**Exhibit 10.13**

******CONFIDENTIAL PORTIONS OF THISAGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANTTO A REQUEST FOR CONFIDENTIAL TREATMENT******

**BIOPHARMACEUTICALDEVELOPMENT AND**

**MANUFACTURING SERVICES AGREEMENT**

ThisBIOPHARMACEUTICAL DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT, effectiveas of this **16th day of August, 2006** (the “EffectiveDate”), between Lpath, Inc., a Delaware corporation (“Customer”),having its principal place of business at 6335 Ferris Square, San Diego, CA92121 and LAUREATE****PHARMA, INC.,a Delaware corporation (“Laureate”), having a principal place ofbusiness at 201 College Road East, Princeton, NJ 08540, (each a “Party”,collectively the “Parties”).

W I T N E S S E T H:

WHEREAS,Laureate provides a full range of bioprocessing services to thebiopharmaceutical industry, including cell line development, processdevelopment, protein production, cell culture, protein purification,bioanalytical chemistry, aseptic filling, and QC testing.

WHEREAS,Customer desires Laureate to perform services in accordance with the terms ofthis Agreement and the Scope (as hereinafter defined) related to the technologytransfer and cGMP production and purification of a recombinant monoclonalantibody, produced by their corresponding cell line, and Laureate desires toperform such services.

NOW,THEREFORE, in consideration of the above statements and other good and valuableconsideration, the sufficiency and receipt of which are hereby acknowledged,the Parties hereto agree as follows:

# Section 1.  Definitions. Terms defined elsewherein this Agreement shall have the meanings set forth therein for all purposes ofthis Agreement unless otherwise specified to the contrary.  The following terms shall have the meaningset forth below in this Section 1:

## 1.1           “Affiliate(s)”for purposes of this Agreement shall mean any person, firm, trust, partnership,corporation, company, or other entity or combination thereof which directly orindirectly: (i) controls a Party; (ii) is controlled by a Party; or (iii) isunder common control with a Party.  Asused in this definition, the terms “control” and “controlled”shall mean ownership of fifty percent (50%) or more (including ownership bytrusts with substantially the same beneficial interests) of the voting andequity rights of such person, firm, trust, partnership, corporation, company,or other entity or combination thereof or the power to direct the management ofsuch person, firm, trust, corporation, or other entity or combination thereof.

## 1.2           “Agreement”means this document as signed by the Parties, including the Scope and anyreferenced appendix and any amendments and additions to this document.

## 1.3           “Assumptions”shall have the meaning as set forth in Section 8(b).

## 1.4           “Batch”means a number of vials each filled at the same time with the same Lot or agroup of Lots of Drug Product.

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## 1.5           “BatchRecord” means a manufacturing record for a Batch generated by Laureate andapproved by Customer made concurrently with the performance of each step of theproduction, purification, and aseptic filling process for the Drug Substancesuch that successive steps in such processes may be traced.

## 1.6           “CellLine” means the Chinese Hamster Ovary (CHO) cell line that has beendesigned and engineered to produce the corresponding monoclonal antibodyproduct as shown in Appendix 1, supplied by Customer to Laureate,particulars of which are set out in the Scope.

## 1.7           “Certificateof Analysis” means a document containing the name, description, andintended purpose of a chemical or biological material, instructions for properuse and storage of the chemical or biological material, and any other technicalinformation deemed necessary for its proper use.

## 1.8           “Claim”shall have the meaning set forth in Section 17(a).

## 1.9           “Contaminants”shall have the meaning set forth in Section 17(c).

## 1.10         “CustomerConfidential Information” means any information, business, technical, orfinancial data confidential or proprietary to Customer, including CustomerKnow-How, that (i) concerns the Cell Line, Drug Substance, or Drug Product andis supplied by Customer to Laureate or (ii) directly and solely relates to theCell Line, Drug Substance, or Drug Product that becomes known to Laureate(other than from Customer) during the course of performing the Program (otherthan the Process).

## 1.11         “CustomerKnow How” means any and all scientific, technical, and other informationrelating to the Cell Line, Drug Substance, or Drug Product known to Customerfrom time-to-time, other than Laureate Confidential Information.

## 1.12         “DrugProduct” means the final dosage form pharmaceutical medicine containingDrug Substance that Customer or its Affiliates will use for clinical trials.

## 1.13**        **“Drug Substance” isthe monoclonal antibody protein, described in Appendix 1, produced andpurified using the Cell Line and the Process.

## 1.14         “Facility”means Laureate’s manufacturing facility located at 201 College Road East,Princeton, NJ 08540.

## 1.15         “FilledProduct” means vials filled with Drug Product from an identified Lot orLots that are in a form ready for release and shipment from the Facility.

## 1.16         “FillingComponents” means vials, stoppers, and crimps used for an aseptic fill ofthe Drug Substance to produce the Drug Product.

## 1.17         “GoodManufacturing Practices” or “GMP” or “cGMP” means currentgood manufacturing practices, as specified in regulations promulgated from timeto time by the FDA for the manufacture and testing of pharmaceuticalproducts.  Laureate’s operational qualitystandards are defined in internal cGMP policy documents and are based onLaureate’s current interpretation of cGMP.

## 1.18         “LaureateConfidential Information” means any information, business, technical, orfinancial data confidential or proprietary to Laureate, including, but notlimited to, Laureate’s production, purification, and aseptic filling processand techniques and Laureate Know How, not known to Customer and supplied byLaureate to Customer.

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## 1.19         “LaureateGroup” shall have the meaning set forth in Section 17(b).

## 1.20         “LaureateKnow How” means all scientific, technical, and other informationproprietary to Laureate relating to the Process, and includes any information,enhancements, or improvements generated as a result of performing the Program,but excluding Customer Confidential Information.

## 1.21         “LaureateSOP” means the written standard operating procedures and methods ofLaureate, as the same may be amended, in Laureate’s sole discretion, from timeto time.

## 1.22         “Loss”shall have the meaning set forth in Section 17(a).

## 1.23         “Lot”means the Drug Substance produced in a single production, which may becontained in one or more containers thereof.

## 1.24         “Materials”means Cell Lines, expression plasmid, raw materials, reference standards,and/or any other substances to be provided by Customer to Laureate in order toundertake the Program as specified in the Scope and Appendix 2 to thisAgreement.

## 1.25         “MediaFill” means a fill of bacteriological growth media into vials forvalidation purposes.

## 1.26         “Modification”shall have the meaning set forth in Section 8(a).

## 1.27         “Person”means an individual, partnership, corporation, limited liability company, jointstock company, unincorporated organization or association, trust or jointventure, or a governmental agency or political subdivision thereof.

## 1.28         “Process”means the proprietary production methods and purification processes used byLaureate for the manufacture of Drug Substance and Drug Product from the CellLine, including any modifications, enhancements or improvements that may bemade thereto from time-to-time.

## 1.29         “ProcessConsumables” means media, raw materials, filters, membranes, disposableanalytical test kits, tubing, filling needles, disposable bags, disposableglass/plasticware, cleaning supplies, and other changeover parts consumedduring the manufacture of Drug Substance or Drug Product.

## 1.30         “ProcessInvention” means any invention or discovery, whether or not patentable,relating to the Process discovered or developed by or on behalf of Laureate inconnection with the Program, provided that such invention or discovery is thenapplicable to an antibody product other than the antibody that is the DrugSubstance.

## 1.31         “Product-DedicatedEquipment” means equipment such as chromatography columns and resins andfilters and filter housings that will be used by Laureate solely for themanufacture of Drug Substance or Drug Products pursuant to this Agreement.

## 1.32         “ProductInvention” means any invention or discovery, whether or not patentable,directly and solely related to Drug Product or Drug Substance (but excludingany Process Invention) discovered or made by or on behalf of Laureate, itsemployees, agents, consultants or contractors, exclusively as a result ofperforming the Program under this Agreement.

## 1.33         “Program”means the services to be performed by Laureate for Customer as described in theScope.

## 1.34         “QualityAgreement” shall have the meaning set forth in Section 3(c).

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***CONFIDENTIALPORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THECOMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.

## 1.35         “Scope”means the detailed scope-of-work documents attached hereto as Appendices 1and 2.

## 1.36         “Specification”means the requirements for tests, analysis, test procedures, and acceptabletest results with which Drug Substance and Materials, other raw materials, andexcipients shall conform as set forth on Appendix 3, as amended fromtime-to-time by the Parties.

## 1.37         “ThirdParty” shall mean any Person other than (i) Customer, Laureate, and theirrespective Affiliates or (ii) any director, officer, employee, or agent ofCustomer, Laureate, or their respective Affiliates.

# Section 2.  Scope of Work; Orders for Products.

### (a)           A detailed Scope prepared by Laureateunder Customer’s direction and approved by Customer is attached to thisAgreement as Appendices 2 and 3, as may be amended from time to time bythe Parties.  Laureate will perform theservices for Customer in accordance with the Scope. The Scope will specify theProgram design, information desired, estimated duration of the Program, and allother matters pertinent to completion of the Program, and will be deemed a partof this Agreement and is incorporated herein by reference.

### (b)           Laureate consulted with Customer indeveloping the Program design in a manner consistent with Laureate’s currentreasonable understanding of United States (the “US”) regulatoryguidelines.  However, Laureate does notrepresent or warrant that the Program and/or the Program results will satisfythe requirements of any regulatory agencies at the time of submission ofProgram results to such agencies. Notwithstanding the foregoing, in the event Laureate fails to provideCustomer with any of the following deliverables:

### (i)            an optimized producing cell linederived from the Cell Line, which cell line is stable and produces not lessthan *** of Drug Substance in a form suitable for subsequent purification intobulk, purified Drug Substance and formulation into Drug Product;

### (ii)           a scalable, commercially reasonablebioreactor process for culturing the Cell Line to yield commercially reasonablequantities of Drug Substance; and

### (iii)          a scalable purification process havinga yield of  not less than *** of DrugSubstance initially input into the purification process, which Drug Substance,once purified in accordance with such process, is suitable for production ofDrug Product,

### or, if delivered, any such deliverable is notaccepted by Customer within ten (10) business days after receipt from Laureate,then either Party will have the right to immediately terminate this Agreement,upon notice to the other without further obligation to each other.  Customer will be deemed to have accepted anydeliverable provided by Laureate to Customer during the course of the Programunless Customer rejects such deliverable by so notifying Laureate within ten(10) business days after receipt of the deliverable from Laureate, and any suchnotice will include a reasonably detailed description of the basis for suchrejection.  For purposes of this Section2(b), “commercially reasonable” shall mean those quantities or yield which theParties determine in good faith to be sufficient given the results andcircumstances at the time the deliverables were made.

### (c)           Laureate’s performance of the Programwill be based on the technical information provided to Laureate by Customer orby Third Parties on Customer’s behalf. Laureate will use such 

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### technicalinformation to prepare the documentations that will comprise the Programdocuments, such as scale up plans, Batch Records and Specifications.  As the Program documents are developed byLaureate, Laureate will offer Customer the opportunity to review and comment onsuch document prior to use by Laureate. Such Program documents, and to the extent not included therein, CustomerConfidential Information and Laureate Confidential Information, will form thesole basis upon which the Program will be implemented.  It is understood and agreed that theimplementation of the Program according to Customer’s instructions and theProgram documents may not result in any specific quantity or quality of DrugProduct or Drug Substance.

### (d)           In addition to routine Programmeetings, a senior representative from each Party shall meet on an occasionalbasis, but not less than monthly or at such other interval as the Parties agreein writing, the first meeting being no later than two (2) weeks from theEffective Date, to review progress of the Program relative to the Scope and toagree on any necessary changes to the Scope, it being understood, however, thanany change to the Scope or to tasks to be performed pursuant to the Programmust be made pursuant to a Change Order (defined below) as set forth in Section8.  Laureate’s representative at suchmeetings shall be the Program Manager (as defined below in Section 3(b)), andCustomer’s representative will be its Customer Representative (as defined belowin Section 3(b)).   Such meetings shallbe at the Facility or such other location as the Parties agree, althoughCustomer shall have the right to direct that any such meeting take placetelephonically.

### (e)           Customer hereby grants Laureate anon-exclusive, royalty-free sub-license to use Materials solely to produce DrugSubstance and Drug Product in accordance with carrying out its obligationsunder this Agreement.

# Section 3.  Program Performance.

### (a)           Laureate shall perform the Program asprovided in the Scope, as it may be modified as provided herein, at itsFacility using commercially reasonable efforts and employing staff havingappropriate training and skill necessary to complete the Program, in accordancewith the terms of this Agreement. Laureate will maintain an appropriate, securework site for conducting the Program in its Facility.  Laureate will cause its research teamperforming the Program to keep detailed contemporaneous records and data inconnection with the Scope, and to prepare reports detailing work to date, whichwill be furnished to Customer in a timely manner in accordance with the Scopeor as otherwise agreed between the Parties. Any Laureate personnel working on the Program will be obligated underhis/her terms and conditions of employment to (i) assign his/her entireworldwide right, title, and interest in and to any discovery, invention,improvement, or technological advance, including any Process Invention orProduct Invention, and any associated intellectual property, to Laureate, and(ii) comply at all times with the confidentiality obligations imposed onLaureate under this Agreement.  In theevent of any conflict between the terms and provisions of this document and theScope, the terms of this document shall control.

### (b)           Laureate will appoint a Laureaterepresentative (the “Program Manager”) to be responsible for thecompletion of the Program by Laureate. The Program Manager will coordinate performance of the Program with arepresentative designated by Customer (the “Customer Representative”),which representative shall have responsibility over all matters relating toperformance of the Program on behalf of Customer.  Unless otherwise agreed in the Scope, ormutually agreed to by the Parties, all communications between Laureate andCustomer regarding the conduct of the Program pursuant to the Scope shall beaddressed to or routed through the Program Manager and Customer Representative. Laureate may, at its option and uponnotice to and after consultation with Customer, substitute the Program Managerduring the course of the Program. Customer may, at its option and upon notice to Laureate, substitute itsCustomer Representative during the course of the Program.

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### (c)           Within thirty (30) days after theEffective Date, or such longer period as the Parties agree in writing, andprior to Laureate commencing the Program in any event, the Parties will preparea detailed document (“Quality Agreement”) specifying the quality andregulatory procedures and responsibilities of the Parties hereunder withrespect to the manufacture of Drug Substance and Drug Product.

(d)           Customer’srepresentatives may visit the Facility at appropriate times consistent with theProgram to observe the progress of the Program or to audit the Program, subjectto the limitations provided in Appendix 6 to this Agreement.

(e)           Duringthe term of the Program, Laureate will maintain a commercially reasonableprogram consistent with standard industry practice and/or applicable cGMP toregularly monitor and test the Facility, and undertake such precautions andprocedures as are commercially reasonable so as to minimize the risks ofcontamination from or to the Facilities and/or Materials as well as any damagethat occur in the event of an incident of contamination.  Upon reasonable prior request and duringbusiness hours, Laureate will provide access to Customer, in accordance withthe terms set forth in Appendix 6, to review documentation detailing theprocedures and testing used by Laureate for such purposes.  In the event Laureate becomes aware of anyincident of contamination at the Facility that could have an impact on theProgram, Laureate will (i) immediately implement such commercially reasonablysteps as are necessary to minimize and mitigate damage to the Facility,Materials, and Third Party property that may then be present in the Facilityand (ii) so notify Customer within two (2) business days after the dateLaureate becomes aware of the contamination.

# Section 4.  Program Materials.

### (a)           Customer will provide Laureate withsufficient amounts of Cell Line, reference standards, or other substances withwhich to perform the Program as specified in the Scope, as well as all documentationand such other data as may be necessary to apprise Laureate of the stability ofthe Materials, process characteristics, proper storage, and manufacturing andsafety requirements, including, without limitation, a certificate of analysisrelating to the Cell Line and reference standards as specified in Appendix 4.  Any Product-Dedicated Equipment provided toLaureate by Customer shall be in good operating condition and free from allmaterial defects.  Laureate will maintainwithin its sole possession and control any Cell Line and biological materialderived therefrom (for example, nucleic acids such as expression vectors, genesencoding the Drug Substance, etc.), as well as any cell line derived therefromby Laureate for production of Drug Substance pursuant to the Program.  Notwithstanding anything to the contraryherein, except for the purpose of carrying out the activities specified in theScope, Laureate will not for its own account or for the benefit of a ThirdParty propagate, culture, express, produce, distribute, dispose of, transfer,or sell any Cell Line or Material for any purpose whatsoever without the priorwritten consent of Customer.

### (b)           Laureate shall procure the Materials,Filling Components, and Process Consumables for use in the Program and eachmanufacturing run. By written notice to Laureate, Customer may procure certainFilling Components specified in the Scope, such as media, resins, vials,overseals, or stoppers.

### (c)           Laureate shall identify to Customersuch Product-Dedicated Equipment as may be required, including recommendedvendors, quantities, and such other information as needed by Customer in orderto procure Product-Dedicated Equipment required by Laureate to perform theProgram.  Upon   Customer’s authorization, Laureate mayprocure the Product-Dedicated Equipment and pass through the costs to Customerconsistent with Section 7, provided that Customer has approved in writing inadvance Laureate’s purchase thereof. By written notice to Laureate, Customermay procure certain Product-Dedicated Equipment for use in the Program at itsown expense.

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### (d)           Upon completion of the Program, (i)the Product-Dedicated Equipment will be returned to the Customer, at theCustomer’s expense, and (ii) any remaining samples of the Materials or othersubstances, documentation, or data provided to Laureate will be returned to theCustomer or retained by Laureate in compliance with applicable regulatoryrequirements or destroyed/disposed of by Laureate under written authorizationfrom Customer.

# Section 5.  Use of Subcontractors.

### (a)           Laureate reserves the right to employsubcontractors from time-to-time to undertake certain activities related to theProgram, provided that in any such event, Customer shall have the right, itselfor through a third party contractor of Customer that is reasonably acceptableto Laureate, to perform such activities. All Laureate subcontractors will be pre-approved by Customer and will beheld under obligations of confidentiality consistent with Section 9 of thisAgreement.  A list of known and approvedsubcontractors is provided in Appendix 5 to this Agreement.

### (b)           Neither Laureate nor Customer will beheld responsible or liable for the performance of any pre-approvedsubcontractor used for the Program or for any costs, expenses, damage or lossof any nature, whether direct or consequential occasioned by the performance ofor failure to perform the subcontracted services.

### (c)           Laureate will not be held responsibleor liable for the performance of any Third Party retained by Customer toperform services related to the Program, including, without limitation,distributors, consultants, and testing entities.

# Section 6.  Compliance with Government Regulations.

### (a)           Laureate will perform the Program inaccordance with the Scope.  Subject toSection 6(b), below, Laureate will also comply in all material respects withapplicable government regulatory requirements concerning cGMP appropriate tothe Program.

### (b)           Should such government regulatoryrequirements concerning cGMP and applicable to the Program be changed, Laureatewill make every reasonable effort to comply in all material respects with thenew requirements.  In the event thatcompliance with such new regulatory requirements necessitates, in the solediscretion of Laureate, a change in the Scope or the Program or the cost of theservices provided by Laureate, pursuant to Section 8, below, Laureate willsubmit to Customer a revised technical and cost proposal for Customer’sacceptance.  Unless the Parties agree toa revised Scope or Program or cost structure, as the case may be, Laureate willnot be obligated to continue to perform the existing Program, and either Partyshall have the right to immediately terminate this Agreement upon notice to theother Party; thereafter, neither Party shall have any further obligation witheach other.

### (c)           In the event of a conflict ingovernment regulations, Customer will designate, in writing, which regulationsshall be followed by Laureate in its performance of the Program and shall holdLaureate harmless for following such written designation.

# Section 7.  Compensation.

### (a)           Subject to the terms of thisAgreement, Laureate shall be paid the development and service fees listed on Appendix7 (the “ Service Fees”) to perform the services set forth on Appendix3, which Service Fees shall be subject to increase in accordance with theprovisions of Section 8, and Customer shall pay Laureate such fees inaccordance with the payment schedule set forth on Appendix 7.  Laureate will invoice Customer for Product-DedicatedEquipment purchased for the Program, provided 

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***CONFIDENTIALPORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THECOMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.

### Customer pre-approves suchpurchases in writing.  An administrativefee equal to ten percent (10%) of Laureate’s actual cost of Product DedicatedEquipment purchased for the Program will be added to Product-DedicatedEquipment invoices.  Payments are duethirty (30) days from the date of invoice, except that the Service Fees’payments are due at the times indicated on Appendix 7.  Late payments are subject to an interestcharge of one percent (1%) per month.

### (b)           As *** to have ***of the DrugSubstance and Drug Product paid by Customer, *** with a ***, which *** shallbe  ***. The foregoing *** shall not apply to any ***, including, but not limitedto, those ***.

# Section 8.  Change Orders.

### (a)           The Service Fees are subject to anumber of specific and general assumptions. The specific assumptions relate to the Scope and Program design andobjectives, timing, capital expenditure requirements, if any, and other mattersrelating to the completion of the Program as set forth in the Scope (the “ProgramAssumptions”).  Laureate also assumesthat the Customer will cooperate and perform its obligations under theAgreement and Scope in a timely manner, that no event outside the control ofLaureate will occur, including, without limitation, the events described inSection 21, and that there are no material changes during the term of theAgreement to any applicable laws, rules, or regulations that affect the Program(the foregoing assumptions together with the Program Assumptions, collectively,the “Assumptions”).  In the eventthat any of the Assumptions require modification or a deliverable listed inSection 2(b), above or Appendix 3, below, cannot be delivered based on theAssumptions (each being a “Modification”), then, upon written mutualagreement, the Scope may be amended as provided in paragraph (b) of thisSection 8.

### (b)           In the event a Modification isidentified by the Customer or by Laureate, the identifying Party shall notifythe other Party as soon as is reasonably possible.  Laureate shall use reasonable efforts toprovide the Customer with a change order containing an estimate of the requiredadjustments to the Service Fees within ten (10) business days of receiving ordelivering such notice (the “Change Order”).  Laureate agrees to refrain from performingthat aspect of the Program pertaining to a Change Order until Customer approvesthe Change Order. Customer shall use its best efforts to respond in writing tosuch Change Order promptly, with the understanding that if Customer does notapprove a Change Order in writing within ten (10) business days of its receiptfrom Laureate, Customer shall be deemed to have disapproved of the ChangeOrder.  If Customer does not approve suchChange Order and has not terminated this Agreement and the Program inaccordance with Section 23 but wants the Program to be modified to take intoaccount the Modification, then Customer and Laureate shall use commerciallyreasonable efforts to agree on a Change Order that is mutually acceptable,during which time, if practicable under such circumstances, Laureate may, inits discretion, continue to work on the Program, but Laureate shall not beobligated to continue to work on the Program during any such negotiations.  Laureate shall not commence work with respectto a Change Order unless authorized to do so in writing by Customer.  Any disagreement between the Partiesconcerning a Change Order (including, without limitation, the failure of theParties to agree upon a mutually acceptable Change Order) shall be addressed inaccordance with the dispute-resolution procedures set forth in Section 16(a)hereof; provided, however, that if the Parties are unable to ultimately agreeon the Change Order, either Party shall have the right to immediately terminatethis Agreement upon notice.  If this Agreementis terminated for failure of the Parties to agree to a Change Order, (i) ***,as set forth in Section ***; and (ii) ***.

# Section 9.  Confidential Information/Legal Proceedings.

### (a)           Laureate will not disclose, withoutCustomer’s written permission, Customer Confidential Information unless suchdisclosure:  (i) is to an Affiliate ofLaureate that is under a similar 

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### obligation to keep suchinformation confidential; (ii) is to a subcontractor that has been pre-approvedby Customer and that is under a similar obligation to keep such informationconfidential; (iii) is or becomes publicly available other than as a result ofa breach of this Agreement by Laureate; (iv) is disclosed by a Third Partywhich Laureate reasonably believes is entitled to disclose it withoutrestriction; (v) is already known to Laureate as shown by its prior writtenrecords; (vi) is independently developed by Laureate without the use ofCustomer Confidential Information or (vii) is required by any law, rule,regulation, order decision, decree, subpoena or other legal process to bedisclosed.  If such disclosure isrequested by legal process, Laureate will make all reasonable efforts to notifyCustomer of this request promptly prior to any disclosure to permit Customer tooppose such disclosure by appropriate legal action.

### (b)           Customer will not disclose, withoutLaureate’s written permission, Laureate Confidential Information unless suchdisclosure:  (i) is to an Affiliate ofCustomer that is under a similar obligation to keep such informationconfidential; (ii) is or becomes publicly available other than as a result of abreach of this Agreement by Customer; (iii) is disclosed by a Third Party whichCustomer reasonably believes is entitled to disclose it without restriction;(iv) is already known to Customer as shown by its prior written records; (v) isindependently developed by Customer without the use of Laureate ConfidentialInformation (including Laureate Know-How) or (vi) is required by any law, rule,regulation, order decision, decree, subpoena or other legal process to bedisclosed.  If such disclosure isrequested by legal process, Customer will make all reasonable efforts to notifyLaureate of this request promptly prior to any disclosure to permit Laureate tooppose such disclosure by appropriate legal action.

### (c)           Laureate will not transfer anyMaterials without Customer’s written permission to any Third Party unless suchtransfer is to a pre-approved subcontractor and is consistent with the Program.

### (d)           If Laureate shall be obliged toprovide testimony or records regarding the Program in any legal oradministrative proceeding, then Customer shall reimburse Laureate for itsreasonable out-of-pocket costs plus a reasonable hourly fee for its employeesor representatives at Laureate’s standard commercial rates.

# Section 10.  Work Product.

### (a)           All work outputs (e.g., reports) willbe prepared on Laureate’s standard format unless otherwise specified in theScope.

### (b)           Periodically during performance ofthe Program and at the conclusion thereof, Laureate will provide at no additionalcost to Customer the biological materials, data, information, and reportslisted in the Scope (collectively, the “Laureate Deliverables”).

# Section 11.  Inventions; Patents; License.

### (a)           Laureate shall promptly notifyCustomer of any Product Invention made by or on behalf of Laureate in thecourse of performing the Program. For good and valuable consideration, thereceipt and sufficiency of which is hereby acknowledged, Laureate herebyassigns to Customer, and Customer hereby accepts, Laureate’s entire worldwideright, title, and interest in and to any Product Invention.  If Customer requests, at Customer’s expense,Laureate will, or cause those of its employees, consultants, or other personnelto execute any and all applications, assignments, or other instruments, and, ifnecessary, to give testimony which shall be necessary to apply for and obtainLetters of Patent of the U.S. or of any foreign country with respect to theProduct Invention.  If, in the exerciseof its reasonable business judgment, Laureate believes that any request made byCustomer pursuant to this Section 11(a) is likely to require more than one (1)man-hour of effort in order to comply, Laureate shall so inform Customer, andif Customer requests Laureate to proceed and such efforts do exceed more thanone (1) man-hour in the 

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***CONFIDENTIALPORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THECOMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.

### particular instance, Customeragrees to promptly reimburse Laureate for those documented man-hours expendedin excess of one (1) man-hour, at the rate of *** per hour or portionthereof.  Notwithstanding the foregoing,with respect to the giving of testimony, court appearances, and the like, atCustomer’s request, Customer agrees to promptly reimburse Laureate on an hourlybasis at the rate of *** per hour or portion thereof, up to a maximum of eight(8) hours per business day, in addition to reimbursement for all documented,reasonable expenses associated with such testimony or appearance, includingmeals, lodging, and travel-related expenses.

### (b)           Notwithstanding anything to thecontrary herein, Laureate shall (i) retain all rights to any inventions,enhancements, improvements, or modifications relating to the Process,manufacturing methods, and processes, including any production, purification,and aseptic filling process, owned or controlled by Laureate as of theEffective Date, and (ii) own all rights in and to any Process Inventions andall Laureate Confidential Information, or any improvements, modifications, orenhancements thereto.

### (c)           Customer acknowledges that theProcess, Process Inventions, and Laureate Confidential Information are vestedin Laureate and that Customer shall not at any time have any right, title, orinterest in or to the Process, Process Inventions, Laureate ConfidentialInformation, or any other intellectual property rights relating to the Process,and any improvement, enhancements, or modifications to the Process, except asprovided in Section 11(e), below.

### (d)           Laureate reserves the right toutilize data generated during the course of the Program to supportapplications, assignments, or other instruments necessary to apply for andobtain Letters of Patent of the U.S. or of any foreign country with respect toProcess Inventions.

### (e)           Subject to Customer’s payment ofService Fees associated with cell line development, bioreactor processdevelopment, and/or purification process development in accordance withProgram, Laureate hereby grants to Customer, and Customer hereby accepts, aroyalty-free, fully paid-up, irrevocable worldwide non-exclusive license,including the rights to assign such licenses to Customer’s Affiliates,successors, and permitted assigns and to grant and authorize sublicenses undersuch license, to practice the Process (to the extent then developed) andProcess Inventions for the sole purpose of making and have made Drug Product orDrug Substance for Customer, provided that Customer obtains Laureate’s priorwritten consent for any sublicense to Third Parties, which consent shall not beunreasonably withheld, provided, however, that such consent shall not berequired in the event Customer grants a sublicense hereunder to a Third Partyin connection with the further clinical development and commercialization ofDrug Product or Drug Substance, provided that any such Third Party is notengaged primarily in the business of contract manufacturing of biologicalproducts for third parties and Customer provides prompt notification to Laureatealong with a copy of the executed sublicense agreement.

### (f)            Any technology transfer oradditional documentations or reports not covered within the Scope shall be atCustomer’s sole cost and expense. Subject to the reasonable requirements of its business and at Customer’sexpense, and provided that a license as set forth in Section 11(e) has comeinto effect, during the term of this Agreement and thereafter Laureate agreesto provide such technical assistance as may be reasonably requested by Customerin connection with establishing and utilizing the Process, or a portionthereof, at a facility owned by or contracted to Customer.  Laureate will provide such assistance at itsthen current rates for such services, and Customer will promptly pay Laureatefor any such services so requested and rendered, in addition to reimbursingLaureate for all documented, reasonable out-of-pocket expenses incurred byLaureate in rendering such services, including meals, lodging, andtravel-related expenses for Laureate personnel providing such services.

# Section 12.  Independent Contractor. Laureate shallperform the Program as an independent contractor of Customer, and shall havecomplete and exclusive control over its Facility, equipment, employees, and 

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# agents.  Nothing in this Agreement or otherarrangements for which it is made shall constitute Laureate, or anyone furnishedor used by Laureate in the performance of the Program, as an employee, jointventure, partner, or servant of Customer. Laureate also agrees that it shall not have any rights to receive anyemployee benefits such as health insurance and accident insurance, sick leave,or vacation as are in effect generally for employees of Customer.  Laureate will not enter into any agreementsor incur obligations on behalf of Customer nor commit Customer in any othermanner without prior written consent from a duly authorized officer orrepresentative of Customer.

# Section 13.  Insurance.

### (a)           Laureate agrees to maintain (i)workers’ compensation insurance, to the extent required by law in the state ofLaureate’s incorporation or location of the Facility; (ii) businessinterruption insurance having policy limits that are commercially reasonablegiven Laureate’s business of providing Program-related services; and (iii) astandard property insurance policy covering the Drug Product, Drug Substance,and Materials while under control and care of Laureate during the term of thisAgreement, including the replacement cost of Drug Product, Drug Substance,and/or Materials.

### (b)           Additionally, each of Laureate andCustomer agrees to maintain general liability insurance including coverage forbodily injury, death, and property damage in the amount of *** Dollars (US$***)per occurrence and *** Dollars (US$***) in the aggregate, during the term ofthis Agreement.  At such time as Customerbegins to administer Drug Substance or Drug Product to humans, and for so longas Customer is conducting a human clinical trial in respect of the DrugSubstance or Drug Product, Customer agrees to maintain general liabilityinsurance, including bodily injury, death, property damage, and product liabilitycoverage, in the amount of *** Dollars (US$***) per occurrence and *** Dollars(US$***) in the aggregate, and to name Laureate as an additional insured undersuch policy at no cost to Laureate.  Inaddition to the foregoing, Customer agrees that it will maintain workers’compensation insurance applicable to those of its employees who will be workingat the Facility.

### (c)           Customer further agrees to provideLaureate with a certificate(s) of insurance issued to Customer for an insurancepolicy or policies directed to the aforementioned insurance coverage, thatnames Laureate as an additional insured.

### (d)           Once Drug Product is received byCustomer’s shipping agent at Facility, Customer acknowledges that it shall bearall risk of loss, destabilization, alteration, or contamination of the DrugProduct or Materials due to any and all causes or hazards unless Laureate isfound to be grossly negligent or have engaged in intentional misconduct, aswell as risks associated with patent or other intellectual property rights ofThird Parties alleged to have been infringed by the manufacture, use,importation, or sale of the Drug Product or Materials by Laureate, providedthat such allegations relate only to Materials, Customer ConfidentialInformation, or Customer Know How and not to the use of Laureate ConfidentialInformation or the exercise of rights granted under Section 11(e), above.

# Section 14.  Shipping.  Laureate shall package for shipment DrugSubstance, Drug Product, samples, or other Materials in accordance withCustomer’s written instructions and at the Customer’s expense.  All shipments will be F.C.A. (Incoterms2000), Facility, and Customer shall bear all packaging, shipping, and insurancecharges as per Appendix 8. Delivery of Drug Substance, samples, or other materials by Laureateshall be deemed to have taken place upon delivery to carrier at theFacility.  Title and risk of loss shalltransfer to Customer on transfer to carrier at the Facility.  Laureate shall accept no liability orresponsibility and risk associated with failure of Filled Products to meetSpecifications once this transfer has occurred, provided that such failure isnot attributable to acts or omissions of Laureate that occurred prior to suchtransfer.  Laureate shall retainrepresentative samples of Drug Product and Filled Products for record keeping,testing, and regulatory purposes.

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# Section 15.  Default.

### (a)           Notwithstanding anything to thecontrary herein, if Laureate is in default of a material obligation under thisAgreement (“Default”), then Customer shall promptly notify Laureate in writingof any such Default.   Laureate shallhave a period of forty-five (45) days from the date of receipt of such noticewithin which to cure such Default, provided that if such Default renders furtherperformance of the Program commercially impracticable or invalid, then Laureateshall, at Customer’s option, either (1) repeat the Program at Laureate’s costwithin a time period mutually agreed to by Laureate and Customer or (2) refundthe Service Fees paid by Customer.  IfLaureate shall fail to cure such Default within the specified cure period orrepeat the Program, as the case may be, then this Agreement shall, at Customer’soption, immediately terminate upon notice by Customer to Laureate to such effect,without further obligation to Laureate. In the event of such termination, Customer’s sole remedy shall be, inthe case where such Default has not rendered completion of the Programcommercially impracticable, a reduction in the Service Fees in an amount equalto the difference between (1) the Service Fees paid by Customer for that aspectof the program and (2) the value of the work properly performed, as documentedby Laureate in meeting minutes, time sheets, and such other documentation asmanintained by Laureate for the purpose of tracking Program-related expenses.

### (b)           Notwithstanding anything to thecontrary herein, if Customer is in default of a material obligation under thisAgreement, Laureate shall promptly notify Customer in writing of any suchdefault.  Customer shall have a period offorty-five (45) days from the date of receipt of such notice within which tocure such default, provided that if Customer fails to cure such breach withinthe specified cure period, this Agreement shall, at Laureate’s option,immediately terminate upon notice by Laureate to Customer to such effect.  Notwithstanding the cure period specified inthe preceding sentence, if Customer fails to make any payment to Laureatewithin the time period specified in Section 7 and/or Appendix 7 attachedhereto, Laureate may, in its discretion, suspend performance of the Programuntil Laureate receives such outstanding payment.

# Section 16.  Dispute Resolution.

### (a)           In the event any dispute shall arisebetween the Customer and Laureate with respect to any of the terms andconditions of this Agreement or the Program, then a senior executive of each ofCustomer and Laureate shall meet as promptly as practicable, but in no eventwithin less than fifteen (15) business days, after notice of such dispute toattempt to resolve in good faith such dispute.

### (b)           Except as otherwise provided in thisAgreement, if senior executives of Customer and Laureate are unable tosatisfactorily resolve a dispute, then such dispute shall be finally settled bybinding arbitration in accordance with this Section 16.  The arbitration will be held in the State ofNew Jersey, and except as noted below, shall be conducted in accordance withthe rules of the American Arbitration Association (or such successor organization)by one (1) arbitrator appointed by mutual agreement of the Parties, or if theParties are unable to agree on an arbitrator within fifteen (15) business daysof a Party requesting arbitration, by the American Arbitration Association (orsuch successor organization) upon receipt of a request by one of theParties.  The arbitrator shall have noauthority to vary from or ignore the terms of this Agreement and shall be boundby controlling law.  Finally, the Partiesmay seek judicial intervention for emergency relief, such as restraining ordersand injunctions where appropriate.

### (c)           Any decision by the arbitrator shallbe final and binding upon the Parties, and may be entered as final judgment inany court having competent jurisdiction. The cost of any arbitration proceeding shall be borne by the Parties asthe arbitrator shall determine if the Parties have not otherwise agreed.  The arbitrator shall render his/her finaldecision in writing to the Parties.

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# Section 17.  Indemnification.

### (a)           Laureate shall defend, indemnify, andhold harmless Customer and its Affiliates and their respective officers, directors,and employees for any loss, cost, damage, or expense (a “Loss”) arisingfrom any lawsuit, action, claim, demand, assessment, or proceeding (a “Claim”)by a Third Party for (i) personal injury or property damage arising oroccurring during the conduct of the Program as a result of Laureate’snegligence or intentional misconduct; (ii) the negligence or intentionalmisconduct or inaction of or breach by Laureate in the performance of itsobligations under this Agreement; or (iii) Laureate’s breach of any of therepresentations or warranties contained in this Agreement; provided, however,that if such Loss or Claim arises in whole or in part from Customer’snegligence or intentional misconduct, then the amount of the Loss that Laureateshall indemnify Customer for pursuant to this Section 17 shall be reduced by anamount in proportion to the percentage of Customer’s responsibilities for suchLoss.

### (b)           Customer shall defend, indemnify, andhold harmless Laureate and its Affiliates and their respective officers,directors, employees, and agents (the “Laureate Group”) for any Lossarising from any Claim by a Third Party for (i) personal injury or propertydamage directly or indirectly caused by the Cell Line, Materials, Drug Product,or Drug Substance; (ii) the harmful or otherwise unsafe effect of the DrugProduct or Drug Substance resulting from exposure thereto; (iii) the use,consumption, sale, distribution, or marketing of the Drug Substance or DrugProduct; (iv) the negligence or intentional misconduct or inaction of or breachby Customer in the performance of its obligations under this Agreement; (v) theinfringement of any patents or other intellectual property rights of any ThirdParty with respect to Laureate’s use of Materials, Customer Confidential Information,Customer Know How, Drug Substance, or Drug Product pursuant to performing theProgram, provided that such infringement is not the result of Laureate’s use orpractice of Laureate Confidential Information or a Laureate SOP, or (vi)  Customer’s breach of any of therepresentations, warranties, or covenants contained in this Agreement;provided, however, that if such Loss or Claim arises in whole or in part fromLaureate’s negligence or intentional misconduct (including infringement Claimthat is directly attributable to Laureate’s use of Laureate ConfidentialInformation), then the amount of such Loss that Customer shall indemnify theLaureate Group for pursuant to this Section 17 shall be reduced by an amount inproportion to the percentage of Laureate’s responsibilities for such Loss.

### (c)           Subject to the limitations set forthin Section 18(a), below, Laureate’s compliance with its obligations underSection 3(e), above, and to the extent not covered by worker’s compensationinsurance carried by Laureate, which worker’s compensation insurance shall beprimary, Customer agrees to assume responsibility for *** for which Laureate isotherwise uncompensated in the event that the handling of Cell Line, Materials,Drug Substance, or Drug Product on its premises, in accordance with LaureateSOP, the Scope, and the terms of this Agreement results in contamination ofequipment, facilities, personnel, or Third Parties by an infectious agent (inany event, a “Contaminant”) in the Cell Line, Materials, Drug Substance,or Drug Product as received by Laureate from Customer, but only to the extentsaid Contaminant(s) have been conclusively determined to have arisen from theinfectious agent.  Here, “infectiousagent” refers to any (i) noxious, toxic, or corrosive agent, or (ii) anymicrobiological or viral agents of infection, including, but not limited, tobacteria, fungae, mycoplasmas, prions, and viruses detectable in accordancewith GMP.  For purposes of this Section17(c), *** shall be deemed to include ***. To the extent that any contamination of equipment, facilities,personnel, or Third Parties is conclusively determined to be materially causedby Laureate’s negligent conduct (or that of a subcontractor retained byLaureate to perform one or more aspects of the Program), including a failure tofollow GMP (if applicable) or Laureate SOP or the terms of this Agreement, thenLaureate will assume full responsibility for any such direct damages andCustomer shall have no obligation in this regard with respect to such contamination.

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### (d)           Upon receipt of notice of any Claimthat may give rise to a right of indemnity from the other Party hereto, theParty seeking indemnification (the “Indemnified Party”) shall givewritten notice thereof to the other Party (the “Indemnifying Party”) ofthe Claim for indemnity within a time period that does not prejudice the rightsof the Indemnifying Party to exercise its full rights to provideindemnification hereunder.  An obligationto defend, indemnify, and hold harmless shall include the right of subrogationwith respect to any Claim for which indemnification is sought under this Agreement.  Such Claim for indemnity shall indicate thenature of the Claim and the basis therefore. Promptly after a Claim is made for which the Indemnified Party seeksindemnity, the Indemnified Party shall permit the Indemnifying Party, at itsoption and expense, to assume the complete defense, including settlement, ofsuch Claim; provided, however, that (i) the Indemnified Party will have theright to participate in the defense of any such Claim at its own cost andexpense; (ii) the Indemnified Party may retain separate counsel at IndemnifyingParty’s cost and expense if Indemnified Party shall have reasonably concluded,upon the advice of outside counsel, that there is a conflict of interestbetween the Indemnified Party and the Indemnifying Party; (iii) theIndemnifying Party will conduct the defense of any such Claim with due regardfor the business interests and potential related liabilities of the IndemnifiedParty; and (iv) the Indemnifying Party will, prior to making any settlement,consult with the Indemnified Party as to the terms of such settlement.  The Indemnifying Party will not, in defenseof any such Claim, except with the consent of the Indemnified Party, whichconsent shall not be unreasonable withheld, consent to the entry of anyjudgment or enter into any settlement which does not include, as anunconditional term thereof, the giving by the claimant or plaintiff to theIndemnified Party of a release from all liability in respect thereof.  After notice to the Indemnified Party of theIndemnifying Party’s election to assume the defense of such Claim, theIndemnifying Party shall only be liable to the Indemnified Party for suchreasonable legal or other expenses subsequently incurred by the IndemnifiedParty in connection with the defense thereof at the request of the IndemnifyingParty.  As to those Claims with respectto which the Indemnifying Party does not elect to assume control of thedefense, the Indemnifying Party shall be liable for all reasonable legal orother expenses incurred by the Indemnified Party in connection with the defensethereof, and the Indemnified Party will afford the Indemnifying Party anopportunity to participate in such defense at the Indemnifying Party’s own costand expense, and will not settle or otherwise dispose of any of the samewithout the consent of the Indemnifying Party. In the event an Indemnified Party does not provide an Indemnifying Partywith adequate notice of a Claim for which indemnification is sought hereunder,then the Indemnifying Party shall owe the Indemnified Party no furtherobligation with respect to such Claim.

# Section 18:  Limitations on Liability.

### (a)           UNDER NO CIRCUMSTANCES SHALL EITHERPARTY BE LIABLE TO THE OTHER PARTY, AN AFFILIATE OF THE OTHER PARTY, OR ANYTHIRD PARTY FOR INCIDENTAL, INDIRECT, CONSEQUENTIAL, OR SPECIAL DAMAGES ARISINGIN CONNECTION WITH THIS AGREEMENT, THE SCOPE, THE PROGRAM, OR ANY DOCUMENTS ORAPPENDICES RELATED THERETO.  IN NO EVENTSHALL LAUREATE’S LIABILITY UNDER THIS AGREEMENT EXCEED the aggregate ServiceFees received by Laureate at the time the liability in question arose, and inno event shall Customer’s liability to Laureate exceed *** Dollars ($***)***.  These limitations of liabilityreflect the allocation of risk between the Parties.  The limitations specified in this Section 18will survive expiration or termination of this Agreement.

### (b)           By way of clarification, Laureate’saggregate liability resulting from the loss, destabilization, alteration, orcontamination of Drug Product of a particular Batch in crude or purified formas a result of Laureate’s breach of this Agreement, failure to comply with amaster Batch Record or negligence, wherein such Drug Product is lost,destabilized, altered, or contaminated such that it cannot be used in clinicaltrials or cannot be placed into commerce, shall not exceed the Service Feesreceived by Laureate with respect to the Batch in question.

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### (c)           By way of clarification, Laureate’saggregate liability in respect of any Claim by Customer shall not exceed theService Fees paid by Customer to Laureate up through the date of such Claim.

# Section 19.  Representations and Warranties.

### (a)           Customer hereby represents andwarrants to Laureate that it has legal title and/or a valid license to the CellLine and Materials and that, to the best of its knowledge as of the EffectiveDate, Laureate’s performance in making and use of the Cell Line and Materialsin performance of the Program will not violate or infringe on the patents,industrial property rights, trade secrets, trademarks, tradenames,servicemarks, copyrights, or any other intellectual property rights of anyThird Party.  Customer further representsand warrants that it is and throughout the term of this Agreement shall remainentitled to supply Cell Line, Materials, and Customer Confidential Information,and Customer Know How to Laureate.

### (b)           Laureate hereby represents andwarrants that it has legal title and/or a valid license to use LaureateConfidential Information and Laureate Know How in performing the Program, andthat to the best of its knowledge as of the Effective Date, Laureate’s use ofLaureate Confidential Information and/or Laureate Know How in performing theProgram will not violate or infringe on the patents, industrial propertyrights, trade secrets, trademarks, tradenames, servicemarks, copyrights, or anyother intellectual property rights of any Third Party.

### (c)           Customer will notify Laureateimmediately if Customer becomes aware that it is no longer entitled to supplythe Cell Line, Materials, Customer Confidential Information, or Customer KnowHow to Laureate or that the use by Laureate of such materials and/orinformation infringes or is alleged to infringe any rights (including anyintellectual or industrial property rights) vested in any Third Party.

### (d)           Laureate will notify Customerimmediately if Laureate becomes aware that Customer’s practice of the Processor Process Invention infringes or is alleged to infringe any rights (includingany intellectual or industrial property rights) vested in any Third Party.

### (e)           Customer hereby represents toLaureate that the Customer has performed all testing required by Laureate toassure that the Materials and Cell Line are safe, stable, and effective, andare and will be in compliance with all federal, state, and local laws andregulations required for use, distribution, and testing of such materials andthat such materials pose no environmental risk.

### (f)            Laureate hereby represents andwarrants that it will perform or have performed all testing specified byCustomer with respect to the Cell Line and in accordance with Customer’swritten instructions.

### (g)           Customer hereby represents andwarrants to Laureate that any technical or regulatory information ordocumentation supplied by Customer or on its behalf to Laureate (including, butnot limited to, process details, analytical methods, Specifications,development reports, technology transfer documents, plans, engineeringdocuments and other documents) and required for execution of the Program isaccurate and suitable for its intended use

### (h)           Laureate hereby represents andwarrants to Customer that if the Program is successfully completed, Laureatewill provide the necessary technical or regulatory information or documentationin order for Customer to practice the Process, and any Process Invention, forthe production of Drug Product for human clinical use.

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### (i)            Each Party hereby represents andwarrants to the other Party that it has full power and authority to enter into,deliver, and perform its obligations under this Agreement, and it has taken allaction required to authorize the execution and delivery of this Agreement andto consummate the transactions contemplated hereby, and the person signing thisAgreement on behalf of such Party has been duly authorized to act on behalf ofand to bind such Party.

### (j)            Laureate warrants and representsthat (i) the Program will be performed in accordance in with standard industrycustom, (ii) it will use all commercially reasonable efforts to achieve thespecified deadlines for the Program, (iii) the Drug Product will meet in allmaterial respects the Specifications set forth in the Program at the time ofdelivery to Customer; and (iv) that the Drug Product will be manufactured andtested, and all associated documentation will be prepare and maintained, inaccordance with GMP, to the extent applicable, and Customer’s writteninstructions.

### (k)           THE EXPRESS WARRANTIES OF LAUREATESET FORTH IN SECTION 19 ARE IN LIEU OF ALL CONDITIONS, WARRANTIES, ANDSTATEMENTS IN RESPECT OF THE PROGRAM AND/OR THE DRUG PRODUCT, WHETHER EXPRESSOR IMPLIED BY STATUTE, CUSTOM OF THE TRADE, OR OTHERWISE, INCLUDING ANY SUCHCONDITION, WARRANTY, OR STATEMENT RELATING TO THE DESCRIPTION OR QUALITY OF THEDRUG PRODUCT UPON COMPLETION OF LAUREATE’S SERVICES, ITS FITNESS FOR APARTICULAR PURPOSE, OR USE UNDER ANY CONDITIONS, WHETHER OR NOT KNOWN TOLAUREATE, AND THAT ANY SUCH CONDITION, WARRANTY, OR STATEMENT IS EXCLUDED FROMTHIS AGREEMENT.

# Section 20.  Force Majeure.  Either Party shall be excused from performingits respective obligations under this Agreement if its performance is delayedor prevented by any event beyond such Party’s reasonable control, including,but not limited to, acts of God, fire, explosion, weather, disease, war,terrorism, insurrection, civil strife, riots, government action, or powerfailure, provided that such performance shall be excused only to the extent ofand during such disability.  Any timespecified for completion of performance in the Scope falling due during orsubsequent to the occurrence of any or such events shall be automaticallyextended for a period of time reasonably necessary to recover from suchdisability.  Laureate will promptlynotify Customer if, by reason of any of the events referred to herein, Laureateis unable to meet any such time for performance specified in the Scope.  If any part of the Program is invalid as aresult of such disability, Laureate will, upon written request from Customer,but at Customer’s sole cost and expense, repeat that part of the Program affectedby the disability.

# Section 21.  Use of Names.  Each party shall be permitted to use the nameand logo of the other Party in the promotion of its business.  Usage shall be permitted for (i) promotionalpurposes, (ii) sales and marketing materials, (iii) web sites, and (iv) othercustomary business uses agreed to by the Parties.  Without the consent of the other Party, suchusage shall be limited to general factual statements concerning therelationship between Laureate and Customer, including, without limitation, thatLaureate and Customer have entered into an agreement for the provision ofproduction, purification, and aseptic filling services to Customer, but shallnot include any financial terms.

# Section 22.  Term; Termination.

### (a)           This Agreement shall commence on theEffective Date and shall continue in full force and effect until December 31,2007, unless earlier terminated in accordance with the other provisions of thisAgreement.  Customer shall also have theright to terminate this Agreement and the Program with immediate effect, uponnotice to Laureate, upon the occurrence of any of the events specified inSection 2(b), Section 6(b), Section 8(b) (Modification initiated by Laureate),or Section 15(a), in which event Laureate shall immediately cease performancehereunder, and upon presentation by Laureate to Customer 

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### of a final invoice fornon-cancelable obligations and other payments then due in accordance with Appendix7 for services already provided pursuant to the Scope (the “FinalInvoice”), Customer will, within thirty (30) days after receipt of theFinal Invoice, pay to Laureate those amounts invoiced for non-cancelableobligations incurred by Laureate prior to Customer’s notice of termination, itbeing understood and agreed that Customer shall have no further paymentobligation to Laureate hereunder and that Customer may, at its option, apply anyamounts advanced to Laureate but not applied to the payment of suchnon-cancelable obligations, if any; and provided further that Laureate shallrefund to Customer the balance of any advance(s) not then applied.  ** **Additionally, (i) up until ten (10)business days after *** in accordance with Section ***, above, Customer shallhave the right to terminate this Agreement for any reason, effective ***, and(ii) after *** in accordance with Section ***, above, Customer shall have theright to terminate this Agreement for any reason and at any time prior tocompletion of the Program by giving ninety (90) days written notice toLaureate, in which event Laureate shall comply with such notice and terminatework on the Program as soon as practicable, and use its commercially reasonableefforts to complete all activities underway and reduce cost to Customer, and***.  For purposes of clarification, ***is applicable for any early termination of this Agreement except for terminationsmade pursuant to Section ***, Section ***, Section ***, and Section ***.

### (b)           The termination of this Agreement forany reason shall not relieve either Party of its obligation to the other Partyfor obligations in respect of (i) compensation for services performed prior toreceipt of notice of termination (Section 7, Section 8, Section 22 and Appendix7), (ii) confidentiality of information (Section 9), (iii) inventions andpatents (Section 11), (iv) insurance (Section 13), (vi) indemnification(Section 17), and (vii) consents for advertising purposes and publications(Section 21).  In addition, any provisionthat, by it nature, is intended to survive expiration or termination hereof,shall survive.

# Section 23.  Assignment.  This Agreement may not be assigned orotherwise transferred by either Party without the prior written consent of theother Party; provided, however, either Party may, without such consent, assignthis Agreement (i) in connection with the transfer or sale of all orsubstantially all of the assets of such Party or, in the case of Customer, theCell Line, Drug Substance, or Drug Product; (ii) in the event of the merger orconsolidation of a Party hereto with another company; or (iii) to any Affiliateof the assigning Party.  Any purportedassignment in violation of the preceding sentence shall be void.  Any permitted assignee shall assume allobligations of its assignor under this Agreement, provided however that ifCustomer assigns this Agreement to an Affiliate, the Customer shall continue toremain obligated under this Agreement.

# Section 24.  Notice.

### (a)           All notices to be given as requiredin the Agreement shall be in writing and may be delivered personally, or mailedeither by a reputable overnight carrier with required receipt signature orcertified mail, postage prepaid to the Parties at the addresses set forth aboveor at such other address as either Party may provide by written notice to theother Party in accordance with the provisions of this Section 25. Such noticeshall be effective: (i) on the date sent, if delivered personally or byfacsimile (receipt of which is confirmed); (ii) the date after delivery if sentby overnight carrier; or (iii) on the date received if sent by certified mail.

If to Customer

Lpath, Inc.

6335 Ferris Square

San Diego, CA 92121

Attn:   President & CEO

Telefax:  858-678-0900

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If to Laureate

Laureate, Inc.

201 College Road East

Princeton, NJ 08540

Attn:  Robert J. Broeze, Ph.D., Chief ExecutiveOfficer

Telefax:  (609) 520-3963

 

With a copy to:

 

Safeguard Scientifics,Inc.

800 The Safeguard Building

435 Devon Park Drive

Wayne, PA  19087

Attn:   Legal Department

Fax:  (610) 975 - 0261

# Section 25.  Choice of Law.  This Agreement, and all matters arisingdirectly or indirectly hereunder, shall be governed by, and construed inaccordance with the laws of the State of New Jersey.

# Section 26.  Headings.  The heading of each paragraph of thisAgreement is for descriptive purposes only and shall not be deemed to modify orqualify any of the provisions, rights, or obligations set forth in thisAgreement.

# Section 27.  Waiver/Severability. No waiver of anyprovision of this Agreement, whether by conduct or otherwise, in any one ormore instances shall be deemed to be or be construed as a further or continuingwaiver of any such provision, or of any other provision or condition of thisAgreement.  The invalidity of any portionof this Agreement shall not affect the validity, force, or effect of theremaining portions of this Agreement.  Ifit is ever held that any provision hereunder is too broad to permit enforcementof such provision to its fullest extent, such provision shall be enforced tothe maximum extent permitted by law.

# Section 28.  Entire Agreement;Modification/Counterparts.  Thisdocument (and the Scope and Appendices attached hereto) sets forth the entireAgreement between the Parties hereto with respect to the performance of theProgram by Laureate for Customer and as such, supersedes all prior andcontemporaneous negotiations, agreements, representations, understandings, andcommitments with respect thereto and shall take precedence over all terms,conditions, and provisions on any purchase order form or form of orderacknowledgment or other document purporting to address the same subjectmatter.  This Agreement shall not bewaived, released, discharged, changed, or modified in any manner except by aninstrument signed by the duly authorized officers of each of the Partieshereto, which instrument shall make specific reference to this Agreement andshall express the plan or intention to modify same.  This Agreement may be executed in one or morecounterparts, each of which shall be deemed an original but all of whichtogether shall constitute one and the same instrument.  In the event of any conflict between thisAgreement and the Scope, as it may be modified as provided herein, the terms ofthis Agreement shall control.  Forpurposes of execution, facsimile signatures shall be deemed originals.

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This Agreementbecomes effective and binding on both Parties as of the Effective Date.  Should terms contained herein be at variancewith the terms and conditions specified in Customer’s written acceptance, thenthe terms and conditions contained herein take precedence.

 
| LAUREATE PHARMA, INC. |
|-----------------------|
|                  |
|                  |
|                  |
| By:                   |   |   |   |
| Name:                 | Robert J. Broeze, Ph.D. |
| Title:                | President & Chief Executive Officer |
|                  |
| LPATH, INC.           |
|                  |
|                  |
|                  |
| By:                   |   |   |   |
| Name:                 |   |
| Title:                |   |

 

 

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APPENDIX 1

Cell Lines andTheir Products

1.             “Humanized SphingomabTM”, a recombinant “humanized”monoclonal antibody specific for sphingosine-1-phosphate (S1P) for use inclinical trials as a therapeutic for diseases such as cancer and variousinflammatory and cardiovascular conditions, which recombinant “humanized”monoclonal antibody constitutes the “Drug Substance” referenced in thisAgreement.

2.             Other antibodies / proteins as may be agreed upon inwriting by the Parties.

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***CONFIDENTIAL PORTIONSOF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSIONPURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.

APPENDIX 2

Scope of Work

Materials and Informationto be Provided by Customer

Customer shall providethe following information and materials to Laureate:

1.             A technology transfer information package that includes:

a.             Information about each Cell Lineand Drug Substance that it produces, including results of sterility,mycoplasma, and additional adventitious agent testing and characterization ofthe Cell Line, to the extent such information is then available to Customer.

b.             Known information and procedurespertaining to the production, purification, impurities, testing, stability, anduse of the Drug Substance, including Laureate’s product informationquestionnaires for “Contract Production Services,” “ContractPurification Services”, and “Aseptic Filling Services”, asappropriate for each Drug Substance.  Itis understood, however, that, as of the Effective Date, Customer has notproduced Drug Substance, which is a “humanized” monoclonal antibody based onCustomer’s murine monoclonal SphingomabTM antibody (“Murine SphingomabTM”).  As a result, most, if not all, informationprovided by Customer to Laureate re Drug Substance will be based on MurineSphingomabTM.

c.             A Material Safety Data Sheet (MSDS)for the Drug Substance or Murine SphingomabTM, as the case may be.

2.             A plasmid containing the genes encoding Drug Substanceand a selectable marker.  Customer willalso provide the Cell Line.  Customerwill provide documentation demonstrating that it has obtained all necessarylicenses for Customer and Laureate to use the selected expression system andits components.

3.             The test method for the binding ELISA, as well as othertest methods developed by Customer that will be transferred to Laureate for usesolely in connection with the Program. If available, development reports for the methods will be provided.

4.             At least *** of purified Murine SphingomabTM for use asan interim reference standard.

5.             Any other technical documents or information in thepossession of or available to Customer that are required by Laureate tocomplete the Program.

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***CONFIDENTIAL PORTIONSOF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSIONPURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.

APPENDIX 3

Scope of Work

Scope of Activities To BePerformed By Laureate

1.             Technology transfer of project information andmaterials.

a.     Customer will transfer to Laureate allinformation and materials required to initiate cell line development and tobegin development of process and method development.

b.     Laureate will provide Customer with a Ganttchart of proposed timelines for studies outlined in Appendix 3.

2.             Cell line transfection.

a.     ***. Select a lead clone.

b.     Evaluate the growth and productivity of theclone under the following conditions:

(i)            Batch culture, continue cultureuntil cell viability is ***.  Determineantibody titer, antibody potency, cell count, and cell viability daily.

(ii)           Batch culture, change media andsuspend cells in fresh media daily, continue culture until cell viability is***.   Determine antibody titer, antibodypotency, cell count, and cell viability daily.

(iii)          ***. Continue culture***.  Run may bestopped earlier if good growth and antibody productivity is not achieved orsustained.  Determine antibody titer,antibody potency, cell count, and cell viability daily.

(iv)          ***, continue culture until cellviability is less then ***, with the duration of the culture***.  Determine antibody titer, antibody potency,cell count, and cell viability daily.

3.             Cell Line Development

a.             Assist Customer in transfecting ***or *** cell lines, as specified by Customer, with plasmid DNA containing theDrug Substance genes and a selectable marker, such a *** or ***. Carry out***.

b.             Screen and select clones for goodgrowth and productivity, as well as antibody potency, as determined by ELISA.

c.             Select and expand approximately ***clones.  Evaluate growth and productivityin shake flask cultures.  Screening willalso include antibody potency, as determined by ELISA.

d.             Select *** lead clones and evaluategrowth and productivity in commercially available serum-free media.  Screening will also include antibody potency,as determined by ELISA.

e.             Select *** lead clones and a cellculture medium; evaluate stability of each of the *** clones for 50generations.  Screening will also includeantibody potency, as determined by ELISA.

f.              Select a lead clone, based ondouble time, productivity and stability. Arrange pre-bank testing, creation of a master cell bank, and testing ofthe master cell bank.

g.             Provide updates on the progress ofthis aspect of the Program from time to time, as mutually agreed upon andscheduled by Laureate and Customer, and provide a final written report toCustomer detailing the creation and development of the above-referenced celllines. If the above activities 3(a)-(f) do not yield a lead clone demonstratinggood growth, productivity, and antibody potency, Laureate will *** with respectthereto in an effort to obtain a lead clone demonstrating good growth,productivity, and antibody potency.

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***CONFIDENTIAL PORTIONSOF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSIONPURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.

4.             Bioreactor Process Development (selection of engineeringplatform to be based upon results obtained pursuant to conducting the studiesreferenced in activity 2, above, of this Appendix 3)

a.             Evaluate growth and productivity ofthe lead clone ***, with control of pH, temperature, dissolved oxygen, andagitation.  Evaluation to includeantibody potency, as determined by ELISA.

b.             Develop a commercially reasonable,scalable fed batch production process by optimizing the times and amounts offeed addition.  Evaluation to includeantibody potency, as determined by ELISA.

c.             Evaluate and optimize a temperatureshift in order to increase Drug Substance production.  Evaluation to include antibody potency, asdetermined by ELISA.

d.             Complete *** runs *** and *** runs*** in order to demonstrate reproducibility and initial scalability of theselected process.  Evaluation to includeantibody potency, as determined by ELISA.

e.             Provide updates on the progress ofthis aspect of the Program from time to time and provide a final written reportto Customer detailing the bioreactor process and its development.

5.             Purification Process Development

a.             Develop a commercially reasonable,scalable process for the purification of Drug Substance from the bioreactorharvest that optimizes product recovery and results in a product that meetstarget specifications for product purity, activity, and viral clearance.  Evaluation to include antibody potency, asdetermined by ELISA.

b.             Write and carry out a protocol forvalidation of viral clearance; provide same to Customer.  The study, using a scaled-down process, willbe carried out at a third party contract virus testing facility, such as CharlesRiver Laboratories.

6.             Analytical method transfer and qualification

a.             Qualify all test methods bydemonstrating that the methods meet mutually agreed upon performancerequirements.  Performance requirementsand assays will be described in an “Assay Transfer and Qualification Protocol”,which Laureate will develop in consultation with Customer.  The following test methods will be qualified:SDS-PAGE, IEF, SE-HPLC, endotoxin, binding ELISA, host cell protein (HCP)ELISA, and Protein A ELISA.

b.             Provide a final written report toCustomer describing the results of the qualification.

c.             Outsource other required DrugSubstance testing, with the understanding that Customer will have the firstoption to provide any such required Drug Substance testing.

7.             Formulation Development and Stability Study

a.             Develop and carry out a protocol toevaluate the effect of pH, buffers, salts, and excipients on Drug Substancepotency, integrity, and stability. Evaluate the effect of elevated temperature and agitation on Drug Substanceintegrity.  Carry out a 6-week study offormulations selected by the Parties. Describe the formulations and results in a detailed final writtenreport, to be provided to Customer.

8.             Production of Drug Substance for non-clinical studies

a.             Perform a non-cGMP production runin ***, and purify the Drug Substance from the harvest.

b.             Analyze purified Drug Substanceusing the following methods: pH, appearance, protein concentration, SDS-PAGE,IEF, SE-HPLC, activity ELISA, HCP ELISA, Protein A ELISA, and endotoxin.  Results will be shared in writing withCustomer.  Other analysis may be requiredand will be outsourced, with the understanding that Customer will have thefirst option to provide any such required Drug Substance testing.

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***CONFIDENTIAL PORTIONSOF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSIONPURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.

9.             Process scale-up and Engineering Run

a.             Write specifications, standardoperating procedures, and master batch records required for the process;provide same to Customer.

b.             Order, receive, and releasematerials required for the process.

c.             Perform an engineering productionrun in the 200 L bioreactor and purify the antibody from the harvest.

d.             Analyze Drug Substance using thefollowing methods: pH, appearance, protein concentration, SDS-PAGE, IEF,SE-HPLC, activity ELISA, HCP ELISA, Protein A ELISA, and endotoxin.  Results will be shared in writing withCustomer.  Other analysis may be requiredand will be outsourced, with the understanding that Customer will have thefirst option to provide any such required Drug Substance testing.

e.             Material may be used for stabilitystudies, toxicology study, viral clearance validation, or other non-clinicalstudies.

f.              If requested, aseptically fillDrug Substance to make Drug Product.

10.           Clinical material production (cGMP)

a.             Production and purification at the*** to meet Customer requirements for Drug Substance.

b.             Aseptic filling of Drug Product.

c.             Release testing of Drug Substanceand Drug Product.

11.           Stability studies of bulk DrugSubstance and vialed Drug Product

a.             Stability studies by protocolagreed to by Customer.

b.             Stability data summarized at eachtime point and described in a detailed written report provided to Customer at theend of each study.

Activities Not Includedin Scope: Arrangement of transportation and carrier insurance of bulk or vialedDrug Substance or Drug Product to Customer.

Laureate Deliverables

(i)            During the performance of theProgram, Laureate will provide Customer with at least *** viable aliquots ofany cell line adapted by Laureate for production of Drug Substance using theProcess.

(ii)           During the performance of theProgram, Laureate will provide Customer with secure online access toinformation generated in the course of performing the Program in accordancewith such procedures as are customary with other Laureate customers.

(iii)          Within ten (10) days after the end ofeach calendar month during the performance of the Program, Laureate willprovide Customer with all data relevant to the optimization or production ofDrug Substance using the Process, in electronic and paper forms reasonablyacceptable to Customer.

(iv)          Laureate will provide Customer with atleast three (3) samples of conditioned medium, each in triplicate, forin-process testing, which samples will be taken during the course of eachscale-up, engineering, or production run performed in accordance with activity3, 4, 8, 9, or 10, of this Appendix 3 in respect of making Drug Substance usingthe Process. Laureate will inform Customer of antibody potency results and ofany excess cell supernatant during the periodic teleconferences to be conductedbetween the Parties during the conduct of the Program.  Customer has the option to request 

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shipment of supernatantto Customer for internal analysis. Customer will supply a FedEx account number to support shipment ofbiological materials to Customer or its designee.

(v)           Laureate will promptly provideCustomer with copies of the Batch Record for each lot of Drug Substanceproduced using the Process.

(vi)          At the conclusion of the Program orsuch other time as indicated, Laureate will provide Customer the following:

1.             atCustomer’s request and expense, at the conclusion of the cell line developmentphase for any Cell Line (activity 3, above), or such later time as Customer mayrequest, a master cell bank of viable aliquots of the cell line that Laureateand Customer select as the optimum Drug Substance producer (i.e., the CellLine), in such quantity as is reasonable; and

2.             such additional documentation asCustomer may reasonably request in order for Customer to prepare a completeregulatory information package needed to support Customer’s  clinical trial application and such othersubmissions Customer may elect to make for regulatory review and approval inrespect of the Drug Product.

Each Party providingdata, information, and reports shall provide the same in hard copy andelectronic versions, in each instance in a form acceptable to the other Party.

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APPENDIX 4

Testing to beProvided by Laureate

Cell Line: Review ofCertificate of Analysis and supporting documentation provided by Customer andtesting vendors.

Materials:

1.             Review ofinformation or Certificate of Analysis provided by Customer or its testingvendor

2.             Identity testing as appropriate

Bulk Drug Substance: Asagreed by the Parties

Filled Vials: As agreedby the Parties

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***CONFIDENTIAL PORTIONSOF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSIONPURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.

**APPENDIX 5**

**Approved Subcontractors andServices**

| Subcontractor | ** ** | **Service Provided**                           |
|---------------|------------|------------------------------------------------|
| ***           |       | Sterility, analytical, and bioburden testing   |
| ***           |       | Testing, Cell Banking, Viral Clearance Studies |
| ***           |       | Testing, Cell Banking, Viral Clearance Studies |

 

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***CONFIDENTIAL PORTIONSOF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSIONPURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.

APPENDIX 6

Access and Audits

1.             Access to production areas:

During the course of theProgram, Laureate will arrange Customer access to the Facility, manufacturingfloor, and its subcontractors’ facilities. Laureate escort will be assigned and will accompany the Customer’srepresentative(s) at all times while in controlled areas of the Facility.During this time it is critical that the Customer:

a.             Follows all GMP / access / gowning/ safety procedures as directed by Laureate personnel.

b.             Does not touch or operate anyequipment in the production area.

c.             Does notdirect manufacturing personnel. Suggestions or recommendations may be made to an area manager ordirector.

d.             Does not remove any documentationor in-process data.  Requests fordocumentation must be made in writing to an area manager or Director.  Any documentation provided in this fashionwill be tracked by the area Director.

e.             Makes all requests for additionalimmediate in-process sampling, in writing to the area Manager or Director withfull justification, prior to sampling.

f.              Does not enter areas whereproduction is ongoing for another customer.

g.             Does not take any photos inside anyLaureate facility.  Laureate can providedigital photographs as appropriate.

h.             Lack of adherence to these verybasic guidelines will result in immediate loss of access to production areas.

2.             GMP Audits:

a.             Within ninety (90) days after theEffective Date, and then once per calendar year thereafter, Laureate willsupport 1 (one) GMP audit during an active contract.

b.             The audit may be performed byCustomer or by a Third Party, with Third Party costs being at the sole expenseof the Customer.  A maximum of  auditors / Customer participants will beallowed to take part in the actual audit, due to space limitations anddedicated Laureate personnel availability.

c.             Dates for the audit must bearranged and agreed with Laureate a minimum of one month prior to theaudit.   Laureate reserves the right tomake final approval of audit dates, based on availability of the facility andappropriate Laureate personnel.

d.             Three weeks before the auditoccurs, a list of areas / topics to be covered in the audit will need to bereceived by Laureate. This will allow Laureate to ensure appropriate Laureatepersonnel availability during the audit, while also ensuring minimal impact toprograms in production for other customers.

e.             No access will be allowed intoareas where production is underway for another customer.

f.              Any audit observations being sentto Laureate for review or response must be provided by the Customer, notdirectly from a Third Party auditor. Laureate will formally respond to audit findings within 45 days.

g.             ll audit observations areconfidential, covered in the confidentiality agreement between Laureate and theCustomer, and may not be shared with any other party without express writtenpermission.  All Third Party auditorsmust also sign confidentiality agreements with Laureate confirming adherence tothis condition and may not share their findings beyond the Customer whocontracts the audit, without express written permission from Laureate.

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***CONFIDENTIAL PORTIONSOF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSIONPURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.

APPENDIX 7

Service Fees and PaymentSchedule
| **Service**                                                                                                                                                                                                                                                                                                         | ** ** | **Price****        | ** ** | **Payment Terms***                                                                                                               |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--------------------|------------|----------------------------------------------------------------------------------------------------------------------------------|
| Cell Line  Development 

·Variant  1 Cell Line 

·Variant  2 Cell Line                                                                                                                                                                                                                                    |       |  

$***

$*** |       | ·  ***                                                                                                                 |
| Evaluation of  potential *** cell line inhibition by Spingomab produced by the *** cell  line. Includes transfection, selection of a clone and evaluation in  suspension and perfusion hollow-fiber cell culture                                                                                                    |       | $***               |       | ·  ***                                                                                                                 |
| Bioreactor  Process Development                                                                                                                                                                                                                                                                                     |       | $***               |       | ·  ***                                                                                                                 |
| Purification  Process Development                                                                                                                                                                                                                                                                                   |       | $***               |       | ·  ***                                                                                                                 |
| Analytical  Method Transfer and Qualification                                                                                                                                                                                                                                                                       |       | $***               |       | ·  ***                                                                                                                 |
| Formulation  Development and Stability Study                                                                                                                                                                                                                                                                        |       | $***               |       | ·  ***                                                                                                                 |
| Arrange creation  and testing of Master Cell Bank                                                                                                                                                                                                                                                                   |       | $***               |       | ·  ***                                                                                                                 |
| Non-GMP ***  production 2 x 100 L and one purification from combined harvest                                                                                                                                                                                                                                        |       | $***               |       | ·  ***reservation fee to schedule production  timeslot

·  *** due upon ***

·  *** due upon ***   |
| Preparation of  cGMP production documents (specifications, SOPs, batch records) (4 weeks)                                                                                                                                                                                                                           |       | $***               |       | ·  ***                                                                                                                 |
| **Engineering  and 200 L bioreactor production and purification (Non-cGMP). Note: Laureate  offers its clients this price for a pilot run when scheduled together with  cGMP production run. Pilot run will take place in the cGMP facility using the  same equipment and staff as will be used for the cGMP run.** |       | $***               |       | ·  ***reservation fee to schedule production  timeslot 

·  *** due upon *** 

·  *** due upon *** |
| Viral clearance  validation. 2 viruses, 4 process steps. Includes labor provided by Laureate.**Does not include pricing from contract lab. *****                                                                                                                                                                    |       | $***/***           |       | ·  ***                                                                                                                 |
| cGMP 2000 L  production, purification                                                                                                                                                                                                                                                                               |       | $***/***           |       | ·  ***reservation fee to schedule production  timeslot 

·  *** due upon *** 

·  *** due upon *** |
| Quality Control  release testing of bulk drug substance                                                                                                                                                                                                                                                             |       | $***/ lot          |       | ·  ***                                                                                                                 |

 

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***CONFIDENTIAL PORTIONSOF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSIONPURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.
| One-time product-specific  filling set-up charge, including documentation.                                                        |   | $***                                                                                     |   | ·  ***                                                                                                                 |
|-----------------------------------------------------------------------------------------------------------------------------------|--------|------------------------------------------------------------------------------------------|--------|----------------------------------------------------------------------------------------------------------------------------------|
| Media Fill, if  non-qualified vial requested, standard quantity is 3000 vials                                                     |   | $***                                                                                     |   | ·  ***                                                                                                                 |
| Aseptic filling  of product into vials. 100% visual inspection of filled vials and packaging  of filled vials into trays.         |   | $***for up to 1,000 vials   $***for 1,001 to 5,000 vials   $***for 5,001 to 10,000 vials |   | ·  ***reservation fee to schedule production  timeslot 

·  *** due upon *** 

·  *** due upon *** |
| Quality Control  release testing of vialed product                                                                                |   | $***/ lot                                                                                |   | ·  To be determined                                                                                                    |
| Other services  (e.g. stability studies, regulatory support, validation studies, tech  transfer to an alternative commercial CMO) |   | To be determined                                                                         |   | ·  To be determined                                                                                                    |

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*Notes:

·                  Paymentterms of ***.

·                  Costfor Process Consumables and supplies are included in above pricing, except forcolumns and resins, filters and membranes, which are Product-DedicatedEquipment shall be paid for by Customer and become the property of Customer.

·                  Outsourcedactivities provided by a third party subcontractor of Laureate, including anyrequired contract testing services (e.g., sterility, bioburden), will be billed***.

·                  Anycells brought into Laureate’s developmental facility must have documentation toshow that the cells are sterile and free of mycoplasma. For cells to enter theFacility, they must meet the most recent “Points to Consider” FDAguidelines for cell lines used to produce products for human use.

·                  Chargesfor any required outside testing beyond that listed are not included.Outsourced activities, including any required contract testing services, willbe billed ***.

**  Indicatesthat the ***, other than as provided in Section ***.

**  If the *** by Laureate, Customer shall be ***at the ***, as provided in Section ***, above.

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***CONFIDENTIAL PORTIONSOF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSIONPURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.

APPENDIX 8

Shipping

1.             The shipment and timely arrival of samples, DrugProduct, Drug Substance, and other materials that Laureate produces and storesfor Customer is critical to keep the Program on schedule.

2.             Laureate requires a minimum of one week notice prior toshipping (not prior to receipt at a remote location).  One week notice is reasonable for the vastmajority of the shipments.  Laureaterecognizes that there will be instances that will necessitate shippingmaterials where a one week notice is not possible.   Laureate will continue to meet thoserequirements; however, there will be an additional charge for shipments thatneed to occur with less than the one week notice.  The charges for the shipping are summarizedin the table below.  Customer will beresponsible for the cost of shipping and insurance.  Customer will provide contact and accountinformation for approved shipping agent. Customer will review and authorize shipping configuration.

3.             Prior to shipment Drug Product will be stored atLaureate under cGMP compliance conditions that will include but not be limitedto the following:

Temperature controlledand monitored

Controlled access

Back-up power supply

Call out servicefor alarms generated outside of normal business hours

4.             Shipping Policy:   
| **Notice Period  Prior To Shipping** | ** ** | **Shipping Charge**              | ** ** | **Additional Fee  For Expedited Shipments** |
|--------------------------------------|------------|----------------------------------|------------|---------------------------------------------|
| 7 calendar days  or longer           |       | The actual costs of shipping *** |       | No additional fee                           |
| 4 days to 6 days                     |       | The actual costs of shipping *** |       | An additional fee of $***.                  |
| 2 days to 3 days                     |       | The actual costs of shipping *** |       | An additional fee of $***.                  |
| Same day  shipping                   |       | The actual costs of shipping *** |       | An additional fee of $***.                  |

 

 

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