**Exhibit10.6**

 

NON-EXCLUSIVELICENSE AGREEMENT

 

This Agreement is made and entered into thislst day of January, 2001 (the “EFFECTIVE DATE”), by and betweenAdvanced Cell Technology, Inc., a Delaware corporation with officeslocated at One Innovation Drive, Worcester, Massachusetts 01605 (“ACT”), andPPL Therapeutics (Scotland) Limited, a company incorporated under the laws ofScotland, registered number 99179; whose registered office is at Roslin,Midlothian, EH 25 9PP, Scotland, UK (“PPL”) (ACT and PPL sometimes hereinafterreferred to as the “parties”).  As setforth below, the University of Massachusetts, a public institution of highereducation of the Commonwealth of Massachusetts (the “University”), has agreedto certain provisions of this Agreement.

 

WITNESSETH

 

WHEREAS, ACT owns or has licensed with asublicensable interest the PATENT RIGHTS (as defined below); and

 

WHEREAS, PPL desires to obtain a nonexclusivelicense from ACT under the PATENT RIGHTS upon the terms and conditionshereinafter set forth; and

 

WHEREAS, ACT is willing to grant such a license to PPL upon the termsand conditions set forth below;

 

NOW, THEREFORE, in consideration of the premises and the mutualcovenants contained herein, the parties hereto agree as follows:

 

ARTICLE 1*-*DEFINITIONS

 

For the purposes of this Agreement, the following words and phrasesshall have the following meanings:

 

1.1           “PERMITTED TRANSFEREE”means a single legal entity (such as a corporation, partnership, limitedliability company or joint venture) in which PPL is a shareholder and has aright to appoint a director to whom this Agreement and the xenotransplantationbusiness of PPL to which this Agreement relates will be transferred.

 

1.2           “PATENT RIGHTS” meansthe patents and patent applications identified on Exhibit A attachedhereto, all divisionals, continuations and continuations-in-part that derivefrom the identified patent applications (including from the patent applicationsfor the identified patents), foreign filings related to the foregoing patents andpatent applications, and any patents issuing on said applications together withall reissues, reexaminations, extensions and substitutions (or the equivalent)thereof.  The parties agree that AppendixA may be revised from time to time after the EFFECTIVE DATE to reflectchanges thereto.

 

1.3           A “LICENSED PRODUCT”shall mean any product, or part thereof or derived therefrom, the development,manufacture, sale, lease, use or import of which is covered in whole

 

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or in part by a VALID CLAIM of the PATENT RIGHTS in the country inwhich any such product or part thereof is developed, made, used, sold orimported by PPL (or by any third party on PPL’s behalf).  By way of illustration but not limitation, theparties agree that Licensed Products include cloned swine, the progeny of suchswine, and organs obtained or derived from cloned swine and the progeny of suchcloned swine.

 

1.4           “NET SALES” shall meanthe gross amount of any and all cash payments, royalties, milestone payments,success fees, equity payments and any other consideration of any kindwhatsoever which, directly or Indirectly is received by or inures to thebenefit of PPL (or by any third party on PPL’s behalf) from any person orentity for the development, manufacture, sale, lease, use or import of LICENSEDPRODUCTS less, to the extent applicable, the following:

 

(a)           discounts allowed;

 

(b)           sales, tariff duties,use and other taxes directly imposed with reference to particular sales; and

 

(c)           amounts allowed orcredited on returns.

 

Any such allowed deductions shall be listed on the invoice for theapplicable LICENSED PRODUCT.

 

1.5           “FIELD OF USE” shallmean the cloning of swine for the sole purpose of developing, producing andselling swine and/or swine-derived organs (including organs from the progeny ofsuch swine) (but excluding cells (other than associated immune cells requiredto induce tolerance of the organs) and tissues) for transplantation of suchorgans in humans.

 

1.6           “VALID CLAIM” means aclaim of any unexpired United States or foreign patent or patent applicationwithin the PATENT RIGHTS which shall not have been withdrawn, cancelled ordisclaimed, nor held invalid by a court of competent jurisdiction.

 

1.7           “UMASS LICENSE” meansthe Exclusive License Agreement between ACT and the University, dated April 16,1996,as amended by Amendment to Exclusive License Agreement dated September 1,1997and Second Amendment to Exclusive License Agreement dated May 31,2000.

 

1.8           “UMASS PATENT RIGHTS”means PATENT RIGHTS licensed by ACT from the University under the UMASS LICENSE.

 

1.9           “CONFIDENTIALINFORMATION” means confidential or proprietary information of ACT or PPLrelating to the PATENT RIGHTS or LICENSED PRODUCTS.  CONFIDENTIAL INFORMATION may be in written,graphic, oral or physical form and may include scientific knowledge, know-how,processes, inventions, techniques, formulae, products,

 

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business operations, customer requirements, designs, sketches,photographs, drawings, specifications, reports, studies, findings, data, plansor other records, biological materials, and/or software.  CONFIDENTIAL INFORMATION shall not include:

 

(a)           information which is,or later becomes, generally available to the public through no fault of therecipient;

 

(b)           informationwhich is provided to the recipient by an independent third party having noobligation to keep the information secret;

 

(c)           information which therecipient can establish by written documentation was previously known to it; or

 

(d)           informationwhich the recipient can establish by written documentation was independentlydeveloped by it without reference to the CONFIDENTIAL INFORMATION.

 

The parties agree that the specific terms (but not the overallexistence) of this Agreement shall be considered CONFIDENTIAL INFORMATION;provided, however, that the parties may disclose the terms of this Agreement toinvestors or potential investors and in any prospectus, offering, memorandum,or other document or filing required by applicable security laws or otherapplicable law or regulation.  Theparties may also disclose CONFIDENTIAL INFORMATION that is required to bedisclosed to comply with applicable law or court order, provided that therecipient gives reasonable prior written notice of the required disclosure tothe discloser and reasonably cooperates with the discloser’s efforts to preventsuch disclosure.

 

ARTICLE 2– LICENSE GRANT

 

2.1           ACT hereby grants toPPL, and PPL accepts, subject to the terms and conditions hereof, a worldwide,nonexclusive license in the FIELD OF USE to use the PATENT RIGHTS to make, havemade, use, sell, lease and import LICENSED PRODUCTS.  To the extent this grant includes a sublicenseof any UMASS PATENT RIGHTS, such sublicense is subject to the relevant terms ofthe UMASS LICENSE as it may be amended from time to time.

 

2.2           Notwithstanding theprovisions of Section 13.11, PPL shall have the right to assign thisAgreement in its entirety to a PERMITTED TRANSFEREE, provided that in any suchassignment:

 

(a)            theassignment shall expressly prohibit any further assignment or transfer of thisAgreement or the rights granted hereunder (including without limitation bysublicense) by the PERMITTED TRANSFEREE under the terms of this Section 2.2and the assignment agreement shall be subject to the consent of the University,which consent shall be granted or denied in the sole discretion of theUniversity.

 

(b)           PPLshall consult with ACT and the University, and shall furnish ACT and

 

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the University with any proposed assignment agreement with thePERMITTED TRANSFEREE, to permit ACT and the University to engage in discussionswith PPL (and the PERMITTED TRANSFEREE if appropriate) regarding the form andsubstance of the assignment agreement.  Upon execution of the assignment agreement,PPL shall promptly provide ACT and the University with a fully executed copy ofthe agreement, which shall be deemed CONFIDENTIAL INFORMATION subject to theprovisions of Article 10 of this Agreement.

 

(c)           Uponsuch assignment, PPL’s rights and obligations under this Agreement shall cease,and the PERMITTED TRANSFEREE shall be substituted for PPL in all respects underthe terms of this Agreement.

 

2.3           The license “to havemade” granted in Section 2.1 means only that PPL may contract with a thirdparty or parties to develop, manufacture or sell LICENSED PRODUCTS on behalf ofPPL.

 

2.4           Promptly followingexecution of this Agreement, ACT shall provide PPL with all information anddata relating to the PATENT RIGHTS and as may be reasonably necessary to allowPPL to exploit the license granted hereunder.

 

2.5           To the extent theUniversity, the federal government or any other parties have rights in thePATENT RIGHTS pursuant to Article 2 of the UMASS LICENSE, the License grantedhereunder is subject to such rights.

 

2.6           PPL acknowledges that aportion of the PATENT RIGHTS licensed to PPL hereunder is owned by theUniversity and is licensed to ACT under the UMASS LICENSE.  PPL acknowledges, understands and agrees thatin the event the UMASS LICENSE is terminated for any reason pursuant to theprovisions of the UMASS LICENSE, this Agreement shall automatically be assignedto the University and PPL will thereafter make any payments due to ACT underthis Agreement directly to the University.  Further, promptly following such termination,PPL and the University will enter into a direct license agreement reflectingthe applicable terms of this Agreement and the UMASS LICENSE.

 

ARTICLE 3- DUE DILIGENCE

 

3.1           PPL shall usecommercially reasonable and diligent efforts to bring one or more LICENSEDPRODUCTS to market through an active and diligent program for exploitation ofthe PATENT RIGHTS and to continue active, diligent marketing efforts for one ormore LICENSED PRODUCTS throughout the life of this Agreement.  Without limiting the generality of theforegoing, PPL shall, at its expense and for a period of two years from thedate hereof, undertake product development and other activities intended toenhance and further commercialize the PATENT RIGHTS in the FIELD OF USE.

 

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3.2           PPL shall maintaincomplete and accurate records of LICENSED PRODUCTS that are made, used, sold,leased or imported by PPL (or by any third party on behalf of PPL) under thisAgreement.  Not later than May lstof each year following the year concluding on the first anniversary of theEFFECTIVE DATE, PPL shall furnish ACT with a summary report on the progress ofits efforts during the prior year to develop and commercialize LICENSEDPRODUCTS, including without limitation research and development efforts,efforts to obtain regulatory approval, marketing efforts (including LICENSEDPRODUCTS made, used, sold or imported) and sales figures, provided that suchreports shall be deemed confidential information subject to the provisions of Article 10of this Agreement.

 

ARTICLE 4- CONSIDERATION

 

4.1           Initial Payment.PPL shall pay to ACT an initial License Fee of FIFTY THOUSAND DOLLARS($50,000), one hundred percent (100%) of which payment shall be deemed earnedand shall be due and payable on or before January 21, 2002. Except asprovided in Section 9.3, the License Fee is not refundable and is notcreditable against other payments due to ACT under this Agreement.

 

4.2           Milestone Payments.PPL shall pay ACT a milestone payment of $1,000,000 upon the first marketapproval by the U.S. Food and Drug Administration (or foreign equivalent) of aLICENSED PRODUCT in the FIELD OF USE.  Themilestone payment is nonrefundable and is not creditable against any otherpayments due to ACT under this Agreement.  The milestone payment shall be due and payablewithin thirty (30) days after the issuance or grant of the market approvaldescribed above.

 

4.3           Royalties and otherConsideration. (a) In partial consideration of the license granted toPPL from ACT in Article 2 of this Agreement, PPL shall pay to ACT aroyalty equal to 2% of the Net Sales of all LICENSED PRODUCTS developed, made,used, sold, leased or imported by PPL (or by any third party on PPL’s behalf)or any customer of PPL, provided, however, that in the event that PPL islegally required to make royalty payments to one or more third parties (otherthan to an affiliated or related company) in order to make, use, sell, lease orimport LICENSED PRODUCTS, the royalty payment shall be decreased by one-quarterof one percent (0.25%) for each one percent (1%) of actual royalty paymentsmade to third parties under such required licenses, but in no event shall suchroyalty payment due to ACT be reduced below 1.5%.  (b) No multiple royalties shall bepayable because any LICENSED PRODUCT, its manufacture, use, sale, lease orimport are or shall be covered by more than one patent or patent applicationwithin the PATENT RIGHTS. (c) The obligation of PPL to pay royalties onsales of LICENSED PRODUCTS covered by a VALID CLAIM of the PATENT RIGHTS shallterminate on a country-by-country basis concurrently with the expiration ortermination of the last applicable VALID CLAIM within the PATENT RIGHTS in thecountry in which the LICENSED PRODUCT is manufactured, used, sold, leased, usedor imported.

 

4.4           Assignment Proceeds.PPL shall pay to ACT three percent (3%) of the the gross amount of any and allconsideration of any kind whatsoever, including, without limitation, cash orequity payments (the “Assignment Proceeds”) which, directly or indirectly, isreceived by or

 

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inures to the benefit of PPL in connection with the assignment of thisAgreement to a PERMITTED TRANSFEREE; provided, however, that if said assignmentis to a PERMITTED TRANSFEREE that is controlled by PPL, PPL shall have noobligation to pay to ACT any of the ASSIGNMENT PROCEEDS.  For purposes of this paragraph, the term “control”means (a) in the case of corporate entities, direct or indirect ownershipof more than fifty percent (50%) of the stock or shares entitled to vote forthe election of directors; and (b) in the case of non-corporate entities,direct or indirect ownership of more than fifty percent (50%) of the equityinterest with the power to direct the management and policies of suchnon-corporate entities.

 

4.5           All payments duehereunder shall be paid in fall without deduction of (i.e., net of) anyVAT or other taxes or other fees which may be imposed by any government andwhich shall be paid by PPL.

 

4.6           All payments duehereunder shall be paid by PPL to ACT in United States dollars.  If any currency conversion shall be requiredin connection with the payment of royalties or other amounts due hereunder,such conversion shall be at the rate of conversion reported in the Wall StreetJournal on the last working day of the calendar quarter to which the paymentrelates.

 

4.7           PPL shall pay ACTinterest on any overdue amounts at the rate of eighteen percent (18%) perannum, or the maximum rate allowed under applicable law, whichever is higher,from the date when such payment should have been made pursuant to Section 4.1,4.2, 4.3, 4.4 or 5.3, as applicable.

 

ARTICLE 5- REPORTS AND RECORDS

 

5.1           PPL shall keep full,true and accurate books of account containing all particulars that may benecessary for the purpose of showing the amounts payable to ACT hereunder.  Said books of account shall be kept at PPL’sprincipal place of business or at such other location as may be agreed upon bythe parties.  Said books and thesupporting data shall be open upon reasonable advance notice (and no morefrequently than once per calendar year) for three (3) years following the endof the calendar year to which they pertain, to the inspection of ACT or its agentsfor the purpose of verifying PPL’s royalty statement or compliance in otherrespects with this Agreement.  If anysuch audit discloses an error in any payment to ACT, PPL shall (without limitingACT’s other remedies with respect thereto) pay to ACT, within thirty (30) daysof the discovery of the error, (a) all deficiencies in such payments, (b) intereston such deficiencies from the date such payment was due until the date paid atthe rate equal to one and one-half percent (11/2%) permonth, and (c) if such error is in excess of ten percent (10%) of anypayment, the cost of the audit.  In allother cases, the costs of the audit shall be paid for by ACT.

 

5.2           After the firstcommercial sale of a LICENSED PRODUCT by PPL (or by any third party on PPL’sbehalf), PPL, within sixty (60) days after March 31, June 30, September 30and December 31, of each year, shall deliver to ACT a true and accuratereport, giving such particulars of the business conducted by PPL during thepreceding three-month period under this Agreement as shall be pertinent to aroyalty accounting hereunder.  Each suchreport shall include at least the following:

 

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(a)           number(s)and type(s) of LICENSED PRODUCTS manufactured, sold, leased, used or importedby PPL (or by third parties on PPL’s behalf);

 

(b)           totalbillings and consideration received for LICENSED PRODUCTS developed,manufactured, sold, leased, used or imported by PPL (or by third parties on PPL’sbehalf);

 

(c)           deductionsapplicable as provided in Paragraph 1.4;

 

(d)           namesand addresses of third party subcontractors of PPL.

 

5.3           With each such reportsubmitted, PPL shall pay to ACT the royalties and other payments due andpayable under this Agreement.  If noroyalties or other payments shall be due, PPL shall so report.

 

ARTICLE 6- PATENT PROSECUTION

 

ACT shall be solely responsible for thecontinued prosecution of pending patent applications included in the PATENTRIGHTS and the issuance of such applications after allowance.  Additionally, ACT shall pay all governmentFees in any given country required to maintain the PATENT RIGHTS, and shallsubmit evidence to PPL upon request that such fees have been timely paid.  The prosecution, filing and maintenance of allpatents and applications included in the PATENT RIGHTS shall be the soleresponsibility of ACT.

 

ARTICLE 7- PROSECUTION OF INFRINGERS

 AND DEFENSE OF PATENT RIGHTS

 

The parties agree to notify each other in writing of any actual orthreatened infringement by a third party of PATENT RIGHTS or of any claim ofinvalidity, unenforceability, or non-infringement of the PATENT RIGHTS.  ACT shall have the sole responsibility toprosecute or defend such claims, as applicable.  PPL shall if requested provide reasonableassistance to ACT, at ACT’s expense, in connection with the prosecution ordefense of such claims; provided, however, that PPL shall have no obligation toprovide such assistance if it providing such assistance would breach theenforceable terms of the June 2, 1998 License Agreement between PPL andthe Roslin Institute.

 

ARTICLE 8- INDEMNIFICATION,

 LIMITATION OF LIABILITY AND INSURANCE

 

8.1           PPL shall at all timesduring the term of this Agreement and thereafter, indemnify, defend and holdharmless ACT and the University and their trustees, directors, officers,employees and affiliates against all liabilities of any kind whatsoever,including legal expenses and reasonable attorneys’ fees, arising out of thedeath of or injury to any person or persons or out of any damage to propertyresulting from the development, import, production, manufacture,

 

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sale,use, lease, performance, consumption or advertisement of the LICENSED PRODUCT(s)or arising from any obligation, act or omission, or from a breach of anyrepresentation or warranty of PPL hereunder, excepting only claims that thePATENT RIGHTS infringe third party intellectual property rights or claims thatresult from any material breach by ACT of this Agreement.  Any indemnification obligations set forth inthis Agreement shall be subject to the following conditions: (i) theindemnified party shall notify the indemnifying party in writing promptly uponlearning of any claim or suit for which indemnification is sought; (ii) theindemnifying party shall have control of the defense or settlement, providedthat the indemnified party shall have the right (but not the obligation) toparticipate in such defense or settlement with counsel at its selection and atits sole expense; and (iii) the indemnified party shall reasonablycooperate with the defense, at the indemnifying party’s expense.

 

8.2           EXCEPT AS OTHERWISEEXPRESSLY SET FORTH IN THIS AGREEMENT, ACT, ITS TRUSTEES, DIRECTORS, OFFICERS,EMPLOYEES, AND AFILIATES MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OFANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OFMERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF PATENT RIGHTSCLAIMS, ISSUED OR PENDING, AND THE ABSENCE OF LATENT OR OTHER DEFECTS, WHETHEROR NOT DISCOVERABLE.  NOTHING IN THISAGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION MADE OR WARRANTY GIVEN BY ACTTHAT THE PRACTICE BY PPL OF THE LICENSE GRANTED HEREUNDER SHALL NOT INFRINGETHE PATENT RIGHTS OF ANY THIRD PARTY.  INNO EVENT SHALL ACT, ITS TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES AND AFFILIATESBE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDINGECONOMIC DAMAGE OR INJURY TO PROPERTY AND LOST PROFITS, REGARDLESS OF WHETHERACT SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OFTHE POSSIBILITY OF SUCH DAMAGES.

 

8.3           PPL agrees to maintain insurance orself-insurance that is reasonably adequate to fulfill any potential obligationto the indemnified parties.  PPL shallcontinue to maintain such insurance or self-insurance during the term of thisAgreement and after the expiration or termination of this Agreement for aperiod of five (5) years.

 

ARTICLE 9 – TERMINATION

 

9.1           This Agreement shall be effective on theEFFECTIVE DATE and shall extend ten (10) years or until the expiration ofthe last to expire of the PATENT RIGHTS, whichever is later, unless soonerterminated as provided in this Article 9.

 

9.2           ACT may terminate thisAgreement and the rights, privileges and license granted hereunder by writtennotice upon a breach or default of this Agreement by PPL, as follows:

 

(i)            non-paymentof any amounts due which is not cured within ten (10) days of receipt ofwritten notice of such non-payment; or

 

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(ii)           breachof any obligation which is****not cured within thirty (30) daysof a written request to remedy such breach, or if the breach cannot be curedwithin said thirty (30) day period, failure of PPL within said thirty (30) dayperiod to proceed with reasonable promptness thereafter to cure the breach; or

 

(iii)          bankruptcy,appointment of a receiver, or involvement in any other insolvency proceeding.

 

Such termination shall become automatically effective unless PPL shallhave cured any such material breach or default prior to the expiration of theapplicable cure period.

 

9.3           PPL shall have theright to terminate this Agreement immediately by written notice to ACT in theevent that the University denies PPL’s request for the University’s consent tothe transfer or assignment of this Agreement to a PERMITTED TRANSFEREE pursuantto Section 2.2 hereof.  Upontermination of this Agreement by PPL pursuant to this Section 9.3, ACTshall refund to PPL, within thirty (30) days of ACT’s receipt of said notice oftermination, the initial License Fee of FIFTY THOUSAND DOLLARS ($50,000) paidto ACT by PPL pursuant to Section 4.1 hereof.

 

9.4           PPL shall have theright to terminate this Agreement at any time on six (6) months’ prior noticeto ACT, and upon payment of all amounts due ACT through the effective date ofthe termination.

 

9.5           Upon termination ofthis Agreement for any reason, nothing herein shall be construed to releaseeither party from any obligation that matured prior to the effective date of suchtermination; and Articles/Sections 1, 5.1, 8, 9.4, 10 and 12, and any otherSections or provisions which by their nature are intended to survivetermination, shall survive any such termination.

 

ARTICLE 10- CONFIDENTIALITY

 

During the course of this Agreement, ACT andPPL may provide each other with CONFIDENTIAL INFORMATION.  CONFIDENTIAL INFORMATION may be disclosed inoral, visual or written form, and includes such information that is designatedin writing as such by the discloser at the time of disclosure, orally disclosedinformation that is designated in writing as confidential within 30 days aftersuch oral disclosure, or information which, under all of the givencircumstances ought reasonably be treated as CONFIDENTIAL INFORMATION of thedisclosing party.  ACT and PPL eachintend to maintain the confidential or trade secret status of theirCONFIDENTIAL INFORMATION.  Each shallexercise reasonable care to protect the CONFIDENTIAL INFORMATION of the otherfrom disclosure to third parties; no such disclosure shall be made without theother’s written permission.  Upontermination or expiration of this Agreement, ACT and/or PPL shall comply withthe other’s written request to return all CONFIDENTIAL INFORMATION that is inwritten or tangible form.  Except asexpressly provided herein, neither ACT nor PPL is granted any license to usethe other’s CONFIDENTIAL

 

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INFORMATION.  The obligations ofACT and PPL under this Article 10 shall survive any expiration ortermination of this Agreement.

 

ARTICLE 11- PAYMENTS, NOTICES, AND OTHER COMMUNICATIONS

 

Any payment, notice or other communicationrequired or otherwise given pursuant to this Agreement shall be in writing andsent by certified first class mail, return receipt requested, postage prepaid,or by nationally recognized overnight carrier addressed to the parties at thefollowing addresses or such other addresses as such party furnishes to theother party in accordance with this paragraph.  Such notices, payments or other communicationsshall be effective upon receipt.

 
| In the case of ACT: |                                         |
|---------------------|----------------------------------------------|
|                | Advanced Cell Technology, Inc.          |
|                | One Innovation Drive                         |
|                | Worcester, MA 01605                          |
|                | Attention: Michael D. West, Ph.D., President |
|                |                                         |
| With a copy to:     |                                         |
|                |                                         |
|                | Pierce Atwood                                |
|                | One Monument Square                          |
|                | Portland, ME 04101                           |
|                | Attention:  William L. Worden, Esq.          |
| In the case of PPL: |                                         |
|                |                                         |
|                | PPL  Therapeutics (Scotland) Limited         |
|                | Roslin                                       |
|                | Midlothian                                   |
|                | EH 25 9PP                                    |
|                | Scotland, UK                                 |

 

ARTICLE 12- REPRESENTATIONS AND WARRANTIES

 

12.1         ACT represents andWarrants that it owns or has licensed with a sublicensable interest the PATENTRIGHTS, that it has the full legal right and power to grant the licenses grantedhereunder, that this Agreement constitutes the binding legal obligation of ACT,enforceable in accordance with its terms, and that the execution andperformance of this Agreement by ACT will not violate, contravene or conflictwith any other agreement to which ACT is a party or by which it is bound orwith any law, rule or regulation applicable to ACT.

 

12.2         PPL represents andwarrants that it has full corporate power and authority to enter into thisAgreement, that this Agreement constitutes the binding legal obligation of PPL,enforceable in accordance with its terms, and that the execution andperformance of this

 

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Agreementby PPL will not violate, contravene or conflict with any other agreement to which PPL is a party or by which itis bound or with any law, rule or regulation applicable to PPL, and thatany permits, consents or approvals necessary or appropriate for PPL to enterinto this Agreement have been obtained.

 

12.3         This Section 12 shall survive expirationor termination of this Agreement.

 

ARTICLE 13- MISCELLANEOUS PROVISIONS

 

13.1         PPL shall comply with all local, state,federal and international laws and regulations relating to the development,manufacture, use, sale, lease and import of LICENSED PRODUCTS.  Without limiting the generality of theforegoing, PPL agrees to comply with the following:

 

(a)           PPL shall obtain all necessary approvals fromthe FDA and any similar governmental authorities of any foreign jurisdiction inwhich PPL intends to make, use, sell, lease or import LICENSED PRODUCTS.

 

(b)           PPL shall comply with any and all applicablelocal, state, federal and international laws and regulations relating to theLICENSED PRODUCTS and the PATENT RIGHTS, including without limitation allexport or import regulations and rules now in effect or as may be issuedfrom time to time by any governmental authority which has jurisdiction relatingto the export of LICENSED PRODUCTS and any technology relating thereto(including all United States laws and regulations controlling the export of certaincommodities and technical data, including without limitation all ExportAdministration Regulations of the United States Department of Commerce.  Among other things, these laws and regulationsprohibit, or require a license for, the export of certain types of commoditiesand technical data to specified countries).  PPL hereby gives written assurance that itwill comply will all such laws and regulations, that it bears soleresponsibility for any violation of such laws and regulations, and that it willindemnify, defend, and hold ACT and the University harmless (in accordance withSection 8.1 of Article 8 hereof) for the consequences of any suchviolation.

 

(c)           To the extent that any invention claimed inthe PATENT RIGHTS has been partially funded by the United States Government,and only to the extent required by applicable laws and regulations, PPL agreesthat any LICENSED PRODUCTS used or sold in the United States will bemanufactured substantially in the United States or its territories.  Current law provides that if domestic manufactureris not commercially feasible under the circumstances, ACT and/or the Universitymay seek a waiver of this requirement from the relevant federal agency onbehalf of PPL and, upon PPL’S request, shall cooperate with PPL in seeking sucha waiver.

 

13.2         PPL shall not create or incur or cause to beincurred or to exist any lien.

 

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13.9         The provisions of thisAgreement are severable, and in the event that any provisions of this Agreementshall be determined to be invalid or unenforceable under any controlling bodyof the law, such invalidity or unenforceability shall not in any way affect thevalidity or enforceability of the remaining provisions hereof.

 

13.10       The failure of either partyto assert a right hereunder or to insist upon compliance with any term orcondition of this Agreement shall not constitute a waiver of that right orexcuse a similar subsequent failure to perform any such term or condition bythe other party.

 

13.11       This Agreement may not beassigned by either party without the prior written consent of the other party,except that either party may assign this Agreement to an affiliate or to asuccessor in connection with a merger or consolidation, or the sale of all orsubstantially all of its assets or that portion of its business to which thisAgreement relates; provided, however, that any assignment by PPL pursuant tothis Section 13.11 shall be subject to the consent of the University,which consent shall be granted or denied at the sole discretion of theUniversity.

 

IN WITNESSWHEREOF, the parties have duly executed this Agreement as of the EFFECTIVE DATEset forth above.

 
| ADVANCED CELL TECHNOLOGY, INC.      |              |
|-------------------------------------|-------------------|
|                                |              |
|                                |              |
| By:                                 | /s/ Jose Cibelli  |   |
| Printed Name:                       | Jose Cibelli      |   |
| Title:                              | VP - RESEARCH     |   |
|                                |              |
| PPL THERAPEUTICS (SCOTLAND) LIMITED |              |
|                                |              |
|                                |              |
| By:                                 | /s/ Alan Colman   |   |
| Printed Name:                       | ALAN COLMAN       |   |
| Title:                              | RESEARCH DIRECTOR |   |
|                                     |                   |  |  |  |  |  |

 

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CONSENT AND AGREEMENT

 

For value received, the University hereby consents to the sublicense byACT to PPL of the UMASS PATENT RIGHTS in accordance with the terms of thisAgreement.

 

 
| THE UNIVERSITY OF MASSACHUSETTS |                                 |
|---------------------------------|--------------------------------------|
|                            |                                 |
|                            |                                 |
| By:                             | /s/ Thomas Chmura                    |   |
| Printed Name:                   | Thomas Chmura                        |   |
| Title:                          | Vice President, Economic Development |   |
| Date:                           |                                 |
|                            |                                 |
|                            |                                 |
| By:                             | /s/ Joseph F.X. McGuirl              |   |
| Printed Name:                   | Joseph F.X. McGuirl                  |   |   |
| Title:                          | Executive Director, Office           |   |
|                            | of Commercial Ventures               |   |
|                            | and Intellectual Property            |   |
| Date:                           |                                 |   |
|                                 |                                      |  |  |  |  |  |  |

 

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