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JOINT DEVELOPMENT AGREEMENT

Development Agreement

JOINT DEVELOPMENT AGREEMENT | Document Parties: Impax Laboratories, Inc | Medicis Pharmaceutical Corporation You are currently viewing:
This Development Agreement involves

Impax Laboratories, Inc | Medicis Pharmaceutical Corporation

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Title: JOINT DEVELOPMENT AGREEMENT
Governing Law: Arizona     Date: 5/6/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

JOINT DEVELOPMENT AGREEMENT, Parties: impax laboratories  inc , medicis pharmaceutical corporation
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Exhibit 10.61

      ***  INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

JOINT DEVELOPMENT AGREEMENT

     THIS JOINT DEVELOPMENT AGREEMENT (this “ Agreement ”) dated as of November 26, 2008 (the “ Effective Date ”) is entered into between Medicis Pharmaceutical Corporation, a Delaware corporation with offices located at 7720 North Dobson Road, Scottsdale, Arizona 85256 on behalf of itself and its Affiliates (collectively, “ Medicis ”), and Impax Laboratories, Inc., a Delaware corporation with offices located at 30831 Huntwood Avenue, Hayward, California 94544 on behalf of itself and its Affiliates (collectively, “ Impax ”).

     WHEREAS, Medicis is the owner or otherwise has rights to certain patents, formulations and know-how related to its minocycline products marketed as of the Effective Date under the trademark Solodyn ® (the “ Original Products ”);

     WHEREAS, Impax has the expertise and know-how to conduct a joint development program with Medicis to create a next generation derivative of the Original Products and to research, develop and commercialize certain generic drugs, and Impax has certain proprietary intellectual property that will be useful to Medicis with respect to such next generation derivative of the Original Products; and

     WHEREAS, Medicis desires to collaborate with Impax regarding the research and development of (a) the next generation derivative of the Original Products, and (b) certain generic drugs in exchange for a share of the Gross Profit (as defined below), all on the terms and conditions of this Agreement.

     NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

     1.  DEFINITIONS.

          1.1 “*** NDA” means the following NDA, which was approved prior to the Effective Date: NDA # *** .

          1.2 “ *** NDC ” means the following NDCs: *** .

          1.3 “*** Products” means one or more products that are generic equivalents of the products that are (a) marketed under the trademark *** and (b) approved pursuant the *** NDA or a supplement thereto and/or sold under an *** NDC, in each case at any strength, dosage or form; provided that with respect to any obligations on Impax under Section 5.1.1 or Medicis’ milestone payment obligations under Sections 6.2(e) or (f), “ *** Product ” shall mean only the *** mg strength.

          1.4 “ Affiliate ” means, with respect to any entity, any other entity that directly or indirectly controls, is controlled by, or is under common control with, such entity. An entity shall be regarded as in control of another entity if it owns, or directly or indirectly controls, at

 


 

least fifty percent (50%) of the voting stock or other ownership interest of the other entity, or if it directly or indirectly possesses the power to direct or cause the direction of the management and policies of the other entity by any means whatsoever.

          1.5 “ ANDA ” means an Abbreviated New Drug Application and any supplements thereto.

          1.6 “ ANDA Product ” means each of the following products (including any future packaging changes or pack sizes): (a) the *** Products; (b) the *** Products; (c) the *** Products; and (d) the *** Products.

          1.7 “Authorized Product” means any product that is in the same form as a New Product approved under a NDA held by Medicis or its sublicensee but is relabeled and marketed as a generic product.

          1.8 “ Confidential Information ” means all non-public materials, information and data concerning the disclosing party and its operations that is disclosed the disclosing party to the receiving party pursuant to the Confidentiality Agreement, this Agreement, the License Agreement or the Distribution Agreement (as defined in the License Agreement), orally or in written, electronic or tangible form, or otherwise obtained by the receiving party through observation or examination of the disclosing party’s operations. Confidential Information includes, but is not limited to, information about the disclosing party’s financial condition and projections; business, marketing or strategic plans; sales information, customer lists; price lists; databases; trade secrets; product prototypes and designs; techniques, formulae, algorithms and other non-public process information. Notwithstanding the foregoing, Confidential Information of a party shall not include that portion of such materials, information and data that, and only to the extent, the recipient can establish by written documentation: (a) is known to the recipient as evidenced by its written records before receipt thereof from the disclosing party, (b) is disclosed to the recipient free of confidentiality obligations by a Third Party who has the right to make such disclosure without obligations of confidentiality, (c) is or becomes part of the public domain through no fault of the recipient, or (d) the recipient can reasonably establish is independently developed by persons on behalf of recipient without the use of the information disclosed by the disclosing party.

          1.9 “Confidentiality Agreement” means the letter agreement dated February 24, 2008 from David Greenbaum, counsel for Medicis Pharmaceutical Corporation, to Roger Chin, counsel for Impax Laboratories, Inc.

          1.10 “Control” means with respect to any material, information, or intellectual property right, that a party (a) owns such material, information, or intellectual property right, or (b) has a license or right to use such material, information, or intellectual property right, in each case with the ability to grant to the other party access, a right to use, a license, or a sublicense (as applicable) to such material, information, or intellectual property right on the terms and conditions set forth herein, without violating the terms of any agreement or other arrangement with any Third Party.

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          1.11 “ Cost of Sales ” means, on a per ANDA Product basis and for a given calendar quarter, the sum of the Manufacturing Costs, Distribution and Sales Costs, and Third Party IP Costs for such ANDA Product sold during such calendar quarter.

          1.12 “ Development Plan ” means the plan for the research and development of the New Product, which plan shall be consistent with Section 2.1, prepared by the parties and periodically updated upon mutual written agreement of the parties.

          1.13 “ Development Program ” means the development program described in Section 2.1.

          1.14 “ Diligent Efforts ” means with respect to the research, development or commercialization of a product, as applicable, efforts and resources commonly used in the pharmaceutical industry for a product at a similar stage of research, development or commercialization, and having similar market potential. Diligent Efforts shall be determined by taking into account the characteristics of the product, the technical risk and stage of research, development, or commercialization of the product, the cost-effectiveness of efforts or resources applied towards such product, the competitiveness of alternative Third Party products that are or are expected to be in the relevant marketplace, the regulatory and business environment, the likelihood of achieving the goal of such research or of obtaining regulatory approval and product reimbursement (as applicable), the profitability of the product (without taking into account any payments to be made to other party pursuant to this Agreement) and the relative potential for product liability exposure. Diligent Efforts shall be determined on a product and market basis, and it is anticipated that the level of efforts and resources will change over time reflecting changes in the status of the product or the market involved.

          1.15 “ Distribution and Sales Costs ” means, on a per ANDA Product basis and for a given calendar quarter, (a) an amount equal to *** % of Net Sales of such ANDA Product during such quarter, which amount shall serve as an estimate of the costs for the distribution of such ANDA Product by Impax for use or sale in the Territory, including freight, insurance and other costs of shipping such ANDA Product, (b) an amount equal to *** % of Net Sales of such ANDA Product in the Territory during such quarter, which amount shall serve as an estimate of the costs of marketing, selling and promoting such ANDA Product, and (c) the actual direct cost incurred with respect to *** .

          1.16 “*** NDA” means the following NDA, which was approved prior to the Effective Date: NDA # *** .

          1.17 “ *** NDC ” means the following NDCs: *** .

          1.18 “ *** Products ” means one or more products that are generic equivalents of the products that are (a) marketed under the trademark *** and (b) approved pursuant the *** NDA or a supplement thereto and/or sold under a *** NDC, in each case at any strength, dosage or form; provided that with respect to any obligations on Impax under Section 5.1.1, “ *** Product ” shall mean only the *** strengths and further provided that Impax’s obligations under Section 5.1.2 and *** Product, as defined below.

          1.19 “ *** Product ” means the *** Product.

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          1.20 “ Exclusion Lists ” mean: (a) the HHS/OIG List of Excluded Individuals/Entities (available through the Internet at http://www.oig.hhs.gov) ; and (b) the General Services Administration’s List of Parties Excluded from Federal Programs (available through the Internet at http://www.epls.gov ).

          1.21 “ FDA ” means the United States Food and Drug Administration or any successor entity thereto.

          1.22 “ FD&C Act ” means the United States Federal Food, Drug and Cosmetic Act, as may be amended from time to time.

          1.23 “ Gross Profit ” means, on a per ANDA Product basis and for a given calendar quarter, the remainder, if any, that results from Net Sales of such ANDA Product in the Territory minus the Cost of Sales of such ANDA Product. *** .

          1.24 “ Impax Know-How Rights ” means all trade secret and other know-how rights in and to all data, information, compositions and other technology (including, but not limited to, formulae, procedures, protocols, techniques and results of experimentation and testing) which are necessary or useful to make, use, develop or sell the New Product and which Impax Controls as of the Effective Date or during the term of this Agreement; provided, however, that the foregoing shall not apply to any trade secret or other know-how rights in and to all data, information, compositions or other technology that that (a) is Controlled by an entity that becomes an Affiliate of Impax as a result of such entity’s or its Affiliate’s acquisition of Impax and (b) was Controlled by such entity prior to such acquisition.

          1.25 “ Impax IP Rights ” means the Impax Patent Rights and Impax Know-How Rights.

          1.26 “ Impax Patent Rights ” means all patents and patent applications (including utility, model and design patents and certificates of invention) in any country of the world that claim or cover the New Product or the manufacture or use thereof and that Impax (but not including any entity that first becomes an Affiliate of Impax after the Effective Date) Controls as of the Effective Date or during the term of this Agreement; provided, however, that the foregoing shall not apply to any patent or patent application that (a) is Controlled by an entity that becomes an Affiliate of Impax as a result of such entity’s or its Affiliate’s acquisition of Impax and (b) was Controlled by such entity prior to such acquisition.

          1.27 “ Ineligible Person ” means a person who: (a) is currently excluded, debarred, suspended, or otherwise ineligible to participate in the Federal health care programs or in Federal procurement or non-procurement programs; or (b) has been convicted of a criminal offense that falls within the ambit of 42 U.S.C. § 1320a-7(a), but has not yet been excluded, debarred, suspended, or otherwise declared ineligible.

          1.28 “License Agreement” means the License and Settlement Agreement between Medicis and Impax dated as of the Effective Date.

          1.29 “ Manufacturing Costs ” means (a) the delivered cost to Impax of an ANDA Product for use or sale in the Territory if a Third Party is the manufacturer of such

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ANDA Product, or (b) where Impax is itself the manufacturer, the sum of Materials Costs, labor costs, Overhead and Freight And Taxes incurred by Impax to produce such ANDA Product for use or sale in the Territory, including the costs of rejected or failed batches of such ANDA Product. As used herein, “ Materials Cost” means Impax’s procurement costs for (i) raw materials (both active and inactive ingredients), and (ii) packaging, labeling and storing materials, incurred in connection with the manufacture, testing, labeling, purchasing and distribution of such ANDA Product; “ Overhead” means all indirect costs of manufacturing such ANDA Product including, without limitation, insurance, inspection, testing, quality control and quality assurance, depreciation, maintenance and repair costs, all as determined in accordance with the U.S. GAAP, and “ Freight And Taxes ” means all insurance, freight and shipping charges, import taxes and duties and similar taxes and duties levied by the United States or other government entity with jurisdiction, and port and loading charges, all to the extent not already deducted under Distribution and Sales Costs.

          1.30 “ NDA ” means a New Drug Application as defined in the FD&C Act or FDA Regulations (21 CFR).

          1.31 “ Net Sales ” means, with respect to a given ANDA Product or New Product, the aggregate gross price of such ANDA Product or New Product received, in the case of an ANDA Product, by Impax or its sublicensees or, in the case of a New Product, by Medicis or its sublicensees (except with respect to a sublicensee’s sales of Authorized Products), in each case from unaffiliated retailers, distributors or other customers, less the sum of the following items, all of which must directly relate to the sale and distribution of such ANDA Product or New Product and be determined in accordance with GAAP applied in a manner consistent with past practices of the applicable party: (a) returns, credits, rebates, discounts, allowances, promotional payments, free goods, chargebacks and other price reduction programs customary to the trade or required by law, (b) actual packaging, freight and insurance costs incurred in transporting such New Product in final form to customers (this clause (b) shall not apply to ANDA Products, for which an allowance has already been incorporated into Distribution and Sales Costs), (c) sales, valued-added and other taxes, (d) customs duties, surcharges and other governmental charges, (e) administrative fees, marketing fees and other similar fees, payments or credits paid to unaffiliated third parties customary to the trade or required by law, and (f) commercially reasonable write-offs for doubtful accounts. Sales between or among a party and its Affiliates shall not be included in Net Sales unless such party or its Affiliates are the end user of such ANDA Product or New Product, as applicable.

          1.32 “ New Product ” means (a) a product that (i) contains *** and (ii) is to be developed by the parties under this Agreement with the goal of achieving the Target Product Profile, or (b) any other product agreed to in writing by the parties to serve as a substitute for the product described in subsection (a) above (in which case the product descried in subsection (a) shall cease to be a “New Product”), in each case including any *** .

          1.33 “ New Product Technology ” means all discoveries, inventions, improvements and other technology that is developed by Impax, Medicis or both in the conduct of the Development Program.

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          1.34 “ Non-Specific Technology ” means any of the New Product Technology (including without limitation manufacturing processes) that is not specific to the New Product.

          1.35 “*** NDA” means the following NDA, which was approved prior to the Effective Date: NDA # *** .

          1.36 “ *** NDC ” means the following NDCs: *** .

          1.37 “*** Products” means one or more products that are generic equivalents of the products that are (a) marketed under the trademark *** and (b) approved pursuant the *** NDA or a supplement thereto and/or sold under an *** NDC, in each case at any strength, dosage or form; provided that with respect to any obligations on Impax under Sections 5.1.1 and 5.1.2 and *** strength.

          1.38 “ Oral Acne Field ” means the treatment or palliation of acne (including acne rosacea) through an oral administration.

          1.39 “Regulatory Approval” means, with respect to a particular regulatory jurisdiction, the approval of a NDA or its equivalent in such regulatory jurisdiction by the applicable regulatory authority in such regulatory jurisdiction and such other regulatory approvals as are required in order to market the New Product in such regulatory jurisdiction.

          1.40 “*** NDA” means the following NDA, which was approved prior to the Effective Date: NDA # *** .

          1.41 “ *** NDC ” means the following NDCs: *** .

          1.42 “*** Products” means one or more products that are generic equivalents to the products that are (a) marketed under the trademark *** and (b) approved pursuant the *** NDA or a supplement thereto and/or sold under a *** NDC, in each case at any strength, dosage or form; provided that with respect to any obligations on Impax under Section 5.1.1 and *** strength.

          1.43 “ Steering Committee ” means the committee composed of representatives of Impax and Medicis described in Section 2.3 below.

          1.44 “ Target Product Profile ” means the product criteria set forth in Exhibit A.

          1.45 “Territory” means the United States of America including its territories and possessions.

          1.46 “Third Party ” means any person or entity other than Medicis or Impax.

          1.47 “Third Party IP Costs” means, on a per ANDA Product basis and for a given calendar quarter, the royalties and other payments (including upfront fees and milestone payments) paid by Impax to a Third Party in consideration for a license or other rights to

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intellectual property necessary or useful for the manufacture, development, commercialization, use, or sale of such ANDA Product in the Territory.

          1.48 “ Valid Claim ” means a claim in an issued patent, whether such patent issues before, on or after the Effective Date, in the Impax Patent Rights or any issued patent owned by Medicis pursuant to Section 3.3, in each case that has not: (a) expired or been canceled; (b) been declared invalid by a decision of a court or other appropriate body of competent jurisdiction from which no appeal has been timely taken or may be taken (e.g., as a result of denial of a petition for writ of certiorari); (c) been admitted to be invalid or unenforceable through reissue or disclaimer, provided that actions taken during reexamination shall not, prior to the issuance of a final certificate of reexamination, be construed as admissions of invalidity or unenforceability of the claims contained in such patent prior to the initiation of such reexamination; or (d) been abandoned.

     2.  DEVELOPMENT PROGRAM; STEERING COMMITTEE.

          2.1 Overview . The goal of the Development Program is to develop the New Product. Each party’s obligations under the Development Program shall be as set forth in this Section 2.1 or as agreed in writing by the parties after the Effective Date. Each party shall use commercially reasonable efforts to timely conduct its obligations under the Development Programs in accordance with the Development Plan. Subject to Medicis’ payment of the amount set forth in Section 6.1, each party shall bear its own costs to conduct its obligations under the Development Program. Impax shall use commercially reasonable efforts to use its proprietary technology in existence as of the Effective Date to formulate a product that meets or approaches the Target Product Profile and to perform standard in vitro analytic testing upon such resulting New Product to determine whether it meets the Target Product Profile criteria. Without limiting the generality of the foregoing, Impax shall perform no more than three (3) in vivo pharmacokinetic studies upon such New Product to determine whether it meets the Target Product Profile criteria. Impax shall also provide a reasonable amount of technical advice to Medicis with respect to pre-clinical manufacturing scale up work for the New Product. For clarity, Impax shall not have any obligation to (i) perform more than three (3) in vivo pharmacokinetic studies in the course of performing the Development Program, (ii) perform any manufacturing scale up work for the New Product, (iii) manufacture the New Product for clinical (except for the 3 pharmacokinetic studies described above) or commercial use, (iv) make any filings with the FDA or any other regulatory agency with respect to the New Product, (v) conduct any clinical trials for the New Product (except for the 3 pharmacokinetic studies described above) or (vi) conduct any commercialization-related activities with respect to the New Product. Impax shall not incorporate any know-how, patented technology or other intellectual property Controlled by Impax into the New Product, the New Product Technology or the manufacturing process therefor without notifying Medicis in writing. If Medicis notifies Impax in writing, within thirty (30) days of Impax’s notice, that Medicis, based on its freedom to operate analysis, has a good faith concern that the use of such know-how, technology or intellectual property with respect to the New Product may infringe the intellectual property of a Third Party, then the parties will discuss such matter and, if such discussion does not reasonably resolve Medicis’ concern, then Medicis will notify Impax in writing within thirty (30) days of such discussion and Impax, following receipt of such notice, will not incorporate such know-how, technology or intellectual property into the New Product.

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          2.2 Amendment of Development Plan . The Development Plan may be amended from time to time by mutual written agreement of the parties or by the Steering Committee pursuant to Section 2.3.1.

          2.3 Steering Committee .

               2.3.1 Composition of the Steering Committee . The Steering Committee shall foster the collaborative relationship between the parties and shall in particular monitor the progress of the Development Program and Impax’s progress with respect to the ANDA Products. The Steering Committee shall be comprised of two (2) named representatives of Impax and two (2) named representatives of Medicis. Each party shall appoint its respective representatives to the Steering Committee from time to time, and may substitute one or more of its representatives, in its sole discretion, effective upon notice to the other party of such change but shall use commercially reasonable efforts to maintain stability of Steering Committee representation. The Steering Committee shall not have the power to amend the terms of this Agreement but shall have the power to change the Development Plan upon agreement of at least one (1) representative of the Steering Committee from each party.

               2.3.2 Meetings . The Steering Committee shall meet not less than four (4) times each calendar year, on such dates and at such times and places as agreed to by Impax and Medicis, alternating between Scottsdale, Arizona and Hayward, California or such other locations as the parties shall agree, including without limitation via teleconference. At such meetings, the Steering Committee shall discuss the progress of the Development Program and set priorities therefor.

               2.3.3 Committee Actions . Any approval, determination or other action agreed to by all of the members of the Steering Committee present at the relevant Steering Committee meeting shall be the approval, determination or other action of the Steering Committee; provided, however, that at least one (1) representative of each party is present at such meeting, and that such approval, determination or other action is documented in (a) a writing signed by a representative of each party at such meeting or (b) the approved minutes for such meeting. The Steering Committee also may act by unanimous written consent without a meeting or between meetings.

               2.3.4 Steering Committee Minutes and Reports . One representative of each party shall be designated to take minutes of each Steering Committee meeting. Within fifteen (15) days following each Steering Committee meeting during the term of the Agreement, the Steering Committee shall prepare and provide to each party a reasonably detailed written report which shall summarize the outcome of the meeting.

               2.3.5 Term . The term of the Steering Committee shall commence on the Effective Date and continue until Impax has completed its obligations under the Development Plan.

          2.4 Records . Impax shall maintain complete and accurate records of all work it conducts under the Development Program and all results, data and developments made in connection therewith. Such records shall be complete and accurate and shall fully and properly

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reflect all work done and results achieved in the performance of the Development Program in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes. Medicis shall have the right to review and copy such records (including raw data and scientific notebooks) at reasonable times to the extent necessary for Medicis to exercise its rights under this Agreement with respect to New Product Technology and the development and commercialization of the New Product.

          2.5 Reports . Within thirty (30) days following the end of each calendar quarter during the term of the Development Program, Impax shall prepare and deliver to Medicis a written summary report which shall describe the research performed to date under the Development Program and all results, analysis and conclusions thereof.

     3.  INTELLECTUAL PROPERTY.

          3.1 Research License . During the term of the Development Program, Medicis hereby grants to Impax a fully paid, non-exclusive, non-transferable (except as permitted in Section 11.6) license (without the right to grant sublicenses), under all patents, know-how and other intellectual property rights Controlled by Medicis, for the sole purpose of conducting the Development Program. Prior to engaging any subcontractors to perform work under the


 
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