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LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

Development Agreement

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT | Document Parties: PROQUEST PHARMACEUTICALS INC. | GUILFORD PHARMACEUTICALS INC | Kansas Center for Research, Inc You are currently viewing:
This Development Agreement involves

PROQUEST PHARMACEUTICALS INC. | GUILFORD PHARMACEUTICALS INC | Kansas Center for Research, Inc

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Title: LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Governing Law: New York     Date: 3/7/2005
Industry: Biotechnology and Drugs     Law Firm: Shook, Hardy & Bacon LLP    

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT, Parties: proquest pharmaceuticals inc. , guilford pharmaceuticals inc , kansas center for research  inc
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EXHIBIT 10.30 A

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

     THIS LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (the “Agreement”) is made effective as of the 2nd day of March, 2000 (the “Effective Date”) by and between GUILFORD PHARMACEUTICALS INC., a Delaware corporation having its principal place of business at 6611 Tributary St., Baltimore, Maryland, U.S.A. 21224 (“Guilford”), on the one hand, PROQUEST PHARMACEUTICALS INC., a Kansas corporation having an address at 4913 Stoneback Place, Lawrence, Kansas 66047 (“ProQuest”). Guilford and ProQuest are sometimes referred to herein individually as a “Party” and collectively as the “Parties”. References to Guilford and ProQuest shall include their respective Affiliates, as defined herein.

RECITALS

     1. Pursuant to a License Agreement, dated April 2, 1999 (the “KU License”), between ProQuest and the University of Kansas Center for Research, Inc. (“KUCR”), ProQuest holds certain rights with respect to a proprietary compound, PQ-1002, as further described in the attached Schedule 1 (“PQ-1002”), and related intellectual property as further described in the attached Schedule 2, which it is using to develop a pro-drug of propofol, currently marketed for use as an anesthetic.

     2. Guilford possesses research, development and commercialization capabilities sufficient to perform the activities contemplated in this Agreement.

     3. The Parties desire to enter into this Agreement pursuant to which (a) ProQuest shall grant to Guilford an exclusive license to PQ-1002 and certain related compounds; and (b) Guilford agrees to develop and commercialize such products, all on the terms and conditions of this Agreement.

     NOW, THEREFORE, in consideration of the foregoing and of the mutual covenants and agreements hereinafter set forth, the parties hereto agree as follows:

ARTICLE 1. DEFINITIONS

The following capitalized terms shall have the following meanings as used in this Agreement:

      1.1 “Act” shall mean the U.S. Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder.

      1.2 “Affiliate” shall mean a Person that, directly or indirectly, through one or more intermediates, controls, is controlled by, or is under common control with the Person specified.

      1.3 “Agreement Compound” shall mean (i) PQ-1002; (ii) any other compound in ProQuest’s Control on the Effective Date or during the term of this Agreement which is a prodrug of propofol or of a propofol analog; or (iii) any other compound which Guilford (and/or a sublicensee of Guilford’s rights under this Agreement) may derive from ProQuest Patent Rights or ProQuest Know-how and that delivers (A) the propofol nucleus; or (B) a propofol analog. “Propofol analog” as used in this Agreement shall mean any compound that is derived from or

 


 

similar to the propofol nucleus and is intended or expected to have similar pharmacological properties to propofol. “Propofol nucleus” as used in this Agreement shall mean 2,6-di-isopropylphenol.

      1.4 “Bankruptcy Event” shall mean, with respect to a particular Party, that voluntary or involuntary proceedings by or against such Party are instituted in bankruptcy or under any insolvency law, or a receiver or custodian is appointed for such, or proceedings are instituted by or against such Party for corporate reorganization or the dissolution of such Party, which proceedings, if involuntary, shall not have been dismissed within sixty (60) days after the date of filing, or such Party makes an assignment for the benefit of its creditors, or substantially all of the assets of such Party are seized or attached and not released within sixty (60) days thereafter.

      1.5 “Commercialize” or “Commercialization” shall mean those activities relating to the promotion, marketing and sale of any Agreement Compound.

      1.6 “Commercially Reasonable Efforts” shall mean efforts and resources commonly used in the research-based pharmaceutical industry for a product at a similar stage in its product life or similar market potential, taking into account efficacy, the competitiveness of alternative products in the marketplace, the degree of intellectual property protection available for the product (whether to Guilford or to Third Parties), the likelihood of regulatory approval given the regulatory structure involved, the profitability of the product including the royalties payable to licensors of Patent Rights, alternative products and other relevant factors. Commercially Reasonable Efforts shall be determined on a market-by-market basis for a particular product, and it is anticipated that the level of effort will change over time, reflecting changes in the status of the product and the market involved. For the avoidance of doubt, the Parties agree that Guilford (or its Affiliates or sublicensees) may elect not to sell a Program Product in a particular country if there is no patent covering same in such country.

      1.7 “Confidential Information” shall mean with respect to a particular Party, non-public proprietary data, information and/or materials that are owned or licensed in whole or in part by such Party (including, without limitation, the terms and conditions of the KU License, and the proprietary business, patent prosecution, process, technical information and data specified in Section 6.01 of the KU License).

      1.8 “Consent and Agreement” shall mean the Consent and Agreement, dated as of even date hereof, as the same may be amended from time to time, among Guilford, ProQuest and KUCR, the form of which is attached hereto and made a part hereof as Exhibit C .

      1.9 “Controls” or “Controlled” shall mean, with respect to intellectual property, possession of the ability to grant licenses or sublicenses without violating the terms of any agreement or other arrangement with, or the rights of, any Third Party.

      1.10 “Determination Date” shall mean the earlier of (i) the date on or before sixty (60) days following Guilford’s commencement of the Infusion Study contemplated in Section 3.2, or (ii) the date that Guilford delivers written notice to ProQuest and the Escrow Agent as set forth in Section 5.2.

      1.11 “Develop” or “Development” shall mean those activities related to the clinical development of an Agreement Compound including those activities related to the obtainment of Regulatory Approvals for the clinical testing and commercial sale of an Agreement Compound. Development activities will specifically include (i) all activities relating to toxicology, in vitro assays, animal models of clinical efficacy and other studies required to support a Regulatory Filing to initiate clinical testing of an Agreement Compound and (ii) all activities relating to clinical studies and determination of safety and efficacy of an Agreement Compound in humans to support a Regulatory Filing to initiate Commercialization of an Agreement Compound.

      1.12 “Effective Date” shall mean the date of this Agreement first above written.

 


 

      1.13 “Escrow Agreement” shall mean the Escrow Agreement, dated of even date hereof, as the same may be amended from time to time, between Guilford and ProQuest, the form of which is attached hereto and made a part hereof as Exhibit B .

      1.14 “Europe” or “European Country” shall mean, for purposes of Sections 3.3, 5.3(c)(ii) and 8.6, any of the following countries: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, Switzerland and the United Kingdom.

      1.15 “Exclusive Cooperation Field” shall mean the Development of PQ-1002 or any other Agreement Compound, either alone or in combination with any other compound, and irrespective of indication, formulation, or other factors, but only in the field of human pharmaceutical or veterinary applications.

      1.16 “Exclusive License” shall mean an exclusive, worldwide, royalty-bearing license, subject to the University of Kansas’s retained rights under Sections 2.03 and 2.04 of the KU License.

      1.17 “FDA” shall mean the Federal Food and Drug Administration of the United States Department of Health and Human Services or any successor agency thereof.

      1.18 “Force Majeure” shall mean any occurrence beyond the reasonable control of a Party that prevents or substantially interferes with the performance by the Party of any of its obligations hereunder. Without limiting the generality of the foregoing, any of the following: any act of God, flood, fire, explosion, breakdown of plant, earthquake, strike, lockout, labor dispute, casualty or accident, war, revolution, civil commotion, acts of public enemies, blockage or embargo, injunction, law, order, proclamation, regulation, ordinance, demand, regulatory delay, or requirement of any government or of any subdivision, authority or representative of any such government, inability to procure or use materials, labor, equipment, transportation, or energy sufficient to meet manufacturing needs without the necessity of allocation, or clinical, technical, medical, scientific, or manufacturing delays, or any other cause whatsoever, whether similar or dissimilar to those above enumerated, provided that in all such cases it is beyond the reasonable control of such Party, shall constitute Force Majeure.

      1.19 “Governance Committee” shall have the meaning defined in Article 4.

      1.20 “Guilford Know-how” shall mean any and all of Guilford’s techniques and data, including, but not limited to, the identity of and information relating to PQ-1002 or any other Agreement Compound, inventions, practices, methods, knowledge, skill, experience, test data including pharmacological, toxicological, pharmacokinetic and clinical test data, analytical and quality control data, marketing, pricing, distribution, cost, sales, manufacturing, patent and legal data, assays and biological materials relating to PQ-1002 or any other Agreement Compound, and any other information reasonably necessary for Guilford to Develop and Commercialize PQ-1002 or any other Agreement Compound and to otherwise perform its obligations under this Agreement which (i) Guilford discloses to ProQuest under this Agreement or (ii) Guilford Controls on the Effective Date and/or during the term of this Agreement. Guilford Know-how shall exclude Guilford Patent Rights.

      1.21 “Guilford Patent Rights” shall mean the Patent Rights which cover a composition of matter, use, method, process or other matter relating to any Agreement Compound or Program Product, or derived from ProQuest Patent Rights or ProQuest Know-how, which Patent Rights are Controlled by Guilford from and after the Effective Date and during the term of this Agreement.

      1.22 “IND” shall mean an “Investigational New Drug Application,” as defined in the Act, and all supplements thereto, covering an Agreement Compound.

 


 

      1.23 “License Field” shall mean the research, Development or Commercialization or any other use (including manufacture, marketing, sale or distribution), for profit or not-for-profit, of any Agreement Compound, but only for human pharmaceutical or veterinary applications.

      1.24 “Milestones” or “Milestone Payments” shall mean the payments to be made to ProQuest by Guilford upon occurrence of certain events as set forth in Article 5.

      1.25 “NDA” shall mean a “New Drug Application,” as defined in the Act, and all supplements thereto, covering an Agreement Compound.

      1.26 “Net Sales” shall mean gross sales revenues from the sale or other supply of Program Products by Guilford, its Affiliates, sublicensees or non-Affiliated distributors to non-Affiliated Third Parties, less trade discounts (including without limitation, cash discounts, prompt payment or volume discounts, chargebacks from wholesalers, other allowances granted to customers or wholesalers of products and payments to government agencies, whether in cash or trade, rebates, retroactive price reductions or allowances actually allowed or granted from the billed amount), credits or allowances actually granted upon claims, rejections or returns of Program Products (including pursuant to recalls), and sales, value-added and other taxes actually paid based on sales price (when included in gross sales), but not including taxes when assessed on income derived from such sales. In order to insure ProQuest the full royalty payments contemplated hereunder, Guilford agrees that in the event any Program Product is sold or otherwise transferred to an Affiliate or a sublicensee, or to a corporation, firm or association with which Guilford has an arrangement which could result in an artificial reduction in the price paid by such party to Guilford for an Program Product ( e.g ., such purchaser has an option to purchase Guilford’s stock, or has actual ownership of Guilford stock, or an arrangement with Guilford involving division of profits or special rebates or allowances respecting such Program Product) (collectively, “Affiliated Purchasers”), the royalties to be paid hereunder for such Program Product shall be based upon the greater of: (1) the net selling price at which such Affiliated Purchaser resells such Program Product to the end-user; (2) the fair market value of the Program Product being sold at that level of distribution; or (3) the net price paid by such Affiliated Purchaser for Program Product. Notwithstanding anything to the contrary in this Section 1.26, if a Program Product is distributed or invoiced for a discounted price substantially lower than customary in the trade or distributed at no cost to Affiliates or otherwise for bona fide business, scientific or charitable reasons (including without limitation in connection with clinical trials, compassionate sales or an indigent program), Net Sales shall be based on the actual price received (which may be a discounted price, or even $0, if distributed free in such bona fide cases). In the event that Guilford, its Affiliate or its sublicensee sells a Program Product in combination with other active ingredients or substance, the Net Sales for purposes of royalty payments shall be based on the sales revenues received with respect to the sales price of the component(s) consisting of such Program Product, and if such active components are not priced separately, based on such sales price as Guilford or its Affiliate may reasonably allocate to the Program Product included in such combination, subject to the reasonable approval of ProQuest.

      1.27 “Patent Rights” shall mean all patents and patent applications and foreign counterparts thereof, in all cases in any jurisdiction in the world, including any existing or future extensions, registrations, confirmations, reissues, continuations, divisions, substitutions, revalidations, continuations-in-part, re-examinations or renewals of such patent or application, including without limitation Supplementary Protection Certificates or the equivalent thereof.

      1.28 “Person” shall mean any individual, firm, corporation, partnership, limited liability company, trust, unincorporated organization or other entity or a government agency or political subdivision thereto, and shall include any successor (by merger or otherwise) of such Person.

      1.29 “Program Patent Rights” shall mean any ProQuest Patent Rights or Guilford Patent Rights, and includes any Patent Rights, the subject of which is an invention conceived by either Guilford or ProQuest, or by

 


 

Guilford and ProQuest jointly, or by a Third Party on behalf of Guilford and/or ProQuest pursuant to a contractual arrangement, either solely or jointly with Guilford and/or ProQuest, during the term of this Agreement or a 12 month period thereafter, and related to PQ-1002 or any other Agreement Compound.

      1.30 “Program Product” shall mean a product, the manufacture, use, sale, offer to sell or importation of which would (but for a right granted or retained by KUCR, ProQuest, Guilford or a sublicensee or other partner of Guilford) infringe one or more claims of a valid, issued patent included in the Program Patent Rights if any such activities were conducted in (i) the country of sale, (ii) the United States, or (iii) each of Germany, France and the United Kingdom.

      1.31 “ProQuest Know-how” shall mean any and all of ProQuest’s techniques, data and other information relating to PQ-1002 or any other Agreement Compound (including, but not limited to, the identity of and information relating to PQ-1002 or any other Agreement Compound, inventions, practices, methods, knowledge, skill, experience, test data including pharmacological, toxicological, pharmacokinetic and clinical test data, analytical and quality control data, marketing, pricing, distribution, cost, sales, manufacturing, patent and legal data, assays and biological materials, and any other information reasonably necessary for Guilford to Develop and Commercialize PQ-1002 or any other Agreement Compound), which ProQuest Controls on the Effective Date and/or during the term of this Agreement. ProQuest Know-how shall exclude ProQuest Patent Rights.

      1.32 “ProQuest Patent Rights” shall mean Patent Rights which cover a composition of matter, use, method, process or other matter relating to PQ-1002 or any other Agreement Compound, which is owned or Controlled by ProQuest as of the Effective Date or during the term of this Agreement, including any joint interest it may have from time to time in Program Patent Rights, including without limitation the patent applications set forth on Schedule 2 attached hereto.

      1.33 “Regulatory Approval” shall mean any approvals (including, where necessary for the marketing, use or other distribution of a drug in a regulatory jurisdiction, pricing and reimbursement approvals), licenses, registrations, or authorizations or equivalents necessary for the manufacture, use, storage, import, export, clinical testing, transport, marketing, sale and distribution of a Program Product or Agreement Compound in a regulatory jurisdiction anywhere in the world (including without limitation authorization or authority to distribute a drug pursuant to laws, regulations or other permission covering the distribution of drugs on an orphan drug, named patient compassionate sale or similar bases).

      1.34 “Regulatory Filings” shall mean, collectively, INDs, Biologics License Applications, Drug Master Files, NDAs and/or any other comparable filings as may be required by any federal, state or local regulatory agency, department, bureau or other governmental entity, in order to obtain Regulatory Approvals.

      1.35 “Royalty” shall have the meaning defined in Section 6.1 of this Agreement.

      1.36 “Stock Purchase Agreement” shall mean the Stock Purchase Agreement, dated as of even date herewith, as the same may be amended from time to time, between Guilford and ProQuest, the form of which is attached hereto and made a part hereof as Exhibit A .

      1.37 “Third Party” shall mean any Person other than Guilford or ProQuest or their respective Affiliates, including governmental agencies and bodies.

      1.38 “Third Party Royalties” shall mean royalties payable by Guilford, its Affiliates or sublicensees to a non-Affiliate Third Party (or multiple non-Affiliate Third Parties) to make, have made, use, sell, offer for sale or import Agreement Compounds where the royalty payable to such non-Affiliate Third Party is based on Patent Rights owned or Controlled by a Third Party.

 


 

     Capitalized terms not defined in this Article 1 shall have the meaning ascribed to them as set forth in this Agreement below.

ARTICLE 2. EXCLUSIVITY AND LICENSE GRANT

      2.1 Exclusivity. Subject to the terms and conditions of this Agreement, each of Guilford and ProQuest agrees to work exclusively with the other during the term of this Agreement in the Exclusive Cooperation Field, and neither it nor any of its Affiliates will directly or indirectly conduct, have conducted or fund any research, development, regulatory, manufacturing or commercialization activity within the Exclusive Cooperation Field, except as otherwise agreed by the Parties or permitted in this Agreement.

      2.2 License Grant to Guilford. Subject to the terms and conditions of this Agreement, ProQuest hereby grants to Guilford an Exclusive License, including under the ProQuest Patent Rights, to make, have made, use, sell, offer to sell and import PQ-1002, and to the extent any license is necessary to engage in such activities, any other Agreement Compound in the Licensed Field (provided, however, that Guilford shall not be entitled to practice its rights under this Agreement with respect to an Agreement Compound other than PQ-1002 unless and until the Parties have agreed on the appropriate Milestones, Milestone Payments and Royalties for such Agreement Compound, as contemplated in Sections 5.3(d) and 6.4(i) below). Guilford may sublicense, and grant the right to further sublicense, its rights licensed from ProQuest under this Agreement. Guilford shall provide a copy of any such sublicense agreement to ProQuest within thirty (30) days of its effective date. Each such sublicense shall be consistent with the terms of this Agreement, except as may otherwise by agreed in writing by the Parties.

      2.3 Transfer of ProQuest Know-how. ProQuest represents and warrants that no later than ten (10) days following the Effective Date, it will transfer, disclose or otherwise make available to Guilford, or will have transferred, disclosed or made available, all existing ProQuest Know-how for use by Guilford to perform the “Infusion Experiment” contemplated in Section 3.2 below and described in Schedule 3 hereto, and to otherwise Develop and Commercialize PQ-1002. ProQuest further agrees and covenants to promptly transfer, disclose or make available, or have transferred, disclosed or made available, all ProQuest Know-how within its Control, or which it can disclose without breaching a contractual obligation to a Third Party, related to any Agreement Compound during the term of this Agreement to enable Guilford to research, Develop and Commercialize any Agreement Compound.

ARTICLE 3. SCOPE; ALLOCATION OF RESPONSIBILITIES OF THE PARTIES

      3.1 Cooperation Undertaking; Exclusivity. During the term of this Agreement, ProQuest agrees to cooperate with Guilford as Guilford may reasonably request, at Guilford’s expense for ProQuest’s out-of-pocket expenses, in order to enable or facilitate the research, Development and Commercialization by Guilford of PQ-1002 or any other Agreement Compound in accordance with the terms of this Agreement. Without limiting the generality of the foregoing, during the term of this Agreement, ProQuest agrees to promptly disclose to Guilford all ProQuest Patent Rights, and ProQuest Know-how Controlled by it or which ProQuest can disclose to Guilford without breaching a contractual obligation to a Third Party. ProQuest further agrees not to engage in research, Development or Commercialization of Agreement Compound except under this Agreement.

      3.2 Infusion Study. Following mutual execution and delivery of this Agreement, Guilford will conduct or cause to be conducted a preclinical animal chronic infusion study with PQ-1002 in the manner set forth in Schedule 3 attached hereto (the “Infusion Study”). Guilford agrees to use Commercially Reasonable Efforts to commence the Infusion Study as soon as practicable following the Effective Date, but the Parties acknowledge and understand that commencement of the Infusion Study will depend on the availability of Guilford’s contract research

 


 

organization. Guilford agrees to use Commercially Reasonable Efforts to complete the Infusion Study and share any results thereof with ProQuest on or before the Determination Date.

      3.3 Guilford Development and Commercialization Undertaking. During the term of this Agreement, Guilford agrees, using Commercially Reasonable Efforts, to conduct all Development and Commercialization of PQ-1002, whether independently or in collaboration with one or more corporate partners as Guilford may choose in its sole and absolute discretion. Guilford shall have the right to control all aspects of such Development and Commercialization. Specifically, Guilford agrees to use Commercially Reasonable Efforts to:

 

(i)  

commence the first human clinical trial (whether under an IND or otherwise) of PQ-1002 no later than 18 months following the Determination Date; and

 

 

(ii)  

file the first NDA for PQ-1002 no later than the fifth anniversary of the Determination Date.

 

 

     If Guilford in the exercise of Commercially Reasonable Efforts determines that another Agreement Compound is a more desirable candidate for Development or Commercialization than PQ-1002, then Guilford in its sole discretion may elect to Develop and Commercialize such an Agreement Compound in lieu of PQ-1002, in which event Guilford shall use Commercially Reasonable Efforts to so Develop and Commercialize such Agreement Compound (subject to Section 2.2 above and Sections 5.3(d) and 6.4(i) below). Guilford, either directly or through any corporate partner(s) it chooses, shall be responsible for paying all expenses associated with the Development and Commercialization of PQ-1002 (or any other Agreement Compound, if applicable).

     If and when PQ-1002 (or another Agreement Compound, if applicable) has been successfully Developed, Guilford agrees to use its Commercially Reasonable Efforts to obtain the necessary Regulatory Approvals and market it in the United States, Europe and Japan, as well as such other regions and countries as Guilford may deem it commercially reasonable to do so. In so doing, Guilford shall have the right to grant one or more exclusive or non-exclusive marketing, sales, sales agency and/or distribution rights.

      3.4 Regulatory Matters. Without limiting its rights under this Agreement, Guilford in its sole discretion will have complete control, authority, and responsibility for the regulatory strategies adopted for the Development and Commercialization of any Agreement Compound. Guilford will be responsible for and will own all Regulatory Filings and Regulatory Approvals for any Agreement Compound, except as otherwise provided in Section 10.4(b).

      3.5 Manufacturing. Without limiting its rights under this Agreement, Guilford in its sole discretion will have complete control, authority and responsibility for manufacturing of an Agreement Compound, whether directly or through Affiliates, contracted sublicensees or other Third Parties.

      3.6 Hart-Scott Rodino Antitrust Improvements Act of 1976. Each of ProQuest and Guilford shall cooperate with one another in determining whether any filing of notification and report forms under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, is required in connection with the consummation of the transactions contemplated by this Agreement and the Stock Purchase Agreement, and preparing and making any such filing and furnishing information required in connection therewith. If such a filing is required, each Party shall be responsible for preparing and making its own filing, and each Party shall be responsible for paying its own costs and expenses associated with making the filing. Guilford shall be responsible for the fee required to be paid in connection with any such filing.

 


 

ARTICLE 4. GOVERNANCE

      4.1 Governance Committee. The development of PQ-1002 (or another Agreement Compound, if applicable), and the relationship between the Parties, will be periodically reviewed by a Governance Committee which shall be composed of at least five (5) persons, two (2) of whom shall be representatives of ProQuest, and the remainder of which will be representatives of Guilford. Each Party shall, no later than thirty (30) days following the Effective Date, appoint its representatives to the Governance Committee by giving written notice to the other Party. The Governance Committee will be chaired by one representative designated by Guilford. Members of the Governance Committee shall serve in such capacities, on such terms and conditions, and for such duration as shall be determined by the Party appointing same. Each Party may designate an alternate member to serve temporarily in the absence of a permanent member designated by such Party. Each Party may from time to time upon prior written notice change its representative members on the Governance Committee

      4.2 Meetings of the Governance Committee. Unless otherwise agreed by the Parties from time to time, the Governance Committee shall hold meetings at such times and places as shall be determined by the Parties, but in no event shall such meetings be held less frequently than once every calendar quarter, commencing no more than sixty (60) days following the Effective Date. Meetings may be conducted in person or by conference telephone or video conference. Before the conclusion of a meeting, the date and location of the next meeting will be decided by the Parties. The Chairperson may in his/her discretion decide that minutes of the meeting be kept, by designating any attendee to serve as secretary of the meeting.

      4.3 Purpose of the Governance Committee. The Governance Committee shall serve as a forum for overseeing the relationship of the Parties arising out of this Agreement and for jointly reviewing the Development and Commercialization of PQ-1002 (or any other Agreement Compound), and shall perform such other functions as the Parties may agree in order to further the purposes of this Agreement. At least quarterly at a Governance Committee meeting, Guilford will deliver a report on the Development and Commercialization of PQ-1002 (or any other Agreement Compound), and Guilford will (either at such meeting or as a follow up to such meeting) provide such further information (including Guilford Know-how) relating to the Development and Commercialization of PQ-1002 (or any other Agreement Compound) as ProQuest may reasonably request, all subject to Article 7 below.

      4.4 Agendas. Each Party will use Commercially Reasonable Efforts to notify the other at least three (3) business days prior to the date of a meeting of the Governance Committee, proposing the agenda items it wishes to discuss at such meeting. Notwithstanding the foregoing, the Governance Committee shall be free to consider any matter related to this Agreement.

      4.5 Independent Contractors. Subject to the terms of this Agreement, the activities and resources of each Party shall be managed by such Party, acting independently and in its individual capacity and the Parties shall have a relationship of independent contractors with respect to each other. No term or condition of this Agreement is intended to create nor shall any such term or condition create any fiduciary duty on the part of either Party for the benefit of the other, and shall not require either Party to expend either funds or efforts or commit resources other than as explicitly agreed in this Agreement.

ARTICLE 5. FEES AND MILESTONES

      5.1 Payment at Signing. As payment for the entering into of this Agreement and the Stock Purchase Agreement, Guilford shall pay simultaneously with the execution and delivery of this contract (i) by wire transfer of immediately available funds to the account of ProQuest the sum of Five Hundred Thousand Dollars ($500,000) and (ii) by check or wire transfer to the Escrow Agent, the sum of Five Hundred Thousand Dollars ($500,000) which shall be held by the Escrow Agent in accordance with the terms of the Escrow Agreement.

 


 

      5.2 Determination Date. On or before the Determination Date, Guilford shall determine whether it desires to proceed with the Development and Commercialization of an Agreement Compound pursuant to this Agreement and shall provide written instructions to the Escrow Agent advising it of its decision. The Escrow Agent shall, upon such instruction and in accordance with the terms of the Escrow Agreement, release the escrowed funds (i) to ProQuest at a closing to occur no later than ten (10) days after the Determination Date (the “First Closing”) in the event that Guilford desires to proceed or (ii) to Guilford in the event that Guilford does not desire to proceed, provided that in either event, ProQuest shall be entitled to any interest (or other income or gains) earned on the escrowed funds. In the event that Guilford desires to proceed, the $500,000 payment to ProQuest (referred to in Section 5.1(i) above) shall be applied towards the purchase of Common Stock at the First Closing, as set forth in the Stock Purchase Agreement. In the event that Guilford does not desire to proceed, then ProQuest shall retain such $500,000 payment and shall have no obligation to issue Common Stock or convey other property to Guilford with respect to such payment.

      5.3 Milestone Payments.

      (a) Development Milestones for PQ-1002. As additional consideration, Guilford shall pay the following amounts at each Additional Closing (as defined in the Stock Purchase Agreement) to occur after completion of the following development milestones (each a “Milestone”) with respect to PQ-1002 (whether Developed by Guilford or its Affiliate or sublicensee):

 

(i)  

$250,000 upon the Additional Closing following dosing of the first human; and

 

 

(ii)  

$750,000 upon the Additional Closing following dosing of the first patient in a Phase II clinical trial; and

 

 

 

 

(iii)  

$1 million upon the Additional Closing following dosing of the first patient in a Phase III clinical trial.

 

 

     Except as set forth in the Stock Purchase Agreement, all milestone payments set forth above shall be deemed payment for the purchase of ProQuest common stock and, in accordance with the Stock Purchase Agreement, Additional Closings shall be held following achievement of each Milestone. The price per share shares of Common Stock to be issued upon achievement of each Milestone shall be a price per share equal to 110% of the price per share of Common Stock (or conversion price per share of securities convertible into the Company’s Common Stock) issued in the Company’s most recent “Qualified Equity Infusion” (as that term is defined in the Stock Purchase Agreement) prior to the relevant Additional Closing.

      (b) NDA or Equivalent Filing Milestone. Guilford shall pay to ProQuest $2 million following submission of an NDA (or equivalent application for Regulatory Approval) which would enable the general marketing of PQ-1002 in a particular country. Of this $2 million, $1 million shall be paid as cash within five (5) business days following achievement of this Milestone, and, except as otherwise set forth in the Stock Purchase Agreement, $1 million shall be deemed payment for the purchase of ProQuest common stock upon the achievement of this Milestone, payable at an Additional Closing in accordance with the Stock Purchase Agreement.

      (c) NDA or Equivalent Approval Milestone. Guilford shall pay the following amounts in cash (which shall not be deemed payment towards a purchase of ProQuest common stock) to ProQuest within five (5) business days following achievement of the following Milestones for an Agreement Compound (whether by Guilford or its Affiliates or sublicensees) in the following territories:

 


 

 

(i)  

$5 million upon receipt of NDA clearance and any other Regulatory Approvals needed to enable the marketing and selling of PQ-1002 generally in the United States;

 

 

(ii)  

$3 million upon receipt of all final Regulatory Approvals needed from the first European Country to enable the marketing and selling of PQ-1002 generally in that European Country; and

 

 

 

 

(iii)  

$1 million upon receipt of all final Regulatory Approvals needed to enable the marketing and selling of PQ-1002 generally in Japan.

 

 

      (d) Milestone Payments for Other Agreement Compounds. If Guilford desires to Develop any other Agreement Compound in lieu of or in addition to PQ-1002, the Parties must first agree in writing on any Milestone Payments for the Development of such Agreement Compound.

      (e) Notification of Milestones. No later than five (5) business days following the achievement of each Milestone, Guilford shall notify ProQuest in writing that such Milestone has occurred.

ARTICLE 6. ROYALTIES

      6.1 Royalties. Guilford agrees to pay ProQuest a running royalty on worldwide Net Sales of PQ-1002 (“Royalty”) in the following amounts:

 

(i)  

five percent (5%) of Net Sales on the first One Hundred Million Dollars ($100,000,000) in worldwide Net Sales in any calendar year;

 

 

(ii)  

seven percent (7%) on the next One Hundred Million Dollars ( i.e. , between $100,000,000 and $200,000,000) in worldwide Net Sales in any calendar year; and

 

 

 

 

(iii)  

nine percent (9%) on all amounts of worldwide Net Sales in excess of Two Hundred Million Dollars ($200,000,000) in any such calendar year.

 

 

      6.2 Third Party Royalty Credit . On a country by country basis, fifty percent (50%) of any Third Party Royalties paid by Guilford will be creditable against Royalties payable to ProQuest under this Agreement. Credit for Third Party Royalties will be made on a quarterly basis; provided, however, that no such credit shall reduce the amount of Royalties paid by Guilford for a particular calendar quarter by more than 50%.

      6.3 Term of Royalty. Royalty will be payable on a country by country basis until the last to expire of the patent or patents in such country covering PQ-1002, and, in a country where no patent ever issued covering PQ-1002, then until the last to expire of the patent or patents in the U.S., France, Germany or the United Kingdom covering PQ-1002.

      6.4 Reports and Payments.

      (a) Cumulative Royalties. The obligation to pay Royalties under this Article 6 shall be imposed only once (i) with respect to any sale of the same unit of Program Product; and (ii) with respect to a single unit of Program Product regardless of how many valid issued or, assuming they were to issue, patent claims included in Program Patent Rights would be infringed by Third Parties by the making, using or selling of such Program Product.

      (b) Statements and Payments. Guilford shall deliver to ProQuest within sixty (60) days after the end of

 


 

each calendar quarter, a statement certified by Guilford as accurate to the best of its ability based on information available to Guilford, setting forth for the previous quarter the following information on a country-by-country basis: (i) Net Sales of Program Products; (ii) the basis for any Royalty adjustments; and (iii) the Royalty due hereunder, which report shall be accompanied by a remittance of the Royalty due.

      (c) Interest. If Guilford fails to pay undisputed Royalty within fifteen (15) days of the date such Royalty is due, Guilford shall pay interest on the amount of such overdue Royalty (from the original due date) at the rate of 10% per annum until it is paid in full. If any disputed Royalty withheld by Guilford is later determined to have been properly owing as of the original due date, Guilford shall likewise pay interest on the amount of such Royalty withheld at such interest rate from the original due date until date of payment.

      (d) Taxes. All taxes levied on account of Royalties accruing under this Agreement shall be paid by ProQuest. If laws or regulations require withholding of taxes from any payment by Guilford to ProQuest hereunder, the taxes will be deducted by Guilford from remittable Royalty to ProQuest and will be paid by Guilford to the proper taxing authority. Guilford will furnish ProQuest with the original copies of all official receipts for such taxes. In the event of any such withholding, the Parties agree to confer and cooperate in good faith regarding any filings with tax authorities and other measures that may be taken to minimize the amount of any such withholding.

      (e) Currency. All amounts payable and calculations hereunder shall be in United States dollars, and all payments under this Article 6 shall be made to ProQuest. As applicable, Net Sales shall be translated into United States dollars at the rate of exchange at which United States dollars are listed in International Financial Statistics (publisher, International Monetary Fund) or if it is not available, The Wall Street Journal for the currency of the country in which the sale is made at the average of the calendar quarter in which such sales were made.

      (f) Audit. Guilford shall maintain (and shall cause its Affiliates and sublicensees to maintain) books and records as necessary to allow the accurate calculation of Royalties due hereunder including any records required to calculate any Royalty adjustments hereunder. Once per yea


 
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