Document:

Exhibit

Execution Version

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

SUPPLY AGREEMENT
This SUPPLY AGREEMENT (this "Agreement") is made and entered into as of October 5, 2015 ("Effective Date"), by and between CANTEX Pharmaceuticals, Inc. formerly known as PARINGENIX, INC., a Delaware corporation ("Cantex") and SCIENTIFIC PROTEIN LABORATORIES LLC, a Delaware limited liability company ("SPL"). 
RECITALS
WHEREAS, Cantex is the inventor and owner of certain proprietary technology relating to "ODSH" (as defined herein) which Cantex is using in the development of innovative therapeutic products to enhance the anticancer effects of existing chemotherapy and radiation therapy while reducing the toxicity of those therapies. 
WHEREAS, the Parties entered into a certain Supply Agreement for the production of ODSH dated August 3, 2011 ("Prior Agreement") pursuant to which SPL agreed to manufacture and supply to Cantex an agreed quantity of ODSH in accordance with the terms of the Prior Agreement. 
WHEREAS, the Parties desire to terminate the Prior Agreement and enter into this Agreement pursuant to which SPL shall procure, qualify, manufacture and sell API (as defined below) to Cantex for the production of Products in accordance with the terms hereof, but the Parties acknowledge that SPL created Intellectual Property for and on behalf of Cantex under the Prior Agreement which is included in Cantex Intellectual Property in accordance with the terms of such Prior Agreement and as described in Article VII of this Agreement. 
NOW, THEREFORE, in consideration of the mutual promises and covenants herein contained and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound hereby, the Parties hereto agree as follows:
ARTICLE I
DEFINITIONS
Capitalized words and phrases used in this Agreement shall have the following meanings:
1.1    "Act" means the United States Food, Drug and Cosmetic Act, as amended from time to time, and the regulations promulgated thereunder.
1.2    "Affiliate" means, with reference to a specified Person, a Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with, the specified Person.  For purposes of this paragraph, "control" shall be presumed to exist if one of the following conditions is met:  (a) in the case of corporate entities, direct or indirect ownership of at least 50% of the stock or shares having the right to vote for the election of directors, and (b) in the case of non-corporate entities, direct or indirect ownership of at least 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

50% of the equity interest with the  power to direct the management and policies of such non-corporate entities.
1.3    "API" (also referred to interchangeably in this agreement as "O-Desulfated Heparin" and/or "ODSH") shall mean both [*], the active pharmaceutical ingredient for the Product.  The API will start from Heparin and shall conform to the API Specifications.
1.1    "API Purchase Price" shall have the meaning set forth in Section 2.2.
1.2    "API Specifications" means the specifications set forth on Exhibit A attached hereto.
1.3    "Arbitrator" shall mean, as the case may be, the independent accounting firm described in Section 2.4, the expert described in Section 2.3 (Facility Expansion) or the person described in Section 12.3(b).
1.4    "cGMPs" means current good manufacturing practice and standards as provided for (and as amended from time to time) in the European Community Directive  91/356/EEC (principles and guidelines of good manufacturing practice for medicinal Products) and in the Current Good Manufacturing Practice Regulations of the U.S. Code of Federal Regulations Title 21 (21 C.F.R. §§ 210 and 211) in relation to the production of pharmaceutical intermediates and active pharmaceutical ingredients, as interpreted by the ICH Harmonized Tripartite Guideline, Good Manufacturing Practice, Guide for Active Pharmaceutical Ingredients, Q7a and subject to any arrangements, additions or clarifications, and respective roles and responsibilities, agreed from time to time between the Parties as set forth in the Quality Agreement. 
1.5     "Cantex Intellectual Property" means collectively all Cantex Intellectual Property Rights in existence on the date hereof and as described in Article VII of this Agreement.
1.6    "Certificate of Analysis" has the meaning set forth in Section 2.7(a).
1.7    "Change of Control" shall mean (a) a merger, consolidation, stock sale or similar transaction with respect to a Party in which the stockholder or limited liability company members of such Party immediately prior to such transaction would own, in the aggregate, less than 50% of the total combined voting power of all classes of stock or membership interests of the Party normally entitled to vote for the election of directors, managers or other governing body of the Party, or (b) the sale by such Party of all or substantially all of the assets of such Party in one transaction or in a series of related transactions; or (c) other transactions the intent of which is to sell all or substantially all of the assets or business of such Party.
1.8    "Claim" has the meaning set forth in Section 10.3.
1.9    "Commercially Reasonable Efforts" shall mean, with respect to each Party, efforts and commitment of resources in accordance with such Party's reasonable business, legal, medical, and scientific judgment that are consistent with the efforts and resources that such Party uses for other products owned by it or to which it has exclusive rights, that are of similar market 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

potential and at a similar stage in their life cycle, taking into account the competitiveness of the marketplace, the regulatory structure involved, the profitability of the applicable products and other relevant factors, including technical, legal, scientific, medical, sales performance, and/or marketing factors, including the good faith performance of any associated commitments under this Agreement.
1.10    "Competitive Product" has the meaning set forth in Section 2.10 below.
1.11    "Confidentiality Agreement" has the meaning set forth in Section 8.2.
1.12    "Confidential Information" shall mean "Confidential Information" as defined in the Confidentiality Agreement.
1.13    "Conforming API" has the meaning set forth in Section 4.6.
1.14    "Dispute" has the meaning set forth in Section 12.3(a).
1.15    "Dispute Notice" has the meaning set forth in Section 12.3(a).
1.16    "Ex-Works" means "Ex-works" as that term is defined in INCOTERMS 2010.
1.17    "Facility Expansion" shall have the meaning set forth in Section 2.3.
1.18    "Facility Ready Date" has the meaning set forth in Section 2.2.
1.19    "FDA" means the U.S. Food and Drug Administration, or any successor entity thereto.
1.20    "Event of Force Majeure" has the meaning set forth in Section 12.1.
1.21    "Governmental Authority" means any federal, state, local, municipal, foreign or other governmental or quasi-governmental authority of any nature (including any governmental agency, branch, department, official or entity and any court or other tribunal, including an arbitral tribunal), any multi-national organization or body, or any similar body exercising, or entitled to exercise, any administrative, executive, judicial, legislative, police, regulatory or taxing power of any nature.
1.22    "Heparin" means the active pharmaceutical ingredient Heparin Sodium, USP produced by SPL and produced only from raw materials sourced and originating within North America.  
1.23    "Indemnitee" has the meaning set forth in Section 10.3.
1.24    "Indemnitor" has the meaning set forth in Section 10.3.
1.25    "Intellectual Property Rights" means all intellectual property rights including without limitation, all patents, patent applications, supplementary protection certificates, petty 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

patents, utility models, trademarks, database rights, rights in designs, copyrights and topography rights (whether or not any of these rights are registered, and including applications and the right to apply for registration of any such rights), formulas, formulations, specifications, production methods, analytical methods and all inventions, know-how, trade secrets, techniques and confidential information and other proprietary knowledge and information, and all rights and forms of protection of a similar nature or having equivalent or similar effect to any of these which may subsist anywhere in the world, in each case for their full term, and together with any improvements thereto or derivatives therefrom and all renewals or extensions.
1.26    "Judgment" means any award, decision, injunction, judgment, order, ruling, subpoena, or verdict of any court, arbitral tribunal, administrative agency or other Governmental Authority having jurisdiction over a Party.
1.27    "Law" means any applicable federal, state, local, municipal, foreign, international, multinational or other administrative order, constitution, law, ordinance, principle of common law, regulation, statute or treaty.
1.28    “Not Pursuing” has the meaning set forth in Section 11.2(a)(iii)
1.29    "Parties" or "Party" means Cantex and/or SPL collectively or individually as the case may be.
1.30    "Permit" has the meaning set forth in Section 6.1.
1.31    "Person" means any individual, corporation (including any non-profit corporation), general or limited partnership, limited liability company, joint venture, estate, trust, association, organization, labor union, Governmental Authority or other entity.
1.32    "Preliminary Period" has the meaning set forth in Section 2.2.
1.33    "Price Negotiation Period" has the meaning set forth in Section 2.4.
1.34    "Product" shall mean any proprietary drug candidate which has been or may be developed for any specified human or veterinary indication by Cantex which uses any form of [*] active pharmaceutical ingredient.
1.35    "Quality Agreement" has the meaning set forth in Section 4.1.
1.36    "Raw Material Costs" means the actual out of pocket costs incurred by SPL in acquiring and transporting the raw materials necessary to produce to the API.
1.37    "Regulatory Approval" means the approvals or authorizations of the FDA or any other regulatory authorities necessary for the marketing and sale of a Product in the Territory.
1.38    "Regulatory Authority" means the FDA, or any Governmental Authority that performs a function for a political subdivision similar to the function performed by the FDA for the United States with regard to the approval, licensing, registration or authorization to test, 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

manufacture, promote, market, distribute, use, store, import, transport or sell Products in a defined territory or political subdivision(s). 
1.39    "Regulatory Requirements" means (a) any and all permits, licenses, filings and certifications required by the FDA or other Regulatory Authorities, and compliance with the cGMPs of the FDA or other Regulatory Authorities, applicable to any manufacturing or processing activities under this Agreement and (b) any Laws, rules, guidelines, regulations, and standards of any Governmental Authority, whether within or outside the United States (including the Environmental Protection Agency (EPA), the Occupational Safety and Health Administration (OSHA), the Drug Enforcement Administration (DEA) and state and local authorities), that apply to any manufacturing or processing activities under this Agreement.
1.40    "Representative" means, with respect to a particular Person, any director, manager, officer, employee, agent, consultant, legal counsel, accountants and financial advisors.
1.41    "SEC" means United States Securities and Exchange Commission.
1.42      "SPL Intellectual Property" means collectively all SPL Intellectual Property Rights in existence on the date hereof and as described in Article VII of this Agreement. 
1.43    "SPL's Waunakee Facility" means SPL's Waunakee Facility located at 700 E. Main Street Waunakee, WI 53597.
1.44    "Term" has the meaning set forth in Section 11.1.
1.45    "Territory" means the world.
1.46    "Third Party" means any Person other than the Parties and their respective Representatives and Affiliates.
1.47    "Transfer Taxes" has the meaning set forth in Section 3.2.
1.48    "Two-Year Period" has the meaning set forth in Section 2.4.
ARTICLE II
SUPPLY, PURCHASE ORDER AND DELIVERY
2.1    Supply of Products.  During the Term and subject to the terms and conditions hereof, SPL shall manufacture and sell the API to Cantex, and Cantex shall purchase the API produced by SPL at a rate estimated to be [*] per year at SPL's current small scale facility for manufacturing API.  Following the Facility Expansion, the amount of API to be purchased shall be determined in good faith by the Parties.  Except as expressly provided herein, SPL shall be the exclusive supplier of the API.  All such API shall be sold to Cantex free and clear of all liens and security interests.
2.2    Purchase Price for the Preliminary Period.  The purchase price for the API (the "API Purchase Price") during the [*] of the Preliminary Period of the Term (as defined in Article 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

11 below) of this Agreement will be U.S. [*], Ex-Works at SPL's Waunakee facility.  The "Preliminary Period" shall mean the period commencing on the date hereof and ending on the date the Facility Expansion receives all necessary regulatory approvals with respect to the supply of the API and is ready for commencement of production ("Facility Ready Date").  If the Preliminary Period extends [*], the Parties will negotiate in good faith the API Purchase Price for the remaining Preliminary Period in accordance with the same procedures set forth in Section 2.4 below.  Thus, SPL is committing to the API Purchase Price for [*], but acknowledges that Cantex is only making a [*] purchase commitment at this time.
2.3    Negotiation of Facility Expansion.  The Parties recognize that by the end of [*], Cantex's requirements for API may exceed SPL's current capacity to manufacture and supply API.  At any time, Cantex may request that SPL increase its capacity to manufacture and supply API to Cantex to a commercially reasonable capacity given likely demand for the Product, keeping in mind that it will likely take no less than [*] to build and qualify such new facility.  Upon such a request, the Parties shall enter into a negotiation in good faith to discuss the terms and conditions for such an expansion (a "Facility Expansion").  In addition, the Parties will negotiate in good faith such other matters as are commercially reasonable in connection with the Facility Expansion.  Subject to reaching a mutual agreement, the Parties may enter into a Facility Expansion agreement detailing the manner in which SPL shall increase its API manufacturing capacity and supply such API to Cantex.  Cantex may elect to undertake the Facility Expansion if Cantex has reasonably concluded that FDA Approval is likely to be forthcoming in the reasonably foreseeable future.  In such event, the Parties will discuss in good faith the scope of the Facility Expansion, its design, the requisite capital equipment and similar items necessary to complete a Facility Expansion, including a budget and reasonable "take or pay" arrangement with respect to API that is producible from such Facility Expansion.  Cantex may require SPL to pay for the Facility Expansion once FDA Approval of a Product is received, provided that the volume of API to be purchased from the Facility Expansion is an amount reasonably sufficient to allow SPL to amortize the costs of the Facility Expansion over a reasonable period.  If Cantex requests that SPL pay for the Facility Expansion before FDA Approval is received, SPL shall have the right to refuse to pay for the Facility Expansion and in such case, Cantex may terminate this Agreement as its sole recourse; provided, however, that neither Party shall be prohibited from pursuing available remedies at law or equity in connection with the other Party's breach of any other provision of this Agreement.  In the event Cantex determines to undertake a Facility Expansion and the Parties are unable to reach agreement on all terms of the Facility Expansion, the Parties will submit the open issues to binding arbitration in accordance with this Section 2.3 and Section 12.3.  SPL may not refuse to undertake a Facility Expansion if Cantex is funding the Facility Expansion or if Facility Expansion is to be undertaken after FDA Approval is received.  The Facility Expansion shall not exceed in size and scope the facility required to produce the reasonably expected requirements of API for the [*] period following the completion of the Facility Expansion, except by mutual agreement of the Parties.
The "Arbitrator," under this Section 2.3 shall be a party with expertise in the construction of facilities for the production of biologic pharmaceutical products.  The Arbitrator for the Facility Expansion will not determine API Purchase Price for the period following the Facility Expansion.

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

2.4    Commercial Pricing and Quantity.  For the period of the Term following the Preliminary Period, the API Purchase Price shall be determined and subject to adjustment in accordance with this Section 2.4.  
(a)    At least four (4) months prior to the date the Parties agree that commercial scale production will begin from the Facility Expansion, and, thereafter, at least four (4) months prior to the expiration of the [*] period following the date on which the API Purchase Price is agreed with respect to the Facility Ready Date and on a biennial basis thereafter during the remainder of the Term (in each case the "Price Negotiation Period"), the Parties shall discuss changes to the API Purchase Price and shall reach agreement in good faith on a revised API Purchase Price for the succeeding [*] period (the "[*] Period").  The negotiation of the API Purchase Price shall be based on factors such as market conditions with respect to the supply chain and taking into account the increased volumes and efficiencies made available by the Facility Expansion as well as the Party who has funded the Facility Expansion, the amortization and depreciation of the Facility Expansion, other capital expenditures and costs needed to commission start-up and operate the facility.  
(b)    During the first two (2) months of the Price Negotiation Period, either of the Parties may request that the Chief Executive Officers of each of the Parties participate in the negotiation process.  During the Price Negotiation Period, the Parties will negotiate in good faith a commercially reasonable API Purchase Price for the succeeding [*] Period.  During the Term of this Agreement, the commercially reasonable API Purchase Price will not exceed the API Purchase Price for the Preliminary Period in the absence of a catastrophic disruption to the heparin market, and then only during the period that Raw Material costs are elevated by such catastrophic disruption.
(c)    During the last two (2) months of the Price Negotiation Period, in the event the Parties have not reached agreement on the API Purchase Price, either Party may request arbitration for the API Purchase Price for the succeeding [*] Period by providing written notice of arbitration to the other Party.  Within ten (10) days of receipt of such notice the Parties shall appoint as Arbitrator an independent accounting firm of regional or national stature who shall make the determination of the API Purchase Price for the succeeding [*] Period pursuant to the procedure set forth below.  The Arbitrator shall be a firm that has not provided any services to either Party or their Affiliates for at least a three-year period prior to the arbitration.  Such Arbitrator shall as a condition of being appointed arbitrator execute and deliver such commercially reasonable nondisclosure agreements as may be required by the Parties.  In the event the Parties are unable to agree upon such Arbitrator, the Arbitrator will be appointed by the Chief Judge of Federal District Court of the Western District of Wisconsin.  Each of the Parties shall submit in writing to the Arbitrator such Party's final and best API Purchase Price for the [*] Period, and the Arbitrator may select in its determination an API Purchase Price that is not less than the API Purchase Price submitted by Cantex, nor more than the API Purchase Price submitted by SPL.  Each of the Parties shall also submit in writing to the Arbitrator, the rationale of such Party for API Purchase Price it proposes, as well as data and other information as the Arbitrator may request.  SPL may provide costing information to the Arbitrator, but such information shall be kept in confidence, and shall not be provided to Cantex.  The Arbitrator shall make such determination as expeditiously as 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

possible, and such determination shall be final and binding upon the Parties for the succeeding [*] Period.  SPL may not withhold deliveries of API during the Price Negotiation Period, and Cantex will timely pay to SPL an amount equal to the price that had been in effect for the prior [*] Period in the event the arbitration process runs into the next succeeding [*] Period.  If the final determination is received after the commencement of the [*] Period, the amount to be paid shall be "trued up" if necessary, and an immediate payment shall be made from Cantex to SPL if the API Purchase Price is higher than that paid to date by Cantex; or a credit shall be provided to Cantex from SPL in the event the API Purchase Price has been higher than the new API Purchase Price during the succeeding [*] Period.  
(d)    In determining the API Purchase Price for each succeeding [*] Period, the Parties shall take into account changes in market conditions, Raw Material Costs, manufacturing efficiencies, the amortization and depreciation of Facility Expansion Costs paid by SPL, other capital expenditures needed by SPL in connection with the Facility Expansion and profit margin percentages during the Preliminary Period.  Thus, by way of example, if SPL funds some or all of the Facility Expansion, the API Purchase Price may be higher than if it does not fund any of the Facility Expansion and if Cantex funds the Facility Expansion, the API Purchase Price may be lower.  Changes in Raw Material Costs shall not be taken into consideration unless Raw Material Costs are plus or minus [*] of Raw Material Costs as of the date of this Agreement absent a catastrophic disruption to the heparin market as described above.  For purposes of determining "Raw Material Costs," SPL shall detail the Raw Material Costs for producing the API as of the date of the Agreement in auditable form.  In the event there is a change in the Raw Material Costs above or below the benchmark as of the date of the Agreement, SPL shall notify Cantex of such change, and will allow audit of such benchmark and change by Cantex's independent firm of certified public accountants, who shall not provide any information to Cantex other than the percentage by which Raw Material Costs are above or below the benchmark.  Any determination dispute will be subject to arbitration in accordance with Section 2.4.
2.5    Purchase Orders and Acceptance.
(a)    Purchase Orders.  Immediately after the execution of this Agreement, Cantex shall issue a purchase order for [*] of API satisfying Cantex's purchase obligations for the first twelve (12) months of the Term, [*] of which is to be delivered in 2015.].  For the remainder of the Preliminary Period Cantex shall have the right, but not the obligation to issue purchase orders for API up to a maximum of [*] per year.  [*]  Three (3) months prior to the end of each year of this Agreement, Cantex shall provide SPL with a notice for the subsequent year of the Term that it intends to purchase up to a maximum of [*] per year of API from SPL (or such additional maximum amount following the Facility Expansion) by issuing a binding purchase order to SPL.
(b)    Acceptance.  SPL agrees to fulfill the purchase orders submitted by Cantex in accordance with Section 2.5(a) above.  SPL shall provide Cantex with a written acknowledgement of its receipt of each Cantex purchase order together with the date on which production of the API will commence (which shall be no later than ten (10) days from the date of receipt of the purchase order).  

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

2.6    Delivery.  All delivery and transit arrangements for the API shall be Ex-Works SPL's Waunakee Facility to the location as stated in the purchase order and within five (5) business days of the delivery date specified in the purchase order.  Such delivery date will be a reasonable date following the receipt of the purchase order in order to allow SPL adequate time to manufacture the API.  Shipping shall be conducted in accordance with those controlled environment and other shipping conditions as are reasonably specified by Cantex in the purchase orders or otherwise in writing.  SPL shall invoice Cantex for any actual reasonable out-of-pocket shipping costs (including insurance costs) paid by SPL pursuant to the foregoing arrangement as a separate line item on the invoice, to the extent such costs are not already taken into account.  Title to the API shall pass to Cantex upon delivery to the carrier at SPL's Waunakee Facility.  SPL agrees that Cantex may specify that the delivered API be stored in a SPL cGMP-qualified storage facility, the cost of which storage shall be mutually agreed between the Parties and paid by Cantex.  For the sake of clarity, title to the stored API shall pass to Cantex when the instructions are received by SPL to store the product; it will also be invoiced at that time.  With respect to the delivery of each batch of API, Cantex may elect to have SPL store such batch until such time that Cantex elects to take delivery or otherwise notifies SPL in writing to deliver such API to a party designated by Cantex.  With respect to the storage of API, Cantex and SPL shall mutually agree on a fee for such storage and SPL shall store the API in accordance with Cantex's storage guidelines and other customary terms associated with the storage of third party-owned products.  
2.7    Documentation.
(a)    Certificates.  Each shipment of API shall be accompanied by a "Certificate of Analysis" confirming that API delivered is Conforming API pursuant to Section 4.1.
(b)    Shipping Documentation.  Each shipment of API shall be accompanied by commercially appropriate shipping documentation (including bills of lading), which shall, subject to the provisions of the Quality Agreement, (i) identify the shipment and batch numbers comprised in the shipment, (ii) state any purchase order number for the shipment that has been provided by Cantex, and (iii) show the destination where such shipment is being sent.  
2.8    Exclusivity.  SPL acknowledges and agrees that the production of the API involves SPL's access to and use of confidential and proprietary Cantex Intellectual Property [*].  Accordingly, SPL agrees as follows:
(a)    throughout the Term, SPL and its Affiliates shall not directly or indirectly in the Territory engage in the development, manufacture, commercialization, sale or distribution (or assist in the development, manufacture, commercialization, sale or distribution) of a Competitive Product whether for itself or for any Affiliate or Third Party other than Cantex; 
(b)    following the expiration or termination of this Agreement, SPL and its Affiliates shall not and are perpetually excluded from directly or indirectly in the Territory engaging in the development, manufacture, commercialization, sale or distribution (or assist in the development, manufacture, commercialization, sale or distribution) of a Competitive Product that contains or makes use of any Cantex Intellectual Property (including any Cantex Confidential Information) whether for itself or for any Affiliate or Third Party; and

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

(c)    following expiration or termination of this Agreement, and for the Applicable Period (as defined below), SPL and its Affiliates shall not directly or indirectly in the Territory engage in the development, manufacture, commercialization, sale or distribution (or assist in the development, manufacture, commercialization, sale or distribution) of any active pharmaceutical ingredient or product containing [*] and which do not make use of Cantex Intellectual Property or Cantex Confidential Information for itself or any Third Party.  
(d)    The "Applicable Period" shall have the following meaning: 
(i)    [*] following the expiration of the Term of this Agreement in accordance with Section 11.1; 
(ii)    the longer of [a] the remaining unexpired Term of this Agreement plus [*] or [b] [*] from the date of termination, in the event Cantex terminates this Agreement under Section 11.2(b)(i) or Section 11.2(c); 
(iii)    [*] from the date of termination, in the event Cantex terminates this Agreement as a result of an Event of Force Majeure affecting the ability of SPL to perform this Agreement (in which the case the exclusivity requirement in Section 2.9 shall not apply); provided, however, in the event SPL [a] cures the Event of Force Majeure within [*] of the date of such termination and [b] can demonstrate to Cantex's reasonable satisfaction that SPL is capable of supplying at least [*] of Cantex's requirements, then the Agreement shall be deemed to continue (provided however, that the exclusivity requirement in Section 2.9 shall be suspended with respect to any  reasonable supply agreement or arrangement  Cantex may have in effect due to the Event of Force Majeure causing the termination) and the exclusivity provisions of this Section 2.8 shall continue to apply for the remaining Term of this Agreement and beyond pursuant to the various provisions of this Section 2.8;
(iv)    [*] if the Agreement terminates for failure to obtain FDA approval or abandonment in accordance with the provisions of Section 11.2(a)(iii);
(v)    [*] from the date of the material breach in the event SPL terminates this Agreement upon a material breach by Cantex, as set forth in Section 11.2(a), subject to the cure rights described in Section 11.2(a)(i) in which case, upon a timely cure by Cantex, the Agreement shall be deemed to continue and the exclusivity provisions of this Section 2.8 shall continue to apply for the remaining Term of this Agreement and beyond pursuant to the various provisions of this Section 2.8;
(vi)    [*] in the event SPL terminates this Agreement upon the insolvency of Cantex as set forth in Section 11.2(c); 
(vii)    [*] in the event Cantex terminates the Agreement upon SPL's determination not to pay for a Facility Expansion prior to FDA approval as described in Section 2.3.
(viii)    [*] in the event SPL terminates this Agreement as a result of an Event of Force Majeure affecting the ability of Cantex to perform its obligations under this 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

Agreement; provided, however, if Cantex cures the Event of Force Majeure within [*] of the effective date of SPL's termination, Cantex may request that SPL continue as the exclusive supplier in which case, the Agreement shall be deemed to continue and the exclusivity provisions of this Section 2.8 shall continue to apply for the remaining Term of this Agreement and beyond pursuant to the various provisions of this Section 2.8;
2.9    [*].  
2.10    Competitive Product.  For purposes of this Agreement, the term "Competitive Product" means any active pharmaceutical ingredient or product (i) [*] or (ii) [*].  

ARTICLE III
PAYMENT
3.1    Payment Terms.  Payment of all amounts shall be in U.S. Dollars, by a Cantex company check or wire transfer of immediately available funds to the financial institution, account number and account party's name designated in writing by SPL as the place of payment.  SPL shall invoice Cantex against the deliveries of API ordered in connection with the purchase orders submitted in accordance with Section 2.5.  Except as otherwise permitted herein, Cantex shall pay SPL within thirty (30) days of the date on which Cantex receives the invoice, which invoice shall not be issued earlier than upon the delivery date of the API to Cantex; notwithstanding the foregoing, if SPL stores API for Cantex, the delivery date will be deemed to be the date SPL places such API in storage.  In the event SPL invoices remain unpaid after thirty (30) days from the date of Cantex's receipt of the invoice, other than for reasons of an invoice that is being disputed by Cantex in good faith and in writing (and only as to such portion of an invoice that is in dispute), then the amount outstanding under that invoice shall bear interest at a rate per annum equal to the highest rate permitted under New York law.
3.2    Taxes.  Cantex shall be responsible for paying all federal, state and local sales, use, consumption, value added or excise taxes, custom charges, tariffs, duties and other similar assessments and taxes which may be imposed by any Governmental Authority upon SPL (other than income taxes) as a purchaser of the API on an Ex Works basis ("Transfer Taxes") in connection with this Agreement.
ARTICLE IV
QUALITY OF PRODUCTS 
4.1    Quality Agreement.  The Parties agree to execute, simultaneously with this Agreement, an agreement which shall specify the roles and responsibilities of Cantex and SPL with respect to testing, storage, release, cGMP, regulatory and other quality assurance requirements relating to the manufacture, supply and shipment of API by SPL under this Agreement (the "Quality Agreement") which shall be attached hereto as Exhibit B. 
4.2    Qualification of Sources.  All procurement of raw materials for the manufacture of the API supplied hereunder shall comply in all material respects with the Quality Agreement.  

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

SPL shall comply with all Regulatory Requirements pertaining to procurement of raw materials for the API, including any testing or documentation required.
4.3    Storage and Use of API.  SPL shall ensure that the storage of all API is in accordance with the Quality Agreement and Regulatory Requirements.  Cantex shall be responsible for storage of the API which has been shipped to Cantex pursuant to Article II, but may request that SPL provide proper storage for delivered shipments at SPL qualified facilities (at Cantex's expense) until such time that Cantex requires use of the API.  Cantex will be responsible for any shelf life issues with respect to stored API.
4.4    API Testing and Release.  SPL shall perform in-process and product release testing and manage sub-contracting testing lab, review and release of the API, and issue a Certificate of Analysis for the API in accordance with Section 2.7(a) and in accordance with the Quality Agreement.
4.5    Approval of Subcontracting.  Except as contemplated by this Agreement, SPL shall not have the right to subcontract, sublicense or otherwise delegate all or any portion of its obligations under this Agreement without Cantex's prior written consent, which shall not be unreasonably withheld; provided, however, that SPL may subcontract testing and analytical services only to (a) its Affiliates located in North America  and (b)  Third Parties located in North America, in each case without the consent of, but with prior notice to Cantex and provided further that such Affiliates have agreed in writing to Cantex to be bound by the exclusivity and confidentiality requirements set forth in this Agreement and Third Parties have agreed to be bound by the confidentiality and intellectual property ownership requirements of this Agreement.  To the extent that use of a subcontractor is permitted under this Section 4.5, SPL shall (i) fully qualify each such subcontractor and (ii) ensure that all such approved subcontractors comply with the provisions of this Agreement to the extent applicable thereto.  Notwithstanding SPL's use of a subcontractor, subject to the limitations on liability set forth in this Agreement, SPL shall remain primarily responsible and liable to Cantex with respect to each subcontractor's breach of its confidentiality obligations concerning Cantex Confidential Information or failure to perform its obligations in a manner consistent with the terms of this Agreement.  
4.6    Product Warranty.  SPL represents and warrants to Cantex that all API manufactured hereunder will be manufactured, labeled, packaged, stored, tested, documented, released and shipped in accordance with the API Specifications, SPL's responsibilities under the Quality Agreement, applicable Regulatory Requirements, this Agreement and all applicable Laws.  Such API meeting the requirements of the preceding sentence shall be deemed "Conforming API".
4.7    Non-Conforming API.
(a)    Cantex shall have the right at any time following delivery of the API to test the API and determine whether the API is Conforming API.  During shipment and following receipt of the API by Cantex, Cantex shall cause the API to be properly maintained and stored.  If, Cantex learns that any API delivered under this Agreement are not Conforming API by reason of non-compliance with the API Specifications, Quality Agreement or the Regulatory Requirements, then 

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Cantex shall notify SPL in writing of such discovered defect promptly after such noncompliance is confirmed.  Cantex shall notify SPL of such nonconformance within a reasonable time after such API is delivered to Cantex.
(b)    If Cantex notifies SPL that the API received are not Conforming API, then SPL shall be offered a reasonable opportunity to examine the evidence purporting to show why such API are or were non-Conforming API and to inspect or test such API.  In the event of any dispute as to whether any API are or were non-Conforming API, and rightfully rejected by Cantex pursuant to the above provisions relating thereto, the matter shall be referred to an independent testing organization mutually acceptable to the Parties to resolve the dispute.  The fees and expenses of such organization shall be paid by the Party in error.
4.8    Rights and Remedies for Delivery of Non-Conforming API.  With respect to any API that are non-Conforming API, as agreed by the Parties or determined by an independent testing organization pursuant to Section 4.7(b), SPL shall, at Cantex's option, (a) replace the non-Conforming API at SPL's sole cost and expense or (b) provide a credit to Cantex with respect to such non-Conforming API.  In the event Cantex purchases replacement API from another party (which shall not constitute a breach of Cantex's exclusivity obligations under Section 2.9), in addition to refunding the cost of the API charged by SPL, SPL shall be responsible for paying to Cantex the reasonable costs of cover (i.e., the difference between the price of the API charged to Cantex by SPL for the non-Conforming API and the reasonable price for the replacement API).  Following replacement, reimbursement in full (including such reasonable costs of cover) with respect to the non-Conforming API, the non-Conforming API shall be owned by and available to SPL for pick-up at SPL's expense.  SPL shall destroy all non-Conforming API and shall not use such non-Conforming API for any commercial purpose.  Cantex shall have the right to retain or dispose of any non-Conforming API that is not collected by SPL within thirty (30) days of the determination that the API is non-Conforming API.
ARTICLE V
RECORDS
5.1    Records Retention.  With respect to the API, SPL shall generate and maintain complete and accurate records (including files, certificates and authorizations) necessary to evidence compliance with this Agreement, the Quality Agreement, applicable Laws, Regulatory Requirements and other requirements of applicable Governmental Authorities, including, where necessary, available sourcing data, development reports, batch records, quality control and laboratory testing, and any other data reasonably associated with ascertaining the quality and origin thereof.  All such records, and all samples required to be maintained under this Agreement, shall be securely maintained for a period of not less than seven (7) years from the date of release of each shipment of API in accordance with the provisions of the Quality Agreement and Regulatory Requirements.
5.2    Availability.  Upon the reasonable request of Cantex , SPL shall make relevant documents available to Cantex for inspection on site, including, but not limited to the batch records.  

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All such documents and records shall be considered "Confidential Information" subject to the Confidentiality Agreement in effect between the Parties.
ARTICLE VI
REGULATORY MATTERS
6.1    Permits.  SPL shall obtain and maintain in good order, at its sole cost and expense, such governmental registrations, permits and licenses as are required by Governmental Authorities and Regulatory Requirements in order for SPL to perform all of its obligations under this Agreement (including any registrations granted by the FDA and any comparable registrations and/or licenses granted by any other Regulatory Authority) (each, a "Permit"), for so long and insofar as is necessary to permit SPL to perform any activity contemplated hereunder.
6.2    Compliance with cGMPs; Monitoring of Records.  Throughout the Term, SPL shall ensure that the manufacturing of the API and the performance of SPL's services hereunder comply with cGMPs, as applicable, including through the establishment and implementation of such operating procedures and the training of personnel as are required to assure such compliance.  Throughout the Term and for so long thereafter as is reasonably necessary, SPL also shall monitor and maintain appropriate records with respect to its compliance with cGMPs with respect to the Product and permit Cantex access to such records in accordance with Section 5.2 above with respect to the Product.  
6.3    Regulatory Communications and Correspondence.  Each Party shall promptly notify the other Party of all such Party's communications from and to the FDA or other Regulatory Authorities which may impact or change the manufacturing or processing activities performed by SPL hereunder, or affect the ability of SPL to comply with its obligations under this Agreement.  In all cases involving changes to the manner in which the API is manufactured or processed, the terms set forth herein and in the Quality Agreement shall apply with respect to any required modification to the manufacturing process.
ARTICLE VII
INTELLECTUAL PROPERTY RIGHTS
7.1    SPL IP. SPL has decades of experience in the development, testing and production of heparin and its derivatives.  All Intellectual Property Rights developed by or on behalf of SPL and related to the procurement of the appropriate raw material, the formulas, formulations, specifications, production methods and analytical methods for heparin and its derivatives (excluding ODSH, the API and Products and not including those constituting improvements to or derivatives of Cantex Intellectual Property) are proprietary to SPL and are SPL Intellectual Property.  All improvements to SPL Intellectual Property belong to SPL. 
7.2    Cantex IP.  All Intellectual Property Rights including the formulas, formulations, specifications, production methods and analytical methods for the API and Products which have been developed by, or on behalf of, Cantex and its predecessor comprise Cantex Intellectual Property and are owned by Cantex.  Cantex Intellectual Property also includes the [*] analytical method for use with the API and Products and the specification for [*] by which the lots of Heparin 

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are selected to produce the API and Products.  All improvements to or derivatives of the API and the Product formulas, formulations, specifications, production methods analytical methods or other Cantex Intellectual Property (but not including those constituting improvements to or derivatives of SPL Intellectual Property), are proprietary to Cantex and are Cantex Intellectual Property, and to the extent that SPL has participated in the development of such improvements or derivatives, SPL shall promptly disclose such information to Cantex in writing. 

7.3    Claims.  SPL and its Affiliates shall make no claims with respect to the Cantex Intellectual Property and will have no right thereto.  Cantex shall make no claims with respect to the SPL Intellectual Property, and will have no right thereto.

7.4    Licenses; Assistance. 
 
(a)    In order to perform its obligations under this Agreement, SPL will need to use the Cantex Intellectual Property.  Cantex hereby grants to SPL a limited, royalty free, terminable, revocable, non-exclusive, non-transferable, non-sublicensable license to the Cantex Intellectual Property solely as may be necessary to allow SPL to perform its manufacturing and related obligations under this Agreement.   Such license shall terminate upon the termination of this Agreement.  
(b)    SPL hereby consents, during the term of this Agreement, to Cantex's use of Heparin for the manufacture and commercialization of the API and the Product.  Such consent terminates upon the termination of this Agreement for any reason; provided however, that such consent shall remain in effect with respect to existing API and Product and work in process. 
 (c)    Throughout the Term, SPL agrees to assist Cantex (at Cantex's expense) with any testing reasonably requested by Cantex in connection with obtaining Regulatory Approval of the API or Products from any Regulatory Authority.   
7.1    Assignment to Cantex.  Regarding Cantex Intellectual Property Rights, SPL shall assume all rights to employee inventions in accordance with applicable laws on employee inventions and hereby assigns to Cantex, in advance as of the Effective Date, title to any and all Cantex Intellectual Property Rights developed by SPL and its Affiliates, employees and subcontractors.  To the extent that an assignment of the Cantex Intellectual Property Rights should not be possible under the applicable law, SPL shall assign to Cantex such Cantex Intellectual Property Rights upon their coming into existence, and Cantex shall accept such assignment.  To the extent that an assignment of Cantex Intellectual Property Rights should not be possible at all under the applicable law, SPL, in advance as of the Effective Date, grants to Cantex an exclusive, perpetual, irrevocable, worldwide, transferable, fully paid-up license, which includes the right to grant sub-licenses and permit sub-sublicenses, to use and commercialize such Cantex Intellectual Property Rights in any way.  Cantex herewith accepts such grant of license.  The Parties acknowledge and agree that SPL shall be solely responsible for paying its employees any remuneration due under applicable law on employee inventions in connection with Cantex Intellectual Property Rights developed by such employees and SPL Intellectual Property Rights.  Should any such claims for remuneration be directed against Cantex, its Affiliates and/or sub-

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licensees, Cantex shall immediately notify SPL of such claims, tender the defense of such claims to SPL and SPL will indemnify Cantex with respect to such claims as set forth and subject to the limitations set forth in Article X below.  
ARTICLE VIII
PUBLICITY; CONFIDENTIALITY
8.1    Publicity.  Except as required by Law or the standards of any securities regulatory authority, including the SEC, NASDAQ and NYSE, SPL and Cantex may not make any official press release, announcement or other formal publicity relating to the terms of this Agreement or transactions that are the subject of this Agreement without first obtaining in each case the prior written consent of Cantex or SPL, respectively (which consent may not be unreasonably withheld).  If any Party is required to file this Agreement with the SEC or another applicable securities regulatory authority, such Party must seek confidential treatment for any provisions of this Agreement that any Party believes would disclose trade secrets or confidential commercial or financial information and therefore, in such case, the Parties shall coordinate such filing efforts.  Except as required by Law or the standards of any securities regulatory authority, SPL and Cantex may not use the name or trademarks of Cantex or SPL, respectively, or any Representative thereof or any adaptation thereof without the prior written approval of Cantex or SPL, respectively.
8.2    Confidentiality.  The Parties hereby confirm and agree to remain to be bound by the terms of the Mutual Confidentiality Agreement and attached hereto as Exhibit C ("Confidentiality Agreement") and notwithstanding any provisions concerning termination set forth therein, such Confidentiality Agreement shall remain in effect throughout the Term of this Agreement and shall survive the termination of this Agreement without limitation.

ARTICLE IX
REPRESENTATIONS AND WARRANTIES
9.1    Representations and Warranties of Cantex.  Cantex hereby represents and warrants to SPL as follows:
(a)    Cantex is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware.  Cantex is duly qualified to do business and is in good standing in each jurisdiction where its ownership or leasing of property or the conduct of its business requires it to be so qualified.
(b)    The execution, delivery, and performance of this Agreement by Cantex has been duly authorized by all requisite corporate action and does not require any further action or approval.
(c)    Cantex has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder.
(d)    The execution, delivery, and performance by Cantex of this Agreement and its compliance with the provisions of this Agreement does not and shall not conflict with or result 

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in a breach of any of the terms and provisions of or constitute a default under (i) any other agreement to which it is a party; (ii) the provisions of its organizational documents; or (iii) any Judgment, writ, or decree of any court or Governmental Authority entered against it or by which any of its property is bound.
(e)    Cantex has obtained each consent, approval or authorization of or has provided any notice, declaration, filing or registration with, any Governmental or Regulatory Authority required for the execution, delivery and performance of this Agreement, and the execution, delivery and performance of this Agreement will not violate any Law, rule or regulation applicable to Cantex .
(f)    This Agreement has been duly executed and delivered and constitutes Cantex's legal, valid and binding obligation, enforceable against Cantex in accordance with its terms subject, as to enforcement, to bankruptcy, insolvency, reorganization and other laws of general applicability relating to or affecting creditors' rights and to the availability of particular remedies under general equity principles.
(g)    Cantex will not use in any capacity the services of any persons debarred or convicted under 21 U.S.C. § 335(a) or 335(b) in connection with the performance of this Agreement.  Cantex does not currently have, and covenants that it will not hire, as an officer or an employee any person who has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the Act.
(h)    Cantex shall comply with all Laws, rules and regulations relating to its activities under this Agreement.
(i)    As of the Effective Date, Cantex is not aware of any third party Intellectual Property Rights that will be infringed by the manufacture of the API, and Cantex will promptly inform SPL if it receives notice of any claim or potential claim relating to infringement or alleged infringement of any third party Intellectual Property Rights by virtue of the manufacture of API hereunder;
(j)    Cantex warrants that it has ownership of the Cantex Intellectual Property described in Article VII.
9.2    Representations and Warranties of SPL.  SPL represents and warrants to Cantex as follows:
(a)    SPL is a limited liability company duly organized, validly existing and in good standing under the laws of the State of Delaware.  SPL is duly qualified to do business and is in good standing in each jurisdiction where its ownership or leasing of property or the conduct of its business requires it to be so qualified.
(b)    The execution, delivery and performance by SPL of this Agreement have been duly authorized by all requisite limited liability company action and does not require any further action or approval.

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(c)    SPL has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder.
(d)    The execution, delivery, and performance by SPL of this Agreement and its compliance with the provisions of this Agreement does not and shall not conflict with or result in a breach of any of the terms and provisions of or constitute a default under (i) any other agreement to which it is a party; (ii) the provisions of its organizational documents; or (iii) any Judgment, writ, or decree of any court or Governmental Authority entered against it or by which any of its property is bound.
(e)    SPL has obtained each consent, approval or authorization of or has filed each notice, declaration, filing or registration with, any Governmental or Regulatory Authority required for the execution, delivery and performance of this Agreement, and the execution, delivery and performance of this Agreement will not violate any Law, rule or regulation applicable to SPL.
(f)    This Agreement has been duly executed and delivered and constitutes SPL's legal, valid and binding obligation, enforceable against SPL in accordance with its terms subject, as to enforcement, to bankruptcy, insolvency, reorganization and other laws of general applicability relating to or affecting creditors' rights and to the availability of particular remedies under general equity principles.
(g)    SPL will not use in any capacity the services of any persons debarred or convicted under 21 U.S.C. § 335(a) or 335(b) in connection with the manufacture of the Products.  SPL does not currently have, and covenants that it will not hire, as an officer or an employee any person who has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the Act.
(h)    SPL shall require that all subcontractors shall comply with all Laws, rules and regulations relating to its activities under this Agreement. 
(i)    As of the Effective Date, SPL is not aware of any third party Intellectual Property Rights that will be infringed by the manufacture of the API, and SPL will promptly inform Cantex if it receives notice of any claim or potential claim relating to infringement or alleged infringement of any third party Intellectual Property Rights by virtue of the manufacture of API hereunder;
(j)    SPL will involve in the performance of the manufacturing services hereunder only those of its employees who have been previously informed in writing of their obligations under laws applicable to employee inventions to notify any inventions and/or improvements made in connection with the performance of the manufacturing services to their respective employer and to assign any rights to such inventions or improvements to such employer. 
(k)    SPL warrants that it has ownership of the SPL Intellectual Property described in Article VII.

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9.3    Disclaimer of Warranties.  
(a)    THE WARRANTIES PROVIDED IN SECTION 9.1 ABOVE ARE THE EXCLUSIVE WARRANTIES GIVEN BY CANTEX TO SPL WITH RESPECT TO THE MATTERS SET FORTH HEREIN, AND ARE GIVEN AND ACCEPTED IN LIEU OF ANY AND ALL OTHER WARRANTIES, GUARANTEES, CONDITIONS AND REPRESENTATIONS, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
(b)    THE WARRANTIES PROVIDED IN SECTION 4.6 AND 9.2 ABOVE ARE THE EXCLUSIVE WARRANTIES GIVEN BY SPL TO CANTEX WITH RESPECT TO THE MATTERS SET FORTH HEREIN, AND ARE GIVEN AND ACCEPTED IN LIEU OF ANY AND ALL OTHER WARRANTIES, GUARANTEES, CONDITIONS AND REPRESENTATIONS, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
ARTICLE X
INDEMNIFICATION
10.1    Indemnification by SPL .  SPL shall indemnify, defend and hold harmless Cantex and its Affiliates and their respective officers, managers, equity holders, employees, agents and representatives (each a "Cantex Indemnified Party") from and against any and all claims, actions, suits, proceedings, losses, liabilities, damages, penalties, fines, costs and expenses (including, without limitation, reasonable attorneys' fees) (collectively, "Losses") incurred, sustained or suffered by such Cantex Indemnified Party by reason of a Third Party claim arising out of or resulting from:
(a)     any breach by SPL of any of its representations, warranties, covenants, undertakings or obligations under this Agreement; or 
(b)    any negligent or wrongful act or omission or misconduct by SPL or any of its Affiliates or any of their respective employees, subcontractors, representatives or agents in connection with the performance of SPL's obligations under this Agreement; or
(c)    any infringement or alleged infringement or breach of any Intellectual Property Rights of a Third Party caused by use of the SPL Intellectual Property Rights by SPL or its subcontractors in the performance of the manufacturing services hereunder; or
(d)    any recalls, seizures, product liability claims or claims of personal injury relating to the API or any Product to the extent such claim is based (i) on SPL's negligence or intentional wrongdoing in manufacturing the API or in performing any other obligations under this Agreement, or (ii) on the breach of any of SPL's warranties under Section 4.6 or Section 9.2 hereunder;

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provided, however, that SPL shall not be required to indemnify any Cantex Indemnified Party with respect to any such Losses to the extent that Cantex is obligated to indemnify SPL under Section 10.2. 
10.2    Indemnification by Cantex .  Cantex shall indemnify, defend and hold harmless SPL and its Affiliates and their respective officers, managers, equity holders, employees, agents and representatives (each a "SPL Indemnified Party") from and against any and all Losses incurred, sustained or suffered by such SPL Indemnified Party by reason of a Third Party claim arising out of or resulting from: 
(a)    any breach by Cantex of any of its representations, warranties, covenants, undertakings or obligations under this Agreement; or 
(b)    any negligent or wrongful act or omission or misconduct by Cantex or any of its employees, subcontractors, representatives or agents in connection with the performance of their obligations under this Agreement; or 
(c)    any recalls, seizures, product liability claims or claims of personal injury or property damage arising from the manufacture, packaging (including labeling), use, sale or distribution of any Products by Cantex or any of its employees, subcontractors, representatives, customers or agents; 
(d)    any infringement or alleged infringement or breach of any Intellectual Property Rights of a Third Party caused by use of Cantex Intellectual Property Rights.
provided, however, that Cantex shall not be required to indemnify any SPL Indemnified Party with respect to any such Losses to the extent that SPL is obligated to indemnify Cantex under Section 10.1.  
10.3    Procedure for Indemnification. Each Party seeking to be reimbursed, indemnified, defended, and/or held harmless under Sections 10.1 or 10.2 (each, an "Indemnitee") shall provide the Party obligated to indemnify such Indemnitee (the "Indemnitor") with prompt, written notice of any claim, suit, demand, or other action for which such Indemnitee seeks to be reimbursed, indemnified, defended, and/or held harmless (each, a "Claim"), which notice shall include a reasonable identification of the alleged facts giving rise to such Claim.  The failure to give such notice shall not relieve the Indemnitor from any liability that it may have to Indemnitee, except to the extent that the Indemnitor's ability to defend such claim or suit is materially prejudiced by such failure to give notice.  Each Indemnitee shall have the right to participate in the defense of any Claim for which Indemnitee seeks to be reimbursed, indemnified, defended, or held harmless, by using attorneys of such Indemnitee's choice, at such Indemnitee's expense.  The Indemnitor shall not enter into any settlement agreement, which would materially adversely affect the rights or obligations of the Indemnitee under this Agreement without the Indemnitee's prior written consent.
10.4    Offset of Insurance Proceeds.  Any indemnification hereunder shall be made net of any insurance proceeds recovered by the Indemnitee; provided, that, if, following the payment 

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to the Indemnitee of any amount under Article X, such Indemnitee recovers any insurance proceeds in respect of the claim for which such indemnification payment was made, such Indemnitee shall promptly pay an amount equal to the amount of such insurance proceeds (but not exceeding the amount of such indemnification payment from the Indemnitee) to the Indemnitor.
10.5    Required Insurance.  Without limiting their obligations hereunder, both Parties shall maintain at their individual sole expense, commencing with the Effective Date and continuing throughout the Term and any renewals thereof, sufficient insurance coverage to satisfy their obligations hereunder.  Without derogating from the foregoing, this shall include, at minimum, the following insurance:  (a) commercial general liability insurance, including broad form contractual liability and personal injury coverage, with limits of not less than [*] per occurrence and [*] annual aggregate, general liability umbrella with a coverage limit of not less than [*]; (b) product liability insurance with a coverage limit of not less than [*] per occurrence and [*] annual aggregate.  The required limits for general liability and product liability may be satisfied through a combination of primary and umbrella coverage.  In the event that the Product is approved by the FDA and is commercialized, Cantex shall obtain customary product liability coverage to mitigate the additional risk of commercial distribution.  Both Parties agree to provide 60 days' notice of cancellation or non-renewal of required insurance.  Prior to the performance of any activities under this Agreement, each Party shall provide the other with a certificate of insurance evidencing its respective insurance coverage.  
10.6    Limitation of Liability.  EXCEPT WITH RESPECT TO (A) EACH PARTY'S  INDEMNIFICATION OBLIGATIONS PURSUANT TO ARTICLE X, (B) A BREACH OF SPL's OBLIGATIONS UNDER SECTION 2.8, (C) A BREACH OF CANTEX'S OBLIGATIONS UNDER SECTION 2.9 AND (D) A BREACH OF THE CONFIDENTIALITY OBLIGATIONS UNDER ARTICLE VIII, NEITHER PARTY SHALL BE LIABLE WITH RESPECT TO ANY CLAIM RELATED TO THIS AGREEMENT FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES, INCLUDING ANY LOSS OF INCOME, LOSS OF PROFITS, COSTS OF SUBSTITUTION, COSTS OF COVER EXCEPT AS SET FORTH IN SECTION 4.8 OR INCREASED CAPITAL COSTS, REGARDLESS OF THE FORM OR NATURE OF ACTION, WHETHER IN CONTRACT, BREACH OF WARRANTY, STRICT LIABILITY, EQUITY, INDEMNITY, NEGLIGENCE, INTENTIONAL CONDUCT, TORT OR OTHERWISE, EVEN IF SUCH DAMAGES WERE FORESEEABLE OR IF THE PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
ARTICLE XI
TERM AND TERMINATION
11.1    Term.  This Agreement shall commence on the Effective Date and, unless earlier terminated in accordance with the terms and conditions of this Agreement, shall continue in effect for [*].

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11.2    Grounds for Termination.
(a)    Termination by SPL.  This Agreement may be terminated by SPL:
(i)    Cantex has breached any of its material obligations under this Agreement, provided however, that termination with respect to those breaches that are capable of being cured shall be subject to a cure period of ninety (90) days of written notice of the breach provided by SPL, and provided further, if a breach capable of being cured by Cantex is not curable within ninety (90) days, this Agreement shall remain in effect and shall not terminate as long as Cantex is diligently curing such breach as expeditiously as possible but not in excess of 120 days.  Notwithstanding the foregoing, if a termination under this Section 11.2(a)(i) is in dispute by Cantex, then the cure period shall be extended during the resolution period of such dispute and if Cantex cures the breach during such period, the Agreement shall not terminate and SPL's obligations under Section 2.8 (in addition to its other obligations hereunder) shall remain in effect. Provided, however, in no event shall such cure period extend to beyond one hundred eighty (180) days from such notice.
(ii)    upon forty-five (45) days' written notice if Cantex has breached a payment obligation under this Agreement, which is not then in dispute, and has not cured such breach within such forty-five (45) day period; or
(iii)    upon forty-five (45) days written notice if (i) Cantex has not received FDA approval for the marketing and sale of any Product incorporating the API within [*] of the date of this Agreement and Cantex is Not Pursuing (as defined below) further any FDA approval for a Product or (ii) Cantex and its successors have abandoned (i.e., have determined to no longer sell) an approved Product.  For purposes of this Section 11.2(a)(iii), "Not Pursuing" means a lack of activity by Cantex with FDA in the [*] prior to SPL's written notice to Cantex under this Section 11.2(a)(iii)  respect to Product approval; provided however, that inactivity that is a result of waiting for an applicable response from FDA or other delay not caused by Cantex shall not be counted for purposes of the determining the [*].
(b)    Termination by Cantex .  This Agreement may be terminated by Cantex in the event that: 
(i)    SPL has breached any of its material obligations under this Agreement, provided however, that termination with respect to those breaches that are capable of being cured shall be subject to a cure period of ninety (90) days of written notice of the breach provided by Cantex, and provided further, if a breach capable of being cured by SPL is not curable within ninety (90) days, this Agreement shall remain in effect and shall not terminate as long as SPL is diligently curing such breach as expeditiously as possible but not in excess of one hundred twenty (120) days; 
(ii)    upon at least ninety (90) days' prior written notice to SPL, if the FDA withdraws Regulatory Approval or fails to grant Regulatory Approval for the Product when reasonably expected or Cantex reasonably believes that the FDA will take (or, as context requires, fail to take) any such action or if Cantex reasonably believes that clinical data or other indicators 

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will have an adverse impact on the commercial viability of the Product, provided that Cantex shall provide ninety (90) days' prior written notice to SPL; or
(iii)    upon at least forty-five (45) days' written notice if SPL determines not to undertake a Facility Expansion prior to FDA approval as described in Section 2.3. 
(c)    Termination for Insolvency.  Either Party may terminate this Agreement immediately in the event that the other Party becomes the subject of a voluntary or involuntary proceeding relating to insolvency, receivership, liquidation, or composition for the benefit of creditors.
(d)    Termination Due to Force Majeure.  Cantex may terminate this Agreement upon written notice to SPL in the event that an Event of Force Majeure prevents SPL from performing its obligations under this Agreement for a period of one hundred eighty (180) days or is reasonably expected to be prevented from performing its obligations hereunder for a period of at least one hundred eighty (180) days.  SPL may terminate this Agreement upon written notice to Cantex in the event that an Event of Force Majeure prevents Cantex from performing its obligations under this Agreement for a period of one hundred eighty (180) days or is reasonably expected to be prevented from performing its obligations under this Agreement for a period of at least one hundred eighty 180 days.
(a)    Termination and Cure of Material Breach.  Notwithstanding the provisions of Section 11.1(b)(i) or (ii) or Section 11.2(b)(i), if either Party asserts (the "Nonbreaching Party") that the other Party (the "Breaching Party") is in material breach of this Agreement, and the Breaching Party disputes either that it is in breach or that the breach is material, the Breaching Party may submit the relevant issue(s) of breach or material to Dispute Resolution and binding arbitration pursuant to Section 12.3 of this Agreement by providing written notice thereof to the Nonbreaching Party.  If the Arbitrator determines that a material breach has occurred, the Breaching Party shall have an additional period of sixty (60) days from the date of the Arbitrator's determination to cure such material breach before termination is effective; provided, however, if the breach is a failure to make payment, the Breaching Party shall have ten (10) days from the Arbitrator's payment to cure such breach.  Neither Party may suspend performance under this Agreement while a matter is pending before the Arbitrator or is subject to Dispute Resolution.  However, in the event of a payment dispute, Cantex shall pay to SPL in accordance with this Agreement all amounts that are not in dispute.  The date that the material breach by Cantex or SPL occurred will be determined by the Arbitrator.
11.3    Effects of Termination.
(a)    Rights and Obligations.  Upon the termination of this Agreement for any reason whatsoever all further rights and obligations of the Parties shall cease, except that the Parties shall not be relieved of:  (i) any obligations accruing before the effective date of termination or (ii) any other obligation hereunder which survives termination pursuant to the express provisions of this Agreement.  

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(b)    Work in Process.  Upon termination, and provided that SPL is not in material breach with respect to such purchase order, Cantex shall be obligated to purchase the API subject to an effective purchase order pursuant to terms set forth in this Agreement  or pay the reasonable and documented Raw Material Costs (excluding the raw material costs associated with the production of [*] to the extent that SPL can use such [*] for other customers or products) incurred by SPL in preparing to fulfill such API order (if such amount is lower) if such Raw Material Costs have been incurred, but production has not yet commenced.  
(c)    Confidential Information.  In any event of expiration or termination of this Agreement, any Confidential Information, documentation and possible reproductions as well as tools and other means provided or disclosed by the disclosing Party to the other Party and all copies thereof (in whatever form), shall be immediately returned to the disclosing Party or, upon the disclosing Party's request, destroyed and destruction certified to the Disclosing Party, except for a single copy of such Confidential Information or other documentation which may be retained for the other Party's legal records, provided that such copy shall be subject to the confidentiality, non-use and nondisclosure obligations under Article VIII hereof. 
(d)    Transition of Manufacturing.  Upon termination of this Agreement, SPL shall provide such cooperation as reasonably requested by Cantex to transfer and transition the manufacturing of the API to a Third Party manufacturer.  SPL's transition obligation shall not include any obligation to provide SPL Intellectual Property Rights to a Third Party.  Thus, any transition services and technology transfer shall be limited to Cantex Intellectual Property Rights.  SPL shall not be entitled payment with respect to such transition services, in the case of a termination by Cantex upon material breach by SPL or upon insolvency of SPL.  SPL shall be entitled to commercially reasonable payments with respect to transition services in a termination by SPL or Cantex as a result of an event of Force Majeure.  SPL shall be entitled to twice its normal charges for transition services provided in the material breach or insolvency of Cantex; and provided further, if Cantex is delinquent in payments to SPL, SPL shall not be required to commence or continue providing transition services unless Cantex pays SPL all amounts in arrears and remains current in payments to SPL.  Provided, if after a Force Majeure event preventing the performance of SPL, Cantex reengages SPL to supply API as described in Section 2.8(b)(iii) above, SPL shall credit transition payments made to SPL by Cantex.
(e)    Survival.  Termination or expiration of this Agreement shall not affect the rights and obligations that may have accrued to either Party under this Agreement prior to the date of termination or expiration, or that, by their terms, expressly survive termination,  including, without limitation Article I, Section 2.8, Section 2.10, Section 3.2, Section 4.3 (if API continues to be stored by SPL), the last sentence of Section 4.5, Sections 4.6, 4.7, 4.8, Article V, Section 6.2 (concerning record retention), Article VII, Article VIII, Section 9.3, Article X, Section 11.3, Article XII, the Confidentiality Agreement and Sections 7.4.1, 7.5.1, 8.4.5 and 8.5 of the Quality Agreement. 

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ARTICLE XII
MISCELLANEOUS
12.1    Force Majeure.  No Party shall be responsible to the other under this Agreement for failure or delay in performing any obligations under this Agreement, other than payment obligations, due to factors beyond its reasonable control, including but not limited to war, terrorism, sabotage, revolution, riot or civil commotion, strikes, lock-outs, regulatory changes, changes in capital markets, intervention or failure of the government, failure of raw material supply, including that caused by animal disease, including the significant lack of availability or scarcity of animal or porcine mucosa, failure of supplies of power or fuel, prohibitions against imports or exports of Products or raw materials used for the Products, explosion, sabotage, fire, flood, natural disaster or act of God (each such factor, an "Event of Force Majeure").  Upon the occurrence of an Event of Force Majeure, the Party failing or delaying performance shall (a) promptly notify the other Party in writing, setting forth the nature of the occurrence, its expected duration, and how that Party's performance is affected, (b) use Commercially Reasonable Efforts to avoid, rectify or remove the Event of Force Majeure.  Any Party subject to an Event of Force Majeure shall resume performing its obligations under this Agreement as soon as practicable following resolution of the Event of Force Majeure.  Except as otherwise provided herein, if an Event of Force Majeure occurs, the affected Party shall be excused from performing and the time for performance shall be extended as long as that Party is unable to perform as a result of the Event of Force Majeure.   
12.2    Governing Law.  The Agreement shall be governed under the law of the State of New York, without regard to its principles of conflicts of laws. 
12.3    Dispute Resolution.  
(a)    In the event of any dispute, controversy or claim arising out of, relating to or in connection with any provision of this Agreement or the rights or obligations of the Parties hereunder (a "Dispute"), the Parties will use good faith efforts to resolve such Dispute amicably between themselves as contemplated herein before initiating legal proceedings with respect to such Dispute.  Either Party may initiate such informal dispute resolution by sending written notice to the other Party setting forth in reasonable detail the nature of the dispute (the "Dispute Notice").  Within thirty (30) days after delivery of such Dispute Notice, senior representatives of each Party with authority to resolve such matter shall meet to negotiate in good faith a resolution to the Dispute.  Any specific discussions and correspondence among the representatives of the Parties taking place for purposes of any negotiations or mediation hereunder shall be treated as Confidential Information developed for purposes of settlement, shall be exempt from discovery and production and shall not be admissible in any lawsuit without the concurrence of all Parties.  However, any documents identified in, or provided with, such communications, which are not prepared for purposes of such negotiations or mediation are not so exempted and may, if otherwise admissible, be admitted in evidence in any arbitration or lawsuit.
(b)    Arbitration.  If a dispute cannot be resolved by the Parties within the timeframe as set forth in Section 12.3(a) above, which time may be extended by mutual consent of both Parties, then the dispute shall be determined by binding arbitration in accordance with the arbitration rules of the American Arbitration Association ("Rules") in force when the notice of 

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arbitration is submitted in accordance with these Rules.  The arbitration shall be conducted in New York, New York, by a single arbitrator having relevant industry experience and knowledge.  The arbitration proceedings shall be conducted in English.  The Arbitrator shall not be empowered to award damages in excess of those permitted under the Agreement.  The use of any alternative dispute resolution procedure will not be construed, under the doctrine of laches, waiver, or estoppel, to adversely affect the rights of either Party.  Judgment on the arbitration award may be entered in any court of competent jurisdiction.  The prevailing Party in any dispute arising out of or relating to this Agreement shall be entitled to reasonable attorneys' and arbitrators' fees and costs.  All information relating to a dispute and subsequent mediation and/or arbitration hereunder shall be treated as Confidential Information.
(c)    If there is a dispute under this Agreement, the Parties shall continue to fulfill their respective obligations under this Agreement unless specified otherwise in this Agreement.
(d)    Notwithstanding the foregoing, the provisions of this paragraph will not limit or delay in any way either Party's right to seek preliminary injunctive or other equitable relief from any court having jurisdiction, whether or not such Party has pursued informal resolution or arbitration in accordance with this paragraph.  
12.4    Assignment.
(a)    Assignment.  No Party may assign any of its rights or delegate any performance under this Agreement, without the prior written consent of the non-assigning Party, which shall not be unreasonably withheld.  An event which results in a Change of Control of a Party shall not be deemed to be an assignment for purposes of this provision, and no rights shall arise upon a Change of Control except as set forth herein.
(b)    Assignment without Consent.  Any purported assignment in contravention of Section 12.4(a) shall, at the option of the non-assigning Party, (i) be null and void and of no effect or (ii) terminate this Agreement.  If the non-assigning Party elects to terminate this Agreement, the termination is effective as of the assignment's occurrence.  Any termination is without prejudice to the non-assigning Party's claim for damages.
(c)    Assignment with Consent.  With respect to any assignment in compliance with Section 12.4, the terms and conditions of this Agreement shall inure to the benefit of and be binding upon the respective successors and permitted assigns of the Parties.
12.5    Amendment; Approvals.  Except as expressly provided herein, this Agreement may not be amended except by an instrument in writing referencing this Agreement and signed on behalf of both Parties.  To be deemed effective pursuant to this Agreement, all approvals required hereunder shall be in writing.
12.6    Waivers.  No term or provision of this Agreement shall be considered waived by either Party hereto, and no breach consented to by either Party hereto, unless such waiver or consent is in writing signed on behalf of the Party against whom the waiver or consent is asserted.  No consent to or waiver of a breach by either Party hereto, whether express or implied, shall 

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constitute a consent to, waiver of, or excuse for any other, different or subsequent breach by such Party.
12.7    Construction.  This Agreement is being entered into by and among competent and sophisticated parties who are experienced in business matters and represented by counsel and other advisors, and have been reviewed by the Parties and their counsel and advisors.  Therefore, any ambiguous language in this Agreement will not be construed against any particular Party as the drafter of the language.
12.8    Notices.
(a)    All notices and other communications hereunder shall be in writing and shall be sent to the respective Parties at the following addresses:
If to Cantex:
Cantex Pharmaceuticals, Inc.
1792 Bell Tower Lane, Weston, FL 33326
Attn:  Stephen Marcus, President

with a copy to (which shall not constitute notice)

Greenberg Traurig LLP
3333 Piedmont Road, Suite 2500
Atlanta, GA 30305
Attn:  Wayne H. Elowe, Esq.

and

If to SPL:

Scientific Protein Laboratories LLC
700 East Main Street
P.O. Box 158
Waunakee, WI 53597
Attn:  President/CEO

with a copy to (but which shall not constitute notice):
Reinhart Boerner Van Deuren s.c.
1000 North Water Street
Milwaukee, WI 53202
Attn:  Lawrence Burnett, Esq.

(b)    All notices shall be deemed received: (i) if given by hand, immediately, (ii) if given by certified mail, three (3) business days after posting, (iii) if given by overnight courier service, 

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the next business day in the jurisdiction of the recipient, or (iv) if given by facsimile or electronic mail, upon confirmed receipt thereof by the recipient.  Any Party may, by notice given in accordance with Section 12.8 of the Agreement to the other Party, designate another address or Person for receipt of notices hereunder.
12.9    Independent Contractor.  In making and performing this Agreement, the Parties hereto are acting and shall act as independent contractors.  Neither Party is, nor shall be deemed to be, an agent, legal representative, joint venturer or partner of the other Party for any purpose.  Except as expressly permitted hereunder or with the prior written consent of the other Party, neither Party shall be entitled to (a) enter into any contracts in the name of or on behalf of the other Party, (b) pledge the credit of the other Party in any way or hold itself out as having authority to do so or (c) make commitments or incur any charges or expenses for or in the name of the other Party.
12.10    Severability.  Wherever possible, each provision of this Agreement shall be interpreted in a manner as to be effective and valid under applicable Law.  If, however, any provision of this Agreement, or portion thereof, is prohibited by Law or found invalid under any Law, only such provision or portion thereof shall be ineffective, without in any manner invalidating or affecting the remaining provisions of this Agreement or valid portions of such provision, which are hereby deemed severable.
12.11    Section Headings.  All personal pronouns used in this Agreement, whether used in the masculine, feminine, or neuter gender, shall include all other genders, and the singular shall include the plural and vice versa.  Titles of articles, sections and subsections are for convenience only and neither limit nor amplify the provisions of this Agreement.  The use herein of the word "including," then following any general statement, term, or matter, shall not be construed to limit such statement, term, or matter to the specific items or matters set forth immediately following such word or to similar items or matters, whether or not non-limiting language (such words as "without limitation," or "but not limited to," or words of similar import) is used with reference thereto, but rather shall be deemed to refer to all other items or matters that could reasonably fall within the broadest possible scope of such general statement, term, or matter.
12.12    Supersession of Prior Agreements.  This Agreement supersedes all prior agreements between the Parties.  Upon execution of this Agreement, the Prior Agreement is hereby terminated and of no further force or effect.
12.13    Further Assurances.  Each Party hereto agrees to do all acts and things and to make, execute and deliver such written instruments, as shall from time to time be reasonably required to carry out the terms and provisions of this Agreement.
12.14    Entire Agreement.  Except where any other document (whether dated prior to or contemporaneously with this Agreement) expressly refers to this Agreement, this Agreement and the exhibits attached hereto constitute the entire understanding between the Parties with respect to the subject matter hereof and shall supersede any prior agreements, whether written or oral, arrangements or understandings, between the Parties relating to the subject matter hereof.

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12.15    Counterparts.  The Agreement may be executed in multiple counterparts, each of which shall be deemed an original, and all of which together shall constitute one and the same instrument.  Signatures delivered by facsimile or by e-mail in portable document format (PDF) shall be binding for all purposes hereof.
[Remainder of Page Intentionally Left Blank]

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IN WITNESS WHEREOF, the Parties have executed and delivered this Agreement effective as of the Effective Date.
	
		
	CANTEX PHARMACEUTICALS , INC.

By:   /s/ Stephen G. Marcus                      
Name:  Stephen G. Marcus                       
Title:  President & CEO                            

	SCIENTIFIC PROTEIN LABORATORIES LLC

By: /s/ Yan Wang                                          
      Yan Wang, PhD.
      President

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EXHIBIT A
Specifications
Attached at the end of EXHIBIT B.

    

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

EXHIBIT B
Quality Agreement
[*]Exhibit

Execution Version

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

LICENSE AGREEMENT
THIS LICENSE AGREEMENT (“Agreement”), effective as of September 30, 2019 (the “Effective Date”), is made by and between CHIMERIX, INC., a corporation organized and existing under the laws of the State of Delaware (“Chimerix”), and SYMBIO PHARMACEUTICALS LIMITED, a corporation organized and existing under the laws of Japan (“SymBio”).  
RECITALS
WHEREAS, Chimerix owns or otherwise controls patents, patent applications, know-how and other information relating to the compound known as brincidofovir;
WHEREAS, SymBio is engaged in the discovery and development of antiviral therapies; and
WHEREAS, SymBio desires to obtain, and Chimerix is willing to grant to SymBio, a license under the Chimerix Technology to develop, make, have made, use, sell, have sold, offer for sale and import Compounds and Products in the Field, on the terms and subject to the conditions set forth herein. 
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
ARTICLE 1
 
DEFINITIONS
Unless specifically set forth to the contrary herein, the following terms shall have the respective meanings set forth below:
1.1    “Acceptance for Filing” shall mean, with respect to an NDA filed for a Product: (a) in the United States, the receipt of written notice from the FDA in accordance with 21 C.F.R. §314.101(a)(2) (or its successor regulation) that such NDA is officially “filed”; (b) in an EU Market, the receipt of written notice of acceptance for filing of such NDA from the EMA or the applicable national Regulatory Authority in such EU Market (as applicable); or (c) in Japan, the receipt of written notice of acceptance for filing of such NDA from the PMDA.  
1.2    “Accounting Standards” shall mean (a) U.S. generally accepted accounting principles, (b) Japan generally accepted accounting principles, or (c) international financial reporting standards; in any case, consistently applied throughout the organization of a Party (or a Related Party, as applicable).

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1.3    “Acquirer Compound” shall mean: 
(a)    any Converting Compound that is Controlled by a Third-Party Acquirer of Chimerix, or any Affiliate of such Third-Party Acquirer, immediately prior to such Third-Party Acquirer’s acquisition of Chimerix; or 
(b)    any Converting Compound that is Controlled by a Third-Party Acquirer of Chimerix, or any Affiliate of such Third-Party Acquirer, following such Third-Party Acquirer’s acquisition of Chimerix, provided that such Converting Compound (i) was invented or reduced to practice without the use of any Chimerix Know-How (including any of Chimerix’s confidential or proprietary information existing prior to such Third-Party’s acquisition of Chimerix) and (ii) is not claimed by any of the Chimerix Patent Rights set forth in Exhibit A.  
1.4    “Act” shall mean, as applicable, the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§301 et seq., or the Public Health Service Act, 42 U.S.C. §§262 et seq., as such may be amended from time to time.
1.5    “Actual Combination Product Net Sales” shall have the meaning provided in Section 1.50.
1.6    “Affiliate” shall mean, with respect to any Person, any other Person that directly or indirectly controls, is controlled by or is under common control with such Person.  A Person shall be deemed to control another Person if such Person possesses the power to direct or cause the direction of the management, business and policies of such Person, whether through the ownership of 50% or more of the voting securities of such Person, by contract or otherwise.  For clarity, once a Person ceases to be an Affiliate of a Party then without any further action, such Person shall cease to have any rights under this Agreement by reason of being an Affiliate of such Party. 
1.7    “Applicable Laws” shall mean the laws of any jurisdiction that are applicable to any of the Parties or their respective Affiliates in carrying out activities hereunder or to which any of the Parties or their respective Affiliates in carrying out the activities hereunder is subject, and shall include all statutes, enactments, acts of legislature, laws, ordinances, rules, regulations, notifications, guidelines, policies, directions, directives and orders of any statutory authority, tribunal, board, or court or any central or state government or local authority or other governmental entity in such jurisdictions.
1.8    “Business Day” shall mean any day other than Saturday, Sunday, or a national holiday in Japan or the United States. 
1.9    “Chimerix Field Patent Rights” shall mean Chimerix Patent Rights the claims of which are limited to methods of use in the Field and that do not claim methods of use of Compound or Product outside the Field.
1.10    “Chimerix Know-How” shall mean all Know-How Controlled by Chimerix or any of its Affiliates as of the Effective Date or during the Term. 

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1.11    “Chimerix NPP” shall have the meaning provided in Section 2.4. 
1.12    “Chimerix Patent Rights” shall mean any and all Patent Rights Controlled by Chimerix or any of its Affiliates as of the Effective Date or during the Term that claim or otherwise Cover the composition of matter, manufacture or use of any Compound or Product (but excluding claims solely and specifically claiming the composition of matter, use, or manufacture of any Other Active); but specifically excluding Chimerix’s (and its Affiliates’) rights in Joint Patent Rights.  The Chimerix Patent Rights shall include those listed in Exhibit A.  Chimerix shall update Exhibit A from time-to-time, but no less than once per calendar year during the Term, to reflect the then-current list of Chimerix Patent Rights.  Notwithstanding the foregoing, Chimerix Patent Rights shall not include any Patent Rights Controlled by any Third-Party Acquirer of Chimerix, or any Affiliate of such Third-Party Acquirer, except for any such Patent Rights claiming inventions made by such Third-Party Acquirer or its Affiliate after such Third-Party Acquirer’s acquisition of Chimerix through (a) the use of Chimerix Know-How or (b) the practice of any invention that is then Covered by a Valid Claim of the Chimerix Patent Rights listed in Exhibit A.  
1.13    “Chimerix Product” shall mean a Compound or Product developed, manufactured or commercialized by Chimerix, its Affiliates or licensees for the treatment or prevention of an Excluded Indication. 
1.14    “Chimerix Technology” shall mean Chimerix Patent Rights and Chimerix Know-How. 
1.15    “Combination Product” shall mean a pharmaceutical product comprising a fixed-dose formulation of Product or Compound and at least one Other Active. 
1.16    “Commercially Reasonable Efforts” shall mean, (a) with respect to the efforts to be expended by a Party to accomplish any objective (other than any objective relating to development or commercialization of a Product, which is covered by clause (b) below), such reasonable, diligent, and good faith efforts as such Party would normally use to accomplish a similar objective under similar circumstances, and (b) with respect to the efforts to be expended by a Party with respect to development or commercialization of a Product, the level of reasonable, diligent, good faith efforts that biopharmaceutical companies typically devote to the development, registration and commercialization of products owned by them that are at a similar stage in their development or product life and are of similar market potential taking into account efficacy, safety, approved labeling, the competitiveness of alternative products in the marketplace, the patent and other proprietary position of the product, the likelihood of regulatory approval, the profitability of the product, and other relevant factors.  “Commercially Reasonable Efforts” shall be determined on a country-by-country and Product-by-Product basis, and it is anticipated that the level of effort and resources that constitute “Commercially Reasonable Efforts” will change over time, reflecting changes in the status of a Product, as applicable, and the country or countries involved.  It is expressly understood that the cessation of all development and commercialization efforts with respect to Product shall not constitute use of Commercially Reasonable Efforts.  As used in this Section 1.16, “biopharmaceutical companies” shall mean companies in the biopharmaceutical industry of a size and stage of development similar to that of such Party, including those having human pharmaceutical product candidates or products in a similar stage of development to the Compound.   

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1.17    “Compound” shall mean: 
(a)    the 3-(Hexadecyloxy)propyl hydrogen ({[(2S)-1-(4-amino-2-oxo-1(2H)-pyrimidinyl)-3-hydroxy-2-propanyl]oxy}methyl)phosphonate (alternatively named Phosphonic acid, P-[[(S)-2-(4-amino-2-oxo-1(2H)-pyrimidinyl)-1-(hydroxymethyl)ethoxy]methyl]mono[3-(hexadecyloxy)propyl]ester), known as “brincidofovir”; 
(b)    any Converting Compound that is Controlled by Chimerix as of the Effective Date;
(c)    any Converting Compound that is Controlled by Chimerix after the Effective Date and during the Term; but excluding any Acquirer Compound;
(d)    any metabolite of any of the compounds (excluding Acquirer Compounds) described in the preceding subparagraphs (a)-(c);
(e)    any prodrug, conjugate or complex of any of the compounds (excluding Acquirer Compounds) described in the preceding subparagraphs (a)-(d); or 
(f)    any salt, free acid/base, solvate, enantiomer, isomer, hydrate, ester, racemate or polymorphic form of any of the compounds (excluding Acquirer Compounds) described in the preceding subparagraphs (a)-(e).
1.18    “Compound INDs” shall mean INDs # [*].
1.19    “Committee” shall mean the joint review committee established to facilitate the collaboration hereunder, as more fully described in Section 3.4.
1.20    “Confidential Information” shall mean any and all Information, whether communicated in writing or orally or by any other method, which is provided by or on behalf of one Party to the other Party in connection with this Agreement or pursuant to that certain Mutual Non-Disclosure Agreement between the Parties dated August 27, 2018. 
1.21    “Control”, “Controls” or “Controlled by” shall mean, with respect to any Patent Rights, Information, Know How, other intellectual property rights, or compounds, the possession by a Party or its Affiliates of the ability (whether by ownership, license or other right, other than pursuant to a license granted under this Agreement) to grant access to, or a license or sublicense of, such Patent Rights, Know-How, Information, other intellectual property rights, or compounds to the other Party as contemplated by this Agreement without violating the terms of any agreement or other arrangement with any Third Party.  
1.22    “Converting Compound” shall mean a pharmaceutically active compound that is converted in vivo into the active moiety cidofovir diphosphate.  It is understood that brincidofovir is a Converting Compound.
1.23    “Cover” shall mean, with respect to a Patent Right and a Compound or Product, that, in the absence of a license under or ownership of such Patent Right, the manufacture, use, sale, 

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offer for sale or import of such Compound or Product would Infringe such Patent Right (or, in the case of a claim of a pending patent application, would, upon the issuance of a patent containing such claim, Infringe such claim).  Cognates of the word “Cover” shall have correlative meanings.
1.24    “EMA” shall mean the European Medicines Agency or any successor entity thereto with jurisdiction over the European Union. 
1.25    “Entity” shall mean any corporation, general partnership, limited partnership, limited liability partnership, joint venture, estate, trust, company (including any limited liability company or joint stock company), firm or other enterprise, association, organization or entity. 
1.26    “EU Market” shall mean any European Union member state, including the United Kingdom, whether or not a member of the European Union at any given time.
1.27    “Excluded Indication” shall mean the treatment or prevention of Smallpox. 
1.28    “Export Control Laws” shall mean all applicable U.S. laws and regulations relating to (a) sanctions and embargoes imposed by the Office of Foreign Assets Control of the U.S. Department of Treasury or (b) the export or re-export of commodities, technologies, or services, including the Export Administration Act of 1979, 24 U.S.C. §§2401-2420, the International Emergency Economic Powers Act, 50 U.S.C. §§1701-1706, the Trading with the Enemy Act, 50 U.S.C. §§1 et seq., the Arms Export Control Act, 22 U.S.C. §§2778 and 2779, and the International Boycott Provisions of Section 999 of the U.S. Internal Revenue Code of 1986 (as amended).
1.29    “FCPA” shall mean the U.S. Foreign Corrupt Practices Act (15 U.S.C. §§78dd-1, et seq.) as amended.
1.30    “FDA” shall mean the U.S. Food and Drug Administration and any successor entity thereto. 
1.31    “Field” shall mean the use of Compound or Product for the treatment or prevention of any and all Indications, but specifically excluding the use of Compound or Product for the treatment or prevention of any Excluded Indication.  
1.32    “First Commercial Sale” shall mean, with respect to a given Product in a given country, the first commercial transfer or disposition for value of such Product by SymBio or a Related Party to a Third Party (other than a Related Party) for end use or consumption of such Product in such country after receipt of Marketing Approval for such Product in such country.  For clarity, First Commercial Sale shall be determined on a Product-by-Product and country-by-country basis.  
1.33    “Generic Version” shall mean, with respect to a Product, on a country-by-country basis, a pharmaceutical product that: (a) is sold in a given country by a Third Party, other than a Related Party or any other Person in a chain of distribution originating from SymBio or a Related Party; (b) contains the same Compound as such Product in the same dosage form as such Product; and (c) has been approved for marketing by the relevant Regulatory Authority in such country in 

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reliance on the Marketing Approval for such Product in such country, including any such pharmaceutical product that has been approved for marketing (i) in the United States, pursuant to Section 505(b)(2) or Section 505(j) of the Act (21 U.S.C. §355(b)(2) or 21 U.S.C. §355(j), respectively), (ii) in the European Union or a European Union member state, as a “generic medicinal product” pursuant to Article 10 of Parliament and Council Directive 2001/83/EC as amended (including an application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision), (iii) in Japan, Article 14, Paragraph 1 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No 145 of 1960, as amended), or (iv) in any other country or jurisdiction, pursuant to any equivalent of the foregoing laws, regulations or directives, wherein the approval of such pharmaceutical product is based on reference to the Marketing Approval for such Product in such country and a demonstration of bio-equivalence to such Product and that may be substituted for the Product without any additional action by the physician or health care practitioner.  
1.34    “GCP” shall mean the then current “good clinical practices” as such term is defined from time to time by the FDA, EMA, MHLW, or other Regulatory Authority of competent jurisdiction pursuant to its regulations, guidelines or otherwise, as applicable.  Notwithstanding the foregoing, for purposes of the representations and warranties made by Chimerix in Section 7.2, “GCP” shall mean the then current “good clinical practices” as such term is defined from time to time by the FDA pursuant to its regulations, guidelines or otherwise.
1.35    “GLP” shall mean the then current “good laboratory practices” as such term is defined from time to time by the FDA, EMA, MHLW, or other Regulatory Authority of competent jurisdiction pursuant to its regulations, guidelines or otherwise, as applicable.  Notwithstanding the foregoing, for purposes of the representations and warranties made by Chimerix in Section 7.2, “GLP” shall mean the then current “good laboratory practices” as such term is defined from time to time by the FDA pursuant to its regulations, guidelines or otherwise, as applicable.
1.36    “GMP” shall mean the then current “good manufacturing practices” as such term is defined from time to time by the FDA, EMA, MHLW, or other Regulatory Authority of competent jurisdiction pursuant to its regulations, guidelines or otherwise, as applicable.  Notwithstanding the foregoing, for purposes of the representations and warranties made by Chimerix in Section 7.2, “GMP” shall mean the then current “good manufacturing practices” as such term is defined from time to time by the FDA pursuant to its regulations, guidelines or otherwise, as applicable.
1.37    “ICH” means the International Council for Harmonisation (formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use).
1.38    “IND” shall mean an investigational new drug application, clinical study application, clinical trial exemption, or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority, including any such application filed with the FDA pursuant to 21 CFR Part 312. 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

1.39    “Indication” shall mean a separate, and distinct class of disease, syndrome or medical condition in humans for which a separate NDA or a supplement (or other addition) to an existing NDA is required.  For clarity, different stages of the same disease or condition shall not be different Indications, different lines of treatment of the same disease or condition shall not be different Indications, and the treatment or prevention of the same disease or condition in different populations (e.g., adult and pediatric) shall not be different Indications. 
1.40    “Information” shall mean any and all proprietary data, information, materials and know-how (whether patentable or not) that are not in the public domain, including, (a) ideas, discoveries, inventions, improvements, technology or trade secrets, (b) pharmaceutical, chemical and biological materials, products, components or compositions, (c) methods, procedures, formulas, processes, tests, assays, techniques, regulatory requirements and strategies, (d) biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, clinical, safety, manufacturing and quality control data and information related thereto, (e) technical and non-technical data and other information related to the foregoing, and (f) drawings, plans, designs, diagrams, sketches, specifications or other documents containing or relating to such information or materials.
1.41    “Infringe” or “Infringement” means any infringement of a Patent Right as determined by Applicable Law, including direct infringement, contributory infringement or any inducement to infringe.
1.42    “Initiates” or “Initiation” shall mean, with respect to a human clinical trial, the administration of the first dose to the first patient/subject in such trial. 
1.43    “Invention” shall mean any invention, whether or not patentable, made in the course and as a result of the conduct of the activities contemplated by this Agreement.
1.44    “Joint Invention” shall have the meaning provided in Section 8.1.
1.45    “Joint Patent Rights” shall have the meaning provided in Section 8.1. 
1.46    “Know-How” shall mean any and all Information related to a Compound or Product, or any formulation, product improvement or Indication thereof, or necessary or useful for the development, manufacture, commercialization or use of any of the foregoing; but excluding, in each case, Information solely and specifically related to any Other Active.
1.47    “Marketing Approval” shall mean all approvals from the relevant Regulatory Authority in a given country necessary to market and sell a pharmaceutical product in such country, including pricing and reimbursement approvals if required for marketing or sale of such product in such country.
1.48    “MHLW” shall mean the Japanese Ministry of Health, Labor and Welfare, or any related or successor agency, or subagency thereto, including without limitation the Pharmaceuticals and Medical Devices Agency of Japan (the “PMDA”).

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1.49    “NDA” shall mean: (a) in the United States, a New Drug Application (as more fully defined in 21 CFR 314.5, et seq.) filed with the FDA, or any successor application thereto; (b) in Japan, a New Drug Application as filed with the MHLW, or any successor application thereto; or (c) in any other country or group of countries, the equivalent application or submission for approval to market a pharmaceutical product filed with the governing Regulatory Authority in such country or group of countries. 
1.50    “Net Sales” shall mean the gross amounts invoiced for sales or other dispositions of Products by or on behalf of SymBio or any of its Related Parties (each, a “Selling Party”) to Third Parties (other than Related Parties), less the following deductions actually incurred, allowed, paid or accrued by the Selling Party and specifically attributable to Products, all in compliance with applicable Accounting Standards, consistently applied by the Selling Party:
(a)    normal and customary trade discounts, including trade, cash and quantity discounts or rebates credits or refunds, actually allowed or taken;
(b)    credits or allowances actually granted or made for rejection of or return of previously sold Products, including recalls, or for retroactive price reductions and billing errors or for stocking allowances;
(c)    governmental and other rebates (or credits or other equivalents thereof) actually granted to managed health care organizations, commercial insurance companies, pharmacy benefit managers (or equivalents thereof), distributors, national, state/provincial, local, and other governments, their agencies and purchasers, and reimbursers, or to trade customers, in each case with respect to Product;
(d)    reasonable fees paid to wholesalers, distributors, selling agents (excluding sales representatives of the Selling Party), group purchasing organizations, Third-Party payors, other contractees and managed care entities, in each case with respect to the Product; 
(e)    charges separately invoiced for freight, insurance, transportation, postage and handling;
(f)    taxes, custom duties or other governmental charges (including any tax such as a value added or similar tax or government charge but excluding what is commonly known as income tax) levied on or measured by the billing amount for Products, as adjusted for rebates and refunds; and
(g)    the amount of any actual write-offs for bad debt on previously sold Product in accordance with the applicable Accounting Standards used by the Selling Party, consistently applied, not to exceed [*] in any calendar quarter; provided that any amount written off that is subsequently collected shall be treated as Net Sales in the calendar quarter in which it is collected; 
provided that, in each case ((a) through (g)): (1) each such deduction is calculated in a manner consistent with the Selling Party’s customary practice for pharmaceutical products and in accordance with applicable Accounting Standards, consistently applied by the Selling Party; (2) each such 

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deduction is directly allocable to Product, or apportioned on a good faith, fair and equitable basis to Product and other products of the Selling Party and its Affiliates such that Product does not bear a disproportionate portion of such deductions; and (3) in no event shall any particular amount identified above be deducted more than once in calculating Net Sales (i.e., no “double counting” of deductions).  
Sale or other disposition of Product by a Selling Party to another Selling Party for resale by such other Selling Party to a Third Party (other than a Selling Party) shall not be deemed a sale for purposes of this definition of Net Sales, provided that the subsequent resale to a Third Party (other than a Selling Party) is included in the computation of Net Sales.  In the event of any sale or other disposition of Product for any consideration other than exclusively monetary consideration on bona fide arm’s-length terms (including any sale or other disposition of Product by a Selling Party to another Selling Party for end use by such other Selling Party), or in the event Product is “bundled” for sale together with one or more other products for a single price in a country, then for purposes of calculating Net Sales under this Agreement, such Product shall be deemed to have been sold exclusively for cash at the weighted (by sales volume) average sale price of such Product in bona fide arm’s-length transactions (when sold alone, and not with other products) in the applicable country in which such sale or other disposition occurred during the applicable accounting period.  Transfers or dispositions of Product for charitable, research and development, clinical or humanitarian purposes (in each case, without consideration), and Products provided at or below their manufacturing cost (determined in accordance with applicable Accounting Standards, consistently applied) and used in compassionate use or named patient programs, shall be disregarded in determining Net Sales.
On a country-by-country basis, if a Product is sold in a country as part of a Combination Product in a calendar quarter, Net Sales of such Product in such country during such calendar quarter for the purpose of determining royalties and commercialization milestone payments due hereunder shall be calculated as follows.
(i)    In the event that both (x) a Single-Agent Product containing the Compound in such Combination Product is sold separately in finished form in such country during such calendar quarter and (y) the Other Active(s) in such Combination Product are sold separately in finished form in such country during such calendar quarter, then Net Sales of such Product shall be determined by multiplying the actual Net Sales of the Combination Product calculated pursuant to the preceding provisions of this Section 1.50 (“Actual Combination Product Net Sales”) in such country during such calendar quarter by the fraction, A / (A+B) where A is the weighted average sale price of such Single-Agent Product when sold separately in finished form in such country during such calendar quarter, and B is the weighted average sale price of the Other Active(s) in the Combination Product when sold separately in finished form in such country during such calendar quarter. 
(ii)    In the event that Single-Agent Product containing the Compound in such Combination Product is sold separately in finished form in such country during such calendar quarter, but the Other Active(s) in such Combination Product are not sold separately in finished form in such country during such calendar quarter, then Net Sales of such Product shall be calculated 

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by multiplying the Actual Combination Product Net Sales of the Combination Product in such country during such calendar quarter by the fraction A / C where A is the weighted average sale price of such Single-Agent Product when sold separately in finished form in such country during such calendar quarter and C is the weighted average sale price of the Combination Product in such country during such calendar quarter.
(iii)    In the event that no Single-Agent Product containing the Compound in such Combination Product is sold separately in finished form in such country during such calendar quarter, but the Other Active(s) in such Combination Product are sold separately in finished form in such country during such calendar quarter, Net Sales of such Product shall be calculated by multiplying the Actual Combination Product Net Sales of the Combination Product by the fraction (C‐B) / C, where B is the weighted average sale price of the Other Active(s) in the Combination Product when sold separately in finished form in such country during such calendar quarter, and C is the weighted average sale price of the Combination Product in such country during such calendar quarter.
(iv)    In the event that neither a Single-Agent Product containing the Compound in such Combination Product is sold separately in finished form in such country during such calendar quarter, nor the Other Active(s) in such Combination Product are sold separately in finished form in such country during such calendar quarter, then the methodology for determining Net Sales of such Product in such country shall be mutually agreed in writing by the parties in good faith based on the relative contributions of the Compound and the Other Active(s) in such Combination Product to the total value of the Combination Product. 
1.51    “Other Active” shall mean any active pharmaceutical ingredient that is not a Compound.
1.52    “Party” shall mean SymBio and Chimerix, individually, and “Parties” shall mean SymBio and Chimerix, collectively.
1.53    “Patent Rights” shall mean: (a) patents and patent applications (which for the purposes of this Agreement shall be deemed to include certificates of invention and applications for certificates of invention); (b) any and all divisionals, continuations, continuations-in-part, reissues, renewals, substitutions, registrations, re-examinations, revalidations, extensions, supplementary protection certificates and the like of any such patents and patent applications; and (c) any and all foreign equivalents of the foregoing.
1.54    “Person” shall mean any natural person or Entity.
1.55    “Phase 3 Clinical Trial” shall mean a human clinical trial of a Product in any country designed to: (a) establish that such Product is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the Product in the dosage range to be prescribed; and (c) support regulatory approval of such Product that would satisfy the requirements of 21 CFR 312.21(c) or its non-US equivalents. 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

1.56    “Pivotal Trial” shall mean: (a) a Phase 3 Clinical Trial; or (b) any other human clinical trial that the applicable Regulatory Authority has agreed, whether before Initiation of such trial (e.g., pursuant to a special protocol assessment agreement with the FDA) or after Initiation of such trial (e.g., based on an interim data analysis), is sufficient to form the primary basis of an efficacy claim in an NDA submission, regardless of whether the sponsor of such trial characterizes or refers to such trial as a “Phase 3,” “Phase 2b” or “Phase 2b/3” trial (or otherwise) in the applicable protocol, on clinicaltrials.gov, or in any other context.  If a human clinical trial does not constitute a Pivotal Trial at the time of Initiation of such trial, but is later determined by the applicable Regulatory Authority to be sufficient to form the primary basis of an efficacy claim in an NDA submission, then, for purposes of Section 4.2 hereof, and notwithstanding Section 1.42, “Initiation” of such Pivotal Trial shall be deemed to have occurred on the date of such determination by the applicable Regulatory Authority. 
1.57    “PMDA” shall have the meaning set forth in Section 1.48. 
1.58    “Product” shall mean any pharmaceutical composition or preparation in final form containing a Compound, in any formulation or dosage strength.  For clarity, different formulations or dosage strengths of a given Product shall not be considered different Products for purposes of this Agreement, provided that nothing in this Section shall be interpreted to alter royalty payments or the calculation of the Royalty Term, as described in Article 4, or other references to “Product-by-Product” in this Agreement. For example, depending on the circumstances, one formulation of a given Product may, or may not, have a different Royalty Term in a country than another formulation of such Product in such country.  By way of further example, if a Product in a particular formulation sold in a country is Covered by a Valid Claim of Chimerix Patent Rights, and a Product in a different formulation sold in that country is not Covered by such Valid Claim, the Royalty Term for the first Product in such country may be longer than the Royalty Term for the other Product in such country.
1.59    “Product Filings” shall have the meaning provided in Section 1.61.  
1.60    “Regulatory Authority” shall mean any country, federal, supranational, state or local regulatory agency, department, bureau or other governmental or regulatory authority having the administrative authority to regulate the development or marketing of pharmaceutical products in any country or other jurisdiction.
1.61    “Regulatory Documentation” shall mean all regulatory applications, filings, submissions, registrations, licenses, authorizations and approvals, including all INDs, NDAs and Marketing Approvals (collectively, “Product Filings”); all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority); and all reports and documentation in connection with clinical studies and tests (including study reports and study protocols, and copies of all interim study analysis), and all data contained in any of the foregoing, including all INDs, NDAs, advertising and promotion documents, manufacturing data, drug master files, clinical data, adverse event files and complaint files, in each case related to a Compound or Product. 
1.62    “Regulatory Exclusivity” shall mean exclusive marketing rights or data exclusivity rights conferred by the applicable Regulatory Authority in a country or jurisdiction on the holder 

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of a Marketing Approval for a pharmaceutical product in such country or jurisdiction, including, by way of example and not of limitation, regulatory data exclusivity, orphan drug exclusivity, new chemical entity exclusivity and pediatric exclusivity. 
1.63    “Related Party” shall mean each of SymBio’s Affiliates and its and their respective Sublicensees hereunder. 
1.64    “Royalty Term” shall have the meaning provided in Section 4.5. 
1.65    “Single-Agent Product” shall mean a Product containing Compound as its sole active pharmaceutical ingredient.
1.66    “Smallpox” shall mean any orthopox virus, including variola virus.
1.67    “Sublicensee” shall mean a Third-Party sublicensee under the license granted by Chimerix to SymBio pursuant to Section 2.1, whether such Third Party’s sublicense was granted to it directly by SymBio or its Affiliate or indirectly through one or more tiers of sublicense.  As used in this Agreement, “Sublicensee” shall not include: (a) a Third Party distributor of Product that has no royalty or other payment obligations to SymBio or any of its Affiliates that are calculated based on amounts invoiced or received by such Third Party for sales of Product; (b) a Third Party distributor of Product that (i) does not take title to Product, (ii) does not invoice Product sales to Third Party customers and (iii) is responsible only for inventory management and distribution with respect to Product on behalf of SymBio or its Affiliate; or (c) a Third Party to which SymBio or its Affiliates has granted the right solely to market or promote, but not to sell or offer for sale, Product in the Field.  
1.68    “SymBio Know-How” shall mean all Know-How that: (a) is generated, developed or obtained by or on behalf of SymBio or any of its Affiliates or Sublicensees during the Term in the course of conducting research, development, manufacturing, regulatory or commercialization activities with respect to Compound or Product; or (b) is otherwise Controlled by SymBio or any of its Affiliates during the Term and is necessary for, or is actually used in, the conduct of development, manufacture, use or commercialization activities with respect to Compound or Product.  
1.69    “SymBio Patent Rights” shall mean: (a) all Patent Rights claiming or Covering Inventions made by or on behalf of SymBio or any of its Affiliates or Sublicensees during the Term in the course of conducting research, development, manufacturing, regulatory or commercialization activities with respect to Compound or Product; and (b) all other Patent Rights Controlled by SymBio or any of its Affiliates that claim inventions that are necessary for, or is actually used in, the conduct of development, manufacture, use or commercialization activities with respect to Compound or Product; but specifically excluding SymBio’s (and its Affiliates’) rights in Joint Patent Rights.  
1.70    “SymBio Technology” shall mean SymBio Patent Rights and SymBio Know-How. 
1.71    “Term” shall have the meaning provided in Section 9.1. 

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1.72    “Territory” shall mean the entire world.
1.73    “Third Party” shall mean an Entity other than SymBio and its Affiliates, and Chimerix and its Affiliates. 
1.74    “Third-Party Acquirer” shall have the meaning provided in Section 12.5(a). 
1.75    “Upfront Payment” shall have the meaning provided in Section 4.1. 
1.76    “Valid Claim” shall mean: (a) a claim of an issued and unexpired patent, or a supplementary protection certificate thereof, which has not been held permanently revoked, unenforceable or invalid by a decision of a court, patent office or other forum of competent jurisdiction, unappealable or unappealed within the time allowed for appeal and that is not admitted to be invalid or unenforceable through reissue, disclaimer or otherwise; or (b) a claim of a pending patent application that has not been abandoned, finally rejected or expired without the possibility of appeal or re-filing and that has not been pending for more than seven (7) years from the filing date of the earliest patent application from which such claim derives priority. 
ARTICLE 2
 
LICENSE GRANT
2.1    License Grant.  Subject to the terms and conditions of this Agreement, Chimerix hereby grants to SymBio an exclusive (even as to Chimerix and its Affiliates), royalty‐bearing license including the right to sublicense through multiple tiers, under the Chimerix Technology and Chimerix’s interest in the Joint Patent Rights; in each case, solely to discover, develop, make, have made, use, sell, have sold, offer for sale, market, export, import or otherwise commercialize Compounds and Products in the Field in the Territory during the Term.  
2.2    Sublicensing.  Any sublicense granted by SymBio under this Agreement (directly or indirectly through its Affiliate) to a Third Party shall be: (a) in writing; and (b) subject and subordinate in all respects to, and consistent with, the terms and conditions of this Agreement.  SymBio shall provide Chimerix with a copy of any sublicense agreement entered into by SymBio or its Affiliate, and any amendment thereto, within 30 days of its execution; provided that any such copy may be redacted to exclude any information not reasonably necessary to confirm compliance with the terms hereof.  SymBio shall be liable for the failure of its Sublicensees to comply with the relevant obligations under this Agreement and shall, at its own cost, enforce compliance by Sublicensees with the terms of the sublicense agreements.  Chimerix shall provide reasonable cooperation with SymBio’s efforts to enforce compliance by Sublicensees through litigation or arbitration when necessary, by providing documents within its control and making witnesses available to the extent reasonable and practicable, at the request of SymBio. SymBio will reimburse Chimerix for actual expenses incurred in connection with such cooperation.

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2.3    Technology Transfer.  
(a)    Inventory.  By a date mutually agreed between the Parties, not to exceed 120 days after the Effective Date, but subject to Chimerix’s receipt of the Upfront Payment, Chimerix shall transfer to SymBio at no additional cost to SymBio, inventory of Compound as set forth on Exhibit B (collectively, “Inventory”). 
(b)    Manufacturing Technology Transfer.  Within 20 Business Days after the Effective Date, subject to Chimerix’s receipt of the Upfront Payment, Chimerix shall transfer or cause to be transferred (including from its Third-Party contract manufacturers) to SymBio, or an Affiliate or Third-Party manufacturer designated by SymBio, copies of all Chimerix Know-How related to the manufacture of Compound or Product in Chimerix’s Control (whether in the possession of Chimerix, its Affiliate or a Third-Party contract manufacturer), in order to enable SymBio (or its designee) to manufacture Compound or Product for use in the Field using the process employed by or on behalf of Chimerix to manufacture Compound or Product in accordance with the plan set forth on Exhibit C.  In addition, Chimerix shall provide SymBio with an introduction to Chimerix’s Third-Party contract manufacturer(s) for Compound and Product and shall deliver to such contract manufacturer(s) written authorization to: (i) contract with SymBio for the manufacture and supply of Compound and Product; (ii) manufacture Compound and Product on behalf of SymBio; and (iii) disclose to SymBio such Chimerix Know-How regarding manufacture of Compound and Product in the possession of such contract manufacturer as is necessary or useful for SymBio to manufacture or have manufactured Compound and Product for use in the Field.  Chimerix shall use Commercially Reasonable Efforts to provide support to SymBio or its Affiliate (as may be designated by SymBio) in obtaining the services of a Third-Party contract manufacturer.
(c)    Chimerix Know-How.  Within 20 Business Days after the Effective Date, subject to Chimerix’s receipt of the Upfront Payment, Chimerix shall transfer to SymBio all clinical safety, toxicology and other information (including Information) within the Chimerix Know-How related to the Compound or Product that is available in written, graphic, electronic or other tangible form (or true and complete copies thereof), and to the extent such data exists in electronic form, Chimerix may provide the same to SymBio in electronic form.  If Chimerix generates any material new clinical safety, toxicology and other information (including Information) within the Chimerix Know-How related to the Compound or Product that is available in written, graphic, electronic or other tangible form, Chimerix shall promptly (at the latest within 45 days from when the information is generated) transfer true and complete copies thereof to SymBio, and to the extent such data exists in electronic form, Chimerix may provide the same to SymBio in electronic form.
(d)    Scientific Information.  Within 20 Business Days after the Effective Date, subject to Chimerix’s receipt of the Upfront Payment, Chimerix shall disclose to SymBio all existing data and information generated in any preclinical or clinical study of Compound or Product in the Field conducted by or on behalf of Chimerix, including a copy of the final study report from each such study, and provide to SymBio copies of all Regulatory Documentation for Compound and Product in the Field in Chimerix’s possession.  
Subject to the terms and conditions of this Agreement, Chimerix grants SymBio the right to access and reference all Product Filings for Product in the Territory that are held by Chimerix 

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as of the Effective Date or during the Term, solely for the purpose of obtaining and maintaining regulatory approvals for Product in the Field in the Territory; and SymBio grants Chimerix the right to access and reference all Product Filings for Product in the Territory that are held by SymBio or any of its Affiliates or Sublicensees during the Term, solely for the purpose of obtaining and maintaining regulatory approvals for Product outside the Field in the Territory.  Any translation costs associated with any access and reference of future regulatory filings and correspondences with Regulatory Authorities under this Agreement shall be borne by the Party seeking the right to access and reference the applicable filing.  Each Party shall, promptly upon request of the other Party, file with applicable Regulatory Authorities such letters of authorization, access or cross-reference as may be necessary to accomplish the intent of this Section 2.3(d).
(e)    PV Agreement.  Prior to initiation by SymBio of any clinical trial of Product, the Parties shall negotiate in good faith and enter into a pharmacovigilance/safety data exchange agreement for Products (the “PV Agreement”), which shall set forth standard operating procedures governing the collection, investigation, reporting, and exchange of information concerning adverse drug reactions or experiences sufficient to permit each Party to comply with its regulatory and other legal obligations within the applicable timeframes.  The PV Agreement’s terms and conditions shall be no less stringent than U.S., Japan and ICH guidelines, such that each Party shall be able to comply with all regulatory and legal requirements regarding the management of safety data by providing for the exchange of relevant information in appropriate format within applicable timeframes.  Subject to the foregoing, each Party shall be responsible for monitoring all clinical experiences with respect to Product in the course of its own Product development activities and filing all required reports with respect thereto in its respective field (i.e., with respect to SymBio, in the Field, and with respect to Chimerix, in the Excluded Indication).
(f)    Technical Assistance.  For a period of [*], beginning on the Effective Date (the “Technical Assistance Period”), at SymBio’s request and upon reasonable advance notice to Chimerix, Chimerix shall provide reasonable technical assistance to SymBio in the practice of the Chimerix Know‐How transferred to SymBio pursuant to this Section 2.3 (“Technical Assistance”).  For clarity, Technical Assistance excludes, and Chimerix will not be responsible for, the performance of any additional research, development or manufacturing (including CMC) work, as well as the meetings of the Joint Review Committee in Section 3.4.  Technical Assistance shall be provided by Chimerix as follows: [*] SymBio shall reimburse Chimerix for Technical Assistance at the following hourly rates:
	
		
	[*] hours
	$[*]

	[*] hours
	$[*]

	[*] hours
	$[*]

Chimerix shall use Commercially Reasonable Efforts to provide the Technical Assistance in a timely manner consistent with the timelines set forth in Exhibit C hereto.  In no event shall Chimerix be obligated to provide more than an aggregate of [*] of Technical Assistance pursuant to this 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

Section 2.3(f) during the Technical Assistance Period, or to provide any Technical Assistance after the Technical Assistance Period.  For clarity, SymBio may contract with Chimerix’s contract manufacturer of Compound or Product for technical assistance at SymBio’s sole expense, which will not be considered Technical Assistance under this Section 2.3(f).
(g)    Regulatory Support.  Without limiting Chimerix’s obligations set forth elsewhere in this Section 2.3, at SymBio’s reasonable request, Chimerix shall provide reasonable cooperation, and reasonable support in the form of reasonable consultation to SymBio, in connection with SymBio’s preparing and submitting Regulatory Documentation to applicable Regulatory Authorities, including [*].  For clarity, SymBio shall be solely responsible for preparing and submitting Product Filings for Product in the Field in the Territory.
(h)    No Transfer of Compound INDs.  For clarity, in no event shall Chimerix have any obligation to transfer or assign to SymBio any Compound INDs. 
2.4    Reserved Rights.  Chimerix hereby expressly reserves the exclusive right to practice, and to grant licenses under, the Chimerix Technology for any and all purposes other than the specific purposes for which the Chimerix Technology is exclusively licensed to SymBio under Section 2.1.  Without limiting the generality of the foregoing, Chimerix hereby expressly reserves the exclusive, worldwide right to practice, and to grant licenses under, the Chimerix Technology to discover, develop, make, have made, use, sell, have sold, offer for sale, market, import, export and otherwise commercialize (a) Chimerix Products, (b) Compound or Product outside the Field, or (c) any compound that is not a Compound or product that is not a Product for any and all uses.  In addition to the foregoing, and notwithstanding the exclusivity of the license granted in Section 2.1, Chimerix shall have the right to continue its existing named patient program for Product (the “Chimerix NPP”) until such time as Chimerix’s existing supply of Product for such purpose is exhausted.  SymBio shall have no responsibility for the Chimerix NPP. 
2.5    Negative Covenants.  
(a)    By SymBio.  SymBio hereby covenants not to practice, and not to permit or cause any Related Party or other Third Party to practice, any Chimerix Technology for any purpose other than as expressly authorized in this Agreement.  Without limiting the generality of the foregoing, SymBio shall not, directly or indirectly: 
(i)    develop, use, make, have made, sell, have sold, offer for sale, export, import or otherwise commercialize any Compound or Product outside the Field, including any Chimerix Product in any Excluded Indication; or
(ii)    permit or cause any of its Related Parties or any Third Party to engage in any of the activities described in the preceding clause (i).  
(b)    By Chimerix.  Chimerix hereby covenants not to practice, and not to permit or cause any Affiliate, licensee or other Third Party to practice, any SymBio Technology for any purpose other than as expressly authorized in this Agreement.  Without limiting the generality of the foregoing, Chimerix shall not, directly or indirectly: 

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(i)    practice any SymBio Patent Rights for any purpose other than as expressly authorized in Section 2.6; or
(ii)    develop, use, make have made, sell, have sold, offer for sale, export, import or otherwise commercialize any Compound or Product (including Chimerix Product) in the Field. 
2.6    License Grant-Back to Chimerix.  Subject to the terms and conditions of this Agreement, SymBio hereby grants to Chimerix a limited, exclusive, royalty‐free, fully‐paid, irrevocable, perpetual license, with the right to sublicense through multiple tiers, under SymBio Technology and SymBio’s interest in the Joint Patent Rights, solely to develop, make, have made, use, sell, have sold, offer for sale, export, import and otherwise commercialize Chimerix Products outside the Field in the Territory.  Chimerix shall, during the Term, provide SymBio access to Chimerix Controlled Information that is directly related to the use of any SymBio Technology or SymBio’s interest in the Joint Patent Rights licensed to Chimerix pursuant to this Section 2.6.  Prior to, and as a condition of, Chimerix granting to any Third Party a sublicense under the license granted to Chimerix pursuant to this Section 2.6, Chimerix shall procure from such Third Party licensee the right to share, and shall share with SymBio, any subsequent Information generated by such Third Party sublicensee related to the Product.  For the avoidance of doubt, Chimerix is not obligated to share with SymBio any Information generated by any Third Party licensee that is a government entity.  
2.7    No Implied Licenses.  No right or license under any Patent Rights, Know-How or other Information is granted or shall be granted by implication.  All such rights or licenses are or shall be granted only as expressly provided in the terms of this Agreement.  For the avoidance of doubt, Chimerix does not grant to SymBio any license or other right with respect to any active pharmaceutical ingredient that is not a Compound.  SymBio does not grant to Chimerix any license or other right with respect to any other SymBio intellectual property except as described in Section 2.6 and, if applicable, Section 9.5(b).
ARTICLE 3
 
DEVELOPMENT, MANUFACTURING AND COMMERCIALIZATION
3.1    Responsibility.  SymBio (itself or with or through its Related Parties or subcontractors) shall be solely responsible, at its own expense, for, and shall control all aspects of, worldwide development (including pre-clinical and clinical development), manufacture, registration and commercialization (including marketing, promoting, selling, distributing and determining pricing for) Compounds and Products in the Field in the Territory.  Without limiting the generality of the foregoing, SymBio (itself or with or through its Related Parties or subcontractors) shall be solely responsible for preparing and submitting all required regulatory filings in connection with obtaining and maintaining Marketing Approvals with respect to Compounds and Products in the Field in the Territory, including all INDs and NDAs, at SymBio’s sole expense.  All of such submissions and other regulatory filings relating to any Compound or Product in the Field shall be submitted in the name of, and owned by, SymBio (or a Related Party, as applicable).  For clarity, SymBio shall have no responsibility for: (a) any research, development, 

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manufacture, use or commercialization of Compound or Product conducted by or on behalf of Chimerix prior to the Effective Date; or (b) the conduct of the Chimerix NPP either before or after the Effective Date.  
3.2    Diligence.  SymBio (itself or with or through its Related Parties or subcontractors) shall use Commercially Reasonable Efforts to develop and obtain Marketing Approval for at least one Product in the Field in Japan, the United States and the EU Market.  Without limiting the generality of the foregoing, SymBio (itself or with or through its Related Parties or subcontractors) shall use Commercially Reasonable Efforts to perform SymBio’s development plan for the Product in the Field, as such development plan may be amended by SymBio from time to time in its sole discretion (the “Development Plan”).  The initial Development Plan is attached hereto as Exhibit D.  SymBio (itself or with or through its Related Parties or subcontractors) shall use Commercially Reasonable Efforts to promote, market, distribute, sell, have sold and otherwise commercialize at least one Product in the Field in each of Japan, the United States and the EU Market, in each case, after Marketing Approval is obtained in such territory.  Should Chimerix decide to abandon any Marketing Approval for the Excluded Indication for any reason, Chimerix shall: (1) provide reasonably prompt notice to SymBio; and (2) discuss with SymBio via teleconference or in person for a period of at least 30 days (or such period as the parties otherwise mutually agree) after giving SymBio such notice and consider SymBio’s position in good faith in determining whether to abandon the relevant Marketing Approval.  
3.3    Records.  SymBio shall maintain, or cause to be maintained, complete and accurate records of all development work conducted by or on behalf of SymBio with respect to Compound or Product in the Field, including all results, data, inventions and developments made in the performance of such development work.  Chimerix shall maintain, or cause to be maintained, complete and accurate records of all development work conducted by or on behalf of Chimerix with respect to Compound or any Chimerix Product outside of the Field, including all results, data, inventions and developments made in the performance of such development work.  All such records maintained by either Party pursuant to this Section 3.3 shall be in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes.  Each Party shall maintain records under this Section 3.3 regardless of whether they have been provided to the other Party.  Records maintained under this Section 3.3 shall be maintained for at least the minimum required period under applicable law. 
3.4    Joint Review Committee
(a)    Composition of the Joint Review Committee.  The Parties hereby establish a joint review committee (the “Committee” or the “JRC”) to review, consider, and discuss the development, manufacture, and commercialization of the Product in the Field in the Territory.  The Committee shall be comprised of three (3) representatives of Chimerix and three (3) representatives of SymBio.  Each Party shall provide the other with a list of its initial members of the Committee no later than thirty (30) days after the Effective Date, and each Party may change its representatives on the Committee from time to time, in its sole discretion, effective upon notice to the other Party of such change.  These representatives shall have appropriate technical credentials, experience and knowledge, and familiarity with respect to development, manufacture and commercialization of 

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pharmaceutical compounds.  Additional non‐employee representatives or consultants of a Party may from time to time, by mutual consent of the Parties, be invited to attend Committee meetings, subject to such representative’s or consultant’s written agreement to comply with the requirements of Section 6.1.  The Committee shall be chaired by a representative of SymBio, who shall prepare written draft minutes of all Committee meetings within thirty (30) days following such meetings, and shall circulate such minutes to the Committee members.  Chimerix shall provide comments, if any, within thirty (30) days from circulation of the draft minutes.  SymBio shall issue final minutes within thirty (30) days following receipt of Chimerix’s written comments, if any.  Decisions of the Committee shall be made by unanimous vote, with each Party’s representatives collectively having a single vote.  In the event that the Committee cannot or does not, after good faith efforts for a period of thirty (30) days, reach agreement on an issue, the issue will be escalated and communicated to the appropriate CEO of SymBio and the Chief Executive Officer of Chimerix (together, the “Executives”), who shall endeavor to facilitate a resolution of such issue.  If the Executives have not resolved such issue within ten (10) Business Days following the communication of the issue to them, then the resolution and/or course of conduct shall be determined by SymBio, in its sole discretion (and such matter shall not be subject to dispute resolution pursuant to Section 11.2), subject to Section 3.4(c).  Each Party shall bear its own expenses related to the attendance of such meetings by its representatives. 
(b)    Meetings and Responsibilities.  The Committee shall meet in accordance with a schedule established by mutual written agreement of the Parties, but no less frequently than twice annually, with the location for such meetings to be determined by agreement between the Parties.  Alternatively, the Committee may meet by means of teleconference, videoconference or other similar communications equipment.  The Committee shall be responsible for:
(i)    reviewing development and regulatory strategy for Product in the Field in the Territory;
(ii)    reviewing amendments to the Development Plan;
(iii)    facilitating the exchange of Product-related data and information between the Parties;  
(iv)    serving as the principal means for SymBio to keep Chimerix reasonably informed regarding SymBio’s development, manufacturing, registration and commercialization plans, efforts and results with respect to Product in the Territory; and
(v)    serving as the principal means for Chimerix to keep SymBio reasonably informed regarding development and regulatory progress with respect to formulations of Compound for the Excluded Indication relevant to development and regulatory process in the Field (subject to any Chimerix confidentiality restrictions). 
(c)    Limitation on JRC Authority.  Notwithstanding the establishment and existence of the JRC, each Party shall retain the rights, powers and discretion granted to it hereunder, and the JRC shall not be delegated or vested with rights, powers or discretion unless such delegation 

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or vesting is expressly provided herein.  In addition, and notwithstanding any other provision of this Agreement to the contrary, the JRC shall have no right or authority: 
(i)    to interpret, modify, amend, or waive compliance with any provision of, or any right or remedy under, this Agreement; 
(ii)    to determine whether or not a Party has complied with any of its obligations under this Agreement; 
(iii)    to determine whether or not, or when, any milestone event set forth in Section 4.2 or Section 4.3 has been achieved; 
(iv)    to determine any issue in a manner that would conflict with the express terms of this Agreement; or
(v)    to make any decision or approve any matter that is expressly stated to require the mutual written agreement of the Parties or the written consent of one or both Parties. 
3.5    Compliance with Applicable Laws.  SymBio shall conduct, and shall cause its Related Parties to conduct, all development, regulatory, manufacturing, promotion, marketing, distribution, sale and pharmacovigilance activities with respect to Compounds and Products anywhere in the world in compliance with all Applicable Laws and, as applicable, GLP, GCP or GMP. 
ARTICLE 4
 
PAYMENTS
4.1    Upfront Payment.  In partial consideration for the rights and licenses granted to SymBio hereunder, SymBio shall pay to Chimerix, no later than fifteen (15) Business Days after the Effective Date, an upfront payment in the amount of $5 million USD (the “Upfront Payment”).  SymBio’s failure to pay the Upfront Payment within fifteen (15) Business Days of the Effective Date shall render this Agreement null and void ab initio.
4.2    Development and Regulatory Milestone Payments.  Within 45 days of the first achievement of each of the milestone events set forth in the table below by SymBio or any Related Party, SymBio shall provide Chimerix with written notice of such achievement and shall pay to Chimerix the corresponding one‐time, non‐refundable, non‐creditable milestone payment set forth below:

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	Milestone Event by Country/Region
	Milestone Payment (USD)

	(Japan)
[*]   
	 $[*] million

	[*]   
	$[*] million

	[*]   
	$[*] million

	(US/EU)
[*]   
	$[*] million

	[*]   
	$[*] million

	[*]   
	$[*] million

Each of the above milestone payments shall only be paid once, for the first achievement of the corresponding milestone event by any Product (regardless of the number of times such milestone event is achieved by a Product, the number of Indications for which such milestone event is achieved by a Product, or the number of Products that achieve such milestone event, and regardless of whether any such milestone event is achieved by the same Product that achieved any other milestone event or by a different Product).  
4.3    Commercialization Milestone Payments.  Within [*] days following the end of the first calendar year in which each of the events set forth below is achieved, SymBio shall pay to Chimerix the corresponding one-time, non‐refundable, non‐creditable milestone payment set forth below:
	
		
	Commercialization Milestone Event (USD)
	Commercialization Milestone Payment (USD)

	First calendar year in which aggregate annual Net Sales of all Products in the Territory exceed $[*]
	$[*] million

	First calendar year in which aggregate annual Net Sales of all Products in the Territory exceed $[*]
	$[*] million

	First calendar year in which aggregate annual Net Sales of all Products in the Territory exceed $[*]
	$[*] million

	First calendar year in which aggregate annual Net Sales of all Products in the Territory exceed $[*]
	$[*] million

Each of the foregoing commercial milestone payments shall be paid only once, for the first calendar year in which the corresponding commercial milestone event is achieved.  If multiple commercial milestone events are achieved in any given calendar year, the commercial milestone payments corresponding to all of such achieved commercial milestone events shall be paid within [*] days of the end of such calendar year.
4.4    Royalties.  Subject to Sections 4.5, 4.6, 4.7 and 4.8 below, SymBio shall pay Chimerix a royalty equal to [*]% of Net Sales of all Products in the Territory by SymBio and Related Parties.  

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4.5    Royalty Term.  Royalties under Section 4.4 shall be payable on a Product-by-Product, country-by-country basis during the period of time commencing on the First Commercial Sale of a Product in a country and ending upon the latest of: (a) 10 years from the date of First Commercial Sale of such Product in such country; (b) expiration of Regulatory Exclusivity for such Product in such country; and (c) expiration of the last-to-expire Valid Claim of the Chimerix Patent Rights Covering the manufacture, use or sale of such Product in such country (the “Royalty Term”).  On a Product-by-Product and country-by-country basis, upon expiration of the Royalty Term for a Product in a country, SymBio’s license under Section 2.1 with respect to such Product in such country shall become fully paid-up, irrevocable and perpetual.  Notwithstanding the foregoing, for sales of a Product in a country that occur (x) after 10 years from the date of First Commercial Sale of such Product in such country and (y) after either (i) expiration of the last-to-expire Valid Claim of the Chimerix Patent Rights Covering the manufacture, use or sale of such Product, or (ii) a Generic Version of such Product is on the market with a market share of more than [*]% and less than [*]% (as calculated in Section 4.8), in each case ((i) and (ii)) in such country where (z) a Regulatory Exclusivity of the Product exists in such country, SymBio shall pay to Chimerix a royalty equal to [*]% of Net Sales of the Product in the Indication that are covered by the Regulatory Exclusivity in such country with no adjustment for generic competition, and no royalty shall be due for sales of Product in an Indication not covered by the Regulatory Exclusivity in such country. 
4.6    Third-Party Licenses.  In the event that SymBio determines that it is necessary to obtain one or more licenses under issued and unexpired Patent Rights of Third Parties in order to make, have made, use, offer to sell, sell or import Product in a country (“Third-Party Patent Licenses”), [*]% of the royalties actually paid to Third Parties under such Third-Party Patent Licenses by SymBio for the sale of such Product in such country for a calendar quarter shall be creditable against the royalty payments due Chimerix by SymBio with respect to Net Sales of such Product in such country for such calendar quarter; provided, however, that in no event shall the royalties otherwise owed by SymBio to Chimerix for such calendar quarter in such country be reduced by more than [*]% as a result of any and all such offsets under this Section 4.6 in the aggregate.  Any portion of the royalties paid to Third Parties under such Third-Party Patent Licenses with respect to such Product in such country that SymBio would, but for the foregoing limitation on royalty reductions, be entitled to deduct under this Section 4.6 shall be carried over and applied against royalties payable to Chimerix in respect of such Product in such country in subsequent calendar quarters until the full deduction is taken; provided, however, that in no event shall the royalties otherwise owed by SymBio to Chimerix for any calendar quarter in such country be reduced by more than [*]% as a result of any and all such offsets under this Section 4.6 in the aggregate.  For clarity, in no event shall SymBio be entitled to deduct from royalties payable to Chimerix hereunder any royalties or other amounts that may be paid or payable by SymBio to any Third Party with respect to Patent Rights or other intellectual property rights Covering any Other Active in a Product that is a fixed-dose combination of Compound and one or more Other Actives.
4.7    Compulsory Licenses.  If a compulsory license is granted to a Third Party with respect to Product in any country with a royalty rate lower than the royalty rate under Section 4.4, then the royalty rate applicable to Net Sales of such Product in that country under Section 4.4 shall be reduced to a rate that is [*] ([*]%) percentage points (i.e., [*] basis points) less than the rate paid by the compulsory licensee; provided, however, that if the royalty rate payable by the compulsory 

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licensee with respect to Net Sales of such Product in such country is [*]% or less, then SymBio shall pay to Chimerix [*]% of the royalties received by SymBio or its Affiliate with respect to Net Sales of such Product in such country by such compulsory licensee. 
4.8    Adjustment for Generic Competition.  Subject to the exception set forth in Section 8.4(a)(ii), on a Product-by-Product and country-by-country basis, during any portion of the Royalty Term for a Product in a country if one or more Generic Versions of such Product account for [*]% or more of aggregate unit sales of such Product and such Generic Version(s) in such country in a calendar quarter, as determined by reference to applicable sales data obtained from IQVIA or from such other source for such sales data as may be agreed upon by the Parties (provided that such other source, if any, shall be generally recognized as a reliable source for pharmaceutical sales data among major pharmaceutical companies), then for the remainder of the Royalty Term for such Product in such country, the royalties payable by SymBio under Section 4.4 with respect to Net Sales of such Product in such country shall be reduced by [*]%.  
ARTICLE 5
 
PAYMENT; RECORDS; AUDITS
5.1    Payment; Reports.  Royalties under Section 4.4 shall be calculated and reported for each calendar quarter during the Royalty Term and shall be paid within [*] days after the end of the calendar quarter.  Each payment of royalties shall be accompanied by a report of Net Sales of Products by SymBio and Related Parties in sufficient detail to permit confirmation of the accuracy of the payment made, including gross sales and Net Sales of Products on a Product-by-Product and country-by-country basis, the deductions from gross sales (by major category as set forth in the definition of Net Sales), details of any royalty credits taken pursuant to Section 4.6 on a Third-Party Patent License-by-Third-Party Patent License basis, any applicable reductions or adjustments made pursuant to Section 4.7 or Section 4.8, the royalty payable, and the exchange rates used.  
5.2    Exchange Rate; Manner and Place of Payment.  All payment amounts in this Agreement are expressed in U.S. dollars, and all payments hereunder shall be payable in U.S. dollars.  When conversion of payments from any foreign currency is required, such conversion shall be calculated using an exchange rate equal to the average of the interbank rates of exchange for such currency as reported at OANDA.com during the calendar quarter for which  payment is due.  All payments owed under this Agreement shall be made by wire transfer in immediately available funds to the bank and account designated in writing by Chimerix. 
5.3    Income Tax Withholding.  Chimerix shall pay any and all taxes levied on account of any payments made to it under this Agreement.  If any taxes are required to be withheld by SymBio from any payment made to Chimerix under this Agreement, SymBio shall (a) deduct such taxes from the payment made to Chimerix, (b) timely pay the taxes to the proper taxing authority, (c) send proof of payment to Chimerix and certify its receipt by the taxing authority within 60 days following such payment, and (d) cooperate with Chimerix in any way reasonably requested by Chimerix, to obtain available reductions, credits or refunds of such taxes.  Without limiting the generality of the foregoing, upon request by Chimerix, SymBio shall provide Chimerix such information in SymBio’s possession as may be reasonably necessary for Chimerix to obtain the 

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benefit of any present or future treaty against double taxation that may apply to payments made to Chimerix under this Agreement.
If SymBio is required to make a payment to Chimerix subject to a deduction or withholding of taxes, and if such deduction or withholding of tax obligation arises solely as a result of the assignment of this Agreement by SymBio or as a result of any failure on the part of SymBio to comply with Applicable Laws relating to the withholding of taxes, in each case, after the Effective Date, that has the effect of increasing the deduction or withholding of taxes on such payment above the amounts of deduction or withholding of taxes that would otherwise be deducted or withheld prior to such assignment of this Agreement or prior to such failure by SymBio to comply with such Applicable Laws, as applicable (a “SymBio Withholding Tax Action”), then the payment by SymBio (in respect of which such deduction or withholding of taxes is required to be made) shall be increased by the amount of such additional deduction or withholding taxes (the “Additional Tax”), but solely to the extent that (i) such Additional Tax arises solely as a direct result of such SymBio Withholding Tax Action and (ii) such Additional Tax cannot be recovered by Chimerix.  The Additional Tax, along with any other taxes deducted and withheld from the payment made by SymBio, shall be timely remitted to the proper governmental authority for the account of Chimerix in accordance with Applicable Laws.  
5.4    Audits.  SymBio shall keep (and shall cause its Affiliates and Sublicensees to keep) complete and accurate records pertaining to the sale or other disposition of Products in sufficient detail to permit Chimerix to confirm the accuracy of all royalty payments due hereunder for at least three (3) full calendar years following the end of the calendar year to which they pertain.  Chimerix shall have the right, once annually, to cause an independent, certified public accountant reasonably acceptable to SymBio to audit such records solely to confirm Net Sales and royalties for a period covering not more than the preceding three (3) full calendar years.  No calendar year shall be subject to audit under this Section 5.4 more than once.  Such audits may be exercised during normal business hours upon reasonable prior written notice of not less than 45 days to SymBio in the location where the records are maintained.  The auditor shall execute a reasonable written confidentiality agreement with SymBio and shall disclose to Chimerix only such information as is reasonably necessary to provide Chimerix with information regarding any actual or potential discrepancies between amounts reported and actually paid and amounts payable under this Agreement.  The auditor shall send a copy of the report to SymBio at the same time it is sent to Chimerix.  The report sent to both Parties shall include the methodology and calculations used to determine the results.  Prompt adjustments shall be made by the Parties to reflect the results of such audit.  Chimerix shall bear the full cost of such audit unless such audit discloses an underpayment by SymBio of more than the greater of [*]% of the amount due for any calendar year under this Agreement or [*] Dollars ($[*]), in such case, SymBio shall bear the full cost of such audit and shall promptly remit to Chimerix the amount of any underpayment.  If such audit discloses an overpayment by SymBio, then SymBio shall deduct the amount of such overpayment from amounts otherwise owed to Chimerix under this Agreement. 
5.5    Late Payments.  In the event that any payment due under this Agreement is not made when due, the payment shall accrue interest at a rate per annum that is [*] basis points (i.e., [*] percentage points) above the then-current prime rate quoted by Citibank in New York City for the period from the due date for payment until the date of actual payment; provided, however, that 

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in no event shall such rate exceed the maximum legal annual interest rate.  The payment of such interest shall not limit Chimerix from exercising any other rights it may have as a consequence of the lateness of any payment. 
ARTICLE 6
 
CONFIDENTIALITY AND PUBLICATION
6.1    Confidential Information.  Except to the extent expressly authorized by this Agreement, each Party (in such capacity, the “Receiving Party”) agrees that, during the Term and for 7 years thereafter (or, with respect to any Confidential Information that constitutes a trade secret of the Disclosing Party (as defined below), until such time as the relevant Confidential Information no longer constitutes a trade secret), it shall keep confidential and shall not publish or otherwise disclose to any Third Party, and shall not use for any purpose other than as expressly provided for in this Agreement or any other written agreement between the Parties, any Confidential Information furnished or made available to it by or on behalf of the other Party (in such capacity, the “Disclosing Party”).  The Receiving Party shall use at least the same standard of care as it uses to protect proprietary or confidential information of its own (but in no event less than reasonable care) to ensure that its, and its Affiliates’, employees, agents, consultants and other representatives do not disclose or make any unauthorized use of the Confidential Information.  The Receiving Party shall promptly notify the Disclosing Party upon discovery of any unauthorized use or disclosure of the Disclosing Party’s Confidential Information. 
6.2    Exceptions.  Confidential Information shall not include any information that the Receiving Party can prove by competent evidence: (a) is now, or hereafter becomes, through no act or failure to act on the part of the Receiving Party, generally known or available; (b) is known by the Receiving Party or any of its Affiliates at the time of receiving such information, as evidenced by its records; (c) is hereafter furnished to the Receiving Party or any of its Affiliates by a Third Party, as a matter of right and without restriction on disclosure; or (d) is independently discovered or developed by the Receiving Party or any of its Affiliates, without the use of Confidential Information of the Disclosing Party.  Any combination of features or disclosures shall not be deemed to fall within the exclusions set forth in the preceding clauses (a) and (b) merely because individual features are published or available to the general public or in the rightful possession of the Receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the Receiving Party.
6.3    Authorized Disclosure.  Notwithstanding the provisions of Section 6.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances: 
(a)    filing or prosecuting Patent Rights as permitted by this Agreement; 
(b)    enforcing such Party’s rights under this Agreement and in performing its obligations under this Agreement;

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(c)    prosecuting or defending litigation as permitted by this Agreement;
(d)    complying with applicable court orders, Applicable Laws, rules or regulations, or the listing rules of any exchange on which the Receiving Party’s securities are traded;
(e)    disclosure to Affiliates, actual and potential Third-Party licensees and sublicensees of the Receiving Party, and employees, consultants, subcontractors, agents, or other business partners of the Receiving Party who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential licensee or sublicensee, employee, consultant, subcontractor, agent, or other business partner, agrees to be bound by terms of confidentiality and non-use comparable in scope to those set forth in this Article 6; and
(f)    disclosure to Third Parties in connection with due diligence or similar investigations by such Third Parties, and disclosure to potential Third-Party investors in confidential financing documents, provided, in each case, that any such Third Party agrees to be bound by reasonable obligations of confidentiality and non-use.  
Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 6.3(c) or 6.3(d), it shall, except where impracticable, give reasonable advance notice to the Disclosing Party of such disclosure and use efforts to secure confidential treatment of such information at least as diligent as the Receiving Party would use to protect its own confidential information, but in no event less than reasonable efforts.  In any event, the Receiving Party agrees to take all reasonable action to avoid disclosure of Confidential Information hereunder.  
6.4    Publications.  SymBio and its Affiliates shall have the right to publish or disclose the results of their development activities, including clinical trials, with respect to the Compounds and Products in the Field, provided that Chimerix shall have the right to review and comment on any such proposed publication or disclosure to the extent the publication or disclosure is related to, inter alia, pre-clinical trial results, clinical trial results or safety issues (“Drafts”).  Before a Draft is submitted for publication or disclosure (other than oral presentation materials and abstracts, which are specifically addressed below), SymBio shall deliver a complete copy to Chimerix at least 20 days prior to submitting the material to a publisher or initiating such other disclosure, and Chimerix shall review any such material and give its comments to SymBio within 10 days of the delivery of such material to Chimerix, which comments shall be considered by SymBio in good faith.  With respect to oral presentation materials and abstracts, SymBio shall deliver a complete copy to Chimerix at least 10 days prior to the anticipated date of the presentation, and Chimerix shall make reasonable efforts to expedite review of such materials and abstracts, and shall return such items as soon as practicable to SymBio with appropriate comments, if any, but in no event later than 5 days from the date of delivery to Chimerix, which comments shall be considered by SymBio in good faith.  SymBio shall comply, or cause its Affiliate to comply (as applicable), with Chimerix’s requests to delete references to Chimerix’s Confidential Information in any such material and agrees to delay any submission for publication or other public disclosure for a period of up to an additional 60 days for the purpose of preparing and filing appropriate patent applications.  In addition, SymBio shall comply with Chimerix’s request to delete from such materials any unpublished chemical structure 

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of any Compound or any unpublished method of synthesis of any Compound.  Chimerix shall not publish any information relating to Compounds or Products in the Field without the prior written consent of SymBio (such consent not to be unreasonably withheld or delayed); provided, however, that, notwithstanding the foregoing or any other provision of this Agreement to the contrary, Chimerix or its academic collaborator(s) shall be free to publish the results of research and development activities with respect to Chimerix Products, whether conducted before or after the Effective Date provided that such publications do not refer to or disclose the Confidential Information of SymBio.  To the extent practicable under the circumstances and to the extent Chimerix has the right and ability to do so, Chimerix shall use reasonable efforts to provide SymBio with the opportunity to review and comment on any proposed publication of the results of research and development activities with respect to Chimerix Products and shall comply with SymBio’s request to delete references to SymBio’s Confidential Information; provided, however, that the failure to provide SymBio with the opportunity to review and comment on any such proposed publication by an academic collaborator of Chimerix (even if one or more Chimerix employees is a named co-author of such publication or Chimerix’s contributions to such research and development are acknowledged in such publication) that does not contain or refer to the Confidential Information of SymBio shall not constitute a breach of Chimerix’s obligation under this sentence if such academic collaborator has the right, by contract, institutional policy or otherwise, to make such publication.
6.5    Publicity.  
(a)    Press Releases.  No later than one (1) Business Day following the Effective Date, the Parties shall issue a joint press release, in substantially the form attached hereto as Exhibit E, announcing the execution of this Agreement.  Except as required (as such requirement is reasonably determined by such Party) by applicable securities laws or the listing rules of any stock exchange on which securities issued by a Party or its Affiliates are traded, neither Party shall make any other public announcement concerning this Agreement or the subject matter hereof without the prior written consent of the other, which shall not be unreasonably withheld or delayed; provided that each Party may make any public statement in response to questions by the press, analysts, investors or those attending industry conferences or financial analyst calls, respond to queries by any exchange on which such Party’s securities are traded, or issue press releases, so long as any such public statement, response, or press release is not inconsistent with prior public disclosures or public statements made in accordance with this Section 6.5 and that do not reveal non‐public information about the other Party.  In the event of a required public announcement, to the extent practicable under the circumstances, the Party making such announcement shall use reasonable efforts to provide the other Party with a copy of the proposed text of such announcement sufficiently in advance of the scheduled release to afford such other Party a reasonable opportunity to review and comment upon the proposed text, unless the proposed text is substantially the same as that used in any prior public disclosure, press release or public statement made in accordance with this Section 6.5.
(b)    Filing of this Agreement.  The Parties shall coordinate in advance with each other in connection with the filing of this Agreement (including redaction of certain provisions of this Agreement) with any securities authority or with any stock exchange on which securities issued by a Party or its Affiliate are traded, and each Party shall use reasonable efforts to seek confidential 

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treatment for the terms proposed to be redacted; provided that each Party shall ultimately retain control over what information to disclose to any securities authority or stock exchange, as the case may be, and provided further that the Parties shall use their reasonable efforts to file redacted versions with any governing bodies that are consistent with redacted versions previously filed with any other governing bodies.  Other than such obligation, neither Party (nor any of its Affiliates) shall be obligated to consult with or obtain approval from the other Party with respect to any filings to any securities authority or stock exchange.
6.6    Prior Non-Disclosure Agreement.  As of the Effective Date, the terms of this Article 6 shall supersede any prior non-disclosure, secrecy or confidentiality agreement between the Parties (or their Affiliates) dealing with the subject of this Agreement, including the Mutual Non-Disclosure Agreement between the Parties dated August 27, 2018.  Any information disclosed by a Party pursuant to any such prior agreement shall be deemed Confidential Information of such Party for purposes of this Agreement. 
ARTICLE 7
 
REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS
7.1    Mutual Representations and Warranties.  Each Party represents and warrants to the other that, as of the Effective Date: (a) it is duly organized and validly existing under the laws of its jurisdiction of incorporation or formation, and has full corporate or other power and authority to enter into this Agreement and to carry out the provisions hereof; (b) it is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the Person or Persons executing this Agreement on its behalf has been duly authorized to do so by all requisite corporate or partnership action; and (c) this Agreement is legally binding upon it, enforceable in accordance with its terms, and does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it.  
7.2    Chimerix Representations and Warranties.  Chimerix represents and warrants to SymBio that as of the Effective Date of this Agreement:  
(a)    Exhibit A attached hereto contains a true and complete list of the Chimerix Patent Rights existing on the Effective Date.  The Chimerix Patent Rights listed in Exhibit A include all of the Patent Rights Controlled by Chimerix as of the Effective Date that Cover the Compound or any compound Controlled by Chimerix as of the Effective Date that is known to be a Converting Compound, or the manufacture, use, sale, offer for sale or import of any of the foregoing; 
(b)    Chimerix has: (i) the right to grant the licenses and other rights that it purports to grant to SymBio herein; and (ii) not granted to any Third Party any license or other right with respect to any Compound, Product or Chimerix Technology that conflicts with the license and rights granted to SymBio herein;
(c)    there are no agreements in effect as of the Effective Date between Chimerix and a Third Party under which rights in the Chimerix Technology are being licensed to Chimerix; 

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(d)    Chimerix is the sole and exclusive owner of all right, title and interest in and to the Chimerix Patent Rights in existence on the Effective Date; 
(e)    to the best of Chimerix’s knowledge, having made reasonable inquiries, the issued and unexpired claims included in the Chimerix Patent Rights existing as of the Effective Date are valid and enforceable;
(f)    to the best of Chimerix's knowledge, having made reasonable inquiries, no reexamination, interference, invalidity, opposition, nullity or similar claim or proceeding is pending or threatened with respect to any Chimerix Patent Right; 
(g)    to the best of Chimerix’s knowledge, neither the development of Compound or Product, nor the manufacture of Compound or Product for use in development activities, Infringes the Patent Rights of any Third Party or misappropriates the proprietary information of any Third Party;
(h)    neither Chimerix nor any of its Affiliates has instituted any claim against a Third Party alleging that such Third Party is infringing Chimerix Patents or misappropriating Chimerix Know-How, and, to Chimerix’s knowledge, no Third Party is infringing Chimerix Patents or misappropriating Chimerix Know-How;
(i)    the rights in the Chimerix Technology granted to SymBio under this Agreement are sufficient to enable SymBio or its appointed subcontractor to manufacture the Compound and Product as the Compound and Product have been manufactured by or on behalf of Chimerix as of the Effective Date;
(j)    there are no claims, judgments or settlements against or owed by Chimerix (or any of its Affiliates) with respect to the Chimerix Technology, and Chimerix is not a party to any legal action, suit or proceeding relating to the Chimerix Technology or any Compound or Product, nor has Chimerix received any written communication from any Third Party, including any Regulatory Authority or other government agency, threatening such action, suit or proceeding; 
(k)    all tangible or recorded information and data provided by or on behalf of Chimerix to SymBio related to Compound or Product on or before the Effective Date in contemplation of this Agreement was and is true, accurate and complete in all material respects, and Chimerix has not failed to disclose, or failed to cause to be disclosed, any such information or data related to Compound or Product in its possession and Control that would cause the information and data that has been disclosed to be misleading in any material respect; 
(l)    neither Chimerix nor any of its Affiliates has obtained, or filed for, any INDs (other than the Compound INDs and its progeny that have been disclosed to SymBio), NDAs or Marketing Approvals for any Compound or Product in the Field, and, to Chimerix’s knowledge, no other Person has obtained, or filed for, any INDs, NDAs or Marketing Approvals for any Compound or Product in the Field in the Territory; 

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(m)    at the time of delivery to SymBio, the Inventory (other than any reference standards) (i) shall be free and clear of any liens or encumbrances, (ii) shall conform to applicable specifications, and (iii) shall have been manufactured in compliance with U.S. GMP, and (iv) shall not be adulterated or misbranded within the meaning of the Act. Certificates of analysis and certificates of conformance shall be accurate and complete.  Except as expressly set forth in this Section 7.2(m), the Inventory is provided on an as is/where is basis without any representation or warranty of any kind; 
(n)    all research and development (including non-clinical studies and clinical trials) conducted by or on behalf of Chimerix or any of its Affiliates related to the Compounds or Products prior to the Effective Date was conducted in compliance in all material respects with all Applicable Laws and, to the extent applicable, U.S. GLP, U.S. GCP or U.S. GMP;
(o)    neither Chimerix nor any of its Affiliates is debarred or disqualified under the Act or comparable Applicable Laws outside of the United States; 
(p)    neither Chimerix nor any of its Affiliates has employed or otherwise used in any capacity, in connection with the development or manufacture of Compound or Product, the services of any Person debarred or disqualified under United States law, including 21 U.S.C. §335a, or any foreign equivalent thereof; 
(q)    Chimerix and, to its knowledge, its directors, officers, employees, and any agent, representative, subcontractor or other Third Party acting for or on such its behalf, has not, directly or indirectly, offered, paid, promised to pay, or authorized such offer, promise or payment, of anything of value, to any Person for the purposes of obtaining or retaining business through any improper advantage in connection with the development, commercialization or exploitation of a Product, or that would otherwise violate any Applicable Laws, rules and regulations concerning or relating to public or commercial bribery or corruption, and Chimerix’s books, accounts, records and invoices related to the Product are complete and accurate; 
(r)    Chimerix has not violated the FCPA or Export Control Laws in connection with the development of the Compound prior to the Effective Date of this Agreement; and
(s)    neither Chimerix nor any of its Affiliates (or any of their respective employees and contractors), in connection with the exercise of Chimerix's rights or performance of Chimerix's obligations under this Agreement, has violated any Export Control Laws or any terms and conditions of any applicable export license or authorization.
7.3    Chimerix Covenants.  In addition to any covenants made by Chimerix elsewhere in this Agreement, Chimerix hereby covenants to SymBio that during the Term, Chimerix shall not grant any Third Party any license or other right with respect to any Compound, Product, Chimerix Technology, or Joint Invention in derogation of the license and other rights granted to SymBio hereunder.   
Neither Chimerix nor any of its Affiliates shall employ or use the services of any Person who is debarred or disqualified under United States law, including 21 U.S.C. §335a, or any foreign 

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equivalent thereof, in connection with activities relating to any Compound or Product; and in the event that Chimerix becomes aware of the debarment or disqualification or threatened debarment or disqualification of any Person providing services to Chimerix or any of its Affiliates with respect to any activities relating to any Compound or Product under United States law, including 21 U.S.C. §335a, or any foreign equivalent thereof, Chimerix shall immediately notify SymBio in writing and Chimerix shall cease, or cause its Affiliate to cease (as applicable), employing, contracting with, or retaining any such Person to perform any services relating to any Compound or Product. 
Chimerix further covenants that neither Chimerix nor any of its Affiliates (or any of their respective employees and contractors) shall, in connection with the exercise of its rights or performance of its obligations under this Agreement, directly or indirectly through Third Parties, pay, promise or offer to pay, or authorize the payment of, any money or give any promise or offer to give, or authorize the giving of anything of value to (a) any officer, employee (including physicians, hospital administrators, or other healthcare professionals), agent, representative, department, agency, de facto official, representative, Entity, instrumentality or subdivision of any government, military or international organization, including any ministry or department of health or any state-owned or affiliated company or hospital, or (b) any candidate for political office, any political party or any official of a political party (collectively, “Public Official”) or other Person for the purpose of obtaining or retaining business for or with, or directing business to, any Person, including Chimerix and its Affiliates, nor shall Chimerix or any of its Affiliates directly or indirectly promise, offer or provide any corrupt payment, gratuity, emolument, bribe, kickback, illicit gift or hospitality or other illegal or unethical benefit to any Public Official or any other Person in connection with the exercise of Chimerix’s rights or performance of Chimerix’s obligations under this Agreement.
7.4    SymBio Representations and Warranties.  SymBio represents and warrants to Chimerix that as of the Effective Date of this Agreement neither SymBio nor any of its Affiliates is debarred or disqualified under the Act or comparable Applicable Laws outside the United States.
7.5    SymBio Covenants.  In addition to any covenants made by SymBio elsewhere in this Agreement, SymBio hereby covenants to Chimerix as follows: 
(a)    neither SymBio nor any of its Affiliates shall employ or use the services of any Person who is debarred or disqualified under United States law, including 21 U.S.C. §335a, or any foreign equivalent thereof, in connection with activities relating to any Compound or Product; and in the event that SymBio becomes aware of the debarment or disqualification or threatened debarment or disqualification of any Person providing services to SymBio or any of its Affiliates with respect to any activities relating to any Compound or Product, SymBio shall immediately notify Chimerix in writing and SymBio shall cease, or cause its Affiliate to cease (as applicable), employing, contracting with, or retaining any such Person to perform any services relating to any Compound or Product; 
(b)    neither SymBio nor any of its Affiliates (or any of their respective employees and contractors) shall, in connection with the exercise of its rights or performance of its obligations under this Agreement, directly or indirectly through Third Parties, pay, promise or offer to pay, or authorize the payment of, any money or give any promise or offer to give, or authorize the giving 

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of anything of value to a Public Official or other Person for purpose of obtaining or retaining business for or with, or directing business to, any Person, including SymBio and its Affiliates, nor shall SymBio or any of its Affiliates directly or indirectly promise, offer or provide any corrupt payment, gratuity, emolument, bribe, kickback, illicit gift or hospitality or other illegal or unethical benefit to a Public Official or any other Person;
(c)    neither SymBio nor any of its Affiliates (or any of their respective employees and contractors), in connection with the exercise of SymBio’s rights or performance of SymBio’s obligations under this Agreement, violate Export Control Laws or any terms and conditions of any applicable export license or authorization;
(d)    neither SymBio nor any of its Affiliates (or any of their respective employees and contractors), in connection with the exercise of SymBio’s rights or performance of SymBio’s obligations under this Agreement, shall cause Chimerix to be in violation of applicable anti-corruption laws (including the FCPA) or Export Control Laws; and
(e)    SymBio shall immediately notify Chimerix if it has any information or suspicion that there may be a violation of applicable anti-corruption laws (including the FCPA) or Export Control Laws in connection with the exercise of SymBio’s rights or performance of SymBio’s obligations under this Agreement. Chimerix shall have the right, upon reasonable prior written notice and during SymBio’s regular business hours, to audit SymBio’s books and records in the event of a suspected violation of any of the covenants in this Section.  SymBio will fully cooperate with Chimerix on such audit. 
7.6    Performance by Affiliates, Sublicensees and Subcontractors.  The Parties recognize that each Party may perform some or all of its obligations or exercise some or all of its rights under this Agreement through one or more Affiliates, subcontractors, agents, or other business partners, or, in the case of SymBio and subject to Section 2.2, Sublicensees; provided, in each case, that (a) none of the other Party’s rights hereunder are diminished or otherwise adversely affected as a result of such delegation or subcontracting, and (b) each such Affiliate, subcontractor, agent or other business partner, or Sublicensee undertakes in writing obligations of confidentiality and non-use regarding Confidential Information and ownership of Inventions that are substantially the same as those undertaken by the Parties pursuant to Article 6 and Section 8.1; and provided, further, that such Party shall at all times be fully responsible for the performance and payment of such Affiliate, subcontractor, agent, or other business partner or Sublicensee.
7.7    Disclaimer.  Except as expressly set forth in this Agreement, THE TECHNOLOGY AND INTELLECTUAL PROPERTY RIGHTS PROVIDED BY EACH PARTY HEREUNDER ARE PROVIDED “AS IS.”  Except as expressly set forth in this Agreement, EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF PATENTS, NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES.

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7.8    Limitation of Liability.  EXCEPT FOR LIABILITY FOR BREACH BY EITHER PARTY OF Article 6, OR IN THE CASE OF FRAUD OR INTENTIONAL MISCONDUCT, NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES IN CONNECTION WITH THIS AGREEMENT OR ANY LICENSE GRANTED HEREUNDER; provided, however, that this Section 7.8 shall not be construed to limit either Party’s indemnification obligations under Article 10.
ARTICLE 8
 
INTELLECTUAL PROPERTY
8.1    Ownership.  Except as otherwise expressly agreed by the Parties in writing, (a) a Party shall have and retain all right, title and interest in any Invention discovered, generated, conceived or reduced to practice solely by one or more employees or agents of such Party or its Affiliates or other Persons acting under its authority and (b) the Parties shall jointly own rights in any Invention discovered, generated, conceived or reduced to practice jointly by one or more employees or agents of each Party or its Affiliates or other Persons acting under its authority (“Joint Inventions”) and Patent Rights therein (“Joint Patent Rights”).  Subject to the rights and licenses granted under this Agreement, each Party shall have the right to practice and use, and grant licenses to practice and use, any Joint Inventions and Joint Patent Rights without the other Party’s consent and has no duty to account to the other Party for such practice, use or license, and each Party hereby waives any right it may have under the laws of any country to require any such consent or accounting.  This Section shall not be interpreted to allow Chimerix to discover, develop, make, have made, use, sell, have sold, offer for sale, market, export, import or otherwise commercialize any Compounds or Products in the Field nor to allow SymBio to do the same outside the Field.
8.2    Patent Prosecution and Maintenance.  
(a)    Chimerix Patent Rights.  Chimerix shall have the first right, but not the obligation, to control the preparation, filing, prosecution and maintenance of Chimerix Patent Rights at Chimerix’s sole expense and by counsel of its choice.  In the event that Chimerix desires to abandon or cease prosecution or maintenance of any Chimerix Patent Right in a country (other than a Chimerix Patent Right the claims of which are limited to methods of use of Compound or Product outside the Field), Chimerix shall provide written notice to SymBio of such intention to abandon promptly after Chimerix makes such determination (which notice shall be given no later than 90 days prior to the next deadline for any action that must be taken with respect to such Chimerix Patent Right in the relevant patent office).  In such case, SymBio shall have the right, in its discretion, exercisable upon written notice to Chimerix delivered no later than 30 days after receipt of notice from Chimerix, to assume responsibility for prosecution and maintenance of such Chimerix Patent Right in such country, at its sole cost and expense and by counsel of its own choice.  
(b)    Joint Patent Rights.  Chimerix shall have the first right, but not the obligation, to control the preparation, filing, prosecution and maintenance of Joint Patent Rights at Chimerix’s sole expense and by counsel of its choice.  In the event that Chimerix desires to abandon or cease prosecution or maintenance of any Joint Patent Right, Chimerix shall provide written notice 

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to SymBio of such intention to abandon promptly after Chimerix makes such determination (which notice shall be given no later than 90 days prior to the next deadline for any action that must be taken with respect to such Joint Patent Right in the relevant patent office).  In such case, SymBio shall have the right, in its discretion, exercisable upon written notice to Chimerix delivered no later than 30 days after receipt of notice from Chimerix, to assume responsibility for prosecution and maintenance of such Joint Patent Right in the Field in the Territory, at its sole cost and expense and by counsel of its own choice.  If SymBio requests that Chimerix file a patent application claiming a particular Joint Invention in a particular country in which Chimerix has not done so, and if Chimerix does not file a patent application claiming such Joint Invention in such country within a reasonable time period following its receipt of such notice from SymBio, SymBio shall have the right to assume responsibility for the preparation, filing, prosecution and maintenance of Joint Patent Rights claiming such Joint Invention in such country in accordance with this Section 8.1.
(c)    SymBio Patent Rights.  SymBio shall have the sole right, but not the obligation, to control the preparation, filing, prosecution and maintenance of SymBio Patent Rights, at SymBio’s sole expense and by counsel of its choice. 
(d)    Cooperation of the Parties.  Each Party agrees to cooperate fully in the preparation, filing, prosecution and maintenance of Patent Rights under this Agreement and in the obtaining and maintenance of any patent extensions, supplementary protection certificates and the like with respect to any Patent Right.  Such cooperation includes: (i) executing all papers and instruments, or requiring its employees or contractors to execute such papers and instruments, so as to effectuate the ownership of Inventions, including Joint Inventions and Joint Patent Rights, as set forth in Section 8.1, and to enable the other Party to apply for and to prosecute patent applications in any country in accordance with the foregoing provisions of this Section 8.1; and (ii) promptly informing the other Party of any matters coming to such Party’s attention that may be reasonably expected to affect the preparation, filing, prosecution or maintenance of any such patent applications.  
8.3    Interference, Opposition, Invalidation, Reexamination and Reissue.  
(a)    Chimerix Patent Rights.  Chimerix shall, within 10 days of learning of any request for, or filing or declaration of, any interference, opposition, invalidation, reissue or reexamination relating to claims of the Chimerix Patent Rights, inform SymBio thereof.  
(i)    Chimerix Field Patent Rights.  With respect to any request for, or filing or declaration of, any interference, opposition, invalidation, reissue or reexamination with respect to Chimerix Field Patent Rights, Chimerix shall have the first right (in its discretion) to initiate, prosecute or respond, to such action or proceeding, provided that Chimerix shall consult with SymBio with respect to any such action or proceeding and shall consider SymBio’s position in good faith.  In the event that Chimerix elects to initiate, prosecute or respond to any interference, opposition, invalidation, reexamination, or reissue proceeding with respect to any Chimerix Field Patent Right, the expenses thereof shall be borne solely by Chimerix.  Chimerix shall not settle any interference, opposition, invalidation, reissue or reexamination action or proceeding relating to any Chimerix Field Patent Right without the prior written consent of SymBio, which consent shall not be unreasonably withheld.  Chimerix shall keep SymBio informed of developments in any such action or proceeding involving any Chimerix Field Patent Right.  Chimerix shall promptly (but in 

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any event within a reasonable time period in advance of any applicable deadline) inform SymBio in the event that Chimerix elects not to initiate, prosecute or respond to any interference, opposition, invalidation, reissue or reexamination relating to any Chimerix Field Patent Right, and in such case, SymBio shall have the right to do so (in SymBio’s discretion), at its cost and expense.  SymBio shall not settle any interference, opposition, invalidation, reissue or reexamination action or proceeding relating to any Chimerix Field Patent Right without the prior written consent of Chimerix, which consent shall not be unreasonably withheld.  SymBio shall keep Chimerix informed of developments in any such action or proceeding involving any Chimerix Field Patent Rights. 
(ii)    Other Chimerix Patent Rights.  With respect to any request for, or filing or declaration of, any interference, opposition, invalidation, reissue or reexamination with respect to any Chimerix Patent Rights other than Chimerix Field Patent Rights, Chimerix shall have the sole right (in its discretion) to initiate, prosecute or respond, to such action or proceeding, at Chimerix’s sole expense.  Chimerix shall keep SymBio informed of developments in any such action or proceeding involving any such Chimerix Patent Right. 
(b)    Joint Patent Rights.  Each Party shall, within 10 days of learning of such event, inform the other Party of any request for, or filing or declaration of, any interference, opposition, invalidation, reissue or reexamination with respect to Joint Patent Rights.
(i)    Chimerix First Right.  With respect to any request for, or filing or declaration of, any interference, opposition, invalidation, reissue or reexamination with respect to claims of the Joint Patent Rights, Chimerix shall have the first right (in its discretion) to initiate, prosecute or respond, to such action or proceeding, provided that Chimerix shall consult with SymBio with respect to any such action or proceeding and shall consider SymBio's position in good faith.  In the event that Chimerix elects to initiate, prosecute or respond to any interference, opposition, invalidation, reexamination, or reissue proceeding with respect to any Joint Patent Claim, the expenses thereof shall be borne solely by Chimerix.  Chimerix shall not settle any interference, opposition, invalidation, reissue or reexamination action or proceeding relating to any Joint Patent Claim without the prior written consent of SymBio, which consent shall not be unreasonably withheld.  Chimerix shall keep SymBio informed of developments in any such action or proceeding involving any Joint Patent Claim.  
(ii)    SymBio Back-Up Right.  Chimerix shall promptly (but in any event within a reasonable time period in advance of any applicable deadline) inform SymBio in the event that Chimerix elects not to initiate, prosecute or respond to any interference, opposition, invalidation, reissue or reexamination relating to any Joint Patent Claim, and in such case, SymBio shall have the right to do so (in Chimerix’s discretion), at its cost and expense.  SymBio shall not settle any interference, opposition, invalidation, reissue or reexamination action or proceeding relating to any Joint Patent Claim without the prior written consent of Chimerix, which consent shall not be unreasonably withheld.  SymBio shall keep Chimerix informed of developments in any such action or proceeding involving any Relevant Joint Patent Claim.  
(c)    SymBio Patent Rights.  SymBio shall have the sole right, in its discretion, to handle any interference, opposition, invalidation, reissue, or reexamination proceeding relating to SymBio Patent Rights, and Chimerix shall have no rights in connection therewith. 

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8.4    Enforcement and Defense of Patent Rights.  Each Party shall notify the other Party in writing within 10 Business Days (except as expressly set forth below) of becoming aware of any alleged or threatened Infringement by a Third Party of any of the Chimerix Patent Rights, Joint Patent Rights or SymBio Patent Rights (“Infringement”), including (x) any such alleged or threatened Infringement on account of a Third Party’s manufacture, use or sale of a Compound or Product in the Field, (y) any certification filed in the United States under 21 U.S.C. §355(b)(2) or 21 U.S.C. §355(j)(2) or similar provisions in other jurisdictions in connection with an ANDA (an Abbreviated New Drug Application in the United States or a comparable application for Marketing Approval under Applicable Law in any country other than the United States) or other NDA for a Product in the Field (a “Patent Certification”), and (z) any declaratory judgment action filed by a Third Party that is developing, manufacturing or commercializing a Compound or Product in the Field alleging the invalidity, unenforceability or non-infringement of any of the Chimerix Patent Rights, Joint Patent Rights or SymBio Patent Rights ((x)-(z), collectively, “SymBio Competitive Infringement”); provided, however, that each Party shall notify the other Party of any Patent Certification regarding any Chimerix Patent Right or Joint Patent Right that it receives, and provide the other Party with a copy of such Patent Certification, within five (5) days of receipt. 
(a)    Chimerix Patent Rights. 
(i)    Chimerix Field Patent Rights.
(1)    SymBio Competitive Infringement.  SymBio shall have the first right, but not the obligation, to bring (or defend) and control any action or proceeding with respect to SymBio Competitive Infringement of a Chimerix Field Patent Right in any country, at SymBio’s own expense and by counsel of its own choice, and Chimerix shall have the right to be represented in any such action or proceeding, at Chimerix’s own expense and by counsel of its own choice.  If SymBio fails to bring any such action or proceeding with respect to SymBio Competitive Infringement of any Chimerix Field Patent Right in such country within 90 days following the notice of alleged SymBio Competitive Infringement, Chimerix shall have the right to bring (or defend) and control any such action at its own expense and by counsel of its own choice, and SymBio shall have the right, at its own expense, to be represented in any such action by counsel of its own choice; provided, however, that if the applicable SymBio Competitive Infringement is the result of SymBio’s receipt of a Patent Certification with respect to a Chimerix Field Patent Right in a country, SymBio shall notify Chimerix of SymBio’s decision to bring (or defend) and control any action or proceeding in such country within 10 days of SymBio’s receipt of such Patent Certification with respect to a Chimerix Field Patent Right, after which time, Chimerix shall have the right to bring (or defend) and prosecute such action, and SymBio shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. 
(2)    Other Infringement.  Chimerix shall have the sole right, but not the obligation, to bring (or defend) and control any action or proceeding with respect to any Infringement of any Chimerix Field Patent Right that is not SymBio Competitive Infringement in any country, at its own expense and by counsel of its own choice.  
(ii)    Other Chimerix Patent Rights.  Chimerix shall have the sole right, but not the obligation, to bring (or defend) and control any action or proceeding with respect to any 

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Infringement (including SymBio Competitive Infringement) of any Chimerix Patent Right that is not a Chimerix Field Patent Right in any country, at its own expense and by counsel of its own choice, and, only if and to the extent such action or proceeding is with respect to SymBio Competitive Infringement in such country, SymBio shall have the right to be represented in any such action or proceeding, at SymBio’s own expense and by counsel of its own choice.  If Chimerix fails to bring (or defend) any such action or proceeding with respect to SymBio Competitive Infringement of any such Chimerix Patent Right in such country within 90 days following the notice of alleged SymBio Competitive Infringement, SymBio may request that Chimerix permit SymBio to bring (or defend) and control any such action at its own expense and by counsel of its own choice.  Chimerix shall consider any such request in good faith but shall have the right to withhold such consent in its sole discretion.  However, if (A) such SymBio Competitive Infringement in such country is occurring more than 10 years after the First Commercial Sale of the Product with which such SymBio Competitive Infringement is competing in such country, (B) a Generic Version of such Product is on the market in such country (regardless of the market share obtained by such Generic Version), and (C) Chimerix withholds its consent to permit SymBio to bring (or defend) and control such action, then, for the remainder of the Royalty Term for such Product in such country, the royalties payable by SymBio under Section 4.4 with respect to Net Sales of such Product in such country shall be reduced by [*]%.  
(b)    Joint Patent Rights.  
(i)    SymBio Competitive Infringement.  SymBio shall have the first right, but not the obligation, to bring (or defend) and control any action or proceeding with respect to SymBio Competitive Infringement of any Joint Patent Right, at its own expense and by counsel of its own choice, and Chimerix shall have the right, at its own expense, to be represented in any such action by counsel of its own choice.  If SymBio fails to bring any such action or proceeding with respect to SymBio Competitive Infringement of any Joint Patent Right within 90 days following the notice of alleged Infringement, Chimerix shall have the right to bring (or defend) and control any such action at its own expense and by counsel of its own choice, and SymBio shall have the right, at its own expense, to be represented in any such action by counsel of its own choice; provided, however, that if the applicable SymBio Competitive Infringement is the result of SymBio’s receipt of a Patent Certification with respect to a Joint Patent Right, SymBio shall notify Chimerix of SymBio’s decision to bring (or defend) and control any action or proceeding within 10 days of SymBio’s receipt of such Patent Certification with respect to a Joint Patent Right, after which time, Chimerix shall have the right to bring (or defend) and prosecute such action, and SymBio shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. 
(ii)    Chimerix Competitive Infringement.  Chimerix shall have the first right, but not the obligation, to bring (or defend) and control any action or proceeding with respect to Infringement of any Joint Patent Right to the extent the Infringement is competitive with a Chimerix Product being developed or commercialized by Chimerix or any of its Affiliates or Third-Party licensees or sublicensees (“Chimerix Competitive Infringement”), at its own expense and by counsel of its own choice, and SymBio shall have the right, at its own expense, to be represented in any such action by counsel of its own choice.  If Chimerix fails to bring any such action or proceeding with respect to Chimerix Competitive Infringement of any Joint Patent Right within 

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90 days following the notice of alleged Infringement, SymBio shall have the right to bring (or defend) and control any such action at its own expense and by counsel of its own choice, and Chimerix shall have the right, at its own expense, to be represented in any such action by counsel of its own choice; provided, however, that if the applicable Chimerix Competitive Infringement is the result of Chimerix’s receipt of a Patent Certification with respect to a Joint Patent Right, Chimerix shall notify SymBio of Chimerix’s decision to bring (or defend) and control any action or proceeding within 10 days of Chimerix’s receipt of such Patent Certification with respect to a Chimerix Patent Right, after which time Chimerix shall have the right to bring (or defend) and prosecute such action, and SymBio shall have the right, at its own expense, to be represented in any such action by counsel of its own choice.
(iii)    Other Infringement.  The Parties shall mutually agree on a case-by-case basis (A) whether to bring (or defend) and control any action or proceeding with respect to Infringement of any Joint Patent Right to the extent the Infringement is neither SymBio Competitive Infringement nor Chimerix Competitive Infringement, (B) which Party would bring (or defend) and control such action, and (C) how the expenses of, and any recovery from, any such action would be allocated. 
(c)    SymBio Patent Rights.  SymBio shall have the sole right, but not the obligation, to bring (or defend) and control any action or proceeding with respect to Infringement of any SymBio Patent Right at its own expense and by counsel of its own choice.
(d)    Cooperation.  In the event a Party brings (or defends) an infringement action in accordance with this Section 8.4, or in the event a Party is entitled to bring (or defend) an infringement action in accordance with this Section 8.4 but lacks standing to do so, the other Party shall cooperate fully, including, if required to bring (or defend) such action, the furnishing of a power of attorney or being named as a party.  Neither Party shall enter into any settlement or compromise of any action under this Section 8.4 that would in any manner alter, diminish, or be in derogation of the other Party’s rights under this Agreement without the prior written consent of such other Party, which shall not be unreasonably withheld.  
(e)    Recovery.  Except as otherwise agreed by the Parties in connection with a cost-sharing arrangement, any recovery realized by a Party as a result of any action or proceeding pursuant to this Section 8.4, whether by way of settlement or otherwise, shall be applied first to reimburse the documented out-of-pocket legal expenses of the Party that brought (or defended) and controlled such action or proceeding incurred in connection with such action or proceeding, and second to reimburse the documented out-of-pocket legal expenses of the other Party incurred in connection with such action or proceeding, and any remaining amounts shall be retained by the Party that brought (or defended) and controlled such action; provided, however, that: 
(i)    any recovery realized by SymBio as a result of any action brought (or defended) and controlled by SymBio pursuant to Section 8.4(a)(i)(1) or Section 8.4(b)(i) (after reimbursement of the Parties’ documented out-of-pocket legal expenses relating to the action or proceeding) shall be allocated as follows: 

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(1)    compensatory damages shall be treated as Net Sales of Products in the quarter in which such damages are received for purposes of Section 4.4; and  
(2)    non‐compensatory damages shall be divided [*]% to SymBio and [*]% to Chimerix; and 
(ii)    any recovery realized by Chimerix as a result of any action brought (or defended) and controlled by Chimerix pursuant to Section 8.4(a)(ii) (after reimbursement of the Parties’ documented out-of-pocket legal expenses relating to the action or proceeding) shall be allocated as follows:
(1)    all compensatory and non‐compensatory damages that are specifically attributable to SymBio Competitive Infringement shall be divided [*]% to Chimerix and [*]% to SymBio; and
(2)    all compensatory and non‐compensatory damages that are not specifically attributable to SymBio Competitive Infringement shall belong to Chimerix.
8.5    Patent Term Extensions.  
(a)    Chimerix Patent Rights.  SymBio shall have the right to determine the Chimerix Patent Rights for which it will apply for patent extension in any country or region for any Product in the Field, subject to Chimerix’s prior written consent, not to be unreasonably withheld, provided that Chimerix may withhold such consent in its sole discretion with respect to any Chimerix Patent Right in any country or region: (i) that Covers a Chimerix Product; or (ii) for which Chimerix (or its Affiliate or Third-Party licensee or sublicensee) has already applied for or received patent extension for any compound that is not a Compound or product that is not a Product.  If Chimerix grants such consent, SymBio shall file for any such extension at SymBio’s cost and expense.  Chimerix shall provide all reasonable assistance to SymBio in connection with such filings with respect to which Chimerix provides its consent, provided that SymBio shall pay or reimburse any out-of-pocket costs incurred by Chimerix in providing such assistance.
(b)    Joint Patent Rights.  SymBio shall have the right to determine the Joint Patent Rights for which it will apply for patent extension in any country or region for any Product in the Field, and SymBio shall file for any such extension at SymBio’s cost and expense; provided, however, that, solely in the case of Joint Patent Rights that do not claim or Cover any Product in the Field, Chimerix shall have the right to determine those of such Joint Patent Rights for which it will apply for patent extension in any country or region for a Chimerix Product, and Chimerix shall file for any such extension at Chimerix’s cost and expense.  Each Party shall provide all reasonable assistance to the other Party in connection with such filings, provided that the Party filing for any such extension shall pay or reimburse any out-of-pocket costs incurred by the other Party in providing such assistance.
(c)    SymBio Patent Rights.  SymBio shall have the sole right to apply for extension of any SymBio Patent Right in any country or region for any product, including any Product in the Field, at SymBio’s sole cost and expense. 

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8.6    Infringement of Third-Party Rights.  Each Party shall promptly notify the other in writing of any allegation by a Third Party that the manufacture, use, sale or importation of any Compound or Product Infringes or may Infringe the intellectual property rights of such Third Party.  Neither Party shall have the right to settle any patent infringement litigation under this Section 8.6 in a manner that diminishes the rights or interests of the other Party without the written consent of such other Party (which shall not be unreasonably withheld). 
8.7    Marking.  To the extent required by applicable law, SymBio shall, and shall cause its Related Parties to, mark all Products made, used or sold in the Field, or their containers, with the number of each issued Chimerix Patent Right that applies to such Product; provided, however, that in any event SymBio shall, and shall cause its Related Parties to, mark all Products made, used or sold in the Field, or their containers, with the number of each issued Chimerix Patent Right that applies to such Product.  
8.8    Trademarks.  SymBio shall have the right to commercialize the Product in the Field in the Territory with those trademarks of SymBio that are associated with SymBio’s name or identity (“SymBio Housemarks”) and any other trademarks and trade names it determines appropriate, which may vary by country or within a country (the “Product Marks”).  SymBio shall own all rights in, and shall have the right to register and maintain, the SymBio Housemarks and the Product Marks in the countries and regions that it determines reasonably necessary, at its own cost and expense, and all goodwill therein or relating thereto shall accrue to SymBio.  Neither Party shall use, or shall permit its Affiliates, sublicensees, subcontractors, and agents to use, any trademark of the other Party in connection with the commercialization of the Products except as expressly set forth in this Agreement or with the prior written consent of such other Party. 
8.9    Registration of Exclusive License.  Within 30 days of the Effective Date, Chimerix shall file, and shall cause its relevant Affiliates to file (as the case may be), a request at the Japan Patent Office (“JPO”) to register as a registered exclusive license (a Senyo-Jisshiken under Section 77 of the Japanese Patent Law or a Kari-Senyo-Jisshiken under Section 34-2 of the Japanese Patent Law), along with equivalent requests for registration (where applicable) at all relevant patent offices in the Territory, SymBio’s exclusive license under the Chimerix Patent Rights to develop, package, manufacture, and commercialize the Product in the Field in the Territory in accordance with this Agreement.  For clarity, during the Term, Chimerix shall not grant a license in respect of the Product under the Chimerix Patent Rights in the Field in the Territory to any Third Party or Affiliate of Chimerix, in each case (Third Party or Affiliate) in conflict with the license granted to SymBio under this Agreement, nor register such license to a Third Party or Affiliate of Chimerix as a Senyo-Jisshiken, Kari-Senyo-Jisshiken or otherwise.
ARTICLE 9
 
TERM AND TERMINATION
9.1    Term.  The term of this Agreement shall commence on the Effective Date and, unless earlier terminated in accordance with this Article 9, continue until the expiration of the last-to-expire of all Royalty Terms hereunder (the “Term”). 

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9.2    Termination for Material Breach. 
(a)    Each Party shall have the right to terminate this Agreement in its entirety upon written notice to the other Party if such other Party is in material breach of this Agreement and has not cured such breach within 90 days (or 30 days with respect to any payment breach) after notice from the terminating Party requesting cure of the breach.  Any such termination shall become effective at the end of such 90-day (or 30-day with respect to any payment breach) period unless the breaching Party has cured such breach prior to the end of such period.  Any right to terminate under this Section 9.2(a) shall be stayed and the cure period tolled in the event that, during any cure period, the Party alleged to have been in material breach shall have initiated dispute resolution in accordance with Article 11 with respect to the alleged breach.  Such stay and tolling shall continue until such dispute has been resolved in accordance with Article 11.  
(b)    For clarity, in the event of material breach of this Agreement by Chimerix that is not cured within the applicable notice period set forth in Section 9.2(a), SymBio, at its sole discretion, may either:
(i)    terminate this Agreement in accordance with Section 9.2(a) (in addition to pursuing any remedy that may be available to SymBio at law or in equity as a result of Chimerix’s breach of this Agreement); or 
(ii)    elect (A) not to terminate this Agreement, (B) to retain the license granted under Section 2.1, subject to all terms and conditions hereof, and (C) pursue any remedy that may be available to SymBio at law or in equity as a result of Chimerix’s breach of this Agreement, without prejudice to SymBio’s right to terminate this Agreement at a later date pursuant to Section 9.2(a) (for that uncured material breach or any other uncured material breach of this Agreement by Chimerix) or pursuant to Section 9.3. 
9.3    Termination for Patent Challenge.  Chimerix shall have the right to terminate this Agreement immediately upon written notice to SymBio if SymBio or its Affiliate directly, or through assistance granted to a Third Party, commences any interference or opposition proceeding with respect to, challenges the validity or enforceability of, or opposes any extension of, or the grant of a supplementary protection certificate with respect to, any Chimerix Patent Right. 
9.4    At-Will Termination by SymBio.  SymBio shall have the right to terminate this Agreement on a country–by-country basis for any reason, or for no reason, at any time upon 90 days’ prior written notice to Chimerix.  
9.5    Effect of Expiration or Termination.  
(a)    Expiration.  Upon expiration (but not on earlier termination) of this Agreement, all licenses granted by Chimerix to SymBio that were in effect immediately prior to such expiration shall survive on a fully‐paid, royalty‐free, irrevocable and perpetual basis in accordance with Section 4.5. 

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(b)    Any Termination.  Upon any termination of this Agreement prior to its expiration, the license (on a country-by-country basis in the event of partial termination by SymBio under Section 9.4) granted to SymBio pursuant to Section 2.1 shall automatically terminate and revert to Chimerix, and all other rights and obligations of the Parties under this Agreement shall terminate, except as expressly provided below in this Section 9.5 or elsewhere in this Article 9. 
(c)    Termination by Chimerix Pursuant to Section 9.2(a) or 9.3 or by SymBio Pursuant to Section 9.4.  Solely in the event of termination of this Agreement by Chimerix pursuant to Section 9.2(a) or Section 9.3, or by SymBio pursuant to Section 9.4, the following provisions shall apply.
(i)    Effective as of such termination, SymBio shall, and it hereby does, grant to Chimerix: (A) an exclusive, worldwide, royalty-free, fully-paid, perpetual, irrevocable license (on a country-by-country basis in the event of partial termination by SymBio pursuant to Section 9.4), with the right to sublicense through multiple tiers of sublicense, under those SymBio Patent Rights that claim any Invention made solely by one or more employees or agents of SymBio or its Affiliates in the course of conducting research, development, manufacturing, regulatory or commercialization activities contemplated by this Agreement, the SymBio Know-How, and SymBio’s interest in the Joint Patent Rights; (B) a non‐exclusive, worldwide, royalty-free, fully-paid, perpetual, irrevocable license (on a country-by-country basis in the event of partial termination by SymBio pursuant to Section 9.4), with the right to sublicense through multiple tiers of sublicense, under Blocking Patents (defined below); and (C) an exclusive, worldwide, royalty-bearing (as specified below), perpetual, irrevocable license (on a country-by-country basis in the event of partial termination by SymBio pursuant to Section 9.3), with the right to sublicense through multiple tiers of sublicense, under Useful Patents (defined below) in each case, solely to develop, make, have made, use, sell, offer for sale, and import Compounds and Products in the Field.  For purposes of this Section 9.5(c)(i), “Blocking Patents” shall mean SymBio Patent Rights other than those described in clause (A) of this Section 9.5(c)(i), but excluding any such SymBio Patent Right claiming any technology that was not actually used by SymBio (or any of its Related Parties) prior to termination in the development, manufacture or commercialization of Compounds or Products in the Field; and “Useful Patents” shall mean SymBio Patent Rights other than those described in clause (A) of this Section 9.5(c)(i) and Blocking Patents.  Notwithstanding the foregoing, to the extent the Blocking Patents or Useful Patents include Patent Rights licensed to SymBio by a Third Party (other than a Sublicensee) that are subject to royalty or milestone payment obligations to such Third Party with respect to Compounds or Products, then SymBio shall so notify Chimerix, together with a true, complete and correct description of such royalty and milestone payment obligations, and the inclusion of such Blocking Patents in the license granted to Chimerix under clause (B) of this Section 9.5(c)(i) or of such Useful Patents in the license granted to Chimerix under clause (C) of this Section 9.5(c)(i), as applicable, shall be subject to Chimerix’s agreeing in writing to reimburse, and promptly reimbursing, SymBio for all royalty and milestone payments that become due to such Third Party by reason of Chimerix’s exercise of such Blocking Patents or Useful Patents (as applicable) in the development, manufacture or commercialization of Compounds or Products in the Field.   In addition to any pass-through royalties or milestone payments that may be due to Third Parties with respect to Useful Patents licensed to SymBio by a Third Party pursuant to the preceding sentence, Chimerix shall pay to SymBio a royalty of [*]% of Net Sales (mutatis mutandis) 

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by Chimerix, its Affiliates and their respective sublicensees of any Product that is Covered by a Valid Claim of the Useful Patents, such royalties to be payable on a Product-by-Product and country-by-country basis until expiration of the last-to-expire Valid Claim of the Useful Patents Covering the manufacture, use or sale of a Product in a country.  For purposes of Chimerix’s royalty payment obligations with respect to the Useful Patents, the provisions of Article 5 of this Agreement shall apply, mutatis mutandis.
(ii)    As promptly as practicable (and in any event within 90 days) after such termination, SymBio shall (on a country-by-country basis in the event of partial termination by SymBio under Section 9.4): (a) to the extent not previously provided to Chimerix, deliver to Chimerix true, correct and complete copies of all Regulatory Documentation held by SymBio or any of its Affiliates or Sublicensees, and disclose to Chimerix all previously-undisclosed SymBio Know-How; (b) transfer or assign, or cause to be transferred or assigned, to Chimerix or its designee (or to the extent not so assignable, take all reasonable actions to make available to Chimerix or its designee the benefits of) all INDs, NDAs and Marketing Approvals for Products, whether held in the name of SymBio or any of its Related Parties; and (c) take such other actions and execute such other instruments, assignments and documents as may be necessary to effect, evidence, register and record the transfer, assignment or other conveyance of rights under this Section 9.5(c)(ii) to Chimerix. 
(iii)    SymBio shall (on a country-by-country basis in the event of partial termination by SymBio under Section 9.4), as directed by Chimerix, either promptly wind-down any ongoing development activities with respect to Products in an orderly fashion or promptly transition such development activities to Chimerix or its designee, with due regard for patient safety and in compliance with all Applicable Laws and GCP.
(iv)    Chimerix shall have the right (on a country-by-country basis in the event of partial termination by SymBio under Section 9.4), but not the obligation, to purchase from SymBio any or all usable inventory of Compounds and Products in SymBio’s or its Affiliates’ possession as of the date of termination.  Such inventory shall be provided at a transfer price equal to SymBio’s cost of such inventory. 
(v)    If SymBio was (on a country-by-country basis in the event of partial termination by SymBio under Section 9.4), prior to termination, manufacturing, or having manufactured on its behalf, any quantities of Compounds or Products, then at Chimerix’s request, until the earlier of (a) such time as Chimerix has secured another source thereof that is able to meet Chimerix’s quality and quantity requirements, and (b) 18 months after such termination, SymBio shall use Commercially Reasonable Efforts to supply, or cause to be supplied, to Chimerix such quantities thereof as Chimerix may reasonably require for the development and commercialization of Products in the Field; provided that Chimerix shall use Commercially Reasonable Efforts to secure another source of supply as soon as reasonably practicable.  Such material shall be provided at a transfer price equal to SymBio’s cost of such materials.
9.6    Accrued Obligations; Survival.  Neither expiration nor any termination of this Agreement shall relieve either Party of any obligation or liability accruing prior to such expiration or termination, nor shall expiration or any termination of this Agreement preclude either Party from 

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pursuing all rights and remedies it may have under this Agreement, at law or in equity, with respect to breach of this Agreement.  In addition, the Parties’ rights and obligations under Sections 2.6, 6.1, 6.2, 6.3, 6.6, 7.7, 7.8, 8.1, 9.5, 9.6, 9.7 and 9.8, and Articles 1, 5, 10, 11 and 12 (other than 12.6 and 12.7) of this Agreement shall survive expiration or any termination of this Agreement.  SymBio's right in the first sentence of Section 8.8 shall survive on a Product-by-Product and country-by-country basis after expiration of the Royalty Term for a Product in a country. 
9.7    Return of Confidential Information.  Within 30 days following the expiration or termination of this Agreement, except to the extent that a Party retains a license from the other Party as provided in this Article 9, each Party shall promptly return to the other Party, or delete or destroy, all relevant records and materials in such Party’s possession or control containing Confidential Information of the other Party; provided that such Party may keep one copy of such materials for archival purposes only subject to a continuing confidentiality obligations.
9.8    Damages; Relief.  Termination of this Agreement shall not preclude either Party from claiming any other damages, compensation or relief that it may be entitled to hereunder. 
ARTICLE 10
 
INDEMNIFICATION
10.1    Indemnification by SymBio.  SymBio hereby agrees to save, defend, indemnify and hold harmless Chimerix, its Affiliates, its and their respective officers, directors, agents, employees, successors and assigns (the “Chimerix Indemnitees”), from and against any and all losses, damages, liabilities, expenses and costs, including reasonable legal expense and attorneys’ fees (“Losses”), to which any Chimerix Indemnitee may become subject as a result of any claim, demand, action or other proceeding by any Third Party (each, a “Claim”) to the extent such Losses arise out of or relate to (a) the gross negligence or willful misconduct of any SymBio Indemnitee (defined below), (b) the breach by SymBio of any warranty, representation, covenant or agreement made by SymBio in this Agreement, or (c) the development, manufacture, use, handling, storage, sale, offer for sale, import or other disposition by or on behalf of SymBio or any of its Related Parties of any Compound or Product, or any other exercise of the license granted to SymBio pursuant to Section 2.1 by or on behalf of SymBio or any of its Related Parties; except, in each case, to the extent such Losses result from the gross negligence or willful misconduct of any Chimerix Indemnitee or the breach by Chimerix of any warranty, representation, covenant or agreement made by Chimerix in this Agreement.  
10.2    Indemnification by Chimerix.  Chimerix hereby agrees to save, defend, indemnify and hold harmless SymBio, its Affiliates and their respective officers, directors, employees, consultants and agents (the “SymBio Indemnitees”) from and against any and all Losses to which any SymBio Indemnitee may become subject as a result of any claim, demand, action or other proceeding by any Third Party to the extent such Losses arise out of or relate to (a) the gross negligence or willful misconduct of any Chimerix Indemnitee, (b) the breach by Chimerix of any warranty, representation, covenant or agreement made by Chimerix in this Agreement, (c) the development, manufacture, use, handling, storage, sale, offer for sale, import or other disposition by or on behalf of Chimerix or any of its Related Parties of any Compound or Product prior to the 

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Effective Date or following termination of this Agreement, (d) the conduct of the Chimerix NPP, or (e) the exercise by or on behalf of Chimerix or any of its Affiliates or Third-Party licensees or sublicensees of the license granted to Chimerix pursuant to Section 2.6 or, if applicable, any license granted to Chimerix pursuant to Section 9.5(c)(i); in each case except to the extent such Losses result from the gross negligence or willful misconduct of any SymBio Indemnitee or the breach by SymBio of any warranty, representation, covenant or agreement made by SymBio in this Agreement.
10.3    Control of Defense.  In the event a Party (the “Indemnified Party”) seeks indemnification under Section 10.1 or 10.2, it shall inform the other Party (the “Indemnifying Party”) of a claim as soon as reasonably practicable after it receives notice of the claim (it being understood and agreed, however, that the failure by an Indemnified Party to give notice of a claim as provided in this Section 10.3 shall not relieve the Indemnifying Party of its indemnification obligation under this Agreement except and only to the extent that such Indemnifying Party is actually damaged as a result of such failure to give notice), shall permit the Indemnifying Party to assume direction and control of the defense of the claim (including the right to settle the claim solely for monetary consideration) using counsel reasonably satisfactory to the Indemnified Party, and shall cooperate as requested (at the expense of the Indemnifying Party) in the defense of the claim.  If the Indemnifying Party does not assume control of such defense within 15 days after receiving notice of the claim from the Indemnified Party, the Indemnified Party shall control such defense and, without limiting the Indemnifying Party’s indemnification obligations, the Indemnifying Party shall reimburse the Indemnified Party for all costs, including reasonable attorney fees, incurred by the Indemnified Party in defending itself within 30 days after receipt of any invoice therefor from the Indemnified Party.  The Party not controlling such defense may participate therein at its own expense.  The Party controlling such defense shall keep the other Party advised of the status of such action, suit, proceeding or claim and the defense thereof and shall consider recommendations made by the other Party with respect thereto.  The Indemnified Party shall not agree to any settlement of such action, suit, proceeding or claim without the prior written consent of the Indemnifying Party, which shall not be unreasonably withheld, delayed or conditioned.  The Indemnifying Party shall not agree to any settlement of such action, suit, proceeding or claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Indemnified Party from all liability with respect thereto, that imposes any liability or obligation on the Indemnified Party or that acknowledges fault by the Indemnified Party without the prior written consent of the Indemnified Party.  If the Parties cannot agree as to the application of Section 10.1 or 10.2 to any claim, pending resolution of the dispute pursuant to Article 11, the Parties may conduct separate defenses of such claims, with each Party retaining the right to claim indemnification from the other Party in accordance with Section 10.1 or 10.2, as applicable, upon resolution of the underlying claim.  
10.4    Insurance.  Each Party shall procure and maintain insurance, including comprehensive or commercial general liability insurance (including contractual liability and product liability), adequate to cover its obligations hereunder and that is consistent with normal business practices of prudent companies similarly situated.  It is understood that such insurance shall not be construed to create a limit of either Party’s liability with respect to its indemnification obligations under this Article 10 or otherwise.  Each Party shall provide the other Party with written evidence of such insurance upon request.  Each Party shall provide the other Party with written notice at least 

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30 days prior to the cancellation, non-renewal or material change in such insurance that materially adversely affects the rights of the other Party hereunder.
ARTICLE 11
 
DISPUTE RESOLUTION
11.1    Disputes.  Subject to Section 11.3, any claim, dispute, or controversy arising out of or relating to this Agreement, including as to the breach, enforcement, interpretation or validity of this Agreement (each, a “Dispute”) shall be referred to the Chief Executive Officer of Chimerix and the Chief Executive Officer of SymBio for attempted resolution.  In the event such executives are unable to resolve such Dispute within 30 days of such Dispute being referred to them, then, upon the written request of either Party to the other Party, the Dispute shall be subject to arbitration in accordance with Section 11.2, except as expressly set forth in Section 11.3 
11.2    Arbitration.  Subject to Section 11.3 below, any Dispute that is not resolved under Section 11.1 within the applicable 30-day period shall be finally and exclusively settled by binding arbitration in accordance with the applicable rules of the International Chamber of Commerce (“ICC”) as then in effect (the “ICC Rules”), except to the extent any such ICC Rule conflicts with the express provisions of this Section 11.2.  The Parties agree as follows:
(a)    The seat, or legal place, of arbitration shall be New York City, New York. The language of the arbitration shall be English. 
(b)    The arbitration shall be conducted by an arbitral tribunal of three neutral arbitrators.  Each Party shall appoint one (1) arbitrator in accordance with this Section 11.2.  The Party initiating the arbitration shall select an arbitrator in the request for arbitration.  The responding Party shall select an arbitrator within thirty (30) days after receipt of the request for arbitration.  The third arbitrator, who shall act as the presiding arbitrator, shall be selected by the two Party-appointed arbitrators within forty five (45) days of the selection of the second arbitrator.  Any arbitrator(s) not selected within these time periods shall be selected by the ICC.  Arbitrators shall not be current or former employees or directors, or current stockholders, of either Party, any of their respective Affiliates or any Sublicensee.  Each arbitrator shall have experience and familiarity with commercial licensing practices in the pharmaceutical and biotechnology industries. 
(c)    The parties shall be entitled to engage in an exchange of documents that are relevant and material to the outcome of the dispute, consistent with the IBA Rules on the Taking of Evidence in International Arbitration or such other rules as may be agreed by the Parties.  All costs of translation associated with such exchange of documents shall be shared equally between the Parties. 
(d)    Except to the extent necessary to confirm or enforce an award or as may be required by Applicable Law or the rules of any exchange on which a Party’s securities are traded, neither a Party nor the arbitral tribunal may disclose the existence, content, or results of an arbitration without the prior written consent of both parties.

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

(e)    The arbitral tribunal shall, in rendering an award, apply the substantive law of the State of New York, USA, in accordance with Section 12.2 and without giving effect to any conflicts of law provisions thereof that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction, and without giving effect to any of its rules or laws relating to arbitration.  The award shall include a written statement describing the essential findings and conclusions upon which the award is based, including the calculation of any damages awarded.  The Tribunal’s authority to award special, incidental, consequential or punitive damages shall be subject to the limitation set forth in Section 7.8, except to the extent the substantive laws of the State of New York, USA, do not permit such limitation.  The award rendered by the Tribunal shall be final, binding and non-appealable (subject only to the Parties’ right to request correction of any errors in computation, clerical or typographical errors, or other errors of a similar nature, and the Tribunal’s right to make any such correction on its own initiative, in each case, in accordance with the Rules), and judgment upon the award may be entered in any court of competent jurisdiction.
(f)    Each Party shall bear its own attorney’s fees, costs, and disbursements arising out of the arbitration, and shall pay an equal share of the fees and costs of the Tribunal; provided, however, the Tribunal shall be authorized to determine whether a Party is the prevailing party, and if so, to award to that prevailing party reimbursement for any or all of its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges, travel expenses, etc.), or the fees and costs of the ICC and the Tribunal.
11.3    Court Actions.  Nothing contained in this Agreement shall deny either Party the right to seek injunctive or other equitable relief from a court of competent jurisdiction in the context of a bona fide emergency or prospective irreparable harm, and such an action may be filed and maintained notwithstanding any ongoing discussions between the Parties or any ongoing arbitration proceeding.  In addition, either Party may bring an action in any court of competent jurisdiction to resolve disputes pertaining to the validity, construction, scope, enforceability, Infringement or other violations of Patent Rights or other intellectual property rights, and no such claim shall be subject to arbitration pursuant to Section 11.2.
ARTICLE 12
 
MISCELLANEOUS
12.1    Rights Upon Bankruptcy.  All rights and licenses granted under or pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11 of the United States Code and other similar laws in any jurisdiction outside the U.S. (collectively, the “Bankruptcy Laws”), licenses of rights to be “intellectual property” as defined under the Bankruptcy Laws.  If a case is commenced during the Term by or against a Party under Bankruptcy Laws then, unless and until this Agreement is rejected as provided in such Bankruptcy Laws, such Party (in any capacity, including debtor-in-possession) and its successors and assigns (including a trustee) shall perform all of the obligations provided in this Agreement to be performed by such Party.  If a case is commenced during the Term by or against a Party under the Bankruptcy Laws, this Agreement is rejected as provided in the Bankruptcy Laws and the other Party elects to retain 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

its rights hereunder as provided in the Bankruptcy Laws, then the Party subject to such case under the Bankruptcy Laws (in any capacity, including debtor-in-possession) and its successors and assigns (including a Title 11 trustee), shall provide to the other Party copies of all Information necessary for such other Party to prosecute, maintain and enjoy its rights under the terms of this Agreement promptly upon such other Party’s written request therefor.  All rights, powers and remedies of the non-bankrupt Party as provided herein are in addition to and not in substitution for any and all other rights, powers and remedies now or hereafter existing at law or in equity (including the Bankruptcy Laws) in the event of the commencement of a case by or against a Party under the Bankruptcy Laws.  
12.2    Governing Law.  This Agreement shall be governed by and construed in accordance with the laws of the State of New York, excluding its conflicts of laws principles with the exception of sections 5-1401 and 5-1402 of New York General Obligations Law.  The Parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods.
12.3    Entire Agreement; Amendments.  This Agreement (including the Exhibits hereto) is both a final expression of the Parties’ agreement and a complete and exclusive statement with respect to all of its terms.  This Agreement supersedes all prior and contemporaneous agreements and communications, whether oral, written or otherwise, concerning any and all matters contained herein.  The Exhibits to this Agreement are incorporated herein by reference and shall be deemed a part of this Agreement.  This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives of both Parties hereto.
12.4    Non-Waiver.  The failure of a Party to insist upon strict performance of any provision of this Agreement or to exercise any right arising out of this Agreement shall neither impair that provision or right nor constitute a waiver of that provision or right, in whole or in part, in that instance or in any other instance.  Any waiver by a Party of a particular provision or right shall be in writing, shall be as to a particular matter and, if applicable, for a particular period of time and shall be signed by such Party.  
12.5    Assignment.  Except as expressly provided hereunder, neither this Agreement nor any rights or obligations hereunder may be assigned or otherwise transferred by either Party without the prior written consent of the other Party (which consent shall not be unreasonably withheld); provided, however, that either Party may assign this Agreement and its rights and obligations hereunder without the other Party’s consent: 
(a)    in connection with the transfer or sale of all or substantially all of the business of such Party to which this Agreement relates to a Third Party (“Third-Party Acquirer”), whether by merger, sale of stock, sale of assets or otherwise (each, a “Sale Transaction”), provided that in the event of a Sale Transaction (whether this Agreement is actually assigned or is assumed by the Third-Party Acquirer or the surviving corporation resulting from such Sale Transaction by operation of law (e.g., in the context of a reverse triangular merger)), intellectual property rights of the Third-Party Acquirer that existed prior to the Sale Transaction shall not be included in the technology licensed hereunder or otherwise subject to this Agreement; or 

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

(b)    to an Affiliate, provided that the assigning Party shall remain liable and responsible to the non‐assigning Party hereto for the performance and observance of all such duties and obligations by such Affiliate.  
The rights and obligations of the Parties under this Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties, and the name of a Party appearing herein shall be deemed to include the name of such Party’s successors and permitted assigns to the extent necessary to carry out the intent of this Section 12.5.  Any assignment not in accordance with this Agreement shall be void.
12.6    Force Majeure.  Except for the obligation to make payment when due, each Party shall be excused from liability for the failure or delay in performance of any obligation under this Agreement by reason of any event beyond such Party’s reasonable control, including but not limited to Acts of God, fire, flood, explosion, earthquake, or other natural forces, war, civil unrest, acts of terrorism, accident, destruction or other casualty, any lack or failure of transportation facilities, any lack or failure of supply of raw materials, any strike or labor disturbance, or any other event similar to those enumerated above.  Such excuse from liability shall be effective only to the extent and duration of the event(s) causing the failure or delay in performance and provided that the Party has not caused such event(s) to occur.  The affected Party shall notify the other Party of such force majeure circumstances as soon as reasonably practical, and shall promptly undertake all reasonable efforts necessary to cure such force majeure circumstances.
12.7    Severability.  If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties.  The Parties shall in such an instance use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) that, insofar as practical, implement the purposes of this Agreement.
12.8    Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
12.9    Notices.  All notices that are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:
		
	If to Chimerix, to:
	Chimerix, Inc.

2505 Meridian Parkway
Suite 340
Durham, NC  27713
USA
Attn:    Legal Department
Facsimile No.: +1 919-806-1146

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

		
	If to SymBio, to:
	SymBio Pharmaceuticals Limited.

Toranomon 30 Mori Building
3-2-2 Toranomon
Minato-ku, Tokyo 105-0001
Japan
Attn: Legal Department
Facsimile No.: +81 (03) 5472-3054Japan

or to such other address(es) as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith.  Any such notice shall be deemed to have been given: (a) when delivered, if personally delivered or sent by facsimile on a Business Day (or if delivered or sent on a non-Business Day, then on the next Business Day); (b) on the Business Day after dispatch, if sent by nationally-recognized overnight courier; or (c) on the third (3rd) Business Day following the date of mailing, if sent by mail.
12.10    Interpretation.  The headings of clauses contained in this Agreement preceding the text of the sections, subsections and paragraphs hereof are inserted solely for convenience and ease of reference only and shall not constitute any part of this Agreement, or have any effect on its interpretation or construction.  All references in this Agreement to the singular shall include the plural where applicable.  The words “including,” “includes,” “include,” “for example,” and “e.g.” and words of similar import will be deemed to be followed by the words “without limitation,” and the word “or” has the inclusive meaning represented by the phrase “and/or.”  Unless otherwise specified, references in this Agreement to any section shall include all subsections and paragraphs in such Section and references in this Agreement to any subsection shall include all paragraphs in such subsection.  All references to days in this Agreement shall mean calendar days, unless otherwise specified.  Ambiguities and uncertainties in this Agreement, if any, shall not be interpreted against either Party, irrespective of which Party may be deemed to have caused the ambiguity or uncertainty to exist.  This Agreement has been prepared in the English language, and the English language shall control its interpretation.  In addition, all notices required or permitted to be given hereunder, and all written, electronic, oral or other communications between the Parties regarding this Agreement shall be in the English language. 
12.11    Relationship between the Parties.  The Parties’ relationship, as established by this Agreement, is solely that of independent contractors.  This Agreement does not create any partnership, joint venture or similar business relationship between the Parties.  Neither Party is a legal representative of the other Party, and neither Party may assume or create any obligation, representation, warranty or guarantee, express or implied, on behalf of the other Party for any purpose whatsoever. 
12.12    Cumulative Remedies.  No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

12.13    No Third-Party Rights.  The provisions of this Agreement are for the exclusive benefit of the Parties, and no other Person or Entity shall have any right or claim against any Party by reason of these provisions or be entitled to enforce any of these provisions against any Party. 
12.14    Counterparts.  This Agreement may be executed in counterparts, each of which shall be deemed an original document, and all of which, together with this writing, shall be deemed one instrument.  This Agreement may be executed by facsimile or PDF signatures, which signatures shall have the same force and effect as original signatures. 
[Remainder of this page intentionally left blank.]

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    IN WITNESS WHEREOF, the parties hereto have duly executed this License Agreement as of the Effective Date.
	
		
	Chimerix, Inc.
	SymBio Pharmaceuticals Limited

	By: /s/ Mike Sherman   
Name:  Mike Sherman
Title:  President and Chief Executive Officer
	By: /s/ Fuminori Yoshida
Name:  Fuminori Yoshida
Title:  President and Chief Executive Officer

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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

EXHIBIT A
CHIMERIX PATENT RIGHTS AS OF THE EFFECTIVE DATE
[*]

A-1

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

EXHIBIT B
INVENTORY
	
		
	[*]
	[*] vials

	[*]
	[*] kilograms#

	[*]
	[*] vials of [*] g
[*] mg each (actual amounts provided TBD and subject to availability)

*Chimerix shall provide SymBio with all related Certificates of Analysis and Certificates of Conformance. 
ǂ Chimerix shall provide SymBio with: (i) all related Certificates of Analysis and Certificates of Conformance; and (ii) all related retest data.
#[*].
Inventory provided to SymBio pursuant to this Exhibit B does not contain [*]. 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

EXHIBIT C
TECHNOLOGY TRANSFER PLAN
BCV IV Liquid Product Transfer Activities

	
		
	Month 1

	1.    Chimerix to provide manufacturing information including formulation, manufacturing process and batch records
1.1.    MSDS
1.2.    QTPP
1.3.    Raw materials
1.4.    Vial, stopper and seal materials
1.5.    Cleaning procedure
1.6.    Development report (Liquid)
1.7.    Batch records
1.7.1.    Formulation
1.7.2.    Process diagrams
1.7.3.    Manufacturing process
1.7.4.    Filling process
1.7.5.    Packaging info
2.    Chimerix to provide, as applicable, certificate of analysis of API, Standard, BCV IV solution as well as raw materials
3.    Chimerix to provide [*]
4.    Chimerix to provide Finish Product test methods and specifications (and test methods performed by product manufacturer upon receipt of API)
4.1.    API test methods performed at receipt
4.1.1.    Identification by IR
4.1.2.    Endotoxin test
4.2.    In-process test methods and specifications
4.2.1.    pH
4.2.2.    Assay by UV
4.3.    Finished product test methods with specifications
4.3.1.    Finished product specification
4.3.2.    Non-compendial Finished product methods – ID by HPLC, ID by UV, Assay, Drug Related Impurities (Early-eluting and Late-eluting)
4.3.3.    Identify HPLC columns
4.3.4.    Working Standards and markers
4.3.5.    API
4.3.6.    Raw material samples

	To be discussed
	5.    3-Phase Approach for Analytical Method Transfer
5.1.       Phase 1 – SymBio to thoroughly examine product specification and methods, obtain all equipment and supplies needed for application of methods, and interface with Chimerix on any questions related to In-process test method and specifications
5.2.       Phase 2 – SymBio and/or SymBio-chosen contract facility to perform analytical methods on R&D samples of finished product and informally compare data to data generated by Lancaster and/or Chimerix.  SymBio and Chimerix to assess mock transfer data and determine if more work is needed or if formal transfer should proceed
5.3.       Phase 3 – SymBio and/or SymBio-chosen contract facility to draft formal method transfer protocol and acceptance criteria.  SymBio/SymBio-chosen contract facility and Chimerix/Lancaster to review and approve formal method transfer protocol.  Both groups will receive and test representative samples and complete methods transfer activities and report

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

	
		
	To be discussed
	6.    SymBio to provide the name of their selected Japanese CMOs and Chimerix should assess their capabilities and review their facility and equipment validation including media fills/environmental information
7.    SymBio should name their CMO
8.    Chimerix to provide technical assistance to SymBio in assessing CMO’s equipment and capabilities
8.1.    Purchasing a [*] or smaller dedicated tank based on SymBio batch size requirement
8.2.    Dedicated compounding tank [*] or smaller based on SymBio batch size requirement
8.3.    IQ, PQ, OQ of the tank
8.4.    Formally evaluate aseptic process and terminal serialization
9.    Product safety
9.1.    Acceptable daily exposure determination and OEL
9.2.    API industrial Hygiene analytical method development and validation
10.    SymBio or CMO to provide transfer protocol including gap analysis and risk assessment on gaps and mitigation plan for reducing the risks (estimated duration 3-4 weeks)
11.    SymBio or CMO should perform initial assessments on their CMO capabilities with BCV IV solution
11.1.    Pump and nozzles evaluation on 2 mL vials
11.2.    Suitability evaluation of manufacturing process with filling and packaging
11.3.    Run a full/small scale IV batch to assess manufacturing capabilities to identify the critical process parameters
12.    SymBio must perform the extractable/ leachable study from the container closure systems
13.    CMO must perform the media fill or process simulation test 
14.    SymBio to provide MBR and PBR to Chimerix for review (estimated duration 4-6 weeks)
15.    Chimerix to review MBR and PBR and comments (estimated duration 4 weeks)
16.    Chimerix to provide MBR and PBR and all subsequent revisions (estimated duration 4 weeks)
17.    CMO to manufacture a Demo/Engineering batch (estimated duration 4 weeks)
17.1.    Test the specification T=0
17.2.    Initiate stability study
17.3.    Chimerix to be onsite
17.4.    Tech transfer report
18.    CMO to manufacture a cGMP/Clinical batch (estimated duration 4 weeks, 12 weeks after the Demo batch stability study initiation)
18.1.    cGMP batch records including manufacturing and packaging
18.2.    Initiate stability, including stability protocols
18.3.    Chimerix to be onsite (optional)
19.    CMO to produce DoE batches to evaluate the critical process parameters and their impact on critical product quality attribute (CPQA). Ideal to manufacture small scale batches if the capability permissible by CMO (estimated duration 8-10 weeks)
20.    CMO to manufacture a DOE parameters confirmation /pre-validation batch (estimated duration 4 weeks)
20.1.    Initiate stability, including stability protocols
20.2.    Chimerix to be onsite (optional)
21.    CMO to produce risk assessment documents on manufacturing process (estimated duration 4 weeks)
22.    CMO to generate validation protocols
22.1.    Facility
22.2.    Equipment
22.3.    Training of operators
22.4.    Media fills 
22.5.    Aseptic operation
22.6.    Microbiological
22.7.    Manufacturing process 
22.8.    Packaging process
22.9.    WFI 
22.10.    Environmental
23.    CMO to manufacture [*] validation batches minimum
23.1.    Master batch record
23.2.    Stability, including stability protocols
23.3.    Executed batch report
23.4.    Validation report
23.5.    All other reports including any deviations

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

BCV Drug Substance for IV Liquid Product Transfer Activities
	
		
	Month 1

	1.    Chimerix to provide drug substance manufacturing and analytical documentation including master batch records, analytical method validation reports, and specifications
1.1.       Starting material/Intermediate method validation reports and specifications
1.1.1.    [*]
1.1.2.    [*]
1.1.3.    [*]
1.1.4.    [*]
1.1.5.    [*]
1.1.6.    [*]
1.2.       Master batch records 
1.2.1.    [*]
1.2.2.    [*]
1.2.3.    [*]
1.2.4.    [*]
1.3.       Raw material (solvents and reagents) specifications
1.4.       CMX001 method validation reports and release specifications
1.5.       [*] and [*] validation protocols and reports
2.    Chimerix to provide 2 kg of drug substance manufactured at [*] with retest extension based of stability
3.    Chimerix to provide, if available, [*] of reference materials/markers for those used in CMX001 DS manufacturing.  Intermediate markers that are maintained at [*] will remain at [*]

	

[*]

	Months 3-5
	4.    Chimerix to provide [*] drug substance from final [*] validation batch (manufactured with WFi water) pending [*]

	To be discussed
	5.    Chimerix to provide support for manufacture of [*] engineering batch (using WFi water) at [*]
6.    Chimerix to provide support for manufacture of [*] validation batches (using WFi water) at [*]

	

Potential back up CDMO for BCV Drug Substance

	Within 24 months from the Effective Date
	7.    3-Phase Approach for Analytical Method Transfer
7.1.       Phase 1 – SymBio to thoroughly examine product specification and methods, obtain all equipment and supplies needed for application of methods, and interface with Chimerix on any questions related to In-process test method and specifications
7.2.       Phase 2 – SymBio and/or SymBio-chosen contract facility to perform analytical methods on R&D samples of finished product and informally compare data to data generated by Chimerix.  SymBio and Chimerix to assess mock transfer data and determine if more work is needed or if formal transfer should proceed
7.3.       Phase 3 – SymBio and/or SymBio-chosen contract facility to draft formal method transfer protocol and acceptance criteria.  SymBio/SymBio-chosen contract facility approve formal method transfer protocol.   SymBio/SymBio-chosen contract facility will receive and test representative samples and complete methods transfer activities and report

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

	
		
	Within 24 months from the Effective Date
	8.    SymBio to provide the name of their selected CDMOs and Chimerix should assess their technical capabilities and review their facility for appropriateness
8.1.    Facility capable of handling high potency API and dichloroethane (DCE)
8.2.    Facility equipment/analytical instrumentation evaluation
8.3.    Quality management system 
9.    SymBio should name their CDMO
10.    RSM procurement ([*]) 
10.1.    CMX004 transfer
11.    SymBio or CDMO to provide transfer protocol including gap analysis and risk assessment on gaps and mitigation plan for reducing the risks (estimated duration 3-4 weeks). Chimerix to review and provide documentation/support for technical transfer necessary to prepare for process validation
11.1.    [*] transfer 
11.2.    [*] transfer 
11.3.    [*] transfer
11.4.    [*] Milling
12.    SymBio or CDMO should perform initial assessments on their CDMO capabilities with BCV API process including [*] and [*]
12.1.    Run a full/small scale batch to assess manufacturing capabilities (time depends on scale)
13.    SymBio to provide Master Batch Records to Chimerix for review (estimated duration 4-6 weeks depending upon CDMO) SymBio to provide translation of batch records and all other documents to be reviewed by Chimerix if they are not in English
14.    Chimerix to review MBRs and comments (estimated duration 4 weeks)

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

EXHIBIT D
SYMBIO DEVELOPMENT PLAN 

[*]

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

EXHIBIT E
FORM OF JOINT PRESS RELEASE

Chimerix and SymBio Pharmaceuticals Establish Strategic Collaboration for Antiviral Drug Candidate BRINCIDOFOVIR

– SymBio to develop BRINCIDOFOVIR for multiple antiviral indications –

[Intentionally left blank – text of joint press release to be determined.]

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