Document:

Exhibit 10.1

 

ADVENT SOFTWARE, INC.

 

EXECUTIVE SEVERANCE PLAN

 

This Executive Severance Plan (the “Plan”) originally adopted by Advent Software, Inc. (the “Company” effective March 14, 2006, (the “Effective Date”) and amended and restated October 1, 2008, is hereby amended and restated as of October 12, 2012.  The Plan applies to members of the Company’s executive management team (each, an “Executive”).

 

RECITALS

 

1.             It is expected that the Company from time to time will consider the possibility of restructuring within the Company or an acquisition by another company or other change of control.  The Board of Directors of the Company (the “Board”) recognizes that such consideration can be a distraction to the Executive and can cause the Executive to consider alternative employment opportunities.  The Board has determined that it is in the best interests of the Company and its stockholders to assure that the Company will have the continued dedication and objectivity of the Executive, notwithstanding the possibility, threat or occurrence of a restructuring or Change of Control (as defined herein) of the Company.

 

2.                                      The Board believes that it is in the best interests of the Company and its stockholders to provide the Executive with an incentive to continue his employment and to motivate the Executive to maximize the value of the Company upon a Change of Control for the benefit of its stockholders.

 

3.                                      The Board believes that it is imperative to provide the Executive with certain severance benefits upon the Executive’s termination of employment, including following a Change of Control.  These benefits will provide the Executive with enhanced financial security and incentive and encouragement to remain with the Company notwithstanding the possibility of a Change of Control.

 

4.                                      Certain capitalized terms used in the Plan are defined in Section 4 below.

 

PLAN

 

1.              Term of Plan.  This Plan shall terminate upon the date that all of the obligations of the parties hereto with respect to this Plan have been satisfied.

 

2.              At-Will Employment.  The Executive’s employment with the Company is “at-will” employment and may be terminated by the Company at any time with or without cause or notice.  This Plan does not create any right to continued employment.  Further, the Executive’s job performance or promotions, commendations, bonuses or the like from the Company do not give rise to or in any way serve as the basis for modification, amendment, or extension, by implication or otherwise, of his employment with the Company.

 

 

3.              Severance and Termination.

 

(a)                                 Involuntary Termination.  If Executive’s employment with the Company is terminated other than voluntarily or for “Cause” (as defined herein), and Executive signs the Company’s standard release of claims in favor of the Company, then  Executive shall be entitled to (i) continuing payments of severance pay at a rate equal to his base salary rate, as then in effect, for a period of twelve (12) months from the date of such termination, to be paid periodically in accordance with the Company’s normal payroll policies; (ii) receive all expense reimbursements and any other benefits due to Executive through the date of termination of employment in accordance with established Company plans and policies applicable to Executive, (iii) receive Company-paid coverage for a period of twelve (12) months for himself and his eligible dependents under the Company’s health benefit plans (or, at the Company’s option, coverage under a separate plan), (iv) have all of Executive’s outstanding equity compensation (stock options (right to purchase common stock of the Company), stock appreciation rights, restricted stock, restricted stock units, or performance shares, “Equity Compensation”)  on the termination date, have their vesting accelerated as to twelve (12) months of additional vesting; with post-termination exercisability as specified in the applicable Equity Compensation agreement, and (v) receive such other compensation or benefits from the Company as may be required by law.

 

(b)                                 Termination due to Death or Disability.  If Executive’s employment with the Company is terminated due to his death or his becoming Disabled, then Executive or Executive’s estate (as the case may be) will (i) receive the Base Salary for a period of six (6) months from the date of such termination of employment, (ii) receive Company-paid coverage for a period of six (6) months for Executive (if applicable) and Executive’s eligible dependents under the Company’s health benefit plans (or, at the Company’s option, coverage under a separate plan), (iii) receive all expense reimbursements and any other benefits due to Executive through the date of termination of employment in accordance with Company-provided or paid plans and policies applicable to Executive, and (iv) not be entitled to any other compensation or benefits from the Company except to the extent required by law.

 

(c)                                  Involuntary Termination for Cause.  If the Company terminates Executive’s employment with the Company for Cause, then Executive will (i) receive the Base Salary through the date of termination of employment, (ii) receive all expense reimbursements and any other benefits due to Executive through the date of termination of employment in accordance with established Company plans and policies applicable to Executive, and (iii) not be entitled to any other compensation or benefits from the Company except as may be required by law.  No other compensation or benefits will be paid or provided to the Executive under this Plan on account of a termination for Cause, or for periods following the date when such a termination of employment is effective.

 

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(d)                                 Change of Control Benefits.  If the Executive’s employment with the Company is terminated (i) other than (A) voluntarily without Good Reason or (B) for Cause, and (ii) within twelve (12) months after a Change of Control, then promptly following such termination of employment, subject to Executive signing the Company’s standard release of claims in favor of the Company, Executive will (i) receive all expense reimbursements and any other benefits due to Executive through the date of termination of employment in accordance with the Company’s then existing employee benefit plans and policies applicable to Executive, (ii) be paid his then existing Base Salary for a period of twelve (12) months following his termination of employment, (iii) receive Company-paid coverage for a period of twelve (12) months for himself and his eligible dependents under the Company’s health benefit plans (or, at the Company’s option, coverage under a separate plan), (iv) have all of Executive’s outstanding equity compensation (stock options (right to purchase common stock of the Company), stock appreciation rights, restricted stock, restricted stock units, or performance shares, “Equity Compensation”)  on the termination date, have their vesting accelerated as to thirty (30) months of additional vesting; with post-termination exercisability as specified in the applicable Equity Compensation agreement, and (v)  receive such other compensation or benefits from the Company as may be required by law.

 

4.                                      Definitions.

 

(a)                                 Cause.  For purposes of this Plan, “Cause” is defined as:

 

(i)                                     a material violation by Executive of a federal or state law or regulation applicable to the business of the Company that has a material adverse effect on the Company;

 

(ii)                                  Executive’s misappropriation or embezzlement of Company funds or property or an act of fraud upon the Company made by Executive;

 

(iii)                               Executive’s conviction of, or plea of nolo contendre to, a felony; or

 

(iv)                              the willful failure by Executive to perform his or her material duties for the Company if such failure to perform is not fully cured by Executive within ten (10) days after he or she receives written notice of such failure; or

 

(v)                                 a willful violation of a written Company policy, the violation of which is stated in such policy to be grounds for termination; or

 

(vi)                              an act by the Executive which constitutes gross misconduct and which is materially and demonstrably injurious to the Company.

 

No act, or failure to act, by the Executive shall be considered “willful” unless committed without good faith and without a reasonable belief that the act or omission was in the Company’s best interests.

 

(b)                                 Change of Control.  For purposes of this Plan, “Change of Control” means (i) the sale, lease, conveyance or other disposition of all or substantially all of the Company’s assets to any “person” (as such term is used in Section 13(d) of the Securities Exchange Act of 1934, as amended), entity or group of persons acting in concert; (ii) any “person” or group of persons becoming the “beneficial owner” (as defined in Rule 13d-3 under said Act), directly or indirectly, of securities of the Company representing 35% or more of the total voting power represented by the Company’s then outstanding voting securities; (iii) a merger or consolidation of the Company with

 

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any other corporation, other than a merger or consolidation that would result in the voting securities of the Company outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity or its controlling entity) at least 50% of the total voting power represented by the voting securities of the Company or such surviving entity (or its controlling entity) outstanding immediately after such merger or consolidation; or (iv) a contest for the election or removal of members of the Board that results in the removal from the Board of at least 50% of the incumbent members of the Board.

 

(c)                                  Disabled.  For purposes of this Plan, “Disabled” means Executive being unable to perform the principal functions of his duties due to a physical or mental impairment, but only if such inability has lasted or is reasonably expected to last for at least three months.  Whether Executive is Disabled shall be determined by the Board based on evidence provided by one or more physicians selected by the Board.

 

(d)                                 Good Reason.  “Good Reason” shall mean without the Executive’s express written consent (i) a material reduction of the Executive’s duties, title, authority or responsibilities, relative to the Executive’s duties, title, authority or responsibilities as in effect immediately prior to such reduction, or the assignment to Executive of such reduced duties, title, authority or responsibilities; provided,  however, that a reduction in duties, title, authority or responsibilities solely by virtue of the Company being acquired and made part of a larger entity (as, for example, when the Chief Executive Officer of the Company remains the Chief Executive Officer of the subsidiary or business unit containing the Company’s business following a Change of Control) shall not by itself constitute grounds for a “Good Reason” termination; (ii) a substantial reduction of the facilities and perquisites (including office space and location) available to the Executive immediately prior to such reduction; (iii) a ten-percent (10%) or greater reduction by the Company in the base compensation of the Executive as in effect immediately prior to such reduction; (iv) a material reduction by the Company in the kind or level of benefits to which the Executive was entitled immediately prior to such reduction with the result that such Executive’s overall benefits package is significantly reduced; or (v) the relocation of the Executive to a facility or a location more than thirty-five (35) miles from such Executive’s then present location; provided, however, that such events shall not constitute grounds for a Good Reason termination unless the Executive has provided notice to the Company of the existence of the one or more of the above conditions within 90 days of its initial existence and the Company has been provided at least 30 days to remedy the condition.

 

5.                                      Limitation on Payments. In the event that the severance and other benefits provided for in this Plan or otherwise payable to the Executive (i) constitute “parachute payments” within the meaning of Section 280G of the Internal Revenue Code of 1986, as amended (the “Code”) and (ii) but for this Section 5, would be subject to the excise tax imposed by Section 4999 of the Code, then the Executive’s severance benefits under Section 3(d) shall be either:

 

(a)                                 delivered in full, or

 

(b)                                 delivered as to such lesser extent which would result in no portion of such severance benefits being subject to excise tax under Section 4999 of the Code, whichever of the foregoing amounts, taking into account the applicable federal, state and local income taxes and the excise tax imposed by Section 4999, results in the receipt by the Executive on an after-tax basis, of

 

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the greatest amount of severance benefits, notwithstanding that all or some portion of such severance benefits may be taxable under Section 4999 of the Code.  Unless the Company and the Executive otherwise agree in writing, any determination required under this Section 5 shall be made in writing by the Company’s independent public accountants immediately prior to Change of Control (the “Accountants”), whose determination shall be conclusive and binding upon the Executive and the Company for all purposes.  For purposes of making the calculations required by this Section 5, the Accountants may make reasonable assumptions and approximations concerning applicable taxes and may rely on reasonable, good faith interpretations concerning the application of Sections 280G and 4999 of the Code.  The Company and the Executive shall furnish to the Accountants such information and documents as the Accountants may reasonably request in order to make a determination under this Section.  The Company shall bear all costs the Accountants may reasonably incur in connection with any calculations contemplated by this Section 5.  If a reduction in severance and other benefits constituting “parachute payments” as defined in Section 280G of the Code, is necessary so that benefits are delivered to a lesser extent, reduction will occur in the following order: (1) reduction of the cash severance payments; (2) cancellation of accelerated vesting of equity awards; and (3) reduction of continued employee benefits.  In the event that the accelerated vesting of equity awards is to be cancelled, such vesting acceleration will be cancelled in the reverse chronological order of the Executive’s equity awards’ grant dates.

 

6.                                      Section 409A.  Notwithstanding anything to the contrary in this Plan, if the Company determines that Executive is a “specified employee” within the meaning of Section 409A of the Internal Revenue Code (“Section 409A”) at the time of the Executive’s termination of employment (other than due to death), then to the extent delayed commencement of any portion of the benefits to which Executive is entitled pursuant to this Plan, when considered together with any other severance payments or separation benefits that are considered deferred compensation under Section 409A (together, the “Deferred Compensation Separation Benefits”), is required to avoid a prohibited distribution under Section 409A(a)(2)(B)(i) of the Code, then such benefits will be delayed until the first payroll date that occurs on or after the date six (6) months and one (1) day following the date of the Executive’s termination of employment.  All subsequent Deferred Compensation Separation Benefits, if any, will be payable in accordance with the payment schedule applicable to each payment or benefit.  Notwithstanding anything herein to the contrary, if the Executive dies following the Executive’s termination of employment but prior to the six (6) month anniversary of the Executive’s termination of employment, then any payments delayed in accordance with this paragraph will be payable in a lump sum as soon as administratively practicable after the date of the Executive’s death and all other Deferred Compensation Separation Benefits will be payable in accordance with the payment schedule applicable to each payment or benefit.  Each payment and benefit payable under this Plan is intended to constitute separate payments for purposes of Section 1.409A-2(b)(2) of the Treasury Regulations.  Notwithstanding anything to the contrary in this Plan, no Deferred Compensation Separation Benefits payable under this Plan will be considered due or payable until and unless Executive has a “separation from service” within the meaning of Section 409A.

 

To the extent that any reimbursements payable pursuant to this Plan are subject to Section 409A, any such reimbursements payable to you pursuant to the Plan shall be paid no later than December 31 of the year following the year in which the expense was incurred, the amount of expenses reimbursed in one year shall not affect the amount eligible for reimbursement in any subsequent year, and Executive’s right to reimbursement under this Plan will not be subject to liquidation or exchange for another benefit.

 

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The foregoing provisions are intended to comply with the requirements of Section 409A so that none of the Plan’s benefits will be subject to the additional tax imposed under Section 409A, and any ambiguities herein will be interpreted to so comply.  The Company reserves the right to amend the Plan and to take such reasonable actions which are necessary, appropriate, or desirable to avoid imposition of any additional tax or income recognition prior to actual payment to Executive under Section 409A, provided that such amendment or action may not materially reduce the benefits provided or to be provided to Executive under the Plan.

 

7.                                      Release of Claims.  The receipt of any severance pursuant to this Plan is subject to Executive signing and not revoking the Company’s standard release of claims in favor of the Company (the “Release”); provided that such Release is effective within sixty (60) days following Executive’s termination of employment or such shorter period specified in the Release (the “Release Deadline”).  No severance will be paid or provided until the Release becomes effective.  If the Release is not effective by the Release Deadline, Executive forfeits Executive’s right to any severance or similar payment under the Plan.  In the event Executive’s termination of employment occurs at a time during the calendar year where it would be possible for the Release to become effective in the calendar year following the calendar year in which Executive’s termination of employment occurs, then any severance that would be considered Deferred Compensation Separation Benefits (as defined above) will be paid on the first payroll date to occur during the calendar year following the calendar year in which such termination of employment occurs, or such later time as required by (i) the payment schedule applicable to each payment or benefit, (ii) the date the Release becomes effective, or (iii) the time required by Section 6 of the Plan.

 

8.                                      Successors.

 

(a)                                 The Company’s Successors.  Any successor to the Company (whether direct or indirect and whether by purchase, merger, consolidation, liquidation or otherwise) to all or substantially all of the Company’s business and/or assets shall assume the obligations under this Plan and agree expressly to perform the obligations under this Plan in the same manner and to the same extent as the Company would be required to perform such obligations in the absence of a succession.  For all purposes under this Plan, the term “Company” shall include any successor to the Company’s business and/or assets which executes and delivers the assumption agreement described in this Section 7(a) or which becomes bound by the terms of this Plan by operation of law.

 

(b)                                 The Executive’s Successors.  The terms of this Plan and all rights of the Executive hereunder shall inure to the benefit of, and be enforceable by, the Executive’s personal or legal representatives, executors, administrators, successors, heirs, distributees, devisees and legatees.

 

9.                                      Notices.  All notices, requests, demands and other communications called for hereunder shall be in writing and shall be deemed given (i) on the date of delivery, or, if earlier, (ii) one (1) day after being sent by a well established commercial overnight service, or (iii) three (3) days after being mailed by registered or certified mail, return receipt requested, prepaid and

 

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addressed to the parties or their successors at the following addresses, or at such other addresses as the parties may later designate in writing

 

	
If   to the Company:
    	
Advent   Software, Inc.
    
	
 
    	
600   Townsend Street
    
	
 
    	
San   Francisco, California 94103
    
	
 
    	
Attention:   Chief Executive Officer
    

 

or to such other address or the attention of such other person as the recipient party has previously furnished to the other party in writing in accordance with this paragraph.

 

10.                               Miscellaneous Provisions.

 

(a)                                 No Duty to Mitigate.  The Executive shall not be required to mitigate the amount of any payment contemplated by this Plan, nor shall any such payment be reduced by any earnings that the Executive may receive from any other source.

 

(b)                                 Headings.  All captions and section headings used in this Plan are for convenient reference only and do not form a part of this Plan.

 

(c)                                  Severability.  The invalidity or unenforceability of any provision or provisions of this Plan shall not affect the validity or enforceability of any other provision hereof, which shall remain in full force and effect.

 

(d)                                 Withholding.  All payments made pursuant to this Plan will be subject to withholding of applicable income and employment taxes.

 

 

	
COMPANY:
    
	
 
    
	
Advent Software, Inc.
    
	
 
    
	
 
    
	
By:   
    	
/s/   John P. Brennan
    	
 
    
	
 
    	
 
    	
 
    
	
Title:
    	
Senior   Vice President of Human Resources
    	
 
    
	
 
    	
 
    	
 
    
	
Date:
    	
October 12,   2012
    	
 
    

 

7Exhibit 10.2

 

DEVELOPMENT AND LICENSE AGREEMENT

 

between

 

TEVA PHARMACEUTICALS USA, INC.

1090 Horsham Road, North Wales, PA 19454

(“Teva”)

 

and

 

BIOSANTE PHARMACEUTICALS, INC.

111 Barclay Boulevard, Lincolnshire, IL 60069

(“BioSante”)

 

WHEREAS, BioSante is engaged in the development of pharmaceutical products and has in development the pharmaceutical product listed in Annex A hereto (the “Product” as defined further below);

 

WHEREAS, Teva, together with its Affiliates (as defined below), is engaged in the development, manufacture, sale, marketing and distribution of pharmaceutical products;

 

WHEREAS, BioSante desires to grant to Teva an exclusive license to the Product Know-How (as defined below) so that Teva may register, obtain Approval for, manufacture, market, sell and distribute the Product in the United States, all in accordance with and subject to the conditions set forth in this Agreement;

 

NOW THEREFORE, intending to be legally bound hereby and in consideration of the mutual representations, warranties and covenants set forth herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, IT IS HEREBY AGREED BY THE PARTIES AS FOLLOWS:

 

1.                                      INTERPRETATION AND DEFINITIONS

 

1.1                               The preamble to this Agreement forms an integral part hereof.

 

1.2                               Section headings in this Agreement are intended solely for convenience of reference and should be given no effect in the interpretation of this Agreement.

 

1.3                               All annexes to this Agreement, signed by both Parties, whether attached at the time of signature hereof or at any time thereafter, should be construed as an integral part of this Agreement.

 

1.4                               For the purposes of this Agreement, the following words and phrases shall bear the respective meanings assigned to them below (and cognate expressions shall bear corresponding meanings):

 

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1.4.1                     “Affiliates” — shall mean with respect to either Party, any Person that is controlled by, controls, or is under common control with that Party. For this purpose, “control” of a corporation or other business entity shall mean direct or indirect beneficial ownership of more than fifty percent (50%) of the voting interest in, or more than fifty percent (50%) in the equity of, or the right to appoint more than fifty percent (50%) of the directors or management of such corporation or other business entity.

 

1.4.2                     “ANDA” — shall mean an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.

 

1.4.3                     “Applicable Law” — shall mean the applicable laws, rules, regulations, guidelines and requirements related to the development, registration, manufacture, importation and Marketing of the Product in the Territory.

 

1.4.4                     “Approval(s)” — shall mean any and all approvals, licenses, registrations or authorizations of the applicable Regulatory Authority necessary for the Marketing of the Product and reimbursement, if applicable, in the Territory.

 

1.4.5                     “Calendar Quarter” — shall mean a three (3) consecutive month period ending on March 31, June 30, September 30 or December 31.

 

1.4.6                     “Competing Product” — shall mean any finished pharmaceutical product for sale in the prescription drug marketplace that contains the same active ingredient in the same dosage form and strength as the Product.

 

1.4.7                     “Confidential Information” — shall mean all information, data and/or know-how disclosed by either Party and/or its Affiliates to the other Party and/or its Affiliates in writing (or if disclosed orally, visually and/or in another non-written form, identified as confidential at the time of disclosure, and summarized in reasonable detail in writing as to its general content within thirty (30) days after original disclosure) concerning the Product or concerning the technology, marketing strategies or business of the disclosing Party (whether disclosed prior to or subsequent to the Effective Date). Confidential Information shall not include information, data or know-how that the receiving Party can show:

 

(a)                                 was in the public domain at the time of the disclosure by the disclosing Party, or thereafter becomes part of the public domain without any fault of the receiving Party;

 

(b)                                 rightfully was in its possession prior to the disclosure by the disclosing Party;

 

(c)                                  was lawfully obtained from a third party, who had the right to make such disclosures as evidenced by written records; or

 

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(d)                                 was developed by it independently of such disclosure as evidenced by written records.

 

1.4.8                     “Effective Date” — shall mean the date on which this Agreement is signed by the latter of the Parties to sign this Agreement.

 

1.4.9                     “FDA” — shall mean the United States Food and Drug Administration and all agencies under its direct control or any successor organization.

 

1.4.10              “Force Majeure Events” — shall have the meaning set forth in Section 16.

 

1.4.11              “Launch Date” — shall mean the date on which Teva makes its first commercial sale of the Product to an unrelated third party in an arms-length transaction in the Territory.

 

1.4.12              “Market” — shall mean to promote, distribute, market, advertise and/or sell.

 

1.4.13              “Marketing Term” — shall mean a period of ten (10) years from the Launch Date of the Product in the Territory, unless terminated prior to such date as expressly provided for in this Agreement.

 

1.4.14              “Net Sales” — shall mean the gross amount invoiced for the Product by Teva or Teva’s Affiliates sold on an arms-length basis in the Territory, less the sum of: (a) trade, quantity and/or cash discounts, allowances, rebates, retroactive price adjustments, free goods, bad debts, cash incentive payments (e.g. slotting allowance), and chargebacks; (b) credits or refunds for rejected, outdated or returned Product; (c) any tax, duty or other government charge upon or related to the sale, delivery or use of that Product; (d) cost of short dated Product, which is destroyed by Teva or its Affiliates; and (e) other specifically identifiable amounts included in the Product’s gross sales that will have been or ultimately will be credited and are substantially similar to those listed above; in each case determined in accordance with U.S. GAAP.

 

1.4.15              “Party”, “Parties” — shall mean Teva and/or BioSante, as applicable.

 

1.4.16              “Person” — shall mean any individual, partnership, association, corporation, limited liability company, trust, or other legal person or entity.

 

1.4.17              “Product” — shall mean the finished pharmaceutical product listed in Annex A developed by BioSante.

 

1.4.18              “Product Know-How” — shall mean the Regulatory Documentation, Technical Package and any and all other proprietary methods, devices, technology, trade secrets, inventions, patent applications, patents,

 

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compositions, designs, formulae, know-how, show-how, technical and training manuals and documentation and other information, including processes and analytical methodologies used in development, testing, analysis and manufacture, and medical, clinical testing as well as other scientific testing, related to or used in connection with the Product or any ingredient thereof, and/or the formulation, development, registration, manufacture, use or sale thereof, in BioSante’s (or its Affiliates’) possession or under its control whether now known or hereafter developed or otherwise acquired, directly or indirectly.

 

1.4.19              “Regulatory Authority” — shall mean any and all governmental bodies, organizations and agencies whose approval is necessary to develop, manufacture, import, use, and/or Market the Product in the Territory.

 

1.4.20              “Regulatory Documentation” — shall mean all submissions to Regulatory Authorities, including clinical studies, tests, and biostudies relating to the Product, including, without limitation, all ANDAs, 505(b)(2) applications, and DMFs, as well as all correspondence with Regulatory Authorities (registration and licenses, regulatory drug lists, advertising and promotion documents), adverse event files, complaint files, manufacturing records and inspection reports.

 

1.4.21              “Regulatory Expenses” — shall mean all reasonable out-of-pocket direct costs and expenses in connection with preparing, submitting, obtaining and maintaining Approvals of the Product.

 

1.4.22              “Royalties” — shall mean an amount equal to seven and one half percent (7.5%) of Net Sales; provided, however, that during the period of time that Teva is the sole marketer of a generic 1% testosterone gel AB-rated to AndroGel® in the Territory such amount shall be equal to ten percent (10%) of Net Sales.

 

1.4.23              “Technical Package” — shall have the meaning set forth in Section 2.4.

 

1.4.24              “Term” — shall mean the duration of this Agreement starting on the Effective Date and continuing until the end of the Marketing Term, unless terminated prior to such date pursuant to Section 12.

 

1.4.25              “Territory” — shall mean the U.S.

 

1.4.26              “U.S.” — shall mean the United States of America and its territories, districts and possessions.

 

1.4.27              “U.S. GAAP” — shall mean generally accepted accounting principles in the U.S., consistently applied.

 

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2.                                      GRANT OF RIGHTS

 

2.1                               BioSante, for itself and its Affiliates, grants to Teva and its Affiliates in accordance with the terms and conditions of this Agreement, the exclusive right (even as to BioSante and its Affiliates), under all of the existing or future Product Know-How owned or controlled by BioSante or its Affiliates, to register, make or have made, develop, import/export or have imported/exported, use or have used, Market, offer for sale or have sold, and otherwise exploit the Product on a sole and exclusive basis (even as to BioSante and its Affiliates) in or for the Territory.

 

2.2                               Neither BioSante nor its Affiliates shall, directly or indirectly, during the Term, Market the Product or cause or permit the Product to be Marketed in or for the Territory, except as otherwise may be specifically permitted by the terms of this Agreement.

 

2.3                               BioSante and its Affiliates shall not, directly or indirectly, during the Term, disclose to any third party any Product Know-How, if such third party may or has the ability to use such Product Know-How to directly or indirectly Market a Competing Product in or for the Territory.

 

2.4                               BioSante shall provide to Teva by no later than the Effective Date (a) all Regulatory Documentation in BioSante’s (or its Affiliates’) possession or under its control; and (b) all technical information, data and know-how in BioSante’s (or its Affiliates’) possession or under its control with respect to the Product, including, without limitation, any and all raw material, work in process and samples related to the Product, useful or necessary for Teva or its nominee to continue the development of the Product and to set up a facility for the commercial manufacture of the Product (the “Technical Package”). BioSante shall promptly forward to Teva any such Regulatory Documentation and/or Technical Package materials that should later become available to BioSante during the Term of this Agreement.

 

2.5                               Teva shall have the right to subcontract, in whole or in part, the manufacturing of the Product to a third party.

 

3.                                      REGULATORY APPROVAL

 

3.1                               Teva shall prepare the necessary Approval applications for the Product to obtain Approval of the Product in the Territory from the applicable Regulatory Authorities.

 

3.2                               Teva shall use its commercially reasonable efforts customarily employed by Teva with respect to other generic drug products to conduct all tests and studies reasonably required to enable Teva to apply for, obtain and maintain Approval for the Product in the Territory.

 

3.3                               Teva shall be responsible for all communications with the Regulatory Authorities relating to the Approval for the Product in the Territory. Teva shall provide to

 

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BioSante copies of all Regulatory Documentation submitted to the Regulatory Authorities with respect to obtaining Approval for the Product.

 

3.4                               Upon the request of BioSante, Teva shall provide BioSante with periodic updates (no more often than once per Calendar Quarter) concerning the development of the Product.

 

3.5                               The Approval applications shall be filed in Teva’s name and Teva shall be the sole and exclusive owner of such Approval applications and all Regulatory Documentation in connection therewith.

 

3.6                               BioSante shall grant Teva reasonable and unrestricted access, without any charges, costs or expense, to any and all relevant documentation, data, information, tests, studies or know-how related to the Product, in its possession or under its control, and provide free of charge any and all assistance that Teva may reasonably request in order for Teva to obtain Approval for the Product in the Territory, and as necessary in connection with the manufacture and Marketing of the Product in or for the Territory.

 

3.7                               Teva or its Affiliates shall be responsible for filing the Product, and thereafter processing such filing, with appropriate federal, state or private formularies in the Territory.

 

3.8                               Each Party shall perform, or cause to be performed, its activities in furtherance of the provisions of this Section 3 in a good scientific manner, in compliance in all material respects with all requirements of Applicable Law, and in an efficient and expeditious manner.

 

3.9                               Teva agrees that it will use its commercially reasonable efforts customarily used by Teva with respect to other generic drug products to Market the Product in the Territory.

 

3.10                        Teva has the sole and exclusive right to determine all terms and conditions for the sale of the Product in the Territory, including the determination of timing of launch of the Product in the Territory, which timing of launch shall be consistent with that customarily used by Teva for other generic products.

 

3.11                        Subject to pre-approval by Teva, Teva shall bear all Regulatory Expenses incurred by BioSante after July 1, 2002. Payments with respect to Regulatory Expenses shall be made by Teva within thirty (30) days following the end of each month and upon receipt of an invoice and all supporting documentation from BioSante.

 

3.12                        Upon the request of BioSante, the Parties will discuss in good faith how Teva may provide assistance to BioSante in manufacturing the Product for sale outside the Territory.

 

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4.                                      TRADE MARK(S)

 

Teva and its Affiliates shall have the right, in their respective sole discretion and at their expense, to select and to register any of their trademarks, as they wish to employ in connection with the Marketing of the Product in the Territory and to Market Product using such trademarks. Teva or its Affiliates shall own all right, title and interest in and to all such trademarks, and BioSante hereby agrees it shall have no right, title or interest in same.

 

5.                                      ROYALTIES

 

5.1                               Commencing on the Launch Date for the Product in the Territory, Teva shall pay to BioSante the Royalties as set forth in Section 5.2 below.

 

5.2                               No later than thirty (30) days after the end of each Calendar Quarter, Teva shall report to BioSante the Net Sales for the Product sold by Teva and/or its Affiliates in the Territory and the Royalties due to BioSante for such period. The payment of Royalties by Teva to BioSante shall be made within thirty (30) days after the end of each Calendar Quarter.

 

6.                                      AUDITS

 

6.1                               Teva and its Affiliates shall permit an independent certified public accounting firm selected by BioSante, and reasonably acceptable to Teva, to have access, during normal business hours and upon reasonable prior notice (not more often than once in any calendar year), to those books and records maintained by Teva necessary for BioSante to verify the accuracy of Teva’s calculation of any Net Sales and Royalties hereunder for any period ending not more than two (2) years prior to the date of such request. All such information shall be retained on a confidential basis by the accounting firm, and such accounting firm’s use of such information shall be limited to the aforementioned verification.

 

6.2                               BioSante and its Affiliates shall permit an independent certified public accounting firm selected by Teva, and reasonably acceptable to BioSante, to have access, during normal business hours and upon reasonable prior notice (not more often than once in any calendar year), to those books and records maintained by BioSante necessary for Teva to verify the accuracy of BioSante’s calculation of any Regulatory Expenses hereunder for any period ending not more than two (2) years prior to the date of such request. All such information shall be retained on a confidential basis by the accounting firm, and such accounting firm’s use of such information shall be limited to the aforementioned verification.

 

6.3                               Teva shall calculate and record Net Sales and Royalties in accordance with U.S. GAAP, and shall maintain all books and records related thereto in accordance with standard cost accounting policies and practices, in accordance with U.S. GAAP for the Term plus an additional three (3) years thereafter.

 

6.4                               Each Party shall promptly supply the other Party with a copy of any notices or reports received from any Regulatory Authority related to an audit or other

 

7

 

investigation by the Regulatory Authority with respect to the Product. Each Party shall use its commercially reasonable best efforts to provide such Regulatory Authority with a prompt, accurate and complete response to any deficiencies noted, and to promptly address, and if necessary correct, any and all such deficiencies to the satisfaction of the Regulatory Authority.

 

7.                                      MILESTONE PAYMENTS

 

In partial consideration of the rights granted herein and subject to the terms and conditions set forth in this Agreement, Teva shall be obligated to BioSante for the following milestone payments:

 

(a)                                 One Million Five Hundred Thousand U.S. Dollars (U.S. $1,500,000) upon the Effective Date;

 

(b)                                 One Million U.S. Dollars (U.S. $1,000,000) within thirty (30) days following acceptance by the FDA of the ANDA for the Product;

 

(c)                                  One Million U.S. Dollars (U.S. $1,000,000) within thirty (30) days following final Approval by the FDA for the Product; and

 

(d)                                 provided that Teva is the sole marketer in the Territory of a generic 1% testosterone gel AB-rated to AndroGel® for at least one hundred and eighty (180) days immediately following the Launch Date in the Territory, then, in such event, Teva shall pay to BioSante, within thirty (30) days following such one hundred and eighty (180) day period, an amount equal to Four Million U.S. Dollars (U.S. $4,000,000).

 

8.                                      ADDITIONAL REPRESENTATIONS, WARRANTIES AND COVENANTS OF BIOSANTE

 

8.1                               BioSante hereby represents and/or warrants and/or undertakes to Teva that:

 

8.1.1                     it has the corporate authority to enter into this Agreement and to perform its obligations hereunder;

 

8.1.2                     neither the execution and delivery of this Agreement by BioSante nor its performance hereunder conflicts with or results in any violation or breach of, or constitutes (with or without due notice or lapse of time or both) a default under any of the terms or conditions of any note, bond, mortgage, indenture, license, agreement or other instrument or obligation to which it or any of its Affiliates is a party or by which it or any of its Affiliates or any of their respective properties or assets may be bound, or to its best knowledge, violate any statute, law, rule, regulation, writ, injunction, judgment, order or decree of any court, administrative agency or governmental authority binding on it or any of its Affiliates or any of their respective properties or assets, excluding any such breaches or defaults that, individually and in the aggregate, would not have a material adverse effect on its business or financial condition;

 

8

 

8.1.3                     this Agreement is a legal, valid and binding agreement of BioSante enforceable in accordance with its terms;

 

8.1.4                     neither it nor any of its Affiliates have or will, directly or indirectly, enter into any contract or any other transaction with any third party or Affiliate that conflicts or derogates from its undertakings hereunder;

 

8.1.5                     neither the Product nor the process for making the Product violates, infringes, or otherwise conflicts or interferes with the intellectual property rights of any third party in the Territory;

 

8.1.6                     BioSante has furnished Teva with a complete copy of the Regulatory Documentation and Technical Package for the Product, and BioSante is and was, at all times prior to the Effective Date, the lawful holder of all rights under the Product Know-How; and

 

8.1.7                     BioSante has the right, power and authority to grant the rights to Teva hereunder.

 

9.                                      ADDITIONAL REPRESENTATIONS, WARRANTIES AND COVENANTS OF TEVA

 

9.1                               Teva hereby represents and/or warrants and/or undertakes to BioSante that:

 

9.1.1                     it has the corporate authority to enter into this Agreement and to perform its obligations hereunder;

 

9.1.2                     neither the execution and delivery of this Agreement by Teva nor its performance hereunder conflicts with or results in any violation or breach of, or constitutes (with or without due notice or lapse of time or both) a default under any of the terms or conditions of any note, bond, mortgage, indenture, license, agreement or other instrument or obligation to which it is a party or by which it or any of its properties or assets may be bound, or to its best knowledge, violate any statute, law, rule, regulation, writ, injunction, judgment, order or decree of any court, administrative agency or governmental authority binding on it or any of its properties or assets, excluding any such breaches or defaults that, individually and in the aggregate, would not have a material adverse effect on its business or financial condition;

 

9.1.3                     this Agreement is a legal, valid and binding agreement of Teva, enforceable in accordance with its terms; and

 

9.1.4                     it has not and will not, directly or indirectly, enter into any contract or any other transaction with any third party or Affiliate that conflicts or derogates from its undertakings hereunder.

 

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10.                               INDEMNIFICATIONS AND LIABILITY

 

10.1                        BioSante shall indemnify, defend and hold Teva, its Affiliates, and their respective officers, directors, employees, and representatives harmless from and against any and all losses, liabilities, damages, costs and expenses, including reasonable attorney’s fees and disbursements, (collectively, “Damages”) in connection with any and all suits, investigations, claims or demands by third parties resulting from or arising out of: (a) any breach or alleged breach by BioSante (or its Affiliates) of any representation, warranty, undertaking or covenant in this Agreement ; or (b) any negligence or willful misconduct by BioSante (or its Affiliates).

 

10.2                        Teva shall indemnify, defend and hold BioSante, its Affiliates, and their respective officers, directors, employees, and representatives harmless from and against any and all Damages as defined above in connection with any and all suits, investigations, claims or demands by third parties resulting from or arising out of: (a) any breach or alleged breach by Teva (or its Affiliates) of any representation, warranty, undertaking or covenant in this Agreement; (b) any negligence or willful misconduct by Teva (or its Affiliates); or (c) any claims of strict product liability, whether based on allegations of design defect or unreasonable dangerousness, if allegedly arising out of Teva’s or its designees’ actions related to the Product, including but not limited to the manufacturing or Marketing of the Product.

 

10.3                        In the event that in determining the respective obligation of indemnification under this Section 10, it is found that the fault of BioSante, Teva or their respective Affiliates, contributes to any Damages relating to the Product supplied and/or distributed or sold hereunder, then each of BioSante and Teva shall be responsible for that portion of the Damages to which its fault contributed.

 

10.4                        As soon as a Party becomes aware of the possibility of a claim involving indemnification under this Section 10, the indemnified Party shall give the indemnifying Party prompt written notice in writing and shall permit the indemnifying Party to have control over the defense of such claim or suit. The indemnified Party agrees to provide all reasonable information and assistance to the indemnifying Party in such defense. No such claims shall be settled other than by the Party defending the same, and then only with the consent of the other Party, which shall not be unreasonably withheld or delayed; provided, however, that the indemnified Party shall have no obligation to consent to any settlement of any such claim which imposes on the indemnified Party any liability or obligation which cannot be assumed and performed in full by the indemnifying Party.

 

10.5                        Except in the event of and to the extent of Damages awarded to a third party in connection with the indemnification provisions set forth in Sections 10.1 and 10.2, above, neither Teva nor BioSante shall be liable to the other for special, indirect, incidental or consequential damages, whether in contract, warranty, negligence, tort, strict liability or otherwise.

 

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11.                               CONFIDENTIALITY

 

11.1                        Each of the Parties agrees that: (a) it will not disclose any Confidential Information of the other to any third party at any time during the Term without the prior written consent of the disclosing Party; (b) it will not make use of any Confidential Information of the other Party for any purpose other than for the purposes set forth in, or in furtherance of the transactions contemplated by this Agreement; and/or (c) it will use all reasonable efforts to prevent unauthorized publication or disclosure by any person of such Confidential Information including requiring its employees, consultants or agents to enter into confidentiality agreements that require them to maintain Confidential Information in confidence to the same degree as its own confidential information.

 

11.2                        Notwithstanding the foregoing, either Party may upon reasonable prior written notice to the other Party disclose Confidential Information as required by law or court order, except that upon receipt of any such request or requirement of law or court order, each Party agrees to promptly notify the other in order to give the other a reasonable opportunity to seek a protective order in the appropriate forum.

 

11.3                        All Confidential Information in any form must be returned to the Party who disclosed the Confidential Information within thirty (30) days of the termination or expiration of this Agreement, save for the retention of one (1) copy of the Confidential Information by the receiving Party as a record of the receiving Party’s ongoing confidentiality obligations under this Agreement.

 

11.4                        Each of the Parties agrees that all Confidential Information that it receives from the other Party and/or its Affiliates in connection with the Product is the sole property of the disclosing Party and shall be used by it only in accordance with the terms and provisions of this Agreement.

 

11.5                        This Section 11 shall be in effect during the Term and for a period of five (5) years following the termination or expiration thereof.

 

11.6                        The Parties acknowledge that it is their intention to limit the disclosure of Confidential Information hereunder to the Product and matters directly related thereto.

 

12.                               TERM AND TERMINATION

 

12.1                        Upon expiration of the Term, BioSante shall grant to Teva and its Affiliates a perpetual, fully paid, royalty free, exclusive license to manufacture and Market the Product in or for the Territory and to use any Product Know-How existing as of the date of such expiration necessary to enable Teva and/or its Affiliates to manufacture and/or Market the Product in or for the Territory.

 

12.2                        This Agreement may be terminated by either Party by written notice provided to the other Party at any time during the Term if the other Party (the “Breaching Party”) is in material breach or default of any of its obligations hereunder

 

11

 

(including, without limitation, any payment obligations) or any of its representations or warranties hereunder were untrue in a material respect when made, as follows: (i) the terminating Party shall send written notice of the material breach or material default to the Breaching Party, and (ii) the termination shall become effective sixty (60) days after written notice thereof was provided to the Breaching Party, unless the Breaching Party has cured any such material breach or default prior to the expiration of the sixty (60) day period or if such material breach or material default is not capable of being cured within such sixty (60) day period, and the Breaching Party has commenced activities reasonably expected to cure such material breach or material default within such sixty (60) day period and thereafter uses diligent efforts to complete the cure as soon as practicable, but in no event shall such period exceed ninety (90) days.

 

12.3                        Subject to the provisions of Section 13.3 hereof, BioSante may terminate this Agreement effective upon issuance of written notice if, at any time, Teva files a petition in bankruptcy, or enters into an arrangement with its creditors, or applies for or consents to the appointment of a receiver or trustee, or makes an assignment for the benefit of creditors, or suffers or permits the entry of an order adjudicating it to be bankrupt or insolvent.

 

13.                               CONSEQUENCES OF TERMINATION

 

13.1                        Termination of this Agreement for whatever reason shall not affect the liabilities or obligations of the Parties hereunder in respect of matters accrued at the time of such termination, and shall be without prejudice to any other right or remedies available at law or in equity.

 

13.2                        In the event of early termination of this Agreement by BioSante pursuant to Section 12.2 and without derogating from any other rights or remedies available to BioSante, all rights, Approvals and data shall be promptly returned to BioSante without charge, and Teva agrees to execute without delay all documentation necessary to effectuate this purpose.

 

13.3                        All rights and licenses granted pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of 11 U.S.C. §101 et seq. (the “Bankruptcy Code”), licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code. The Parties agree that Teva, as a licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights (including, without limitation, any right to enforce any exclusivity provision of this Agreement (including any embodiment of such “intellectual property”)), remedies and elections under the Bankruptcy Code. To the fullest extent permitted by Applicable Law, the Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against BioSante under the Bankruptcy Code, Teva shall be entitled to all applicable rights under Section 365 of the Bankruptcy Code, including but not limited to, a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all

 

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embodiments of such intellectual property upon written request therefore by Teva, and such, if not already in its possession, shall be promptly delivered to Teva.

 

14.                               INDEPENDENT CONTRACTORS

 

The status of the Parties under this Agreement shall be that of independent contractors. Nothing is this Agreement shall be construed as establishing a partnership or joint venture relationship between the Parties hereto. No Party shall have the right to enter into any agreements on behalf of the other Party, nor shall it represent to any person that it has any such right or authority. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party.

 

15.                               SUCCESSORS AND ASSIGNS

 

The terms and provisions hereof shall inure to the benefit of, and be binding upon, Teva, BioSante and their respective successors and permitted assigns. Neither Party shall assign this Agreement or any part of it to any third party without the prior written consent of the other Party, such consent not to be unreasonably withheld; provided, however, that either party may, without obtaining the consent of the other Party but upon written notice to the other Party, assign this Agreement or delegate any of its rights or obligations hereunder to any of its Affiliates.

 

16.                               FORCE MAJEURE

 

16.1                        Neither Party shall be liable for non-performance or delay in the fulfillment of its obligations when any such non-performance or delay shall be occasioned by any unforeseeable cause beyond the reasonable control of Teva or BioSante, as the case may be, including without limitation, acts of God, fire, flood, earthquakes, explosions, sabotage, strikes, or labor disturbances (regardless of the reasonableness of the demands of the labor force), civil commotion, riots, military invasions, wars, failure of utilities, failure of carriers, or any acts, restraints, requisitions, regulations, or directives issued by a competent government authority not engendered by any act or omission of the Party (“Force Majeure Events”).

 

16.2                        In the event that either Party is prevented from discharging its obligations under this Agreement on account of a Force Majeure Event, such Party shall notify the other forthwith, and shall nevertheless make every endeavor, in the utmost good faith, to discharge its said obligations, even if in a partial or compromised manner.

 

17.                               CURRENCY

 

All payments under this Agreement shall be made in U.S. Dollars and, as applicable, the calculation of exchange rates shall be based upon the average over a twenty (20) business day period preceding the date that payment is due of the applicable rate of exchange as published in the Wall Street Journal.

 

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18.                               PUBLICITY AND DISCLOSURE OF AGREEMENT

 

Concurrently with the execution of this Agreement, the Parties shall agree in good faith on a form of press release that BioSante may release.  The Parties agree that no future press releases or other public announcements concerning the transactions contemplated hereby shall be issued without the advance written consent of the other Party, which consent shall not be unreasonably withheld, to the extent such release or announcement includes statements concerning terms of this Agreement and/or explicitly includes the Product or either Parties’ name(s), except to the extent such release or announcement may be required by Applicable Law.  For releases or announcements required by law, the Party making the release or announcement shall, before making any such release or announcement, afford the other Party a reasonable opportunity to review and comment.  Any copy of this Agreement to be filed with the Securities and Exchange Commission or any other Regulatory Authority shall be redacted to the fullest extent permitted by Applicable Law and to the reasonable satisfaction of both Parties; provided, however, in the event that the Securities and Exchange Commission or Regulatory Authority, as applicable, objects to the redaction of any portion of the Agreement after the initial submission, the filing Party shall inform the other Party of the objections and shall in good faith respond to the objections in an effort to limit the disclosure required by the Securities and Exchange Commission or Regulatory Authority, as applicable.

 

19.                               SEVERABILITY

 

Should any part or provision of this Agreement be held unenforceable or in conflict with Applicable Law, the invalid or unenforceable part or provision shall, provided that it does not go to the essence of this Agreement, be replaced with a revision which accomplishes, to the extent possible, the original commercial purpose of such part or provision in a valid and enforceable manner, and the balance of this Agreement shall remain in full force and effect and binding upon the Parties hereto.

 

20.                               ENTIRE AGREEMENT

 

This Agreement (including its Annexes) constitutes the entire agreement between the Parties with respect to its subject matter and supersedes all prior agreements, arrangements, dealings or writings between the Parties.  This Agreement may not be amended or modified except in writing executed by the duly authorized representatives of both Parties.

 

21.                               WAIVER

 

No waiver of a breach or default hereunder shall be considered valid unless in writing and signed by the Party giving such waiver, and no such waiver shall be deemed a waiver of any subsequent breach or default of the same or similar nature.

 

22.                               GOVERNING LAW

 

This Agreement shall be governed, interpreted and construed in accordance with the laws of the Commonwealth of Pennsylvania, without regard to principles of conflicts of law.  To the extent that it may otherwise be applicable, the Parties hereby expressly agree to exclude from the operation of this Agreement the United Nations Convention on Contracts for the International

 

14

 

Sale of Goods, concluded at Vienna, on 11 April 1980, as amended and as may be amended further from time to time.

 

23.                               NOTICES

 

Notices provided for under this Agreement shall be given in writing, in English, by facsimile; by first-class mail, federal express or similar service to the mailing address or facsimile numbers set out below:

 

	
If   to Teva
    	
TEVA   PHARMACEUTICALS USA, INC.
    
	
 
    	
1090   Horsham Road
    
	
 
    	
North   Wales, PA 19454
    
	
 
    	
Attention:   President
    
	
 
    	
Telephone:
    	
215-591-3000
    
	
 
    	
Facsimile:
    	
215-591-8846
    
	
 
    	
 
    	
 
    
	
With   a copy to:
    	
TEVA   NORTH AMERICA
    
	
 
    	
1090   Horsham Road
    
	
 
    	
North   Wales, Pennsylvania 19454
    
	
 
    	
Attention:
    	
Vice   President and General Counsel
    
	
 
    	
 
    	
Teva   North America
    
	
 
    	
Telephone:
    	
(215)   591-3000
    
	
 
    	
Facsimile:
    	
(215)   591-8813
    
	
 
    	
 
    	
 
    
	
If   to BioSante
    	
BIOSANTE   PHARMACEUTICALS, INC.
    
	
 
    	
Stephen   Simes
    
	
 
    	
111   Barclay Boulevard
    
	
 
    	
Lincolnshire, IL   60069
    
	
 
    	
Telephone:
    	
847   478-0500, ext 100
    
	
 
    	
Facsimile:
    	
847   478-9260
    
	
 
    	
 
    	
 
    
	
With   a copy to:
    	
GARY   I. LEVENSTEIN
    
	
 
    	
Ungaretti &   Harris
    
	
 
    	
3500   Three First National Plaza
    
	
 
    	
Chicago, Illinois   60602-4283
    
	
 
    	
Telephone:
    	
312   977-4400
    
	
 
    	
Facsimile:
    	
312   977-4405
    

 

or to such other addresses or facsimile numbers as a Party shall designate by notice, similarly given, to the other Party. Notices shall be deemed to have been sufficiently given and served the day transmitted by facsimile (with confirmed transmission) or a date five (5) business days after the date of express mail or by mail courier.

 

24.                               RESOLUTION OF DISAGREEMENTS

 

If disagreements should arise under this Agreement, both BioSante and Teva agree to make good faith efforts to resolve the disagreements by discussion and negotiation. Any disagreements in

 

15

 

connection with this Agreement or a Party’s alleged breach of this Agreement that either Party believes has not been satisfactorily resolved through discussion and negotiation shall be resolved upon the written notice of either Party to the other requesting final and binding arbitration. If initially requested by Teva, the arbitration shall be held in Chicago, Illinois. If initially requested by BioSante, the arbitration shall be held in a location of Teva’s selection within the Commonwealth of Pennsylvania. Such arbitration shall be before three (3) arbitrators, where each Party shall select one (1) arbitrator and the two (2) selected shall choose the third, and conducted under the Commercial Arbitration Rules of the American Arbitration Association. The prevailing Party in any such arbitration shall be entitled to recover only reasonable out-of-pocket costs of the arbitration (not attorney’s fees) in addition to any award determined by the arbitrators. Any award rendered in such arbitration may be entered and enforced by either Party in any court having jurisdiction.

 

25.                               STEERING COMMITTEE

 

The Parties agree that a Steering Committee, comprised of two (2) representatives of each Party, shall be formed within thirty (30) days of the Effective Date and shall work cooperatively, and meet from time to time as it shall deem desirable, with the goals of effectuating smooth and prompt implementation of the Parties’ obligations under this Agreement and avoidance and resolution of disagreements between the Parties; and to provide updates of information as provided for in this Agreement.

 

IN WITNESS WHEREOF, each of the Parties has executed this Agreement and Annexes as of the date below.

 

	
TEVA   PHARMACEUTICALS USA, INC.
    	
 
    	
BIOSANTE   PHARMACEUTICALS, INC.
    
	
 
    	
 
    	
 
    
	
Signature:
    	
/s/   George S. Barrett
    	
 
    	
Signature:
    	
/s/   Stephen M. Simes
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
George   S. Barrett
    	
 
    	
Name:
    	
Stephen   M. Simes
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
President &   CEO
    	
 
    	
Title:
    	
President &   CEO
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Date:
    	
December 23,   2002
    	
 
    	
Date:
    	
12/27/02
    
							

 

16

 

ANNEX A

 

The Product

 

1% testosterone gel AB-rated to AndroGel®

 

17

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