Amendment of License Agreement between Optimer Pharmaceutical, Inc Delaware Corporation and Optimer Biotechnology, Inc., A Taiwan CorporationLicense Agreement |
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*** Test Omitted and Filed Separately The license agreement between Optimer Pharmaceuticals, Inc., USA (Optimer) and Optimer Biotechnology, Inc., Taiwan (OBI) was originally signed on December 8, 2003 with the goal to spin off the Asian operation into an independent entity. Fund raising effort was postponed to focus on Optimer's late-stage pipeline products. OBI's current management team has made contributions to the overall progress. We have made amendments to the original signed agreement, to give additional credit for OBI contributions and to reflect the spirit of the collaboration relationship. In addition, Optimer and OBI had agreed in December 2003 to treat all of OBI's post-agreement operational expenses from January 2004 to December 31, 2006, in the amount of approximately US$2.0M, as an interest-free loan from Optimer to accurately reflect its "independent" status. This agreement will continue, and OBI is to pay back this loan in the future. However, OBI will not use its raised fund to pay back the loan at this time. OBI will pay back this loan from its royalty income due from Optimer, projected to be starting in 2009. Both parties have agreed that the loan will be paid back in two equal installments, projected to be on October 1, 2009 and October 1, 2010, respectively. This amendment is effective on September 30, 2006, the projected closing date of OBI's Series A round. Article I—Definition 1.7 "OPT-22 Patents B" means those OPTIMER Patents under the corresponding heading in Exhibit A . 1.8 "OPT-22 Patents C" means those OPTIMER Patents under the corresponding heading in Exhibit A . 1.12 "Candidate Patents" means OPT-22 Patents A, OPT-22 Patents B, and OPT-80 Patents. 1.26 "Licensed Products" means Chemzyme Products, OPopS™ Products, OPT-22 Products and OPT-80 Products. Amendment: Delete 1.7 and 1.8. Modify 1.2 and 1.26 1.12 "Candidate Patents" means OPT-22 Patents A, OPT-22 Patents D, OPT-99 patens and OPT-80 Patents. 1.26 "Licensed Products" means OPT-99, OPT-22 Products and OPT-80 Products. Original: 2.2 Candidate Licenses. Subject to the terms of
this Agreement, OPTIMER hereby grants to OBI: (i) an exclusive royalty-bearing license in the Candidate Territory under the OPT-22 Patents A in the OPT-22 Field I to make, have made, use, sell, have sold, import and develop OPT-22 Products I, with the right to grant and authorize sublicenses; an exclusive royalty-bearing license in the Candidate Territory under the OPT-22 Patents B in the OPT-22 Field II to make, have made, use, sell, have sold, import and develop OPT-22 Products II, with the right to grant and authorize sublicenses; (iii) a non-exclusive royalty-bearing license in the Candidate Territory under the OPT-22 Patents A and OPT-22 Patents C in the OPT-22 Field II, and under OPT-22 Patents D in the OPT-22 Field I and OPT-22 Field II, to make, have made, use, sell, have sold, import and develop OPT-22 Products I and OPT-22 Products II, with the right to grant and authorize sublicenses; (iv) an exclusive license royalty-bearing license in the Candidate Territory under the OPT-80 Patents in the OPT-80 Field to make, have made, use, sell, have sold, import and develop OPT-80 Products, with the right to grant and authorize sublicenses. Amendment: Delete (ii), revise (i), (iii) and (iv) and add (v)— Optimer, USA, has returned patents B and C (Exhibit A) to MSKCC since June 30, 2005. They are not part of license agreement any more. (i) an exclusive royalty-bearing license in the Candidate Territory under the OPT-22 Patents A in the OPT-22 Field I to manufacture know how, make, have made, use, sell, have sold, import and develop OPT-22 Products I, with the right to grant and authorize sublicenses; (ii)
(iii) a non-exclusive royalty-bearing license in the Candidate Territory under the OPT-22 Patents A in the OPT-22 Field II, and under OPT-22 Patents D in the OPT-22 Field I and OPT-22 Field II, to manufacture know how, make, have made, use, sell, have sold, import and develop OPT-22 Products I and OPT -22 Products II, with the right to grant and authorize sublicenses; (iv) an exclusive license royalty-bearing license in the Candidate Territory under the OPT-80 Patents in the OPT-80 Field to manufacture know how, make, have made, use, sell, have sold, import and develop OPT-80 Products, with the right to grant and authorize sublicenses. (v) an exclusive license or pass-through license in the Candidate Territory under the OPT-99 Patents in the OPT-99 Field to manufacture know how, make, have made, use, sell, have sold, import and develop OPT-99 Products, with the right to grant and authorize sublicenses. Original: Section 3.2 and 3.3 3.1 Within sixty (60) days of the Effective Date, OPTIMER and OBI shall mutually agree upon a timeline for preclinical and clinical development of Licensed Products with clinical therapeutic or diagnostic applications ("Timeline") for which OPTIMER holds territorial rights. Agreement to the Timeline for such Licensed Products shall not be unreasonably withheld by OPTIMER. Such Timeline shall be appended as an Exhibit to this Agreement, and may be amended from time to time as necessary and by mutual consent. In the event that agreement cannot be reached on the Timeline within sixty (60) days of the Effective Date, or any developmental milestone specified in the Timeline is not met by OBI, OPTIMER shall have the right to terminate this Agreement in accordance with Section 12.4. 2 In addition, OBI shall adhere to the following milestones: (a) OBI shall have delivered to OPTIMER prior to the execution of this Agreement, its detailed business, research and development plan including, for example, relevant schedules of capital investments needed to implement the plan, financial, equipment, facility plans, number and kind of personnel and time planned for each phase of development of the OPTIMER Patents for a three year period , to the extent formed by OBI. Similar reports shall be provided to OPTIMER annually to relay update and status information on OBI's business, research and development progress, including projections of activity anticipated for the next reporting year. (b) OBI shall be responsible for diligently and promptly taking all reasonable steps to secure all required and/or necessary governmental approvals to sell, exploit, or market any and all Licensed Products. OBI shall advise OPTIMER, through annual reports described in Section 3.3(a) above of its program of development for obtaining said approvals. Amendment: Amend 3.2 and 3.3 3.2 and 3.3—OBI had submitted updated Business Plan, Budge and Financial Projections, and Optimer agrees that OBI has full filled these terms. Original: Section 4.1 (a) 4.1 (a)—20,400,000 shares (equivalent to $6 MM USD) of Optimer Biotechnology, Inc. Series A Common Stock, par value NT$10 (US$0.294) per share (the "Shares"), issuable within thirty (30) days on the Effective Date of this Agreement. Shares will be subjected to final audit upon closing of financing. In connection with the issuance of the Shares, OPTIMER shall enter into the Common Stock Issuance Agreement, attached hereto as Exhibit C ("Common Stock Issuance Agreement"). Amendment: 4.1 (a)—In connection with the issuance of 20,400,000 shares related to technology valuation (equivalent to $6 MM USD) of Optimer Biotechnology, Inc. Common Stock, par value NT$10 (US$0.294) per share (the "Shares"), OPTIMER and OBI shall enter into the Common Stock Issuance Agreement, attached hereto as Exhibit C ("Common Stock Issuance Agreement") within sixty days (60) after the Effective Date of this agreement. Shares will be subjected to final auditing upon closing of OBI's Series A financing. Original: Section 4.1(b) 4.1 (b)—For OPT-22 Products and OPT-80 Products, OBI will make payments to OPTIMER upon accomplishing (itself or through a sublicensee) the following milestones: For OPT-22 Products: • $[***] upon initiation of the first Phase II (or equivalent) efficacy study in the Discovery Territory • $[***] upon commencement of the first pivotal studies in the Discovery Territory • $[***] upon first New Drug Application or equivalent in the Discovery Territory • $[***] upon the first marketing approval in the first Candidate Territory. 3 • $[***] upon completion of the first Phase II (or equivalent) efficacy study in the United States of America. • $[***] upon commencement of the first pivotal studies in the Candidate Territory • $[***] upon first New Drug Application or equivalent in the Candidate Territory • $[***] upon the first marketing approval in the Candidate Territory. Amendment: For OPT-22 Products: OBI will proceed with Phase 2/3 pivotal trial directly, therefore the $[***] payment upon initiation of the first Phase II does not apply. 4.1 (b)—The milestone payments will be deducted from the future royalty payment. The royalty commencing time is projected to be in January 1, 2009 . Original: Section 4.1 (f) 4.1 (f) Minimum annual royalty payments, starting in the Royalty Year commencing January 1 after the Execution Date, in the amount of [***] dollars ($[***]). The royalty payments shall be credited against the earned royalty payments required in Section 4.1(c) for the same Royalty Year only, and shall be paid within thirty days following the end of the Royalty Year. Amendment: 4.1 (f)—There shouldn't be royalty responsibility before any product is approved or launched in the territory. Delete 4.1 Original: Section 4.4 (a) 4.4 (a)—OBI shall pay to OPTIMER interest on any amounts not paid when due. Likewise, OPTIMER shall pay to OBI interest on any amounts not paid when due. Such interest will accrue from the forty-fifth (45 th ) day after the payment was due at a rate two percent (2%) above the daily prime interest rate, as determined by J.P. Morgan Chase or its successor entity, on each day the payment is delinquent, and the interest payment will be due and payable on the first day of each month after interest begins to accrue, until full payment of all amounts due OPTIMER or OBI is made. Amendment: 4.4 (a)—This interest clause will be implemented from July 1, 2009. Original: Section 4.5 (a) 4.5 (a)—A royalty in an amount equal to [***]% of monies received by OPTIMER for OPT-22 Product sales in any or all of the countries outside of the Candidate Territories. Amendment: 4.5 (a)—A royalty in an amount equal to [***]% (Not [***]%) of monies received by OPTIMER for OPT-22 Product sales in any or all of the countries outside of the Candidate Territories. 4 4.5 (b)—A royalty in an amount equal to [***]% of monies received by OPTIMER for OPT-80 Product sales in any or all of the countries outside of the Candidate Territories. Amendment: 4.5 (b)—A royalty in an amount equal to [***]% (Not [***]%) of monies received by OPTIMER for OPT-80 Product sales in any or all of the countries outside of the Candidate Territories. Original: Section 6.1 6.1—OBI shall be responsible for and pay all future costs and expenses incurred by OPTIMER for the preparation, filing, prosecution, issuance, and maintenance of Candidate Patents in the Candidate Territory. For costs and expenses incurred prior to the Effective Date of this Agreement shall be reimbursed to OPTIMER by OBI as a one-time payment of $[***] and shall be paid by OBI within forty-five (45) days of the Effective Date. Such costs and expenses incurred after the Effective Date shall be paid by OBI as they are incurred. Amendment: 6.1—OBI shall be responsible for the preparation, filing, prosecution, issuance, and maintenance of Candidate Patents in the Candidate Territory. For costs and expenses incurred prior to the Effective Date of this Agreement shall be reimbursed to OPTIMER by OBI within 60 days of Series A closing. OBI shall not use the names of OPTIMER or its Affiliates, nor any of their employees, nor any adaptation thereof, in any advertising, promotional or sales literature without prior written consent obtained from OPTIMER in each case; provided that once a particular disclosure has been approved, further disclosures which do not differ materially therefrom may be made by OBI without obtaining any further consent of OPTIMER. Amendment: OBI shall not use the names of Optimer Pharmaceuticals, Inc. The official registered name of OBI is Optimer Biotechnology, Inc. 11.1 This Agreement may not be assigned by OBI without prior written consent from OPTIMER. OPTIMER may assign this Agreement freely. Notwithstanding the foregoing prohibition, OBI may without OPTIMER's consent assign this Agreement to any entity that it may merge into, consolidate with, or transfer substantially all of its assets ("substantially" being EIGHTY PERCENT (80%) or more thereof) to which this Agreement relates, so long as the successor surviving corporation in any such merger, consolidation, transfer or reorganization assumes in writing the obligations of this Agreement. Such merger, consolidation, transfer or reorganization shall not in itself be a breach of this Article XI, nor be any default under this Agreement. 5 Remove this article since OBI is independent from Optimer Pharmaceuticals, Inc., USA. Any payment, notice or other communication pursuant to this Agreement shall be sufficiently made or given when delivered by courier or other means providing proof of delivery to such party at its address below or as it shall designate by written notice given to the other party: In the case of OPTIMER: Optimer
Pharmaceuticals, Inc. In the case of OBI: Optimer
Biotechnology, Inc. Amendment: In the case of OPTIMER: Optimer Pharmaceuticals, Inc. In the case of OBI: Optimer Biotechnology, Inc. 6 IN WITNESS WHEREOF, authorized representatives of the parties have signed and dated this Agreement below.
7 "OPTIMER Patents" means all the United States patents and patent applications listed below, and their continuations, continuations-in-part, divisionals, and other continuing applications, all patents issuing on the foregoing, all reissues, re-examinations, extensions of any kind, substitutions, registrations and corresponding foreign patents and patent applications: OPT-22 Patents A US patent 5,708,163 "Synthesis of the Breast Tumor-Associated Antigen Defined by Monoclonal Antibody MBrl and Uses Thereof" US patent 6,090,789 "Synthesis of the Breast Tumor-Associated Antigen Defined by Monoclonal Antibody MBrl and Uses Thereof" US patent application 09/017,611 "Synthesis of Glycoconjugates of the Globo-H Epitope and Uses Thereof" OPT-22 Patents D—A nonexclusive in field I, see updated patent portfolio US patent application 09/794,905 "Affinity Matrix Bearing Tumor-Associated Carbohydrate or Glycopeptide-Based Antigens and Uses Thereof" OPopS™ Category Patents—See attached patent portfolio . US provisional patent application #60/096/001. "Programmed One-Pot Multistep Assembly of Oligosaccharides." OPT-80 Patents-See attached patent portfolio US provisional patent application #60/399,956. "Tiacumicin Production." OPT-99 NCE and process patent—See attached patent portfolio 8
8 This License Agreement ("Agreement") is effective on the date last subscribed below (the "Effective Date"), and is by and between Optimer Pharmaceuticals, Incorporated (hereinafter referred to as "OPTIMER"), a Delaware corporation with principal offices at 10110 Sorrento Valley Road, Suite C, San Diego, California 92121, and Optimer Biotechnology, Inc. , a Taiwan corporation with principal offices located at Suite D, 14F, 207 Tun Hwa S. Road, Sec. 2, Taipei, 106 Taiwan, ROC (hereinafter referred to as "OBI"). WHEREAS, OPTIMER is the owner or licensee of certain patents and know-how and has the right to grant licenses under said patents and know-how; and WHEREAS, OPTIMER desires to have said patents and know-how utilized to develop commercial therapeutics in certain fields and territories and is willing to grant a license to its interest thereunder; and WHEREAS, OBI seeks to commercially develop said patents and know-how through a thorough, vigorous and diligent program of commercializing the said patents and know-how in said fields and territories. NOW, THEREFORE, in consideration of the premises and the mutual covenants contained herein, the parties hereto agree as follows: For the purpose of this Agreement, the following words and phrases shall have the following meanings: 1.1 "Affiliate" of a party means any person, firm, corporation or other entity controlling, controlled by, or under common control with that party. The term "control" wherever used throughout this Agreement means ownership, directly or indirectly, of more than 50% of the equity capital. 1.2 "OBI" as used in this Agreement shall include OBI's Affiliates. 1.3 "OPTIMER Patents" shall have the meaning as defined in Exhibit A. 1.4 "Chemzyme Patents" means those OPTIMER Patents under the corresponding heading in Exhibit A. 1.5 "OPopS™ Patents" means those OPTIMER Patents under the corresponding heading in Exhibit A. 1.6 "OPT-22 Patents A" means those OPTIMER Patents under the corresponding heading in Exhibit A. 1.7 "OPT-22 Patents B" means those OPTIMER Patents under the corresponding heading in Exhibit A. 1.8 "OPT-22 Patents C" means those OPTIMER Patents under the corresponding heading in Exhibit A. 1.9 "OPT-22 Patents D" means those OPTIMER Patents under the corresponding heading in Exhibit A. 1.10 "OPT-22 Patents" means OPT-22 Patents A, OPT-22 Patents B, OPT-22 Patents C and OPT-22 Patents D. 1.11 "OPT-80 Patents" means those OPTIMER Patents under the corresponding heading in Exhibit A. 9 "Candidate Patents" means OPT-22 Patents A, OPT-22 Patents B, and OPT-80 Patents. 1.13 "Chemzyme Field" means the discovery and development using Chemzyme Patents of novel engineered proteins for use in human therapeutic drug applications. 1.14 "OPopS™ Field" means the discovery and development using OPopS™ Patents of new analogs of tiacumicin B and other human therapeutic drugs for use in human therapeutic drug applications. 1.15 "Clustered Carbohydrate Antigen" means an immunogenic molecule consisting of two or more identical or different carbohydrate antigens attached to a common peptide backbone. 1.16 "OPT-22 Field I" means the treatment or prevention of human cancer with a carbohydrate vaccine comprising Globo H as the sole antigen. Specifically excluded from OPT-22 Field I are (i) vaccines comprising mixtures of more than one type of carbohydrate antigen, one of which may be Globo H, and (ii) vaccines comprising Clustered Carbohydrate Antigens wherein the carbohydrate antigens have not been synthesized using OPTIMER's OPopS™ technology. 1.17 "OPT-22 Field II" means the treatment or prevention of human cancer with a carbohydrate vaccine comprising Clustered Carbohydrate Antigens wherein the carbohydrate antigens have been synthesized using OPTIMER's OPopS™ technology. 1.18 "OPT-80 Field" means the treatment of human C. difficile -associated diarrhea with analogs of (tiacumicin B). 1.19 "Chemzyme Products" means any and all products and services within the Chemzyme Field, whether or not covered by OPTIMER Patents. 1.20 "OPopS™ Products" means any and all products and services within the OPopS™ Field, whether or not covered by OPTIMER Patents. 1.21 "OPT-22 Products I" means any and all products and services within the OPT-22 Field I, whether or not covered by OPTIMER Patents. 1.22 "OPT-22 Products II" means any and all products and services within the OPT-22 Field II, whether or not covered by OPTIMER Patents. 1.23 "OPT-22 Products" means OPT-22 Products I and OPT-22 Products II. 1.24 "OPT-80 Products" means any and all products and services within the OPT-80 Field, whether or not covered by OPTIMER Patents. 1.25 "Know-How" means any technical information, know-how, processes, procedures, compositions, devices, methods, formulas, protocols, techniques, designs, data or other subject matter owned or controlled by OPTIMER which is necessary for the manufacture, sale and/or use of Licensed Products, in each case, which is not in the public domain. 1.26 "Licensed Products" means Chemzyme Products, OPopS™ Products, OPT-22 Products and OPT-80 Products. 10 "Net Sales" of a Licensed Product means OBI's or
its sublicensee's, as indicated, billings for sales of that product
to an unaffiliated third party, less the sum of the following: a) Discounts allowed in amounts customary in the trade; b) Sales, tariff duties and/or use taxes directly imposed and with reference to particular sales; c) Outbound transportation prepaid or allowed; d) Amounts allowed or credited on returns; and e) Bad debts and uncollectible receivables provided that, in any calendar year, such deduction will not exceed four percent (4%) of the total billings for sales of Licensed Products sold in that year. No deductions shall be made for commissions paid to individuals whether they be with independent sales agencies or regularly employed by OBI or its Affiliates and on its payroll, or for cost of collections. Licensed Products shall be considered "sold" when billed or invoiced. 1.28 "Royalty Year" means each twelve month period commencing January 1 and ending December 31 during the term of this Agreement. For the first year of this Agreement, the Royalty Year shall be the period of time between the signing of the Agreement and December 31. 1.29 "Candidate Territory" means the countries of Taiwan R.O.C., China, the territory of Hong Kong, and the ASEAN Secretariat countries, comprising Thailand, Vietnam, Laos, Cambodia, Burma, Thailand, Malaysia, Singapore, Brunei, Indonesia, Philippines, Australia, and New Zealand. 1.30 "Discovery Territory" means worldwide. 2.1 Discovery Licenses . Subject to the terms of this Agreement, OPTIMER hereby grants to OBI: (i) a non-exclusive royalty-bearing license in the Discovery Territory under the OPopS™ Patents in the OPopS™ Field to make, have made, use, sell, have sold, import and develop OPopS™ Products, with the right to grant and authorize sublicenses that do not include the right to grant further sublicenses; and (ii) a non-exclusive royalty-bearing license in the Discovery Territory under the Chemzyme Patents in the Chemzyme Field to make, have made, use, sell, have sold, import and develop Chemzyme Products, with the right to grant and authorize sublicenses that do not include the right to grant further sublicenses. 11 2.2 Candidate Licenses . Subject to the terms of this Agreement, OPTIMER hereby grants to OBI: (i) an exclusive royalty-bearing license in the Candidate Territory under the OPT-22 Patents A in the OPT-22 Field I to make, have made, use, sell, have sold, import and develop OPT-22 Products I, with the right to grant and authorize sublicenses; (ii) an exclusive royalty-bearing license in the Candidate Territory under the OPT-22 Patents B in the OPT-22 Field II to make, have made, use, sell, have sold, import and develop OPT-22 Products II, with the right to grant and authorize sublicenses; (iii) a non-exclusive royalty-bearing license in the Candidate Territory under the OPT-22 Patents A and OPT-22 Patents C in the OPT-22 Field II, and under OPT-22 Patents D in the OPT-22 Field I and OPT-22 Field II, to make, have made, use, sell, have sold, import and develop OPT-22 Products I and OPT-22 Products II, with the right to grant and authorize sublicenses; (iv) an exclusive license royalty-bearing license in the Candidate Territory under the OPT-80 Patents in the OPT-80 Field to make, have made, use, sell, have sold, import and develop OPT-80 Products, with the right to grant and authorize sublicenses. 2.3 OPTIMER shall have the right of first refusal to exclusively license rights to new OPopS™ Products and Chemzyme Products (collectively, "New Candidates") outside of the Candidate Territory arising from OBI's or its sublicensees' exercise of the licenses in Section 2.1. Prior to commercializing or granting rights to any third party with respect to any New Candidates, OBI shall engage in good faith negotiations with OPTIMER for a period not to exceed 30 (thirty) days regarding an exclusive license for the New Candidates. Following such negotiation period, OBI may enter into negotiations with a third party with respect to said New Candidates. Upon arriving at mutually acceptable license terms with a third party, OBI may enter into a formal license agreement with a third party provided that: (1) OBI first presents the terms of such proposed third party license agreement to OPTIMER and offers to enter into an agreement with OPTIMER on the same terms (2) OPTIMER has declined that offer, in writing, after a 14 (fourteen) day evaluation period. 2.4 Notwithstanding any othe | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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