ATRYN AGREEMENT
Exhibit 10.2
THIS AGREEMENT (this “Agreement”) is effective as of March 31, 2014 (the “Effective Date”), by and between rEVO Biologics, Inc., a Massachusetts corporation, having its principal place of business located at 000 Xxxxxxxx Xxxxxxxxx, Xxxxxxxxxx, Xxxxxxxxxxxxx, 00000 (“rEVO”) and Laboratoire français du Fractionnement et des Biotechnologies, a French Corporation, having its principal place of business located at 0 xxxxxx xxx Xxxxxxxxx - XX xx Xxxxxxxxxxx, 00000 (“LFB” and together with rEVO, the “Parties” and each a “Party”).
W I T N E S S E T H :
WHEREAS, rEVO owns the rights to develop and commercialize ATryn for all Indications in the United States of America (“rEVO Territory”)
WHEREAS, LFB is the exclusive licensee of the right to develop and commercialize ATryn for all Indications in all countries other than the United States of America (“LFB Territories”)
WHEREAS, rEVO and LFB desire to coordinate and leverage their respective efforts with respect to the development and commercialization of ATryn in both LFB Territories and rEVO Territory; and
WHEREAS, to facilitate such coordination and leverage, rEVO and LFB desire to grant each other certain rights and options with respect to ATryn on the terms set forth herein.
NOW, THEREFORE, subject to the terms, conditions, covenants and provisions of this Agreement, rEVO and LFB each mutually covenant and agree as follows:
1. DEFINITIONS
(a) “ATryn” means the product consisting of a recombinant form of human antithrombin (antithrombin alfa) obtained from the milk of a transgenic animal.
(b) “Cumulative PE Development Expenses” mean all Development Expenses incurred by rEVO in connection with the development of ATryn for the Preterm Preeclampsia Indication starting with the date that rEVO files an investigational new drug application with the United States Food and Drug Administration to initiate clinical testing of ATryn for the Preterm Preeclampsia Indication.
(c) “Development Expenses” means costs of research and development of a product, including costs of studies on the toxicological, pharmacokinetical, metabolical or clinical aspects of such product, whether conducted internally or by external investigators, including the cost of clinical supplies used in connection therewith, and the preparation of applications and materials to be submitted to regulatory authorities in connection with obtaining, maintaining and/or expanding marketing approval of such product, regulatory and validation activities for
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
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manufacturing plant and product, including GMP certification, process development, process improvement and scale-up and recovery costs, qualification lots, costs for preparing, submitting, reviewing or developing data or information for the purpose of submission to a governmental authority to obtain, maintain and/or expand marketing approval of such product.
(d) “New ATryn Indication” means the use of ATryn to treat any disease or condition in humans other than (i) to prevent peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients and (ii) to treat preterm preeclampsia.
(e) “New Indication Data” means all preclinical, clinical and regulatory data generated by or on behalf of a Party in connection with its development of ATryn in a New ATryn Indication.
(f) “Preterm Preeclampsia Indication” means the treatment of preterm preeclampsia in humans.
(g) “PE Data” means all preclinical, clinical and regulatory data generated by or on behalf of rEVO in connection with its development of ATryn in the Preterm Preeclampsia Indication.
(h) “Third Party” means any and all entities or persons other than the Parties and their Affiliates
2. ATryn PE DATA PURCHASE
(a) Purchase of Data Rights.
(i) Subject to the terms set forth herein, LFB hereby purchases from rEVO, and rEVO hereby sells to LFB, an exclusive right to use all PE Data in connection with LFB’s efforts (whether alone or with or through its affiliates, strategic partners, distributors, licensees or sublicensees) to develop and commercialize ATryn in the Preterm Preeclampsia Indication outside of the United States of America.
(ii) In consideration of the grant of rights under Section 2(a)(i), LFB shall pay to rEVO a total amount of Ten Million U.S. Dollars ($10,000,000) in five (5) installments, following achievement by rEVO of each of the following events:
Event |
Payment Amount | |||
[***] |
[ | ***] | ||
[***] |
[ | ***] | ||
[***] |
[ | ***] | ||
[***] |
[ | ***] | ||
[***] |
[ | ***] |
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
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The foregoing payments shall each be due and payable within [***] days after the end of the calendar year during which rEVO provides to LFB an invoice, and access to supporting documentation, indicating the achievement of the relevant events described in the table above.
(iii) If the Cumulative PR Development Expenses exceed [***], the Parties will negotiate in good faith the payment by LFB of an additional payment to retain the exclusive right granted in Section 2(a)(i).
3. RECIPROCAL OPTION FOR ATryn NEW INDICATION DATA
(a) Reciprocal Option Grant. Each Party (the “Grantor”) hereby grants to the other Party (the “Grantee”) an exclusive option to obtain an exclusive right to use all New Indication Data in connection with Grantor’s efforts (whether alone or with or through its affiliates, strategic partners or licensees) to develop and commercialize ATryn for a New Indication on the terms set forth herein. Where rEVO is the Grantor and LFB is the Grantee, such right shall be an exclusive right for LFB to use all New Indication Data in connection with LFB’s efforts (whether alone or with or through its affiliates, strategic partners or licensees) to develop and commercialize ATryn in a New ATryn Indication outside of the United States of America. Where LFB is the Grantor and rEVO is the Grantee, such right shall be an exclusive right for rEVO to use all New Indication Data in connection with rEVO’s efforts (whether alone or with or through its affiliates, strategic partners or licensees) to develop and commercialize ATryn in a New ATryn Indication within the United States of America.
(b) Exercise and Payment. Each Party will provide the other Party with a summary description of its efforts to develop ATryn for a New ATryn Indication from time-to-time as such efforts are commenced and continue. In the event a Party wishes to exercise the option granted to it in Section 3(a), it may do so by providing written notice to the other Party. Upon receipt of such notice, the Parties shall commence good faith negotiations for the payment and other terms related to the exercise of the option and the grant of the rights described in Section 3(a).
4. ROFN FOR EX-US ATryn RIGHTS
(a) Grant of ROFN. LFB hereby grants to rEVO a right of first negotiation to obtain an exclusive license to develop and commercialize ATryn for any and all indications in each country in the LFB Territories excluding [***], France [***]. If and when LFB desires to entrust to a Third Party rights to develop and/or commercialize ATryn in a country in the LFB Territories, LFB shall first so notify rEVO of the such decision. Upon receipt of such notice, rEVO shall have a period of [***] to notify LFB of its desire to exercise the right of first negotiation set forth in this Section 4(a). If rEVO timely provides such notice to LFB, the Parties will negotiate in good faith, for a period of up to [***] after LFB’s initial notice to rEVO regarding such rights, towards an agreement pursuant to which rEVO would develop and
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
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commercialize ATryn for all indications in such country. If the Parties are unable to reach agreement during such [***] period, such right of first negotiation may be extended by the Parties or such right of first negotiation shall lapse and shall be of no further force or effect with respect to the indications and the countries identified in LFB’s notice to rEVO.
5. CONFIDENTIALITY
(a) Confidential Information. All information that is disclosed or provided by one party (the “Disclosing Party”) to the other party (the “Recipient”) pursuant to this Agreement, whether in oral, written, graphic, electronic, or any other form, shall be the “Confidential Information” of the Disclosing Party. Except to the extent expressly authorized by this Agreement or by the other party in writing, during the term of this Agreement and for five (5) years thereafter, each party shall maintain in strict trust and confidence and shall not disclose to any third party or use for any purpose other than as provided for in this Agreement any Confidential Information of the other party. Each party may use the other party’s Confidential Information only in connection with the exercise of rights granted to such party hereunder, and for no other purpose. Each party agrees that it shall not use the other party’s Confidential Information for any purpose or in any manner that would constitute a violation of applicable laws.
(b) Exceptions. The obligations of confidentiality and nonuse set forth in Section 7.1(a) shall not apply to any specific portion of information that the Recipient can demonstrate by competent written proof: (a) is in the public domain or comes into the public domain through no fault of the Recipient; (b) is furnished to the Recipient by a third party rightfully in possession of such information and not subject to a duty of confidentiality with respect thereto; (c) is already known by the Recipient at the time of receiving such Confidential Information from the Disclosing Party as evidenced by the Recipient’s prior written records; or (d) is independently developed by the Recipient without access to the Disclosing Party’s Confidential Information.
(c) Authorized Disclosure. Notwithstanding the foregoing in this Section 7, the Recipient may disclose certain Confidential Information of the Disclosing Party to the extent such disclosure is required by law or regulation, or pursuant to a valid order of a court or other governmental body having jurisdiction; provided that the Recipient provides the Disclosing Party with reasonable prior written notice of such disclosure and reasonable assistance in obtaining a protective order or confidential treatment preventing or limiting the disclosure and/or requiring that the Confidential Information so disclosed be used only for the purposes for which the law or regulation required, or for which the order was issued.
(d) Return of Confidential Information. Upon termination or expiration of the Agreement, or upon written request of the Disclosing Party, the Recipient shall promptly return to the Disclosing Party or destroy all documents, notes and other tangible materials representing the Disclosing Party’s Confidential Information and all copies thereof; provided, however, that each party may retain (i) a single archival copy of the other party’s Confidential Information for the sole purpose of facilitating compliance with the surviving provisions of this Agreement and (ii) computer generated back-up copies that are difficult to locate.
(e) Injunctive Relief. The parties expressly acknowledge and agree that any breach or threatened breach of this Section 7 may cause immediate and irreparable harm to the non-breaching party that may not be adequately compensated by damages. Each party therefore
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
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agrees that in the event of such breach or threatened breach and in addition to any remedies available at law, the non-breaching party shall have the right to secure equitable and injunctive relief, without the necessity of securing bond, in connection with such a breach or threatened breach.
6. TERM
(a) Term.
(a) This Agreement shall become effective on the date hereof and shall continue in effect for twenty five (25) years thereafter unless sooner terminated in accordance with the provisions of this Agreement (the “Expiration Date”). Additionally, this Agreement may be renewed or extended by mutual written agreement of rEVO and LFB.
(b) This Agreement shall terminate upon the following terms and conditions:
i. Mutual Termination. This Agreement may be terminated upon the mutual agreement of rEVO and LFB;
ii. Defaults. If either party defaults or otherwise materially breaches any provisions of this Agreement, and fails to cure such default or breach within [***] after a written demand for performance by the other party, the non-defaulting party, in addition to any other rights it may have under applicable law, may, at its option, terminate this Agreement by giving written notice thereof to the defaulting party which shall specify the effective date of termination; or
iii. Insolvency. If a petition under any bankruptcy or insolvency law is filed by or against a party, or if either party suspends business or commits any act amounting to a business failure, the other party may, at its option, terminate this Agreement by giving written notice thereof to the insolvent party which shall specify the effective date of termination.
(b) Effects of Termination; Survival of Certain Obligations. In the event of a termination or expiration of this Agreement in accordance with the terms hereof, this Agreement shall immediately become null and void and have no effect, except that Section 5, this Section 6(b) and all other obligations of the parties specifically intended to be performed after the termination of this Agreement shall survive any termination of this Agreement. All obligations of rEVO and LFB under this Agreement that arose prior to its termination or expiration and that have not been fully performed in accordance with the terms of this Agreement prior to such termination or expiration shall survive any such termination or expiration of this Agreement.
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
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7. MISCELLANEOUS
(a) Complete Agreement. This Agreement constitutes the entire agreement and supersedes all prior agreements and understandings, both written and oral, among the parties hereto, or any of them, with respect to the subject matter hereof.
(b) Counterparts. This Agreement may be executed in counterparts, all of which shall be considered one and the same agreement and shall become effective when counterparts have been signed by each of the parties, it being understood that all parties need not sign the same counterpart.
(c) Notices. All notices, requests, claims, demands and other communications under this Agreement will be in writing and will be deemed given if delivered personally, sent by overnight courier (providing written proof of delivery) or via facsimile (providing written proof of transmission), in each case with a copy (which shall not constitute notice) via electronic mail to the parties at their e-mail address (if available):
If to LFB:
Laboratoire français du Fractionnement
et des Biotechnologies
3 avenue des Tropiques
XX xx Xxxxxxxxxxx, 00000
Xxxxxxxxx: General Counsel
Fax: + 00 0 00 00 00 00
E-mail: xxxxxxx@xxx.xx
If to rEVO Biologics, Inc.
000 Xxxxxxxx Xxxx.
Xxxxxxxxxx, XX 00000
Attention: President
Fax: 000-000-0000
E-mail: xxxx.xxxxxxxx@xxxxxxxxxxxxx.xxx
(d) Amendments; Waivers. The parties may mutually amend or waive any provision of this Agreement at any time. No amendment or waiver of any provision of this Agreement shall be valid unless the same shall be in writing and signed by each of the parties. No waiver by any party of any default, misrepresentation or breach of warranty or covenant hereunder, whether intentional or not, shall be deemed to extend to any prior or subsequent default, misrepresentation or breach of warranty or covenant hereunder or affect in any way any rights arising by virtue of any prior or subsequent such occurrence.
(e) Assignment; Reliance of Other Parties. Neither this Agreement nor any of the rights, interests or obligations hereunder shall be assigned by any of the parties hereto in whole or in part (whether by operation of law or otherwise) without the prior written consent of the other parties and any attempt to make any such assignment without such consent shall be null and void. Subject to the preceding sentence, this Agreement will be binding upon, inure to the benefit of and be enforceable by the parties and their respective successors and assigns. This
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
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Agreement (including the documents and instruments referred to herein) is not intended to confer upon any person or entity other than the parties hereto any rights or remedies under or by reason of this Agreement.
(f) Interpretation.
(a) Titles and headings to sections herein are for convenience of reference only, do not constitute part of this Agreement and shall not be deemed to limit or otherwise affect any of the provisions hereof.
(b) The parties have participated jointly in negotiating and drafting this Agreement. In the event that an ambiguity or a question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties, and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any provision of this Agreement.
(c) The appendices hereto shall be construed with and as an integral part of this Agreement to the same extent as if the same had been set forth verbatim herein.
(d) In the event of any inconsistency between this Agreement and any appendix hereto, the appendix shall prevail.
(g) Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware without regard to any rules of conflict of laws that would require the application of the laws of any other jurisdiction.
(h) Dispute Resolution.
(i) In the event of any dispute, controversy or claim among the parties, or any of them, arising out of or relating to this Agreement or matter related hereto, or the breach or invalidity thereof (collectively, a “Dispute”), the parties shall attempt in the first instance to resolve such Dispute through consultation among the executive officers of the parties having requisite authority. The parties agree to attempt to resolve all Disputes arising hereunder promptly, equitably and in a good faith manner. The parties further agree to provide each other with reasonable access during normal business hours to any and all non-privileged records, information and data pertaining to such Dispute, upon reasonable advance notice.
(ii) If the parties are unable to resolve the Dispute amicably within thirty (30) days after giving notice of the dispute to the other party’s executive officer having requisite authority, the parties hereby (i) irrevocably and unconditionally submit to the jurisdiction of the state courts of Massachusetts and to the jurisdiction of the United States District Court located in Boston, Massachusetts for the purpose of any suit, action or other proceeding arising out of or based upon this Agreement, (ii) agree not to commence any suit, action or other proceeding arising out of or based upon this Agreement except in the state courts of Massachusetts or the United States District Court located in Boston, Massachusetts, (iii) waive, and agree not to assert, by way of motion, as a defense, or otherwise, in any such suit, action or proceeding, any claim that it is not subject personally to the jurisdiction of the above-named courts, that its property is
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
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exempt or immune from attachment or execution, that the suit, action or proceeding is brought in an inconvenient forum, that the venue of the suit, action or proceeding is improper or that this Agreement or the subject matter hereof may not be enforced in or by such court and (iv) agree that the process may be served in the manner provided in above for giving notices, or otherwise as permitted by statute of rule of court.
(iii) WAIVER OF JURY TRIAL. EACH PARTY HERETO HEREBY WAIVES, TO THE FULLEST EXTENT PERMITTED BY LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY SUIT, ACTION OR PROCEEDING DIRECTLY OR INDIRECTLY ARISING OUT OF, UNDER OR IN CONNECTION WITH THIS AGREEMENT.
(iv) Notwithstanding the foregoing of this Section, either party shall have the right, without waiving any right or remedy available to such party under this Agreement or otherwise, to seek and obtain from any court of competent jurisdiction any interim or provisional relief that is necessary or desirable to protect the rights or property of such party.
(i) Force Majeure. No party shall bear any responsibility or liability for any damages arising out of any delay, inability to perform or interruption of its performance of its obligations under this Agreement due to any acts or omissions of the other party hereto or for events beyond its reasonable control including, without limitation, acts of God, acts of governmental authorities, acts of terrorism, acts of a public enemy, acts of civil or military authority including governmental priorities, or due to war, riot, fire, flood, civil commotion, insurrection, lack of or shortage of electrical power, or any other cause beyond the reasonable control of such party.
(j) Severability. In the event that any one or more provisions of this Agreement shall for any reason be held invalid, illegal or unenforceable in any respect, by any court of competent jurisdiction, such invalidity, illegality or unenforceability shall not affect any other provisions of this Agreement and the parties shall use their reasonable best efforts to substitute a valid, legal and enforceable provision which, insofar as practicable, implements the original purposes and intents of this Agreement.
(k) Relationship of Parties. Nothing in this Agreement is intended or should be construed to create a partnership, joint venture, or employer-employee relationship between rEVO and LFB or any of their respective employees or agents.
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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed the day and year first above written.
Laboratoire français du Fractionnement et des Biotechnologies | ||
By: | /s/ Christian Bechon | |
Name: | Christian Bechon | |
Title: | CEO | |
rEVO Biologics, Inc. | ||
By: | /s/ Xxxx Xxxxxxxx | |
Name: | Xxxx Xxxxxxxx | |
Title: | President |
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.