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EXHIBIT 10.1 LICENSE AGREEMENT

License Agreement

EXHIBIT 10.1 LICENSE AGREEMENT 

     
 | Document Parties: ADVENTRX PHARMACEUTICALS INC | SD Pharmaceuticals, Inc | Theragenex, LLC You are currently viewing:
This License Agreement involves

ADVENTRX PHARMACEUTICALS INC | SD Pharmaceuticals, Inc | Theragenex, LLC

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Title: EXHIBIT 10.1 LICENSE AGREEMENT
Governing Law: California     Date: 10/23/2006
Industry: Biotechnology and Drugs     Law Firm: Wilson Sonsini Goodrich & Rosati, P.C.; Hutchison Law Group PLLC    

EXHIBIT 10.1 LICENSE AGREEMENT 

     
, Parties: adventrx pharmaceuticals inc , sd pharmaceuticals  inc , theragenex  llc
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EXHIBIT 10.1

LICENSE AGREEMENT

     This License Agreement (this “ Agreement ”), executed as of October 20, 2006 (the “ Effective Date ”), between ADVENTRX Pharmaceuticals, Inc., a Delaware corporation, through its wholly-owned subsidiary SD Pharmaceuticals, Inc., Delaware corporation (“ ADVENTRX ”), and Theragenex, LLC., a North Carolina limited liability company (“ THERAGENEX ”). ADVENTRX and THERAGENEX may be referred to individually by name as a “ Party ” or collectively as the “ Parties .”

BACKGROUND

A.

 

ADVENTRX holds certain patent rights, as described in more detail below, that may be useful in the prevention, treatment and/or mitigation of virus-mediated diseases, including but not limited to common cold, influenza and herpes; and

 

 

 

B.

 

WHEREAS, THERAGENEX desires to acquire an exclusive license under such patent rights, all on the terms and conditions as set forth herein below.

     NOW, THEREFORE, in consideration of the mutual covenants and agreements provided herein below, ADVENTRX and THERAGENEX hereby agree as follows:

Article 1. DEFINITIONS .

     For purposes of this Agreement, the following definitions shall be applicable:

     1.1 “ Active Ingredient ” means any chemical or biological entity that is a Cationic Polymer, Cationic Surfactant, and/or a Multivalent Metal Component, whether or not such chemical or biological entity is labeled as an active ingredient in a given Licensed Product.

          (a) “ Cationic Polymer ” means any positively charged, pharmacologically acceptable molecule formed of repeating units (including homopolymers, co-polymers, and heteropolymers), which may be linear, branched or crosslinked.

          (b) “ Cationic Surfactant ” means any positively charged compound capable of lowering surface tension of a liquid.

          (c) “ Multivalent Metal Component ” means any compound or composition that may release a multivalent metal cation.

     1.2 “ Affiliate ” means any entity directly or indirectly controlled by, controlling, or under common control with, a Party, but only for so long as such control shall continue. For purposes of this definition, “ control ” (including, with correlative meanings, “controlled by”, “controlling” and “under common control with”) of an entity means possession, direct or indirect, of (i) the power to direct or cause direction of the management and policies of such entity (whether through ownership of securities or other ownership interests, by partnership, contract or otherwise), or (ii) more than

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fifty percent (50)% of the voting securities (whether directly or beneficially) or other comparable equity interests of such entity.

     1.3 “ ADVENTRX Patent Rights ” means: (i) the patents and patent applications identified on Exhibit A ; and (ii) any continuation, continuation-in-part (but only to the extent such continuation-in-part covers the subject matter of the patents and patent applications identified on Exhibit A and does not cover any new subject matter), division, substitution, and patent of addition of the patents and patent applications listed in part (i) above, together with all registrations, reexaminations, extensions (including extensions under the United States Patent Term Restoration Act) or reissues thereof.

     1.4 “ Business Day ” means a day other than a Saturday, Sunday, bank or other public holiday in New York, New York.

     1.5 “ Calendar Quarter ” means each of the four (4) three (3)-month periods beginning on January 1 st , April 1 st , July 1 st and October 1 st , respectively.

     1.6 “ Control ” means, with respect to particular Technology or a particular Patent, possession by ADVENTRX of the ability, whether arising by ownership, license, or otherwise, to disclose and deliver the particular Technology to THERAGENEX, and to grant and authorize under such Technology or Patent the right or license, as applicable, of the scope granted to THERAGENEX in this Agreement without, in the case of licensed Technology or Patents, violating the terms of any written agreement between ADVENTRX and the owner or licensor thereof. “ Controlled ” and “ Controlling ” shall have their correlative meanings.

     1.7 “ Cover ” means, with respect to any subject matter, the development, manufacture, use, sale, offering for sale, importation, exportation or other exploitation of such subject matter would, but for the rights or licenses granted under this Agreement, infringe a Valid Claim of the ADVENTRX Patent Rights. As used in this Section 1.7, “infringe” shall include contributorily infringing or inducing the infringement of such Valid Claim. For clarity with respect to a Valid Claim within a patent application, “Cover” includes infringing a Valid Claim in such patent application assuming such application were an issued patent. “ Covered ” or “ Covering ” shall have their correlative meanings.

     1.8 “ FDA ” means the United States Food and Drug Administration and any successor agency thereto.

     1.9 “ FDCA ” means the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder.

     1.10 “ Field ” means any and all fields.

     1.11 “ Homeopathic Pharmacopoeia ” means the Homeopathic Pharmacopoeia of the United States (HPUS) as published by the Homeopathic Pharmacopoeia of the United States (HPCUS) and any successor agency thereto, and that is approved under the FDCA.

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     1.12 “ Governmental Authority ” means any court, agency, department, authority or other instrumentality of any multi-national, national, state, county, city or other political subdivision.

     1.13 “ Launch ” means, with respect to a Licensed Product, the first shipment of such Licensed Product for commercial sale anywhere in the Territory by THERAGENEX, its Affiliates or Sublicensees to an unaffiliated Third Party.

     1.14 “ Law ” or “ Laws ” means all applicable laws, statutes, rules, regulations, orders, judgments and/or ordinances of any applicable Governmental Authority.

     1.15 “ Licensed Product ” means any product which is Covered by the ADVENTRX Patent Rights. One Licensed Product shall be deemed different from another Licensed Product, even if they have substantially the same composition, if they differ in (a) the medical or disease condition(s) for which they are labeled or (b) consumer accessibility. For purposes of clarification, Licensed Products shall be deemed to differ in consumer accessibility if such Licensed Products differ in any one or more of the following methods of accessibility by consumers (in which case each such difference shall constitute a separate Licensed Product): (x) by the consumer directly (“off the shelf” or “over the counter”), (y) with the assistance of personnel at the location at which such product is purchased (“behind the counter”) or (z) by prescription.

     1.16 “ Marketing Approval ” means with respect to a Licensed Product in a particular jurisdiction, all approvals, licenses, registrations or authorizations necessary for the marketing of such Licensed Product in such jurisdiction (e.g., approval in the United States by the FDA of a NDA for a Licensed Product or satisfaction of the applicable conditions and requirements to market a Licensed Product under an OTC Monograph or under the Homeopathic Pharmacopoeia).

     1.17 “ NDA ” means a New Drug Application, as more fully defined in 21 C.F.R. §314.50 et. seq.

     1.18 “ Net Sales ” means, with respect to each Licensed Product, the gross amount invoiced for sales of THERAGENEX, its Affiliates and Sublicensees (each, a “ Selling Party ”) of such Licensed Product to an unaffiliated Third Party, less (i) actual bad debts related to such Licensed Product and (ii) credits for sales returns and allowances actually paid, granted or accrued, (iii) normal and customary trade, quantity and cash discounts and any other adjustments actually allowed and taken with respect to such invoiced amounts, including granted on account of price adjustments, billing errors, damaged or defective goods, recalls, returns, rebates, chargeback rebates, reimbursements or similar payments granted or given to wholesalers or other distributors, (iv) customs or excise duties, sales tax, consumption tax, value added tax, and other taxes (except income taxes) or duties relating to sales in each case invoiced as a specific line item in an invoice (to the extent such taxes are actually incurred by the Selling Party, and are not reimbursable, refundable or creditable to the Selling Party) and (v) freight and insurance levied on the invoiced amount in each case invoiced as a specific line item in an invoice (to the extent that the Selling Party actually incurs the cost of freight and insurance for a Licensed Product and are not reimbursable, refundable or creditable to the Selling Party), in each case as determined from books and records of the Selling

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Party maintained in accordance with generally acceptable accounting principles in the United States, consistently applied.

     1.19 “ OTC Monograph ” means an over-the counter drug monograph, as more fully described in 21 C.F.R. §330 et. seq.

     1.20 “ Patent ” means any of the following, whether existing now or in the future anywhere in the world: (i) any issued patent, including without limitation inventor’s certificates, utility model, substitutions, extensions, confirmations, reissues, re-examination, renewal or any like governmental grant for protection of inventions; and (ii) any pending application for any of the foregoing, including without limitation any continuation, divisional, substitution, additions, continuations-in-part, provisional and converted provisional applications.

     1.21 “ Regulatory Authority ” means any Governmental Authority with authority over the discovery, development, commercialization or other use or exploitation (including the granting of Marketing Approvals) of Licensed Products in any jurisdiction, including the FDA, the European Medicines Evaluation Agency, and the Ministry of Health, Labor and Welfare in Japan.

     1.22 “ Regulatory Filing ” shall mean any filing or application with any Regulatory Authority, including Investigational New Drug Applications and NDAs and their equivalents in jurisdictions other than the United States, and authorizations, approvals or clearances arising from the foregoing, including Marketing Approvals, and all correspondence with the FDA or other relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the FDA or other Regulatory Authority, in each case with respect to Licensed Products.

     1.23 “ Royalty Term ” means, on a Licensed Product-by-Licensed Product basis, the period commencing on the date of the first commercial sale of such Licensed Product by THERAGENEX, its Affiliates, or Sublicensees and ending on the later of (i) latest date on which such Licensed Product is Covered by a Valid Claim or (ii) twenty (20) years from the date of the first commercial sale of such Licensed Product by THERAGENEX, its Affiliates, or Sublicensees.

     1.24 “ Sublicensee ” means any Third Party to whom THERAGENEX has granted the right, directly or indirectly, to (i) make and sell any Licensed Product or (ii) sell any Licensed Product.

     1.25 “ Technology ” means technical information and materials comprising (i) ideas, discoveries, inventions (to the extent that disclosure thereof would not result in loss or waiver of privilege or similar protection), improvements or trade secrets, (ii) research and development data, such as preclinical data, pharmacology data, chemistry data (including analytical, product characterization, manufacturing, and stability data), toxicology data, clinical data, statistical analyses, expert opinions and reports, safety and other electronic databases), analytical and quality control data and stability data, in each case together with supporting data, (iii) practices, methods, techniques, specifications, formulations, formulae, knowledge, (iv) techniques, processes, manufacturing information, (iv) research materials, reagents and compositions of matter, including

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biological material and (v) compositions of matter. Technology shall not include any Patent rights with respect thereto.

     1.26 “ Term ” means the period commencing on the Effective Date and, unless earlier terminated as herein provided, ending on the last to expire Royalty Term.

     1.27 “ Territory ” means the United States of America (including its territories and possessions).

     1.28 “ Third Party ” means any entity other than ADVENTRX, THERAGENEX or their respective Affiliates.

     1.29 “ Valid Claim ” means a claim of any issued, unexpired patent or a claim of a pending patent application within the ADVENTRX Patent Rights which has not been dedicated to the public, disclaimed, abandoned or held invalid or unenforceable by a Governmental Authority of competent jurisdiction in a decision from which no appeal can be taken or is otherwise not taken.

Article 2. LICENSE GRANT .

     2.1 Exclusive Licenses . Subject to the terms and conditions of this Agreement, ADVENTRX hereby grants to THERAGENEX an exclusive license under the ADVENTRX Patent Rights to develop, make, have made, use, sell, offer for sale, and import Licensed Products in the Field in the Territory (the “ License ”). THERAGENEX shall have the right to exercise such License through its Affiliates solely for as long as such entity remains an Affiliate of THERAGENEX, and THERAGENEX shall remain responsible for the compliance of such Affiliate with the applicable terms of this Agreement.

     2.2 Sublicenses .

          (a) The License includes the right to sublicense (a “ Sublicense ”) within the scope thereof; provided however that: (i) each sublicense agreement shall be subject to the prior written approval of ADVENTRX, such approval not to be unreasonably withheld, (ii) each sublicense shall include all of the applicable terms and conditions from this Agreement; and (iii) THERAGENEX shall promptly provide ADVENTRX a copy of the final executed version of each such sublicense agreement, redacted for information not pertinent to this Agreement.

          (b) THERAGENEX shall be responsible for the failure by its Sublicensees to comply with, and THERAGENEX guarantees the compliance by each of its Sublicensees with, all relevant restrictions, limitations and obligations in this Agreement.

          (c) In the event of a material default by any Sublicensee under a sublicense agreement, THERAGENEX shall take such action that in THERAGENEX’s reasonable business judgment is required to remedy such default.

          (d) If this Agreement is terminated pursuant to Section 9.2, all Sublicenses shall survive such termination to the extent provided in such Sublicenses; provided that such Sublicensees

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agree, in writing with ADVENTRX, to the same obligations of THERAGENEX hereunder, including without limitation to the diligence obligations described in Section 3.2 and the milestone and royalty payments described in Article 4.

     2.3 No Further Rights . Each Party acknowledges that the rights and licenses granted under this Article 2 and elsewhere in this Agreement are limited to the scope expressly granted. Accordingly, except for the rights expressly granted under this Agreement, no right, title, or interest of any nature whatsoever is granted whether by implication, estoppel, reliance, or otherwise, by either Party to the other Party. All rights with respect to Technology, Patents or other intellectual property rights that are not specifically granted herein are reserved to the owner thereof.

     2.4 Exclusivity of Efforts . Except for the conduct of activities directed toward the development and commercialization of Licensed Products in accordance with this Agreement, during the Term and for twelve (12) months thereafter THERAGENEX agrees on its behalf and on behalf of its Affiliates (i) not to conduct, participate in or sponsor, directly or indirectly, inside or outside of the Territory, any activities directed toward the development or commercialization of any product containing an Active Ingredient, for an indication or market segment for which THERAGENEX has already Launched a Licensed Product hereunder (collectively, such activities “ Competing Activities ”) or (ii) appoint, license or otherwise authorize any Third Party, whether pursuant to such license, appointment, or authorization or otherwise to perform any Competing Activities.

Article 3. THERAGENEX RESPONSIBILITIES AND DILIGENCE .

     3.1 Responsibilities . Subject to Section 3.2, THERAGENEX shall fund, take the lead and be solely responsible for conducting the development of Licensed Products, including clinical trials, as may be reasonably necessary to expeditiously obtain Marketing Approvals for Licensed Products for applications in the Field throughout the Territory. Further, THERAGENEX shall fund, take the lead and be solely responsible for commercialization of Licensed Products in the Field throughout the Territory. Without limiting the foregoing, THERAGENEX agrees to launch Licensed Products in the Field in the Territory as soon as reasonably practicable, and thereafter to use commercially reasonable efforts to market, promote and sell such Licensed Products for multiple market segments and indications in the Field in the Territory so as to maximize Net Sales with respect thereto. It is understood and agreed that all development and commercialization efforts for the Licensed Products in the Field in the Territory shall be at the sole expense of THERAGENEX.

     3.2 Diligence Milestones . THERAGENEX shall meet each of the following minimum development and commercialization milestones (each, a “ Diligence Milestone ”):

          (a) Launch a Licensed Product on or before December 31, 2007.

          (b) Launch a second Licensed Product on or before December 31, 2008.

If THERAGENEX fails to meet either of the Diligence Milestones set forth above within the applicable time period, as such time period may be extended pursuant to Section 3.2(c), such failure

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shall be deemed a material breach of this Agreement and, accordingly, ADVENTRX may terminate this Agreement pursuant to Section 9.2(a).

          (c) In the event that THERAGENEX is not able to achieve a Diligence Milestone by the milestone achievement date set forth above, it shall promptly inform ADVENTRX, and provided that THERAGENEX has been and continues at all times working diligently toward the achievement of such Diligence Milestone, THERAGENEX shall be entitled to require ADVENTRX to extend the milestone achievement date by one additional six (6) month period for each Diligence Milestone. In this event, for each milestone achievement date so extended, THERAGENEX shall pay to ADVENTRX within fifteen (15) days of the original milestone achievement date a payment in the amount of Five Hundred Thousand Dollars ($500,000).

     3.3 Conference Call Updates; Reports .

          (a) THERAGENEX shall make reasonably available during normal business hours, on a quarterly basis, its representatives responsible for the development and commercialization of Licensed Products for conference calls with ADVENTRX’s representatives, during which THERAGENEX shall describe, in reasonable detail, the progress made in the development and commercialization of Licensed Products. In addition, THERAGENEX shall provide a written report to ADVENTRX in reasonable detail on an annual basis regarding the development, commercialization and other activities taken since the last such report and plans for the Licensed Products for the upcoming twelve (12) months (each such report, an “ Update Report ”). The Update Reports shall be deemed THERAGENEX Confidential Information provided it is marked “CONFIDENTIAL” or marked with another similar legend.

          (b) If within twenty (20) Business Days after receipt of an Update Report ADVENTRX would like to request a meeting with representatives of THERAGENEX to discuss such report, then ADVENTRX may notify THERAGENEX of such request, and the Parties shall meet at the offices of ADVENTRX, or such other mutually agreed upon location, within thirty (30) days of THERAGENEX’s receipt of such request from ADVENTRX. At such meeting THERAGENEX shall make reasonably available its representatives responsible for the applicable activities and plans in the Update Report for discussion and to answer questions from ADVENTRX’s representatives regarding the Licensed Products. In no event may THERAGENEX be required to attend more than one (1) such meeting for any Update Report.

Article 4. PAYMENTS AND ROYALTIES .

     4.1 Upfront Payment . In partial consideration of the License and other rights granted hereunder, THERAGENEX shall make a non-creditable, non-refundable upfront payment to ADVENTRX of One Million Dollars ($1,000,000). The first half payment of $500,000 is due 70 days after closing of the agreement (December 31, 2006), the second half payment is due 6 months thereafter (June 30 2007).

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     4.2 Milestone Payments . In further consideration of the License and other rights granted hereunder, THERAGENEX shall make a non-creditable, non-refundable milestone payment of One Million Dollars ($1,000,000) to ADVENTRX upon the Launch of each Licensed Product within forty-five (45) days after such Launch.

     4.3 Royalty Payments .

     (a) In addition to the payments under Sections 4.1 and 4.2, THERAGENEX shall pay to ADVENTRX each Calendar Quarter, in consideration of the License and other rights granted herein, the following royalty payments on the aggregate Net Sales of Licensed Products made during such Calendar Quarter (the “ Royalty Payments ”):

 

 

 

 

 

Quarterly Net Sales

 

Royalty on Net Sales

That portion of aggregate Net Sales of all Licensed Products up to and including Two Million Five Hundred Thousand Dollars ($2,500,000)

 

 

15

%

 

 

 

 

 

That portion of aggregate Net Sales of all Licensed Products in excess of Two Million Five Hundred Thousand Dollars ($2,500,000)and up to and including Three Million Seven Hundred Fifty Thousand Dollars ($3,750,000)

 

 

18

%

 

 

 

 

 

That portion of aggregate Net Sales of all Licensed Product in excess of Three Million Seven Hundred Fifty Thousand Dollars ($3,750,000)

 

 

20

%

     For purposes of the foregoing, “aggregate Net Sales” of all Licensed Products shall mean the aggregate Net Sales of all types and formulations of Licensed Products made within the particular Calendar Quarter. In the event THERAGENEX and ADVENTRX determine that Patent rights or Technology of a Third Party is necessary to make or sell a Licensed Product in the Territory, the Parties will discuss a reduction in the royalty rates set forth above, if any.

          (b) The Royalty Payments for a Licensed Product shall continue until the expiration of the Royalty Term, and thereafter the License shall become, royalty-free, non-exclusive and perpetual for such Licensed Product.

Article 5. ACCOUNTING AND PROCEDURES FOR PAYMENT .

     5.1 Inter-Company Sales . Sales between or among THERAGENEX, its Affiliates or Sublicensees shall not be subject to Royalty Payments; Royalty Payments shall only be calculated upon Net Sales to an unaffiliated Third Party. THERAGENEX shall be responsible for payments on Net Sales by its Affiliates and Sublicensees.

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     5.2 Currency . All Royalty Payments shall be computed and paid in United States dollars. For the purposes of determining the amount of Royalty Payments due for the relevant Calendar Quarter, the amount of Net Sales in any foreign currency shall be converted into United States dollars at the spot rate of exchange published by The Board of Governors of the Federal Reserve System in Statistical Release H.10 (http://www.federalreserve.gov/releases/H10) for the date that is five (5) Business Days before the date payment is due.

     5.3 Royalty Payments . Royalty Payments by THERAGENEX are due and payable by the 45th day after the end of each Calendar Quarter, and each payment shall be accompanied by a report identifying in the aggregate and on a Licensed Product-by-Licensed Product basis: (i) total gross amount invoiced for sales of Licensed Products by THERAGENEX and its Affiliates and Sublicensees; (ii) amounts deducted by category (e.g., normal and customary trade, quantity and cash discounts actually allowed and taken with respect to such invoiced amounts) from gross amounts invoiced to calculate Net Sales; (iii) Net Sales and (iv) royalties payable. Said reports shall be deemed THERAGENEX Confidential Information.

     5.4 Method of Payments . All payments hereunder shall be made by electronic transfer in immediately available funds via a bank wire transfer, or any other means of electronic funds transfer, at THERAGENEX’S election, to such bank accounts as ADVENTRX shall designate in writing at least five (5) Business Days before the payment is due. All payments under this Agreement shall bear interest from the date due until paid at a rate equal to the thirty (30) day U.S. Dollar LIBOR rate effective for the date that payment was due, as published by The Wall Street Journal , Eastern U.S. Edition, on the date such payment was due, plus two percent (2%).

     5.5 Inspection of Records . THERAGENEX shall, and shall cause its Affiliates and Sublicensees to, keep full and accurate books and records setting forth gross amounts invoiced for each Licensed Product, Net Sales of each Licensed Product, itemized deductions from gross amounts invoiced to calculate Net Sales and amounts payable hereunder to ADVENTRX for each such Licensed Product. THERAGENEX shall permit ADVENTRX, by independent certified public accountants retained by ADVENTRX and reasonably acceptable to THERAGENEX, to examine such books and records at THERAGENEX at any reasonable time upon prior written request, but not later than three (3) years following the rendering of any corresponding reports, accountings and payments pursuant to Section 5.3. The foregoing right of review may be exercised only once during each twelve (12) month period; provided, however, that if a review uncovers an underpayment by THERAGENEX of Royalty Payments of more than five percent (5%) such review shall not count as an exercise of such right of review. Such accountants may be required by THERAGENEX to enter into a reasonably acceptable confidentiality agreement, and in no event shall such accountants disclose to ADVENTRX any information other than such as relates to the accuracy of reports and payments made or due hereunder. The opinion of said independent accountants regarding such reports, accountings and payments shall be binding on the Parties other than in the case of clear error. ADVENTRX shall bear the cost of any such review; provided that if the review shows an underpayment of Royalty Payments of more than five percent (5%) of the amount due for the applicable period, then THERAGENEX shall promptly reimburse ADVENTRX for all costs incurred in connection with such review. THERAGENEX shall promptly pay to ADVENTRX the amount of any underpayment of Royalty Payments revealed by a review. ADVENTRX’s review

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rights under this Section 5.5 shall survive for a period of three (3) years after any termination or expiration of this Agreement.

     5.6 No Withholding Taxes . Unless reimbursable to ADVENTRX as a reduction in U.S. tax liability, all payments required to be made pursuant to this Agreement shall be without deduction or withholding for or on account of any taxes or similar governmental charge. Such taxes are referred to herein as “Withholding Taxes” and such Withholding Taxes shall be the sole responsibility of THERAGENEX. THERAGENEX shall provide a certificate evidencing payment of any Withholding Taxes under this Agreement. It is understood and agreed that all payment obligations rest solely on THERAGENEX, a North Carolina limited liability company, and that all payments due under this Agreement shall be made by THERAGENEX, a North Carolina limited liability company to ADVENTRX, a Delaware corporation. As a result, the Parties anticipate that no Withholding Taxes will be assessed against THERAGENEX on ADVENTRX’s behalf.

Article 6. PATENTS AND INFRINGEMENT .

     6.1 Prosecution and Maintenance . As between the Parties, ADVENTRX shall have the right to control the Prose


 
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