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COLLABORATION AND COMMERCIALIZATION AGREEMENT

Collaboration Agreement

COLLABORATION AND COMMERCIALIZATION AGREEMENT | Document Parties: REPLIDYNE INC | Forest Laboratories Holdings Limited,  | Daiichi Asubio Pharmaceutical, Inc. You are currently viewing:
This Collaboration Agreement involves

REPLIDYNE INC | Forest Laboratories Holdings Limited, | Daiichi Asubio Pharmaceutical, Inc.

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Title: COLLABORATION AND COMMERCIALIZATION AGREEMENT
Governing Law: New York     Date: 4/5/2006
Industry: Biotechnology and Drugs     Law Firm: Forest Laboratories, Inc.;Cooley Godward llp;    

COLLABORATION AND COMMERCIALIZATION AGREEMENT, Parties: replidyne inc , forest laboratories holdings limited   , daiichi asubio pharmaceutical  inc.
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[ *** ] = 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 406 of the Securities Exchange Act Of 1933, as amended.

Exhibit 10.18

COLLABORATION AND COMMERCIALIZATION AGREEMENT

           This Collaboration and Commercialization Agreement (the “Agreement” ) is entered into as of February 10, 2006 (the “Effective Date” ) by and among Replidyne, Inc. , a Delaware corporation ( “Replidyne” ), having its principal place of business at 1450 Infinite Drive, Louisville, Colorado 80027, and Forest Laboratories Holdings Limited , an Irish corporation ( “Forest” ), having its principal place of business at Milner House, 18 Parliament Street, Hamilton HM11, Bermuda.

Recitals

           Whereas , Replidyne and Daiichi Asubio Pharmaceutical, Inc. ( “DAP” ) (successor-in-interest to Daiichi Suntory Pharma Co., Ltd.) entered into a License Agreement dated March 15, 2004 as may be amended in accordance with its terms (the “DAP Agreement” ), pursuant to which DAP granted to Replidyne an exclusive license to certain patents and know-how to develop and commercialize faropenem medoxomil (formerly designated as faropenem daloxate) in the Field (as defined below) in specified countries;

           Whereas, Forest develops, manufactures and markets pharmaceutical products, and in particular, has expertise in promoting pharmaceutical products to primary care physicians;

           Whereas, Replidyne develops anti-infective and other pharmaceutical products and is building an organization to promote pharmaceutical products to specialist physicians;

           Whereas, Forest and Replidyne desire to collaborate on the further development of faropenem medoxomil for the treatment of community-acquired infectious diseases in the Territory (as defined below), with the intent that Forest will market and promote the product(s) primarily to primary care physicians, and Replidyne will market and promote the product(s) primarily to certain medical specialists, including pediatricians;

           Whereas, Forest desires to acquire, and Replidyne is willing to grant to Forest, certain licenses under patents and know-how controlled by Replidyne to develop and commercialize faropenem medoxomil in the Field in the Territory (as defined below), in accordance with foregoing and the terms and conditions set forth in this Agreement.

Agreement

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

1.

 

Definitions

           1.1 “ADEs” has the meaning provided in Section 5.12.

           1.2 “Administrator” has the meaning provided in Section 14.2 .

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           1.3 “Affiliate” means any company or entity controlled by, controlling, or under common control with a party hereto. For this purpose, the term “control” shall mean the direct or indirect ownership of more than 50% of the voting stock or other ownership interests of that entity, or the power, directly or indirectly to cause the direction of the management and policies of such entity.

           1.4 “AECB Indication” means a separate, labeled use for the treatment of acute exacerbations of chronic bronchitis in humans.

           1.5 “ANDA” shall mean an Abbreviated New Drug Application filed with the FDA (as more fully defined in 21 USC §355(j)).

           1.6 “ANDA Proceeding” has the meaning provided in Section 9.4(b) .

           1.7 “AOM Indication” means a separate, labeled use for the treatment of acute otitis media in humans.

           1.8 “API Supply Agreement” means the agreement setting forth the terms and conditions for the supply of Drug Substance from NISSO through DAP to Replidyne dated December 20, 2004, as the same may be amended or assigned to Forest as contemplated in Section 6.2 hereof.

           1.9 “Applicable Laws” means all applicable laws, rules and regulations that apply to the development, manufacturing or commercialization of Product in the Territory or the performance of either party’s obligations under this Agreement, including without limitation any rules, regulations, guidelines or other requirements of the FDA, that may be in effect from time to time.

           1.10 “Arbitrators” has the meaning provided in Section 14.2 .

           1.11 “Bayer” means Bayer AG, a prior licensee of the DAP Know-How and DAP Patents pursuant to a license agreement with Suntory Ltd., Tokyo, Japan, a predecessor in interest to DAP, dated June 28, 1999, which was terminated November 19, 2003.

           1.12 “Bayer Know-How” means the data, information, documentation, know-how and technology, relating to Drug Substance and/or Products that was generated or acquired by Bayer and/or its Affiliates and actually provided to Replidyne by DAP.

           1.13 “Calendar Quarter” means each respective period of three (3) consecutive months ending on March 31, June 30, September 30 and December 31.

           1.14 “Canadian Rights” has the meaning provided in Section 5.9(b) .

           1.15 “Ciba-Geigy Patents” means the patents owned by Ciba-Geigy (currently Novartis) as listed in Exhibit A hereof.

           1.16 “Claim” has the meaning provided in Section 14.2 .

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

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           1.17 [ *** ] Threshold” has the meaning provided in Section 7.3(d) .

           1.18 “Combination Product” means a Product containing one or more other therapeutically active ingredients in addition to the Drug Substance.

           1.19 “Commercially Reasonable Efforts” means, with respect to the development or commercialization of the Product, except as otherwise explicitly set forth in this Agreement, the level of efforts required to carry out such obligation in a sustained manner consistent with the efforts a biotechnology company or pharmaceutical company, as the case may be, devotes to a product of similar market potential, profit potential or strategic value resulting from its own research efforts, based on market conditions then prevailing, consistent with the exercise of prudent scientific and/or business judgment in accordance with generally accepted practices in the pharmaceutical industry. Commercially Reasonable Efforts shall be determined without regard to the particular circumstances of a party, including any other product opportunities of such party. Commercially Reasonable Efforts requires, with respect to such an obligation, that the party: (a) promptly assign responsibility for such obligation to specific employee(s) who are held accountable for progress and monitor such progress on an on-going basis; (b) set and consistently seek to achieve specific, meaningful and measurable objectives for carrying out such obligation; and (c) consistently make and implement decisions and allocate resources designed to advance progress with respect to such objectives. The term “commercially reasonable” has the corresponding meaning.

           1.20 “Competitive Product” has the meaning set forth in Section 5.10.

           1.21 “Confidential Information” has the meaning provided in Section 11.1 .

           1.22 “Control” means, with respect to any information, Patent or other intellectual property right, possession by a party of the ability (whether by ownership, license or otherwise) to grant access, a license or a sublicense to such information, Patent or intellectual property right without violating the terms of any agreement or other arrangement with any Third Party.

           1.23 “Cost of Goods” for any dosage strength and formulation of the Product for any period shall mean actual direct out-of-pocket cost incurred by a party for the acquisition of Drug Substance and actual direct out-of-pocket costs incurred by a party for the acquisition, manufacture, shipping from the manufacturer to Forest’s initial distribution site, storage at such site, and final labeling and packaging of the Product for such period, including the cost of commercially reasonable strategies for hedging of exchange rate risk (in each case, to the extent not already deducted in the calculation of Net Sales or included in Distribution Costs), as recognized and recorded in accordance with US GAAP.

           1.24 “Cost of Goods Committee” or “CGC” means the committee formed pursuant to Section 3.3 .

           1.25 “DAP Improvement” means any and all developments, enhancements, modifications, inventions or discoveries in the Field relating to Products for use in the Field, that are developed or created by or on behalf of DAP (other than by Replidyne, its Affiliates, licensees and sublicensees, and their respective employees, agents, consultants, subcontractors

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

3.


 

and other representatives) at any time during the term of the DAP Agreement, whether patentable or not, including but not limited to, developments, inventions or discoveries intended to enhance the safety or efficacy of Drug Substance and/or Products, and all intellectual property rights thereto which are necessary or useful for Forest to exercise the rights licensed to it under Section 2.1 of this Agreement, but excluding those related specifically to manufacturing of Drug Substance.

           1.26 “DAP Know-How” means any and all data, information, documentation, know-how and technology, whether patentable or not, relating to Drug Substance and/or Products, including, without limitation, information regarding their stability, pharmacology, toxicology, clinical use, compositions and formulations for administration, and any scientific information and data developed by Wyeth relating to Drug Substance and to Products; in each case that was generated or acquired by DAP and/or its Affiliates prior to the effective date of the DAP Agreement or is generated by DAP and/or its Affiliates during the term of the DAP Agreement, but excluding data, information, documentation, know-how and technology, whether patentable or not, related specifically to manufacturing of Drug Substance.

           1.27 “DAP Logogram” means the logogram adopted by DAP at any time during the term of the DAP Agreement.

           1.28 “DAP Patents” means the patent applications and patents listed in Exhibit B attached hereto, and patents issuing from such patent applications, and any and all patents and patent applications covering DAP Improvements, in each case including any continuations, continuations-in-part, provisionals, divisionals, reissues, reexaminations, extensions, substitutions, restorations, additions, revalidations, registrations, confirmations, renewals and counterparts thereof in the Territory that are necessary or useful for the use, development, manufacture, marketing, promotion, distribution, sale and/or commercialization of Products in the Territory for use in the Field.

           1.29 “Detail” means an interactive face-to-face contact of a sales representative, who is fully equipped with, and knowledgeable of, applicable promotional materials and product labeling for the Product, with a target physician or other medical professional licensed to prescribe drugs or other healthcare professional that has a significant impact or influence on prescribing decisions, during which relevant characteristics of the Product are described by the sales representative. Details shall be deemed to include only presentations in the first or second position in a sales presentation and shall not be deemed to include “tertiary” or “reminder” details, in each case as such terms are generally understood in the pharmaceutical industry. “Detailing” shall have a corresponding meaning.

           1.30 “Detailing Commencement Date” means the first day following NDA Approval on which Detailing of the Product by Replidyne begins, as determined by the JMC.

           1.31 “Detailing Year” means, with respect to the first Detailing Year, the twelve (12) month period commencing on the Detailing Commencement Date, and with respect to subsequent Detailing Years, each successive twelve (12) month period thereafter.

           1.32 “Detail Reports” means a report of Details performed by a party during the

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

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Calendar Quarter covered by such statement containing such information and in such format as determined by the JMC.

           1.33 “Development Costs” means with respect to a particular Product the sum of all internal costs, including to the extent allocated to the foregoing directly related overhead (but not general or corporate overhead), and direct out-of-pocket costs, in each case incurred by a party and/or its Affiliates in connection with the conduct of the activities assigned to it by the JDC pursuant to the Development Plan, including, without limitation, FTE costs (which fairly reflect the actual FTE costs of each party for its personnel in the applicable functional areas (but excluding senior executives), to be discussed and agreed upon by the parties respective finance departments), costs of preparation of regulatory filings, costs of clinical supply of Product, and any other activities conducted under the Development Plan that support obtaining or maintaining NDA Approval of Product in the Territory, such as surveillance studies and pharmacovigilance. Development Costs shall be determined in accordance with US GAAP and in accordance with the relevant party’s accounting standards applied on a consistent basis.

           1.34 “Development Information” means any and all information generated by a party (or a party’s Affiliates or any Third Party on behalf of a party) in the development of the Drug Substance and/or Product for the Territory as provided in this Agreement, including, without limitation, protocols, analysis plans, annotated case report forms per study, analysis datasets, programs, raw data and other relevant documentation used for the study reporting efforts, FDA outputs relating to the development of, and/or filing of NDAs for, Drug Substance and/or Product in the Territory (including, without limitation, all substantive correspondence with the FDA, responses from the FDA, requests for information from the FDA, briefing documents and other materials relating to interactions with the FDA, and summaries of outputs resulting from substantive correspondence/ conversations or meetings with the FDA), and information from clinical advisory boards and investigators.

           1.35 “Development Plan” means the plan and related budget for conducting research and development of the Drug Substance and Products in the Field in the Territory, as amended from time to time by the JDC. The initial outline of the Development Plan has been agreed upon by the parties in writing as of the Effective Date.

           1.36 “Development Program” means a research and development program carried out by Replidyne and, as applicable, Forest pursuant to Article 4 , as more fully described in the Development Plan.

           1.37 “Distribution Costs” for any dosage strength and formulation of the Product for any period shall mean a reasonable estimate of the direct out-of-pocket costs of shipping, handling and other Product-specific logistical costs, including, without limitation, quality assurance and quality control procedures and regulatory reporting obligations, related to distribution of the Product from Forest’s initial distribution site to Forest’s customers (to the extent not already deducted in the calculation of Net Sales or included in Costs of Goods) as recognized and recorded in accordance with US GAAP. The parties’ finance departments will mutually agree upon a simple rule for Distribution Costs (e.g., as a percentage of Net Sales) after mutual review and discussion of Forest’s actual Distribution Costs from time to time.

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

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           1.38 “Drug Substance” means the chemical substance identified as faropenem medoxomil as its generic name (formerly designated as faropenem daloxate) and having the chemical structure: (5-Methyl-2-oxo-1, 3-dioxolen-4-yl) methyl (5R, 6S)-6-[(R)-1-hydroxyethyl]-2-[(R)-2-tetrahydro-furyl] penem-3-carboxylate.

           1.39 “FDA” means the United States Food and Drug Administration, or any successor agency thereto having the administrative authority to regulate the marketing of human pharmaceutical products or biological therapeutic products, delivery systems and devices in the United States of America.

           1.40 “Field” means the treatment, amelioration or prevention of infectious diseases in humans and all other pharmaceutical uses and indications for the Product.

           1.41 “First Commercial Sale” means, with respect to any Product, the first sale for end use or consumption of such Product in the United States after NDA Approval. Sale to an Affiliate or sublicensee shall not constitute a First Commercial Sale unless the Affiliate or sublicensee is the end user of the Product.

           1.42 “Forest Costs” has the meaning provided in Section 7.3(d) .

           1.43 “Forest Indemnitee” has the meaning provided in Section 13.1 .

           1.44 “Forest Inventions” has the meaning provided in Section 9.1 .

           1.45 “Forest Know-How” means any and all data, information, documentation, know-how and technology Controlled by Forest or any of its Affiliates on the Effective Date or during the Term that is useful for purposes of the Development Program or necessary or useful for the manufacture of Product (including Drug Substance) anywhere in the world, or the commercialization or use of the Drug Substance or Product in the Field in the Territory, including, without limitation, all such data, information, documentation, know-how and technology that is developed or acquired by Forest or any of its Affiliates in the course of performance of, or pursuant to any right granted under, this Agreement, but excluding the Forest Patents and the Joint Patents.

           1.46 “Forest Patents” means all Patents Controlled by Forest or any of its Affiliates on the Effective Date or during the Term to the extent useful for purposes of the Development Program or necessary or useful for the manufacture of Product (including Drug Substance) anywhere in the world, or the commercialization or use of the Drug Substance or Product in the Field in the Territory, including, without limitation, any Patents that claim or disclose any Forest Invention, but excluding the Joint Patents.

           1.47 “Forest Sales Force” means those members of Forest’s sales force (whether Forest employees, contractors or agents), who promote Product in the Field in the Territory, but excluding the Replidyne Pediatrician Sales Force and Replidyne Specialty Sales Force, together with field-based sales managerial personnel having direct and sole responsibility for the management of such sales force.

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

6.


 

           1.48 “Forest Technology” means the Forest Patents and Forest Know-How.

           1.49 “FTE” means the equivalent of the work time of an employee or consultant of Replidyne or Forest (or their Affiliates, as applicable) with appropriate qualifications performing work under the Development Plan on a full-time basis over a 12-month period (including normal vacations, sick days and holidays).

           1.50 “Generic Equivalent” shall mean, on a Product-by-Product basis, a product that is therapeutically equivalent to a Product and that: (a) is pharmaceutically equivalent to such Product (contains the same active ingredient(s) and has the same dosage form, route of administration and strength); and (b) has gained market approval through an ANDA filed in accordance with 505(j) of the U.S. Food Drug & Cosmetic Act and prepared in accordance with 21 CFR 314.94 or through any equivalent mechanism under any successor law or regulation in the United States.

           1.51 “Generic Profits” shall mean, with respect to a generic Product sold by Forest, its Affiliates or permitted sublicensees, on a Product-by-Product basis, an amount, which shall not be less than zero (0) for purposes of this Agreement, equal to (a) Net Sales of such generic Product, minus (b) Cost of Goods, Distribution Costs and sales and marketing costs (such as trade advertising) of Forest for such generic Product in the Territory.

           1.52 “IND” means an Investigational New Drug Application filed with the FDA, or the equivalent application or filing filed with any equivalent agency or governmental authority outside the United States of America (including any supra-national agency such as in the European Union) necessary to commence human clinical trials in such jurisdiction.

           1.53 “Initial Period” means the first [ *** ] months of the Replidyne Specialist Promotion Period.

           1.54 “Inventions” has the meaning provided in Section 9.1 .

           1.55 “Joint Development Committee” or “JDC” means the committee formed pursuant to Section 3.1 .

           1.56 “Joint Inventions” has the meaning provided in Section 9.1 .

           1.57 “Joint Marketing Committee” or “JMC” means the committee formed pursuant to Section 3.2 .

           1.58 “Joint Patents” means all Patents in the Territory that claim or disclose a Joint Invention.

           1.59 “Joint Supply Committee” or “JSC” means the committee formed pursuant to Section 6.1 .

           1.60 “Licensed Know-How” means any and all data, information, documentation, know-how and technology Controlled by Replidyne as of the Effective Date or during the Term that is useful for purposes of the Development Program or necessary or useful for the

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

7.


 

manufacture of Product (including Drug Substance) anywhere in the world (excluding, with respect to the DAP Know-How, rights in Japan, except to the extent rights in Japan are included in the rights granted to Replidyne under the DAP Agreement), or the commercialization or use of Drug Substance or Product in the Field in the Territory, including, without limitation, the DAP Know-How and the Bayer Know-How, but excluding the Licensed Patents and the Joint Patents.

           1.61 “Licensed Patents” means the Replidyne Patents, the Ciba-Geigy Patents and the DAP Patents.

           1.62 “Licensed Technology” means the Licensed Patents and Licensed Know-How.

           1.63 “Losses” has the meaning provided in Section 13.1 .

           1.64 “Manufacturing Technology” means all information and documentation necessary or advisable to enable Replidyne or its designee to manufacture Drug Substance, including without limitation, NISSO’s standard operating procedures, NISSO’s Improvements, and the Drug Master File sections relevant to chemical manufacturing, testing and release, Sensitive Manufacturing Information, and all updates thereto.

                (a)  “NISSO’s Improvements” means all information, documents and tangible and intangible materials which result from or are related to the performance by NISSO of the services contemplated by the API Supply Agreement (including, without limitation, data, test results, measurements, quantitative and qualitative analyses, processes, samples, inventions, discoveries, improvements, intellectual property, derivative works, technology and/or any other work product, whether patentable or not) developed under the API Supply Agreement by NISSO or on behalf of NISSO by any of its representatives relating to the Drug Substance or the Products.

                (b)  “Drug Master File” means the drug master file, as defined in 21 CFR Section 314.420 or successor provision, filed with the FDA with respect to the Drug Substance, which permits NISSO to authorize others to rely on the information in such file to support an NDA for the Products.

                (c)  “Sensitive Manufacturing Information” means the confidential manufacturing information that is included in the Drug Master File.

           1.65 “Marketing and Sample Expense” means, generally, the external, out-of-pocket costs which are incurred by a party or for its account attributable to the marketing of any dosage strength and formulation of the Product in the Territory, including, without limitation, the sum of Advertising, Consumer and Physician Promotion, Education, Market and Consumer Research, Phase IV Programs, Promotional Management and Trade Promotion Expenses, each of which is specified below. To the extent multiple products are involved and some of such products are not Product, then such expenses will be allocated on a pro rata basis based upon net sales of each respective product by such party during the most recent Calendar Quarter. The costs of activities which promote a party’s business as a whole without being product specific (such as corporate image advertising) are specifically excluded from Marketing and Sample Expense.

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

8.


 

                (a)  “Advertising” means all media costs associated with advertising the Product in the Territory including, but not limited to the following: production expense/artwork including set up; design and art work for an advertisement; advertising agency fees; the cost of securing print space, air time and the like in newspapers, magazines, trade journals, television, radio, billboards and other media.

                (b)  “Consumer and Physician Promotion” means the expenses associated with programs to promote the Product in the Territory directly to the prescriber or end user, including, but not limited to, expenses associated with promoting products directly to the professional community such as professional samples (including Cost of Goods of samples), professional literature, promotional material costs, patient aids and detailing aids.

                (c)  “Education” means expenses associated with professional education with respect to the Product in the Territory through any means not covered under subsections (a) and (b) above, including, but not limited to, articles appearing in journals, newspapers, magazines or other media; seminars, lunch and dinner programs, CME programs and professional society programs, scientific exhibits, and conventions; and symposia, advisory boards and opinion leader development activities.

                (d)  “Market and Consumer Research” means payments to Third Parties related to conducting and monitoring professional and consumer appraisals of existing, new or proposed Product in the Territory, such as market share services (e.g., IMS data), special research testing, focus groups, as well as qualitative and quantitative research studies.

                (e)  “Phase IV Programs” means payments to Third Parties and the directly allocable internal costs of a party (including directly related overhead but not corporate or general overhead) for functions (such as data collection and analysis) that a party performs internally on a reasonably cost-effective basis compared to Third Party costs for such functions, in each case for Phase IV marketing studies of the Product in the Territory, including, but not limited to, the cost of clinical grants and the cost of clinical research organizations.

                (f)  “Promotional Management” means payments to Third Parties for development or management of marketing or promotional strategies, planning and programs for the Product in the Territory, including, but not limited to, costs associated with developing overall sales and marketing strategies (e.g., product line or customer segment), and planning and programs for the Product in the Territory, including, but not limited to, launch sales force meetings, promotional meetings, other meetings scheduled solely for the Product (but not periodic sales force meetings of a party), conventions and seminars. In addition, payments to Third Parties in connection with Trademark selection, filing, prosecution and enforcement in the Territory are included in this category.

                (g)  “Trade Promotion” means the allowances given to retailers, brokers, distributors, hospital buying groups and similar groups for purchasing, promoting, and distribution of the Product in the Territory, including, but not limited to, purchasing, advertising, new distribution, and display allowances as well as free goods, wholesale allowances and reasonable field sales samples (to the extent not already deducted in the calculation of Net Sales).

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

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           1.66 “Marketing Expense Ratio” has the meaning set forth in Section 5.3(e) .

           1.67 “Marketing Plan” means the annual marketing and commercial plan for the Product in the Field in the Territory that includes the related budget for Marketing and Sample Expense, as the same is from time to time in effect in accordance with the terms hereof.

           1.68 “NDA” means a New Drug Application (as more fully defined in 21 C.F.R. 314.5 et seq. ) and all amendments and supplements thereto filed with the FDA, including all documents, data, and other information concerning a pharmaceutical product which are necessary for gaining approval to market such pharmaceutical product in the United States.

           1.69 “NDA Acceptance” means the submission of a NDA for Product to the FDA and filing of such NDA by the FDA.

           1.70 “NDA Approval” means the issuance by the FDA of an action letter indicating that an NDA for Product is approved. For avoidance of doubt, NDA Approval does not mean that the FDA issues an action letter indicating that an NDA for Product is approvable.

           1.71 “Net Sales” means, for the applicable period, the gross amount invoiced for sales or other transfers of the Products (including, for purposes of Section 7.5 , any generic Product) by Forest and its Affiliates and permitted sublicensees to Third Parties that are not Affiliates or permitted sublicensees of Forest (and to any Affiliate or sublicensee of Forest if such Affiliate or sublicensee is the final user of and does not further sell such Product, in which case the amount billed therefor shall be deemed to be the amount that would be billed to an independent Third Party in an arm’s length transaction), less the following items as allocable to such Products, all as recorded in accordance with US GAAP and in a manner consistent with Forest’s revenue recognition policies from the sale of pharmaceutical products consistently applied:

                (a)  trade discounts, credits or allowances, including without limitation, discounts provided by means of chargebacks, rebates and administrative fees charged by customers or health care organizations determined based upon sales;

                (b)  credits or allowances additionally granted upon returns, rejections or recalls (except where any such recall arises out of Forest’s or its Affiliate’s gross negligence, willful misconduct or fraud);

                (c)  freight, shipping and insurance charges;

                (d)  taxes, duties or other governmental tariffs (other than income taxes); and

                (e)  rebates, discounts or other payments on sales of Product that are mandated by the government.

          In the case of the Combination Products, the Net Sales shall be calculated by multiplying actual Net Sales of the Combination Product (calculated as if such Combination Product did not contain other therapeutically active ingredients) by the fraction A/(A+B) where A is the invoice price of a Product containing only Drug Substance, if sold separately, and B is the total invoice price of the other active ingredient or ingredients in the combination, if sold separately. If the

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

10.


 

other active ingredient or ingredients in the Combination Product are not sold separately in the Territory, Net Sales shall be calculated by multiplying actual Net Sales thereof by the fraction A/C where A is the invoice price of a Product containing only Drug Substance, if sold separately, and C is the invoice price of the Combination Product.

          If the Product containing only Drug Substance is not sold separately in the Territory, the parties shall, in good faith, negotiate and agree upon how to calculate the Net Sales on sales of the Combination Product, with a view to achieving to the greatest extent possible the economic balance and mutual understanding established between the parties for calculation of Net Sales on the Combination Product as reflected in this section.

           1.72 “NISSO” means Nippon Soda Co., Ltd., which is the contract manufacturer of the Drug Substance for Replidyne as of the Effective Date.

           1.73 “Oral Suspension” means a finished pharmaceutical preparation containing the Drug Substance as an active ingredient, consisting of a dosage formulation of the Drug Substance suspended in a liquid for delivery by mouth.

           1.74 “Patents” means: (a) an unexpired patent which has not been held invalid or unenforceable by a court of competent jurisdiction from which no appeal can be taken or has been taken within the required time period, including without limitation any substitution, extension, registration, confirmation, reissue, re-examination, renewal or any like filing thereof; and (b) pending patent applications, including without limitation any provisional, converted provisional, continued prosecution application, continuation, divisional or continuation-in-part thereof.

           1.75 “Pediatrician” means a physician specializing in the development, care, and treatment of children from birth through adolescence and board certified in pediatrics.

           1.76 “Pediatrician Promotion Option” has the meaning set forth in Section 5.5.

           1.77 “Pediatrician Promotion Rights” has the meaning set forth in Section 5.5 , as further described in Schedule 5.5 .

           1.78 “Phase 2 Clinical Trial” means a human clinical trial that would satisfy the requirements for a Phase 2 study as defined in 21 C.F.R. 312.21(b) (or its successor regulation).

           1.79 “Phase 3 Clinical Trial” means a human clinical trial that would satisfy the requirements for a Phase 3 study as defined in 21 C.F.R. 312.21(c) (or its successor regulation).

           1.80 “Pre-Launch Period” means, with respect to a Product, the twelve (12) month period preceding the anticipated Detailing Commencement Date for such Product.

           1.81 “Primary Care Physician” or “PCP” means a physician, such as a general practitioner or internist, chosen by an individual to serve as his or her health-care professional and capable of handling a variety of health-related problems, of keeping a medical history and medical records on the individual, and of referring the person to Specialists as needed.

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

11.


 

           1.82 “Product” means a finished pharmaceutical preparation containing the Drug Substance as an active ingredient, in any dosage or formulation, including but not limited to a Tablet or an Oral Suspension.

           1.83 “Replidyne Indemnitee” has the meaning provided in Section 13.2 .

           1.84 “Replidyne Inventions” has the meaning provided in Section 9.1 .

           1.85 “Replidyne Patents” means all Patents Controlled by Replidyne as of the Effective Date or during the Term that are useful for purposes of the Development Program or necessary or useful for the manufacture of Product (including Drug Substance) anywhere in the world, or the commercialization or use of Drug Substance or Product in the Field in the Territory, including, without limitation, any Patents that claim or disclose any Replidyne Invention, but excluding the Ciba-Geigy Patents, the DAP Patents and the Joint Patents.

           1.86 “Replidyne Pediatrician Sales Force” means those members of Replidyne’s sales force (subject to the provisions of Section 2.4(b) of Schedule 5.5 , whether Replidyne employees, contractors or agents), who promote Product to Pediatricians in the Territory pursuant to Replidyne’s exercise of the Pediatrician Promotion Option, together with field-based sales managerial personnel having direct and sole responsibility for the management of such sales force.

           1.87 “Replidyne Specialist Promotion Period” means the period beginning on the Detailing Commencement Date and ending on the last day of the fifth (5 th ) Detailing Year, unless extended by mutual agreement of the parties or sooner terminated in accordance with the terms of this Agreement.

           1.88 “Replidyne Specialty Sales Force” means those members of Replidyne’s sales force (subject to the provisions of Section 5.4(a) , whether Replidyne employees, contractors or agents), who promote Product to Target Specialists in the Field in the Territory pursuant to Section 5.2 , together with field-based sales managerial personnel having direct and sole responsibility for the management of such sales force.

           1.89 “Royalty Payments” shall have the meaning provided in Section 7.5(a) .

           1.90 “Royalty Term” means, in the case of any Product in the Territory (on a Product-by-Product basis), the period of time commencing on the First Commercial Sale of such Product in the Territory and, subject to the provisions of Section 7.5 , ending upon the later of: (a) the expiration of the last to expire valid claim of the Licensed Patents, Forest Patents or Joint Patents claiming the manufacture, use or sale of such Product in the Territory, including any period of extended commercial exclusivity for the Product granted under any such Licensed Patent, Forest Patent or Joint Patent or under any other laws or regulations in the Territory, (b) the commercial introduction by a Third Party of a Generic Equivalent to such Product in the Territory; and (c) twelve (12) years after the date of First Commercial Sale of such Product in the Territory.

           1.91 “Sales Force Expense” means the salaries, bonuses, other cash compensation payments and benefits provided by Replidyne to the Replidyne Specialty Sales Force, together

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

12.


 

with direct out-of-pocket expenses of Replidyne in utilizing the Replidyne Specialty Sales Force in the Detailing of the Product (such as automobile, travel and lodging, equipment and other support costs) recognized and recorded in accordance with US GAAP. In addition, “Sales Force Expense” shall include out-of-pocket costs of activities in support of the Replidyne Specialist Sales Force (for example, training and technology support services), provided that Replidyne shall first consult with Forest to determine whether such support services may be provided by Forest (in which case Forest shall have the option to provide such services and Replidyne shall utilize such services if so provided by Forest) and to the extent not so available from Forest, such costs shall only be included in Sales Force Expense to the extent such costs do not exceed the incremental costs Forest would have incurred in providing such services to its own sales force. Promptly following the Effective Date, the JMC will develop a mutually agreed protocol consistent with this definition to more specifically identify and standardize the components of Sales Force Expense to facilitate the reimbursement of such expense as contemplated by this Agreement.

           1.92 “Specialists” means physicians whose practices are limited to treating a specific disease, specific parts of the body, a specific age group or specific procedures, who are potential prescribers of the Products.

           1.93 “Standstill Period” has the meaning provided in Section 15.1 .

           1.94 “Supply Transition” means the period of time, commencing on the Effective Date, during which the parties shall transition responsibility from Replidyne to Forest under the API Supply Agreement and Replidyne’s other agreements with Third Party contract manufacturers for the Product.

           1.95 “Tablet” means a finished pharmaceutical preparation containing the Drug Substance as an active ingredient, consisting of a solid dosage formulation for delivery by mouth intended to be swallowed whole and to dissolve in the gastrointestinal tract.

           1.96 “Target Specialists” means infectious disease specialists, otolaryngologists, and such other Specialists (other than Pediatricians) as to which the JMC may agree warrant Detailing of the Product.

           1.97 “Term” has the meaning provided in Section 12.1 .

           1.98 “Territory” means the United States of America, and its territories and possessions, including Puerto Rico irrespective of political status.

           1.99 “Third Party” means any entity other than Replidyne or Forest or an Affiliate of Replidyne or Forest.

           1.100 “Trademark” means any trade names or trademarks for the Product that are selected for use in the marketing and promotion of the Product in the Territory in accordance with the terms hereof (but not including trademarks or trade names of general use in a party’s business and not specifically related to the Product).

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

13.


 

           1.101 “US GAAP” means generally recognized accounting principles in the United States of America.

           1.102 “Wyeth” means Wyeth-Ayerst, a prior licensee of the DAP Know-How and DAP Patents pursuant to a license agreement with Suntory Ltd., Tokyo, Japan, a predecessor in interest to DAP, dated May 27, 1992, which was terminated March 22, 1996.

2.

 

Licenses

           2.1 License Grants. Subject to the terms and conditions of this Agreement, Replidyne hereby grants to Forest during the Term:

                (a)  a co-exclusive license (or sublicense, as the case may be) under the Licensed Technology, with the right to sublicense to Affiliates under Section 2.2 , to conduct development of Product in the Field in the Territory pursuant to the Development Plan;

                (b)  an exclusive license (or sublicense, as the case may be) under the Licensed Technology, with the right to sublicense to Affiliates under Section 2.2 , to make and have made anywhere in the world, excluding Japan (except to the extent rights in Japan are included in the rights granted to Replidyne under the DAP Agreement), Product for the Territory from Drug Substance supplied by a Third Party approved by Replidyne;

                (c)  a co-exclusive license (or sublicense, as the case may be) under the Licensed Technology, with the right to sublicense under Section 2.2 , to use, market and promote Product in the Field in the Territory;

                (d)  an exclusive license (or sublicense, as the case may be) under the Licensed Technology, with the right to sublicense under Section 2.2 , to sell, offer for sale and import Product in the Field in the Territory; and

                (e)  a co-exclusive license (or sublicense, as the case may be) with the right to sublicense under Section 2.2 , to use and display the Trademarks and the DAP Logogram in connection with the promotion, marketing and commercialization of Product in the Field in the Territory.

          The licenses (or sublicenses, as the case may be) granted in Section 2.1(a) , (c) and (e) shall be co-exclusive with Replidyne, meaning that Forest and Replidyne will share such rights, on an exclusive basis as to Third Parties, with respect to Products in the Territory as set forth in this Agreement. The licenses (or sublicenses, as the case may be) granted in Section 2.1(b) and (d) shall be exclusive, meaning that such rights with respect to Products in the Territory are exclusive, even as to Replidyne, its Affiliates and any Third Parties, but subject to the rights of Replidyne as set forth in this Agreement.

          In addition, in the event the launch of a Generic Equivalent to a Product (on a Product-by-Product basis) by a Third Party [ *** ] , the licenses granted to Forest pursuant to this Agreement shall be deemed to include the sale and distribution by Forest of such Product as a generic Product subject to Section 7.5 . For purpose of this Agreement, references to “generic

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

14.


 

Product” means a product having the same active ingredient(s), dosage form, route of administration and strength as the Product, but is sold by Forest without use of the Trademark [ *** ] in a manner typical of the generic industry.

          Forest shall not exercise the foregoing license if it appears that the Generic Equivalent [ *** ] . However, Forest or its Affiliates or sublicensees may nevertheless exercise the foregoing license if, [ *** ] . If sales of the Generic Equivalent terminate for any reason, then Forest will promptly cease the sale and distribution of its generic Product or, to the extent to do so would be prohibited by law or would violate best industry practices, cease the active promotion for sale of the generic Product.

           2.2 Sublicenses. Forest shall have the right to grant sublicenses of the rights granted to it under this Agreement (a) to its Affiliates upon prior written notice to Replidyne and (b) to Third Parties with the prior written consent of Replidyne in its sole discretion, and Forest shall have no other right to sublicense. Sublicenses granted by Forest to its Affiliates under this Agreement shall not permit the further grant of sublicenses unless agreed to in writing by Replidyne in its sole discretion. Any sublicense granted by Forest under this Agreement shall be subject and subordinate to, and consistent with, the terms and conditions of this Agreement. Forest shall remain fully responsible for the conduct of its Affiliates and Third Party sublicensees under the terms of this Agreement, including any breach of the terms hereof by such Affiliates or sublicensees, and any action or inaction by such Affiliate or Third Party sublicensee shall be considered the action or inaction of Forest under this Agreement (including, without limitation, for purposes of the definition of Net Sales). In the event of a material default by an Affiliate or Third Party under a sublicense agreement with Forest, Forest will inform Replidyne and take such action as necessary or appropriate to cure such default.

           2.3 Grant to Replidyne by Forest. Subject to the terms and conditions of this Agreement, Forest hereby grants to Replidyne and its Affiliates, during the Term, (a) a non-exclusive, worldwide, [ *** ] license under the Forest Technology to: (i) perform Replidyne’s obligations under the Development Plan (with no right to sublicense); and (ii) to develop, make, have made, use, sell, offer for sale and import the Product outside the Territory (with the right to sublicense to the extent and during any period that Replidyne has the necessary licenses from DAP with respect to territories outside the Territory); and (b) a fully paid, royalty-free license under the Forest Technology, with the right to sublicense only to Affiliates of Replidyne, to use, market and promote the Product in the Field in the Territory in accordance with Replidyne’s promotion rights and obligations under this Agreement. Notwithstanding the preceding, in the event that [ *** ] .

      2.4 Related Compounds. If a party proposes to develop or acquire rights to any analogs, homologues, derivatives, salts, metabolites, esters, isomers, enantiomers, polymorphs or pro-drugs of Drug Substance during the Term, the parties agree to work together with regard to such activities and shall discuss and agree upon matters regarding intellectual property rights and payment for costs prior to the development or acquisition of the foregoing. Any rights developed or acquired by a party during the Term as to any analogs, homologues, derivatives, salts, metabolites, esters, isomers, enantiomers, polymorphs or pro-drugs of Drug Substance shall be included in the definition of Drug Substance and shall be deemed governed by and subject to the terms and conditions hereof ( i.e. , irrespective of which party acquires such rights, all intellectual

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

15.


 

property rights relating thereto shall be deemed included in Licensed Technology licensed to Forest pursuant to Section 2.1 or in Forest Technology licensed to Replidyne pursuant to Section 2.3 , and any finished pharmaceutical product containing such compound shall be deemed a “Product” for all purposes of this Agreement). No such product shall be commercialized in the Territory during the term without the mutual agreement of the parties.

           2.5 Trademark and Trade Dress Matters.

                (a)  Sale under Trademarks . In the Territory, Forest and its Affiliates will sell Products exclusively under the Trademark in accordance with the terms and conditions set forth in this Agreement. The Trademark has been selected by Replidyne and submitted to the FDA prior the Effective Date. If the FDA does not approve the use of such submitted Trademark or if either party determines to use an alternate Trademark in the Territory, the parties shall select by mutual agreement an alternate Trademark for use with the Product. The Trademark shall be owned by Replidyne, subject to the license granted to Forest herein.

                (b)  Use of Names and Logos on Product and Related Materials . Subject to Applicable Laws, all packaging and labels and all sales, advertising and promotional literature and other materials used in connection with Products in the Territory shall indicate that the Product is sold under license from Replidyne and shall bear the names and logos of both Replidyne and Forest. As used in this Agreement, “labels” or “labeling” means labels and other written, printed or graphic matter, including without limitation artwork upon the Products or any container utilized with the Products, and “packaging” means containers, cartons, shipping cases, package inserts or other similar material used in packing or accompanying the Products. The place and manner of use of the names and logos of Replidyne and Forest shall be determined by Forest in consultation with Replidyne, but in any event shall be of equal size and prominence.

                (c)  Use of DAP Name and DAP Logogram . Subject to Applicable Laws and provided that there is adequate space, Forest and its Affiliates shall specify on certain packaging and labels used in connection with Products, as mutually agreed (but not including any sales, advertising or promotional literature or other materials), that Products are manufactured and sold under a license from Daiichi Asubio Pharmaceutical, Inc., Tokyo Japan, and Forest and its Affiliates shall use on Products and certain of their labels, packaging, literature, advertising and other printed materials as mutually agreed the DAP Logogram. The place and manner of such information and DAP Logogram shall be subject to agreement with DAP, such approval not to be withheld if such information and DAP Logogram are used in accordance with DAP’s normal practices.

                (d)  Trademark Use . The manner of use of the Trademarks shall be subject to periodic review by the JMC. Forest shall not use the Trademarks in a way that would diminish their value, and Forest shall not use a trademark confusingly similar to one of the Trademarks with any of its other products or use the Trademarks in combination with Forest’s other trademarks in a manner which would create combination marks. Forest shall comply with reasonable policies for usage of Trademarks, as approved by the JMC from time to time. Replidyne shall utilize the Trademarks within the Territory only in accordance with this Agreement. Replidyne may utilize the Trademarks outside the Territory, except that, if there is a reasonable likelihood of a negative impact from parallel imports of Product (or corresponding

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

16.


 

Generic Equivalents) using the Trademark from outside the Territory into the Territory, then Replidyne may utilize such Trademark outside the Territory only with Forest’s prior written approval, which shall not be unreasonably withheld or delayed in light of Replidyne’s proposals to address such negative impact from parallel imports. If Forest reasonably withholds its approval of the use of the Trademark outside the Territory, Replidyne shall not authorize the use of the Trademark by DAP outside the Territory. If DAP nevertheless uses the Trademark outside the Territory, Replidyne shall be responsible, in its sole discretion, to enforce its rights with respect to the Trademark under the DAP Agreement. Replidyne shall hold Forest harmless from any direct damages incurred by Forest as a result of parallel imports of Product attributable to DAP’s un-authorized use of the Trademark outside the Territory or as a result of other actions taken by DAP directly resulting from Replidyne’s refusal to permit DAP to use the Trademark outside the Territory, subject to Section 10.5 .

           2.6 Sales Outside the Territory. To the extent not otherwise prohibited by law, neither Forest nor its Affiliates or permitted sublicensees shall sell Product to customers outside the Territory or to any Third Party in the Territory that Forest has reasonable grounds to believe are likely to export Product outside the Territory. If Forest becomes aware that a Third Party in the Territory is exporting Products acquired from Forest to a country outside the Territory, then Forest shall use Commercially Reasonable Efforts within its legal rights and the remedies afforded by Applicable Laws to deter such Third Party from continuing such exportation, including, without limitation by ceasing or limiting the supply of Product to such Third Party. All inquiries or orders received by Forest for Products to be delivered outside of the Territory shall be referred to Replidyne. To the extent not otherwise prohibited by law, neither Replidyne nor its Affiliates or licensees will sell Product to customers inside the Territory or to any Third Party that Replidyne has reasonable grounds to believe are likely to import Product into the Territory. If Replidyne becomes aware that a Third Party outside the Territory is exporting Product acquired from Replidyne or any Affiliate or licensee to a country within the Territory, then Replidyne shall use Commercially Reasonable Efforts within its legal rights and the remedies afforded by Applicable Laws to deter such Third Party from continuing such exportation, including, without limitation, by ceasing or limiting the supply of Product to such Third Party. All inquiries or orders received by Replidyne for Products to be distributed within the Territory shall be referred to Forest.

      2.7 Retained Rights; No Implied Licenses. For avoidance of doubt, the licenses granted in Section 2.1 shall not in any way be interpreted as granting Forest a license to manufacture or have manufactured Drug Substance or to sell the Drug Substance, except to the extent included in rights granted to Replidyne under the DAP Agreement, the API Supply Agreement or otherwise included in the Licensed Patents and Licensed Know-How. Replidyne hereby expressly reserves the right to practice, and to grant licenses under, the Licensed Patents, the Joint Patents and the Licensed Know-How for any and all purposes except to the extent that Forest has been granted a license under Section 2.1 and reserves such rights to practice intellectual property rights, including the Manufacturing Technology, to which it may obtain a license under the API Supply Agreement except to the extent that Forest may be granted a license under Section 6.5 . No right or license under any Patents or other intellectual property rights of either party is granted or shall be granted by implication to the other, and each party agrees not to practice any Patents or other intellectual property rights of the other party except

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

17.


 

pursuant to the licenses expressly granted in this Agreement or any other written agreement between the parties. All such rights or licenses are or shall be granted only as expressly provided in the terms of this Agreement.

3.

 

Collaboration Governance

           3.1 Joint Development Committee.

                (a)  Formation . Promptly after the Effective Date, the parties will form a Joint Development Committee (the “JDC” ) comprised of three (3) representatives of each of Forest and Replidyne. One (1) member of the JDC shall be selected to act as the chairperson of the JDC, with each chairperson acting for a term of twelve (12) months. The chairperson shall be selected alternately by Replidyne and Forest, and Replidyne shall designate the first chairperson. The JDC shall meet at least four (4) times per year or at such greater frequency as the JDC agrees. Such meetings may be conducted by videoconference, teleconference or in person, as agreed by the parties (except that at least two (2) of such meetings per year shall be conducted in person), and the parties shall agree upon the time of meetings. Within thirty (30) days after each meeting, the JDC chairperson will prepare and distribute to the other members of the JDC for review and comment reasonably detailed minutes of such meeting, which will be approved as the first order of business at the immediately succeeding JDC meeting. Subject to prior coordination with the other party, a reasonable number of additional representatives of a party may attend meetings of the JDC in a non-voting capacity, consistent with the agendas and purposes for such meetings.

                (b)  Responsibilities . The JDC shall oversee and manage the development (including clinical and non-clinical activities) and regulatory approval of the Product in the Field in the Territory. In addition to its general responsibilities, the JDC shall in particular:

                     (i)  encourage and facilitate communication between the parties with respect to the Development Program;

                     (ii)  establish, update, amend, review and approve the Development Plan for accomplishing the goals of the Development Program;

                     (iii)  oversee development and regulatory strategies for Products;

                     (iv)  monitor progress of the Development Program and each party’s diligence in carrying out its responsibilities thereunder; and

                     (v)  carry out the other duties and responsibilities described for it in this Agreement.

                (c) JDC Decision-Making . Decisions of the JDC shall be made by unanimous vote, with the Replidyne members collectively having one (1) vote and the Forest members collectively having one (1) vote. No vote of the JDC may be taken unless at least two (2) of each party’s representatives on the JDC are present to vote. If the JDC is unable to reach a unanimous vote on any matter, then the matter shall be referred to the Chief Executive Officer of Replidyne

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

18.


 

and the Chief Executive Officer of Forest’s corporate parent, Forest Laboratories, Inc. ( “Forest Parent” ) for further discussion and resolution. These individuals shall as soon as practicable attempt in good faith to resolve the matter and thereby make the decision on behalf of the JDC. These individuals may obtain the advice of other employees or consultants as they deem necessary or advisable in order to make the decision.

                (d) Limits on Authority . The JDC will have only such powers as are specifically delegated to it in this Agreement, and will have no power to amend this Agreement or waive a party’s rights or obligations under this Agreement.

           3.2 Joint Marketing Committee.

                (a)  Formation . Promptly after the Effective Date, the parties will form a Joint Marketing Committee (the “JMC” ) comprised of three (3) representatives of each of Forest and Replidyne. The chairperson of the JMC shall be selected by Forest. The JMC shall meet at least four (4) times per year or at such greater frequency as the JMC agrees. Such meetings may be conducted by videoconference, teleconference or in person, as agreed by the parties (except that at least two (2) of such meetings per year shall be conducted in person), and the parties shall agree upon the time of meetings. Within thirty (30) days after each meeting, the JMC chairperson will provide the parties with a written report describing, in reasonable detail, the status of the parties’ activities under the Marketing Plan, a summary of the results and progress to date, the issues requiring resolution, and the agreed resolution of previously reported issues. Subject to prior coordination with the other party, a reasonable number of additional representatives of a party may attend meetings of the JMC in a non-voting capacity, consistent with the agendas and purposes for such meetings. Each party shall make available personnel having responsibility for Product development for consultation with or membership on the JMC at such times and to the extent the JMC is considering issues relating to Phase IV or other clinical trials of the Product.

                (b)  Responsibilities . The JMC shall oversee and manage the commercialization strategy for Products in the Field in the Territory. In addition to its general responsibilities, the JMC shall in particular:

                     (i)  review and approve the Marketing Plan, including, without limitation, the portions relating to marketing to Target Specialists and Pediatricians, and amendments and updates thereto;

                     (ii)  develop strategies for conducting Phase IV clinical trials of Products following the initial NDA Approval to support marketing the Product;

                     (iii)  coordinate the parties selling activities among Primary Care Physicians and Specialists, including Target Specialists and Pediatricians; and

                     (iv)  carry out the other duties and responsibilities described for it in this Agreement.

                (c)  JMC Decision Making . Decisions of the JMC shall be made by

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

19.


 

unanimous vote, with the Replidyne members collectively having one (1) vote and the Forest members collectively having one (1) vote. No vote of the JMC may be taken unless at least two (2) of each party’s representatives on the JMC are present to vote. If the JMC is unable to reach a unanimous vote on any matter, including, without limitation, as to the approval or amendment of any Marketing Plan, the matter shall be referred to the Chief Executive Officer of Replidyne and the Chief Executive Officer of Forest Parent for further discussion and resolution. These individuals shall as soon as practicable attempt in good faith to resolve the matter and thereby make the decision on behalf of the JMC. These individuals may obtain the advice of other employees or consultants as they deem necessary or advisable in order to make the decision. Except as provided in the following two sentences, if the Chief Executive Officer of Replidyne and the Chief Executive Officer of Forest Parent are unable to reach agreement on any such matter, including, without limitation, as to the approval or amendment of any Marketing Plan (including the determination of aggregate Marketing and Sampling Expense and the allocation thereof among the various components of such expense, such as medical education, sales aids, sample expense and journal advertising), the Chief Executive Officer of Forest Parent shall have the final decision-making authority on such matter. If Replidyne is then participating in promotional activities with respect to Target Specialists, the strategic objectives and total funding commitment and allocation thereof for promotional activities directed to Target Specialists to be reflected in the Marketing Plan will be decided as above, however any matter relating to the implementation of the strategic objectives of the Marketing Plan with respect to the promotion of the Product to Target Specialists, including the specific uses of allocated funding, must be resolved by the Chief Executive Officer of Replidyne and the Chief Executive Officer of Forest Parent, which resolution must be consistent with the overall marketing strategy determined by the JMC for the Tablets, as reflected in the Marketing Plan. If Replidyne has exercised the Pediatrician Promotion Option and is then participating in promotional activities with respect to Pediatricians, then any matter that relates to the pediatric portion of the Marketing Plan (including its approval or amendment, provided, however, that such pediatric portion of the Marketing Plan shall be consistent with the overall Marketing Plan) or its implementation including, without limitation, marketing and Detailing of the Oral Suspension to Pediatricians and non-Pediatricians, must be resolved by the Chief Executive Officer of Replidyne and the Chief Executive Officer of Forest Parent.

                (d)  Limits on Authority . The JMC will have only such powers as are specifically delegated to it in this Agreement, and will have no power to amend this Agreement or waive a party’s rights or obligations under this Agreement.

           3.3 Cost of Goods Committee.

                (a)  Formation . Promptly after the Effective Date, the parties will form a Cost of Goods Committee comprised of two (2) representatives of each of Forest and Replidyne, and the CGC will be operative during any period that it appears reasonably likely, based upon objective evidence discussed by the parties, that the Cost of Goods for a period will exceed [ *** ] . The CGC shall oversee matters impacting the Cost of Goods for Products [ *** ] . For example, the CGC shall review financial decisions for each formulation of the Product that relate to: (i) pricing and discounting strategies; (ii) dosing and duration of therapy; and (iii) Drug Substance cost reduction strategies, including hedging of exchange rate risk. The CGC shall meet at least two (2) times per year or at such greater frequency as the CGC agrees. Such

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

20.


 

meetings may be conducted by videoconference, teleconference or in person, as agreed by the parties (except that at least two (2) of such meetings per year shall be conducted in person), and the parties shall agree upon the time of meetings. Within thirty (30) days after each meeting, the CGC chairperson will provide the parties with a written report describing, in reasonable detail, relevant matters pertaining to Cost of Goods, any issues requiring resolution, and the agreed resolution of previously reported issues. Subject to prior coordination with the other party, a reasonable number of additional representatives of a party may attend meetings of the CGC in a non-voting capacity, consistent with the agendas and purposes for such meetings.

                (b)  CGC Decision Making . Decisions of the CGC shall be made by unanimous vote, with the Replidyne members collectively having one (1) vote and the Forest members collectively having one (1) vote. No vote of the CGC may be taken unless at least one (1) of each party’s representatives on the CGC is present to vote. If the CGC is unable to reach a unanimous vote on any matter, such matter shall instead be referred to the Chief Executive Officer of Replidyne and the Chief Executive Officer of Forest Parent for further discussion and resolution. These individuals shall as soon as practicable attempt in good faith to resolve the matter and thereby make the decision on behalf of the CGC. These individuals may obtain the advice of other employees or consultants as they deem necessary or advisable in order to make the decision. If the Chief Executive Officer of Replidyne and the Chief Executive Officer of Forest Parent are unable to reach agreement on any matter, the Chief Executive Officer of Forest Parent shall have the final decision-making authority on such matter.

                (c)  Limits on Authority . The CGC will have only such powers as are specifically delegated to it in this Agreement, and will have no power to amend this Agreement or waive a party’s rights or obligations under this Agreement.

4.

 

Conduct of the Development Program

           4.1 Development Program Activities. Development and regulatory activities for Products in the Field in the Territory will be conducted as outlined in the Development Plan. For clarification, Phase IV marketing studies are not considered to be development activities. The JDC shall determine on a Calendar Quarter basis the number of FTEs of each party that will work on the Development Program during such Calendar Quarter. Any amendments or revisions to the Development Plan shall be in writing and shall require unanimous approval of the JDC. Each party, as applicable, will use Commercially Reasonable Efforts to execute and to perform, or cause to be performed, the activities set forth in the Development Plan, in each case in compliance with the terms of this Agreement and Applicable Laws. If a party proposes development activities for Products in the Field in the Territory, but the JDC does not reach agreement to include such development activities in the Development Plan, the parties will discuss and agree whether one party can proceed with such development activities at its own expense and, if so, on what terms the results of such development activities would be made available to the other party by the party that conducts such development activities.

           4.2 Oral Suspension Development. As a specific activity under the Development Program, the parties will collaborate to complete development of an Oral Suspension, with the goal of maximizing efficiency and controlling Development Costs by utilizing the expertise and existing resources of each of the parties. The JDC shall allocate tasks between the parties and to

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

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Third Parties based on the availability of expertise to conduct development activities cost effectively. The allocation of each party’s responsibilities shall be set forth in the Development Plan.

           4.3 Technology and Information Transfer. Commencing promptly after the Effective Date and from time to time thereafter during the Term, Replidyne shall disclose to Forest such Licensed Technology in Replidyne’s possession as is reasonably necessary or useful to enable Forest to exercise fully the licenses granted to Forest under Article 2 . Commencing promptly after the Effective Date and from time to time thereafter during the Term, Forest will disclose to Replidyne such Forest Technology in Forest’s possession as is reasonably necessary or useful to enable Replidyne to perform its Development Program activities hereunder in accordance with the Development Plan and otherwise to exercise fully the licenses granted to Replidyne under Article 2 hereof. Each party will, at no cost or expense to the other party, provide such other party with copies of or access to any and all Development Information generated or otherwise obtained in the development of Products as provided in this Section 4.3 , all of which Development Information may be used and referenced by or on behalf of Forest in the development, manufacture and/or commercialization of Product in the Field in the Territory in accordance with the terms of this Agreement and by or on behalf of Replidyne in the performance by Replidyne of the development and commercialization activities with respect to the Product in the Field in the Territory in accordance with the terms of this Agreement and (including, as appropriate and, without limitation, by DAP) in the development, manufacture and/or commercialization of Product in the Field outside the Territory, including, without limitation, in the preparation, submission, filing, prosecution and maintenance of regulatory approvals in the applicable territory. Moreover, upon reasonable written notice from a party, the other party will provide regulatory authorities with access to any Development Information for inspection and/or review as may be required under Applicable Law.

           4.4 Clinical Supply. The parties will utilize Replidyne’s Product facility for Development Program purposes (e.g., Oral Suspension and Tablet formulation development) unless and until alternative facilities are available, with the costs incurred for such activity treated as Development Costs. Costs of manufacture and supply of Drug Substance and Product for development activities, including clinical trials, shall be treated as a Development Cost. Subject to the foregoing, the JSC (or if the JSC no longer exists, the party that is in charge of supply) shall be responsible for arranging for the supply of Drug Substance necessary for producing required clinical quantities of Product. Responsibility for packaging and labeling of clinical quantities of Product shall be assigned in the Development Plan.

           4.5 Development Reports. Each party shall keep the other party fully informed as to all discoveries and technical developments (including, without limitation, any Inventions) made in the course of performing activities under the Development Program. In particular, each party shall prepare, and distribute to all members of the JDC no later than ten (10) days prior to the next JDC meeting, such report as the JDC may request setting forth such information regarding the results and progress of performance of the Development Program. Nothing herein shall require a party to disclose information received from or generated for a Third Party that remains subject to bona fide confidentiality obligations to such Third Party; provided that neither party shall undertake any such confidentiality obligations in favor of Third Parties to the extent such obligations could reasonably be expected to prevent the sharing of information necessary or

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

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useful for the efficient conduct of the Development Program.

           4.6 Development Costs.

                (a)  Allocation of Costs . Replidyne will bear [ *** ] percent ( [ *** ] %) and Forest will bear [ *** ] percent ( [ *** ] %) of the Development Costs incurred by the parties under the Development Plan, including without limitation Development Costs incurred for clinical development necessary to support NDAs for a Tablet in a 600 mg dosage and an Oral Suspension.

                (b)  Reports and Payments . Each party shall report to the other party within thirty (30) days after the end of each Calendar Quarter the Development Costs incurred by such party during such Calendar Quarter. Such report shall specify in reasonable detail all amounts included in such Development Costs during such Calendar Quarter (broken down by activity) and shall be accompanied by invoices or other appropriate supporting documentation for any payments made by such party to Third Parties that individually exceed fifty thousand dollars ($50,000) or as may be determined by the JDC. Within forty five (45) days after the end of each Calendar Quarter, the party that has paid less than its share of such Development Costs as provided in Section 4.6(a) shall make a reconciling payment to the other party to achieve the appropriate allocation of Development Costs provided in Section 4.6(a) . Each such report shall enable the receiving party to compare the reported Development Costs against the Development Plan, on both a quarterly basis and a cumulative basis for each activity. The parties shall seek to resolve any questions related to such accounting statements within fifteen (15) days following receipt by each party of the other party’s report hereunder.

           4.7 Registration Activities. Regulatory strategy for the Product and all decision-making with respect thereto shall be determined by the JDC. Prior to the Effective Date, Replidyne has prepared and submitted to the FDA a NDA for a Tablet in a 300 mg dosage. Replidyne and Forest will collaborate to develop and prepare for submission any supplemental NDAs or additional NDAs for the Products, with the specific responsibilities of each party’s personnel to be assigned by the JDC based on the availability of expertise and resources within each party’s organization. Replidyne shall hold the NDA for the Tablet and any subsequent supplemental NDAs for the Tablet until approval of the NDA for the Tablet, at which time Forest will become the holder of such NDA. The IND and NDA for the Oral Suspension will be filed in Replidyne’s name, and Replidyne shall hold the NDA and any subsequent supplemental NDAs for the Oral Suspension until approval of the NDA for the Oral Suspension, at which time Forest will become the holder of such NDA. Irrespective of which party prepares any such NDA or portion thereof, the other party shall be given the opportunity to review and provide comments on any such submission and no such NDA (including any supplemental NDA) shall be submitted for filing to the FDA without the mutual agreement of Forest and Replidyne, such consent not to be unreasonably withheld or delayed. Forest and Replidyne shall keep one another fully informed of the registration process of Product through the Joint Development Committee. Each party shall use Commercially Reasonable Efforts to obtain in a timely manner NDA Approvals for Products.

           4.8 Meetings and Communications with the FDA. As of the date(s) to be mutually agreed by the parties, but in any event within six (6) months after the Effective Date, Forest shall

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

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be designated as Replidyne’s agent for purposes of adverse event reporting, sample tracking and submissions and interactions with the FDA’s Division of Drug Marketing, Advertising and Communications with respect to Products in the Territory and shall have the primary responsibility for the associated subject matters. Subject to the provisions of Section 4.7 , Replidyne shall be primarily responsible for and have the authority to conduct interactions with the FDA regarding NDA approval matters until transfer of the NDA to Forest, following which Forest shall have such primary contact responsibilities. Irrespective of which party has such primary contact responsibility, the other party shall be notified in advance of any substantive communications with the FDA and shall be afforded the opportunity to participate in such communications. Subject to the preceding sentence, to the extent permitted by the FDA, Replidyne and Forest shall mutually attend all meetings, participate in any oral communications and agree upon any written communications with the FDA relating to Product and labeling discussions with the FDA shall be conducted jointly by Forest and Replidyne.

           4.9 Subcontracts. Each party may perform some of their obligations under the Development Plan through one (1) or more Affiliates or subcontractors; provided that (a) none of the rights of either party hereunder are diminished or otherwise adversely affected as a result of such subcontracting, and (b) the Affiliate or subcontractor undertakes in writing obligations of confidentiality and non-use regarding Confidential Information which are substantially the same as those undertaken by the parties pursuant to Article 11 hereof. If a party performs any of its obligations under this Agreement through an Affiliate or subcontractor, then such party will at all times be responsible for the performance and payment of such Affiliate or subcontractor and will actively monitor and supervise the work of such Affiliate or subcontractor. Notwithstanding the foregoing, in the event a party desires to use a subcontractor hereunder, it will first offer the other party the opportunity to provide the affected services utilizing its internal resources to the extent such other party possesses qualified resources to provide such services in a timely and efficient manner and at a cost competitive to the use of Third Party resources.

           4.10 Materials Transfer. In order to facilitate the Development Program, either party may provide to the other party certain biological materials or chemical compounds Controlled by the supplying party (collectively, “Materials” ) for use by the other party in furtherance of the Development Program. Except as otherwise provided under this Agreement, all such Materials delivered to the other party will remain the sole property of the supplying party, will be used only in furtherance of the Development Program in accordance with this Agreement, will not be used or delivered to or for the benefit of any Third Party without the prior written consent of the supplying party, and will be used in compliance with all applicable laws, rules and regulations. The Materials supplied under this Agreement must be used with prudence and appropriate caution in any experimental work because not all of their characteristics may be known. Except as expressly set forth herein, and provided that the materials shall comply with any certificate of analysis or specifications provided by or on behalf of the supplying party, the Materials are provided “as is” and without any representation or warranty, express or implied, including without limitation any implied warranty of merchantability or of fitness for any particular purpose or any warranty that the use of the Materials will not infringe or violate any patent or other proprietary rights of any third party.

           4.11 Liability. In connection with the conduct of the Development Program, Replidyne will bear [ *** ] and Forest will bear [ *** ] of any liability for personal injury or

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

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property damage arising in connection with the conduct of the clinical development activities and the indemnification obligations of the parties set forth in Article 13 with respect to these matters shall be applied in a manner consistent with such allocation of liability; provided, however , that each party shall be responsible for, and hereby assumes, any and all risks of personal injury or property damage attributable solely to the negligence or willful misconduct of that party or its Affiliates, and their respective directors, officers, employees and agents.

5.

 

Commercialization

           5.1 Forest General Commercial Responsibilities. Forest or its Affiliate shall be responsible, at its own expense, for the conduct of all promotion, marketing, sampling, pre-launch, launch and sales activities with respect to Products in the Field in the Territory, subject to Replidyne’s promotion, marketing, sampling and sales activities with respect to Products to Target Specialists in the Territory, as more fully described in Section 5.4 , and if Replidyne exercises the Pediatrician Promotion Option pursuant to Section 5.5 , to Pediatricians in the Territory.

           5.2 Marketing Plans. Within a reasonable period of time after the Effective Date, Forest or its Affiliate shall prepare and submit to the Joint Marketing Committee for review and approval a Marketing Plan. The Marketing Plan for each Detailing Year shall include (a) marketing strategy, (b) sales forecasts, (c) amounts budgeted for expenditures by Forest on Marketing and Sample Expense for the Product in such Detailing Year, (d) a sampling plan with respect to the Product, (e) the aggregate number and monthly or quarterly breakdown of Detailing calls with respect to the Product that are projected in such Detailing Year, including the frequency of Details and the proportion of Details to be provided in first and second positions, and (f) the percentage of the total Detailing calls with respect to the Product to be performed by the Replidyne Specialty Sales Force in such Detailing Year and shall be prepared with input from Replidyne, including specifically, input as to those portions of the Marketing Plan describing activities directed to Target Specialists, which shall be consistent with the overall Marketing Plan for non-Target Specialists. A separate Marketing Plan shall be prepared for each Product subsequently launched, the initial version of which shall be submitted to the JMC for review and approval not later than three (3) months after NDA Acceptance for such Product. The Marketing Plan shall be updated on an annual basis approximately [ *** ] months in advance of the beginning of the next applicable Detailing Year. The JMC shall then discuss and agree upon such updated Marketing Plan within thirty (30) days after submission of such Marketing Plan to the JMC.

           5.3 Diligence.

                (a)  Forest shall use Commercially Reasonable Efforts to promote, market and sell Product in the Field in the Territory in accordance with the Marketing Plan.

                (b)  The launch of the Tablet in a 300 mg dosage by Forest or its Affiliates in the Territory shall take place within no more than six (6) months following NDA Approval of such Product, including, for this purpose, FDA approval of labeling and product launch promotional materials for such Product (provided that such that such NDA Approval includes approval for use in (i) acute sinusitis and (ii) and one of the following: (A) community acquired

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

25.


 

pneumonia; or (B) the AECB Indication, unless the JMC determines that seasonality considerations support extending the launch time by up to an additional three (3) months). In addition, Forest’s obligation to launch is subject to having approved dating for the Product of at least eighteen (18) months and having available launch supplies of Product having such dating (it being agreed that Forest shall be required to order Drug Substance when it is commercially reasonable to do so, with the understanding that receipt of an approvable letter from the FDA is not necessary for a determination that it is commercially reasonable to order Drug Substance for such Product supplies).

           (c) Without limiting the generality of the foregoing, Forest agrees that in each of the first [ *** ] sales years following the First Commercial Sale of the first Tablet subject to NDA Approval, Forest (i) will provide at least [ *** ] Details for the Tablet and (ii) will incur at least [ *** ] dollars ($ [ *** ] ) in Marketing and Sample Expense; provided that if there is any development (including Forest’s launch of the Product with only one approved respiratory indication) that is material and adverse to the market potential for the Tablet or materially and adversely affects the commercial value of Detailing efforts, and such specific commitment is no longer commercially reasonable in light of such development, then the preceding specific commitment shall be reduced to a commercially reasonable level mutually agreed by the parties.

           (d) Following launch of the first Oral Suspension, Commercially Reasonable Efforts with respect to the promotion and marketing of the Product to all audiences in the Territory shall require a significant increase over the level of resources applied to the promotion of the Tablets alone in the preceding year to reflect the additional value of the Oral Suspension. Without limiting the generality of the foregoing, the party responsible for promotional activities directed toward Pediatricians (i.e., Replidyne, if Replidyne has exercised the Pediatrician Promotion Option, and otherwise Forest) shall provide at least [ *** ] Details directed to Pediatricians during each of the first [ *** ] sales years following the First Commercial Sale of the Oral Suspension; provided that if there is any development (including launch of the Oral Suspension without approval of the AOM Indication) that is material and adverse to the market potential for the Oral Suspension or materially and adversely affects the commercial value of Detailing efforts, and such specific commitment is no longer commercially reasonable in light of such development, then the preceding specific commitment shall be reduced to a commercially reasonable level mutually agreed by the parties.

           (e) Irrespective of which party performs Detailing activities directed toward Pediatricians, the Marketing Plan will contain sections describing activities directed to Pediatricians, as well as the marketing of the Oral Suspension to non-Pediatricians, which sections will be consistent with the JMC’s overall marketing strategy for the Product in the Territory and with the overall Marketing Plan. The Marketing Plan shall establish goals for Detailing of the Product to Pediatricians and Detailing of the Oral Suspension to non-Pediatricians for each Detailing Year, including establishing the number and frequency of Details to be provided and the proportion of Details to be provided in first and second positions. In addition, the Marketing Plan for each Detailing Year shall also specify the proportion of Marketing and Sample Expense for efforts directed to Primary Care Physicians and other non-Pediatricians, on the one hand, to Marketing and Sample Expense for efforts directed to Pediatricians, on the other hand (the “Marketing Expense Ratio” ), with the JMC allocating Forest’s Marketing and Sample Expense directed to Primary Care Physicians and other non-

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

26.


 

Pediatricians on a reasonable basis between the Tablet and the Oral Suspension so that such Marketing and Sample Expense related to the Oral Suspension may be used as the Non-Pediatrician Suspension Marketing and Sample Expense, and shall specify minimum marketing contributions to be made by Forest and Replidyne (if Replidyne has exercised the Pediatrician Promotion Option), respectively, based on the Marketing Expense Ratio. In the absence of objective evidence to the contrary, the Marketing Expense Ratio shall assume an equal per physician value of promotion to Pediatricians and non-Pediatricians. In addition, whether or not Replidyne has exercised the Pediatrician Promotion Option, the party performing promotional activities directed to Pediatricians will use Commercially Reasonable Efforts to execute such activities and the diligence requirements of Section 2.3 of Schedule 5.5 shall apply to such promotional activities.

      5.4 Replidyne Commercial Activities for Target Specialists. Forest shall, through Forest Parent, engage Replidyne to perform all marketing and promotion-related activities for the Products directed to Target Specialists. Replidyne will promptly notify Forest at any time that it appears reasonably likely that Replidyne will not be able to substantially achieve required levels of Detailing over any significant period or in any significant area. Following any such notice, the parties will meet and confer in good faith to develop a plan to achieve such required levels of Detailing as promptly as practicable, including through the reallocation of Replidyne personnel, if practicable and without adversely affecting Replidyne’s Detailing efforts, and the utilization of Forest sales force personnel as reasonably required to achieve the required levels of Detailing. Following the development of such plan, Forest shall have the right to call on Target Specialists as provided by the plan, in which case the JMC will coordinate the efforts of each of Forest and Replidyne with respect to the Detailing of Product to Target Specialists by each party. In addition, if (a) Replidyne elects not to provide Details of the Product to certain Target Specialists (e.g., due to a particular geographical location), the Detail Reports indicate that Replidyne’s Detailing has not achieved material Detailing requirements to be performed by Replidyne as targeted by the Marketing Plan (as to number or position of Details) over a significant period or (b) the JMC determines, prior to a formal annual update to the Marketing Plan, that Detailing efforts to Target Physicians in addition to those in the then current Marketing Plan are appropriate and authorizes additional funds, if required (subject to the maximum funding set forth in Section 7.10(c) ), to support such additional Detailing efforts to Target Physicians, the parties will meet and confer in the manner set forth above to develop a plan to address the provision of additional Details, which plan will be based on the considerations, and implemented by the parties, as provided above. In any such event requiring the utilization of Forest sales force personnel, the parties will cooperate to transition Detailing efforts to Replidyne as promptly as practicable in light of the need to assure a smooth transition of Detailing activities once Replidyne possesses adequate resources to provide Detailing efforts targeted by the Marketing Plan. During the Replidyne Specialist Promotion Period, Replidyne will use its Commercially Reasonable Efforts to provide Detailing to Target Specialists in accordance with the Marketing Plan through the Replidyne Specialty Sales Force.

      (a)  Organization of Replidyne Specialty Sales Force . The JMC will determine the number of Target Specialists to be on the call plan, call frequency and other matters necessary to determine the size of the Replidyne Specialty Sales Force. The JMC will also determine what ancillary personnel and activities, if any, are needed to enhance Target

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

27.


 

Specialist promotional efforts and which are to be: (i) provided by Replidyne at Replidyne’s cost; (ii) provided in-kind by Forest for Replidyne’s use; or (iii) provided by Replidyne but reimbursed by Forest. For purposes of determining the size and geographical distribution of the Replidyne Specialty Sales Force, the call plan will contemplate approximately [ *** ] Target Specialists and a call frequency of an average of [ *** ] Details per Detailing Year; provided that in any event, the Replidyne Specialty Sales Force will be comprised of at least fifty (50) sales representatives, each having a sales territory that allows such sales representative to call upon a reasonable number of Target Specialists within a reasonable geographic area (i.e., without overly-burdensome travel requirements). During the Pre-Launch Period, Replidyne shall use its Commercially Reasonable Efforts to engage and organize the Replidyne Specialty Sales Force. The Replidyne Specialty Sales Force will be organized by Replidyne under the general recommendations and supervision of the JMC as to numbers and qualifications of sales representatives and field-based sales managerial personnel and the timing of hiring in light of the then-current Marketing Plan. Such sales representatives shall have qualification and experience at least comparable to Forest’s sales representatives and shall be entitled to incentive compensation with respect to the marketing of the Product on a basis not materially less favorable to the Product than provided by Forest to its sales representatives. During the Initial Period, the Replidyne Specialty Sales Force may be comprised of personnel provided by a contract sales organization; provided that at the end of the first [ *** ] of the Initial Period, the JMC shall determine whether:

                (i)  the Replidyne Specialty Sales Force has delivered [ *** ] percent ( [ *** ] %) of the Details set forth in the Marketing Plan for that time period;

                (ii)  at least [ *** ] percent ( [ *** ] %) of the Details performed by Replidyne Specialty Sales Force during that time period were delivered to Target Specialists on the call panel and with the frequency and Detail position established by the JMC; and

                (iii)  the performance by the Replidyne Specialty Sales Force meets the metrics previously established by the JMC to be measured in an ImpactRX report obtained at the [ *** ] benchmark point.

     If the Replidyne Specialty Sales Force fails to meet the foregoing requirements, Replidyne will provide written notice to Forest within [ *** ] of such determination by the JMC, indicating whether Replidyne will (A) transition to a sales force comprised of personnel who are full-time employees of Replidyne and coordinate Detailing to Target Specialists together with Forest’s sales representatives pending the achievement of a full-time employee trained and qualified sales force or (B) terminate its promotional efforts with respect to Target Specialists, in each case over the course of the [ *** ] month period immediately following such notice.

           (b) Training Materials and Sessions . Forest shall provide Replidyne with training materials Forest provides to the Forest Sales Force, sufficient in quantity and quality to allow Replidyne to train the Replidyne Specialty Sales Force in Product-specific sales skills and to Detail the Product in a manner consistent with the Detailing performed by the Forest Sales Force. Replidyne will prepare or have prepared any supplementary training materials required for Detailing the Product to the Target Specialists, consistent with the applicable Marketing Plan. Forest will permit Replidyne sales representatives to participate in training sessions of the Forest

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

28.


 

Sales Force in Product-specific sales skills with respect to the Product and the indications for the Product and will provide reasonable advance notice to Replidyne of scheduled training events. Without limiting the generality of the foregoing, the parties intend that the Replidyne Specialty Sales Force will participate in the initial Product launch and subsequent sales force meetings to the extent related to the Product.

           (c) Promotional Materials . Forest shall provide Replidyne with sales and promotional materials reasonably sufficient to permit Replidyne to perform Detailing calls in a manner consistent with the Detailing calls performed by the Forest Sales Force. Replidyne will create or have created on its behalf such additional sales and promotional materials intended to be specific to the Target Specialist audience as called for under, and consistent with, the Marketing Plan. The project managers of each party will share with one another any such materials, and no such materials may be utilized until completion of Forest’s regulatory and compliance review.

           (d) Sampling . Forest shall provide Replidyne with Product samples reasonably sufficient to permit Replidyne to perform Detailing calls in accordance with the Marketing Plan. Replidyne shall be responsible for accounting for sample distribution by the Replidyne Specialty Sales Force and shall maintain all records with respect to sample distribution as required by applicable laws and regulations. Within thirty (30) days after the end of each month, Replidyne shall provide to Forest a written report summarizing samples distributed by the Replidyne Specialty Sales Force for such calendar month. In addition, Replidyne shall ensure, through appropriate routine monitoring and auditing standards which conform with current good industry practices, that sampling of the Product is carried out by Replidyne in a manner which is in compliance with all Applicable Laws. Replidyne shall immediately advise Forest of its discovery of any act or omission of Replidyne regarding sample distribution that could violate or require reporting under applicable law. Forest shall be solely responsible for the filing of any necessary reports to FDA in connection with sampling. Within thirty (30) days after the expiration or termination of the Replidyne Specialist Promotion Period, Replidyne shall return, or otherwise dispose of in accordance with written instructions from Forest, all remaining samples and will provide Forest with a certified statement that all remaining samples have been returned or otherwise properly disposed of in accordance with Forest’s instructions and that Replidyne is no longer in possession or control of any samples in any form or fashion.

           (e) Funding . Forest will reimburse Replidyne for the Sales Force Expense and Marketing and Sampling Expense incurred by Replidyne in the performance of the activities to be conducted by the Replidyne Specialty Sales Force and ancillary personnel of Replidyne in accordance with the Marketing Plan, as provided in Section 7.10 . If Replidyne engages a contract sales organization rather than hiring its own employees for purposes of forming the Replidyne Specialty Sales Force, [ *** ] . Replidyne shall not be obligated to incur expenses for any marketing or promotional activities directed at Target Specialists, other than those expenses that are Sales Force Expense and Marketing and Sampling Expense to be reimbursed by Forest, unless Replidyne elects in its sole discretion to do so, provided that, unless Replidyne elects to cease promotional activities to Target Specialists and to transition such activities to Forest within a six-month period, Replidyne shall be responsible for the ancillary costs of the Replidyne Specialty Sales Force which are not Sales Force Expense. If at any time during the Replidyne

[ *** ] = 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 406 of the Securities Exchange Act of 1933, as amended.

29.


 

Specialist Promotion Period, the limits on Forest’s reimbursement of the Sales Force Expense and Marketing and Sampling Expense as set forth in Section 7.10 are such that Forest’s funding of the Replidyne activities directed to Target Specialists falls below the level sufficient to execute the Marketing Plan with respect to Target Specialists, except to the extent of the ancillary costs referred to in the preceding sentence, Replidyne shall not be obligated to supplement the funding to meet the goals of the Marketing Plan with respect to Target Specialists.

           (f) Additional Support . Forest will offer to Replidyne, free of charge, but at no additional out-of-pocket cost to Forest, reasonable access to Forest’s personnel and technology infrastructure as may be available to provide support for Replidyne’s marketing and promotion to Target Specialists (including without limitation, External Scientific Affairs and trainers, information technology support personnel and personnel responsible for accounting for sample distribution, database access, and access to Forest sample ordering systems).

           (g) Extension; Termination . The Replidyne Specialist Promotion Period shall be subject to renewal or extension by the written agreement of the parties. Replidyne reserves the right to terminate its promotional efforts under Section 5.4 at any time during the Replidyne Specialist Promotion Period, effective upon twelve (12) months written notice to Forest. If Replidyne exercises the foregoing right, Replidyne shall provide such transition activities as and for such period as Forest may reasonably request, including, without limitation, arranging for meetings between members of the Replidyne Specialty Sales Force and sales representatives of Forest, to assure a smooth transition of marketing to Target Specialists, subject to Forest’s payment of Sales Force Expense and Marketing and Sample Expense incurred by Replidyne with respect to such transition activities during any such transition period.

           (h) Forest Termination Right . If Forest ceases the promotion, sale or distribution of the Product in the Territory under the circumstances permitted under this Agreement, then upon written notice to Replidyne, Forest may terminate the Replidyne Specialist Promotion Period, effective within a reasonable period of time in light of the circumstances underlying any such cessation by Forest. In addition, Forest reserves the right to terminate the Replidyne Specialist Promotion Period, effective upon [ *** ] written notice to Replidyne in the event that the Detail Reports for at least [ *** ] indicate that Replidyne’s Detailing has not achieved at least [ *** ] percent ( [ *** ] %) of the Detailing to be performed by Replidyne as targeted by the Marketing Plan (as to number or position of Details) for each such Calendar Quarter or upon the failure by Replidyne to achieve at least [ *** ] percent ( [ *** ] %) of the Detailing to be performed by Replidyne as targeted by the Marketing Plan (as to numbers or portions of Details) in the aggregate over a period of [ *** ] , unless in either case, during such [ *** ] period Replidyne develops and implements a program of increased Detailing which provides, to Forest’s reasonable satisfaction, assurance that Detail shortfalls will not again occur. Failure of Replidyne to meet the number of Details required under the Marketing Plan with respect to promotion efforts dire


 
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