EX-10.22 8 d503089dex1022.htm EX-10.22 API DEVELOPMENT AGREEMENT
Exhibit 10.22
This API DEVELOPMENT AGREEMENT (this “Agreement”) is entered into as of July 12, 2012 (the “Effective Date”) by and between Aratana Therapeutics Inc., a Delaware corporation (“Aratana”) and RaQualia Pharma Inc., a Japanese corporation (“RaQualia”). Aratana and RaQualia are referred to herein individually as a “Party” and collectively as the “Parties”.
AGREEMENT
Article 1
1.1. | “Act” means the Federal Food and Drug Cosmetic Act of the United States of America, United States Code Title 21, Chapter I, as amended, and the regulations and guidelines promulgated thereunder from time to time, or any applicable European Union counterpart thereof. |
1.2. | “Affiliate” of a Party means any Person, which controls, is controlled by, or is under common control with such Party, where “control” means ownership of fifty percent (50%) or more of the outstanding voting securities. |
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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1.3. | “Applicable Laws” means the applicable, federal, state and local laws, and regulations applicable to this Agreement, including, without limitation, the Act. |
1.4. | “API” means the active pharmaceutical ingredient of the RQ-00000007 Technology, also known as AT-001. |
1.5. | “API Information” means all data, quality control information, manufacturing processes, drug manufacturing file (“DMF”), chemistry, manufacturing and controls (“CMC”) packages, and all other material and information reasonably needed by a third party manufacturer to manufacture commercially suitable API. |
1.6. | “cGMPs” means current Good Manufacturing Practices as established by the FDA Standards as promulgated under and in accordance with the Act, Title 21 of the U.S. Code of Federal Regulations, Parts 210, 211, as each may be amended from time to time, or any successors thereto, or any applicable European Union counterpart thereof. |
1.7. | “CMC Technical Section” means a phrased review component of the Investigational New Animal Drug Application (NADA) which includes CMC of an API and a drug product based on the API reviewed by the Center for Veterinary Medicine’s Division of Manufacturing. Approval of CMC Technical Section is required to gain NADA approval. |
1.8. | “Confidential Information” means, with respect to any party (the “Disclosing Party”), any information relating to the Disclosing Party or the Disclosing Party’s business (including, but not limited to, technical information, research, personnel, financial, marketing, strategic or other information, and, in the case of Aratana, the API Information, API, and Samples) that is disclosed in writing to the other party (“Receiving Party”) in the course of the Parties’ negotiation of or performance under this Agreement (it being understood that if any information is disclosed verbally, in order for that information to be considered Confidential Information, the Disclosing Party must notify the Receiving Party in writing that the information is Confidential Information within [***] days after disclosure or must be disclosed under circumstances such that the Receiving Party knows or reasonably should know such information is to be considered Confidential Information), but shall not include information that the Receiving Party can prove: (a) the Receiving Party knew, owned or controlled prior to receipt from the Disclosing Party as shown by written records; (b) is or becomes public through no fault of the Receiving Party or any Affiliate thereof; (c) is developed by the Receiving Party independent of any disclosure from the Disclosing Party; or (d) the Receiving Party obtains from a third party not under a confidentiality obligation to the Disclosing Party. |
1.9. | “FDA” means the United States Food & Drug Administration, or any successor thereto. |
1.10. | “Governmental Authority” means any federal, state, local or foreign governmental authority, agency or other body having jurisdiction over a Party. |
1.11. | “Intellectual Property Rights” means patent rights, copyrights, database rights, trademark rights, trade secret rights, and any and all other intellectual property rights available under any applicable laws |
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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1.12. | “Person” means any natural person, corporation, partnership, limited liability company, joint venture, trust, proprietorship, or other entity or organization. |
1.13. | “Samples” means samples of the API obtained during the development of the API. |
1.14. | “Specifications” is defined in Section 2.1. |
Article 2
Development, Ownership, and Licensing of API
2.1. | Specification. The specifications for the API to be developed and manufactured by Aratana pursuant to this Agreement are provided in Exhibit A hereto. (the “Specifications”). |
2.2. | API Development. Aratana will use commercially reasonable efforts to develop and establish a manufacturing process for the API that is cGMP compliant and fully characterized and substantially conforms to the Specifications. The target date for completion is no later than [***], provided that Aratana could be delayed due to causes beyond Aratana’s reasonable control. In case that Aratana finds the causes of delay, Aratana should promptly notify RaQualia the causes and the Parties will negotiate and set the next target date. Aratana anticipates all development of the API will take place at Cambridge Major Laboratories (“CML”) and will be performed as generally described in [***] attached hereto as Exhibit B. |
2.3. | Ownership of API. Aratana will exclusively own all right, title, and interest in and to the API and to all Samples and API Information created, conceived, developed, made, or otherwise obtained in the course of development of the API, including all Intellectual Property Rights therein. |
2.4. | API License. Subject to the terms and conditions of this Agreement, including payment to Aratana of the amount set forth in Section 5.1 hereof, upon completion of the development of the API as set forth in Section 2.2 hereof, Aratana will grant RaQualia a limited, non-exclusive right and license to use any Samples and API Information provided by Aratana to RaQualia solely for: (a) conducting research and development; (b) filing applications for regulatory approval; and (c) manufacturing and commercializing drugs incorporating the API for human use only. RaQualia may sublicense the rights granted herein solely in conjunction with licensing RQ-0000007 Technology to a third party for human use only and may transfer the rights granted herein solely in conjunction with transferring RQ-0000007 Technology to a third party for human use only. RaQualia covenants and agrees that this license will not permit the Samples, API Information, or API to be used for the manufacture or commercialization of drugs for use in the animal field. |
Article 3
3.1. | Sample API. Upon completion of the development of the API (the “Completion Date”), Aratana will supply RaQualia up to [***] of API [***]. |
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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3.2. | Supply of API after the Completion Date. With respect to the API which will be manufactured after the Completion Date, the Parties agree to negotiate in good faith an API Supply Agreement based on the form attached hereto as Exhibit C (the “Supply Agreement”), provided that Aratana has no obligation to supply to RaQualia the API manufactured after the Completion Date unless and until the Parties have entered into the Supply Agreement. In addition, the Parties agree that all of the provisions in Exhibit C are negotiable and modifiable under such negotiation provided hereof. |
Article 4
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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Article 5
Purchase Price/Payment
5.1. | API Development Cost. To offset some of the costs incurred by and to be incurred by Aratana to develop a cGMP compliant and fully characterized API that is sufficient for use in FDA monitored studies to prove safety and efficacy in Aratana’s target specifies, RaQualia will pay Aratana (USD) $1.6 million as follows: |
a) | (USD) $800,000 due upon the execution of this Agreement; and |
b) | (USD) $800,000 due upon the delivery of [***] of the API that (i) is cGMP compliant, (ii) substantially meets the Specifications, and (iii) conforms to International Conference on Harmonisation (ICH) guidelines for new drug substances. The API will be suitable for use in human clinical trials, but not necessarily for commercialization. Within [***] business days after receiving the API, RaQualia must send to Aratana a written notice of acceptance or rejection of the API, and if RaQualia is rejecting the API, RaQualia must describe in writing in detail the basis for the rejection. Failure to provide such notice within such period or any use of the API other than for purposes of determining acceptance or rejection will be deemed acceptance of the API by RaQualia. Upon receiving a written notice of acceptance from RaQualia, Aratana will send an invoice to RaQualia. |
RaQualia will make all payments due under Section 5.1 within [***] days of the receipt of the invoice.
Article 6
During the terms of this Agreement and for a period of [***] years following the termination or expiration of this Agreement, each Party shall hold in confidence and use only in furtherance of its rights and obligations under this Agreement all Confidential Information that it acquires from the other Party pursuant to this Agreement, unless (a) the Disclosing Party consents to the Receiving Party’s disclosure or use, or (b) disclosure of the Disclosing Party’s Confidential
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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Information by the Receiving Party is required by order of any Governmental Authority, in which event the Receiving Party will notify the Disclosing Party of that order as soon as practicable, shall use reasonable efforts (at the Disclosing Party’s expense) to obtain a protective order covering the Confidential Information and shall disclose only such Confidential Information that its legal counsel determines is legally required. Each Party shall make Confidential Information that it acquires from the other Party pursuant to this Agreement available only to those of its Affiliates, directors, officers, employees, consultants, advisors or representatives who need to have access thereto for the purposes of this Agreement and who are bound by an obligation of confidentiality consistent with the provisions herein.
Article 7
7.2. | By RaQualia. RaQualia will defend, indemnify, and hold Aratana, Aratana’s Affiliates, and their directors, officers, employees, and agents harmless from and against any and all claims, losses, liabilities, damages, costs, and expenses (including attorneys’ fees, expert witness fees, and court costs) directly or indirectly arising from or relating to (i) any claims based on the use of any API, API Information, or products incorporating the API Information by RaQualia, its licensees, its manufacturers, its distributors, or any of their customers, or (ii) any negligence, willful misconduct, or violation of Applicable Laws by RaQualia or its directors, officers, employees, or agents in the performance of this Agreement or in connection with the use of the API, API Information, or products incorporating the API. |
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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Article 8
Effective Date, Term and Termination
8.6. |
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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incorporating the API for human use, if the license granted under Section 2.4 is to survive as stated in this Section 8.6. In addition, the Parties agree that if this Agreement is terminated prior to the Completion Date, the Supply Agreement will automatically terminate. |
8.8. | Survival. Upon termination or expiration of this Agreement, Sections 2.3, 2.4 (solely as stated in Section 8.6), 4.1, 4.3, 4.4, 5.1, and 8.6 and Articles 1, 3, 6, 7, and 9 will survive. |
Article 9
If to RaQualia to:
RaQualia Pharma, Inc. 5-2 Taketoyo, Aichi 470-2341 Japan Attention: President Phone No.: 00 000 000 0000 | If to Aratana, to:
Aratana Therapeutics Inc. 0000 Xxxxxx Xxxxxxxxx Xxxxxx Xxxx, XX 00000 XXX Attention: President & COO Phone No.: 000-000-0000 |
9.2. | Governing Law; Arbitration. This Agreement will be construed in accordance with and governed in all respects by the laws of the State of New York, USA. Any dispute, controversy or claim arising out of or in connection with this Agreement, or breach, termination or invalidity thereof, shall be settled by arbitration in accordance with the commercial arbitration rules of the International Chamber of Commerce (“ICC”). The arbitral tribunal shall be composed of three arbitrators, one to be appointed by Aratana and one to be appointed by RaQualia and the chairman to be appointed by the two arbitrators. If the two aforementioned Parties have not appointed their arbitrators within [***] weeks from the request of the other Party, or the two arbitrators have not agreed on the chairman within three weeks after their appointment, the ICC shall appoint the arbitrator or the chairman, as the case may be. In the event arbitration is requested by |
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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RaQualia, the place of arbitration shall be [***]; in the event arbitration is requested by Aratana, the place of arbitration shall be [***]. The arbitration proceedings will be conducted in English. The results of the arbitration procedure will be considered Confidential Information of the Parties. Any arbitration decision rendered will be final and binding, and judgment thereon may be entered in any court of competent jurisdiction. Notwithstanding this Section, neither Party will be required to arbitrate any dispute or controversy relating to any actual or threatened unauthorized use or disclosure of its intellectual property or confidential information. |
9.6. | Independent Contractors. This Agreement is not intended to establish any partnership, joint venture, employment, or other relationship between the Parties except that of independent contractors. |
9.8. | Counterparts. This Agreement may be executed in several counterparts, each of which will constitute an original and all of which, when taken together, will constitute one agreement. |
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first above written.
RaQualia Pharma, Inc. | Aratana Therapeutics, Inc. | |||||||
By: | /s/ Xxxxxxx Xxxxxxxx | By: | /s/ Xxxxx X. Xxxxx | |||||
Name: | Xxxxxxx Xxxxxxxx | Name: | Xxxxx X. Xxxxx | |||||
Title: | President & CEO | Title: | President & COO | |||||
Date: | July 23, 2012 | Date: | 12 July 12 |
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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EXHIBIT A – SPECIFICATION OF RQ-00000007
TEST DESCRIPTION | METHOD | COMPONENTS | ACCEPTANCE CRITERIA | |||
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[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | ||||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
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[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] |
Note 1: [***]
Note 2: [***]
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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EXHIBIT B - CML PROPOSAL
[***]
[A total of 13 pages have been redacted from this Exhibit B.]
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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EXHIBIT C - API SUPPLY AGREEMENT
This API SUPPLY AGREEMENT (this “Agreement”) is entered into as of (the “Effective Date”) by and between Aratana Therapeutics Inc., a Delaware corporation (“Aratana”) and RaQualia Pharma Inc., a Japanese corporation (“RaQualia”). Aratana and RaQualia are referred to herein individually as a “Party” and collectively as the “Parties”.
WHEREAS, the Parties have entered into that certain API Development Agreement dated July 12, 2012 (the “Development Agreement”), pursuant to which Aratana carried out development of the API (as defined in the Development Agreement); and
AGREEMENT
Article 1
1.1 | “Act” means the Federal Food and Drug Cosmetic Act of the United States of America, United States Code Title 21, Chapter I, as amended, and the regulations and guidelines promulgated thereunder from time to time, or any applicable European Union counterpart thereof. |
1.2 | “Affiliate” of a Party means any Person, which controls, is controlled by, or is under common control with such Party, where “control” means ownership of fifty percent (50%) or more of the outstanding voting securities. |
1.3 | “Applicable Laws” means the applicable, federal, state and local laws, and regulations applicable to this Agreement, including, without limitation, the Act. |
1.4 | “API” means the active pharmaceutical ingredient of the RQ-00000007 Technology, also known as AT-001. |
1.5 | “API Information” means all data, quality control information, manufacturing processes, drug manufacturing file (“DMF”), chemistry, manufacturing and controls (“CMC”) packages, and all other material and information reasonably needed by a third party manufacturer to manufacture commercially suitable API. |
1.6 | “cGMPs” means current Good Manufacturing Practices as established by the FDA Standards as promulgated under and in accordance with the Act, Title 21 of the U.S. Code of Federal Regulations, Parts 210, 211, as each may be amended from time to time, or any successors thereto, or any applicable European Union counterpart thereof. |
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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1.7 | “Confidential Information” means, with respect to any party (the “Disclosing Party”), any information relating to the. Disclosing Party or the Disclosing Party’s business (including, but not limited to, technical information, research, personnel, financial, marketing, strategic or other information, and, in the case of Aratana, the API Information, API, and Samples) that is disclosed in writing to the other party (“Receiving Party”) in the course of the parties’ negotiation of or performance under this Agreement (it being understood that if any information is disclosed verbally, in order for that information to be considered Confidential Information, the Disclosing Party must notify the Receiving Party in writing that the information is Confidential Information within [***] days after disclosure or must be disclosed under circumstances such that the Receiving Party knows or reasonably should know such information is to be considered Confidential Information), but shall not include information that the Receiving Party can prove: (a) the Receiving Party knew, owned or controlled prior to receipt from the Disclosing Party; (b) is or becomes public through no fault of the Receiving Party or any Affiliate thereof; (c) is developed by the Receiving Party independent of any disclosure from the Disclosing Party; or (d) the Receiving Party obtains from a third party not under a confidentiality obligation to the Disclosing Party. |
1.8 | “FDA” means the United States Food & Drug Administration, or any successor thereto. |
1.9 | “Governmental Authority” means any federal, state, local or foreign governmental authority, agency or other body having jurisdiction over a Party. |
1.10 | “Intellectual Property Rights” means patent rights, copyrights, database rights, trademark rights, trade secret rights, and any and all other intellectual property rights available under any applicable laws |
1.11 | “Person” means any natural person, corporation, partnership, limited liability company, joint venture, trust, proprietorship, or other entity or organization. |
1.12 | “Specifications” means specifications mutually agreed to by the Parties for the API and the manufacture thereof for use in human drug development and commercial application. |
Article 2
Commercial Supply of API
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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Article 3
Article 4
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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4.2 | Forecast. On a basis, RaQualia will provide to Aratana a non-binding months forecast of expected purchase of the API. The forecast will be used by Aratana for planning purposes only. |
Article 5
During the terms of this Agreement and for a period of [***] years following the termination or expiration of this Agreement, each Party shall hold in confidence and use only in furtherance of its rights and obligations under this Agreement all Confidential Information that it acquires from the other Party pursuant to this Agreement, unless (a) the Disclosing Party consents to the Receiving Party’s disclosure or use, or (b) disclosure of the Disclosing Party’s Confidential Information by the Receiving Party is required by order of any Governmental Authority, in which event the Receiving Party will notify the Disclosing Party of that order as soon as practicable, shall use reasonable efforts (at the Disclosing Party’s expense) to obtain a protective
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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order covering the Confidential Information and shall disclose only such Confidential Information that its legal counsel determines is legally required. Each Party shall make Confidential Information that it acquires from the other Party pursuant to this Agreement available only to those of its affiliates, directors, officers, employees, consultants, advisors or representatives who need to have access thereto for the purposes of this Agreement and who are bound by an obligation of confidentiality consistent with the provisions herein.
Article 6
6.2 | By RaQualia. RaQualia will defend, indemnify, and hold Aratana, Aratana’s Affiliates, and their directors, officers, employees, and agents harmless from and against any and all claims, losses, liabilities, damages, costs, and expenses (including attorneys’ fees, expert witness fees, and court costs) directly or indirectly arising from or relating to: (i) any claims based on the marketing, promotion, sale, distribution, or use of any API, or products incorporating the API, by RaQualia or its distributors, or licensees; or (ii) any negligence, willful misconduct, or violation of Applicable Laws by RaQualia or its directors, officers, employees, or agents in the performance of this Agreement. |
Article 7
Effective Date, Term and Termination
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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7.7 | Survival. Upon termination or expiration of this Agreement, Sections 3.3, 3.4, Articles 1, 5, 6, 7, and 8 will survive. For avoidance of doubt, the Parties agree that the termination of this Agreement will not have any effect on the effectiveness of the Development Agreement, unless otherwise provided in the Development Agreement and/or this Agreement. |
Article 8
8.1 |
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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service (return receipt requested). All notices shall be sent to address set forth below (or to such other address as may be designated by a Party by giving written notice to the other party pursuant to this Section 8.1): |
If to RaQualia to:
RaQualia Pharma, Inc. 5-2 Taketoyo, Aichi 470-2341 Japan Attention: President Phone No.: 00 000 000 0000 | If to Aratana, to:
Aratana Therapeutics Inc. 0000 Xxxxxx Xxxxxxxxx Xxxxxx Xxxx, XX 00000 XXX Attention: President & COO Phone No.: 000-000-0000 |
8.2 | Governing Law; Arbitration. This Agreement will be construed in accordance with and governed in all respects by the laws of the State of New York, USA. Any dispute, controversy or claim arising out of or in connection with this Agreement, or breach, termination or invalidity thereof, shall be settled by arbitration in accordance with the commercial arbitration rules of the International Chamber of Commerce (“ICC”). The arbitral tribunal shall be composed of three arbitrators, one to be appointed by Aratana and one to be appointed by RaQualia and the chairman to be appointed by the two arbitrators. If the two aforementioned Parties have not appointed their arbitrators within [***] weeks from the request of the other Party, or the [***] have not agreed on the chairman within three weeks after their appointment, the ICC shall appoint the arbitrator or the chairman, as the case may be. In the event arbitration is requested by RaQualia, the place of arbitration shall be [***]; in the event arbitration is requested by Aratana, the place of arbitration shall be [***]. The arbitration proceedings will be conducted in English. The results of the arbitration procedure will be considered Confidential Information of the Parties. Any arbitration decision rendered will be final and binding, and judgment thereon may be entered in any court of competent jurisdiction. Notwithstanding this Section, neither Party will be required to arbitrate any dispute or controversy relating to any actual or threatened unauthorized use or disclosure of its intellectual property or confidential information. |
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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8.6 | Independent Contractors. This Agreement is not intended to establish any partnership, joint venture, employment, or other relationship between the Parties except that of independent contractors. |
8.8 | Counterparts. This Agreement may be executed in several counterparts, each of which will constitute an original and all of which, when taken together, will constitute one agreement. |
RaQualia Pharma, Inc. | Aratana Therapeutics, Inc. | |||||||
By: |
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Name: |
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Title: |
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Date: |
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first above written.
[***] | Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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