Document:

Exhibit 10.29(b)

 

Subscription Deed

 

 

Mesoblast Limited

ABN 68 109 431 870

 

 

and

 

 

Cephalon International Holdings, Inc.

 

 

Middletons Lawyers

 

 

Melbourne office

Ref:  MLUM.NZM:10024006

 

 

Subscription Deed

 

	
Date
    	
 
    	
2010
    

 

Parties

 

1.                                   Mesoblast Limited ABN 68 109 431 870 of Level 39, 55 Collins Street, Melbourne, Victoria 3000, Australia (Mesoblast)

 

2.                                   Cephalon International Holdings, Inc. of 41 Moores Road, Frazer, PA 19355, United States of America  (Cephalon)

 

Background

 

A.                                 Mesoblast and Angioblast Systems, Inc (Angioblast) have entered into a merger agreement dated as of September 28, 2010 and amended on October 13, 2010 for the acquisition by Mesoblast of all of the issued capital of Angioblast (Merger Agreement).

 

B.                                 Cephalon, simultaneously with the execution of this Subscription Deed, will:

 

(a)                               enter into a licence agreement with Angioblast under which Cephalon is to acquire the license of certain intellectual property rights of Angioblast in specified applications and territories; and

 

(b)                               acquire certain stock in Angioblast which in accordance with the terms of the Merger Agreement will on completion under that agreement be extinguished with Mesoblast issuing new Shares to those persons holding Angioblast stock on the date of completion.

 

C.                                 Mesoblast wishes to issue and Cephalon wishes to subscribe for additional Shares which on issue, in aggregate with the Shares to be issued to Cephalon on completion under the Merger Agreement, will result in Cephalon holding 19.99% of the issued Shares.

 

D.                                 Mesoblast has agreed to issue and Cephalon has agreed to subscribe for the additional Shares as outlined in accordance with recital C on the terms and condition of this Deed.

 

Operative Provisions

 

1.                                   Definitions and interpretation

 

1.1                            Definitions

 

In this Deed:

 

AEDST means Australian Eastern daylight saving time;

 

Angioblast means Angioblast Systems, Inc a company incorporated under the laws of State of Delaware, in the United States;

 

ASX means the Australian Securities Exchange or ASX Limited, as the context requires;

 

ASX Listing Rules means the Official Listing Rules of ASX;

 

 

Business Day means a day which is not a Saturday, Sunday, public holiday or bank holiday in Victoria Australia;

 

Cephalon Associates means any officer of Cephalon or any person or entity who would constitute an “associate” of Cephalon (where Cephalon was an Australian company) within the meaning given to the term “associate” under sections 11, 12 and 15 of the Corporations Act;

 

Cephalon Group means Cephalon and its subsidiaries and controlled entities;

 

Completion  Date means (subject to clause 2.6(b)) that date being not more than 2 Business Days after the date that each of the Conditions Precedent is satisfied;

 

Conditions Precedent means the conditions precedent to the issue of the Subscription Shares as detailed in clause 3.1;

 

Control Proposal means any proposed or possible transaction or arrangement which, if entered into or completed, would result in any person:

 

(a)                               acquiring (whether directly or indirectly):

 

(i)                                  an interest in all or a substantial part of the business of the Mesoblast Group, or a right to acquire any such interest; or

 

(ii)                               a relevant interest in 20% or more of Shares, or a right to acquire any such relevant interest;

 

(b)                               acquiring control (as determined in accordance with section 50AA of the Corporations Act) of Mesoblast;

 

(c)                                otherwise acquiring or merging with Mesoblast;

 

Corporations Act means the Corporations Act 2001 (Cth);

 

Deed means this Deed including the recitals, any schedules and any annexures;

 

Government Agency includes any government, or any government, semi-government or judicial agency or authority;

 

Mesoblast Board means the Board of Directors of Mesoblast;

 

Mesoblast Group means Mesoblast and its related bodies corporate;

 

Notice of Meeting means a notice of meeting of Shareholders to approve the issue of the Subscription Shares to Cephalon for the purposes of ASX Listing Rule 7.1;

 

related body corporate has the meaning given to that term in the Corporations Act;

 

relevant interest has the meaning given to that term in the Corporations Act;

 

Shares means fully paid ordinary shares in the capital of Mesoblast;

 

Subscription Amount means the aggregate Subscription Price per Share for the issue of all of the Subscription Shares being equal to the number of Subscription Shares multiplied by the Subscription Price;

 

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Subscription Price means a price per Subscription Share being the lesser of (a) Au$110,601,295 divided by the total Subscription Shares and (b) Au$4.35;  and

 

Subscription Shares means a number of Shares equal to 19.99% of the issued Shares (after the issue of the Subscription Shares) less that number of Shares already issued to Cephalon under the Merger Agreement.

 

1.2                            Interpretation

 

In this Deed, unless the context requires otherwise:

 

(a)                               the singular includes the plural and vice versa and a gender includes the other genders;

 

(b)                               the headings are used for convenience only and do not affect the interpretation of this Deed;

 

(c)                                other grammatical forms of defined words or expressions have corresponding meanings;

 

(d)                               the word “person” includes a natural person and any body or entity whether incorporated or not;

 

(e)                                the words “in writing” include any communication sent by letter or facsimile transmission;

 

(f)                                 a reference to all or any part of a statute, rule, regulation or ordinance (statute) includes that statute as amended, consolidated, re-enacted or replaced from time to time;

 

(g)                                wherever “include” or any form of that word is used, it must be construed as if it were followed by “(without being limited to)”; and

 

(h)                               a reference to any agency or body, if that agency or body ceases to exist or is reconstituted, renamed or replaced or has its powers or functions removed (defunct body), means the agency or body which performs most closely the functions of the defunct body.

 

2.                                   Issue of Subscription Shares

 

2.1                            Application for Subscription Shares

 

Cephalon by executing this Deed agrees to subscribe for and Mesoblast agrees to issue the Subscription Shares on the terms and conditions of this Deed.  Cephalon’s agreement to subscribe for the Subscription Shares is irrevocable and, except as otherwise provided by this Deed, unconditional.

 

2.2                            Subscriber’s obligations

 

Cephalon must by 3.00pm AEDST on the Completion Date pay (in cleared funds) the Subscription Amount to Mesoblast by bank cheque or electronic funds transfer to an account nominated by Mesoblast.

 

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2.3                            Mesoblast’s obligations

 

Subject to compliance by Cephalon with clause 2.2, Mesoblast must, on the Completion Date:

 

(a)                               allot and issue the Subscription Shares to Cephalon, including by causing Mesoblast’s share registry to register Cephalon as the holder of the Subscription Shares;

 

(b)                               apply for and do everything the ASX reasonably requires to obtain quotation of the Subscription Shares; and

 

(c)                                deliver or cause to be delivered to Cephalon a holding statement for the Subscription Shares.

 

2.4                            Constitution

 

Cephalon agrees to be bound by and to hold the Subscription Shares subject to the terms of Mesoblast’s Constitution (as amended from time to time).

 

2.5                            Cleansing notice

 

If on the Completion Date:

 

(a)                               the requirements of section 708A(5)(a), (b), (c) and (d) of the Corporations Act are satisfied in relation to Mesoblast and the existing issued Shares (as applicable);

 

(b)                               Mesoblast has complied with:

 

(i)                                  the provisions of Chapter 2M of the Corporations Act as they apply to Mesoblast; and

 

(ii)                               section 674 of the Corporations Act; and

 

(iii)                            there is no determination in force under section 708A(2) of the Corporations Act,

 

Mesoblast must, on the Completion Date, issue a notice in accordance with section 708A(5)(e) of the Corporations Act (cleansing statement) in relation to the Subscription Shares issued on the Completion Date.

 

2.6                            Disclosure document

 

If any of the requirements referred to in clause 2.5 will not be satisfied on the Completion Date:

 

(a)                               Mesoblast must so notify Cephalon before the Completion Date promptly upon becoming aware that such requirements will not be satisfied; and

 

(b)                               Mesoblast must as soon as reasonably practicable issue a disclosure document which complies with Part 6D.2 of the Corporations Act (disclosure document) on or prior to the Completion Date (which shall be postponed to such date notified by Mesoblast to Cephalon with the notification given under paragraph (a) as will give Mesoblast sufficient time to prepare and issue the disclosure document) so that

 

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                                              Cephalon will not be subject to any on-sale restrictions in respect of such Shares under section 707(3) of the Corporations Act.

 

Mesoblast’s obligation to issue a disclosure document in accordance with this clause 2.6 is subject to Cephalon and its directors (if applicable) giving the consent required under section 720 of the Corporations Act.  Mesoblast must do everything reasonably required by Cephalon (in accordance with customary procedures and practice) to facilitate Cephalon and its directors (if applicable) giving such consent.

 

3.                                   Precondition to the issue of the Subscription Shares

 

3.1                            Conditions precedent

 

The issue of the Subscription Shares by Mesoblast to Cephalon is conditional on:

 

(a)                               Mesoblast obtaining the approval of its Shareholders for the purposes of ASX Listing Rule 7.1;

 

(b)                               no objection being received and the period of 30 days expiring (or earlier terminated) from the date of the filing by Mesoblast and Cephalon of a merger / acquisition notification (HSR filing) as required under the US Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended; and

 

(c)                                the Treasurer of the Commonwealth of Australia either:

 

(i)                                  issuing a notice stating that the Commonwealth Government does not object to the proposed acquisition of the Subscription Shares by Cephalon, either without conditions or with conditions that Cephalon considers acceptable (acting reasonably); or

 

(ii)                               becoming, or being, precluded under the Foreign Acquisitions and Takeovers Act 1975 (Cth) from making an order in respect of the proposed acquisition of the Subscription Shares by Cephalon,

 

in each case on or before 28 February 2011 or any other date agreed by Mesoblast and Cephalon in writing.

 

3.2                            Duties in relation to Conditions Precedent

 

(a)                               Each party must use its reasonable endeavours to ensure that the Conditions Precedent are fulfilled on or before the date specified in that clause.

 

(b)                               Without limiting the generality of paragraph (a), Mesoblast must use reasonable endeavours to convene a meeting of Shareholders to consider the Shareholders’ approval required by the Condition Precedent in clause 3.1(a), including by dispatching the Notice of Meeting by no later than 15 January 2011.

 

(c)                                Each party must:

 

(i)                                  supply the other with all information and documents necessary or desirable for the purpose of enabling the other party to fulfil or procure the fulfilment of each Condition Precedent; and

 

(ii)                               not take any action that would, or would be likely to, prevent or hinder the fulfilment of each Condition Precedent.

 

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(d)                               Without limiting the generality of paragraph (c), Cephalon must promptly provide Mesoblast with such information in relation to Cephalon and the Cephalon Group (Cephalon Information) as is reasonably required for the purposes of any disclosure that must be included in the Notice of Meeting or the HSR filing.

 

(e)                                Mesoblast must consult with Cephalon as to the content and presentation of the Notice of Meeting and must:

 

(i)                                  provide to Cephalon successive drafts of the Notice of Meeting and of any other document which it is proposed will accompany the Notice of Meeting to enable Cephalon to review and comment on those drafts;

 

(ii)                               take all comments made by Cephalon into account in good faith when producing revised drafts of the Notice of Meeting and any accompanying documents;

 

(iii)                            before issuing the final Notice of Meeting and any accompanying documents, obtain Cephalon’s written approval for the form and content in which the Cephalon Information appears in those documents; and

 

(iv)                           keep Cephalon informed of any issues raised by the ASX or any other person about the Notice of Meeting or generally the transactions to be given effect by this Deed and take into account in good faith in resolving such issues any matters raised by Cephalon.

 

(f)                                 If the parties are unable to agree on the final form of the Notice of Meeting and any accompanying documents, the final form and content shall be determined by Mesoblast acting reasonably but if Cephalon disagrees with such form and content:

 

(i)                                  Mesoblast must include a statement to that effect in the Notice of Meeting; and

 

(ii)                               if the failure to agree relates to the Cephalon Information or any other information concerning the Cephalon Group, Mesoblast must include a statement that Cephalon takes no responsibility for the relevant form and content to the extent that Cephalon disagrees with it.

 

3.3                            Failure of Conditions Precedent

 

Either party may, if not otherwise in breach of this Deed, terminate the obligation on the parties to proceed with the issue of the Subscription Shares in accordance with clause 2 of this Deed by giving written notice to all other party at any time before Completion if the Conditions Precedent are not satisfied before 5.00 pm AEST on the date specified in clause 3.1.

 

3.4                            No Share issues pending satisfaction of Conditions Precedent

 

Mesoblast represents and warrants to Cephalon that Mesoblast does not foresee the need for any additional capital or other funding during the period from the execution of this agreement and the date by which each Condition Precedent must be satisfied or the obligation on the parties to proceed with the issue of the Subscription Shares in accordance with clause 2 is terminated under clause 3.3 (the Condition Satisfaction Period) beyond the funding to be received by Angioblast from Cephalon pursuant to the licence agreement referred to in recital B.  Accordingly, during the Condition Satisfaction

 

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Period, Mesoblast must not issue any Shares, partly paid shares or any other class of shares or securities convertible into shares other than under any employee or Director Share or option plan or remuneration arrangements for employees or Directors (including upon the exercise of options granted under such arrangements).

 

4.                                   Standstill obligation

 

4.1                            Not to acquire any interest in further Shares

 

Subject to clause 4.3, Cephalon agrees that for a period of 12 months from the date of this Deed it will not and it will procure that its Cephalon Associates do not:

 

(a)                               acquire or obtain any right, title or interest of any nature whatever in any further Shares or securities capable of conversion into Shares or which give substantially the economic benefit of Shares; or

 

(b)                               enter into any arrangement, understanding or agreement with any party concerning Shares or securities capable of conversion into Shares which give substantially the economic benefit of Shares,

 

which in aggregate would give Cephalon a relevant interest in Shares of more than 19.99%.  For the purpose of clarity in the event of any dilutive issue (including without limitation those matters referred to in clause 7.3 below) which as a consequence results in Cephalon’s relevant interest being less than 19.99%, Cephalon can buy (on market or off market) from any Mesoblast shareholder which in aggregate would give Cephalon a relevant interest in Shares of no more than 19.99%.

 

4.2                            Not to announce or make any Takeover Offer or like action

 

Subject to clause 4.3, Cephalon agrees that for a period of 12 months from the date of this Deed it will not and it will ensure that its Cephalon Associates do not announce or make any takeover offer or like corporate action to offer to acquire any right, title or interest in further Shares other than in respect of the Shares to be issued to Cephalon under the Merger Agreement or, where the Condition Precedent is satisfied under clause 2 of this Deed, the Shares to be issued under this Deed or as otherwise permitted by this Deed.

 

4.3                            Third Party Control Proposals

 

Clauses 4.1 and 4.2 cease to apply if:

 

(a)                               any person (other than Cephalon or a Cephalon Associate) announces or makes any Control Proposal; or

 

(b)                               Mesoblast announces that it is in any discussions with any person (other than Cephalon or a Cephalon Associate) concerning a Control Proposal.

 

4.4                            No action to cause classification as Controlled Foreign Corporation

 

Cephalon agrees that for a period of 12 months from the date of this Deed it will take no action which is reasonably likely to result in Mesoblast being classified or treated as a controlled foreign corporation for the purpose of the taxation laws of the United States.

 

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5.                                   Parties’ Acknowledgments and Representations

 

5.1                            Cephalon’s acknowledgments

 

Cephalon acknowledges that:

 

(a)                               the issue of the Subscription Shares to Cephalon does not (except pursuant to clause 2.5 or clause 2.6) require a disclosure document, prospectus or like registerable document to be prepared by Mesoblast pursuant to any applicable legislation and therefore Cephalon has not received that information which would otherwise be available to a potential investor in such a document;

 

(b)                               Cephalon has investigated all material matters that a prudent intending subscriber for the Subscription Shares would investigate and has satisfied itself about anything arising from its investigation (but having regard to Mesoblast’s representations and warranties in clauses 5.2 and 5.3);

 

(c)                                it has received independent professional advice in relation to the subscription for the Subscription Shares (including legal, accounting, tax and financial advice), has satisfied itself about anything arising from that advice and is able to evaluate the risks and merits of subscribing for the Subscription Shares;

 

(d)                               an investment in the Subscription Shares is speculative and there is no guarantee that there will be any return on holding the Subscription Shares, any class of shares in Mesoblast or Mesoblast itself (whether by way of dividends or return of capital or any other manner whatever);

 

(e)                                apart from Mesoblast’s representations and warranties in clauses 5.2 and 5.3, neither Mesoblast, nor its officers, agents or advisers, have made any representation or warranty of any kind whatever in connection with this Deed, Mesoblast, its financial position or trading in shares of any class in Mesoblast; and

 

(f)                                 apart from Mesoblast’s representations and warranties in clauses 5.2 and 5.3, to the fullest extent permitted by law, all terms, conditions, undertakings, inducements, warranties or representations (whether express or implied, statutory or otherwise), which relate to or are connected with terms of this Deed are excluded.

 

5.2                            Mutual Representations and Warranties

 

Each party represents and warrants to the other, as an inducement to the other to enter into this Deed and to subscribe for or issue the Subscription Shares that:

 

(a)                               it has full and lawful authority to execute and deliver this Deed and to perform, or cause to be performed, its obligations under this Deed;

 

(b)                               apart from the Conditions Precedent, it has taken all action required and obtained or been granted all consents, approvals, permissions and authorisations, whether internal or external, necessary to enable it to enter into and perform its obligations under this Deed;

 

(c)                                this Deed constitutes a legal, valid and binding obligation of the party enforceable in accordance with its terms by appropriate legal remedy; and

 

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(d)                               the execution, delivery and performance of this Deed will not contravene:

 

(i)                                  any law, regulation, order, judgment or decree of any court or Government Agency which is binding on it or any of its property;

 

(ii)                               any provision of its constitution or equivalent documents; or

 

(iii)                            any agreement, undertaking or instrument which is binding on the party or any of its property.

 

5.3                            Mesoblast’s Representations and warranties

 

Mesoblast represents and warrants to Cephalon, as an inducement to Cephalon to enter into this Deed and to subscribe for the Subscription Shares that:

 

(a)                               Mesoblast has complied with its obligations under ASX Listing Rule 3.1 and, other than as fairly disclosed to Cephalon, is not relying on ASX Listing Rule 3.1A to withhold information from disclosure; and

 

(b)                               Mesoblast has complied with its obligations under Chapter 2M of the Corporations Act.

 

6.                                   Director Appointment

 

6.1                            Appointment of Cephalon Nominee

 

Having regard to the matters described in recital B, Mesoblast agrees to procure that the Mesoblast Board upon the execution of this Deed appoints a person nominated by Cephalon as a Director of Mesoblast (the Cephalon Nominee).  The first Cephalon Nominee will be Mr Kevin Buchi.

 

6.2                            Replacement of Cephalon Nominee

 

Cephalon may nominate a person to replace the existing Cephalon Nominee at any time and in that event Mesoblast must procure the Mesoblast Board to appoint the replacement as a Director, as long as the replacement is suitably qualified and acceptable to the Mesoblast Board acting reasonably.

 

6.3                            Appointment of Alternate

 

Mesoblast must procure that the Mesoblast Board consents to the Cephalon Nominee appointing another person to act as the Cephalon Nominee’s alternate, subject to the alternate meeting the requirement specified in clause 6.2.

 

6.4                            Other Directors

 

Clause 6.1 does not limit Cephalon’s rights as a Shareholder to nominate for election or vote for or against the election or re-election of any Director or proposed Director of Mesoblast (in addition to the Cephalon Nominee) at any general meeting of Mesoblast Shareholders.

 

6.5                            Disclosure of Information by Cephalon Nominee to Cephalon

 

Having regard to the benefits to Mesoblast of having Cephalon’s contribution through the Cephalon Nominee to the deliberations of the Mesoblast Board, Mesoblast agrees that

 

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the Cephalon Nominee may provide information obtained by the Cephalon Nominee as a Director of Mesoblast to Cephalon, officers of Cephalon or Cephalon, Inc. and the advisers to Cephalon or Cephalon, Inc., subject to:

 

(a)                                Cephalon ensuring that any such information which is confidential is not further disclosed unless required by law (including pursuant to an order, rule, regulation or policy of any Government Agency or securities exchange or stock market) and then only to the extent so required and after consulting with Mesoblast to the extent practicable; and

 

(b)                               such information not being used for any purpose other than to obtain Cephalon’s contribution through the Cephalon Nominee to the deliberations of the Mesoblast Board,

 

except where there is an actual conflict of interest between Cephalon and Mesoblast in respect of a particular matter and the information relates to that matter (in which case the relevant information must remain confidential and the Cephalon Nominee may, at the discretion of the other members of the Mesoblast Board, be excluded from deliberations in relation to that matter if required by section 195 of the Corporations Act).

 

6.6                            Disclosure of Financial Information to Cephalon

 

Mesoblast (in this clause 6.6 referred to as the Company) must:

 

(a)                                deliver to Cephalon as soon as practicable, but in any event within ninety (90) days after the end of each fiscal year of the Company, a consolidated income statement for such fiscal year, a consolidated balance sheet as of the end of such year and a consolidated cash flow statement for such fiscal year, such year-end financial reports to be in reasonable detail, prepared in accordance with applicable generally accepted accounting principles consistently applied, and audited in accordance with Australian International Financial Reporting Standards by independent public accountants of nationally recognized standing selected by the Company, and additionally, the Company shall deliver a draft of such year end financial reports to Cephalon as soon as practicable, but in any even within seventy-five (75) days after the end of each fiscal year of the Company;

 

(b)                               deliver to Cephalon as soon as practicable, but in any event within fifteen (15) days after the end of each of the quarter of each fiscal year of the Company, an unaudited consolidated profit or loss statement for such fiscal quarter, an unaudited consolidated balance sheet as of the end of such fiscal quarter and an unaudited consolidated cash flow statement for such fiscal quarter;

 

(c)                                deliver to Cephalon as soon as reasonably practicable, additional supporting financial information as mutually agreed upon by Cephalon and the Company;

 

(d)                               deliver to Cephalon, with respect to the audited financial statements called for in this clause 6.6 and the unaudited financial statements called for in this clause 6.6, an instrument executed by the chief financial officer or chief executive officer of the Company, certifying that such financials were prepared in accordance with International Financial Reporting Standards and generally accepted accounting principles consistently applied with prior practice for earlier periods and fairly present, in all material respects, the consolidated financial condition of the Company and its results of operation for the period specified, subject to year-end audit adjustments and, in the case of the financial statements called for in paragraphs (b) and (c) of this clause 6.6, footnotes;

 

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(e)                                to the extent reasonably necessary to enable Cephalon to prepare all of its statutory financial reporting statements in accordance with the rules of any exchange on which its securities are traded or generally in accordance with its reporting obligations under US Generally Accepted Accounting Principles (US GAAP), the Company must afford appropriately qualified officers and employees (including independent accountants) as agreed in advance with the Company, reasonable access during normal business hours to the offices, properties, employees, financial records and financial information (including computer files, retrieval programs and similar documentation) only to the extent it relates to financial information of the Company.  Cephalon agrees that such investigation shall be conducted in such a manner as not to interfere unreasonably with the operations of the Company and its Subsidiaries.  Cephalon agrees that such information gathered will be used for no further purpose other than to prepare its statutory financial statements, without obtaining the prior consent from the Company; and

 

(f)                                  Cephalon will hold and will procure that Cephalon’s officers, employees and authorized representatives of Cephalon (including independent public accountants and attorneys) will hold, any information obtained pursuant to this clause 6.6 in strict confidence (it being understood that Cephalon shall be permitted to disclose such information to the extent required by applicable requirements of law or the rules of any applicable securities exchange).

 

7.                                   Top-up Right

 

7.1                            Future Placements

 

Subject to clauses 7.2, 7.3 and 7.4, if Mesoblast proposes in the future to make a placement of Shares, partly paid shares or any other class of shares or to issue shares on the conversion of securities convertible into shares (each, Placement Shares) then Mesoblast must offer to Cephalon the right (top-up right) to subscribe for additional Shares on the same terms and, to the extent reasonably practicable, at precisely the same time as Mesoblast proposes to issue such other Shares in such number as would, upon the issue of the Placement Shares and the Shares issued to Cephalon, result in Cephalon’s percentage Shareholding being maintained at the same percentage as Cephalon had immediately prior to such issue.

 

7.2                            Sell down by Cephalon

 

Clauses 6 and 7.1 does not apply if Cephalon ceases to have a relevant interest (as defined in the Corporations Act) in less than 10% of the issued Shares.

 

7.3                            Excluded Issues

 

Clause 7.1 does not apply in relation to any Shares issued by Mesoblast:

 

(a)                                under any employee or Director Share or option plan or remuneration arrangements for employees or Directors (including upon the exercise of options granted under such arrangements) or its options issued to consultants or in respect of the underwriting the Angioblast 2009 Convertible Note Issue; or

 

(b)                               under a dividend reinvestment plan; or

 

(c)                                pursuant to an acquisition agreement or like arrangement to acquire another entity or assets (whether by acquisition, license or other like arrangement).

 

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7.4                            ASX Waiver

 

The top-up right referred to in clause 7.1 is conditional on the ASX granting a waiver of ASX Listing Rule 6.18.  Mesoblast must use reasonable endeavours to obtain such a waiver as soon as possible and must:

 

(a)                                provide to Cephalon drafts of the waiver application to enable Cephalon to review and comment on those drafts;

 

(b)                               take all comments made by Cephalon into account in good faith when producing revised drafts of waiver application; and

 

(c)                                keep Cephalon informed of any issues raised by the ASX or any other person about the waiver and take into account in good faith in resolving such issues any matters raised by Cephalon.

 

In the event that the ASX requires an adjustment to the terms of the top-up right as a condition of the waiver, and such adjustment is acceptable to Cephalon, the parties must adjust the terms of the top-up right as so required.

 

7.5                            No ASX waiver

 

If the ASX does not grant the waiver referred to in clause 7.1, Mesoblast agrees that it will not issue additional Shares, partly paid shares or any other class of shares or securities convertible into shares for a period of 12 months from the Completion Date other than:

 

(a)                                under any employee or Director Share or option plan or remuneration arrangements for employees or Directors (including upon the exercise of options granted under such arrangements) or its options issued to consultants or in respect of the underwriting of the Angioblast 2009 Convertible Note Issue; or

 

(b)                               under a dividend reinvestment plan; or

 

(c)                                pursuant to an acquisition agreement or like arrangement to acquire another entity or assets (whether by acquisition, license or other like arrangement).

 

8.                                   Public Announcement

 

Immediately after the execution of this Deed, Mesoblast must make the announcement to the ASX which is set out in Annexure A.

 

9.                                   GST

 

9.1                            GST Gross-Up

 

If a party (supplier) is required to pay GST in respect of a supply made under or in connection with (including by reason of a breach of) this Deed, the recipient of the supply must (in addition to any other payment for, or in connection with, the supply) pay to the supplier an amount equal to such GST (GST gross-up).

 

9.2                            GST Invoice

 

If a GST gross-up is payable, then the supplier must give the recipient a tax invoice for the supply.

 

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9.3                            Payment

 

Provided a tax invoice has been given, the GST gross-up must be paid by the recipient:

 

(a)                                if any monetary consideration is payable for the supply, at the same time and in the same manner as such monetary consideration; or

 

(b)                               if no monetary consideration is payable for the supply within 10 Business Days after the day on which the tax invoice is given.

 

9.4                            Reimbursement

 

If any payment to be made to a party under or in connection with this Deed is a reimbursement or indemnification of an expense or other liability incurred or to be incurred by that party, then the amount of the payment must be reduced by the amount of any input tax credit to which that party is entitled for that expense or other liability, such reduction to be effected before any increase in accordance with clause 9.1.

 

9.5                            Adjustments

 

If an adjustment event has occurred in respect of a supply made under or in connection with this Deed, any party that becomes aware of the occurrence of that adjustment event must notify the other party as soon as practicable, and the parties agree to take whatever steps are necessary (including to issue an adjustment note), and to make whatever adjustments are required, to ensure that any GST or additional GST on that supply, or any refund of GST (or part thereof), is paid no later than 20 Business Days after the supplier first becomes aware that the adjustment event has occurred.

 

9.6                            Definitions

 

(a)                                Terms used in this clause 9 which are defined in the A New Tax System (Goods and Services Tax) Act 1999  (Cth) have the meaning given to them in that Act.

 

(b)                               In this clause 9, a reference to a payment includes any payment of money and any form of consideration other than payment of money.

 

(c)                                In this Deed, all references to payments and obligations to make payments, including all references to compensation (including by way of reimbursement or indemnity), are, but for the operation of this clause, exclusive of GST.

 

10.                            General

 

10.1                     Time of the Essence

 

In this Deed, time is of the essence unless otherwise stipulated.

 

10.2                     Entire Understanding

 

This Deed and all documents referred to in this Deed contain the entire understanding between the parties concerning the subject matter of the Deed and supersede all prior communications between the parties.  Each party acknowledges that, except as expressly stated in this Deed, that party has not relied on any representation, warranty or undertaking of any kind made by or on behalf of the other party in relation to the subject matter of this Deed.

 

13

 

10.3                     No Adverse Construction

 

This Deed is not to be construed to the disadvantage of a party because that party was responsible for its preparation.

 

10.4                     Further Assurances

 

A party, at its own expense and within a reasonable time of being requested by another party to do so, must do all things and execute all documents that are reasonably necessary to give full effect to this Deed.

 

10.5                     No Waiver

 

A failure, delay, relaxation or indulgence by a party in exercising any power or right conferred on the party by this Deed does not operate as a waiver of the power or right.  A single or partial exercise of the power or right does not preclude a further exercise of it or the exercise of any other power or right under this Deed.  A waiver of a breach does not operate as a waiver of any other breach.

 

10.6                     Severability

 

If any provision of this Deed offends any law applicable to it and is as a consequence illegal, invalid or unenforceable then:

 

(a)                                where the offending provision can be read down so as to give it a valid and enforceable operation of a partial nature, it must be read down to the minimum extent necessary to achieve that result; and

 

(b)                               in any other case the offending provision must be severed from this Deed, in which event the remaining provisions of the Deed operate as if the severed provision had not been included.

 

10.7                     Successors and Assigns

 

This Deed binds and benefits the parties and their respective successors and permitted assigns under clause 10.8.

 

10.8                     No Assignment

 

A party cannot assign or otherwise transfer the benefit of this Deed without the prior written consent of each other party.

 

10.9                     Consents and Approvals

 

Where anything depends on the consent or approval of a party then, unless this Deed provides otherwise, that consent or approval may be given conditionally or unconditionally or withheld, in the absolute discretion of that party.

 

10.10              No Variation

 

This Deed cannot be amended or varied except in writing signed by the parties.

 

14

 

10.11              Costs

 

Each party must pay its own legal costs of and incidental to the preparation and completion of this Deed.

 

10.12              Governing Law and Jurisdiction

 

This Deed is governed by and must be construed in accordance with the laws in force in the State of Victoria, Australia.  The parties submit to the exclusive jurisdiction of the courts of that State and Australia in respect of all matters arising out of or relating to this Deed, its performance or subject matter.

 

10.13              Counterparts

 

If this Deed consists of a number of signed counterparts, each is an original and all of the counterparts together constitute the same document.

 

10.14              Conflicting Provisions

 

If there is any conflict between the main body of this Deed and any schedules or annexures comprising it, then the provisions of the main body of this Deed prevail.

 

10.15              Non Merger

 

No provision of this Deed merges on completion of the subscription by Cephalon for the Subscription Shares. A term or condition of, or act done in connection with, this Deed does not operate as a merger of any of the rights or remedies of the parties under this Deed and those rights and remedies continue unchanged.

 

10.16              No Right of Set-off

 

Unless this Deed expressly provides otherwise, a party has no right of set-off against a payment due to another party.

 

10.17              Relationship of Parties

 

Unless this Deed expressly provides otherwise, nothing in this Deed may be construed as creating a relationship of partnership, of principal and agent or of trustee and beneficiary.

 

10.18              Notices

 

Each communication (including each notice, consent, approval, request and demand) under or in connection with this Deed:

 

(a)                                must be in writing;

 

(b)                               must be addressed as follows (or as otherwise notified by that party to each other party from time to time):

 

	
Mesoblast
    
	
 
    
	
Name:
    	
 
    	
Mesoblast   Limited
    
	
Address:
    	
 
    	
Level 39, 55 Collins Street, Melbourne,   Victoria 3000, Australia
    

 

15

 

	
Fax:
    	
 
    	
 
    
	
For   the attention of:
    	
 
    	
Company   Secretary
    
	
 
    
	
CEPHALON
    
	
 
    
	
Name:
    	
 
    	
Cephalon   International Holdings, Inc. c/- Johnson Winter & Slattery
    
	
Address:
    	
 
    	
Level   30, 264 George Street, Sydney, New South Wales, 2000
    
	
Fax:
    	
 
    	
+61   2 8274 9500
    
	
For   the attention of:
    	
 
    	
Mr.   Damian Reichel
    
					

 

(c)                                must be signed by the party making it or (on that party’s behalf) by the solicitor for, or any attorney, director, secretary or authorized agent of, that party;

 

(d)                               must be delivered by hand or posted by prepaid post to the address, or sent by fax to the number, of the addressee, in accordance with clause 10.18(b); and

 

(e)                                is taken to be received by the addressee:

 

(i)                                  (in the case of prepaid post sent to an address in the same country) on the third day after the date of posting;

 

(ii)                               (in the case of prepaid post sent to an address in another country) on the fifth day after the date of posting by airmail;

 

(iii)                            (in the case of fax) at the time in the place to which it is sent equivalent to the time shown on the transmission confirmation report produced by the fax machine from which it was sent; and

 

(iv)                           (in the case of delivery by hand) on delivery,

 

but if the communication is taken to be received on a day that is not a Business Day or after 5.00 pm, it is taken to be received at 9.00 am on the next Business Day.

 

16

 

	
Executed as a Deed
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Executed by Mesoblast   Limited ACN 109
   431 870 in accordance with section 127 of
   the Corporations Act 2001 (Cth)
    	
 
    	
)

)

)
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
/s/ Brian Jameson
    	
 
    	
 
    	
 
    	
/s/ Kevin   Hollingsworth
    
	
Signature of Director
    	
 
    	
 
    	
 
    	
Signature of   Director/Secretary
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Brian Jameson
    	
 
    	
 
    	
 
    	
Kevin Hollingsworth
    
	
Name of Director (please   print)
    	
 
    	
 
    	
 
    	
Name of Director/Secretary   (please print)
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Executed by Cephalon International
   Holdings, Inc. by its duly authorised
   representative/s:
    	
 
    	
)

)

)
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
/s/ J. Kevin Buchi
    	
 
    	
 
    	
 
    	
 
    
	
Signature of Director
    	
 
    	
 
    	
 
    	
Signature of   Director/Secretary
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
J. Kevin Buchi
    	
 
    	
 
    	
 
    	
 
    
	
Name of Director (please   print)
    	
 
    	
 
    	
 
    	
Name of Director/Secretary   (please print)
    

 

17Exhibit 10.29(c)

 

EXECUTION COPY
 CONFIDENTIAL

 

DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

 

THIS DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (“Agreement”) dated as of December 7, 2010 (“Effective Date”), is entered into by and between Angioblast Systems Inc., a Delaware corporation having its principal place of business at 275 Madison Ave., 4th floor, New York, New York 10016 (“Angioblast”) and Cephalon, Inc., a Delaware corporation having its principal place of business at 41 Moores Road, Frazer, Pennsylvania 19355 (“Cephalon”).

 

BACKGROUND

 

A.            Angioblast has developed a proprietary technology platform based on MPCs (as defined below) that can produce certain novel therapeutic products for the treatment of various indications including those in the Field (as defined below).  Angioblast owns or controls certain patents, know-how and other intellectual property relating to MPCs and Products;

 

B.            Cephalon desires to develop and commercialize the Products in the Field in the Territory (as defined below), and Angioblast desires to have the Products developed and commercialized by and with Cephalon, in accordance with this Agreement; and

 

C.            Cephalon desires to obtain from Angioblast certain rights and licenses for the Products, and Angioblast is willing to grant to Cephalon such rights on the terms and conditions set forth in this Agreement.

 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

 

ARTICLE I
 DEFINITIONS / INTERPRETATION

 

1.1           “Accounting Standards” means then current generally accepted accounting principles in the United States, consistently applied.

 

1.2           “Adverse Drug Reaction” has the meaning as defined in the then-current guidelines and regulations promulgated by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) and shall include any “Adverse Drug Experience” as defined in the then-current 21 CFR Section 314.80.

 

**          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.

 

 

1.3           “Affiliate” means, with respect to a Person, any Person that, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with such first Person, as the case may be, for as long as such control exists.  As used in this Section 1.3, “control” means:  (a) to possess, directly or indirectly, the power to direct the management and policies of such Person, whether through ownership of voting securities or by contract relating to voting rights or corporate governance; or (b) direct or indirect beneficial ownership of at least fifty percent (50%) (or such lesser percentage that is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) of the voting share capital in such Person.

 

1.4           “Angioblast Know-How” means any and all Know-How Controlled by Angioblast during the Term that is (a) useful or necessary for (i) the Development or Commercialization of Products in the Field or (ii) the expansion or other processing of Expanded HPCs in the Oncology Field, in each case in the Territory or (b) otherwise made available to Cephalon hereunder.

 

1.5           “Angioblast Patents” means any and all Patents Controlled by Angioblast during the Term that: (a) but for the Agreement, would be infringed by using, selling or importing any Product for use in the Field in the Territory; (b) but for the Agreement, would be infringed by processing or manufacturing Expanded HPCs using MPCs for use in the Oncology Field in the Territory, in each case including, but not limited to: (i) compositions of matter of any Product, (ii) methods of use, administration or treatment involving any Product (iii) methods of processing or other manufacture of Expanded HPCs using MPCs; or (c) any Patent reasonably necessary or useful for the Development and Commercialization of Products for use in the Field in the Territory in accordance with this Agreement.  Without limiting the foregoing, a list of Angioblast Patents believed to be complete as of the Effective Date is appended hereto as Exhibit 1.5 and will be updated periodically to reflect changes thereto during the Term.

 

1.6           “Angioblast Technology” means, individually and collectively, the Angioblast Know-How and Angioblast Patents, including any Know-How and Patents consisting of Inventions owned by Angioblast hereunder (including any and all Improvements).

 

1.7           “Annual Net Sales” means aggregate Net Sales of all Products sold in the Territory in a particular calendar year.  For such purposes, units of Product shall be considered sold when such units are shipped to a Third Party or the revenue from the sale thereof is recognized by the Selling Party for financial reporting purposes, whichever occurs first.

 

1.8           “Asia-Pacific” means the countries and territories listed on Exhibit 1.8.

 

1.9           “BMT MPCs” means MPCs intended for use [**], which MPCs are packaged and labeled for use in clinical trials or for commercial purposes in accordance with the applicable Specifications and legal requirements in the Territory.

 

**          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.

 

2

 

1.10         “Business Day” means any day other than a Saturday, Sunday or any other day on which commercial banks in New York, New York or Melbourne, Australia (as applicable) are authorized or required by law to remain closed.

 

1.11         “Cardiovascular Field” means use in the following indications: [**] in each case in humans, using any delivery modality; however, the Cardiovascular Field shall exclude [**].

 

1.12         “Cardiovascular Product” means an MPC Product intended for use (whether in clinical trials or end use) in the Cardiovascular Field.

 

1.13         “Cephalon Know-How” means any and all Know-How Controlled by Cephalon during the Term that is (a) used for (i) the Development or Commercialization of Products in the Field or (ii) the expansion or other processing of Expanded HPCs in the Oncology Field, or (b) otherwise made available to Angioblast hereunder.  Cephalon Know-How shall include all Data and Regulatory Materials generated with respect to the Products by or on behalf of Cephalon hereunder.

 

1.14         “CNS Field” means use in the following indications: [**], in each case in humans, using any delivery modality.

 

1.15         “CNS Product” means an MPC Product intended for use (whether in clinical trials or end use) in the CNS Field.

 

1.16         “Collaboration” means all activities performed by or on behalf of each Party with respect to the Field under this Agreement, including all activities of each Party under any Plan.

 

1.17         “Commercialization” (including any variations thereof, such as “Commercialize” and “Commercializing”) means, with respect to a particular Product in the Field, the conduct of any and all processes and activities to establish and maintain sales for such Product (including with respect to reimbursement and patient access), including offering for sale, selling (including prelaunch and launch), marketing (including education and advertising activities), promoting, storing, transporting, distributing, and importing such Product, in each case with respect to the Field.  For clarity, Commercialization shall exclude research and manufacturing activities and processes with respect to the Products.

 

1.18         “Confidential Information” means, with respect to a Party, all information of such Party that is disclosed to the other Party under this Agreement (a) in any form (oral, written, graphic, electronic or otherwise) and which is of the type generally deemed to be proprietary in the pharmaceutical industry or (b) in any tangible form and which is marked “Confidential” or with other similar designation to indicate its confidential or proprietary nature or (c) in oral form and which is indicated to be confidential or proprietary by the Party disclosing such information at the time of initial disclosure and is confirmed in writing as confidential or proprietary by the disclosing Party within forty-

 

**          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.

 

3

 

five (45) days after such disclosure.  All information disclosed by either Party pursuant to the Mutual Confidentiality Agreement between the Parties dated June 24, 2009 (the “Prior Confidentiality Agreement”), shall be deemed to be such Party’s Confidential Information disclosed hereunder.

 

1.19         “Control” (including any variations thereof, such as “Controlled” and “Controlling”), means with respect to Know-How, Patents or other intellectual property rights, possession by the Party granting the applicable right, license or sublicense to the other Party as provided herein, of the power and authority, whether arising by ownership, license, or other authorization, to disclose and deliver the particular Know-How to the other Party, and to grant and authorize under such Know-How, Patent or other intellectual property rights the right, license or sublicense, as applicable, of or within the scope granted to such other Party in this Agreement without giving rise to a violation of the terms of any written agreement with any Third Party existing as of the Effective Date or any written agreement entered into after the Effective Date with respect to Know-How, Patent, or other intellectual property in-licensed after the Effective Date pursuant to which such Party in-licensed such Know-How, Patents or other intellectual property.  Notwithstanding anything to the contrary in this Agreement, the following shall not be deemed to be Controlled by a Party:  (i) any Know-How, Patent or intellectual property owned or licensed by any Acquiring Entity immediately prior to the effective date of merger, consolidation or transfer, and (ii) any Know-How, Patent or intellectual property that any Acquiring Entity subsequently develops independently, without accessing or practicing the Angioblast Technology (in the case of an Acquiring Entity of Angioblast) or the Cephalon Know-How (in the case of an Acquiring Entity of Cephalon).  For purposes of this Section 1.19, “Acquiring Entity” means a Third Party that merges or consolidates with or acquires a Party, or to which a Party transfers all or substantially all of its assets to which this Agreement pertains, except with respect to Mesoblast Limited, which shall not be considered an Acquiring Entity for purposes of this Agreement.

 

1.20         “Data” means any and all research data, pharmacology data, preclinical data, clinical data and/or all regulatory documentation, information and submissions pertaining to, or made in association with any Regulatory Materials or the like for any Product, in each case that are Controlled by a Party during the Term.

 

1.21         “Development” (including any variations thereof, such as “Develop” and “Developing”) means, with respect to any Product in the Field, the conduct of any and all clinical trials, regulatory and associated activities such as data analysis necessary to prepare and file for, obtain and maintain any Marketing Approval for such Product.  For clarity, Development shall (a) include clinical trials for additional indications in the Field for a Product for which a Marketing Approval has been obtained or other label expansion studies, quality of life assessments, pharmacoeconomics, mandatory post-marketing studies, regulatory affairs (including preparation of CMC (chemistry, manufacturing and controls) and Regulatory Materials and (b) exclude research, non-clinical and preclinical testing, toxicology studies and manufacturing activities and processes with respect to the Products.

 

**          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.

 

4

 

1.22         “Dollars” or “$” means the official currency of the United States.

 

1.23         “EMA” means the European Medicines Agency, or any successor entity thereto performing similar functions.

 

1.24         “Europe” means all countries, nations, states or other territories under the jurisdiction of the EMA.

 

1.25         “Existing Mark” means the trademark “[**]” together with all stylizations thereof and representations thereof in any language.

 

1.26         “Expanded HPCs” means any and all [**] expanded or otherwise processed using MPCs in a final packaged form and labeled for use in clinical trials or for commercial purposes in accordance with the applicable Specifications and legal requirements in the Territory.

 

1.27         “FDA” means the United States Food and Drug Administration, or any successor entity thereto performing similar functions.

 

1.28         “Field” means, with respect to the Cardiovascular Product, the Cardiovascular Field; with respect to the CNS Product, the CNS Field and with respect to the Expanded HPCs, the Oncology Field.

 

1.29         “GMP” means the then-current good manufacturing practice (or similar standards) for the manufacture, handling and storage of pharmaceutical products with respect to [**](as applicable) as required by the Regulatory Materials for such [**] in the applicable jurisdiction, including any IND, MAA or Marketing Approval.

 

1.30         “IND” means any Investigational New Drug Application (including any amendments thereto) filed with the FDA pursuant to 21 C.F.R. §321 before the commencement of clinical trials of a Product, or any comparable filings with any Regulatory Authority in any other jurisdiction.

 

1.31         “Initiate” (including any variations thereof, such as “Initiation” and “Initiated”) means, with respect to a clinical trial, the first dosing of a subject in such clinical trial in accordance with the protocol therefor.

 

1.32         “Know-How” means any and all information, tangible materials and other subject matter comprising (i) ideas, discoveries, inventions, improvements or trade secrets, (ii) techniques, methods, formulas, processes and Data, and (iii) compositions of matter, including MPCs.  Know-How shall exclude any Patent rights with respect thereto and any and all patient-specific and other similar data to the extent such exclusion is required by applicable Law.

 

**          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.

 

5

 

1.33         “Knowledge” means with respect to a Party, the actual knowledge of the Party (and with respect to Angioblast, including the actual knowledge of [**]).

 

1.34         “Law” means, individually and collectively, any and all laws, ordinances, orders, rules, rulings, directives and regulations of any kind whatsoever of any governmental or regulatory authority within the applicable jurisdiction.

 

1.35         “Major European Countries” means, collectively, France, Germany, Italy, Spain and the United Kingdom.

 

1.36         “Marketing Approval” means, with respect to a Product in a particular jurisdiction, all approvals, licenses, registrations or authorizations necessary for the Commercialization of such Product in such jurisdiction, including only where mandatory for Commercialization of such Product, approval of labeling, price or reimbursement.

 

1.37         “Marketing Approval Application” or “MAA” means an application submitted to a Regulatory Authority for Marketing Approval (together with supporting documentation), including in the United States a biologic license application (as described in 21 CFR 601.2).

 

1.38         “Marketing Partner” means a Third Party to which Cephalon has granted rights to Commercialize a Product (including any right to promote or co-promote) for use in the Field within the Territory on such Third Party’s own behalf.  For clarity, Marketing Partner shall exclude distributors, wholesalers and resellers of Products appointed by Cephalon that do not engage in any marketing or promotion of the Products.

 

1.39         “MHLW” means Ministry for Health, Labor and Welfare of Japan together with the Pharmaceutical and Medical Devices Agency (formerly known as IYAKUHIN SOGO KIKO), in either case or any successor entity thereto performing similar functions.

 

1.40         “MPC” means [**].

 

1.41         “MPC Product” means a pharmaceutical product containing a population of MPCs in a final packaged form and labeled for use in clinical trials or for commercial purposes in accordance with the applicable Specifications and legal requirements in the Territory.

 

1.42         “Net Sales” means [**]:

 

(a)           [**];

 

(b)           [**];

 

**          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.

 

6

 

(c)           [**];

 

(d)           [**];

 

(e)           [**];

 

(f)            [**]; and

 

(g)           [**].

 

[**].

 

1.43         “Oncology Field” means [**].

 

1.44         “Party” means Angioblast or Cephalon, individually, and “Parties” means Angioblast and Cephalon, collectively.

 

1.45         “Patent(s)” means any patents and patent applications, together with all additions, divisions, continuations, continuations-in-part, substitutions, reissues, re-examinations, extensions, registrations, patent term extensions, supplemental protection certificates and renewals of any of the foregoing.

 

1.46         “Person” means any individual, corporation, partnership, association, joint-stock company, trust, unincorporated organization or government or political subdivision thereof.

 

1.47         “Phase 2a Clinical Trial” means any human clinical trial conducted in the United States on a sufficient number of patients the primary purpose of which is to identify a dose or range of doses of a Product at a limited number of clinical sites, and which clinical trial meets the standards set forth at 21 CFR Section 312.21(b), or, with respect to a jurisdiction other than the United States, a similar clinical trial.

 

1.48         “Phase 2b Clinical Trial” means any human clinical trial conducted in the United States on a sufficient number of patients the primary purpose of which is to make a preliminary or qualitative determination of efficacy of a Product in the patients being studied for the dosage regimes indicated in the related Phase 2a Clinical Trial as required under 21 C.F.R. §312.21(b), or, with respect to a jurisdiction other than the United States, a similar clinical trial.

 

1.49         “Phase 3 Clinical Trial” means any human clinical trial conducted in the United States with respect to a Product, on a sufficient number of patients, which is prospectively designed to demonstrate statistically whether such Product is effective and safe for use in a particular indication in a manner sufficient to support Marketing Approval of such Product for the indication being investigated

 

**          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.

 

7

 

by the study as required under 21 C.F.R. § 312.21(c), any other pivotal clinical trial that is intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of a Product in a manner sufficient to support Marketing Approval of such Product in the indication beings studied, or, with respect to a jurisdiction other than the United States, a similar clinical trial.

 

1.50         “Product” means, individually and collectively, the Cardiovascular Product, the Expanded HPCs, and the CNS Product.

 

1.51         “Prosecution and Maintenance” (including any variations thereof, such as “Prosecute and Maintain” and “Prosecuting and Maintaining”) means, with respect to a Patent, the preparing, filing, prosecuting and maintenance of such Patent, as well as continuations, continuations-in-part, divisionals, re-examinations, reissues and requests for patent term extensions and the like with respect to such Patent, together with the conduct of interferences, the defense of oppositions and other similar proceedings with respect to a Patent.

 

1.52         “Region” means, individually, each of (i) Asia-Pacific, (ii) Europe and (iii) ROT.

 

1.53         “Regulatory Authority” means, in a particular country or regulatory jurisdiction, any applicable governmental authority involved in granting Marketing Approval in such country or jurisdiction, including, (a) in the U.S., the FDA, (b) with respect to Europe, the EMA, (c) in Japan, the MHLW and (d) in China, the SFDA.

 

1.54         “Regulatory Materials” means regulatory applications (including INDs and MAAs), submissions, notifications, communications, correspondence, registrations, approvals (including Marketing Approvals) and/or other filings made to, received from or otherwise conducted with a Regulatory Authority (including minutes of meeting with Regulatory Authorities) that are necessary or reasonably desirable to access in connection with the Development, manufacture or Commercialization of any Product in a particular country or regulatory jurisdiction.

 

1.55         “Rest of Territory” or “ROT” means all countries and territories of the world including the United States, but excluding Asia-Pacific and Europe.

 

1.56         “SFDA” means the State Food and Drug Administration of China, or any successor entity thereto performing similar functions.

 

1.57         “Specifications” means, with respect to the BMT MPCs, Cardiovascular Product or the CNS Product those written specifications therefor initially established by Angioblast as may be modified by mutual agreement of the Parties as set forth in this Agreement.

 

**          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.

 

8

 

1.58         “Sub-Field” means, individually, each of the Cardiovascular Field, the Oncology Field and the CNS Field.

 

1.59         “Term” means the period beginning on the Effective Date and, unless terminated earlier, expiring when this Agreement has expired for each of the Cardiovascular Field, the Oncology Field and the CNS Field in accordance with the provisions of Section 13.1.

 

1.60         “Territory” means all countries and territories of the world.

 

1.61         “Third Party” means any Person other than Angioblast, Cephalon and their respective Affiliates.

 

1.62         Additional Definitions.  Each of the following terms shall have the meaning described in the corresponding section of this Agreement indicated below:

 

	
Term
    	
 
    	
Section Defined
    
	
Agreement
    	
 
    	
Preamble
    
	
Alliance   Manager
    	
 
    	
3.2
    
	
Angioblast
    	
 
    	
Preamble
    
	
Angioblast   Competing Activities
    	
 
    	
2.4(b)
    
	
Angioblast   Indemnitees
    	
 
    	
12.1
    
	
Angioblast   Logos
    	
 
    	
10.2
    
	
BMF
    	
 
    	
4.6(c)
    
	
Cephalon
    	
 
    	
Preamble
    
	
Cephalon   Competing Activities
    	
 
    	
2.4(a)
    
	
Cephalon   Indemnitees
    	
 
    	
12.2
    
	
CMC Information
    	
 
    	
4.6(c)
    
	
[**]
    	
 
    	
[**]
    
	
Commercialization   Plan
    	
 
    	
5.2
    
	
Committee
    	
 
    	
3.3
    
	
Competitive Product
    	
 
    	
2.4(c)
    
	
Conditional   Forecast
    	
 
    	
4.4(c)
    
	
Costs
    	
 
    	
9.4(b)
    
	
Cover
    	
 
    	
9.5(c)
    
	
Defensive   Action
    	
 
    	
9.4(a)
    
	
Dispute
    	
 
    	
14.1
    
	
Effective   Date
    	
 
    	
Preamble
    
	
Enforcement   Action
    	
 
    	
9.3(b)
    
	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    
	
General   Plan
    	
 
    	
4.2(a)
    
	
Improvements
    	
 
    	
9.1(b)
    
	
Indemnitee
    	
 
    	
12.3
    
	
Indemnitor
    	
 
    	
12.3
    
	
Infringing   Product
    	
 
    	
9.3(b)
    
	
Inventions
    	
 
    	
9.1(a)
    
	
JAMS Rules
    	
 
    	
14.3(b)(ii)
    
	
JMC
    	
 
    	
7.7
    
	
Joint   Steering Committee
    	
 
    	
3.1
    
	
Joint   Defense Agreement
    	
 
    	
9.4(a)
    
	
Joint   Interest Agreement
    	
 
    	
9.5(a)
    
	
Joint   Patent
    	
 
    	
9.2(b)
    
	
JSC
    	
 
    	
3.1
    
	
Liabilities
    	
 
    	
12.1
    
	
Noticed   Party
    	
 
    	
9.5(a)
    
	
Noticing   Party
    	
 
    	
9.5(a)
    
	
Other   Dispute
    	
 
    	
14.3
    
	
Other   Enforcement Action
    	
 
    	
9.3(c)
    
	
Other   Infringing Product
    	
 
    	
9.3(c)
    
	
Participating   Party
    	
 
    	
4.7
    
	
Patent   Challenge
    	
 
    	
13.3(c)
    
	
Payee
    	
 
    	
6.6
    
	
Payor
    	
 
    	
6.6
    
	
Plan
    	
 
    	
3.4
    
	
Prior   Confidentiality Agreement
    	
 
    	
1.18
    
	
Research   Plan
    	
 
    	
4.1
    
	
Responsible   Party
    	
 
    	
4.7
    
	
[**]
    	
 
    	
[**]
    
	
SFDA
    	
 
    	
1.56
    
	
Specific   Angioblast Patent
    	
 
    	
9.2(a)
    

 

**          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.

 

9

 

	
Term
    	
 
    	
Section Defined
    
	
[**]
    	
 
    	
[**]
    
	
Supply Agreement
    	
 
    	
7.1
    
	
Territory
    	
 
    	
1.60
    
	
Third Party Claim
    	
 
    	
12.1
    
	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    

 

**          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.

 

10

 

1.63         Interpretation.  Unless specified to the contrary, references to Articles, Sections, Paragraphs and Exhibits mean the particular Articles, Sections, Exhibits and Paragraphs to this Agreement and references to this Agreement include all Exhibits hereto.  Unless the context clearly requires otherwise, whenever used in this Agreement:  (a) the words “include” or “including” shall be construed as incorporating, also, “but not limited to” or “without limitation,” whether or not such additional words are written; (b) the word “or” shall have its inclusive meaning of “and/or” except when paired as “either/or”; (c) the word “day” or “quarter” or “year” means a calendar day or calendar quarter or calendar year unless otherwise specified; (d) the word “notice” shall require notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other communications contemplated under this Agreement; (e) the words “hereof,” “herein,” “hereunder,” “hereby” and derivative or similar words refer to this Agreement (including the Exhibits hereto); (f) provisions that require that a Party, the Parties or a committee hereunder “agree,” “consent” or “approve” or the like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter or otherwise; (g) words of any gender include the other gender; (h) words using the singular or plural number also include the plural or singular number, respectively; (i) references to any specific Law, article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement thereof; (j) the phrase “by or on behalf of” or “on behalf of” means, with respect to a Party, all Persons, including such Party’s employees, contractors, and consultants, acting under such Party’s authority and its Affiliates and, in the case of Angioblast, licensees, or in the case of Cephalon, Marketing Partners; provided, however, neither Party or its Affiliates (including their employees, contractors and consultants acting within the scope of their duties as such) shall be deemed to be acting “by or on behalf of” the other Party or its Affiliates hereto.  This Agreement has been prepared jointly and shall not be strictly construed against either Party.  Ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.

 

ARTICLE II
 GENERAL RIGHTS AND LIMITATIONS

 

2.1           Grant of Rights to Cephalon.

 

(a)           General.  Subject to the terms and conditions of this Agreement (including Angioblast’s right to supply [**]), Angioblast hereby grants to Cephalon an exclusive, transferable (in accordance with Section 15.8) right (even as to Angioblast) under the Angioblast  Technology to:  (i) Develop and Commercialize Cardiovascular Products for use in the Cardiovascular Field in the Territory; (iii) Develop and Commercialize CNS Products for use in the CNS Field in the Territory;

 

**                               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.

 

11

 

and (ii) Develop, expand and otherwise process Expanded HPCs using BMT MPCs supplied hereunder and Commercialize BMT MPCs and such Expanded HPCs for use in the Oncology Field in the Territory.  The rights granted under this Section 2.1(a) shall be irrevocable except as provided under Section 13.2 or 13.3.

 

(b)           Affiliates; Marketing Partners.  Cephalon shall have the right to exercise any of the rights under Section 2.1(a) through one or more of its Affiliates and permitted Marketing Partners.  Angioblast shall have the right to approve any Marketing Partner (such approval not to be unreasonably withheld, conditioned or delayed), if such entity does not have (i) an enterprise value of [**] or more or (ii) revenues from sales of pharmaceutical products in the Territory for indications in the Cardiovascular Field, CNS Field or Oncology Field of [**] or more, or an Affiliate or such Person.  Cephalon shall ensure that each of its Marketing Partners is bound by a written agreement consistent with the terms and conditions of this Agreement and containing provisions as protective of Angioblast and the Products as this Agreement; and Cephalon shall remain responsible to Angioblast for all activities of its Affiliates and Marketing Partners to the same extent as if such activities had been undertaken by Cephalon itself.  Promptly following the execution of each agreement with a Marketing Partner, Cephalon shall provide Angioblast with a complete copy of such agreement, which may be redacted with respect to provisions not applicable to compliance with the terms and conditions of this Agreement.

 

2.2           Grant of Rights to Angioblast.

 

(a)           Cephalon Know-How.  Subject to the terms and conditions of this Agreement, Cephalon hereby grants to Angioblast a non-exclusive transferable (in accordance with Section 15.8) right to use and exploit the Cephalon Know-How (i) for purposes of carrying out is obligations under this Agreement including performing such Development activities with respect to the Products as provided in Section 4.3 and supplying [**] in accordance with ARTICLE VII and (ii) for purposes of researching, developing, manufacturing, using, selling, offering for sale, importing and otherwise exploiting MPC Products for use outside the Field.  The rights granted under this Section 2.2(a) shall be irrevocable.

 

(b)           Covenant Not to Sue.  Subject to the terms and conditions of this Agreement, Cephalon (on behalf of itself, its predecessors, successors, Affiliates, and their respective predecessors, successors, parent and subsidiary corporations, together with each of their assigns, including in bankruptcy) covenants not to bring any action or initiate any proceeding against Angioblast (or any Person acting under authority or on behalf of Angioblast) under any claim of a Patent Controlled by Cephalon or its Affiliate alleging infringement (direct or contributory) or inducement of infringement in connection with the manufacture, use, sale, offer for sale, importation or other exploitation of any pharmaceutical product containing MPCs for use outside of the Field.

 

**                               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.

 

12

 

2.3           Certain Restrictions.

 

(a)           On Cephalon.  Cephalon agrees that neither it, nor any of its Affiliates or Marketing Partners, will sell or provide the Products to any Third Party if Cephalon or its relevant Affiliate or Marketing Partner knows, or has reason to believe, that the Products, as the case may be, sold or provided to such Third Party would be sold or transferred, directly or indirectly, for use outside the Field.  Cephalon and its Affiliates and Marketing Partners shall promptly notify Angioblast in the event it or its Affiliate or Marketing Partner has reason to believe that any such Product sold or otherwise distributed has been or will be used outside the Field.  In addition, except as the Parties may mutually agree in writing from time to time, Cephalon and its Affiliates and Marketing Partners shall not, and shall not authorize, facilitate, collaborate with or assist any Third Party to, conduct any clinical trials, testing or other development activities with respect to the Products for use outside the Field.  Without limiting the foregoing, Cephalon, its Affiliates and Marketing Partners shall not (i) cooperate with any Third Party to develop or use any Product for applications outside the Field, including providing Products or funding for any physician-sponsored trial for such purpose or sponsoring or endorsing any publication indicating the Products are effective for any application outside the Field or (ii) seek any labeling for any Product outside of the Field.

 

(b)           On Angioblast.  Angioblast agrees that neither it, nor any of its Affiliates, will sell or provide MPC Products to any Third Party if Angioblast or its relevant Affiliate knows, or has reason to believe, that the MPC Products sold or provided to such Third Party would be sold or transferred, directly or indirectly, for use in the Field in the Territory.  Angioblast and its Affiliates and licensees shall promptly notify Cephalon in the event it or its Affiliate or licensee has reason to believe that any such MPC Product sold or otherwise distributed has been or will be used in the Field.  In addition, except as the Parties may mutually agree in writing from time to time or in the fulfillment of their obligations hereunder, Angioblast and its Affiliates shall not, and shall not authorize, facilitate, collaborate with or assist any Third Party to, conduct any clinical trials, testing or other development activities with respect to any product containing MPCs for use in the Field.  Without limiting the foregoing, Angioblast and its Affiliates shall not, except in fulfillment of their obligations hereunder, (i) cooperate with any Third Party to develop or use of any products containing MPCs for applications in the Field, including providing such products or funding for any physician-sponsored trial for such purpose or sponsoring or endorsing any publication indicating products containing MPCs are effective for any application in the Field or (ii) seek any labeling for any such product for use in the Field.  It is understood that nothing in this Agreement (including this Section 2.3(b)) shall be deemed to limit Angioblast’s reservation of rights under Section 2.6(b).

 

**                               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.

 

13

 

2.4           Exclusivity.

 

(a)           Cephalon.  During the Term, on a Product-by-Product basis, except for the conduct of the activities pursuant to this Agreement, Cephalon agrees on its behalf and on behalf of its Affiliates (i) not to conduct, participate in or sponsor, directly or indirectly, any activities directed toward the development, manufacture, sales, marketing, promotion or distribution of any Competitive Product for the Field in the Territory (collectively, such activities “Cephalon Competing Activities”) or (ii) not to appoint, license or otherwise authorize any Third Party, whether pursuant to such license, appointment, or authorization or otherwise to perform any Cephalon Competing Activities.

 

(b)           Angioblast.  During the Term, on a Product-by-Product basis, except for the conduct of the activities pursuant to this Agreement, Angioblast agrees on its behalf and on behalf of its Affiliates (i) not to conduct, participate in or sponsor, directly or indirectly, any activities directed toward the sales, marketing, promotion or distribution of any Competitive Product for the Field in the Territory (collectively, such activities “Angioblast Competing Activities”) or (ii) not to appoint, license or otherwise authorize any Third Party, whether pursuant to such license, appointment, or authorization or otherwise to perform any Angioblast Competing Activities.  For clarity, from and after a termination of this Agreement with respect to a Product or Region, Angioblast’s obligations under this Section 2.4(b) shall expire with respect to such Product or Region, as applicable.

 

(c)           Definition of Competitive Product.  For purposes of this Section 2.4, “Competitive Product” means (i) with respect to the Cardiovascular Product, a pharmaceutical product comprising any stem cell(s) or MPC(s) being developed or commercialized for use in any of the following indications in humans: [**] (ii) with respect to CNS Products, a pharmaceutical product comprising any[**] and (iii) with respect to the Expanded HPCs, a pharmaceutical product comprising any [**].

 

(d)           Post-Effective Date Affiliate.  Notwithstanding anything herein to the contrary, if during the Exclusivity Period, Angioblast or any of its Affiliates is acquired by or merges or is otherwise consolidated with any Person that is performing or thereafter initiates performance of an Angioblast Competing Activity or such Person otherwise becomes an Affiliate of Angioblast after the Effective Date, then such Person may continue such Angioblast Competing Activity (an “Outside Competing Activity”) without breach of the exclusivity obligations under Section 2.4(b); provided that Angioblast shall sequester such Outside Competing Activity to ensure that the Outside Competing Activity is kept separate and independent of the Development, research, manufacture and Commercialization of the Products, including using commercially reasonable efforts to ensure that no personnel involved in such Outside Competing Activity has access to Data or Confidential Information relating to the Products.  For clarity, any Data, Know-How, Patent or other intellectual property right resulting from such Outside Competing Activity shall not be included as Angioblast Technology under this Agreement, and nothing in this Agreement shall be construed to grant 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.

 

14

 

rights to Cephalon under such Data, Know-How, Patent or other intellectual property right.  Similarly, the Outside Competing Activity shall not make use of any Angioblast Technology.

 

Notwithstanding anything herein to the contrary, in the event that Angioblast is acquired by or merges or is otherwise consolidated with a Person performing any Other Competing Activity, then Cephalon shall have the right to elect upon written notice to Angioblast referencing this Section 2.4(d) to amend this Agreement such that (i) all rights to the Angioblast Technology granted to Cephalon hereunder shall survive pursuant to the terms hereof, (ii) Cephalon shall have the sole discretion to Develop and Commercialize the Products for use in the Field in the Territory as contemplated hereby, without giving effect to the JSC and other collaborative activities hereunder except as required by Law, (iii) subject to (i) and (ii), Angioblast’s sole obligations under the Agreement would be to supply the BMT MPCs and Cardiovascular Products and CNS Products for use in the Field in the Territory in accordance with ARTICLE VII and the Supply Agreement (once executed) and (iv) Cephalon’s sole obligation under this Agreement would be to pay and report all amounts owed and due in accordance with ARTICLE VI and Exhibit 6.3.  For clarity, any right of Angioblast to terminate this Agreement pursuant to Section 13.3(a) and (b) would no longer apply under the Agreement as amended.

 

2.5           Subcontractors.  Except as otherwise provided under Section 2.1(b), either Party may engage Third Party subcontractors (including contract research organizations) in any country within the Territory to exercise the rights or perform the obligations of such Party under this Agreement; provided that such Party shall ensure that each such Third Party subcontractor is bound by a written agreement containing provisions as protective of the Angioblast Technology and the Products as this Agreement; and such Party shall remain responsible to the other Party for all activities of its Third Party subcontractors to the same extent as if such activities had been undertaken by such Party itself.

 

2.6           No Other Rights.

 

(a)           General.  Except for the rights expressly granted in this Agreement, each Party retains all rights under its intellectual property, and no additional rights shall be deemed granted to the other Party by implication, estoppel or otherwise.

 

(b)           Certain Reservations.  For clarity, (i) the rights granted in this Agreement shall not be construed to convey any licenses or rights under the Angioblast Technology with respect to any product other than the Products and (ii) Angioblast retains all rights under the Angioblast Technology with respect to (A) manufacture of the Products except as otherwise provided in accordance with ARTICLE VII or any Supply Agreement (once executed) and otherwise fulfill its obligations hereunder, and (B) development, manufacture and commercialization (including marketing, promoting, selling and offering for sale) of products for use outside of the Field.

 

**                               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.

 

15

 

ARTICLE III
 GOVERNANCE

 

3.1           Joint Steering Committee.  The Parties shall establish a joint steering committee (“Joint Steering Committee” or “JSC”) to govern certain matters in relation to the Parties actions and interactions under this Agreement as set forth in further detail on Exhibit 3.1.

 

3.2           Alliance Managers.  Promptly following the Effective Date, each Party shall appoint a representative (“Alliance Manager”) to facilitate communications between the Parties (including coordinating the exchange of Data and Know-How of each Party as required under this Agreement) and to act as a liaison between the Parties with respect to such other matters as the Parties may mutually agree in order to maximize the efficiency of the Collaboration.  Each Party may replace its Alliance Manager with an alternative representative satisfying the requirements of this Section 3.2 at any time with prior written notice to the other Party.  For clarity, the Alliance Managers may seek the advice and assistance of other personnel of either Party in fulfilling their obligations hereunder.

 

3.3           Scope of Governance.  Notwithstanding the creation of the JSC and any Subcommittee created by the JSC pursuant to Paragraph 1 of Exhibit 3.1 (each a “Committee”), each Party shall retain the rights, powers and discretion granted to it hereunder, and no Committee shall be delegated or vested with rights, powers or discretion unless such delegation or vesting is expressly provided herein, or the Parties expressly so agree in writing.  No Committee shall have the power to (a) amend or modify this Agreement, (b) to determine whether or not a Party has met its diligence or other obligations under the Agreement, or (c) to determine whether or not a breach of this Agreement has occurred, and no decision of any Committee shall be in contravention of any terms and conditions of this Agreement.  It is understood and agreed that issues to be formally decided by the JSC and any Subcommittee, as applicable, are only those specific issues that are expressly provided in this Agreement to be decided by the JSC and any such Subcommittee, as applicable.

 

3.4           Day-to-Day Responsibilities.  Each Party shall: (i) be responsible for day-to-day implementation and operations of the Development, manufacturing and Commercialization activities with respect to Products in the Field for which it has or is otherwise assigned responsibility under the applicable Plan or this Agreement, and (ii) keep the other Party reasonably informed as to the progress of such activities, as reasonably requested by the other Party.  For purposes of this Agreement, “Plan” means the Development Plan or the Commercialization Plan, in each case then-currently in effect.

 

3.5           Information Sharing.  Without limiting the other provisions of this Agreement, each Party will keep the other reasonably informed on a timely basis as to the plans for and results 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.

 

16

 

activities of the Collaboration carried out by or under authority of such Party through the JSC and Alliance Managers.

 

3.6           Conflicts of Interest.  If Cephalon or its Affiliate or Marketing Partner sells a Product to a Third Party to which it also provides other products or services, Cephalon or such Affiliate or Marketing Partner (as applicable) shall not price, discount or otherwise offer (including bundling or rebating) any Product in any way that benefits such other products or services at the expense of such Product or otherwise disadvantage the Products in a manner intentionally designed to reduce the amounts payable hereunder.  In all events, Cephalon and its Affiliates and Marketing Partners shall price and offer the Products sold by it hereunder in accordance with applicable Law.

 

ARTICLE IV
 DEVELOPMENT AND REGULATORY ACTIVITIES

 

4.1           Certain Research and Preclinical Activities.  The Parties acknowledge that the advancement of the use of Products in certain of the indications within the Field is [**]not otherwise included in the General Plan described under Section 4.2(a) below.  Accordingly from time to time the Alliance Managers shall prepare and submit a plan and budget for such research and preclinical activities for each of the Products for use in the indications in the Field, including timelines setting forth the prioritization of each indication for each Product for use in the Field (the “Research Plan”), and the JSC shall meet within thirty (30) days of the submission of such Research Plan to the JSC to review and approve such Research Plan.  Each Party shall use commercially reasonable efforts to conduct such research and preclinical activities assigned to it in the Research Plan and [**]of the budgeted Third Party costs incurred by the Parties for conducting such activities in accordance with the Research Plan, the amount so incurred shall be reconciled on a quarterly basis in arrears such that [**].  For clarity, neither Party shall be obligated to perform or reimburse the costs of such activities except pursuant to an approved Research Plan therefor.  For clarity, such research and preclinical activities to be performed by Angioblast in accordance with this Section 4.1 shall not include any development work for CMC (chemistry, manufacturing and controls) and Cephalon shall [**].

 

4.2           Development Plans.

 

(a)           General Plan.  A general plan describing overall Development goals, principles and timelines for the Collaboration is attached to this Agreement as Exhibit 4.1 (the “General Plan”) and sets out separately certain Development activities to be conducted by each Party.  The Parties shall use commercially reasonable efforts to Develop each of the Cardiovascular Product, Expanded HPCs and CNS Product for the Territory in a manner compatible with such goals, principles and timelines.

 

**                               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.

 

17

 

(b)           Establishment of the Development Plan.  Within sixty (60) days of the Effective Date, the Alliance Managers shall prepare and submit an initial draft of the Development Plan consistent with the General Plan and all applicable Law, including the standards and review of the FDA and other applicable Regulatory Authorities, and the requirements of Section 4.1(c) for activities to be carried out with respect to Development for each of the Cardiovascular Product, Expanded HPCs and CNS Product for the Territory through the period ending 31 December 2011 to the JSC for review, comment and approval.  Accordingly, the JSC shall meet within thirty (30) days of the provision of such Development Plan to the JSC to review and approve such Development Plan.  If the JSC is unable to reach consensus with respect to the Development Plan during such thirty (30) day period, then the applicable Party shall have the right to exercise its final decision with respect thereto in accordance with Paragraph 5 of Exhibit 3.1.  On or before October 31st of each year, the Alliance Managers shall prepare and submit an updated Development Plan to the JSC for its review and approval following the same procedures.  Without limiting the foregoing, the Alliance Managers may propose updates to the Development Plan from time to time and the JSC shall review the Development Plan and the Parties’ performance thereunder on an ongoing basis. For clarity, except as otherwise expressly provided herein, any material update to the Development Plan shall be subject to the review and approval of the JSC following the same procedures.

 

(c)           Content.  Each Development Plan shall contain a description of the activities to be carried out for the Cardiovascular Product, Expanded HPCs and CNS Product for the Field in the Territory with timelines for the completion of such activities and in a level of detail consistent with practice in the biopharmaceutical industry.  Except as otherwise provided herein, the timing and order of such activities shall be determined by the JSC.  Notwithstanding anything herein to the contrary, each Development Plan shall be consistent with the General Plan and the obligations of the Parties under this ARTICLE IV.

 

(d)           Performance.  Each Party shall (i) use commercially reasonable efforts to conduct those activities assigned to it under the applicable Development Plan in accordance with this ARTICLE IV and (ii) conduct those activities allocated to such Party under the Development Plan in compliance in all material respects with applicable Law and in accordance with good scientific and clinical practices.  For clarity, neither Party shall conduct any Development with respect to Products in the Field for the Territory except in accordance with the Development Plan.

 

4.3           Development Activities of Angioblast.

 

(a)           Conduct of Development Activities.  Angioblast shall use commercially reasonable efforts to conduct those activities assigned to it under the then-current Development Plan in accordance with the timelines specified therein.

 

**                               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.

 

18

 

(i)            If Cephalon provides written notice to Angioblast referencing this Section 4.3(a)(i), (A) requesting that Angioblast conduct a [**] Clinical Trial with respect to any of the following indications [**] Trial for such indication in accordance with Section 4.4(b), then Angioblast (in consultation with Cephalon) shall prepare and present to the JSC a protocol for the conduct of such [**] Clinical Trial for such indication for the JSC’s review and approval.  Angioblast shall use commercially reasonable efforts to Initiate such clinical trial as soon as practicable under the circumstances and thereafter use commercially reasonable efforts to continue such clinical trial to completion in a timely manner in accordance with the protocol approved by the JSC. [**].  For clarity and subject to the terms and conditions of this Agreement, Angioblast may at its own election, conduct one or more [**] for any indication within the Field.

 

(ii)           Except as otherwise provided herein, the timing and order of [**] Clinical Trials to be conducted pursuant to this Section 4.3 shall be determined by the JSC and set forth in the Development Plan.  In this regard, the Alliance Managers will include in the Development Plan submitted to the JSC for its review and approval a plan and budget for Angioblast’s conduct of such activities, and the JSC shall meet within [**] of the submission of such Development Plan to the JSC to review and approve such Development Plan.  Angioblast shall be responsible for and conduct such [**] Clinical Trials in accordance the Development Plan and at its own expense, [**].  For clarity, Angioblast shall have no obligation to perform and Cephalon shall have no obligation to fund such [**]except pursuant to an approved plan and budget therefor.

 

(b)           JSC Review.  Within thirty (30) days of Angioblast’s providing to the JSC the data from a [**]Clinical Trial conducted pursuant to Section 4.3(a), the JSC shall meet and review such data and determine how to proceed with respect to the Development of the Product for such indication.  If any [**](as defined in the applicable protocol) for the applicable Phase 2a Clinical Trial is met, then the JSC shall promptly approve an appropriate protocol consistent with applicable Law so that Cephalon can Initiate a [**] Clinical Trial or [**]Clinical Trial, as determined by the JSC, with respect to the corresponding indication, but in no case longer than [**] after Angioblast presenting the data from the underlying [**] Clinical Trial to the JSC; otherwise, if a primary efficacy endpoint is not met, the JSC shall review such data and make a recommendation as to how to proceed with respect to the Development of the applicable Product for such indication (including for Angioblast to perform additional Development) and the timing therefor.  If the JSC determines to conduct further Development of a Product for a particular indication, then the Development Plan shall be promptly updated accordingly.

 

4.4           Development Activities of Cephalon.

 

(a)           [Intentionally Omitted.]

 

**                               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

 

(b)           Diligence.  Cephalon shall use commercially reasonable efforts to conduct those activities assigned to it under the then-current Development Plan in accordance with the timelines specified therein and with an overall goal to realize the commercial opportunity for the Products for use in the Field in the Territory.  Without limiting the foregoing, subject to Section 4.4(c) below, Cephalon shall Initiate (i) a [**] of the JSC’s approval of the protocol therefor and thereafter use commercially reasonable efforts to continue such clinical trial to completion in a timely manner in accordance with the protocol approved by the JSC, (ii) a [**] of the JSC’s approval of the protocol therefor and thereafter use commercially reasonable efforts to continue such trial to completion in a timely manner in accordance with such protocol; and (iii) a [**], as determined by the JSC, for each indication for which Cephalon has provided prior written notice to Angioblast agreeing to conduct a clinical trial pursuant to this Section 4.4(b) or as determined by the JSC as described in Section 4.3(b) and thereafter use commercially reasonable efforts to continue such trial to completion in a timely manner in accordance with the protocol approved by the JSC.  In any such event, Cephalon (in consultation with Angioblast) shall prepare and present to the JSC a protocol for the conduct of such [**], as applicable; however, Cephalon acknowledges that Angioblast has prepared proposed protocols and identified certain potential clinical sites with respect to the conduct of the clinical trials described in clause (i) and (ii) above, and will consider in good faith using such protocols and clinical sites in the conduct thereof.  If the data generated from clinical trials performed pursuant to this Section 4.4(b) reasonably supports a Marketing Approval in the applicable jurisdiction(s) as determined by the JSC, then Cephalon shall use commercially reasonable efforts to file and prosecute an MAA to obtain such Marketing Approval for the Product subject to such clinical trial.

 

(c)           Conditions Precedent.  Notwithstanding Section 4.4(b) above, Cephalon shall not have the obligation to Initiate any [**] Clinical Trial or [**] Clinical Trial for a Product for use in the Field in the Territory unless and until (i) the applicable Regulatory Authority has accepted CMC Information necessary to support filing an MAA for such Product, and (ii) Angioblast has established through reasonable supporting documentation that it (or its Third Party contract manufacturer) has reasonably sufficient capability to supply the anticipated commercial requirements of Cephalon, its Affiliates and Marketing Partners for such Product [**] for use in the Field in the Territory.  Except as otherwise provided below in this Section 4.4(c), [**] Angioblast’s providing to the JSC the data from a [**] Clinical Trial for a Product for an indication in the Field in the Territory conducted pursuant to Section 4.3(a), Cephalon shall provide to Angioblast a reasonable forecast of the anticipated commercial requirements of it, its Affiliates and Marketing Partners for such Product for the indication in the Field in the Territory based on any sales history for products for such indication in the Field in the Territory and realistic forecasted demand (each a “Conditional Forecast”), and such Conditional Forecast shall be used as the basis to establish the capability of Angioblast (or its Third party contract manufacturer) to supply such requirements under subsection (ii) above.  With respect to the Cardiovascular Product for congestive heart failure in 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.

 

20

 

Cardiovascular Field, Cephalon shall provide Angioblast with a Conditional Forecast for such Product [**].  It is understood that the failure to satisfy the requirements of subsections (i) or (ii) above shall not be deemed to be a breach of Angioblast’s obligations to supply the Products pursuant to ARTICLE VII.

 

4.5           Clinical Protocols.

 

(a)           Each Party shall provide the JSC with copies of proposed clinical trial protocols, investigator brochures, clinical trial analyses and reports, and material correspondence (including all Regulatory Materials) with Regulatory Authorities with respect to each clinical trial and Product for use in the Field in the Territory.  In any event, and without limiting the foregoing, each Party shall provide the JSC with a copy of the clinical plan and protocols for each proposed clinical trial for a Product reasonably in advance of the Initiation thereof for review and approval by the JSC.

 

(b)           In addition, Angioblast agrees to provide to the JSC solely for informational purposes a sufficiently detailed synopsis of protocols to be used for clinical trials of pharmaceutical products containing MPCs for use outside the Field and in the Territory reasonably in advance of the Initiation of such clinical trial to assess whether such clinical trial is likely to present a material adverse risk to the Products for use in the Field in the Territory; however, Angioblast’s obligation to so provide the JSC any such synopsis shall be subject to Angioblast’s right to do so under its agreements with any Third Party; provided further that Angioblast shall use good faith efforts to obtain the right to provide such synopsizes to the JSC for such informational purposes.  In the event a Third Party is unwilling to allow Angioblast provide such synopsizes to the JSC, then Angioblast shall use good faith efforts to obtain the right to provide such synopsizes to an independent clinical development expert acceptable to Cephalon and such Third Party, which expert shall have the right to provide to Cephalon a report stating only whether he/she believes conduct of the clinical trial described in such synopsizes is likely to present a material adverse risk to the Products for use in the Field in the Territory.  For clarity, (i) any synopsizes provided to the JSC under this Section 4.5(b) shall be deemed to be Angioblast Confidential Information hereunder, (ii) neither Angioblast nor any of its Third Party partner shall be obligated to modify any such protocol and (iii) Cephalon agrees that Angioblast may provide similar synopsizes provided under Section 4.5(a) to its Third Party partner(s) for information purposes on a reciprocal basis as such Third Party partner allows access thereto to Cephalon hereunder.

 

4.6           Regulatory Matters.

 

(a)           Assignment of Regulatory Filings.  Subject to Section 4.6(b) below, at reasonable times to be mutually agreed by the Parties in order to maximize the efficiency of the Development of the Products in accordance with each Party’s responsibilities assigned to it under 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.

 

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Development Plan, Angioblast shall assign and deliver, or cause to be assigned and delivered, to Cephalon all Regulatory Materials (including INDs) obtained and maintained by Angioblast or its Affiliate or licensee for the Development of such Product for use in the Field in the Territory; provided, however, that, prior to the assignment of any such Regulatory Materials, Angioblast shall maintain such Regulatory Materials at its expense and shall take all reasonable actions to make available to Cephalon the benefits of such Regulatory Materials to the extent required by Cephalon in connection with its activities under this Agreement.

 

(b)           Responsibility for Regulatory Filings.  Each Party shall be responsible, [**], for filing, obtaining and maintaining approvals for those activities assigned to such Party hereunder in connection with the Development, manufacture and Commercialization of Products for the Field in the Territory.  The Parties acknowledge that, as between the Parties, Cephalon shall have the sole right and responsibility for filing any MAA or Marketing Approval, as well as pricing or reimbursement approvals for the Products for the Field in the Territory and maintaining the same.  All activities under this Section 4.6(b) shall be done subject to the oversight and in full consultation with the JSC.  Prior to the filing any MAA for a Product in the Field in the Territory, Cephalon shall provide a copy thereof to the JSC for its review and approval (including any associated proposed labeling).

 

(c)           BMF; CMC Information.  As long as Angioblast is supplying (or having supplied) to Cephalon the BMT MPCs, Cardiovascular Product or CNS Products pursuant to ARTICLE VII or the Supply Agreement, Angioblast shall, on a Product-by-Product and country-by-country basis: (a) file a biologics master file (“BMF”) in the Territory (or shall arrange for its contractor manufacturers to do so); or (b) provide to Cephalon Angioblast’s then-current CMC Information, in each case, with respect to the [**] supplied by Angioblast (or its contractor manufacturer) to Cephalon under this Agreement or the Supply Agreement; to the extent reasonably necessary for Cephalon to file for, obtain and maintain obtain Marketing Approvals for the applicable Products in the Territory.  Angioblast shall permit Cephalon to cross-reference any such BMF for the purposes of its Regulatory Materials (including INDs and MAAs) for the Products for use in the Field in the Territory in accordance with this Agreement.  Cephalon shall reimburse Angioblast for [**] in accordance with this Section 4.6(c).  For purposes of this Section 4.6(c), “CMC Information” means all Data regarding a Party’s (or its contract manufacturer’s) chemistry, manufacturing and controls filed or required to be filed to in connection with the Development or Commercialization of the Products.

 

4.7           Regulatory Cooperation.  With respect to those Regulatory Materials Angioblast is required to file for, obtain and maintain to perform the Development activities assigned to Angioblast hereunder until such Regulatory Materials are assigned to Cephalon pursuant to Section 4.6(a), Angioblast shall be responsible for liaising with and managing all interactions with Regulatory Authorities with respect to such Product for use in the Field in the Territory, and during 

 

**                               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

 

the period of time from and after such Regulatory Materials are assigned to Cephalon pursuant to Section 4.6(a), Cephalon shall be responsible for liaising with and managing all interactions with Regulatory Authorities with respect to such Product for use in the Field in the Territory.  During the period of time that a Party has responsibility for liaising and managing interactions with Regulatory Authorities (the “Responsible Party”), the other Party (the “Participating Party”) shall be entitled to participate in such interactions as provided in this Section 4.7.

 

(a)           Involvement of the Participating Party.  To the extent relating to the Products for use in the Field within the Territory or activities under the Agreement, the Responsible Party shall provide the Participating Party with:

 

(i)    reasonable advanced notice (and in no event less than ten (10) Business Days’ advance notice whenever feasible) of substantive meetings with any Regulatory Authority within the Territory that are either scheduled with, or initiated by or on behalf of, Responsible Party or its Affiliates, and an opportunity to have a reasonable number (but at least two (2)) representatives participate in all substantive meetings with such Regulatory Authority, and in any case shall keep the Participating Party informed as to all material interactions with such Regulatory Authorities;

 

(ii)   a copy of any material documents, information and correspondence submitted to the FDA or any other Regulatory Authority within the Territory as soon as reasonably practicable, together with English translations and summaries thereof, to the extent such translations and summaries exist; and

 

(iii)  with respect to Cephalon as the Responsible Party, an opportunity to have an observer attend any substantive meetings with Regulatory Authorities that are either scheduled with, or initiated by or on behalf of, the Responsible Party or its Affiliates to the extent such meetings are material to the chemistry, manufacturing and controls or the safety of products containing MPCs for use outside the Field or outside the Territory, and for clarity, such observer may be excluded from portions of any such meetings during which such observer’s attendance would be inappropriate because of Cephalon’s Confidential Information or other matters are discussed.

 

(b)           JSC Approval.  The JSC shall approve the overall strategy and positioning of all material Regulatory Materials (including product labeling) prior to their submission or filing, based upon reasonably detailed reports and summaries of such submissions and filings presented to the JSC by the Responsible Party.  In connection with such review, the Responsible Party shall promptly provide to the JSC such additional information regarding a proposed filing as the Participating Party may reasonably request.

 

**                               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

 

(c)           Other Regulatory Matters.  Each Party will promptly provide the other Party with copies of all material documents, information and correspondence received from a Regulatory Authority (including a written summary of any material communications in which such other Party did not participate) within the Territory and, upon reasonable request, with copies of any other documents, reports and communications from or to any Regulatory Authority within the Territory relating to the Products for use in the Field or activities under the Agreement.  In addition, Angioblast shall provide to Cephalon reasonable advance notice of any substantive meetings with Regulatory Authorities that are either scheduled with, or initiated by or on behalf of, Angioblast or its Affiliates relating to products containing MPCs for use outside the Field within the Territory to the extent such meetings are material to the chemistry, manufacturing and controls or the safety of the Products for use in the Field within the Territory, and an opportunity to have an observer attend in such substantive meetings with such Regulatory Authority.  For clarity, such observer may be excluded from portions of any such meetings during which such observer’s attendance would be inappropriate because a Third Party’s proprietary information or other matters are discussed.

 

4.8           Exchange of Data and Know-How.

 

(a)           By Angioblast.  Promptly following the Effective Date, Angioblast will make available to Cephalon all Angioblast Know-How described in Section 1.4(a) for Cephalon to Develop or Commercialize the Products and process the Expanded HPCs, in each case for use in Field in the Territory, including all Data from research, preclinical studies, and clinical trials for the Products for use in the Field in the Territory existing as of the Effective Date.

 

(b)           By Either Party.  During the Term, each Party shall provide to the other Party all such Party’s Know-How (i.e., in case of Angioblast, Angioblast Know-How described in Section 1.4(a), and in the case of Cephalon, Cephalon Know-How described in Section 1.13(a)) that is Controlled by such Party and that has not previously been provided hereunder, in each case promptly upon request by the other Party.  The Party providing such Party’s Know-How shall provide the same in electronic form to the extent the same exists in electronic form, and shall provide copies as reasonably requested and an opportunity for the other Party or its designee to inspect (and copy) all other materials comprising such Know-How (including for example, original patient report forms and other original source data, to the extent access is allowed under applicable Law).  The Parties, through the Alliance Managers, will cooperate and reasonably agree upon formats and procedures to facilitate the orderly and efficient exchange of the Angioblast Know-How and the Cephalon Know-How.  This Section 4.8(b) shall be the sole obligation of Angioblast and the sole remedy of Cephalon for any breach of the obligation to provide Know-How pursuant to Section 4.8(a) above.

 

(c)           Provision of Data to JSC.  Upon request by the JSC, each Party shall promptly provide the JSC with summaries in reasonable detail of all Data generated or obtained in the course of such Party’s performance of activities under the Development Plan.

 

**                               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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4.9           Sharing of Regulatory Filings.  Without limiting Section 4.8, each Party shall permit the other Party to access, and shall provide the other Party with sufficient rights to reference and use in association with exercising its rights and performing its obligations under this Agreement, all of such Party’s, its Affiliates’ and, to the extent it has the right to do so, its Marketing Partners’ Regulatory Materials (including Data), with respect to the Products in the Field in the Territory.

 

4.10         Inspection Right.

 

(a)           Inspection by a Party.  Each Party shall permit an independent (i.e., having no prior or existing relationship with either Party) Third Party or internal regulatory consultant reasonably acceptable to such Party,  to enter the relevant facilities of such Party and its Affiliates during normal business hours and upon reasonable advance notice to inspect and verify compliance with applicable regulatory and other requirements as well as with this Agreement, with respect to matters relating to the Products for use in the Field in the Territory, all Know-How to be provided to the other Party pursuant to Section 4.8 and the activities under the Collaboration.  Such inspection right shall include the right to examine any internal procedures or records of the inspected Party relating to the Products for use in the Field in the Territory.  The inspected Party shall give such Third Party all necessary and reasonable assistance for a full and correct carrying out of the inspection.  Such inspection shall not relieve the inspected Party of any of its obligations under this Agreement.

 

(b)           Diligence.  Each Party shall use commercially reasonable efforts to secure for the other Party the rights set forth in Section 4.10(a) from Third Parties acting on its behalf, including trial sites and other contractors with respect to the Product for use in the Field (including in the case of Cephalon, any Marketing Partner).  In the event a Party is unable to secure such inspection rights from any such Third Party, the Party agrees to secure such rights for itself and, if requested by the other Party, shall exercise such rights, at its own expense, for the other Party and fully report the results thereof to such other Party.

 

4.11         Reporting; Adverse Drug Reactions.

 

(a)           Pharmaco-Vigilance Agreement.  In conjunction with this Agreement, the Parties shall enter into a pharmaco-vigilance agreement on reasonable and customary terms, including:  (i) providing detailed procedures regarding the maintenance of core safety information and the exchange of safety data relating to the Products; and (ii) ensuring compliance with the reporting requirements of all applicable Regulatory Authorities on a worldwide basis.

 

(b)           Adverse Event Reporting.  As between the Parties, Cephalon shall be responsible for the timely reporting of all Adverse Drug Reactions, complaints and safety data relating to the Products for use in the Field in the Territory to the appropriate Regulatory Authorities 

 

**                               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

 

in all countries in the Territory in accordance with the Law.  Cephalon shall ensure that its Affiliates and Marketing Partners comply with such reporting obligations in the Territory.  To the extent required by applicable Law or as requested by the applicable Regulatory Authority, Angioblast shall provide Cephalon with timely reporting of any Adverse Drug Reactions, complaints and safety data relating to MPC Products for use outside the Field.

 

4.12         Delays Outside of a Party’s Control.  In addition to the provisions of Section 15.1, neither Party will be responsible for failure to meet timelines with respect to the Development of the Products for the Field caused by factors beyond its reasonable control (e.g., regulatory delays, changes in regulatory timelines, being placed on clinical hold) and despite its commercially reasonable efforts to accomplish the objective within the applicable time therefor.

 

ARTICLE V
 COMMERCIALIZATION AND PROMOTION

 

5.1           Commercialization of the Products.  Cephalon shall be responsible for, and shall use commercially reasonable efforts to Commercialize Products in the Field throughout the Territory in a prompt and expeditious manner and meet the sales and other goals set forth in the then-current Commercialization Plan.  It is understood and agreed that, except as otherwise expressly provided herein, all Commercialization efforts for the Products in the Field in the Territory shall be at the sole expense of Cephalon.

 

5.2           Commercialization Plan.  At such time as Cephalon prepares a plan for Commercialization of a Product for its own internal purposes (the “Commercialization Plan”) and update such plan on an annual basis, which plan and updates shall be presented by Cephalon to the JSC for review and approval.  Cephalon shall use commercially reasonable efforts to carry out all marketing, promotion and commercialization of the Products in the Territory in accordance with the then-current Commercialization Plan therefor.

 

ARTICLE VI
 PAYMENTS

 

6.1           Initial License Fee.  Cephalon shall pay to Angioblast an initial license fee in the amount of One Hundred Thirty Million United States Dollars (US$130,000,000) as follows:

 

(i)    One Hundred Million United States Dollars (US$100,000,000) within five (5) days following the Effective Date; and

 

(ii)   Thirty Million United States Dollars (US$30,000,000) within five (5) days following the date on which all Conditions Precedent (as defined in that certain Subscription 

 

**                               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

 

Deed by and between Mesoblast Limited and Cephalon effective as of even date herewith) have been met.

 

The initial license fee set forth in this Section 6.1 shall be paid in accordance with the payment provisions of this ARTICLE VI and shall not be refundable or creditable against any other payments by Cephalon to Angioblast under this Agreement.

 

6.2           Equity Purchase.  Simultaneous with the execution of this Agreement Cephalon and Angioblast have entered into that certain Stock Purchase Agreement dated as of even date herewith by and among Angioblast, Cephalon and the individuals and entities listed on the exhibits thereto pursuant to which Cephalon shall purchase certain currently outstanding equity securities of Angioblast in accordance with the terms of such agreement.

 

6.3           Other Payments.  Cephalon shall make the other payments to Angioblast as set forth in Exhibit 6.3.

 

6.4           Payment Method.  All payments under this Agreement shall be made by bank wire transfer in immediately available funds to an account designated by the Party to which such payments are due.  Any payments or portions thereof due under this Agreement that are not paid by the date such payments are due under this Agreement shall bear interest at a rate equal to: [**].  This Section 6.4 shall in no way limit any other remedies available to the Parties.

 

6.5           Currency Conversion.  Unless otherwise expressly stated in this Agreement, all amounts specified in this Agreement are in Dollars, and all payments by one Party to the other Party under this Agreement shall be paid in Dollars.  If any currency conversion shall be required in connection with the payment of the transfer price under this Agreement, such conversion shall be calculated using the average exchange rate for the conversion of foreign currency into Dollars, quoted for current transactions for both buying and selling Dollars, as reported in The Wall Street Journal (U.S. Internet version at www.wsj.com) for the last Business Day of each month of the calendar quarter to which such payment pertains.

 

6.6           Withholding Taxes.  If Law requires withholding of any taxes by the Party making payment (the “Payor”) of any amount hereunder imposed upon the Party receiving payment (the “Payee”) on account of any payments paid or payable under this Agreement, such taxes shall be deducted by Payor as required by Law from such payment and shall be paid by Payor to the proper taxing authorities.  Official receipts of payment of any such taxes shall be secured and promptly provided to Payee as evidence of such payment together with other documentation reasonably requested by Payee in connection therewith.  The Parties shall cooperate in any lawful manner to reduce or eliminate any such taxes imposed to the extent possible under the provisions of 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.

 

27

 

applicable tax treaty, and shall cooperate in filing any forms required for such reduction or elimination.

 

6.7           Records; Inspection.  Cephalon shall keep, and require its Affiliates and Marketing Partners to keep, complete, true and accurate books of accounts and records for the purpose of determining the amounts payable to Angioblast pursuant to this Agreement.  Such books and records shall be kept for at least five (5) years following the end of the calendar year to which they pertain.  Such records will be open for inspection by an independent (i.e., having no prior or existing relationship with either Party) auditor chosen by Angioblast and reasonably acceptable to Cephalon for the purpose of verifying the amounts payable by Cephalon hereunder.  Such inspections may be made [**], at reasonable times and on reasonable prior written notice.  The records for any particular calendar quarter shall be [**]. The auditor shall be obligated to execute a reasonable confidentiality agreement prior to commencing any such inspection.  Any inspection conducted under this Section 6.7 shall be at the expense of Angioblast, [**].

 

ARTICLE VII
 MANUFACTURING AND SUPPLY

 

7.1           Supply.  Subject to the terms and conditions of this Agreement, Angioblast shall use commercially reasonable efforts to supply or have supplied (by an Affiliate or Third Party) to Cephalon all requirements of (a) [**], (b) [**]and (c) [**], in each case in the Territory, in accordance with this ARTICLE VII and in accordance with a separate written agreement to be negotiated between the Parties pursuant to Section 7.2 (the “Supply Agreement”).  Except as otherwise agreed by the Parties in the Supply Agreement, as between the Parties: (i) Cephalon shall [**] purchase from Angioblast [**]; and (ii) Angioblast shall have the [**]to manufacture and have manufactured the [**].  It is understood that Angioblast shall supply to Cephalon (or its designee) the [**] in accordance with the Specifications therefor.  For clarity, Cephalon shall be responsible for obtaining any import or export approvals required by Regulatory Authorities in the Territory to import or export the [**] to any country or other jurisdiction within the Territory.

 

7.2           Formulation / Specifications.  Angioblast shall be responsible for determining the appropriate formulation for the [**] and associated Specifications (which with respect to activities after the Effective Date shall be done in consultation with Cephalon and subject to the oversight of the JSC); however, upon Cephalon’s reasonable request and agreement to [**], Angioblast shall use commercially reasonable efforts to accommodate any changes in formulation or the Specifications for the [**].

 

7.3           Clinical Supply.  Angioblast shall use commercially reasonable efforts to supply to Cephalon the[**] for use in Development of Products for use in the Field in the Territory in accordance with this Section 7.2.

 

**                               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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(a)           Angioblast shall supply Cephalon with such quantities of the [**] as are reasonably required by Cephalon in order to conduct Development of the Products for use in the Field in the Territory in accordance with the then-current Development Plan.

 

(b)           Such supply shall be at [**] to Cephalon; however, Cephalon shall be responsible for all costs of shipping, handling, transit, taxes (including VAT), packaging, storage and the like in connection with the transport of [**] from the facilities where Angioblast manufactures or has manufactured the same to the location designated by Cephalon.  Accordingly, Cephalon shall choose the carrier and be responsible for all payments thereto.  It being understood that Angioblast shall not be responsible for any loss or damage of [**] in carriage, use or otherwise not caused by Angioblast or a Person acting by or on behalf of Angioblast; however, in the event of such loss or damage, the Parties shall promptly discuss how to address such situation, including Cephalon reimbursing Angioblast’s costs associated with replacing such lost or damaged [**] and any expedite fees associated therewith.

 

(c)           The Parties shall establish reasonable procedures for Cephalon to forecast and submit to Angioblast, and for Angioblast to fill, orders for [**] for use for Development.  Such procedures shall include reasonable schedules for delivery of [**] ordered by Cephalon pursuant to this Section 7.2 consistent with the Development Plan then in effect.  Notwithstanding the foregoing, Angioblast shall not be obligated to supply any quantities of the Product in excess of the Product necessary for Cephalon to conduct the Development activities assigned to it under the Development Plan.  Cephalon agrees that [**] supplied pursuant to this Section 7.2 shall be used solely for purposes of performing Development of the Products for use in the Field in the Territory in accordance with the Development Plan and, unless otherwise agreed by the Parties, for no other purpose.  Accordingly, Cephalon acknowledges that Angioblast shall have the right to package or otherwise mark such [**] in a manner that distinguishes them from those intended for Commercialization.

 

(d)           [**] supplied to Cephalon pursuant to this Section 7.2 shall be manufactured in compliance with all applicable GMP and the Specifications therefor and other requirements therefor established by the applicable Regulatory Authorities.

 

7.4           Commercial Supply.  Upon the written request of Cephalon before a Product receives the first Marketing Approval in the Territory, the Parties shall negotiate and execute a Supply Agreement for the supply by Angioblast to Cephalon of [**] for Commercialization in the Territory, and such Supply Agreement shall include the terms and conditions set forth on Exhibit 7.4 and shall not otherwise be inconsistent with the terms and conditions of this Agreement.  The transfer price for all BMT MPCs, Cardiovascular Products and CNS Products supplied for Commercialization in the Territory shall be as set forth in Section 6.3 above.

 

**                               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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7.5           Quality Agreement.  Angioblast and Cephalon shall execute a mutually acceptable quality agreement that allocates roles and responsibilities to each Party with respect to quality control and regulatory compliance with respect to supply of Products to Cephalon for the Development and Commercialization of the Products pursuant to Sections 7.2 and 7.4 above.

 

7.6           Supply Protection.  Angioblast and Cephalon shall cooperate to establish reasonable plans and procedures to avoid any shortage of supply of [**].  Additionally, in order to mitigate the risk of shortage of supply the JSC may establish requirements for safety stock inventories to be maintained by the Parties and plans to extend the shelf life of [**] including stability trials to be performed by the Parties.

 

7.7           Shortage of Supply.  Angioblast shall promptly notify the JSC of any occurrence of which it becomes aware that it expects will result in a likely shortage or prevent Angioblast from providing on-time delivery of quantities of the Products ordered by Cephalon and accepted by Angioblast in accordance with the terms and conditions of this ARTICLE VII or the Supply Agreement.  In such event, the JSC shall immediately establish a joint manufacturing subcommittee with an equal number of senior manufacturing personnel from each Party (“JMC”) to address the issue, including locating one or more alternative suppliers or manufacturing sites to increase production and identifying other actions necessary to resolve the issue.  The JMC shall determine appropriate measures to prevent any shortage of supply and shall promptly implement such measures.  In any such event Angioblast shall allocate the quantities of such Product that Angioblast has in inventory, and that Angioblast is able to produce, on a reasonable worldwide basis (based upon sales history and realistic forecasted demand), so that Cephalon receives its portion.  In any event, both Parties agree to respond with the level of speed and diligence commensurate with the severity of the problem.

 

7.8           Back-Up Manufacturing Right.  If, despite the foregoing measures undertaken by the Parties pursuant to Sections 7.6 and 7.7 above, Angioblast, as a result of its failure to use commercially reasonable efforts, is unable to supply quantities of the [**], as applicable, ordered by Cephalon and accepted by Angioblast for commercial sale in accordance with the terms and conditions of the Supply Agreement (once executed) and such inability interrupts or is likely to interrupt Cephalon’s ability to meet the market demand for the applicable Products (a “Supply Failure”), then Cephalon shall have the right to qualify a Third Party back-up contractor manufacturer, to which Angioblast has no reasonable objection (each, a “CMO”) for such Product for commercial supply in the Territory and to have its and its Affiliates’ and Marketing Partners’ requirements for such Product manufactured and supplied to Cephalon for commercial sale in the Territory for the remaining Term of the Agreement.  If Cephalon so elects to exercise its rights under this Section 7.8, then Cephalon shall identify and qualify a CMO, and Angioblast shall have the right to participate in and approve such qualification therefor, not to be unreasonably withheld, conditioned or delayed.  Upon Angioblast’s approval of such CMO, Angioblast shall transfer (or

 

**                               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.

 

30

 

cause its existing contract manufacturer to transfer) all relevant Data and other Know-How related to the manufacture and supply of such Product to such CMO in accordance with the provisions set forth in Exhibit 7.8.  Upon completion of such transfer of Data and other Know-How, Angioblast shall no longer have the obligations to supply the requirements for such Product for commercial sale as provided for under this ARTICLE VII and the Supply Agreement.  This Section 7.8 shall be the sole obligation of Angioblast and the sole remedy of Cephalon for a failure to supply any commercial requirements of the Products as set forth in this ARTICLE VII and the Supply Agreement if such exercise is prior to the expiration of Angioblast’s right to terminate pursuant to Section 13.3(a) or 13.3(b), as applicable.  If Cephalon so elects to exercise its rights under this Section 7.8, Cephalon shall not [**]; provided, however, that if Angioblast’s right to terminate pursuant to Section 13.3(a) or 13.3(b), as applicable, has expired, then Cephalon shall [**]. For clarity, such payments shall be made on calendar quarterly basis in arrears consistent with the reconciliation process as provide for under Exhibit 6.3 and provide reports with respect to such sales as set forth under ARTICLE VI and otherwise in accordance with ARTICLE VI.

 

ARTICLE VIII
 CONFIDENTIALITY

 

8.1           Confidential Information.  Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties,  each Party agrees that it shall keep confidential and shall not publish or otherwise disclose and shall not use for any purpose other than as provided for in this Agreement any Confidential Information furnished to it by the other Party pursuant to this Agreement.  The confidentiality and non-use obligations set forth above shall terminate [**] except with respect to any Confidential Information that constitutes a trade secret under applicable Law.  In any event, the confidentiality and non-use obligations set forth above shall not apply with respect to any portion of the other Party’s Confidential Information that the receiving Party can demonstrate by competent written proof:

 

(a)           was already known to the receiving Party or its Affiliate, other than under an obligation of confidentiality, at the time of disclosure by the disclosing Party;

 

(b)           was generally available to the public or otherwise part of the public domain at the time of its disclosure by the disclosing Party;

 

(c)           becomes generally available to the public or otherwise part of the public domain after its disclosure by the disclosing Party, other than through any act or omission of the receiving Party in breach of this Agreement;

 

	
**
    	
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.
    

 

31

 

(d)           is disclosed to the receiving Party or its Affiliate by a Third Party who has a legal right to make such disclosure and who did not obtain such information directly or indirectly from the disclosing Party; or

 

(e)           is independently discovered or developed by employees or contractors of the receiving Party or its Affiliate who have not actually received or have no actual knowledge of the other Party’s Confidential Information.

 

8.2           Authorized Disclosure.  Each Party may disclose Confidential Information belonging to the other Party to the extent such disclosure is reasonably necessary in the following situations:

 

(a)           Prosecuting and Maintaining Patents in accordance with Section 9.2;

 

(b)           complying with the requirement of Regulatory Authorities with respect to filing for, obtaining and maintaining Marketing Approval for the Products in accordance with this Agreement (including conducting Development of the Products);

 

(c)           prosecuting or defending litigation as contemplated by, or arising out of, this Agreement;

 

(d)           complying with applicable Laws and regulations promulgated by security exchanges, court order or administrative subpoenas or orders or otherwise submitting information to tax or other governmental authorities;

 

(e)           disclosure to its or its Affiliates’ employees, agents, consultants, advisors (including financial advisors, lawyers and accounts) and contractors (and Marketing Partners in the case Cephalon and other licensees or sublicensees in the case of Angioblast), in each case only on a need-to-know basis for the sole purpose of performing its or its Affiliates’ obligations or exercising its or its Affiliates’ rights under this Agreement, provided that in each case the recipient of such Confidential Information are bound by written obligations of confidentiality and non-use at least as equivalent in scope as those set forth in this ARTICLE VIII prior to any such disclosure; and

 

(f)            disclosure to existing and potential investors, merger partners or acquirors, including their respective consultants and professional advisors (including financial advisors, lawyers and accounts), solely on a need-to-know basis in order to evaluate an actual or potential investment, acquisition or similar business transactions; and provided that in connection with such disclosure, the disclosing Party shall inform each disclosee of the confidential nature of such terms and cause each disclosee to treat such information as confidential consistent with the nature of the Confidential Information so disclosed.

 

	
**
    	
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.
    

 

32

 

Notwithstanding the foregoing, in the event a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to clause (i), (ii) or (iv) of this Section 8.2, it shall promptly notify the other Party of such required disclosure and shall use reasonable efforts to obtain, or to assist the other Party in obtaining, a protective order or confidential treatment limiting or preventing the required disclosure, and disclose only the minimum information necessary for such disclosure; provided that such Confidential Information disclosed accordingly shall only lose its confidentiality protection for purposes of such disclosure.  In any event, each Party agrees to take all reasonable action to avoid disclosure of Confidential Information of the other Party hereunder.

 

8.3           Prior Non-Disclosure Agreements.  Upon execution of this Agreement, the terms of this ARTICLE VIII shall supersede the Prior Confidentiality Agreement in their entirety.

 

8.4           Publicity; Terms of Agreement.

 

(a)           General.  Each of the Parties agrees not to disclose to any Third Party the terms and conditions of this Agreement without the prior approval of the other Party, except to advisors (including financial advisors, attorneys and accountants), potential and existing investors, financial or commercial partners, merger partners and acquirers and others on a need-to-know basis, in each case under circumstances that reasonably protect the confidentiality thereof, or as otherwise provided in the special authorized disclosure provisions set forth below in this Section 8.4.  The Parties shall make a joint public announcement of the execution of this Agreement, such public announcement to be mutually agreed by the Parties within two (2) Business Days of the Effective Date and released promptly thereafter by the Parties in a coordinated manner.

 

(b)           Future Releases.  After release of such press release, if either Party desires to make a public announcement concerning the material terms of this Agreement, such Party shall give reasonable prior advance notice of the proposed text of such announcement to the other Party for its prior review and approval (except as otherwise provided herein), such approval not to be unreasonably withheld or delayed.  A Party commenting on such a proposed press release shall provide its comments, if any, within two (2) Business Days after receiving the press release for review.  To the extent required by applicable Laws, including regulations promulgated by applicable securities exchange, each Party shall have the right to make a press release announcing the achievement of each milestone under this Agreement as it is achieved, and the achievements of Marketing Approvals in the Territory as they occur, subject only to the review procedure set forth in the preceding sentence.  In relation to a Party’s review of such an announcement, such Party may make specific, reasonable comments on such proposed press release within the prescribed time for commentary, but shall not withhold its consent to disclosure of the information that the relevant milestone has been achieved and triggered a payment hereunder.  Neither Party shall be required to seek the permission of the other Party to repeat any information regarding the terms of this

 

	
**
    	
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.
    

 

33

 

Agreement that has already been publicly disclosed by such Party, or by the other Party, in accordance with this Section 8.4, provided that such information remains accurate as of such time.

 

(c)           Regulatory Disclosures.  The Parties acknowledge that a Party may at some point in time be obligated to file a copy of this Agreement with applicable governmental authorities having regulatory authority over such Party securities or the exchange thereof.  In such case, such Party shall be entitled to make such a required filing, provided that it requests confidential treatment of the commercial terms and sensitive technical terms hereof to the extent such confidential treatment is reasonably available to such Party and permitted by such governmental authority.  In the event of any such filing, such Party will provide the other Party with a copy of the Agreement marked to show provisions for which the filing Party intends to seek confidential treatment and shall reasonably consider and incorporate the other Party’s comments thereon to the extent consistent with the legal requirements governing redaction of information from material agreements that must be publicly filed.  The other Party will as promptly as practical provide any such comments.  The other Party recognizes that applicable Laws, including regulations promulgated by applicable governmental authorities, to which the filing Party is and may become subject to may require the filing Party to publicly disclose certain terms of this Agreement that the other Party may prefer not be disclosed, and that the filing Party is entitled hereunder to make such required disclosures to the minimum extent necessary to comply with such Laws.

 

8.5           Technical Publications.  Neither Party may publish peer reviewed manuscripts, or give other forms of public disclosure such as abstracts and presentations, of data or results of activities under this Agreement with respect to Products for use in the Field in the Territory, without the opportunity for prior review by the other Party, except to the extent required by applicable Laws.  A Party seeking publications shall provide the other Party the opportunity to review and comment on any proposed manuscripts or presentations which relate to any Product at least sixty (60) days prior to their intended submission for publication or presentation.  The other Party shall provide the Party seeking publication with its comments in writing, if any, within thirty (30) Business Days after receipt of such proposed manuscripts or presentations.  The Party seeking publication shall consider in good faith such comments thereto provided by the other Party and shall remove from the proposed manuscripts or presentations any and all of the other Party’s Confidential Information at the request of such other Party.  In addition, the Party seeking publication shall delay the submission for a period up to ninety (90) days in the event that the other Party can demonstrate reasonable need for such delay, including the preparation and filing of a Patent application.  If the other Party fails to provide its comments to the Party seeking publication within such thirty (30) Business Day period, such other Party shall be deemed not to have any comments, and the Party seeking publication shall be free to publish in accordance with this Section 8.5 after the sixty (60) day period has elapsed.  The Party seeking publication shall provide the other Party a copy of the manuscript or presentation at the time of the submission.  The Party seeking publication shall not have the right to publish or present the other Party’s Confidential Information without prior written consent of the other Party,

 

	
**
    	
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.
    

 

34

 

except as expressly permitted in this Agreement.  The contribution of each Party shall be noted in all publications or presentations by acknowledgment or co-authorship, whichever is appropriate.

 

8.6           Equitable Relief.  Each Party acknowledges that its breach of this ARTICLE VIII may cause irreparable harm to the other Party, which cannot be reasonably or adequately compensated in damages in an action at law.  By reasons thereof, each Party agrees that the other Party shall have the right to seek, in addition to any other remedies it may have under this Agreement or otherwise, preliminary or permanent injunctive and other equitable relief to prevent or curtail any actual breach of the obligations relating to Confidential Information set forth in this ARTICLE VIII by such Party.

 

ARTICLE IX
 INTELLECTUAL PROPERTY

 

9.1           Ownership.

 

(a)           General.  As between the Parties and subject to the terms and conditions of this Agreement, all right, title and interest to inventions and other subject matter conceived or created or first reduced to practice in connection with this Agreement (together with all intellectual property rights therein) (“Inventions”) (i) by Persons acting on behalf of Angioblast, independently of Persons acting by or on behalf of Cephalon, shall be owned by Angioblast, (ii) by Persons acting on behalf of Cephalon, independently of Persons acting on behalf of Angioblast, shall be owned by Cephalon and (iii) by Persons acting on behalf of Angioblast and Cephalon shall be jointly owned by Angioblast and Cephalon.  Except as expressly provided in this Agreement, it is understood that neither Party shall have any obligation to obtain any approval of nor pay a share of the proceeds to the other Party to practice, enforce, license, assign or otherwise exploit such jointly-owned Inventions, and each Party hereby waives any right it may have under the Laws of any country to require such approval or sharing.  Notwithstanding anything to the contrary in this Agreement, neither Party is obligated to assign any title or interest in inventions and other subject matter (together with all intellectual property rights therein) conceived or created or first reduced to practice before the Effective Date.

 

(b)           Improvements.  Notwithstanding Section 9.1(a), any and all Inventions that are conceived or created or first reduced to practice by Persons acting on behalf of Cephalon or its Marketing Partners in connection with this Agreement (i) comprising a modification or enhancement of or to a Product or the manufacture, use or formulation thereof; or (ii) enabled by use of the Confidential Information of Angioblast and in each case, all intellectual property rights therein and thereto (“Improvements”) shall be owned solely by Angioblast.  Cephalon agrees to assign and hereby assigns to Angioblast all its rights, title and interests in and to such Improvements, and shall cause its Marketing Partners, as applicable, to do the same.  Cephalon shall promptly notify 

 

	
**
    	
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.
    

 

35

 

Angioblast of any such Improvements and disclose to Angioblast any Data or other Know-How related to such Improvements.

 

(c)           Further Assurances.  Cephalon agrees to execute such documents, render such assistance, and take such other action as Angioblast may reasonably request, to apply for, register, perfect, confirm, and protect Angioblast’s rights in all such Improvements.  Cephalon agrees that if Angioblast is unable because of Cephalon’s unavailability, dissolution or incapacity, or for any other reason, to secure Cephalon’s signature to apply for or to pursue any application for any Patents or copyright registrations covering, in whole or in part, Improvements assigned to Angioblast under Section 9.1(b), then Cephalon hereby irrevocably designates and appoints Angioblast and its duly authorized officers and agents as Cephalon’s agent and attorney in fact, to act for, and in Cephalon’s behalf and stead, to execute and file any such applications and to do all other lawfully permitted acts to further the prosecution and issuance of Patents and copyright registrations thereon with the same legal force and effect as if executed by Cephalon.

 

9.2           Prosecution and Maintenance of Patents.

 

(a)           Angioblast Patents.  As between the Parties, Angioblast shall control, in its discretion, the Prosecution and Maintenance of all Angioblast Patents within the Territory; provided that Angioblast agrees to: (i) keep Cephalon reasonably informed with respect to such activities; (ii) consult in good faith with Cephalon regarding such matters and consider all Cephalon’s comments with respect thereto in good faith; and (iii) with respect to any Angioblast Patent that [**] a Product for use in the Field in the Territory (a “Specific Angioblast Patent”), incorporate any reasonable comments provided by Cephalon to Angioblast in any filings or responses made to any patent authority provided by Cephalon to Angioblast in a reasonable amount of time in advance of submitting such filings or responses.  If Angioblast determines not to file any Patent, or to abandon any Patent, within the Angioblast Patents within the Territory, as applicable, Angioblast shall provide Cephalon with written notice at least sixty (60) days (or if less, as long as reasonably practicable) prior to taking such action, or the date on which such abandonment would become effective.  In such event, Cephalon shall have the right, at its option, to control the Prosecution and Maintenance of such Angioblast Patent, [**] in Angioblast’s name within the Territory; provided that Cephalon shall have the right to [**] for the Prosecution and Maintenance of such Angioblast Patent against any Transfer Payments.  In such case, Cephalon shall keep Angioblast reasonably informed of its activities with respect to such Prosecution and Maintenance.

 

(b)           Joint Patents.  Without limiting any rights under this Section 9.2(b), prior to the filing of any Patent claiming Inventions that are jointly owned pursuant to Section 9.1(a) above (any, a “Joint Patent”), the Parties shall agree on a strategy for the Prosecution and Maintenance thereof, including the particular countries to file for a Patent and scope of the claims to be filed and each Party agrees to take all reasonable action to cooperate fully in this regard.  Each Party shall bear 

 

	
**
    	
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.
    

 

36

 

[**] in connection with such activities as they are incurred, provided that if either Party provides the other Party with sixty-(60) days written notice specifying that it no longer desires to bear such costs and expenses with respect to a particular Joint Patent, then upon the other Party’s receipt of such notice, such notifying Party shall not be responsible for any further costs or expenses under this Section 9.2(b) related to any such Joint Patent; provided  however that such notifying Party shall be responsible for any costs and expenses incurred up to and as of the date the other Party receives such notice, and all right, title and interest in and to such Joint Patent (together with any Patents issuing thereon or therefrom) shall be and is hereby assigned, without further consideration, to the other Party (subject to the rights granted under Sections 2.1 and 2.2 above).

 

(c)           Cooperation.  Each Party shall cooperate with the other Party in connection with all activities relating to the Prosecution and Maintenance of the Angioblast Patents undertaken by such other Party pursuant to this Section 9.2, including:  (a) making available in a timely manner any documents or information such other Party reasonably requests to facilitate such other Party’s Prosecution and Maintenance of the applicable Patents pursuant to this Section 9.2; and (b) if and as appropriate, signing (or causing to have signed) all documents relating to the Prosecution and Maintenance of any applicable Patents by such other Party.  Each Party shall also promptly provide to the other Party all information reasonably requested by such other Party with regard to such Party’s activities pursuant to this Section 9.2.

 

9.3           Enforcement.

 

(a)           Notice.  In the event that either Party reasonably believes that any Angioblast Patent within the Territory is being infringed by a Third Party, or is subject to a declaratory judgment action arising from such infringement, such Party shall promptly notify the other Party.

 

(b)           Initiating Enforcement Actions.  Angioblast shall have the initial right (but not the obligation), at its own expense, to enforce the Angioblast Patents against any infringement of any Angioblast Patents with respect to the manufacture, sale or use within the Territory of a product for use in the Field (an “Infringing Product”), or to defend any declaratory judgment action arising from such infringement, within the Territory (for purposes of this Section 9.3, an “Enforcement Action”) provided, however, that Cephalon may participate in such Enforcement Action at its own expense.  In the event that Angioblast fails to initiate an Enforcement Action under this Section 9.3(b) within [**] days in accordance with the Patient Protection and Affordable Care Act of a request by Cephalon to initiate such Enforcement Action in other circumstances, Cephalon may initiate an Enforcement Action against such infringement, at its own expense, with Angioblast’s consent, not to be unreasonably withheld, conditioned or delayed.  For clarity, it will not be unreasonable for Angioblast to withhold such consent if such Enforcement Action could likely result in such Angioblast Patent being held unpatentable or unenforceable.  In such case, Angioblast shall cooperate in such Enforcement Action at Cephalon’s expense.  In any event, each Party agrees to 

 

	
**
    	
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.
    

 

37

 

keep the other Party hereto reasonably informed of all material developments in connection with any Enforcement Action and each Party may provide input and comments related to the strategy for any Enforcement Action and the other Party shall consider such input and comments in good faith.  Each Party agrees not to settle any Enforcement Action, or make any admissions or assert any position in any Enforcement Action, in a manner that would have a material adverse affect on the other Party’s rights or interests in any Angioblast Patent or Product for use in the Field in the Territory, without the prior written consent of the other Party, which shall not be unreasonably withheld, conditioned or delayed.

 

(c)           Initiating Other Enforcement Actions.  In addition to Section 9.3(b) above, Angioblast shall have the sole and exclusive right (but not the obligation), at its own expense, to enforce the Angioblast Patents against any infringement of any Angioblast Patents with respect to the manufacture, sale or use within the Territory of a product other than an Infringing Product (“Other Infringing Product”), or to defend any declaratory judgment action arising from such infringement, within the Territory (for purposes of this Section 9.3(c), an “Other Enforcement Action”); provided that Cephalon may request that Angioblast initiate an Other Enforcement Action to enforce the Angioblast Patents against an infringement by a Third Party in a country within the Territory that has a commercially significant impact on the sales of the Products in such country within the Territory, and Angioblast upon such request will reasonably consider initiating such Other Enforcement Action, or granting Cephalon the right to bring such Other Enforcement Action, and will not unreasonably deny such request, taking into consideration the effect or likely effect of the sales of such Other Infringing Product on the sales of such Products and Angioblast’s obligations to Third Parties.

 

(d)           Cooperation.  In addition to each Party’s right to participate and provide input and comments on any Enforcement Actions pursuant to Section 9.3(b), the Party initiating or defending any action pursuant to this Section 9.3 shall keep the other Party reasonably informed of the progress of any such action.  In addition, the Parties shall assist one another and cooperate in any such action at the other’s reasonable request and expense (including joining as a party plaintiff to the extent necessary to bring or maintain such action).

 

(e)           Recoveries.  Any damages or other monetary awards recovered from an Enforcement Action within the Territory shall be allocated first to reimburse the costs and expenses of the Party who initiates the Enforcement Action and, if the other Party joins as a party plaintiff, then the unreimbursed costs and expenses of the other Party.  Any amounts remaining shall be [**].  For clarity, as between the Parties, all amounts received in connection with or allocated to an Other Enforcement Action shall inure to the benefit and be retained by Angioblast.

 

9.4           Third Party Infringement Claims.

 

	
**
    	
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.
    

 

38

 

(a)           Notice.  If any Product manufactured, used or sold by or on behalf of a Party, becomes the subject of a Third Party’s claim or assertion of infringement of a Patent granted by a jurisdiction in the Licensed Territory (any such claim or assertion, a “Defensive Action”), the Party first having notice of the Defensive Action shall promptly notify the other Party.  Without limiting the rights of the Parties in Section 9.4(b) below, the Parties shall promptly agree on and enter into a joint defense agreement wherein such Parties agree to their shared, mutual interest in the outcome of such potential dispute (any, a “Joint Defense Agreement”), and thereafter, the Parties shall promptly meet to consider the Defensive Action and the appropriate course of action.

 

(b)           Control.  The Party subject to such Defensive Action shall have the right to direct and control the defense thereof; provided, however, that the other Party may participate in the defense and/or settlement thereof at its own expense with counsel of its choice.  Notwithstanding the foregoing, the provisions of Section 9.3  shall govern the right of a Party subject to such Defensive Action to assert a counterclaim of infringement of any Angioblast Patent or Joint Patent in connection with such Defensive Action.  In any event, each Party agrees to keep the other Party hereto reasonably informed of all material developments in connection with any such Defensive Action.  Each Party agrees not to settle any Defensive Action, or make any admissions or assert any position in any Defensive Action, in a manner that would materially adversely affect the Products or the manufacture, use or sale of the Products for the Field in the Territory, without the prior written consent of the other Party, which shall not be unreasonably withheld or delayed; provided that any determination to acquire a license or other rights under any Patent asserted in such Defensive Action shall be governed by Section 9.5 below.  Without limiting the foregoing, each Party shall be responsible for [**] Costs incurred by a Party as a result of such Defensive Action.  As used herein, “Costs” shall mean out-of-pocket costs incurred by a Party, including reasonable attorney’s fees, damages and other liabilities that are part of any final judgment awarded against such Party, and any amounts paid by such Party in a settlement of the action (except for any payments to a Third Party as a result of acquiring a license or other rights under the Patent asserted in such Defensive Action pursuant to Section 9.5 below and either Party’s exercise of such rights under such Patents, which payments shall be shared by the Parties in accordance with Section 9.5 below).

 

9.5           Third Party Technology.

 

(a)           Third Party Technology.  If a Party identifies (or if a Third Party notifies a Party of) any Patent owned or controlled by a Third Party that it reasonably believes Covers the Development, Commercialization, other use or manufacture (including processing) of any Product for use in the Field in the Territory, then such Party (the “Noticing Party”) shall provide notice of such Third Party’s Patent to the other Party (the “Noticed Party”) through the Noticed Party’s members on the JSC.  In addition, the Noticing Party shall disclose to the Noticed Party through its members on the JSC other relevant information with respect to such Third Party Patent in the Noticing Party’s control; provided that prior to the disclosure of such information, the Parties shall 

 

	
**
    	
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.
    

 

39

 

enter into a joint interest agreement in order to protect the attorney-client and other similar privileges and confidentiality with respect to such matters on standard and customary terms and conditions (any, a “Joint Interest Agreement”).  In such case, the JSC shall promptly (and in no case later than thirty (30) days after the date of such notice) meet to determine the appropriate strategy(ies) with respect to such Third Party Patent (including seeking appropriate licenses or other rights or developing appropriate work arounds with respect thereto).  In the event the JSC agrees to seek a license or other right under such Patent from the Third Party, Angioblast shall take the lead with respect thereto; however, it shall keep Cephalon reasonably informed with respect to the negotiation of any such license or right including notifying Cephalon in advance of meetings with such Third Party and allow Cephalon to reasonably participate therein.  Additionally, Angioblast shall provide Cephalon a copy of any proposed agreement with respect to such Patent prior to its execution for its review and comment, and Angioblast will consider such comments in good faith.  Angioblast shall ensure that under any such agreement it will Control (in accordance with Section 1.19) such Patent so that such Patent shall be an Angioblast Patent for purposes of this Agreement.  Each Party shall be responsible[**] of all amounts payable to such Third Party as a result of Angioblast’s entering into such license agreement or either Party’s exercise of any rights under such Patents (including any milestones and royalties) in accordance with the terms and conditions of this Agreement.

 

(b)           Dispute.  If the JSC disagrees as to whether any such Third Party Patent Covers the Development, Commercialization, other use or manufacture (including processing) of any Product for use in the Field in the Territory or whether to develop appropriate work arounds with respect thereto, then the Parties shall resolve any such dispute in accordance with this Section 9.5(b) (notwithstanding ARTICLE XIV below).  Accordingly, the Parties shall a promptly refer such dispute to an independent patent attorney appointed by the JSC, which attorney has at least fifteen years of experience in pharmaceutical product development.  If the JSC cannot select such an attorney by consensus, then the Noticed Party shall promptly provide the Noticing Party a list of at least five (5) such patent attorneys meeting such qualifications with their curriculum vitae describing their qualifications, and the Noticing Party shall select one (1) from such list.  Such selected patent attorney shall, after reasonable investigation and review, render a written decision selecting one or the other Party’s position on the matter, which decision shall be binding upon the JSC in determining an appropriate strategy with respect to such Third Party Patent under Section 9.5(a) above.  Without limiting the foregoing, the Parties and the selected patent attorney shall use good faith efforts to complete the dispute resolution process within thirty (30) days of the appointment of the patent attorney.  Each Party shall pay its own expenses in connection with the dispute resolution procedures set forth in this Section 9.5(b), provided, that the fees, costs, and expenses of the selected patent attorney shall be borne by the Party against whom the decision is made.

 

(c)           For purposes of this Section 9.5, “Cover” means, with respect to particular claim of a Patent, that the manufacture, use, sale, offer for sale or importation of particular subject

 

	
**
    	
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.
    

 

40

 

matter infringes (either direct or contributory) or induces the infringement of such claim.  For clarity, Cover includes with respect to pending claims, that the manufacture, use, sale, offer for sale or importation of particular subject matter would likely so infringe if such claim were to issue.

 

9.6           Patent Marking.  The JSC shall establish, on a country-by-country basis, any requirements for marking patented Products to be sold or distributed pursuant to this Agreement as the then-current Commercialization Plan contemplates launch of such Product in such country within the Territory; provided that Cephalon agrees to mark, and have its Affiliates and Marketing Partners mark, all patented Products they sell or distribute pursuant to this Agreement in the same manner as Cephalon marks, and has its Affiliates and Third Party partners mark, its other products of similar nature and commercial potential in accordance with the applicable patent statutes or regulations in the country or countries of sale thereof.

 

ARTICLE X
 TRADEMARKS

 

10.1         General.  Cephalon shall have the sole right to determine the trademarks, trade dress, style of packaging, labeling and the like with respect to the Commercialization of Products in the Field in the Territory (such trademarks used or intended for use by Cephalon with the Products (except the Existing Mark), including representations thereof in any language, the “Product Marks”).  Unless otherwise agreed, Cephalon shall have the sole right (but not the obligation) to register and enforce (and retain all recoveries therefrom) the Product Marks, at its own expense, in the Territory.  For clarity, Cephalon shall have the right in accordance with the license set forth in Section 10.3 to use the Existing Mark in connection with its Commercialization of Cardiovascular Products in the Cardiovascular Field in the Territory.

 

10.2         Angioblast Logos.  Cephalon hereby agrees (and shall cause its Affiliates and Marketing Partners) to the extent allowable under applicable Law to include on all labels of and package inserts and marketing materials for Products sold by or under authority of Cephalon to include Angioblast’s trade name and logo, collectively, the “Angioblast Logos”).  It is understood that the size and placement of the Angioblast Marks shall be consistent with Cephalon’s practices with respect thereto, or, if Cephalon is not then including Third Party logos, current pharmaceutical industry practices for similarly situated Third Party logos.  Unless otherwise agreed, Angioblast shall have the sole right (but not the obligation) to register and enforce the Angioblast Logos, at its own expense.

 

10.3         Grant of License.  Subject to the terms and conditions of this Agreement, Angioblast hereby grants to Cephalon (a) an exclusive license to use the Existing Mark in each country 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.
    

 

41

 

Territory for the packaging, marketing, distributing, sale and promotion of the Cardiovascular Products for use in the Cardiovascular Field and (b) a non-exclusive license to use the Angioblast Logos in each country of the Territory for the packaging, marketing, distributing, sale and promotion of the Products for use in the Field, in each case accordance with this Agreement.  The ownership and all goodwill from the use of the Existing Mark and Angioblast Logos shall vest in and inure to the benefit of Angioblast.  Cephalon shall ensure that use of the Existing Mark and Angioblast Logos is consistent with high levels of business professionalism, product standards and Cephalon’s use of its own trademarks.  Notwithstanding anything herein to the contrary, upon Angioblast’s written request, Cephalon, its Affiliates and Marketing Partners agree to cease the use of the Angioblast Logos; provided that (i) Cephalon, its Affiliates and Marketing Partners may continue to use any labels, package inserts and marketing materials in existence or on order as of the receipt of such notice and (ii) in such case, Cephalon’s obligation to include the Angioblast Logos on labels, package inserts and marketing materials for Product(s) shall terminate.

 

10.4         Registration of Trade Marks.  Angioblast shall have the right (but not the obligation) to file, register and maintain, for the Term, at Angioblast’s expense, appropriate registrations for the Existing Mark in each country of the Territory, as requested by Cephalon, in which Products are or will be sold.  Such registrations for the Existing Mark shall be obtained in Angioblast’s name, to the extent permitted by applicable Law in each country within the Territory.  In the event Angioblast elects not to file, register or maintain appropriate registrations for the Existing Mark in a country within the Territory in which Products are or will be sold, Angioblast shall provide Cephalon with written notice of such election within such reasonable time period necessary to preserve such right to file, register or maintain such registrations for the Existing Mark, and Cephalon shall have the right, at its option and expense, to file, register or maintain such registrations for the Existing Mark in such country on behalf of Angioblast, in Angioblast’s name, to the extent permitted by applicable Law in such country.

 

10.5         Ownership.  As between the Parties, Angioblast shall own, and is hereby assigned, all right, title and interest in and to (a) the Existing Mark and the Angioblast Logos throughout the Territory and (b) Cephalon shall own, and is hereby assigned all right, title and interest in and to the Product Marks throughout the Territory.

 

10.6         Recordation of Licenses.  In those countries where a trademark license must be recorded, Angioblast will provide to Cephalon, on Cephalon’s written request, a separate trademark license for the Existing Mark and Angioblast Logos and Cephalon will arrange for the recordation of such trade mark license with the appropriate governmental agency, at Cephalon’s expense, promptly following receipt of such license from Angioblast.  Cephalon shall cooperate in the preparation and execution of such documents.

 

	
**
    	
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.
    

 

42

 

10.7         Approval of Packaging and Promotional Materials.  Cephalon shall submit representative promotional materials, packaging and Products displaying the Product Marks and/or Angioblast’s trade name to Angioblast for Angioblast’s review and approval (which approval shall not be unreasonably withheld, conditioned or delayed) prior to the first use of such promotional materials, packaging or Products and prior to any subsequent change or addition to such promotional materials, packaging or Product; provided that if Angioblast has not responded within thirty (30) days  after the submission of such promotional materials, packaging or Product, Angioblast’s approval will be deemed to have been received.

 

ARTICLE XI
 REPRESENTATIONS, WARRANTIES AND COVENANTS

 

11.1        General Representations.  Each Party hereby represents and warrants to the other Party as of the Effective Date as follows:

 

(a)           Duly Organized.  Such Party is a corporation duly organized, validly existing and is in good standing under the laws of the jurisdiction of its incorporation, is qualified to do business and is in good standing as a foreign corporation in each jurisdiction in which the conduct of its business or the ownership of its properties requires such qualification and failure to have such would prevent such Party from performing its obligations under this Agreement; and

 

(b)           Due Execution; Binding Agreement.  This Agreement is a legal and valid obligation binding upon such Party and enforceable in accordance with its terms.  The execution, delivery and performance of this Agreement by such Party have been duly authorized by all necessary corporate action and do not and will not:  (i) require any consent or approval of its stockholders; (ii) to such Party’s actual knowledge, violate any Law, order, writ, judgment, decree, determination or award of any court, governmental body or administrative or other agency having jurisdiction over such Party; nor (iii) conflict with, or constitute a default under, any agreement, instrument or understanding, oral or written, to which such Party is a party or by which it is bound.  It has the full right and authority to grant the rights as provided herein and not previously granted any right, license or interest that is in conflict with the rights granted to the other Party under this Agreement.

 

11.2        Representations and Warranties of Angioblast.  Angioblast represents, warrants to Cephalon that, as of the Effective Date:

 

(a)           it has not received any written notice of any threatened claims of litigation seeking to invalidate or otherwise challenge the [**] or its rights therein;

 

	
**
    	
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.
    

 

43

 

(b)           to its Knowledge, there is no actual, pending, alleged or threatened (in writing) infringement, misappropriation or other unauthorized use by a Third Party of any of the [**] or the [**];

 

(c)           to its Knowledge, the issued [**] are valid and subsisting, and, to its Knowledge, there are no pending or threatened (in writing) interference, re-examination, opposition or cancellation proceedings involving the [**];

 

(d)           [**], Angioblast owns all right, title and interest in or licenses to each of the [**] identified in Exhibit 1.5 and of the [**] including the Patents [**].  By way of example and not by way of limitation, Angioblast represents and warrants that [**];

 

(e)           Angioblast owns all right, title and interest in and to [**] as of the Effective Date to select for MPCs;.

 

(f)            Angioblast has not received any formal or informal notice (in writing) of any claim that making, using, selling or importing (or having a Third Party conduct those activities) a [**] infringes, misappropriates or otherwise use without authorization any intellectual property right, including Patents, of any Third Party and, to the Knowledge of Angioblast, there is no basis for any such claim;

 

(g)           To its Knowledge, there are no written contracts, agreements, assignments and indemnities that affect Angioblast’s ownership of or ability to license (according to the terms herein), prosecute and/or enforce, any [**] to Cephalon in accordance with the terms and conditions hereof.  By way of example and not by way of limitation, Angioblast represents and warrants that to its Knowledge, [**] and also to its Knowledge that [**];

 

(h)           All registrations for [**] are in force, all applications to register Angioblast Patents are pending and all associated fees therefor are current;

 

(i)            To its Knowledge, Angioblast has the sole and exclusive right to bring actions for infringement or unauthorized use of the [**];

 

(j)            To its Knowledge, Angioblast is not in breach of any agreement affecting Angioblast’s ownership of or ability to license (according to the terms herein), prosecute and/or enforce, as applicable, the [**];

 

(k)           To its Knowledge, the subject matter of [**] have not been developed or otherwise invented using any funding or other resources provided by any governmental or regulatory authority or institution of higher education that would prevent Angioblast from granting to Cephalon the rights under the [**] according to the terms herein;

 

	
**
    	
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.
    

 

44

 

(l)            [**];

 

(m)          Angioblast has entered into agreements with employees, agents and other Third Parties sufficient to maintain the confidentiality of the [**] consistent with customs in the biopharmaceutical industry.  There is no breach or violation by Angioblast under, and, to the Knowledge of Angioblast, no breach or violation by any other party to, any such agreement that would have a material adverse affect on the value of the [**] (in its entirety).  Angioblast has taken adequate steps to prevent the unauthorized disclosure or use of all [**] consistent with customs in the biopharmaceutical industry, and to the Knowledge of Angioblast, all disclosure of such [**] has been made solely pursuant to written confidentiality agreements governing the use and disclosure thereof, except to the extent Angioblast was or is required to disclose such [**] in connection with making filings with any governmental or regulatory authority or would otherwise not have a material adverse effect on the value of the [**] (in its entirety);

 

(n)           [**];

 

(o)           [**]; and

 

(p)           [**].

 

11.3        Representations and Warranties of Cephalon.  Cephalon represents and warrants to Angioblast that, as of the Effective Date, it has the full right and authority to grant the rights granted herein.

 

11.4        DISCLAIMER.  EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT OR VALIDITY OF ANY PATENTS ISSUED OR PENDING.

 

ARTICLE XII
 INDEMNIFICATION

 

12.1        Indemnification by Cephalon.  Cephalon shall indemnify and hold harmless each of Angioblast and its Affiliates and the respective directors, officers and employees of such entities and the respective successors and assigns of any of the foregoing (the “Angioblast Indemnitees”), from and against any and all liabilities, damages, penalties, fines, costs and expenses (including, reasonable attorneys’ fees and other expenses of litigation) (collectively, “Liabilities”) from any claims, actions, suits or proceedings brought by a Third Party (a “Third Party Claim”) incurred by any Angioblast Indemnitee arising from or occurring as a result of: (a) the development,

 

	
**
    	
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.
    

 

45

 

manufacture, storage, handling, use, marketing, distribution, offer for sale, sale or promotion of the Products by or on behalf of Cephalon, its Affiliates or Marketing Partners; (b) any material breach of any representations, warranties or covenants given by Cephalon in ARTICLE XI above; or (c) the gross negligence or intentional misconduct of a Cephalon Indemnitee.  Cephalon’s obligation to indemnify the Angioblast Indemnitees pursuant to this Section 12.1 shall not apply to the extent any such Liabilities arise from: (i) the gross negligence or intentional misconduct of any Angioblast Indemnitee; or (ii) any breach by Angioblast of this Agreement.

 

12.2         Indemnification by Angioblast.  Angioblast shall indemnify and hold harmless each of Cephalon, its Affiliates and Marketing Partners and the respective directors, officers and employees of Cephalon, its Affiliates and Marketing Partners and the respective successors and assigns of any of the foregoing (the “Cephalon Indemnitees”), from and against any and all Liabilities from any Third Party Claims incurred by any Cephalon Indemnitee arising from or occurring as a result of: (a) the development, manufacture, storage, handling, or use of the Products (and any Commercialization of the Products post-termination of this Agreement) by or on behalf of Angioblast or its Affiliates or licensees (other than Cephalon, its Affiliates and Marketing Partners); (b) any material breach of any representations, warranties or covenants given by Angioblast in ARTICLE XI above; (c) such claims described in Exhibit 12.2; or (d) the gross negligence or intentional misconduct of a Angioblast Indemnitee.  Angioblast’s obligation to indemnify the Cephalon Indemnitees pursuant to this Section 12.2 shall not apply to the extent any such Liabilities arise from: (i) the gross negligence or intentional misconduct of any Cephalon Indemnitee; or (ii) any breach by Cephalon of this Agreement.

 

12.3         Procedure.  A Party that intends to claim indemnification under this ARTICLE XII (each, an “Indemnitee”) shall promptly notify the other Party (the “Indemnitor”) in writing of any Third Party Claim, in respect of which the Indemnitee intends to claim such indemnification, and the Indemnitor shall have sole control of the defense and/or settlement thereof.  The indemnity arrangement in this ARTICLE XII shall not apply to amounts paid in settlement of any action with respect to a Third Party Claim, if such settlement is effected without the consent of the Indemnitor, which consent shall not be withheld or delayed unreasonably.  The failure to deliver written notice to the Indemnitor within a reasonable time after the commencement of any action with respect to a Third Party Claim, if prejudicial to its ability to defend such action, shall relieve such Indemnitor of any liability to the Indemnitee under this ARTICLE XII, but the omission to so deliver written notice to the Indemnitor shall not relieve the Indemnitor of any liability that it may have to any Indemnitee otherwise than under this ARTICLE XII.  The Indemnitee under this ARTICLE XII shall cooperate fully with the Indemnitor and its legal representatives in the investigation of any action with respect to a Third Party Claim covered by this indemnification.

 

12.4         Limitation of Liability.  NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT 

 

	
**
    	
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.
    

 

46

 

DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.  NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 12.4 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 12.1 OR 12.2, OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF ITS CONFIDENTIALITY OBLIGATIONS IN ARTICLE VIII OR ARISING FROM A PARTY’S GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT (I.E., WILLFUL WRONGDOING OR OMISSION).

 

ARTICLE XIII
 TERM AND TERMINATION

 

13.1         Term.  This Agreement will commence upon the Effective Date and, except to the extent terminated pursuant to this ARTICLE XIII, shall continue in full force and effect on a Sub-Field-by-Sub-Field basis (i.e., for the Cardiovascular Field, CNS Field and Oncology Field) until none of Cephalon, its Affiliates or Marketing Partners is Developing or Commercializing a Product in the Territory in such Sub-Field.  In the event of an expiration of this Agreement the provisions of Paragraphs 1, 2 and 4 of Exhibit 13 shall apply.

 

13.2        Termination by Cephalon.

 

(a)           Termination of the Agreement in its Entirety.  Cephalon may terminate this Agreement in its entirety upon [**] written notice to Angioblast referencing this Section 13.2(a) and specifying that it is terminating this Agreement in its entirety.  In the event of such termination the provisions of Paragraphs 1, 2, 3, 4 and 5 of Exhibit 13 shall apply.

 

(b)           Termination with respect to a Sub-Field.  Cephalon may terminate this Agreement as to a particular Sub-Field in its entirety upon [**] written notice to Angioblast referencing this Section 13.2(b) and specifying the Sub-Field for which this Agreement is terminated.  In the event of such termination the provisions of Paragraphs 1, 2, 3, 4 and 6 of Exhibit 13 shall apply.

 

(c)           Termination with respect to a Region.  Cephalon may terminate this Agreement as to a particular Region in its entirety upon [**] written notice to Angioblast referencing this Section 13.2(c) and specifying the Region for which this Agreement is terminated.  In the event of such termination the provisions of Paragraphs 1, 2, 3, 4 and 7 of Exhibit 13 shall apply.

 

13.3        Termination by Angioblast.

 

	
**
    	
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.
    

 

47

 

(a)           Cardiovascular Field with respect to a Region.  Angioblast may terminate this Agreement as to the Cardiovascular Field with respect to a particular Region for the failure of Cephalon to achieve the following:

 

(i)    with respect to the [**], to Initiate a [**] Clinical Trial or [**] Clinical Trial for the Cardiovascular Product for use in either [**] of (A) the determination of the JSC to proceed pursuant to Section 4.4(b) above and (B) the satisfaction of all conditions precedent pursuant to Section 4.4(c) above, whichever occurs later, and thereafter use commercially reasonable efforts to continue such trial to completion in a timely manner in accordance with the protocol approved by the JSC therefor and to file for and prosecute an MAA with the [**] for such Cardiovascular Product for use in such indication subject to such [**] Clinical Trial or [**] Clinical Trial;

 

(ii)   with respect to [**], to Initiate a [**] Clinical Trial or Phase 3 Clinical Trial for the Cardiovascular Product for use in either [**] in Europe within [**] of (A) the determination of the JSC to proceed pursuant to Section 4.4(b) above and (B) the satisfaction of all conditions precedent pursuant to Section 4.4(c) above, whichever occurs later, and thereafter use commercially reasonable efforts to continue such trial to completion in a timely manner in accordance with the protocol approved by the JSC therefor and to file for and prosecute an MAA with the EMA for such Cardiovascular Product for use in such indication subject to such Phase 2b Clinical Trial or Phase 3 Clinical Trial;

 

(iii)  with respect to [**], to schedule and meet with the [**], during the time the [**] Clinical Trial or [**] Clinical Trial is being conducted for the Cardiovascular Product for use in either [**] in either the [**], to establish a plan for clinical development of such Cardiovascular Product to support Marketing Approval therefor in [**] and to use commercially reasonable efforts to Initiate such clinical development [**] of obtaining Marketing Approval from the [**] with respect to such Cardiovascular Product for use in either [**] in accordance with the established plan therefor.

 

Without limiting the foregoing, the right of Angioblast to terminate the Agreement pursuant to this Section 13.3(a) shall expire (I) with respect to subsections (i) and (ii), the earlier of (A) obtaining Marketing Approval from the [**], as applicable, with respect to such Cardiovascular Product for use in either [**] or (B) generation of data resulting from the Phase 2b Clinical Trial or Phase 3 Clinical Trial for the Cardiovascular Product for use in each of [**], as applicable, that does not support the filing for or obtaining Marketing Approval therefor, whether determined by the JSC pursuant to Section 4.4(b) or the [**], as applicable; and (II) with respect to subsection (iii), the earlier of (C) expiration of the right of Angioblast to terminate under subsections (i) and (ii) pursuant to clause (B) of this paragraph or (D) Initiation of such clinical development for [**] of the Cardiovascular Product for use in either [**] in accordance with the established plan therefor.  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.
    

 

48

 

addition, the right of Angioblast to terminate the Agreement pursuant to this Section 13.3(a)(i) and (ii) shall expire in both cases with respect to the Cardiovascular Product for use in one of such indications (i.e., [**]) in the event either right of termination pursuant to this Section 13.3(a)(i) or (ii) expires pursuant to clause (B) of this paragraph; and for clarity, the right of Angioblast to terminate the Agreement pursuant to this Section 13.3(a)(i) or (ii) shall remain in force and effect with respect to the Cardiovascular Product for use in the other indication.  For example, if a [**] Clinical Trial or [**] Clinical Trial for the Cardiovascular Product does not support filing for or obtaining Marketing Approval for one of either congestive heart failure or acute myocardial infarction, in either the United States or Europe, then Cephalon’s obligation to Initiate a [**] Clinical Trial or [**] Clinical Trial for the Cardiovascular Product in the [**] under Section 13.3(a)(i) or (ii), as applicable, shall be for the other indication.

 

Such termination shall be effective upon [**] written notice to Cephalon referencing this Section 13.3(a) and specifying it is terminating this Agreement with respect to the Cardiovascular Field in the applicable Region in its entirety; unless, to the extent Cephalon’s failure to meet any of the requirements under this Section 13.3(a) can be cured, Cephalon submits to Angioblast a plan setting forth specific actions to be performed by Cephalon to cure such failure within such thirty (30) days’ period, and actively and diligently pursues such plan to cure such failure within one hundred eighty (180) days from Angioblast’s receipt thereof.  If Cephalon complies with the previous sentence and does so cure, then the termination notice shall have no effect.  In the event of such termination the provisions of Paragraphs 1, 2, 3, 4 and 8 of Exhibit 13 shall apply.

 

(b)           CNS Field.  Angioblast may terminate this Agreement as to the CNS Field in its entirety for the failure of Cephalon to achieve the following: (i) to request Angioblast to conduct [**] Clinical Trial for the CNS Product for use in an indication in the CNS Field pursuant to Section 4.3(a)(i) above or (ii) to Initiate at least one [**] Clinical Trial or [**] Clinical Trial for the CNS Product for use in such indication in the CNS Field [**] of (A) the determination of the JSC to proceed pursuant to Section 4.4(b) above and (B) the satisfaction of all conditions precedent pursuant to Section 4.4(c) above, whichever occurs later.  Without limiting the foregoing, the right of Angioblast to terminate the Agreement pursuant to this Section 13.3(b) shall expire upon the earlier to occur of (I) the [**] Clinical Trial for the CNS Product for use in the CNS Field pursuant to Section 4.3(a)(i) above is unsuccessful as determined by the JSC or (B) Initiation of a [**] Clinical Trial or [**] Clinical Trial as described in clause (ii) of this Section 13.3(b).  Such termination shall be effective upon [**] written notice to Cephalon referencing this Section 13.3(b) and specifying it is terminating this Agreement with respect to the CNS Field in its entirety; unless, to the extent Cephalon’s failure to meet any of the requirements under this Section 13.3(b) can be cured, Cephalon submits to Angioblast a plan setting forth specific actions to be performed by Cephalon to cure such failure [**], and actively and diligently pursues such plan to cure such failure [**] from Angioblast’s receipt thereof.  If Cephalon complies with the previous sentence and does so 

 

	
**
    	
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.
    

 

49

 

cure, then the termination notice shall have no effect.  In the event of such termination the provisions of Paragraphs 1, 2, 3, 4 and 6 of Exhibit 13 shall apply.

 

(c)           Termination for Patent Challenge.  Angioblast may terminate this Agreement at any time if Cephalon or any of its Affiliates or Marketing Partners commence, participate in or actively support or directly or indirectly (except to the extent required by applicable Law) assist in any way any challenge to the validity, ownership, enforceability or scope of any Patents within the Angioblast Patents (a “Patent Challenge”) in any court or before any governmental authority with authority to determine the validity, ownership, enforceability or scope of such Patents, or cause or request a review of the same by any such court or governmental authority.  Such termination shall be effective thirty (30) days after written notice by Angioblast to Cephalon referencing this Section 13.3(c), unless Cephalon, within such thirty (30) days, causes such Patent Challenge to terminate prior to any determination by the applicable governmental authority adverse to the Patents and takes no other actions to facilitate such challenge; provided, however, that if any delay in such termination is caused by delay by Angioblast or its Affiliate in a Patent Challenge proceeding, such thirty (30)-day period shall be extended for the delay caused by Angioblast or its Affiliate.  In the event of such termination the provisions of Paragraphs 1, 2, 3, 4 and 5 of Exhibit 13 shall apply.

 

(d)           Sole Termination Rights.  The termination rights contained in this Section 13.3 shall be the sole termination rights of Angioblast under this Agreement.

 

ARTICLE XIV
 DISPUTE RESOLUTION

 

14.1         Dispute Resolution.  The Parties agree that any dispute arising with respect to the interpretation, enforcement, termination or invalidity of this Agreement, or the failure of the JSC or any Subcommittee to reach unanimous agreement on any issue within its respective authority under this Agreement, any alleged failure to perform, or breach of, this Agreement, or any issue relating to the interpretation or application of this Agreement (each a “Dispute”), shall first be resolved through the procedures set forth in this ARTICLE XIV.

 

14.2         Committee Disputes.  Disputes as to matters within the authority of the JSC or any Subcommittee will be resolved as set forth in Paragraph of Exhibit 3.1; provided that any dispute as to the application of such Paragraph of Exhibit 3.1 shall be subject to the provisions of this ARTICLE XIV.

 

14.3         Other Disputes.  Other than those Disputes resolved as described in Section 14.2 (each, an “Other Dispute”) shall be subject to the provisions of this Section 14.3.

 

	
**
    	
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.
    

 

50

 

(a)           Initial Escalation.  With respect to all Other Disputes, if the Parties are unable to resolve any such Other Dispute [**] after such Other Dispute is first identified by either Party in writing to the other, either Party shall have the right to refer such Other Dispute to the Senior Executives for attempted resolution by written notice to the other Party referencing the particular Other Dispute and this Section 14.3(a).  In such case, the Senior Executives shall conduct good faith negotiations and seek to resolve the Other Dispute [**] after such notice is received, including having at least one (1) in person meeting of the Senior Executive [**] after such notice is received.  If the Senior Executive officers resolve such Other Dispute, a memorandum setting forth their agreement to resolve the Other Dispute will be prepared and signed by both Parties if requested by either Party.  In all events, the Parties shall cooperate in an effort to limit the issues for consideration in such manner as narrowly as reasonably practicable in order to resolve the Other Dispute.

 

(b)           Binding Arbitration.  If the Senior Executive are not able to resolve such Other Dispute referred to them under Section 14.3(a) within such [**], such Other Dispute shall be resolved through binding arbitration, which arbitration may be initiated by either Party by written notice to the other Party referencing the particular Other Dispute and this Section 14.3(b) at any time after the conclusion of such period, on the following basis:

 

(i)    The place of arbitration shall be New York, New York and all proceedings and communications shall be in English.

 

(ii)   The arbitration shall be administered by JAMS pursuant to the Comprehensive Arbitration Rules and Procedures of JAMS then in effect (the “JAMS Rules”).

 

(iii)  The arbitration shall be conducted by a single arbitrator mutually agreed by the Parties, or if the Party’s are unable to agree on a single arbitrator, then a panel of three arbitrators.  In each case, the arbitrators shall be neutral, independent individuals with experience in the pharmaceutical business related to the matter of the Other Dispute.  Within thirty (30) days after the notice initiating the arbitration, each Party shall appoint one arbitrator meeting the foregoing criteria by written notice to the other Party and the two Party-appointed arbitrators shall select the third arbitrator within thirty (30) days of their appointment.  If the Party-appointed arbitrators are unable to agree upon the third arbitrator, the third arbitrator shall be appointed by JAMS.

 

(iv)  Judgment upon the award rendered by such arbitrator(s) shall be binding on the Parties and may be entered by any court or forum having jurisdiction.

 

(v)   Either Party may apply to the arbitrator(s) for interim injunctive relief until the arbitration award is rendered or the controversy is otherwise resolved.  Further, either Party also may, without waiving any remedy under this Agreement, seek from any court having 

 

	
**
    	
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.
    

 

51

 

jurisdiction any injunctive or provisional relief necessary to protect the rights or property of such Party pending the arbitration award.

 

(vi)  The arbitrator(s) shall have no authority to award punitive or any other type of damages not measured by a Party’s compensatory damages; except as allowed under Section 12.4.

 

(vii) Each Party shall bear its own costs and expenses and attorneys’ fees and an equal share of the arbitrator(s)’ and any administrative fees of arbitration, unless the arbitrator(s) determine that a Party has incurred unreasonable expenses due to vexatious or bad faith position taken by the other Party, in which event, the arbitrator may make an award of all or any portion of such expense so incurred.

 

(viii) Reasons for the arbitrators’ decision should be complete and explicit, including determinations of law and fact.  The written reasons should also include the basis for any damages awarded and a statement of how the damages were calculated.  Such written decision should be rendered by the arbitrator(s) following a full comprehensive hearing, as soon as practicable but in no event later than [**] following the selection of the arbitrator(s) under Section 14.3(b)(iii).

 

(ix)   Except to the extent necessary to confirm an award or as may be required by law, neither Party nor any arbitrator may disclose the existence, content, or results of an arbitration without the prior written consent of both Parties.

 

(x)    In no event shall an arbitration be initiated after the date when commencement of a legal or equitable proceeding based on the dispute, controversy or claim would be barred by the applicable statute of limitations; provided that such limitation shall be tolled as of the date a Party notifies the other Party of such Other Dispute pursuant to this ARTICLE XIV.

 

14.4         Patent and Trademark Dispute Resolution.   Any dispute, controversy or claim relating to the ownership, scope, validity, enforceability or infringement of any Patent rights covering the manufacture, use or sale of any Product or of any trademark rights relating to any Product shall be submitted to a court of competent jurisdiction in which such Patent or trademark rights were granted or arose.

 

14.5         Interim Relief.  Notwithstanding anything in this ARTICLE XIV to the contrary, Angioblast and Cephalon shall each have the right to apply to any court of competent jurisdiction for appropriate interim or provisional relief, as necessary to protect the rights or property of that Party, pending the selection of the arbitrator or arbitrator’s determination of the merits of any Dispute.

 

	
**
    	
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.
    

 

52

 

ARTICLE XV
 GENERAL PROVISIONS

 

15.1         Force Majeure.  A Party shall be excused from the performance of its obligations under this Agreement to the extent that such performance is prevented by force majeure and the nonperforming Party promptly provides notice of the prevention to the other Party referencing this Section 15.1.  Such excuse shall be continued so long as the condition constituting force majeure continues and the nonperforming Party takes reasonable efforts to remove the condition.  For purposes of this Agreement, force majeure shall include conditions beyond the control of the affected Party, including without limitation, an act of God, war, civil commotion, terrorist act, labor strike or lock-out, epidemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe, and failure of plant or machinery (provided that such failure could not have been prevented by the exercise of skill, diligence, and prudence that would be reasonably and ordinarily expected from a skilled and experienced person engaged in the same type of undertaking under the same or similar circumstances).  Notwithstanding the foregoing, a Party shall not be excused from making payments owed hereunder because of a force majeure affecting such Party.

 

15.2         Governing Law; Venue.  This Agreement and all questions regarding its validity or interpretation, or the breach or performance of this Agreement, shall be governed by, and construed and enforced in accordance with, the laws of the State of New York, without reference to conflict of law principles.

 

15.3         Waiver of Breach.  Except as otherwise expressly provided in this Agreement, any term or condition of this Agreement may be waived only by a written instrument executed by a duly authorized representative of the Party waiving compliance.  The delay or failure of either Party at any time to require performance of any provision of this Agreement shall in no manner affect such Party’s rights at a later time to enforce the same.  No waiver by either Party of any condition or term in any one or more instances shall be construed as a further or continuing waiver of such condition or term or of another condition or term.

 

15.4         Modification.  No amendment or modification of any provision of this Agreement shall be effective unless in writing signed by a duly authorized representative of each Party.  No provision of this Agreement shall be varied, contradicted or explained by any oral agreement, course of dealing or performance or any other matter not set forth in an agreement in writing and signed by a duly authorized representative of each Party.

 

15.5         Severability.  In the event any provision of this Agreement should be held invalid, illegal or unenforceable in any jurisdiction, the Parties shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties and all 

 

	
**
    	
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.
    

 

53

 

other provisions of this Agreement shall remain in full force and effect in such jurisdiction.  Such invalidity, illegality or unenforceability shall not affect the validity, legality or enforceability of such provision in any other jurisdiction.

 

15.6         Entire Agreement.  This Agreement (including the Exhibits attached hereto), Joint Interest Agreement(s), Joint Defense Agreement(s), Supply Agreement(s) and Quality Agreement(s) (in each case, once entered into) constitutes the entire agreement between the Parties relating to its subject matter and supersedes all prior or contemporaneous agreements, understandings or representations, either written or oral, between Angioblast and Cephalon with respect to such subject matter, including, without limitation, the Prior Confidentiality Agreement.  The foregoing shall not be interpreted as a waiver of any remedies available to either Party as a result of any breach, prior to the Effective Date, by the other Party of its obligations pursuant to the Prior Confidentiality Agreement.  For clarity, this Agreement and the Stock Purchase Agreement are independent.

 

15.7         Notices.  Unless otherwise agreed by the Parties or specified in this Agreement, all communications between the Parties relating to, and all written documentation to be prepared and provided under, this Agreement shall be in the English language.  Any notice required or permitted under this Agreement shall be in writing in the English language:  (a) delivered personally; (b) sent by registered or certified mail (return receipt requested and postage prepaid); (c) sent by express courier service providing evidence of receipt, postage pre-paid where applicable; or (d) sent by facsimile (receipt verified and a copy promptly sent by another permissible method of providing notice described in paragraphs (b), (c) or (d) above), to the following addresses of the Parties or such other address for a Party as may be specified by like notice:

 

	
To   Angioblast: 
    	
 
    	
To   Cephalon: 
    
	
 
    	
 
    	
 
    
	
Angioblast   Systems Inc.
   275 Madison Ave 4th floor 
   New York City, NY 10016 
   phone:  212-880-2060 
   Fax : 212-880-2061 
   Attention Michael Schuster
    	
 
    	
Cephalon, Inc.
   41 Moores Road
   Frazer, PA 19355
   Telephone: (610) 738-6337 
   Facsimile: (610) 738-6258 
   Attention: General Counsel
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
With   a copy to: 
    	
 
    	
With   a copy to: 
    
	
 
    	
 
    	
 
    
	
Wilson,   Sonsini, Goodrich & Rosati 
   650 Page Mill Road 
   Palo Alto, CA 94304 
   Telephone: (650) 493-9300 
    	
 
    	
Sidley   Austin LLP 
   One South Dearborn Street 
   Chicago, IL 60603 
   Telephone: (312) 853-7000 
    

 

	
**
    	
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.
    

 

54

 

	
Facsimile:   (650) 493-6811 
    	
 
    	
Facsimile:   (312) 853-7036 
    
	
Attention:   Ian B. Edvalson
    	
 
    	
Attention :   Pran Jha
    

 

Any notice required or permitted to be given concerning this Agreement shall be effective upon receipt by the Party to whom it is addressed or within five (5) Business Days of dispatch whichever is earlier.

 

15.8         Assignment.  This Agreement shall not be assignable by either Party to any Third Party hereto without the written consent of the other Party hereto; except either Party may assign this Agreement without the other Party’s consent to an entity that acquires substantially all of the business or assets of the assigning Party, whether by merger, acquisition (of assets or stock) or otherwise, provided that the Party to whom this Agreement is assigned assumes this Agreement in writing or by operation of law.  In addition, either Party shall have the right to assign this Agreement to an Affiliate, in whole or in part, upon written notice to the non-assigning Party; provided that the assigning Party guarantees the performance of this Agreement by such Affiliate; and further provided that no such assignment shall relieve Cephalon of its obligations to make payments to Angioblast in accordance with the terms of this Agreement.  Notwithstanding the foregoing, if the non-assigning Party reasonably believes such assignment to an Affiliate could result in material adverse tax consequences to the non-assigning Party, such assignment shall not be made without the non-assigning Party’s consent.  Subject to the foregoing, this Agreement shall inure to the benefit of each Party, its successors and permitted assigns.  Any assignment of this Agreement in contravention of this Section 15.8 shall be null and void.  In the event of any assignment-in-part as permitted under this Section 15.8, the Parties shall agree to amend this Agreement or enter into a separate agreement to clarify the rights and obligations of the Parties as a result of such assignment-in-part.

 

15.9         No Partnership or Joint Venture.  Nothing in this Agreement is intended, or shall be deemed, to establish a joint venture or partnership between Angioblast and Cephalon.  Neither Party to this Agreement shall have any express or implied right or authority to assume or create any obligations on behalf of, or in the name of, the other Party, or to bind the other Party to any contract, agreement or undertaking with any Third Party.

 

15.10       No Third Party Beneficiaries.  Except for the rights to indemnification provided for certain Third Parties as specified in ARTICLE XII, all rights, benefits and remedies under this Agreement are solely intended for the benefit of Angioblast and its Affiliates and Cephalon and its Affiliates, and except for such rights to indemnification expressly provided pursuant to ARTICLE XII, no Third Party shall have any rights whatsoever to (i) enforce any obligation contained in this Agreement (ii) seek a benefit or remedy for any breach of this Agreement, or (iii) take any other action relating to this Agreement under any legal theory, including but not limited to, actions in contract, tort (including but not limited to, negligence, gross negligence and strict liability), or as a defense, setoff or counterclaim to any action or claim brought or made by either Party.

 

	
**
    	
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.
    

 

55

 

15.11       Export Laws.  Notwithstanding anything to the contrary contained herein, all obligations of Angioblast and Cephalon are subject to prior compliance with the export regulations of the United States or any other relevant country and such other Laws in effect in the United States, or any other relevant country as may be applicable, and to obtaining all necessary approvals required by the applicable agencies of the governments of the United States and any other relevant countries.  Angioblast and Cephalon shall cooperate with each other and shall provide assistance to the other as reasonably necessary to obtain any required approvals.

 

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

 

[The remainder of this page left blank intentionally; signature page follows immediately behind.]

 

	
**
    	
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.
    

 

56

 

EXECUTION COPY
 CONFIDENTIAL

 

IN WITNESS WHEREOF, the Parties have executed this Agreement by their duly authorized representatives as of the Effective Date.

 

	
ANGIOBLAST SYSTEMS INC.
    	
CEPHALON   INC.
    
	
 
    	
 
    
	
 
    	
 
    
	
By:
    	
 
    	
 
    	
By:
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
 
    	
 
    	
Name:
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
 
    	
 
    	
Title:
    	
 
    

 

	
**
    	
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.
    

 

57

 

EXHIBIT 13
 EFFECTS OF EXPIRATION OR TERMINATION

 

1.             Accrued Obligations.  Expiration or termination of this Agreement for any reason, whether in its entirety or in any part, shall not release either Party from any obligation or liability which, at the time of such expiration or termination, has already accrued to the other Party or which is attributable to a period prior to such expiration or termination.

 

2.             Non-Exclusive Remedy.  Notwithstanding anything herein to the contrary, termination of this Agreement, in its entirety or in part, by a Party shall be without prejudice to other remedies such Party may have at law or equity under this Agreement.

 

3.             Termination Press Releases.  In the event of termination of this Agreement for any reason, in its entirety or in any part, the Parties shall cooperate in good faith to coordinate public disclosure of such termination and the reasons therefor, and shall not, except to the extent required by applicable Law or the rules of a recognized stock exchange disclose such information without the prior approval of the other Party, such approval not to be unreasonably withheld, conditioned or delayed.  To the extent possible under the situation, the terminating Party shall provide the non-terminating Party with a draft of any such public disclosure it intends to issue five (5) Business Days in advance and with the opportunity to review and comment on such statement, it being understood that if the non-terminating Party does not notify the terminating Party in writing within such five (5) Business Day period (or such shorter period if required by applicable Law or and the rules of a recognized stock exchange in each case as notified to the non-terminating Party in writing) of any reasonable objections, such disclosure shall be deemed approved, and in any event the Parties shall work diligently and reasonably to agree on the text of any such proposed disclosure in an expeditious manner.  The principles to be observed in such disclosures shall be accuracy, compliance with applicable Law and regulatory guidance documents, reasonable sensitivity to potential negative reactions to such news and the need to keep investors and others informed regarding the Parties’ business and other activities.  Accordingly in such situation, neither Party shall withhold, condition or delay its approval of a proposed disclosure that complies with such principles.

 

4.             General Survival.  The following provisions of this Agreement, shall survive expiration or termination of this Agreement in its entirety for any reason:  [**] of the Agreement.  Except as otherwise expressly provided in this Exhibit 13, all rights and obligations of the Parties under this Agreement shall terminate upon expiration or termination of this Agreement in its entirety for any reason.

 

	
**
    	
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.
    

 

58

 

5.             Certain Terminations of this Agreement in its Entirety.  This Paragraph 4 shall apply upon any termination of this Agreement in its entirety pursuant to Section 13.2(a) or 13.3(c).

 

(a)           Ongoing Trials.  If there are any ongoing clinical trials with respect to Products being conducted by or on behalf of Cephalon (or its Affiliates or Marketing Partners) at the time of notice of termination, Cephalon agrees, as requested by Angioblast, to (i) promptly transition to Angioblast or its designee some or all of such clinical trials and the activities related to or supporting such trials (ii) continue to conduct such clinical trials for a period requested by Angioblast up to a maximum of six (6) months after the effective date of such termination, or (iii) terminate such clinical trials as expeditiously as practicable in consultation with the applicable institutional review board (or equivalent).  In such event, Cephalon shall be responsible for the costs of such transition.

 

(b)           Commercialization.  To avoid a disruption in the supply of Products to patients, if the Agreement is terminated after the first commercial sale of any Product in the Territory, Cephalon, its Affiliates and its Marketing Partners shall continue to distribute the Products in each country of the Territory for which Marketing Approval therefor has been obtained, in accordance with the terms and conditions of this Agreement, until the date on which Angioblast notifies Cephalon in writing that Angioblast has secured an alternative distributor or licensee for the Products in such country, but in no event more for than twenty-four (24) months after the effective date of any termination of this Agreement, in whole or in part (the “Wind-down Period”); provided that Cephalon, its Affiliates and its Marketing Partners shall cease such activities, or any portion thereof, in a given country upon sixty (60) days’ notice by Angioblast requesting that such activities (or portion thereof) be ceased.  Notwithstanding any other provision of this Agreement, during the Wind-down Period, Cephalon’s and its Affiliates’ and Marketing Partners’ rights with respect to the Products in the Territory shall be non-exclusive and, without limiting the foregoing, Angioblast shall have the right to engage one or more other distributor(s) and/or licensee(s) of any Products in all or part of the Territory.  Any Products sold or disposed by Cephalon in the Territory during the Wind-down Period shall be subject to applicable payment obligations under ARTICLE VI above.  Within thirty (30) days of expiration of the Wind-down Period, Cephalon shall, upon the request of Angioblast, transfer to Angioblast or its designee, all Products and BMT MPCs in its inventory at the provisional transfer price therefor (as set forth in Paragraph 2 of Exhibit 6.3).

 

(c)           Assignment of Regulatory Materials.  At Angioblast’s request,  Cephalon shall assign or cause to be assigned to Angioblast or its designee (or to the extent not so assignable, Cephalon shall take all reasonable actions to make available to Angioblast or its designee the benefits of) all Regulatory Materials for all Products in the Territory, including any such Regulatory Materials owned by Cephalon’s Affiliates and/or Marketing Partners.  In addition, Cephalon shall promptly provide to Angioblast a copy of all Data and other Cephalon Know-How pertaining to all 

 

	
**
    	
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.
    

 

59

 

Products to the extent not previously provided to Angioblast and Angioblast shall have the right to use and disclose all Data and Cephalon Know How pertaining to such Products following termination of this Agreement.

 

(d)           Marketing Partners.  If requested by Angioblast, any contracts with Marketing Partners of any Products in the Territory engaged by Cephalon other than Cephalon’s Affiliates shall be assigned to Angioblast to the extent Cephalon has the right to do so.  In the event such assignment is not requested by Angioblast or Cephalon does not have the right to do so, then the rights of such Marketing Partners shall terminate upon termination of Cephalon’s rights with respect to the Territory.  Cephalon shall ensure that its Affiliates and such Marketing Partners (if not assigned to Angioblast pursuant to this Paragraph 5(d)) shall transition all Products back to Angioblast in the manner set forth in this Paragraph 4 as if such Affiliate or Marketing Partner were named herein.

 

(e)           Return of Materials.  Within thirty (30) days after the end of the Wind-down Period and without limiting the last sentence of Paragraph 4(b), Cephalon shall either transfer to Angioblast or destroy all tangible items related to the Products including those comprising, bearing or containing any Existing Mark, Product Mark, the Angioblast Logos, Data, photographs, samples, literature, sales and promotional aids and all Confidential Information of Angioblast, that is in Cephalon’s, its Affiliates (or subject to Paragraph 4(d) its Marketing Partners’) possession.  Effective upon the end of the Wind-down Period, Cephalon shall:  (i) cease to use all Existing Marks and Product Marks, and all rights granted to Cephalon hereunder with respect to the Products in the Territory shall terminate; and (ii) assign or cause to be assigned to Angioblast or its designee all right, title and interest in and to the Existing Marks (to the extent such Existing Marks are not maintained in Angioblast’s name) and Product Marks in the Territory.  In addition, all Data generated by or on behalf of Cephalon hereunder during the Term shall, to the extent it specifically pertains to the Products, be deemed Confidential Information of Angioblast and not Confidential Information of Cephalon (and will not be subject to the exclusion under Section 8.1(a) or 8.1(e)).

 

(f)            Transition.  Without limiting the foregoing provisions of this Paragraph 4, Cephalon shall cooperate with Angioblast and/or its designee to effect a smooth and orderly transition in the Development and Commercialization of the Cardiovascular Products and CNS Products and Development, processing and Commercialization of Expanded HPCs in the Territory during the Wind-down Period.  Without limiting the foregoing, Cephalon shall use commercially reasonable efforts to conduct in an expeditious manner any activities to be conducted under this Paragraph 4.  Upon transition of such Development and Commercialization of the Products, Angioblast shall assume all liabilities and obligations resulting from the Development and Commercialization of the Products, including, but not limited to, all liabilities and obligations under any contracts with Marketing Partners assigned to Angioblast pursuant to Paragraph 5.d, that accrue on or after the date of assignment of the obligations of Cephalon under this Paragraph 5; provided, however, that Cephalon shall remain responsible for all liabilities and obligations resulting from 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.
    

 

60

 

Development and Commercialization of the Products, including, but not limited to, all liabilities and obligations under any contracts with Marketing Partners assigned to Angioblast pursuant to Paragraph 5.d, that accrue prior to such date of assignment of this Paragraph 5.

 

6.            Certain Terminations of this Agreement with respect to a Sub-Field/Product.  This Section 5(f) shall apply upon any termination of this Agreement with respect to a particular Sub-Field pursuant to Sections 13.2(b) and 13.3(b).

 

(a)           Exclusion of Sub-Field/Product.  Effective upon such termination of this Agreement with respect to a particular Sub-Field (the “Excluded Sub-Field”), (i) the Excluded Sub-Field shall be excluded from the definition of Field for all purposes of this Agreement and the associated Products (i.e., if the Excluded Sub-Field is the Cardiovascular Field, then the Cardiovascular Products; if the Excluded Sub-Field is the Oncology Field, then the Expanded HPCs; or if the Excluded Sub-Field is the CNS Field, then the CNS Products, in each case the “Excluded Products”) shall be excluded from the definition of Product for all purposes of this Agreement.  Each Party’s rights and obligations under this Agreement with respect to the Excluded Sub-Field and Excluded Products, except to the extent otherwise set forth in this Exhibit 13 and Paragraph 6, shall terminate.  Accordingly and without limiting the foregoing, Cephalon’s rights under Section 2.1 with respect to the Excluded Products and Excluded Sub-Field shall terminate.

 

(b)           Ongoing Trials.  If there are any ongoing clinical trials with respect to Excluded Products being conducted by or on behalf of Cephalon (or its Affiliates or Marketing Partners) at the time of notice of termination, Cephalon agrees, as requested by Angioblast, to (i) promptly transition to Angioblast or its designee some or all of such clinical trials and the activities related to or supporting such trials (ii) continue to conduct such clinical trials for a period requested by Angioblast up to a maximum of six (6) months after the effective date of such termination, or (iii) terminate such clinical trials as expeditiously as practicable in consultation with the applicable institutional review board (or equivalent).  In such event, Cephalon shall be responsible for the costs of such transition.

 

(c)           Commercialization.  To avoid a disruption in the supply of Excluded Products to patients, if the Agreement is terminated after the first commercial sale of any Excluded Product in the Territory, Cephalon, its Affiliates and its Marketing Partners shall continue to distribute the Excluded Products in each country of the Territory for which Marketing Approval therefor has been obtained, in accordance with the terms and conditions of this Agreement, during the Wind-down Period; provided that Cephalon, its Affiliates and its Marketing Partners shall cease such activities, or any portion thereof, in a given country upon sixty (60) days’ notice by Angioblast requesting that such activities (or portion thereof) be ceased.  Notwithstanding any other provision of this Agreement, during the Wind-down Period, Cephalon’s and its Affiliates’ and Marketing Partners’ rights with respect to the Excluded Products in the Territory shall be non-exclusive and, without 

 

	
**
    	
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.
    

 

61

 

limiting the foregoing, Angioblast shall have the right to engage one or more other distributor(s) and/or licensee(s) of any Excluded Products in all or part of the Territory.  Any Excluded Products sold or disposed by Cephalon in the Territory during the Wind-down Period shall be subject to applicable payment obligations under ARTICLE VI above.  Within thirty (30) days of expiration of the Wind-down Period, Cephalon shall, upon the request of Angioblast, transfer to Angioblast or its designee, all Excluded Products or BMT MPCs (if applicable) in its inventory at the provisional transfer price therefor (as set forth in Paragraph 2(c) of Exhibit 6.3).

 

(d)           Assignment of Regulatory Materials.  At Angioblast’s request,  Cephalon shall assign or cause to be assigned to Angioblast or its designee (or to the extent not so assignable, Cephalon shall take all reasonable actions to make available to Angioblast or its designee the benefits of) all Regulatory Materials for all Excluded Products in the Territory, including any such Regulatory Materials owned by Cephalon’s Affiliates and/or Marketing Partners.  In addition, Cephalon shall promptly provide to Angioblast a copy of all Data and other Cephalon Know-How pertaining to all Excluded Products to the extent not previously provided to Angioblast and Angioblast shall have the right to use and disclose all Data and Cephalon Know How pertaining to such Excluded Products following termination of this Agreement with respect to such Excluded Product.

 

(e)           Marketing Partners.  If requested by Angioblast, any contracts with Marketing Partners of any Excluded Products in the Territory engaged by Cephalon other than Cephalon’s Affiliates shall be assigned to Angioblast to the extent Cephalon has the right to do so.  In the event such assignment is not requested by Angioblast or Cephalon does not have the right to do so, then the rights of such Marketing Partners shall terminate upon termination of Cephalon’s rights with respect to the Excluded Products.  Cephalon shall ensure that its Affiliates and such Marketing Partners (if not assigned to Angioblast pursuant to this Paragraph 6.e shall transition all Excluded Products back to Angioblast in the manner set forth in this Paragraph 6 as if such Affiliate or Marketing Partner were named herein.

 

(f)            Return of Materials.  Within thirty (30) days after the end of the Wind-down Period and without limiting the last sentence of Paragraph 6.c, Cephalon shall either transfer to Angioblast or destroy all tangible items related to the Excluded Products including those comprising, bearing or containing any Existing Mark, Product Mark, the Angioblast Logos, Data, photographs, samples, literature, sales and promotional aids and all Confidential Information of Angioblast, that is in Cephalon’s, its Affiliates (or subject to Paragraph 6.e its Marketing Partners’) possession, in each case solely and specifically with respect to the Excluded Product.  Effective upon the end of the Wind-down Period, Cephalon shall:  (i) cease to use all Existing Marks and Product Marks specific to the Excluded Products (the “Excluded Marks”), and all rights granted to Cephalon hereunder with respect to the Excluded Products in the Territory shall terminate; and (ii) assign or cause to be assigned to Angioblast or its designee all right, title and interest in and to the Excluded Marks in 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.
    

 

62

 

Territory.  In addition, all Data generated by or on behalf of Cephalon hereunder during the Term shall, to the extent it specifically pertains to the Excluded Products, be deemed Confidential Information of Angioblast and not Confidential Information of Cephalon (and will not be subject to the exclusion under Section 8.1(a) or 8.1(e)).

 

(g)           Transition.  Without limiting the foregoing provisions of this Paragraph 6, Cephalon shall cooperate with Angioblast and/or its designee to effect a smooth and orderly transition in the Development and Commercialization of the Excluded Products (and processing if the Excluded Products are the Expanded HPCs) in the Territory during the Wind-down Period.  Without limiting the foregoing, Cephalon shall use commercially reasonable efforts to conduct in an expeditious manner any activities to be conducted under this Paragraph 6.  Upon transition of such Development and Commercialization of the Excluded Products, Angioblast shall assume all liabilities and obligations resulting from the Development and Commercialization of the Excluded Products, including, but not limited to, all liabilities and obligations under any contracts with Marketing Partners assigned to Angioblast pursuant to Paragraph 6.e, that accrue on or after the date of assignment of the obligations of Cephalon under this Paragraph 6; provided, however, that Cephalon shall remain responsible for all liabilities and obligations resulting from the Development and Commercialization of the Excluded Products, including, but not limited to, all liabilities and obligations under any contracts with Marketing Partners assigned to Angioblast pursuant to Paragraph 6.e, that accrue prior to such date of assignment.

 

7.            Certain Terminations of this Agreement with respect to a Region.  This Paragraph 7 shall apply upon any termination of this Agreement with respect to a particular Region pursuant to Section 13.2(c).

 

(a)           Exclusion of Region.  Effective upon such termination of this Agreement with respect to a particular Region (the “Excluded Region”), the Excluded Region shall be excluded from the definition of Territory for all purposes of this Agreement.  Each Party’s rights and obligations under this Agreement with respect to the Excluded Region, except to the extent otherwise set forth in this Exhibit 13 and Paragraph 7, shall terminate.  Accordingly and without limiting the foregoing, (i) Cephalon’s rights under Section 2.1 with respect to the Excluded Region shall terminate and (ii) thereafter, Cephalon shall not Develop, Commercialize or otherwise exploit any Product in the Excluded Region (or authorize any Third Party to do so).

 

(b)           Ongoing Trials.  If there are any ongoing clinical trials with respect to Products being conducted by or on behalf of Cephalon (or its Affiliates or Marketing Partners) applicable only to the Excluded Region at the time of notice of termination, Cephalon agrees, as requested by Angioblast, to (i) promptly transition to Angioblast or its designee some or all of such clinical trials and the activities related to or supporting such trials (ii) continue to conduct such clinical trials for a period requested by Angioblast up to a maximum of six (6) months after 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.
    

 

63

 

effective date of such termination, or (iii) terminate such clinical trials as expeditiously as practicable in consultation with the applicable institutional review board (or equivalent).  In such event, Cephalon shall be responsible for the costs of such transition.

 

(c)           Commercialization.  To avoid a disruption in the supply of Products to patients, if the Agreement is terminated after the first commercial sale of any Product in the Excluded Region, Cephalon, its Affiliates and its Marketing Partners shall continue to distribute the Products in each country of the Excluded Region for which Marketing Approval therefor has been obtained, in accordance with the terms and conditions of this Agreement, until the date on which Angioblast notifies Cephalon in writing that Angioblast has secured an alternative distributor or licensee for the Products in such country, during the Wind-down Period; provided that Cephalon, its Affiliates and its Marketing Partners shall cease such activities, or any portion thereof, in a given country of the Excluded Region upon sixty (60) days’ notice by Angioblast requesting that such activities (or portion thereof) be ceased.  Notwithstanding any other provision of this Agreement, during the Wind-down Period, Cephalon’s and its Affiliates’ and Marketing Partners’ rights with respect to the Products in the Excluded Region shall be non-exclusive and, without limiting the foregoing, Angioblast shall have the right to engage one or more other distributor(s) and/or licensee(s) of any Products in all or part of the Excluded Region.  Any Products sold or disposed by Cephalon in the Excluded Region during the Wind-down Period shall be subject to applicable payment obligations under ARTICLE VI above.

 

(d)           Assignment of Regulatory Materials.  At Angioblast’s request,  Cephalon shall assign or cause to be assigned to Angioblast or its designee (or to the extent not so assignable, Cephalon shall take all reasonable actions to make available to Angioblast or its designee the benefits of) all Regulatory Materials specific to the Products in the Excluded Region, including any such Regulatory Materials owned by Cephalon’s Affiliates or Marketing Partners.  In addition, Cephalon shall promptly provide to Angioblast a copy of all Data and other Cephalon Know-How pertaining to Products in the Excluded Region to the extent not previously provided to Angioblast and Angioblast shall have the right to use and disclose all Data and Cephalon Know How pertaining to such Excluded Region following termination of this Agreement with respect to such Excluded Region.

 

(e)           Marketing Partners.  If requested by Angioblast, any contracts with Marketing Partners of any Products in the Excluded Region engaged by Cephalon other than Cephalon’s Affiliates shall be assigned to Angioblast to the extent Cephalon has the right to do so.  In the event such assignment is not requested by Angioblast or Cephalon does not have the right to do so, then the rights of such Marketing Partners shall terminate upon termination of Cephalon’s rights with respect to the Excluded Region.  Cephalon shall ensure that its Affiliates and such Marketing Partners (if not assigned to Angioblast pursuant to this Paragraph 7.e) shall transition all Products 

 

	
**
    	
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.
    

 

64

 

back to Angioblast with respect to the Excluded Region in the manner set forth in this Paragraph 7 as if such Affiliate or Marketing Partner were named herein.

 

(f)            Return of Materials.  Within thirty (30) days after the end of the Wind-down Period, Cephalon shall either transfer to Angioblast or destroy all tangible items related to the Excluded Products including those comprising, bearing or containing any Existing Mark, Product Mark, the Angioblast Logos, Data, photographs, samples, literature, sales and promotional aids specifically with respect to the Excluded Region.  Effective upon the end of the Wind-down Period, Cephalon shall:  (i) cease to use all Existing Marks and Product Marks in the Excluded Region, and all rights granted to Cephalon with respect to the Products in the Excluded Region shall terminate; and (ii) assign or cause to be assigned to Angioblast or its designee all right, title and interest in and to the Existing Marks and Product Marks in the Excluded Region.

 

(g)           Transition.  Without limiting the foregoing provisions of this Paragraph 7, Cephalon shall cooperate with Angioblast and/or its designee to effect a smooth and orderly transition in the Development and Commercialization of the Products (and processing of the Expanded HPCs) in the Excluded Region during the Wind-down Period.  Without limiting the foregoing, Cephalon shall use commercially reasonable efforts to conduct in an expeditious manner any activities to be conducted under this Paragraph 7.  Upon transition of such Development and Commercialization of the Products in the Excluded Region, Angioblast shall assume all liabilities and obligations resulting from the Development and Commercialization of the Products in the Excluded Region, including, but not limited to, all liabilities and obligations under any contracts with Marketing Partners assigned to Angioblast pursuant to Paragraph 7.e, that accrue on or after the date of assignment of the obligations of Cephalon under this Paragraph 7; provided, however, that Cephalon shall remain responsible for all liabilities and obligations resulting from the Development and Commercialization of the Products in the Excluded Region, including, but not limited to, all liabilities and obligations under any contracts with Marketing Partners assigned to Angioblast pursuant to Paragraph 7.e, that accrue prior to such date of assignment.

 

8.             Certain Terminations of this Agreement with respect to the Cardiovascular Field in a Region.  This Paragraph 8 shall apply upon any termination of this Agreement with respect to the Cardiovascular Field in a particular Region pursuant to Section 13.3(a).

 

(a)           Exclusion of the Cardiovascular Field in a Region.  Effective upon such termination of this Agreement with respect to the Cardiovascular Field in a Region (the “Excluded Region”), (i) the Cardiovascular Field shall be excluded from the definition of Field for all purposes of this Agreement and the associated Products (i.e., the Cardiovascular Products) shall be excluded from the definition of Product for all purposes of this Agreement and (ii) the Excluded Region shall be excluded from the definition of Territory for all purposes of this Agreement.  Each Party’s rights and obligations under this Agreement with respect to the the Cardiovascular Field, Cardiovascular 

 

	
**
    	
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.
    

 

65

 

Products, and Excluded Region, except to the extent otherwise set forth in this Exhibit 13 and Paragraph 8, shall terminate.  Accordingly and without limiting the foregoing, (i) Cephalon’s rights under Section 2.1 with respect to the Cardiovascular Field, Cardiovascular Products, and Excluded Region shall terminate and (ii) thereafter, Cephalon shall not Develop, Commercialize or otherwise exploit any Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region (or authorize any Third Party to do so) using any Angioblast Technology.

 

(b)           Ongoing Trials.  If there are any ongoing clinical trials with respect to Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region being conducted by or on behalf of Cephalon (or its Affiliates or Marketing Partners) applicable only to the Excluded Region at the time of notice of termination, Cephalon agrees, as requested by Angioblast, to (i) promptly transition to Angioblast or its designee some or all of such clinical trials and the activities related to or supporting such trials (ii) continue to conduct such clinical trials for a period requested by Angioblast up to a maximum of six (6) months after the effective date of such termination, or (iii) terminate such clinical trials as expeditiously as practicable in consultation with the applicable institutional review board (or equivalent).  In such event, Cephalon shall be responsible for the costs of such transition.

 

(c)           Assignment of Regulatory Materials.  At Angioblast’s request,  Cephalon shall assign or cause to be assigned to Angioblast or its designee (or to the extent not so assignable, Cephalon shall take all reasonable actions to make available to Angioblast or its designee the benefits of) all Regulatory Materials specific to the Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region, including any such Regulatory Materials owned by Cephalon’s Affiliates or Marketing Partners.  In addition, Cephalon shall promptly provide to Angioblast a copy of all Data and other Cephalon Know-How pertaining to the Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region to the extent not previously provided to Angioblast and Angioblast shall have the right to use and disclose all Data and Cephalon Know How pertaining to such Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region following termination of this Agreement with respect to such Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region.

 

(d)           Marketing Partners.  If requested by Angioblast, any contracts with Marketing Partners of any Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region engaged by Cephalon other than Cephalon’s Affiliates shall be assigned to Angioblast to the extent Cephalon has the right to do so.  In the event such assignment is not requested by Angioblast or Cephalon does not have the right to do so, then the rights of such Marketing Partners shall terminate upon termination of Cephalon’s rights with respect to the Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region.  Cephalon shall ensure that its Affiliates and such Marketing Partners (if not assigned to Angioblast pursuant to this Paragraph 8.d) shall transition all Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region back to 

 

	
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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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Angioblast with respect to the Excluded Region in the manner set forth in this Paragraph 8 as if such Affiliate or Marketing Partner were named herein.

 

(e)           Return of Materials.  Within thirty (30) days after the end of the Wind-down Period, Cephalon shall either transfer to Angioblast or destroy all tangible items related to the Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region, including those comprising, bearing or containing any Existing Mark, Product Mark, the Angioblast Logos, Data, photographs, samples, literature, sales and promotional aids specifically with respect to the Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region.  Effective upon the end of the Wind-down Period, Cephalon shall:  (i) cease to use all Existing Marks and Product Marks for the Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region, and all rights granted to Cephalon with respect to the Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region shall terminate; and (ii) assign or cause to be assigned to Angioblast or its designee all right, title and interest in and to the Existing Marks and Product Marks for the Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region.

 

(f)            Transition.  Without limiting the foregoing provisions of this Paragraph 8, Cephalon shall cooperate with Angioblast and/or its designee to effect a smooth and orderly transition in the Development and Commercialization of the Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region in the Excluded Region during the Wind-down Period.  Without limiting the foregoing, Cephalon shall use commercially reasonable efforts to conduct in an expeditious manner any activities to be conducted under this Paragraph 8.  Upon transition of such Development and Commercialization of the Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region, Angioblast shall assume all liabilities and obligations resulting from the Development and Commercialization of the Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region, including, but not limited to, all liabilities and obligations under any contracts with Marketing Partners assigned to Angioblast pursuant to Paragraph 8.d, that accrue on or after the date of assignment of the obligations of Cephalon under this Paragraph 8; provided, however, that Cephalon shall remain responsible for all liabilities and obligations resulting from the Development and Commercialization of the Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region, including, but not limited to, all liabilities and obligations under any contracts with Marketing Partners assigned to Angioblast pursuant to Paragraph 8.d, that accrue prior to such date of assignment.

 

	
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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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