EX-3.12 19 t17062exv3w12.txt EXHIBIT 3.12 EXHIBIT 3.12 CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT. CONFIDENTIAL PROVISIONS HAVE BEEN OBSCURED. BIOVATION LIMITED EXCLUSIVE LICENSE AGREEMENT This Exclusive License Agreement (this "Agreement") is made as of the 8th day of March, 2004 (the "Effective Date") between BIOVATION LIMITED OF CROMBIE LODGE, ABERDEEN SCIENCE PARK, BALGOWNIE DRIVE, ABERDEEN AB22 8GU, UK (hereinafter called "Biovation," which expression includes its successors and assigns) of the one part and VIVENTIA BIOTECH, INC., OF 10 FOUR SEASONS PLACE, SUITE 501, TORONTO, ONTARIO, CANADA M9B 6H7 (hereinafter called "Viventia," which expression includes its successors and permitted assignees) of the other part. Each of Biovation and Viventia are herein sometimes referred to individually as a "Party" and collectively as "Parties." WHEREAS, Biovation Controls certain proprietary Technology related to the genetic engineering of biological materials, including proteins and the removal of immunogenic sequences from proteins to produce genetic variants of such proteins for therapeutic or in vivo diagnostic purposes. WHEREAS, Biovation and Viventia have entered into that certain Research Agreement (the "Research Agreement") dated as of September 20, 2002. WHEREAS, Viventia has exercised its option to obtain an exclusive license to certain proprietary Technology under Section 3.7 of the Research Agreement. NOW, THEREFORE, IT IS HEREBY AGREED as follows: 1. DEFINITIONS. Throughout this Agreement, where the context so requires, the use of the singular form of a word shall be construed to include the plural and the use of the plural shall be construed to include the singular, and the use of any gender shall include all genders. Any words used but not otherwise defined herein shall have the meanings ascribed to them in Section 1 of the Research Agreement. In this Agreement the following words and expressions shall be construed as follows: (a) "Affiliate" shall mean any corporation, company, firm, partnership or other entity that directly or indirectly controls, is controlled by or is under common control with either Party to this Agreement. For purposes of this definition, "control" shall mean the ownership, directly or indirectly, of fifty percent (50%) or more of the issued share capital or shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%) or more of the equity interests in the case of any other entity or the legal power to direct or cause the direction of the general management and policies of the entity in question. (b) "Biovation Technology" shall mean Technology Controlled by Biovation as of the Effective Date or developed hereafter whether or not in the course of the Research Program, by Biovation or jointly by Biovation and Viventia or a third party that is related to the genetic engineering of biological materials, including proteins and plasmids and the removal of immunogenic sequences from proteins or plasmids and the generation of genetic variants thereof, provided that, any Technology Controlled by Viventia or developed by Viventia that is related to the Protein shall be deemed to be Viventia Technology and Viventia shall have exclusive ownership and control of same. (c) "BLA" shall mean a Biologics License Application, or similar application for marketing approval of a Licensed Product for use in the Field submitted to the FDA, or a foreign equivalent of the FDA. (d) "Confidential Information" shall have the meaning set forth in Section 15 of this Agreement. (e) "Contract Year" shall mean the period beginning on the Effective Date and ending on the first anniversary thereof ("Contract Year 1"), and each succeeding twelve (12) month period thereafter during the term of this Agreement (referred to herein as "Contract Year 2," "Contract Year 3," etc.). (f) "Control" or "Controlled" shall mean (i) with respect to any Technology (other than proprietary materials of a Party) and/or Patent Rights, the possession by a Party of the ability to grant a license or sublicense of such Technology and/or Patent Rights as provided herein without violating the terms of any agreement or arrangement between such Party and any third party and (ii) with respect to proprietary materials, the possession by a Party of the ability to supply such proprietary materials to the other Party as provided herein without violating the terms of any agreement or arrangement between such Party and any third party. (g) "DeImmunised Proteins" shall mean the DeImmunised genetic variants of the Protein developed by Biovation under the Research Agreement identified on Schedule A, attached hereto and incorporated herein by reference. (h) "DeImmunised Plasmids" shall mean the genetically engineered plasmids that encode the DeImmunised Protein identified on Schedule A, attached hereto and incorporated herein by reference. (i) "Effective Date" shall have the meaning set forth above in the introduction to this Agreement. (j) "FDA" means the United States Food and Drug Administration or its successor. (k) "Field" shall mean the use of the DeImmunised Protein for therapeutic and in vivo diagnostic purposes in humans. 2 (l) "First Commercial Sale" shall mean the date of the first commercial sale (other than for purposes of obtaining Regulatory Approval) of a Licensed Product by or on behalf of Viventia or any sublicensee. (m) "IND" shall mean Investigational New Drug application filing in the USA or its equivalent in any country in the European Union for approval to undertake a controlled and lawful study in humans of the Licensed Product that is designed to demonstrate statistically whether such Licensed Product is safe for use in humans in a manner sufficient to file a BLA or New Drug Application or its equivalent to obtain regulatory approval to market and sell that Licensed Product in the United States or any country in the European Union. (n) "Joint Patent Rights" shall mean all Patent Rights that claim Joint Program Technology. Joint Patent Rights as of the Effective Date are listed in Schedule B, attached hereto and incorporated herein by reference. (o) "Joint Program Technology" shall mean any and all Technology relating to the Protein or any DeImmunised Plasmid or DeImmunised Protein jointly made, developed conceived and/or reduced to practice (a) by employees of, or consultants to, both Parties, or (b) by Viventia through the material use of Biovation Technology, provided that Joint Program Technology shall not include Technology relating to (i) the Protein (ii) the composition, manufacture, or use of antibodies, antibody fragments (including single chain or single domain antibodies), or peptide-based antibody mimics, whether by themselves or conjugated to or associated with an active molecule, or (iii) fusion proteins.. (p) "Licensed Patent Rights" shall mean all Patent Rights which are Controlled by Biovation as of the Effective Date (including Biovation's interest in Joint Patent Rights). Licensed Patent Rights as of the Effective Date are listed in Schedule C, attached hereto and incorporated herein by reference. (q) "Licensed Product" shall mean any product that (i) incorporates DeImmunised Protein, (ii) is produced by use of a DeImmunised Plasmid, or (iii) the manufacture, use, or sale of which would, absent the license granted to Viventia hereunder, infringe one or more of the claims included in the Licensed Patent Rights that has not expired, been revoked or disclaimed, or found to be invalid or unenforceable in an unappealed or unappealable decision of a court of competent jurisdiction. (r) "Licensed Technology" shall mean all Biovation Technology and Biovation's interest in Joint Program Technology. (s) "New Drug Application" shall mean a new drug application (as defined in Title 21 of the United States Code of Federal Regulations, as amended from time to time) filed with the FDA or its foreign 3 equivalent seeking regulatory approval to market and sell any Licensed Product in the United States or any country in the European Union. (t) "Net Sales" shall mean gross proceeds measured in Dollars as of the date of sale resulting from the invoice price less (a) usual trade and/or cash discounts actually allowed or taken; (b) forwarding expenses, freight, postage and duties actually paid or allowed and taxes imposed directly on licensee for sales, all if separately identified in the invoice; and (c) credits for goods actually returned. No deductions shall be made for commissions paid or for the cost of collections. For Licensed Products sold or otherwise transferred other than for money, "Net Sales" shall be calculated based upon the "fair market value" of the Licensed Product determined in an arm's-length transaction. Net Sales shall be calculated on the price from Viventia, a licensee, a sublicensee, or their Affiliates to the first purchaser who is not a licensee, a sublicensee or Affiliate and not on sales between or among licensees, sublicensees, or their Affiliates. (u) "Patent Rights" shall mean the rights and interests in and to (i) issued patents and pending patent applications without limitation to any country, including, without limitation, all provisional applications, substitutions, continuations, continuations-in-part, divisionals and renewals, all letters patent granted thereon, if any, and all reissues, reexaminations and extensions thereof, and supplemental protection certificates of invention and utility models and (ii) copyrights with respect to data Controlled by a Party. (v) "Phase III Clinical Trial" shall mean, as to a particular Licensed Product for a particular indication, a controlled and lawful study in humans of the safety and efficacy of such Licensed Product for such indication, which is prospectively designed to demonstrate statistically whether such Licensed Product is safe and effective for use in such indication in a manner sufficient to file a BLA or New Drug Application or its equivalent to obtain regulatory approval to market and sell that Licensed Product in the United States or any country for the indication under investigation in such study. (w) "Protein" shall mean the starting protein as specified in Schedule A hereto. (x) "Technology" shall mean and include all inventions, discoveries, improvements, trade secrets and proprietary methods and materials, whether or not patentable, including, but not limited to (i) samples of, methods of production or use of, and structural and functional information pertaining to, chemical compounds, proteins or other biological substances and (ii) technical and scientific information (including any negative results), data, formulations, techniques and know-how. (y) For clarity, is is agreed that "Deliverables" (as defined in the Research Agreement and incorporated in this Agreement) include deimmunised 4 [ ] and the expression products of the inserts of such plasmids. 2. COMMENCEMENT. This Agreement shall be deemed to have been made as of the Effective Date and shall be read and construed accordingly. 3. GRANT OF RIGHTS. (a) Biovation hereby grants to Viventia an exclusive world-wide, royalty-bearing license under Licensed Technology and Licensed Patent Rights solely to develop, have developed, make, have made, use, sell, distribute for sale, have sold, import and/or have imported Licensed Products in the Field, together with the right to grant sublicenses. For clarity, this grant of an exclusive license to Viventia with respect to Licensed Products (including Deliverables, Deimmunised Plasmids and Deimmunised Proteins) shall not prevent Biovation from granting licenses to others under the Biovation Technology, Biovation Patent Rights and Biovation's interest in Joint Program Technology and Joint Patent Rights outside the scope of the exclusive license granted to Viventia. (b) Viventia shall notify Biovation of the grant of each sublicense within thirty (30) days of its effective date, such notification to include the name and address of the sublicensee and the general nature and subject matter of the sublicense. Viventia shall use its best efforts to ensure that any sublicensee performs its obligations under any such sublicense and shall remain liable for the performance of Viventia's obligations hereunder. Biovation will not establish any contact with the sublicensee in relation to the sublicense without the prior written consent of Viventia. 4. PAYMENTS. 4.1 General. The Parties acknowledge that the principal value contributed by Biovation under this Agreement is the Licensed Technology. Viventia acknowledges and agrees that the value it receives hereunder is in its access to the Licensed Technology. Accordingly, Viventia has agreed to pay the license fees and milestones for access to and use of Licensed Technology as set forth herein even though Biovation may not Control patent applications or patents covering the manufacture, sale, use or importation of a particular Licensed Product and, regardless of whether a Licensed Product is covered by a patent application or patent within the Licensed Patents. 4.2 Upfront Payment. In consideration for the exclusive license granted pursuant to Section 3(a) hereof Viventia shall pay to Biovation the sum of [ ] upon signature of this Agreement. 4.3 Milestone Payments. Viventia shall pay Biovation the following amounts upon the achievement of the milestones set forth below: 5 (a) [ ] upon the commencement of [ ] of each and every Licensed Product for a distinct indication. By way of example, the start of two such trials would incur two milestones if the same product was being tested for two indications or if two different products were being tested for the same indication, but would incur only one milestone if each was of the same product for the same indication. Each such milestone payment shall be reduced to a minimum of [ ] according to the following formula if the event triggering such milestone also triggers a milestone payment by Viventia to a third party: Milestone Rate in U.S. dollars = [ ] (b) [ ] upon [ ] the commencement of which triggered a milestone under subsection (a) above. Each such milestone payment shall be reduced to a minimum of [ ] according to the following formula if the event triggering such milestone also triggers a milestone payment by Viventia to a third party: Milestone Rate in U.S. dollars = [ ] (c) [ ] upon submission of [ ] for each and every Licensed Product for each and every clinical indication. Each such milestone payment shall be reduced to a minimum of [ ] according to the following formula if the event triggering such milestone also triggers a milestone payment by Viventia to a third party: Milestone Rate in U.S. dollars = [ ] (d) [ ] upon approval of [ ] the submission of which triggered a milestone payment under subsection (c) above. Each such milestone payment shall be reduced to a minimum of [ ] according to the following formula if the 6 event triggering such milestone also triggers a milestone payment by Viventia to a third party: Milestone Rate in U.S. dollars = [ ] 4.4 Fees. (a) Viventia shall pay Biovation a sublicense fee of [ ] for each and every sublicense that it grants hereunder. (b) Viventia shall also pay to Biovation an annual license fee of [ ] for the maintenance of the license granted pursuant to Section 3 of this Agreement for each Contract Year during the term of this Agreement. Such annual license fees shall be due and payable to Biovation on the first day of each Contract Year during the term of this Agreement and are not creditable against amounts owed by Viventia to Biovation pursuant to Sections 4.3 and 4.5. In the event that Licensee does not receive approval for an IND by the end of Contract Year 5, then the Licensee shall make an additional annual payment of [ ] in addition to the annual license fee payable for the relevant Contract Year (each, an "Additional Annual Payment"). Such Additional Annual Payments shall be due and payable on the first day of Contract Year 6 and each subsequent Contract Year until an IND is approved at which time such Additional Annual Payments will cease. All Additional Annual Payments to be paid under this Section 4.4(b) shall be creditable against amounts required to be paid by Viventia to Biovation under Section 4.3 of this Agreement subsequent to the payment of such Additional Annual Payment. (c) All of the payments set forth in sections 4.2, 4.3 and 4.4 are to be understood net, exclusive of Value Added Tax. 4.5 Royalties. Viventia shall pay Biovation a [ ]% royalty based on aggregate Net Sales of each Licensed Product sold during the License Term (as defined in Section 5 below) by Viventia and/or its Affiliates and sublicensees. The [ ]% royalty rate to be paid to Biovation shall be subject to a reduction if Viventia's total undiscounted royalty to Biovation and third parties on aggregate Net Sales of each Licensed Product would otherwise exceed [ ]%. In such an event, the royalty payable to Biovation will be discounted based on the following formula: [ 7 ] 4.6 Accounting. (a) All payments under this Agreement shall be due in the case of Section 4.3 within thirty (30) days of the occurrence of the relevant milestone event and, in the case of Section 4.4(a) within thirty (30) days of the execution of the sublicense, in each case without the requirement for an invoice from Biovation. Viventia will promptly notify Biovation of the achievement of any milestone event for which a payment to Biovation is required under this Section 4. After the beginning of commercialization of each Licensed Product, all payments relating thereto under this Agreement pursuant to Section 4.5 above shall be due within thirty (30) days following the end of each calendar quarter. (b) The Net Sales used for computing the royalties payable hereunder shall be computed and the royalties shall be paid, in U.S. Dollars. For purposes of determining the amount of royalties due from Viventia, the amount of Net Sales in any foreign currency shall be computed by converting such amount into dollars at the prevailing commercial rate of exchange for purchasing dollars with such foreign currency as reported in The Wall Street Journal as of the last business day of the relevant quarter. (c) Viventia agrees to keep true and accurate records and books of account containing all data necessary for the calculation of the royalties payable to Biovation under Section 4 of this Agreement. Such records and books of account shall upon reasonable notice having been given by Biovation be open during business hours for inspection by a duly authorised, but neutral and independent accountant, who shall be acceptable to both parties without prejudice. Biovation will bear the full cost of such audit unless such audit discloses an underpayment of more than five percent (5%) from the amount of total payments due. In such case, Viventia shall bear the full cost of such audit. The terms of this Section 4.6(c) shall survive any termination or expiration of this Agreement for a period of three (3) years. (d) Viventia shall prepare a statement in respect of each calendar quarter of this Agreement which shall show for the calendar quarter in question Viventia's Net Sales on sales by it, its Affiliates or sublicensees of the Licensed Products on a country by country basis, details of the quantities of Licensed Products manufactured and sold in each country and the royalty and VAT due, if any, to Biovation thereon pursuant to Section 4 above. Such statement shall be submitted to Biovation within thirty (30) days following the end of the calendar quarter or part thereof to which it relates together with a remittance for the royalties and VAT due to Biovation, if any. If Biovation shall give notice to Viventia within thirty (30) days of the receipt of any such statement that it does not accept the same such statement shall be 8 certified by an independent chartered accountant appointed by mutual agreement between the parties hereto or, in default of such an agreement, within fourteen (14) days, by the President for the time being of the Institute of Chartered Accountants of England and Wales in London. Viventia shall make available all books and records required for the purpose of such certification at reasonable times during normal business hours and the statement so certified shall be binding between the parties to this Agreement. The costs of such certification shall be the responsibility of Biovation if the certification shows the original statement to have been accurate and otherwise shall be the responsibility of Viventia. Following any such certification the Parties shall make any adjustments necessary in respect of the royalties already paid to Biovation in relation to the year in question. (e) Viventia shall pay royalties to Biovation free and clear of and without deduction or deferment in respect of any demand, set-off, counterclaim or other dispute and so far as is legally possible such payment shall be made free and clear of any taxes imposed by or under the authority of any government or public authority and in particular but without limitation where any sums due to be paid to Biovation hereunder are subject to any withholding or similar tax. Viventia shall pay such additional amount as shall be required to ensure that the net amount received by Biovation hereunder will equal the full amount which would have been received by it had not such tax, including VAT, been imposed or withheld. Viventia and Biovation, without prejudice to the foregoing, shall use their best endeavours to do all such lawful acts and things and to sign all such lawful deeds and documents as will enable Viventia to take advantage of any applicable legal provision or any double taxation treaties with the object of paying the sums due to Biovation without imposing or withholding any tax. Sums are expressed in this Agreement as exclusive of value added tax. Biovation agrees to provide Viventia with a VAT invoice in respect of every payment affected by VAT. (f) Where Biovation does not receive payment of any sums due to it within the period specified hereunder in respect thereof, interest shall accrue on the sum outstanding at the rate of one percent (1%) per month calculated on a daily basis without prejudice to Biovation's right to receive payment on the due date therefor. 5. LICENSE TERM AND TERMINATION. (a) Subject to the terms and conditions of this Agreement, the term of the license (the "License Term") granted pursuant hereto shall commence upon the Effective Date and continue in force on a country-by-country and product-by-product basis until the longer of (a) the expiration of the last to expire of the Licensed Patent Rights in the country covering the Licensed Product and (b) ten (10) years from the first commercial sale in such country of such Licensed Product. Upon expiration of the Licence Term for each Licensed Product, Viventia shall have a worldwide, exclusive fully paid up, royalty-free licence under any and 9 all Licensed Technology and/or Licensed Patent Rights covering the Licensed Product to the extent necessary or useful to develop, have developed, make, have made, use, sell, distribute for sale, have sold, import and/or have imported Licensed Products in the Field. (b) Viventia may terminate this Agreement and the licenses granted pursuant hereto by giving to Biovation six (6) months prior written notice to Biovation of the same. Such termination shall not prejudice Biovation in its enforcement of the Licensed Patents in the event of subsequent manufacture of Licensed Products by Viventia. (c) Termination of this Agreement or of such licenses shall be without prejudice to any rights of either Party against the other which may have accrued up to the date of such termination and Viventia shall pay to Biovation the appropriate royalties hereunder on all inventory of Licensed Products (on which royalties have not already been paid) held at the date of termination by Viventia or any person engaged by Viventia to manufacture the Licensed Products and shall thereafter be free to sell such Licensed Products on which applicable royalties have been paid to Biovation. Sections 5(a), 9, 11, 14, 15, 16, 19, 20 and 21 shall survive the expiration or termination of this Agreement. (d) Neither Party may terminate this Agreement for breach without first giving the alleged breaching Party written notice of the acts or omissions alleged to constitute a breach and providing a reasonable period of time to cure such alleged breach of not less than sixty (60) days with respect to the payment of money and not be less than one hundred twenty (120) days for any other acts. 6. MUTUAL REPRESENTATIONS AND WARRANTIES. Each Party hereby represents and warrants to the other Party as follows: (a) It is duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is incorporated, and has full power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including, without limitation, the right to grant the licenses granted hereunder. (b) As of the Effective Date, (i) it has the power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of the Agreement and the performance of its obligations hereunder; and (iii) the Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid and binding obligation of such Party and is enforceable against it in accordance with its terms. (c) As of the Effective Date, it has sufficient legal and/or beneficial title under its intellectual property rights necessary to perform activities 10 contemplated under this Agreement and to grant the licenses contained in this Agreement exclusively to Viventia free and clear of the rightful claim of any third party. 7. LIMITATION ON WARRANTIES. (a) Nothing in this Agreement or in any licenses granted pursuant to this Agreement shall be construed as a representation or warranty that any of the Licensed Patent Rights are valid or that any manufacture, use, sale or other disposal of the Licensed Products is not an infringement of any patents or other rights not vested in Biovation. (b) BIOVATION MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE LICENSED TECHNOLOGY AND LICENSED PATENT RIGHTS, DEIMMUNISED PLASMIDS, OR DEIMMUNISED PROTEINS, INCLUDING WITHOUT LIMITATION, ANY REPRESENTATION OR WARRANTY REGARDING VALIDITY, ENFORCEABILITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, INCLUDING ANY CLINICAL PURPOSE OR OTHER USE WITH RESPECT TO HUMANS OR NON-INFRINGEMENT OF THIRD PARTY RIGHTS. ALL TECHNOLOGY PROVIDED TO VIVENTIA BY BIOVATION HEREUNDER IS PROVIDED "AS IS." 8. VIVENTIA COVENANTS. (a) Viventia shall promote the sale of the Licensed Products of good marketable quality and shall use reasonable endeavours to meet the market demand therefore. (b) Viventia will use all Licensed Technology and Licensed Patent Rights, licensed hereunder, in compliance with all applicable laws and regulations, including but not limited to, those relating to animal testing, biotechnological research or the handling and containment of biohazardous materials. 9. INDEMNIFICATION BY VIVENTIA. Viventia shall indemnify, defend and hold harmless Biovation, its Affiliates and their respective directors, officers, employees, and agents and their respective successors, heirs and assigns (the "Biovation Indemnitees"), against any liability, damage, loss or expense (including reasonable attorneys' fees and expenses of litigation) (collectively, "Losses") incurred by or imposed upon the Biovation Indemnitees, or any one of them, in connection with any claims, suits, actions, demands or judgments of third parties, including without limitation personal injury and product liability matters and claims of suppliers and Viventia employees (except in cases where such claims, suits, actions, demands or judgments result from a material breach of this Agreement, negligence or wilful misconduct on the part of Biovation) arising out of (a) the breach or alleged breach of any representation, warranty or covenant of 11 Viventia under Sections 6, 7 or 8 hereof, (b) the negligence or misconduct of Viventia, its Affiliates or their respective employees or agents; or (c) the development, testing, production, manufacture, promotion, import, sale or use by any person of any Licensed Product which is manufactured or sold by Viventia or by an Affiliate, sublicensee, distributor or agent of Viventia. 10. DILIGENCE. Viventia agrees to exercise reasonable commercial efforts to seek regulatory approval to market Licensed Products and develop markets for and market Licensed Products. 11. OWNERSHIP OF LICENSED TECHNOLOGY AND LICENSED PATENT RIGHTS. (a) Viventia acknowledges and agrees that as between the Parties, Biovation shall own all Licensed Technology, and Licensed Patent Rights. (b) Except as provided in paragraph (c) below, Biovation and its Affiliates shall have the right, but not the obligation to prosecute, file and maintain any patent applications or patents relating to any Licensed Patent Rights. To the extent that Biovation decides not to prosecute, file, or maintain any Licensed Patent Rights, it shall notify Viventia of same and Viventia shall have the right, but not the obligation to prosecute, file and maintain any patent applications or patents with respect to Licensed Patent Rights reasonably related to Licensed Products; Biovation shall reasonably cooperate with Viventia in such filings. (c) Viventia shall have the right, but not the obligation, to prosecute, file and maintain any patent applications or patents relating to any Licensed Patent Rights that claim or are otherwise directed to Deliverables, Deimmunised Plasmids and Deimmunised Proteins (including compositions comprising same and methods of making or using all of the foregoing. To the extent that Viventia decides not to prosecute, file or maintain any such patents or applications, it shall notify Biovation of same and Biovation shall have the right, but not the obligation to prosecute, file and maintain them; Vivenia shall reasonably cooperate with Biovation in such filings. 12. INFRINGEMENT. (a) Each Party shall notify the other promptly after such Party becomes aware of any alleged infringement of any Licensed Patent Rights in any country through the sale of a Licensed Product. (b) If any of the Licensed Patent Rights under which Viventia holds a license is infringed by a third party through the sale of a Licensed Product, Biovation shall have the right and option, but not the obligation, to bring an action for infringement, at its sole expense, 12 against such third party in the name of Biovation and/or in the name of Viventia, and to join Viventia as a plaintiff if required. Biovation shall promptly notify Viventia of any such action and shall keep Viventia informed as to the prosecution of any action for such infringement. Biovation shall have the full control over the conduct of such litigation including settlement thereof; provided, however, that Biovation shall make no decision, including, but not limited to, any settlement with respect to such infringement which adversely affects the validity or enforceability or scope of the Licensed Patent Rights or detracts from the exclusivity of the license granted to Viventia hereunder without the prior written consent of Viventia. In the event that Biovation does not institute an infringement proceeding against an infringing third party within one hundred twenty (120) days after becoming aware or receiving notice of any alleged infringement through the sale of a Licensed Product for which it has a right and option to bring an action under this Section 12(b), then Viventia shall have the right and option, but not the obligation, to institute such an action and to retain any recovered damages. If by statute or regulation, a delay of one hundred twenty (120) days would result in a diminshment of rights, including by way of example but not limitation loss of the opportunity for a stay of approval of an infringing product, then the one hundred twenty (120) day period above shall be shortened to the extent required to end ten (10) days before the date on which the diminishment of rights would occur. (c) In any infringement suit either Party may institute to enforce any rights pursuant to this Agreement, the other Party hereto shall, at the request of the Party initiating such suit, cooperate in all respects and, to the extent reasonably possible (without adversely affecting the other Party's normal business operations), have its employees testify when requested and make available relevant records, papers, information, samples, specimens, and the like. All reasonable out-of-pocket costs incurred in connection with rendering cooperation requested hereunder shall be paid by the Party requesting cooperation. (d) The costs and expenses of any action instituted pursuant to this Section 12 including reasonable fees of attorneys and other professionals) shall be borne by the Party instituting the action, or, if the Parties elect to cooperate in instituting and maintaining such action, such costs and expenses shall be borne by the Parties in such proportions as they may agree in writing. Each Party shall execute all necessary and proper documents and take such actions as shall be appropriate to allow the other Party to institute and prosecute such infringement actions (if such other Party has the right to institute and prosecute such infringement actions pursuant to this Section 12). 13. INSURANCE. Viventia shall maintain comprehensive general liability insurance in the amount of [ ] per occurrence during the term of this Agreement and Product Liability Insurance in the amount of 13 [ ] per occurrence for all periods during which it has a Licensed Product for sale. Viventia shall list Biovation as an "Additional Insured" under its insurance policies described above and shall provide a certificate of insurance to Biovation reflecting the same. 14. NOTICES. (a) All notices and statements to either Party required under this Agreement shall be made in writing delivered via certified mail, return receipt requested, courier, provided that evidence of delivery is made, or facsimile with confirmation of such transmission addressed to such Party at the following addresses or faxed to the appropriate numbers set forth below (with the copies to other parties set forth below) or to such other address as may be designated from time to time: To Biovation: With a copy to: Biovation Limited Mintz, Levin, Cohn, Ferris, Glovsky and Crombie Lodge Popeo PC Aberdeen Science Park One Financial Center Balgownie Drive Boston, MA 02111 Aberdeen AB22 8GU Attention: Jeffrey M. Wiesen, Esquire Scotland Tel: 617-542-6000 Attention: Dr. Frank J. Carr Fax: 617-542-2241 President Tel: 44 1224 707337 Fax: 44 1224 708816 To Viventia: With a copy to: Viventia Biotech, Inc. Kenyon & Kenyon 10 Four Seasons Place One Broadway Suite 501 New York, NY 10004-1050 Toronto, ON M9B 6H7 Attention: Richard L. DeLucia, Esq. Canada Tel: 212-425-7200 Attention: Dr. Nick Glover Fax: 212-425-5288 President & CEO Tel: 1 416 291 1277 Fax: 1 416 335 9306 (b) All notices and statements provided to a Party hereunder shall be deemed to have been given as of the date received, or at the time of delivery of a facsimile to the relevant facsimile number above. (c) Each Party hereto may change its address and contact information set forth above for the purpose of this Agreement by providing written notice to the other Party of the same from time to time. 14 15. TREATMENT OF CONFIDENTIAL INFORMATION. For purposes of this Agreement, "Confidential Information" shall mean with respect to a Party (the "Receiving Party"), all information, including without limitation, any Technology disclosed by the other Party (the "Disclosing Party") to the Receiving Party or to any of its employees, consultants, Affiliates, or sublicensees, whether in writing, or by oral or visual disclosure or presentation, provided, however, that "Confidential Information" shall not include information that: (a) was known to Receiving Party at the time such Confidential Information was received by the Receiving Party or its Affiliates, as shown by written documentation, other than by virtue of a prior confidential disclosure to such Receiving Party or its Affiliates; or (b) was publicly known when received from Disclosing Party or thereafter becomes publicly known through no fault or omission of Receiving Party; or (c) is made known to Receiving Party by a third party who did not derive it from Disclosing Party and who has a lawful right to make such disclosure free from any obligation of confidentiality to the Disclosing Party; or (d) is independently developed by or for the Receiving Party without reference to or reliance upon any Confidential Information; or (e) is approved for disclosure by prior written consent of Disclosing Party; or (f) is required to be disclosed by government authority; provided; however, that Receiving Party has provided reasonable advance notice of the impending disclosure to Disclosing Party and will disclose the Confidential Information to the extent necessary and to such authority only. The Receiving Party agrees that it will hold the Confidential Information received from the Disclosing Party in secrecy and confidence and will not disclose it to any third party, nor use it for any purpose other than for the purpose of the performance of this Agreement (which includes with respect to Viventia the full enjoyment of the license rights granted to it by Biovation). Each Party further agrees that it will restrict disclosure of the Confidential Information within its own organisation and affiliates to those persons having a need to know it for the purpose of this Agreement, and that such persons will be advised of the obligation set forth in this Agreement and obligated in like fashion. The above obligations of the Receiving Party with respect to its treatment of Confidential Information shall commence as of the Effective Date and continue through the term of this Agreement and for a period of five (5) years thereafter. This Agreement shall not be construed as granting any license rights with respect to the Confidential Information. Except as otherwise required by applicable laws and regulations, the Parties hereby 15 agree that any disclosure of the terms and conditions of this Agreement (including disclosure in connection with potential stock exchange listings, if any) shall be subject to the other Party's prior written mutual agreement; provided, however, that each Party may disclose the terms and conditions of this Agreement to a prospective investor, and Viventia may disclose the terms of this Agreement to a prospective sublicensee or marketing partner for a Licensed Product, pursuant to a written confidentiality agreement. 16. WAIVER. The waiver by Biovation of any breach, default or omission in the performance or observance of any of the terms of this Agreement by Viventia shall not be deemed to be a waiver of any other such breach, default or omission. 17. FORCE MAJEURE. If the performance of this Agreement or any obligation hereunder (except for the payment of money) is prevented, restricted or interfered with by reason of fire or other casualty or accident, strikes or labour disputes, inability to procure raw materials, power or supplies, war, invasion, civil commotion or other violence, compliance with any order of any governmental authorities or any other act or conditions whatsoever beyond reasonable control of either Party hereto, the Party so affected upon giving a prompt notice to the other Party shall be excused from such performance to the extent of such prevention, restriction or interference; provided however that the Party so affected shall use commercially reasonable efforts to avoid or remove such causes of non-performance and shall continue performance hereunder with the utmost dispatch whenever such causes are removed, to the extent commercially reasonable. 18. ASSIGNMENT. This Agreement shall not be assigned by either Party without the prior written consent of the other Party, which consent shall not be unreasonably withheld. Notwithstanding the foregoing, in the event of a merger, consolidation or similar reorganization of either Party with or into another party, or in the event of a sale of all or substantially all of the assets of a Party, or with respect to Viventia in the event of the sale of the business unit or Licensed Product to which this Agreement pertains, this Agreement shall be assigned to or become the obligation and liability of the acquiring entity, subject to the written notification of such acquisition or merger to the other Party. Any purported assignment in violation of this Section 18 shall be void. The terms and conditions of this Agreement shall be binding upon and inure to the benefit of the permitted successors and assigns of the Parties. 19. GOVERNING LAW. This Agreement shall be governed and interpreted in accordance with the laws of New York without reference to its choice-of-law rules, except that any issue 16 concerning interpretation, infringement, validity, enforceability, term, or effect of a patent shall be governed by national law of the country of such patent. 20. ARBITRATION. All disputes, differences or controversies arising out of or in connection with this Agreement, its interpretation, performance, or termination, which may arise between the Parties arising out of, or related to, this Agreement shall be amicably settled between the Parties. In case of failure of amicable settlement between the Parties, it shall be finally settled by binding arbitration conducted in New York City in accordance with the Rules of Concilliation and Arbitration of the International Chamber of Commerce (Paris, France) (the "ICC"). The arbitration panel shall be composed of three arbitrators, one of whom shall be selected by Biovation, one of whom shall be selected by Viventia and the third of whom shall be selected by the two so selected. If both or either of Biovation or Viventia fails to select an arbitrator or arbitrators within fourteen (14) days after receiving notice of commencement of arbitration or if the two arbitrators fail to select a third arbitrator within fourteen (14) days after their appointment, the ICC shall, in accordance with said rules, upon the request of both or either of the Parties to the arbitration, appoint the arbitrator or arbitrators required to complete the panel. Notwithstanding the terms contained in Section 19 of this Agreement, U.S. patent law shall govern any disputes with respect to inventorship under Sections 4.4, 4.5 and 4.6 of this Agreement. The Parties shall share the costs of the arbitration, including administrative and arbitrators' fees equally. Each Party shall bear its own costs and attorneys' and witnesses' fees; provided, however, that the prevailing Party, as determined by the arbitration panel, shall be entitled to an award against the other Party in the amount of the prevailing Party's costs and reasonable attorneys' fees. If judicial enforcement or review of the arbitrator's decision is sought, the prevailing Party shall be entitled to costs and reasonable attorneys' fees in addition to any amount of recovery ordered by the court. Any dispute between the Parties related to or arising from this Agreement or the Parties' relationship hereunder that is not arbitrable, including any action to confirm, enforce, modify, or set aside an arbitration award, shall be heard exclusively in the state or federal courts located in New York County, New York, to the exclusion of all other courts, and the parties consent to the jurisdiction and venue of such courts for such purpose. 21. MISCELLANEOUS. 21.1 Acknowledgement. Each Party acknowledges that it has negotiated and entered into this Agreement in good faith. 21.2 Severability. In the event any one of the provisions of this Agreement is held unenforceable or in conflict with the law of any jurisdiction, the validity of the remaining provisions shall not be affected by such holding. The Parties agree to negotiate and amend in good faith such provision in a manner consistent with the intentions of the Parties as expressed in the Agreement if 17 any invalid or unenforceable provision affects the consideration of either Party. 21.3 Interpretation. The Parties acknowledge and agree that: (i) each Party and its counsel reviewed and negotiated the terms and provisions of this Agreement and have contributed to its revision; (ii) the rule of construction to the effect that any ambiguities are resolved against the drafting Party shall not be employed in the interpretation of this Agreement; and (c) the terms and provisions of this Agreement shall be construed fairly as to all Parties hereto and not in favor of or against any Party, regardless of which Party was generally responsible for the preparation of this Agreement. 21.4 Entirety of Agreement. This Agreement contains the entire understanding of the Parties hereto with respect to the subject matter contained herein. There are no restrictions, promises, covenants or understandings other than those expressly set forth herein, and no rights or duties on the part of either Party are to be implied or inferred beyond those expressly herein provided for. The Parties may, from time to time during the term of this Agreement, amend, modify, vary, waive or alter any of the provisions of this Agreement, but only by a written instrument that makes specific reference to this Agreement which is duly executed by each Party, or in the case of waiver, by the Party or Parties waiving compliance. 21.5 Further Assurances. Each Party agrees to duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including, without limitation, the filing of such additional assignments, agreements, documents and instruments, that may be necessary or as the other Party hereto may at any time and from time to time reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes of, or to better assure and confirm unto such other Party its rights and remedies under, this Agreement. 21.6 No Partnership. For the purposes of this Agreement and all obligations to be performed hereunder, each Party shall be, and shall be deemed to be, an independent contractor and not an agent, partner, joint venturer or employee of the other Party. Neither Party shall have authority to make any statements, representations or commitments of any kind, or to take any action which shall be binding on the other Party, except as may be explicitly provided for herein or authorized in writing. 21.7 Research Agreement. This Agreement supersedes the Research Agreement with respect to any subject matter addressed herein or any inconsistency. 18 IN WITNESS whereof the Parties have caused this Agreement to be duly executed in duplicate originals by their respective officers hereunto duly authorized, of which one original is to be held by each Party. BIOVATION LIMITED VIVENTIA BIOTECH, INC. By: /s/ Frank J. Carr By: /s/ Nick Glover ----------------- ------------------ Dr. Frank J. Carr Nick Glover, Ph.D. President President & CEO 19 SCHEDULE A VIVENTIA'S PROTEIN = [ ] DEIMMUNISED PROTEIN = [ ] 20 SCHEDULE B JOINT PATENT RIGHTS 21 SCHEDULE C LICENSED PATENT RIGHTS DEIMMUNISATION PATENT FAMILIES DEIMMUNISATION I WO 98/52976 (international publication date 26-Nov-98) Method for the production of non-immunogenic proteins Regional Applications: USA US 10/300215 Europe EPO 98922932.3 Japan 550129/98 Canada 2290485 Australia 75393/98 DEIMMUNISATION II WO 00/34317 (international publication date 15-Jun-00) Modifying protein immunogenicity Regional Applications: USA 09/633516 Europe EPO 99959535.8 Japan 2000-586759 China 99804401.6 Australia 16676/00 Mexico 0007746 Canada 2342967 DEIMMUNISATION III WO 02/069232 (international publication date 6-Sept-02) Method for identification of T-cell epitopes and use for preparing molecules with reduced immunogenicity 22