UNITED STATES COLLABORATION AGREEMENT

Exhibit 10.13

 

Certain confidential information contained in this document, marked by brackets and asterisks, [*], has been omitted pursuant to a request for confidential treatment pursuant to Rule 24b–2 of the Securities Exchange Act of 1934, as amended, and has been filed separately with the Securities and Exchange Commission.

 

UNITED STATES

COLLABORATION AGREEMENT

 

BY AND AMONG

 

SHIRE LLC

 

SHIRE PHARMACEUTICALS GROUP PLC

 

AND

 

NEW RIVER PHARMACEUTICALS INC.

 

DATED AS OF MARCH 31, 2005

 

 

TABLE OF CONTENTS

 

 

i

TABLE OF CONTENTS

(continued)

 

 

ii

TABLE OF CONTENTS

(continued)

 

 

iii

TABLE OF CONTENTS

(continued)

 

 

iv

TABLE OF CONTENTS

(continued)

 

 

v

Exhibits

 

 

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UNITED STATES

COLLABORATION AGREEMENT

 

THIS UNITED STATES COLLABORATION AGREEMENT (the “ Agreement ”) is dated as of March 31, 2005 by and among SHIRE LLC, a Kentucky limited liability company having a principal place of business at 9200 Brookfield Court, Florence, Kentucky 41042 (“ Shire ”), SHIRE PHARMACEUTICALS GROUP PLC, a British public limited company having a principal place of business at Hampshire International Business Park, Chineham, Basingstoke, England RG24 8EP, solely for purposes of the provisions of Section 15.10 of this Agreement, and NEW RIVER PHARMACEUTICALS INC., a Virginia corporation having a principal place of business at 1881 Grove Avenue, Radford, Virginia 24141 (“ New River ”). Shire and New River are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties ”.

 

RECITALS

 

WHEREAS , New River is a specialty pharmaceutical company focused on developing novel pharmaceuticals that are safer and improved versions of widely-prescribed pharmaceutical products, and is clinically developing a proprietary amphetamine conjugate for the treatment of attention deficit/hyperactivity disorder in pediatric and adult patients;

 

WHEREAS , Shire is a worldwide, specialty pharmaceutical company engaged in the development, manufacturing and marketing of pharmaceutical products;

 

WHEREAS , on January 31, 2005 (the “ Effective Date ”), the Parties entered into that certain Collaboration Agreement (the “ January Agreement ”) that established a broad collaboration for the further development and commercialization of Compound in both the US Territory and ROW Territory, with the objective of utilizing the areas of expertise of both New River and Shire to provide products to patients;

 

WHEREAS , pursuant to Section 17.16 of the January Agreement, the Parties agreed to divide the January Agreement into two separate agreements: one relating to the US Territory and the other relating to the ROW Territory;

 

WHEREAS , as contemplated by Section 17.16 of the January Agreement, New River and Shire Pharmaceuticals Ireland Limited, an Affiliate of Shire, are entering into that certain ROW Territory License Agreement (the “ ROW Agreement ”) simultaneously with the execution of this Agreement; and

 

WHEREAS , this Agreement, together with the ROW Agreement, supercede and replace the January Agreement in its entirety.

 

NOW, THEREFORE , in consideration of the foregoing premises and the mutual covenants contained herein, the Parties, intending to be legally bound, agree as follows:

 

ARTICLE 1

DEFINITIONS

 

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

 

1.1 “ Act ” means the United States Federal Food, Drug and Cosmetics Act, as amended from time to time, and the rules, regulations and guidelines promulgated thereunder.

 

1.2 “ ADHD ” means attention deficit/hyperactivity disorder in human beings.

 

1.3 “ Adolescent ” means a human being that has attained the age of thirteen (13) but is less than eighteen (18) years of age.

 

1.4 “ Adult ” means a human being that has attained the age of eighteen (18).

 

1.5 “ Affiliate ” means a Person that controls, is controlled by or is under common control with a Party. For the purposes of this definition, the word “control” (including, with correlative meaning, the terms “controlled by” or “under common control with”) means the actual power, either directly or indirectly through one or more intermediaries, to direct the management and policies of such Person, whether by the ownership of at least fifty percent (50%) of the voting stock of such Person (it being understood that the direct or indirect ownership of a lesser percentage of such stock shall not necessarily preclude the existence of control), or by contract or otherwise.

 

1.6 “ Allowable Expenses ” means those expenses incurred after the First Commercial Sale of a Collaboration Product which are consistent with the budget set forth in the applicable Marketing Plan, and are specifically attributable or reasonably allocable to such Collaboration Product in the US Territory, and shall consist of (i) Cost of Goods Sold, (ii) Marketing Expenses, (iii) Distribution Expenses, (iv) product liability insurance expenses, and (v) Regulatory Expenses (as such terms may be defined in this Article 1 or in Exhibit A ). Allowable Expenses shall exclude Development Expenses, even if incurred after the First Commercial Sale of a Collaboration Product in the US Territory, and shall exclude any costs that are deductible from Net Sales under the definition thereof ( e.g. , distributor fees).

 

1.7 “ Business Day ” means any day other than (i) Saturday or Sunday or (ii) any other day on which banks in New York, New York, United States or London, England are permitted or required to be closed.

 

1.8 “ cGCP ” means the current Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials, including the requirements in 21 C.F.R. Parts 11, 50, 54, 56, 312, and 314, that provide assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

 

1.9 “ cGLP ” means current Good Laboratory Practices (i) as promulgated under the Act at 21 C.F.R. Part 58, as the same may be amended or re-enacted from time to time and (ii) as required by Law in countries other than the United States where non-clinical laboratory studies are conducted.

 

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1.10 “ cGMP ” means all applicable standards relating to manufacturing practices for fine chemicals, active pharmaceutical ingredients, intermediates, bulk products or finished pharmaceutical products, including (i) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 210 and 211 and The Rules Governing Medicinal Products in the European Community, Volume IV Good Manufacturing Practice for Medicinal Products as each may be amended from time to time, (ii) the principles detailed in the ICH Q7A guidelines, (iii) if Shire notifies New River that Shire intends to Commercialize a Collaboration Product in a country, Laws promulgated by any Governmental Authority in such country having jurisdiction over the Manufacture of Compound or Collaboration Product, or (iv) if Shire notifies New River that Shire intends to Commercialize a Collaboration Product in a country, guidance documents promulgated by any Governmental Authority in such country having jurisdiction over the Manufacture of Compound or Collaboration Product (including but not limited to advisory opinions, compliance policy guides and guidelines), which guidance documents are being implemented within the pharmaceutical manufacturing industry.

 

1.11 “ Child ” means a human being that has not attained the age of thirteen (13).

 

1.12 “ Collaboration Product ” means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

 

1.13 “ Combination Product ” means any Collaboration Product that contains the Compound and one or more pharmaceutically active ingredients in addition to Compound, and any and all Improvements thereto.

 

1.14 “ Commercialization ” means any and all activities directed to the commercial Manufacturing, marketing, offering for sale and selling of a Collaboration Product, including Pre-Marketing, advertising, educating, planning, marketing, promoting, distributing and conducting market and product support studies and post-marketing safety surveillance and reporting.

 

1.15 “ Committee ” means the JDC, JMC, JSC or JIPC, as the case may be.

 

1.16 “ Compound ” has the meaning set forth on Exhibit F .

 

1.17 “ Control ” means, with respect to any intellectual property right or other intangible property, that a Party or one of its Affiliates owns or has a license or sublicense to such item or right, and has the ability to grant access, license or sublicense in or to such right without violating the terms of any agreement or other arrangement with any Third Party.

 

1.18 “ Controlled Substances Act ” means the United States Controlled Substances Act, as amended (21 U.S.C. 801 et seq).

 

1.19 “ Co-Promotion ” means those Detailing and promotional activities (including without limitation performing Sales Calls) with respect to a Co-Promote Product undertaken by New River Sales Representatives to encourage appropriate prescribing of such Co-Promote Product in the US Territory.

 

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1.20 “ Cost of Goods Sold ” means the cost of Collaboration Product sold in finished form by Shire or any of its Affiliates or sublicensees to a Third Party, as calculated in the manner set forth in Exhibit A . The term “Cost of Goods” has a separate meaning as set forth in Exhibit A .

 

1.21 “ Detail ” or “ Detailing ” means, with respect to a Collaboration Product, the communication by a Sales Representative during a Sales Call (a) involving face-to-face contact or by means of an e-detail or detailing through video, (b) describing in a fair and balanced manner the FDA-approved indicated uses and other relevant characteristics of such Collaboration Product, (c) using the Promotional Materials in an effort to increase the prescribing and/or hospital ordering preferences of a Collaboration Product for its FDA-approved indicated uses, and (d) made at such medical professional’s office, in a hospital, at marketing meetings sponsored by a Party for the Collaboration Products or other appropriate venues conducive to pharmaceutical product informational communication where the principal objective is to place an emphasis, either primary or secondary, on a Collaboration Product and not simply to discuss a Collaboration Product with such medical professional. For the avoidance of doubt, discussions at conventions or other meetings not specifically sponsored by a Party for a Collaboration Product shall not constitute “Details” or “Detailing”.

 

1.22 “ Development ” means all activities relating to obtaining Regulatory Approval of a Collaboration Product, including all test method development, stability testing, toxicology, formulation, process development, cGMP audits (but only those performed prior to Regulatory Approval and excluding any audits for commercial Manufacture), cGLP audits, cGCP audits, validation, quality assurance/quality control development, preclinical and clinical testing and studies, regulatory affairs and outside counsel regulatory legal services relating to any of the foregoing, and any activities relating to the Manufacture of Collaboration Products other than commercial quantities thereof. For the avoidance of doubt, the conduct of Phase III-B Clinical Studies will be considered Development.

 

1.23 “ Development Expenses ” means the expenses incurred by a Party that are consistent with a Development Plan and are specifically attributable or reasonably allocable to the Development of a Collaboration Product. Development Expenses shall include, but are not limited to, the following costs incurred for the Development of a Collaboration Product: the cost of studies on the toxicological, pharmacokinetic, metabolic or clinical aspects of a Collaboration Product directed to obtaining Regulatory Approval of a Collaboration Product; the cost of Phase III-B Clinical Trials, and costs (and related fees) for preparing, submitting, reviewing or developing data or information for the purpose of submission to a Governmental Authority to obtain Regulatory Approval of a Collaboration Product; and manufacturing process development and scale-up for Collaboration Products in bulk and finished form. Development Expenses shall exclude any [*] incurred by a Party in connection with the Development of a Collaboration Product.

 

1.24 “ Diligent Efforts ” means the carrying out of obligations or tasks consistent with the reasonable best practices of the pharmaceutical industry for the development or commercialization of a pharmaceutical product having similar market potential, profit potential or strategic value as the applicable Collaboration Product, based on conditions then prevailing. Diligent Efforts requires that the Party, at a minimum: (a) determine the general industry

 

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practices with respect to the applicable activities; (b) reasonably promptly assign responsibility for such obligations to specific employee(s) who are held accountable for progress and monitor such progress on an on-going basis; (c) set and consistently seek to achieve specific and meaningful objectives for carrying out such obligations; and (d) make and implement decisions and allocate resources designed to advance progress with respect to such objectives.

 

1.25 “ Drug Approval Application ” means an application for Regulatory Approval required before commercial sale or use of a Collaboration Product as a drug in a regulatory jurisdiction, including a new drug application (“ NDA ”) or supplemental new drug application (“ SNDA ”) or any amendments thereto submitted to the FDA.

 

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

 

1.27 “ Field ” means all human and veterinary pharmaceutical uses.

 

1.28 “ Financial Statement ” means a financial statement in a form as may be reasonably agreed upon by the Parties from time to time in accordance with the terms of this Agreement.

 

1.29 “ First Commercial Sale ” means, with respect to a Collaboration Product and on a country-by-country basis, the first commercial sale after receipt of Regulatory Approval of such Collaboration Product in such country. Sales for clinical studies, compassionate use, named patient programs, sales under a treatment IND, test marketing, any nonregistrational studies, or any similar instance where the Collaboration Product is supplied with or without charge shall not constitute a First Commercial Sale. For clarity, it is understood and agreed that the First Commercial Sale of a Collaboration Product for ADHD in the US Territory shall not occur until the receipt of Regulatory Approval, including the receipt by New River of written notification from the FDA of approval of the Drug Approval Application [*] for such Collaboration Product, and New River has provided such written notification to Shire.

 

1.30 “ Governmental Authority ” means any court, tribunal, arbitrator, agency, legislative body, commission, official or other instrumentality of (i) any government of any country, (ii) a federal, state, province, county, city or other political subdivision thereof or (iii) any supranational body, including without limitation the European Agency for the Evaluation of Medicinal Products.

 

1.31 “ Improvement ” means any enhancement or modification of (i) a Collaboration Product, (ii) the Compound’s or Collaboration Product’s use, dosage form, indication, line extension, presentation or formulation or (iii) the process or method for the Manufacture of the Compound or Collaboration Product, in each case whether or not patentable, that is developed by or for, invented or acquired by, or comes under the Control of, New River or Shire during the Term.

 

1.32 “ IND ” means an Investigational New Drug Application filed with FDA or a similar application filed with an applicable Regulatory Authority outside of the United States such as a clinical trial application (CTA) or a clinical trial exemption (CTX).

 

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1.33 “ Invention ” means any discovery (whether patentable or not) conceived during the Term and potentially useful for the Manufacture, use, Development or Commercialization of the Compound or a Collaboration Product.

 

1.34 “ Joint Invention ” means an Invention that is conceived jointly by an employee of, or person under an obligation of assignment to, each of New River and Shire.

 

1.35 “ Know-How ” means any non-public information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including without limitation, databases, ideas, discoveries, inventions, trade secrets, practices, methods, tests, assays, techniques, specifications, processes, formulations, formulae, knowledge, know-how, skill, experience, materials, including pharmaceutical, chemical and biological materials, products and compositions, scientific, technical or test data (including pharmacological, biological, chemical, biochemical, toxicological and clinical test data), analytical and quality control data, stability data, studies and procedures, drawings, plans, designs, diagrams, sketches, technology, documentation, and patent-related and other legal information or descriptions.

 

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

 

1.37 “ Licensed Know-How ” means all Know-How that is Controlled by New River as of the Effective Date or at any time during the Term and that is potentially useful for the Development, Manufacture, use and/or Commercialization of the Compound, a Collaboration Product and/or a New River Invention; provided, however, that Know-How Controlled by New River disclosing New River’s proprietary Carrierwave ^TM technology shall not be included in Licensed Know-How except to the extent necessary for Shire to exercise its rights and perform its obligations under this Agreement. Notwithstanding anything herein to the contrary, Licensed Know-How shall exclude Licensed Patents.

 

1.38 “ Licensed Patent ” means a Patent that (i) claims the Manufacture, use, Development, Commercialization and/or export of the Compound, a Collaboration Product and/or a New River Invention, and (ii) is Controlled by New River as of the Effective Date or at any time during the Term. For the avoidance of doubt, all New River Collaboration Patents shall be considered Licensed Patents.

 

1.39 “ Losses ” means any and all amounts paid or payable to Third Parties with respect to a Third Party Claim, including without limitation, damages (including all incidental and consequential damages), deficiencies, defaults, awards, settlement amounts, assessments, fines, dues, penalties, costs, liabilities, obligations, taxes, liens, losses, lost profits, fees and expenses (including, without limitation, court costs, interest and reasonable fees of attorneys, accountants and other experts).

 

1.40 “ Manufacture ” means all activities related to the manufacturing of a pharmaceutical product, or any ingredient thereof, including but not limited to manufacturing Compound or supplies for Development, manufacturing Collaboration Product for commercial sale, packaging, in-process and finished product testing, release of product or any component or

 

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ingredient thereof, quality assurance activities related to manufacturing and release of product, ongoing stability tests and regulatory activities related to any of the foregoing.

 

1.41 “ Marketing Plan ” means a written marketing plan and budget for a Collaboration Product during an applicable time period that contains at least the following for the relevant time period: (i) a rolling, good faith forecast of [*] for at least four (4) full, consecutive calendar quarters; (ii) general strategies and programs for promoting, Detailing and marketing such Collaboration Product; and (iii) the definitions of the relative roles, levels, types of efforts and spending for such period.

 

1.42 “ Net Sales ” means, with respect to a Collaboration Product, the amount invoiced by Shire, its Affiliates or sublicensees for sales of such Collaboration Product to a Third Party (“ Invoiced Amount ”) less: (i) transportation charges, freight and insurance (but only insurance related to protecting the particular shipment against physical loss or damage); (ii) taxes (other than taxes based on income), tariffs, customs duty, excise or other duty and any other governmental charges, all to the extent imposed upon the sale, transportation or delivery of such Collaboration Product and paid by the seller; (iii) Third Party distributor fees; (iv) trade discounts, quantity discounts, cash discounts, rebates, reimbursements, cooperative advertising allowances, credits or chargebacks actually granted, allowed or incurred in the ordinary course of business in connection with the sale of such Collaboration Product, including any credits, volume rebates, charge-back and prime vendor rebates, fees, fees for services, reimbursements or similar payments granted or given to wholesalers and other distributors, buying groups, health care insurance carriers, pharmacy benefit management companies, health maintenance organizations or other institutions or health care organizations; (v) adjustments, allowances or credits (calculated on a per unit basis) to customers, not in excess of the selling price per unit of such Collaboration Product, including without limitation on account of price adjustments, governmental requirements, billing errors, rejection, damage, recalls or return of such Collaboration Product; (vi) payments or rebates paid in connection with sales of Collaboration Products to any governmental or regulatory authority in respect of any state or federal Medicare, Medicaid or similar programs; (vii) royalties or technology access fees paid to a Third Party in respect of the sale of such Collaboration Product; (viii) write-offs for bad debts incurred (net of any bad debts later recovered); and (ix) any item substantially similar in character/substance to the foregoing. Net Sales shall be accounted for in accordance with generally accepted accounting principles (“ GAAP ”) consistently applied in the jurisdiction in which the sales occur, it being understood that bad debt write-off shall be deducted in arriving at Net Sales notwithstanding that such treatment may be inconsistent with GAAP, and it being further understood that Shire shall make bad debt write-off decisions consistent with its usual business practices.

 

Amounts received by Shire or its Affiliates or sublicensees for the sale of Collaboration Products among Shire and its Affiliates and sublicensees for resale shall not be included in the computation of Net Sales hereunder. For the avoidance of doubt, no amount of cost, expense or other reduction or adjustment, whether or not specifically referred to in this definition of Net Sales, shall serve to adjust the Invoiced Amount more than once in arriving at Net Sales.

 

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1.43 “ New River Invention ” means an Invention that is conceived, solely or jointly with a Third Party, by an employee of New River or a person under an obligation of assignment to New River.

 

1.44 “ Patent ” means (i) valid and enforceable patents, re-examinations, reissues, renewals, extensions, supplementary protection certificates and term restorations, any confirmation patent or registration patent or patent of addition based on any such patent, (ii) pending applications for patents, including without limitation continuations, continuations-in-part, divisional, provisional and substitute applications, and inventors’ certificates, (iii) all foreign counterparts of any of the foregoing, and (iv) all priority applications of any of the foregoing.

 

1.45 “ Patent Expenses ” means the fees and expenses of outside counsel and payments to Third Parties incurred after the Effective Date in connection with the preparation, filing, prosecution and maintenance of the Licensed Patents, the Joint Collaboration Patents, and the Shire Patents covering Compound and Collaboration Products, including the costs of patent interference and opposition proceedings, net of any reimbursement of such expenses by Third Parties.

 

1.46 “ Person ” means any natural person, corporation, firm, business trust, joint venture, association, organization, company, partnership or other business entity, or any government, or any agency or political subdivisions thereof.

 

1.47 “ Phase III-B Clinical Trials ” means product support clinical trials of a Collaboration Product ( i.e. , a clinical trial which is not required for receipt of initial Regulatory Approval but which may be useful in providing additional drug profile data or in seeking a label expansion) commenced before receipt of Regulatory Approval for the indication for which such trial is being conducted. For the avoidance of doubt, Phase III-B Clinical Trials shall be considered part of Development.

 

1.48 “ Phase IV and Related Expenses ” means certain research and development costs incurred by a Party in relation to a Collaboration Product after the First Commercial Sale and shall exclude administrative expenses and costs that are included within Costs of Goods Sold or Development Expenses. Such post-launch research and development costs shall include the costs of: (i) Phase IV Clinical Trials; (ii) ongoing product support; (iii) ongoing medical affairs; and (iv) fees and expenses of outside counsel in respect of regulatory affairs unrelated to obtaining Regulatory Approvals.

 

1.49 “ Phase IV Clinical Trials ” means product support clinical trials of a Collaboration Product commenced after receipt of Regulatory Approval in the indication for which such trial is being conducted.

 

1.50 “ Pre-Marketing ” means all sales and marketing activities undertaken prior to and in preparation for the launch of a Collaboration Product in a particular territory. Pre-Marketing shall include advertising, education, product-related public relations, health care economic studies, governmental affairs activities for reimbursement and formulary acceptance, sales force training, trademark selection, filing, prosecution and enforcement, and other activities included

 

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within the Marketing Plan prior to the First Commercial Sale of a Collaboration Product in such territory.

 

1.51 “ Pre-Marketing Expenses ” means, with respect to a Collaboration Product, any Marketing Expenses incurred by a Party prior to the First Commercial Sale of such Collaboration Product.

 

1.52 [*] means a [*] during which (i) the applicable [*] is [*] either [*] or [*] , (ii) [*] of such [*] are [*] in the [*] on such [*] , and (iii) such [*] is given the [*] of the [*] during the [*] . For clarity, no more than [*] during a [*] shall be [*] .

 

1.53 “ Promotional Materials ” means all written, printed, video or graphic advertising, promotional, educational and communication materials (other than Collaboration Product labels and package inserts) for marketing, advertising and promotion of the Collaboration Products, including, without limitation, copyrights in any such materials and all designs, industrial designs, design patents, design registrations, and design patent applications developed in connection with such materials, for use by (a) a Sales Representative or (b) advertisements, web sites or direct mail pieces, in accordance with the terms of the applicable Marketing Plan. For clarity, it is understood and agreed that Promotional Materials shall not include corporate communications and general marketing or advertising by a Party or its Affiliate; provided however, that to the extent that such corporate communications or general marketing or advertising include or reference a Collaboration Product or related disease state and do not make any actual or implied claims, then such corporate communications or general marketing or advertising shall be governed by the provisions of Section 10.2.

 

1.54 “ Regulatory Approval ” means all approvals [*] , product and/or establishment licenses, registrations or authorizations of any regional, federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacture, use, storage, import, export, transport, offer for sale, or sale of a pharmaceutical product in a regulatory jurisdiction.

 

1.55 “ ROW Territory ” means the world, excluding the US Territory.

 

1.56 “ Sales Call ” means a personal visit by a Sales Representative to one or several medical professional(s) having prescribing authority in the part of the Field for the indications in which such Collaboration Product is approved, as well as to other individuals or entities that have significant impact or influence on prescribing decisions in the part of the Field in which such Collaboration Product is approved during which such Sales Representative Details a Collaboration Product.

 

1.57 “ Sales Representative ” means a pharmaceutical sales representative engaged or employed by either Party to conduct Detailing and other promotional efforts with respect to the Collaboration Products and who has been trained by Shire in accordance with the terms of this Agreement.

 

1.58 “ Samples ” means Collaboration Product packaged and distributed as a complementary trial for use with patients in the United States and in accordance with the

 

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Prescription Drug Marketing Act of 1987, as amended (the “ PDM Act ”) and free goods provided for this purpose through coupons or other mechanisms.

 

1.59 “ Schedule Classification ” means, with respect to a Collaboration Product, the [*] by [*] under the [*] of a particular [*] for such Collaboration Product, as communicated in writing either by (i) the [*] in the form of the [*] of a [*] any [*] as to [*] , if the [*] is [*] , or (ii) the [*] by publication of a [*] for the Collaboration Product in the [*] .

 

1.60 “ Shire Background Know-How ” means all Know-How Controlled by Shire, other than Shire Collaboration Know-How, that is potentially useful for the Development, Manufacture, use and/or Commercialization of the Compound, a Collaboration Product and/or Shire Invention, to the extent such Know-How is included in a Development Plan or Marketing Plan that has been agreed to and approved by Shire. Notwithstanding anything herein to the contrary, Shire Background Know-How shall exclude Shire Background Patents.

 

1.61 “ Shire Background Patent ” means a Patent Controlled by Shire, other than a Shire Collaboration Patent, that is potentially useful for the Development, Manufacture, use and/or Commercialization of the Compound, a Collaboration Product and/or Shire Invention, to the extent such Patent is included in a Development Plan that has been agreed to and approved by Shire.

 

1.62 “ Shire Collaboration Know-How ” means all Know-How that is developed by Shire or its Affiliates during the Term pursuant to this Agreement or the ROW Agreement and that is potentially useful for the Development, Manufacture, use and/or Commercialization of the Compound, a Collaboration Product and/or Shire Invention. Notwithstanding anything herein to the contrary, Shire Collaboration Know-How shall exclude Shire Collaboration Patents.

 

1.63 “ Shire Invention ” means an Invention that is conceived, solely or jointly with a Third Party, by an employee or Affiliate of Shire or a person under an obligation of assignment to Shire.

 

1.64 “ Shire Know-How ” means the Shire Background Know-How and the Shire Collaboration Know-How. Notwithstanding anything herein to the contrary, Shire Know-How shall exclude Shire Patents.

 

1.65 “ Shire Patents ” means the Shire Background Patents and the Shire Collaboration Patents.

 

1.66 “ [*] ” means [*] .

 

1.67 “ Third Party ” means any entity other than New River or Shire or their respective Affiliates.

 

1.68 “ US Product Profit ” means the profits or losses resulting from the Commercialization of Collaboration Products in the US Territory and shall be equal to Net Sales of Collaboration Products in the US Territory less Allowable Expenses less Phase IV and Related Expenses.

 

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1.69 “ US Territory ” means the United States of America, its territories and possessions.

 

1.70 “ Valid Claim ” means: (a) a claim of an issued Patent that has not (i) expired or been canceled, (ii) been declared invalid or unenforceable by a decision of a court or other appropriate body of competent jurisdiction, from which no appeal is or can be taken, (iii) been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise, or (iv) been abandoned, disclaimed or dedicated to the public; and (b) a claim included in a pending patent application that is being actively prosecuted in accordance with this Agreement and that has not been (i) canceled, (ii) withdrawn from consideration, (iii) finally determined to be unallowable by the applicable governmental authority (from which no appeal is or can be taken), or (iv) abandoned or disclaimed. Notwithstanding the foregoing clause (b), in the event that a pending claim in a pending patent application is rejected and does not issue in an issued Patent within [*] after the earliest date from which such claim was originally presented, such a pending claim will not be a Valid Claim, unless and until such pending claim subsequently issues in an issued Patent, at which time such claim may again be a Valid Claim as of the date of issuance of such Patent, if such claim also meets the requirements of this Section 1.70.

 

Interpretation . Unless the context of this Agreement otherwise requires, (a) words of one gender include the other gender; (b) words using the singular or plural number also include the plural or singular number, respectively; (c) the terms “hereof,” “herein,” “hereby,” and other similar words refer to this entire Agreement; and (d) the terms “Article” and “Section” refer to the specified Article and Section of this Agreement. Whenever this Agreement refers to a number of days, unless otherwise specified, such number shall refer to calendar days.

 

Additional Definitions . Each of the following definitions is set forth in the Section of this Agreement indicated below:

 

 

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ARTICLE 2

MANAGEMENT OF COLLABORATION

 

2.1 General . The general purpose of the collaboration described in this Agreement will be to Develop and Commercialize Collaboration Products. The Parties desire to establish four (4) specialized committees to oversee the Parties’ collaboration under this Agreement and to facilitate communications between the Parties with respect to the Development, Commercialization, Manufacturing and intellectual property strategy of Collaboration Products hereunder and, where applicable, in the ROW Territory. Each of such Committees shall have the responsibilities and authority allocated to it in this Article 2. Each of the Committees shall have the obligation to exercise its authority consistent with the respective purpose for such Committee as stated herein and any such decisions shall be made in good faith. For the avoidance of doubt, the Committees described herein are the same committees as are described in the ROW Agreement, and each such Committee will have the responsibilities and authority set forth in this Agreement and in the ROW Agreement (with the exception of the JMC, which has no authority with respect to the ROW Territory).

 

2.2 Joint Development Committee (JDC).

 

2.2.1 Formation and Purpose . Promptly following the Effective Date, the Parties shall create a joint development committee (the “ JDC ”) to oversee the Development of Collaboration Products hereunder. The purposes of the JDC shall be (a) to determine the Development strategy for the Collaboration Products in the US Territory and Major EU Markets (as defined in the ROW Agreement), (b) to facilitate the management and implementation of the Parties’ Development activities hereunder, and (c) to approve plans and budgets for the Development by New River of Collaboration Products for ADHD in the US Territory. The JDC shall have the membership and shall operate by the procedures set forth in Section 2.6.

 

2.2.2 Specific Responsibilities of the JDC . In addition to its overall responsibilities described in Section 2.2.1, subject to Section 2.7.1, the JDC shall, in particular:

 

(a) select Collaboration Products for research and Development under this Agreement in the US Territory and Major EU Markets;

 

(b) prepare, approve and amend each Development Plan (including regulatory submission strategies and plans) for Collaboration Products in the US Territory and the Major EU Markets;

 

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(c) monitor the progress of the activities undertaken by the Parties pursuant to each Development Plan;

 

(d) review and approve proposals from the Parties to Develop Improvements and/or Combination Products;

 

(e) coordinate and oversee the Parties’ Regulatory Approval submission plans in the US Territory;

 

(f) design and approve all clinical trials of Collaboration Products proposed to be conducted anywhere in the world for consistency and efficiency, including without limitation by creating the protocols, defining the end points, and selecting the primary investigators for such trials;

 

(g) have primary responsibility for establishing the objectives for all Phase IV Clinical Trials of Collaboration Products proposed to be conducted for the US Territory, including without limitation by creating the protocols, defining the end points, and selecting the primary investigators for such trials;

 

(h) manage the flow of information with respect to Development being conducted for each Collaboration Product;

 

(i) review and approve the statistical analysis plans and protocols for all Collaboration Product clinical studies conducted worldwide, and any investigator’s brochure(s) and revisions thereto;

 

(j) work together with the other Committees during the Development of Collaboration Products to assure a smooth transition from Development of such Collaboration Product to Commercialization of such Collaboration Product;

 

(k) review and approve compliance plans whereby the Parties prepare for or participate in a Governmental Authority inspection of the preclinical or clinical data or preclinical sites/clinical sites or laboratories; and

 

(l) review and approve pharmacovigilance plans.

 

2.3 Joint Marketing Committee (JMC).

 

2.3.1 Formation and Purpose . Promptly after the Effective Date, the Parties shall create a joint marketing committee (the “ JMC ”), which shall oversee the Commercialization of Collaboration Products in the US Territory, including the marketing, sales and distribution of Collaboration Products in such territory. The JMC shall have the membership and shall operate by the procedures set forth in Section 2.6.

 

2.3.2 Specific Responsibilities of the JMC . In addition to its overall responsibilities described in Section 2.3.1, subject to Section 2.7.2, the JMC shall, in particular:

 

(a) prepare, approve and amend the Marketing Plan for Collaboration Products in the US Territory;

 

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(b) monitor the progress of the activities undertaken by the Parties pursuant to the Marketing Plan for the US Territory;

 

(c) manage the flow of information with respect to Commercialization activities in the US Territory for each Collaboration Product;

 

(d) coordinate and oversee the Parties’ plans for labeling and selecting trademarks for Collaboration Products in the US Territory;

 

(e) approve packaging designs, and plan and oversee non-independent educational and professional symposia, and speaker and peer-to-peer activity programs, for the Collaboration Products in the US Territory;

 

(f) discuss and suggest a range of suggested prices at which Collaboration Products will be sold to unaffiliated Third Parties in the US Territory and any discount strategies for Collaboration Products in the US Territory; provided that nothing contained herein, except as set forth in Section 4.2.2, shall limit or in any way restrict Shire from having the final decision on setting the price at which a Collaboration Product is sold; and

 

(g) recommend whether to seek new indications, formulations or uses for Collaboration Products in the US Territory, such as for Collaboration Product life cycle management, including the Development and Commercialization of an authorized generic of any Collaboration Product, for approval by the JDC.

 

2.4 Joint Supply Committee (JSC).

 

2.4.1 Formation and Purpose . Promptly after the Effective Date, the Parties shall create a joint supply committee (the “ JSC ”) to facilitate the management and implementation of the Parties’ activities with regard to the Manufacture and supply of Collaboration Products worldwide. The JSC shall have the membership and shall operate by the procedures set forth in Section 2.6.

 

2.4.2 Specific Responsibilities of the JSC . In addition to its overall responsibilities described in Section 2.4.1, and subject to the provisions of Section 2.7.3 and Article 6, the JSC shall, in particular:

 

(a) select which Party and/or Third Party(ies) to engage for the Manufacture and supply of Collaboration Products and components thereof (“ Third Party Manufacturers ”), oversee auditing of Third Party Manufacturers, and approve contracts governing such Manufacture and supply;

 

(b) delineate requirements and responsibilities for development and licensure of manufacturing processes and facilities for Collaboration Products and for worldwide supply of Collaboration Products;

 

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(c) jointly develop a Manufacturing strategy for the US Territory and the ROW Territory to enable development and licensure of manufacturing processes and facilities for Collaboration Products that includes all aspects of Manufacture and release, including but not limited to formulations, intermediate, dosage form, devices, product characterization studies, test methods and process validation studies, stability studies and Manufacturing plans and forecasts and the implementation of Manufacturing Improvements;

 

(d) determine Manufacturing plans and budgets, including timelines and inventory strategies, and allocate responsibilities for and oversee the implementation of such plans in accordance with this Agreement;

 

(e) oversee and approve process development plans prior to the Manufacture of registration batches of Collaboration Products;

 

(f) oversee and approve plans to support Manufacture of commercial supply of Compound and Collaboration Products;

 

(g) review quality assurance efforts, including but not limited to those efforts with respect to the establishment of specifications and quality standards for Collaboration Products;

 

(h) review and coordinate the drafting and contents of the Chemistry, Manufacturing and Controls section of a Drug Approval Application for Collaboration Products;

 

(i) review and approve technology transfer plans for any changes in Manufacturing sites, testing sites, and responsibilities in the supply chain for Collaboration Products, it being understood that decisions regarding the selection of which of a Party’s own Manufacturing and testing sites shall be used to manufacture any component of a Collaboration Product, if a Party Manufactures any component of a Collaboration Product pursuant to this Agreement or any related supply agreement, shall remain in the sole control of such Party;

 

(j) prepare for regulatory inspections and ensure adherence to compliance standards with respect to Collaboration Products;

 

(k) ensure that future logistical strategies and capacity planning are consistent with the forecasts provided in the Marketing Plan for the US Territory, and the corresponding plans for the ROW Territory, as well as inventory levels for Collaboration Products;

 

(l) review quality-related issues concerning the Collaboration Products or any component thereof; and

 

(m) review and approve compliance plans whereby the Parties prepare for or participate in a Governmental Authority inspection of the Manufacturing or testing site of the Compound.

 

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2.5 Joint Intellectual Property Committee (JIPC).

 

2.5.1 Formation and Purpose . Promptly after the Effective Date, the Parties shall create a joint intellectual property committee (the “ JIPC ”) to facilitate the exchange of information between the Parties to the extent required by this Agreement regarding the prosecution, maintenance and enforcement of the Licensed Patents, Licensed Know-How, Shire Collaboration Patents, Shire Collaboration Know-How, and Joint Inventions. The JIPC shall have the membership and shall operate by the procedures set forth in Section 2.6.

 

2.5.2 Specific Responsibilities of the JIPC . In addition to its overall responsibilities described in Section 2.5.1, subject to Section 2.7.4 and Article 11, the JIPC shall, in particular:

 

(a) Exchange information between the Parties regarding the Parties’ activities under this Agreement relating to the filing, prosecution, maintenance and enforcement of the Licensed Patents, Licensed Know-How, Shire Collaboration Patents and Shire Collaboration Know-How; and

 

(b) Consult regarding the filing, prosecution, maintenance and enforcement of Joint Collaboration Patents and Joint Inventions.

 

2.6 General Committee Membership and Procedures.

 

2.6.1 Membership . For the JDC, JMC, JSC and JIPC, each Party shall designate an equal number of representatives who are employees of such Party or an Affiliate of such Party (not to exceed three (3) for each Party) with appropriate expertise to serve as members of such Committee; provided that a Party may designate outside legal counsel as a representative to the JIPC. Each representative may serve on more than one Committee as appropriate in view of the individual’s expertise. Each Party may replace its Committee representatives at any time upon written notice to the other Party. Each Committee shall have co-chairpersons. New River and Shire shall each select from their representatives a co-chairperson for each of the Committees. The co-chairpersons of each Committee shall be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting of such Committee, and preparing and issuing minutes of each meeting within thirty (30) days thereafter; provided, that a Committee co-chairperson shall call a meeting of the applicable Committee promptly upon the written request of the other co-chairperson to convene such a meeting. Such minutes will not be finalized until both chairpersons review and confirm the accuracy of such minutes in writing.

 

2.6.2 Meetings . Each Committee shall hold meetings at such times as it elects to do so, but in no event shall such meetings be held less frequently than once every four (4) months. Meetings of any Committee may be held in person or by means of telecommunication (telephone, video, or web conferences); provided, that at least one meeting per year will be held in person. The Parties will alternate in designating the location for in-person meetings, with New River selecting the first meeting location. Other employees of each Party or any of its Affiliates involved in the Development, Manufacture or Commercialization of Collaboration Products may attend meetings of such Committee as nonvoting participants, and, with the

 

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consent of each Party, consultants, representatives, or advisors involved in the Development, Manufacture or Commercialization of Collaboration Products may attend meetings of such Committee as nonvoting observers; provided, that such Third Party representatives are under obligations of confidentiality and non-use applicable to the Confidential Information of each Party and that are at least as stringent as those set forth in Article 10. Each Party shall be responsible for all of its own expenses of participating in any Committee (including without limitation in any Working Group).

 

2.6.3 Meeting Agendas . Each Party will disclose to the other proposed agenda items along with appropriate information at least seven (7) Business Days in advance of each meeting of the applicable Committee; provided, that under exigent circumstances requiring Committee input, a Party may provide its agenda items to the other Party within a lesser period of time in advance of the meeting, or may propose that there not be a specific agenda for a particular meeting, so long as such other Party consents to such later addition of such agenda items or the absence of a specific agenda for such Committee meeting.

 

2.6.4 Working Groups . From time to time, each Committee may establish and delegate duties to other committees, sub-committees or directed teams (each, a “ Working Group ”) on an “as-needed” basis to oversee particular projects or activities. Each such Working Group shall be constituted and shall operate as the JDC, JMC, JSC or JIPC, as the case may be, determines; provided, that each Working Group shall have equal representation from each Party. Working Groups may be established on an ad hoc basis for purposes of a specific project for the life of a Collaboration Product, or on such other basis as the applicable Committee may determine. Each Working Group and its activities shall be subject to the oversight, review and approval of, and shall report to, the Committee that established such Working Group. In no event shall the authority of the Working Group exceed that specified for the relevant Committee in this Article 2.

 

2.6.5 Limitations of Committee Powers . Each Committee shall have only such powers as are specifically delegated to it hereunder and shall not be a substitute for the rights of the Parties. Without limiting the generality of the foregoing, no Committee shall have any power to amend this Agreement. Any amendment to the terms and conditions of this Agreement shall be implemented pursuant to Section 17.1 below.

 

2.7 Committee Decision-Making . Subject to the terms of this Section 2.7, each Committee will take action by unanimous vote with each Party having a single vote, irrespective of the number of representatives actually in attendance at a meeting, or by a written resolution signed by the designated representatives of each of the Parties. If a Committee is unable to reach unanimous consent on a particular matter within thirty (30) days of its initial consideration of such matter, then either Party may provide written notice of such dispute to the Chief Executive Officer of the other Party. The Chief Executive Officers (or their respective designees, provided that each such designee is not a member of the applicable Committee and occupies a position senior to the positions occupied by the applicable Party’s members of such Committee) of each of the Parties will meet at least once in person or by means of telecommunication (telephone, video, or web conferences) to discuss the dispute and use their good faith efforts to resolve the dispute within thirty (30) days after submission of such dispute to such officers. If any such dispute is not resolved by the Chief Executive Officers or their designees within thirty (30) days

 

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after submission of such dispute to such officers, then the Chief Executive Officer or designee of the Party specified in Section 2.7.1, 2.7.2, or 2.7.3, as applicable, shall have the authority to finally resolve such dispute acting in good faith.

 

2.7.1 JDC Authority.

 

(a) If a dispute in the JDC is not resolved pursuant to Section 2.7 above and such dispute relates primarily to the Development of Collaboration Products for ADHD in the US Territory (other than those relating to Phase IV Clinical Trials), the Required Studies or the [*], then the Chief Executive Officer of [*] shall have the authority to finally resolve such dispute.

 

(b) Notwithstanding anything to the contrary in subsection (a):

 

(i) If a dispute in the JDC is not resolved pursuant to Section 2.7 above and such dispute (A) does not relate primarily to any of the activities specified in subsection (a) above (including, without limitation [*] the [*] of [*] for [*] in the [*] or for any [*] in the [*] for [*] in the [*] or [*] or (B) relates primarily to [*] other than the [*] by [*] pursuant to [*] for which [*] has not [*] at the [*] or [*] the [*] to [*] of any [*] or [*] , then the Chief Executive Officer of [*] shall have the authority to finally resolve such dispute.

 

(ii) If [*] for the first Collaboration Product for ADHD on or before [*] , then, until such time as [*] , the Chief Executive Officer of [*] shall have the authority to finally resolve a dispute that relates primarily to the Development of Collaboration Products for ADHD in the US Territory.

 

2.7.2 JMC Authority . If a dispute in the JMC is not resolved pursuant to Section 2.7 above, then the Chief Executive Officer of [*] shall have the authority to finally resolve such dispute.

 

2.7.3 JSC Authority . If a dispute in the JSC is not resolved pursuant to Section 2.7 above, then the Chief Executive Officer of [*] shall have the authority finally resolve such dispute; provided, however, that with respect to any matter over which [*] has approval (or other consent right) pursuant to Article 6 (including, without limitation, Exhibit D ), such resolution shall require the approval (or other consent) of [*] as set forth in Article 6 (including, without limitation, Exhibit D ).

 

2.7.4 JIPC Authority . If a dispute in the JIPC is not resolved pursuant to Section 2.7 above, then [*] shall have the authority to finally resolve such dispute. The JIPC shall not have decision making authority under this Agreement and any dispute in the JIPC shall be resolved in accordance with the terms of Article 16.

 

2.7.5 Casting Vote . Neither Party shall exercise its right to finally resolve a dispute at a Committee in accordance with this Section 2.7 in a manner that excuses such Party from any of its obligations specifically enumerated under this Agreement.

 

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ARTICLE 3

DEVELOPMENT AND REGULATORY RESPONSIBILITIES

 

3.1 Overview . Subject to the roles of the various Committees described in Article 2 and the terms of this Agreement, the general allocation of responsibility for the Development and Regulatory Approval of Collaboration Products under this Agreement is as follows:

 

(a) New River will be primarily responsible for the Development of the Collaboration Product for ADHD in the US Territory; and

 

(b) the JDC will determine which Party will be primarily responsible for the Development of Collaboration Products for non-ADHD indications in the US Territory.

 

3.2 Development Plans.

 

3.2.1 Scope . The Development of each Collaboration Product in the US Territory under this Agreement shall be governed by a development plan (each, a “ Development Plan ”). Each Development Plan shall be developed in good faith in accordance with a Party’s standard practices with the overall objective of achieving the commercial potential of such Collaboration Product. Each Development Plan shall describe the proposed overall program of Development for the Collaboration Product for each indication in the US Territory, including preclinical studies, toxicology, formulation, process development, clinical studies, pediatric exclusivity plans and regulatory plans and other elements of obtaining Regulatory Approval in each applicable country, as well as timelines to key Governmental Authority meetings, Drug Approval Applications and Regulatory Approvals. Each Development Plan shall include a summary of estimated Development Expenses of the program expected during the Development process through obtaining Regulatory Approval for each proposed indication and route of delivery, to the extent such expenses are to be shared by the Parties under the terms of this Agreement, and shall also include a detailed budget for all such shared Development activities proposed for the following calendar year.

 

3.2.2 Preparation and Approval of Development Plans for the US Territory . Each Development Plan for the US Territory, together with any updates thereto, shall be prepared and approved as follows:

 

(a) Initial Development Plans for the Collaboration Product for ADHD in the US Territory . The initial Development Plan for all Development activities for the Collaboration Product for ADHD in the US Territory [*] is attached to this Agreement as Exhibit C . Within [*] after the Effective Date, New River will prepare the initial Development Plans for the first Collaboration Products for ADHD [*]

 

(b) Development Plans for Improvements and Combination Product in the US Territory . When an Improvement and/or Combination Product is added as a Collaboration Product pursuant to Section 3.6, within sixty (60) days following the date of such inclusion, the Development Plan for the Development of any such Improvement and/or Combination Product in the US Territory will be prepared by the Party designated by the JDC, and submitted to the JDC for its review and approval of such Development Plan.

 

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3.2.3 Updates to the Development Plans . As early as necessary in each year beginning with the first full calendar year after the Effective Date, the Party responsible for preparing the initial Development Plan for a Collaboration Product shall update and prepare the Development Plan for any such Collaboration Product for the following calendar year to take into account completion, commencement or cessation of Development activities not contemplated by the then-current Development Plan, and submit such proposed Development Plan to the JDC no later than September 30 of such year for review and approval.

 

3.2.4 Diligence . In addition to the specific diligence obligations of New River pursuant to Section 3.3.1, each of New River and Shire will use Diligent Efforts to carry out the activities for which it may agree to be responsible set forth in a Development Plan.

 

3.3 Development in the US Territory for ADHD.

 

3.3.1 Diligence . New River will use Diligent Efforts to carry out the activities set forth in the Development Plan for Collaboration Products for ADHD in the US Territory and to seek Regulatory Approval, [*] , for ADHD in the US Territory in accordance with the Development Plan and with the terms of this Agreement.

 

3.3.2 Costs of Development . Notwithstanding Section 3.7 below, (a) New River shall bear all Development Expenses that are related to Developing and obtaining Regulatory Approval for the first Collaboration Products for ADHD [*] in the US Territory, (b) New River shall be responsible for all Phase IV and Related Expenses for all activities that are required in connection with receiving Regulatory Approval by FDA or other Governmental Authorities in the US Territory with respect to such Collaboration Products (“ Required Studies ”), and (c) if there are any additional studies necessary to obtain [*] for the Collaboration Product for ADHD (“ [*] ”), New River shall be responsible for all such Development Expenses and/or Phase IV and Related Expenses related to such [*].

 

3.3.3 Regulatory Activities.

 

(a) Unless otherwise agreed in writing by the Parties, New River, subject to Section 3.3.3(c), shall be responsible for preparing and filing Drug Approval Applications and seeking Regulatory Approvals for Collaboration Products in the US Territory in accordance with the applicable Development Plan, including preparing all reports necessary as part of a Drug Approval Application. All such Drug Approval Applications shall be filed in the name of New River. Each Party shall designate an alliance manager to coordinate and review filings and activities of the Parties in the US Territory described in this Section 3.3.3. New River shall provide Shire with drafts of any material documents or correspondence to be submitted to any Governmental Authority in the US Territory that pertains to the Compound and/or Collaboration Products, including Drug Approval Applications. New River will consult in advance with Shire with respect to any substantive or material filings to be made by New River in accordance with the terms of this Section 3.3.3(a), including Drug Approval Applications, and shall consider in good faith any comments Shire may have with respect to any such filings. New River shall permit Shire access to and grant Shire the right to reference and use, for purposes of the Collaboration Products, all data, regulatory filings and regulatory communications associated with any submissions for Regulatory Approval or other issues associated with any Collaboration

 

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Product, that is or would be relevant to Shire’s Development or Commercialization of a Collaboration Product in the US Territory. To the extent that any such data, regulatory filings or regulatory communications are held by a Third Party, then New River shall arrange direct access to the portions of such data, regulatory filings or regulatory communications that are relevant to the activities of Shire that are contemplated by this Agreement. Any information obtained by a Party pursuant to this Section 3.3.3(a) shall be deemed Confidential Information for purposes of Article 10. Notwithstanding the foregoing, Shire shall be the responsible Party for preparing and filing Drug Approval Applications and seeking Regulatory Approvals and interacting with the Governmental Authorities in the US Territory for any Unilateral Product being Developed by Shire under Section 3.6.5.

 

(b) New River shall provide Shire with reasonable advance notice of any meeting or substantive or material conference call with any Governmental Authority relating to any Drug Approval Application or Regulatory Approval for Collaboration Products in the US Territory, and Shire shall have the right to participate in any such meeting or material conference call as well as have the right to participate in all substantive or material preparation, internal caucus, and debriefing sessions related to such meetings or conference calls. If it is not possible to provide Shire notice of any such meeting or conference call, New River shall immediately thereafter provide Shire with a detailed summary of any such meeting or conference call. New River shall promptly, but in no event more than two (2) Business Days after receipt, furnish Shire with copies of all substantive or material documents or correspondence New River has had with or receives from any Governmental Authority, and contact reports concerning substantive or material conversations or substantive meetings with any Governmental Authority, in each case relating to any Drug Approval Application or Regulatory Approval (including without limitation any minutes from a meeting with respect thereto).

 

(c) Shire shall be primarily responsible for interfacing, corresponding, making required filings and meeting with the Division of Drug Marketing, Advertising and Communications of the FDA (“ DDMAC ”) with respect to the marketing and promotion of the Collaboration Products in the US Territory. New River will provide a letter to the FDA (to be prepared with assistance of Shire) notifying the FDA that Shire has been designated as the agent of New River upon whom all DDMAC communications should be made on behalf of New River with respect to Collaboration Products in the US Territory. Shire, through the JMC, shall provide New River with drafts of any substantive or material documents or correspondence to be submitted to DDMAC in the US Territory that pertains to a Collaboration Product. Shire, through the JMC, will consult in advance with New River with respect to any substantive or material filings to be made by Shire in accordance with the terms of this Section 3.3.3(c), and shall consider in good faith any comments New River may have with respect to any such filings. Shire shall provide New River with reasonable advance notice of any meeting or substantive or material conference call with DDMAC relating to a Collaboration Product in the US Territory, and New River shall have the right to participate in any such meeting or substantive or material conference call as well as have the right to participate in all substantive or material preparation, internal caucus, and debriefing sessions related to such meetings or conference calls. If it is not possible to provide New River notice of any such meeting or conference call, Shire shall immediately thereafter provide New River with a detailed summary of any such meeting or conference call. Shire shall promptly, but in no event more than two (2) Business Days after receipt, furnish New River with copies of all substantive or material documents or

 

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correspondence Shire has had with or receives from DDMAC, and contact reports concerning substantive or material conversations or substantive or material meetings with DDMAC, in each case relating to a Collaboration Product (including without limitation any minutes from a meeting with respect thereto).

 

(d) Within thirty (30) days after the Effective Date, New River shall provide to Shire copies of all substantive or material Manufacturing, pre-clinical and clinical data compiled as of the Effective Date with respect to the Collaboration Product, including any final versions of any study reports and any drafts then-outstanding of any study reports. Thereafter, New River shall provide to Shire copies of all substantive or material Manufacturing, pre-clinical and clinical data compiled with respect to the Collaboration Product as soon as reasonably practicable after such data or results become available or compiled, including any drafts and final versions of any study reports. All disclosures under this Section 3.3.3(d) shall be delivered in electronic format. For clarity, New River shall not be required to disclose New River’s proprietary Carrierwave ^TM technology under this Agreement, except to the extent necessary for Shire to exercise its rights and perform its obligations under this Agreement or as otherwise specifically provided in this Agreement.

 

(e) In the event that any Governmental Authority threatens or initiates any action to remove a Collaboration Product from the market in the US Territory, New River shall notify Shire of such communication immediately, but in no event later than one (1) Business Day, after receipt by New River. Either Party may decide, in good faith, to initiate a recall or withdrawal of Collaboration Product in the US Territory, in consultation with the JDC and JMC. Before Shire initiates a recall or withdrawal, and upon the request for a recall or withdrawal by either Party, the Parties shall promptly and in good faith discuss the reasons therefor and the allocation of the costs of any such recall or withdrawal. Under no circumstances shall either Party unreasonably object to a recall or withdrawal requested by the other Party, and neither Party shall have any right to object to a recall or withdrawal requested by the other Party for failure of a Collaboration Product to meet the applicable specifications, for material safety concerns, or for the Manufacture of such Collaboration Product in a manner that does not comply with applicable Laws. In the event of any recall or withdrawal for Collaboration Products sold in the US Territory, Shire shall implement any necessary action, with assistance from New River as reasonably requested by Shire.

 

3.4 Right of Reference to the ROW Territory . New River shall have the right of cross-reference to all Drug Approval Applications filed by Shire or its Affiliates in the ROW Territory for the purpose of prosecuting Drug Approval Applications in the US Territory, and Shire shall, or shall cause its Affiliates to, take all such reasonable actions to allow such cross-reference.

 

3.5 Reporting . At each meeting of the JDC and the JSC, each Party will present a report describing the Development and Manufacturing activities performed by such Party with respect to Collaboration Products in the US Territory since the last such report.

 

3.6 Development in the US Territory for Indications other than ADHD . In the event that Collaboration Products are to be Developed hereunder in the US Territory for indications other than ADHD, the JDC will designate a lead Development Party for such

 

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Development program in the applicable Development Plan, subject to the terms and conditions of this Section 3.6. For the purposes of clarity, [*] shall have the casting vote on the JDC as to whether a Collaboration Product is to be Developed in the US Territory for non-ADHD indications, including all Improvements or Combination Products; provided that [*] will not be obligated to serve as the lead Development Party without its consent.

 

3.6.1 Submission of Proposal to JDC . If, at any time, Shire or New River desires to Develop a Collaboration Product for a non-ADHD indication, including an Improvement or Combination Product, for Commercialization in the US Territory, such Party shall submit to the JDC a proposal for such Development. Such proposal shall contain, at a minimum, all material information that would otherwise be included in a Development Plan. Each proposal for the Development of a Collaboration Product for a non-ADHD indication, including an Improvement or Combination Product, for Commercialization in the US Territory shall, among other things:

 

(a) identify all major Development tasks to be accomplished prior to submission of filings for Regulatory Approvals;

 

(b) identify key Development objectives, expected associated resources, risk factors, timelines, Go/No Go decision points and relevant decision criteria and, where appropriate, decision trees; and

 

(c) include a reasonably detailed description and budget for the Development activities that are expected to be performed.

 

3.6.2 JDC Agreement to Develop . If the JDC agrees to the Development of a Collaboration Product for a non-ADHD indication, including an Improvement and/or Combination Product, for Commercialization in the US Territory, it shall select the lead Party for such Development. Once the lead Party is selected, that Party will be responsible for the Development of the applicable Collaboration Product for the specified indication, including the design and conduct of clinical trials for such Collaboration Product, subject in any event to the oversight and authority of the various Committees. The Development Expenses incurred in connection with the performance of such Development program will be shared [*] under the terms of Section 3.7 below. Except as set forth in Section 3.3.3(a), New River shall be responsible for preparing and filing Drug Approval Applications and seeking Regulatory Approvals for Collaboration Products in the US Territory, whether or not it is the lead Development Party, including preparing all reports necessary as part of a Drug Approval Application, and all such Drug Approval Applications shall be filed in the name of New River.

 

3.6.3 New River Proposal . Except as provided in this Section 3.6.3, if New River proposes the Development of an Improvement and/or Combination Product to the JDC, but Shire does not vote in favor of such proposal, such Improvement and/or Combination Product shall not be Developed. Notwithstanding the foregoing, after receipt of Regulatory Approval for the first Collaboration Product for ADHD [*] , New River may propose a Combination Product that includes an active pharmaceutical ingredient approved in the US Territory for a [*] ), and the Parties shall develop a plan to determine proof of concept and to generate pharmacokinetic and toxicity data on such proposed Combination Product and shall use Diligent Efforts to implement

 

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such plan. Based on such data, the JDC shall determine whether to Develop such Combination Product. The JDC shall make such determination within a reasonable time following receipt of such data, but in any event within [*] of the commencement of activities pursuant to the applicable plan. If the JDC determines not to Develop such Combination Product, then New River may elect to conduct the Development of such Combination Product itself, pursuant to the terms of Section 3.6.5.

 

3.6.4 Shire Proposal . If Shire proposes the Development of a Collaboration Product for any indication other than the first Collaboration Products for ADHD in each of Adults, Adolescents and Children, including an Improvement and/or Combination Product, to the JDC, but New River does not vote in favor of such proposal, then Shire shall have the right to conduct the Development of such Collaboration Product without New River, pursuant to the terms of Section 3.6.5.

 

3.6.5 Unilateral Development . The Party independently developing a Collaboration Product under Section 3.6.3, in the case of New River, or Section 3.6.4, in the case of Shire (the “ Developing Party ”), shall have the right unilaterally to conduct the Development of the applicable Collaboration Product (each such Collaboration Product, a “ Unilateral Product ”); provided, however, that such right shall be subject to the Developing Party conducting such Development in a manner that would not adversely affect in any significant way any then existing Collaboration Product being Developed or Commercialized under this Agreement. For any Unilateral Product, the non-Developing Party shall have the opportunity to opt back into the Development program and participate in the Development upon the [*] for any such Unilateral Product (a “ [*] Opt-In Right ”). At least [*] prior to [*] of such [*] , the Developing Party shall provide to the other Party an updated proposal that contains, at a minimum the information set forth in Section 3.6.1, to enable such other Party to determine if it desires to exercise its [*] Opt-In Right. Such other Party shall have [*] after receipt of such updated proposal to exercise its [*] Opt-In Right. If such other Party exercises its [*] Opt-In Right, then such other Party shall be required to pay the Developing Party, within [*] days after such exercise, an amount equal to [*] in respect of the Development of the applicable Unilateral Product prior to such exercise, and thereafter the [*] . If the non-Developing Party does not exercise its [*] Opt-In Right but Regulatory Approval is obtained in the US Territory for the Unilateral Product, then the non-Developing Party shall be required to pay the Developing Party, within [*] of receipt of such Regulatory Approval, an amount equal to [*] in respect of such Unilateral Product. In order to conform with the definition of [*] in Article 1 above, for purposes of this Section 3.6.5 only, all [*] in connection with the Development of a Unilateral Product will be treated as if such [*] in connection with a Development Plan.

 

3.7 Shared Expenses.

 

3.7.1 Except as otherwise provided in Sections 3.3.2 and 3.6.5, the Parties will share Development Expenses (“ Shared Expenses ”) as follows:

 

(a) any Development Expenses incurred by either Party that, as determined by the JDC, have worldwide application to the Development or Commercialization of the Collaboration Products will be borne [*] by Shire and [*] by New River, regardless of whether such work is conducted inside or outside of the United States; and

 

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(b) any Development Expenses incurred by either Party for the Development of Collaboration Products to be Commercialized in the US Territory and which do not have worldwide application, will be borne [*] by Shire and [*] by New River.

 

3.7.2 Quarterly Reconciliation of Development Expenses.

 

(a) Each Party shall calculate and maintain records of Shared Expenses incurred by it in accordance with procedures to be agreed upon between the Parties.

 

(b) Within five (5) Business Days following the end of each calendar quarter, Shire shall submit to New River a written report setting forth in reasonable detail, separately with respect to each Collaboration Product, the Shared Expenses it has incurred in such calendar quarter.

 

(c) Within five (5) Business Days following the end of each calendar quarter, New River shall submit to Shire a written report setting forth in reasonable detail, separately with respect to each Collaboration Product, the Shared Expenses it has incurred in such calendar quarter.

 

(d) Within twenty-five (25) days following the end of each calendar quarter, Shire shall submit to New River a written report setting forth in reasonable detail the calculation of all Shared Expenses for each Collaboration Product, and the calculation of any net amount owed by New River to Shire or by Shire to New River, as the case may be, in order to ensure the appropriate sharing of Shared Expenses in accordance with the provisions of Section 3.7. The net amount payable shall be paid by Shire or New River, as the case may be, within thirty five (35) days following the end of each calendar quarter; provided, that, in the event of a dispute, the disputing Party shall pay the amount not in dispute and provide written notice within five (5) Business Days after receipt of the written report in question to the other, specifying such dispute and explaining the basis of the dispute. New River and Shire shall promptly thereafter meet and negotiate in good faith a resolution to such dispute. If such dispute is not resolved within forty-five (45) days after delivery of a notice of dispute with respect thereto to the other Party, the disputing Party may audit the other Party pursuant to the provisions of Section 8.6.2.

 

3.8 Use of Third Parties . Either Party may retain Third Parties to perform Development activities, subject to the terms provided in this Section 3.8 and Section 9.3; provided that prior to either Party subcontracting any Development for the US Territory it shall receive the prior written approval of the other Party, such approval not to be unreasonably withheld, conditioned, or delayed. Each Party shall remain liable for the performance of its obligations hereunder which it delegates to such Third Parties. Shire acknowledges and agrees that New River is currently subcontracting or intends to subcontract certain of the Development in the US Territory to those subcontractors for the designated activities set forth on Schedule 3.8 . New River will not need the prior written approval of Shire to utilize such subcontractors on Schedule 3.8 for the indicated activities. Any Third Parties performing Development activities hereunder shall be subject to confidentiality and non-use obligations at least as stringent as those set forth in Article 10 and must comply with the terms of Article 11.

 

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3.9 Right to Audit . Each Party shall use Diligent Efforts to ensure that the other Party’s authorized representatives, and shall ensure that Governmental Authorities, in both cases to the extent permitted by applicable Law, may, during regular business hours, (a) examine and inspect its facilities or, subject to any Third Party confidentiality restrictions or obligations, the facilities of any subcontractor or any investigator site used by it in the performance of Development of a Collaboration Product for Commercialization in the US Territory, including those sites in the ROW Territory if the Collaboration Product Developed at such site in the ROW Territory will be Commercialized in the US Territory, and (b) subject to applicable Law and any Third Party confidentiality restrictions or obligations, inspect and copy all data, documentation and work products relating to the activities performed by it, the subcontractor or investigator site, including, without limitation, the medical records of any patient participating in any clinical study. This right to inspect and copy all data, documentation, and work products relating to a Collaboration Product for Commercialization in the US Territory, including those sites in the ROW Territory if the Collaboration Product Developed at such site in the ROW Territory will be Commercialized in the US Territory, may be exercised at any time during the term of this Agreement (subject to each Party’s record retention policies then in effect), or such longer period as shall be required by applicable Law.

 

3.10 Assistance . Subject to the terms of this Article 3, each Party agrees to provide the other with all reasonable assistance and take all actions reasonably requested by the other Party that are necessary or desirable to enable the other Party to comply with any Law applicable to the Collaboration Products, including, but not limited to, meeting, reporting and other obligations to maintain and update any Regulatory Approvals for the Collaboration Products.

 

3.11 Compliance with Laws . Each Party or its permitted Third Party contractors shall perform its responsibilities under this Article 3, including those set forth in a Development Plan, in accordance with all applicable Laws, including without limitation cGLPs, cGCPs and cGMPs.

 

ARTICLE 4

COMMERCIALIZATION OF COLLABORATION PRODUCTS

 

4.1 Principles of Commercialization . Shire will be solely responsible for Commercializing Collaboration Products in the US Territory during the Term; provided, however, that, during the Co-Promotion Period, Article 5 will apply to the Parties’ Co-Promotion of the applicable Collaboration Products in the US Territory.

 

4.2 Sales and Distribution of Collaboration Products to Third Parties.

 

4.2.1 Terms of Sale to Third Parties . For each Collaboration Product, including all Improvements, Combination Products and Co-Promote Products, Shire shall be solely responsible for handling all returns, recalls, order processing, invoicing and collection, distribution, and inventory and receivables arising from sales to Third Parties. New River may not accept orders from a Third Party for a Collaboration Product or make sales for its own account (except to Shire) or for Shire’s account. If New River receives any order for a Collaboration Product, it shall refer such orders to Shire for acceptance or rejection. Subject to Section 4.2.2, Shire shall have the right and responsibility for establishing and modifying the terms and conditions with respect to the sale of all Collaboration Products in the US Territory,

 

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including any terms and conditions relating to or affecting the price at which the Collaboration Products will be sold, discounts available to managed care providers, any discount attributable to payments on receivables, distribution of the Collaboration Products, and credits, price adjustments, or other discounts and allowances to be granted or refused.

 

4.2.2 [*] If Shire or its Affiliates or sublicensees sell a Collaboration Product to a Third Party, [*] and at a [*] Shire or its Affiliates or sublicensees for sales of such Collaboration Product [*] , then Shire [*] in respect of such sale.

 

4.3 Marketing Plans and Budgets for the US Territory . Shire shall be responsible for developing a Marketing Plan for each Collaboration Product in the US Territory. Each Marketing Plan developed by Shire shall be adopted in good faith in accordance with Shire’s standard practices with the overall objective of achieving the commercial potential of such Collaboration Product. Each Marketing Plan shall be deemed Confidential Information of Shire.

 

4.3.1 Preparation of Initial Marketing Plan . Commencing [*] prior to the projected First Commercial Sale of a Collaboration Product, Shire will commence preparing an initial [*] Marketing Plan for the US Territory for such Collaboration Product for review and approval by the JMC; provided, however, promptly after the Effective Date, Shire will commence preparing the initial Marketing Plan for the first Collaboration Product for ADHD. As early as necessary in each calendar year thereafter, Shire shall amend and update each Marketing Plan for the US Territory for such Collaboration Products for submission of such proposed Marketing Plan for the US Territory to the JMC no later than September 30 of such year for review and approval.

 

4.3.2 Contents of Initial Marketing Plan . The initial Marketing Plan for each Collaboration Product shall set forth the strategy for the commercial launch of such Collaboration Product in the US Territory in a comprehensive plan that describes the Commercialization activities for such Collaboration Product (including advertising, education, planning, marketing, sales force training and allocation). Each initial draft Marketing Plan will contain such information as Shire believes necessary for the successful commercial launch of such Collaboration Product in the Field and in the US Territory and shall generally conform to the level of detail utilized by Shire in preparation of its own product plans.

 

4.4 Regulatory Obligations During Commercialization.

 

4.4.1 New River Responsibilities . Except as otherwise set forth in Sections 3.3.3(a) and 3.3.3(c), New River will maintain all regulatory filings and Regulatory Approvals in the US Territory for each Collaboration Product Developed pursuant to this Agreement, including all INDs and Drug Approval Applications. As between the Parties, New River will be solely responsible for all activities in connection with maintaining Regulatory Approvals required for the Commercialization of Collaboration Product in the US Territory, including communicating and preparing and filing all reports with the applicable Governmental Authorities, as described in further detail in and subject to Section 3.3.3.

 

4.4.2 Pharmacovigilance . Shire shall be responsible for all processing of information related to any adverse events, including, without limitation, any information

 

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regarding such adverse events that is received from a Third Party, related to a Collaboration Product after the First Commercial Sale of such Product. The Party conducting any clinical studies prior to such First Commercial Sale shall be responsible for all processing of information related to any adverse events associated with such studies. New River shall be responsible for all expedited and periodic reporting of such events to the FDA, all in accordance with 21 C.F.R. Sections 312.32 and 314.80. As soon as reasonably practicable following the date of this Agreement, the pharmacovigilance departments of each of New River and Shire shall meet and determine the approach to be taken for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Products, consistent with the provisions of this Section 4.4.2. Such approach shall be documented in a separate and appropriate written pharmacovigilance agreement between each of New River and Shire. Shire agrees to share relevant information it receives (either directly or indirectly) with New River in a timely manner so as to allow New River to comply with its responsibility to report pharmacovigilance information under this Section 4.4.2.

 

4.5 Diligence in Commercialization.

 

4.5.1 Diligence . Shire will use Diligent Efforts in the US Territory to launch a Collaboration Product after receiving all Regulatory Approvals for such Collaboration Product, and thereafter will use Diligent Efforts to Commercialize the Collaboration Product in the US Territory. With respect to the US Territory, Shire, and if applicable New River, will use Diligent Efforts to perform all activities set forth in the applicable Marketing Plan.

 

4.5.2 Details . Without limiting the generality of the foregoing, with respect to the first Collaboration Product Commercialized hereunder in the US Territory for ADHD, Shire will provide: (a) for a sales force of at least [*] Sales Representatives to promote such Collaboration Product [*] in the US Territory during the [*] following First Commercial Sale of such Collaboration Product in the US Territory; (b) for a sales force of at least [*] Sales Representatives to promote such Collaboration Product [*] in the US Territory during the next [*] ; and (c) a sales force consistent with the then-applicable Marketing Plan thereafter. For the avoidance of doubt, if New River exercises its Co-Promotion Option, any Sales Representatives provided by New River to Co-Promote such Collaboration Product shall count towards the amounts set forth in this Section 4.5.2.

 

4.5.3 [*] . If a Collaboration Product for ADHD is, or is [*] to, the [*] product approved for ADHD and [*] that such Collaboration Product either (a) [*] products for ADHD, or (b) [*] , then Shire will ensure that such Collaboration Product for ADHD is [*] of Shire in the US Territory that [*] formulated for [*] . If a Collaboration Product for ADHD does not originally [*] but the Parties are later able to [*] , the provisions of this Section 4.5.3 shall be applicable.

 

4.6 Cost of Commercialization . In the US Territory, (a) each Party shall bear its own costs in connection with the Commercialization of Collaboration Products, subject to the payment provisions of Article 6 and the sharing and reconciliation provisions described in Section 7.4, and (b) [*] shall bear [*] of any Pre-Marketing Expenses incurred by the Parties, which shall be reported and reimbursed through the mechanisms set forth in Section 7.4.3.

 

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4.7 Use of Third Parties . Each Party covenants and agrees not to use any Third Parties to perform promotional activities for Collaboration Products in the US Territory without the prior written approval of the other Party, such approval not to be unreasonably withheld, conditioned, or delayed. If the Parties agree to engage any such Third Party sales force, such Third Party sales force will be directed, trained and controlled by Shire.

 

4.8 Promotional Materials.

 

4.8.1 Creation of Promotional Materials . Shire will create and develop Promotional Materials for the US Territory in accordance with an applicable Marketing Plan. To the extent that Shire describes in any item of the Promotional Materials New River’s Carrierwave ^TM proprietary technology, Shire shall include in such Promotional Materials the New River trademark for such technology. New River hereby grants Shire a royalty-free license for such purpose. To the extent Shire shall include such description and trademark in the Promotional Materials, Shire shall comply with New River’s then-current guidelines for trademark usage, a copy of which shall be provided to Shire from time to time. Shire shall provide samples of Promotional Materials for use in the US Territory to the JMC for review, prior to distributing such Promotional Materials for use by the Parties’ Sales Representatives in the US Territory.

 

4.8.2 Shire Ownership of Promotional Materials . Shire shall own all right, title and interest in and to any Promotional Materials relating to the Collaboration Products, including without limitation applicable copyrights and trademarks, but excluding trademarks owned by New River in accordance with Section 11.9, and New River hereby assigns all its right, title and interest to such Promotional Materials to Shire and agrees to execute all documents and take all actions as are reasonably requested by Shire to vest title to such Promotional Materials in Shire.

 

4.8.3 Use of Promotional Materials Exclusively for Collaboration Products . The Promotional Materials, and any aspects of those uniquely tied to the Collaboration Products, shall be used exclusively in connection with the Collaboration Products in accordance with the terms of this Agreement.

 

4.8.4 Retention of Rights . Shire and New River, or their respective Affiliates, shall retain, throughout the Term and following termination, all rights, including without limitation all copyrights and trademarks, to all of their respective programs and materials in all formats (print, video, audio, digital, computer, etc.) regarding sales training, patient education and disease management programs owned by them as of the Effective Date or developed by them during the Term but outside of this Agreement, regardless of the fact that such programs or materials are shared with the other Party, as well as any modifications of such programs or materials that they may develop in the future which are not specific to a Collaboration Product. In accordance with Section 4.8.2, Shire shall own any such modifications specific to a Collaboration Product.

 

4.9 Provisions Applicable to Sales Representatives . In the US Territory, Shire agrees with respect to itself and its Affiliates and their respective Sales Representatives, and if

 

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New River exercises its Co-Promotion Right, New River agrees with respect to itself and its Affiliates and their respective Sales Representatives, that:

 

4.9.1 No Changes to the Promotional Materials . Each Party will instruct its Sales Representatives to use, and will monitor its Sales Representatives to ensure that such Sales Representatives use, only Promotional Materials, Samples, and literature approved for use by Shire for the promotion of the Collaboration Product. Neither Party will misbrand, change, alter or adulterate any Promotional Material or Samples supplied to it for distribution or use by such Party or its Sales Representatives.

 

4.9.2 Monitoring of Sales Representatives . Each Party will instruct its Sales Representatives to do the following, and will monitor its Sales Representatives so that such personnel do, the following: (a) limit claims of efficacy and safety for the Collaboration Product to those that are consistent with approved promotional claims in, and not add, delete or modify claims of efficacy and safety in the promotion of the Collaboration Product in any respect from those claims of efficacy and safety that are contained in, the Marketing Plan for such Collaboration Product, with applicable Law, and with product labeling for the Collaboration Product as approved by the FDA; (b) not make any changes in Promotional Materials provided by Shire; (c) use Promotional Materials and Samples in a manner that is consistent with the Marketing Plan, with applicable Law, and with the product labeling for the Collaboration Product as approved by the FDA; and (d) promote the Collaboration Product in adherence in all material respects with applicable Laws, as well as the [*] , the [*] , the [*] for the [*] and any other [*] generally applicable to such Sales Representative.

 

4.9.3 PDM Act and Controlled Substances Act . Each Party shall use Samples in the US Territory strictly in accordance with the then-current applicable Marketing Plan and shall distribute Samples in full compliance with all applicable Laws, including the requirements of the PDM Act and the Controlled Substances Act. Specifically, each Party shall establish, maintain and adhere to written procedures to assure that such Party and its Sales Representatives comply with all requirements of the PDM Act and the Controlled Substances Act, as applicable. Such procedures shall include a requirement that each Party notify the other Party immediately upon learning that any Samples shipped by such Party have been lost or have not been received as scheduled. Each Party will maintain records as required by the PDM Act and all other Laws and shall allow representatives of the other Party to inspect such records on request. Upon reasonable advance notice to a Party, the other Party shall be entitled to conduct an inspection and audit of such Party’s Sample distribution practices by its Sales Representatives in the US Territory and any facilities where Samples are stored by such Party. Such inspection and audit shall be made in accordance with the applicable provisions of the PDM Act and with the provisions of this Agreement. The costs and expenses of conducting such audit shall be deemed a Marketing Expense.

 

4.9.4 Equal Opportunity Employer . Unless exempted from such compliance, each Party will comply with all applicable Laws in the hiring, employment, and discharge of all Sales Representatives. Each Party represents that such Party is an Equal Opportunity Employer and does not discriminate against any person because of race, color, creed, age, sex, sexual preference, marital status, or national origin.

 

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4.9.5 Compliance . Each Party will ensure that its Sales Representatives are informed of all applicable obligations and policies relating to the performance of this Agreement and are bound to comply with same.

 

4.9.6 Insurance . Each Party acknowledges and agrees that the other Party does not and will not maintain or procure any worker’s compensation, healthcare, or other insurance for or on behalf of the other Party’s Sales Representative, all of which shall be such Party’s sole responsibility.

 

4.9.7 No Participation in Benefit Plans . Each Party acknowledges and agrees that all Sales Representatives of such Party are not, and are not intended to be or be treated as, employees of the other Party or any of its Affiliates, and that such individuals are not, and are not intended to be, eligible to participate in any benefits programs or in any “employee benefit plans” (as such term is defined in section 3(3) of ERISA) that are sponsored by the other Party or any of its Affiliates or that are offered from time to time by the other Party or its Affiliates to their own employees (the “ Benefit Plans ”). All matters of compensation, benefits and other terms of employment for any such Sales Representatives shall be solely a matter between a Party and such individual. A Party shall not be responsible to the other Party, or to its Sales Representatives for any compensation, expense reimbursements or benefits (including, without limitation, vacation and holiday remuneration, healthcare coverage or insurance, life insurance, severance or termination of employment benefits, pension or profit-sharing benefits and disability benefits), payroll-related taxes or withholdings, or any governmental charges or benefits (including without limitation unemployment and disability insurance contributions or benefits and workmen’ compensation contributions or benefits) that may be imposed upon or be related to the performance by such Party and such individuals of this Agreement, all of which shall be the sole responsibility of such Party, even if it is subsequently determined by any court or governmental agency that any such individual may be a common law employee of the other Party or any of its Affiliates or is otherwise entitled to such payments and benefits.

 

4.9.8 Responsibility for Acts and Omissions of its Personnel . Each Party shall be solely responsible for its acts and omissions and for those acts or omissions of its Sales Representatives while performing any of the services to be provided under this Agreement. Each Party shall be solely responsible and liable for all probationary and termination actions taken by it, as well as for the formulation, content and dissemination (including content) of all employment policies and rules (including written probationary and termination policies) applicable to its employees and contractors.

 

4.9.9 Indemnification for Employee Reclassification . Each Party will indemnify, defend, and hold harmless the other Party and its Affiliates, and its and their directors, employees and agents from and against any damages, liability, loss and costs that may be paid or payable by any such Person resulting from or in connection with any claim or other cause of action asserted by any Sales Representative of the other Party or any Third Party (including without limitation federal, state or local governmental authorities) arising out of the execution and/or performance of this Agreement that is based on or with respect to:

 

(a) costs, damages and losses that a Party or its Affiliates may incur resulting from any claims for benefits that any Sales Representative of the other Party may make under or with respect to any Benefit Plan;

 

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(b) any payment or obligation to make a payment to any Sales Representative of the other Party relating in any way to any compensation, benefits of any type under any employee benefit plan (as such term is defined in Section 3(3) of ERISA) and corresponding employee benefits plans under any other country’s laws, and any other bonus, stock option, stock purchase, incentive, deferred compensation, supplemental retirement, severance, termination benefits, and other similar fringe or employee benefit plans, programs or arrangements that may be sponsored at any time by Shire or any of its Affiliates or by New River or any of its Affiliates, even if it is subsequently determined by any court or governmental agency that any such Sales Representative may be a common law employee of the other Party or any of its Affiliates or entitled to same;

 

(c) the payment or withholding of any contributions, payroll taxes, or any other payroll-related item by or on behalf of a Party or any of its Sales Representative with respect to which such Party or any such individuals may be responsible hereunder or pursuant to applicable law to pay, make, collect, withhold or contribute, even if it is subsequently determined by any court or any governmental agency that any such Sales Representative may be a common law employee of such Party or any of its Affiliates or otherwise entitled to such benefits; and

 

(d) failure of a Party to withhold or pay required taxes or failure to file required forms with regard to compensation paid to a Party by the other Party and compensation and benefits paid or extended by a Party to any of its Sales Representatives.

 

4.10 Reporting . Until the expiration of the later of (y) the period during which Section 4.5.2 applies or (z) the Co-Promotion Period (for so long as New River is Co-Promoting a Collaboration Product), Shire shall provide New River, within thirty (30) days following the end of each calendar quarter, a report setting forth the total number of Details and Primary Position Details, by decile and target physician, actually performed by the Shire Sales Representatives for such calendar quarter, or in such other form as Shire may regularly prepare for its own internal purposes, redacted for confidential information not related to Collaboration Product.

 

4.11 Compliance with Laws . Each Party or its permitted Third Party contractors shall perform its responsibilities under this Article 4, including those set forth in a Marketing Plan, in accordance with all applicable Laws.

 

ARTICLE 5

CO-PROMOTION OF COLLABORATION PRODUCTS

 

5.1 Option . New River will have the right (the “ Co-Promotion Option ”) to elect from time to time to provide Details for each Collaboration Product in the US Territory up to twenty-five percent (25%) of total Details for such Collaboration Product pursuant to the provisions of this Article 5. In addition to the then-current Marketing Plan, if prior to exercising the Co-Promotion Option, New River reasonably requests additional information Controlled by

 

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Shire relating to the Collaboration Product in order to evaluate the exercise of its Co-Promotion Option, Shire shall promptly provide such information to New River for such purpose. If New River exercises its Co-Promotion Option, it will not be entitled to [*] without the prior written approval of Shire.

 

5.2 Exercise of Option . New River shall provide to Shire at least [*] written notice of the first exercise of its Co-Promotion Option prior to the commencement date of such Co-Promotion. If New River terminates its Co-Promotion with respect to a Collaboration Product in the US Territory, New River shall provide Shire at least [*] written notice of any subsequent exercise of its Co-Promotion Option prior to the commencement date of such Co-Promotion. In each exercise of its Co-Promotion Option, New River will specify the date upon which it will commence Co-Promotion, the percentage of Details that New River intends to provide (up to twenty-five percent (25%) of the total Details for such Collaboration Product) and will commit to Co-Promote a Collaboration Product for at least [*] . New River may adjust the level of its Detail commitment on an annual basis with at least [*] notice, but no such adjustment shall change its Detail commitment by more than [*] of the total Details for such Collaboration Product, and in no event may New River commit to providing more than twenty-five percent (25%) of the total Details for such Collaboration Product.

 

5.3 Co-Promotion Period . The “ Co-Promotion Period ” for each Collaboration Product will commence upon the date specified in New River’s exercise of the Co-Promotion Option and will expire upon the earlier of: (a) termination of the Parties’ Commercialization of the applicable Collaboration Product in the US Territory; and (b) [*] following the date that New River provides written notice to Shire terminating New River’s Co-Promotion activities hereunder.

 

5.4 Amendment of Marketing Plan to Include Co-Promotion Activities . The Parties’ Co-Promotion activities for any Collaboration Product in the US Territory shall be governed by a Marketing Plan. After New River gives notice of its intention to exercise a Co-Promotion Option with respect to a Collaboration Product, Shire shall amend the applicable Marketing Plan to set forth the Co-Promotion activities of the Parties for such Collaboration Product in a manner consistent with the terms of this Agreement. Each Marketing Plan for a Co-Promote Product shall set forth the compensation/incentive plans, targeting an allocation between the Parties of the Co-Promotion activities for the Collaboration Product in the US Territory, using reasonable and good faith efforts to allocate the Co-Promotion activities in a manner to give effect to the sales and marketing strategy described in the applicable Marketing Plan and in the best interests of such Collaboration Product. If at the time of exercise of its Co-Promotion Option, New River commits to Co-Promote a Collaboration Product for at least [*] at a fixed level of Detail commitment, then, except with the consent of New River, the applicable Marketing Plan will allocate between the Parties, on a reasonable pro rata basis, the opportunity to promote such Collaboration Product to high prescribing physicians and in centers of excellence. Each Marketing Plan for a Co-Promote Product shall be approved by the JMC in accordance with the terms of Article 2, and each such plan may be amended in a manner consistent with this Agreement.

 

5.5 Scope . The Co-Promotion by New River of any Collaboration Products under this Agreement shall be subject to the terms and conditions set forth in this Article 5. For

 

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purposes of this Article 5, a Collaboration Product subject to Co-Promotion under this Agreement shall be referred to as a “ Co-Promote Product ”.

 

5.6 Advertising and Promotional Materials.

 

5.6.1 Inclusion in Marketing Plan . Shire will describe in the applicable Marketing Plan for a Co-Promote Product how and the manner in which the Parties will be presented and described to the medical community in any Promotional Materials or other materials related to the Co-Promote Product and the placement of the names and logos of the Parties, in each case as permitted by applicable Law and with the labeling for the Co-Promote Product approved by the FDA. The Marketing Plan for a Co-Promote Product shall also set forth a delivery schedule for Promotional Materials to be provided by Shire to New River.

 

5.6.2 Shire Approval . All written, electronic and visual communications, including all Promotional Materials, provided by a Party to its Sales Representatives Detailing the Co-Promote Product for use by such personnel regarding the Co-Promote Product positioning, selling messages or product strategy will be subject to prior review and approval by Shire; provided, that a communication, once approved, need not be re-submitted for approval again prior to its re-use unless the Co-Promote Product labeling applicable to such communication has been changed in any way since such prior approval date; provided that it is understood that Shire shall have the right to withdraw any such communication even after approval.

 

5.7 Shipment, Storage and Allocation of Samples . If set forth in the applicable Marketing Plan for a Co-Promote Product, Shire shall ship reasonable requirements of Samples for the US Territory to New River’s distribution facility in a timely manner in accordance with the schedule for distribution as outlined in such Marketing Plan. New River shall be responsible for supplying its Sales Representatives in the US Territory with Samples from New River’s distribution facility.

 

5.8 Training.

 

5.8.1 Shire Control . The direction and training of any Sales Representatives of New River for a Co-Promote Product shall be under the control of Shire.

 

5.8.2 Timing; Expenses . Shire shall provide sales training on the Collaboration Products for the New River Sales Representatives who will be performing Sales Calls for a Co-Promote Product similar to the training on such Co-Promote Product Shire provides to its own Sales Representatives who perform Sales Calls on such Co-Promote Product. Shire shall provide such training at a time that is mutually acceptable to the Parties and reasonably prior to the commencement of Co-Promotion activities by the applicable New River Sales Representative. Such training shall be deemed a Pre-Marketing Expense or Marketing Expense, as applicable. Notwithstanding anything to the contrary in this Agreement, New River shall pay all travel and housing costs for it