Document:

Exhibit 4.2

 

EIGHTH AMENDED AND RESTATED STOCKHOLDERS’ AGREEMENT

 

THIS EIGHTH AMENDED AND RESTATED STOCKHOLDERS’ AGREEMENT (this “Agreement”) made as of July 27, 2012, by and among Onconova Therapeutics, Inc., a Delaware corporation (the “Corporation”), the persons listed as owners of Series A Preferred Stock on Schedule I hereto (the “Series A Investors”), the persons listed as owners of Series B Preferred Stock on Schedule I hereto (the “Series B Investors”), the persons listed as owners of Series C Preferred Stock on Schedule I hereto (the “Series C Investors”), the persons listed as owners of Series D Preferred Stock on Schedule I hereto (the “Series D Investors”), the persons listed as owners of Series E Preferred Stock on Schedule I hereto (the “Series E Investors”), the persons listed as owners of Series F Preferred Stock on Schedule I hereto (the “Series F Investors”), the persons listed as owners of Series G Preferred Stock and/or Warrants to purchase Series G Preferred Stock (the “Series G Warrants”) on Schedule I hereto (the “Series G Investors”), the persons listed as owners of Series H Preferred Stock on Schedule I hereto (the “Series H Investors”), the persons listed as owners of Series I Preferred Stock on Schedule I hereto (the “Series I Investors”) and the persons listed as owners of Series J Preferred Stock on Schedule I hereto (the “Series J Investors” and, together with the Series A Investors, Series B Investors, Series C Investors, Series D Investors, Series E Investors, Series F Investors, Series G Investors, Series H Investors and Series I Investors, collectively, the “Investors”), and the persons listed as Common Stockholders on Schedule I hereto (with the Investors, the “Stockholders”).

 

BACKGROUND

 

Each of the Stockholders owns that number of shares of Common Stock, Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock, Series G Preferred Stock and/or Series G Warrants, Series H Preferred Stock, Series I Preferred Stock and Series J Preferred Stock (together with any other shares of capital stock of the Corporation now owned or hereafter acquired by the Stockholders and their successors or assigns from any Person by any means, including without limitation, any acquisition by gift, purchase, dividend, conversion, stock split, recapitalization or otherwise, collectively, the “Shares”) set forth opposite the name of each such Stockholder on Schedule I attached hereto.  It is deemed to be in the best interest of the Corporation and the Stockholders that provision be made for the continuity and stability of the business and policies of the Corporation and, to that end, the Corporation and the Stockholders hereby set forth their agreement with respect to the Shares.

 

NOW, THEREFORE, in consideration of the premises and of the mutual consents and obligations hereinafter set forth, the parties hereto hereby agree as follows:

 

SECTION 1.                            Definitions.  All capitalized terms used in this Agreement shall have the meanings assigned to them elsewhere in this Agreement or as specified below:

 

“Affiliate” of any Person shall mean any Person directly or indirectly controlling, controlled by or under common control with such Person.

 

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“Certificate of Incorporation” shall mean the Corporation’s Ninth Amended and Restated Certificate of Incorporation, setting forth, among other things, the designations, rights, preferences and privileges and qualifications, limitations and restrictions of Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock, Series G Preferred Stock, Series H Preferred Stock, Series I Preferred Stock and Series J Preferred Stock.

 

“Commission” shall mean the United States Securities and Exchange Commission.

 

“Common Stock” shall mean (a) the Corporation’s Common Stock, par value $.0l per share, as authorized on the date of this Agreement, (b) any other capital stock of any class or classes (however designated) of the Corporation, authorized on or after the date hereof, the holders of which shall have the right, without limitation as to amount, either to all or to a share of the balance of current dividends and liquidating distributions after the payment of dividends and distributions on any shares entitled to preference under the Certificate of Incorporation (as the same may be further amended from time to time), and (c) any other securities into which or for which any of the securities described in clause (a) or (b) of this definition may be converted or exchanged pursuant to a plan of recapitalization, reorganization, merger, sale of assets or otherwise.

 

“Corporation Notice” shall have the meaning set forth in Section 3(b) hereof.

 

“Demand Holder” shall mean any holder of Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock, Series G Preferred Stock, Series H Preferred Stock, Series I Preferred Stock and/or Series J Preferred Stock (or shares of Common Stock issued upon conversion of shares of Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock, Series G Preferred Stock, Series H Preferred Stock, Series I Preferred Stock and/or Series J Preferred Stock) owning of record Registrable Securities that have not been sold to the public and, for purposes of this Agreement, a record holder of the Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock, Series G Preferred Stock, Series H Preferred Stock, Series I Preferred Stock and/or Series J Preferred Stock convertible into such Registrable Securities shall be deemed to be the Demand Holder of such Registrable Securities; provided, however, that the Corporation shall in no event be obligated to register the Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock, Series G Preferred Stock, Series H Preferred Stock, Series I Preferred Stock or Series J Preferred Stock, and that Demand Holders of Registrable Securities shall not be required to convert their shares of Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock, Series G Preferred Stock, Series H Preferred Stock, Series I Preferred Stock and/or Series J Preferred Stock into Common Stock in order to exercise the registration rights granted under Section 5(f) hereof, until immediately before the closing of the offering to which the registration relates.

 

“Designated Offering” shall mean a firmly underwritten public offering registered under the Securities Act, where the gross proceeds to the Corporation from such offering, after

 

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deducting underwriters discounts, are not less than $25,000,000, and at a per share price (determined on a common stock equivalent basis) of at least $16.50 (or such lower price, down to $11.50, to which the holders of a majority of the outstanding shares of Series J Preferred Stock may consent in writing) as adjusted for stock splits, stock dividends, stock combinations or stock reclassifications.

 

“Equity Securities” shall have the meaning set forth in Section 2(a) hereof.

 

“Exchange Act” shall mean the Securities Exchange Act of 1934, as amended, and the rules and regulations of the Commission promulgated thereunder, all as the same shall be in effect at the time.

 

“Excluded Form” shall mean a registration statement filed pursuant to the Securities Act on Form S-8, S-4 or any similar or successor forms.

 

“Excluded Securities” shall mean those securities described in Section 2(f) hereof.

 

“Form S-3” shall mean such form under the Securities Act as is in effect on the date hereof or any successor registration form under the Securities Act subsequently adopted by the Commission that permits inclusion or incorporation of substantial information by reference to other documents filed by the Corporation with the Commission.

 

“Founders” shall mean the following individuals: Dr. E. Premkumar Reddy, Dr. John R. Jenkins and Dr. Ramesh Kumar, each of whom has an address specified on Schedule I hereto.

 

“Founders Notice” shall have the meaning set forth in Section 3(c) hereof.

 

“Holder” shall mean any holder of Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock, Series G Preferred Stock, Series G Warrants, Series H Preferred Stock, Series I Preferred Stock and/or Series J Preferred Stock (or shares of Common Stock issued (either directly or indirectly) upon conversion thereof) owning of record Registrable Securities that have not been sold to the public and, for purposes of this Agreement, a record holder of the Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock, Series G Preferred Stock, Series G Warrants, Series H Preferred Stock, Series I Preferred Stock and/or Series J Preferred Stock convertible (either directly or indirectly) into such Registrable Securities shall be deemed to be the Holder of such Registrable Securities; provided, however, that the Corporation shall in no event be obligated to register the Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock, Series G Preferred Stock, Series G Warrants, Series H Preferred Stock, Series I Preferred Stock or Series J Preferred Stock, and that Holders of Registrable Securities shall not be required to convert their shares of Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock, Series G Preferred Stock, Series H Preferred Stock, Series I Preferred Stock and/or Series J Preferred Stock into Common Stock, or exercise their Series G Warrants and convert the shares issued thereunder into

 

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Common Stock, in order to exercise the registration rights granted under Section 5 hereof, until immediately before the closing of the offering to which the registration relates.

 

“Investor Oversubscription Rights” shall have the meaning set forth in Section 2(b) hereof.

 

“Majority Investors” shall have the meaning set forth in Section 2 hereof.

 

“Mehta Investors” shall mean Mehta Partners, LLC and/or its affiliates that are parties to the Series B Purchase Agreement.

 

“Non-Principal Transferring Stockholder” shall have the meaning set forth in Section 3(a) hereof.

 

“Notice of Acceptance” shall have the meaning set forth in Section 2(c) hereof.

 

“Offer” shall have the meaning set forth in Section 2(a) hereof.

 

“Oversubscribing Investor” shall have the meaning set forth in Section 2(b) hereof.

 

“Permitted Transfer” and “Permitted Transferee” shall have the meanings set forth in Section 3(d) hereof.

 

“Person” shall mean and include an individual, a corporation, a limited liability company, a partnership, a trust, an unincorporated organization and a government or any department, agency or political subdivision thereof.

 

“Preferred Stock” shall mean, collectively, the Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock, Series G Preferred Stock, Series H Preferred Stock, Series I Preferred Stock and Series J Preferred Stock.

 

“Principal Stockholders” shall mean the following individuals:  Dr. E. Premkumar Reddy and Dr. Ramesh Kumar, each of whom has an address specified on Schedule I hereto.

 

“Principal Transferring Stockholder” shall have the meaning set forth in Section 3(a) hereof.

 

“Register”, “registered” and “registration” shall refer to a registration effected by preparing and filing a registration statement in compliance with the Securities Act, and the declaration or ordering of effectiveness of such registration statement.

 

“Registrable Securities” shall mean:  (a) all the shares of Common Stock of the Corporation issued or issuable upon the conversion of the shares of Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock, Series G Preferred Stock, Series H Preferred Stock, Series I Preferred Stock and/or Series J Preferred Stock that are now owned or may hereafter be acquired

 

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by any Holder or its permitted successors and assigns, including upon exercise of the Series G Warrants; and (b) any shares of Common Stock of the Corporation issued as (or issuable upon the conversion or exercise of any warrant, right or other security which is issued as) a dividend or other distribution with respect to, or in exchange for or in replacement of, all such shares of Common Stock described in clause (a) of this definition; excluding in all cases, however, (i) any Registrable Securities sold pursuant to registration under the Securities Act or (ii) any Registrable Securities sold, subsequent to the Corporation’s initial public offering of securities registered under the Securities Act, pursuant to Rule 144 (or similar or successor rule) promulgated under the Securities Act.

 

“Registrable Securities then outstanding” shall mean the number of shares of Registrable Securities that are then issued and outstanding or are then issuable pursuant to the exercise or conversion of then outstanding and then exercisable options, warrants or convertible securities.

 

“Remaining Securities” shall have the meaning set forth in Section 2(d) hereof.

 

“Sale Shares” shall have the meaning set forth in Section 3(a) hereof.

 

“Securities Act” shall mean the Securities Act of 1933, as amended, and the rules and regulations of the Commission promulgated thereunder, all as the same shall be in effect at the time.

 

“Series A Preferred Stock” shall mean the Corporation’s authorized 400,000 shares of Series A Convertible Preferred Stock, par value $.0l per share, having the designations, rights, preferences and privileges and qualifications, limitations and restrictions of preferred stock set forth in the Certificate of Incorporation.

 

“Series A Purchase Agreement” shall mean either the Stock Purchase and Subscription Agreement dated as of December 3, 1999 or the Stock Purchase and Subscription Agreement dated as of January 20, 2000, between the Corporation and the Series A Investors, as the same may be amended from time to time individually, or both such agreements together, as the context may require.

 

“Series B Directors” shall have the meaning set forth in Section 15(b) hereof.

 

“Series B Preferred Stock” shall mean the Corporation’s authorized 1,200,000 shares of Series B Convertible Preferred Stock, par value $.01 per share, having the designations, rights, preferences and privileges and qualifications, limitations and restrictions of preferred stock set forth in the Certificate of Incorporation.

 

“Series B Purchase Agreement” shall mean the Series B Convertible Preferred Stock Purchase Agreement dated as of November 14, 2000, between the Corporation and the Series B Investors, as the same may be amended from time to time.

 

“Series C Preferred Stock” shall mean the Corporation’s authorized 1,200,000 shares of Series C Convertible Preferred Stock, par value $.01 per share, having the designations,

 

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rights, preferences and privileges and qualifications, limitations and restrictions of preferred stock set forth in the Certificate of Incorporation.

 

“Series C Purchase Agreement” shall mean the Series C Convertible Preferred Stock Purchase Agreement, dated as of December 27, 2002, between the Corporation and the Series C Investors, as the same may be amended from time to time.

 

“Series D Director” shall have the meaning set forth in Section 15(b) hereof.

 

“Series D Preferred Stock” shall mean the Corporation’s authorized 1,625,000 shares of Series D Convertible Preferred Stock, $0.01 par value, having the designations, rights, preferences, privileges, qualifications, limitations and restrictions set forth in the Certificate of Incorporation.

 

“Series D Purchase Agreement” shall mean the Series D Convertible Preferred Stock Purchase Agreement, dated as of March 19, 2004, between the Corporation and the Series D Investors, as amended by that certain First Amendment to Series D Convertible Preferred Stock Purchase Agreement, between the Corporation and the Series D Investors, dated July 15, 2004.

 

“Series E Preferred Stock” shall mean the Corporation’s authorized 1,650,000 shares of Series E Convertible Preferred Stock, $0.01 par value, having the designations, rights, preferences, privileges, qualifications, limitations and restrictions set forth in the Certificate of Incorporation.

 

“Series E Purchase Agreement” shall mean each of the Series E Convertible Preferred Stock Purchase Agreement, dated as of March 18, 2005, between the Corporation and the Series E Investors and the Second Series E Stock Purchase Agreement, as amended, dated as of December 1, 2005, between the Corporation and the Series E Investors.

 

“Series F Preferred Stock” shall mean the Corporation’s authorized 2,000,000 shares of Series F Convertible Preferred Stock, $0.01 par value, having the designations, rights, preferences, privileges, qualifications, limitations and restrictions set forth in the Certificate of Incorporation.

 

“Series F Purchase Agreement” shall mean the Series F Convertible Preferred Stock Purchase Agreement, dated as of May 15, 2007, between the Corporation and the Series F Investors.

 

“Series G Preferred Stock” shall mean the Corporation’s authorized 2,700,000 shares of Series G Convertible Preferred Stock, $0.01 par value, having the designations, rights, preferences, privileges, qualifications, limitations and restrictions set forth in the Certificate of Incorporation.

 

“Series G Purchase Agreement” shall mean the Series G Convertible Preferred Stock Purchase Agreement, dated as of May 12, 2009, between the Corporation and certain of the Series G Investors, as the same has been amended and may be further amended from time to time.

 

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“Series H Director” shall have the meaning set forth in Section 15(b)(i) hereof.

 

“Series H Preferred Stock” shall mean the Corporation’s authorized 2,042,950 shares of Series H Convertible Preferred Stock, $0.01 par value, having the designations, rights, preferences, privileges, qualifications, limitations and restrictions set forth in the Certificate of Incorporation.

 

“Series H Purchase Agreement” shall mean the Series H Convertible Preferred Stock Purchase Agreement, dated as of September 21, 2010, between the Corporation and the Series H Investors, as the same has been amended and may be further amended from time to time.

 

“Series I Preferred Stock” shall mean the Corporation’s authorized 2,700,000 shares of Series I Convertible Preferred Stock, $0.01 par value, having the designations, rights, preferences, privileges, qualifications, limitations and restrictions set forth in the Certificate of Incorporation.

 

“Series I Conversion Agreement” shall mean that Second Amendment to Convertible Note Purchase Agreement and Amendment to Convertible Notes made as of July 20, 2012, by and among the Corporation and the holders of Convertible Notes representing at least a majority of the principal amount under all Convertible Notes, as defined therein, then outstanding.

 

“Series J Preferred Stock” shall mean the Corporation’s authorized 3,030,303 shares of Series J Convertible Preferred Stock, $0.01 par value, having the designations, rights, preferences, privileges, qualifications, limitations and restrictions set forth in the Certificate of Incorporation.

 

“Series J Purchase Agreement” shall mean the Series J Convertible Preferred Stock Purchase Agreement, dated as of July 27, 2012, between the Corporation and the Series J Investors, as the same has been amended and may be further amended from time to time.

 

“Shares Transfer” shall have the meaning set forth in Section 3(a) hereof.

 

“Subsection (c) Resignation” shall have the meaning set forth in Section 15(c) hereof.

 

“Transfer” shall mean any sale, assignment, transfer, disposition, donation, pledge, bequest, hypothecation, gift, conveyance, encumbrance or any other disposition or transfer of a Share or any interest or rights (legal or equitable) therein by any means whatsoever, whether direct or indirect, absolute or conditional, voluntary or involuntary, by operation of law (including without limitation, by operation of the laws of descent and distribution) or otherwise.

 

“TS Notice” shall have the meaning set forth in Section 3(a) hereof.

 

“Unsubscribed Shares” shall have the meaning set forth in Section 2(b) hereof.

 

“Violation” shall have the meaning set forth in Section 5(i) hereof.

 

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SECTION 2.                            Right of First Offer.  Each Series A Investor owning ten percent (10%) or more of the Series A Preferred Stock originally purchased by such Investor under the Series A Purchase Agreement, each Series B Investor owning ten percent (10%) or more of the Series B Preferred Stock originally purchased by such Investor under the Series B Purchase Agreement, each Series C Investor owning ten percent (10%) or more of the Series C Preferred Stock originally purchased by such Investor under the Series C Purchase Agreement, each Series D Investor owning ten percent (10%) or more of the Series D Preferred Stock originally purchased by such Investor under the Series D Purchase Agreement, each Series E Investor owning ten percent (10%) or more of the Series E Preferred Stock originally purchased by such Investor under the Series E Purchase Agreement, each Series F Investor owning ten percent (10%) or more of the Series F Preferred Stock originally purchased by such Investor under the Series F Purchase Agreement, each Series G Investor owning ten percent (10%) or more of the Series G Preferred Stock originally purchased by such Investor under the Series G Purchase Agreement (including shares issued or issuable upon exercise of the Series G Warrant purchased thereunder), each Series H Investor owning ten percent (10%) or more of the Series H Preferred Stock originally purchased by such Investor under the Series H Purchase Agreement, each Series I Investor owning ten percent (10%) or more of the Series I Preferred Stock originally received by such Investor under the Series I Conversion Agreement and each Series J Investor owning ten percent (10%) or more of the Series J Preferred Stock originally purchased by such Investor under the Series J Purchase Agreement (each, a “Majority Investor”), shall be entitled to the following right of first offer, except with respect to issuances of Excluded Securities, in connection with which there shall be no right of first offer:

 

(a)                                 The Corporation shall not issue, sell or exchange, agree to issue, sell or exchange, or reserve or set aside for issuance, sale or exchange, (i) any shares of Common Stock, (ii) any other equity security of the Corporation, (iii) any debt security of the Corporation which by its terms is convertible into or exchangeable for, with or without consideration, any equity security of the Corporation, (iv) any security of the Corporation that is a combination of debt and equity or (v) any option, warrant or other right to subscribe for, purchase or otherwise acquire any equity security or any such debt security of the Corporation (collectively, the “Equity Securities”), unless in each case the Corporation shall have first offered to sell to the Majority Investors the Equity Securities, at a price and on such other terms as shall have been specified by the Corporation in a writing delivered to the Majority Investors (the “Offer”), which Offer by its terms shall remain open and irrevocable for a period of thirty (30) days from the date the Offer is received by the Majority Investors.

 

(b)                                 The Majority Investors shall have the right to purchase up to their pro rata share of the Equity Securities.  For these purposes, a Majority Investor’s “pro rata share” shall be that amount of the Equity Securities which would result in the Majority Investor’s owning the same percentage of the Corporation’s issued and outstanding Common Stock after the issuance of Equity Securities as the Majority Investor owned immediately prior to the issuance (assuming in each case the issuance of all shares of Common Stock issuable upon the conversion or exchange of all outstanding securities convertible into or exchangeable for Common Stock, including, if applicable, the Equity Securities).  However, each Majority Investor may, in his notice delivered pursuant to Section 2(c), subscribe for any number of the Equity Securities being offered by the Corporation.  Any Equity Securities which are not purchased as part of a Majority Investor’s pro rata share (“Unsubscribed Shares”) may be purchased by the other

 

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Majority Investors (“Oversubscribing Investors”) who indicated the desire to purchase more (specifying the number of shares) than their respective pro rata shares of the Equity Securities in their respective notices of exercise (“Investor Oversubscription Rights”).  If not enough Equity Securities are offered for sale to satisfy all properly exercised Investor Oversubscription Rights, the Unsubscribed Shares shall be sold to and purchased by Majority Investors exercising Investor Oversubscription Rights pro rata.  For the purpose of Investor Oversubscription Rights each Oversubscribing Investor’s pro rata portion will be equal to the total number of shares of Common Stock held by such Oversubscribing Investor as a percentage of the total number of shares of Common Stock held by all Oversubscribing Investors (assuming in each case the issuance of all shares of Common Stock issuable upon the conversion or exercise of all securities convertible into or exchangeable for Common Stock held by the Oversubscribing Investors).

 

(c)                                  Notice of a Majority Investor’s intention to accept, in whole or in part, an Offer shall be evidenced by a writing signed by the Majority Investor and delivered to the Corporation at or prior to the end of the 30-day period commencing with the date the Offer is sent by the Corporation (or, if later, within 10 days after the sending of any written notice of a material change in such Offer), setting forth such portion (specifying number of shares, principal amount or the like) of the Equity Securities as the Majority Investor elects to purchase and giving notice of any exercise of Investor Oversubscription Rights (the “Notice of Acceptance”).

 

(d)                                 The Corporation shall have 60 days from the expiration of the foregoing 30-day period to sell all or any part of such Equity Securities as to which a Notice of Acceptance has not been given by the Majority Investors (the “Remaining Securities”) to any other Person or Persons, but only upon terms and conditions which are no more favorable, in the aggregate, to such other Person or Persons or less favorable to the Corporation than those set forth in the Offer; provided, however, that in the event the Corporation concludes that such terms and conditions are no more favorable, in the aggregate, to such other Person or Persons or less favorable to the Corporation than those set forth in the Offer, but such terms and conditions contain material (whether individually or in the aggregate) modifications to the terms and conditions of the Offer, then the Corporation shall provide to the Majority Investors written notice of such modifications and each Majority Investor shall, by a writing signed by such Majority Investor and delivered to the Corporation at or prior to the end of the five (5)-day period commencing with the date such notice of the Corporation’s conclusion is sent by the Corporation, indicate whether they agree with the Corporation’s conclusion.  A failure to respond within such five (5)-day period shall be deemed an acceptance of the Corporation’s conclusion.  If the holders of a majority of the shares held by the Majority Investors indicate that they disagree with the Corporation’s conclusion, then the Majority Investors shall have the right set forth in subsection (c) above and the notice of the Corporation’s conclusion hereunder shall be deemed to constitute the written notice of material change in such Offer thereunder.  Upon the closing of the sale to such other Person or Persons of all the Remaining Securities, which shall include payment of the purchase price to the Corporation in accordance with the terms of the Offer, if a Majority Investor has timely submitted a Notice of Acceptance, he shall purchase from the Corporation, and the Corporation shall sell to the Majority Investor, the Equity Securities (including Unsubscribed Shares) in respect of which a Notice of Acceptance was delivered to the Corporation by the Majority Investor, at the terms specified in the Offer.

 

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(e)                                  In each case, any Equity Securities not purchased by a Majority Investor or by a Person or Persons in accordance with Section 2(d) may not be sold or otherwise disposed of until they are again offered to the Majority Investors under the procedures specified in Sections 2(a), (b), (c) and (d) hereof.

 

(f)                                   The rights of the Investor under this Section 2 shall not apply to the following securities (the “Excluded Securities”):

 

(i)                                     Common Stock or options to purchase shares of Common Stock issued to officers, employees or directors of, or consultants or advisors to, the Corporation, pursuant to any agreement, plan or arrangement approved by the Board of Directors of the Corporation; provided, however, that the maximum number of shares of Common Stock heretofore or hereafter issued or issuable pursuant to all such agreements, plans and arrangements shall not exceed in the aggregate the number of shares constituting the Fully-Diluted Option Pool (as defined in the Certificate of Incorporation).

 

(ii)                                  Common Stock issued as a stock dividend or upon any stock split or other subdivision or combination of shares of Common Stock;

 

(iii)                               Common Stock issued upon conversion of any shares of Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock, Series G Preferred Stock, Series H Preferred Stock, Series I Preferred Stock or Series J Preferred Stock;

 

(iv)                              any securities issued pursuant to a merger, consolidation, acquisition or similar business combination or a joint venture, corporate partnering, strategic alliance or other similar arrangement (including without limitation, a licensing arrangement); or

 

(v)                                 Common Stock issued in connection with a public offering.

 

(g)                                  Notwithstanding the foregoing provisions of this Section 2, the rights of the Majority Investors and the obligations of the Corporation under this Section 2 shall terminate as to all Majority Investors upon the consummation of a Designated Offering.

 

(h)                                 By execution of this Agreement, the Stockholders hereby waive any and all rights of first offer to purchase any and all shares of Series I Preferred Stock and Series J Preferred Stock issued and sold by the Corporation, whether under the terms of that certain Series I Conversion Agreement or that certain Series J Purchase Agreement dated as of the date of this Agreement or otherwise, at any closing to be held for the sale of such securities.  This waiver also extends to any and all of the shares of Common Stock issuable upon conversion of such shares of Series I Preferred Stock or Series J Preferred Stock and to any notice period required in connection with such right of first offer.

 

SECTION 3.                            Right of First Refusal.  The Corporation, the Founders and the Series D Investors shall be entitled to the following right of first refusal, except with respect to Permitted Transfers in connection with which there shall be no right of first refusal:

 

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(a)                                 Transfer of Shares.  An Investor (including Dr. John R. Jenkins but other than a Principal Stockholder) shall not transfer (each, a “Non-Principal Transferring Stockholder”) and each Principal Stockholder shall not transfer (each, a “Principal Transferring Stockholder” and together with the Non-Principal Transferring Stockholders, the “Transferring Stockholders”) any or all of the Shares or any right or interest therein then owned by him (each, a “Shares Transfer”) except by a Transfer that meets the requirements of this Section 3 and of this Agreement generally.  If a Transferring Stockholder proposes to effect a Shares Transfer, whether voluntarily or involuntarily, then at least sixty (60) days prior to any Shares Transfer, each Non-Principal Transferring Stockholder shall give notice to the Corporation and the Founders and each Principal Transferring Stockholder shall give notice to the Corporation, the Founders and the Series D Investors of his intention to effect the Shares Transfer (in each case, the “TS Notice”).  The TS Notice shall set forth (i) the number, class and series of shares to be sold by the Transferring Stockholder (the “Sale Shares”), (ii) the date or proposed date of the Shares Transfer and the name and address of the proposed transferee, (iii) the principal terms of the Shares Transfer, including the cash or other property or consideration to be received upon such Shares Transfer, and (iv) the percentage which the number of Sale Shares constitutes with respect to the aggregate number of Shares then held by the Transferring Stockholder.  In the case of a proposed Transfer by way of gift or if the nature of the Transfer is such that no readily determinable consideration is to be paid for the Transfer of the Sale Shares, then a bona fide Transfer price for purposes of this Section 3(a) shall be determined by the Board of Directors of the Corporation promptly upon the Corporation’s receipt of, and as of the date of, the TS Notice (the “Board Price”).

 

(b)                                 Corporation’s Option.  The Corporation shall have the option, but not the obligation, to purchase any or all of the Sale Shares on the same terms as specified in the TS Notice.  Within fifteen (15) days after the receipt of the TS Notice, the Corporation shall give written notice to the Transferring Stockholder, the Founders and, in the case of a Principal Transferring Stockholder, to the Series D Investors (the “Corporation Notice”) stating whether or not it elects to exercise its option to purchase, the number of Sale Shares, if any, it elects to purchase, a date and time for consummation of the purchase not more than fifteen (15) days after the receipt of the Corporation Notice by the Transferring Stockholder, and any Board Price determined pursuant to Section 3(a).  Failure by the Corporation to give such notice within such time period shall be deemed an election by it not to exercise its option.  Within five (5) days following the receipt of the Corporation Notice, the Transferring Stockholder shall have the right to rescind the TS Notice and the proposed Transfer if the Board Price is deemed to be unacceptable, as determined in the sole discretion of the Transferring Stockholder.  The Transferring Stockholder shall not be entitled to vote, either as a stockholder or a director (if applicable), in connection with the decision of the Corporation whether to exercise its option to purchase the Sale Shares, provided that, if his vote is required for valid corporate action, then he shall vote in accordance with the decision of the majority of the other directors or stockholders, as the case may be.

 

(c)                                  Founders’ Option.  If the Corporation fails to exercise its right to purchase under Section 3(b) hereof, or exercises its right to purchase for less than all of the Sale Shares and the Transferring Stockholder has not rescinded the TS Notice as described in Section 3(b) hereof, then the Founders shall each have the option, but not the obligation, to purchase up to their pro  rata share of all of the remaining Sale Shares on the same terms as specified in the TS

 

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Notice.  Each Founder’s pro  rata portion of such remaining Sale Shares will be equal to the total number of shares of Common Stock held by such Founder as a percentage of the total number of shares of Common Stock held by all Founders (assuming in each case the conversion or exchange of all securities held by the Founders that are convertible into or exchangeable for Common Stock). Not later than fifteen (15) days after the Founders receive the Corporation Notice, each Founder shall give written notice to the Transferring Stockholder, the Corporation and, in the case of a Principal Transferring Stockholder, to the Series D Investors (the “Founders Notice”) stating whether or not he elects to exercise his option to purchase, the number of Sale Shares, if any, he elects to purchase, and a date and time for consummation of the purchase not more than fifteen (15) days after the receipt of the Founders Notice by the Transferring Stockholder.  Failure by a Founder to give such notice within such time period shall be deemed an election by him not to exercise his option. If a Founder elects not to purchase all of his pro  rata share of the remaining Sale Shares, then the other Founders shall have the right to purchase any or all such unsubscribed Sale Shares (“Unsubscribed Sale Shares”).  To purchase any Unsubscribed Sale Shares, the Founder must have specified in his Founders Notice that he wished to exercise his right to purchase more (specifying the number of shares) than his pro  rata share of the Sale Shares (a “Founder Oversubscription Right”).  If not enough Sale Shares remain to satisfy all properly exercised Founder Oversubscription Rights, then the Unsubscribed Sale Shares shall be sold to and purchased by Founders exercising Founder Oversubscription Rights pro  rata.  For these purposes, a Founder’s pro rata share will be equal to the total number of shares of Common Stock held by such Founder as a percentage of the total number of shares of Common Stock held by all Founders exercising Founder Oversubscription Rights (assuming in each case the issuance of all shares of Common Stock issuable upon the conversion or exchange of all securities convertible into or exchangeable for Common Stock held by the Founders exercising Founder Oversubscription Rights).  Subject to Section 3(d) in the case of Principal Transferring Stockholders, if the Corporation and the Founders do not purchase all the Sale Shares (including any Unsubscribed Sale Shares), then the Transferring Stockholder shall thereafter, for a period of ninety (90) days, be free to transfer all the Sale Shares on the terms provided in the TS Notice (subject to the provisions of Section 5); provided, however, that the Sale Shares shall continue to be subject to the terms of this Agreement and any such transferee shall agree in writing to be bound by the obligations imposed upon Stockholders under this Agreement as if such transferee were originally a signatory to this Agreement.

 

(d)                                 Series D Option.  If, in the case of a Principal Transferring Stockholder, (i) the Corporation fails to exercise its right to purchase under Section 3(b) hereof, or exercises its rights to purchase for less than all of the Sale Shares, (ii) the Founders fail to exercise their right to purchase under Section 3(c) hereof, or exercise their right to purchase for less than all of the Sale Shares and (iii) the Principal Transferring Shareholder has not rescinded the TS Notice as described in Section 3(b) hereof, then the Series D Investors shall each have the option, but not the obligation, to purchase up to their pro  rata share of all of the remaining Sale Shares on the same terms as specified in the TS Notice.  Each Series D Investor’s pro  rata portion of such remaining Sale Shares will be equal to the total number of shares of Common Stock held by such Series D Investor as a percentage of the total number of shares of Common Stock held by all Series D Investors (assuming in each case the conversion or exchange of all securities held by the Series D Investors are convertible or exchangeable into Common Stock).  Not later than fifteen (15) days after the Series D Investors receive the Founders Notice, each Series D Investor 

 

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shall give written notice to the Principal Transferring Stockholder and the Corporation (the “Series D Notice”) stating whether or not he elects to exercise his option to purchase, the number of Sale Shares, if any, he elects to purchase, and a date and time for consummation of the purchase not more than fifteen (15) days after the receipt of the Series D Notice by the Transferring Stockholder.  Failure by a Series D Investor to give such notice within such time period shall be deemed an election by him not to exercise his option. If a Series D Investor elects not to purchase all of his pro  rata share of the remaining Sale Shares, then the other Series D Investors shall have the right to purchase any or all Unsubscribed Sale Shares.  To purchase any Unsubscribed Sale Shares, the Series D Investor must have specified in his Series D Notice that he wished to exercise his right to purchase more (specifying the number of shares) than his pro  rata share of the Sale Shares (a “Series D Oversubscription Right”).  If not enough Sale Shares remain to satisfy all properly exercised Series D Oversubscription Rights, then the Unsubscribed Sale Shares shall be sold to and purchased by Series D Investors exercising Series D Oversubscription Rights pro  rata.  For these purposes, a Series D Investor’s pro rata share will be equal to the total number of shares of Common Stock held by such Series D Investor as a percentage of the total number of shares of Common Stock held by all Series D Investors exercising Series D Oversubscription Rights (assuming in each case the issuance of all shares of Common Stock issuable upon the conversion or exchange of all securities convertible into or exchangeable for Common Stock held by the Series D Investors exercising Series D Oversubscription Rights).  If the Corporation, the Founders and the Series D Investors do not purchase all the Sale Shares (including any Unsubscribed Sale Shares), then the Transferring Stockholder shall thereafter, for a period of ninety (90) days be free to transfer all the Sale Shares on the terms provided in the TS Notice (subject to the provisions of Sections 4 and 5); provided, however, that the Sale Shares shall continue to be subject to the terms of this Agreement and any such transferee shall agree in writing to be bound by the obligations imposed upon Stockholders under this Agreement as if such transferee were originally a signatory to this Agreement.

 

(e)                                  Definitions.  For purposes of this Agreement, the term “Permitted Transfer” shall mean a Shares Transfer (i) to an Affiliate of a Transferring Stockholder or pursuant to a merger, consolidation, acquisition or similar business combination or similar business arrangement of the Transferring Stockholder, (ii) to a spouse (other than pursuant to any divorce or separation proceedings or settlement), parents, brother, sister, children (natural or adopted), stepchildren or grandchildren or a trust for any of their benefit in the case of a Transferring Stockholder that is a natural person (individually, a “Family Member” and collectively, the “Family Members”), (iii) pursuant to an effective registration statement under the Securities Act; (iv) that, after giving effect to all such prior Shares Transfers by such Transferring Stockholder (and its, his or her transferee or predecessor-in-interest, if any) (other than those specified in the foregoing clauses (i), (ii) and (iii)), does not result in such Transferring Stockholder’s transferring Shares representing in the aggregate more than ten percent (10%) of the Shares that such Transferring Stockholder owned on the date of this Agreement; (v) resulting from a Significant Investor’s (as defined below) exercise of its co-sale rights under Section 4 hereof; or (vi) to an equity owner or liquidating trustee of a Transferring Stockholder upon the liquidation or winding up of the Transferring Stockholder (each recipient being a “Permitted Transferee”); provided, however, that for the sake of clarity, it is hereby confirmed that Ventureast Life Fund III, an entity organized under the laws of India and represented by its fund manager, APIDC Venture Capital Private Limited, shall be entitled to reallocate its holdings of Series H Preferred Stock between itself and Ventureast Life Fund III 

 

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LLC, an entity organized under the laws of Mauritius, in such proportion as shall be determined by the former, and such reallocation shall be deemed to be a Permitted Transfer hereunder; and provided, however, that prior to such Permitted Transfer, such Permitted Transferee shall agree in writing to be bound by the obligations imposed upon Stockholders under this Agreement as if such transferee were originally a signatory to this Agreement.

 

(f)                                   Application of Provisions.  In each case, any Sale Shares not purchased by the proposed transferee in accordance with Section 3(d) hereof may not be sold or otherwise disposed of until they are again offered to the Corporation and the Founders, and to the Series D Investors, if appropriate, under the procedures specified herein.

 

(g)                                  Transfers Void.  Any attempted Transfer in violation of the terms of this Section 3 shall be ineffective to vest in any transferee any interest held by the Transferring Stockholder in the Sale Shares.  Without limiting the foregoing, any purported Shares Transfer in violation hereof shall be ineffective as against the Corporation and the Founders, and the Series D Investors, if appropriate, and the Corporation and the Founders, and the Series D Investors, if appropriate, shall have a continuing right and option (but not an obligation), until the restrictions contained in this Section 3 terminate, to purchase the Sale Shares purported to be transferred by the Transferring Stockholders for a price and on terms the same as those at which the purported Shares Transfer was effected.

 

(h)                                 Termination of Restrictions.  The restrictions in this Section 3 shall terminate upon the consummation of a Designated Offering.

 

(i)                                     Founder/Investor.  Notwithstanding the foregoing, a Founder who is also an Investor shall have no right to purchase Sale Shares with respect to any Shares Transfer for which he is the Transferring Stockholder.  Such Founder and Investor shall, however, deliver the TS Notice and otherwise comply with this Section 3.

 

SECTION 4.                            Rights of Co-Sale.  Each Series B Investor that, together with any Affiliates, owns not less than 5% of the then issued and outstanding Series B Preferred Stock (each a “Significant Series B Investor” and, collectively, the “Significant Series B Investors”), each Series C Investor that, together with any Affiliates, owns not less than 5% of the then issued and outstanding Series C Preferred Stock (each a “Significant Series C Investor” and collectively, the “Significant Series C Investors”), each Series D Investor that, together with any Affiliates, owns not less than 5% of the then issued and outstanding Series D Preferred Stock (each a “Significant Series D Investor” and, collectively, the “Significant Series D Investors”), each Series E Investor that, together with any Affiliates, owns not less than 5% of the then issued and outstanding Series E Preferred Stock (each a “Significant Series E Investor,” collectively, the “Significant Series E Investors”), each Series F Investor that, together with any Affiliates, owns not less than 5% of the then issued and outstanding Series F Preferred Stock (each a “Significant Series F Investor,” collectively, the “Significant Series F Investors”), each Series G Investor that, together with any Affiliates, owns not less than 5% of the then issued and outstanding Series G Preferred Stock (each a “Significant Series G Investor,” collectively, the “Significant Series G Investors”), each Series H Investor that, together with any Affiliates, owns not less than 5% of the then issued and outstanding Series H Preferred Stock (each a “Significant Series H Investor,” collectively, the “Significant Series H Investors”), each Series I Investor that,

 

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together with any Affiliates, owns not less than 5% of the then issued and outstanding Series I Preferred Stock (each a “Significant Series I Investor,” collectively, the “Significant Series I Investors”), and each Series J Investor that, together with any Affiliates, owns not less than 5% of the then issued and outstanding Series J Preferred Stock (each a “Significant Series J Investor,” collectively, the “Significant Series J Investors” and, together with the Significant Series B Investors, Significant Series C Investors, Significant Series D Investors, Significant Series E Investors, Significant Series F Investors, Significant Series G Investors, Significant Series H Investors and Significant Series I Investors, the “Significant Investors”) shall be entitled to the following co-sale rights, except with respect to Excluded Transfers (defined below) in connection with which there shall be no co-sale rights:

 

(a)                                 Transfer of Shares.  A Founder shall not Transfer (each, a “Transferring Founder”) any or all of the Shares or any right or interest therein then owned by him (each, a “Founder Shares Transfer”) except by a Transfer that meets the requirements of this Section 4 and of this Agreement generally.  If a Transferring Founder proposes to effect a Founder Shares Transfer, whether voluntarily or involuntarily, then at least sixty (60) days prior to any Founder Shares Transfer, such Transferring Founder shall deliver the TS Notice in accordance with Section 3 above and shall also deliver the TS Notice to the Significant Investors notifying them of his intention to effect the Founder Shares Transfer.

 

(b)                                 Exercise of Co-Sale Rights.  To the extent that the Corporation, the other Founders and the Series D Investors fail to exercise their right of first refusal under Section 3 hereof, then a Significant Investor may exercise its co-sale rights under this Section 4 by delivery of a written notice (the “Co-Sale Notice”) to the Transferring Founder within fifteen (15) days of the date of Founder’s sending the TS Notice.  The Co-Sale Notice shall state the number of Shares that the Significant Investor proposes to include in the proposed sale, up to its Significant Investor’s Share (as defined below).  If a Significant Investor entitled to participate in such sale delivers a Co-Sale Notice, such Significant Investor shall be obligated to sell that number of Shares specified in the Co-Sale Notice upon the same terms and conditions as the Transferring Founder is selling, conditioned upon and contemporaneously with completion of the Transferring Founder’s sale of his Founder Sale Shares (except as provided in Section 4(d)).  The number of Founder Sale Shares that the Founder may actually Transfer to the proposed transferee (after the application of this Section 4) shall be reduced by the number of Significant Investors’ Shares that the proposed transferee purchases pursuant to this Section 4(b).  If no Co-Sale Notice is received within the 15-day period referred to above, the Transferring Founder shall have the right for a one hundred twenty (120)-day period to effect the proposed sale of the Founder Sale Shares on terms and conditions set forth in the Founder Notice and in accordance with the provisions of this Section 4; provided, however, that the Shares shall continue to be subject to the terms of this Agreement and any such transferee shall agree in writing to be bound by the obligations imposed upon the Stockholders under this Agreement as if such transferee were originally a signatory to this Agreement.  “Significant Investor’s Share” means the Shares owned by the Significant Investor multiplied by the percentage determined by dividing (A) the number of shares of Common Stock held by such Significant Investor (assuming conversion of the shares of Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock, Series G Preferred Stock, Series H Preferred Stock, Series I Preferred Stock and/or Series J Preferred Stock, as applicable, into Common Stock), by (B) the number of shares of Common Stock held by the Transferring Founder and all Significant Investors 

 

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participating in the co-sale right (assuming conversion of the shares of Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock, Series G Preferred Stock, Series H Preferred Stock, Series I Preferred Stock and Series J Preferred Stock into Common Stock).

 

(c)                                  Excluded Transfers.  Notwithstanding anything herein to the contrary, a Transferring Founder may make any of the following Founder Shares Transfers without offering the Significant Investors the opportunity to participate (collectively, the “Excluded Transfers”): (i) Founder Shares Transfers to any Family Member or to a corporation, partnership, limited liability company or other entity that is controlled by the Transferring Founder and/or his Family Members, provided that such Family Member or entity agrees in writing to be bound by the provisions of this Agreement; (ii) Founder Shares Transfers to another Founder; (iii) Founder Shares Transfers pursuant to an effective registration statement under the Securities Act; (iv) Founder Shares Transfers that, after giving effect to all such prior Transfers by such Founder (and his or her transferee or predecessor-in-interest, if any) (other than those specified in the foregoing clauses (i), (ii) and (iii)), do not result in the Transferring Founder’s transferring Shares representing in the aggregate more than ten percent (10%) of the Shares that such Transferring Founder owned on the date of this Agreement; or (v) shares transferred to the Corporation, the other Founders and/or the Series D Investors pursuant to their respective rights of first refusal under Section 3 hereof.

 

(d)                                 Prohibited Transfers.  If a Transferring Founder subject to this Section 4 Transfers any Founder Sale Shares in contravention of this Section 4 (a “Prohibited Transfer”), any Significant Investor may, by delivery of written notice to such Transferring Founder (a “Put Notice”) within ten (10) days after the later of (i) the closing of such Prohibited Transfer, and (ii) the date on which such Significant Investor becomes aware of the Prohibited Transfer or the terms thereof, require the Transferring Founder to purchase from such Significant Investor, for cash and on the same terms, the number of Shares which such Significant Investor would have been entitled to sell (or such lesser amount requested by the Significant Investor) had the Transferring Founder complied with the provisions of this Section 4 at a per share price equal to the per share fair market value of the consideration received by the Transferring Founder in the Prohibited Transfer on the date of the closing of the Prohibited Transfer.  The closing of such Transfer to such Transferring Founder will occur within ten (10) days after the date of such Significant Investor’s Put Notice to such Transferring Founder.

 

(e)                                  Notwithstanding the foregoing, the right of first refusal provided for in Section 3 and the co-sale right provided for in Section 4 shall be mutually exclusive and any Significant Investor that elects to exercise its rights with respect to any proposed Shares Transfer under either of such Sections shall not be entitled to exercise its rights, if any, under the other such Section with respect to such proposed sale.

 

(f)                                   Termination.  The co-sale rights arising under this Section 4 shall terminate upon the consummation of a Designated Offering.

 

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SECTION 5.                            Transfer of Securities; Registration Rights.

 

(a)                                 Restriction on Transfer.  The Shares shall not be transferable except upon the conditions specified in this Section 5, which conditions are intended to ensure compliance with the provisions of the Securities Act and applicable state securities laws in respect of the Transfer thereof.

 

(b)                                 Restrictive Legend.  Each certificate for the Shares and each certificate for any such securities issued to subsequent transferees of any such certificate shall (unless otherwise permitted by the provisions of Section 5(c)) be stamped or otherwise imprinted with substantially the following legend:

 

“THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE BEEN ACQUIRED FOR INVESTMENT AND HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR ANY APPLICABLE STATE SECURITIES LAW. THESE SECURITIES MAY NOT BE SOLD OR TRANSFERRED IN THE ABSENCE OF SUCH REGISTRATION OR AN EXEMPTION THEREFROM UNDER SAID ACT.  ADDITIONALLY, THE TRANSFER OF THESE SECURITIES IS SUBJECT TO THE CONDITIONS SPECIFIED IN THE EIGHTH AMENDED AND RESTATED STOCKHOLDERS’ AGREEMENT DATED AS OF JULY 27, 2012, AMONG ONCONOVA THERAPEUTICS, INC. AND CERTAIN OTHER SIGNATORIES THERETO (AS THE SAME MAY BE AMENDED AND/OR RESTATED FROM TIME TO TIME) AND NO TRANSFER OF THESE SECURITIES SHALL BE VALID OR EFFECTIVE UNTIL SUCH CONDITIONS HAVE BEEN FULFILLED.  UPON THE FULFILLMENT OF CERTAIN OF SUCH CONDITIONS, ONCONOVA THERAPEUTICS, INC. HAS AGREED TO DELIVER TO THE HOLDER HEREOF A NEW CERTIFICATE, NOT BEARING THIS LEGEND, FOR THE SECURITIES REPRESENTED HEREBY REGISTERED IN THE NAME OF THE HOLDER HEREOF. COPIES OF SUCH AGREEMENT MAY BE OBTAINED AT NO COST BY WRITTEN REQUEST MADE BY THE HOLDER OF RECORD OF THIS CERTIFICATE TO THE SECRETARY OF ONCONOVA THERAPEUTICS, INC.”

 

In addition, the certificate may be stamped with such legends as the Corporation’s counsel may deem advisable in light of applicable state securities laws.

 

(c)                                  Notice of Transfer.  The holder of any Shares, by acceptance thereof agrees, prior to any Transfer thereof, to give written notice to the Corporation of such holder’s intention to effect such Transfer and to comply in all other respects with the provisions of this Section 5(c) and the other applicable provisions of this Agreement.  Each such notice shall describe the manner and circumstances of the proposed Transfer and shall be accompanied by 

 

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(i) the written opinion, addressed to the Corporation, of counsel for the holder of such Shares, as to whether in the opinion of such counsel (which counsel and opinion shall be reasonably satisfactory to counsel to the Corporation) such proposed Transfer involves a transaction requiring registration of such shares under the Securities Act, and (ii) in the case of Registrable Securities, if in the opinion of such counsel such registration is required, a written request addressed to the Corporation by the Holder of Registrable Securities, describing in detail the proposed method of disposition and requesting the Corporation to effect the registration of such Registrable Securities pursuant to the terms and conditions of Sections 5(d), 5(e) or 5(f), as the case may be; provided, however, that no such opinion shall be required in the case of a Transfer by any Holder of Registrable Securities (A) which is a (1) partnership or limited liability company to a partner or member of such Holder, or a retired partner or member of such Holder who retires after the date hereof, or the estate of any such partner or member or retired partner or member, if the transferee agrees in writing to be subject to the terms of this Section 5 to the same extent as if such transferee were originally a signatory to this Agreement, or (2) corporation to any Affiliate of such corporation, including without limitation, any officer, director or controlling stockholder of such corporation, or (B) in connection with a transaction complying with the requirements of Rule 144 (as amended from time to time) promulgated under the Securities Act (or successor rule thereto). If in such opinion of counsel the proposed Transfer may be effected without registration under the Securities Act, the holder shall thereupon be entitled to Transfer the Shares in accordance with the terms of the notice delivered by it to the Corporation, subject to the other requirements of this Agreement. Each certificate or other instrument evidencing the securities issued upon the Transfer of any Shares (and each certificate or other instrument evidencing any untransferred balance of such securities) shall bear the legend set forth in Section 5(b) unless (x) in such opinion of counsel registration of future Transfer is not required by the applicable provisions of the Securities Act or (y) the Corporation shall have waived the requirement of such legend; provided, however, that such legend shall not be required (1) on any certificate or other instrument evidencing the securities issued upon such Transfer in the event such Transfer shall be made in compliance with the requirements of Rule 144 (as amended from time to time) promulgated under the Securities Act (or successor rule thereto) or (2) on any certificate or other instrument which is immediately resalable without restrictions (whether or not such resale is proposed) under Rule 144 or successor thereto.  Notwithstanding the foregoing, as a condition to any Transfer of Shares, the transferee must agree to be bound by the terms hereof as if it were a signatory hereto, and the shares held by such transferee shall constitute Shares hereunder.

 

(d)                                 Piggyback Registrations.

 

(i)                                     The Corporation shall notify all Holders of Registrable Securities in writing at least thirty (30) days prior to filing any registration statement under the Securities Act for purposes of effecting a public offering of securities of the Corporation (including, but not limited to, registration statements relating to secondary offerings of securities of the Corporation, but excluding registration statements on an Excluded Form or relating to any employee benefit plan or a corporate reorganization) and shall afford each such Holder an opportunity to include in such registration statement all or any part of the Registrable Securities then held by such Holder.  Each Holder desiring to include in any such registration statement all or any part of the Registrable Securities held by such Holder shall, within fourteen (14) days after receipt of the above-described notice 

 

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from the Corporation, so notify the Corporation in writing, and in such notice shall inform the Corporation of the number of Registrable Securities such Holder wishes to include in such registration statement. If a Holder decides not to include all of its Registrable Securities in any registration statement thereafter filed by the Corporation, such Holder shall nevertheless continue to have the right to include any Registrable Securities in any subsequent registration statement or registration statements as may be filed by the Corporation with respect to offerings of its securities, all upon the terms and conditions set forth herein.

 

(ii)                                  If the registration statement under which the Corporation gives notice under this Section 5(d) is for an underwritten offering, the Corporation shall so advise the Holders of Registrable Securities.  In such event, the right of any such Holder’s Registrable Securities to be included in a registration pursuant to this Section 5(d) shall be conditioned upon such Holder’s participation in such underwriting and the inclusion of such Holder’s Registrable Securities in the underwriting to the extent provided herein.  All Holders proposing to distribute their Registrable Securities through such underwriting shall enter into an underwriting agreement in customary form with the managing underwriter or underwriters selected for such underwriting by the Corporation. Notwithstanding any other provision of this Agreement, if the managing underwriter(s) determine(s) in good faith that marketing factors require a limitation of the number of shares to be underwritten, the number of shares that may be included in said underwriting shall be allocated, first, to the Corporation, and second, to each of the Holders requesting inclusion of their Registrable Securities in such registration statement on a pro  rata basis based on the total number of Registrable Securities held by each such Holder; provided, however, that the right of the underwriters to exclude Registrable Securities from the registration and underwriting as described above shall be restricted so that the number of Registrable Securities included in any such registration is not reduced below twenty percent (20%) of the shares included in the registration, except for a registration relating to the Corporation’s initial public offering from which all Registrable Securities may be excluded.  In the event that underwriters exclude Registrable Securities from the registration and underwriting as described above, the Corporation shall use its commercially reasonable efforts to cause the underwriters to furnish a certificate indicating the reasons for such exclusion.  If any Holder disapproves of the terms of any such underwriting, such Holder may elect to withdraw therefrom by written notice to the Corporation and the underwriter, delivered at least five (5) business days prior to the effective date of the registration statement.  Any Registrable Securities excluded or withdrawn from such underwriting shall be excluded and withdrawn from the registration.

 

(iii)                               All registration expenses incurred in connection with a registration pursuant to this Section 5(d) (other than underwriters’ discounts and commissions which shall be borne proportionately by Holders participating in a registration pursuant to this Section 5(d) on the basis of the number of the shares so registered) shall be borne by the Corporation.

 

(e)                                  Form S-3 Registration.  In case the Corporation receives from the Demand Holders a written request or requests that the Corporation effect a registration on Form S-3 with 

 

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respect to all or part of the Registrable Securities owned by such Demand Holders, then the Corporation shall:

 

(i)                                     Promptly give written notice of the proposed registration and the Demand Holders request therefor to all Holders of Registrable Securities; and

 

(ii)                                  As soon as practicable effect such registration; provided, however, that the Corporation shall not be obligated to effect any such registration, qualification or compliance pursuant to this Section 5(e):  (A) if Form S-3 is not available for such offering by the Holders; (B) if the Holders propose to sell Registrable Securities at an aggregate gross offering price to the public of less than $500,000.00; (C) if the Corporation has, within the six (6)-month period preceding the date of such request, already effected one registration on Form S-3 for the Holders pursuant to this Section 5(e); (D) if the Corporation furnishes to the Holders of Registrable Securities a certificate signed by the President or Chief Executive Officer of the Corporation stating that (1) the Corporation is planning to file a registration statement in connection with an underwritten public offering within 120 days of such request for registration, or (2) in the good faith judgment of the Board of Directors of the Corporation, it would be detrimental to the Corporation and its stockholders for such Form S-3 registration statement to be filed at such time, in which event the Corporation shall have the right to defer the filing of the Form S-3 registration statement for a period of not more than 120 days after receipt of the request of the holders of Registrable Securities under this Section 5(e); provided, however, that the Company may not utilize this right more than once in any twelve (12)-month period; or (E) in any particular jurisdiction in which the Corporation would be required to qualify to do business or to execute a general consent to service of process in order to effect such registration in compliance with all applicable laws.

 

(iii)                               Subject to the foregoing, the Corporation shall file a Form S-3 registration statement covering the Registrable Securities to be registered pursuant to this Section 5(e) as soon as practicable after receipt of the request or requests of the requisite Holders for such registration.  All registration expenses incurred in connection with a registration pursuant to this Section 5(e) (other than underwriters’ discounts and commissions which shall be borne proportionately by Holders participating in a registration pursuant to this Section 5(e)) shall be borne by the Corporation.

 

(f)                                   Demand Registration.

 

(i)                                     If the Corporation receives at any time after six (6) months following the effective date of the Corporation’s initial public offering, a written request from the Demand Holders of at least twenty-five percent (25%) of the Registrable Securities then outstanding that the Corporation file a registration statement under the Securities Act covering the registration of the Registrable Securities, then the Corporation shall, within ten (10) business days after the receipt thereof, give written notice of such request to all Demand Holders, and effect, as soon as practicable, the registration under the Securities Act of all Registrable Securities which the Demand Holders request to be registered and included in such registration, subject only to the limitations of this Section 5(f);

 

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(ii)                                  If the Demand Holders initiating the registration request under this Section 5(f) (“Initiating Holders”) intend to distribute the Registrable Securities covered by their request by means of an underwriting, they shall so advise the Corporation as a part of their request made pursuant to this Section 5(f) and the Corporation shall include such information in the written notice referred to in Section 5(f)(i) hereof.  In such event, the right of any Demand Holder to include such Demand Holder’s Registrable Securities in such registration shall be conditioned upon such Demand Holder’s participation in such underwriting and the inclusion of such Demand Holder’s Registrable Securities in the underwriting (unless otherwise mutually agreed by a majority in interest of the Initiating Holders and such Demand Holder) to the extent provided herein.  All Demand Holders proposing to distribute their securities through such underwriting shall enter into an underwriting agreement in customary form with the managing underwriter or underwriters selected for such underwriting by the Corporation.  Notwithstanding any other provision of this Section 5(f), if the underwriter(s) advise(s) the Corporation in writing that marketing factors require a limitation of the number of securities to be underwritten, then the Corporation shall also advise all Demand Holders of Registrable Securities which would otherwise be underwritten pursuant hereto, and the number of Registrable Securities that may be included in the underwriting shall be reduced as required by the underwriter(s) and allocated among the Demand Holders of Registrable Securities on a pro rata basis according to the number of Registrable Securities then outstanding held by each Demand Holder requesting registration (including the Initiating Holders); provided, however, that the number of shares of Registrable Securities to be included in such underwriting and registration shall not be reduced unless all other securities of the Corporation and other stockholders are first entirely excluded from the underwriting and registration.  Any Registrable Securities excluded and withdrawn from such underwriting shall be withdrawn from the registration.

 

(iii)                               The Corporation is obligated to effect only two (2) such registrations pursuant to this Section 5(f).

 

(iv)                              Notwithstanding the foregoing, if the Corporation furnishes to Demand Holders requesting the filing of a registration statement pursuant to this Section 5(f) a certificate signed by the President or Chief Executive Officer of the Corporation stating that in the good faith judgment of the Board of Directors of the Corporation, it would be seriously detrimental to the Corporation and its stockholders for such registration statement to be filed and it is therefore essential to defer the filing of such registration statement, then the Corporation shall have the right to defer such filing for a period of not more than one hundred and twenty (120) days after receipt of the request of the Initiating Holders; provided, however, that the Corporation may not utilize this right more than once in any twelve (12) month period.

 

(v)                                 All expenses incurred in connection with a registration pursuant to this Section 5(f), including without limitation, all federal and “blue sky” registration and qualification fees, printers’ and accounting fees, fees and disbursements of counsel for the Corporation, and of one counsel for the participating Demand Holders (but excluding underwriters’ discounts and commissions), shall be borne by the Corporation.  Each Holder participating in a registration pursuant to this Section 5(f) shall bear its

 

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proportionate share of all discounts, commissions or other amounts payable to underwriters or brokers in connection with such offering.  Notwithstanding the foregoing, the Corporation shall not be required to pay for any expenses of any registration proceeding begun pursuant to this Section 5(f) if the registration request is subsequently withdrawn at the request of the Demand Holders of a majority of the Registrable Securities to be registered; provided, however, that if at the time of such withdrawal, the Holders have learned of a material adverse change in the condition, business, or prospects of the Corporation not known to the Demand Holders at the time of their request for such registration and have withdrawn their request for registration with reasonable promptness after learning of such material adverse change, then the Demand Holders shall not be required to pay any of such expenses and shall retain their rights pursuant to this Section 5(f).

 

(g)                                  Obligations of the Corporation.  Whenever required to effect the registration of any Registrable Securities under this Agreement, the Corporation shall, as expeditiously as reasonably possible:

 

(i)                                     Prepare and file with the Commission a registration statement with respect to such Registrable Securities and use its best efforts to cause such registration statement to become and remain effective.

 

(ii)                                  Prepare and file with the Commission such amendments and supplements to such registration statement and the prospectus used in connection with such registration statement as may be necessary to comply with the provisions of the Securities Act with respect to the disposition of all securities covered by such registration statement and to keep such registration statement effective, in the case of a firm commitment underwriting, until each underwriter has completed the distribution of all securities purchased by it and, in the case of any other offering, until the earlier of the sale of all Registrable Securities covered thereby or one hundred eighty (180) days after the effective date thereof; provided, however, that such 180-day period shall be extended for a period of time equal to the period the Holder refrains from selling any Registrable Securities included in such registration at the request of an underwriter of the Common Stock or if the Corporation has provided the notice described in subparagraph (vii) below.

 

(iii)                               Furnish to the Holders such number of copies of a prospectus, including a preliminary prospectus, in conformity with the requirements of the Securities Act, and such other documents as they may reasonably request in order to facilitate the disposition of the Registrable Securities owned by them that are included in such registration.

 

(iv)                              Use its best efforts to register and qualify the securities covered by such registration statement under such other securities or blue sky laws of such jurisdictions as shall be reasonably requested by the Holders, provided, that the Corporation shall not be required in connection therewith or as a condition thereto to qualify to do business or to file a general consent to service of process in any such states or jurisdictions.

 

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(v)                                 Use its best efforts to list the securities covered by such registration statement with the securities exchange, if any, on which the Common Stock is then listed.

 

(vi)                              In the event of any underwritten public offering, enter into and perform its obligations under an underwriting agreement, in usual and customary form, with the managing underwriter(s) of such offering.  Each Holder participating in such underwriting shall also enter into and perform its obligations under such an agreement.

 

(vii)                           Notify each Holder of Registrable Securities and each underwriter under such registration statement at any time when a prospectus relating thereto is required to be delivered under the Securities Act of the happening of any event as a result of which the prospectus included in such registration statement, as then in effect, includes an untrue statement of a material fact or omits to state a material fact required to be stated therein or necessary to make the statements therein not misleading in the light of the circumstances then existing.

 

(h)                                 Furnish Information.  It shall be a condition precedent to the obligations of the Corporation to take any action pursuant to Sections 5(d), 5(e), and 5(f) that the selling Holders shall furnish to the Corporation such information regarding themselves, the Registrable Securities held by them, and the intended method of disposition of such securities as shall be required to effect the registration of their Registrable Securities.

 

(i)                                     Indemnification.  In the event any Registrable Securities are included in a registration statement under Sections 5(d), 5(e) or 5(f):

 

(i)                                     To the extent permitted by law, the Corporation shall indemnify and hold harmless each Holder, the partners, officers and directors of each Holder, any underwriter (as defined in the Securities Act) for such Holder and each Person, if any, who controls such Holder or underwriter within the meaning of the Securities Act or the Exchange Act (collectively, “Indemnified Persons”), against any losses, claims, damages, or liabilities (joint or several) to which they may become subject under the Securities Act, the Exchange Act or other federal or state law, insofar as such losses, claims, damages or liabilities (or actions in respect thereof) arise out of or are based upon any of the following statements, omissions or violations (collectively, a “Violation”):

 

(A)                               any untrue statement or alleged untrue statement of a material fact contained in such registration statement, including any preliminary prospectus or final prospectus contained therein or any amendments or supplements thereto,

 

(B)                               the omission or alleged omission to state therein a material fact required to be stated therein, or necessary to make the statements therein not misleading, or

 

(C)                               any violation or alleged violation by the Corporation of the Securities Act, the Exchange Act, any federal or state securities law or any rule or

 

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regulation promulgated under the Securities Act, the Exchange Act or any federal or state securities law in connection with the offering covered by such registration statement,

 

and the Corporation shall reimburse each such Indemnified Person for any legal or other expenses reasonably incurred by it, as incurred, in connection with investigating or defending any such loss, claim, damage, liability or action; provided, however, that the indemnity agreement contained in this Section 5(i) shall not apply to amounts paid in settlement of any such loss, claim, damage, liability or action if such settlement is effected without the consent of the Corporation (which consent shall not be unreasonably withheld), nor shall the Corporation be liable in any case for any such loss, claim, damage, liability or action to the extent that it arises out of or is based upon a Violation which occurs in reliance upon and in conformity with written information furnished expressly for use in connection with such registration by an Indemnified Person.

 

(ii)                                  To the extent permitted by law, each selling Holder shall indemnify and hold harmless the Corporation, each of its directors and officers who have signed the registration statement, each Person, if any, who controls the Corporation within the meaning of the Securities Act, any underwriter and any other Holder selling securities under such registration statement or any of such other Holder’s partners, directors or officers or any Person who controls such Holder within the meaning of the Securities Act or the Exchange Act, against any losses, claims, damages or liabilities (joint or several) to which the Corporation or any such Person may become subject under the Securities Act, the Exchange Act or other federal or state law, insofar as such losses, claims, damages or liabilities (or actions in respect thereto) arise out of or are based upon any Violation, in each case to the extent that such Violation occurs in reliance upon and in conformity with written information furnished by such Holder expressly for use in connection with such registration; and each such Holder shall reimburse any legal or other expenses reasonably incurred by the Corporation or any such Person in connection with investigating or defending any such loss, claim, damage, liability or action; provided, however, that the indemnity agreement contained in this Section 5(i) shall not apply to amounts paid in settlement of any such loss, claim, damage, liability or action if such settlement is effected without the consent of the Holder, which consent shall not be unreasonably withheld.

 

(iii)                               Promptly after receipt by an indemnified party under this Section 5(i) of notice of the commencement of any action (including any governmental action), such indemnified party shall, if a claim in respect thereof is to be made against any indemnifying party under this Section 5(i), deliver to the indemnifying party a written notice of the commencement thereof and the indemnifying party shall have the right to participate in, and, to the extent the indemnifying party so desires, jointly with any other indemnifying party similarly noticed, to assume the defense thereof with counsel mutually satisfactory to the parties; provided, however, that an indemnified party shall have the right to retain its own counsel, with the fees and expenses to be paid by the indemnifying party, if representation of such indemnified party by the counsel retained by the indemnifying party would be inappropriate due to actual or potential differing interests between such indemnified party and any other party represented by such counsel in such proceeding. The failure to deliver written notice to the indemnifying party within

 

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a reasonable time of the commencement of any such action, if prejudicial to its ability to defend such action, shall relieve such indemnifying party of any liability to the indemnified party under this Section 5(i), but the omission so to deliver written notice to the indemnifying party shall not relieve it of any liability that it may have to any indemnified party otherwise than under this Section 5(i).

 

(iv)                              If the indemnification provided for in Section 5(i) is unavailable to a party entitled to indemnification in respect of any losses referred to herein, then each indemnifying party, in lieu of indemnifying such indemnified party, shall contribute to the aggregate losses as is appropriate to reflect the relative fault of the indemnified party and the indemnifying party, as well as any other relevant equitable considerations.  The relative fault of such indemnifying party and indemnified parties shall be determined by reference to, among other things, whether any action in question, including any untrue or alleged untrue statement of a material fact or omission or alleged omission to state a material fact, has been made by, or relates to information supplied by, such indemnifying party or indemnified parties, and the parties’ relative intent, knowledge, access to information and opportunity to correct or prevent such action; provided, however, that, in any such case, (1) no Holder shall be required to contribute any amount in excess of the public offering price of all such Registrable Securities offered and sold by such Holder pursuant to such registration statement; and (2) no person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any Person who was not guilty of such fraudulent misrepresentation.

 

(v)                                 The obligations of the Corporation and Holders under this Section 5(i) shall survive the completion of any offering of Registrable Securities in a registration statement, and the termination of this Agreement.

 

(j)                                    “Market Stand-Off” Agreement.  Each Holder hereby agrees that it shall not, to the extent requested by the Corporation and an underwriter of Common Stock of the Corporation, sell or otherwise Transfer any Registrable Securities (other than Registrable Securities being registered in such offering) for up to that period of time following the effective date of a registration statement of the Corporation filed under the Securities Act as is requested by the managing underwriter(s) of such offering, not to exceed one hundred eighty (180) days; provided, however, that all officers, directors and five percent (5%) or greater stockholders of the Corporation then holding Common Stock of the Corporation shall enter into similar agreements.  In order to enforce the foregoing covenant, the Corporation may impose stop transfer instructions with respect to the then-remaining Registrable Securities of each Holder (and the shares or securities of every other Person subject to the foregoing restriction) until the end of such period.

 

(k)                                 Assignment of Registration Rights.  The rights of a Holder under Sections 5(d), (e) and (f) may be assigned by any Holder in connection with any Transfer by a Holder of Registrable Securities provided that:  (i) such Transfer may otherwise be effected in accordance with applicable securities laws; (ii) such Transfer is effected in compliance with the restrictions on Transfer contained in this Agreement and in any other agreement between the Corporation and the Holder; (iii) notice of such Transfer is given to the Corporation; (iv) such assignee or transferee (a) acquires pursuant to such Transfer not less than 50,000 shares of Registrable

 

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Securities (as adjusted for combinations, stock dividends, subdivisions or split-ups), or (b) such assignee or transferee is an Affiliate or a Family Member of a Holder; and (v) such assignee or transferee agrees in writing with the Corporation to be bound by all of the provisions of this Agreement.

 

SECTION 6.  Duration of Agreement.  Except for those provisions that, by their terms, terminate sooner, all rights and obligations of each Stockholder under this Agreement shall terminate as to such Stockholder upon the earlier of (a) the Transfer in accordance with this Agreement of all Shares held by such Stockholder, or (b) upon written consent of (i) the Stockholders holding at least a majority of the shares of Series A Preferred Stock subject to this Agreement (including shares of Common Stock into which converted), (ii) the Stockholders holding at least sixty-six and 67/100 percent (66.67%) of the shares of Series B Preferred Stock subject to this Agreement (including shares of Common Stock into which converted), (iii) the Stockholders holding at least sixty-six and 67/100 percent (66.67%) of the shares of Series C Preferred Stock subject to this Agreement (including shares of Common Stock into which converted), (iv) the Stockholders holding at least sixty-six and 67/100 percent (66.67%) of the shares of Series D Preferred Stock subject to this Agreement (including shares of Common Stock into which converted), (v) the Stockholders holding at least sixty-six and 67/100 percent (66.67%) of the shares of Series E Preferred Stock subject to this Agreement (including shares of Common Stock into which converted), (vi) the Stockholders holding at least sixty-six and 67/100 percent (66.67%) of the shares of Series F Preferred Stock subject to this Agreement (including shares of Common Stock into which converted), (vii) the Stockholders holding at least sixty-six and 67/100 percent (66.67%) of the shares of Series G Preferred Stock subject to this Agreement (including shares of Common Stock into which converted), (viii) the Stockholders holding at least sixty-six and 67/100 percent (66.67%) of the shares of Series H Preferred Stock subject to this Agreement (including shares of Common Stock into which converted), (ix) the Stockholders holding at least sixty-six and 67/100 percent (66.67%) of the shares of Series I Preferred Stock subject to this Agreement (including shares of Common Stock into which converted ), (x) the Stockholders holding at least sixty-six and 67/100 percent (66.67%) of the shares of Series J Preferred Stock subject to this Agreement (including shares of Common Stock into which converted) and (xi) the Stockholders holding at least a majority of the shares of Common Stock subject to this Agreement (other than those shares specified in subparagraphs (i), (ii), (iii), (iv), (v), (vi), (vii), (viii), (ix) and (x) above).

 

SECTION 7.  Severability; Governing Law.  If any provisions of this Agreement shall be determined to be illegal and unenforceable by any court of law, the remaining provisions shall be severable and enforceable in accordance with their terms.  This Agreement shall be governed by, and construed in accordance with, the laws of the State of Delaware, without giving effect to the conflicts of laws principles thereof.

 

SECTION 8.  Benefits of Agreement.  This Agreement shall be binding upon and inure to the benefit of the parties and their respective successors and assigns, legal representatives and heirs; provided, that, except as otherwise specifically permitted pursuant to this Agreement, neither this Agreement nor any of the rights, interests or obligations hereunder shall be assigned by any party hereto without the prior written consent of the other parties.  This Agreement sets forth the entire agreement and understanding among the parties as to the subject

 

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matter hereof and merges and supersedes all prior discussions, agreements and understandings of any and every nature among them.

 

SECTION 9.  Notices.  All notices, requests, consents and other communications hereunder to any party shall be deemed to be sufficient if contained in a written instrument delivered in person, sent by overnight courier, or duly sent by first class registered or certified mail (or air mail, if to a party not located in North America), return receipt requested, postage prepaid, addressed to such party at the address set forth below or such other address as may hereafter be designated in writing by the addressee to the addressor listing all parties:

 

(a)                                 If to the Corporation, to:

 

Onconova Therapeutics, Inc.
 375 Pheasant Run

Newtown, PA  18940

 

Attention:                                       Dr. Ramesh Kumar

 

with a copy to:

 

Dechert LLP
 902 Carnegie Center
 Suite 500
 Princeton, NJ  08540-6531

 

Attention:                                         James J. Marino, Esq.

 

(b)                                 If to the Stockholders, to the names and addresses set forth on Schedule I.

 

All such notices, advises and communications shall be deemed to have been received (a) in the case of personal delivery or by overnight courier, on the date of such delivery and (b) in the case of mailing, on the third day after the posting thereof.

 

SECTION 10.  Changes.  The terms and provisions of this Agreement may not be modified or amended, or any of the provisions hereof waived (either generally or in a particular instance and either retroactively or prospectively), except pursuant to the written consent of (a) the Corporation, (b) the Stockholders holding at least a majority of the shares of Series A Preferred Stock subject to this Agreement (including shares of Common Stock into which converted), (c) the Stockholders holding at least sixty-six and 67/100 percent (66.67%) of the shares of Series B Preferred Stock subject to this Agreement (including shares of Common Stock into which converted), (d) the Stockholders holding at least sixty-six and 67/100 percent (66.67%) of the shares of Series C Preferred Stock subject to this Agreement (including shares of Common Stock into which converted), (e) the Stockholders holding at least sixty-six and 67/100 percent (66.67%) of the shares of Series D Preferred Stock subject to this Agreement (including shares of Common Stock into which converted), (f) the Stockholders holding at least sixty-six and 67/100 percent (66.67%) of the shares of Series E Preferred Stock subject to this Agreement (including shares of Common Stock into which converted), (g) the Stockholders holding at least sixty-six and 67/100 percent (66.67%) of the shares of Series F Preferred Stock subject to this

 

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Agreement (including shares of Common Stock into which converted), (h) the Stockholders holding at least sixty-six and 67/100 percent (66.67%) of the shares of Series G Preferred Stock subject to this Agreement (including shares of Common Stock into which converted), (i) the Stockholders holding at least sixty-six and 67/100 percent (66.67%) of the shares of Series H Preferred Stock subject to this Agreement (including shares of Common Stock into which converted), (j) the Stockholders holding at least sixty-six and 67/100 percent (66.67%) of the shares of Series I Preferred Stock subject to this Agreement (including shares of Common Stock into which converted), (k) the Stockholders holding at least sixty-six and 67/100 percent (66.67%) of the shares of Series J Preferred Stock subject to this Agreement (including shares of Common Stock into which converted), and (l) the Stockholders holding at least a majority of the shares of Common Stock subject to this Agreement (other than those shares specified in Sections 10(b), (c), (d), (e) (f), (g), (h), (i), (j) and (k) above); provided, however, that any rights that inure specifically to the benefit of the Series A Investors as a group, the Series B Investors as a group, the Series C Investors as a group, the Series D Investors as a group, the Series E Investors as a group, the Series F Investors as a group, the Series G Investors as a group, the Series H Investors as a group, the Series I Investors as a group, the Series J Investors as a group, or the Founders as a group, may be effectively waived by the Stockholders holding at least a majority of the shares of the Series A Preferred Stock subject to this Agreement in the case of the Series A Investors, at least sixty-six and 67/100 percent (66.67%) of the shares of the Series B Preferred Stock subject to this Agreement in the case of the Series B Investors, at least sixty-six and 67/100 percent (66.67%) of the shares of the Series C Preferred Stock subject to this Agreement in the case of the Series C Investors, at least sixty-six and 67/100 percent (66.67%) of the shares of the Series D Preferred Stock subject to this Agreement in the case of Series D Investors, at least sixty-six and 67/100 percent (66.67%) of the shares of Series E Preferred Stock subject to this Agreement in the case of Series E Investors, at least sixty-six and 67/100 percent (66.67%) of the shares of Series F Preferred Stock subject to this Agreement in the case of Series F Investors, at least sixty-six and 67/100 percent (66.67%) of the shares of Series G Preferred Stock subject to this Agreement in the case of Series G Investors, at least sixty-six and 67/100 percent (66.67%) of the shares of Series H Preferred Stock subject to this Agreement in the case of Series H Investors, at least sixty-six and 67/100 percent (66.67%) of the shares of Series I Preferred Stock subject to this Agreement in the case of Series I Investors, at least sixty-six and 67/100 percent (66.67%) of the shares of Series J Preferred Stock subject to this Agreement in the case of Series J Investors and at least a majority of the shares of Common Stock owned by the Founders and subject to this Agreement in the case of the Founders, respectively, without the need for the required vote of any other group.

 

SECTION 11.  Captions.  The captions herein are inserted for convenience only and shall not define, limit, extend or describe the scope of this Agreement or affect the construction hereof.

 

SECTION 12.  Nouns and Pronouns.  Whenever the context may require, any pronouns used herein shall include the corresponding masculine, feminine or neuter forms and the singular form of names and pronouns shall include the plural and vice-versa.

 

SECTION 13.  Merger Provision.  This Agreement (as the same may be amended from time to time) constitutes the entire agreement among the parties pertaining to the subject matter hereof and supersedes all prior and contemporaneous agreements therewith, including

 

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without limitation, the Seventh Amended and Restated Stockholders’ Agreement dated as of September 21, 2010, as amended (the “Original Agreement”), among the Corporation and certain stockholders named therein, which Original Agreement is hereby terminated and no longer of any force or effect.  By execution of this Agreement, the holders of the Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock, Series G Preferred Stock and Series H Preferred Stock hereby waive their rights of first offer and any related notice and/or closing requirements (including without limitation the timing of such closing) required under Section 2 of the Original Agreement with respect to the issuance and sale of the Series I Preferred Stock and the Series J Preferred Stock.

 

SECTION 14.  Counterparts.  This Agreement may be executed in one or more counterparts, each of which shall be deemed to be an original, but all of which taken together shall constitute one and the same instrument.

 

SECTION 15.  Board of Directors.

 

(a)                                 The Board of Directors of the Corporation shall consist of ten (10) directors.

 

(b)                                 At each annual meeting of the stockholders of the Corporation, and at each special meeting of the stockholders of the Corporation called for the purpose of electing directors of the Corporation, and at any time at which stockholders of the Corporation shall have the right to, or shall, vote for or consent in writing to the election of directors of the Corporation, then, and in each such event the Stockholders agree that they shall vote all shares owned by them for the election of the Board of Directors in the following manner:

 

(i)                                     The Series H Investors agree to elect directors as set forth in this Section 15(b)(i).  The holders of record of Series H Preferred Stock voting together as a separate class shall elect one (1) director (the “Series H Director”), which Series H Director shall be designated for nomination by VenturEast Life Fund III LLC (“VenturEast”) for so long as VenturEast continues to own, in the aggregate, at least fifty percent (50%) of the Series H Preferred Stock originally purchased from the Corporation under the Series H Purchase Agreement.  In the event VenturEast owns less than fifty percent (50%) of the Series H Preferred Stock originally purchased by them from the Corporation under the Series H Purchase Agreement, then the holders of record of Series H Preferred Stock shall not have the right to elect any Series H Director.

 

(ii)                                  The Series D Investors agree to elect directors as set forth in this Section 15(b)(ii).  The holders of record of Series D Preferred Stock voting together as a separate class shall elect one (1) director (the “Series D Director”), which Series D Director shall be designated for nomination by ICICI Venture Funds Management Company Limited and/or its Affiliates (“ICICI”) for so long as ICICI continues to own, in the aggregate, at least fifty percent (50%) of the Series D Preferred Stock originally purchased by them from the Corporation under the Series D Purchase Agreement.  In the event ICICI owns less than fifty percent (50%) of the Series D Preferred Stock originally purchased by them from the Corporation under the Series D Purchase Agreement, the

 

29

 

holders of Series D Preferred Stock voting together as a separate class shall have the right to elect the Series D Director, who shall be designated for nomination by the holders of record of a majority of the shares of Series D Preferred Stock then outstanding.

 

(iii)                               The Series B Investors agree to elect directors as set forth in this Section 15(b)(iii).  For so long as the Series B Investors continue to own, in the aggregate, more than fifty percent (50%) of the Series B Preferred Stock originally purchased by them from the Corporation under the Series B Purchase Agreement, the holders of record of the Series B Preferred Stock voting together as a separate class shall elect two (2) directors (the “Series B Directors”), one of whom shall be designated for nomination by the Mehta Investors and the other of whom shall be designated for nomination by Cadila Healthcare Limited (“Cadila”).  In the event the Series B Investors own, in the aggregate, no less than twenty five percent (25%) but no more than fifty percent (50%) of the Series B Preferred Stock originally purchased by them from the Corporation under the Series B Purchase Agreement, the holders of record of the Series B Preferred Stock voting together as a separate class shall elect only one (1) Series B Director, who shall be designated for nomination by the following Persons:

 

(A)                               if, at that time, Cadila owns no less than 260,870 shares of Series B Preferred Stock, then by Cadila; and

 

(B)                               in all other cases, by the holders of record of a majority of the shares of Series B Preferred Stock then outstanding and held by the original Series B Investors.

 

In the event the Series B Investors own, in the aggregate, less than twenty-five percent (25%) of the Series B Preferred Stock originally purchased by them from the Corporation under the Series B Purchase Agreement, the holders of record of Series B Preferred Stock shall not have the right to elect any Series B Director.

 

(iv)                              The holders of record of Common Stock and Series A Preferred Stock voting together as a separate class (on an as-converted basis) shall elect the remaining directors (collectively, the “Common Directors”) (and if the holders of Series B Preferred Stock or the holders of Series H Preferred Stock are no longer entitled to elect a Series B Director(s) or the Series H Director, as the case may be, then the holders of record of shares of Common Stock and Series A Preferred Stock voting together as a separate class (on an as-converted basis) shall vote to fill that directorship(s) with a Common Director as well), all of whom shall be designated for nomination by the holders of record of a majority of the shares of Common Stock and Series A Preferred Stock then outstanding (on an as-converted basis).

 

The Corporation agrees that it shall cause its Board of Directors to nominate for election all such nominees so designated by the Stockholders in accordance with subsections (i) through (iv) above.

 

(c)                                  At such time as the holders of Series B Preferred Stock or Series H Preferred Stock are no longer entitled to designate for nomination and elect the Series B

 

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Director(s) or the Series H Director, as the case may be, the Corporation shall so advise the Series B Director(s) or the Series H Director, as appropriate, and each such Director shall be required to promptly tender his resignation to the Corporation (and the holders of Series B Preferred Stock or Series H Preferred Stock, as the case may be, shall cause their designee to so resign) (a “Subsection (c) Resignation”).

 

(d)                                 At any such meeting called for the purpose of electing directors, the presence in person or by proxy of (A) the holders of a majority of the shares of Series H Preferred Stock then outstanding, in the case of the election of the Series H Director, (B) the holders of a majority of the shares of Series D Preferred Stock then outstanding, in the case of the election of the Series D Director, (C) the holders of a majority of the shares of Series B Preferred Stock then outstanding, in the case of the election of a Series B Director(s), and (D) the holders of a majority of the shares of Common Stock and Series A Preferred Stock then outstanding (on an as-converted to Common Stock basis), in the case of the election of a Common Director), shall constitute a quorum for the election of directors to be elected by such holders.

 

(e)                                  The Series H Director who shall have been elected as provided in this Section 15 may be removed during his term of office, whether with or without cause, only by the holders of record of a majority of Series H Preferred Stock then outstanding; the Series D Director who shall have been elected as provided in this Section 15 may be removed during his term of office, whether with or without cause, only by the holders of record of a majority of Series D Preferred Stock then outstanding; each Series B Director who shall have been elected as provided in this Section 15 may be removed during his term of office, whether with or without cause, only by the holders of record of a majority of the shares of Series B Preferred Stock then outstanding; and each Common Director who shall have been elected as provided in this Section 15 may be removed during his term of office, whether with or without cause, only by the holders of record of a majority of the shares of Common Stock and Series A Preferred Stock then outstanding (on an as-converted basis).

 

(f)                                   A vacancy in any directorship (whether as a result of death, permanent disability, resignation (other than a Subsection (c) Resignation) or removal) elected by the holders of shares of Series H Preferred Stock shall be filled only by vote or written consent of the holders of shares of Series H Preferred Stock in the manner set forth in this Section 15.  A vacancy in the directorship (whether as a result of death, permanent disability, resignation or removal) elected by the holders of shares of Series D Preferred Stock shall be filled only by vote or written consent of holders of shares of Series D Preferred Stock in the manner set forth in this Section 15.  A vacancy in any directorship (whether as a result of death, permanent disability, resignation (other than a Subsection (c) Resignation) or removal) elected by the holders of shares of Series B Preferred Stock shall be filled only by vote or written consent of the holders of shares of Series B Preferred Stock in the manner set forth in this Section 15.  A vacancy in any directorship (whether as a result of death, permanent disability, resignation (including as a result of a Subsection (c) Resignation) or removal) elected by the holders of record of shares of Common Stock and Series A Preferred Stock shall be filled by the remaining Common Directors then in office or, if there is none, then by vote or written consent of the holders of record of shares of Common Stock and Series A Preferred Stock, in the manner set forth in this Section 15.

 

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(g)                                  Each Series H Director, Series D Director, Series B Director and Common Director shall be entitled to one (1) vote.  Holders of the Series C Preferred Stock, holders of the Series E Preferred Stock, holders of the Series F Preferred Stock, holders of the Series G Preferred Stock, holders of the Series I Preferred Stock and holders of the Series J Preferred Stock are not entitled to vote for directors.

 

(h)                                 The Series B Investors, the Series D Investors and the Series J Investors shall each have the right to designate one person as an observer to the Board of Directors (the “Board Observers”).  The Board Observers shall be given the same notices regarding Board and committee meetings (or written consents or other Board actions), shall be given the same materials and shall be entitled to attend all Board meetings and any executive session thereof (but not to vote thereat) as if he/she were a director, subject to the execution of confidentiality agreements.  Notwithstanding the foregoing, the Corporation may withhold any information and exclude any such Board Observer from any portion of any meeting of its Board of Directors or any committee meeting thereof where access to any such information or attendance at any such portion of a meeting would (i) present a direct conflict of interest for such Board Observer, including, but not limited to, in connection with any license, manufacturing or other agreement with any Series J Investor or any Affiliate thereof, or (ii) expose him or her to competitively sensitive business information which, if known to an industry competitor, would reasonably be expected to adversely affect the business or prospects of the Corporation.

 

(i)                                     The Corporation shall provide to each director and Board Observer:

 

(i)                                     Quarterly progress reports on the Corporation’s scientific work;

 

(ii)                                  Reports, if any, from the Corporation’s Scientific Advisory Committee;

 

(iii)                               Copies of all material documents filed with government agencies (including the Internal Revenue Service, the Environmental Protection Agency and the Securities and Exchange Commission) within sixty (60) days after such filing; provided that routine filings, including, but not limited to, the filing of tax returns, will only be provided upon written request to the Corporation;

 

(iv)                              Pleadings in any material lawsuits filed by or against the Corporation;

 

(v)                                 Copies of any notice regarding material defaults of any material agreement to which the Corporation is a party within sixty (60) days of receipt of such notice by the Corporation;

 

(vi)                              Prompt notice of any material adverse change or effect on the operations or financial position of the Corporation; and

 

(vii)                           The Corporation’s annual operating plan and budget, including monthly projections, at least thirty (30) days before the beginning of each fiscal year of the Corporation.

 

32

 

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33

 

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STOCKHOLDERS’ AGREEMENT

 

IN WITNESS WHEREOF, the undersigned parties representing the Series I Investors, the Series J Investors and the Stockholders holding at least (a) a majority of the shares of Series A Preferred Stock subject to this Agreement, (b) 66.67% of the shares of Series B Preferred Stock subject to this Agreement, (c) 66.67% of the shares of Series C Preferred Stock, (d) 66.67% of the shares of Series D Preferred Stock, (e) 66.67% of the shares of Series E Preferred Stock, (f) 66.67% of the shares of Series F Preferred Stock, (g) 66.67% of the shares of Series G Preferred Stock, (h) 66.67% of the shares of Series H Preferred Stock  and (i) a majority of the shares of Common Stock subject to this Agreement, have caused this Agreement to be duly executed on their behalf as of the day first above written.

 

	
 
    	
ONCONOVA   THERAPEUTICS, INC.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
         /s/   Ramesh Kumar
    
	
 
    	
 
    	
Name:
    	
Ramesh   Kumar, Ph.D.
    
	
 
    	
 
    	
Title:
    	
President
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   F, G and H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
2007   Health, LLC
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Eric Aroesty
    
	
 
    	
 
    	
Name:   Eric Aroesty
    
	
 
    	
 
    	
Title:   Manager
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   C, D, E, F, G, H and I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
21st Century, L.L.C.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   J. Christopher Bumgarner
    
	
 
    	
 
    	
Name:   J. Christopher Bumgarner
    
	
 
    	
 
    	
Title:   Manager
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Anandh R. Haridh
    
	
 
    	
Anandh   R. Haridh
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Muthu Krishnan
    
	
 
    	
Muthu   Krishnan
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Kalyan Narayanan
    
	
 
    	
Kalyan   Narayanan
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
Baker   NYE, LP
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Richard Nye
    
	
 
    	
Name:
    	
Richard   Nye
    
	
 
    	
Title:   
    	
Managing   G.P.
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Bala Shiva Prasad
    
	
 
    	
Bala   Shiva Prasad
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   J CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
BAXTER   HEALTHCARE SA
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Benedikt Kubik
    
	
 
    	
 
    	
Name:   Benedikt Kubik
    
	
 
    	
 
    	
Title:   Finance Director
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Sarah Byrne-Quinn
    
	
 
    	
 
    	
Name:   Sarah Byrne-Quinn
    
	
 
    	
 
    	
Title:   VP Business Development & Strategy
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Bhoopal Reddy Benjaram
    
	
 
    	
Bhoopal   Reddy Benjaram
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   E, F, G, H and I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Brian T. Bristol
    
	
 
    	
Brian   T. Bristol
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Susannah B. Bristol
    
	
 
    	
Susannah   B. Bristol
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   B and C CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
Cadila   Healthcare Limited
    
	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
By:
    	
/s/   Pankaj R. Patel
    
	
 
    	
 
    	
Name:   Pankaj R. Patel
    
	
 
    	
 
    	
Title:   Chairman and Mg. Director
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   E, F and H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Carol Lili Lynton
    
	
 
    	
Carol   Lili Lynton
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   A CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Catherine G. Fine
    
	
 
    	
Catherine   G. Fine, Ph.D.
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Chepyala Anuradha
    
	
 
    	
Chepyala   Anuradha
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Anurag Gard
    
	
 
    	
Choral   Technologies Pvt. Ltd
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   F and H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Christopher Wilson
    
	
 
    	
Christopher   Wilson
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   D, E, F, G, H and I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
Coneway   Investment Partners, L.P.
    
	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
By:
    	
/s/   Peter Coneway
    
	
 
    	
 
    	
Name:   Peter Coneway
    
	
 
    	
 
    	
Title:   General Partner
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   F CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Daniel Motulsky
    
	
 
    	
Daniel   Motulsky
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   David Ward
    
	
 
    	
David   Ward
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   B CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
Delta   Partners
    
	
 
    	
 
    
	
 
    	
By:   
    	
Delta   Partners MS, LLP
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
 
    	
By:   
    	
JBS   Managers, LLC
    
	
 
    	
 
    	
Title:   
    	
Managing   Partner
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
By:   
    	
/s/   James Thomas
    
	
 
    	
 
    	
Name:   
    	
James   Thomas
    
	
 
    	
 
    	
Title:   
    	
Member
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Diwakar Reddy Onteddu
    
	
 
    	
Diwakar   Reddy Onteddu
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   D.L. Subhardramma
    
	
 
    	
D.   L. Subhadramma
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   D and E CONVERTIBLE PREFERRED STOCKHOLDER and COMMON STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Alan R. Williamson
    
	
 
    	
Dr. Alan   R. Williamson
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Ramalakshmi Marri
    
	
 
    	
Dr. Ramalakshmi   Marri
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G and H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Drew Katz
    
	
 
    	
Drew   Katz
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   A, B, C, D, E, F, G, H and I CONVERTIBLE PREFERRED STOCKHOLDER and COMMON   STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   E. Premkumar Reddy
    
	
 
    	
E.   Premkumar Reddy, Ph.D.
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Ellen F. McLean
    
	
 
    	
Ellen   F. McLean
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   B, D and F CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Ernest H. Pomerantz
    
	
 
    	
Ernest   H. Pomerantz
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   E and G CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/ Estate of Stanley C. Bell, Ph.D, by Janice W. Bell, Executrix
    
	
 
    	
Estate   of Stanley C. Bell, Ph.D., by Janice W. Bell, Executrix
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   G. Yeshwanth Reddy
    
	
 
    	
G.   Yeshwanth Reddy
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Geoffrey G. Jones
    
	
 
    	
Geoffrey   G. Jones
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   B CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
Gerlach &   Co.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Keith Whyte
    
	
 
    	
 
    	
Name:  Keith Whyte
    
	
 
    	
 
    	
Title:   A-VP
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   F CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Gregory A. Beard
    
	
 
    	
Gregory   A. Beard
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H and I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Gulab Shrimal
    
	
 
    	
Gulab   Shrimal
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Gulab Shrimal
    
	
 
    	
Gulab   Shrimal
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Prashant Shrimal
    
	
 
    	
Prashant   Shrimal
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Hanimi Reddy Mettu
    
	
 
    	
Hanimi   Reddy Mettu
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   M. Satyavathy
    
	
 
    	
Satyavathy   Mettu
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Hanumanth K. Reddy
    
	
 
    	
Hanumanth   K. Reddy
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Geetha Reddy
    
	
 
    	
Geetha   R. Komatireddy
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
HANUMANTH &   GEETHA KOMATIREDDY
    
	
 
    	
TRUST
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Geetha Reddy
    
	
 
    	
 
    	
Name:   Geetha Komatireddy
    
	
 
    	
 
    	
Title:   Member
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Henry S. Bienen
    
	
 
    	
Henry   S. Bienen
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   B and F CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
ICMC   Strategic Asset Fund, Ltd.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Ralph Heffelman
    
	
 
    	
 
    	
Name:   Ralph Heffelman
    
	
 
    	
 
    	
Title:   President ICMC, ICMC General Partner
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   D, E and F CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
I-Ven   Biotech Ltd.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   T.S. Suresh
    
	
 
    	
 
    	
Name:   T.S. Suresh
    
	
 
    	
 
    	
Title:   Director
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G and H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   James R. Jones
    
	
 
    	
James   R. Jones
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Olivia Barclay Jones
    
	
 
    	
Olivia   Barclay Jones
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
COMMON   STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Janice W. Bell
    
	
 
    	
Janice   W. Bell
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Jeffrey Halis
    
	
 
    	
Jeffrey   Halis
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   A, C, F, G and H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Joel A. Fein
    
	
 
    	
Joel   A. Fein, M.D.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Victoria A. Levin
    
	
 
    	
Victoria   A. Levin
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   F CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   John Bertuzzi
    
	
 
    	
John   Bertuzzi
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   E CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   John French
    
	
 
    	
John   French
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   John Kunze
    
	
 
    	
John   Kunze
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   F and H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   John Motulsky
    
	
 
    	
John   Motulsky
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   A, B, D, E, F and H CONVERTIBLE PREFERRED STOCKHOLDER and COMMON STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   John R. Jenkins
    
	
 
    	
John   R. Jenkins, Ph.D.
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Jude A. Olinger
    
	
 
    	
Jude   A. Olinger
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Kalpana Onteddu
    
	
 
    	
Kalpana   Onteddu
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Kavitha Mandadi
    
	
 
    	
Kavitha   Mandadi
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   John Stayapaul Gunja
    
	
 
    	
John   Stayapaul Gunja
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Kiran Kalakata
    
	
 
    	
Kiran   Kalakata
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Aishwarya Ganapa
    
	
 
    	
Aishwarya   Ganapa
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   E and G CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Lee H. Carson
    
	
 
    	
Lee   H. Carson
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
COMMON   STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
M.V.   Ramana Reddy
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   M.V. Ramana Reddy
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Madhava R. Marri
    
	
 
    	
Madhava   R. Marri
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Jeffrey Choppin
    
	
 
    	
Jeffrey   Choppin
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Madhava R. Marri
    
	
 
    	
Madhava   R. Marri
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Sarala R. Marri
    
	
 
    	
Sarala   R. Marri
    

 

 

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SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Marlene Hess
    
	
 
    	
Marlene   Hess
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   D CONVERTIBLE PREFERRED STOCKHOLDER and COMMON STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Marvin L. Miller
    
	
 
    	
Marvin   L. Miller
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   F CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
Michael   and Jane Hoffman 2012 Descendants Trust
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Michael B. Hoffman
    
	
 
    	
 
    	
Name:   Michael B. Hoffman
    
	
 
    	
 
    	
Title:
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G and H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
MOHAN   KOKA, TRUSTEE OF THE MOHAN KOKA REVOCABLE TRUST AND SAYEE KOKA, TRUSTEE OF   THE SAYEE KOKA REVOCABLE TRUST, AS EQUAL TENANTS IN COMMON
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Mohan Koka
    
	
 
    	
 
    	
Mohan   Koka
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Sayee Koka
    
	
 
    	
 
    	
Sayee   Koka
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G, H and I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Mohan Krishna Reddy Aryabumi
    
	
 
    	
Mohan   Krishna Reddy Aryabumi
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   F CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   N. John Lancaster
    
	
 
    	
N.   John Lancaster
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   D, E, F, G and H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
Naftali   Investments Ltd.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Meir Hadar
    
	
 
    	
 
    	
Name:   Meir Hadar
    
	
 
    	
 
    	
Title:   President & CEO
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G, H and I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Nathaniel A. Bristol
    
	
 
    	
Nathaniel   A. Bristol
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   F CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Neil Weiss
    
	
 
    	
Neil   Weiss
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   F CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
New   Cavendish Finance Corporation
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Marcio Fainziliber
    
	
 
    	
 
    	
Name:   Marcio Fainziliber
    
	
 
    	
 
    	
Title:   Attorney-in-fact
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Nirmala Onteddu
    
	
 
    	
Nirmala   Onteddu
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Ramakrishna Reddy Pulimamidi
    
	
 
    	
Ramakrishna   Reddy Pulimamidi
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Prabhat Kumar
    
	
 
    	
Prabhat   Kumar
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Shirly Dsilva
    
	
 
    	
Shirly   Dsilva
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   F, H and I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
Quod   Erat Demonstrandum (QED) Limited
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   N.R. Landor
    
	
 
    	
 
    	
Name:   N.R. Landor
    
	
 
    	
 
    	
Title:   Director for Consortia Directors Limited
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Radha Reddy Gurram
    
	
 
    	
Radha   Reddy Gurram
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Rajender Benjaram
    
	
 
    	
Rajender   Benjaram
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Ramakrishna Reddy Pulimamidi
    
	
 
    	
Ramakrishna   Reddy Pulimamidi
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Nirmala Onteddu
    
	
 
    	
Nirmala   Onteddu
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Ramakrishna Reddy Pulimamidi
    
	
 
    	
Ramakrishna   Reddy Pulimamidi
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   A, B, C, D, E, F, G, H and I CONVERTIBLE PREFERRED STOCKHOLDER and COMMON   STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Ramesh Kumar
    
	
 
    	
Ramesh   Kumar, Ph.D.
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G and H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Robert Hotz
    
	
 
    	
Robert   Hotz
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   F, G, H and I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Robert S. Mancini
    
	
 
    	
Robert   S. Mancini
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   F, H and I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
Robert   T. Clutterbuck, Trustee, Robert T. Clutterbuck Trust Dtd 11/07/1994
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Robert T. Clutterbuck
    
	
 
    	
 
    	
Name:
    
	
 
    	
 
    	
Title:
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   B, C, E and F CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
Rocky   Way Partners, L.P.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
 /s/ David S. Steiner
    
	
 
    	
 
    	
Name:   David S. Steiner
    
	
 
    	
 
    	
Title:   General Partner
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   B and C CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Roy M. Ambinder
    
	
 
    	
Roy   M. Ambinder, M.D.
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
/s/   Rupinder Singh Gill
    
	
 
    	
Rupinder   Singh Gill
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Rupinder Gill
    
	
 
    	
Rupinder   Gill
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Raminder Gill
    
	
 
    	
Raminder   Gill
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G and H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Sanford A. Bristol
    
	
 
    	
Sanford   A. Bristol
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Saroja Koppala
    
	
 
    	
Saroja   Koppala
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   K. Sudhir Reddy
    
	
 
    	
K.   Sudhir Reddy
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Sasanka Reddy Sirigireddy
    
	
 
    	
Sasanka   Reddy Sirigireddy
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Satish Kumar Thulla
    
	
 
    	
Satish   Kumar Thulla
    

 

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   D, E, F and G CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
Select   Equity Advisory Services Pvt. Ltd.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
 /s/ Arjun Sharma
    
	
 
    	
 
    	
Name:   Arjun Sharma
    
	
 
    	
 
    	
Title:   Director
    

 

 

SIGNATURE PAGE TO EIGHTH AMENDED AND RESTATED

STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   D, E, F and G CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
Select   Synergies and Services Pvt. Ltd.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
 /s/ Arjun Sharma
    
	
 
    	
 
    	
Name:   Arjun Sharma
    
	
 
    	
 
    	
Title:   Authorized Signatory
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Shravan K. Mettu
    
	
 
    	
Shravan   K. Mettu
    
	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
/s/   Varun Radhakrishnan
    
	
 
    	
Varun   Radhakrishnan
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   F and I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
SLATER   CAPITAL I, LLC
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Steven L. Martin
    
	
 
    	
 
    	
Name:   Steven L. Martin
    
	
 
    	
 
    	
Title:   Managing Member
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Vijay Bhasker Reddy Lachagari
    
	
 
    	
Vijay   Bhasker Reddy Lachagari
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Raji Reddy Nalla
    
	
 
    	
Raji   Reddy Nalla
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Thomas S. Riggs
    
	
 
    	
Thomas   S. Riggs
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G and H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Sreedevi Avuku
    
	
 
    	
Sreedevi   Avuku
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Venkata Vijaya Kumar Reddy Avuku
    
	
 
    	
Venkata   Vijaya Kumar Reddy Avuku
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   D, E, F and G CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
Starec   Trust
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
 /s/ Michael Recanati
    
	
 
    	
 
    	
Name:   Michael Recanati
    
	
 
    	
 
    	
Title:   Trustee
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   E, F and I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Stephen J. Schaefer
    
	
 
    	
Stephen   J. Schaefer
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   E, G and H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Stephen T. Kelly
    
	
 
    	
Stephen   T. Kelly
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   F CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
Steven   J. Hefter Trustee of the Steven J. Hefter Trust
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Steven J. Hefter
    
	
 
    	
 
    	
Name:
    
	
 
    	
 
    	
Title:
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
/s/   Steven L. Martin
    
	
 
    	
Steven   L. Martin
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
Sylvia   Steiner 1999 Trust
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   David S. Steiner
    
	
 
    	
 
    	
Name:   David S. Steiner
    
	
 
    	
 
    	
Title:   Trustee
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H and I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
The   Beutner Family 2001 Long-Term Trust
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Austin M. Beutner
    
	
 
    	
 
    	
Name:   Austin M. Beutner
    
	
 
    	
 
    	
Title:
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Steven L. Martin
    
	
 
    	
 
    	
Name:   Steven L. Martin
    
	
 
    	
 
    	
Title:   Trustee
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   B, C, D, E, F, G, H and I CONVERTIBLE PREFERRED STOCKHOLDER and COMMON   STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
The   Jane & Michael B. Hoffman 1998 Trust For Issue
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Jane S. Hoffman
    
	
 
    	
 
    	
Name:   Jane S. Hoffman
    
	
 
    	
 
    	
Title:   Trustee
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
The   Michael Recanati Trust
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Michael Recanati
    
	
 
    	
 
    	
Name:   Michael Recanati
    
	
 
    	
 
    	
Title:   Trustee
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   C, E and F CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
The   Testa Family Limited Partnership
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Robert Testa
    
	
 
    	
 
    	
Name:   Robert Testa
    
	
 
    	
 
    	
Title:   General Partner
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
Thunderhill   Associates, LLC
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Paul B. Guenther
    
	
 
    	
 
    	
Name:   Paul B. Guenther
    
	
 
    	
 
    	
Title:   Managing Member
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   B, C, D, E, F, G, H and I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
/s/   Timothy G. Lalonde
    
	
 
    	
Timothy   G. Lalonde
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G and I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
TRUST   UNDER DEED OF WILLIAM M. BRISTOL III AS AMENDED AND RESTATED ON AUGUST 16,   2003
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Mary Jayne Comey
    
	
 
    	
 
    	
Name:   Mary Jayne Comey
    
	
 
    	
 
    	
Title:
    

 

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
/s/   Tulla Kishore
    
	
 
    	
Tulla   Kishore
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
/s/   Raghavendra Goud Vaggu
    
	
 
    	
Raghavendra   Goud Vaggu
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
/s/   Utkarsh Palnitkar
    
	
 
    	
Utkarsh   Palnitkar
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
VenturEast   Life Fund III LLC
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Akshar Maherally
    
	
 
    	
 
    	
Name:   Akshar Maherally
    
	
 
    	
 
    	
Title:   Director
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G and H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
Vieco   3 Limited
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Alison Renouf
    
	
 
    	
 
    	
Name:   Alison Renouf
    
	
 
    	
 
    	
Title:   Director
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   G and H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
/s/   Vijay Kumar Reddy Bondugula
    
	
 
    	
Vijay   Kumar Reddy Bondugula
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   B, C and D CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
Viram Foundation
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/ Amita Rodman Mehta
    
	
 
    	
 
    	
Name: Amita Rodman Mehta
    
	
 
    	
 
    	
Title: Trustee
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   F and H CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
/s/   Wayne J.D. Teetsel
    
	
 
    	
Wayne   J.D. Teetsel
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   F CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
/s/   Wesley R. Edens
    
	
 
    	
Wesley   R. Edens
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    
	
 
    	
Wyandanch   Partners, L.P.,
    
	
 
    	
By:   Gollust Management Inc., its General Partner
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
 
    	
By:
    	
/s/   Keith R. Gollust
    
	
 
    	
 
    	
 
    	
Name:   Keith R. Gollust
    
	
 
    	
 
    	
 
    	
Title:   President
    

 

 

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STOCKHOLDERS’ AGREEMENT

 

	
 
    	
SERIES   I CONVERTIBLE PREFERRED STOCKHOLDER:
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
/s/   Yarlagadda Manoj Kumar
    
	
 
    	
Yarlagadda   Manoj Kumar
    

 

 

CONSENT OF SPOUSE TO EIGHTH AMENDED AND RESTATED STOCKHOLDERS’ AGREEMENT

 

CONSENT OF SPOUSE

 

I,                                           , spouse of                                           , acknowledge that I have read the Eighth Amended and Restated Stockholders’ Agreement, dated as of July 27, 2012, by and among Onconova Therapeutics, Inc. (the “Corporation”) and the stockholders signatory thereto (as may be amended from time to time, the “Agreement”), which is attached as Exhibit A hereto, and that I know the contents of the Agreement.  I am aware that the Agreement contains provisions regarding the voting and transfer of shares of capital stock of the Corporation that my spouse may own, including any interest I might have therein.

 

I hereby agree that my interest, if any, in any shares of capital stock of the Corporation subject to the Agreement shall be irrevocably bound by the Agreement and further understand and agree that any community property interest I may have in such shares of capital stock of the Corporation shall be similarly bound by the Agreement.

 

I am aware that the legal, financial and related matters contained in the Agreement are complex and that I am free to seek independent professional guidance or counsel with respect to this Consent.  I have either sought such guidance or counsel or determined after reviewing the Agreement carefully that I will waive such right.

 

 

	
Dated:
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
[Name]
    

 

 

JOINDER AGREEMENT

 

Joinder Agreement

 

The undersigned, the holder of                  shares of [Series      ] Convertible Preferred Stock, par value $.01 per share, of Onconova Therapeutics, Inc., a Delaware corporation (the “Corporation”), hereby agrees with the Corporation that it is hereby a party to the Eighth Amended and Restated Stockholders’ Agreement, dated as of July 27, 2012, by and among the Corporation and the stockholders signatory thereto (as may be amended from time to time, the “Stockholders’ Agreement”) and it is bound by the obligations therein imposed upon, and entitled to the benefits therein of, a [“Series A Investor”,] [a “Series B Investor”,] [a “Series C Investor”,] [a “Series D Investor”,] [a “Series E Investor”,] [a “Series F Investor”,] [a “Series G Investor”,] [a “Series H Investor”,] [a “Series I Investor”], an “Investor” and a “Stockholder,” with the same effect as if it had executed the Stockholders’ Agreement on the original date thereof.

 

 

	
Dated   as of                       ,   20
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
 
    
	
 
    	
 
    	
Name:
    
	
 
    	
 
    	
Title:
    

 

 

EXHIBIT A TO CONSENT OF SPOUSE

 

Exhibit A

 

Eighth Amended and Restated Stockholders’ Agreement

 

 

 

JOINDER AGREEMENT

 

THIS AGREEMENT, dated as of December 21, 2012, is made by Onconova Therapeutics, Inc., a Delaware corporation (the “Company”), and Citco Global Custody (NA) NV ref Altair Stars LP (together, “Transferee”).  Capitalized terms used but not defined herein shall have the same meanings assigned to them in that certain Eighth Amended and Restated Stockholders’ Agreement, as the same may be amended from time to time, dated as of July 27, 2012, between the Company and the other stockholders named therein (the “Stockholders’ Agreement”).

 

WHEREAS, Citco Global Custody (NA) NV ref Altair Stars Fund Ltd. (“Transferor”) is the holder of 3,379 shares of the Company’s Series B Convertible Preferred Stock, par value $.01 per share (the “Series B Stock”);

 

WHEREAS, Transferor desires to transfer to Transferee without consideration 3,379 shares of the Series B Stock;

 

WHEREAS, Transferor has determined that Transferee is a Permitted Transferee as defined in Section 3(e)(i) of the Stockholders’ Agreement; and

 

WHEREAS, Transferee desires to become bound by the obligations imposed by, and entitled to the benefits under, the Stockholders’ Agreement.

 

NOW THEREFORE, for good and valuable consideration, Transferor hereby conveys and assigns to Transferee as of the date hereof all of its right, title and interest, free and clear of all liens, claims, and encumbrances in the Series B Stock, except as provided for in the Stockholders’ Agreement.  Transferee hereby agrees with the Company that, by signing this Joinder Agreement, it is hereby a party to the Stockholders’ Agreement and it is bound by the obligations therein imposed upon, and entitled to the benefits therein of, a “Series B Investor”, an 

 

 

“Investor” and a “Stockholder,” with the same effect as if it had executed the Stockholders’ Agreement on the original date thereof.

 

[The rest of this page intentionally left blank.]

 

 

[SIGNATURE PAGE TO JOINDER AGREEMENT]

 

Please indicate your acceptance of the foregoing by signing and returning the enclosed counterpart of this Joinder Agreement, whereupon the Stockholders’ Agreement shall be a binding agreement between the Company and you.

 

 

	
 
    	
ONCONOVA   THERAPEUTICS, INC.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Ramesh Kumar
    
	
 
    	
 
    	
Ramesh   Kumar, Ph.D.
    
	
 
    	
 
    	
President
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
CITCO   GLOBAL CUSTODY (NA) NV REF ALTAIR STARS LP
    
	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Ray Creedon
    
	
 
    	
 
    	
Name:   Ray Creedon
    
	
 
    	
 
    	
Title:   Authorized Signatory
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Cristina Silva
    
	
 
    	
 
    	
Name:   Cristina Silva
    
	
 
    	
 
    	
Title:   Authorized Signatory
    

 

 

AGREED TO AND ACCEPTED as of the date first above written.

 

	
 
    	
CITCO   GLOBAL CUSTODY (NA) NV REF ALTAIR STARS FUND LTD.
    
	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Ray Creedon
    
	
 
    	
 
    	
Name:   Ray Creedon
    
	
 
    	
 
    	
Title:   Authorized Signatory
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Cristina Silva
    
	
 
    	
 
    	
Name:   Cristina Silva
    
	
 
    	
 
    	
Title:   Authorized Signatory
    

 

 

JOINDER AGREEMENT

 

THIS AGREEMENT, dated as of February 28, 2013, is made by Onconova Therapeutics, Inc., a Delaware corporation (the “Company”), and The Michael and Jane Hoffman 2013 Descendants Trust (“Transferee”).  Capitalized terms used but not defined herein shall have the same meanings assigned to them in that certain Eighth Amended and Restated Stockholders’ Agreement, as the same may be amended from time to time, dated as of July 27, 2012, between the Company and the other stockholders named therein (the “Stockholders’ Agreement”).

 

WHEREAS, The Jane & Michael B. Hoffman 1998 Trust for Issue (“Transferor”) is the holder of those shares of the Company’s capital stock listed on Schedule A attached hereto (collectively, the “Stock”);

 

WHEREAS, Transferor desires to transfer to Transferee, without consideration, the Stock;

 

WHEREAS, Transferor has determined that Transferee is a Permitted Transferee as defined in Section 3(e)(i) of the Stockholders’ Agreement; and

 

WHEREAS, Transferee desires to become bound by the obligations imposed by, and entitled to the benefits under, the Stockholders’ Agreement.

 

NOW THEREFORE, for good and valuable consideration, Transferor hereby conveys, transfers and assigns to the Transferee as of the date hereof all of its right, title and interest, free and clear of all liens, claims, and encumbrances in the Stock, except as provided for in the Stockholders’ Agreement.  The Transferee hereby agrees with the Company that, by signing this Joinder Agreement, it is hereby a party to the Stockholders’ Agreement and it is bound by the obligations therein imposed upon, and entitled to the benefits therein of, a 

 

 

“Common Stockholder”, a “Series B Investor”, a “Series C Investor”, a “Series D Investor”, a “Series E Investor”, a “Series F Investor”, a “Series G Investor”, a “Series H Investor”, a “Series I Investor”, an “Investor” and a “Stockholder,” with the same effect as if it had executed the Stockholders’ Agreement on the original date thereof.

 

 

[SIGNATURE PAGE TO JOINDER AGREEMENT]

 

Please indicate your acceptance of the foregoing by signing and returning the enclosed counterpart of this Joinder Agreement, whereupon the Stockholders’ Agreement shall be a binding agreement between the Company and you.

 

 

	
 
    	
ONCONOVA   THERAPEUTICS, INC.
    
	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Ramesh Kumar
    
	
 
    	
 
    	
Ramesh   Kumar, Ph.D.
    
	
 
    	
 
    	
President
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
THE   MICHAEL AND JANE HOFFMAN 2013 DESCENDANTS TRUST
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Jane Hoffman
    
	
 
    	
Name:   Jane Hoffman
    
	
 
    	
Title:   Trustee
    

 

 

[SIGNATURE PAGE TO JOINDER AGREEMENT]

 

AGREED TO AND ACCEPTED as of the date first above written.

 

 

	
 
    	
THE   JANE & MICHAEL B. HOFFMAN 1998 TRUST FOR ISSUE
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Jane Hoffman
    
	
 
    	
Name:   Jane Hoffman
    
	
 
    	
Title:   Trustee
    

 

 

[SIGNATURE PAGE TO JOINDER AGREEMENT]

 

Schedule A

 

	
DATE
   BECAME
   OWNER
   OF
   RECORD
    	
 
    	
CERT.
   NO.
    	
 
    	
CLASS
   OR
   SERIES
   OF
   SHARES
    	
 
    	
NO. OF
   SHARES
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
12/27/06
    	
 
    	
19
    	
 
    	
Common
    	
 
    	
322,765
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
6/23/10
    	
 
    	
40
    	
 
    	
Common
    	
 
    	
128,204
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
9/24/12
    	
 
    	
57
    	
 
    	
Common
    	
 
    	
12,500
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
12/31/12
    	
 
    	
85
    	
 
    	
Common
    	
 
    	
395,863
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
11/14/00
    	
 
    	
BCP5
    	
 
    	
Series B
    	
 
    	
43,478
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
12/11/06
    	
 
    	
BCP68
    	
 
    	
Series B
    	
 
    	
2,855
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
12/11/06
    	
 
    	
BCP69
    	
 
    	
Series B
    	
 
    	
1,162
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
12/11/06
    	
 
    	
BCP70
    	
 
    	
Series B
    	
 
    	
1,855
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
12/5/11
    	
 
    	
BCP93
    	
 
    	
Series B
    	
 
    	
50,000
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
12/27/02
    	
 
    	
CP1
    	
 
    	
Series C
    	
 
    	
140,449
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
3/19/04
    	
 
    	
DP4
    	
 
    	
Series D
    	
 
    	
141,396
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
7/15/04
    	
 
    	
DP15
    	
 
    	
Series D
    	
 
    	
214,132
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
3/18/05
    	
 
    	
EP2
    	
 
    	
Series E
    	
 
    	
102,460
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
12/1/05
    	
 
    	
EP28
    	
 
    	
Series E
    	
 
    	
204,919
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10/31/06
    	
 
    	
EP52
    	
 
    	
Series E
    	
 
    	
10,246
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
9/26/11
    	
 
    	
EP55
    	
 
    	
Series E
    	
 
    	
317,000
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
8/30/07
    	
 
    	
FP50
    	
 
    	
Series F
    	
 
    	
39,062
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
2/22/12
    	
 
    	
FP67
    	
 
    	
Series F
    	
 
    	
72,165
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
5/12/09
    	
 
    	
G14
    	
 
    	
Series G
    	
 
    	
102,145
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10/5/11
    	
 
    	
G91
    	
 
    	
Series G
    	
 
    	
51,072
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10/28/11
    	
 
    	
G92
    	
 
    	
Series G
    	
 
    	
76,608
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
9/21/10
    	
 
    	
H27
    	
 
    	
Series H
    	
 
    	
199,144
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
6/6/11
    	
 
    	
H85
    	
 
    	
Series H
    	
 
    	
102,146
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
7/25/12
    	
 
    	
I3
    	
 
    	
Series I
    	
 
    	
1,635,514
    

 

 

JOINDER AGREEMENT

 

THIS AGREEMENT, dated as of December 17, 2012, is made by Onconova Therapeutics, Inc., a Delaware corporation (the “Company”), Ramesh Kumar, Ph.D. (“Transferor”), and The Ramesh Kumar 2012 Trust (“Transferee”).  Capitalized terms used but not defined herein shall have the same meanings assigned to them in that certain Eighth Amended and Restated Stockholders’ Agreement, dated as of July 27, 2012, between the Company and the other stockholders named therein, as the same may be amended from time to time (the “Stockholders’ Agreement”).

 

WHEREAS, Transferor is the holder of 323,853 shares of the Company’s Common Stock, par value $.01 per share (“Transferor’s Shares”);

 

WHEREAS, Transferor desires to transfer to Transferee without consideration 200,000 shares of Transferor’s Shares (the “Shares”);

 

WHEREAS, Transferor has determined that Transferee is a Permitted Transferee as defined in Section 3(e)(ii) of the Stockholders’ Agreement and said transfer is an Excluded Transfer as defined in Section 4(c)(i) of the Stockholders’ Agreement; and

 

WHEREAS, Transferee desires to become bound by the obligations imposed by, and entitled to the benefits under, the Stockholders’ Agreement.

 

NOW THEREFORE, for good and valuable consideration, Transferor hereby conveys and assigns to the Transferee, as of the date hereof, all of his rights, title and interest in the Shares, free and clear of all liens, claims, and encumbrances, except as provided for in the Stockholders’ Agreement.  The Transferee hereby agrees with the Company that, by signing this Joinder Agreement, it is hereby a party to the Stockholders’ Agreement and it is bound by the obligations therein imposed upon, and entitled to the benefits therein of, a “Founder” and a “Stockholder,” with the same effect as if it had executed the Stockholders’ Agreement on the original date thereof.

 

[The rest of this page intentionally left blank.]

 

 

[SIGNATURE PAGE TO JOINDER AGREEMENT]

 

IN WITNESS WHEREOF, the undersigned have executed this Joinder Agreement as of the date first above written.

 

	
 
    	
ONCONOVA   THERAPEUTICS, INC.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By: 
    	
/s/ Ramesh Kumar
    
	
 
    	
Name:   Ramesh Kumar, Ph.D.
    
	
 
    	
Title:   President
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
TRANSFEROR:
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
/s/ Ramesh Kumar
    
	
 
    	
Ramesh Kumar, Ph.D.
    

 

 

[SIGNATURE PAGE TO JOINDER AGREEMENT]

 

Please indicate your acceptance of the foregoing by signing and returning the enclosed counterpart of this Joinder Agreement, whereupon the Stockholders’ Agreement shall be a binding agreement between the Company and you.

 

AGREED TO AND ACCEPTED as of the date first above written.

 

 

	
 
    	
TRANSFEREE:
    
	
 
    	
 
    
	
 
    	
THE   RAMESH KUMAR 2012 TRUST
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Ramesh Kumar
    
	
 
    	
Name:   Ramesh Kumar, Ph.D.
    
	
 
    	
Title:   Trustee
    

 

 

JOINDER AGREEMENT

 

THIS AGREEMENT, dated as of December 28, 2012, is made by Onconova Therapeutics, Inc., a Delaware corporation (the “Company”) and Thomas F. Diorio and Citicorp Trust, N.A., as trustees of the Mancini Family 2012 Trust (“Transferee”).  Capitalized terms used but not defined herein shall have the same meanings assigned to them in that certain Eighth Amended and Restated Stockholders’ Agreement, as the same may be amended from time to time, dated as of July 27, 2012, between the Company and the other stockholders named therein (the “Stockholders’ Agreement”).

 

WHEREAS, Robert S. Mancini (“Transferor”) is the holder of 22,727 shares of the Company’s Series F Convertible Preferred Stock, par value $.01 per share (the “Series F Stock”), 24,514 shares of the Company’s Series G Convertible Preferred Stock, par value $.01 per share (the “Series G Stock”), 10,215 shares of the Company’s Series H Convertible Preferred Stock, par value $.01 per share (the “Series H Stock”), and 9,109 shares of the Company’s Series I Convertible Preferred Stock, par value $.01 per share (the “Series I Stock”);

 

WHEREAS, Transferor desires to transfer to Transferee, without consideration, the Series F Stock, the Series G Stock, the Series H Stock, and the Series I Stock;

 

WHEREAS, Transferor has determined that Transferee is a Permitted Transferee as defined in Section 3(e)(ii) of the Stockholders’ Agreement; and

 

WHEREAS, Transferee desires to become bound by the obligations imposed by, and entitled to the benefits under, the Stockholders’ Agreement.

 

NOW THEREFORE, for good and valuable consideration, Transferor hereby conveys, transfers and assigns to the Transferee as of the date hereof all of its right, title and interest, free and clear of all liens, claims, and encumbrances in the Series F Stock, the Series G 

 

 

Stock, the Series H Stock, and the Series I Stock, except as provided for in the Stockholders’ Agreement.  The Transferee hereby agrees with the Company that, by signing this Joinder Agreement, it is hereby a party to the Stockholders’ Agreement and it is bound by the obligations therein imposed upon, and entitled to the benefits therein of, a “Series F Investor”, a “Series G Investor”, a “Series H Investor”, a “Series I Investor”, an “Investor” and a “Stockholder,” with the same effect as if it had executed the Stockholders’ Agreement on the original date thereof.

 

 

[SIGNATURE PAGE TO JOINDER AGREEMENT]

 

Please indicate your acceptance of the foregoing by signing and returning the enclosed counterpart of this Joinder Agreement, whereupon the Stockholders’ Agreement shall be a binding agreement between the Company and you.

 

 

	
 
    	
ONCONOVA   THERAPEUTICS, INC.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Ramesh Kumar
    
	
 
    	
 
    	
Ramesh   Kumar, Ph.D.
    
	
 
    	
 
    	
President
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
THE   MANCINI FAMILY 2012 TRUST
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Thomas F. Diorio
    
	
 
    	
 
    	
Name:   Thomas F. Diorio
    
	
 
    	
 
    	
Title:   Trustee
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
By:   Citicorp Trust, N. A., Trustee
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
 
    	
By:   
    	
/s/   Jane Monahan
    
	
 
    	
 
    	
 
    	
Name:   Jane Monahan
    
	
 
    	
 
    	
 
    	
Title:   Director and Senior Trust Officer
    

 

 

AGREED TO AND ACCEPTED as of the date first above written.

 

 

	
 
    	
/s/   Robert S. Mancini
    
	
 
    	
ROBERT   S. MANCINI
    

 

 

 

 

 

 

JOINDER AGREEMENT

 

THIS AGREEMENT, dated as of May 20, 2013, is made by Onconova Therapeutics, Inc., a Delaware corporation (the “Company”), and Monte F. Bourjaily, III Family Trust and Dr. Nicholas Babiak (together, “Transferees”).  Capitalized terms used but not defined herein shall have the same meanings assigned to them in that certain Eighth Amended and Restated Stockholders’ Agreement, as the same may be amended from time to time, dated as of July 27, 2012, between the Company and the other stockholders named therein (the “Stockholders’ Agreement”).

 

WHEREAS, Ritter & Bourjaily, Inc. (“Transferor”) is the holder of 6,260 shares of the Company’s Series B Convertible Preferred Stock, par value $.01 per share (the “Series B Stock”);

 

WHEREAS, Transferor desires to transfer for value to each Transferee 3,130 shares of the Series B Stock; and

 

WHEREAS, Transferees desire to become bound by the obligations imposed by, and entitled to the benefits under, the Stockholders’ Agreement.

 

NOW THEREFORE, for good and valuable consideration, Transferor hereby transfers, conveys and assigns to the Transferees as of the date hereof all of its right, title and interest, free and clear of all liens, claims, and encumbrances in the Series B Stock, except as provided for in the Stockholders’ Agreement.  Each Transferee hereby agrees with the Company that it is hereby a party to the Stockholders’ Agreement and it is bound by the obligations therein imposed upon, and entitled to the benefits therein of, a “Series B Investor”, an “Investor” and a “Stockholder,” with the same effect as if it had executed the Stockholders’ Agreement on the original date thereof.

 

 

[SIGNATURE PAGE TO JOINDER AGREEMENT]

 

Please indicate your acceptance of the foregoing by signing and returning the enclosed counterpart of this Joinder Agreement, whereupon the Stockholders’ Agreement shall be a binding agreement between the Company and you.

 

 

	
 
    	
ONCONOVA   THERAPEUTICS, INC.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Ramesh Kumar, Ph.D.
    
	
 
    	
 
    	
Ramesh   Kumar, Ph.D.
    
	
 
    	
 
    	
President
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
MONTE   F. BOURJAILY, III FAMILY TRUST
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Margaret Bourjaily
    
	
 
    	
 
    	
Name:
    	
Margaret   Bourjaily
    
	
 
    	
 
    	
Title:
    	
Trustee
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Dr. Nicholas Babiak
    
	
 
    	
Dr. Nicholas   Babiak
    

 

 

[SIGNATURE PAGE TO JOINDER AGREEMENT]

 

AGREED TO AND ACCEPTED as of the date first above written.

 

	
 
    	
RITTER &   BOURJAILY, INC.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Margaret Bourjaily
    
	
 
    	
 
    	
Name:
    	
Margaret   Bourjaily
    
	
 
    	
 
    	
Title:
    	
Vice   President
    

 

 

JOINDER AGREEMENT

 

THIS JOINDER AGREEMENT, dated as of January 1, 2013, is made by Onconova Therapeutics, Inc., a Delaware corporation (the “Company”), and Clay B. Lifflander and Alan L. Rivera (“Transferees”).  Capitalized terms used but not defined herein shall have the same meanings assigned to them in that certain Eighth Amended and Restated Stockholders’ Agreement, dated as of July 27, 2012, between the Company and the other stockholders named therein, as the same may be amended from time to time (the “Stockholders’ Agreement”).

 

WHEREAS, MMI Partners, L.L.C. (“Transferor”) is the holder of 43,478 shares of the Company’s Series B Convertible Preferred Stock, par value $.01 per share (the “Series B Stock”);

 

WHEREAS, Transferor desires to transfer to Transferees, without consideration, the Series B Stock as follows:  39,130 shares to Clay B. Lifflander and 4,348 shares to Alan L. Rivera;

 

WHEREAS, Transferor has determined that Transferees are Permitted Transferees as defined in Section 3(e)(i) of the Stockholders’ Agreement; and

 

WHEREAS, Transferees desire to become bound by the obligations imposed by, and entitled to the benefits under, the Stockholders’ Agreement.

 

NOW THEREFORE, for good and valuable consideration, Transferor hereby conveys, transfers and assigns to the Transferees as of the date hereof all of its right, title and interest, free and clear of all liens, claims, and encumbrances in the Series B Stock, except as provided for in the Stockholders’ Agreement.  The Transferees hereby agree with the Company that, by signing this Joinder Agreement, each is hereby a party to the Stockholders’ Agreement and each is bound by the obligations therein imposed upon, and entitled to the benefits therein of,

 

 

a “Series B Investor”, an “Investor” and a “Stockholder,” with the same effect as if each had executed the Stockholders’ Agreement on the original date thereof.

 

[The rest of this page intentionally left blank.]

 

 

[SIGNATURE PAGE TO JOINDER AGREEMENT]

 

Please indicate your acceptance of the foregoing by signing and returning the enclosed counterpart of this Joinder Agreement, whereupon the Stockholders’ Agreement shall be a binding agreement between the Company and you.

 

 

	
 
    	
ONCONOVA   THERAPEUTICS, INC.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Ramesh Kumar, Ph.D.
    
	
 
    	
 
    	
Ramesh   Kumar, Ph.D.
    
	
 
    	
 
    	
President
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Clay B. Lifflander
    
	
 
    	
Clay   B. Lifflander
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Alan L. Rivera
    
	
 
    	
Alan   L. Rivera
    

 

 

[SIGNATURE PAGE TO JOINDER AGREEMENT]

 

AGREED TO AND ACCEPTED as of the date first above written.

 

	
 
    	
MMI   PARTNERS, L.L.C.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Alan L. Rivera
    
	
 
    	
 
    	
Name:
    	
Alan   L. Rivera
    
	
 
    	
 
    	
Title:
    	
Vice   President
    

 

 

JOINDER AGREEMENT

 

THIS JOINDER AGREEMENT, dated as of March 19, 2013, is made by Onconova Therapeutics, Inc., a Delaware corporation (the “Company”), and Select Holiday Resorts Private Limited (“Transferee”).  Capitalized terms used but not defined herein shall have the same meanings assigned to them in that certain Eighth Amended and Restated Stockholders’ Agreement, dated as of July 27, 2012, between the Company and the other stockholders named therein, as the same may be amended from time to time (the “Stockholders’ Agreement”).

 

WHEREAS, Select Synergies & Services Pvt. Ltd. (“Transferor”) is the holder of (a) 160,599 shares of the Company’s Series D Convertible Preferred Stock, par value $.01 per share (the “Series D Stock”), (b) 17,076 shares of the Company’s Series E Convertible Preferred Stock, par value $.01 per share (the “Series E Stock”), (c) 43,854 shares of the Company’s Series F Convertible Preferred Stock, par value $.01 per share (the “Series F Stock”), and (d) 43,399 shares of the Company’s Series G Convertible Preferred Stock, par value $.01 per share (the “Series G Stock”);

 

WHEREAS, Transferor desires to transfer to Transferee, at cost, 80,300 shares of the Series D Stock, 8,538 shares of the Series E Stock, 21,927 shares of the Series F Stock, and 21,699 shares of the Series G Stock;

 

WHEREAS, Transferor has determined that Transferee is a Permitted Transferee as defined in Section 3(e)(i) of the Stockholders’ Agreement; and

 

WHEREAS, Transferee desires to become bound by the obligations imposed by, and entitled to the benefits under, the Stockholders’ Agreement.

 

 

NOW THEREFORE, for good and valuable consideration, Transferor hereby conveys, transfers and assigns to Transferee, as of the date hereof, all of its right, title and interest, free and clear of all liens, claims, and encumbrances in the Series D Stock, the Series E Stock, the Series F Stock, and the Series G Stock, except as provided for in the Stockholders’ Agreement.  The Transferee hereby agrees with the Company that, by signing this Joinder Agreement, it is hereby a party to the Stockholders’ Agreement and is bound by the obligations therein imposed upon, and entitled to the benefits therein of, a “Series D Investor”, a “Series E Investor” , a “Series F Investor”, a “Series G Investor”, an “Investor” and a “Stockholder,” with the same effect as if it had executed the Stockholders’ Agreement on the original date thereof.

 

[The rest of this page intentionally left blank.]

 

 

[SIGNATURE PAGE TO JOINDER AGREEMENT]

 

Please indicate your acceptance of the foregoing by signing and returning the enclosed counterpart of this Joinder Agreement, whereupon the Stockholders’ Agreement shall be a binding agreement between the Company and you.

 

 

	
 
    	
ONCONOVA   THERAPEUTICS, INC.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Ramesh Kumar, Ph.D.
    
	
 
    	
 
    	
Ramesh   Kumar, Ph.D.
    
	
 
    	
 
    	
President
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
SELECT   HOLIDAY RESORTS PRIVATE LIMITED
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Brijesh Saxena
    
	
 
    	
 
    	
Name:   Brijesh Saxena
    
	
 
    	
 
    	
Title:
    

 

 

[SIGNATURE PAGE TO JOINDER AGREEMENT]

 

AGREED TO AND ACCEPTED as of the date first above written.

 

	
 
    	
SELECT   SYNERGIES & SERVICES PVT. LTD.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Neeraj Ghei
    
	
 
    	
 
    	
Name:
    	
Neeraj   Ghei
    
	
 
    	
 
    	
Title:
    	
Director
    

 

 

JOINDER AGREEMENT

 

THIS JOINDER AGREEMENT, dated as of April 17, 2013, is made by Onconova Therapeutics, Inc., a Delaware corporation (the “Company”), and Peter A. Solomon 2010 Trust (“Transferee”).  Capitalized terms used but not defined herein shall have the same meanings assigned to them in that certain Eighth Amended and Restated Stockholders’ Agreement, dated as of July 27, 2012, between the Company and the other stockholders named therein, as the same may be amended from time to time (the “Stockholders’ Agreement”).

 

WHEREAS, Peter Solomon (“Transferor”) is the holder of Eight Hundred (800) shares of the Company’s Series F Convertible Preferred Stock, par value $.01 per share (the “Series F Stock”);

 

WHEREAS, Transferor desires to transfer to Transferee, without consideration, the Series F Stock;

 

WHEREAS, Transferor has determined that Transferee is a Permitted Transferee as defined in Section 3(e)(ii) of the Stockholders’ Agreement; and

 

WHEREAS, Transferee desires to become bound by the obligations imposed by, and entitled to the benefits under, the Stockholders’ Agreement.

 

NOW THEREFORE, for good and valuable consideration, Transferor hereby conveys, transfers and assigns to Transferee, as of the date hereof, all of its right, title and interest, free and clear of all liens, claims, and encumbrances in the Series F Stock, except as provided for in the Stockholders’ Agreement.  The Transferee hereby agrees with the Company that, by signing this Joinder Agreement, it is hereby a party to the Stockholders’ Agreement and is bound by the obligations therein imposed upon, and entitled to the benefits therein of, a

 

 

“Series F Investor”, an “Investor” and a “Stockholder,” with the same effect as if it had executed the Stockholders’ Agreement on the original date thereof.

 

[The rest of this page intentionally left blank.]

 

 

[SIGNATURE PAGE TO JOINDER AGREEMENT]

 

Please indicate your acceptance of the foregoing by signing and returning the enclosed counterpart of this Joinder Agreement, whereupon the Stockholders’ Agreement shall be a binding agreement between the Company and you.

 

 

	
 
    	
ONCONOVA   THERAPEUTICS, INC.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Ramesh Kumar, Ph.D.
    
	
 
    	
 
    	
Ramesh   Kumar, Ph.D.
    
	
 
    	
 
    	
President
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
PETER   A. SOLOMON 2010 TRUST
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Peter Solomon and /s/ Jamie Fanelli
    
	
 
    	
 
    	
Name:
    	
Peter   Solomon and Jamie Fanelli
    
	
 
    	
 
    	
Title:
    	
Trustees
    

 

 

[SIGNATURE PAGE TO JOINDER AGREEMENT]

 

AGREED TO AND ACCEPTED as of the date first above written.

 

 

	
 
    	
/s/   Peter Solomon
    
	
 
    	
Peter   SolomonExhibit 10.1

 

Execution Version

 

CONFIDENTIAL MATERIAL OMITTED AND FILED
 SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
 DOUBLE ASTERISKS DENOTE SUCH OMISSIONS.

 

DEVELOPMENT AND LICENSE AGREEMENT

 

This DEVELOPMENT AND LICENSE AGREEMENT (this “Agreement”) is entered into on this 19th day of September, 2012 (the “Effective Date”), by and between Onconova Therapeutics, Inc., a company organized under the laws of the State of Delaware with its principal place of business at 375 Pheasant Run, Newtown, PA 18490 (“Onconova”) and Baxter Healthcare SA, a company organized under the laws of the Switzerland with its principal place of business at Thurgauerstrasse 130 8152 Glattpark (Opfikon) Switzerland (“Baxter”).  Onconova and Baxter may each be referred to herein individually as a “Party” and collectively as the “Parties.”

 

RECITALS

 

WHEREAS, Onconova is developing a pharmaceutical product under the trademark Estybon® (also known as rigosertib or ON 01910.Na) for use in oncology, and owns or controls certain proprietary patents, technology, know-how and information relating to such product; and

 

WHEREAS, Baxter is engaged in the research, development and commercialization of pharmaceutical products, and desires to acquire an exclusive license in the Licensed Territory (as defined below) under Onconova’s patents, technology, know-how and other information relating to such product, and Onconova desires to grant such exclusive license, on the terms and conditions of this Agreement.

 

AGREEMENT

 

NOW, THEREFORE, in consideration of the mutual promises and covenants set forth below and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:

 

ARTICLE I.
 DEFINITIONS

 

The following terms as used in this Agreement shall have the meanings set forth in this Section (which meanings shall be applicable both to the singular and the plural forms of such terms):

 

1.1.                            “Additional Indication” has the meaning set forth in Section 4.3.1.

 

1.2.                            “Affiliate” means with respect to each Party, any Person that directly or indirectly is controlled by, controls or is under common control with a Party.  For the purposes of this definition only, the term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to a Person means (a) in the case of a corporate entity, direct or indirect ownership of voting securities entitled to cast at least fifty percent (50%) of the votes in the election of directors or (b) in the case of a non-corporate entity, direct or indirect ownership of at least fifty percent (50%) of

 

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the equity interests or (c) with respect to any Person, the power to direct the management and policies of such entity.

 

1.3.                            “Baxter Confidential Information” has the meaning set forth in Section 13.2.1(a).

 

1.4.                            “Baxter Improvements” has the meaning set forth in Section 10.1.3.1.

 

1.5.                            “Baxter Indemnitees” has the meaning set forth in Section 14.1.

 

1.6.                            “Baxter Know-How” means Information Controlled by Baxter or its Affiliates that is necessary for the development, manufacture, use, sale, offer for sale and/or importation of the Licensed Products in the Licensed Field.  Notwithstanding anything herein to the contrary, Baxter Know-How shall exclude Baxter Patents.

 

1.7.                            “Baxter Patents” means Patents Controlled by Baxter or its Affiliates that claim inventions necessary for the development, manufacture, use, sale, offer for sale and/or importation of Licensed Products within the Licensed Field, including without limitation Baxter’s interest in any Joint Patents.

 

1.8.                            “Baxter Trademarks” has the meaning set forth in Section 11.1.

 

1.9.                            “Big Five EU Countries” means **.

 

1.10.                     “Business Day” means a day other than Saturday, Sunday or other day on which commercial banks in New York, New York are authorized or required by Law to close.

 

1.11.                     “Clinical Trial” means a human clinical study conducted on sufficient numbers of human subjects that is designed to (a) establish that a pharmaceutical product is reasonably safe for continued testing; (b) investigate the safety and efficacy of the pharmaceutical product for its intended use, and to define warnings, precautions and adverse reactions that may be associated with the pharmaceutical product in the dosage range to be prescribed; or (c) support Marketing Approval of such pharmaceutical product or label expansion of such pharmaceutical product.

 

1.12.                     “Combination Product” means the Licensed Product that includes the Compound and at least one (1) additional therapeutically active pharmaceutical ingredient other than the Compound.  Except for those drug delivery vehicles, adjuvants or excipients that are recognized by the applicable Regulatory Authority as active ingredients, drug delivery vehicles, adjuvants, and excipients are hereby deemed not to be “therapeutically active pharmaceutical ingredients,” and their presence shall not be deemed to create a Combination Product for purposes of this Section 1.12.

 

1.13.                     “Commercial Failure” means (a) the failure of the Licensed Product to meet the specifications for the Licensed Product as set forth in Schedule 1.13(a) and/or the failure of the Licensed Product to meet other criteria for the Licensed Product identified in the Development Plan, including meeting clinical endpoints, in each case if such failure materially and adversely alters the ability to develop the Licensed Product as contemplated by the Development Plan or to commercialize the Licensed Product, (b) an issue involving safety, toxicity, efficacy, or pharmacokinetics of the Licensed Product that materially and

 

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adversely alters the development of the Licensed Product as contemplated by the Development Plan or commercialization of such Licensed Product, (c) determination by an independent expert that it is not technically feasible to scale up manufacturing for a Licensed Product to a production lot size that is consistent with what is required to continuously meeting the Licensed Territory demands for the applicable Licensed Product throughout the Term, (d) a regulatory requirement comes into effect after the Effective Date that would materially and adversely alter the development of a Licensed Product as contemplated by the Development Plan or commercialization of such Licensed Product or (e) the failure of Licensed Product to achieve at least ** of projected Net Sales, as set forth in Schedule 1.13(e), in the Licensed Territory for any calendar year following ** after receipt of Marketing Approval for the Licensed Product in the European Union.

 

1.14.                     “Commercialization Plan” shall have the meaning set forth in Section 7.1.4.

 

1.15.                     “Commercially Reasonable Efforts” means with respect to either Party, those efforts and resources that such Party would normally devote to a product or compound owned by it or to which it has rights of the type it has hereunder, which is of similar market potential at a similar stage in its development or product life, taking into account the competitiveness of the global and local marketplace, the pricing and launching strategy for the respective product, the proprietary position of the product, the profitability and the relative potential safety and efficacy of the product and other relevant factors, including technical, legal, scientific, regulatory or medical factors then prevailing.  “Commercially Reasonable” as used herein shall be interpreted in a corresponding manner.

 

1.16.                     “Competing Product” shall have the meaning set forth in Section 2.9.

 

1.17.                     “Compound” means the substance that is a sodium salt of (E)-2,4,6-trimethoxystyryl-3-carboxymethylamino-4-methoxybenzyl sulfone, or any Derivative/Improvement thereof.

 

1.18.                     “Confidentiality Agreement” means that certain Mutual Confidential Disclosure Agreement between Baxter and Onconova dated April 17, 2012.

 

1.19.                     “Control” means the possession of the ability to grant a license, sublicense or access as provided for under this Agreement without (a) violating the terms of any agreement or other arrangement with any Third Party or (b) increasing at any time the amount of any payments required under any such agreement or arrangement; provided that this clause (b) shall not apply (i) if the other Party elects in writing to be responsible for all such increased payments as provided in Section 2.8, or (ii) to the Upstream Agreements.

 

1.20.                     “Damages” has the meaning set forth in Section 14.1.

 

1.21.                     “Derivative/Improvement” means **.

 

1.22.                     “Development Milestone” has the meaning set forth in Section 9.2.1.

 

1.23.                     “Development Plan” means the development plan attached hereto as Schedule 1.23.

 

1.24.                     “Direct License” has the meaning set forth in Section 12.3.3.2.

 

1.25.                     “** Royalty Rates” has the meaning set forth in Section 9.3.1.

 

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1.26.                     “Drug Approval Application” means an application for Marketing Approval required before commercial sale or use of a pharmaceutical product as a drug in a regulatory jurisdiction or country.

 

1.27.                     “Election Time Period” has the meaning set forth in Section 14.3.1.

 

1.28.                     “EMA” means the European Medicines Agency or any successor agencies thereto.

 

1.29.                     “Enforcing Party” has the meaning set forth in Section 10.5.4.

 

1.30.                     “European Union” or “EU” means all countries of the European Union, as may be included from time to time.

 

1.31.                     “Executive Officers” has the meaning set forth in Section 3.2.

 

1.32.                     “FDA” means the United States Food and Drug Administration or any successor agencies thereto.

 

1.33.                     “Field Correction” means any action taken or changes performed affecting a distributed product to mitigate a risk to health or correct issues with misbranded or non-conforming product.

 

1.34.                     “First Commercial Sale” means, with respect to a Licensed Product and any country in the Licensed Territory, the first sale of such Licensed Product under this Agreement for use in the Licensed Field to a Third Party in such country, after such Licensed Product has been granted Marketing Approval in the Licensed Field.  For avoidance of doubt, First Commercial Sales excludes transfers or dispositions of a Licensed Product for charitable, promotional (including samples), pre-clinical, clinical or regulatory purposes and transfers among Baxter and any of its Affiliates or from Baxter or any of its Affiliates to any of their respective Sublicensees.

 

1.35.                     “Force Majeure” has the meaning set forth in Section 15.4.1.

 

1.36.                     “Governmental Authority” means any nation or government, any state, local or other political subdivision thereof, and any entity, department, commission, bureau, agency, authority, board, court, official or officer, domestic or foreign, exercising executive, judicial, regulatory or administrative governmental functions.

 

1.37.                     “Improvement” means any improvement or modification of the Licensed Product or Compound, including any Derivative/Improvement, that is developed by (a) Onconova or, if rights thereto are obtained by Onconova pursuant to Section 10.1.2, its Licensees or (b) Baxter or, if rights thereto are obtained by Baxter pursuant to Section 10.1.3, its Sublicensees, for use in the Licensed Field.

 

1.38.                     “Indemnification Claim Notice” has the meaning set forth in Section 14.3.1.

 

1.39.                     “Indemnified Party” has the meaning set forth in Section 14.3.1.

 

1.40.                     “Indemnifying Party” has the meaning set forth in Section 14.3.1.

 

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1.41.                     “Information” means techniques, data, inventions, practices, methods, knowledge, know-how, skill, experience, test data including pharmacological, toxicological and pre-clinical and clinical test data, analytical and quality control data or descriptions, including all proprietary information submitted to relevant Regulatory Authorities to support a Drug Approval Application.

 

1.42.                     “Initial Indications” means MDS Oral, MDS IV and Pancreatic Cancer.

 

1.43.                     “Invention” means any and all discoveries, developments, improvements, modifications, formulations, analogs, homologs, compositions of matter, cell lines, processes, manufactures and other inventions (whether patentable or not patentable) made in the course of activities performed under this Agreement by or on behalf of either Party or both Parties.

 

1.44.                     “Joint Inventions” has the meaning set forth in Section 10.2.

 

1.45.                     “Joint Patent” has the meaning set forth in Section 10.4.3.

 

1.46.                     “Joint Steering Committee” or “JSC” means the joint steering committee established pursuant to Section 3.1.

 

1.47.                     “Law” means all applicable laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision, domestic or foreign.

 

1.48.                     “Licensed Field” means all therapeutic indications.

 

1.49.                     “Licensed Product” means a pharmaceutical product in finished form that contains the Compound and all present and future formulations, dosages and dosage forms thereof.

 

1.50.                     “Licensed Rights” has the meaning set forth in Section 2.1.

 

1.51.                     “Licensed Territory” means (a) Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom, and (b) Liechtenstein, Monaco, Norway, San Marino, Switzerland and Turkey.

 

1.52.                     “Licensee” means any Third Party to which Onconova has granted rights under the Onconova Patents or Onconova Know-How for the Licensed Product in the Licensed Field outside of the Licensed Territory.

 

1.53.                     “Licensee Improvements” has the meaning set forth in Section 10.1.3.1.

 

1.54.                     “Litigation Conditions” has the meaning set forth in Section 14.3.1.

 

1.55.                     “Marketing Approval” means, with respect to a particular country or regulatory jurisdiction, the registrations, authorizations and approvals of the applicable Regulatory Authority or Governmental Authority in such country or regulatory jurisdiction (including, but not limited to, the EMA) that are necessary to market and sell the Licensed Product in such country or regulatory jurisdiction (e.g., a “Marketing Authorization” in the EMA).

 

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1.56.                     “MDS” means myelodysplastic syndromes.

 

1.57.                     “MDS IV” means the treatment, amelioration and/or prevention of MDS using the Licensed Product in an intravenous formulation.

 

1.58.                     “MDS IV Bonus Condition” means **.

 

1.59.                     “MDS Oral” means the treatment, amelioration and/or prevention of MDS using the Licensed Product in an oral formulation (e.g., tablet or capsule).

 

1.60.                     “MDS Oral Phase 2 Clinical Trial” means the ONTARGET (Oral ON 01910.Na in TrAnsfusion-RequirinG patients with myElodysplasTic syndrome) trial having a Clinicaltrials.gov study identifier of NCT01584531.

 

1.61.                     “Net Sales” means the gross amounts invoiced or otherwise billed by Baxter and its Affiliates and Sublicensees in connection with the sale, lease or other transfer for value of Licensed Products to unaffiliated Third Parties in the applicable country of the Licensed Territory, less the following to the extent allocable to the Licensed Product and actually allowed, incurred or paid by the invoiced party during the applicable royalty period:

 

(a)                                 customary trade and quantity discounts actually allowed and taken;

 

(b)                                 amounts actually allowed or credited due to returns of Licensed Products previously sold as reflected in written invoices (and not to exceed the original invoice amount);

 

(c)                                  shipping, freight and insurance, to the extent separately invoiced and charged;

 

(d)                                 credits, allowances and rebates actually given pursuant to federal, state and/or government-mandated programs, which require a manufacturer/distributor rebate, and allowances for uncollectible accounts actually taken (it being understood that “Net Sales” will include all amounts received for any uncollectible accounts at a subsequent date); and

 

(e)                                  value added or import/export taxes, sales taxes, excise taxes or customs duties, to the extent applicable to such sale, and included in the invoice in respect of such sale and actually paid;

 

provided that all of the foregoing deductions are incurred in the ordinary course and calculated in accordance with then-current Generally Accepted Accounting Principles or International Financial Reporting Standards, as applicable, consistently applied, during the applicable calculation period throughout the selling party’s organization.  All such discounts, allowances, credits, rebates, and other deductions granted for a range of products shall be fairly and equitably allocated to the Licensed Product and other products of Baxter and its Affiliates and Sublicensees such that the Licensed Product does not bear a disproportionate portion of such deductions.

 

Notwithstanding the foregoing, in the event the Licensed Product is sold in a country in the Licensed Territory as part of a Combination Product, Net Sales of the Licensed Product will be calculated as follows:

 

(i)                                     If the Licensed Product and other therapeutically active pharmaceutical ingredient(s) included in the Combination Product each are sold separately in such country,

 

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Net Sales will be calculated by multiplying the total Net Sales (as described above) of the Combination Product by the fraction A/(A+B), where A is the average gross selling price in such country of the Licensed Product sold separately in the same formulation and dosage, and B is the sum of the average gross selling prices in such country of such other therapeutically active pharmaceutical ingredient(s) sold separately in the same formulation and dosage, during the applicable calendar year.

 

(ii)                                  If the Licensed Product is sold independently of the other therapeutically active pharmaceutical ingredient(s) included in the Combination Product in such country, but the average gross selling price of such other therapeutically active pharmaceutical ingredient(s) cannot be determined, Net Sales will be calculated by multiplying the total Net Sales (as described above) of the Combination Product by the fraction A/C where A is the average gross selling price in such country of such Licensed Product sold independently and C is the average gross selling price in such country of the entire Combination Product.

 

(iii)                               If the other therapeutically active pharmaceutical ingredient(s) included in the Combination Product are sold independently of the Licensed Product therein in such country, but the average gross selling price of such Licensed Product cannot be determined, Net Sales will be calculated by multiplying the total Net Sales (as described above) of the Combination Product by the fraction [1-B/C], where B is the average gross selling price in the Licensed Territory of such other therapeutically active pharmaceutical ingredient(s) and C is the average gross selling price in the Licensed Territory of the entire Combination Product.

 

(iv)                              If the Licensed Product and other therapeutically active pharmaceutical ingredient(s) included in the Combination Product are not sold separately, or if they are sold separately but the average gross selling price of neither such Licensed Product nor the other therapeutically active pharmaceutical ingredient(s) can be determined, in such country, Net Sales of the Combination Product shall be equal to Net Sales of the Combination Product multiplied by a mutually agreed percentage or, pending agreement on such a percentage, fifty percent (50%).

 

The average gross selling price for the product(s) contained in the Combination Product other than the Licensed Product shall be calculated for each applicable time period by dividing the gross aggregate sales revenues for such other product by the units of such other product(s) sold during such time period, as published by IMS or another mutually agreed independent source; provided that in the absence of appropriate IMS or other mutually agreed independent source of such data, such average gross selling price shall be calculated as follows:  in the calendar year during which a Combination Product is first sold in a country, a forecasted average gross selling price shall be used for the Licensed Product and the other therapeutically active pharmaceutical ingredient(s), to be determined in good faith by Baxter.  Any over- or under-payment due to a difference between forecasted and actual average gross selling prices in such country shall be paid or credited, as applicable, in the first royalty payment of the following calendar year.  In the following calendar year the average gross selling price of both the Licensed Product and the other therapeutically active pharmaceutical ingredient(s) included in the Combination Product in the previous calendar year shall apply.

 

1.62.                     “Onconova Confidential Information” has the meaning set forth in Section 13.1.1(a).

 

1.63.                     “Onconova Improvements” has the meaning set forth in Section 10.1.3.2.

 

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1.64.                     “Onconova Indemnitees” has the meaning set forth in Section 14.2.

 

1.65.                     “Onconova Know-How” means Information Controlled by Onconova or its Affiliates that is necessary for the development, manufacture, use, sale, offer for sale and/or importation of Licensed Products in the Licensed Field in the Licensed Territory.  Notwithstanding anything herein to the contrary, Onconova Know-How shall exclude Onconova Patents.

 

1.66.                     “Onconova Patents” means all Patents Controlled by Onconova or its Affiliates that claim inventions necessary for the development, manufacture, use, sale, offer for sale and/or importation of Licensed Products within the Licensed Field in the Licensed Territory, including Onconova’s interest in any Joint Patents.  Onconova Patents include the Patents listed in Schedule 1.66.

 

1.67.                     “Onconova Trademarks” means the trademarks set forth on Schedule 1.67.

 

1.68.                     “ONTIME Phase 3 Clinical Trial” means the ONTIME (ON 01910.Na Trial In Myelodysplastic SyndromE) trial, having a Clinicaltrials.gov study identifier of  NCT01241500.

 

1.69.                     “ONTRAC Interim Analysis” means the interim analysis to be performed by the Data Safety Monitoring Committee of the Pancreatic Cancer Phase 2/3 Clinical Trial after one hundred and fifty (150) patients have been enrolled in such trial and one hundred (100) deaths have occurred, as described in the clinical trial protocol for the Pancreatic Cancer Phase 2/3 Clinical Trial.

 

1.70.                     “Pancreatic Cancer” means the treatment, amelioration and/or prevention of pancreatic cancer using the Licensed Product in treatment of naïve patients having pancreatic cancer.

 

1.71.                     “Pancreatic Cancer Phase 2/3 Clinical Trial” means the ONTRAC (ON 01910.Na TRial in patients with Advanced pancreatic Cancer) trial, having a Clinicaltrials.gov study identifier of NCT01360853.  This trial, originally commenced as a Phase 2/3 clinical trial, is now designated a Phase 3 Clinical Trial with a Data Safety Monitoring Committee review and go/no go decision (futility analysis) after 100 events in the first 150 patients.

 

1.72.                     “Patent” means (a) letters patent (or other equivalent legal instrument), including without limitation utility and design patents, and including without limitation any extension, substitution, registration, confirmation, reissue, re-examination or renewal thereof, (b) applications for letters patent, a reissue application, a continuation application, a continuation-in-part application, a divisional application or any equivalent of the foregoing applications, that are pending at any time during the term of this Agreement before a government patent authority and (c) all foreign or international equivalents of any of the foregoing in any country.

 

1.73.                     “Patent Term Extensions” has the meaning set forth in Section 10.8.

 

1.74.                     “Paying Party” has the meaning set forth in Section 9.6.

 

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1.75.                     “Person” means any individual, firm, corporation, partnership, limited liability company, trust, business trust, joint venture, Governmental Authority, association or other entity.

 

1.76.                     “Phase 2 Clinical Trial” means a Clinical Trial as defined in 21 C.F.R. 312.21(b), as may be amended from time to time, or any equivalent thereto in any other jurisdiction in the Licensed Territory.

 

1.77.                     “Phase 3 Clinical Trial” means a Clinical Trial as defined in 21 C.F.R. 312.21(c), as may be amended from time to time, or any equivalent thereto in any jurisdiction in the Licensed Territory.

 

1.78.                     “Phase 4 Clinical Trial” means a Clinical Trial conducted after a submission of an application for Marketing Approval of a Licensed Product, carried out for purposes of conducting safety surveillance, ongoing technical support of the Licensed Product or market access.

 

1.79.                     “Product Infringement” has the meaning set forth in Section 10.5.2(a).

 

1.80.                     “Prosecuting Party” has the meaning set forth in Section 10.4.3.

 

1.81.                     “Publications” has the meaning set forth in Section 13.1.3.

 

1.82.                     “Recipient Party” has the meaning set forth in Section 9.6.

 

1.83.                     “Recall” means the removal or correction of a marketed product that the FDA or other Regulatory Authority considers to be in violation of the laws it administers and against which the agency would initiate legal action (e.g., seizure) and may be conducted on a firm’s own initiative, by FDA or other Regulatory Authority request, or by FDA or other Regulatory Authority order under statutory authority.  The words ‘recalled’ ‘recalling’, etc. shall have correlative meanings.

 

1.84.                     “Recall Costs” means all out-of-pocket expenses directly relating to or arising out of compliance with any order of a Regulatory Authority for a Recall, Withdrawal or Field Correction and out-of-pocket expenses incurred by either Party relative to notification, shipping, disposal and return of the Recalled or Withdrawn product and the notification and correction of any product subject to a Field Correction.

 

1.85.                     “Regulatory Authority” means any national, supra-national, regional, state or local regulatory authority, department, bureau, commission, council or other Governmental Authority in such country (including, but not limited to, the FDA and EMA) that is responsible for overseeing the development (including the conduct of clinical trials), manufacture, distribution, importation, exportation, transport, storage, marketing, promotion, offer for sale, use, or sale of the Compound and/or the Licensed Product.

 

1.86.                     “Regulatory Exclusivity” means any rights or protections which are recognized, afforded or granted by any Regulatory Authority in any country or region of the Licensed Territory in association with the Marketing Approval of the Licensed Product, providing such Licensed Product: (a) a period of marketing exclusivity during which the applicable Regulatory Authority shall refrain from either reviewing or approving a marketing authorization application or similar regulatory submission submitted by a Third Party seeking

 

9

 

to market a competing product, or (b) a period of data exclusivity during which a Third Party seeking to market a competing product is precluded from either referencing or relying upon, without an express right of reference from the dossier holder, such Licensed Product’s clinical dossier or relying on previous Regulatory Authority findings of safety or effectiveness with respect to such Licensed Product to support the submission, review or approval of a marketing authorization application or similar regulatory submission before the applicable Regulatory Authority.  Regulatory Exclusivity shall include rights conferred in the European Union pursuant to Section 10.1(a)(iii) of Directive 2001/EC/83.

 

1.87.                     “Regulatory Filings” means any application for Marketing Approval, notification or other submission made to or with a Regulatory Authority that is necessary or reasonably desirable to develop, manufacture or commercialize the Licensed Product in the Licensed Field in a particular country or regulatory jurisdiction, whether made before or after receipt of Marketing Approval in the country or regulatory jurisdiction.  The term ‘Regulatory Filings’ shall include Drug Approval Applications, and amendments and supplements to any of the foregoing, applications for pricing and reimbursement approvals, and all proposed labels, labeling, package inserts, monographs and packaging for a Licensed Product in a particular country.

 

1.88.                     “Royalty Term” has the meaning set forth in Section 9.3.2

 

1.89.                     “Sales Milestone” has the meaning set forth in Section 9.2.2.

 

1.90.                     “Sales Report” means with respect to each calendar quarter a report detailing:

 

(a)                                 the relevant gross amounts invoiced or billed in each local currency by Baxter or its Affiliates or Sublicensees to Third Parties, including wholesalers, hospitals or other intermediate Third Parties, indicating the breakdown of sales by each type of the Licensed Product;

 

(b)                                 the deductions from gross amounts invoiced or billed used to calculate Net Sales;

 

(c)                                  the Net Sales in each local currency;

 

(d)                                 the currency exchange rates used; and

 

(e)                                  the sum of royalties due pursuant to Section 9.3.

 

1.91.                     “Sole Inventions” has the meaning set forth in Section 10.2.

 

1.92.                     “** Royalty Rates” has the meaning set forth in Section 9.3.1.

 

1.93.                     “Sublicensee” means, with respect to Baxter, any Affiliate or Third Party to which Baxter sublicenses the Licensed Rights and, with respect to Onconova, any Affiliate or Third Party to which Onconova sublicenses the rights granted under Section 2.2.

 

1.94.                     “Sublicensee Improvements” has the meaning set forth in Section 10.1.3.2.

 

1.95.                     “Success Criteria” means either: (a) the achievement of **, or (b) mutual agreement of the Parties to file for any Marketing Approval in either the European Union as a whole or in all of the Big Five EU Countries **.

 

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1.96.                     “Supply Agreement” means a Manufacturing and Supply Agreement between Onconova and Baxter pursuant to which Onconova will, by itself or through a Third Party contract manufacturing organization acceptable to Baxter and Onconova, supply to Baxter its requirements of Licensed Product for sale and distribution in the Licensed Territory.

 

1.97.                     “Third Party” means any person or corporation or unincorporated body other than Onconova and Baxter and their respective Affiliates, including Governmental Authorities.

 

1.98.                     “Trademark Infringement” has the meaning set forth in Section 11.2.5.

 

1.99.                     “Temple Agreement” means the January 1, 1999 License Agreement between Temple University and Onconova, as amended from time to time.

 

1.100.              “Term” has the meaning set forth in Section 15.1.

 

1.101.              “Upstream Agreement” means each agreement existing as of the Effective Date under which Onconova obtains a license or other right from a Third Party to develop, make, use, sell, offer for sale or import the Compound and/or the Licensed Product in the Licensed Territory.  Schedule 1.101 sets forth a true and complete list of all Upstream Agreements.

 

1.102.              “USD” means United States Dollar.

 

1.103.              “U.S.” means the United States of America, its territories and possessions.

 

1.104.              “Valid Claim” means, for a country, a claim of an issued and unexpired Patent, or a Patent application (excluding provisional Patent applications) that has not been pending for more than ** after its priority date, in each case, that is within the Onconova Patents (including the Joint Patents), and that has not been held unpatentable, invalid, or unenforceable by a final unappealable or unappealed decision of a court or other Governmental Authority of competent jurisdiction, or admitted to be invalid or unenforceable through reissue, re-examination, disclaimer, or otherwise.

 

1.105.              “Withdrawal” means a removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or other Regulatory Authority, or which involves no violation of a Law.  The words ‘withdrawn’ ‘withdrawing’, etc. shall have correlative meanings.

 

1.106.              “Withholding Taxes” has the meaning set forth in Section 9.6.

 

ARTICLE II.

 

GRANT OF LICENSES

 

2.1.                            License to Baxter.  Subject to the terms and conditions of this Agreement, Onconova hereby grants to Baxter, and Baxter accepts, an exclusive (even as to Onconova except as provided in Section 2.3), royalty-bearing, non-transferable (except pursuant to Section 16.1) right and license under Onconova Know-How and Onconova Patents, with the right to, subject to Section 2.4, grant sublicenses through multiple tiers of Sublicensees, to research, develop, make, have made, import, export, use, sell, offer for sale, have sold and otherwise commercialize the Licensed Product in the Licensed Field in the Licensed Territory

 

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(the “Licensed Rights”).  Notwithstanding the foregoing, Baxter agrees that it shall not exercise its right to “make or have made” with respect to the Licensed Product unless (a) there has been a “Failure to Supply” as such term is defined in the Supply Agreement or (b) the Parties have not entered into the Supply Agreement by ** (or ** if such date is extended pursuant to Section 8.1.2).

 

2.2.                            License to Onconova.  Subject to the terms and conditions of this Agreement, Baxter hereby grants to Onconova, and Onconova accepts, (a) a non-exclusive, royalty-free, non-transferable (except pursuant to Section 16.1) right and license under Baxter Know-How and Baxter Patents, with the right to, subject to Section 2.4, grant sublicenses through multiple tiers of Sublicensees, to (i) conduct research and development activities with respect to the Licensed Products in the Licensed Territory as contemplated under the Development Plan and as contemplated under Section 4.2, (ii) research and develop the Licensed Product in the Licensed Territory solely to support development and commercialization of the Licensed Product outside of the Licensed Territory, and (iii) manufacture and have manufactured the Licensed Product in the Licensed Territory (x) to fulfill its obligations under the Supply Agreement and (y) to support the development and commercialization of the Licensed Product outside of the Licensed Territory, and (b) an exclusive, royalty-free, non-transferable (except pursuant to Section 16.1) right and license under Baxter Know-How and Baxter Patents, with the right to, subject to Section 2.4, grant sublicenses through multiple tiers of Sublicensees, to research, develop, make, have made, import, export, use, sell, offer for sale, have sold and otherwise commercialize the Licensed Product in the Licensed Field outside of the Licensed Territory.

 

2.3.                            Onconova Reservation of Rights.  Onconova hereby retains the right under the Onconova Patents and Onconova Know-How to (a) conduct research and development activities with respect to the Licensed Products in the Licensed Territory as contemplated under the Development Plan and as contemplated under Section 4.2, (b) research and develop the Licensed Product in the Licensed Territory solely to support development and commercialization of the Licensed Product outside of the Licensed Territory, and (c) subject to the rights granted to Baxter to manufacture or have manufactured Licensed Products in the event of a Failure (as such term is defined in the Supply Agreement) manufacture and have manufactured the Licensed Product in the Licensed Territory (i) to, subject to Section 8.1.2, fulfill its obligations under the Supply Agreement and (ii) to support the development and commercialization of the Licensed Product outside of the Licensed Territory.

 

2.4.                            Sublicenses.

 

2.4.1.                  Baxter shall have the right to sublicense its rights under Section 2.1 to its Affiliates and to Third Parties; provided that if Baxter proposes to grant a sublicense to a Third Party granting the Third Party the right to commercialize the Licensed Product in **, Baxter shall provide Onconova with written notice of such sublicense at least ** in advance of executing such sublicense, which notice shall include a reasonable level of detail regarding the terms of the proposed sublicense, and during such ** period Baxter agrees to discuss in good faith any concerns identified by Onconova regarding such sublicense and to reasonably consider any comments provided by Onconova with respect to such sublicense.  Each agreement between Baxter and a Sublicensee (a) shall be in writing and subject and subordinate to, and consistent with, the terms and conditions of this Agreement; (b) shall not diminish, reduce or eliminate any of Baxter’s obligations under this Agreement; (c) shall require the Sublicensee(s) to comply with all applicable terms of this Agreement (except for the payment obligations, for which Baxter shall remain financially responsible); and (d) shall

 

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prohibit further sublicensing except on terms consistent with this Section 2.4.1.  Baxter shall provide written notice to Onconova of any agreement entered into with a Sublicensee, and shall provide a complete copy of such agreement to Onconova within ** of its execution, which copy may be redacted by Baxter to the extent that such redactions do not reasonably impair Onconova’s ability to ensure compliance with this Agreement.  Baxter shall be responsible for the performance of each Sublicensee and shall ensure that each Sublicensee complies with all relevant provisions of this Agreement.

 

2.4.2.                  Onconova shall have the right to sublicense its rights under Section 2.2 to its Affiliates and to Third Parties.  Each agreement between Onconova and a Sublicensee (a) shall be in writing and subject and subordinate to, and consistent with, the terms and conditions of this Agreement; (b) shall not diminish, reduce or eliminate any of Onconova’s obligations under this Agreement; (c) shall require the Sublicensee(s) to comply with all applicable terms of this Agreement; and (d) shall prohibit further sublicensing except on terms consistent with this Section 2.4.2.  Onconova shall provide written notice to Baxter of any agreement entered into with a Sublicensee, and shall provide a complete copy of such agreement to Baxter within ** of its execution, which copy may be redacted by Onconova to the extent that such redactions do not reasonably impair Baxter’s ability to ensure compliance with this Agreement. Onconova shall be responsible for the performance of each Sublicensee and shall ensure that each Sublicensee complies with all relevant provisions of this Agreement.

 

2.5.                            Temple University.  The licenses granted by Onconova pursuant to Section 2.1 are, with respect to any Onconova Know-How and Onconova Patents licensed to Onconova under the Temple Agreement, subject to Temple’s reserved rights for non-commercial educational and research purposes under Section 3.1 of the Temple Agreement. The Parties acknowledge that inventions that are included in the Onconova Patents that are Controlled, but not owned, by Onconova that are licensed to Onconova pursuant to the Temple Agreement may have resulted from United States Government funding, and any such Onconova Patents shall be subject to any applicable Laws of the United States related to federally funded inventions.

 

2.6.                            No Other Licenses.  Neither Party grants to the other Party any rights, licenses or covenants in or to any intellectual property, whether by implication, estoppel, or otherwise, other than the license rights that are expressly granted under this Agreement or the Supply Agreement.  Notwithstanding anything to the contrary herein, neither Party grants to the other Party any license or other right to manufacture, develop or commercialize any active ingredients other than the Compound (or any Derivative/Improvement thereof), including without limitation any method of making any active ingredients other than the Compound (or any Derivative/Improvement thereof), any composition or formulations of any active ingredients other than the Compound (or any Derivative/Improvement thereof), or any method of using or administering any active ingredients other than the Compound (or any Derivative/Improvement thereof).

 

2.7.                            Third Party IP.  Baxter and Onconova will ** for any economics related to any obligations owed to Third Parties (other than the Upstream Agreements which shall remain the sole responsibility of Onconova pursuant to Sections 2.7.1 and 9.4) in respect of Third Party intellectual property rights that are necessary for the commercialization of the Licensed Product as set forth in this Section 2.7.  If either Party reasonably determines that a license to the intellectual property rights of a Third Party is necessary in order to commercialize the License Product, such Party shall provide written notice thereof to the other Party.

 

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2.7.1.                  If the other Party agrees with such determination, then the Parties shall negotiate in good faith to determine which Party shall secure such license and the terms on which such license shall be obtained, and the Parties agree ** the costs and expenses of obtaining and maintaining such license; provided that:

 

(a)                                 to the extent that Licensees also benefit from such license, then the Parties shall mutually agree upon an appropriate allocation of such IP costs and expenses;

 

(b)                                 such Third Party license shall be reviewed on an annual basis to determine whether or not it continues to be necessary in order to commercialize the Licensed Product;

 

(c)                                  Onconova shall be responsible for any payments required to be made **; and

 

(d)                                 Baxter shall be responsible for any payments required to be made to any Third Party for a license to ** that Baxter licenses.

 

2.7.2.                  If the other Party does not agree with such determination, then the Party making such determination may **.

 

2.8.                            Controlled IP.  Subject to Section 2.7, if, after the Effective Date, either Party enters into an agreement or other arrangement to obtain a license or other rights to or under Information or Patents that are owned or controlled by a Third Party and that would, solely but for the operation of Section 1.19(b), in the case of Onconova be included in the Onconova Information or Onconova Patents or, in the case of Baxter, be included in the Baxter Information or Baxter Patents, then the Party obtaining such license or rights shall promptly notify the other Party and shall specify in such notice the type and amount of payments that would be due to such Third Party by reason of the practice or use of, or access to, such Information or Patents by the other Party pursuant to the license set forth in Section 2.1 or 2.2, as applicable (but not by reason of the practice or use of, or access to, such Information or Patents outside the scope of such license).  The Party receiving such notice may elect in writing to bear the responsibility for such additional payments, and upon such receiving Party’s written election to bear such responsibility, the Information or Patents as applicable, shall thereafter be deemed “Controlled” by the Party originally obtaining such license or rights (notwithstanding Section 1.19(b)), and shall be subject to the license under Section 2.1 or 2.2, as applicable.

 

2.9.                            Exclusivity.  During the Term, each Party covenants and **.

 

ARTICLE III.
  JOINT STEERING COMMITTEE

 

3.1.                            Joint Steering Committee.

 

3.1.1.                  Within** after the Effective Date, each Party shall appoint ** of its senior employees to serve on the JSC.  Each Party may replace its JSC representatives by written notice to the other Party.  The chairperson of the JSC shall, during **, be a JSC member appointed by Onconova, and thereafter shall alternate on a meeting by meeting basis between Onconova and Baxter (beginning with Baxter).  The chairperson will be responsible for calling meetings and, after seeking input from the other Party, setting the agenda (which

 

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shall include a list of all participants expected at a meeting) and circulating such agenda at least ** prior to each meeting and distributing minutes of the meetings within ** following such meeting, but will not otherwise have any greater power or authority than any other member of the JSC.  JSC members shall have such expertise as appropriate to the activities of the JSC from time to time, and the JSC may invite personnel of the Parties having non-clinical safety and animal pharmacology, pharmaceutical development, clinical, biostatistical, regulatory affairs, pharmacovigilance, formulation, manufacturing, commercial, marketing and other expertise to participate in discussions of the JSC from time to time as appropriate to assist in the activities of the JSC.  The JSC may appoint committees and subcommittees as desired, such committees and subcommittees to have equal representation from the Parties and subject to governance by the JSC.  Promptly after the Effective Date, the JSC shall appoint: (a) an intellectual property sub-committee that shall be responsible for developing a patent strategy for the Licensed Product in the Licensed Territory and (b) a regulatory sub-committee that shall be responsible for developing the regulatory strategy for the Licensed Product in the Licensed Territory.

 

3.1.2.                  The JSC shall oversee and direct the development, regulatory and commercialization strategy of the Licensed Product in the Licensed Field in the Licensed Territory, and shall coordinate communications among the Parties’ and the exchange of Information regarding the development and marketing activities pursuant to the Agreement as further specified in Articles VI and VII.  The JSC’s responsibilities shall include:

 

(a)                                 reviewing and evaluating progress under the Development Plan on a ** basis;

 

(b)                                 reviewing and approving amendments to the Development Plan;

 

(c)                                  performing ** monitoring of progress of pre-clinical, pharmaceutical and clinical studies of the Licensed Product and proposing additional studies for the Licensed Product;

 

(d)                                 reviewing and commenting on regulatory submissions in the Licensed Territory relating to the Licensed Products;

 

(e)                                  establishing procedures regarding the collection, sharing and reporting of Adverse Event information related to the Licensed Product consistent with the Pharmacovigilance Agreement to be entered into in accordance with the terms of the Supply Agreement or Section 8.1.2, as applicable;

 

(f)                                   reviewing and commenting on worldwide publication strategy with respect to the Compound and Licensed Product;

 

(g)                                  reviewing and discussing each version of the Commercialization Plan pursuant to Section 7.1.4;

 

(h)                                 identifying, prioritizing and approving future indications for the Licensed Product beyond the Initial Indications; and

 

(i)                                     determining whether an Additional Indication falls outside hematology or oncology for purposes of Section 4.3.1(iv).

 

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3.1.3.                  The JSC shall meet at least once every ** at times mutually agreed upon by the Parties.  At least one (1) meeting each ** shall be held in person, and all other such meetings may be held by teleconference or videoconference.  The location of the meetings of the JSC to be held in person shall be agreed upon by the Parties (with the intent that it should alternate between the Parties’ headquarters locations).  Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JSC.  If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative.  Each Party shall bear all the expenses of its representatives on the JSC.

 

3.1.4.                  The minutes of each JSC meeting shall be distributed to the teams within ** after the completion of the relevant JSC meeting and shall provide a description in reasonable detail of the discussions held at the meeting and a list of any actions, decisions or determinations approved by the JSC.  Minutes of each JSC meeting shall be approved or disapproved, and revised as necessary, within ** of the applicable JSC meeting.

 

3.2.                            Elevation and Dispute Resolution.  Each Party’s representatives on the JSC will collectively have one (1) vote on all matters that are within the responsibility of the JSC.  The members of the JSC will use reasonable efforts to reach unanimous consensus on all decisions.  In the event that the members of the JSC are unable to reach consensus on a particular issue within ** after such issue is first presented to the JSC, such issue shall be referred to an executive officer of each Party or their designees (the “Executive Officers”) for resolution.  If such Executive Officers are unable to resolve such issue within ** after such issue is referred to them, then (a) with respect to all** relating to the Licensed Product in the Licensed Field in the Licensed Territory (excluding, for the avoidance of doubt,**, the decision of **’s Executive Officer shall be final and determinative, and (b) with respect to all ** related to the Licensed Product in the Licensed Field in the Licensed Territory, the decision of **’s Executive Officer shall be final and determinative.  For the avoidance of doubt, the JSC shall have no power to amend or waive compliance with this Agreement nor, without the consent of the affected Party, materially increase or reduce the obligations of the Parties under this Agreement.

 

ARTICLE IV.
  DEVELOPMENT RESPONSIBILITIES

 

4.1.                            Onconova Development Obligations.  Subject to Section 4.2, Onconova shall, subject to the oversight of the JSC, use its Commercially Reasonable Efforts to direct, coordinate and manage the development of the Licensed Product for the Initial Indications in the Licensed Territory in accordance with the Development Plan.  During the Term, Onconova shall develop, and the JSC shall have the authority to review and, if it deems appropriate, approve, amendments to the Development Plan on an ongoing basis as necessary; provided that the Development Plan shall at all times contain terms that are consistent with this Article IV.  Baxter may suggest to Onconova changes and additions to the Development Plan and Onconova shall reasonably consider including such changes and additions when developing amendments to the Development Plan in accordance with this Section 4.1.  Except as otherwise set forth in this Agreement (including Section 4.2), ** shall be responsible for all costs and expenses incurred by Onconova and its Affiliates in developing the Licensed Product for the Initial Indications in the Licensed Territory; provided that, without limitation of Section 6.2, **.

 

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4.2.                            Additional Clinical Trials for Initial Indications; Safety Registration.

 

4.2.1.                  MDS IV.  Onconova shall be responsible for and shall promptly, but in any case within ** of the final readout of survival data from the ONTIME Phase 3 Clinical Trial, undertake, if Commercially Reasonable, and shall **, any additional clinical studies (including any additional Phase 3 Clinical Trials) required to obtain Marketing Approval in the European Union for the Licensed Product for MDS IV (excluding, for avoidance of doubt, any safety registry obligations mandated in connection with obtaining or maintaining Marketing Approval in the European Union).  Onconova shall keep Baxter fully-informed of the status of any feedback from the Regulatory Authorities with respect to such clinical trials, shall seek input from Baxter and shall, in good faith consider such input; provided, however, that, **. **. **.

 

4.2.2.                  MDS Oral and Pancreatic Cancer.

 

(a)                                 Onconova shall use its Commercially Reasonable Efforts to develop the Licensed Product for MDS Oral through the MDS Oral Phase 2 Clinical Trial and for Pancreatic Cancer through the Pancreatic Cancer Phase 2/3 Clinical Trial, at **’s cost and expense (unless otherwise agreed by ** in writing).  Promptly after completion of the final study report for the MDS Oral Phase 2 Clinical Trial, Onconova shall provide to Baxter the draft study report, raw data (excluding, for the avoidance of doubt, any private patient data), findings, conclusions and other results of such Phase 2 Clinical Trial within Onconova’s possession or Control.  Promptly after receipt of the Data and Safety Monitoring Committee’s recommendation regarding the continued conduct of the Pancreatic Cancer Phase 2/3 Clinical Trial after the ONTRAC Interim Analysis has occurred, Onconova shall notify Baxter of such recommendation.  During the ** period after Onconova’s provision of such materials or recommendation, as applicable, to Baxter, the Parties shall discuss, in the case of MDS Oral, progressing the development of the Licensed Product for MDS Oral beyond the MDS Oral Phase 2 Clinical Trial (including additional Clinical Trials or submission of a Drug Approval Application for MDS Oral in the Licensed Territory) or, in the case of the Pancreatic Cancer Phase 2/3 Clinical Trial, continuing with the conduct of such trial after the ONTRAC Interim Analysis, conducting additional Clinical Trials or submission of a Drug Approval Application for Pancreatic Cancer.  The Parties shall act reasonably and in good faith in such discussions and shall make their decision to pursue or not pursue further development of MDS Oral or Pancreatic Cancer solely based on the Clinical Trial data and a reasonable assessment of the likelihood of success of the Licensed Product for such indication based on the safety, toxicity, efficacy, or pharmacokinetics of the Licensed Product for such indications.

 

(b)                                 If the Parties mutually agree in writing during ** to progress the development of the Licensed Product for MDS Oral or Pancreatic Cancer, as the case may be, as contemplated by Section 4.2.2(a) above (which includes, for avoidance of doubt, submission of a Drug Approval Application for MDS Oral or Pancreatic Cancer in the Licensed Territory and a decision to continue to conduct the Pancreatic Cancer Phase 2/3 Clinical Trial after the recommendation of the Data Safety Monitoring Committee), then **, and Onconova shall use its Commercially Reasonable Efforts to, consistent with the then-applicable Development Plan, progress the development of the Licensed Product for MDS Oral or Pancreatic Cancer, as the case may be, as contemplated by Section 4.2.2(a) (excluding, for avoidance of doubt, any safety registry obligations mandated in connection with obtaining or maintaining Marketing Approval in the European Union), all at **’s cost and expense.  The Parties agree that Onconova shall not have the right to withhold its agreement

 

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with respect to progressing the development of the Licensed Product for MDS Oral; provided, however, that if Onconova has informed Baxter of its desire not to progress the development of the Licensed Product for MDS Oral within ** period, in performing its obligations under this Section 4.2.2 for activities related to MDS Oral, **.

 

(c)                                  If Baxter is the Party withholding its agreement during such ** period to progress the development of the Licensed Product for MDS Oral or Pancreatic Cancer, as the case may be, then Onconova shall have the right, but not the obligation, at its sole cost and expense, to progress the development of the Licensed Product for MDS Oral or Pancreatic Cancer, as the case may be, for purposes of obtaining Marketing Approval therefor and Baxter shall retain all rights to commercialize the Licensed Product.

 

(d)                                 If Onconova is the Party withholding its agreement during such ** period to progress the development of the Licensed Product for Pancreatic Cancer (it being understood and agreed that Onconova shall not have the right to withhold its agreement with respect to MDS Oral), then Baxter shall have the right, but not the obligation, at its sole cost and expense, to progress the development of the Licensed Product for Pancreatic Cancer for purposes of obtaining Marketing Approval therefor and Baxter shall retain all rights to commercialize the Licensed Product.  In such case, Onconova agrees to reasonably cooperate with Baxter in such further development of the Licensed Product, including by providing Baxter with access to Onconova subject matter experts, technical expertise and Information reasonably requested by Baxter and making any submissions to Regulatory Authorities that may be required to obtain Marketing Approval for Pancreatic Cancer.  Baxter shall reimburse Onconova for its reasonable costs and expenses incurred in providing such cooperation.

 

4.2.3.                  Safety Registration Obligations.  Baxter shall be responsible for any and all safety registry obligations mandated by a Regulatory Authority in connection with obtaining or maintaining Marketing Approval in the Licensed Territory for the Licensed Product, and Baxter shall bear all costs and expenses related to such safety registry obligations.

 

4.3.                            Additional Indications.

 

4.3.1.                  Baxter and Onconova shall work together in good faith to maximize the value of the Licensed Product in future indications in hematology, oncology and other indications (beyond the Initial Indications).  Not less than once every **, Onconova shall review with Baxter potential new indications for the Licensed Product in the Licensed Field beyond the Initial Indications (each such indication, an “Additional Indication”) within the Licensed Territory. Onconova shall inform Baxter in writing of such Additional Indication(s) and the Parties shall discuss the estimated timing, cost, revenue expectations, pre-clinical or clinical data and other relevant aspects of such Additional Indication(s).  Baxter shall, within ** of receipt of Onconova’s written proposal: (a) inform Onconova in writing of its intent to participate in the development of such Additional Indication(s) or (b) inform Onconova in writing that it is deferring the decision to participate in the clinical development for such Additional Indication(s).  Baxter’s failure to respond to Onconova’s proposal within such ** period shall be deemed Baxter’s deferring the decision to participate in the development for such Additional Indication(s).

 

(i)                                     If Baxter chooses to participate in development of an Additional Indication at inception pursuant to Section 4.3.1, then:

 

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(1)                                 (A) Onconova and Baxter shall work jointly to develop the Licensed Product for the Additional Indication in the Licensed Territory, (B) the Additional Indication shall be developed pursuant to Onconova’s written proposal provided under Section 4.3.1 (as such may be modified from time-to-time by mutual agreement of the Parties), and (C) except as provided in the last sentence of Section 6.2.1, ** shall be responsible for and shall pay for ** of all research and development costs and expenses allocable to the research and development of such Additional Indication for the Licensed Territory; and

 

(2)                                 Upon receipt of Marketing Approval for an Additional Indication from the EMA Baxter shall pay to Onconova ** for such Additional Indication.  If, instead of a centralized EMA filing, the Regulatory Approval was sought from individual countries within the Licensed Territory, then (A) upon receipt of Marketing Approval for an Additional Indication from the applicable Regulatory Authorities in the earlier to occur of either **, Baxter shall pay to Onconova ** for such Additional Indication and (B) upon receipt of Marketing Approval for an Additional Indication from the applicable Regulatory Authorit(y/ies) for **, as applicable, for such Additional Indication, Baxter shall pay to Onconova **for such Additional Indication.

 

Further, all Net Sales of the Licensed Product for such Additional Indication shall be aggregated with all other Licensed Product Net Sales, but shall bear royalties at **.

 

(ii)                                  If Baxter defers the decision to participate in development of the Additional Indication at inception pursuant to Section 4.3.1, Onconova shall have the exclusive right, but not the obligation, to further develop the Licensed Product for the Licensed Territory at its own cost and expense. Onconova will consult with Baxter during development and may advance such development, at Onconova’s expense, until such time as Onconova has generated **.  Prior to submission of a Drug Approval Application for the Additional Indication in the European Union, Onconova will provide Baxter in writing estimated timing, cost, pre-clinical or clinical data and other relevant aspects of such Additional Indication and the associated Drug Approval Application.  Baxter shall have the right, within ** from the provision of such information by Onconova, to elect whether it wishes to participate in the further development of such Additional Indication, including filing of a Drug Approval Application in the European Union, or to again defer its decision, by providing written notice thereof to Onconova.  If Baxter elects to participate in such further development of the Additional Indication, Baxter shall reimburse Onconova for ** of all of the research and development expenses incurred by Onconova and its Affiliates for such Additional Indication through such time that are allocable to the Licensed Territory and shall thereafter be responsible for and shall pay for ** of all additional research and development costs and expenses for such Additional Indication that are allocable to the Licensed Territory, including preparation and filing of Drug Approval Applications for the Licensed Territory.  Upon receipt of Marketing Approval for the Additional Indication from the EMA, Baxter shall pay to Onconova ** for such Additional Indication.  If, instead of a centralized EMA filing, the Regulatory Approval was sought from individual countries within the Licensed Territory, then (A) upon receipt of Marketing Approval for an Additional Indication from the applicable Regulatory Authorities in the earlier to occur of **, or (ii) **, Baxter shall pay to Onconova ** for such Additional Indication and (B) upon receipt of Marketing Approval for an Additional Indication from the applicable Regulatory Authorit(y/ies) for the remaining **, as applicable, for such Additional Indication, Baxter shall pay to Onconova ** for such Additional Indication (in either case, pursuant to Section 9.2.4)

 

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Further, all Net Sales of Licensed Product for such Additional Indication(s) shall be aggregated with all other Licensed Product Net Sales, but **, and shall be calculated in the manner described in Section 4.3.1(i)(2) above.  Baxter’s failure to respond to Onconova’s proposal within the ** period referenced above shall be deemed Baxter’s deferring the decision to participate in the development for such Additional Indication.

 

(iii)                               If Baxter had previously deferred its decision to participate in the development of the Additional Indication and Onconova obtains a Marketing Approval for the Licensed Product for such Additional Indication from the EMA or, if filed separately in individual countries within the Licensed Territory, from the applicable Regulatory Authorities in the earlier to occur of **, Baxter shall reimburse Onconova for ** of all of the research and development expenses incurred by Onconova for such Additional Indication that are allocable  to the Licensed Territory. Further, provided that the Additional Indication has estimated peak gross sales greater than or equal to ** (or such lesser amount as may be mutually agreed by the Parties) on a ** basis (as mutually agreed upon by the Parties in writing or, if the Parties are not able to mutually agree on such estimated peak gross sales, as determined pursuant to Section 16.14), Baxter shall be obligated to pay to Onconova: (A) ** for each such Additional Indication to Onconova if the Marketing Approval for the Licensed Product for the Additional Indication was received from the EMA or (B)(1) ** for each such Additional Indication if the Marketing Approval for the Licensed Product for such Additional Indication was received in the earlier to occur of either **, and (2) ** for each such Additional Indication upon receipt of the Marketing Approval for the Licensed Product for such Additional Indication in the remaining **, as applicable (in either case, pursuant to Section 9.2.4).

 

Further, all Net Sales of Licensed Product for such Additional Indication(s) shall be aggregated with all other Licensed Product Net Sales, but **, and shall be calculated in the manner described in Section 4.3.1(i)(2) above.  Baxter shall thereafter be obligated to commercialize the Licensed Product for such Additional Indication(s) pursuant to Article VII.

 

(iv) The amount of the ** set forth in this Section 4.3 apply only to Additional Indications within hematology and oncology.  For all Additional Indications outside hematology and oncology, the research and development cost participation and royalties would be the same as in hematology and oncology, but the approval milestone would be commensurate with the market opportunity for the Additional Indication, as determined by mutual agreement of the Parties, and in the absence of such mutual agreement, pursuant to Section 16.14.

 

(v)                                 Under no circumstances shall Onconova have the right to commercialize the Licensed Product in the Licensed Territory, either by itself or through one or more Third Parties whether for the Initial Indications or any other indication including, without limitation, the Additional Indications.

 

(vi)  For purposes of determining what portion of the costs and expenses for the development of an Additional Indication are ‘allocable’ to the Licensed Territory and should be borne by Baxter, consideration shall be given not only to the existing Licensees and licensed territories for such Additional Indication but also to potential worldwide sales for the Additional Indication and such other factors as the Parties reasonably determine in good faith.  The portion that is allocated to Baxter must be mutually agreed by the Parties in writing and any disputes as to the allocation of the costs and expenses shall be resolved pursuant to Section 16.14.

 

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4.4.                            Investigator-Initiated Studies.  Subject to Onconova’s written approval on a case by case basis, Baxter and Onconova shall ** all costs and expenses related to the conduct and funding of investigator initiated studies for the Licensed Product that are recommended by Baxter.

 

4.5.                            Post-Approval Studies.  Baxter shall be responsible for, and shall bear all expenses related to, any post-Marketing Approval studies (including Phase 4 Clinical Trials) required by individual countries in the Licensed Territory for the Licensed Product.  Baxter shall bear all costs and expenses related to the establishment of any safety registry mandated as part of Marketing Approvals in the Licensed Territory.

 

4.6.                            Additional Development.  Except as set forth in Section 4.1, Section 4.2 and Section 4.3, Onconova shall not have any obligation to develop the Licensed Product in the Licensed Territory.

 

ARTICLE V.
  DEVELOPMENT COOPERATION

 

5.1.                            Sharing of Development Updates and Related Information.

 

5.1.1.                  Whenever any material event occurs in the course of the development of the Licensed Product by Onconova or its Licensees of which Onconova becomes aware, but in no event less than once every ** until such time as Marketing Approval for the Licensed Product has been obtained in each country of the Licensed Territory, Onconova shall disclose to Baxter Information regarding and resulting from all development activities with respect to the Compound and/or the Licensed Product conducted by Onconova or its Licensees, which Information is necessary or useful for development or commercialization of the Licensed Product in the Licensed Territory, and a description of the status of such development efforts.

 

5.1.2.                  Whenever any material event occurs in the course of the development of the Licensed Product by Baxter or its Sublicensees of which Baxter becomes aware, but in no event less than once every ** during the Term, Baxter shall disclose to Onconova Information regarding and resulting from all development activities with respect to the Compound and/or the Licensed Product conducted by Baxter or its Sublicensees which Information is necessary or useful for development or commercialization of the Licensed Product outside the Licensed Territory, and a description of the status of such development efforts.

 

5.1.3.                  Each Party shall have the right, at no additional expense, to use all Information disclosed to it pursuant to Section 5.1.1 or Section 5.1.2, as applicable, for the development and commercialization of the Licensed Product, and to grant to its Licensees (as to Onconova) or Sublicensees (as to Baxter) the right to use such Information for the development and commercialization of the Licensed Product, without any obligation to the other Party except as otherwise set forth in this Agreement.

 

5.1.4.                  Onconova and its Licensees shall have the right to cross-reference, for purposes of developing Licensed Products outside of the Licensed Territory, all Drug Approval Applications and other filings with Regulatory Authorities made by Baxter or its Sublicensees for Licensed Products.  Baxter and its Sublicensees shall have the right to cross-reference, for purposes of developing Licensed Products in the Licensed Territory, all Drug

 

21

 

Approval Applications and other filings with Regulatory Authorities made by Onconova or its Licensees.

 

5.2.                            Interaction with Licensees and Sublicensees.  Onconova shall facilitate Baxter’s interaction with Onconova’s Licensees involved in any development activities, by using Commercially Reasonable Efforts to coordinate, and if appropriate participate in, written and oral communications between Baxter and such Licensees, for purposes of developing Licensed Products in the Licensed Territory and enabling Baxter and such Licensees to comply with their respective obligations under applicable Law.  Baxter shall facilitate Onconova’s interaction with Baxter’s Sublicensees involved in any development activities, by using Commercially Reasonable Efforts to coordinate, and if appropriate participate in, written and oral communications between Baxter and such Sublicensees, for purposes of developing Licensed Products outside of the Licensed Territory and enabling Onconova and such Sublicensees to comply with their respective obligations under applicable Law.

 

5.3.                            Information Sharing Coordination.  The JSC shall coordinate the Parties’ sharing of Information as required under this Agreement or under applicable Laws:

 

5.3.1.                  Except as set forth in Section 4.2.2, Onconova shall share with Baxter, free of charge (except for amounts becoming due and payable to Onconova pursuant to Article IX), any and all Onconova Information generated or compiled during the term of this Agreement for use in development and commercialization of the Licensed Product in the Licensed Territory.

 

5.3.2.                  Except as set forth in Section 15.3, Baxter shall share with Onconova, free of charge, any and all Baxter Information generated or compiled during the term of this Agreement for use in development and commercialization of the Licensed Product outside of the Licensed Territory.

 

5.3.3.                  Baxter agrees that all Onconova Information delivered by Onconova or any of its Affiliates or Licensees hereunder shall, as between the Parties, at all times be and remain sole and exclusive property of Onconova or its Affiliates or Licensees, respectively.

 

5.3.4.                  Onconova agrees that all Baxter Information delivered by Baxter or any of its Affiliates or Sublicensees hereunder shall, as between the Parties, at all times be and remain sole and exclusive property of Baxter or its Affiliates or Sublicensees, respectively.

 

ARTICLE VI.
 REGULATORY MATTERS

 

6.1.                            Ownership of Regulatory Filings.  Subject to the obligations of the Parties under ARTICLE XV, Onconova shall own all Marketing Approvals and Regulatory Filings related to the Licensed Product in the Licensed Territory.

 

6.2.                            Regulatory Filing Responsibility.

 

6.2.1.                  Onconova will be responsible for the creation of a global dossier that will be the basis for all worldwide license applications. Baxter will provide specific technical regulatory expertise for assistance in developing the submission strategy and defining

 

22

 

technical content. Baxter’s global regulatory affairs representative will be invited to attend critical meetings with Regulatory Authorities in the Licensed Territory associated with the submission of Regulatory Filings for the Licensed Product in the Licensed Territory, and Onconova’s regulatory affairs representative will be invited to attend all meetings with key health authorities related to the commercialization of the Licensed Product in the Licensed Territory.

 

6.2.2.                  Without limitation of Section 6.2.4, and except for any Regulatory Filings required to be made in relation to safety registration activities and post-Marketing Approval studies under Section 4.5, Onconova shall be responsible for and shall have final decision making authority  with respect to the preparation and filing of Regulatory Filings for the Licensed Product in the Licensed Territory with respect to the Initial Indications and Additional Indications, utilizing the global dossier. Baxter shall be responsible for providing guidance and having final review (but not approval) of all Regulatory Filings for the Licensed Product in the Licensed Territory with respect to the Initial Indications and Additional Indications.  In Europe, Baxter will collaborate with Onconova on the assessment for Rapporteur and Co-Rapporteur with Baxter having the final authority on selection. Onconova will designate Baxter as its authorized agent in the Licensed Territory for all regulatory matters for the Licensed Product.  For global regulatory communications involving the Licensed Product, Baxter and Onconova will seek to develop such communications collaboratively and perform parallel reviews in accordance with mutually agreed upon defined timelines, subject to the rights of, and obligations owed to, Onconova Licensees.  If Baxter is unable to meet the pre-defined timelines or is resource constrained, Onconova may submit such regulatory communications without formal Baxter review in any territory.   Except as otherwise set forth in Section 4.2, Section 4.3 and in Section 6.2.3, each Party shall bear its own costs and expenses incurred in preparing and filing Regulatory Filings for the Licensed Product in the Licensed Territory.

 

6.2.3.                  Notwithstanding anything to the contrary herein, Baxter shall be responsible for (a) **, and (b) **, and Baxter shall reimburse Onconova for all such costs and expenses incurred by Onconova or its Affiliates within ** of Onconova’s invoice therefor.

 

6.2.4.                  Baxter shall be responsible for and shall have final decision making authority with respect to discussions and negotiations with Regulatory Authorities in respect of Marketing Approval and labeling discussions for the Licensed Product in the Licensed Territory, all of which shall be conducted by Baxter consistent with its obligation to obtain Marketing Approval for the Licensed Products pursuant to Section 7.1.1.

 

6.2.5.                  Notwithstanding the foregoing, each Party shall keep the other Party reasonably well informed with respect to the contents of any Regulatory Filings related to the Licensed Products in the Licensed Territory and discussions with the applicable Regulatory Authorities.  Onconova shall consider in good faith any comments that Baxter may provide with respect to the Regulatory Filings related to the Licensed Products in the Licensed Territory, and Baxter shall consider in good faith any comments that Onconova may provide with respect to Baxter’s negotiations with Regulatory Authorities in respect of Marketing Approval and labeling discussions for the Licensed Product in the Licensed Territory.

 

6.3.                            Safety Information; Adverse Events.

 

6.3.1.                  Each Party shall provide to the other Party all information of which it becomes aware (including, as to Baxter, information provided by its Sublicensees, and in the

 

23

 

case of Onconova, information provided by its Licensees) relating to the occurrence of any serious adverse event or any adverse event in connection with the Licensed Product as further detailed in the Supply Agreement and the attachments thereto (including, without limitation, the Quality Agreement and/or the pharmacovigilance agreement contemplated therein).

 

6.3.2.                  If the Parties do not execute a Supply Agreement pursuant to Section 8.1, then (a) each Party shall provide to the other Party the information described in Section 6.3.1 promptly after becoming aware of such information, and (b) details regarding the adverse event reporting and recall procedures shall be set out in a pharmacovigilance agreement which shall be negotiated and entered into by and between Onconova and Baxter ** prior to the anticipated First Commercial Sale of the Licensed Product in the Licensed Territory.

 

6.3.3.                  The JSC will coordinate the maintenance of safety databases and the preparation of global safety reports.

 

ARTICLE VII.
 LAUNCH AND COMMERCIALIZATION 
 OF LICENSED PRODUCT

 

7.1.                            Launch and Commercialization.

 

7.1.1.                  Baxter shall have full responsibility for all commercialization activities for the Licensed Product in the License Territory, at Baxter’s sole cost and expense.  Baxter shall market, promote, sell and otherwise commercialize the Licensed Product in the Licensed Territory in accordance with the terms of this Agreement and in material conformity with all applicable Laws.  Baxter shall use Commercially Reasonable Efforts to obtain Marketing Approval for the Licensed Product in each country of the Licensed Territory.

 

7.1.2.                  After receiving Marketing Approval of the Licensed Product for a country in the Licensed Territory, Baxter shall use Commercially Reasonable Efforts to market, promote and sell the Licensed Product in such country.  Baxter shall commence the marketing of the Licensed Product under either the Onconova Trademark or another trademark selected and owned or Controlled by Baxter, as Baxter in its sole discretion shall decide and as set forth in Article XI, in the Licensed Territory within ** after obtaining the first Marketing Approval of the Licensed Product. Baxter shall notify Onconova promptly of the date of First Commercial Sale of a Licensed Product in the Licensed Territory.

 

7.1.3.                  Baxter shall use Commercially Reasonable Efforts to obtain pricing reimbursement in accordance with the Commercialization Plan required under Section 7.1.4.  Further, Baxter shall use Commercially Reasonable Efforts to (a) launch commercially a Licensed Product in a given country in the Licensed Territory no later than ** after ** for such Licensed Product in such country, and (b) not withdraw a Licensed Product from sale or abandon for more than ** the sale of a Licensed Product; provided that Baxter shall not be in breach of the foregoing obligations to the extent that Baxter’s failure to launch or abandonment of the Licensed Product as described above results from: (y) the failure of Onconova to supply Licensed Product to Baxter pursuant to the terms of the Supply Agreement if executed pursuant to Section 8.1 or (z) any recall, withdrawal or field correction ordered by a Regulatory Authority or undertaken by Baxter on its own in good faith pursuant to Section 7.3, and further provided that if Section 15.4 applies, then Baxter

 

24

 

shall not be deemed in breach of this Section 7.1.3 and the Parties shall have the rights and obligations set forth in Section 15.4.

 

7.1.4.                  In addition to the foregoing requirements, Baxter shall undertake appropriate activities, reflecting Commercially Reasonable Efforts to commercialize and maximize sales of Licensed Product, related to pre-launch and launch commercialization of a Licensed Product in each of **, which activities may include the development of: (i) a market access strategy including Licensed Product pricing and reimbursement approval, (ii) a pre-launch and post launch publication strategy and the scheduling of targeted meetings for presentations of clinical data, (iii) a product supply chain distribution strategy, (iv) a patient education plan for the Licensed Products, (v) an overall sales and marketing strategy for the Licensed Product, (vi) patient support programs, (vii) a physician and hospital targeting plan and (viii) a sales execution plan.  By **, Baxter shall have prepared and delivered to Onconova a preliminary, non-binding commercialization plan documenting the activities, plans and strategies that will be implemented, consistent with the first sentence of this Section 7.1.4, to market and commercialize such Licensed Product.  Every ** thereafter, Baxter shall provide to Onconova an updated, non-binding version of such commercialization plan, and Baxter shall provide to Onconova a final, binding version of such commercialization plan (the “Commercialization Plan”) not less than the earlier of ** after filing of a Drug Approval Application in the Licensed Territory for a Licensed Product or ** prior to the planned commercial launch of a Licensed Product in the Licensed Territory.  The Parties shall review and discuss each version of the Commercialization Plan through the JSC, and Baxter will, in good faith, consider any proposed changes made by Onconova to each version of the Commercialization Plan.  When finalized, the Commercialization Plan shall be incorporated into this Agreement as Schedule 7.1.4.  Baxter shall use Commercially Reasonable Efforts to implement and execute the Commercialization Plan.

 

7.2.                            Coordination of Marketing Efforts.  The JSC shall coordinate communications regarding certain aspects of the Parties’ marketing efforts for the Licensed Product as follows:

 

7.2.1.                  Onconova shall share with Baxter free of charge any and all of marketing information in the Control of Onconova with respect to the Licensed Product, including, complete promotion plans and strategies, as well as all promotional and sales materials used for the launch and marketing of the Licensed Product outside the Licensed Territory.  Onconova shall use its Commercially Reasonable Efforts to obtain from its Licensees the right to provide such marketing information generated by such Licensees.

 

7.2.2.                  Baxter shall share with Onconova free of charge any and all of marketing information in the Control of Baxter with respect to the Licensed Product, including without limitation, complete promotion plans and strategies, as well as all promotional and sales activities and materials used for the launch and marketing of the Licensed Product in the Licensed Territory, whether generated by Baxter or its Sublicensees; provided, however, that Onconova may only use such information and materials for non-commercial purposes, including to audit Baxter’s compliance with the terms of this Agreement as well as to provide Baxter with any comments or recommendations.  Notwithstanding the foregoing, Onconova and its Licensees may use such information and materials for commercial purposes upon payment to Baxter of: (a) ** and (b) **.

 

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7.3.                            Recalls.

 

7.3.1.                  Generally.  In the event that either Party:

 

7.3.1.1.        determines that an event, incident, or circumstance has occurred which may result in the need for a Recall, Withdrawal, Field Correction or other removal of any Licensed Product or any lot or lots thereof from the market in the Licensed Territory;

 

7.3.1.2.        determines that an event, incident, or circumstance that could reasonably adversely affect the Licensed Product in the Licensed Territory has occurred which is reasonably likely to result in the need for a Recall, Withdrawal Field Correction or other removal of any Licensed Product, or any lot or lots thereof from the market;

 

7.3.1.3.        becomes aware that a Regulatory Authority is threatening or has initiated an action to remove the Licensed Product from the market in the Licensed Territory or, if such event could reasonably adversely affect the Licensed Product in the Licensed Territory, any Regulatory Authority is threatening or has initiated an action to remove the Licensed Product from the market; or

 

7.3.1.4.        is required by any Regulatory Authority to distribute a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product in the Licensed Territory or, if such event could reasonably adversely affect Licensed Product in the Licensed Territory, any Regulatory Authority has required distribution of a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product outside the Licensed Territory,

 

it shall promptly advise the other Party in writing with respect thereto, and shall provide to the other Party copies of all relevant correspondence, notices, and the like in the possession or Control of such Party.  In such event, Baxter shall have the sole authority to determine if a Recall or other removal of the Licensed Product is required in the Licensed Territory, and shall be responsible for conducting any such Recall, Withdrawal, Field Correction or other removal of any Licensed Product from the Licensed Territory, whether voluntary or involuntary, or taking such other remedial action required by applicable Laws in the Licensed Territory.

 

7.3.2.                  Onconova Assistance.  At Baxter’s reasonable request, Onconova shall assist Baxter with respect to any such recall or remedial action, and shall provide Baxter with all information that Baxter may reasonably request in connection with its dealings with a Regulatory Authority in connection with such recall or remedial action.

 

7.3.3.                  Recall Costs.  Notwithstanding anything else contained in this Agreement to the contrary, if a Recall, Withdrawal, Field Correction or other removal of any Licensed Product or any lot or lots thereof from the market in the Licensed Territory:

 

7.3.3.1.        **;

 

7.3.3.2.        **;

 

7.3.3.3.        **; and

 

7.3.3.4.        **.

 

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7.3.4.                  Activities Outside the Licensed Territory.  For avoidance of doubt, Onconova shall have the sole authority to determine if a Recall, Withdrawal Field Correction or other removal of the Licensed Product is required outside of the Licensed Territory and shall bear all costs and expenses incurred therewith.

 

7.4.                            Parallel Imports.

 

7.4.1.                  Onconova shall not at any time during the Term enter into any agreement whereby it would: (a) sell, market, promote or distribute, directly or indirectly, the Licensed Product in the Licensed Field in the Licensed Territory; or (b) sell or distribute the Licensed Product to any Third Party outside the Licensed Territory if Onconova has knowledge that such person intends to sell such Licensed Product in the Licensed Field in the Licensed Territory.  To the extent permitted by Law, Onconova shall secure from such Third Party its obligation to abide by the restrictions relating to inside the Licensed Territory contained in this Section 7.4.1, including refraining from knowingly engaging, directly or indirectly, in parallel importation or dealing in “grey market” products in connection with its sale and distribution of the Licensed Products.  Onconova will use Commercially Reasonable Efforts to take legal action against its Licensees as is necessary to prevent the importation into the Licensed Territory of Licensed Product sold and intended for sale outside of the Licensed Territory.

 

7.4.2.                  Baxter shall not at any time during the Term enter into any agreement whereby it would: (a) sell, market, promote or distribute, directly or indirectly, the Licensed Product in the Licensed Field outside of the Licensed Territory; or (b) sell or distribute the Licensed Product to any Third Party inside the Licensed Territory if Baxter has knowledge that such person intends to sell such Licensed Product in the Licensed Field outside of the Licensed Territory. To the extent permitted by Law, Baxter shall secure from such Third Party its obligation to abide by the restrictions relating to inside the Licensed Territory contained in this Section 7.4.2, including refraining from knowingly engaging, directly or indirectly, in parallel importation or dealing in “grey market” products in connection with its sale and distribution of the Licensed Products.  Baxter will use Commercially Reasonable Efforts to take legal action against its Sublicensees as is necessary to prevent the exportation outside of the Licensed Territory of Licensed Product sold and intended for sale inside of the Licensed Territory.

 

ARTICLE VIII.
  MANUFACTURING AND SUPPLY

 

8.1.                            Supply Agreement Covenant.

 

8.1.1.                  The Parties acknowledge and agree that it was their original intent that the Supply Agreement would be executed concurrent with the execution of this Agreement.  Due to the fact that,**, the Parties were unable to finalize the Supply Agreement.  Notwithstanding the foregoing, the Parties agree that promptly following **, they shall enter into good faith negotiations directed toward the execution of a Supply Agreement that is satisfactory to the Parties in both form and substance.  The Supply Agreement shall include: (a) representations, warranties, covenants and indemnities substantially consistent with the draft manufacturing and supply agreement delivered by Baxter to Onconova ** and (b) ** to ensure that all such Third Party contract manufacturers are qualified as Baxter suppliers.

 

27

 

8.1.2.                  If the Parties have not executed the Supply Agreement by **, which date may be extended one time ** upon Onconova’s request, then Section 8.1.1 shall cease to apply and be null and void, and Baxter shall have the right, in its sole discretion, to continue such negotiations with Onconova (and Onconova shall in good faith participate therein) but shall also have the right to (a) negotiate with and enter into one or more agreements with Third Parties for the manufacture and supply to Baxter and its Affiliates and agents of their collective requirements for Licensed Product in the Licensed Territory and/or (b) manufacture the Licensed Products on its own or through its Affiliates.  If Baxter engages a Third Party or elects to manufacture the Licensed Products on its own, Onconova shall cooperate with Baxter reasonable requests, **, to engage in a technology transfer to allow Baxter to manufacture Product (through the first commercial batch of Product) itself or by through its designated Third Party manufacturer by transferring all know-how, technology, trade secrets and patent rights owned or Controlled by Onconova that are necessary to manufacture Product (including, without limitation, the Onconova Know-How), thereby enabling Baxter (or such Third Party) to manufacture the Licensed Products.

 

ARTICLE IX.
 PAYMENTS

 

9.1.                            Upfront Fee.  In consideration of the licenses and other rights granted to Baxter under this Agreement, and to compensate Onconova for the costs and expenses it will incur in generating and compiling the Onconova Information and in further developing the Compound, Baxter shall pay to Onconova, no later than ** after the Effective Date, a one-time, non-refundable, non-creditable license fee equal to fifty million dollars (USD 50,000,000).

 

9.2.                            Milestones.

 

9.2.1.                  Development Milestones.  As additional consideration for the licenses and other rights granted to Baxter under this Agreement, and to compensate Onconova for the costs and expenses it will incur in generating and compiling the Onconova Information and in further developing the Compound, Baxter shall pay to Onconova the following non-creditable, non-refundable amounts within ** after the first occurrence of each of the following events (each, a “Development Milestone”):

 

	
Event
    	
 
    	
Milestone
   Payment
    
	
(a) **
    	
 
    	
**
    
	
 
    	
 
    	
 
    
	
(b) **
    	
 
    	
**
    
	
 
    	
 
    	
 
    
	
(c) **
    	
 
    	
**
    
	
 
    	
 
    	
 
    
	
(d) **
    	
 
    	
 
    
	
**
    	
 
    	
**
    
	
**
    	
 
    	
**
    

 

28

 

	
**
    	
 
    	
**
    
	
 
    	
 
    	
 
    
	
(e) **
    	
 
    	
 
    
	
**  

 

**  

 

-    **  

 

**  

 

-    **  

 

**
    	
 
    	
**   

 

 

 

 

 

**
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
**
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
**
    
	
 
    	
 
    	
 
    
	
(f) **
    	
 
    	
**
    
	
(g) **
    	
 
    	
**
    

 

9.2.2.                  Sales Milestones.  As additional consideration for the licenses and other rights granted to Baxter under this Agreement, Baxter shall pay to Onconova the following non-creditable, non-refundable amounts within ** ** after the first occurrence of each of the following events (each, a “Sales Milestone”):

 

	
Annual Calendar Year 
   Net Sales Level
    	
 
    	
Milestone
   Payment
    
	
**
    	
 
    	
**
    
	
**
    	
 
    	
**
    
	
**
    	
 
    	
**
    
	
**
    	
 
    	
**
    

 

29

 

For purposes of clarity, Baxter shall only be obligated to make a Sales Milestone payment corresponding to each of the foregoing events only once, regardless of whether such Sales Milestone event occurs during more than one calendar year.  If more than one Sales Milestone event are first achieved in the same calendar year, Baxter shall be obligated to pay the corresponding milestone payment for all such events.

 

9.2.3.                  Payment in Cash.  All payments under this Section 9.2 shall be made in USD.  All payments under Section 9.2  shall be made without setoff or deduction of any kind.

 

9.2.4.                  Milestone Notification.  Baxter shall notify Onconova of the achievement of each of the Development Milestones within ** of its achievement, and each of the Sales Milestones within ** after Baxter or its Sublicensee closes its books for the relevant annual period in which such Sales Milestone payment becomes due.  All payments under Section 9.2 shall be made within ** after achievement of the applicable Development Milestone or Sales Milestone, except as set forth below.

 

(a)                                 With respect to the ** set forth in Section 9.2.1, if **, then no later than ** after **, Baxter shall pay to Onconova ** and shall pay royalties for Net Sales in respect of ** at the ** Royalty Rates.

 

(b)                                 If no Competing Product for treatment, amelioration and/or prevention of refractory MDS has received Marketing Approval in any country in the European Union within ** for MDS IV by the EMA or, if filed separately in individual countries in the Licensed Territory, within ** for MDS IV (if granted by **), then on **, Baxter shall pay the ** to Onconova and a ** payment accounting for the difference between the ** that should have been paid and the ** that were paid to Onconova.

 

(c)                                  If a Competing Product for the treatment, amelioration and/or prevention of refractory MDS receives Marketing Approval in the European Union within ** for MDS IV from the EMA or, if filed separately, from the applicable Regulatory Authorities for **, and Baxter had previously paid to Onconova the **, then Baxter shall withhold ** payable to Onconova until **, at which point Baxter shall resume paying ** due to Onconova under this Agreement.

 

9.3.                            Royalty Payment; Audits.

 

9.3.1.                  Royalty Payments.  In addition to the payments specified in Sections 9.1 and 9.2, in consideration of the rights granted to Baxter under this Agreement, Baxter shall pay to Onconova the following incremental royalties on annual Net Sales of the Licensed Product in the Licensed Territory:

 

	
Annual Calendar Year 
   Net Sales in the Licensed
   Territory
    	
 
    	
“**
   Royalty
   Rates”
    	
 
    	
“**
   Royalty
   Rates”
    
	
**
    	
 
    	
**
    	
 
    	
**
    
	
**
    	
 
    	
**
    	
 
    	
**
    
	
**
    	
 
    	
**
    	
 
    	
**
    
	
**
    	
 
    	
**
    	
 
    	
**
    

 

30

 

(a)  If Onconova obtains Marketing Approval for the Licensed Product for MDS IV from the EMA or, if filed separately in individual countries in the Licensed Territory, from the applicable Regulatory Authorities for the earlier to occur of **, or (ii) **, without undertaking **, then the ** Royalty Rates above shall apply, (b) if Onconova **, have resulted in the granting of Marketing Approval for MDS IV from the EMA or, if filed separately in individual countries in the Licensed Territory, from the applicable Regulatory Authorities for the earlier to occur of either (i) **, or (ii) **, and no Competing Product for the treatment, amelioration and/or prevention of refractory MDS has received Marketing Approval from the EMA or from the applicable Regulatory Authorities for the ** referenced in clauses (i) or (ii) above, as applicable, where Marketing Approval for MDS IV was granted **, within ** of the granting of Marketing Approval for MDS IV, the ** Royalty Rates above shall apply or (c) if Onconova is required to ** for MDS IV in order to obtain Marketing Approval for MDS IV from the EMA or, if filed separately in individual countries in the Licensed Territory, from the applicable Regulatory Authorities for the earlier to occur of either (i) **, or (ii) any **, and the EMA Marketing Approval for MDS IV or the last Marketing Approval for ** referenced in clause (i) or clause (ii) above, as applicable, is granted **, then the ** Royalty Rates above shall apply.

 

9.3.2.                  Royalty Term.  Baxter’s obligation to pay royalties pursuant to Section 9.3.1 shall expire, on a country-by-country and Licensed Product-by-Licensed Product basis, upon the last to expire of (a) the last to expire Valid Claim of an Onconova Patent or Joint Patent in such country that covers the manufacture, use, sale, offer for sale or importing of such Licensed Product in the Licensed Field in such country, (b) all applicable Regulatory Exclusivity for such Licensed Product in the Licensed Field in such country, and (c) ** from the First Commercial Sale of such Licensed Product in such country (the “Royalty Term”).  If, during any portion of the foregoing ** period from First Commercial Sale of a Licensed Product in a country in the Licensed Territory, there is no Valid Claim and no applicable Regulatory Exclusivity as described in clauses (a) and (b) above exists, then royalties shall be payable at the rate of ** of Net Sales.

 

9.3.3.                  Royalty Payment Timing; Royalty Reports.  Payment of royalties pursuant to this Section 9.3 shall be due ** after the end of each calendar quarter and shall be made in USD.  All payments under this Section 9.3 shall be made without setoff or deduction of any kind.  Upon payment of royalties, Baxter shall deliver to Onconova the respective Sales Report.

 

9.3.4.                  Accounting.

 

(a)                                 Baxter agrees to keep, and to require its Affiliates and Sublicensees to keep, full, clear and accurate records for a minimum period of ** after the relevant payment is owed pursuant to this Agreement, setting forth the sales and other disposition of Licensed Products sold or otherwise disposed of in sufficient detail to enable royalties and compensation payable to Onconova hereunder to be determined.

 

(b)                                 Onconova and Temple University each shall have the right, no more than once during each calendar quarter during the Term and for ** thereafter, to have an independent certified public accountant (“Accountant”) of its own selection (subject to Baxter’s acceptance of such Accountant, not to be unreasonably withheld, conditioned or delayed) and at its own expense audit the relevant books and records of account of Baxter in connection with the payment of royalties and any other amounts under this Agreement during normal business hours, and upon reasonable prior notice, to determine whether appropriate

 

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accounting has been performed and payments have been made to Onconova hereunder; provided that such Accountant shall be bound to treat all information reviewed during such audit as confidential, and does not disclose to Onconova any information other than information which shall have previously been given to Onconova pursuant to any provision of this Agreement or information regarding the payments due to or by Onconova as a result of such audit.  Notwithstanding the right of Onconova and Temple University to each conduct the audit contemplated by this Section 9.3.4(b), Onconova shall endeavor to minimize the disruptions on Baxter’s operations by conducting its audit at the same time that Temple University conducts its audit.

 

(c)                                  If the Accountant determines that the Sales Report has not been true or accurate, then Baxter shall refund Onconova for the costs of the Accountant if Baxter has underpaid such royalties by more than **, and the royalties shall be re-calculated on the basis of the Accountant’s findings.  Such Accountant’s findings shall be binding for both Parties absent manifest error.

 

(d)                                 Royalties payable under this Section 9.3 shall be payable only once with respect to a particular unit of Licensed Product and shall be paid only once regardless of the number of Patents applicable to such Licensed Product.

 

9.4.                            Upstream Agreements.  For clarity, Onconova shall be solely responsible for paying all amounts due pursuant to the Upstream Agreements.

 

9.5.                            Payment Mechanics.

 

9.5.1.                  Payment Account.  All payments to be made to Onconova under this Agreement shall be made by wire transfer to the following account:

 

**

 

or such other account as may be specified by Onconova in writing to Baxter.

 

9.5.2.                  Currency Conversion.  When calculating Net Sales, the amount of such sales in foreign currencies shall be converted into USD using the standard methodologies employed by Baxter for consolidation purposes.  Baxter shall provide reasonable documentation of the calculation and reconciliation of the conversion figures on a Licensed Product-by-Licensed Product and country-by-country basis as part of its report of Net Sales for the period covered under the applicable report.

 

9.6.                            Taxes.  All payments under this Agreement shall be made without any deduction or withholding for or on account of any tax, except as set forth in this Section 9.6.  The Parties agree to cooperate with one another and use reasonable efforts to minimize under applicable Law obligations for any and all income or other taxes required by Law to be withheld or deducted from any of the royalty and other payments made by or on behalf of a Party hereunder (“Withholding Taxes”).  The applicable paying Party under this Agreement (the “Paying Party”) shall, if required by Law, deduct from any amounts that it is required to pay to the recipient Party hereunder (the “Recipient Party”) an amount equal to such Withholding Taxes; provided that the Paying Party shall give the Recipient Party reasonable notice prior to paying any such Withholding Taxes.  Such Withholding Taxes shall be paid to the proper taxing authority for the Recipient Party’s account and, if available, evidence of such payment shall be secured and sent to recipient within ** of such payment.  The Paying

 

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Party shall, at the Recipient Party’s cost and expense, do all such lawful acts and things and sign all such lawful deeds and documents as the Recipient Party may reasonably request to enable the Paying Party to avail itself of any applicable legal provision or any double taxation treaties with the goal of paying the sums due to the Recipient Party hereunder without deducting any Withholding Taxes.

 

Notwithstanding anything to the contrary herein:

 

(i) based on Onconova being a US corporation and thus, a resident of the United States as that term is defined in Article 4 of the US-Switzerland Income Tax Treaty, Baxter, who will make all payments under this Agreement to Onconova, will take the position that any such payment is treated for all tax purposes as being sourced in Switzerland and being a royalty exempt from Withholding Taxes pursuant to Article 12 of the US-Switzerland Income Tax Treaty, provided that Onconova shall have provided Baxter on a timely basis with the  documentation required to support such an exemption, and provided there are no changes to the treaty that would affect the exemption; and

 

(ii) if there is an assignment of the Agreement by Baxter or the payment of the royalty by a party other than Baxter that results in the imposition of a Withholding Tax then there will be an obligation on the party making such payment and Baxter to increase or “gross up” any payments made hereunder so that the net amount paid, after deduction of Withholding Taxes, shall equal the amount that would have been paid if no Withholding Taxes had been imposed.

 

9.7.                            Late Payments.  If Onconova does not receive payment of any sum due to it under this Agreement on or before the due date, simple interest shall thereafter accrue on the sum due to Onconova from the due date until the date of payment at the ** per annum or the maximum rate allowable by applicable Law, whichever is less.

 

ARTICLE X.
  INVENTIONS; ACCESS TO IMPROVEMENTS; PATENTS

 

10.1.                     Improvements and Inventions.

 

10.1.1.           The Parties acknowledge that Baxter and its Sublicensees may improve or modify the Licensed Products or otherwise make Inventions in the course of exercising Baxter’s rights and performing its obligations under this Agreement, and that Onconova and its Licensees may improve or modify the Licensed Products and otherwise make Inventions as Onconova and its Licensees continue to develop the Licensed Product outside the Licensed Territory and to manufacture Licensed Product for supply to Baxter for the Licensed Territory.

 

10.1.2.           Onconova will use Commercially Reasonable Efforts to obtain from its Licensees Control of Improvements made or developed by or on behalf of such Licensees, as well as Control of all intellectual property rights therein that are owned or controlled by such Licensees, in each case as necessary to provide Baxter access to rights to such Improvements as part of the Onconova Information, Onconova Know-How or Onconova Patents, as applicable, in the Licensed Territory pursuant to this Agreement.  Any such Improvements made by or on behalf of Onconova’s Licensees of which Onconova obtains Control shall be included in the Onconova Know-How, and all Patents claiming such Improvements of which Onconova obtains Control shall be included in the Onconova Patents; provided that if any

 

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royalties or other fees are required to be paid to a Licensee in respect of such rights, Baxter shall be responsible for such payments to the extent reasonably allocable to the Licensed Product in the Licensed Territory.

 

10.1.3.           Baxter will use Commercially Reasonable Efforts to obtain from its Sublicensees Control of Improvements made or developed by or on behalf of such Sublicensees, as well as Control of all intellectual property rights therein that are owned or controlled by such Sublicensees, in each case as necessary to provide Onconova access to rights to such Improvements as part of the Baxter Information, Baxter Know-How or Baxter Patents, as applicable, pursuant to this Agreement.  Any such Improvements made by or on behalf of Baxter’s Sublicensees of which Baxter obtains Control shall be included in the Baxter Know-How, and all Patents claiming such Improvements of which Baxter obtains Control shall be included in the Baxter Patents; provided that if any royalties or other fees are required to be paid to a Sublicensee in respect of such rights, Onconova shall be responsible for such payments to the extent reasonably allocable to the Licensed Product outside the Licensed Territory.

 

10.1.3.1.           Onconova shall have the right to grant sublicenses under Section 2.2 with respect to Baxter Know-How and Baxter Patents that constitute Improvements (“Baxter Improvements”) to any Licensees who agree to provide to Onconova Control of Improvements made by or on behalf of such Licensee (“Licensee Improvements”) on a royalty-free, fully-paid basis, enabling Onconova to provide to Baxter a sublicense pursuant to Section 2.1 under such Licensee Improvements at no additional cost to Baxter.  If Onconova desires to grant sublicenses to Baxter Improvements under Section 2.2 to any Licensees who do not agree to provide to Onconova Control of Licensee Improvements made by or on behalf of such Licensee on such a royalty-free, fully-paid basis, the Parties will negotiate commercially reasonable terms under which Onconova may grant such a sublicense under Baxter Improvements to such Licensee for up to ** after Onconova requests that it have the right to grant such a sublicense to such Licensee.  In such case, Onconova may only grant a sublicense under such Baxter Improvements to such Licensee after the Parties agree in writing on the applicable commercial terms.

 

10.1.3.2.           Baxter shall have the right to grant sublicenses under Section 2.1 with respect to Onconova Know-How and Onconova Patents that constitute Improvements (“Onconova Improvements”) to any Sublicensees who agree to provide to Baxter Control of Improvements made by or on behalf of such Sublicensee (“Sublicensee Improvements”) on a royalty-free, fully-paid basis, enabling Baxter to provide to Onconova a sublicense pursuant to Section 2.2 under such Sublicensee Improvements at no additional cost to Onconova.  If Baxter desires to grant sublicenses to Onconova Improvements under Section 2.1 to any Sublicensees who do not agree to provide to Baxter Control of Sublicensee Improvements made by or on behalf of such Sublicensee on such a royalty-free, fully-paid basis, the Parties will negotiate commercially reasonable terms under which Baxter may grant such a sublicense under Onconova Improvements to such Sublicensee for up to ** after Baxter requests that it have the right to grant such a sublicense to such Sublicensee.  In such case, Baxter may only grant a sublicense under such Onconova Improvements to such Sublicensee after the Parties agree in writing on the applicable commercial terms.

 

10.2.                     Ownership of Inventions.  Inventorship shall be determined in accordance with U.S. patent laws.  Any Invention made solely by employees, agents, or independent contractors of a Party or its Affiliates in the course of performing activities under this Agreement, together with all intellectual property rights therein (“Sole Inventions”) shall be

 

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owned by such Party; provided that Onconova shall own, and Baxter (on behalf of itself and its Affiliates) hereby assigns to Onconova, all Sole Inventions related to the composition of matter or use of the Licensed Product and all other Sole Inventions specifically related to the Licensed Product.  Any Invention made jointly by at least one (1) employee, agent, or independent contractor of each Party or such Party’s Affiliate, together with all intellectual property rights therein (“Joint Inventions”), shall be owned jointly by the Parties in accordance with joint ownership interests of co-inventors under U.S. patent laws, with each joint Party having, unless otherwise set forth in this Agreement, the unrestricted right to license and grant rights to sublicense any such Joint Invention; provided that Onconova shall own, and Baxter (on behalf of itself and its Affiliates) hereby assigns to Onconova, all Joint Inventions related to the composition of matter or use of the Licensed Product and all other Joint Inventions specifically related to the Licensed Product.  To the extent necessary to effect the foregoing, each Party hereby grants to the other party a nonexclusive, royalty-free, worldwide license, with the right to grant sublicenses, under such Party’s interest in Joint Inventions, for any and all purposes; provided that the foregoing shall not apply to any uses of such Joint Inventions for which the receiving Party otherwise retains an exclusive license pursuant to this Agreement, with such proviso to apply only for so long as such receiving Party retains such exclusive license.  For the avoidance of doubt, Baxter Inventions and Joint Inventions relating generally to the formulation and/or administration of pharmaceutical products do not relate to the composition of matter or use of the Licensed Product and shall not be assigned solely to Onconova, but (in the case of Joint Inventions) shall remain jointly owned by the Parties or (in the case of Baxter Inventions) shall be deemed Baxter Know-How and, if the subject of patent rights, Baxter Patents.

 

10.3.                     Disclosure of Inventions.  Each Party shall promptly disclose to the other Party in writing any Invention disclosures, or other similar documents, submitted to it by its employees, agents, or independent contractors describing each and every Invention that may be either a Sole Invention or a Joint Invention, and all Information relating to such Invention.

 

10.4.                     Prosecution of Patents.

 

10.4.1.           Onconova Patents Other than Joint Patents.  Onconova shall have the first right and authority to file, prosecute, and maintain Onconova Patents, other than Joint Patents, on a worldwide basis at its sole discretion, subject to this Section 10.4.1.  The Parties shall ** all costs of such filing, prosecution and maintenance in the Licensed Territory; otherwise, **.  To the extent that there are multiple parties benefiting from the Onconova Patents in the Licensed Territory, then the Parties shall mutually agree upon an appropriate allocation of such Patent expenses.  Onconova shall provide Baxter with the opportunity to review and comment on any and all prosecution efforts, but in no case less than **, if reasonably practicable, prior to any filing deadlines, regarding the Onconova Patents within the Licensed Territory; provided that Onconova shall have final control over such prosecution efforts after reasonably considering Baxter’s comments, if any.  Onconova shall provide Baxter with a copy of material communications from patent authorities in the Licensed Territory regarding the Onconova Patents, and shall provide drafts of any material filings or responses to be made to such Patent authorities in a timely manner.  Notwithstanding the foregoing, if Onconova determines in its sole discretion to abandon or not maintain in the Licensed Territory any Onconova Patent, other than a Joint Patent, Onconova shall provide Baxter with ** prior written notice of such determination and, if Baxter so requests, shall provide Baxter with the opportunity to prosecute and maintain such Onconova Patent in the Licensed Territory in the name of Onconova.  Thereafter, the Parties shall ** all expenses of

 

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filing, prosecuting and maintaining such Onconova Patent in the Licensed Territory.

 

10.4.2.           Upstream Patents.  Baxter acknowledges that certain of the Onconova Patents are subject to the rights of Onconova’s licensors pursuant to the Upstream Agreements.  Notwithstanding the provisions of Section 10.4.1, Baxter agrees that the rights of such licensors are precedent to Onconova’s obligations, and Baxter’s rights under Section 10.4.1, and Onconova compliance with the terms of the Upstream Agreements, shall not, if contrary to the terms of Section 10.4.1, constitute a breach hereof, including with respect to the ** review period described above; provided, however, that Onconova shall notify Onconova’s licensors pursuant to the Upstream Agreements of its desire to abandon or not maintain any Onconova Patent in the Licensed Territory only after (a) Onconova first provides to Baxter ** prior written notice of such intent as provided in the preceding paragraph and (b) Baxter elects not to prosecute and maintain such Onconova Patents within such ** period.

 

10.4.3.           Joint Patents.  With respect to any potentially patentable Joint Invention, the Parties shall meet and agree upon which Party shall prosecute and maintain Patent applications covering such Joint Invention (any such Patent application and any Patents issuing therefrom, a “Joint Patent”) in particular countries and jurisdictions throughout the world.  Unless otherwise agreed by the Parties, Baxter will prosecute and maintain any Joint Patents in the Licensed Territory, and Onconova will prosecute and maintain the Joint Patents outside the Licensed Territory, subject to the Parties coordinating their efforts as appropriate to make such prosecution activities as efficient, convenient, and harmonious as possible.  The Parties ** all expenses of filing, prosecuting and maintaining such Joint Patents.  The Party that prosecutes a Joint Patent (the “Prosecuting Party”) shall provide the other Party the opportunity to review and comment on any and all such prosecution efforts regarding the applicable Joint Patent in the particular jurisdictions, and such other Party shall provide the Prosecuting Party reasonable assistance in such efforts; provided that the Prosecuting Party shall have final control over such prosecution efforts after reasonably considering the other Party’s comments, if any.  The Prosecuting Party shall provide the other Party with a copy of all material communications from any Patent authority in the applicable jurisdictions regarding the Joint Patent being prosecuted by such Party, and shall provide drafts of any material filings or responses to be made to such patent authorities a reasonable amount of time in advance of submitting such filings or responses.  In particular, each Party agrees to provide the other Party with all information necessary or desirable to enable the other Party to comply with any duty of candor and/or duty of disclosure requirements of any Patent authority.  Except to the extent a Party is restricted by the licenses granted by such Party to the other Party under the terms of this Agreement, and/or the other covenants contained in this Agreement, each Party shall be entitled to practice, and grant licenses to Third Parties and Affiliates of such Third Parties to practice, the Joint Patents and all Joint Inventions without restriction or an obligation to account to the other Party, and the other Party shall consent and hereby consents, without additional consideration, to any and all such licenses.

 

10.4.4.           Cooperation in Prosecution.  Each Party shall provide the other Party all reasonable assistance and cooperation in the Patent prosecution efforts described above in this Section 10.4, including providing any necessary power of attorney and executing any other required documents or instruments for such prosecution.

 

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10.5.                     Infringement of Patents by Third Parties.

 

10.5.1.           Notification.  Each Party shall promptly notify the other Party in writing of any existing or threatened infringement of the Onconova Patents (including Joint Patents) of which it becomes aware in the Licensed Territory, and shall provide to the other Party any and all evidence and information available to such Party regarding such alleged infringement.

 

10.5.2.           Product Infringement of Onconova Patents (Including Joint Patents) in the Licensed Territory.

 

(a)                                 If a Party becomes aware of any actual or alleged existing or threatened infringement by a Third Party of any Onconova Patent, including any Joint Patent, by making, using, importing, offering for sale, or selling the Compound and/or the Licensed Product (such activities, “Product Infringement”) in the Licensed Territory, such Party shall notify the other Party as provided in Section 10.6.1.  Baxter shall have the first right, but not the obligation, to bring an appropriate suit or other action against any person or entity engaged in such Product Infringement in the Licensed Territory, subject to Section 10.5.2(b).  Baxter shall have a period of ** after such notification to or by Baxter, to elect to so enforce such Onconova Patent in the Licensed Territory.  If Baxter does not so elect, Baxter shall so notify Onconova in writing during such **, or ** prior to any deadline relating to loss of any rights with respect to the Product Infringement, whichever is earlier, and Onconova shall have the right, but not the obligation, to commence a suit or take action to enforce such Onconova Patent against such Third Party allegedly perpetrating such Product Infringement.  Each Party shall provide to the Party enforcing any such rights under this Section 10.5.2(a) reasonable assistance in such enforcement, including joining an action as a party plaintiff if so required by Laws to pursue such action, at the enforcing Party’s sole expense.  The enforcing Party shall keep the other Party regularly informed of the status and progress of such enforcement efforts, and shall reasonably consider the other Party’s comments on any such efforts.  Except as set forth above, the enforcing Party shall bear and be responsible for all costs incurred in connection with each Party’s activities under this Section 10.5.2(a).

 

(b)                                 The Party not bringing an action with respect to Product Infringement under this Section 10.5.2 shall be entitled to separate representation in such matter by counsel of its own choice and at its own expense, but such Party shall at all times cooperate fully with the Party bringing such action.  Additionally, the Party not bringing an action under this Section 10.5.2 may have an opportunity to participate in such action to the extent that the Parties may mutually agree at the time the other Party elects to bring an action hereunder.

 

10.5.3.           Product Infringement of Onconova Patents (including Joint Patents) Outside the Licensed Territory; Non-Product Infringement of Onconova Patents.

 

(a)                                 For any and all infringement of Onconova Patents other than Joint Patents anywhere outside the Licensed Territory, and for any and all infringement other than Product Infringement of the Onconova Patents  (other than Joint Patents) in the Licensed Territory, Onconova shall have the sole and exclusive right to bring an appropriate suit or other action against any person or entity engaged in such infringement of such Patents, in its sole discretion, and as between the Parties Onconova shall bear all related expenses and retain all related recoveries.

 

(b)                                 If a Third Party infringes a Joint Patent by Product Infringement activities outside the Licensed Territory, Onconova shall have the sole and

 

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exclusive right to bring an appropriate suit or other action against any person or entity engaged in such infringement of such Joint Patent, in its sole discretion, and as between the Parties Onconova shall bear all related expenses and retain all related recoveries.  Baxter shall provide to Onconova reasonable assistance in such enforcement, at Onconova’ request and expense, including without limitation joining such action as a party plaintiff if so required by Laws to pursue such action.

 

10.5.4.           Non-Product Infringement of Joint Patents Anywhere in the World.  For infringement of the Joint Patents that is not Product Infringement, the Parties shall confer to determine which Party shall have the first right to bring an appropriate suit or other action against any person or entity engaged in such infringement, and the manner in which they shall bear costs and share related recoveries of such suit or action.  The Party that brings such suit or actions (the “Enforcing Party”) shall keep the other Party regularly informed of the status and progress of such enforcement efforts, and shall reasonably consider the other Party’s comments on any such efforts.  The other Party shall cooperate with the enforcing Party in enforcing Joint Patents against such infringement, without limitation joining an action as a party plaintiff if so required by Laws to pursue such action.  If the Parties are unable to reach agreement upon which Party shall bring an appropriate suit or other action against any person or entity engaged in such infringement of such Joint Patent within **, or ** prior to any deadline relating to loss of any rights with respect to such infringement, whichever is earlier, then Baxter shall have the first right, but not the obligation, to bring such suit or other actions against such infringement in the Licensed Territory at its sole expense, and Onconova shall have the first right, but not the obligation, to bring such suit or other actions against such infringement outside of the Licensed Territory.  The other Party shall have the right to participate in such actions at its expense upon written notice to the other Party.

 

10.5.5.           Settlement.  Baxter shall not settle any claim, suit, or action that it brings under this Section 10.5 involving Onconova Patents (excluding Joint Patents) in any manner that would negatively impact Onconova, including settlements involving the ownership, validity or enforceability of any of the Onconova Patents, or that do not include a full and unconditional release from all liability of Onconova, without the prior written consent of Onconova, which shall not be unreasonably withheld, conditioned or delayed.  Onconova shall not settle any claim, suit, or action that it brings under this Section 10.5 involving Onconova Patents (excluding Joint Patents) in the Licensed Territory in any manner that would negatively impact Baxter, without the prior written consent of Baxter, which shall not be unreasonably withheld, conditioned or delayed.  Moreover, any settlement by Baxter involving Onconova Patents (excluding Joint Patents), or by Onconova involving Onconova Patents (excluding Joint Patents) in the Licensed Territory, that (i) results in cross-licensing or (ii) results in sublicenses to Third Parties shall require the other Party’s prior written consent.  Neither Party shall settle any claim, suit, or action that it brings under this Section 10.5 involving Joint Patents in any manner that would negatively impact the other Party, including the ownership, validity or enforceability of any of the Joint Patents, or if the settlement does not include a full and unconditional release from all liability of the other Party, without the prior written consent of such other Party.

 

10.5.6.           Allocation of Proceeds.  Except as otherwise provided in this Section 10.5, if either Party recovers monetary damages from any Third Party in a suit or action brought under this Section 10.5, whether such damages result from the infringement of Baxter Patents or Onconova Patents, such recovery shall be allocated **.

 

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10.6.                     Infringement of Third Party Rights in the Licensed Territory.

 

10.6.1.           Notice. If the development, manufacture, use, sale, offer for sale, import or export of the Licensed Product in the Licensed Field and in the Licensed Territory results in a claim for Patent infringement by a Third Party, the Party first having notice of such claim shall promptly notify the other Party in writing of such a claim. Following such notice, the Parties agree to enter into either a joint defense or common interest agreement, under which agreement the Parties can share the known facts of such infringement in reasonable detail, if they are advised to do so by counsel.

 

10.6.2.           Third Party Claims. Baxter shall assume control of the defense of any claims brought by Third Parties alleging infringement of Third Party intellectual property rights in connection with the development, manufacture, use, sale, offer for sale, import or export of the Licensed Product in the Licensed Field in the Licensed Territory, represented by its own counsel. If requested by Baxter, Onconova agrees to join in any litigation, and in any event shall reasonably cooperate with Baxter, at Baxter’s expense. Baxter shall have the exclusive right to settle any such claim without the consent of Onconova, unless such settlement shall negatively impact on Onconova, including without limitation on the ownership, validity or enforceability of any Onconova Patents. Any expenses incurred in defending any such claims shall be solely the responsibility of Baxter.

 

10.7.                     Patent Oppositions and Other Proceedings.

 

10.7.1.           By the Parties.  If either Party desires to bring an opposition, action for declaratory judgment, nullity action, interference, declaration for non-infringement, reexamination, or other attack upon the validity, title, or enforceability of a Patent owned or controlled by a Third Party that covers, in the Licensed Territory, the Compound or the Licensed Product, or the manufacture, use, sale, offer for sale, or importation of the Compound or the Licensed Product (except insofar as such action is a counterclaim to or defense of, or accompanies a defense of, a Third Party’s claim or assertion of infringement under Section 10.6, in which case the provisions of Section 10.6 shall govern), such Party shall so notify the other Party, and the Parties shall promptly confer to determine whether to bring such action or the manner in which to settle such action.  Baxter shall have the first right, but not the obligation, to bring in its sole control and at its sole expense such action in the Licensed Territory.  If Baxter does not bring such action within ** of notification thereof pursuant to this Section 10.7 (or earlier, if required by the nature of the proceeding), then Onconova shall have the right, but not the obligation, to bring, in Onconova’s sole control and at its sole expense, such action.  The Party not bringing an action under this Section 10.7 shall join the action as a joint party plaintiff if required to enable the other Party to bring such action, at the other Party’s expense.  Additionally, if appropriate, the Party not bringing an action under this Section 10.7 shall be entitled to separate representation, at its sole expense, in such proceeding by counsel of its own choice, and shall cooperate fully with the Party bringing such action.  Any awards or amounts received in bringing any such action shall be first allocated to reimburse the Parties’ expenses in such action, and any remaining amounts shall be retained by the Party bringing such action.

 

10.7.2.           By Third Parties.  If an Onconova Patent (including a Joint Patent) becomes the subject of any proceeding commenced by a Third Party in the Licensed Territory in connection with an opposition, reexamination request, action for declaratory judgment, nullity action, interference, or other attack upon the validity, title or enforceability thereof (except insofar as such action is a counterclaim to or defense of, or accompanies a defense of,

 

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an action for infringement against a Third Party under Section 10.5, in which case the provisions of Section 10.5 shall govern), then Onconova shall have the first right, but not the obligation, to control such defense at its sole cost.  Onconova shall permit Baxter to participate in the proceeding to the extent permissible under Laws, and to be represented by its own counsel in such proceeding, as Baxter’s sole expense.  If Onconova decides that it does not wish to defend against such action, then Baxter shall have a backup right to assume defense of such Third-Party action.  Except as set forth above, all expenses incurred by the Parties in such an action shall be borne by the Party controlling the defense of the Third-Party action.  Any awards or amounts received in defending any such Third-Party action, if any, shall be allocated between the Parties as provided in Section 10.5.6 as if the Party controlling the defense of the Third-Party Action were the Party that brought an action against an alleged infringer.

 

10.8.                     Patent Term Extensions in the Licensed Territory.  The patent counsel of each Party shall discuss and recommend for which, if any, of the Onconova Patents in the Licensed Territory the Parties should seek any term extensions, supplementary protection certificates, and equivalents thereof offering Patent protection beyond the initial term with respect to any issued Patents (“Patent Term Extensions”) in the Licensed Territory.  Baxter shall have the final decision-making authority with respect to applying for any such Patent Term Extensions in the Licensed Territory; provided that Baxter shall not unreasonably fail or refuse to do so, and shall have the sole right to apply for any such Patent Term Extensions Baxter decides to seek, at its expense.  Onconova shall cooperate fully with Baxter, at Baxter’s expense, in making such filings or taking any related actions, for example and without limitation, making available all required regulatory data and information and executing any required authorizations to apply for such Patent Term Extension.

 

10.9.                     Registration of License.  Onconova agrees that Baxter may, if applicable, register its license under the Onconova Patents with the patent authorities in the Licensed Territory. Baxter shall, at its expense, prepare and deliver to Onconova such instruments and other documents reasonably necessary and in proper form for such registration. The Parties shall mutually agree on the form of documents to be used for such purpose, and shall cooperate to preserve confidentiality of this Agreement to the extent permitted under applicable Laws in the relevant country. Onconova shall execute and return to Baxter such instruments and documents within ** from the receipt thereof.

 

10.10.              Patent Marking.  Baxter agrees to mark or have marked with the Onconova Patents to the extent consistent with applicable Laws any Licensed Product sold by Baxter or by its Sublicensees in accordance with the statutes of any country within the Licensed Territory relating to the marketing of patented articles, including without limitation to the extent required under Section 12.1 of the Temple Agreement.

 

ARTICLE XI.
  TRADEMARKS

 

11.1.                     Baxter Trademarks.  Baxter shall be responsible for the selection, registration and maintenance of all trademarks which it employs in connection with the commercialization of any Licensed Product in the Licensed Territory under this Agreement, other than the Onconova Trademarks (the “Baxter Trademarks”). Baxter shall solely own the Baxter Trademarks and pay all relevant costs thereof.  Baxter shall not select, register or otherwise use any trademark that is the same as or confusingly similar to, misleading or deceptive with respect to or that dilutes any of the Onconova Trademarks.  Onconova shall

 

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not use any trademark that is the same as or confusingly similar to, misleading or deceptive with respect to or that dilutes any of the Baxter Trademarks.  Baxter shall have the sole right to initiate at its own discretion legal proceedings against any infringement or threatened infringement of any Baxter Trademark.

 

11.2.                     Election to Use Onconova Trademarks.  Within a reasonable time after the Effective Date, but in no event later than the first anniversary thereof, Baxter shall inform Onconova in writing if Baxter elects to use the Onconova Trademarks in connection with the commercialization of the Licensed Product in the Licensed Territory.  If Baxter so notifies Onconova, the following shall apply:

 

11.2.1.           Onconova shall and hereby does grant to Baxter an exclusive, royalty-free license, with the right to grant sublicenses through multiple tiers of Sublicensees (subject to Section 2.4.1), to use the Onconova Trademarks on or in connection with the commercialization of the Licensed Product in the Licensed Territory in the Licensed Field.

 

11.2.2.           Baxter shall not use any trademark that is confusingly similar to, misleading or deceptive with respect to or that dilutes any of the Onconova Trademarks.

 

11.2.3.           Baxter shall properly designate the Onconova Trademarks on the packaging of the final Licensed Product, to the extent required or permissible by the applicable Marketing Approvals and Baxter agrees that all Licensed Products with which the Onconova Trademarks are used shall conform to all requirements of any Applicable Laws and any Regulatory Authorities in the Licensed Territory and shall be of a level of quality commensurate to Onconova’s Licensed Products outside of the Licensed Territory, but in no event less than a reasonable level of quality.

 

11.2.4.           Except as otherwise provided in this Section 11.2, Onconova shall have the first right and authority, but not an obligation, to register and maintain the Onconova Trademarks in the Licensed Territory (subject to this Section 11.2).  The Parties shall ** all costs of such registration and maintenance.  Baxter shall provide Onconova reasonable opportunity to review and comment on such registration efforts regarding the Onconova Trademarks.  Baxter shall provide Onconova with a copy of material communications from any Governmental Authority in the Licensed Territory regarding the Onconova Trademark, and shall provide drafts of any material filings or responses to be made to such authorities in a timely manner.  Notwithstanding the foregoing, if Onconova determines in its sole discretion to abandon or not maintain any Onconova Trademark in the Licensed Territory, Onconova shall provide Baxter with ** prior written notice of such determination and, if Baxter so requests, shall provide Baxter with the opportunity to register and maintain such Onconova Trademark in the Licensed Territory in the name of Onconova.  Thereafter, the Parties shall share equally all costs of filing, prosecuting and maintaining such Onconova Trademark in the Licensed Territory.

 

11.2.5.           If a Party becomes aware of any actual or alleged existing or threatened infringement by a Third Party of any Onconova Trademark in the Licensed Territory (such activities, “Trademark Infringement”), such Party shall notify the other Party, and shall provide to the other Party any and all evidence and information available to such Party regarding such alleged infringement.  Baxter shall have the first right, but not the obligation, to bring an appropriate suit or other action against any person or entity engaged in such Trademark Infringement, at its sole expense, subject to this Section 11.2.5).  Baxter shall have a period of ** after such notification to or by Baxter, to elect to so enforce such

 

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Onconova Trademark.  If Baxter does not so elect, Baxter shall so notify Onconova in writing during such **, or ** prior to any deadline relating to loss of any rights with respect to the Trademark Infringement, whichever is earlier, and Onconova shall have the right, but not the obligation, to commence a suit or take action to enforce such Onconova Trademark against such Third Party, at its sole expense.  Each Party shall provide to the Party enforcing any such rights under this Section 11.2.5 reasonable assistance in such enforcement, at such enforcing Party’s request and expense, including without limitation joining an action as a party plaintiff if so required by Laws to pursue such action.  The enforcing Party shall keep the other Party regularly informed of the status and progress of such enforcement efforts, and shall reasonably consider the other Party’s comments on any such efforts.

 

11.2.6.           The Party not bringing an action with respect to Trademark Infringement under Section 11.2.5 shall be entitled to separate representation in such matter by counsel of its own choice and at its expense, but such Party shall at all times cooperate fully with the Party bringing such action.  Additionally, the Party not bringing an action under Section 11.2.5 may have an opportunity to participate in such action to the extent that the Parties may mutually agree at the time the other Party elects to bring an action hereunder.

 

11.3.                     Infringement of Baxter Trademarks by Third Parties.  With respect to any Baxter Trademarks associated with Licensed Products in the Licensed Territory, each Party shall notify the other Party promptly upon learning of any actual or alleged threatened or existing infringement of any trademark or of any unfair trade practices, trade dress imitation, passing off of counterfeit goods, or like offenses, against such trademark.  Baxter shall have the sole right, in its own discretion and at its own expense, to bring an action to address such infringement.

 

ARTICLE XII.
  REPRESENTATIONS AND WARRANTIES

 

12.1.                     The Parties’ Representations and Warranties.  Each Party hereby represents and warrants to the other Party, as of the Effective Date, as set forth below.

 

12.1.1.           Such Party (a) is a corporation duly organized and subsisting under the applicable Laws of its jurisdiction of organization, and (b) has full power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as it is contemplated to be conducted by this Agreement.

 

12.1.2.           Such Party has the power, authority and legal right, and is free to enter into this Agreement and, in so doing, will not violate any other agreement to which such Party is a party as of the Effective Date.

 

12.1.3.           This Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal, valid, and binding obligation of such Party and is enforceable against it in accordance with its terms, subject to the effects of bankruptcy, insolvency, or other applicable Laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity.

 

12.1.4.           Such Party has taken all corporate action necessary to authorize the execution and delivery of this Agreement.

 

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12.1.5.           Except with respect to Marketing Approvals for the Licensed Product or as otherwise described in this Agreement, such Party has obtained all necessary consents, approvals, and authorizations of all Regulatory Authorities and other Third Parties required to be obtained by such Party in connection with the execution and delivery of this Agreement and the performance of its obligations hereunder.

 

12.1.6.           The execution and delivery of this Agreement and the performance of such Party’s obligations hereunder (a) do not conflict with or violate any requirement of applicable Laws or any provision of the articles of incorporation, bylaws, limited partnership agreement, or any similar instrument of such Party, as applicable, in any material way, and (b) do not conflict with, violate, or breach or constitute a default or require any consent under, any applicable Laws or any contractual obligation or court or administrative order by which such Party is bound.

 

12.1.7.           All of such Party’s employees, officers, independent contractors, consultants, and agents have executed agreements requiring assignment to such Party of all Inventions made during the course of and as a result of their association with such Party and obligating the individual to maintain as confidential the confidential information of such Party.

 

12.1.8.           Neither such Party, nor any of such Party’s employees, independent contractors, consultants, agents or officers: (a) has ever been debarred or is subject to debarment or, to such Party’s knowledge, convicted of a crime for which a Person could be debarred before a Regulatory Authority under applicable Laws, or (b) to such Party’s knowledge, has ever been under indictment for a crime for which a Person could be debarred under such Laws.

 

12.1.9.           All documents, information and know-how furnished or transferred by such Party to the other Party under this Agreement shall be, to its knowledge, free of errors in any material respect.

 

12.2.                     Onconova’s Representations and Warranties. Onconova hereby represents and warrants to Baxter, as of the Effective Date, as set forth below:

 

12.2.1.           A complete listing of all of the Upstream Agreement s is attached hereto as Exhibit 1.101 and a true and complete copy of each of the Upstream Agreements together with all exhibits, schedules, appendices, attachments and amendments thereto has been provided to Baxter prior to the Effective Date. The Upstream Agreements have not been modified, supplemented or amended since such copy was provided to Baxter. The Upstream Agreements are, to Onconova’s knowledge, in full force and effect, all payments to date required to be made thereunder by Onconova have been made, and Onconova is in compliance in all material respects with its obligations thereunder.

 

12.2.2.           Onconova has not received or provided any notice of termination of any of the Upstream Agreements, or any notices of breach of any of the Upstream Agreements.

 

12.2.3.           Onconova has sufficient legal and/or beneficial title under its intellectual property rights necessary to grant the licenses contained in this Agreement.

 

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12.2.4.           There is no pending or, to Onconova’s knowledge, threatened claim, litigation or any other proceeding brought by a Third Party against Onconova challenging the validity of the Onconova Patent Rights in the Licensed Territory, or claiming that the development, manufacture or commercialization of the Licensed Product in the Licensed Field in any portion of the Licensed Territory constitutes or would constitute infringement of such Third Party’s intellectual property right(s), and Onconova has no present knowledge of any Third Party intellectual property right that would reasonably be expected to give rise to any such claim, litigation or proceeding.

 

12.2.5.           There is no pending or, to Onconova’s knowledge, threatened claim, litigation or any other proceeding brought by a Third Party against Onconova claiming that the development or manufacture of the Licensed Product at the location where Onconova currently manufactures such Licensed Product constitutes or would constitute infringement of such Third Party’s intellectual property right(s), and Onconova has no present knowledge of any Third Party intellectual property right that would reasonably be expected to give rise to any such claim, litigation or proceeding.

 

12.2.6.           Onconova has not received any written communications alleging that it has violated or that it would violate, through the manufacture, use, import, export, sale, and/or offer for sale of the Licensed Product in the Licensed Field and in the Licensed Territory or any portion thereof, any intellectual property rights of any Third Party.

 

12.2.7.           To Onconova’s knowledge, no invention claimed by the Onconova Patents was made or reduced to practice using any funding of the United States Government; provided that Onconova does not make any representation or warranty with respect to inventions licensed under the Upstream Agreements.

 

12.2.8.           Onconova is not in possession of any in-licensed Third Party know-how, technology, trade secrets or patent rights that are necessary to manufacture a Licensed Product but are not Controlled by Onconova.

 

12.3.                     The Parties’ Covenants. Each Party hereby covenants throughout the term of this Agreement as set forth below:

 

12.3.1.           Such Party shall not enter into any agreement with a Third Party that will conflict with the rights granted to the other Party under this Agreement.

 

12.3.2.           If during the term of this Agreement, a Party has reason to believe that it or any of its employees, officers, independent contractors, consultants, or agents rendering services relating to the Licensed Product: (x) is or will be debarred or convicted of a crime for which such Person could be debarred before a Regulatory Authority under applicable Laws, or (y) is or will be under indictment under such Laws, then such Party promptly shall notify the other Party of same in writing.

 

12.3.3.           Onconova’s Covenants. Onconova hereby covenants throughout the term of this Agreement as set forth below:

 

12.3.3.1.           Onconova shall not agree to amend any terms or conditions of the Upstream Agreements in any manner that would adversely affect the rights granted to Baxter under this Agreement in any respect without the prior written consent of Baxter. Onconova further agrees that it shall not terminate the Upstream Agreements, shall

 

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not cease to exercise its rights under the Upstream Agreements, and shall not amend the Upstream Agreements in any manner that would adversely affect Baxter, in each case without the prior written consent of Baxter. Onconova shall comply with the terms of the Upstream Agreements in all material respects; provided that Onconova shall not be in breach of the foregoing obligations to the extent that Onconova’s failure to comply results from Baxter’s non-compliance with the terms of this Agreement, and further  provided that if Section 15.4  applies, then Onconova shall not be deemed in breach of this Section 12.3.3.1 and the Parties shall have the rights and obligations set forth in Section 15.4.  Onconova shall notify Baxter of any anticipated termination of the Upstream Agreements by Onconova prior to such termination. Onconova shall further notify Baxter when it has received any notice from any Third Party that is a party to an Upstream Agreement stating that such Third Party intends to terminate or is terminating such Upstream Agreement.

 

12.3.3.2.           Onconova shall use Commercially Reasonable Efforts to assist Baxter in obtaining from the licensor of any Upstream Agreement written assurance that in the event of termination of Onconova’s rights under such Upstream Agreement, all rights granted to Baxter by Onconova pursuant to this Agreement that constitute a sublicense under rights granted to Onconova pursuant to such Upstream Agreement shall survive such termination of Onconova’s rights, such that Baxter would have a direct license or other grant of rights from such licensor as necessary to allow Baxter to continue to practice such rights within the scope of Baxter’s license as set forth in Section 2.1 (a “Direct License”).  Baxter shall be responsible for any payments in consideration of such Direct License that solely relate to the Licensed Product in the Licensed Territory and that are approved in advance by Baxter in writing.

 

ARTICLE XIII.
  CONFIDENTIALITY

 

13.1.                     Confidentiality Obligation of Baxter.

 

13.1.1.           During the term of this Agreement and for a period of ** thereafter, or ** from the Effective Date, whichever is longer, Baxter:

 

(a)                                 shall hold in strict confidence any and all information disclosed to it by Onconova, including Onconova Information (together “Onconova Confidential Information”), and shall not use, nor disclose or supply to any Third Party, nor permit any Third Party, to have access to the Onconova Confidential Information, without first obtaining the written consent of Onconova, except as expressly permitted in this Agreement;

 

(b)                                 shall take all reasonable precautions necessary or prudent to prevent material in its possession or control that contains or refers to Onconova Confidential Information from being destroyed or lost, or discovered, received, used, intercepted or copied by any Third Party; and

 

(c)                                  may disclose the Onconova Confidential Information only to its employees, consultants, independent contractors, agents, Affiliates, actual and potential Sublicensees and actual and potential acquirers; provided that such employees, consultants, independent contractors, agents, Affiliates, actual and potential Sublicensees and actual and potential acquirers are bound by terms and conditions of confidentiality no less protective than the terms and conditions that bind Baxter hereunder.

 

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For the avoidance of doubt, it is understood that Baxter shall be liable for any breach of the confidentiality obligation under this Section 13.1 by any person or corporation to whom the Onconova Confidential Information is disclosed by Baxter.

 

13.1.2.           Baxter’s obligations of confidentiality and non-use under this Section 13.1 shall not apply and Baxter shall have no further obligations with respect to any of the Onconova Confidential Information, to the extent Baxter can establish by competent proof that such Onconova Confidential Information:

 

(a)                                 is or becomes part of the public domain without breach by Baxter of this Agreement;

 

(b)                                 was in Baxter’s possession before disclosure by Onconova and was not acquired directly or indirectly from Onconova; or

 

(c)                                  is obtained from a Third Party with no obligation of confidentiality to Onconova, who has a right to disclose it to Baxter;

 

(d)                                 is developed independently by Baxter without use of the Onconova Confidential Information, as evidenced by Baxter’s written records; or

 

(e)                                  is required to be revealed in response to a court decision or administrative order, or to comply with Laws of a Governmental Authority or rules of a securities exchange, in which case Baxter shall inform Onconova immediately by written notice and cooperate with Onconova using its Commercially Reasonable Efforts either to seek protective measures for such Onconova Confidential Information, or to seek confidential treatment of such Onconova Confidential Information, and in any case Baxter shall disclose only such portion of the Onconova Confidential Information which is so required to be disclosed.

 

13.1.3.           Nothing herein shall prevent Baxter from disclosing any Onconova Confidential Information to the extent that such Onconova Confidential Information is required to be used or disclosed for the purposes of seeking or obtaining Marketing Approvals of Licensed Products in the Licensed Territory or seeking patent protection for Inventions it owns or has responsibility for prosecuting under Article X.  Baxter shall further have the right to present Onconova Confidential Information at conferences or to publish Onconova Confidential Information in journals (collectively “Publications”); provided that if the Onconova Confidential Information concerned has not been previously published such Publication is subject to Onconova’s prior written consent, not to be unreasonably withheld, conditioned or delayed.

 

13.1.4.           Baxter acknowledges that certain Onconova Confidential Information was provided to Onconova by Temple University pursuant to the Temple Agreement and is subject to the confidentiality provisions of Article 2 of the Temple Agreement. To the extent the provisions of Article 2 of the Temple Agreement are more stringent than those in this ARTICLE XIII, Baxter agrees to comply with such more stringent terms with respect to any such Confidential Information of Temple University that is disclosed by Onconova to Baxter and labeled as “Confidential Information of Temple University.”

 

13.1.5.           Baxter acknowledges Temple University’s right to publish its research as provided in Section 2.5 of the Temple Agreement; provided that Baxter reserves absolutely

 

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the right to prevent any disclosure of Baxter Confidential Information without its prior written consent, which consent may be withheld at Baxter’s sole discretion.

 

13.2.                     Confidentiality obligation of Onconova

 

13.2.1.           During the term of this Agreement and for a period of ** thereafter, or ** from the Effective Date, whichever is longer, Onconova:

 

(a)                                 shall hold in strict confidence any and all information disclosed to it by Baxter, including Baxter Information (together “Baxter Confidential Information”) and shall not use, nor disclose or supply to any Third Party nor permit any Third Party to have access to the Baxter Confidential Information, without first obtaining the written consent of Baxter, except as expressly permitted in this Agreement;

 

(b)                                 shall take all reasonable precautions necessary or prudent to prevent material in its possession or control that contains or refers to Baxter Confidential Information from being destroyed or lost, or discovered, received, used, intercepted or copied by any Third Party; and

 

(c)                                  may disclose the Baxter Confidential Information to its employees, consultants, independent contractors, agents, Affiliates, actual and potential Licensees and Sublicensees and actual and potential acquirers; provided that such employees, consultants, independent contractors, agents, Affiliates, actual and potential Licensees and actual and potential acquirers are bound by terms and conditions of confidentiality no less protective than the terms and conditions that bind Onconova hereunder.

 

For the avoidance of doubt, it is understood that Onconova shall be liable for any breach of the confidentiality obligation under this Section 13.2 by any person or corporation to whom the Baxter Confidential Information is disclosed by Onconova.

 

13.2.2.           Onconova’s obligations of confidentiality and non-use under this Section 13.2 shall not apply and Onconova shall have no further obligations with respect to any of the Baxter Confidential Information to the extent that Onconova can establish by competent proof that such Baxter Confidential Information:

 

(a)                                 is or becomes part of the public domain without breach by Onconova of this Agreement;

 

(b)                                 was in Onconova’s possession before disclosure by Baxter to Onconova and was not acquired directly or indirectly from Baxter;

 

(c)                                  is obtained from a Third Party with no obligation of confidentiality to Baxter, who has a right to disclose it to Onconova;

 

(d)                                 is developed independently by Onconova without use of the Baxter Confidential Information, as evidenced by Onconova’s written records; or

 

(e)                                  is required to be revealed in response to a court decision or administrative order, or to comply with Laws of a Governmental Authority or rules of a securities exchange, in which case Onconova shall inform Baxter immediately by written notice and cooperate with Baxter using its Commercially Reasonable Efforts either to seek protective measures for such Baxter Confidential Information, or to seek confidential

 

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treatment of such Baxter Confidential Information, and in any case Onconova shall disclose only such portion of the Baxter Confidential Information which is so required to be disclosed.

 

13.2.3.           Nothing herein shall prevent Onconova from disclosing any Baxter Confidential Information to the extent that such Baxter Confidential Information is required to be used or disclosed for the purposes of seeking or obtaining Marketing Approvals of Licensed Products inside or outside the Licensed Territory or seeking patent protection for Inventions it owns or has responsibility for prosecuting under ARTICLE X. Onconova and its Licensees shall further have the right to disclose any Baxter Confidential Information in a Publication; provided that if the Baxter Confidential Information concerned has not been previously published, such Publication is subject to Baxter’s prior written consent, not to be unreasonably withheld, delayed or conditioned.

 

13.3.                     Press Releases; Publicity.  Except with respect to the press release attached hereto as Schedule 13.3 which may be issued by either or both of the Parties upon execution of this Agreement, no press release or public announcement shall be made by either Party concerning the execution of this Agreement or the terms and conditions hereof without the prior written consent of the other Party, which shall not be unreasonably withheld, conditioned or delayed.  Notwithstanding the foregoing, either Party may disclose the existence of this Agreement and the terms and conditions hereof without the prior written consent of the other pursuant to Section 13.1.2(d) or Section 13.2.2(d), as applicable, or in connection with a due diligence process associated with any future financing by either Party or the negotiation or exploration of a possible strategic transaction involving such Party; provided that such disclosure is made in the course of such diligence, negotiation or exploration pursuant to confidentiality obligations consistent with those set forth in this Agreement.  Each Party may issue a press release or public announcement concerning the development of the Compound or the Licensed Products, provided that such Party shall provide the other Party with a copy of such press release or public announcement at least ** in advance of its intended publication or release thereof and shall consider in good faith the comments of the other Party which comments shall be provided as promptly as reasonably practicable following receipt of the press release or public announcement from the Party desiring to make the disclosure.  Further, each Party agrees that it shall cooperate fully and in a timely manner with the other Party with respect to all disclosures required by the Securities and Exchange Commission and any other Governmental Authority or Regulatory Authority, including requests for confidential treatment of Confidential Information of either Party included in any such disclosure.  Notwithstanding the foregoing, either Party may issue any public announcement that it is advised by legal counsel is required under applicable Laws, provided that such Party provides to the other Party a copy of such press release or public announcement not less than ** in advance of its release if legally permissible.

 

ARTICLE XIV.
  INDEMNIFICATION

 

14.1.                     Onconova Indemnity.  Onconova shall defend, indemnify and hold harmless Baxter and its Affiliates and their respective directors, officers, agents, successors, assignees and employees (the “Baxter Indemnitees”) from and against any and all claims, liabilities, losses, costs, actions, suits, damages and expenses, including reasonable attorneys’ fees (collectively “Damages”) to the extent arising from any claim, action or proceeding made or brought against Baxter Indemnitees by a Third Party in connection with (a) the gross negligence, recklessness, or intentional wrongful acts or omissions of Onconova or its Affiliates or their respective employees, officers, independent contractors, consultants, or

 

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agents, in connection with the performance by or on behalf of Onconova of Onconova’s obligations or exercise of its rights under this Agreement; (b) any breach by Onconova, or its Affiliates or their respective independent contractors of any representation, warranty, covenant, or obligation of Onconova set forth in this Agreement; and (c) the development, manufacture, use, handling, storage, commercialization, transfer, importation, exportation or labeling, of the Compounds and/or Licensed Products by or for Onconova or its Affiliates either prior to the Effective Date anywhere in the world, or on or after the Effective Date outside the Licensed Territory; except in any such case to the extent such Damages are attributable to any gross negligence, recklessness, willful misconduct, or breach of this Agreement by Baxter or a Baxter Indemnitee.

 

14.2.                     Baxter Indemnity.  Baxter shall defend, indemnify and hold harmless Onconova, Temple University and their respective Affiliates, directors, officers, agents, successors, assignees and employees (the “Onconova Indemnitees”) from and against any and all Damages to the extent arising from any claim, action or proceeding made or brought against Onconova Indemnitees by a Third Party in connection with (a) the gross negligence, recklessness, or intentional wrongful acts or omissions of Baxter or its Affiliates or their respective employees, officers, independent contractors, consultants, or agents, in connection with the performance by or on behalf of Baxter of Baxter’s obligations or exercise of its rights under this Agreement; (b) any breach by Baxter or its Affiliates or their respective independent contractors of any representation, warranty, covenant, or obligation of Baxter set forth in this Agreement; and (c) the development, manufacture (other than by Onconova, its agents, contract manufacturers or any other Third Parties engaged by Onconova), use, handling, storage, commercialization, transfer, importation, exportation or labeling of the Compounds and/or Licensed Products by or for Baxter or any of its Affiliates or their agents and independent contractors on or after the Effective Date; except in any such case to the extent such Damages are reasonably attributable to any gross negligence, recklessness, willful misconduct, or breach of this Agreement by Onconova or an Onconova Indemnitee; provided that Baxter’s obligation to defend, indemnify and hold harmless Temple University shall be to the extent Onconova would be required to indemnify Temple University pursuant to the Temple Agreement for the relevant claims.

 

14.3.                     Indemnification Procedure.

 

14.3.1.           Each Party shall notify the other in the event it becomes aware of a claim for which indemnification may be sought pursuant to this Article XIV.  In case any proceeding (including any governmental investigation) shall be instituted involving any Party in respect of which indemnity may be sought pursuant to this Article XIV, such Party (the “Indemnified Party”) shall promptly notify the other Party (the “Indemnifying Party”) in writing (an “Indemnification Claim Notice”).  The Indemnifying Party and Indemnified Party shall promptly meet to discuss how to respond to any claims that are the subject matter of such proceeding.  At its option, the Indemnifying Party may assume the defense of any Third Party claim subject to indemnification as provided for in this Section 14.3 by giving written notice to the Indemnified Party within ** (or until such time provided in any applicable extension to appropriately answer any complaint, if any, but no longer than ** (the “Election Time Period”); with the Indemnified Party being obligated to make all reasonable efforts to obtain any such extension) after the Indemnifying Party’s receipt of an Indemnification Claim Notice, solely for claims (a) that solely seek monetary damages and (b) as to which the Indemnifying Party expressly agrees in writing that, as between the Indemnifying Party and the Indemnified Party, the Indemnifying Party shall be solely obligated to satisfy and

 

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discharge the claim in full (the matters described in (a) and (b), the “Litigation Conditions”). The Indemnified Party may assume responsibility for such defense if the Litigation Conditions are not satisfied, by written notice to the Indemnifying Party within the Election Time Period.  If the Indemnified Party fails to promptly provide an Indemnification Claim Notice, and such failure materially prejudices the defense of such claim, then the Indemnifying Party shall be relieved of its responsibility to indemnify the Indemnified Party.

 

14.3.2.           Upon assuming the defense of a Third Party claim in accordance with this Section 14.3, the Indemnifying Party shall be entitled to appoint lead and any local counsel in the defense of the Third Party claim.  Should the Indemnifying Party assume and continue the defense of a Third Party claim, except as otherwise set forth in this Section 14.3, the Indemnifying Party will not be liable to the Indemnified Party for any legal expenses subsequently incurred by such Indemnified Party after the date of assumption of defense in connection with the analysis, defense, countersuit or settlement of the Third Party claim.  Without limiting this Section 14.3, any Indemnified Party will be entitled to participate in, but not control, the defense of a Third Party claim for which it has sought indemnification hereunder and to engage counsel of its choice for such purpose; provided, however, that such engagement will be at the Indemnified Party’s own expense unless (a) the engagement thereof has been specifically requested by the Indemnifying Party in writing, or (b) the Indemnifying Party has failed to assume and actively further the defense and engage counsel in accordance with this Section 14.3 (in which case the Indemnified Party will control the defense), or (c) the Indemnifying Party no longer satisfies the Litigation Conditions.

 

14.3.3.           Subject to the Litigation Conditions being satisfied, the Indemnifying Party will have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Damages, on such terms as the Indemnifying Party, in its reasonable discretion, will deem appropriate (provided, however that such terms shall include a complete and unconditional release of the Indemnified Party from all liability with respect thereto), and will transfer to the Indemnified Party all amounts which said Indemnified Party will be liable to pay pursuant to such settlement or disposal of such claim prior to the time such payments become due by the Indemnified Party.  With respect to all other Damages in connection with Third Party claims, where the Indemnifying Party has assumed the defense of the Third Party claim in accordance with this Section 14.3, the Indemnifying Party will have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Damages; provided it obtains the prior written consent of the Indemnified Party, not to be unreasonably withheld, conditioned or delayed.

 

14.3.4.           The Indemnifying Party that has assumed the defense of the Third Party claim in accordance with this Section 14.3 will not be liable for any settlement or other disposition of any Damages by an Indemnified Party that is reached without the written consent of such Indemnifying Party.  The Indemnified Party will not admit any liability with respect to, or settle, compromise or discharge, any Third Party claim without first offering to the Indemnifying Party the opportunity to assume the defense of the Third Party claim in accordance with this Section 14.3.  If the Indemnifying Party chooses to defend or prosecute any Third Party claim, the Indemnified Party will cooperate in the defense or prosecution thereof and will furnish such records, information and testimony, provide such witnesses including to the extent possible, former employees and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection with such Third Party claim.  Such cooperation will include access during normal business hours afforded to the Indemnifying Party to, and reasonable retention by the Indemnified Party of,

 

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records and information that are reasonably relevant to such Third Party claim, and making employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder.  The Indemnifying Party will reimburse the Indemnified Party for all its reasonable out-of-pocket expenses incurred in connection with such cooperation.

 

14.3.5.           Each Party shall maintain, at its cost, a program of insurance and/or self insurance against liability and other risks associated with its activities and obligations under this Agreement, including its clinical trials, the commercialization of any Licensed Products and its indemnification obligations hereunder, in such amounts, subject to such deductibles and on such terms as are customary for the activities to be conducted by it under this Agreement.  All insurance required by this Section 14.3.5 shall be maintained during the Term and each Party shall, from time to time, provide copies of certificates of such insurance to the other party upon request.  Further, each Party shall list the other Party as an additional insured on all insurance policies.  All insurance required by this Section 14.3.5 shall be maintained in (a) at least ** following expiration or termination of this Agreement or, (b) for at least ** after the termination or expiration of this Agreement if insurance is written on a claims-made basis.

 

14.4.                     Limitation of Liability; Exclusion of Damages; Disclaimer.

 

14.4.1.           EXCEPT WITH RESPECT TO DAMAGES AWARDED TO A THIRD PARTY BY A COURT OF COMPETENT JURISDICTION THAT ARE REQUIRED TO BE INDEMNIFIED UNDER SECTION 14.1 OR SECTION 14.2, AND EXCEPT IN THE CASE OF A BREACH OF ARTICLE XIII, AND WITHOUT LIMITING THE LIABILITY OF A PARTY FOR INFRINGEMENT OR MISAPPROPRIATION OF THE INTELLECTUAL PROPERTY RIGHTS OF THE OTHER PARTY OR FOR FRAUD OR WILLFUL MISCONDUCT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES (INCLUDING WITHOUT LIMITATION DAMAGES RESULTING FROM LOSS OF USE, LOSS OF PROFITS, INTERRUPTION OR LOSS OF BUSINESS, OR OTHER ECONOMIC LOSS) ARISING OUT OF THIS AGREEMENT OR WITH RESPECT TO A PARTY’S PERFORMANCE OR NON-PERFORMANCE HEREUNDER.

 

14.4.2.           EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY PROVIDES ANY WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS OR IMPLIED, REGARDING THE LICENSED PRODUCT AND EACH PARTY HEREBY DISCLAIMS ALL OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS AND IMPLIED, INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND FREEDOM FROM INFRINGEMENT OF THIRD PARTY RIGHTS.

 

ARTICLE XV.
  TERM; TERMINATION

 

15.1.                     Term.  This Agreement shall expire in its entirety upon the expiration of all applicable Royalty Terms in the Licensed Territory and satisfaction of the applicable payment obligations (including milestone payments) under this Agreement with respect to all Licensed Products in all countries in the Licensed Territory (the “Term”).

 

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15.1.1.           Effect of Expiration.  Upon expiration of this Agreement in accordance with Section 15.1:

 

(a)                                 the Licensed Rights shall continue in full force and effect and be considered to be fully paid-up; and

 

(b)                                 Subject to the Confidentiality obligations contained in ARTICLE XIII, Baxter and Onconova shall each have the right to freely use all Information disclosed to it by the other Party hereunder solely in connection with the development, manufacture and commercialization of Licensed Product.

 

15.2.                     Early Termination.

 

15.2.1.           By Either Party for Breach.  Without prejudice and in addition to any other contractual remedy the non-defaulting Party may have under this Agreement, either Party may terminate this Agreement in writing forthwith, if the other Party commits a material breach of any provision of this Agreement and such breach is not cured within ** after written notice of the breach is received by the other Party, which notice shall specify the nature of the breach and demand its cure.  Notwithstanding the foregoing, if a material breach is not susceptible to cure within the cure period specified above, the non-breaching Party’s right of termination shall be suspended only if, and for so long as, (a) the breaching Party has provided to the non-breaching Party a written plan that is reasonably calculated to effect a cure, (b) such plan is reasonably acceptable to the non-breaching Party and (c) the breaching Party commits to and does carry out such plan; provided, however, that, unless otherwise mutually agreed by the Parties in such plan, in no event shall such suspension of the non-breaching Party’s right to terminate extend beyond ** after the original cure period.

 

15.2.2.           By Either Party for Force Majeure.  The Agreement may be terminated by either Party in the event of a Force Majeure (as hereinafter defined) pursuant to Section 15.4.

 

15.2.3.           By Either Party for Insolvency.  Either Party may terminate this Agreement upon written notice if the other Party is dissolved or liquidated, files or has filed against it a petition under any bankruptcy or insolvency law that is not dismissed within **, makes an assignment for the benefit of its creditors or has a receiver or trustee appointed for all or substantially all of its property.

 

15.2.4.           By Onconova for Baxter Patent Challenge.  In the event that Baxter or any of its Affiliates commences or otherwise, directly or indirectly, pursues (or, other than as required by Law or legal process, voluntarily assists any Third Party to pursue in any material respect where Baxter has knowledge that its assistance will be used by the Third Party to pursue) any proceeding seeking to have any of the Onconova Patents revoked or declared invalid, unpatentable, or unenforceable, Onconova may declare a material breach hereunder, terminate this Agreement on written notice to Baxter and shall then have the right to exercise the remedies available under Section 15.3 with immediate effect.

 

15.2.5.           By Either Party for Commercial Failure.  In the event of a Commercial Failure, either Party shall have the right to terminate this Agreement upon ** prior written notice to the other Party; provided, however, that Onconova shall not have a right to terminate this Agreement pursuant to this Section 15.2.5 if such Commercial Failure results,

 

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directly or indirectly, from the failure of Onconova or its Affiliates or agents to supply Product under the Supply Agreement if executed pursuant to Section 8.1.

 

15.2.6.           By Baxter for Convenience.  Commencing ** after the Effective Date, Baxter shall have the right to terminate this Agreement upon ** prior written notice to Onconova.

 

15.3.                     Obligations upon Early Termination.

 

15.3.1.           In the event of termination of this Agreement by either Party in accordance with Section 15.2:

 

(a)                                 all Licensed Rights shall revert to Onconova without any compensation to be paid by Onconova;

 

(b)                                 Baxter shall promptly return to Onconova any and all Onconova Information;

 

(c)                                  Baxter shall promptly transfer to Onconova or its nominee any and all Marketing Approvals and all other filings and submissions with and to Regulatory Authorities owned by Baxter or its Affiliates with respect to the Licensed Product; provided that the Parties shall agree upon commercially reasonable compensation to Baxter to reflect the value of such assets.  To this end Baxter shall make Commercially Reasonable Efforts to file for transfer with the relevant Regulatory Authorities and to give all other notifications and approvals necessary under law for the transfer of Marketing Approvals and such other filings and submissions;

 

(d)                                 Baxter shall grant to Onconova a worldwide license, with the right to sublicense, to use any Baxter Trademarks (including, without limitation, the goodwill symbolized by such Baxter Trademarks) used to brand the Licensed Product, and a license to reproduce, distribute, perform, display and prepare derivative works of Baxter’s copyrights used to brand or promote the Licensed Product, in each case solely to the extent necessary or useful for commercializing the Licensed Product; provided that such license shall bear a commercially reasonable royalty to be agreed by the Parties in good faith;

 

(e)                                  The licenses granted by Baxter to Onconova pursuant to Section 2.2 and other provisions of this Agreement shall continue in effect solely to the extent necessary or useful for developing or commercializing the Licensed Product, in addition to those sections that also survive pursuant to Section 15.4.3;

 

(f)                                   Baxter shall furnish Onconova with reasonable cooperation, at Baxter’s expense, to assure a smooth transition of any clinical or other studies in progress then being conducted by Baxter or its Affiliates related to the Compound or Licensed Products which Onconova determines to continue in compliance with applicable Laws and ethical guidelines applicable to the transfer or termination of any such studies. In the event that Onconova informs Baxter that it does not intend to continue specific development activities then in progress, each Party shall bear its own costs incurred in closing out such activities; and

 

(g)                                  Baxter shall not withdraw or cancel any Marketing Approval or Drug Approval Application, unless expressly instructed so by Onconova in writing; provided

 

53

 

that Onconova shall be responsible for all costs and expenses for the maintenance of all Marketing Approvals and Drug Approval Applications following the effective date of termination.

 

15.4.                     Force Majeure

 

15.4.1.           No failure or delay by either Party in the performance of any obligation hereunder shall be deemed a breach of this Agreement nor create any liability for any damages, increased cost or losses which the other Party may sustain by reason of such failure or delay of performance, if the same shall arise from any cause or causes beyond the control of that Party, such as earthquake, storm, flood, fire, other acts of nature, epidemic, war, riot, hostility, public disturbance, cessation of transport, act of public enemies, prohibition or act by a Government Authority or public agency, strike or other labor dispute or work stoppage (collectively “Force Majeure”); provided, however, that the Party so prevented shall continue to take all commercially reasonable actions within its power to comply with its obligations hereunder as fully as possible and to mitigate possible damages.

 

15.4.2.           The Party so prevented shall without undue delay notify the other Party in writing thereof.

 

15.4.3.           Should the event of Force Majeure continue for more than **, the Parties shall promptly discuss their further performance under this Agreement and whether to modify or terminate this Agreement in view of the effect of the event of Force Majeure.  If no agreement can be reached within ** after expiration of such **, either Party may terminate this Agreement effective immediately upon written notice to the other Party.

 

15.5.                     Survival.  For the avoidance of doubt, it is understood that provisions under Articles 1 and 14 and Sections 6.3.1, 9.2.3, 9.3, 9.5, 9.6, 9.7, 10.2, 13.1 (for the term set forth therein), 13.2 (for the term set forth therein), 15.1.1, 15.3, 15.5, 15.6, 16.2, 16.3, 16.5, 16.13, 16.14 and 16.15 shall survive the expiration of this Agreement.

 

15.6.                     Other Remedies.  Termination or expiration of this Agreement for any reason shall not release any party from any liability or obligation that has accrued prior to such expiration or termination, nor affect the survival of any provision hereof to the extent it is expressly stated to survive termination.  Termination or expiration of this Agreement for any reason shall not constitute a waiver or release of, or otherwise be deemed to prejudice or adversely affect, any rights, remedies, or claims, whether for damages or otherwise, that a Party may have hereunder or that may arise out of or in connection with such termination or expiration.

 

ARTICLE XVI.
  GENERAL PROVISIONS

 

16.1.                     Assignment.  This Agreement is binding upon and will inure to the benefit of the Parties and their respective permitted assignees or successors in interest, including without limitation those that may succeed by assignment, transfer or otherwise to the ownership of either of the Parties or of the assets necessary to the conduct of the business to which this Agreement relates. This Agreement may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned or delayed; provided, however, that either Party may, without such consent, assign this Agreement together with all of its rights and obligations

 

54

 

hereunder to its Affiliates, or to a successor in interest in connection with the transfer or sale of all or substantially all of its business to which this Agreement relates, or in the event of its merger or consolidation or similar transaction, subject to the assignee agreeing to be bound by the terms of this Agreement. Any purported assignment in violation of the preceding sentences shall be void. Any permitted successor shall assume and be bound by all obligations of its assignor or predecessor under this Agreement.

 

16.2.                     Headings.  Headings are inserted for convenience and shall not affect the meaning or interpretation of this Agreement.

 

16.3.                     Waiver.  No waiver of any default hereunder by either Party or any failure to enforce any rights hereunder shall be deemed to constitute a waiver of any subsequent default with respect to the same or any other provision hereof.

 

16.4.                     Notices.  Any and all notices given by one Party to the other Party under this Agreement must be in writing and shall be delivered by hand, sent by registered or certified air mail (postage prepaid), international courier service or fax to the other Party’s address as set forth below or to the latest address of such Party as shall have been communicated to the other Party.

 

If to Baxter:

 

Baxter Healthcare SA

Thurgauerstrasse 130

8152 Glattpark (Opfikon)

Switzerland

Attention: President

Telephone: +41 44 878 6000

Facsimile:  +41 44 878 6350

 

With copies to:

 

Baxter Healthcare Corporation

One Baxter Parkway

Deerfield, Illinois 60015

Attention: President BioScience

Telephone: +1 847.940.6255

Facsimile:  +1 847.940.6271

 

Baxter Healthcare SA

Thurgauerstrasse 130

8152 Glattpark (Opfikon)

Switzerland

Attention: Legal Counsel

Telephone: +41 1 878 6199

Facsimile:  +41 1 878 6352

 

If to Onconova:

 

Onconova Therapeutics, Inc.

375 Pheasant Run

 

55

 

Newtown, PA 18490

Attention: Commercial Department

Telephone: +1 267.759.3680

Facsimile:  +1 267.759.3681

 

With copies to:

 

Onconova Therapeutics, Inc.

375 Pheasant Run

Newtown, PA 18490

Attention: Chief Executive Officer

Telephone: +1 267.759.3680

Facsimile:  +1 267.759.3681

 

Dechert LLP

902 Carnegie Center, Suite 500

Princeton, NJ 08540

Attention: James J. Marino

Telephone: +1 609.955.3230

Facsimile:  +1 609 955.3259

 

16.5.                     Severability.  Should any part of this Agreement be held unenforceable or in conflict with the applicable Laws of any jurisdiction, the invalid or unenforceable part or provision shall be replaced with a provision which accomplishes, to the extent possible, the original business purpose of such part or provision in a valid and enforceable manner, and the remainder of this Agreement shall remain binding upon the Parties hereto.

 

16.6.                     Entire Agreement.  This Agreement constitutes the whole agreement between the Parties and shall cancel and supersede any and all prior and contemporaneous negotiations, correspondence, understandings and agreements, whether oral or written, between the Parties respecting the subject matter hereof, including without limitation the Confidentiality Agreement (with any information disclosed thereunder being deemed to be disclosed pursuant to this Agreement and subject to the terms of Articles 11 or 12 respectively).

 

16.7.                     Amendment.  Any amendment or modification to this Agreement shall only be made in writing and shall only be valid when signed by the due representatives of the Parties.

 

16.8.                     Counterparts.  This Agreement may be executed in more than one counterpart, each of which shall be deemed an original, but all of such counterparts taken together shall constitute one and the same agreement.

 

16.9.                     Agency.  Neither Party is, nor shall be deemed to be, an employee, agent, co-venturer, or legal representative of the other Party for any purpose. Neither Party shall be entitled to enter into any contracts in the name of, or on behalf of the other Party, nor shall either Party be entitled to pledge the credit of the other Party in any way or hold itself out as having the authority to do so.

 

16.10.              Further Actions.  Each Party agrees to execute, acknowledge, and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

 

56

 

16.11.              Compliance with Laws.  Each Party will comply with all Laws in performing its obligations and exercising its rights hereunder, including without limitation all Laws relating to the export, re-export or other transfer of any Information transferred pursuant to this Agreement or the Licensed Product.

 

16.12.              Third Party Beneficiary.  Each Party acknowledges and agrees that Temple University is a third party beneficiary of this Agreement to the extent required for Temple University to enforce this Agreement against Baxter in its capacity as a sublicensee under the Temple Agreement, and to enforce Temple’s rights under Section 16.2.

 

16.13.              Governing Law.  The construction, validity and performance of this Agreement shall be governed in all respects by the laws of the state of Delaware, excluding its provisions regarding conflicts of law. The UNCITRAL Convention on the International Sale of Goods shall not apply.

 

16.14.              Dispute Resolution; Jurisdiction.  Any disputes under this Agreement shall be submitted initially by either Party for resolution by the Executive Officers.  The Executive Officers shall meet and discuss such matter within ** after a Party proposes that such Executive Officers meet to discuss the dispute.  In the event the Executive Officers of each Party are unable to resolve the dispute within ** after receiving notice of the dispute (or such longer period as the Parties may mutually agree upon), then such dispute shall be submitted upon the initiative of either Party after expiration of the ** period for resolution as set forth in Exhibit 16.14.

 

16.15.              Bankruptcy Code.  All rights and licenses granted under or pursuant to this Agreement by Onconova or Baxter are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code and of any similar provisions of applicable Laws under any other jurisdiction (collectively, the “Bankruptcy Laws”), licenses of right to “intellectual property” as defined under the Bankruptcy Laws. Onconova agrees that Baxter, as a licensee of rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Laws.

 

[Signature Page Follows]

 

57

 

[Signature Page to License Agreement]

 

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed in duplicate by their respective duly authorized officers or representatives.

 

 

	
ONCONOVA THERAPEUTICS,
    	
 
    	
BAXTER   HEALTHCARE SA
    
	
INC.
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Signature:
    	
/s/   Ramesh Kumar
    	
 
    	
Signature:
    	
/s/   Benedikt Kubik
    
	
Name:
    	
Ramesh   Kumar
    	
 
    	
Name:
    	
Benedikt   Kubik
    
	
Title:
    	
President   and CEO
    	
 
    	
Title:
    	
Finance   Director
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
Signature:
    	
/s/   Sarah Byrne-Quinn
    
	
 
    	
 
    	
 
    	
Name:
    	
Sarah   Byrne-Quinn
    
	
 
    	
 
    	
 
    	
Title:
    	
VP   Business Development & Strategy
    

 

58

 

Schedule 1.13(a)

 

**

 

59

 

Schedule 1.13(e)

 

**(1)

 

**

 

(1)  **

 

60

 

Schedule 1.23

 

**

 

61

 

Schedule 1.66

 

**

 

62

 

Schedule 1.67

 

**

 

63

 

Schedule 1.101

 

Upstream Agreements

 

The January 1, 1999 License Agreement between Temple University and Onconova, as amended from time to time.

 

64

 

Schedule 13.3

 

Form of Press Release

 

65

 

Exhibit 16.14

 

**

 

(a) **

 

(b) **

 

(c) **

 

(d) **

 

(e) **

 

(f) **

 

(g) **

 

66

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