTICLE 6 PRODUCT CLAIMS AND RECALLS |
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6.1 |
Product Claims. |
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6.2 |
Product Recalls and Returns. |
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6.3 |
Patheon’s Responsibility for Defective and Recalled Products. |
22 |
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6.4 |
Disposition of Defective or Recalled Products. |
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6.5 |
Healthcare Provider or Patient Questions and Complaints. |
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6.6 |
[* * *]. |
23 |
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
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7.1 |
Quarterly Review. |
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7.2 |
Governmental Agencies. |
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7.3 |
Records and Accounting by Patheon. |
23 |
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7.4 |
Inspection. |
24 |
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7.5 |
Access. |
24 |
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7.6 |
Notification of Regulatory Inspections. |
24 |
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7.7 |
Reports. |
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7.8 |
Regulatory Filings. |
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7.9 |
Technology Transfer. |
26 |
ARTICLE 8 TERM AND TERMINATION |
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8.1 |
Initial Term. |
26 |
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8.2 |
Termination for Cause. |
27 |
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8.3 |
Obligations on Termination. |
27 |
ARTICLE 9 REPRESENTATIONS, WARRANTIES AND COVENANTS |
29 |
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9.1 |
Authority. |
29 |
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9.2 |
Client Warranties. |
29 |
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9.3 |
Patheon Warranties. |
30 |
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9.4 |
Permits. |
31 |
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9.5 |
No Warranty. |
31 |
ARTICLE 10 REMEDIES AND INDEMNITIES |
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10.1 |
Consequential and Other Damages. |
31 |
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10.2 |
Limitation of Liability. |
31 |
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10.3 |
Patheon Indemnity. |
32 |
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10.4 |
Client Indemnity. |
32 |
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10.5 |
Reasonable Allocation of Risk. |
33 |
ARTICLE 11 CONFIDENTIALITY |
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11.1 |
Confidential Information. |
33 |
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11.2 |
Use of Confidential Information. |
33 |
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11.3 |
Exclusions. |
34 |
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11.4 |
Photographs and Recordings. |
34 |
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11.5 |
Permitted Disclosure. |
34 |
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11.6 |
Marking. |
35 |
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11.7 |
Return of Confidential Information. |
35 |
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11.8 |
Remedies. |
35 |
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
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12.1 |
Commercial Disputes. |
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12.2 |
Technical Dispute Resolution. |
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ARTICLE 13 MISCELLANEOUS |
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13.1 |
Inventions. |
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13.2 |
Intellectual Property. |
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13.3 |
Compliance with Tufts License. |
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13.4 |
Insurance. |
39 |
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13.5 |
Independent Contractors. |
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13.6 |
No Waiver. |
40 |
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13.7 |
Assignment and Subcontracting. |
40 |
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13.8 |
Force Majeure. |
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13.9 |
Additional Product. |
41 |
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13.10 |
Notices. |
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13.11 |
Severability. |
42 |
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13.12 |
Entire Agreement. |
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13.13 |
Other Terms. |
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13.14 |
No Third Party Benefit or Right. |
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13.15 |
Execution in Counterparts. |
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13.16 |
Use of Client Name. |
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13.17 |
Taxes. |
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13.18 |
Governing Law. |
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13.19 |
Further Assurances.. |
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13.20 |
Supply and Quality Committee |
45 |
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
MASTER MANUFACTURING SERVICES AGREEMENT
THIS MASTER MANUFACTURING SERVICES AGREEMENT (the “Agreement”) is made as of July 28, 2017 (the “Effective Date”)
B E T W E E N:
PATHEON UK LIMITED,
a corporation existing under the laws of England whose registered office is at Xxxxxxxxxx Xxxxx, Xxxxxxxxx, Xxxxxxx, XX0 0XX, Xxxxxx Xxxxxxx
(“Patheon”),
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PARATEK PHARMACEUTICALS, INC.,
a corporation existing under the laws of Delaware
of 0xx Xxxxx, 00 Xxxx Xxxxx,
Xxxxxx, XX 00000, XXX
(“Client”, along with Patheon, the “Parties” and each, a “Party”).
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:
Structure of Agreement and Interpretation
This Agreement establishes the general terms and conditions under which Patheon or, subject to the terms of this Agreement, any Affiliate of Patheon as of the Effective Date may perform Manufacturing Services for Client or any Affiliate of Client, at the manufacturing site where Patheon or the relevant Affiliate of Patheon resides. This “master” form of agreement is intended to allow the Parties, or any of their Affiliates, to contract for the manufacture of multiple Products through Patheon’s global network of manufacturing sites through the issuance of site specific Product Agreements without having to re-negotiate the basic terms and conditions contained herein. For Client’s [* * *] Product, Injectable Omadacycline, Patheon shall manufacture such Product for commercial use in [* * *], moving to [* * *] as required volumes of Product increase in the years following Product launch. The Parties agree that a separate technology
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
transfer agreement shall be agreed prior to such move within the Manufacturing Site, setting out the terms of the technology transfer. Product manufactured by Patheon in the PDS Area prior to the Effective Date may be released for commercial use on or after the Effective Date, and the terms of this Agreement (and not any prior agreement entered into between the Parties) shall apply to the release of the Product for commercial use and generally thereafter (including, without limitation, recall, insurance and liability and indemnities).
1.2Product Agreements.
This Agreement is structured so that a Product Agreement may be entered into by the Parties for the manufacture of a particular Product or multiple Products at a Patheon manufacturing site. Each Product Agreement will be governed by the terms and conditions of this Agreement unless the Parties to the Product Agreement expressly modify the terms and conditions of this Agreement in the Product Agreement. Unless otherwise agreed by the Parties, each Product Agreement will be in the general form and contain the information set forth in Appendix 1 hereto.
The following terms will, unless the context otherwise requires, have the respective meanings set out below and grammatical variations of these terms will have corresponding meanings:
“Active Materials”, “Active Pharmaceutical Ingredients” or “API” means the materials listed in a Product Agreement on Schedule D;
[* * *]
“Actual Annual Yield” or “AAY” has the meaning specified in Section 2.2(a);
[* * *]
“Affiliate” means:
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(a) |
a business entity which owns, directly or indirectly, a controlling interest in a Party to this Agreement, by stock ownership or otherwise; or |
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(b) |
a business entity which is controlled by a Party to this Agreement, either directly or indirectly, by stock ownership or otherwise; or |
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(c) |
a business entity, the controlling interest of which is directly or indirectly common to the majority ownership of a Party to this Agreement; |
For this definition, “control” means the ownership of shares carrying at least a majority of the votes for the election of the directors of a corporation;
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
“Annual Product Review Report” means the annual product review report prepared by Patheon or an Affiliate of Patheon as described in Title 21 of the United States Code of Federal Regulations, Section 211.180(e);
“Annual Report” means the annual report to the FDA which is required to be prepared and filed by Client regarding the Product as described in Title 21 of the United States Code of Federal Regulations, Section 314.81(b)(2);
“Annual Volume” means the minimum volume of Product to be manufactured in any Year of this Agreement as set forth in a Product Agreement on Schedule B;
“Applicable Laws” means [* * *].
“Authority” means any governmental or regulatory authority, department, body or agency or any court, tribunal, bureau, commission or other similar body, whether federal, state, provincial, county or municipal;
“Xxxx Back Items” means the expenses for all third party supplier fees for the purchase or use of columns, standards, tooling, non-standard pallets, PAPR or PPE suits (where applicable) and other project-specific items necessary for Patheon to perform the Manufacturing Services, and which are not included as Components;
“Breach Notice” has the meaning specified in Section 8.2(a);
“Business Day” means a day other than a Saturday, Sunday or a day that is a statutory holiday in (a) Boston, Massachusetts, (b) United Kingdom or (c) the jurisdiction where the relevant Manufacturing Site is located;
“Calendar Quarter” means, with respect to any given calendar year, the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31; provided, however, that (a) the first Calendar Quarter of the Term shall extend from the Effective Date to the end of the first complete Calendar Quarter thereafter and (b) the last Calendar Quarter of the Term shall end upon the effective date of expiration or termination of this Agreement;
“Capital Equipment Agreement” means a separate agreement that the Parties may enter into that will address responsibility for the purchase of capital equipment and facility modifications that may be required to perform the Manufacturing Services under a particular Product Agreement;
“cGMPs” means, as applicable, current good manufacturing practices as described in:
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(a) |
Parts 210 and 211 of Title 21 of the United States' Code of Federal Regulations; |
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
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(c) |
Division 2 of Part C of the Food and Drug Regulations (Canada); |
together with the latest Health Canada, FDA and EMA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time;
“Client Intellectual Property” means Intellectual Property [* * *];
“Client Property” has the meaning specified in Section 8.3(a)(vi);
“Client Representatives” has the meaning specified in Section 10.3(a);
“Client-Supplied Components” means those Components to be supplied by Client or that have been supplied by Client;
“Components” means, collectively, all packaging components, raw materials, ingredients, and other materials (including labels, product inserts and other labelling for the Products) required to manufacture the Products in accordance with the Specifications, other than the Active Materials;
“Confidential Information” has the meaning specified in Section 11.1;
[* * *];
“CTD” has the meaning specified in Section 7.8(c);
“Deficiencies” have the meaning specified in Section 7.8(d);
“Deficiency Notice” has the meaning specified in Section 6.1(a);
“Delivery Date” means the date scheduled for shipment of Product under a Firm Order as set forth in Section 5.1(d);
“Disclosing Party” has the meaning specified in Section 11.1;
“EMA” means the European Medicines Agency;
“FDA” means the United States Food and Drug Administration;
“Firm Orders” have the meaning specified in Section 5.1(c);
“Force Majeure Event” has the meaning specified in Section 13.8;
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
“Gross Negligence” means [* * *];
“GST” has the meaning specified in Section 13.17(a)(iii);
“Health Canada” means the section of the Canadian Government known as Health Canada and includes, among other departments, the Therapeutic Products Directorate and the Health Products and Food Branch Inspectorate;
[* * *];
“Initial Product Term” has the meaning specified in Section 8.1;
“Initial Term” has the meaning specified in Section 8.1;
“Intellectual Property” includes, without limitation, rights in patents, patent applications, formulae, trademarks, trademark applications, trade-names, Inventions, copyrights, industrial designs, trade secrets, and know how;
“Invention” means information about any innovation, improvement, development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, whether or not written or otherwise fixed in any form or medium, regardless of the media on which it is contained and whether or not patentable or copyrightable;
“Inventory” means all inventories of Components and work-in-process produced or held by Patheon for the manufacture of the Products but, for greater certainty, does not include the Active Materials;
“Laws” means all laws, statutes, ordinances, regulations, rules, by-laws, judgments, decrees or orders of any Authority;
“Long Term Forecast” has the meaning specified in Section 5.1(a);
“Manufacturing Services” means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;
“Manufacturing Site” means the facility owned and operated by Patheon or an Affiliate of Patheon where the Manufacturing Services will be performed as identified in a Product Agreement;
“Materials” means all Components and Xxxx Back Items required to manufacture the Products in accordance with the Specifications, other than the Active Materials;
[* * *]
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
“Minimum Order Quantity” means the minimum number of batches of a Product to be produced during the same cycle of manufacturing as set forth in a Product Agreement on Schedule B;
“Obsolete Stock” has the meaning specified in Section 5.2(b);
“PAI” has the meaning specified in Section 7.5;
[* * *]
“Patheon Intellectual Property” means Intellectual Property [* * *];
“Patheon Representatives” has the meaning specified in Section 10.4(a);
“Price” means the fees to be charged by Patheon for performing the Manufacturing Services, and includes the cost of Components (other than Client-Supplied Components), certain cost items as set forth in a Product Agreement on Schedule B, and annual stability testing fees as set forth in a Product Agreement on Schedule C;
“Product(s)” means the product(s) listed in a Product Agreement on Schedule A;
“Product Agreement” means the agreement between Patheon and Client issued under this Agreement in the form set forth in Appendix 1 (including Schedules A to D) under which Patheon will perform Manufacturing Services at a particular Manufacturing Site;
“Product Claims” have the meaning specified in Section 6.3(c);
“Quality Agreement” means the agreement between the Parties entering into a Product Agreement, or between the applicable Affiliate of Patheon and Client if the Manufacturing Services are subcontracted to such Affiliate by Patheon, that sets out the quality assurance standards and the Specifications for the Manufacturing Services to be performed by Patheon for Client;
“Recall” has the meaning specified in Section 6.2(a);
“Recipient” has the meaning specified in Section 11.1;
“Regulatory Approval” has the meaning specified in Section 7.8(a);
“Regulatory Authority” means the FDA, EMA, and Health Canada and any other foreign regulatory agencies competent to grant marketing approvals for pharmaceutical products including the Products in the Territory;
“Remediation Period” has the meaning specified in Section 8.2(a);
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
“Representatives” means a Party’s directors, officers, employees, advisers, agents, consultants, subcontractors, service partners, professional advisors, or representatives;
[* * *];
“Shortfall” has the meaning specified in Section 2.2(b);
“Specifications” means the file, for each Product, which is given by Client to Patheon in accordance with the procedures listed in a Product Agreement on Schedule A and which contains documents relating to each Product, including, without limitation:
|
(a) |
specifications for Active Materials and Components; |
|
(b) |
manufacturing specifications, directions, and processes; |
|
(c) |
storage requirements; |
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(d) |
all environmental, health and safety information for each Product including material safety data sheets; and |
|
(e) |
the finished Product specifications, packaging specifications and shipping requirements for each Product; |
all as updated, amended and revised from time to time by Client in accordance with the terms of this Agreement;
“Supply and Quality Committee” has the meaning specified in Section 13.20;
“Surplus” has the meaning specified in Section 2.2(c);
“Target Yield” has the meaning specified in Section 2.2(a);
“Target Yield Determination Batches” has the meaning specified in Section 2.2(a);
“Technical Dispute” has the meaning specified in Section 12.2;
“Term” has the meaning specified in Section 8.1;
“Territory” means the geographic area described in a Product Agreement where Products manufactured by Patheon will be distributed by Client, as may be mutually extended by the Parties in writing from time to time (subject to agreement between the Parties on any revised costs of Manufacturing Services relating to provision of Manufacturing Services for the additional Territory or Territories);
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
“Third Party Rights” means the Intellectual Property of any third party;
“VAT” has the meaning specified in Section 13.17(d);
“Year” means in the first year of this Agreement or in the first year of a Product Agreement, the period from the Effective Date up to and including December 31 of the same calendar year, and thereafter will mean a calendar year;
[* * *];
“Zero Forecast Period” has the meaning specified in Section 5.1(f).
Unless otherwise agreed in a Product Agreement, all monetary amounts expressed in this Agreement are in United States Dollars.
The division of this Agreement into Articles, Sections, Subsections, an Appendix, Schedules and Exhibits and the insertion of headings are for convenience of reference only and will not affect the interpretation of this Agreement. Unless otherwise indicated, any reference in this Agreement to a Section, Appendix, Schedule or Exhibit refers to the specified Section, Appendix, Schedule or Exhibit to this Agreement. In this Agreement, the terms "this Agreement", "hereof", "herein", "hereunder" and similar expressions refer to this Agreement as a whole and not to any particular part, Section, Appendix, Schedule or Exhibit of this Agreement.
Except as otherwise expressly stated or unless the context otherwise requires, all references to the singular will include the plural and vice versa.
1.7Xxxxxxxx 0, Xxxxxxxxx and Exhibits.
Appendix 1 (including the Schedules thereto) and the following Exhibits are attached to, incorporated in, and form part of this Agreement:
Appendix 1 |
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Form of Product Agreement (Including Schedules A to D) |
Exhibit A |
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Technical Dispute Resolution |
Exhibit B |
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Quarterly Active Materials Inventory Report |
Exhibit C |
- |
[* * *] |
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
PATHEON'S MANUFACTURING services
Patheon will perform the Manufacturing Services for the Territory for the Price specified in a Product Agreement in Schedules B and C to manufacture Products for Client. Schedule B to a Product Agreement sets forth a list of cost items that are included in the Price for Products; all cost items that are not included in the Price are subject to additional fees to be paid by Client. The fees set out in Schedules B and C to a Product Agreement may be amended as set forth in ARTICLE 4. Patheon may change the Manufacturing Site for the Products only with the prior written consent of Client, this consent not to be unreasonably withheld. In performing the Manufacturing Services, Patheon and Client agree that:
|
(a) |
Conversion of Active Materials and Components. Patheon will convert Active Materials and Components into Product. |
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
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undertaken to investigate the cause of the failure [* * *]. Patheon will give Client all stability test data and results at Client’s request. |
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
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Components will be adequately contained, packaged, and labeled and will conform to the affirmations of fact on the container. |
|
(g) |
Xxxx Back Items. The Xxxx Back Items will be mutually agreed by the Parties and will be charged to Client at [* * *]. |
|
(h) |
Validation Activities (if applicable). Upon Client’s request, Patheon may assist in the development and approval of the validation protocols for analytical methods and manufacturing procedures (including packaging procedures) for the Products. The fees for this service are not included in the Price and will be set out separately in Schedule C to a Product Agreement. |
Quantity Received: The total quantity of Active Materials that complies with the Specifications and is received at the Manufacturing Site during the applicable period.
Quantity Dispensed: The total quantity of Active Materials dispensed at the Manufacturing Site during the applicable period. The Quantity Dispensed is calculated by adding the Quantity Received to the inventory of Active Materials that complies with the Specifications held at the beginning of the applicable period, less the inventory of Active Materials that complies with the Specifications held at the end of the period. The Quantity Dispensed will only include Active Materials received and dispensed in commercial manufacturing of Products, including Active Materials lost in the warehouse prior to and during dispensing, and will not include any (i) Active Materials that must be retained by Patheon as samples, (ii) Active Materials contained in Product that must be retained as samples, (iii) Active Materials used in testing (if applicable), and (iv) Active Materials received or dispensed in technical transfer activities or development activities during the applicable period, including without limitation, any regulatory, stability, validation or test batches manufactured during the applicable period.
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
Quantity Converted: The total amount of Active Materials contained in the Products manufactured with the Quantity Dispensed (including any additional Products produced in accordance with Section 6.3(a) or 6.3(b)), delivered by Patheon, and not rejected, recalled or returned in accordance with Section 6.1 or 6.2 because of Patheon’s failure to perform the Manufacturing Services in accordance with Specifications, cGMPs, and Applicable Laws.
Within 60 days after the end of each Year, Patheon will prepare an annual reconciliation of Active Materials on the reconciliation report form set forth in Exhibit C including the calculation of the “Actual Annual Yield” or “AAY” for the Product at the Manufacturing Site during the Year. AAY is the percentage of the Quantity Dispensed that was converted to Products and is calculated as follows:
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Quantity Converted during the Yearx100% |
Quantity Dispensed during the Year
After Patheon has produced a minimum of [* * *] successful commercial production batches of Product and has produced commercial production batches for at least [* * *] at the Manufacturing Site (collectively, the “Target Yield Determination Batches”), the Parties will work in good faith to agree upon a reasonable target yield for the Product at the Manufacturing Site (the “Target Yield”). If the Parties cannot agree on such Target Yield, the Target Yield shall be determined by [* * *]. The Target Yield will thereafter be revised annually to reflect the actual manufacturing experience as agreed to by the Parties. If, in any Year, the Parties cannot agree on any such revision to the Target Yield, the Target Yield for such Year will be [* * *]. Notwithstanding anything to the contrary in this Agreement, in no event shall the Target Yield for a Year be less then [* * *] unless such lower Target Yield is caused by factors outside Patheon’s reasonable control (for example, less potent API).
[* * *]
[* * *]
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
|
(i) |
Shortfall Credit. If there is a Shortfall for a Product in a Year, then Patheon will credit Client’s account for the amount of the Shortfall not later than 60 days after the end of each Year. |
|
(ii) |
Surplus Credit. If there is a Surplus for a Product in a Year, then Patheon will be entitled to apply the amount of the Surplus as a credit against any Shortfall for that Product which may occur in the next Year. If there is no Shortfall in the next Year the Surplus credit will expire. |
Each credit under this Section 2.2 will be summarized on the reconciliation report prepared in the form set forth in Exhibit C. Upon expiration or termination of a Product Agreement, any remaining Shortfall credit amount owing under this Section 2.2 will be paid to Client.
CLIENT'S OBLIGATIONS
Client will pay Patheon for performing the Manufacturing Services according to the Prices specified in Schedules B and C in a Product Agreement. These Prices may be subject to adjustment under other parts of this Agreement. Client will also pay Patheon for any Xxxx Back Items agreed upon by the Parties pursuant to Section 2.1(g).
3.2Active Materials and Qualification of Additional Sources of Supply.
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Master Manufacturing Services Agreement
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Active Materials received by Patheon will only be used by Patheon to perform the Manufacturing Services for Client. [* * *] |
[* * *] COMPONENT COSTS
The Price for the first Year will be listed in Schedules B and C in a Product Agreement and will be subject to the adjustments set forth in Sections 4.2 and 4.4. The Price may also be increased or decreased [* * *]. Patheon will have no obligation to deliver any supporting documents that are subject to obligations of confidentiality between Patheon and its suppliers but will use commercially reasonable efforts to obtain consent from its suppliers to deliver such documentation if relevant.
4.2Price Adjustments – Subsequent Years’ Pricing.
After the first Year of the Product Agreement, Patheon may adjust the Price effective January 1 of each Year as follows:
|
(a) |
Manufacturing and Stability Testing Costs. Patheon may [* * *] unless the Parties otherwise agree in writing. [* * *] |
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Master Manufacturing Services Agreement
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(c) |
Pricing Basis. Client acknowledges that the Price in any Year is quoted based upon [* * *]. |
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
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(g) |
Adjustments Due to Currency Fluctuations. If the Parties agree in this Product Agreement to invoice in a currency other than the local currency for the Manufacturing Site, [* * *]. |
4.3[* * *]
On or before June 10 of each Year starting in the Year in which the Product has received Regulatory Approval in a country in the Territory, Client will notify Patheon of the volume of Product required by Client under this Agreement and the Product Agreement for the next two Years of the Product Agreement on a rolling forward basis (such volume anticipated for a given Year, the “Yearly Forecast Volume” or “YFV” for such Year). The YFV for the first Year in any such notice shall be [* * *]. Notwithstanding anything to the contrary in this Agreement, if Client provides a Yearly Forecast Volume for a Product in a Year prior to the relevant Product receiving Regulatory Approval, the YFV shall not be deemed binding and no Capacity Reservation Fee shall be owed for the subsequent Year if YFV is not ordered.
4.4Price Adjustments – Current Year Pricing.
During any Year, the Prices set out in Schedule B of a Product Agreement will be adjusted as follows:
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Master Manufacturing Services Agreement
4.5Adjustments Due to Technical Changes or Regulatory Authority Requirements.
Amendments to the Specifications or the Quality Agreement requested by Client will be implemented only following a technical and cost review that Patheon will perform [* * *] and are subject to Client and Patheon reaching agreement on Price changes, if any, required because of the amendment. The Parties shall use good faith efforts in discussing and working to reach agreement on any such required Price changes. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site requested by Patheon will only be implemented following the written approval of Client. If Client accepts a proposed Price change, the proposed change in the Specifications or the Quality Agreement and the associated scope of work will be implemented [* * *] and the Price change will become effective, only for those orders of Product that are manufactured under the revised Specifications. [* * *]
4.6Multi-Country Packaging Requirements.
If Client decides to have Patheon perform Manufacturing Services for the Product for countries outside the Territory, then Client will inform Patheon of the packaging requirements for each new country and Patheon will prepare a quotation for consideration by Client of any additional costs for Components (other than Client-Supplied Components) and the change-over fees for the Product destined for each new country. The agreed additional packaging requirements and related packaging costs and change over fees will be set out in a written amendment to the Product Agreement.
ORDERS, SHIPMENT, INVOICING, PAYMENT
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Master Manufacturing Services Agreement
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Master Manufacturing Services Agreement
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communicate any changes to the quota requirements for the then-current Year in sufficient time to allow Patheon to file and finalize DEA filings supporting the changes; (iv) upon Patheon receiving the necessary forecast information from Client in order to request additional quota, Patheon will submit to the DEA, on a timely basis, all filings necessary to obtain DEA or equivalent agency quotas for Active Materials and will use commercially reasonable efforts to secure sufficient quota from the DEA so as to achieve Delivery Dates for Product as set forth in applicable Firm Orders and forecasts submitted to Patheon by Client or its designee; and (v) Patheon will not be responsible for DEA’s refusal or failure to grant sufficient quota for reasons beyond the reasonable control of Patheon. |
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Master Manufacturing Services Agreement
Client may order Manufacturing Services for batches of Products only in multiples of the Minimum Order Quantities as set out in Schedule B to a Product Agreement.
Delivery of Products will be made [* * *] unless otherwise agreed in a Product Agreement. Subject to Section 8.3(a)(vi), risk of loss or of damage to Products will [* * *]. Products will be transported in accordance with the Specifications.
Invoices will be sent by email to the email address given by Client to Patheon in writing. Invoices will be issued when the Product is released by Patheon. Patheon will also submit to Client, with each shipment of Products, a duplicate copy of the invoice covering the shipment. Patheon will also give Client an invoice covering any Inventory or Components which are to be purchased by Client under Section 5.2 of this Agreement. Each invoice will, to the extent applicable, identify Client’s Manufacturing Services purchase order number, Product numbers, names and quantities, unit price, freight charges, and the total amount to be paid by Client. Client will pay all invoices within [* * *]; provided that if any portion of an invoice is disputed, Client will pay Patheon for the undisputed amount and the Parties will use good faith efforts to reconcile the disputed amount as soon as practicable. Interest on undisputed past due amounts will accrue at [* * *].
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Master Manufacturing Services Agreement
6.2Product Recalls and Returns.
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Master Manufacturing Services Agreement
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(b) |
Recalls. If (i) any Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a "Dear Doctor" letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all cGMPs and Applicable Laws. |
|
(c) |
Product Returns. Client will have the responsibility for handling customer returns of the Product. Patheon will give Client any assistance that Client may reasonably require to handle the returns. |
6.3Patheon’s Responsibility for Defective and Recalled Products.
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(c) |
Other than as set forth in Section 6.3(a) or Section 6.3(b), [* * *] |
6.4Disposition of Defective or Recalled Products.
Client will not dispose of any damaged, defective, returned, or Recalled Products for which it intends to assert a claim against Patheon without Patheon’s prior written authorization to do so. Alternatively, Patheon may instruct Client to return the Products to Patheon. [* * *]
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Master Manufacturing Services Agreement
6.5Healthcare Provider or Patient Questions and Complaints.
Client will have the sole responsibility for responding to questions and complaints from its customers. Questions or complaints received by Patheon from Client's customers, healthcare providers or patients will be promptly referred to Client. Patheon will co-operate as reasonably required to allow Client to determine the cause of and resolve any questions and complaints. This assistance will include follow-up investigations, including testing. In addition, Patheon will give Client all agreed upon information that will enable Client to respond properly to questions or complaints about the Product as set forth in the Quality Agreement. [* * *]
Each Party will forthwith upon execution of this Agreement appoint one of its employees to be a relationship manager responsible for liaison between the Parties, which employee may be a member of the Supply and Quality Committee. The relationship managers will meet not less than once per Calendar Quarter, including at Supply and Quality Committee meetings, to review the current status of the business relationship and manage any issues that have arisen.
Subject to Section 7.8, each Party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting Regulatory Approval for the Products, regarding the Products if, in the opinion of that Party's counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation. Unless, in the reasonable opinion of its counsel, there is a prohibition under one or more Applicable Laws against doing so, either Party will, where relevant, permit the other Party to accompany and take part in any communications with the agency, and to receive copies of all communications from the agency. Subject to Section 7.5, Patheon will lead all communications relating to the Manufacturing Site and Client will lead all Product-specific communications. Each Party will keep the other informed as appropriate.
7.3Records and Accounting by Patheon.
Patheon will keep records of the manufacture, testing, and shipping of the Products, and retain samples of the Products as are necessary to comply with manufacturing regulatory requirements applicable to Patheon, as well as to assist with resolving Product complaints and other similar investigations. Unless otherwise agreed to in the Quality Agreement, copies of the records and samples will be retained for [* * *], or longer if required by law or regulation, following which time Client will be
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Master Manufacturing Services Agreement
contacted concerning the delivery and destruction of the documents and/or samples of Products. Patheon reserves the right to destroy or return to Client, at Client’s sole expense, any document or samples for which the retention period has expired if Client fails to arrange for destruction or return within 30 days of receipt of notice from Patheon. Client is responsible for retaining samples of the Products necessary to comply with the legal/regulatory requirements applicable to Client.
Client may inspect Patheon reports and records relating to this Agreement, the Product Agreement or the Quality Agreement during normal business hours and with reasonable advance notice, but a Patheon representative must be present during the inspection.
Patheon will give Client reasonable access at agreed times to the areas of the Manufacturing Site in which the Products are manufactured, stored, handled, or shipped to permit Client to verify that the Manufacturing Services are being performed in accordance with the Specifications, cGMPs, and Applicable Laws. But, with the exception of “for-cause” audits, Client will be limited [* * *]. The right of access set forth in Section 7.4 and this Section 7.5 will not include a right to access or inspect Patheon’s financial records. [* * *]
7.6Notification of Regulatory Inspections.
Each Party will notify the other within [* * *] of any inspections by any governmental agency at the Manufacturing Site specifically involving the Products. Patheon will also notify Client of receipt of any form 483s or warning letters or any other significant regulatory action which Patheon’s quality assurance group determines in good faith could impact the regulatory status or supply of the Products.
Upon request, Patheon will supply on an annual basis a copy of the Annual Product Review Report which includes all Product data in its control, including release test results, complaint test results, and all investigations (in manufacturing, testing, and storage), that Client reasonably requires in order to complete any filing under any applicable regulatory regime, including any Annual Report that Client is required to file with the FDA. Any additional data or report requested by Client beyond the scope of cGMPs and customary FDA requirements, including Continuous Process Verification data, will be subject to an additional reasonable fee to be agreed upon in good faith between Patheon and Client.
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Master Manufacturing Services Agreement
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Master Manufacturing Services Agreement
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Regulatory Authority until Patheon has reviewed the requested documents; provided that such review shall take no longer than [* * *]; and until any deficiencies in the documentation relating to Patheon’s work are remedied. Any review by Patheon under this Section 7.8(f) shall be at no cost to Client. |
Patheon shall provide reasonable support and documentation to Client to enable Client to perform a technology transfer of the Product manufacturing process to a third party manufacturer who is to be a secondary source of supply. [* * *]
This Agreement will become effective as of the Effective Date and will continue for five years from the Effective Date (the "Initial Term"), unless terminated earlier by one of the Parties in accordance herewith. This Agreement will automatically renew after the Initial Term for successive terms of two Years each if there is a Product Agreement in effect, unless either Party gives written notice to the other Party of its intention to terminate this Agreement at least 18 months prior to the end of the then-current term, including the Initial Term (the Initial Term and any such renewal terms, collectively, the “Term”). In any event, the legal terms and conditions of this Agreement will continue to govern any Product Agreement in effect as provided in Section 1.2. Each Product Agreement will have an initial term from the Effective Date of the Product Agreement until December 31 of the Year agreed to by the Parties in the Product Agreement (each, an “Initial Product Term”). Product Agreements will automatically renew after the Initial Product Term for successive terms of two Years each unless either Party gives written notice to the other
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Master Manufacturing Services Agreement
Party of its intention to terminate the Product Agreement at least 18 months prior to the end of the then-current term, including the Initial Product Term.
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(b) |
Either Party at its sole option may immediately terminate this Agreement or a Product Agreement upon written notice, but without prior advance notice, to the other Party if: (i) the other Party is declared insolvent or bankrupt by a court of competent jurisdiction; (ii) a voluntary petition of bankruptcy is filed in any court of competent jurisdiction by the other Party; or (iii) this Agreement or a Product Agreement is assigned by the other Party for the benefit of creditors. |
8.3Obligations on Termination.
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(a) |
If a Product Agreement is completed, expires, or is terminated in whole or in part for any reason, then: |
|
(i) |
Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement (i.e. that are |
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Master Manufacturing Services Agreement
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conforming Products) that are not unmarketable due to the failure of Patheon or the Manufacturing Site to comply with Specifications, Applicable Laws or cGMPs under a Firm Order [* * *]; |
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(iv) |
Patheon shall provide reasonable support and documentation to Client to enable Client to perform a technology transfer of the Product manufacturing process to a third party manufacturer. [* * *]; |
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Master Manufacturing Services Agreement
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Client Property and it will be Client’s responsibility to have appropriate insurance coverage in place for this risk. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction. |
REPRESENTATIONS, WARRANTIES AND COVENANTS
Each Party covenants, represents and warrants that, as of the Effective Date it has the full right and authority to enter into this Agreement and that it is not aware of any impediment that would inhibit its ability to perform its obligations hereunder.
Client covenants, represents and warrants, that:
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(a) |
the Specifications for each of the Products are its or its Affiliate's property and that Client may lawfully disclose the Specifications to Patheon; |
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Master Manufacturing Services Agreement
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(c) |
as of the Effective Date, Client has received no written notification of any actions or other legal proceedings involving Client that claim the infringement of Third Party Rights by the [* * *]; |
Patheon covenants, represents, and warrants that:
|
(a) |
it will perform the Manufacturing Services in accordance with the Specifications, cGMPs, the Quality Agreement and Applicable Laws; |
|
(b) |
each Product at the time of delivery to Client shall (i) conform with Specifications, cGMPs and Applicable Laws, (ii) not be adulterated or misbranded within the meaning of the FD&C Act; |
|
(c) |
it will allocate reasonably adequate resources to execute its obligations under this Agreement or any Product Agreement on the basis of Client’s reasonable forecasts; |
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(d) |
any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights; |
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(e) |
[* * *]; |
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(f) |
it will not in the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b); |
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Master Manufacturing Services Agreement
PATHEON MAKES NO WARRANTY OR CONDITION OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW, OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS AGREEMENT. PATHEON MAKES NO WARRANTY OR CONDITION OF FITNESS FOR A PARTICULAR PURPOSE NOR ANY WARRANTY OR CONDITION OF MERCHANTABILITY FOR THE PRODUCTS.
ARTICLE 10
10.1Consequential and Other Damages.
Except [* * *]and except in cases of [ * * *] neither Party will be liable to the other for (i) any (direct or indirect) loss of profits, of anticipated savings, of business, or goodwill or (ii) any costs or expenditures incurred to evaluate the viability of entering into this Agreement or to prepare for performance under this Agreement or (iii) for any other liability, damage, costs, penalty, or expense of any kind incurred by the other Party of an indirect or consequential nature, regardless of any notice of the possibility of these damages, in each case whether in contract, tort, negligence, breach of statutory duty, or otherwise.
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(a) |
[* * *] |
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(b) |
[* * *] |
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(d) |
[* * *] |
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Master Manufacturing Services Agreement
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(b) |
If a claim occurs, Client will: (a) promptly notify Patheon of the claim; (b) use commercially reasonable efforts to mitigate the effects of the claim; (c) reasonably cooperate with Patheon in the defense of the claim; and (d) permit Patheon to control the defense and settlement of the claim, all at Patheon's cost and expense. But Patheon shall not be permitted to settle the claim in a manner that imposes any financial liability or other obligation on the part of Client or requires an admission of liability, wrongdoing or fault or a waiver of rights, on the part of Client, without Client’s prior written consent. |
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(b) |
If a claim occurs, Patheon will: (a) promptly notify Client of the claim; (b) use commercially reasonable efforts to mitigate the effects of the claim; (c) reasonably cooperate with Client in the defense of the claim; and (d) permit Client to control the defense and settlement of the claim, all at Client's cost and expense. But Client shall not be permitted to settle the claim in a manner that imposes any financial liability or other obligation on the part of Patheon or requires an admission of liability, wrongdoing or fault or a waiver of rights, on the part of Patheon, without Patheon’s prior written consent. |
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Master Manufacturing Services Agreement
10.5Reasonable Allocation of Risk.
This Agreement (including, without limitation, this ARTICLE 10) is reasonable and creates a reasonable allocation of risk for the relative profits the Parties each expect to derive from the Products. Patheon assumes only a limited degree of risk arising from the manufacture, distribution, and use of the Products because Client has developed and holds the marketing approval for the Products, Client requires Patheon to manufacture and label the Products strictly in accordance with the Specifications, and Client, not Patheon, is best positioned to inform and advise potential users about the circumstances and manner of use of the Products.
“Confidential Information” means any information disclosed by the Disclosing Party to the Recipient (whether disclosed in oral, written, electronic or visual form) that is non-public, confidential or proprietary including, without limitation, information relating to the Disclosing Party’s patent and trademark applications, process designs, process models, drawings, plans, designs, data, databases and extracts therefrom, formulae, methods, know-how and other Intellectual Property, its clients or client confidential information, finances, marketing, products and processes and all price quotations, manufacturing or professional services proposals, information relating to composition, proprietary technology, and all other information relating to manufacturing capabilities and operations. In addition, all analyses, compilations, studies, reports or other documents prepared by any Party's Representatives containing the Confidential Information will be considered Confidential Information. Samples or materials provided hereunder as well as any and all information derived from the approved analysis of the samples or materials will also constitute Confidential Information. For the purposes of this ARTICLE 11, a Party or its Representative receiving Confidential Information under this Agreement is a “Recipient”, and a Party or its Representative disclosing Confidential Information under this Agreement is the “Disclosing Party”.
11.2Use of Confidential Information.
The Recipient will use the Confidential Information solely for the purpose of meeting its obligations under this Agreement. The Recipient will keep the Confidential Information strictly confidential and will not disclose the Confidential Information in any manner whatsoever, in whole or in part, other than to those of its Representatives who (i) have a need to know the Confidential Information for the purpose of this Agreement; (ii) have been advised of the confidential nature of the Confidential Information and (iii) have obligations of confidentiality and non-use to the Recipient no less restrictive than those of this Agreement. Recipient will protect the Confidential Information disclosed to it by using reasonable precautions to prevent the unauthorized disclosure, dissemination or use of the Confidential Information, which precautions will in no event be less than those exercised by Recipient with respect to its own confidential or proprietary Confidential Information of a similar nature.
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Master Manufacturing Services Agreement
The obligations of confidentiality will not apply to the extent that the information:
|
(a) |
is or becomes publicly known through no breach of this Agreement or fault of the Recipient or its Representatives; |
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(b) |
is in the Recipient's possession at the time of disclosure by the Disclosing Party other than as a result of the Recipient's breach of any legal obligation; |
|
(d) |
is independently developed by the Recipient without use of or reference to the Disclosing Party's Confidential Information as evidenced by Recipient’s written records; or |
|
(e) |
is expressly authorized for release by the written authorization of the Disclosing Party. |
Any combination of information which comprises part of the Confidential Information are not exempt from the obligations of confidentiality merely because individual parts of that Confidential Information were publicly known, in the Recipient’s possession, or received by the Recipient, unless the combination itself was publicly known, in the Recipient’s possession, or received by the Recipient.
11.4Photographs and Recordings.
Neither Party will take any photographs or videos of the other Party’s facilities, equipment or processes, nor use any other audio or visual recording equipment (such as camera phones) while at the other Party’s facilities, without that Party’s express written consent.
Notwithstanding any other provision of this Agreement, the Recipient may disclose Confidential Information of the Disclosing Party to the extent required, as advised by counsel, in response to a valid order of a court or other governmental body or as required by law, regulation or stock exchange rule. But the Recipient will advise the Disclosing Party in advance of the disclosure to the extent practicable and permissible by the order, law, regulation or stock exchange rule and any other Applicable Laws, will reasonably cooperate with the Disclosing Party, if required, in seeking an appropriate protective order or other remedy, and will otherwise continue to perform its obligations of confidentiality set out herein. If any public disclosure is required by law, the Parties will consult concerning the form of announcement prior to the public disclosure being made.
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Master Manufacturing Services Agreement
The Disclosing Party will use reasonable efforts to summarize in writing the content of any oral disclosure or other non-tangible disclosure of Confidential Information within [* * *] of the disclosure, but failure to provide this summary will not affect the nature of the Confidential Information disclosed if the Confidential Information was identified as confidential or proprietary when disclosed orally or in any other non-tangible form.
11.7Return of Confidential Information.
Upon the written request of the Disclosing Party, the Recipient will promptly return the Confidential Information to the Disclosing Party or, if the Disclosing Party directs, destroy all Confidential Information disclosed in or reduced to tangible form including any copies thereof and any summaries, compilations, analyses or other notes derived from the Confidential Information except for one copy which may be maintained by the Recipient for its records. The retained copy will remain subject to all confidentiality provisions contained in this Agreement.
The Parties acknowledge that monetary damages may not be sufficient to remedy a breach by either Party of this ARTICLE 11 and agree that the non-breaching Party will be entitled to seek specific performance, injunctive and/or other equitable relief to prevent breaches of this ARTICLE 11 and to specifically enforce the provisions hereof in addition to any other remedies available at law or in equity. These remedies will not be the exclusive remedies for breach of this ARTICLE 11 but will be in addition to any and all other remedies available at law or in equity.
If any dispute arises out of this Agreement or any Product Agreement (other than a dispute under Section 6.1(b) or a Technical Dispute, as defined herein), the Parties will first try in good faith to resolve it in meetings of the Supply and Quality Committee. If the Supply and Quality Committee fails to resolve the matter within [* * *], the dispute will immediately be referred to the Chief Operating Officer (or another officer as he/she may designate) of each Party who will meet and discuss as necessary to try to resolve the dispute amicably. Should the Parties fail to reach a resolution under this Section 12.1, the dispute will be referred to arbitration in accordance with Section 13.17(a).
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Master Manufacturing Services Agreement
12.2Technical Dispute Resolution.
If a dispute arises (other than disputes under Section 12.1) between the Parties that is exclusively related to technical aspects of the manufacturing, packaging, labelling, quality control testing, handling, storage, or other activities under this Agreement (a “Technical Dispute”), the Parties will make all reasonable efforts to resolve the dispute by good faith negotiations in the Supply and Quality Committee. In that regard, the Supply and Quality Committee will, as soon as possible and in any event no later than [* * *] after a written request from either Party to the other, meet in good faith to resolve any Technical Dispute. If, despite this meeting, the Parties are unable to resolve a Technical Dispute within a reasonable time, and in any event within [* * *] of the written request, the Technical Dispute will, at the request of either Party, be referred for determination to an expert in accordance with Exhibit A. If the Parties cannot agree using good faith efforts that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater certainty, the Parties agree that the release of the Products for sale or distribution under the applicable marketing approval for the Products will not by itself indicate compliance by Patheon with its obligations for the Manufacturing Services and further that nothing in this Agreement (including Exhibit A) will remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are to be released for sale or distribution.
|
(c) |
All Patheon Intellectual Property will be the exclusive property of Patheon. Patheon hereby grants to Client a perpetual, irrevocable, non-exclusive, paid-up, royalty-free |
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
|
(d) |
Each Party will be solely responsible for the costs of filing, prosecution, and maintenance of patents and patent applications on its own Inventions. |
Neither Party has, nor will it acquire, any interest in any of the other Party’s Intellectual Property unless otherwise expressly agreed to in writing. Neither Party will use any Intellectual Property of the other Party, except as specifically authorized by the other Party or as required for the performance of its obligations under this Agreement.
13.3Compliance with Tufts License.
|
(a) |
Patheon agrees that it will not use the name “Tufts University”, or any variant thereof, or identify Tufts or any portion of Tufts, or any inventor of any Tufts Technology, as a party |
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
|
to the Tufts License or this Agreement, or as a participant in inventing the inventions within the Tufts Technology or creating the Tufts Technology, including, without limitation, any advertising or promotional sales literature, without the prior express written consent of Client, which consent may be withheld or withdrawn by Client in its complete and uncontrolled discretion for any reason whatsoever and at any time or times. Patheon shall impose and enforce the requirements of this Section 13.3.1(a) on its Affiliates. |
|
(b) |
Patheon hereby agrees and gives its assurance to Tufts that Patheon will not, unless any required prior authorization is obtained from the U.S. Office of Export Control, re-export directly or indirectly any technical data within the Tufts Technology and will not export directly the Products or such technical data to any country listed on either the Commodity Control List or Militarily-Critical Technologies List. Tufts makes no representation as to whether any such license is required or, if one is required, as to whether it will be issued by the U.S. Department of Commerce. In addition to the foregoing export control requirements, Patheon agrees that it and its subsidiaries will comply with all applicable mandatory or permissive patent marking laws, rules, and regulations and comply with all other laws, rules, and regulations of all governmental authorities applicable to any of their activities contemplated by this Agreement, and will comply with all necessary and desirable practices in connection and compliance with safety recommendations of trade associations or governmental authorities. |
|
(i) |
TUFTS MAKES NO REPRESENTATIONS, EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED (INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR PURPOSE), AND ASSUMES NO RESPONSIBILITIES WHATSOEVER, WITH RESPECT TO THE TUFTS TECHNOLOGY OR THE USE THEREOF, OR THE MANUFACTURE, POSSESSION, USE OR OTHER DISPOSITION BY TUFTS, THE PARTIES OR ANYONE ELSE, OF PRODUCTS OR ANY OTHER PRODUCTS OR SERVICES (INCLUDING, WITHOUT LIMITATION, PRODUCTS MADE BY TUFTS, AND TUFTS SERVICES, THAT ARE OR WERE FURNISHED TO A PARTY AT ANY TIME BEFORE, ON OR AFTER THE EFFECTIVE DATE). |
|
(ii) |
Without limitation of the foregoing generality, nothing contained herein or in any disclosure of the Tufts Technology made by or on behalf of Tufts shall be construed as extending any representation or warranty with respect to the Tufts Technology or Products or the results to be obtained by the use of the Client Intellectual Property or any Products, or that anything made, used, or sold by use of the Tufts Technology or any part thereof, alone or in combination, will be free from infringement of patents of third parties. |
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
In the event of any expiration or termination of the Tufts License for any reason, the license granted to Patheon under Section 13.1(a) shall automatically terminate with respect to the Tufts Technology.
13.3.2 |
[* * *] |
13.3.4 |
If a claim is made by [* * *] which falls within the scope of Section 13.3.3, [* * *] |
Each Party will maintain commercial general liability insurance, including blanket contractual liability insurance covering the obligations of that Party under this Agreement through the term of this Agreement and for a period of [* * *] thereafter. Patheon’s insurance policy will have policy limits of not less than [* * *]. If requested Patheon will give Client a certificate of insurance evidencing the above and showing the name of the issuing company, the policy number, the effective date, the expiration date, and the limits of liability. Such insurance certificate will further provide for a minimum of [* * *] written notice to the insured of a cancellation of, or material change in, the insurance.
The Parties are independent contractors and this Agreement and any Product Agreement will not be construed to create between Patheon and Client any other relationship such as, by way of
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
example only, that of employer-employee, principal agent, joint-venturer, co-partners, or any similar relationship, the existence of which is expressly denied by the Parties.
Neither Party's failure to require the other Party to comply with any provision of this Agreement or any Product Agreement will be deemed a waiver of the provision or any other provision of this Agreement or any Product Agreement, with the exception of Sections 6.1 and 8.2 of this Agreement.
13.7Assignment and Subcontracting.
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
Neither Party will be liable for the failure to perform its obligations under this Agreement or any Product Agreement if the failure is caused by an event beyond that Party's reasonable control and without that Party’s fault or negligence (a "Force Majeure Event"). A Party claiming a right to excused performance under this Section 13.8 will immediately notify the other Party in writing of the extent of its inability to perform, which notice will specify the event beyond its reasonable control that prevents the performance. Neither Party will be entitled to rely on a Force Majeure Event to relieve it from an obligation to pay money (including any interest for delayed payment) which would otherwise be due and payable under this Agreement or any Product Agreement.
Additional Products may be added to, or existing Products deleted from, any Product Agreement by amendments to the Product Agreement including Schedules A, B, C, and D as applicable.
Unless otherwise agreed in a Product Agreement, any notice, approval, instruction or other written communication required or permitted hereunder will be sufficient if made or given to the other Party by personal delivery or confirmed receipt email or by sending the same by first class mail, postage prepaid to the respective addresses or electronic mail addresses set forth below:
If to Client:
Email addresses (any notice to be sent to both): [* * *]
If to Patheon:
Patheon UK Limited
Kingfisher Drive
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
Xxxxxxx XX0 0XX
Xxxxxx Xxxxxxx
Attention: [* * *]
or to any other addresses or electronic mail addresses given to the other Party in accordance with the terms of this Section 13.10. Notices or written communications made or given by personal delivery, or electronic mail will be deemed to have been sufficiently made or given when sent (receipt acknowledged), or if mailed, five days after being deposited in the United States, Canada, or European Union mail, postage prepaid or upon receipt, whichever is sooner.
If any provision of this Agreement or any Product Agreement is determined by a court of competent jurisdiction to be invalid, illegal, or unenforceable in any respect, that determination will not impair or affect the validity, legality, or enforceability of the remaining provisions, because each provision is separate, severable, and distinct.
This Agreement, together with the applicable Product Agreement and the Quality Agreement, constitutes the full, complete, final and integrated agreement between the Parties relating to the subject matter hereof and supersedes all previous written or oral negotiations, commitments, agreements, transactions, or understandings concerning the subject matter hereof. Any modification, amendment, or supplement to this Agreement or any Product Agreement must be in writing and signed by authorized representatives of both Parties. In case of conflict, the prevailing order of documents will be this Agreement, the Product Agreement, and the Quality Agreement.
No terms, provisions or conditions of any purchase order or other business form or written authorization used by Client or Patheon will have any effect on the rights, duties, or obligations of the Parties under or otherwise modify this Agreement or any Product Agreement, regardless of any failure of Client or Patheon to object to the terms, provisions, or conditions unless the document specifically refers to this Agreement or the applicable Product Agreement and is signed by both Parties.
13.14No Third Party Benefit or Right.
For greater certainty, nothing in this Agreement or any Product Agreement will confer or be construed as conferring on any third party any benefit or the right to enforce any express or implied term of this Agreement or any Product Agreement.
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
13.15Execution in Counterparts.
This Agreement and any Product Agreement may be executed in two or more counterparts, by original, facsimile or “pdf” signature, each of which will be deemed an original, but all of which together will constitute one and the same instrument.
Patheon will not make any use of Client’s name, trademarks or logo or any variations thereof, alone or with any other word or words (including in customer lists or related marketing and promotion material), without the prior written consent of Client, which consent will not be unreasonably withheld.
|
(b) |
Notwithstanding Section 13.17(a), 13.17(c) or 13.17(f), Patheon shall be responsible for (i) any taxes or Duties that are recoverable by Patheon or its Affiliates in the ordinary course of business for purchases made by Patheon in the course of providing its Manufacturing Services, such as VAT, (ii) any Tax based on net income or gross income that is imposed on Patheon or its Affiliates by its respective jurisdiction of formulation or incorporation (“Resident Jurisdiction”), or (iii) any Tax based on net income or gross income that is imposed on Patheon or its Affiliates by jurisdictions other than its respective Resident Jurisdiction if this tax is based on a permanent establishment or the location of the conduct of business of Patheon or its Affiliates. However, if Patheon is acting as Client’s buying agent, Patheon will always charge to the Client VAT in the relevant territory in addition to the amount paid by Patheon to supplier. |
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
|
certificate is furnished by Client to Patheon. “FATCA” as used in this Section 13.17(c) refers to Sections 1471 through 1474 of the Code, as of the date of this Agreement (or any amended or successor version thereof or any similar non-U.S. law), any current or future regulations or official interpretations thereof (including any Revenue Ruling, Revenue Procedure, Notice or similar guidance issued by the IRS thereunder as a precondition to relief or exemption from taxes under such provisions), and any intergovernmental agreements and any agreements entered into pursuant to Section 1471(b) of the Code. |
|
(d) |
The Parties shall each make reasonable efforts to, and reasonably cooperate with each other to, recover, eliminate or minimize the amount of any such taxes or Duties imposed on or arising from the transactions contemplated in this Agreement at all times in accordance with Applicable Laws and good practice. |
|
(e) |
Any Tax that Client pays, or is required to pay, but which Client believes should properly be paid by Patheon pursuant hereto may not be offset against sums due by Client to Patheon whether due pursuant to this Agreement or otherwise. |
|
(f) |
[* * *] |
|
(g) |
If Patheon (i) receives any refund (whether by payment, offset, credit or otherwise) or (ii) utilizes any overpayment of taxes to reduce a tax that would otherwise have been the responsibility of Patheon, in each case, with respect to taxes that are borne by Client pursuant to this Agreement, then Patheon will promptly pay, or cause to be paid, to Client the amount of such refund or overpayment (including, for the avoidance of doubt, any interest or other amounts received with respect to such refund or overpayment), net of any additional taxes Patheon incurs or will incur as a result of the receipt of such refund or such overpayment. |
13.18Governing Law.
This Agreement and any Product Agreement, unless otherwise agreed by the Parties in the Product Agreement and then only for the purposes of that Product Agreement, will be construed and enforced in accordance with the laws of England, without regard to the conflict of laws principles thereof. All disputes arising out of or in connection with the present contract shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by one or more arbitrators appointed in accordance with said Rules. The seat of the arbitration shall be Boston, MA, USA. The UN Convention on Contracts for the International Sale of Goods will not apply to this Agreement.
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
Each Party shall duly execute and deliver or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
13.20Supply and Quality Committee
|
(d) |
Decision-Making. All of each Party’s representatives on the Supply and Quality Committee shall collectively have [* * *] with respect to decisions before the Supply and Quality Committee. All decisions of the Supply and Quality Committee must be made by unanimous consent, which shall be documented in written minutes of the Supply and Quality Committee and signed by a representative of each Party. |
[Signature page to follow]
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
IN WITNESS WHEREOF, the duly authorized representatives of the Parties have executed this Agreement as of the Effective Date.
PATHEON UK LIMITED
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By: |
/s/ Xxxxxx Xxxxxxxx |
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Name: |
Xxxxxx Xxxxxxxx |
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|
Title: |
Director |
|
|
Date: |
7/28/17 |
|
PARATEK PHARMACEUTICALS INC.
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By: |
/s/ Xxxxxxx X. Xxxxxx |
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Name: |
Xxxxxxx X. Xxxxxx |
|
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Title: |
SVP, General Counsel and Corporate Secretary |
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|
Date: |
7/28/17 |
|
[Signature page to Master Manufacturing Services Agreement]
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
FORM OF PRODUCT AGREEMENT
(Includes Schedules A to D)
PRODUCT AGREEMENT
This Product Agreement (this “Product Agreement”) is issued under the Master Manufacturing Services Agreement dated July 28, 2017 between Patheon UK Limited and Paratek Pharmaceuticals Inc. (the “Master Agreement”), and is entered into [insert effective date] (the “Effective Date”), between Patheon UK Limited, a corporation existing under the laws of England [or applicable founding jurisdiction for Patheon Affiliate], having a principal place of business at Xxxxxxxxxx Xxxxx, Xxxxxxxxx, Xxxxxxx, XX0 0XX, Xxxxxxx (“Patheon”) and Paratek Pharmaceuticals Inc. a corporation existing under the laws of Delaware, of 0xx Xxxxx, 00 Xxxx Xxxxx, Xxxxxx, XX 00000, XXX (“Client”).
The terms and conditions of the Master Agreement are incorporated herein except to the extent this Product Agreement expressly references the specific provision in the Master Agreement to be modified by this Product Agreement. All capitalized terms that are used but not defined in this Product Agreement will have the respective meanings given to them in the Master Agreement.
The Schedules to this Product Agreement are incorporated into and will be construed in accordance with the terms of this Product Agreement.
|
1. |
Product List and Specifications (See Schedule A attached hereto) |
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2. |
Minimum Order Quantity, Annual Volume, and Price (See Schedule B attached hereto) |
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3. |
Annual Stability Testing and Validation Activities (if applicable) (See Schedule C attached hereto) |
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4. |
Active Materials[* * *] (See Schedule D attached hereto) |
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5. |
[* * *] |
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6. |
Territory: (insert the description of the Territory here) |
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7. |
Manufacturing Site: (insert address of Patheon Manufacturing Site where the Manufacturing Services will be performed) |
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
[* * *]
|
10. |
Initial Product Term: (per Section 8.1 of the Master Agreement) from the Effective Date until December 31, 20__ |
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12. |
Other Modifications to the Master Agreement: (if applicable under Section 1.2 of the Master Agreement) |
|
13. |
[* * *] |
________________________________________
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
IN WITNESS WHEREOF, the duly authorized representatives of the Parties have executed this Product Agreement as of the Effective Date set forth above.
PATHEON UK LIMITED
By: _____________________________
Name: ___________________________
Title: _____________________________
Date: ______________________________
PARATEK PHARMACEUTICALS INC.
By: _____________________________
Name: ___________________________
Title: _____________________________
Date: _____________________________
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
SCHEDULE A
PRODUCT LIST AND SPECIFICATIONS
Product List
[insert product list]
Specifications
Prior to the start of commercial manufacturing of Product under this Agreement, Client will give Patheon the originally executed copies of the Specifications as approved by the applicable Regulatory Authority, which shall be appropriately referred to in the Quality Agreement. If the Specifications received are subsequently amended, then Client will give Patheon the revised and originally executed copies of the revised Specifications. Upon acceptance of the revised Specifications, Patheon will give Client a signed and dated receipt indicating Patheon’s acceptance of the revised Specifications.
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
[* * *] PRICE
[Insert Price Table] |
Manufacturing Assumptions:
Packaging Assumptions:
Testing Assumptions:
The following cost items are included in the Price for the Products:
|
• |
[* * *] |
The following cost items are not included in the Price for the Products:
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• |
[* * *] |
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
ANNUAL STABILITY TESTING [and VALIDATION ACTIVITIES (if applicable)]
Patheon and Client will agree in writing on any stability testing to be performed by Patheon on the Products. This agreement will specify the commercial and Product stability protocols applicable to the stability testing and the fees payable by Client for this testing including the Price for the Product withdrawn for the stability testing.
[NTD: Schedule C should clearly indicate when and/or under what conditions Patheon’s responsibility to perform stability testing will end]
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
ACTIVE MATERIALS
Active Materials |
Supplier |
• |
• |
• |
• |
[* * *]
[End of Product Agreement]
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
TECHNICAL DISPUTE RESOLUTION
Technical Disputes which cannot be resolved by negotiation as provided in Section 12.2 will be resolved in the following manner:
1.Appointment of Expert. Within [* * *] after a Party requests under Section 12.2 that an expert be appointed to resolve a Technical Dispute, the Parties will jointly appoint a mutually acceptable expert with experience and expertise in the subject matter of the dispute. If the Parties are unable to so agree within the [* * *] period, or if there is a disclosure of a conflict by an expert under Paragraph 2 hereof which results in the Parties not confirming the appointment of the expert, then an expert (willing to act in that capacity hereunder) will be appointed by an experienced arbitrator on the roster of the American Arbitration Association.
2.Conflicts of Interest. Any person appointed as an expert will be entitled to act and continue to act as an expert even if at the time of his appointment or at any time before he gives his determination, he has or may have some interest or duty which conflicts or may conflict with his appointment if before accepting the appointment (or as soon as practicable after he becomes aware of the conflict or potential conflict) he fully discloses the interest or duty and the Parties will, after the disclosure, have confirmed his appointment.
3.[* * *]
4.Procedure. Where an expert is appointed:
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(a) |
Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the Parties and that he issues the authorizations to the Parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within [* * *] (or another date as the Parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof. |
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(c) |
Advisors. Each Party may appoint any counsel, consultants and advisors as it feels appropriate to assist the expert in his determination and so as to present their respective cases so that at all times the Parties will co-operate and seek to narrow and limit the issues to be determined. |
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
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(e) |
Final and Binding. The determination of the expert will, except for fraud or manifest error, be final and binding upon the Parties. |
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(f) |
Costs. Each Party will bear its own costs for any matter referred to an expert hereunder and, in the absence of express provision in the Agreement to the contrary, the costs and expenses of the expert will be shared equally by the Parties. |
For greater certainty, the release of the Products for sale or distribution under the applicable marketing approval for the Products will not by itself indicate compliance by Patheon with its obligations for the Manufacturing Services and further nothing in this Agreement (including this Exhibit A) will remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are to be released for sale or distribution.
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Master Manufacturing Services Agreement
QUARTERLY ACTIVE MATERIALS INVENTORY REPORT
TO:Paratek Pharmaceuticals Inc.
FROM:PATHEON UK LIMITED [or applicable Patheon Affiliate]
RE: |
Active Materials quarterly inventory report under Section 2.2(a) of the Master Manufacturing Services Agreement dated • (the "Agreement") |
Reporting quarter: |
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Active Materials on hand at beginning of quarter: |
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kg |
(A) |
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Active Materials on hand at end of quarter: |
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kg |
(B) |
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Quantity Received during quarter: |
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kg |
(C) |
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Quantity Dispensed1 during quarter: |
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kg |
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(A + C – B) |
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Quantity Converted during quarter: |
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kg |
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(total Active Materials in Products produced |
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and not rejected, recalled or returned or in work-in-process) |
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Capitalized terms used in this report have the meanings given to the terms in the Agreement.
PATHEON UK LIMITED |
DATE: |
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[or applicable Patheon Affiliate] |
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Per: |
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Name: |
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Title: |
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
[* * *]
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
This Product Agreement (this “Product Agreement”) is issued under the Master Manufacturing Services Agreement dated July 28, 2017 between Patheon UK Limited and Paratek Pharmaceuticals Inc. (the “Master Agreement”), and is entered into as of July 28, 2017 (the “Effective Date”), between Patheon UK Limited, a corporation existing under the laws of England, having a principal place of business at Xxxxxxxxxx Xxxxx, Xxxxxxxxx, Xxxxxxx, XX0 0XX, Xxxxxxx (“Patheon”) and Paratek Pharmaceuticals Inc. a corporation existing under the laws of Delaware, of 0xx Xxxxx, 00 Xxxx Xxxxx, Xxxxxx, XX 00000, XXX (“Client”).
The terms and conditions of the Master Agreement are incorporated herein except to the extent this Product Agreement expressly references the specific provision in the Master Agreement to be modified by this Product Agreement. All capitalized terms that are used but not defined in this Product Agreement will have the respective meanings given to them in the Master Agreement.
The Schedules to this Product Agreement are incorporated into and will be construed in accordance with the terms of this Product Agreement.
|
14. |
Product List and Specifications (See Schedule A attached hereto). |
|
15. |
Minimum Order Quantity Annual Volumes and Price (See Schedule B attached hereto). |
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16. |
Annual Stability Testing (See Schedule C attached hereto). |
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17. |
Active Materials[* * *] (See Schedule D attached hereto). |
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18. |
[* * *] |
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19. |
Territory: [* * *] |
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20. |
Manufacturing Site: [* * *] |
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21. |
Inflation Index: the inflation index is, the consumer Price Index, published by ISTAT. This index is set forth at the following web address: xxxx://xxxx.xxxxxx.xx/?xxxxxxx |
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22. |
Currency: US Dollars |
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23. |
[* * *] |
|
24. |
Initial Product Term: per Section 8.1 of the Master Agreement, from the Effective Date until December 31, 2022. |
|
25. |
Notices: As stated in Section 13.10 of the Master Agreement |
26. |
Other Modifications to the Master Agreement: |
[* * *]
[Signature page to Product Agreement]
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
IN WITNESS WHEREOF, the duly authorized representatives of the Parties have executed this Product Agreement as of the Effective Date set forth above.
PARATEK PHARMACEUTICALS INC.
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By: |
/s/ Xxxxxxx X. Xxxxxx |
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|
Name: |
Xxxxxxx X. Xxxxxx |
|
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Title: |
SVP, General Counsel and Corporate Secretary |
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Date: |
7/27/17 |
|
[Signature page to Product Agreement]
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
PRODUCT LIST AND SPECIFICATIONS
Product List
Product |
Vial Size |
Fill Volume |
Lyo Cycle Duration |
Packaging Configuration |
PTK0796 lyophilized vials |
[* * *] |
[* * *] |
[* * *] |
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Specifications
Prior to the start of commercial manufacturing of Product under this Agreement, Client will give Patheon the originally executed copies of the Specifications as approved by the applicable Regulatory Authority, which shall be appropriately referred to in the Quality Agreement. If the Specifications received are subsequently amended, then Client will give Patheon the revised and originally executed copies of the revised Specifications. Upon acceptance of the revised Specifications, Patheon will give Client a signed and dated receipt indicating Patheon’s acceptance of the revised Specifications.
[Signature page to Product Agreement]
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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Manufacturing Assumptions:
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Packaging Assumptions:
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Testing Assumptions:
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Cleaning Assumptions:
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Supply Chain Assumptions:
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The following cost items are included in the Price for the Products:
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The following cost items are not included in the Price for the Products:
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
ANNUAL STABILITY TESTING
Patheon and Client will agree in writing on any stability testing to be performed by Patheon on the Products. The Quality Agreement will specify the commercial and Product stability protocols applicable to the stability testing and the fees payable by Client for this testing including the Price for the Product withdrawn for the stability testing.
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
ACTIVE MATERIALS
Active Materials |
Supplier |
ptk0796 |
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