Document:

Exhibit 10.28

 

Confidential Information

 

SETTLEMENT AND LICENSE AGREEMENT

 

This Settlement and License Agreement (the “Agreement”) is entered into this 7th day of October, 2010 (the “Agreement Date”), by and between Anesta AG and Eurand, Inc., each on their own behalf and on behalf of their Affiliates, and Impax Laboratories, Inc., on its own behalf and on behalf of its Affiliates.

 

WHEREAS, there is now pending in the United States District Court for the District of Delaware a lawsuit filed by Anesta and Eurand against Impax Laboratories, Inc., Civil Action No. 09-018, involving United States Patent No. [**]; and

 

WHEREAS, Impax has filed counterclaims against Anesta and Eurand in the Litigation, [**]; and

 

WHEREAS, the parties wish to settle the Litigation;

 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual representations, covenants and conditions herein set forth, the receipt and sufficiency of which consideration are hereby acknowledged, the parties agree as follows:

 

1.                                      DEFINITIONS

 

For purposes of this Agreement, the terms set forth hereinafter shall be defined as follows:

 

1.1.          “Affiliate” of, or any entity “Affiliated” with, a specified entity shall mean any corporation, company, partnership, joint venture or other legal entity that controls, is controlled by, or is under common control with the entity specified, where “control” means 50% or greater equity ownership or the ability to direct management activity.

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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1.2.          “AMRIX®” shall mean the drug listed in the FDA Orange Book under NDA 21-777, cyclobenzaprine hydrochloride extended release capsule, and any supplements thereto relating to additional strengths.

 

1.3           “Anesta” shall mean Anesta AG and all of its Affiliates including but not limited to Cephalon, Inc. (“Cephalon”).

 

1.4.          “Anesta and Eurand” shall mean Anesta AG and Eurand, Inc., and all of their Affiliates.

 

1.5           “Applicable Law(s)” shall mean applicable laws, rules, statutes, codes, regulations, orders, judgments, ordinances or requirements of any court, tribunal, agency, legislative body, commission or instrumentality of any federal, state, province, county or city government related to the development, registration, manufacturing or marketing of pharmaceutical products in the Territory, or the performance of the Parties’ obligations under this Agreement.

 

1.6.          “At-Risk Launch”  shall mean the [**].

 

1.7.          “At-Risk Launch Period” shall mean the period starting on the date of an At-Risk Launch and ending on the date that is the earlier of:  (i) the date the Third Party/Parties who undertook the At-Risk Launch stops the commercial sale of Generic Equivalent Product, either as required by Court order or otherwise; (ii) the date of a final, non-appealable judgment of invalidity, unenforceability or non-infringement of claims asserted against such Third Party of any Orange Book Patents; or (iii) the License Effective Date occurs pursuant to Sections 3.2(a), (b), (c) or (e).

 

1.8.          “Authorized Generic Product” shall mean the listed product, AMRIX®, that is marketed, sold, or distributed directly or indirectly to retail class of trade with labeling,

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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packaging, product code, labeler code, trade name, or trademark that differs from that of AMRIX.

 

1.9           “Confidential Information” shall mean all confidential or other proprietary information that is disclosed by one Party (the “disclosing party”), to another Party (the “receiving party”), during the term of this Agreement.  When a disclosing party provides Confidential Information to a receiving party, such information should be marked as “Confidential”, “Restricted” or “Proprietary” (or with words of similar import) at the time of first written disclosure or if first disclosed orally or visually, then designated as “Confidential”, “Restricted” or “Proprietary” (or with words of similar import) within thirty (30) days of the oral or visual disclosure, provided, however, any proprietary or confidential information that the receiving party, through the exercise of reasonable judgment, understands or should understand to be confidential or proprietary, shall also be considered Confidential Information of the disclosing party for purposes of this Agreement.  Information which: (i) is or becomes public knowledge without any action by, or involvement of, the receiving party; (ii) is disclosed by the receiving party with the prior written approval of the disclosing party; (iii) is intentionally disclosed by the disclosing party to a third party without restriction on disclosure; or (iv) is rightfully received by the receiving party from a third party without a duty of confidentiality, shall not be deemed Confidential Information, even if such information is so identified by the disclosing party.  For the avoidance of doubt, this Agreement shall constitute Confidential Information of both Parties.

 

1.10.        “Covered Patents” shall mean [**].

 

1.11.        “Eurand” shall mean Eurand, Inc., and all of its Affiliates.

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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1.12.        “FDA” shall mean the United States Food and Drug Administration or any successor agency thereof.

 

1.13.        “First to File Exclusivity” means the period of one hundred eighty (180) days of marketing exclusivity in the Territory granted by FDA under and pursuant to 21 U.S.C. section 355(j)(5)(B)(iv).

 

1.14.        “Fully Allocated Manufacturing Costs” shall mean [**].

 

1.15.        “Generic Equivalent Product” shall mean (a) a pharmaceutical product which has been approved by or submitted for approval to FDA under an ANDA as a therapeutic equivalent (as defined in FDA regulations) to AMRIX®, or (b) an Authorized Generic Product.

 

1.16.        “Gross Profits” shall mean [**].

 

1.17.        “Impax” shall mean Impax Laboratories, Inc., and all of its Affiliates.

 

1.18.        “Impax ANDA Product” shall mean [**].

 

1.19.        “Impax Authorized Generic Product” shall mean an Authorized Generic Product supplied to Impax by, or on behalf of, Anesta and/or Eurand.

 

1.20.        “Licensed Patents” shall mean Covered Patents and Orange Book Patents.

 

1.21.        “License Effective Date” shall have the meaning provided in Section 3.2 below.

 

1.22.        “Licensed Product” shall mean either the Impax ANDA Product or the Impax Authorized Generic Product.

 

1.23.        “Net Sales” shall mean, [**].

 

1.24.        “Orange Book Patents” shall mean any and all patents that are listed, now or in the future, in the Orange Book in relation to NDA No. 21-777 (Anesta’s AMRIX® product).

 

1.25         The “Parties” shall mean collectively, Anesta, Eurand, and Impax.

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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1.26.        “Person” shall mean an individual, corporation, partnership or other entity and its Affiliates.

 

1.27.        “Quarterly Period” shall mean that three (3) month period of the calendar year ending on March 31, June 30, September 30 and December 31, respectively.

 

1.28.        “Sales and Distribution Costs” means, [**].

 

1.29.        “Territory” shall mean the United States and its territories and possessions, including Puerto Rico.

 

1.30.        “Third Party” shall mean a party that is neither Anesta, Eurand, nor Impax.

 

1.31.        “Third Party Licensed Product” shall mean a Generic Equivalent Product sold by a Third Party pursuant to authorization or license from Anesta and/or Eurand.

 

1.32.        “Transfer Price” shall [**].

 

1.33.        “Valid Patent Claim” shall mean an unexpired claim in any issued Orange Book Patent which has not been held invalid or unenforceable by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable by the owner through reissue or disclaimer.  If there should be two or more such decisions conflicting with respect to the validity of the same claim, the decision of the higher or highest tribunal shall thereafter control; however, should the tribunals be of equal dignity, the decision or decisions holding the claim valid shall prevail, unless and until the invalidity decision becomes a final, non-appealable decision.

 

2.                                      SETTLEMENT TERMS

 

2.1.          Stipulation and Dismissal of the Litigation

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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The parties agree to execute a stipulation for the dismissal of the Litigation with prejudice, and without cost to either party.  The proposed stipulated dismissal shall be jointly submitted to the Court within five (5) business days of the Agreement Date.

 

2.2.          Anesta, Cephalon, and Eurand’s Release

 

[**].

 

2.3.          Impax’s Release

 

[**].

 

2.4           Acknowledgement of Infringement, Validity and Enforceability [**]

 

Impax hereby stipulates [**].  Notwithstanding the foregoing, no admission made in this Section 2.4 (including admissions regarding validity and enforceability) shall apply outside the United States or to any product other than the Licensed Products.

 

2.5           Agreement Not to Assist Third Parties

 

Impax covenants not to assist, coordinate with, or otherwise help any Third Party in prosecuting, defending or settling litigation regarding any Covered Patent in connection with a Third Party Generic Equivalent Product in any context or forum, including but not limited to any court or proceeding before the United States Patent and Trademark Office (including reexamination proceedings).

 

2.6           Agreement Not to Challenge Validity or Enforceability

 

Solely with respect to the Licensed Product, Impax covenants not to challenge the validity or enforceability of any claim of the Licensed Patents in any context or forum in the Territory, including but not limited to any court or USPTO proceeding (including reexamination proceedings), including, but not limited to, initiating a declaratory judgment action with respect to any of the Licensed Patents.  Notwithstanding the foregoing, if Anesta, Eurand or their

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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Affiliates or any third party with rights to enforce the Covered Patents brings an action against Impax for infringement of any of the Covered Patents, Impax may assert any defense with respect to said patent only, except if such action is in consequence of breach of this agreement by Impax in which case paragraph 3.7 of this Agreement shall govern such action.  With respect to products other than the Licensed Product, nothing herein shall limit or restrict Impax’s ability to challenge the validity or enforceability of the Licensed Patents or asserting that such products do not infringe any claim of the Licensed Patents.

 

2.7           Impax Agreement to Abide by License Effective Date

 

Except as permitted under the license in Section 3 below, Impax agrees not to (i) make, use, import, offer to sell, or sell in the Territory, (ii) actively induce or assist any other entity to make, use, import, offer to sell or sell in the Territory, or (iii) import or cause to be imported in the Territory, the Licensed Product before the License Effective Date, except as permitted by the License in Section 3 of this Agreement.

 

3.                                      LICENSE TERMS

 

3.1.          Grant

 

Subject to the terms and conditions herein, Anesta and Eurand hereby grant to Impax a non-exclusive license under the Licensed Patents: (i) to make, have made, or offer to sell the Impax ANDA Product, effective as of the Agreement Date, but only for the limited purpose of preparing for a launch of the Licensed Product consistent with the terms of this Agreement, and (ii) to promote, use, import, and sell Licensed Product in the Territory as of the License Effective Date.  Impax shall not have the right to sublicense the Licensed Patents to any Third Party.  In connection with the above license, Eurand shall not be required to transfer any know how, trade secrets or other information relating to its manufacture or formulation of any product to Impax.

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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3.2.          License Effective Date

 

The “License Effective Date,” shall be the date which is the earliest of:

 

(a)                                  The later of February 26, 2024 or, in the event the date of expiration of US Patent No. 7,387,793 is extended under 35 U.S.C. § 154(b) (“Extension of Patent Term”), 21 U.S.C. § 355 (“Pediatric Studies of Drugs”), or under both such provisions of law, the date that is one year earlier than the date of expiration of the patent as extended;

 

(b)                                 In the event that Anesta and/or Eurand license or authorize any Third Party who is entitled to First to File Exclusivity to sell Generic Equivalent Product in the Territory, on the date immediately following the expiration of any applicable First to File Exclusivity period after that first filer begins the commercial sale of its Generic Equivalent Product;

 

(c)                                  the same entry date that any Third Party which is not entitled to First to File Exclusivity is licensed or authorized by Anesta and/or Eurand to begin selling Generic Equivalent Product in the Territory;

 

(d)                                 the date of an At-Risk Launch, provided that the license granted pursuant to this Section 3.2(d) shall only extend for the At-Risk Launch Period, after which Impax shall immediately exit the market unless the license has become effective under another provision of this Section 3.2; and

 

(e)                                  The date that a Third Party obtains a final, non-appealable judgment of invalidity, unenforceability or non-infringement of all asserted claims of any Orange Book Patents, following the expiration of any applicable First to File Exclusivity period.

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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Anesta and Eurand will notify Impax [**] following any settlement with any other defendant that would result in a License Effective Date earlier than that provided in § 3.2(a).

 

3.3.          Exclusivity waiver.  Anesta and Eurand hereby agree to waive any period of regulatory exclusivity to the extent such exclusivity would preclude or impede the launch of the Impax ANDA Product as of the License Effective Date.  Anesta and Eurand agree to provide reasonable cooperation to Impax in connection with such waiver, including by submitting a mutually agreeable notice to FDA of the existence of such waiver and not opposing the approval of Impax ANDA Product effective as of the License Effective Date based on any applicable regulatory exclusivity in force at the time.  Such notice will be delivered by Anesta to FDA within five (5) business days of receipt of written request from Impax.  For purposes of clarity, nothing in this Section 3.3 is intended to or does accelerate the License Effective Date as determined under Section 3.2.

 

3.4           Transfer Price and Royalties.

 

3.4.1        In addition to the Royalties specified in Section 3.4.2 below, Impax shall pay Eurand the Transfer Price for all Authorized Generic Product purchased by Impax from Eurand.

 

3.4.2        Royalties shall be paid to Anesta as follows:

 

a)                      License Effective Date of 3.2(a), (b), (c) or (e):

 

1) [**].

 

b)                     License Effective Date of 3.2(d) (At-Risk Launch)

 

1) [**].

 

2) [**].

 

3.5.          Royalty Term

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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Impax’s obligation to pay the royalties pursuant to paragraphs 3.4.2(a) and 3.4.2(b), as applicable, shall remain in effect [**].

 

3.6.          Accounting and Records

 

(a)           [**]the Quarterly Period in respect of which payments are due under paragraph 3.4, Impax shall prepare and send to Anesta a report setting forth [**] during such Quarterly Period, which report shall [**].  All reports submitted hereunder shall be deemed Impax Confidential Information pursuant to Section 5.

 

(b)           Simultaneously with the submission of each report pursuant to paragraph 3.6(a), Impax shall, in a commercially reasonable manner, make payments, in United States currency, to Anesta or to a party or parties designated by Anesta, of the amounts due for the period covered by the report.  In the event any payments are made later than the dates set forth herein, Impax shall also pay interest on such late payments, [**].  Impax shall be entitled to make all payments by corporate check or wire transfer.

 

(c)           All payments to Anesta required under this Agreement shall be made to the name or account of Anesta or a party or parties designated by Anesta at an address designated by Anesta.  Any and/or all of such payments shall be subject to such withholding tax laws, rules and regulations as may be applicable and, if such laws, rules or regulations require a withholding to be made, such payment(s) will be reduced by such amount(s) withheld and the payment of (a) the reduced amount(s) to Anesta and (b) the withheld amount to the taxing agency or body shall constitute full compliance of Impax’s payment obligation under this Agreement.  Impax shall provide to Anesta appropriate proof of payment of any and all such taxes withheld.  Impax shall timely pay any such taxes withheld and any penalty or surcharge assessed to Impax or Anesta for late payment of such taxes.

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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(d)           Impax shall keep accurate records in respect of all sales of the Licensed Product by Impax and its Affiliates and shall maintain such records [**].  Anesta shall have the right, at its sole cost and expense, [**], to have Impax’s records reviewed [**] at times that are reasonably convenient to Impax, using an independent certified public accountant designated by Anesta, provided the independent accountant signs a confidentiality agreement with Impax providing that such records, books of account, information and data shall be treated as Confidential Information which may be disclosed only to Anesta.  Any report rendered by Impax prior to the date of such review and to which Anesta raises no reasonable written objection [**] shall be deemed conclusive and binding, provided that Impax has not unreasonably impeded such review.  If the review determines that [**] reported by Impax for such Quarterly Period pursuant to paragraph 3.6(a), then [**].  Any deficiencies in payment shall be payable with interest from the date the initial payment was due at the rate specified in paragraph 3.6(b).

 

(e)           At the termination of this Agreement, Impax shall render a final report to Anesta [**] the end of the Quarterly Period in which such termination occurs, and payments shall be made to Anesta for that Quarterly Period (or portion thereof) in which such termination occurs.

 

3.7.          Consequence of Breach by Impax

 

In the event of a judicial determination, after hearing before the United States District Court for the District of Delaware, that Impax sold or distributed the Licensed Product before the License Effective Date, [**].

 

[**]

 

4.             AUTHORIZED GENERIC

 

4.1           At any time that is prior to the License Effective Date, Impax may elect by providing written notice to Eurand and Anesta to have Eurand supply Impax Authorized

 

**   Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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Generic Product to Impax for sale in the Territory from and after the applicable License Effective Date subject to all of the terms and conditions of this Agreement.  Anything in this agreement to the contrary notwithstanding, [**], Eurand will use [**] supply Impax Authorized Generic Product to Impax by the License Effective Date or as soon thereafter as is reasonably practical.

 

4.2           Supply of Impax Authorized Generic Product; Forecasts; Purchase Orders.

 

(a)           Subject to the terms, conditions and limitations hereof, during the Supply Term, Eurand agrees to supply Impax Authorized Generic Product to Impax for marketing and in accordance with the terms of this Agreement.  In order to be in a position to timely and effectively enter the generic market, the Parties shall cooperate in good faith to determine and prepare for the applicable License Effective Date, including communicating to one another, on an ongoing basis, developments which may reasonably affect the License Effective Date and information necessary to label the Impax Authorized Generic Product for sale as a generic by Impax.

 

(b)           All Impax Authorized Generic Product supplied will be supplied in bulk form which complies with Anesta’s NDA.  Subject to compliance with Anesta’s NDA, Impax will provide Eurand and Anesta with appropriate and customary generic package and label design for Anesta’s and Eurand’s approval prior to Impax packaging the Impax Authorized Generic Product, such approval not to be unreasonably withheld.  Impax will provide Anesta with final specimens.  Eurand and Anesta will timely make all appropriate regulatory filings in order to enable Impax to package the Impax Authorized Generic Product at the Impax site. Any

 

**   Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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costs incurred by Eurand in performing other manufacturing specifications (such as capsule imprints) requested by Impax (all of which must be consistent with the approved specifications under the NDA) and to which Eurand agrees (such agreement not to be unreasonably withheld, delayed or conditioned), including related capital expenditures, shall be at Impax’s sole cost and expense.

 

(c)           At the time Impax provides notice under Section 4.1 that it elects to market Impax Authorized Generic Product, [**] before the date Impax requests delivery of Launch Quantities (subject to Section 4.1), Impax will provide to Eurand a good faith Forecast (as defined below) of the quantities of Impax Authorized Generic Product required for the initial Launch of Impax Authorized Generic Product ([**], beginning with the License Effective Date) (the “Launch Quantities”).  The Launch Quantities may be adjusted from time to time by Impax, upon the consent of Eurand (not to be unreasonably withheld, delayed or conditioned), based on reasonable assessments of changes in market conditions.  In anticipation of the Launch of Impax Authorized Generic Product by Impax, Eurand shall use commercially reasonable efforts to deliver the Launch Quantities as soon as practicable to Impax on or before the License Effective Date, so that Impax may Launch on the License Effective Date.  Notwithstanding the foregoing, in the event the License Effective Date occurs under Section 3.2(d) due to an At-Risk Launch earlier than Impax’s requested delivery of Launch Quantities, the parties shall reasonably cooperate to supply Launch Quantities requested by Impax to enable Impax to launch Impax Authorized Generic Product

 

**   Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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as soon as reasonably practicable following the License Effective Date under Section 3.2(d).

 

(d)           [**] following the License Effective Date, and [**] thereafter beginning with the date [**] the License Effective Date, Impax shall deliver a forecast (a “Forecast”) to Eurand of the quantities of Impax Authorized Generic Product, by SKU, which Impax reasonably anticipates it will require for marketing [**] the License Effective Date in the first instance, and thereafter [**] the date of such Forecast and shall include quantities required to be delivered [**] of the Forecast Period.  The foregoing notwithstanding, the first such Forecast shall be for [**] after the License Effective Date.  For each such Forecast, [**] of the Forecast Period shall be known as the “Purchase Order Period” and the amounts specified in the Forecast for the Purchase Order Period shall constitute a binding purchase order for such period.  Additionally, in each subsequent Forecast, the amount ordered for the Purchase Order Period shall not deviate [**] (as to the entire period or any month therein) from [**] of the immediately preceding Forecast.  Other than the specifically provided in this paragraph, the amounts set forth in the Forecasts shall only constitute a non-binding estimate of the Impax Authorized Generic Product requirements.

 

(e)           Eurand shall use commercially reasonable efforts to make deliveries of Impax Authorized Generic Product [**] of the agreed upon delivery dates, which delivery dates shall be at least [**] from the date a binding purchase order is received by Eurand.  All such shipments of Impax Authorized Generic Product shall be [**] Eurand’s manufacturing facilities to a carrier designated by Impax.

 

**   Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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Title and risk of loss shall pass, and delivery shall occur, [**].  In no event shall Eurand be required to [**].  The terms and conditions of this Agreement shall be controlling over any conflicting terms and conditions stated in Impax’s purchase order or Eurand’s invoice or confirmation.  Any other document which shall conflict with or be in addition to the terms and conditions of this Agreement is hereby rejected (unless the Parties shall have mutually agreed to the contrary in writing in respect of a particular instance).

 

(f)            Eurand shall promptly notify Impax in writing if at any time Eurand has reason to believe that Eurand will not be able to [**] in accordance with the delivery schedule specified herein pursuant to the terms and conditions of this Agreement.

 

(g)           Eurand shall invoice Impax at the time of each shipment of Impax Authorized Generic Product at the Transfer Price for such shipment.  Impax shall pay each such invoice [**].

 

(h)           In addition to the foregoing, the Parties shall work together in good faith and make commercially reasonable efforts to timely satisfy any changes in the quantities and delivery dates of Impax Authorized Generic Product specified in the Forecasts due to changes in demand.

 

(i)            Impax Authorized Generic Products supplied by Eurand shall (i) have a shelf life[**] and (ii) conform to Anesta’s NDA.  The foregoing notwithstanding, the Launch Quantities shall instead have a shelf life [**].

 

(j)            All Impax Authorized Generic Products will be supplied by Eurand as bulk capsules packaged in drums, as described in Section 4.2(b) above and in

 

**   Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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accordance with the terms and conditions of this Agreement, Anesta’s NDA, the Eurand/Impax Quality Agreement (as defined below) , and Applicable Laws.

 

(k)           Impax shall be solely responsible for packaging and labeling the bulk product provided by Eurand into the finished dosage form in accordance with this Agreement, the Anesta/Impax Quality Agreement, and Applicable Laws.  For clarity, Impax acknowledges that if it chooses not to use a site currently authorized under the NDA, or if it chooses to use a container closure system not specified in the NDA, additional regulatory filings will be required, possibly resulting in delays pending FDA approval.  Anesta will reasonably cooperate with Impax in timely making the appropriate regulatory filings.

 

(l)            During the Term, and for a period of [**] thereafter, Eurand shall, and shall ensure that its Affiliates shall, keep at either its normal place of business, or at an off-site storage facility, detailed, accurate and up to date information and data contained in any invoices provided to Impax in connection with this Agreement.

 

4.3          Quality Assurance; Acceptance

 

(a)           Eurand represents, covenants and warrants to Impax that:

 

(i)            all Impax Authorized Generic Product hereunder shall be produced in accordance with cGMP, and Applicable Laws, rules and regulations and that none of the Impax Authorized Generic Product supplied hereunder shall be adulterated or misbranded as defined by Applicable Law; and

 

**   Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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(ii)           all shipments of Impax Authorized Generic Product supplied hereunder shall at the time of delivery, meet the specifications set forth in Anesta’s NDA (including expiration dating).

 

(b)           Eurand will use commercially reasonable efforts to maintain throughout the term of this Agreement all permits, licenses, registrations and other forms of governmental authorization and approval required in order for Eurand to perform its obligations hereunder in accordance with all Applicable Laws.

 

(c)           to Eurand’s knowledge upon due investigation, as of the Effective Date the manufacture or marketing of the Impax Authorized Generic Products in the Territory pursuant to this Agreement does not infringe, misappropriate or otherwise conflict with any intellectual property rights of any Third Party.

 

(d)           Eurand shall perform all quality control tests and other inspections required by applicable cGMP standards and Anesta’s NDA and shall furnish to Impax a certificate of analysis together with each lot of Impax Authorized Generic Product shipped to Impax.  Eurand will also provide Impax with Material Safety Data Sheets (hereinafter “MSDS”) for the Impax Authorized Generic Products, and updates of same as necessary, but in no event will Eurand provide any specifications and/or quality control standards under the NDA beyond those necessary for Impax to conduct the testing specified in subparagraph 4.3(f).

 

(e)           Anesta will promptly notify Impax of any request from the FDA to change Impax Authorized Generic Product specifications or labeling and will notify Impax of any changes in specifications.

 

**   Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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(f)            Impax shall conduct, at its own expense, such tests as it deems necessary to determine the compliance of the Impax Authorized Generic Product with the requirements of Section 4.3(a).  Impax shall notify Eurand and Anesta within thirty (30) days of its receipt of each shipment of the Impax Authorized Generic Product of any non-compliance of the Impax Authorized Generic Product with the requirements of Section 4.3(a) revealed by such testing, and with respect to any latent defect, within ten (10) days of becoming aware of such defect and provide documents alleged to support any such contention.

 

(g)           Subject to the provisions of Section 4.3(h), Eurand shall replace, at its own expense, including all freight costs, any Impax Authorized Generic Product that does not meet the requirements of Section 4.3(a) upon delivery (including shelf life dating).

 

(h)           If, no more than 30 days following the timely delivery of a notice by Impax pursuant to the provisions of Section 4.3(f), Impax and Eurand do not agree that any lot or lots of the Impax Authorized Generic Product referred to in the notice meets the requirements of Section 4.3(a), that lot or those lots of the Impax Authorized Generic Product shall be tested for such compliance, within thirty (30) days after notice of the defect is delivered to Eurand, by a disinterested Third Party expert selected by the mutual agreement of Impax and Eurand.  The decision of such Third Party expert with respect to the question of compliance shall be binding upon Impax and Eurand for the purposes of Section 4.3(g) of this Agreement.  The costs of such testing shall be borne by Eurand if such lot or lots

 

**   Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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are found not to meet the requirements of Section 4.3(a) and by Impax in all other circumstances.

 

(i)            Impax represents, covenants and warrants to Eurand that all Impax Authorized Generic Product marketed by Impax will be packaged, labeled, stored, shipped and handled in accordance with cGMP, Anesta’s NDA, and all Applicable Laws.

 

4.4          Regulatory Responsibilities; Adverse Event Reporting; Recalls

 

(a)           Anesta will have sole authority to deal with regulatory matters relating to Anesta’s NDA or Impax Authorized Generic Product.  During the term hereof, Anesta shall maintain Anesta’s NDA in accordance with all applicable requirements of the FDA, including, without limitation, the filing of all annual requirements and other reports or filings required by the FDA.  Impax shall provide Anesta all information as required for Anesta to submit regulatory filings, including annual reports, as required by FDA in accordance with a schedule as specified by Anesta or its Affiliates.

 

(b)           Impax shall submit to Anesta all reports of adverse drug experiences, together with all relevant information possessed by it, in time for Anesta to meet all expedited and periodic regulatory obligations to the FDA.  Impax shall also promptly submit to Anesta all Impax Authorized Generic Product inquiries or complaints for handling by Anesta.  Each Party shall cooperate with the other and provide information in its possession to the extent necessary for the other Party to comply with all legal requirements relating to the manufacture or marketing of Impax Authorized Generic Product.

 

**   Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

19

 

(c)           Each of Eurand, Anesta and Impax will immediately inform the other in writing if it believes one or more lots of any Impax Authorized Generic Product should be subject to recall from distribution, setting forth the reasons therefore with reasonable specificity.  To the extent permitted by legal or public safety requirements, the Parties will confer before initiating any recall.  [**].  The Party initiating the recall shall initially bear the cost thereof and shall carry out the recall in accordance with best industry practices.  In the event it is determined that a recall resulted from a breach by Eurand of any of its representations or warranties set forth in Section 4.3(a) hereunder, [**].

 

(d)           Eurand shall keep, or cause its Affiliates to keep, as required, such samples and such records (or copies thereof) in respect of the Impax Authorized Generic Products as are required by Applicable Law for such period of time as may be required thereunder.

 

(e)           Each of Eurand, Anesta, and Impax shall promptly inform the other of any correspondence from the FDA that would materially affect its ability to meet its obligations under this Agreement.  Eurand shall notify Impax promptly, but in no event later than ten (10) business days following the occurrence of any materially adverse inspections by the FDA or other regulatory authorities which pertain to the Impax Authorized Generic Products or to the facilities where the Impax Authorized Generic Products are being manufactured or stored.

 

(f)            Within forty-five (45) days following the date that Impax provides notice to Eurand that it elects to be supplied Impax Authorized Generic Product under Section 4.1, Eurand and Impax shall enter into a Quality Agreement in form and

 

**   Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

20

 

content reasonably acceptable to Impax and Eurand (“Eurand/Impax Quality Agreement”) and within 45 days following the date that Impax provides notice to Anesta that it elects to be supplied with Impax Authorized Generic Product under Section 4.1, Impax and Anesta (and Eurand, if Eurand so elects) shall enter into a Quality Agreement in form and content reasonably acceptable to Impax and Anesta (“Impax/Anesta Quality Agreement”).  The Impax/Anesta Quality Agreement will include protocols and specific quality responsibilities for handling Impax Authorized Generic Product quality complaints, ADE reports, and professional medical services inquiries in accordance with Anesta’s standard operating procedures and in conformity with Applicable Laws.

 

(g)                                 Impax and Anesta (and Eurand if Eurand so elects) shall meet within thirty (30) days from the date that Impax provides notice under Section 4.1 to negotiate in good faith and agree on a process and procedure for sharing adverse event information which shall be documented in a pharmacovigilance agreement (“PVA”).  Also, upon execution of this Agreement, each Party shall assign a representative to ensure such a pharmacovigilance agreement is adopted prior to the Impax Authorized Generic Product being distributed and marketed.  Following adoption of the PVA, the parties shall ensure the prompt exchange of any and all information concerning adverse events related to use of the Impax Authorized Generic Product regardless of source, complying with the contents of the PVA and legal requirements in their respective territories.

 

(h)                                 Consistent with Anesta’s obligations as NDA holder, if Impax elects to create and/or distribute any promotional material for an Impax Authorized

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

21

 

Generic Product, such promotional materials shall be subject to Anesta’s prior written approval for the limited purpose of ensuring that they comply with any obligations under the NDA, such approval not to be unreasonably withheld.  Impax shall ensure that its promotional materials contain no representations, warranties, or claims with respect to an Impax Authorized Generic Product, except as approved in writing by Anesta pursuant to this paragraph.  For purposed of clarity, if Impax elects to distribute Impax Authorized Generic Product, Impax at a minimum shall be permitted to disclose that such product is an Authorized Generic Product.

 

5.                                      CONFIDENTIALITY

 

5.1                                 Confidentiality.  During the term of this Agreement and for a period of [**], the Parties shall maintain as confidential and not disclose to any Third Party any Confidential Information supplied by another Party.  The Parties shall use the Confidential Information of the other Parties solely for the performance of their respective obligations under this Agreement.

 

5.2                                 Exclusions.  The obligations of confidentiality and non-use under Section 5.1 shall not apply to any information that: (i) is shown by contemporaneous documentation of the receiving Party to have been in its rightful possession on a non-confidential basis prior to receipt from the disclosing Party; (ii) is or becomes, through no fault of the receiving Party, publicly known; (iii) is furnished to the receiving Party by a Third Party without breach of a duty to the disclosing Party; or (iv) is independently developed by the receiving Party without access to the Confidential Information of the disclosing Party.

 

5.3                                 Exceptions.  Notwithstanding Section 5.1, a Party receiving Confidential Information may disclose such Confidential Information to the extent that such disclosure has

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

22

 

been ordered by a court of law or otherwise required by law or regulation, provided that the disclosure is limited to the extent ordered or required and wherever practicable, the Party owning the Confidential Information has been given written notice in advance in order to enable it to seek protection or confidential treatment of such Confidential Information.  In the event any Party determines that disclosure of this Agreement or any terms of this Agreement is required under applicable securities laws or regulations, such party shall provide the proposed disclosure in writing to the other Parties for an opportunity to comment thereon.  Such proposed disclosure shall be provided [**] the date of the disclosure, provided, however, that if the disclosing Party is required to make the disclosure in a shorter period of time, such Party will nonetheless give the other Parties such notice and as much opportunity to comment thereon as is practical in advance of such disclosure.

 

5.4                                 Notwithstanding the foregoing, Anesta shall have the right to disclose this Agreement and any other documents associated with it to ECR Pharmaceuticals, Inc. (“ECR”) and/or its representatives for the limited purpose of satisfying obligations to ECR under Anesta’s agreement (as amended) with ECR related to the acquisition of AMRIX, provided that such disclosure is undertaken under a confidentiality agreement preventing further disclosure of this Agreement and any other documents associated with it that are subject to paragraph 5.1.

 

5.5                                 Impax understands that Anesta and Eurand are currently and may in the future be in patent litigation against Third Parties relating to Third Party Generic Equivalent Products (“non-Impax litigations”), and that ANDA 90-771 and related FDA correspondence produced by Impax in the Litigation (“Impax Documents”) [**].

 

For the avoidance of doubt, the Protective Order in the Litigation remains in full force and effect except as expressly modified herein, including but not limited to Anesta’s and

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

23

 

Eurand’s obligation to destroy all information and documents produced by Impax in the Litigation other than the Impax Documents.  [**].

 

6.                                      ADDITIONAL TERMS OF AGREEMENT

 

6. 1                              Parties in Interest

 

The parties hereby represent and warrant to each other that they have not sold, assigned, transferred, conveyed or otherwise disposed of any right or claim covered or released by this

 

Agreement and that they have the authority to enter into this Agreement.

 

6.2                                 Successors and Assigns

 

This Agreement shall be binding upon and inure to the benefit of and be enforceable by the parties hereto and their respective successors and assigns.  This Agreement may not be assigned by either party without the prior written consent of the other, which consent shall not be unreasonably withheld.

 

6.3                                 All Negotiations and Representations Superseded — Entire Agreement

 

This Agreement, the Eurand/Impax Quality Agreement, the Impax/Anesta Quality Agreement, the Transfer Price Agreement between Eurand and Impax, and PVA (if applicable) are the entire agreements between the parties and supersede any and all prior negotiations and understandings among all of the parties concerning the subject matter hereof.

 

6.4                                 Representation by Impax

 

Impax represents that ANDA No 90-771 is its only application for approval referencing the AMRIX® product, and further represents that it neither filed nor assisted in the Suitability Petition currently docketed at the FDA as Docket No. FDA 2009 P 0168.

 

6.5                                 Representations by Eurand and Anesta

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

24

 

(a)                                  Eurand and Anesta have the right to grant all of the rights and licenses granted herein to Impax and neither is under any obligation to any Third Party that conflicts with the terms of this Agreement.

 

(b)                                 Anesta owns and possesses all right, title and interest in NDA 21-777.

 

6.6.                              Amendments in Writing

 

This Agreement may not be amended or modified except by a written agreement signed by all parties.  No breach of any provision of this Agreement can be waived unless in writing.  Waiver of any one breach shall not be deemed to be a waiver of any other breach of the same or any other provision hereof.

 

6.7.                              Severability

 

In the event that any condition or covenant herein is held to be invalid or void by any court of competent jurisdiction, the same shall be deemed severable from the remainder of the Agreement, and shall in no way affect any other covenant or condition contained herein.  If any condition or covenant of this Agreement is deemed invalid or void due to its scope or breadth, such provision shall be deemed valid to the extent permitted by law.

 

6.8.                              Governing Law

 

This Agreement is made pursuant to, and shall be governed by, the laws of the State of Delaware without regard to Delaware’s conflict of laws principles.

 

6.9.                              Advice of Counsel

 

The parties hereto represent and declare that, in executing this Agreement, they rely solely upon their own judgment, belief and knowledge, and the advice and recommendations of their own independently selected counsel, concerning the nature, extent and duration of their rights and claims, and they have not been influenced to any extent whatsoever in executing the

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

25

 

same by any representations or statements made or omitted to be made by the other party hereto or by any person representing the other party.

 

6.10.                      Indemnification

 

(a)                                  Impax will indemnify, defend, and hold Anesta and Eurand harmless against any actions, claims, liabilities and expenses resulting from the manufacture, sale or use of the Impax ANDA Product sold by Impax, its Affiliates or their customers (“Impax Indemnification Claims”).  Impax’s indemnification obligations are conditioned upon prompt written notification by Anesta and Eurand of any Impax Indemnification Claims and Anesta and Eurand’s reasonable cooperation, at Impax’s expense, in Impax’s defense of such claims.

 

(b)                                 Eurand will indemnify, defend and hold Impax harmless against any actions, claims, liabilities and expenses resulting from failure by Eurand to manufacture the Impax Authorized Generic Product in accordance with this Agreement, except that this indemnification shall not apply to personal injury claims caused by the actions or negligence of Impax (“Eurand Indemnification Claims”).  Eurand’s indemnification obligations are conditioned upon prompt written notification by Impax of any Eurand Indemnification Claims and Impax’s reasonable cooperation, at Eurand’s expense, in Eurand’s defense of such claims.

 

6.11.                      Termination and Effect of Termination

 

(a)                                  Term.  [**].

 

(b)                                 Termination.  This Agreement may be terminated in the event that a party fails to perform or otherwise breaches any material obligations hereunder.  Additionally, in the event that Impax breaches paragraph 2.7 above, Anesta and Eurand shall have the right to terminate this Agreement, although Impax’s agreements, and acknowledgements referenced in paragraph 3.7 shall survive such termination.  Termination is effected by one party giving notice to the

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

26

 

other party in writing of its intent to terminate, while stating with specificity the grounds therefore.  Unless otherwise provided herein, the party so notified shall have sixty (60) days after receipt of the notice to cure the breach or seek legal redress.  In no event shall such notice of intention to terminate be deemed to waive any right to damages or any other remedy which the party giving the notice may have as a consequence of such failure or such breach.  Termination of this Agreement shall serve to terminate all licenses granted hereunder.

 

6.12                         Dispute Resolution.

 

(a)                                  Preliminary Process.  If there is a disagreement among the Parties as to the interpretation of this Agreement or in relation to any aspect of the performance by either Party of its obligations under this Agreement, the Parties shall, within ten (10) Business Days of receipt of a written request from any Party, meet in good faith and try to resolve the disagreement without recourse to legal proceedings.

 

(b)                                 Escalation of Dispute.  If resolution of the disagreement does not occur within five (5) business days after such meeting, the matter shall be escalated for determination by the President of Impax Generics Division and Ross Oehler for Anesta and/or Manya Deehr for Eurand for resolution, who may resolve the matter themselves or jointly appoint a mediator or independent expert to do so.

 

(c)                                  Equitable Relief.  Nothing in this Section 6.12 restricts any Party’s freedom to seek urgent relief to preserve a legal right or remedy, or to protect a proprietary or trade secret right, or to otherwise seek legal remedies through any available channel if resolution is not otherwise achieved under this Section 6.12.

 

(d)                                 Section 3.7 Supersedes.  Nothing in this Section 6.12 restricts Anesta and/or Eurand’s freedom to invoke the remedies of Section 3.7 for sale by Impax of Licensed Product before the License Effective Date.

 

6.13.                      Relationship of Parties

 

None of the parties or their agents and employees shall under any circumstance be deemed an agent or representative of any other party, and none shall have authority to act for and/or bind the other in any way, or represent that it is in any way responsible for acts of the

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

27

 

other.  This Agreement does not establish a joint venture, agency or partnership between the parties.

 

6.14.                        Notice

 

Any notice required or permitted to be given by this Agreement shall be given by postpaid first class certified mail, or overnight delivery service or by facsimile with confirmation of receipt, addressed to:

 

In the case of Anesta and Eurand:

 

Anesta AG

Baarerstrasse 23

6300 Zug

Switzerland

 

With a copy to:

 

Anesta AG

Attn: Kevin Buchi

c/o Cephalon, Inc.

41 Moores Road

Frazer, PA 19355

USA

 

In the case of Impax:

 

Impax Laboratories, Inc.

30831 Huntwood Avenue

Hayward, CA 94544

Attention:  CEO

Facsimile:  (510) 972-7756

 

with copy to:

 

Legal Department

Impax Laboratories, Inc.

31047 Genstar Road

Hayward, CA 94544

Facsimile:  (510) 972-7756

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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Such addresses may be altered by written notice.  If no time limit is specified for a notice required or permitted to be given under this Agreement, the time limit therefore shall be two (2) full business days, not including the day of mailing.

 

6.15.                        Counterparts

 

This Agreement may be executed in any number of counterparts, each of which shall be an original and all of which, taken together, shall constitute one and the same instrument.

 

6.16                           Government Review

 

The Parties agree to submit this Agreement to the U.S. Federal Trade Commission (“FTC”) and the U.S. Department of Justice (“DOJ”) as required by statute.

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

29

 

IN WITNESS WHEREOF, the parties have by their duly authorized representatives hereunder set their hands the day and year first above written.

 

 

	
DATED:   October 7, 2010
    	
ANESTA   AG
    
	
 
    	
On   behalf of itself and its Affiliates,
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   J. Kevin Buchi
    
	
 
    	
Print   Name: J. Kevin Buchi
    
	
 
    	
Title:   Chairman of the Board
    
	
 
    	
 
    
	
DATED:   October 8, 2010
    	
EURAND, INC.
    
	
 
    	
On   behalf of itself and its Affiliates,
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   John Framer
    
	
 
    	
Print   Name: John Framer
    
	
 
    	
Title:   President
    
	
 
    	
 
    
	
 
    	
 
    
	
DATED:   October 7, 2010
    	
IMPAX   LABORATORIES, INC.
    
	
 
    	
On   behalf of itself and its Affiliates,
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Larry Hsu
    
	
 
    	
Print   Name: Larry Hsu
    
	
 
    	
Title:   Chief Executive Officer
    

 

**          Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

30Exhibit 10.29(a)

STOCK PURCHASE AGREEMENT

 

This STOCK PURCHASE AGREEMENT (the “Agreement”) is made as of December 7, 2010 by and among Angioblast Systems, Inc., a Delaware corporation (the “Company”), the individuals and entities listed on Exhibit A hereto (the “Sellers,” and each a “Seller”), the individuals and entities listed on Exhibit B hereto (the “Non-Selling Holders”) and Cephalon International Holdings, Inc. (the “Purchaser”).

 

Recitals

 

WHEREAS, each of the Sellers currently holds that number of shares of common stock, par value $0.0001 (the “Common Stock”), of the Company, as provided on Exhibit A hereto;

 

WHEREAS, the Purchaser desires to purchase from each Seller an amount equal to 42.9415389% of the total number of shares of Common Stock owned by such Seller at a per share price of $275.5736 USD, for an aggregate of Four Hundred Eighty-Five Thousand Eight Hundred Forty-Seven (485,847) shares of Common Stock (the “Shares”) at an aggregate purchase price of $133,886,606.84 USD (the “Purchase Price”), as provided on Exhibit A hereto (the “Transfer”);

 

WHEREAS, pursuant to Section 1.8(a) of that certain Second Amended and Restated Investor Rights Agreement, dated as of November 14, 2008, by and among the Company and the parties listed on Exhibit A thereto (the “Investor Rights Agreement”), the Sellers and the Non-Selling Holders are entitled to certain rights, including notice rights and tag along rights, with respect to the proposed Transfer;

 

WHEREAS,  the Purchaser’s willingness to consummate the Transfer is conditioned upon the terms contained herein;

 

WHEREAS, the Sellers and the Non-Selling Holders desire to consummate the Transfer on the terms contained herein and are willing to waive and amend certain of their rights under the Investor Rights Agreement to accommodate the Transfer;

 

WHEREAS, pursuant to Section 4.4 of the Investor Rights Agreement, (i) the Investor Rights Agreement or any provisions thereof benefitting the holders of shares of Common Stock may be amended, waived, discharged or terminated with the written consent of the holders holding at least a majority of the shares of Common Stock then held by the holders of shares of Common Stock (the “Majority Common Holders”) so long as the effect thereof will be that all holders of shares of Common Stock will be treated equally and (ii) the Investor Rights Agreement or any provisions thereof benefitting Mesoblast Limited (“Mesoblast”) may be waived by the holders of a majority of the shares of the Company’s capital stock owned by Mesoblast;

 

WHEREAS, this Agreement constitutes a waiver and amendment of the Investor Rights Agreement and (i) affects all parties to the Investor Rights Agreement similarly; (ii) does not decrease the rights of any single party under the Investor Rights Agreement in comparison to such party’s current rights in regards the other holders of shares of the Company’s capital stock; and (iii) does not increase such party’s obligations under the Investor Rights Agreement; all except as specifically waived or amended herein;

 

WHEREAS, the undersigned constitute the Company, the Majority Common Holders and Mesoblast;

 

 

WHEREAS,  the Company, Mesoblast, and Angioblast Acquisition Corp, a wholly-owned subsidiary of Mesoblast (the “Sub”) are parties to that certain Agreement and Plan of Merger, dated as of September 28, 2010 and subsequently amended on October 13, 2010 (the “Merger Agreement”), pursuant to which the Sub will merge with and into the Company and the Company will become a wholly-owned subsidiary of Mesoblast immediately following the Transfer and all Shares as well as all other outstanding capital stock of the Company shall be treated as set forth in the Merger Agreement (the “Merger”);

 

WHEREAS, pursuant to the Merger Agreement, upon the Merger, the Shares shall be cancelled and automatically converted into the right to receive ordinary shares of Mesoblast;

 

WHEREAS, pursuant to the terms of the Merger Agreement, each of the Sellers is entitled to elect to receive fifteen percent (15%) of such Seller’s pro rata share of the merger consideration in cash (the “Cash Election”);

 

WHEREAS, as a condition to the Transfer, (a) the Sellers and (b) the Purchaser must each agree to waive any and all rights to the Cash Election;

 

WHEREAS, the Sellers and the Purchaser are each willing to waive any and all rights to the Cash Election in order to accommodate the Transfer; and

 

WHEREAS, the parties desire to set forth certain representations, warranties and covenants made by each to the other to induce the sale of the Shares to the Purchaser and the consummation of the transactions contemplated by this Agreement.

 

NOW, THEREFORE, in consideration of the premises and of the mutual representations, warranties and covenants herein contained, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged and accepted, the parties hereby agree as follows:

 

1.     Purchase of Stock.

 

(a)   Purchase.  Subject to the terms and conditions of this Agreement, each of the Sellers agree to sell to the Purchaser, and the Purchaser agrees to purchase from each of the Sellers, the Shares in exchange for the Purchase Price, in the amounts provided on Exhibit A hereto.

 

(b)   Closing Date.  The closing of the purchase contemplated by this Agreement (the “Closing”) shall take place at such location to be determined by the Sellers and the Purchaser on the date hereof (the “Closing Date”).

 

(c)   Delivery.

 

(1)   At the Closing, the Purchaser will deliver to each of the Sellers, each such Seller’s share of the Purchase Price, in the amounts provided on Exhibit A hereto, paid by check or wire transfer.

 

(2)   At the Closing, each of the Sellers shall (i) deliver the original stock certificate(s) or stock power(s) evidencing ownership and transfer of the Shares registered in his, her or its name to the Company and (ii) the Company shall deliver to the Purchaser an original stock certificate evidencing ownership of the Shares registered in the name of the Purchaser.

 

2

 

(3)   Promptly following the Closing, the Company shall (i) deliver to each of the Sellers an original stock certificate evidencing ownership of the balance of the shares of the Company’s Common Stock registered in the name of such Seller and (ii) update its stock record books to reflect the purchase of the Shares by the Purchaser and the issuance of the remaining shares to the Sellers.

 

(d)   Assignment by Sellers.  The Sellers hereby agree to assign and transfer to the Purchaser the Shares standing in each of the Sellers’ names on the Company’s books at the Closing, and hereby irrevocably constitute and appoint Wilson Sonsini Goodrich & Rosati, Professional Corporation, as attorney to transfer the Shares on the books of the Company with full power of substitution in the premises.

 

(e)   Further Assurances.  The Purchaser and each of the Sellers, respectively, shall use all reasonable efforts to take, or cause to be taken, all actions, and to do, or cause to be done, all things necessary, proper or advisable to consummate and make effective, in the most expeditious manner practicable, the transactions contemplated by this Agreement, including the execution or delivery of any additional instruments necessary to consummate the transactions contemplated by, and to fully carry out the purposes of, this Agreement.

 

2.     Representations and Warranties of the Purchaser.  The Purchaser represents and warrants to each of the Sellers as follows:

 

(a)   Authority.  The Purchaser has the requisite corporate power and authority to enter into this Agreement, and has taken all action necessary to authorize the transactions effected hereby.  This Agreement has been duly and validly executed and delivered by, and is the valid, legal and binding obligation of, the Purchaser, enforceable in accordance with its terms except as such enforceability may be limited by bankruptcy, insolvency, reorganization or other similar laws affecting the enforcement of creditors’ rights generally and general principles of equity.

 

(b)   No Violations.  Neither the execution nor the delivery of this Agreement, nor the consummation of the transactions herein contemplated and the fulfillment of the terms hereof will conflict with or result in any violation of or constitute a default under any terms of any material written agreement, mortgage, indenture, franchise, license, permit, authorization, lease or other instrument, judgment, decree, order, law or regulation, to which the Purchaser is subject or by which it may be bound.

 

(c)   Investment Representations.  The Purchaser hereby represents and warrants to the Company as follows:

 

(1)           Authorization.  The Purchaser has the requisite corporate power and authority to execute, deliver and perform this Agreement.  This Agreement, when executed and delivered by the Purchaser, will constitute a valid and legally binding obligation of the Purchaser, enforceable in accordance with its terms, except as limited by applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally and by laws relating to the availability of specific performance, injunctive relief or other equitable remedies.

 

(2)           Accredited Investor.  The Purchaser is an accredited investor, as defined in Rule 501 promulgated under the Securities Act of 1933, as amended (the “Securities Act”).

 

(3)           Purchase Entirely for Own Account.  The Purchaser confirms that the Shares are being acquired for investment for the Purchaser’s own account, not as a nominee or agent, and not with a view to the resale or distribution of all or any part thereof, and that the Purchaser has no present intention of selling, granting any participation in, or otherwise distributing the same.  By executing this

 

3

 

Agreement, the Purchaser further represents that it does not have any contract, undertaking, agreement or arrangement with any person to sell, transfer or grant participations to such person or to any third person with respect to any of the Shares.

 

(4)           Access to Data.  The Purchaser has received and reviewed information about the Company and has had an opportunity to discuss the Company’s business, management and financial affairs with its management and to review the Company’s facilities.

 

(5)           Investment Experience.  The Purchaser has such knowledge and experience in financial or business matters that the Purchaser is capable of evaluating the merits and risks of the investment in the Shares, and the Purchaser can bear the economic risk of its investment, including the risk of total loss.

 

(6)           Address.  The state and country of the principal place of business of the Purchaser is correctly set forth on signature page hereto.

 

3.     Representations and Warranties of the Sellers.  Each of the Sellers, severally and not jointly, represents and warrants to the Purchaser as follows:

 

(a)   Authority.  The Seller has full power and authority to enter into this Agreement, and to consummate the transactions contemplated hereby and has taken all action necessary to authorize the transactions effected hereby.  This Agreement has been duly and validly executed and delivered by, and is the valid, legal and binding obligation of, the Seller, enforceable in accordance with its terms except as such enforceability may be limited by bankruptcy, insolvency, reorganization or other similar laws affecting the enforcement of creditors’ rights generally and general principles of equity.

 

(b)   No Violations.  Neither the execution nor the delivery of this Agreement, nor the consummation of the transactions herein contemplated and the fulfillment of the terms hereof will conflict with or result in any violation of or constitute a default under any terms of any written agreement, mortgage, indenture, franchise, license, permit, authorization, lease or other instrument, judgment, decree, order, law or regulation, to which the Seller is subject or by which the Seller may be bound.

 

(c)   Title to the Shares.  The Seller is the sole record and beneficial owner of the Shares.  The Seller has, and will deliver to the Purchaser, good and valid title to the Shares, free and clear of any mortgages, liens, encumbrances or other interests of third parties of any nature, including but not limited to any right of first refusal.  Seller has not granted any right to purchase the Shares to any other person or entity.  The Seller has the sole right to transfer the Shares to the Purchaser.

 

(d)   Tax Liability.  The Seller has reviewed with the Seller’s own tax advisors the federal, state, local and foreign tax consequences of the transactions contemplated by this Agreement.  The Seller relies solely on such advisors and not on any statements or representations of the Company or any of its agents for the federal, state, local and foreign tax consequences to the Seller that may result from the transactions contemplated by this Agreement.  The Seller understands that the Seller (and not the Company or the Purchaser) shall be responsible for any tax liability of the Seller that may arise as a result of the transactions contemplated by this Agreement.

 

(e)   Brokers or Finders.  The Seller has not incurred, and will not incur, directly or indirectly, as a result of any action taken by the Seller, any liability for brokerage or finders’ fees or agents’ commissions or any similar charges in connection with this Agreement or any of the transactions contemplated hereby.

 

4

 

4.     Acknowledgements by Purchaser and Sellers.  The Purchaser and each of the Sellers acknowledge and represent to the Company that the purchase price for the Shares hereby is agreed to solely between the Purchaser and each of the Sellers.  The Purchaser and each of the Sellers acknowledge and agree that the Company takes no position on the appropriateness or adequacy of the purchase price and makes no representation or warranty regarding the value of the Shares.  The Purchaser and each of the Sellers acknowledge and agree that the actual value of the Shares may be substantially different than the purchase price for the Shares paid by the Purchaser to any of the Sellers hereunder.

 

5.     Conditions to Obligation of the Purchaser to Close.  The obligations of the Purchaser to purchase the Shares at the Closing are subject to the satisfaction, at or prior to the Closing Date, of the following conditions:

 

(a)   Representations and Warranties Correct.  The representations and warranties made by each of the Sellers in Section 3 of this Agreement shall be true and correct on the Closing Date.

 

(b)   Delivery of Stock Certificates and/or Stock Powers.  Each of the Sellers shall have delivered to the Company all original stock certificate(s) and/or stock power(s) evidencing ownership and transfer of the Shares.

 

(c)   Wire Transfer Instructions.  Wire transfer instructions for each of the Sellers shall be correctly set down on the signature pages hereto.

 

6.     Conditions to Obligation of the Sellers to Close.  The obligations of each of the Sellers to sell the Shares at the Closing are subject to the satisfaction, at or prior to the Closing Date, of the following conditions:

 

(a)   Representations and Warranties Correct.  The representations and warranties made by the Purchaser in Section 2 of this Agreement shall be true and correct on the Closing Date.

 

(b)   Delivery of Purchase Price.  The Purchaser shall have delivered to each of the Sellers the Purchase Price for the Shares.

 

7.     Amendment of Investor Rights Agreement.

 

(a)   Section 1.6(a) of the Investor Rights Agreement is hereby amended and restated in its entirety and replaced with the following:

 

“(a)         Any Shareholder may transfer up to one third of their then current shareholding in which case (but only in the case of this Section 1.6(a)) Tag Along Rights and Drag Along Rights shall not apply but the transferee must enter into an agreement (1) to be bound by the terms of that certain Stock Purchase Agreement, dated as of December 6, 2010, by and among the Company, the Selling Holders listed on Exhibit A thereto, the Non-Selling Holders listed on Exhibit B thereto and Cephalon International Holdings, Inc. (the “December 2010 Stock Purchase Agreement”) and (2) acknowledging and approving the terms of that certain Agreement and Plan of Merger, by and among Mesoblast, the Company and Angioblast Acquisition Corp., dated as of September 28, 2010 and subsequently amended on October 13, 2010 (the “Merger Agreement”); and”

 

(b)   Section 1.8 of the Investor Rights Agreement is hereby amended by adding the following Section 1.8(g):

 

5

 

“(g)         This section 1.8 shall not apply to the offer or sale of shares of the Company by certain of its stockholders pursuant to the December 2010 Stock Purchase Agreement.”

 

(c)   Section 4 of the Investor Rights Agreement shall be amended by adding the following Section 4.12:

 

“4.12       Termination.  This Agreement shall terminate and be of no further force and effect immediately prior to the closing of the merger contemplated by the Merger Agreement.”

 

8.     Waiver of Rights under Investor Rights Agreement.

 

(a)   Waiver.  Each of the Sellers and Mesoblast hereby waive any and all rights pursuant to Section 1.8 of the Investor Rights Agreement with respect to the Transfer (the “Waiver”).

 

(b)   Effectiveness.  Notwithstanding anything to the contrary contained herein, this Waiver shall become effective and binding on all the holders of shares of Common Stock upon execution by the Company, the Sellers and Mesoblast.  The failure of one or more holders of shares of Common Stock to sign this Waiver shall not affect its effectiveness.

 

(c)   Effect.  This Waiver applies solely with respect to the Transfer and not with respect to any other sale, transfer or other transaction.

 

9.     Waiver of Right to Cash Election.  Each of the Sellers and the Purchaser, severally and not jointly, waives any and all right to the Cash Election pursuant to the terms of the Merger Agreement.

 

10.   Restrictions on Transfer.

 

(a)   Investment Representations and Legend Requirements.  The Purchaser understands and agrees that the Company shall cause the legends set forth below, or substantially equivalent legends, to be placed upon any certificate(s) evidencing ownership of the Shares, together with any other legends that may be required by the Company or by applicable state or federal securities laws:

 

“THE SHARES REPRESENTED BY THIS CERTIFICATE HAVE BEEN ACQUIRED FOR INVESTMENT AND HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.  SUCH SHARES MAY NOT BE SOLD, TRANSFERRED OR PLEDGED IN THE ABSENCE OF SUCH REGISTRATION OR UNLESS THE COMPANY RECEIVES AN OPINION OF COUNSEL (WHICH MAY BE COUNSEL FOR THE COMPANY) REASONABLY ACCEPTABLE TO IT STATING THAT SUCH SALE OR TRANSFER IS EXEMPT FROM THE REGISTRATION AND PROSPECTUS DELIVERY REQUIREMENTS OF SAID ACT.”

 

“THE SHARES REPRESENTED BY THIS CERTIFICATE MAY BE TRANSFERRED ONLY IN ACCORDANCE WITH THE TERMS OF A CERTAIN INVESTOR RIGHTS AGREEMENT BY AND AMONG THE COMPANY, THE STOCKHOLDER AND THE OTHER PARTIES IDENTIFIED THEREIN, A COPY OF WHICH IS ON FILE WITH THE SECRETARY OF THE COMPANY.”

 

(b)   Stop-Transfer Notices.  The Purchaser hereby agrees that to ensure compliance with the restrictions referred to herein, the Company may issue appropriate “stop transfer” instructions to its

 

6

 

transfer agent, if any, and that, if the Company transfers its own securities, it may make appropriate notations to the same effect in its own records.

 

(c)   Refusal to Transfer.  The Purchaser hereby agrees that the Company shall not be required (i) to transfer on its books any Shares that have been sold or otherwise transferred in violation of any of the provisions of this Agreement or (ii) to treat as owner of such Shares or to accord the right to vote or pay dividends to any purchaser or other transferee to whom such Shares shall have been so transferred.

 

11.   Miscellaneous Provisions.

 

(a)   Governing Law.  This Agreement will be construed in accordance with Delaware law, without giving effect to its choice of law provisions, as applied to agreements among Delaware residents entered into and to be performed entirely within Delaware.

 

(b)   Counterparts.  This Agreement may be executed in any number of counterparts and each will be considered an original, and together they will constitute one Agreement.  Facsimile signatures will be considered original signatures for all applicable purposes.

 

(c)   Survival.  The representations, warranties, covenants and agreements made herein shall survive any investigation made by the parties hereto and the closing of the transactions contemplated hereby.

 

(d)   Entire Agreement.  This Agreement and the agreements contemplated hereby set forth the entire understanding as the parties hereto and supercede any prior and or written agreements and understandings with respect to the subject matter hereof.

 

(e)   Amendments and Modification.  This Agreement may not be modified, amended, altered or supplemented except upon the execution and delivery of a written agreement executed by each of the parties.

 

(f)    Reliance on Counsel and Advisors.  Each of the Company, the Purchaser, the Sellers and the Non-Selling Holders acknowledge that he, she or it had the opportunity to review this Agreement and the transactions contemplated hereby with his, her or its own legal counsel, tax advisors and other advisors.  Each of the Company, the Purchaser, the Sellers and Non-Selling Holders are relying solely on his, her or its own counsel and advisors and not on any statements or representations of the Company or its agents for legal or other advice with respect to this investment or the transactions contemplated by this Agreement.

 

(g)   Section Headings.  The section headings and subheadings contained in this Agreement are for convenient reference only, and will not in any way affect the interpretation of this Agreement.

 

(h)   Binding Effect.  All of the terms, covenants, representations, warranties and conditions of this Agreement will be binding upon, and inure to the benefit of and be enforceable by, the parties and their respective successors, assigns or other legal representatives, but this Agreement and the rights and obligations hereunder may only be assigned with the prior written consent of the parties.

 

(i)    Expenses.  Each of the Company, the Purchaser, the Sellers and Non-Selling Holders agree to bear their own legal, accounting and other professional expenses in connection with the preparation and consummation of this Agreement and the transactions contemplated hereby.

 

7

 

(j)    Notices.  Any notice, demand, offer, request or other communication required or permitted to be given by either the Company, the Sellers, the Non-Selling Holder or the Purchaser pursuant to the terms of this Agreement shall be in writing and shall be deemed effectively given the earlier of (i) when received, (ii) when delivered personally, (iii) one business day after being delivered by facsimile (with receipt of appropriate confirmation), (iv) one business day after being deposited with an overnight courier service or (v) four days after being deposited in the U.S. mail, First Class with postage prepaid and return receipt requested, addressed: (i) if to the Company, to Angioblast Systems, Inc., 275 Madison Avenue, 4th Floor, New York, NY, 10016, Attn: CEO, with a copy to Mark R. Fitzgerald, Esq., 1700 K Street NW, Washington, D.C., 20006 (which copy shall not constitute notice), (ii) if to the Purchaser, to such address set forth under the Purchaser’s name on the signature page hereto, (iii) if to a Seller, to such address set forth under the such Seller’s name on Exhibit A hereto,  and  (iv) if to a Non-Selling Holder, to such address set forth under such Non-Selling Holder’s name on Exhibit B hereto,  or such other address as a party may request by notifying the others in writing.

 

(k)   Assignment; Transfers.  Except as set forth in this Agreement, this Agreement, and any and all rights, duties and obligations hereunder, shall not be assigned, transferred, delegated or sublicensed by the Purchaser without the prior written consent of the Company.  Any attempt by the Purchaser without such consent to assign, transfer or delegate any rights, duties or obligations that arise under this Agreement shall be void.  .

 

(l)    Adjustment for Stock Split.  All references to the number of Shares and the purchase price of the Shares in this Agreement shall be adjusted to reflect any stock split, stock dividend or other change in the Shares which may be made after the date of this Agreement.

 

(m)  Severability.  In the event that any provision of this Agreement becomes or is declared by a court of competent jurisdiction to be illegal, unenforceable or void, this Agreement shall continue in full force and effect without said provision, provided that no such severability shall be effective if it materially changes the economic benefit of this Agreement to any party.

 

[SIGNATURE PAGE FOLLOWS]

 

8

 

IN WITNESS WHEREOF, the Company, the Purchaser, the Sellers and the Non-Selling Holders have executed this Stock Purchase Agreement or caused this Stock Purchase Agreement to be executed, all as of the date and year first above written.

 

	
 
    	
COMPANY:
    
	
 
    	
 
    
	
 
    	
ANGIOBLAST   SYSTEMS, INC.
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Carter Eckert
    
	
 
    	
 
    
	
 
    	
Name:   Carter Eckert
    
	
 
    	
 
    
	
 
    	
Title:   Chairman
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
PURCHASER:
    
	
 
    	
 
    
	
 
    	
Cephalon   International Holdings, Inc.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   J. Kevin Buchi
    
	
 
    	
 
    
	
 
    	
Name:   J. Kevin Buchi
    
	
 
    	
 
    
	
 
    	
Title:   Chief Operating Officer
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
Address:
    
	
 
    	
41   Moores Road
    
	
 
    	
Frazer,   PA 19355 U.S.A.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
Telephone:   610-344-0200
    
	
 
    	
Facsimile:   610-344-0065
    
	
 
    	
Email:
    	
 
    
				

 

[SIGNATURE PAGE TO STOCK PURCHASE AGREEMENT]

 

 

	
 
    	
NON-SELLING HOLDER:
    
	
 
    	
 
    
	
 
    	
MESOBLAST   LIMITED
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Brian Jamieson
    
	
 
    	
Name:   Brian Jamieson
    
	
 
    	
Title:   Chairman
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Kevin Hollingsworth
    
	
 
    	
Name:   Kevin Hollingsworth
    
	
 
    	
Title:   Company Secretary
    

 

[SIGNATURE PAGE TO STOCK PURCHASE AGREEMENT]

 

 

	
 
    	
SELLER:
    
	
 
    	
 
    
	
 
    	
DR.   SILVIU ITESCU
    
	
 
    	
 
    
	
 
    	
/s/ Silviu Itescu
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
Wire   Transfer Instructions:
    

 

[SIGNATURE PAGE TO STOCK PURCHASE AGREEMENT]

 

 

	
 
    	
SELLER:
    
	
 
    	
 
    
	
 
    	
MICHAEL   SCHUSTER
    
	
 
    	
 
    
	
 
    	
/s/ Michael Schuster
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
Wire   Transfer Instructions:
    

 

[SIGNATURE PAGE TO STOCK PURCHASE AGREEMENT]

 

 

	
 
    	
SELLER: THORNEY   HOLDINGS PTY LTD
    
	
 
    	
 
    
	
 
    	
c/o   ANZ NOMINEES LIMITED CUSTODIAL
   ACCOUNT: 283700021108
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Ashley West
    
	
 
    	
 
    
	
 
    	
Name:   Ashley West
    
	
 
    	
 
    
	
 
    	
Title:   Director
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
SELLER: THORNEY   HOLDINGS PTY LTD
    
	
 
    	
 
    
	
 
    	
c/o   ANZ NOMINEES LIMITED CUSTODIAL
   ACCOUNT: 283700021108
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Craig Smith
    
	
 
    	
 
    
	
 
    	
Name:   Craig Smith
    
	
 
    	
 
    
	
 
    	
Title:   Secretary
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
Wire   Transfer Instructions:
    

 

[SIGNATURE PAGE TO STOCK PURCHASE AGREEMENT]

 

 

	
 
    	
SELLER:
    
	
 
    	
 
    
	
 
    	
ABBOTT   CARDIOVASCULAR SYSTEMS, INC.
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Robert B. Hance
    
	
 
    	
 
    
	
 
    	
Name:   Robert B. Hance
    
	
 
    	
 
    
	
 
    	
Title:   Authorized Signatory
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
Wire   Transfer Instructions:
    

 

[SIGNATURE PAGE TO STOCK PURCHASE AGREEMENT]

 

 

	
 
    	
SELLER:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
WS   INVESTMENT COMPANY, LLC (2003A)
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   James Terranova
    
	
 
    	
 
    
	
 
    	
Name:   James Terranova
    
	
 
    	
 
    
	
 
    	
Title:
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
Wire   Transfer Instructions:
    

 

[SIGNATURE PAGE TO STOCK PURCHASE AGREEMENT]

 

 

	
 
    	
SELLER:
    
	
 
    	
 
    
	
 
    	
CARTER   ECKERT
    
	
 
    	
 
    
	
 
    	
/s/   Carter Eckert
    
	
 
    	
Carter   Eckert
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
Wire   Transfer Instructions:
    

 

[SIGNATURE PAGE TO STOCK PURCHASE AGREEMENT]

 

 

	
 
    	
SELLER:
    
	
 
    	
 
    
	
 
    	
ABBOTT   CARDIOVASCULAR SYSTEMS, INC.
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Robert B. Hance
    
	
 
    	
 
    
	
 
    	
Name:   Robert B. Hance
    
	
 
    	
 
    
	
 
    	
Title:   Authorized Signatory
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
Wire   Transfer Instructions:
    

 

[SIGNATURE PAGE TO STOCK PURCHASE AGREEMENT]

 

 

	
 
    	
SELLER:
    
	
 
    	
 
    
	
 
    	
THE   TRUSTEES OF COLUMBIA UNIVERSITY IN
   THE CITY OF NEW YORK
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Orin Herskowitz
    
	
 
    	
 
    
	
 
    	
Name:   Orin Herskowitz
    
	
 
    	
 
    
	
 
    	
Title:   Executive Director, CTV
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
Wire   Transfer Instructions:
    

 

[SIGNATURE PAGE TO STOCK PURCHASE AGREEMENT]

 

 

EXHIBIT A

SELLING HOLDERS

 

	
Name and Address
    	
 
    	
Total
   Shares of
   Angioblast
   Systems,
   Inc.
   Common
   Stock
    	
 
    	
Shares of
   Angioblast
   Systems, Inc.
   Common
   Stock to be
   Transferred
    	
 
    	
Aggregate
   Purchase Price
   (AUD)
    	
 
    	
Aggregate
   Purchase Price
   (USD)
    	
 
    	
Shares of
   Angioblast
   Systems,
   Inc.
   Common
   Stock held
   following
   Transfer
    	
 
    
	
Silviu Itescu

c/o Angioblast Systems,   Inc.

275 Madison Avenue, 4th   Floor

New York, NY, 10016

Fax:  +1.212.880.2061
    	
 
    	
905,050
    	
 
    	
388,642
    	
 
    	
$
    	
108,191,873.25
    	
 
    	
$
    	
107,099,475.05
    	
 
    	
516,408
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Michael Schuster

c/o Angioblast Systems,   Inc.

275 Madison Avenue, 4th   Floor

New York, NY, 10016

Fax:  +1.212.880.2061
    	
 
    	
20,000
    	
 
    	
8,588
    	
 
    	
$
    	
2,390,847.00
    	
 
    	
$
    	
2,366,626.08
    	
 
    	
11,412
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
ANZ Nominees Ltd,   Custodial Account:  283700021108

c/o Thorney Holdings   Pty Ltd.

55 Collins Street,   Level 39

Melbourne 3000

Australia
    	
 
    	
19,950
    	
 
    	
8,566
    	
 
    	
$
    	
2,384,870.10
    	
 
    	
$
    	
2,360,563.46
    	
 
    	
11,384
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Abbott Cardiovascular   Systems, Inc.

3200 Lakeside Drive

Santa Clara, CA 95054

Attn: Division Vice   President and Section Head, Legal
    	
 
    	
70,091
    	
 
    	
30,098
    	
 
    	
$
    	
8,378,843.85
    	
 
    	
$
    	
8,294,214.21
    	
 
    	
39,993
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Carter Eckert

c/o Angioblast Systems,   Inc.

275 Madison Avenue, 4th   Floor

New York, NY, 10016

Fax:  +1.212.880.2061
    	
 
    	
37,500
    	
 
    	
16,103
    	
 
    	
$
    	
4,482,840.30
    	
 
    	
$
    	
4,437,561.68
    	
 
    	
21,397
    	
 
    

 

 

	
WS Investment Company,   LLC (2003A)

650 Page Mill Road

Palo Alto, CA  94304-1050

Attn:  Jim Terranova

Fax:  1.650.493.6811
    	
 
    	
15,000
    	
 
    	
6,441
    	
 
    	
$
    	
1,793,135.25
    	
 
    	
$
    	
1,774,969.56
    	
 
    	
8,559
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
The Trustees of   Columbia University 

in the City of New York

Executive Director   Science and Technology Ventures

Columbia Innovation   Enterprises

Columbia University

Engineering Terrace,   Suite 363

500 West 120th Street,   Mailcode 2206

New York, NY 10027

Attn: Michael J. Cleare
    	
 
    	
63,829
    	
 
    	
27,409
    	
 
    	
$
    	
7,630,269.75
    	
 
    	
$
    	
7,553,196.80
    	
 
    	
36,420
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Total:
    	
 
    	
1,131,420
    	
 
    	
485,847
    	
 
    	
$
    	
135,252,679.50
    	
 
    	
$
    	
133,886,606.84
    	
 
    	
645,573
    	
 
    

 

 

EXHIBIT B

NON-SELLING HOLDERS

 

	
Name and Address
    	
 
    	
Total Shares of Angioblast
   Systems, Inc. Common Stock
    	
 
    
	
Mesoblast Limited

55 Collins Street, Level 39

Melbourne   3000

Australia
    	
 
    	
705,323
    	
 
    

 

 

EXHIBIT C

ILLUSTRATIVE EXAMPLE

 

Shares of Mesoblast to be issued pursuant to Merger following Transfer

 

	
Name and Address
    	
 
    	
Total Shares of
   Mesoblast
    	
 
    	
Shares of
   Mesoblast Shares
   to be Received by
   Cephalon in
   Merger
    	
 
    	
Shares of
   Mesoblast
   held by
   Seller
   following
   Merger
    	
 
    
	
Silviu Itescu

c/o Angioblast   Systems, Inc.

275 Madison   Avenue, 4th Floor

New York, NY,   10016

Fax:  +1.212.880.2061
    	
 
    	
57,919,899
    	
 
    	
24,871,695
    	
 
    	
33,048,204
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Michael Schuster

c/o Angioblast   Systems, Inc.

275 Madison   Avenue, 4th Floor

New York, NY,   10016

Fax:  +1.212.880.2061
    	
 
    	
1,279,927
    	
 
    	
549,620
    	
 
    	
730,307
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
ANZ Nominees   Ltd, Custodial Account:  283700021108

c/o Thorney   Holdings Pty Ltd.

55 Collins   Street, Level 39

Melbourne 3000

Australia
    	
 
    	
1,276,727
    	
 
    	
548,246
    	
 
    	
728,481
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Abbott   Cardiovascular Systems, Inc.

3200 Lakeside   Drive

Santa Clara, CA   95054

Attn: Division   Vice President and Section Head, Legal
    	
 
    	
4,485,568
    	
 
    	
1,926,171
    	
 
    	
2,559,397
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Carter Eckert

c/o Angioblast   Systems, Inc.

275 Madison Avenue,   4th Floor

New York, NY,   10016

Fax:  +1.212.880.2061
    	
 
    	
2,399,863
    	
 
    	
1,030,538
    	
 
    	
1,369,325
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
WS Investment   Company, LLC (2003A)

650 Page Mill   Road

Palo Alto,   CA  94304-1050

Attn:  Jim Terranova

Fax:  1.650.493.6811
    	
 
    	
959,945
    	
 
    	
412,215
    	
 
    	
547,730
    	
 
    

 

 

	
The Trustees of   Columbia University 

in the City of   New York

Executive Director   Science and Technology Ventures

Columbia Innovation   Enterprises

Columbia University

Engineering Terrace,   Suite 363

500 West 120th Street,   Mailcode 2206

New York, NY 10027

Attn: Michael J.   Cleare
    	
 
    	
4,084,823
    	
 
    	
1,754,085
    	
 
    	
2,330,738
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Total:
    	
 
    	
117,544,851
    	
 
    	
31,092,570
    	
 
    	
41,314,182
    	
 
    

 

FOR EXPLANATORY PURPOSES ONLY.

 

ACTUAL SHARE NUMBERS MAY VARY.

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