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MASTER AGREEMENT

Development Agreement

MASTER AGREEMENT | Document Parties: Edwards Lifesciences PVT, Inc., | 3F Therapeutics, Inc., You are currently viewing:
This Development Agreement involves

Edwards Lifesciences PVT, Inc., | 3F Therapeutics, Inc.,

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Title: MASTER AGREEMENT
Governing Law: California     Date: 6/6/2005
Industry: Biotechnology and Drugs     Law Firm: Gibson, Dunn Crutcher LLP; Reed Smith, LLP    

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Exhibit 10.1

 

MASTER AGREEMENT

 

This MASTER AGREEMENT (this “ Agreement ”) is made and entered into as of this 2 nd  day of June, 2005, by and between Edwards Lifesciences PVT, Inc., a Delaware corporation (“ Edwards ”), and 3F Therapeutics, Inc., a Delaware corporation (“ 3F Therapeutics ” and, together with Edwards, are each referred to herein as a “ Party ” and collectively as the “ Parties ”).

 

RECITALS

 

WHEREAS, reference is made to (i) the Development and Supply Agreement, dated as of June 13, 2002, as amended by the First Amendment to Development and Supply Agreement, dated as of October 31, 2002, and the Second Amendment to Development and Supply Agreement, dated as of May 27, 2003 (as so amended, the “ 3F Development and Supply Agreement ”), by and between 3F Therapeutics and Edwards (as successor to Percutaneous Valve Technologies, Inc. (“ PVT ”)) and (ii) the Development Agreement, dated as of November 14, 2001, as amended by the First Amendment to Development Agreement, dated as of October 31, 2002 and the Second Amendment to Development Agreement, dated as of May 27, 2003 (as so amended, the “ VenPro Development Agreement ” and, together with the 3F Development and Supply Agreement, the “ Subject Agreements ”), by and between 3F Therapeutics (as successor to VenPro Corporation (“ VenPro ”)) and Edwards (as successor to PVT);

 

WHEREAS, Edwards, as successor in interest to PVT under the Subject Agreements, and 3F Therapeutics, under the 3F Development and Supply Agreement and as successor in interest to VenPro under the VenPro Development Agreement, mutually desire to terminate the Subject Agreements and to release one another of certain liabilities and obligations between the Parties under the Subject Agreements, all upon the terms and subject to the conditions set forth in this Agreement;

 

WHEREAS, in connection with the termination of the Subject Agreements pursuant to this Agreement, the Parties have agreed that (i) Edwards shall grant to 3F licenses with respect to certain of Edwards’ patent and patent applications, upon the terms and subject to the conditions set forth in a license agreement in the form attached as Exhibit A hereto (the “ Edwards License Agreement ”), (ii) 3F Therapeutics shall grant to Edwards licenses to produce and sell products incorporating certain of 3F Therapeutics’ manufacturing know-how and intellectual property, upon the terms and subject to the conditions set forth in a license agreement in the form attached as Exhibit B hereto (the “ 3F License Agreement ”) and (iii) 3F Therapeutics shall supply Edwards with certain products and provide Edwards with training with respect to certain of 3F Therapeutics’ know-how and intellectual property needed by Edwards in connection with certain of Edwards’ manufacturing processes, upon the terms and subject to the conditions set forth in a supply and training agreement in the form attached as Exhibit C hereto (the “ Supply and Training Agreement ” and, together with the Edwards License Agreement and 3F License Agreement, the “ Related Transaction Agreements ”); and

 

WHEREAS, in connection with the transactions contemplated by this Agreement and upon the terms and subject to the conditions contained herein, Edwards shall pay to 3F

 



 

Therapeutics, or cause to be paid to 3F Therapeutics on its behalf, the consideration set forth herein.

 

NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements hereinafter set forth, the Parties agree as follows:

 

1.              TERMINATION OF THE SUBJECT AGREEMENTS AND RELEASE.   Effective on the Closing Date (as defined below):

 

1.1           Termination .  Upon the terms and subject to the conditions contained in this Agreement, the Subject Agreements shall be irrevocably terminated and extinguished in their entirety as of the Closing Date, and upon such termination and extinguishment, no provision of either of the Subject Agreements shall have any force or effect.

 

1.2           No Surviving Provisions .  Notwithstanding any provision in any Subject Agreement providing for the survival of such provision or any other provision following termination of such Subject Agreement (each such provision and other provision, a “ Non-Surviving Provision ”), the parties hereby agree that no provision contained in either Subject Agreement shall survive the termination and extinguishment of the Subject Agreements pursuant to this Agreement.

 

1.3           Release .  Each of Edwards, on the one hand, and 3F Therapeutics, on the other hand, on behalf of itself and each of its respective affiliates, employees, agents, successors and assigns (each, a “ Releasing Party ”), hereby fully releases and discharges the other and each of its respective affiliates, employees, agents, successors and assigns (each, a “ Released Party ”), from, and to the extent applicable, relinquishes, all rights, obligations, liabilities, claims and actions, whether known or unknown, now existing or hereafter arising, at law or in equity or otherwise, that each such Releasing Party now has or may have against any Released Party, arising out of or in connection with the Subject Agreements (the “ Released Obligations ”); provided, however, that the outstanding obligations of Edwards to 3F Therapeutics and the outstanding obligations of 3F Therapeutics to Edwards, each as set forth in Exhibit D , shall not be released.

 

2.              CLOSING AND PAYMENT OF THE CONSIDERATION.

 

2.1           Closing .  The closing (the “ Closing ”) of the transactions contemplated under this Agreement shall take place on the date both Parties have executed and delivered this Agreement.

 

2.2           Consideration for Termination of Subject Agreements .  In full consideration of the termination of the Subject Agreements in accordance with Section 1 above, Edwards agrees to pay to 3F Therapeutics, or cause to be paid to 3F Therapeutics on its behalf, the aggregate sum of up to twenty four million seven hundred fifty thousand dollars and no cents ($24,750,000.00), as follows:

 

(a)            On the Closing Date, Edwards shall pay to 3F Therapeutics, or cause to be paid to 3F Therapeutics on its behalf, the sum of twenty two million seven hundred fifty thousand dollars and no cents ($22,750,000.00) (the “ Initial Termination Fee ”), by wire transfer of immediately available funds to an account designated by 3F Therapeutics; and

 

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(b)            On the date that is the first business day following the expiration of the Term (as such term is defined in the Supply and Training Agreement) of the Supply and Training Agreement in accordance with its terms, or such other date as the Parties may mutually determine (the “ Transitional Agreement Termination Date ”), Edwards shall pay to 3F Therapeutics, or cause to be paid to 3F Therapeutics on its behalf, the sum of two million dollars and no cents ($2,000,000.00) (the “ Holdback Amount ”), by wire transfer of immediately available funds to an account designated by 3F Therapeutics, provided, however , that Edwards’ obligations under this Section 2.2(b) shall be subject to the condition that there shall not have been any breach by 3F Therapeutics of any of its obligations under the Supply and Training Agreement as provided in Section 5.6 thereof at any time during the Term.  In the event that the aforementioned condition is not satisfied, Edwards shall have no obligation to pay to 3F Therapeutics, or cause to be paid to 3F Therapeutics on its behalf, any portion of the Holdback Amount under this Section 2.2(b).

 

2.3           Consideration for 3F License Agreement .  In full consideration of the execution and delivery of the 3F License Agreement by 3F Therapeutics, Edwards shall pay to 3F Therapeutics on the Closing Date, or cause to be paid to 3F Therapeutics on its behalf, the sum of two hundred fifty thousand dollars and no cents ($250,000.00) (the “ License Agreement Fee ”), by wire transfer of immediately available funds to an account designated by 3F Therapeutics.

 

2.4           Full Consideration .  3F Therapeutics hereby agrees that the Initial Termination Fee, the Holdback Amount (to the extent that Edwards is obligated to pay, or cause to be paid on its behalf, the Holdback Amount under the provisions of Section 2.2(b)) and the License Agreement Fee shall constitute consideration in full for 3F Therapeutics’ agreement to be bound by the provisions in this Agreement.

 

2.5           Documents to be Delivered .  Concurrently with the consummation of the transactions set forth in Sections 2.2 and 2.3 on the Closing Date, each Party shall duly execute and deliver to the other Party each of the Related Transaction Agreements.

 

3.              REPRESENTATIONS AND WARRANTIES OF EDWARDS .  Edwards represents and warrants to 3F Therapeutics, as of the Closing Date:

 

3.1           Organization and Corporate Power .  Edwards is a corporation duly organized, validly existing, and in good standing under the laws of the State of Delaware, and has all required corporate power and corporate authority to perform its obligations under this Agreement.

 

3.2           Authorization and Approval .  The execution, delivery and performance by Edwards of each of this Agreement and the Related Transaction Agreements have been duly authorized by all necessary corporate action of Edwards, including approval of such execution, delivery and performance by the board of directors of Edwards.  Edwards has duly executed and delivered each of this Agreement and the Related Transaction Agreements, which constitutes the valid and legally binding obligation of Edwards, enforceable in accordance with its terms, except that enforcement thereof may be limited by (a) applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally and (b) general principles of equity, whether such enforceability is considered in a proceeding in equity or at law.

 

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3.3           Agreements .  Edwards acknowledges that the Subject Agreements constitute all of the agreements, whether written or oral, entered into by and between the Parties with respect to the subject matter covered under the Subject Agreements, and that the termination of the Subject Agreements and the release of the Released Obligations pursuant to this Agreement effectively terminates all and any agreements or arrangements between the Parties with respect to such subject matter (including each Non-Surviving Provision) and releases 3F Therapeutics of all and any liabilities and obligations under all such agreements and arrangements, except those set forth in Exhibit D as referenced in Section 1.3 hereof.

 

4.              REPRESENTATIONS AND WARRANTIES OF 3F THERAPEUTICS.   3F Therapeutics represents and warrants to Edwards, as of the Closing Date:

 

4.1           Organization and Corporate Power .  3F Therapeutics is a corporation duly organized, validly existing, and in good standing under the laws of the State of Delaware, and has all required corporate power and corporate authority to perform its obligations under this Agreement.

 

4.2           Authorization and Approval .  The execution, delivery and performance by 3F Therapeutics of each of this Agreement and the Related Transaction Agreements have been duly authorized by all necessary corporate action of 3F Therapeutics, including approval of such execution, delivery and performance by the board of directors of 3F Therapeutics.  3F Therapeutics has duly executed and delivered each of this Agreement and the Related Transaction Agreements, which constitutes the valid and legally binding obligation of 3F Therapeutics, enforceable in accordance with its terms, except that enforcement thereof may be limited by (a) applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally and (b) general principles of equity, whether such enforceability is considered in a proceeding in equity or at law.

 

4.3           Agreements .  3F Therapeutics acknowledges that the Subject Agreements constitute all of the agreements, whether written or oral, entered into by and between the Parties with respect to the subject matter covered under the Subject Agreements, and that the termination of the Subject Agreements and the release of the Released Obligations pursuant to this Agreement effectively terminates all and any agreements or arrangements between the Parties with respect to such subject matter (including each Non-Surviving Provision) and releases Edwards of all and any liabilities and obligations under all such agreements and arrangements, except those set forth in Exhibit D as referenced in Section 1.3 hereof.

 

5.              MATTERS REGARDING TERMINATION AND RELEASE.

 

5.1           Certain Agreements and Acknowledgements.

 

(a)            3F Therapeutics hereby agrees and acknowledges that it shall not use or otherwise access any data, results and information generated by the testing, analysis, evaluation, or other means of the Investigational PVT Product (as defined in the 3F Development and Supply Agreement) (such data, results and information, the “ Test Data ”); provided , however , that

 

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3F Therapeutics shall have the right to use in the Surgical Field of Use (as such term is defined in the 3F License Agreement) (i) any Test Data that is in 3F Therapeutics’ possession as of the Closing Date and as set forth on Exhibit E and (ii) any additional Test Data in Edwards’ possession that was generated by Edwards prior to the Closing Date, to the extent required for regulatory purposes.

 

(b)            Edwards hereby acknowledges that (i) no license with respect to 3F Technology (as such term is defined in the 3F Development and Supply Agreement) was granted to Edwards or PVT by 3F Therapeutics by operation of Section 6.18 of the 3F Development and Supply Agreement and (ii) neither it nor PVT has obtained any right to exercise, or has exercised, the license with respect to 3F Patents (as such term is defined in the 3F Development and Supply Agreement) pursuant to Section 7.3 of the 3F Development and Supply Agreement.

 

(c)            3F Therapeutics hereby acknowledges that (i) no license with respect to PVT Technology (as such term is defined in the 3F Development and Supply Agreement) was granted to 3F Therapeutics by Edwards or PVT by operation of Section 6.16 of the 3F Development and Supply Agreement and (ii) it has not obtained the right to, and has not, exercised the license with respect to PVT Patents (as such term is defined in the 3F Development and Supply Agreement) pursuant to Section 7.2 of the 3F Development and Supply Agreement.

 

(d)            3F Therapeutics hereby acknowledges that (i) no license with respect to PVT Patents (as such term is defined in the VenPro Development Agreement) was granted to 3F Therapeutics or VenPro by Edwards or PVT by operation of Section 6.10 of the VenPro Development Agreement and (ii) neither it nor VenPro has obtained any right to exercise, or has exercised, the license with respect to PVT Patents (as such


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