Document:

Exhibit 10.2

 

APPENDIX A TO THE 2009 STOCK OPTION PLAN

 

STEADYMED, LTD.

 

2013 STOCK INCENTIVE SUBPLAN

 

ARTICLE I

PURPOSE

 

The purpose of this 2013 Stock Incentive Subplan (the “Plan”) of SteadyMed, Ltd., an Israeli corporation (the “Company”), is to specify the terms under which Options under the 2009 Stock Option Plan may be granted to individuals performing services on behalf of the Company in the United States for its subsidiary, SteadyMed Therapeutics, Inc., a Delaware Corporation. Except as provided herein, in the event of a conflict between the terms of the Plan and the 2009 Stock Option Plan, the terms of the plan which is more restrictive shall control. This Plan is authorized under Section 2(b) of the 2009 Stock Option Plan.

 

Like the 2009 Stock Option Plan, this Plan advances the interests of the Company and its shareholders by providing officers, directors, key employees, consultants and other independent contractors of the Company and Affiliates, upon whose judgment, initiative and efforts the Company and Affiliates largely depend, with additional incentive to perform in a superior manner. This Plan is also designed to attract and retain key personnel and to reward such individuals for achievement of corporate and individual performance goals.

 

ARTICLE II

DEFINITIONS

 

As used in this Plan or any Award hereunder, the following defined terms have the meanings indicated below:

 

“Affiliate” means an affiliate of the Company, with the word “affiliate” as defined in Rule 12b-2 promulgated by the SEC under the Exchange Act.

 

“Award” means a Stock Grant or a grant of an Option pursuant to the provisions of this Plan.

 

“Board of Directors” or “Board” means the board of directors of the Parent Company.

 

“Cause” means the termination of employment or other services for negligence, personal dishonesty, incompetence, willful misconduct, any breach of fiduciary duty involving personal profit, failure to perform stated or assigned duties, or the willful violation of any law, rule or regulation (other than traffic violations or similar offenses); provided, however, if an Employee has an employment agreement with the Company or an Affiliate and such employment agreement defines a termination for “cause,” then “Cause” as used herein shall have the same meaning as set forth in such employment agreement.

 

 

“Change in Control” means the occurrence of any one of the following events, unless stated otherwise in an Award or as otherwise required by Code Section 409A to avoid the additional taxes therein: (a) any person or more than one person acting as a group becomes the “beneficial owner” (as defined in Rule 13d-3 under the Exchange Act) of stock of the Company, that together with stock held by such person or group, constitutes more than 50% of the total fair market value or total voting power of stock of the Company (excluding any additional stock acquired by a person or more than one person acting as a group who prior to the acquisition is considered to own more than 50% of the total fair market value or total voting power of such securities); (b) the consummation of a merger or consolidation of the Company with or into any other corporation or any other corporate reorganization if more than 70% of the combined voting power of the voting stock of the Company or such surviving entity (or any parent thereof) outstanding immediately after such merger, consolidation, or reorganization is owned by persons who were not stockholders of the Company immediately prior to such merger, consolidation or reorganization; (c) the complete liquidation or dissolution of the Company; or (d) the sale or disposition of all or substantially all of the Company’s assets (in one transaction or a series of related transactions within any period of twelve (12) consecutive months), other than a sale or disposition by the Company of all or substantially all of the Company’s assets to (i) a shareholder of the Company in exchange for or with respect to its stock, (ii) an entity, 50% or more of the total value or voting power of which is owned, directly or indirectly, by the Company, (iii) a person, or more than one person acting as a group, that owns, directly or indirectly, 50% or more of the total value or voting power of all of the outstanding stock of the Company, or (iv) an entity, at least 50% of the total value or voting power of which is owned, directly or indirectly, by a person described in the preceding clause (iii). If an Option is granted as an Option subject to the requirements of Code Section 409A (Alternative B for Non-Qualified Stock Option grants under Section 2.4 of the Stock Option Agreement), then solely for purposes of determining whether a Change in Control has occurred under Section 2.4 (Alternative B) and 2.5 of the Stock Option Agreement, the term Change in Control shall mean a Change in Control described above, but only if such Change in Control would also be considered a “change in control event” under Treasury Regulations Section 1.409A-3(i)(5), and, solely for purposes of determining whether a Change in Control has occurred for purposes of Section 2.4 (Alternative B) of the Stock Option Agreement, the term Change in Control shall not include a transaction in which the ownership or assets of the Company as transferred to a subsidiary of the Company.

 

“Code” means the Internal Revenue Code of 1986, as amended. Any reference to a specific provision of the Code includes any successor provision(s) thereto and any regulations promulgated thereunder.

 

“Company” has the meaning set forth in Article I.

 

“Date of Grant” means the date an Award is effective pursuant to the terms hereof.

 

“Disability” has the meaning set forth in Code Section 409A or any regulations or other guidance thereunder.

 

“Effective Date” has the meaning set forth in Article XVI.

 

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“Employee” means any person who, on the particular Date of Grant or other time of determination as the context requires, is currently employed by the Company or an Affiliate.

 

“Exchange Act” means the Securities Exchange Act of 1934, as amended. Any reference to a specific provision of the Exchange Act includes any successor provision(s) thereto and any regulations promulgated thereunder.

 

“Exercise Notice” has the meaning set forth in Section 10.1.

 

“Fair Market Value” means, as of a particular date, the fair market value of one share of Ordinary Shares as determined by the Plan Administrator in a manner consistent with Code Section 409A and any regulations or other guidance thereunder. It is the intent that such determinations shall be made in such a manner so that this Plan and Awards granted hereunder are not subject to the additional taxes referenced in Code Section 409A.

 

“Non-Qualified Stock Option” means an Option that is not an Incentive Stock Option.

 

“Option” means an Award granted under Article VIII or Article IX of this Plan.

 

“Option Period” means the time period within which the Option holder may exercise the right to purchase Ordinary Shares under an Award.

 

“Ordinary Shares” means the ordinary or common stock of the Company.

 

“Participant” means an eligible person who receives an Option or Stock Grant pursuant to this Plan.

 

“Plan” has the meaning set forth in Article I.

 

“Plan Administrator” means the Board or if delegated by the Board, the compensation committee or other committee of the Board.

 

“SEC” means the United States Securities and Exchange Commission.

 

“Stock Option Agreement” means the document entitled “SteadyMed, Ltd. 2013 Stock Incentive Subplan Stock Option Agreement” particular to the Participant which memorializes the grant of Ordinary Shares accompanied by such restrictions, if any, as may be determined by the Plan Administrator under Article VIII of this Plan.

 

“Stock Grant” means a grant of Ordinary Shares accompanied by such restrictions, if any, as may be determined by the Plan Administrator under Article VII of this Plan.

 

ARTICLE III

ADMINISTRATION

 

3.1          General. This Plan shall be administered by the Plan Administrator. The Plan Administrator shall act by vote or written consent of a majority of its members. The Plan Administrator is authorized, subject to the provisions of this Plan, to establish, amend, suspend

 

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and waive such rules and regulations as it deems necessary for the proper administration of this Plan and to make whatever determinations and interpretations in connection with this Plan it deems necessary or advisable with respect to Participants. The Plan Administrator’s decision and determinations under this Plan need not be uniform and may be made selectively among Participants, regardless of whether they are similarly situated. All determinations and interpretations made by the Plan Administrator shall be binding and conclusive on such Participants and on their legal representatives and beneficiaries.

 

3.2          Power and Authority of the Plan Administrator. Subject to the other terms and conditions set forth herein, the Plan Administrator shall have the power and authority, in its discretion, to determine from time to time which Participants will be granted Awards under this Plan, the number of Ordinary Shares subject to each Award, the exercise price of an Option and the restrictions, if any, that will be applicable to each Stock Grant and Option. In making all such determinations, the Plan Administrator shall take into account the duties, responsibilities and performance of each respective Participant, his, her or its present and potential contributions to the growth and success of the Company, his, her or its compensation, and such other factors as the Plan Administrator shall deem relevant to accomplishing the purposes of this Plan. In addition, the Plan Administrator shall have the power and authority to determine other terms, conditions, restrictions and other provisions of Awards, and to interpret, administer and make factual determinations with respect to this Plan and Awards and agreements and instruments related to or made under this Plan.

 

3.3          Limitation on Liability. No member of the Plan Administrator shall be liable for any action or determination made in good faith with respect to this Plan, any rule, regulation or procedure adopted by it pursuant thereto or any Awards granted under it.

 

ARTICLE IV

TYPES OF AWARDS

 

Awards under this Plan may be granted in any one or a combination of the following:

 

Stock Grants

 

Non-Qualified Stock Options

 

ARTICLE V

STOCK SUBJECT TO THIS PLAN

 

Subject to adjustment as provided in Article XIII, the maximum number of shares reserved for Stock Grants and for purchase pursuant to the exercise of Options under this Plan is subject to the number of shares authorized under the 2009 Stock Option Plan, all of which may be awarded in the form of Incentive Stock Options. The Ordinary Shares subject to this Plan may be either authorized but unissued shares or shares previously issued and reacquired by the Company. To the extent that Options are granted and Stock Grants are made under this Plan, the shares underlying such Options and Stock Grants will be unavailable for future grants under this Plan. However, to the extent that the Options or Stock Grants granted under this Plan are forfeited, terminate, expire or are canceled without having been exercised, the shares for such

 

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Options and Stock Grants shall not be counted against the maximum number of shares available for issuance hereunder and new Awards may be made with respect to such shares.

 

ARTICLE VI

ELIGIBILITY

 

Employees and independent contractors, including, without limitation, consultants, advisory board members, vendors, strategic partners, directors and officers of the Company or Affiliates, are eligible to receive Stock Grants and Non-Qualified Stock Options under this Plan.

 

ARTICLE VII

STOCK GRANTS

 

7.1          Terms of Stock Grants. Each Stock Grant may be accompanied by such conditions, restrictions and contingencies, or may be made without any, as may be determined in the discretion of the Plan Administrator as provided in the Award. Such conditions, restrictions and contingencies may include, without limitation, requirements that the Participant remain in the continuous employment or service of the Company or Affiliates for a specified period of time, that the Participant meet designated individual performance goals or that the Company, an Affiliate or a combination thereof meet designated organizational performance goals.

 

7.2          Issuance Procedures. A stock certificate representing the number of Ordinary Shares covered by a Stock Grant shall be registered in the Participant’s name and may be held by the Participant; provided,  however, unless the Plan Administrator provides otherwise in the specified Award or otherwise consents in writing, if a Stock Grant is subject to certain restrictions or performance obligations, the Ordinary Shares covered by such Stock Grant shall be registered in the Participant’s name and held in custody by the Company. Unless the Plan Administrator provides otherwise in the specified Award or otherwise consents in writing, a Participant who has been awarded a Stock Grant shall have the rights and privileges of a shareholder of the Company as to the Ordinary Shares covered by such Stock Grant, including the right to receive dividends and the right to vote such shares, except that the dividends shall be accumulated in an escrow account by the Company and shall not be paid to the Participant unless and until the expiration of any restrictions or satisfaction of any performance requirements. None of the Ordinary Shares covered by the Stock Grant may be sold, transferred, assigned, pledged or otherwise encumbered or disposed of prior to the expiration of any applicable restrictions or satisfaction of any performance requirements. Unless the Plan Administrator provides otherwise in the specified Award or otherwise consents in writing, all of the Ordinary Shares covered by a Stock Grant shall be forfeited and all rights of a Participant who has been awarded such Stock Grant to such shares shall terminate without further obligation on the part of the Company in the event that any applicable restrictions or performance obligations do not expire or are not satisfied. Upon forfeiture of Ordinary Shares, such shares shall be transferred to the Company without further action by the Participant. Upon the expiration of the applicable restrictions and satisfaction of the applicable performance obligations, whether in the ordinary course or under circumstances set forth in Section 7.3, certificates evidencing Ordinary Shares subject to the related Stock Grant shall be delivered to the Participant, or the Participant’s beneficiary or estate, as the case may be, free of such restrictions and applicable restrictive legends, but still subject to applicable transfer restrictions as contemplated by Article XII.

 

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7.3          Acceleration. If the Plan Administrator so provides in the specified Award or otherwise consents in writing, the vesting and the lifting of conditions, performance obligation requirements, restrictions and contingencies in whole or in part may be accelerated for any reason or upon the occurrence of any event.

 

ARTICLE VIII

NON-QUALIFIED STOCK OPTIONS

 

Non-Qualified Stock Options granted under this Plan are subject to the following terms and conditions:

 

8.1          Price. The purchase price per share of Ordinary Shares deliverable upon the exercise of each Non-Qualified Stock Option shall be equal to at least the Fair Market Value on the Date of Grant, unless the Plan Administrator provides otherwise in the specified Award, in which case the terms of such Non-Qualified Stock Option shall comply with the requirements of Code Section 409A to avoid the additional taxes referenced therein.

 

8.2          Option Period Generally. The Plan Administrator shall determine the Option Period during which each Non-Qualified Stock Option may be exercised as set forth in the Award.

 

8.3          Vesting. The Plan Administrator shall determine the date or dates on which each Non-Qualified Stock Option vests (may be exercised) as set forth in the Award and may provide that a Non-Qualified Stock Option is exercisable in installments. If the Plan Administrator so provides in the specified Award or otherwise consents in writing, the shares comprising each installment may be purchased in whole or in part at any time after such installment becomes purchasable. Notwithstanding the foregoing, if the Non-Qualified Stock Option is granted as an Option subject to the requirement of Code Section 409A (Alternative B in Section 2.4 of the Stock Option Agreement), then there shall be no discretion to accelerate the earliest time at which the Non-Qualified Stock Option may be exercised as set forth in the Stock Option Agreement..

 

8.4          Acceleration. If the Plan Administrator so provides in the specified Award or otherwise consents in writing, the vesting and the earliest time during which any Non-Qualified Stock Option may be exercised in whole or in part may be accelerated for any set reason or upon the occurrence of any set event. Notwithstanding the foregoing, if the Non-Qualified Stock Option is granted as an Option subject to the requirement of Code Section 409A (Alternative B in Section 2.4 of the Stock Option Agreement), then there shall be no discretion to accelerate the earliest time at which the Non-Qualified Stock Option may be exercised as set forth in the Stock Option Agreement.

 

8.5          Extension by Plan Administrator. The Plan Administrator may extend the Option Period of a Non-Qualified Stock Option to a date no later than the earlier of the latest date upon which the Non-Qualified Stock Option could have expired by its original terms under any circumstances or the seventh (7th) anniversary of the original date of grant of the Non-Qualified Stock Option. Notwithstanding the foregoing, if the Non-Qualified Stock Option is granted as an Option subject to the requirement of Code Section 409A (Alternative B in Section 2.4 of the

 

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Stock Option Agreement), the Plan Administrator shall not be allowed to consent to an exercise period other than the exercise period set forth in the original Stock Option Agreement.

 

8.6          Termination of Service.

 

(a)           Termination for Cause. Unless the Plan Administrator provides otherwise in the specified Award or otherwise consents in writing, in the event a Participant’s employment with or provision of services to the Company are terminated by the Company or Affiliate for Cause, all rights under the Participant’s Non-Qualified Stock Options shall expire upon termination, regardless of whether the purchase right is vested.

 

(b)           Termination for Other Reasons. Unless the Plan Administrator provides otherwise in the specified Award or otherwise consents in writing, upon the termination of a Participant’s employment with or provision of service to the Company and all Affiliates because of any reason other than for Cause, the Participant’s Non-Qualified Stock Options shall be exercisable only as to those shares which were immediately purchasable by the Participant at the date of termination and only for up to ninety (90) days following termination. Notwithstanding the foregoing, if the Non-Qualified Stock Option is granted as an Option subject to the requirement of Code Section 409A (Alternative B in Section 2.4 of the Stock Option Agreement), then there shall be no discretion to accelerate the earliest time at which the Non-Qualified Stock Option may be exercised as set forth in the Stock Option Agreement, and the exercise period shall be limited to the period set forth in the Stock Option Agreement.

 

8.7          Other Conditions, Restrictions, Contingencies. Each Award may specify other conditions, restrictions and contingencies to which the Non-Qualified Stock Option is subject as deemed appropriate in the sole discretion of the Plan Administrator.

 

ARTICLE IX

RESERVED

 

ARTICLE X

MISCELLANEOUS REQUIREMENTS OF OPTIONS

 

10.1        Method of Exercise. Each Option shall be exercised pursuant to the terms of this Plan by giving written notice to the Company at its principal place of business. Unless the Plan Administrator consents in writing to the contrary, the form of such notice shall be substantially similar to the exercise notice contained in Exhibit A, which may be amended and otherwise updated from time to time by the Plan Administrator (the “Exercise Notice”). No Option granted under this Plan may be exercised or Award granted unless, at the time of exercise or grant, Ordinary Shares to be issued qualifies for exemption from, or is registered pursuant to, applicable federal and state securities laws. In the event there is not then on file with the SEC an effective registration statement, including a prospectus relating to the shares subject to the Award, the Plan Administrator may require the Participant to execute and deliver to the Company prior to receipt by such Participant of any such shares under this Plan, an investment representations statement in form and substance satisfactory to the Company. Unless the Plan Administrator provides otherwise in the specified Award or consents in writing (as limited by

 

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Section 12 of the 2009 Stock Option Plan), shares may be purchased pursuant to an Option only upon full payment of the purchase price in cash.

 

10.2        Rights of a Shareholder. No Participant shall have any rights as a shareholder with respect to any shares covered by an Option until the date of issuance of a stock certificate for such shares. Nothing in this Plan or in any Award granted confers on any person any right to continue in the employ of the Company or Affiliates or to continue as a director, officer, consultant or independent contractor of the Company or Affiliates or interferes in any way with the right of the Company or Affiliates to terminate a Participant’s services at any time.

 

10.3        Limited Transferability. Except as otherwise provided in an Award or unless the Plan Administrator consents in writing to the contrary, Options may only be transferred pursuant to the laws of descent and distribution upon a Participant’s death. Except as otherwise provided in an Award or unless the Plan Administrator consents in writing to the contrary, during the lifetime of a Participant granted Options, such Options may only be exercised by such Participant or such Participant’s guardian or legal representative. The Plan Administrator has the power and authority to establish additional rules and regulations from time to time specifically governing the transfer of Options as it deems necessary or advisable.

 

10.4        Change in Control through Dissolution or Liquidation. In the event of dissolution or liquidation of the Company, the Company shall have no obligation to notify the Participant of such event and any Award that has not been previously exercised will terminate immediately prior to the consummation of such proposed action. Notwithstanding the foregoing, in the event of a voluntary liquidation of the Company that is not considered a merger or acquisition, the Administrator shall notify each Participant as soon as practicable, prior to the effective date of such proposed transaction, that the Participant will have the right to exercise his or her vested Awards within five (5) working days from receipt of such notice, but in any case not later than the effective date of such transaction. For an Option granted subject to the requirements of Code Section 409A (pursuant to Section 2.4 (Alternative B)) of a Stock Option Agreement, payment shall be allowed only to the extent allowed under Treasury Regulations Sections 1.409A-3(j)(4)(i) and 1.409A-3(j)(4)(ix). To the extent it has not been previously exercised, an Award will terminate immediately prior to the consummation of such proposed action, unless the Board has authorized a longer period to exercise such vested Awards.

 

10.5        Change in Control (Other than through Dissolution or Liquidation).

 

Except to the extent set forth in the Stock Option Agreement, in the event of a Change in Control (other than a complete dissolution or liquidation in Section 10.4 of this Plan):

 

(a)           Each outstanding Award shall be assumed or an equivalent Award substituted by the successor company or a parent or subsidiaries of the successor company. In the case of such assumption and/or substitution of Awards, appropriate adjustments shall be made in the number of Award shares and exercise price to reflect such action, and all other terms and conditions of the Award, such as the vesting dates, shall remain in force, all as will be determined by the Board whose determination shall be final.

 

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(b)           The Plan Administrator shall determine, in its discretion, the proper exchange ratio of the Awards and the fair value of such Awards for purpose of such substitution, and shall be authorized to accelerate the vesting date of any or all Awards and shall be authorized to make all necessary adjustments in the terms of the Awards and the substituted Awards (including, without limitation, adjustments in the exercise price) that are fair under the circumstances.

 

(c)           In the event that the successor company refuses to assume or substitute for the Awards, the Participant shall retain the right to exercise vested Awards, to the extent allowed under the Award, and the Plan Administrator shall notify the Participant in writing that such Awards shall be exercisable for a period not less than fifteen (15) days from the date of such notice, and the Awards shall terminate upon the expiration of such period (unless Section 2.4 of the Stock Option Agreement requires a shorter exercise period). Should the Change in Control occur within one year of the Date of Grant, such Participant shall be eligible to exercise a proportion of such Awards as determined by the Plan Administrator, however, to the extent the Award is subject to the requirement of Code Section 409A, this subsection shall only apply to the extent the Change in Control also meets the requirements of Change in Control for purposes of Section 2.4 of the Stock Option Agreement.

 

(d)           For the purposes of this Section 10.5, Awards shall be considered assumed if, following the Change in Control, the Award (or substitute award) confers upon the Participant the right to purchase or receive, for each Award share for which the Award was exercisable immediately prior to the Change in Control, the pro rata consideration (whether shares, stock options, cash, or other securities or property) received in the Change in Control by holders of shares for each share held on the effective date of the transaction (and if such holders were offered a choice of consideration, the type of consideration chosen by the holders of a majority of the outstanding shares); provided, however, that if such consideration received in the Change in Control is not solely ordinary shares (or their equivalent) of the successor company or its parent, the Plan Administrator may, with the consent of the successor company, provide: for the consideration to be received upon the exercise of the Award, for each Award share, to be solely ordinary shares (or their equivalent) of the successor company or its parent equal in fair market value to the per share consideration received by holders of a majority of the outstanding shares in the Change in Control and provided further that the Plan Administrator may determine, in its sole discretion, that in lieu of such assumption or substitution of Awards for awards by the acquiring corporation or its parent or subsidiaries, such Awards will be substituted for by any other type of asset or property including cash which is fair under the circumstances. Such calculation may not result in a decrease in the initial exercise price such that an Option that is not subject to Code Section 409A becomes subject to Code Section 409A.

 

10.6        Bring-Along. Shares acquired upon exercise of an Option shall be subject to “bring-along” provisions in the Articles of Association of the Company, if any. In the event that the Award Shares acquired upon exercise of the Awards are not subject to “bring-along” provisions In the Articles of Association, then at any time prior to the Company’s initial public offering, in the event that (i) one or more bona fide offers (the “Offeror’’) is made to purchase Shares comprising at least seventy percent 70% of the Company’s issued and outstanding ordinary shares on an as-converted to ordinary shares basis (the “‘Threshold Percent”), (ii) such sale is conditioned upon the sale of Shares of the Company at not less than the Threshold

 

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Percent, and (iii) a majority of the Company’s shareholders, with the exception of the Grantees under this Plan (the “Proposing Shareholders”) propose to sell their Shares to such Offeror, then the Grantees shall be required, if so demanded by the Proposing Shareholders, to sell all Shares acquired by the Grantees pursuant to this Plan to such Offeror at the same price and under the same terms and conditions as in the offer made to the Proposing Shareholders. Should the Offeror purchase less than 100% of the Company’s Shares, the number of Shares purchased by the Offeror in excess of those sold by the Proposing Shareholders shall be divided proportionally between the Grantees. In such an event, any sale, assignment, transfer, pledge, hypothecation, mortgage) disposal or encumbrance of Award shares by the Grantee other than in connection with the proposed acquisition shall be absolutely prohibited.

 

10.7        Tag-Along and Other Restrictions. Shares acquired upon exercise of an Option will be subject to rights of first refusal, “tag-along” and all other transfer restrictions, limitations and provisions in the Articles of Association, to the extent that such provisions exist, to which Shares are subject.

 

ARTICLE XI

AGREEMENT WITH GRANTEES

 

Each Award will be evidenced by a written agreement, executed by the Participant and the Company or Affiliates. Each Award will describe the conditions for receiving such Award, the Date of Grant, the purchase price, if any, applicable Option Periods, performance or other periods, terms and conditions as may be required by applicable securities or tax laws and other terms and conditions that are not inconsistent with the terms of this Plan.

 

ARTICLE XII

SHAREHOLDERS AGREEMENT

 

The Plan Administrator may require that, as a condition precedent to the exercise of any Option under this Plan (or the receipt of any Stock Grant under this Plan), the Participant simultaneously execute a counterpart of a shareholders agreement or a joinder agreement to a shareholders agreement (in form satisfactory to the Company). Such shareholders agreement may contain, among other things, transfer restrictions pertaining to the Ordinary Shares issuable upon such exercise and the right of the Company or the other shareholders to repurchase such Ordinary Shares upon the happening of certain events.

 

ARTICLE XIII

DILUTION AND OTHER ADJUSTMENTS

 

In the event of any change in the outstanding Ordinary Shares of the Company by reason of any stock dividend or split, recapitalization, merger, consolidation, conversion, spin-off, reorganization, combination or exchange of shares, or other similar corporate change, or other increase or decrease in such shares without receipt or payment of consideration by the Company, the Plan Administrator will make such adjustments to previously granted Awards, to prevent dilution or enlargement of the rights of the Participant, including any or all of the following:

 

(a)           adjustments in the aggregate number or kind of Ordinary Shares that may be awarded under this Plan;

 

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(b)           adjustments in the aggregate number or kind of Ordinary Shares covered by Awards already made under this Plan; or

 

(c)           adjustments in the purchase price of outstanding Options.

 

No such adjustments may, however, materially change the value of benefits available to a Participant under a previously granted Award.

 

ARTICLE XIV

WITHHOLDING; TAXATION

 

14.1        Withholding. Unless the Plan Administrator provides otherwise in the specified Award or consents in writing, as a condition to the exercise of any Option granted hereunder or the issuance of a Stock Grant, or the release of stock certificates from the Company’s custody in connection with a Stock Grant, the Participant shall make payment to the Company in an amount required for the satisfaction of any federal, state or local withholding tax obligations that may arise in connection with such exercise, issuance or release, as determined by the Plan Administrator in its sole discretion. If the Plan Administrator so provides in the specified Award or consents in writing, the Participant may make other arrangements for the payment of such withholding tax obligations, including, without limitation, the deduction of any such required withholding from any payments due or to become due to the Participant.

 

14.2        No Guarantee of Tax Treatment. Notwithstanding any provisions of this Plan, the Company does not guarantee nor make any warranty to any Participant or any other person with an interest in an Option that any Option intended to be exempt from Code Section 409A shall be so exempt, nor that any Option intended to comply with Code Section 409A shall so comply, nor will the Company or any Affiliate indemnify, defend or hold harmless any individual with respect to the tax consequences of any such failure.

 

ARTICLE XV

TERMINATION AND AMENDMENT OF THIS PLAN

 

The Shareholders may at any time, and from time to time, terminate, modify or amend this Plan in any respect and for any reason, including, but not limited to, for the purpose of obtaining or retaining any statutory or regulatory benefits under tax, securities or other laws. No Awards under this Plan shall be granted after June 17, 2019. Except as otherwise provided in this Plan or the specified Award, such termination, modification or amendment may not affect the rights of a Participant under such Award.

 

ARTICLE XVI

EFFECTIVE DATE OF PLAN

 

Subject to the approval of the shareholders of the Company, the effective date of this Plan shall be as of            , 2013 (the “Effective Date”). This Plan shall remain in effect subject to the terms hereof, until the earlier of the following: (1) June 17, 2019; (2) termination of this Plan by the Board of Directors; or (3) the purchase of all shares to be delivered pursuant to this Plan.

 

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ARTICLE XVII

APPLICABLE LAW

 

This Plan will be administered in accordance with the laws of the State of Delaware. Notwithstanding any provision to the contrary in the 2009 Stock Option Plan, any dispute arising under this Plan shall be heard in U.S. District Court for the Northern District of California.

 

ARTICLE XVIII

COMPLIANCE WITH SECTION 16

 

With respect to Participants subject to Section 16 of the Exchange Act, transactions under this Plan are intended to comply with all applicable conditions of Rule 16b-3 or its successors under the Exchange Act. To the extent any provision of this Plan or action by the Plan Administrator fails to so comply, it shall be deemed null and void, to the extent permitted by law and deemed advisable by the Plan Administrator.

 

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EXHIBIT A

 

STEADYMED THERAPEUTICS, LTD.

 

2013 STOCK INCENTIVE SUBPLAN

 

EXERCISE NOTICE

 

SteadyMed, Ltd.

c/o SteadyMed Therapeutics, Inc.

2410 Camino Ramon, Suite 285

San Ramon, CA 94583

 

Attn: 2013 Stock Incentive Subplan Administrator

 

1.             Exercise of Option. Effective as of today,                 , 20      , the undersigned (“Option Holder”) hereby elects to exercise his or her option to purchase                 Ordinary Shares (the “Shares”) of SteadyMed, Ltd. (the “Company”), under and pursuant to the Company’s 2013 Stock Incentive Subplan (the “Plan”) and the Stock Option Agreement dated                 , 20      , (the “Option Agreement”), of which                 shares are pursuant to the exercise of incentive stock options and                 shares are pursuant to the exercise of non-qualified stock options.

 

2.             Delivery of Payment/Withholding. Enclosed is the full purchase price for the Shares and any applicable withholding (unless other arrangements have been made for such withholding), as set forth in the Option Agreement.

 

3.             Rights as Shareholder. Option Holder understands that until the issuance of the Shares (as evidenced by the appropriate entry on the books of the Company or of a duly authorized transfer agent of the Company), no right to vote or receive dividends or any other rights as a shareholder shall exist due to Option Holder’s exercise of the Option. The certificate evidencing the Shares shall be issued to Option Holder as soon as practicable after the Option is exercised. No adjustment shall be made for a dividend or other right for which the record date is prior to the date of issuance except as provided in the Plan.

 

4.             Tax Consultation. Option Holder acknowledges that the Company has not guaranteed Option Holder or any other person with an interest in the Option Agreement that any Option intended to be exempt from Code Section 409A taxation shall be so exempt, nor that any Option intended to comply with Code Section 409A shall so comply, nor will the Company or any Affiliate indemnify, defend or hold harmless any individual with respect to the tax consequences of any such failure. Option Holder understands that Option Holder may suffer adverse tax consequences as a result of Option Holder’s purchase or disposition of the Shares. Option Holder represents that Option Holder has had the opportunity to consult with any tax consultants Option Holder deems advisable in connection with the purchase or disposition of the Shares and that Option Holder is not relying on the Company for any tax advice.

 

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5.             Entire Agreement. Option Holder delivers herewith the documents as may be reasonably required by the Company, including, without limitation, a joinder agreement to the Shareholders Agreement and the Investment Representations Statement attached hereto. These documents, together with the Plan and Option Agreement constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and Option Holder with respect to the subject matter hereof.

 

	
Submitted by:
    	
 
    	
Accepted by:
    
	
 
    	
 
    	
 
    
	
OPTION HOLDER
    	
 
    	
STEADYMED, LTD.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
By:
    	
 
    
	
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A-2

 

ATTACHMENT 1 TO EXHIBIT A

 

INVESTMENT REPRESENTATION STATEMENT

 

	
OPTION HOLDER:
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
COMPANY:
    	
 
    	
SteadyMed, Ltd.
    
	
 
    	
 
    	
 
    
	
SECURITY:
    	
 
    	
Ordinary Shares
    
	
 
    	
 
    	
 
    
	
AMOUNT:
    	
 
    	
            Ordinary   Shares
    
	
 
    	
 
    	
 
    
	
DATE:
    	
 
    	
 
    	
 
    

 

All capitalized terms not otherwise defined in the text of this Investment Representations Statement have the meanings attributed to them in the SteadyMed, Ltd. 2013 Stock Incentive Subplan (as the same may be amended, restated, supplemented and otherwise modified from time to time). In connection with the purchase of the above-listed securities (the “Securities”), the undersigned Option Holder represents to the Company the following:

 

(a)           The Option Holder has had an opportunity to discuss the Company’s business, management, financial affairs and the terms and conditions of the offering of the Ordinary Shares with the Company’s management. The Option Holder understands that such discussions, as well as other written information delivered by the Company to the Option Holder, were intended to describe the aspects of the Company’s business that, at the time such information was provided, it believed to be material.

 

(b)           The Option Holder is acquiring the Ordinary Shares for the Option Holder’s own account for investment, not with a view to, or for sale in connection with, any distribution thereof, nor with any present intention of distributing or selling the same; and the Option Holder does not presently have any contract, undertaking, agreement or arrangement with any person to sell, transfer or grant participations to such person or to any third person, with respect to any of the Ordinary Shares. If applicable, the Option Holder has not been formed for the specific purpose of acquiring the Ordinary Shares.

 

(c)           The Option Holder understands that the Ordinary Shares have not been, and will not be, registered under applicable state or federal securities law, and have been issued by reason of a specific exemption from the registration provisions of applicable state and federal securities laws which depends upon, among other things, the bona fide nature of the investment intent and the accuracy of the Option Holder’s representations as expressed herein. The Option Holder understands that the Ordinary Shares are restricted securities under applicable state and federal securities laws and that, pursuant to these laws, the Option Holder must hold the Ordinary Shares indefinitely unless they are registered with the U.S. Securities and Exchange Commission and qualified by state authorities, or an exemption from such registration and qualification requirements is available. The Option Holder acknowledges that the Company has no obligation to register or qualify the Ordinary Shares for resale. The Option Holder further acknowledges

 

A-3

 

that if an exemption from registration or qualification is available, it may be conditioned on various requirements including, but not limited to, the time and manner of sale, the holding period for the Ordinary Shares, and on requirements relating to the Company that are outside of the Option Holder’s control, and that the Company is under no obligation, and may not be able, to satisfy.

 

(d)           The Option Holder understands that no public market now exists for any of the Ordinary Shares issued by the Company, and that the Company has made no assurances that a public market will ever exist for such shares.

 

 

	
 
    	
 
    	
 
    
	
 
    	
Signature of Option Holder
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
Date:
    	
 
    	
 
    
				

 

A-4Exhibit 10.3

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

SUPPLY AGREEMENT

 

This Agreement (“Agreement”) is entered into as of 10th day of December 2013, (the “Effective Date”) by and between

 

[*], a company incorporated in [*] and Corporate Office located at [*] (herein after referred to as “[*]” which expression shall include its successors and permitted assigns) of the one part

 

AND

 

SteadyMed Ltd, a company incorporated in Tel Aviv, Israel and Corporate Office located at 5 Oppenheimer St., Park Tamar, Rehovot 76701, Israel, together with its subsidiaries including SteadyMed Therapeutics, Inc. with the Headquarters at 2410 Camino Ramon, San Ramon, CA 94583, USA and affiliates, (hereinafter collectively referred to as “Buyer” which expression shall include its successors and permitted assigns), [*] and Buyer are sometimes hereafter referred to individually as a “Party” and collectively as the “Parties”.

 

WHEREAS [*] is a pharmaceutical company in [*], engaged in the manufacturing, and sale, supply and distribution of pharmaceutical active ingredients in the local and overseas markets.

 

AND WHEREAS Buyer is a pharmaceutical company, engaged in the development, registration, manufacturing, marketing, distribution and selling of pharmaceutical preparations / products in various markets of the world.

 

AND WHEREAS Buyer desires to develop, register, market, distribute and sell by itself or through its licensee, pharmaceutical Finished Drug Product (as hereinafter defined) in the Territory (as hereinafter defined) incorporating the Product (as hereinafter defined), and [*] desires to supply such Product to Buyer.

 

THEREFORE, in consideration of the premises, and the mutual agreements hereinafter set forth, [*] and Buyer hereby agree as follows:

 

1.              DEFINITIONS

 

[*] Information:  Shall mean any and all technical information reasonably needed for submission of a registration dossier for the Finished Drug Product in accordance with regulations and directives currently in force in all countries in the Territory;

 

Confidential Information: shall mean any and all technical, commercial, scientific and other data, processes, documents and other information (whether in oral or written form) and all physical objects (including without limitation, specimens or samples) which have been or shall be received by either Party or its Affiliates or Representatives, either prior to or after the date of this Agreement, that may be confidential or proprietary to either Party. For the purposes of this Agreement, Confidential Information: shall include but not be limited to the [*] Information in relating to the Product pursuant terms and conditions of this Agreement and/or shall also include all copies,

 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

summaries, records, descriptions, modifications and duplications of any of the foregoing data, processes, documents, other information or physical objects received from the other Party.  The failure of either Party to designate information as “Confidential” shall not mean that such information should not be deemed confidential.  For example, information which is generally understood to be confidential shall continue to be confidential, not withstanding such designation.  If either Party is in doubt regarding the confidentiality of any Confidential Information it shall inquire of the other Party in writing, who shall respond within five (5) business days of receipt of the letter or facsimile.

 

Effective Date:  Shall mean the date first herein above entered.

 

Calendar Year:  Shall mean the time period beginning Jan. 1 of one calendar year and ending Dec. 31 of the same calendar year.

 

Finished Drug Product:  Shall mean any medicinal product manufactured by Buyer and containing the Product, manufactured by [*], as an active ingredient.

 

GMP (Good Manufacturing Practices or Current Good Manufacturing Practices):  Shall mean Good Manufacturing Practices requirements from time to time promulgated by Regulatory Authority, including the practices set out in the Guidelines published as the Good Manufacturing Practices by the drug authority(ies) in the Territory, as amended from time to time, for the manufacture of pharmaceutical Products for sale in the Territory.

 

Product(s):  Shall mean the Active Pharmaceutical Ingredient Treprostinil Sodium and associated Tresprostinil reference standard and working standard, in conformance with the specifications and other provisions set forth in Exhibit D.

 

Territory:  Shall mean initially [*].  The parties agree that the Territory may be expanded from time to time upon reasonable notice from Buyer to [*] of additional countries in which it desires to distribute, market or sell Finished Drug Product.

 

Term:  A period of time from the Effective Date until ten (10) years after the Finished Drug Product is launched in the Territory.

 

2.              SUPPLY AND PURCHASE ARRANGEMENTS

 

2.1             Upon the terms and conditions set forth herein, and after having received from Buyer the purchase order for the development and validation quantities of the Product; referred to as the tentative project timeline and forecast as provided in Exhibit B and against clearance of payments to pending invoices, [*] agrees to deliver to Buyer, the [*] Information.  For the avoidance of doubt, [*] will deliver to Buyer the Product information necessary for Buyer’s development work including but not limited to clinical trials, formulation development, manufacturing scale up, regulatory filings, and third party audits or diligence and any other information reasonably requested by Buyer in connection with regulatory matters or approvals.

 

2.2            Subject to satisfaction of the terms and conditions herein, Buyer commits to purchase its entire requirements of the Product up to the [*] per year [*] from [*] for the Term with an additional period to be negotiated in good faith and mutually agreed upon at least 12 months prior to expiration of the Term.  For quantities greater than [*] per year, Buyer may, but is not obligated, to purchase Product from [*], and [*] agrees to supply such additional quantities of Product to Buyer.  [*] agrees

 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

to sell and supply the Product to Buyer in accordance with the terms and conditions as set forth in this Agreement to enable Buyer to manufacture Finished Drug Product using the Product for onward sale and distribution thereof in the Territory.

 

2.3             Buyer shall [*] the Product from [*] for development and validation purposes as outlined in Exhibit E and for commercial purpose after the launch of the Finished Drug Product in the Territory.  After receiving the corresponding approvals from the Health Authorities, or earlier, the quantities for the commercial scale production of the Finished Drug Product would be decided by Buyer.  Thereafter, quarterly, Buyer shall provide [*] on a calendar quarter basis a rolling [*] schedule of forecast requirement of the Product and shall submit to [*] firm quantity commitment.  The first [*] of such forecast shall be binding (“Binding Forecast”) and the remaining [*] shall be based on Buyer’s good faith best estimate as of the date thereof and shall not be binding and subject to change at Buyers discretion (“Non-Binding Forecast”).  As an example, in January 2014, Buyer shall submit to [*] a Binding Forecast for [*] and a Non-Binding forecast for [*].  Thereafter, in April 2014, the Buyer shall submit to [*] a Binding Forecast for [*] (which will be the same as the previous Binding Forecast) [*] and a Non-Binding Forecast for [*].

 

[*] agrees that it will, if requested by Buyer, produce and sell to Buyer up to [*] of the Binding Forecast or such greater amounts as the parties may agree.  Buyer agrees and acknowledges that in the event Buyer gives notice to terminate this Agreement and such proposed termination date is prior to the completion on all scheduled deliveries of the Product, Buyer shall remain liable for the purchasing of the remaining balance of the Product under the Binding Forecast and any amounts owing prior to or after the termination in relation to the purchasing of the Product.

 

2.4             Buyer shall place firm written purchase orders for the Product with [*], minimum [*] before the desired delivery date and such purchase order will be subject to confirmation within fifteen (15) days of receipt by [*].  If [*] gives no response within the aforementioned period then such purchase order will be deemed to have been accepted by [*].  Once a firm written purchase order is placed by the Buyer, it shall be fulfilled and cannot be canceled.

 

2.5             The risk of loss, title and interest in the goods in respect of all supplies will be transferred from [*] to Buyer as soon as the Product has left [*]’s facility.

 

2.6             In case Buyer does not purchase the Product directly themselves from [*], Buyer may direct its contract manufacturer, or affiliate or licensee to place orders for the Product on the same conditions as contained in this Agreement and Buyer shall inform [*] the relationship with the concerned party in advance prior to placing the orders.  Buyer will ensure compliance of the quantity commitment, payments and confidentiality contained herein and that all the conditions and terms of this Agreement are applied to any contract manufacturer, affiliate or licensee.

 

2.7            [*] shall maintain in its supply chain and its own inventory a supply of raw materials in sufficient quantity to produce Buyer Product requirements for all Firm Purchase Orders and the estimated quantities pursuant to the aforementioned Binding Forecast and Non-Binding Forecast.  In addition, [*] shall assure a continuous supply of raw materials needed to produce the Product.

 

3.              DELIVERY

 

All shipments of the Product under this Agreement shall be delivered to Buyer, provided freight prepaid against Section 2.5, by [*] at a mutually agreed place in Territory as mentioned in each single purchase order or at any other custom point in the Territory or elsewhere as may be mutually agreed upon from time to time during the validity of this Agreement.  All such shipments of the

 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

Product shall be accompanied with a commercial invoice in duplicate, bill of lading or airway bill, Certificate of Analysis, Packing list, all in the form of Exhibits A and C hereto.

 

4.              PRICES AND PAYMENT

 

4.1                   [*] shall sell and supply the Product to Buyer after the execution of the agreement.

 

4.2                   Buyer shall pay [*] on ex-works basis for the Product, per the following schedule:

 

USD[*]/gm at the development stage with each delivery of not less than [*]

USD[*]/gm at the commercial stage with annual order of [*] per year

USD[*]/gm at the commercial stage with annual order of [*] per year

 

4.3                   Buyer shall make payments for each shipment of Product to [*] within 30 days of the receipt by Buyer of the documents identified in Section 3 of this Agreement with respect to such shipment.  In case of delay in payment, Buyer will pay interest to [*] at the rate of ten percent (10%) per annum for any overdue amount.

 

5.              PRODUCT ACCEPTANCE

 

5.1                   Each shipment of the Product delivered pursuant to Section 3 herein above shall always conform to the relevant specifications as agreed jointly in Exhibit E.  Buyer, may within [*] of delivery thereof, notify [*] in writing (with supporting documentation such as description of the defect, laboratory testing details, and other reasonable information by [*], and samples of the shipment concerned) that it does not find the particular shipment, or part thereof, to comply with the relevant specifications.  If such dispute is not raised by Buyer within the aforementioned period, the shipment should have deemed accepted.  [*] will not be obliged to entertain any claims and / or bear any expenses / losses for any alleged quality failures for the Product after a shipment of the Product has been accepted by Buyer.

 

5.2                   If the Parties are unable to agree within 30 days after a notification as referred to pursuant to Clause 5.1 above on whether a delivery complies with the relevant specifications or not, the matter shall be submitted to a mutually agreed independent quality control laboratory, as mutually agreed to from time to time.  The Laboratory will be appointed as an expert and shall give its decision within thirty (30) days from the date of submitting the sample(s).  Their decision shall be final and binding upon the Parties.  All costs and expenses of such Laboratory shall be on account of the Party whose results were found in error.

 

5.3                   In the event any shipment of the Product delivered pursuant to Section 3 hereinabove does not conform to the relevant specifications agreed jointly, and if both Parties agree or if the decision of the independent laboratory pursuant to Clause 5.2 hereinabove acknowledges Buyer’s results, the Party who is responsible for the quality defect shall bear all cost and expense for returning such shipment to [*].  At [*]’s request, Buyer shall return such shipment including the documents, samples and/or the defective goods of the Product to [*] without any delay.  In any event, [*] shall promptly deliver to Buyer a replacement quantity of Product that meets the relevant specifications.

 

6.              REPRESENTATIONS AND WARRANTIES

 

6.1                               [*] represents and warrants that:

 

(a)         It will manufacture the Product in accordance with the current GMP;

 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

(b)         It will file a Drug Master File (“DMF”) or similar regulatory filing in each jurisdiction identified by Buyer within [*] of notice from Buyer identifying such jurisdictions.  [*] shall permit Buyer to review each DMF or similar filing before it is submitted

 

(c)          It will manufacture the Product in accordance with the specifications contained in its DMF of the Territory

 

(d)         It will manufacture the Product in accordance with all relevant laws, statutes, and regulations of [*].

 

(e)          It will manufacture the Product in accordance with its internal quality standards and its standard operating procedures, and shall obtain and maintain all necessary permits registrations and licenses required to manufacture, export and supply the Product to Buyer under this Agreement.

 

(f)           [*] represents and warrants that the Product sold hereunder will (i) be produced in full compliance with cGMPs applicable to the Product, (ii) will manufacture the Product in accordance with the specifications contained in its DMF, (iii) will meet all Specifications, (iv) will manufacture the Product in accordance with its internal quality standards and its standard operating procedures, and shall obtain and maintain all necessary permits, registrations and licenses required to manufacture, export and supply the Product to Buyer under this Agreement and (v) will have a minimum shelf-life of [*] months from its manufacturing date (i.e., that Product during the entire shelf-life, will comply with the Specifications) provided the delivery, handling, storage as well as dispensing by Buyer conform to [*]’s instructions.  Upon request from Buyer, [*] will provide to Buyer summary reports or necessary data concerning the shelf-life of the Product having or beyond the [*] month period reference above.

 

(g)          [*] represents and warrants that there is no claim, suit, proceeding or investigation pending or, to the knowledge of [*], threatened against [*] or any of its affiliates which might prevent or interfere with [*]’s performance under this Agreement.

 

(h)         [*] represents and warrants to Buyer that to the best knowledge of [*], Product sold hereunder by [*] will not be:

 

i.                  in violation of Sections 5 or 12 of the Federal Trade Commission Act or improperly labeled under applicable Federal Trade Commission Trade Practice Rules, or other similar laws (for the countries set forth on Exhibit A), as and to the extent applicable hereunder,

 

ii.               adulterated or misbranded within the federal Food, Drug and Cosmetic Act, as amended, within the meaning of any regulations of any regulatory agency of countries listed in Exhibit A or any state or municipal law in which the definition of adulteration and misbranding are substantially identical to those contained in the United States Federal Food, Drug and Cosmetic Act, or articles which may not under the provisions of Sections 404 or 505 of said Act be introduced into interstate commerce or which may not under similar provisions of any foreign, state or municipal law be introduced into commerce,

 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

iii.            manufactured or sold in violation of the federal Controlled Substances Act, as amended, or any substantially similar legislation of applicable country (for the countries set forth on Exhibit A) or state law,

 

iv.           manufactured in violation of any applicable federal, state or local environmental law or regulation of the countries set forth on Exhibit A, or

 

v.              manufactured in violation of any agreement (commercial or otherwise), judgment, order or decree to which [*] is a party after this agreement is signed.

 

(i)             [*] certifies that neither it nor any of its affiliates nor any member of their staff has been disqualified or debarred by the FDA, or any other domestic regulatory authority, or any other applicable regulatory agency of any of the countries set forth on Exhibit A for any purpose.

 

(j)            [*] warrants and represents that neither it nor any of its affiliates nor any member of their staff have been charged with or convicted under federal law, or other applicable laws of the countries set forth on Exhibit A, for conduct relating to the development or approval, or otherwise relating to the regulation of any drug product under the Generic Drug Enforcement Act of 1992 or any other relevant statute, law or regulation.

 

(k)         [*] hereby represents and warrants that [*] has all rights or has licensed necessary rights to manufacture and sell the Product to Buyer, and [*], to its best knowledge, does not infringe any intellectual property or other right in connection with its manufacture and sale of Product to Buyer.

 

6.2                               Buyer represents and warrants that

 

(a)         It is engaged in the development of and preparation for registration, manufacturing, marketing, distribution and selling of pharmaceutical preparations / products in various markets of the world.

 

(b)         It is seeking a regular supply of Product from [*] and developing pharmaceutical Finished Drug Product in order to register, market, distribute and sell directly or by sublicense the same only in the Territory.  It shall not re-sell the Product to any third party.

 

(c)          It is in compliance with all laws governing the formulation of Finished Drug Product in accordance with the applicable regulations, statutes and guidelines provided by regulatory authority of the Territory in which Buyer or its sublicensees develop, register or sell Finished Drug Product and shall take up commercial scale production of the Finished Drug Product only after receiving approvals from the Health Authorities.

 

7.              CONFIDENTIALITY

 

7.1                         [*] warrants that it is the owner of Confidential Information to be disclosed by it under this Agreement and that it has the right to disclose the information without any obligation to any third party.

 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

7.2                         Both Parties shall hold in confidence and shall not divulge, disclose or communicate to any third party any Confidential Information of a written or oral nature including product license dossiers, which is received by either Party except for information that:

 

(a)         was in public domain prior to its receipt or which thereafter becomes part of public domain through no fault of it;

(b)         was lawfully in the possession of either Party prior to the time of its receipt with reasonable proof;

(c)          is received at or prior to the time of disclosure, from a third party who is not under a similar obligation of confidentiality or

(d)         is independently developed by its employees without access to either Party’s information.

 

7.3                         All obligations created by confidentiality clauses or responsibilities defined herein shall survive change or termination of this agreement or the business relationship for a period of [*] of Buyer and [*].

 

7.4.                      The confidential obligations/clauses/sections/commitments herein shall be deemed supplementary to the Confidentiality Agreement duly signed by both Parties prior to this Agreement and shall not supersede previous understandings with respect to Confidential Information and/or confidential obligations and/or confidentiality restrictions.

 

7.5.                      Nothing in this Agreement, nor any disclosure of Confidential Information by one party pursuant to this Agreement, shall operate to confer any intellectual property rights including patents, copyrights, trademarks, trade secrets or other rights on the other party nor be effective to license or transfer to the other party any right, title or interest in the Confidential Information, or to otherwise create a partnership, joint venture or other commercial relationship, nor shall it otherwise bind any party to conclude such an agreement except as may otherwise be agreed in writing.

 

8.              TERM

 

8.1                         Unless terminated in accordance with the provisions set forth in this Agreement, the term of this Agreement shall be valid for a period (the “Initial Period”) of [*] years starting from the Effective Date of this Agreement until [*] years from the Finished Drug Product launch date and shall cover all Purchase Orders issued during such duration.  The Agreement shall be reviewed in good faith at least 12 months prior to the expiration of the Initial Period and renewed for an additional period of [*] years on each expiry date unless one of the parties notifies the other of its intention not to renew it at least [*] prior to the end of the initial period or any of its extensions.

 

8.2                         Notwithstanding the above, either Party shall be entitled to terminate this Agreement without any notice in the event when:

 

(a)         The other Party commits case such material breach of any provision of this Agreement and in case such material breach is capable of being rectified, such Party fails to remedy or rectify the same within the [*] after receipt of a written notice to that effect from the non-breaching Party;

 

(b)         The property of the other Party is subjected to any court order under any bankruptcy, insolvency, or other similar laws affecting enforcement or creditor’s rights.

 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

8.3                         The failure of either Party to terminate this Agreement for breach of any conditions or covenant shall not affect its right to terminate it for subsequent breaches of the same or other conditions or covenants.

 

8.4                               Buyer shall have exclusive right to terminate this agreement forthright on:

 

(a)         Quality not being adhered to for at least [*], as defined within the product specification and following the terms described in Section 5 Product Acceptance.

(b)         [*] being unable to supply in at least [*] (except to the extent permitted by Clause 11.1 due to a Force Majeure Event) the quantity as ordered by Buyer and accepted by [*].

(c)          Either party becoming aware after the Effective Date that the process for manufacture of the Product used by [*] infringes upon any third party intellectual property rights in the Territory.

 

8.5                               [*] shall have the exclusive right to terminate this agreement if Buyer is not able to fulfill its quantity commitments toward its “Binding Forecast” for [*] pursuant to Clause 2.3.

 

8.6                               [*] shall have the right immediately to cancel and terminate this Agreement at any time by notice to Buyer in the event that Buyer has failed to make payments that are undisputed and has failed to correct such default within [*] after written notice thereof.

 

8.7                               Upon termination of this Agreement, both parties shall continue to maintain the confidentiality of all Confidential Information and abide by the confidentiality agreement signed by both parties.

 

9.              APPLICABLE LAW, FORUM.

 

This Agreement shall be interpreted, construed and enforced in accordance with the laws of [*] for the purpose of resolving any dispute hereunder.

 

10.       INTELLECTUAL PROPERTY RIGHTS

 

10.1            Upon Buyer’s request, [*] will provide Buyer a non-infringement letter reasonably satisfactory to Buyer evidencing that its process in manufacturing of the Products does not infringe any third party patents to the best knowledge of [*] at the time of issuing such letter.

 

10.2            [*] hereby grants to Buyer, and Buyer accepts from [*] a [*] right and license to reproduce and use its trademark(s), and the associated trade dress relating to the Products in connection with the marketing, promotion, advertising, use and sale or other distribution of the Products within the Licensed Field, and for no other purpose.  [*] shall, at all times, own all rights, title, and interest in and to the marks and such ownership shall survive any termination of this Agreement.  Buyer agrees not to use any of the marks, or any marks, names, or indicia which are or may be confusingly similar, except as expressly authorized in this Agreement or by the prior written consent of [*].  As an example, Buyer can use the [*] logo or trademark, in connection with its marketing, promotion, advertising use and sale of its Products.

 

10.3           Both parties agree to take all action necessary or appropriate to maintain in full force and effect for the duration of this Agreement all intellectual property rights, including licensed rights, that such party may own or have rights to relating to the Product or this Agreement.

 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

10.4            Any inventions and any right, title, interest or goodwill arising out of any inventions resulting from the use of [*]’s intellectual property rights shall be the sole property of [*], unless otherwise agreed by the parties.

 

10.5            Neither Party shall at any time whether during the term of or after termination of this Agreement) authorize any other person to register or attempt to register in any country any intellectual property rights resulting from or in connection with any Confidential Information of the other Party.

 

11.       DISPUTE RESOLUTION

 

Should the parties fail to resolve any controversy or claim arising out of or relating to the interpretation or application of any term or provision set forth herein, or the alleged breach thereof, such controversy or claim shall be resolved by arbitration under the [*].  Such arbitration shall be held in [*] unless otherwise agreed between the parties in writing.  Any award rendered pursuant to the terms and conditions set forth herein shall be final and binding.  The Parties expressly agree to abide by the arbitration award.  The language for conducting the arbitration proceedings shall be English.

 

12.       BINDING EFFECT AND ASSIGNMENT

 

This Agreement shall inure to the benefit of and be binding upon the parties hereto, their successors and assigns; provided, however, that neither party shall, without the prior written consent of the other party, assign or transfer any of its rights, benefits, obligations, or other interest under this Agreement to any other party, except that, upon notification to the other party, either party may assign this Agreement to any entity or person it controls, it is controlled by or is under common control with, or to any entity or person that acquires all or substantially all of its stock, assets or business or acquires that portion of its business to which this Agreement relates, whether by merger, acquisition, sale or otherwise.

 

13.       GENERAL

 

13.1            Force Majeure.  Neither party shall be responsible or liable to the other party for, nor shall this Agreement be terminated as a result of, any failure to perform any of its obligations hereunder, if such failure results from circumstances beyond the control of the party, including, without limitation, requisition or seizure by any government authority, the effect of any statute, ordinance or governmental order or regulation, wars, strikes, lockouts, riots, disease, an act of God, civil commotion, fire, failure of public utilities, common carriers or supplies, or any other circumstances, whether or not similar to the above causes and whether or not foreseeable.  The parties shall use their reasonable commercial efforts to avoid or remove any such causes and shall resume performance under this Agreement as soon as practicable whenever such cause is removed; provided, however, that the foregoing shall not be construed to require either party to settle any third party dispute, to commence, continue or settle any litigation, or to incur any unusual or extraordinary expenses.

 

13.2            Amendments.  The failure of either party to enforce any provision of this Agreement at any time or for any period of time shall not be construed to be a waiver of any right of either party hereunder not to prevent the subsequent enforcement thereof or of any other provision hereof in accordance with its terms.

 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

13.3            No Waiver.  The failure of either party to enforce any provision of this Agreement at any time or for any period of time shall not be construed to be a waiver of any right of either party hereunder nor to prevent the subsequent enforcement thereof or of any other provision hereof in accordance with its terms.

 

13.4            Execution of Additional Documents.  Each party hereto agrees, without charge, to promptly execute and deliver such further applications, assignments, descriptions and other instruments and documents and otherwise to cooperate with the other party as may be reasonably necessary or desirable to effect the purpose of this Agreement and carry out its provisions.

 

13.5.         Entire Agreement.  This Agreement and the Quality Agreement of even date herewith between the parties constitute the entire understanding between the parties with respect to the subject matter hereof and shall supersede all prior contracts, agreements (excluding the confidentiality agreement) and understandings related to the same subject matter between the parties unless a prior written consent is duly signed by both Parties.

 

13.6.         Assignment.  Neither party may assign this Agreement or any of its rights and obligations to a third party, without the prior written consent of the other.

 

13.7            Subcontracting.  [*] shall not have the right to subcontract any of its obligations hereunder without the prior written consent of Buyer.  Unless the parties agree otherwise, [*] shall remain solely liable for the performance of any of [*]’s obligations by its approved subcontractor.

 

13.8            Further Assurance.  Each party shall execute such other instruments, give such further assurance and perform such acts which are or may become necessary or appropriate to effectuate and carry out the provisions of this Agreement.

 

13.9            Remedies Cumulative.  Each and every right granted hereunder and the remedies provided for under this Agreement are cumulative and are not exclusive for any remedies or rights that may be available to any party at law, in equity, or otherwise.

 

13.10     No Benefit to Others.  The provisions set forth in this Agreement are for the sole benefit of the parties hereto and their successors and permitted assigns, and they shall not be construed as conferring any rights on any other persons or entities.

 

13.11     Severability.  If any provision of this Agreement, under any set of circumstances, whether or not foreseeable by the parties, is hereafter held to be invalid, illegal or unenforceable in its present form and scope in any jurisdiction or proceeding, the remaining provisions of this Agreement shall continue to be given full force and effect, without regard to the invalid, illegal or unenforceable provision in such jurisdiction or proceeding, and shall be liberally construed in order to carry out the intentions of the parties hereto as nearly as may be possible, and such holding shall not affect the validity, legality or enforceability of this Agreement in its entirety in any other jurisdiction or proceeding.

 

13.2            Relationship.  This agreement is on a principal to principal basis.  Neither party is an agent of the other.  This Agreement does not constitute any partnership or joint venture between the parties.

 

13.3            Notice.  All communications between Buyer and [*] under this Agreement shall be sent by registered airmail, recognized overnight delivery service, courier, fax or telex in English at respective offices as below:

 

10

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

If to Buyer:

 

c/o SteadyMed Therapeutics, Ltd.

2410 Camino Ramon

Suite 285

San Ramon, CA  94583

Tel: +1(925)309-9076

Attn:                    Robert Zwolinski

 

If to [*]:

 

[*]

Tel: [*]

Fax: [*]

Attn:                    [*]

 

All notices shall be deemed to have been received by the addressee within fourteen days of posting with acknowledgment or twenty four hours (24) if sent by fax or telex to the correct fax or telex number (with correct answer back) of the addressee.

 

11

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

IN WITNESS WHEREOF, and intending to be legally bound, the parties hereto have caused this Agreement to be executed by their duly authorized representatives on the day, month and year first hereinabove written.

 

	
 
    	
SteadyMed Therapeutics Ltd.
    	
 
    	
[*]
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
By:
    	
/s/ Jonathan Rigby
    	
 
    	
By:
    	
/s/ [*]
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Name:
    	
Jonathan Rigby,   President
    	
 
    	
Name: [*]
    
	
 
    	
Title:
    	
President and CEO
    	
 
    	
Title: [*]
    

 

12

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

Exhibit A
 Form of Commercial Invoice

 

(To be mutually agreed to at a later date.)

 

13

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

Exhibit B
 Form of Certificate of Analysis

 

(To be mutually agreed to at a later date.)

 

14

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

Exhibit C
 Form of Packing List

 

(To be mutually agreed to at a later date.)

 

15

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

Exhibit D
 Product Specifications

 

(To me mutually agreed to at a later date.)

 

16

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

Exhibit E
 Tentative Project Timeline and Forecast (Non-binding)

 

	
Timeline
    	
 
    	
Project
    	
 
    	
Forecast
   (g)
    	
 
    	
Remarks
    
	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    

 

17

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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