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Manufacturing Collaboration and Services Agreement
M nchensteinerstrasse 38
- hereinafter Lonza -
Aurinia Pharmaceuticals Inc.
1203-4464 Markham Street
Victoria BC V8Z 7X8 Canada
Effective as of 22 November 2016 (the Effective Date )
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| Page | ||||||
| 1 | Definitions and Interpretation | 1 | ||||
| 2 | Performance of Services | 6 | ||||
| 3 | Project Management / Steering Committee | 8 | ||||
| 4 | Quality | 9 | ||||
| 5 | Insurance | 10 | ||||
| 6 | Forecasting, Ordering and Cancellation | 10 | ||||
| 7 | Delivery and Acceptance | 12 | ||||
| 8 | Price and Payment | 13 | ||||
| 9 | Capital Equipment | 14 | ||||
| 10 | Intellectual Property | 15 | ||||
| 11 | Warranties | 17 | ||||
| 12 | Indemnification and Liability | 18 | ||||
| 13 | Confidentiality | 19 | ||||
| 14 | Term and Termination | 20 | ||||
| 15 | Force Majeure | 21 | ||||
| 16 | Miscellaneous | 22 |
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WHEREAS, Customer is engaged in the development
and research of certain products and requires assistance in the development and manufacture of its proprietary product voclosporin;
its Affiliates have expertise in the evaluation, development and manufacture of products;
WHEREAS, Customer wishes to engage Lonza for Services relating
to the development and manufacture of the Product as described in this Agreement; and
WHEREAS, Lonza, or its Affiliate, is prepared to perform such
Services for Customer on the terms and subject to the conditions set out herein.
NOW, THEREFORE, in consideration of the mutual promises contained
herein, and for other good and valuable consideration, the parties intending to be legally bound, agree as follows:
| Affiliate | means, as of any point in time and for as long as such relationship continues to exist, any company, partnership or other entity which directly or indirectly Controls, is Controlled by or is under common Control with the relevant Party. Control means the ownership of more than fifty percent (50%) of the issued share capital or the legal power to direct or cause the direction of the general management and policies of the relevant Party. | |
| Agreement | means this agreement incorporating all Appendices, as amended from time to time by written agreement of the Parties. | |
| Applicable Laws | means all relevant U.S., Japanese, Canadian and European Union federal, state and local laws, statutes, rules, and regulations which are applicable to a Party s activities hereunder, including the applicable regulations and guidelines of any Governmental Authority and all applicable cGMP together with amendments thereto. | |
| Approval | means the first marketing approval by the FDA or EMA of Product from the Facility for commercial supply. |
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| Background Intellectual Property | means, subject to Clause 10.2, any Intellectual Property either (i) owned or controlled by a Party prior to the Effective Date or (ii) developed or acquired by a Party independently from the performance of the Services hereunder during the Term of this Agreement. | |
| Batch | means the Product derived from a single run of the Manufacturing Process. | |
| Batch Price | means the Price of each Batch. | |
| Campaign | means a series of no less than three (3) cGMP Batches manufactured consecutively. | |
| Cancellation Fee | has the meaning given in Clause 6.5. | |
| Capital Equipment | means those certain pieces of equipment described in the Project Plan used to produce the Product that are purchased by Customer or for which Customer reimburses Lonza, including the related documentation regarding the design, validation, operation, calibration and maintenance of such equipment. | |
| Certificate of Analysis | means a document prepared by Lonza listing tests performed by Lonza or approved External Laboratories, the Specifications and test results. | |
| cGMP | means those laws and regulations applicable in the U.S., Japan, Canada and Europe, relating to the manufacture of medicinal products for human use, including current good manufacturing practices as specified in the ICH guidelines, including ICH Q7A ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients , US Federal Food Drug and Cosmetic Act at 21CFR (Chapters 210, 211, 600 and 610) and the Guide to Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 91/356/EEC. For the avoidance of doubt, Lonza s operational quality standards are defined in internal cGMP policy documents. |
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| cGMP Batches | means any Batches which are required under the Project Plan to be manufactured in accordance with cGMP. | |
| Change | means any change to the Services, pricing or Scope of Work incorporated into a written amendment to the Agreement in accordance with Clause 16.2 or effected in accordance with the Quality Agreement. | |
| Commencement Date | means the date of commencement of manufacturing activities for a Batch hereunder. | |
| Confidential Information | means Customer Information and Lonza Information, as the context requires. | |
| Customer Information | means all technical and other information not known to Lonza (excluding information known to Lonza pursuant to the Isotechnika Agreements) or in the public domain relating to the Manufacturing Process or the Product disclosed from time to time by the Customer to Lonza, including any materials supplied by Customer to Lonza in accordance with the Project Plan. | |
| Customer Materials | means any Raw Materials, components of Product, or other materials of any nature provided by or on behalf of Customer under this Agreement. | |
| EMA | means the European Medicines Agency, or any successor agency thereto. | |
| Engineering Batches | means a Batch that is intended to demonstrate the transfer of the Manufacturing Process to the Facility. | |
| External Laboratories | means any Third Party instructed by Lonza, with Customer s prior consent, which is to conduct activities required to complete the Services. | |
| Facility | means Lonza s manufacturing facilities in Visp, Switzerland or such other Lonza facility as may be agreed upon by the Parties. | |
| FDA | means the United States Food and Drug Administration, or any successor agency thereto. |
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| Governmental Authority | means any Regulatory Authority and any national, multi-national, regional, state or local regulatory agency, department, bureau, or other governmental entity in the U.S., Japan, Canada or European Union. | |
| Intellectual Property | means (i) inventions (whether or not patentable), patents, trade secrets, copyrights, trademarks, trade names and domain names, rights in designs, rights in computer software, database rights, rights in confidential information (including know-how) and any other intellectual property rights, in each case whether registered or unregistered, (ii) all applications (or rights to apply) for, and renewals or extensions of, any of the rights described in the foregoing clause (i) and (iii) and all rights and applications that are similar or equivalent to the rights and application described in the foregoing clauses (i) and (ii), which exist now, or which come to exist in the future, in any part of the world. | |
| Isotechnika Agreements | Isotechnika Lona Toll Manufacturing Agreement of March 4, 2008 and June 7, 2004 between Isotechnika Inc. and Lonza. | |
| Lonza Information | means all technical and other information not known to Customer or in the public domain that is proprietary to Lonza or any Affiliate of Lonza and that is maintained in confidence by Lonza or any Affiliate of Lonza that is disclosed by Lonza or any Affiliate of Lonza to Customer under or in connection with this Agreement. | |
| Manufacturing Process | means the production process provided by Customer for the manufacture of Product, as such process may be improved or modified from time to time by agreement of the Parties in writing. | |
| Master Batch Record | means the document, proposed by Lonza and approved by Customer, which defines the manufacturing methods, test methods and other procedures, directions and controls associated with the manufacture and testing of Product. | |
| New Customer Intellectual Property | has the meaning given in Clause 10.2. |
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| New General Application Intellectual Property | has the meaning given in Clause 10.3. | |
| Party | means each of Lonza and Customer and, together, the Parties . | |
| Price | means the price for the Services and Products as set out in Appendix A. | |
| Process Validation Batch | means a Batch that is produced with the intent to show reproducibility of the Manufacturing Process and is required to complete process validation studies. | |
| Product | means the proprietary molecule identified by Customer as Voclosporin, to be manufactured using the Manufacturing Process by Lonza for Customer as specified in the Project Plan. | |
| Project Plan | means the plan(s) describing the Services to be performed by Lonza under this Agreement, including any update and amendment of the Project Plan to which the Parties may agree from time to time. The initial Project Plan is attached hereto as Appendix A. | |
| Quality Agreement | means the quality agreement, attached hereto as Appendix B, or if not attached hereto, as agreed between the Parties, acting reasonably, as soon as possible after the Effective Date, setting out the responsibilities of the Parties in relation to quality as required for compliance with cGMP. | |
| Raw Materials | means all ingredients, solvents and other components of the Product required to perform the Manufacturing Process or Services set forth in the bill of materials detailing the same (but excluding any consumables or wearables). | |
| Raw Materials Fee | means the procurement and handling fee of the acquisition cost of Raw Materials by Lonza that is charged to the Customer in addition to the cost of such Raw Materials. | |
| Regulatory Authority | means the FDA, EMA and any other similar regulatory authorities as may be agreed upon in writing by the Parties. |
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| Release | has the meaning given in Clause 7.1. | |
| Services | means all or any part of the services to be performed by Lonza under this Agreement (including process and analytical method transfer, process development, process optimization, validation, clinical and commercial manufacturing, as well as quality control and quality assurance activities), particulars of which are set out in a Project Plan. | |
| Specifications | means the specifications of the Product as specified in Appendix C, which may be amended from time to time in accordance with this Agreement. | |
| Term | has the meaning given in Clause 14.1. | |
| Third Party | means any party other than Customer, Lonza and their respective Affiliates. |
In this Agreement references to the Parties are to the Parties to this Agreement, headings are used for convenience only and
do not affect its interpretation, references to a statutory provision include references to the statutory provision as modified or re-enacted or both from time to time and to any subordinate legislation made under the statutory provision, references
to the singular include the plural and vice versa, and references to the word including are to be construed without limitation.
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The primary function of the Steering Committee is to ensure the ongoing communication between the Parties and discuss and resolve any issues
arising under this Agreement. In addition to the primary function described above, the Steering Committee shall also take on the following responsibilities:
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IN WITNESS WHEREOF, each of the Parties hereto has caused this Manufacturing Services Agreement to be executed by its duly authorized
representative effective as of the date written above.
| LONZA LTD | ||||
| By: | (signed) Bart A.M. Aarnhem | |||
| Name | Bart A.M. Aarnhem | |||
| Title | Senior Legal Counsel | |||
| By: | (signed) Marie Leblanc | |||
| Name | Marie Leblanc | |||
| Title | Director, Strategic Marketing | |||
| Aurinia Pharmaceuticals Inc. | ||||
| By: | (signed) Michael R. Martin | |||
| Name | Michael R. Martin | |||
| Title | Chief Operating Officer |