Preview of our top selling Collaboration Agreement
Johnson & Johnson / GTX - Joint Collaboration & License Agreement
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
EXHIBIT 10.24
JOINT COLLABORATION AND LICENSE AGREEMENT
THIS JOINT COLLABORATION AND LICENSE AGREEMENT (the "Agreement") is made effective as of the 16th day of March, 2004 (the "Effective Date") by and between GTx, Inc., a Delaware corporation having its principal place of business at 3 North Dunlap St., 3rd Floor, Memphis, Tennessee 38163 ("GTx") and Ortho Biotech Products L.P., a limited partnership having its principal place of business at Route 22 East, Bridgewater, NJ 08807 ("Ortho"), each on behalf of itself and its Affiliates. GTx and Ortho are sometimes referred to herein individually as a "Party" and collectively as the "Parties", and references to "GTx" and "Ortho" shall include their respective Affiliates.
RECITALS
Ortho is a wholly owned subsidiary of Johnson & Johnson, a multinational healthcare company with research, development and marketing activities worldwide, which desires to obtain additional potential drug products for osteoporosis and wasting, and possible other indications.
GTx is a men's healthcare company, which is developing compounds, including Andarine, an orally active, non-steroidal, selective androgen receptor modulator (SARM). GTx has conducted several Phase I clinical trials of Andarine and is planning Phase II and III clinical trials of such compound.
The Parties desire to develop and commercialize Andarine and possibly other specified SARM compounds throughout the world.
ARTICLE I
DEFINITIONS
The following terms shall have the following meanings as used in this Agreement:
1.1 "Active Ingredient" means the material(s) in the Collaboration Product which provide its pharmacological activity.
1.2 "Additional Collaboration Compound" means any Collaboration Compound selected for Development other than, and in addition to, Andarine or a Replacement Collaboration Compound for Andarine.
1.3 "Affiliate" means an entity that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with GTx or Ortho. For the purposes of this definition, the term "control" (including, with correlative
meanings, the terms "controlled by" and "under common control with") as used with respect to a Party, shall mean the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such person or entity, whether through the ownership of voting securities, by contract or otherwise.
1.4 "Andarine" means [ * ], and [ * ] that have the activity described in Section 1.36(2).
1.5 "Business Day" means a day on which banking institutions in New York, NY are open for business.
1.6 "Clinical Studies" means human studies designed to measure the Safety, efficacy, Tolerability and appropriate dosage of a Collaboration Compound and/or Collaboration Product. Clinical Studies includes Phase I Clinical Trial, Phase IIA Clinical Trial, Phase IIB Clinical Trial, Phase III Clinical Trial, Phase IIIB Clinical Trial, and Phase IV Clinical Trial, as defined herein.
1.7 "Collaboration Compound" means (i) initially, Andarine and (ii) any other GTx SARM Compound selected by Ortho for Development pursuant to this Agreement. Collaboration Compounds include without limitation Additional Collaboration Compounds and Replacement Collaboration Compounds.
1.8 "Collaboration Product" means a drug product for use in humans in a form suitable for sale to an end user and/or for use in conducting Clinical Studies, containing as an Active Ingredient at least one Collaboration Compound.
1.9 "Combination Product" means (i) any pharmaceutical product that consists of a Collaboration Product that also contains another Active Ingredient that is not a Collaboration Compound, or (ii) any combination of a Collaboration Product and another pharmaceutical product that is not a Collaboration Product where such products are not formulated together but are sold together for a single invoiced price.
1.10 "Commercialization Activities" means activities relating to the manufacture of a Collaboration Product for sale to end users, or to the marketing and sale of a Collaboration Product, including Pre-Marketing activities, which in the Co-Promotion Territory is undertaken pursuant to a Marketing and Sales Plan.
1.11 "Confidential Information" shall have the meaning set forth in Section 9.1.
1.12 "Control" or "Controlled" means the possession of the right to grant a license or sublicense to intangible property rights (including patent rights, know-how and/or trade secret information), and the right to provide access to or cross-reference to regulatory filings or other data or information, in each case to the extent not in violation of the terms of any pre-existing agreement or other arrangement with any Third Party. "Control" expressly includes the right of ownership, in whole or in part, unless the Party having such right is restricted by contract or under law from granting such a license, access or right to reference.
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1.13 "Co-Promotion" shall have the meaning set forth in Article VI, and "Co-Promote" shall have a correlative meaning.
1.14 "Co-Promotion Territory" means the United States, but only after GTx exercises its option to Co-Promote a Collaboration Product to the GTx Audience, on a Collaboration Product by Collaboration Product basis.
1.15 "Detail" (or "Details" and "Detailing") means, with respect to the Collaboration Product, the activity undertaken by a sales representative [ * ] to provide [ * ] of the Collaboration Product, in a fair and balanced manner consistent with the requirements of the Food Drug and Cosmetics Act, including but not limited to, the regulations of 21 C.F.R. 202, and [ * ] in an effort to increase the number of physicians prescribing the Collaboration Product and/or the number of prescriptions for Collaboration Product, but excluding [ * ].
1.16 "Development" or "Develop" means activities relating to obtaining Regulatory Approval of Collaboration Products, and activities relating to developing and scaling up the ability to manufacture and to continue to manufacture Collaboration Compounds and Collaboration Products, including activities of Third Party manufacturers to develop such manufacturing capabilities for Collaboration Products. Development includes but is not limited to Pre-Clinical Studies, pharmacology studies, toxicology studies, formulation, manufacturing process development and scale-up (including bulk compound production), quality assurance and quality control, technical support, pharmacokinetic studies, Clinical Studies, regulatory affairs activities and outside counsel regulatory legal services. For clarity, Development shall not include medicinal chemistry efforts directed at the production of new chemical variants of any GTx SARM Compound that are not themselves GTx SARM Compounds, but may include (to the extent provided in the Development Plan) the production of modified GTx SARM Compounds that contain radioactive isotopes (whether or not such modified compounds are included in GTx SARM Compounds) or other labeling or tracing residues that are used in analyzing the activity, pharmacokinetics or pharmacodynamics of Collaboration Compounds as provided in the Development Plan, and activities directed toward developing a process for manufacturing Collaboration Compounds.
1.17 "Development Budget" shall have the meaning set forth in Article IV.
1.18 "Development Expenses" means the expenses incurred by a Party or for its account by a Third Party (including capital expenditures made by a Third Party and reimbursed by a Party) which are generally consistent with a Development Plan and Development Budget and are specifically attributable to the Development of a Collaboration Compound or Collaboration Product not otherwise recovered or reimbursed. Development Expenses shall include, but are not limited to, the cost of labor (calculated, as to GTx, as provided in Section 4.5) and materials incurred in connection with Pre-Clinical and Clinical Studies (whether conducted internally or by a Third Party, individual investigators or consultants), toxicological, pharmacological, pharmacokinetic, metabolic, analytical, formulation, and chemical studies, final product scale-up, and qualification and validation batches as required by the FDA for the purpose of obtaining
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Regulatory Approval of a Collaboration Product, and costs (and related fees) for preparing, submitting, reviewing or developing data or information for the purpose of submission to a governmental authority to obtain and/or maintain Regulatory Approval of a Collaboration Product.
1.19 "Development Plan" shall have the meaning set forth in Article IV.
1.20 "Drug Approval Application" means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.
1.21 "Education" means professional and customer education, through any means, including (i) articles appearing in journals, newspapers, magazines, or other media, including direct mail and electronic media; (ii) seminars, exhibits and conventions; (iii) educational literature, visual aids, three dimensional educational items, and other educational materials; (iv) market research; and (v) symposia, advisory boards and opinion leader development activities; provided, however, that such term shall exclude direct sales force activity. All such Education means must be within current healthcare compliance guidelines.
1.22 "Effective Date" shall have the meaning set forth on page one of this Agreement.
1.23 "EMEA" means the European Medicine Evaluation Agency or any successor thereto.
1.24 "Executive Officers" means the Chief Executive Officer of GTx (or a senior officer of GTx designated by GTx's Chief Executive Officer) and the President of Ortho (or a senior officer of Ortho or one of its Affiliates).
1.25 "FDA" means the United States Food and Drug Administration or any successor thereto.
1.26 "First Collaboration Compound" means Andarine or its Replacement Collaboration Compound.
1.27 "[ * ]" means [ * ].
1.28 "FTE" means the equivalent of the work of one (1) employee full time for one (1) calendar year (consisting of at least a total of [ * ] per calendar year) of work pursuant to the Development Plan with respect to Collaboration Products. Any employee who devotes less than [ * ] per calendar year shall be treated as an FTE on a pro-rata basis calculated by dividing the actual number of hours worked during such calendar year by [ * ].
1.29 "FTE Cost" means the cost to GTx of its [ * ] personnel directly dedicated to the execution of the Development Plan [ * ], and shall be calculated by multiplying the
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FTE Rate by the number of GTx employees, agents or independent contractors performing such Development pursuant to the Development Plan.
1.30 "FTE Rate" means, as of the Effective Date, [ * ] per FTE. Such rate shall be adjusted annually to reflect the total percentage increase in the U.S. Consumer Price Index for the time period from the Effective Date until the time at which such index was recalculated at the time of adjustment (with the first adjustment to occur January 1, 2005, with subsequent adjustments on each anniversary thereof).
1.31 "Generic" means a product that contains the same chemical entity as a Collaboration Product and that has received regulatory approval to be marketed and sold for an Indication for which the Collaboration Product is marketed and sold. In the United States, Generics shall only include those products approved under an ANDA based on the NDA of the Collaboration Product.
1.32 "GTx Audience" means those urologists who are licensed to practice in the United States to whom GTx will promote Collaboration Product, as designated pursuant to Section 6.3.
1.33 "GTx Know-how" means Information which (i) GTx discloses to Ortho under this Agreement and (ii) is within the Control of GTx. Notwithstanding anything herein to the contrary, GTx Know-how shall exclude GTx Patents.
1.34 "GTx/Ortho Development" means Development of Collaboration Compounds for Indications that are primarily directed to the treatment of male health diseases and/or conditions.
1.35 "GTx Patent" means the rights granted by any governmental authority under a Patent which claims Andarine and/or GTx SARM Compounds, or methods of using and processes for making such compounds, which Patent is owned or Controlled by GTx. A list of the GTx Patents identified as of the Effective Date is attached hereto as Exhibit A. GTx Patents include without limitation GTx's interest in any Joint Patents.
1.36 "GTx SARM Compounds" means Andarine and/or non-steroidal selective androgen receptor modulators that (1) [ * ], are [ * ], any [ * ] issued, any [ * ] and [ * ]; and (2) (a) [ * ]; (b) [ * ]; and (c)(i) [ * ]; or (ii) [ * ]; or (iii) [ * ]. GTx SARM Compounds shall also include [ * ] described in (1) that also [ * ] in (2). For avoidance of doubt, if a compound is described in (1) but does not also meet the requirements of (2), such compound shall not be a GTx SARM Compound and GTx shall retain all rights to such compound. It is understood by the Parties that GTx has [ * ] and that [ * ] may include GTx SARM Compounds and/or Excluded SARM Compounds. "Excluded SARM Compounds" means compounds that are [ * ] and/or compounds that are included in Exhibit D2. For example, the GTx Patents listed on Exhibit A includes continuation-in-part applications which include Excluded SARM Compounds. GTx shall retain all rights to Excluded SARM Compounds. For avoidance of doubt, the parties have set forth on Exhibit D1 certain compounds that, as of the Effective Date, are [ * ] and are included within clause (1) of the first sentence of this Section 1.36 (and are therefore eligible to be
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GTx SARM Compounds if they also fulfill the requirements of clause (2) of this Section 1.36), and on Exhibit D2 certain compounds that are, as of the Effective Date, Excluded SARM Compounds.
1.37 "IND" shall mean (i) an Investigational New Drug Application as defined in the United States Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder by the FDA, or (ii) the equivalent application to the equivalent agency in any other country or group of countries, the filing of which is necessary to commence clinical testing of a pharmaceutical product in humans in a particular jurisdiction.
1.38 "Indication" means any disease or condition for which a Collaboration Compound may have therapeutic, ameliorative or preventive activity and for which a Collaboration Compound can be Developed.
1.39 "Information" means (i) techniques and data relating to Collaboration Compounds, Collaboration Products, Combination Products or GTx SARM Compounds to the extent provided to a Party for use in joint Development, or for Commercialization thereof, including (but not limited to) inventions, practices, methods, knowledge, know-how, skill, experience, test data including pharmacological, toxicological, Pre-Clinical Studies and clinical test data, analytical and quality control data, marketing, pricing, distribution, cost, sales and manufacturing data or descriptions, and compounds, compositions of matter, assays and biological materials related thereto.
1.40 "Joint Development Committee" or "JDC" means the committee established pursuant to Article II.
1.41 "Joint Patent" shall have the meaning set forth in Section 10.4.
1.42 "Koseisho" means the Japanese Ministry of Health and Welfare, or any successor agency thereto.
1.43 "Launch Date" means the date of the first offer for commercial sale, following Regulatory Approval, of a Collaboration Product.
1.44 "Major European Country" means any of the United Kingdom, France, Germany, Spain and Italy.
1.45 "Market Exclusivity" means, as to a given country, a given product and a given time period, that no Generic version of such product is then being sold in such country.
1.46 "Marketing" means the sale, promotion and advertising of a Collaboration Product in the Co-Promotion Territory as set forth in Article VI and in the Marketing and Sales Plan.
1.47 "Marketing Expenses" means the costs that are generally consistent with a Marketing and Sales Plan that are incurred after the Launch Date of a Collaboration
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Product and are specifically attributable to the sale, promotion, advertising, and marketing of such Collaboration Product. Marketing Expenses shall include costs of Phase IV Clinical Trials.
1.48 "Marketing and Sales Committee" shall have the meaning set forth in Section 6.4.
1.49 "Marketing and Sales Plan" shall have the meaning set forth in Section 6.5.
1.50 "Material Breach" shall have the meaning set forth in Section 13.2(e).
1.51 "NDA" means a complete New Drug Application and all amendments and supplements thereto filed with the FDA, including all documents, data, and other information concerning a Collaboration Product, which are necessary for, or included in, an application for Regulatory Approval by the FDA to market such Collaboration Product, as more fully defined in 21 C.F.R. Section 314.5 et seq.
1.52 "NDA Approval" means the approval of an NDA by the FDA required before commercial sale or use of a Collaboration Product as a drug in the United States.
1.53 "Net Sales" means, consistent with, in the United States, generally accepted accounting principles and, in the rest of the Royalty Bearing Territory, Ortho worldwide practices and procedures, and in each such case as consistently applied across the Ortho pharmaceutical product line, the amount invoiced by Ortho, its Affiliates, and its distributors and sub-licensees to Customers for sales of licensed Product in the Royalty Bearing Territory, less accruals estimated, credits taken, and actual payments (to the extent not previously accrued) made for:
(a) discounts, credits, retroactive price reductions, rebates, refunds, charge backs, allowances and adjustments granted to non-sublicensee Third Parties, including Medicaid, and managed care and similar types of rebates, rejections, market withdrawals, recalls (provided such recalls are in accordance with Section 6.22 of this Agreement) and returns, and administrative fees charged by hospital buying groups and managed care organizations in the United States, each to the extent consistent with Ortho's usual course of dealing for its products other than the Products;
(b) trade, quantity and cash discounts and rebates actually allowed or given (other than to a distributor that is an Affiliate of Ortho), each to the extent consistent with Ortho's usual course of dealing for its products other than the Product;
(c) sales, excise, turnover, value-added, and similar taxes assessed on the sale of the Product (other than income taxes of Ortho, its Affiliates or sublicensees), and import and customs duties;
(d) shipping and insurance charges, postage, and freight out; and
(e) government imposed rebates or discounts.
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Sales of Product by and between Ortho and its Affiliates and sublicensees are not sales to Third Parties and shall be excluded from Net Sales calculations for all purposes. Sales of Product for use in conducting clinical trials of Product in a country in order to obtain the first Regulatory Approval of Product in such country shall be excluded from Net Sales calculations for all purposes. Net Sales shall be determined in a manner consistent for all products sold by or on behalf of Ortho and in accordance with applicable U.S. generally accepted accounting principles.
In the event the Product is sold as part of a Combination Product in a country, the Net Sales of the Product, for the purposes of determining payments based on Net Sales, shall be determined by multiplying the Net Sales of the Combination Product in such country, during the applicable Net Sales reporting period, by the fraction, A/(A+B), where:
A is the average sale price of the Product by Ortho, its Affiliates or sublicensees when sold separately in finished form in such country and B is the average sale price by Ortho, its Affiliates or sublicensees of the other product(s) included in the Combination Product when sold separately in finished form in such country, in each case during the applicable Net Sales reporting period.
In the event the Product is sold as part of a Combination Product and is sold separately in finished form in such country, but the other product(s) included in the Combination Product are not sold separately in finished form in such country, the Net Sales of the Product, for the purposes of determining payments based on Net Sales, shall be determined by multiplying the Net Sales of the Combination Product in such country by the fraction C/D where:
C is the average sale price, in such country, of the Product contained in such Combination Product when sold separately and D is the average sale price, in such country, for the Combination Product, in each case during the applicable Net Sales reporting period. Under no circumstances can C/D exceed one hundred percent (100%).
In the event that the Product is not sold separately in finished form in the country, but all of the other product(s) included in the Combination Product in such country are sold separately, the Net Sales of the Product, for the purposes of determining payments based on Net Sales, shall be determined by multiplying the Net Sales of the Combination Product in such country by the fraction (D-E)/D, where:
D is the average sale price, in such country, of the Combination Product, and E is the average sale price of the other product(s) included in the Combination Product in finished form in such country, in each case during the applicable Net Sales reporting period, provided that in no event shall (D-E)/D be [ * ].
In the event that the Net Sales of the Product when included in a Combination Product cannot be determined using the methods above, Net Sales for the purposes of determining payments based on Net Sales shall be calculated by multiplying the Net Sales of the Combination Product by the fraction of F/(F+G) where:
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F is the fair market value of the Product and G is the fair market value of all other pharmaceutical product(s) included in the Combination Product, as reasonably determined in good faith by the Parties.
1.54 "Ortho Development" means all Development other than the GTx/Ortho Development.
1.55 "Ortho Know-how" means Information which (i) Ortho discloses to GTx under this Agreement and (ii) is within the Control of Ortho. Notwithstanding anything herein to the contrary, Ortho Know-how shall exclude Ortho Patents.
1.56 "Ortho Patent" means the rights granted by any governmental authority under a Patent which covers an invention relating to the composition of matter, formulation, method of making or method of using Collaboration Compounds or Collaboration Products, which Patent is Controlled by Ortho. As of the Effective Date, Ortho has not identified any Ortho Patents. Ortho Patents include Ortho's interest in any Joint Patents.
1.57 "Osteoporosis Indication" means the treatment of [ * ].
1.58 "[ * ]" means [ * ].
1.59 "Patent" means (i) valid and enforceable United States or foreign patents, reexaminations, reissues, renewals, extensions, term restorations, and foreign counterparts thereof, and (ii) pending applications for United States or foreign patents thereof.
1.60 "Patent Expenses" means the fees, expenses and disbursements of outside counsel, and payments to Third Party agents, incurred in connection with the preparation, filing, prosecution and maintenance of GTx Patents or Ortho Patents covering Collaboration Compounds or Collaboration Products, including the costs of patent interference and opposition proceedings but excluding the costs of any other Patent enforcement proceedings.
1.61 "Phase I Clinical Trial" means that portion of the clinical development program which provides for the first introduction into humans of a Product with the purpose of determining human toxicity, metabolism, absorption, elimination and other pharmacological action, as more fully defined in 21 C.F.R. Section 312.21(a).
1.62 "Phase IIA Clinical Trial" means that portion of the clinical development program which provides for the initial trials of a Collaboration Compound on a limited number of patients for the purpose of determining whether the Collaboration Compound affects a surrogate marker or indicator of pharmacological or clinical activity in the proposed therapeutic indication.
1.63 "Phase IIB Clinical Trial" means that portion of the clinical development program which provides for the definitive, well controlled clinical trials of a Collaboration Compound in patients for the purpose of determining the safe and effective
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dose range in the proposed therapeutic indication, as more fully described in 21 C.F.R. Section 312.21(b).
1.64 "Phase III Clinical Trials" means that portion of the clinical development program which provides for continued trials of a Product on sufficient numbers of patients to establish the safety and efficacy of a Product and generate pharmaco-economic data to support Regulatory Approval in the proposed therapeutic indication, as more fully defined in 21 C.F.R. Section 312.21(c).
1.65 "Phase IIIB Clinical Trials" means product support clinical trials of a Collaboration Product, which is not required for receipt of initial Regulatory Approval but which may be useful in providing additional drug profile data or expansion of the Collaboration Product's label claim, and which is commenced after NDA filing but before NDA Approval.
1.66 "Phase IV Clinical Trials" means product support clinical trials, including but not limited to trials including new drug delivery systems, of a Collaboration Product with an approved label claim that is commenced after receipt of Regulatory Approval in the country where such trial is being conducted. These trials shall be considered a part of Commercialization.
1.67 "Pre-Clinical Studies" means studies of a Collaboration Product in animals other than humans, including those studies conducted in whole animals and other test systems, designed to determine the toxicity, bioavailability, and pharmacokinetics of a Collaboration Compound and whether the Collaboration Compound has a desired effect.
1.68 "Pre-Marketing" means Commercialization Activities undertaken prior to and in preparation for the launch of a Collaboration Product, consistent with a Marketing and Sales Plan and prior to the first commercial launch of such Collaboration Product. Pre-Marketing activities shall include, but are not limited to, advertising, Education, market research, Phase IIIB Clinical Trials, Phase IV Clinical Trials, sales force training, trademark activities (including selection, filing, prosecution and enforcement) and other activities included within the Marketing and Sales Plan prior to the first commercial launch of such Collaboration Product.
1.69 "Products" means Collaboration Products.
1.70 "Proof of Concept Trial" means any Phase IIA Clinical Trial or Phase IIB Clinical Trial that is designed to demonstrate that a Collaboration Product meets clinical criteria established by the JDC with respect to a given indication.
1.71 "Regulatory Agency" means any governmental authority, including without limitation the FDA or EMEA, with responsibility for granting any licenses or approvals or granting pricing and/or reimbursement approvals necessary for the marketing and sale of a Collaboration Product in any country or group of countries.
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1.72 "Regulatory Approval" means any approvals by government pricing or health authorities in a country or supra-national organization (including, but not limited to, FDA and EMEA), product and/or establishment licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, in each case that are necessary for the commercial manufacture, use, storage, importation, export, transport or sale of Collaboration Products in a regulatory jurisdiction.
1.73 "Replacement Collaboration Compound" means a GTx SARM Compound that is selected to replace a Collaboration Compound then under development as described in Section 4.6.
1.74 "Royalty Bearing Product" means a Collaboration Product marketed directly or indirectly by Ortho, its Affiliate or sublicensee alone or together with GTx or its Affiliates in the Royalty Bearing Territory.
1.75 "Royalty Bearing Sales" means the Net Sales in the Royalty Bearing Territory.
1.76 "Royalty Bearing Territory" means the world.
1.77 "Royalty Term" shall have the meaning set forth in Section 3.5.
1.78 "Safety" means the absence of adverse experiences associated with the administration of a drug to a patient that are significant, serious or life threatening to the patient or demonstrate significant toxicological effect(s) of such drug on one or more body tissues that are not balanced by a countervailing benefit to the patient. The Safety of a product will be determined in view of the risk to benefit relationship of such product in the relevant patient population.
1.79 "[ * ]" means [ * ].
1.80 "Third Party" means any entity other than GTx or Ortho and their respective Affiliates.
1.81 "Tolerability" means the absence of adverse experiences, other than those that are Safety-related experiences, associated with administration of a drug to patients that such patients, or their physicians, deem unpleasant to an extent that can materially and adversely affect market potential or market penetration of a Collaboration Product.
1.82 "Trademark Expenses" means the fees, expenses and disbursements of outside counsel, and payments to Third Party agents incurred in connection with the preparation, filing, prosecution, registration and maintenance of trademarks covering Collaboration Compounds or Collaboration Products, including the costs of trademark interference and opposition proceedings, but excluding other trademark enforcement proceedings.
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1.83 "Unit Net Sales Price" means the average Net Sales amount received during either the applicable calendar quarter (as used in Section 7.1) or during the applicable period (as used in Section 13.6) by Ortho, its Affiliates or sublicensees for each tablet or other dosage form of a Collaboration Product written by a Urologist and filled and sold by a pharmacist in the United States.
1.84 "Urologist" means a urologist licensed to practice in the United States, or a nurse practitioner or physician assistant who works for such a urologist.
1.85 "UTRF" means the University of Tennessee Research Foundation.
1.86 "Valid Patent Claim" means a claim (a) of any issued, unexpired patent that has not been revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be taken, or with respect to which an appeal is not taken within the time allowed for appeal, and that has not been disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise, or (b) of any patent application that has not been cancelled, withdrawn or abandoned or been pending more than seven (7) years.
1.87 "Wasting Indication" means the treatment of the effects of diseases involving a reduction in lean body weight, whether due to [ * ] or other chronic medical conditions.
ARTICLE II
MANAGEMENT
2.1 Joint Development Committee.
(a) Formation of JDC. GTx and Ortho shall form a Joint Development Committee ("JDC"). The JDC shall be comprised of equal numbers (up to three (3) from each Party) of appropriately expert and experienced individuals, with one such person assigned by each Party as such Party's co-chair. Either Party may designate a substitute for a committee member to participate in the event one of that Party's regular committee members is unable to be present at a meeting.
(b) Meetings. Meetings of each of the JDC may be called by either Party on ten (10) calendar days written notice to the other unless such notice is waived by the Parties. Such committees may be convened, polled or consulted from time to time by means of telecommunication, video communication, or correspondence. The JDC will meet at least quarterly, at sites to be designated by the chairpersons of such committees or through teleconference or video conference, as agreed upon by the JDC.
(c) Agendas. Each Party will disclose to the other proposed agenda items along with appropriate Information at least five (5) calendar days in advance of each meeting of the JDC.
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(d) Responsibilities of the JDC. The JDC will oversee the Parties' efforts for Ortho Development and will oversee and coordinate the Parties' efforts with respect to GTx/Ortho Development. The JDC will review and comment on the Development Plans and Development Budgets and make recommendations with respect to adjustment of GTx/Ortho Development, budget and timetables and the assessment of whether a Collaboration Compound shall proceed to the next stage of Development. Ortho will update the JDC periodically, but at least quarterly, of all Development activities. The JDC will review and approve, with respect to GTx/Ortho Development, the addition of new indications, the ceasing of Development of Andarine, and the addition of a Replacement Collaboration Compound or an Additional Compound. In, addition, the JDC shall review and approve any proposal by GTx to designate a compound not to be a GTx SARM Compound, as defined herein. In this regard, GTx agrees to provide the JDC with sufficient information and data in connection with [ * ] so that the JDC can agree or disagree with GTx's position. Such information shall be provided at a JDC meeting and the JDC shall have thirty (30) calendar days after it receives the information and data to decide whether or not it agrees with GTx. If the JDC disagrees with GTx's position, GTx may proceed to develop and commercialize its compound independent of this collaboration, provided, however, Ortho shall retain its rights to arbitrate the classification of such compound under Article XV (and GTx may also initiate such an arbitration in order to clarify its rights to such compound). If the JDC agrees that the compound is not a GTx SARM Compound, Ortho shall promptly provide to GTx a written statement confirming that Ortho has no rights under this Agreement in or to such compound.
(e) Decisions by the JDC.
(i) Ortho shall present to the JDC the portion of the Development Plan and Development Budget that relates to the Ortho Development at the same level of detail as is contained in the portion of the Development Plan and Development Budget that relates to the GTx/Ortho Development. However, this presentation and any subsequent discussion of the contents of the portion of the Development Plan and Development Budget related to the Ortho Development shall be for advisory purposes only.
(ii) All decisions by the JDC that relate to GTx/Ortho Development shall be made unanimously, after an open and informed discussion of the matters as to which decisions are being made, including, but not limited to those matters relating to the portion of the Development Plan and Budget directed to GTx/Ortho Development. If the JDC is unable to make a unanimous decision on such matters, the matter will be referred to the Executive Officers of GTx and Ortho. If such officers do not reach agreement on such matter within twenty (20) calendar days after it is referred to them, then subject to Section 4.1, the decision of Ortho on such matter will be final and determinative, so long as such decision does not contradict or modify the terms of this Agreement.
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(f) Subcommittees of the JDC. The JDC will have the power to form subcommittees with equal (unless otherwise agreed in writing) and appropriate representation from GTx and Ortho.
ARTICLE III
LICENSING FEES; MILESTONE PAYMENTS; ROYALTIES; REP...
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