Back to top

CONFIDENTIAL CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN FILED SEPARATELY WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION AMENDED AND RESTATED LICENSE, COMMERCIALIZATION AND SUPPLY AGREEMENT

Supply Agreement

CONFIDENTIAL CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN FILED SEPARATELY WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION AMENDED AND RESTATED LICENSE, COMMERCIALIZATION AND SUPPLY AGREEMENT | Document Parties: INDEVUS PHARMACEUTICALS INC | ALLERGAN, INC | ESPRIT PHARMA, INC | INDEVUS PHARMACEUTICALS, INC You are currently viewing:
This Supply Agreement involves

INDEVUS PHARMACEUTICALS INC | ALLERGAN, INC | ESPRIT PHARMA, INC | INDEVUS PHARMACEUTICALS, INC

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.
Title: CONFIDENTIAL CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN FILED SEPARATELY WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION AMENDED AND RESTATED LICENSE, COMMERCIALIZATION AND SUPPLY AGREEMENT
Governing Law: New York     Date: 9/21/2007

CONFIDENTIAL CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN FILED SEPARATELY WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION AMENDED AND RESTATED LICENSE, COMMERCIALIZATION AND SUPPLY AGREEMENT, Parties: indevus pharmaceuticals inc , allergan  inc , esprit pharma  inc , indevus pharmaceuticals  inc
50 of the Top 250 law firms use our Products every day

EXHIBIT 10.1

 

CONFIDENTIAL

   Execution Copy

CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN FILED SEPARATELY WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION

AMENDED AND RESTATED LICENSE,

COMMERCIALIZATION AND SUPPLY AGREEMENT

by and between

INDEVUS PHARMACEUTICALS, INC.

and

ESPRIT PHARMA, INC.

dated

September 18, 2007

 


TABLE OF CONTENTS

 

               Page
1.    D EFINITIONS    1
2.    G RANT OF R IGHTS    14
   2.1    Grants by Indevus    14
   2.2    Sublicenses of Third Party Rights    15
   2.3    Retained Rights; No Implied Licenses; Limitations    16
   2.4    Non-Competition    16
   2.5    Proposed Sublicense by Esprit    16
   2.6    Regulatory Filings    17
   2.7    Access to Information    18
   2.8    Grant by Esprit    18
   2.9    No Further Development by Indevus    18
3.    G OVERNANCE    19
   3.1    Development Committee    19
   3.2    Marketing Committee    20
   3.3    Supply Committee    22
   3.4    Meetings    24
   3.5    Minutes of Committee Meetings    24
   3.6    Disbanding of Committees    24
   3.7    Project Coordinators    25
4.    D EVELOPMENT AND R EGULATORY M ATTERS    25
   4.1    Development    25
   4.2    Regulatory Matters    25
5.    P ROMOTION OF P RODUCTS    29
   5.1    General    29
   5.2    Promotion Plan    30
   5.3    Target Prescribers; Product Advisors    30
   5.4    Esprit Promotional Activities    31
   5.5    Indevus Promotional Activities    31
   5.6    Promotional Materials and Activities    33
   5.7    Samples    35
   5.8    Training Program    35
   5.9    Additional Services and Assistance by Esprit    37
   5.10    Additional Personnel and Support    38
   5.11    Covenants of the Parties    38

 


6.    P AYMENTS AND S TATEMENTS    39
   6.1    Upfront and Milestone Payments    39
   6.2    Sublicensing Royalties, Minimum Royalties and Third Party Royalties    40
   6.3    Sales Force Reimbursement    44
   6.4    Reports and Payments    45
   6.5    Audits    47
   6.6    License to Dominating Patent    48
7.    R EPRESENTATIONS AND W ARRANTIES    48
   7.1    General Representations    48
   7.2    Additional Representations and Warranties of Indevus    49
   7.3    Additional Representations and Warranties of Esprit    51
   7.4    Disclaimer of Additional Warranties    51
   7.5    Limitation of Liability    51
8.    P ATENT M ATTERS    52
   8.1    Ownership    52
   8.2    Maintenance and Prosecution    52
   8.3    Third Party Infringement    53
   8.4    Third Party Intellectual Property    54
   8.5    Patent Term Extensions    54
   8.6    Conflict with Certain Existing Agreements    55
9.    T RADEMARK M ATTERS    55
   9.1    General    55
   9.2    Maintenance    55
   9.3    Use of Trademark    55
   9.4    Enforcement    55
   9.5    Avoidance of Confusion    56
   9.6    Trademark Security Interest    56
10.    A DVERSE E XPERIENCES    56
11.    C ONFIDENTIALITY AND P UBLICITY    57
   11.1    Non-Disclosure and Non-Use Obligations    57
   11.2    Permitted Disclosure of Proprietary Information    58
   11.3    Disclosure of Agreement to Governmental Authority    58
   11.4    Publications    59
   11.5    Other Public Statements    59
12.    T ERM AND T ERMINATION    60
   12.1    Term and Expiration    60
   12.2    Early Termination    60
   12.3    Rights Not Affected    61

 


   12.4    Effect of Expiration or Termination    62
13.    I NDEMNIFICATION AND I NSURANCE    63
   13.1    Indemnity    63
   13.2    Esprit Indemnification    63
   13.3    Indevus Indemnification    63
   13.4    Indemnification Procedure    64
   13.5    Defense of Claims    64
   13.6    Settlement of Indemnified Claims    65
   13.7    Product Liability Claims    65
   13.8    Insurance    67
14.    O RDERS AND S UPPLY    67
   14.1    Orders and Terms of Sale    67
   14.2    Misdirected Orders    67
   14.3    Product Returns    67
   14.4    Supply Obligations    68
   14.5    Forecasts for Products    68
   14.6    Purchase Orders    70
   14.7    Delivery    70
   14.8    Supply Price and Payments    71
   14.9    Conformity; Specifications; Quality Control    72
   14.10    Inspection; Non-conformance    73
   14.11    Inventory Management    74
   14.12    Shortages; Failure to Supply    74
   14.13    Assumption of Processing Activities    75
   14.14    Ex-US Supply Agreement    77
15.    M ISCELLANEOUS    77
   15.1    Force Majeure    77
   15.2    Assignment    77
   15.3    Severability    78
   15.4    Notices    78
   15.5    Specific Performance    79
   15.6    Applicable Law and Venue    80
   15.7    Entire Agreement    80
   15.8    Independent Contractors    80
   15.9    Waiver    80
   15.10    Headings; References; Interpretation    80
   15.11    Release    81
   15.12    Counterparts    81

 


THIS AMENDED AND RESTATED LICENSE, COMMERCIALIZATION AND SUPPLY AGREEMENT (the “ Agreement ”) is made as of September 18, 2007 (the “ Execution Date ”), and, except as otherwise specified herein, is to become effective on the Effective Date (as defined below), by and between INDEVUS PHARMACEUTICALS, INC. , a corporation organized and existing under the laws of the State of Delaware and having its principal office at 99 Hayden Avenue, Suite 200, Lexington, MA 02421, United States (“ Indevus ”), and ESPRIT PHARMA, INC. , a corporation organized and existing under the laws of the State of Delaware and having its principal office at 2 Tower Center Boulevard, East Brunswick, NJ 08816, United States (“ Esprit ”).

RECITALS

WHEREAS, Odyssey Pharmaceuticals, Inc. and Indevus entered into a certain License, Commercialization and Supply Agreement, effective as of April 6, 2004, as amended by Amendment No. 1 thereto, dated as of April 30, 2005, as further amended by the Amendment and Consent Agreement, dated as of May 14, 2005 by and among Indevus, Odyssey Pharmaceuticals, Inc. and Esprit (f/k/a Saturn Pharmaceuticals, Inc.) (collectively, the “ Original Agreement ”);

WHEREAS , pursuant to a certain Asset Purchase Agreement, effective as of May 14, 2005, Odyssey Pharmaceuticals, Inc. assigned to Esprit (formerly known as “Esprit Pharma Holding Company, Inc.” and prior to that “Saturn Pharmaceuticals, Inc.”) the rights of Odyssey Pharmaceuticals, Inc., and Esprit assumed the obligations of Odyssey Pharmaceuticals, Inc., in and under the Original Agreement;

WHEREAS , simultaneously with the execution of this Agreement, Esprit Pharma Holding Company, Inc. (“ Esprit Holding ”), the current parent company of Esprit is entering into an Agreement and Plan of Merger by and among Allergan, Inc., a Delaware corporation (“ Allergan ”), Andrew Einhorn, solely in his capacity as the Escrow Participants’ Representative, Esmerelde Acquisition, Inc., a Delaware corporation and wholly-owned subsidiary of Allergan, and Esprit Holding (the “ Merger Agreement ”);

WHEREAS , pursuant to the Merger Agreement, Esmerelde Acquisition, Inc. will merge with and into Esprit Holding, and Esprit Holding will survive the merger as a wholly-owned subsidiary of Allergan; and

WHEREAS , Indevus and Esprit desire to amend and restate the Original Agreement to reflect the agreements of the Parties to be effective as of the Effective Date or, as specifically set forth in Article 14, on the Execution Date, all on the terms and conditions set forth below.

NOW, THEREFORE , in consideration of the foregoing statements and the mutual agreements and covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Indevus and Esprit hereby agree as follows:

 

  1. D EFINITIONS

Unless specifically set forth to the contrary herein, the following terms, where used in the singular or plural, shall have the respective meanings set forth below:

1.1Act ” means the United States Food, Drug, and Cosmetic Act of 1938, as amended, and the rules and regulations promulgated thereunder, or any successor act, as the same shall be in effect from time to time.

 


1.2Adverse Experience ” or “AE(s)” means adverse drug experiences, as defined by 21 CFR Section 314.80.

1.3Affiliate ” of a Party means (i) any corporation or business entity of which at least fifty percent (50%) of the securities or other ownership interests representing the equity, the voting stock or general partnership interest are owned, controlled or held, directly or indirectly, by a Party; (ii) any corporation or business entity which, directly or indirectly, owns, controls or holds at least fifty percent (50%) (or the maximum ownership interest permitted by law) of the securities or other ownership interests representing the equity, voting stock or general partnership interest of a Party; (iii) any corporation or business entity of which, directly or indirectly, an entity described in the immediately preceding subsection (ii) controls or holds at least fifty percent (50%) (or the maximum ownership interest permitted by law) of the securities or other ownership interests representing the equity, voting stock or general partnership interest of such corporation or entity; or (iv) any corporation or business entity of which a Party has the right to acquire, directly or indirectly, at least fifty percent (50%) of the securities or other ownership interests representing the equity, voting stock or general partnership interest thereof.

1.4Agreement Term ” has the meaning set forth in Section 12.1.

1.5Allergan ” has the meaning set forth in the Recitals.

1.6Annual Purchased Amount ” means, with respect to Finished Product and/or Samples of Trospium Twice-Daily the sum of (a) the amount of such Finished Product and/or Samples that is delivered to Esprit during any one (1) year period commencing on September 1, 2007 or an anniversary thereof plus (b) the amount of such Finished Product and/or Samples subject to accepted and open (non-cancelled) firm Purchase Orders submitted by Esprit and requesting delivery during the applicable annual period, in accordance with the terms and conditions of Article 14, if such Finished Product and/or Samples have not been delivered on a timely basis through no fault of Esprit.

1.7Batch ” means a specific quantity of Product or Compound that is produced in a process or series of processes according to a single manufacturing order during the same cycle of manufacture so that it is homogeneous within specified limits. The batch quantities are approximately * tablets for Trospium Twice-Daily and are estimated to be approximately * capsules for Trospium Once-Daily.

1.8Business Day ” means any day that is not a Saturday or a Sunday or a day on which the New York Stock Exchange is closed.

1.9Calendar Quarter ” means for each Calendar Year, each of the three (3) month periods ending March 31, June 30, September 30 and December 31; provided , however , that (a) the first Calendar Quarter of any particular period shall extend from the commencement of such period to the end of the first complete Calendar Quarter thereafter; and (b) the last Calendar Quarter shall end upon the expiration or termination of this Agreement.

 

* CONFIDENTIAL TREATMENT REQUESTED

2

 


1.10Calendar Year ” means (a) for the first Calendar Year of the Agreement Term, the period beginning on the Effective Date and ending on (i) December 31, 2007 if the Effective Date occurs prior to December 31, 2007 or (ii) December 31, 2008 if the Effective Date occurs after December 31, 2007 and prior to December 31, 2008, (b) for each Calendar Year of the Agreement Term thereafter, each successive period beginning on January 1 and ending twelve (12) consecutive calendar months later on December 31, and (c) for the last Calendar Year of the Agreement Term, the period beginning on January 1 of the Calendar Year in which the Agreement terminates or expires and ending on the effective date of expiration or termination of this Agreement.

1.11Catalent Agreements ” means the (a) Manufacturing and Supply Agreement by and between Catalent Pharma Solutions LLC (“ Catalent ”) and Indevus, entered into as of September 17, 2007 and (b) Quality Agreement by and between Catalent and Indevus, entered into as of September 13, 2007; in each case, as in effect as of the Execution Date.

1.12CFR ” means the United States Code of Federal Regulations.

1.13cGMP ” means current Good Manufacturing Practice as defined in Parts 210 and 211 of Title 21 of the CFR, as may be amended from time to time, or any successor thereto.

1.14Claims ” has the meaning set forth in Section 13.2.

1.15Collateral ” has the meaning set forth in Section 2.6(b)(i).

1.16Commercially Reasonable Efforts ” means that degree of skill, effort, expertise, and resources normally used (including the promptness in which such efforts and resources would be applied) consistent with standards generally accepted in the pharmaceutical industry, with respect to the diligent development, manufacture and commercialization of pharmaceutical products of similar market and profit potential at a similar stage in development or product life as a Product in the Field.

1.17Competing Product ” means any product in the Field that contains Compound as one of its active ingredients *

1.18Compound ” means the chemical compound known as Trospium Chloride whose specific chemical name is 3-alpha-benziloyloxynortropane-8-spiro-1’-pyrrolidinium chloride, also known as spiro[8-azoniabicyclo[3,2,1]octane-8,1’-pyrrolidinium]-3-[(hydroxydiphenyl-acetyl)-oxy]chloride((1 µ , 3ß, 5 µ ))-(9Cl) and any related analogues, homologues, derivative and other pharmaceutically active salts.

1.19Control ” means possession of the ability to grant a license or sublicense as provided for herein without violating the terms of any agreement with any Third Party.

 

* CONFIDENTIAL TREATMENT REQUESTED

3

 


1.20Copromotion Period ” means the period commencing on the Effective Date and expiring on (a) September 30, 2008, or (b) if extended by Indevus in accordance with Section 5.5(b)(ii), on December 31, 2008 or March 31, 2009, as applicable, or (c) the last day of any applicable Cure Period in which Indevus completes its Detail Obligations in accordance with Section 5.5(b)(ii) after the dates set forth in subsections (a) and (b) above.

1.21Cure Period ” means any two (2) consecutive Calendar Quarters immediately following a Deficient Quarter.

1.22Data ” means any and all research data, pharmacology data, preclinical data, clinical data and/or all other documentation submitted, or required to be submitted, to the FDA in association with an IND or NDA for a Product (excluding any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (CMC) data, or similar documentation).

1.23Deficient Quarter ” means any Calendar Quarter in which the Indevus Sales Force fails to deliver * of the Quarterly Indevus Details applicable to such Calendar Quarter.

1.24Deploy ” means the act of designating a particular employee of Esprit or Indevus as a member of the Esprit Sales Force or Indevus Sales Force, as applicable, and the inception by such member of services to Detail the Products; provided , however , that no such member shall be Deployed without first satisfying the requirements set forth in Section 5.8.

1.25Detail ” means a face-to-face contact by a Representative with a Target Prescriber in an individual or group practice setting (not including dinner meetings, medical conventions, medical education meetings, Sample drops or incidental contacts that do not otherwise constitute a Detail as defined herein), and during which the FDA-approved indicated uses, safety, effectiveness, contraindications, side effects, warnings, and other relevant characteristics of a Product are described by the Representative in a fair and balanced manner consistent with the requirements of the Act and with FDA-approved Product information sheets, and using, as necessary or desirable, the Product Labeling and/or the Promotional Materials. When used as a verb, “ Detail ” shall mean to engage in a Detail.

1.26Development Committee ” has the meaning set forth in Section 3.1(a).

1.27Effective Date ” means the Effective Time (as such term is defined in the Merger Agreement).

1.28Esprit Sales Force ” has the meaning set forth in Section 5.4(a).

1.29Ex-US Supply Agreement ” means, if Indevus exercises the Ex-US Supply Option, the agreement to be effective as of the Processing Assumption Date between Indevus and Esprit pursuant to which Esprit shall supply Indevus or its designees with bulk capsules of Trospium Once-Daily prior to being in their finished, labeled and packaged form solely for use outside the Territory.

1.30Ex-US Supply Option ” has the meaning set forth in Section 14.14.

 

* CONFIDENTIAL TREATMENT REQUESTED

4

 


1.31FDA ” means the United States Food and Drug Administration and any successor agency having substantially the same functions.

1.32FDA Approval ” means with respect to a Product in the Field, all authorizations by the FDA that are required for the marketing of such Product in the United States.

1.33Field ” means *

1.34Finished Product ” means Trospium Twice-Daily or Trospium Once-Daily, as applicable, in its finished, labeled and packaged form, ready for distribution in the Field in the Territory.

1.35Firm Commitment ” has the meaning set forth in Section 14.5(b)(ii).

1.36Force Majeure ” means, with respect to a Party, any fire, flood, earthquake, explosion, storm, blockage, embargo, war, acts of war (whether war be declared or not), terrorism, insurrection, riot, civil commotion, strike, lockout or other labor disturbance, failure of public utilities or common carriers, act of God or act, omission or delay in acting by any governmental authority or the other Party.

1.37Forecasted Supply Price ” has the meaning set forth in Section 14.8(b)(ii).

1.38GAAP ” means generally accepted accounting principles in the United States, consistently applied.

1.39Generic Competition ” shall be deemed to exist as of any date if Generic Products have a market share in the United States of * or greater of the total unit volume of Trospium Once-Daily in the United States (as so shown by the average of the monthly IMS (or IMS-equivalent) data) for the most recent Calendar Quarter ended prior to such date.

1.40Generic Product ” means any product containing Compound that is an AB rated equivalent to Trospium Once-Daily as defined in the 23rd edition of Approved Drug Products with Therapeutic Equivalence Evaluations issued by the United States Department of Health and Human Services, for which FDA Approval in the United States has been obtained *

1.41Helsinn Agreements ” means the (a) API Supply Agreement dated as of November 22, 2006 by and between Indevus and Helsinn Chemicals SA and Helsinn Advanced Synthesis SA (collectively, “ Helsinn ”) and (b) Quality Technical Agreement dated as of August 21, 2007 by and between Helsinn and Indevus; in case, as in effect as of the Execution Date and as amended from time to time during the Agreement Term.

1.42Improvements ” means all inventions and know-how, patentable or otherwise, made, created, developed, conceived or reduced to practice by or on behalf of a Party and/or any of its Affiliates during the Agreement Term, that have application or relate to Compound or Products for use in the Field, including developments in the manufacture, formulation, ingredients, preparation, presentation, means of delivery or administration, dosage,

 

* CONFIDENTIAL TREATMENT REQUESTED

5

 


indication, methods of use or packaging and/or sale of Products in the Field, including a process for manufacturing a Product, an intermediate used in such process, a formulation of a Product in the Field, or a use or indication of a Product in the Field.

1.43IND ” means an Investigational New Drug application, as described in 21 CFR Section 312.23, obtained for purposes of conducting clinical trials in accordance with the requirements of the Act and the regulations promulgated thereunder, including all supplements and amendments thereto, relating to the use of Compound or a Product in the Field.

1.44Indevus Intellectual Property ” means Indevus Patent Rights and Indevus Know-How.

1.45Indevus Invention ” has the meaning set forth in Section 8.1.

1.46Indevus Know-How ” means all unpatented information and Data that are as of the Effective Date or become during the Agreement Term owned or otherwise Controlled by Indevus, including discoveries, Improvements, processes, formulas, inventions, know-how and trade secrets, to the extent necessary or useful for the development, manufacture, and/or commercialization of a Compound or Product in the Field. Indevus Know-How does not include any Patent Rights. Indevus Know-How also includes, other than marketing rights and marketing approvals transferred to Esprit on the NDA Transfer Date, all marketing authorizations and marketing approvals granted by the FDA (e.g., approved NDAs, INDs, and related applications and other forms of marketing authorization) to Indevus for the marketing of Products in the Field in the Territory. Such marketing authorizations and marketing approvals shall be deemed embodiments of Data and Indevus Know-How.

1.47Indevus Logo ” has the meaning set forth on Schedule 1.47.

1.48Indevus Patent Rights ” means all Patent Rights in the Territory that are as of the Effective Date or become during the Agreement Term owned or otherwise Controlled by Indevus and that generically or specifically claim, or are otherwise related to, the making, having made, use, offer for sale, sale or importation of Products in the Field or claim any Improvements in the Field made by Indevus, including Indevus’ interest in any Patent Rights in Joint Inventions.

1.49Indevus Sales Force ” means those Representatives Deployed by Indevus on a full-time basis and the field sales management supervising such Representatives.

1.50Indevus Target Prescribers ” means those Target Prescribers with whom, pursuant to the terms of this Agreement, the Indevus Sales Force conducts Primary Position Details and/or Secondary Position Details; provided that such Target Prescribers shall be determined from a list of Target Prescribers agreed to in writing between the Parties prior to the Effective Date, as such list may be amended from time to time with the prior written approval of both Parties.

1.51Initial Indication ” means the use of a Product in the treatment of overactive bladder and/or urinary incontinence.

 

6

 


1.52Initial Purchase Order ” has the meaning set forth in Section 14.6.

1.53Joint Invention ” has the meaning set forth in Section 8.1.

1.54Launch Period ” means the period commencing on the date of launch of Trospium Once-Daily in the United States and expiring on the last day of the (a) fourth (4th) complete Calendar Quarter commencing after such launch date if such launch date is on or after the forty-fifth (45th) day of a Calendar Quarter or (b) third (3rd) complete Calendar Quarter commencing after such launch date if such launch date is prior to the forty-fifth (45th) day of a Calendar Quarter.

1.55Law(s) ” means all laws, statutes, rules, regulations, ordinances and other pronouncements having the binding effect of law of any governmental authority.

1.56Losses ” means any and all damages (including all incidental, consequential, statutory and treble damages), awards, deficiencies, settlement amounts, defaults, assessments, fines, dues, penalties (including penalties imposed by any governmental authority), costs, fees, liabilities, obligations, taxes, liens, losses, lost profits and expenses (including court costs, interest and reasonable fees of attorneys, accountants and other experts) awarded or otherwise paid or payable to Third Parties.

1.57Madaus ” means Madaus GmbH, a successor to Madaus AG, a company with limited liability organized under the laws of Germany and having its principal office at Colonia-Allee 15, 51067 Cologne, Germany, and any successor thereto.

1.58Madaus Agreements ” means the Madaus Amendment, Madaus Compound Supply Agreement, Madaus License, Madaus License and Supply Agreement, and the Madaus Supply Agreement, as any of such agreements may be amended from time to time during the Agreement Term.

1.59Madaus Amendment ” means the Amendment and Agreement by and between Indevus and Madaus, made as of November 3, 2006, as in effect as of the Execution Date.

1.60Madaus Compound Supply Agreement ” means the Compound Supply Agreement by and between Indevus and Madaus, made as of November 3, 2006, as in effect as of the Execution Date.

1.61Madaus License ” means the License Agreement by and between Madaus and Indevus effective as of November 26, 1999, as in effect as of the Execution Date and as amended by the Madaus Amendment.

1.62Madaus License and Supply Agreement ” means the License and Supply Agreement by and between Indevus and Madaus, made as of November 3, 2006, as in effect as of the Execution Date.

 

7

 


1.63Madaus Supply Agreement ” means the Supply Agreement by and between Indevus and Madaus, made as of December 16, 2002, as in effect as of the Execution Date.

1.64Marketing Committee ” has the meaning set forth in Section 3.2(a).

1.65Merger Agreement ” has the meaning set forth in the Recitals.

1.66Minimum Requirement ” has the meaning set forth in Section 14.5(b)(iii).

1.67Minimum Royalties ” means the minimum royalties payable to Indevus by Esprit in the applicable Calendar Year determined in accordance with the table set forth in Section 6.2(b)(i).

1.68Minimum Royalty Shortfall ” has the meaning set forth in Section 6.2(b)(i).

1.69NDA ” means a New Drug Application as defined in the Act that is submitted under Section 505 (b) of the Act to apply for FDA Approval.

1.70NDA Transfer Date ” means the earlier of (a) September 30, 2012 and (b) at Esprit’s sole election, the date, if any, that Indevus assigns its rights or obligations under this Agreement to another person or entity in connection with the transfer or sale of Indevus’ business or all or substantially all of its assets or in the event of a merger, consolidation, change in control or similar corporate transaction.

1.71Net Sales ” means the gross amount invoiced for all commercial sales of Finished Products to Third Parties in the Field in the Territory by Esprit and its Affiliates, less the following deductions actually allowed or taken in accordance with GAAP:

(a) credits or allowances actually granted for damaged or spoiled Finished Product, returns, recalls or rejections of such Finished Product, and retroactive price adjustments;

(b) normal and customary trade, cash and quantity discounts, allowances and credits actually allowed for such Finished Product;

(c) sales, value added, excise or similar taxes paid or allowed, or other governmental charges imposed upon the importation, use or sale of such Finished Product in the Territory;

(d) fees paid to Third Party distributors and legally allowed chargebacks, rebates or similar payments actually granted to customers with respect to such Finished Product, including managed health care organizations, wholesalers, distributors, buying groups, retailers, health care insurance carriers, pharmacy benefit management companies, health maintenance organizations or other institutions or health care organizations or to federal, state/provincial, local and other governments, their agencies and purchasers and reimbursers;

 

8

 


(e) freight, postage, shipping and insurance charges related to delivery of such Finished Product; and

(f) any other items that reduce gross sales amounts as required by GAAP.

Sales or other transfers between Esprit and its Affiliates shall be excluded from the computation of Net Sales and no payments will be payable on such sales or transfers except where such Affiliates are end users, but Net Sales shall include the subsequent sales to Third Parties by such Affiliates.

1.72Original Agreement ” has the meaning set forth in the Recitals.

1.73Party ” means Indevus or Esprit.

1.74Patent Rights ” means any patents, patent applications, certificates of invention, or applications for certificates of invention and any supplemental protection certificates, together with any extensions, registrations, confirmations, reissues, substitutions, divisions, continuations or continuations-in-part, reexaminations or renewals thereof.

1.75PDMA ” means the United States Prescription Drug Marketing Act of 1987, as amended, or any successor act thereto, and the regulations promulgated thereunder from time to time.

1.76Phase IV Clinical Trials ” means a human clinical trial for a Product in the Field commenced after receipt of FDA Approval in the United States and that is conducted within the parameters of the FDA Approval for such Product. Phase IV Clinical Trials may include epidemiological studies, modeling and pharmacoeconomic studies, investigator sponsored clinical trials of such Product and post-marketing surveillance studies.

1.77Primary Position Detail ” means a Detail of a Product in the Field in which (a) such Product is the first product Detailed during a Detail to a Target Prescriber, (b) at least * of the total time of the Detail is spent on the presentation of such Product, and (c) the Representative delivers a message to the Target Prescriber in which key attributes of such Product are verbally promoted.

1.78Primary Training ” has the meaning set forth in Section 5.8(a).

1.79Prime Rate ” has the meaning set forth in Section 6.4(d).

1.80Processing Activities ” means the activities required to be undertaken by (a) Indevus or its Third Party Manufacturers in order to manufacture and supply Esprit with Trospium Once-Daily Finished Product and/or Samples prior to the Processing Assumption Date, and (b) in the event the Ex-US Supply Agreement is executed between the Parties, Esprit or its Third Party Manufacturers in order to manufacture and supply Indevus and/or its designees after the Processing Assumption Date with Trospium Once-Daily solely for use outside the Territory either in (i) bulk capsule form prior to being in its finished, labeled and packaged form or (ii) finished, labeled and packaged form.

 

* CONFIDENTIAL TREATMENT REQUESTED

9

 


1.81Processing Assumption Date ” means the effective date of Esprit’s assumption of the Processing Activities of Indevus in accordance with the terms of Section 14.13, which date shall be agreed to by the Parties in writing, but in any event shall not be earlier than the Effective Date nor later than June 30, 2008.

1.82Product ” means any pharmaceutical preparation in final form (or, where the context so indicates, the form under development) containing Compound as a primary active therapeutic ingredient that, except for Samples thereof, requires a prescription from a physician or other health care professional, for use in the Territory.

1.83Product Adverse Event ” means the occurrence of any of the following: (a) Generic Competition; (b) any materially adverse change to a Trospium Once-Daily Product label such as an FDA-mandated addition of a “Black Box” warning on the Product Labeling of Trospium Once-Daily that is unique to such product among the class of anti-cholinergic drugs for the treatment of overactive bladder; (c) any recall or withdrawal of Trospium Once-Daily mandated by the FDA or reasonably initiated by a Party (other than actions arising out of or resulting from the manufacturing of Trospium Once-Daily on or after the Processing Assumption Date); (d) a determination by a court of competent jurisdiction that a patent owned by a Third Party is infringed by the manufacture, use, sale, offer for sale or importation of Trospium Once-Daily in the Territory; or (e) failure to deliver at least (i) * of Trospium Once-Daily Finished Product and Samples for receipt by Esprit or its designee by * ( provided that Esprit provides any modifications requested by Esprit to the trade dress for such Finished Product and Samples on or before *, and the FDA does not reject any such modifications to the trade dress, provided that, if Esprit does not provide such modifications or if the FDA rejects any such modifications to the trade dress, such delivery date shall be extended by a period of time equal to the period between * and the date upon which Esprit provides such modifications or the FDA approves such trade dress, as applicable), (ii) * (not including the * to be delivered by *, as described in subsection (i) above) of Trospium Once-Daily Finished Product and Samples by *, and/or (iii) * (not including the * to be delivered by *, as applicable, as described in subsections (i) and (ii) above) of Trospium Once-Daily Finished Product and Samples by *.

1.84Product Label(ing) ” has the same meaning as defined in the Act and as interpreted by the FDA.

1.85Product Liability Claims ” means any and all claims by purchasers or users of Products in the Field, or their family members, insurers, health care providers, subrogees or assignees, seeking damages for personal injury, death, expense, economic loss (including loss of value of such Products), or any other relief or remedy, arising out of or related to any alleged defect in the design, labeling, packaging or marketing of such Products, including a failure to warn.

1.86Product NDAs ” means the NDAs owned by Indevus as of the Effective Date relating to Trospium Twice-Daily (No. 21-595) and Trospium Once-Daily (No. 22-103), together with all amendments, supplements and updates thereto, as well as the corresponding INDs (with respect to Trospium Twice-Daily, IND 61,381, and with respect to Trospium Once-Daily, IND 71,305).

 

* CONFIDENTIAL TREATMENT REQUESTED

10

 


1.87Product Procurement Costs ” means the costs associated with the manufacturing, purchasing, procurement and warehousing of Trospium Twice-Daily, Trospium Once-Daily and Compound, as applicable, and with any other Processing Activities, that are actually incurred by Indevus ( provided that in all cases such amounts are not included in, and do not form the basis of, any payments payable by Esprit to Indevus pursuant to Section 6.2(c)), including (a) costs associated with procuring active pharmaceutical ingredients and other materials used to manufacture Finished Products and/or Samples, (b) the cost of transportation, testing, inspections, shrinkage and scrap, related taxes (but in all cases excluding taxes based upon income or receipts), (c) the cost of storage, insurance and any subcontracted costs, and amounts payable to Third Party Manufacturers in connection with the manufacture and supply of Finished Products and/or Samples, including any fees related to minimum purchase requirements, (d) direct labor and, to the extent not in excess of (i)* for Trospium Once-Daily and Trospium Twice-Daily through the Processing Assumption Date, provided the aggregate production Batches do not exceed * through the Processing Assumption Date, and (ii) * annually thereafter for Trospium Twice-Daily provided aggregate annual production Batches do not exceed* (plus, solely with respect to this Section 1.87(d)(ii), the increase on * and each anniversary of such date in the Producer Price Index, Pharmaceutical Preparations (Series ID 325412325412) (as published by the U.S. Bureau of Labor and Statistics (http://www.bls.gov/ppi)) multiplied by such price ) , overhead costs, including an allocation for Indevus’ internal costs and expenses for supply chain management, including supply chain production planning, the formulation and placement of orders with Third Party Manufacturers, the management of inventories throughout the supply chain process, quality control/quality assurance, regulatory and Third Party Manufacturer oversight and cost accounting and including, with respect to Trospium Once-Daily Finished Product, and (e) an amount equal to the amounts payable by Indevus to Madaus pursuant to Section 3.7(b)(2) of the Madaus License ( provided that such amounts are not included in any payments payable by Esprit to Indevus pursuant to Section 6.2(c)).

1.88Promotion ” means those activities normally undertaken by a pharmaceutical company to implement promotion plans and strategies aimed at encouraging the appropriate use of a particular prescription pharmaceutical product under a common trademark, up to the point of offering a product for sale. When used as a verb, “ Promote ” shall mean to engage in such activities.

1.89Promotional Materials ” means all written, printed or graphic material, other than Product Labeling, packaging, or trade dress, intended for use by Representatives during Details of Trospium Twice-Daily or Trospium Once-Daily under this Agreement, including visual aids, file cards, premium items, clinical studies, reprints, business cards, identification tags and any other promotional support items or advertisements provided in accordance with the terms of the relevant Promotion Plan and Section 5.6.

1.90Promotion Plan ” means the then-current plan relating to the Promotion of a Product, as contemplated by and in accordance with the requirements of Section 5.2.

1.91Proprietary Information ” means any and all scientific, clinical, regulatory, marketing, financial and commercial information or data, whether communicated in writing, orally or by any other means, that is owned and under the protection of one Party and is provided by that Party to the other Party in connection with this Agreement.

 

* CONFIDENTIAL TREATMENT REQUESTED

11

 


1.92Pro Rated Minimum Royalty ” has the meaning set forth in Section 6.2(b)(i).

1.93Purchase Order ” has the meaning set forth in Section 14.6.

1.94Quarterly Indevus Details ” means the aggregate number of Details to be performed by the Indevus Sales Force to the Indevus Target Prescribers during each Calendar Quarter period of the Copromotion Period, as set forth in Section 5.5(b).

1.95Regulatory Documents ” means filings, applications, modifications, amendments, supplements, revisions, reports, submissions, authorizations and approvals, including any IND or NDA, and any reports or amendments necessary to maintain FDA Approvals.

1.96Representative ” means a sales representative employed (or in the case of Esprit, otherwise engaged) on a full-time basis by a Party to conduct Details pursuant to this Agreement.

1.97Rolling Forecast ” has the meaning set forth in Section 14.5(b)(i).

1.98Sales Force(s) ” means the Esprit Sales Force and/or the Indevus Sales Force, as applicable.

1.99Sales Force Reimbursement ” has the meaning set forth in Section 6.3.

1.100Samples ” means units of the Product described in the Specifications distributed or provided to health care professionals in the Territory for dispensing, in turn, to patients for “trial use” at no cost to the patient pursuant to Law.

1.101Secondary Position Detail ” means a promotional message involving a Product delivered by a Representative during a face-to face contact with a Target Prescriber in which key product attributes are verbally presented after presenting a detail for another product, consistent with the terms of this Agreement, and where such Product is given an important but not primary emphasis, and shall be at least * of the total time of such face-to face contact. A Secondary Position Detail shall meet all of the requirements for a Detail, except as specified in this Section 1.101 and Section 5.5(b)(ii).

1.102Sublicensing Royalties ” has the meaning set forth in Section 6.2(a)(i).

1.103Specifications ” means the respective specifications for Trospium Twice-Daily and Trospium Once-Daily Finished Product as set forth in the applicable Product NDAs, as such may be modified from time to time in such Product NDAs and pursuant to Section 4.2(x).

 

* CONFIDENTIAL TREATMENT REQUESTED

12

 


1.104Supernus ” means Supernus Pharmaceuticals, Inc. (f/k/a Shire Laboratories, Inc.), a Delaware corporation with a principal place of business at 1550 East Gude Drive, Rockville, Maryland 20850.

1.105Supernus Agreement ” means the Development and License Agreement by and between Supernus and Indevus, effective as of March 11, 2003, as in effect as of the Execution Date, and as such agreement may be amended from time to time.

1.106Supply Committee ” has the meaning set forth in Section 3.3(a).

1.107Supply Price ” has the meaning set forth in Section 14.8(b).

1.108Supply Term ” has the meaning set forth in Section 14.4.

1.109Target Prescribers ” means those physicians determined to be high potential prescribers of urologic products to treat overactive bladder and set forth in a list specified in the Promotion Plan by the Marketing Committee.

1.110Technology Transfer ” means the transfer of technology to Esprit in connection with Esprit’s assumption of Processing Activities, as set forth in Section 14.13 and as may be further agreed to by the Parties.

1.111Territory ” means the United States of America, including the District of Columbia, and its territories and possessions, such as Puerto Rico.

1.112Third Party(ies) ” means a person or entity who or which is neither a Party nor an Affiliate of a Party.

1.113Third Party Manufacturer(s) ” means Third Parties that have been, or may during the Agreement Term be, engaged by a Party to perform services or supply facilities or goods (including Finished Product and/or Samples) in connection with any part of the manufacture, testing and/or packaging of Finished Product and/or Samples.

1.114Third Party Royalties ” means the amount payable by Indevus (a) to Madaus pursuant to Section 5.2.1(d)(ii) of the Madaus License as a result of payments made by Esprit to Indevus pursuant to Section 6.2(a) and (b); provided that the amounts payable by Esprit to Indevus pursuant to Section 6.2(c) shall not give effect to the credit due to Indevus from Madaus as provided for in Section 5.1(a) of the Madaus License; and/or (b) to Supernus pursuant to Section 5.6.1 of the Supernus Agreement.

1.115Trademark(s) ” means the SANCTURA trademarks, owned by Esprit, and all related domain names and other trademark related rights, and/or any other trademark that either Party may apply to register in the Territory if such alternate trademark is selected for use in the Promotion of a Product in the Field by the Parties under this Agreement.

1.116Training Program(s) ” means the training program(s) described in Section 5.8.

 

13

 


1.117Trospium Once-Daily ” means a controlled or extended-release oral formulation of Product that is indicated for administration once per day for the Initial Indication.

1.118Trospium Twice-Daily ” means a twenty milligram (20 mg) dosage oral formulation of Product that is indicated for administration twice per day for the Initial Indication and that is marketed by Esprit in the Territory as of the Execution Date as SANCTURA ® .

 

  2. G RANT OF R IGHTS

2.1 Grants by Indevus . In consideration of the commitments and undertakings of Esprit under this Agreement, and subject to the terms and conditions of this Agreement, Indevus hereby grants to Esprit during the Agreement Term:

(a) an exclusive (even as to Indevus, subject to Section 2.8) right and license in the Field (with the right to grant sublicenses, subject to the provisions of Section 2.5), under the Indevus Intellectual Property, to use, import, offer for sale, and Promote Products in the Territory;

(b) an exclusive (even as to Indevus) right and license in the Field (with the right to grant sublicenses, subject to the provisions of Section 2.5), under the Indevus Intellectual Property, to sell and distribute Products in the Territory;

(c) effective on the Processing Assumption Date, an exclusive right and license under the Indevus Intellectual Property, to make and have made Trospium Once-Daily for use in the Field in the Territory; and

(d) during the Copromotion Period and any period of time thereafter that Esprit has Promotional Materials that were printed prior to the end of the Copromotion Period and that contain the Indevus Logo, an exclusive (even as to Indevus, subject to Section 2.8) right and license in the Field in the Territory (with the right to grant sublicenses, subject to the provisions of Section 2.5) to use the Indevus Logo on the Promotional Materials solely in accordance with this subsection (d). All representations of the Indevus Logo that Esprit intends to use, if not previously approved by Indevus, will first be submitted to Indevus for approval, such approval not to be unreasonably withheld. Indevus will have thirty (30) days to review the representation of the Indevus Logo. If Indevus does not provide written notice of its approval or disapproval (together with its reasons for such disapproval) within such thirty (30) day period, Indevus will be deemed to have approved such representation.

Notwithstanding the rights and licenses granted under Sections 2.1(a), (b) and (c), Esprit does not expect or anticipate receiving any further Indevus Intellectual Property subsequent to the NDA Transfer Date, and through the Agreement Term, as Indevus has represented to Esprit that it believes that it is remote that after the NDA Transfer Date that Indevus will be performing any research or development activities which would generate any future Indevus Intellectual Property related to the licenses granted hereunder with respect to Product in the Field. Indevus shall not refund any consideration received from Esprit or pay any penalties if Indevus terminates any or all development activities which may result in additional Indevus Intellectual Property on or prior to NDA Transfer Date.

 

14

 


2.2 Sublicenses of Third Party Rights .

(a) The licenses granted to Esprit under Section 2.1 include exclusive sublicenses by Indevus in the Field of Indevus’ rights under the Madaus License and the Supernus Agreement to use, import, offer for sale, and sell Products in and, effective as of the Processing Assumption Date, make Trospium Once-Daily for use in, the Territory. Esprit acknowledges that it is a sublicensee under the Madaus License and the Supernus Agreement to the extent stated in the foregoing sentence and agrees not to act inconsistently with the terms of such agreements to the extent applicable to the sublicenses granted to Esprit hereunder.

(b) Provided that Esprit is in compliance with its obligations to pay the applicable Third Party Royalties in accordance with this Agreement, the payments required by Section 14.13(e)(iv) and the portion of Product Procurement Costs described in Section 1.87(e), and is otherwise in material compliance with its obligations hereunder, Indevus shall pay all amounts that Indevus shall owe to Madaus or Supernus under the Madaus Agreements or the Supernus Agreement, respectively, by virtue of this Agreement and shall perform in all material respects its obligations under the Madaus Agreements or the Supernus Agreement, as applicable, that are required to enable Esprit to perform its obligations or exercise the rights granted to Esprit under this Agreement. In the event that Indevus fails to make any such payment when due, Esprit, in its sole discretion, may elect to directly pay Madaus or Supernus, as applicable, any such payment and to offset against any payments due from Esprit to Indevus under this Agreement an amount equal to such payments made by Esprit to Madaus or Supernus. Indevus shall use good faith efforts to obtain the right, including by amendment of the Madaus Agreements and the Supernus Agreement, for Esprit to make such payments to Madaus and Supernus, as applicable, as described in and in accordance with this Section 2.2(b). Without limiting the generality of the foregoing, (i) as between the Parties, Indevus shall be responsible for any required milestone payments to Madaus pursuant to the Madaus Agreements and to Supernus pursuant to the Supernus Agreement, and (ii) Esprit shall, to the extent required by and in accordance with the terms of Section 6.2(c), reimburse Indevus for any Third Party Royalties payable pursuant to such agreements.

(c) In the event that Indevus receives notice from Madaus or Supernus that Indevus has breached the Madaus Agreements (other than the Madaus License and Supply Agreement) or the Supernus Agreement, respectively, which breach gives rise to a right (whether upon further notice, or with or without the passage of time) by Madaus or Supernus, as applicable, to terminate the respective agreement in a way that would terminate or materially adversely affect Esprit’s ability to perform its obligations or exercise the rights granted to Esprit under this Agreement, Indevus shall notify Esprit of such situation as soon as practicable, and in any event within sixty (60) hours after receipt of such notice, and use commercially reasonable efforts to promptly cure such breach. Provided that Esprit is in compliance with its obligations to pay the applicable Third Party Royalties in accordance with this Agreement, the payments required by Section 14.13(e)(iv) and the portion of Product Procurement Costs described in Section 1.87(e), and is otherwise in material compliance with its obligations hereunder, if Indevus is unable to cure such breach, and Esprit has not materially breached its obligations under this Agreement, Indevus shall, to the extent possible, permit Esprit to cure such breach (and any costs or expenses of Esprit incurred in curing such breach shall, at Esprit’s election, either be reimbursed by Indevus to Esprit or offset by Esprit against any amounts owed to Indevus under this

 

15

 


Agreement). As soon as reasonably practicable after the Effective Date, Indevus shall also use commercially reasonable efforts to obtain the agreements of each of Madaus and Supernus, as applicable, to grant, in the event that the Madaus Agreements (other than the Madaus License and Supply Agreement) or Supernus Agreement, as applicable, are terminated for any reason and Esprit is in compliance with its obligations to pay the applicable Third Party Royalties in accordance with this Agreement, the payments required by Section 14.13(e)(iv) and the portion of Product Procurement Costs described in Section 1.87(e), and is otherwise in material compliance with its obligations hereunder, substantially equivalent rights on substantially equivalent terms as those granted to Indevus pursuant to the Madaus Agreements (other than the Madaus License and Supply Agreement) or Supernus Agreement, as applicable, as are necessary for Esprit to exercise its rights and perform its obligations under this Agreement.

(d) Notwithstanding anything to the contrary in this Agreement, except with respect to the payment obligation in Section 6.2(c)(i), Section 14.13(e)(iv), and the portion of Product Procurement Costs described in Section 1.87(e), in no event shall Esprit be responsible for or liable with respect to, or have any obligation to reimburse Indevus in respect of, any payments, claims, demands, actions, causes of action, damages, costs, expenses, attorneys’ fees, obligations and liabilities of whatever kind or nature, in law or equity, arising under the Madaus Agreements or the Supernus Agreement, and, as between the Parties, Indevus shall be solely responsible and liable with respect to any such payments, claims, demands, actions, causes of action, damages, costs, expenses, attorneys’ fees, obligations and liabilities, and shall bear all costs associated therewith.

2.3 Retained Rights; No Implied Licenses; Limitations . All rights not specifically granted by a Party in this Agreement are reserved and retained by such Party. Nothing in this Agreement shall be deemed to constitute the grant of any license or other right to either Party, to or in respect of any product, patent, trademark, Proprietary Information, trade secret or other data or any other intellectual property of the other Party, except as expressly set forth herein. Except as otherwise set forth in this Agreement, neither Party shall grant any license to, or permit or authorize, any Third Party to Promote Products in the Field in the Territory without the prior written consent of the other Party.

2.4 Non-Competition . During the Agreement Term, neither Party will Promote, or permit its Affiliates to Promote, market or sell any Competing Product in the Territory, or acquire, or permit its Affiliates to acquire, directly or indirectly any rights or interest in or to a Competing Product that is being detailed, Promoted, marketed or sold in the Territory; provided , however , that, in the event that *

2.5 Proposed Sublicense by Esprit . Esprit shall have the right to grant sublicenses to an Affiliate under any of the rights or licenses granted to it by Indevus under this Agreement as set forth in this Section 2.5. Esprit shall advise Indevus in advance of any proposed sublicense and give due consideration to Indevus’ comments with respect thereto. Any sublicense shall be subject to the terms and conditions of this Agreement, including the provisions relating to payments set forth in Article 6, and Esprit shall be responsible to Indevus for any non-performance by any sublicensee of Esprit’s obligations under this Agreement that are assumed by the sublicensee. In the event Esprit grants a sublicense to an Affiliate, any payment due to Indevus under this Agreement must be received in its full amount by Indevus in the United States without any tax withholding or tax deduction therefrom.

 

* CONFIDENTIAL TREATMENT REQUESTED

16

 


2.6 Regulatory Filings .

(a) Transfer of Product NDAs. Indevus hereby assigns to Esprit all right, title and interest in the Product NDAs, effective as of the NDA Transfer Date. On the NDA Transfer Date, Indevus shall submit to the FDA a letter authorizing the transfer of ownership from Indevus to Esprit of the Product NDAs. As soon as practicable after the submission of such letter and the receipt by Esprit of the FDA’s acknowledgment letter, Esprit shall execute and submit to the FDA a letter, accompanied by the Product NDA transfer letter referred to in the preceding sentence, acknowledging Esprit’s commitment to assume ownership of the Product NDAs.

(b) Security Interest.

(i) Grant of Security Interest. The Parties acknowledge and agree that pursuant to the Original Agreement, as security for Indevus’ performance of its material covenants and obligations thereunder, Indevus granted to Esprit a security interest in Indevus’ right, title and interest in and to Indevus’ FDA marketing authorizations or marketing approvals related to a Product in the Field in the Territory (including the Product NDAs), subject to the Madaus Agreements (other than the Madaus License and Supply Agreement) and the Supernus Agreement and to Laws. Indevus hereby reaffirms the grant of such security interest, and hereby grants Esprit, as security for Indevus’ performance of its material covenants and obligations hereunder, a security interest in Indevus’ right, title and interest in and to any Indevus’ FDA marketing authorizations or marketing approvals related to a Product in the Field in the Territory that were not in existence as of the date of the Original Agreement (together with the subject matter described in the first sentence of this Section 2.6(a), the “ Collateral ”). The security interest is granted as security only and, except for the security interest granted, shall not transfer or in any way otherwise affect or modify any rights of Indevus with respect to the Collateral. The security interest shall be released on the earlier of (A) the NDA Transfer Date or (B) termination of this Agreement by Indevus pursuant to Section 12.2(a).

(ii) Further Assurances and Attorney in Fact.

(A) Indevus agrees that from time to time, at Esprit’s expense, Indevus shall promptly execute and deliver all further instruments and documents, and take all further action, that Esprit may reasonably request in order to perfect, protect or more fully evidence any security interest granted or purported to be granted hereby or to enable Esprit to exercise or enforce its rights and remedies hereunder with respect to the Collateral.

(B) To the extent permitted by Law, Indevus hereby authorizes Esprit, to file at Esprit’s expense, one or more financing or continuation statements, and amendments thereto and assignments thereof, relating to all or any part of the Collateral now existing or hereafter arising without the signature of Indevus, and Esprit shall promptly upon the filing thereof by it deliver to Indevus a copy of each such financing or continuation statement or amendment or assignment. To the extent permitted by Law, a carbon, photographic or other reproduction of this Agreement or any financing statement covering the Collateral or any part thereof shall be sufficient as a financing statement.

 

17

 


(C) Indevus hereby irrevocably appoints Esprit as Indevus’ attorney in fact, with full authority in the place and stead of Indevus and in the name of Indevus or otherwise, from time to time in Esprit’s reasonable discretion upon the occurrence and during the continuance of a material default by Indevus of its covenants and obligations hereunder, to take any action and to execute any instrument that Indevus may reasonably deem necessary or advisable to accomplish the purposes of the security interests in the Collateral granted by Indevus hereunder.

2.7 Access to Information . Subject to the terms and conditions of this Agreement, Indevus shall promptly provide to Esprit all Data obtained by Indevus or any of its licensees related to the Products and data and information with respect to pharmacovigilance related to the Products, and Indevus shall cooperate in good faith to provide Esprit access to and reasonable assistance with all Indevus Intellectual Property and other Proprietary Information as may be required for Esprit to exercise the rights and licenses explicitly granted and to perform its obligations hereunder. After the disbanding of any committee pursuant to Section 3.6, Esprit shall have the right to continue to receive the information it would otherwise be entitled to receive under this Agreement.

2.8 Grant by Esprit . In consideration of the commitments and undertakings of Indevus under this Agreement, and subject to the terms and conditions of this Agreement, Esprit hereby grants to Indevus, during the Copromotion Period:

(a) an exclusive (except as to Esprit), nontransferable right and license in the Field in the Territory to Promote Products solely for the purpose of co-Promoting Products with Esprit in accordance with and subject to the terms of Article 5; and

(b) an exclusive (except as to Esprit), nontransferable right and license in the Field in the Territory to use the trademarks owned or otherwise controlled by Esprit that are included in Promotional Materials provided by Esprit pursuant to this Agreement in connection with the use of such Promotional Materials in connection with the Promotion of Products; provided that Indevus shall not have the right to use any representations of such trademark except as set forth in Section 5.6(e).

2.9 No Further Development by Indevus . The Parties acknowledge and agree that Indevus has no obligation under this Agreement to develop or continue to develop any Indevus Intellectual Property and that after the NDA Transfer Date Indevus shall not be permitted to develop or continue to develop any inventions or intellectual property in the Field in the Territory relating to Products.

 

18

 


  3. G OVERNANCE

3.1 Development Committee.

(a) Members. Pursuant to the Original Agreement, the Parties established a joint development committee with certain obligations and powers. Effective as of the Effective Date, the Parties shall establish a new joint development committee (the “ Development Committee ”) composed of four (4) individuals, two (2) of whom shall be appointed by Indevus and two (2) of whom shall be appointed by Esprit and all of whom shall be qualified to appropriately represent their respective Party at the Development Committee level. The members of the Development Committee as of the Effective Date shall be as set forth on Schedule 3.1. Membership shall include representation from each Party’s scientific, clinical development, and regulatory affairs and/or such other departments as the Development Committee may deem appropriate. Either Party may replace any or all of its representatives on the Development Committee at any time upon written notice to the other Party. A Party may designate a substitute to temporarily attend and perform the functions of such Party’s designated representative at any meeting of the Development Committee. The Development Committee shall be chaired by a representative of Esprit. The chairperson shall appoint a secretary of the Development Committee, who shall be a representative of Indevus.

(b) Role and Responsibilities. The Development Committee shall have as its overall purpose, subject to Section 4.2 and Section 5.6, the oversight of development, including review of clinical protocols and timetables for development, oversight of development and selection of entities or individuals, including Indevus or Esprit, to perform tasks required in connection with development of Products in the Field in the Territory. In particular, the Development Committee shall perform the following functions:

(i) Review development activities conducted under this Agreement with respect to Compound and Products in the Field in the Territory, including any Phase IV Clinical Trials;

(ii) Monitor regulatory strategy and communications with FDA;

(iii) In concert with the Marketing Committee, assist in the coordination and monitoring of regulatory strategy and activities for Phase IV Clinical Trials in the Field in the Territory;

(iv) Review and approve in advance any Promotional Materials or educational materials and literature related to Trospium Twice-Daily or Trospium Once-Daily, including Product advertising;

(v) Oversee any changes to the Specifications proposed by the Parties and propose whether any such changes require any supplements to a Product NDA, as further described in Section 4.2(a)(x); and

(vi) Have such other responsibilities as may be assigned to the Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.

(c) Primary Contact. Indevus and Esprit each shall appoint a person (a “ Development Primary Contact ”) to be the primary contact between the Parties with respect to development and to coordinate related correspondence between the Parties. The Development Primary Contact of each Party as of the Effective Date is set forth on Schedule 3.1. Each Party shall notify the other in writing as soon as practicable upon changing its Development Primary Contact. The Development Primary Contact of each Party will be one of its representatives on the Development Committee.

 

19

 


(d) Oversight. The Development Committee may make decisions with respect to any subject matter that is subject to the Development Committee’s decision-making authority and responsibilities as set forth in Section 3.1(b). The Development Committee shall use its good faith efforts to resolve by consensus any issue relevant to development of Products. The Development Committee shall give consideration to the views, position and recommendations of each Party on any issue that has been brought before the Development Committee. If the Development Committee shall arrive at a consensus on any issue relating to the development of a Product, such consensus shall be binding upon the Parties. All decisions of the Development Committee shall be made by unanimous vote or written consent, as indicated by all members signing the written minutes thereof, with Esprit representatives collectively having one (1) vote and Indevus representatives collectively having one (1) vote in all decisions. If the Development Committee cannot reach consensus on a matter brought to its attention, Esprit shall be entitled to make the final decision with respect to such matter, subject to Section 3.1(e) and Section 5.6(a).

(e) The Development Committee shall have only the powers assigned to it in this Section 3.1. All activities conducted by the Development Committee shall be consistent with and subject to the provisions of this Agreement, and the Development Committee shall not have any power to take any action that conflicts with the terms of this Agreement or to amend, modify or waive compliance with this Agreement.

3.2 Marketing Committee .

(a) Members. Pursuant to the Original Agreement, the Parties established a joint marketing committee with certain obligations and powers. Effective as of the Effective Date, the Parties shall establish a new joint marketing committee (the “ Marketing Committee ”) composed of four (4) individuals, two (2) of whom shall be appointed by Indevus and two (2) of whom shall be appointed by Esprit and all of whom shall be qualified to appropriately represent such Party at the Marketing Committee level. The members of the Marketing Committee as of the Effective Date shall be as set forth on Schedule 3.2. Either Party may replace any or all of its respective representatives on the Marketing Committee at any time upon written notice to the other Party. Either Party may designate a substitute to temporarily attend and perform the functions of such Party’s designated representative at any meeting of the Marketing Committee. The Marketing Committee shall be chaired by a representative of Esprit. The chairperson shall appoint a secretary of the Marketing Committee, who shall be a representative of Indevus.

(b) Role and Responsibilities. The Marketing Committee will be used as the forum for the Parties to discuss the Promotion strategy for Products and, subject to the terms and conditions of this Agreement, will review the pre-launch, launch, post-launch and ongoing Promotional activities for Products in the Territory. In particular, the Marketing Committee shall perform the following functions:

(i) Review and provide recommendations regarding the Promotion Plan and any material amendments or modifications to the Promotion Plan;

 

20

 


(ii) Discuss the actual results of the Promotion of Trospium Twice-Daily and Trospium Once-Daily in the Territory as compared to the Promotion Plan;

(iii) In concert with the Development Committee, assist in the coordination and monitoring of regulatory strategy and activities for Phase IV Clinical Trials in the Field in the Territory;

(iv) Propose the launch date for Trospium Once-Daily in the Territory, subject to the provisions of Section 5.1;

(v) Discuss the state of the markets for Trospium Twice-Daily and Trospium Once-Daily in the Territory and opportunities and issues concerning the Promotion of such Products in the Territory, including consideration of marketing and promotional strategy, marketing research plans, labeling, Product positioning and Product profile issues, to determine the kind of marketing and selling efforts that are appropriate, in accordance with the Promotion Plan and Law;

(vi) Review Training Program(s) and promotional activities to be performed by the Parties in the Promotion of Trospium Twice-Daily and Trospium Once-Daily in the Territory;

(vii) Review the overall performance and effectiveness of the Sales Forces;

(viii) Review and propose physicians to be high potential prescribers of urologic products to treat overactive bladder and propose a list of such physicians for inclusion in the Promotion Plan;

(ix) Review in advance any Promotional Materials or educational materials and literature related to Trospium Twice-Daily or Trospium Once-Daily, including Product advertising; and

(x) Have such other responsibilities and address any other matters delegated to the Marketing Committee under this Agreement or as may be mutually agreed upon in writing by the Parties from time to time, as well as any other matters pertaining to each Party’s performance of its Promotion obligations under this Agreement.

(c) Primary Contact. Indevus and Esprit each shall appoint a person (a “ Marketing Primary Contact ”) to be the primary contact between the Parties with respect to the Promotion Plan and to coordinate related correspondence between the Parties. The Marketing Primary Contact is set forth on Schedule 3.2. Each Party shall notify the other in writing as soon as practicable upon changing its Marketing Primary Contact appointment. The Marketing Primary Contact of each Party will be one of its two representatives on the Marketing Committee.

 

21

 


(d) Oversight. The Marketing Committee may make decisions with respect to any subject matter that is subject to the Marketing Committee’s decision-making authority and responsibilities as set forth in Section 3.2(b). The Marketing Committee shall use its good faith efforts to resolve by consensus any issue relevant to the commercialization of Products. Each Party shall provide input with respect to the Promotion Plan, and the Marketing Committee shall give substantial consideration to the views, position and recommendations of each Party on any issue that has been brought before the Marketing Committee. If the Marketing Committee shall arrive at a consensus on any issue relating to the commercialization of Products, such consensus shall be binding upon the Parties. All decisions of the Marketing Committee shall be made by unanimous vote or written consent, as indicated by all members signing the written minutes thereof, with Esprit representatives collectively having one (1) vote and Indevus representatives collectively having one (1) vote in all decisions. If the Marketing Committee cannot reach consensus on a matter brought to its attention, Esprit shall be entitled to make the final decision with respect to such matter, subject to Section 3.2(e).

(e) The Marketing Committee shall have only the powers assigned to it in this Section 3.2. All activities conducted by the Marketing Committee shall be consistent with and subject to the provisions of this Agreement, and the Marketing Committee shall not have any power to take any action that conflicts with the terms of this Agreement or to amend, modify or waive compliance with this Agreement.

3.3 Supply Committee .

(a) Members. Effective as of the Effective Date, the Parties shall establish a joint supply committee (the “ Supply Committee ”) composed of four (4) individuals, two (2) of whom shall be appointed by Indevus and two (2) of whom shall be appointed by Esprit and all of whom shall be qualified to appropriately represent their respective Party at the Supply Committee level. The members of the Supply Committee as of the Effective Date are set forth on Schedule 3.3. Membership shall include representation from each Party’s manufacturing department and/or such other departments as the Supply Committee may deem appropriate. Either Party may replace any or all of its respective representatives on the Supply Committee at any time upon written notice to the other Party. A Party may designate a substitute to temporarily attend and perform the functions of such Party’s designated representative at any meeting of the Supply Committee. The Supply Committee shall be chaired by a representative of Esprit. The chairperson shall appoint a secretary of the Supply Committee, who shall be a representative of Indevus.

(b) Role and Responsibilities. The Supply Committee shall oversee all aspects of supply of Trospium Twice-Daily and Trospium Once-Daily under this Agreement and shall have as its overall purpose the management of the supply to Esprit of Finished Products and/or Samples prior to the Processing Assumption Date, the transition of Processing Activities from Indevus to Esprit pursuant to the terms of this Agreement and, if Indevus exercises the Ex-US Supply Option, the management of the supply of Trospium Once-Daily solely for use outside the Territory either in (i) bulk capsule form prior to being in its finished, labeled and packaged form or (ii) finished, labeled and packaged form. In particular, the Supply Committee shall perform the following functions:

(i) Oversee all aspects of the supply of Trospium Twice-Daily prior to the NDA Transfer Date and Trospium Once-Daily prior to the Processing Assumption Date;

 

22

 


(ii) Prepare a supply plan coordinating the entire supply chain to support all needs for Products in the Field within and outside the Territory;

(iii) Oversee all Processing Activities;

(iv) Identify and propose actions to prevent potential interruptions of supply;

(v) Oversee audits of Third Party Manufacturers;

(vi) Propose new Third Party Manufacturers, subject to the terms and conditions of Indevus’ agreements with Third Party Manufacturers;

(vii) Oversee quality control and assurance, implementation process improvements, cost reduction initiatives, and logistics initiatives;

(viii) Coordinate the supply of Compound in sufficient quantities for Indevus to satisfy its obligations under Section 14.6(b);

(ix) Coordinate assumption by Esprit of Processing Activities, including the Technology Transfer, and recommend a timeline and procedures for the Technology Transfer in its first meeting; and

(x) Have such other responsibilities and address any other matters delegated to the Supply Committee under this Agreement or as may be mutually agreed upon in writing by the Parties from time to time, as well as any other matters pertaining to each Party’s performance of its supply obligations under this Agreement.

(c) Oversight. The Supply Committee may make decisions with respect to any subject matter that is subject to the Supply Committee’s decision-making authority and responsibilities as set forth in Section 3.3(b). The Supply Committee shall use its good faith efforts to resolve by consensus any issue relevant to the supply of Finished Products and/or Samples. Each Party shall provide input with respect to the supply of Finished Products and/or Samples, and the Supply Committee shall give substantial consideration to the views, position and recommendations of each Party on any issue that has been brought before the Supply Committee. If the Supply Committee shall arrive at a consensus on any issue relating to the supply of Finished Products and/or Samples, such consensus shall be binding upon the Parties. All decisions of the Supply Committee shall be made by unanimous vote or written consent, as indicated by all members signing the written minutes thereof, with Esprit representatives collectively having one (1) vote and Indevus representatives collectively having one (1) vote in all decisions. If the Supply Committee cannot reach consensus on a matter brought to its attention, Esprit shall be entitled to make the final decision with respect to such matter, subject to Section 3.3(d).

 

23

 


(d) The Supply Committee shall have only the powers assigned to it in this Section 3.3. All activities conducted by the Supply Committee shall be consistent with and subject to the provisions of this Agreement and, if applicable, the Ex-US Supply Agreement, and the Supply Committee shall not have any power to take any action that conflicts with the terms of this Agreement or to amend, modify or waive compliance with this Agreement.

3.4 Meetings . The chairpersons of the Development Committee, Marketing Committee, and Supply Committee shall call meetings as reasonably requested by one of the Parties; provided , however , that:

(a) the Marketing Committee shall meet at least three (3) times per year (with a meeting to be held not later than thirty (30) days after the Effective Date at Esprit’s offices) through the end of the Copromotion Period, unless the Parties agree otherwise;

(b) the Development Committee shall meet at least three (3) times per year (with a meeting to be held not later than thirty (30) days after the Effective Date at Indevus’ offices) through the NDA Transfer Date, unless the Parties agree otherwise; and

(c) the Supply Committee shall meet on at least a Calendar Quarterly basis (with a meeting to be held not later than thirty (30) days after the Effective Date at Indevus’ offices) through the Processing Assumption Date, unless the Parties agree otherwise, and, after the Processing Assumption Date through the NDA Transfer Date, the Supply Committee shall meet at least three (3) times per year.

Meetings may be held in person, by telephone, or by video conference call, and, except as set forth above, the location of each meeting shall alternate between the Parties’ headquarters or such other location as may be mutually agreed upon by the Parties. On advance written notice to the other Party, additional participants may be invited by any representative to attend meetings where appropriate. Each Party shall be responsible for all travel and related costs and expenses of its members and other representatives to participate or attend committee meetings. The Parties shall cause their respective representatives on the committees to use good faith efforts to resolve all matters presented to them. Any Proprietary Information disclosed in any meeting of the Development Committee, Marketing Committee, or Supply Committee by a Party shall remain Proprietary Information of the disclosing Party.

3.5 Minutes of Committee Meetings . Minutes of the each committee meeting shall be transcribed and issued by the secretary within thirty (30) days after each meeting (or, if shorter, at least ten (10) Business Days prior to the date of the next scheduled meeting of such committee) and shall be approved as the first order of business at the immediately succeeding meeting of such committee. Such minutes shall include only key discussion points and decisions made and provide a list of any identified issues yet to be resolved, either within such committee or through the relevant resolution process, if any.

3.6 Disbanding of Committees.

(a) The Parties shall have the right to disband any or all of the Development Committee, Marketing Committee, and Supply Committee, upon mutual agreement. Additionally, to the extent the applicable committee is not disbanded pursuant to the

 

24

 


preceding sentence, the Development Committee shall be automatically disbanded effective on the NDA Transfer Date, the Marketing Committee shall be automatically disbanded effective on the expiration of the Copromotion Period, and the Supply Committee shall be automatically disbanded effective on the NDA Transfer Date.

(b) After the disbanding of a committee, Esprit shall be entitled to make the final decision with respect to any and all matters or actions for which it had the right to make such decisions prior to the disbanding of any such committee subject to any provisions applicable to such decision.

3.7 Project Coordinators . Promptly following the Effective Date, each Party shall designate an appropriate expert to facilitate communication and coordination of the Parties’ activities under this Agreement relating to Products and to provide support and guidance to the Development Committee, Marketing Committee, and Supply Committee (each, a “ Project Coordinator ”). Each Project Coordinator shall be experienced in project management and may also serve as one of the representatives of its respective Party on any of the Development Committee, Marketing Committee, and Supply Committee. From time to time each Party may replace its Project Coordinator by written notice to the other Party specifying such replacement.

 

  4. D EVELOPMENT AND R EGULATORY M ATTERS

4.1 Development.

(a) General. After the Effective Date, Development of Products in the Field in the Territory shall be conducted, administered and funded solely by Esprit or its designees, and Indevus shall not conduct any development activities with respect to Products in the Field in the Territory.

(b) Phase IV Clinical Trials. After the Effective Date, all Phase IV Clinical Trials or other pre-clinical or clinical trials that are required by the FDA as a condition to or in connection with an FDA Approval in the United States shall be conducted, administered and funded solely by Esprit or its designees. Indevus shall have the right, but not the obligation, to provide appropriate personnel to support and assist in the conduct of such Phase IV Clinical Trials, as mutually agreed to between the Parties, subject to reimbursement of Indevus’ costs and expenses associated therewith.

4.2 Regulatory Matters.

(a) Prior to the NDA Transfer Date. The Parties acknowledge that Indevus has obtained FDA Approval for Trospium Twice-Daily and Trospium Once-Daily and is the owner of the Product NDAs as of the Execution Date and is expected to be the owner of the Product NDAs as of the Effective Date. Prior to the NDA Transfer Date:

(i) Indevus shall own and control all Regulatory Documents relating to a Product in the Field in the Territory.

(ii) Indevus shall have sole authority and responsibility for the timely preparation, filing, prosecution, and maintenance of all Regulatory Documents relating to a Product in the Field in the Territory, including Product NDAs and any reports or amendments necessary to maintain FDA Approvals, and for seeking any revisions of the conditions of each FDA Approval.

 

25

 


(iii) Indevus shall have sole authority and responsibility to seek and/or obtain any necessary FDA approvals of any Product Label(ing), packaging, advertising or other promotional or informational materials used in connection with Product and Promotional Materials and for determining whether the same requires FDA approval, and Indevus shall submit Promotional Materials to the FDA after approval of both Parties, in accordance with the procedures set forth in Section 5.6.

(iv) Indevus shall remain the primary contact with the FDA and shall be solely responsible for all communications with the FDA that relate to any IND or NDA relating to a Product in the Field in the Territory prior to and after any FDA Approval.

(v) Esprit shall have the right, but not the obligation, to assist and consult with Indevus with respect to all regulatory submissions, including applications for FDA Approvals, prior to making any such submissions. At least thirty (30) days prior to the filing of any documents with the FDA relating to Products in the Field, Indevus shall provide Esprit with copies of all such filings, submissions, authorizations and FDA Approvals, including any correspondence related to manufacturing of Products in the Field; provided that, if Indevus believes it is required by Law to make such submission sooner, Indevus shall provide Esprit with final copies of such submissions for Esprit’s review at least two (2) Business Days prior to filing them with the FDA. Indevus shall consider in good faith any comments of Esprit with respect to the foregoing.

(vi) Indevus shall provide Esprit with a copy of all safety data received by Indevus regarding Products in the Field worldwide.

(vii) Indevus shall provide advance notice to Esprit of any planned meetings, discussions, or other communications with the FDA relating to Products in the Field. Esprit shall have the right, but not the obligation, to participate with respect to such meetings, discussions, or other communications; provided that, in providing any such assistance, Esprit shall not contact the FDA without the prior approval of Indevus and, if contacted by the FDA with respect to Product, shall refer such contact to Indevus.

(viii) If contacted by the FDA with respect to a Product in the Field, Indevus shall notify Esprit within two (2) Business Days of such contact, and provide Esprit with any related official correspondence received from the FDA, including as applicable minutes of any meetings or telephone conferences and/or discussions between Indevus and the FDA. Esprit shall have a right to participate in and provide comments with respect to any subsequent meetings, discussions, or other communications with respect to such contact.

(ix) To the extent Esprit reasonably believes that a filing or submission relating to Products in the Territory is required by Law, Esprit shall notify Indevus. If Indevus decides not to prepare such filing or submission, Indevus shall promptly notify Esprit, but in no event later than thirty (30) days, unless notified by Esprit that a shorter period of review

 

26

 


is mandated by FDA or Law, after such notice by Esprit of such decision, and Esprit shall be entitled to prepare such filing or submission, to be filed or submitted by Indevus; provided that Esprit shall use good faith efforts to include any comments of Indevus in such filing or submission.

(x) Prior to the Processing Assumption Date, changes to the Specifications shall be made only by mutual prior agreement of the Parties, except as required by Law. The Parties shall determine whether any such changes require any supplements to a Product NDA, and each Party shall provide the other Party with notice of any such changes as soon as practicable. After the Processing Assumption Date, but prior to the NDA Transfer Date, changes to the Specifications shall be made only after prior notification to Indevus of any such changes as soon as practicable, and the Parties shall determine whether any such changes require any supplements to a Product NDA, except as required by Law.

(xi) Notwithstanding anything herein to the contrary, Indevus shall not file with the FDA any regulatory submissions that are intended to change or modify the Product label or FDA-approved prescribing information for, or the indications of, Trospium Twice-Daily or Trospium Once-Daily in the Territory without providing to Esprit a draft of such submission at least ten (10) days prior to planned submission to the FDA and giving prompt and reasonable consideration to any comments Esprit may have; provided that, if and to the extent required by Law Indevus is required to file any such submission in less than ten (10) days after notice from the FDA, Indevus will notify Esprit of any such requirement promptly and in no event later than two (2) Business Days after such notice.

(xii) Notwithstanding Section 14.13(f), during the period beginning on the Processing Assumption Date and ending on the NDA Transfer Date, in connection with Indevus’ responsibilities as holder of the Product NDAs, Indevus and Esprit shall cooperate in good faith, in coordination with the Supply Committee, for Indevus to subcontract or assign the performance and management of quality assurance responsibilities to Esprit, while retaining the authority for Indevus to monitor Esprit’s performance, as subcontractor to Indevus with respect to such activities, consistent with Indevus’ quality obligations under the Product NDA for Trospium Once-Daily.

(b) After the NDA Transfer Date. After the NDA Transfer Date:

(i) Esprit shall own and control all Regulatory Documents relating to a Product in the Field in the Territory. Indevus hereby assigns to Esprit all right, title and interest in such Regulatory Documents, effective as of the NDA Transfer Date.

(ii) Esprit will be solely responsible for the timely preparation, filing, prosecution, and maintenance of all Regulatory Documents relating to a Product in the Field in the Territory, including Product INDs and NDAs and any reports or amendments necessary to maintain FDA Approvals, and for seeking any revisions of the conditions of each FDA Approval.

 

27

 


(iii) Esprit shall have sole authority and responsibility to develop, modify, seek and/or obtain any necessary FDA approvals of any Product Label(ing), packaging, advertising or other promotional or informational materials used in connection with Product in the Field in the Territory, and Promotional Materials and for determining whether the same requires FDA approval.

(iv) Esprit will be the primary contact with the FDA and shall be solely responsible for all communications with the FDA that relate to any IND or NDA relating to a Product in the Field in the Territory prior to and after any FDA Approval.

(v) Esprit may, in its sole discretion, file any submissions that are intended to change or modify the Product label or FDA-approved prescribing information for, or the indications of, Trospium Twice-Daily or Trospium Once-Daily in the Territory provided that, except as required by Laws, it provides to Indevus a draft of such submission at least ten (10) days prior to planned submission to the FDA and gives prompt and reasonable consideration to any comments Indevus may have.

(vi) To the extent Indevus reasonably believes that a filing or submission relating to Products in the Field in the Territory is required by Law, Indevus shall notify Esprit. If Esprit decides not to prepare such filing or submission, it shall promptly notify Indevus, but in no event later than thirty (30) days, unless notified by Indevus that a shorter period of review is mandated by FDA or Law, after such notice by Indevus of such decision, and Indevus shall be entitled to prepare such filing or submission, to be filed or submitted by Esprit; provided that Indevus shall use good faith efforts to include any comments of Esprit in such filing or submission.

(vii) Indevus may, but is not required to, assist Esprit, at Esprit’s election, in Esprit’s efforts to seek and obtain FDA Approvals, subject to reimbursement of Indevus’ related costs and expenses.

(c) Regulatory Cooperation. Each Party shall inform the Development Committee or, if the Development Committee has been disbanded, the other Party, within twenty four (24) hours, of its receipt of any information that: (i) raises any concern regarding the safety of Compound or Product; (ii) concerns suspected or actual tampering, counterfeiting (excluding diversion, which is subject to Section 5.7(c)) or contamination or other similar problems with respect to Compound or Product; (iii) is reasonably likely to lead to a recall or market withdrawal of a Product; or (iv) concerns any ongoing or potential FDA investigation, inspection, detention, seizure or injunction involving a Compound or Product.

(d) Adverse Experiences. The reporting of Adverse Experiences shall be governed by Article 10.

(e) Recalls and Other Corrective Action. The Development Committee shall make all final decisions with respect to any recall, market withdrawal or any other corrective action related to a Product in the Field in the Territory, and neither Party shall initiate any such action without the approval of the Development Committee; provided , however , that nothing herein shall prohibit Indevus, prior to the NDA Transfer Date, from initiating or conducting any recall or other corrective action mandated by the FDA or Law. At a Party’s request, the other Party shall provide reasonable assistance in conducting such recall, market

 

28

 


withdrawal or other corrective action, including providing all pertinent records that such Party may reasonably request to assist in effecting such action, subject to reimbursement of such other Party’s reasonable costs and expenses associated with providing such cooperation. Any documented, direct, out-of-pocket costs incurred (paid or accrued) with respect to such recall, market withdrawal or other corrective action prior to the Processing Assumption Date shall be borne by Indevus; provided , however , that, in the event that the recall or other corrective action is attributable solely to Promotional activities under Article 5, Esprit shall bear such expenses. Any documented, direct, out-of-pocket costs incurred (paid or accrued) with respect to a recall, market withdrawal or other corrective action with respect to Products in the Field in the Territory after the Processing Assumption Date shall be borne by Esprit. Neither Party shall have any obligation to reimburse or otherwise compensate the other Party or its Affiliates for any consequential damages, lost profits or income that may arise in connection with any recall, market withdrawal or corrective action with respect to Products.

 

  5. P ROMOTION OF P RODUCTS

5.1 General.

(a) Subject to the terms and conditions of this Agreement, Esprit shall during the Agreement Term, and Indevus shall during the Copromotion Period, use Commercially Reasonable Efforts to Promote Products in the Field in the Territory and to perform their respective obligations under this Agreement. All activity conducted by a Party under this Agreement shall occur at such Party’s sole expense except as otherwise expressly provided in this Agreement.

(b) Without limiting the generality of the foregoing, Esprit shall use Commercially Reasonable Efforts to launch Trospium Once-Daily in the United States by *, subject to the following:

(i) If Indevus has complied in all material respects with its obligations under this Agreement and there has not been an event of Force Majeure, Esprit shall launch Trospium Once-Daily in the United States by the later of (a) * or (b) * in the event that Esprit pays Indevus, on or before *, if necessary, * or such other amount, if any, agreed to by *, or (c) such other date to which the Parties may mutually agree.

(ii) If, because of a Force Majeure event, Esprit is unable to launch Trospium Once-Daily in the United States on or before *, Esprit shall launch Trospium Once-Daily in the United States on the date that is the number of days beyond * equal to the number of days of Force Majeure, and Indevus, on or before *, shall be required to obtain an extension of the launch requirement * if required to prevent a breach of *.

 

* CONFIDENTIAL TREATMENT REQUESTED

29

 


(iii) If, because Indevus has not complied with its obligations under this Agreement, Esprit is unable to launch Trospium Once-Daily in the United States on or before *, Indevus, on or before *, shall be required to obtain an extension of the launch date requirement, which extended launch date requirement shall not be before *, including *, if necessary, * (in which case the extended launch date requirement shall be *) or such other lesser amount, if any, agreed to *; and Indevus shall not have the right to terminate this Agreement for Esprit’s failure to launch Trospium Once-Daily on or before * provided that Esprit launches Trospium Once-Daily by such extended launch date requirement.

(c) Notwithstanding anything herein to the contrary, if Esprit determines, in consultation with the Development Committee prior to the NDA Transfer Date, in its sole discretion, that market acceptance of Trospium Once-Daily relative to Trospium Twice-Daily justifies the discontinuation of Trospium Twice-Daily, it shall have the right to discontinue Promotion of Trospium Twice-Daily and to require Indevus to provide notice of discontinuation of Trospium Twice-Daily to the FDA by providing written notice to Indevus and citing this Section 5.1(c). For the avoidance of doubt, the exercise of the rights provided in this Section 5.1(c) by Esprit and the related obligation by Indevus shall not be deemed a Product Adverse Event.

5.2 Promotion Plan. Esprit will prepare a Promotion Plan and budget, which will be provided to the Marketing Committee by not later than * before the commencement of the Launch Period, covering the Copromotion Period; provided that any and all Promotion Plans shall terminate and shall have no effect upon termination of the Copromotion Period. Subject to the other terms and conditions of this Agreement, the Promotion Plan shall focus on the Promotion of Products in the Field in the Territory, and shall include matters such as:

(a) The determination and review of the content, quantity, method of distribution of, and guidelines for the use of Promotional Materials related to, Trospium Twice-Daily and Trospium Once-Daily, including any claims made about such Products, including any seminars, conferences or medical education materials, which shall be consistent with the provisions of Section 5.6.

(b) The quantity and timing of distribution of Samples of Trospium Twice-Daily and Trospium Once-Daily.

(c) The level of marketing and other support for Trospium Twice-Daily and Trospium Once-Daily to be provided by either Party; provided , however , that no additional obligations or costs may be imposed upon either Party without the prior written consent of such Party.

5.3 Target Prescribers; Product Advisors.

(a) For each Calendar Year, Esprit shall review with the Marketing Committee by October 1 of the immediately preceding Calendar Year (or, for the Calendar Year ending December 31, 2008, thirty (30) days after the Effective Date) the specific Target Prescribers for Trospium Twice-Daily and Trospium Once-Daily and the planned copromotion

 

* CONFIDENTIAL TREATMENT REQUESTED

30

 


coverage by Esprit and Indevus; provided , however , that (a) the Target Prescribers for the Indevus Sales Force shall be the Indevus Target Prescribers; and (b) Esprit may also conduct Details to the Indevus Target Prescribers.

(b) Notwithstanding and in addition to any rights or requirements set forth in any other provision of this Agreement, during the Copromotion Period, Indevus shall, with the prior consent of Esprit, and at Indevus’ cost, have the right to (i) have reasonable access to all medical advisors and consultants and with medical education, advertising and public relations agencies engaged by any Party with respect to Trospium Twice-Daily and Trospium Once-Daily (collectively, “ Product Advisors ”) and (ii) participate in meetings or discussions relating to marketing, medical education programs, advertising or any other promotional activities relating principally to Trospium Twice-Daily and Trospium Once-Daily between any Party or any Affiliate of any Party and any Product Advisor.

5.4 Esprit Promotional Activities.

(a) Esprit intends to provide a professional fully trained sales force to support Esprit’s obligations under this Agreement (the “ Esprit Sales Force ”). The Esprit Sales Force shall include Representatives Promoting Products to Target Prescribers and sales managers and sales directors who shall observe and supervise each Esprit Representative in the field, conduct and provide meaningful field evaluations, time supervision, territory management and field reports and other miscellaneous paperwork on behalf of the Esprit Sales Force. Esprit will provide the Marketing Committee at each meeting (but not more often than each meeting) with a report with respect to the monthly number and composition of the Esprit Sales Force.

(b) The Esprit Sales Force may conduct Details of products other than Products, as may be determined by Esprit from time to time. Esprit acknowledges and agrees that the absence of a requirement in this Agreement that Esprit provide a specified minimum number of Representatives or annual or quarterly Details shall not in any way minimize Esprit’s commitment to Promote Products hereunder.

5.5 Indevus Promotional Activities.

(a) The Indevus Sales Force shall include Representatives Promoting Products to the Indevus Target Prescribers and sales managers and sales directors who shall observe and supervise each such Indevus Representative in the field, conduct and provide meaningful field evaluations, time supervision, territory management and field reports and other miscellaneous paperwork on behalf of the Indevus Sales Force. Indevus will provide the Marketing Committee at each meeting (but not more often than each meeting) with a report with respect to the monthly number and composition of the Indevus Sales Force.

(b) Detail Requirements.

(i) For the portion of the Copromotion Period ending September 30, 2008, the number of Quarterly Indevus Details, all of which shall be Primary Position Details, to be delivered to the Indevus Target Prescribers shall * during each Calendar Quarter; provided , however , that, if the period from the Effective Date to the end of the first Calendar Quarter ending after the Effective Date is less a full Calendar Quarter, the number of such Details shall be subject to pro rata adjustment to the give effect to the reduced number of days in such period.

 

* CONFIDENTIAL TREATMENT REQUESTED

31

 


(ii) Indevus may extend the Copromotion Period until December 31, 2008 by providing written notice of such extension to Esprit by not later than July 31, 2008. Indevus may further extend the Copromotion Period until March 31, 2009 by providing written notice of such extension to Esprit by not later than October 31, 2008. In the event Indevus elects to extend the Copromotion Period, the determination as to the number of Quarterly Indevus Details during each extended Calendar Quarter shall be mutually agreed to by the Parties by not later than June 30, 2008 and September 30, 2008 for the Calendar Quarter ending December 31, 2008 and March 31, 2009, respectively; provided , however , that the number of Quarterly Indevus Details during each such extended Calendar Quarter shall be not less than * The foregoing Details in each such extended Calendar Quarter may be Primary Position Details or Secondary Position Details in such proportion as is specified by Indevus on or prior to June 30, 2008 or September 30, 2008, as applicable; provided that, for the purpose of determining the number of Details completed pursuant to this Section 5.5(b)(ii), each Primary Position Detail conducted by Indevus during such extended Calendar Quarter shall equal one (1) Detail, and each Secondary Position Detail conducted by Indevus during such extended Calendar Quarter shall equal * Detail.

(c) Detail Adjustments. The Quarterly Indevus Details may be adjusted from time to time based on the Marketing Committee’s determination that the Product is promotionally sensitive as measured by immediate sales increases through promotional efforts and such other measurements of then-current market conditions (qualitative or/and quantitative) as may be commercially reasonable; provided , however , that any such adjustments shall be subject to the prior written approval of Indevus. The Indevus Sales Force may also conduct details of products other than Product, as may be determined by Indevus from time to time.

(d) Failure to Meet Detail Requirements. If, for any Calendar Quarter during the Copromotion Period, the Indevus Sales Force delivers less than one hundred percent (100%) of the Quarterly Indevus Details set forth in Section 5.5(b) for such Calendar Quarter, such Calendar Quarter shall be deemed a Deficient Quarter, and the following shall be applicable:

(i) If the Indevus Sales Force delivers less than one hundred percent (100%) but greater than * of the Quarterly Indevus Details set forth in Section 5.5(b) for such Deficient Quarter, the Indevus Sales Force shall cure the deficiency by delivering the deficient number of Details during the Cure Period in addition to its required Quarterly Indevus Details for the Cure Period.

(ii) If the Indevus Sales Force delivers less than or equal to * but greater than * of the Quarterly Indevus Details set forth in Section 5.5(b) for such Deficient Quarter, (A) the Indevus Sales Force shall, at Esprit’s election, cure the deficiency by delivering the deficient number of Details during the Cure Period in addition to its required Quarterly Indevus Details for the Cure Period and (B) Esprit’s Sales Force Reimbursement payment obligations for such Deficient Quarter pursuant to Section 6.3 shall be reduced to * of the amount that would otherwise have been due for such Calendar Quarter pursuant to Section 6.3.

 

* CONFIDENTIAL TREATMENT REQUESTED

32

 


(iii) If the Indevus Sales Force delivers less than or equal to * but greater than * of the Quarterly Indevus Details set forth in Section 5.5(b) for such Deficient Quarter, (A) the Indevus Sales Force shall, at Esprit’s election, cure the deficiency by delivering the deficient number of Details during the Cure Period in addition to its required Quarterly Indevus Details for the Cure Period and (B) Esprit’s Sales Force Reimbursement payment obligations for such Deficient Quarter pursuant to Section 6.3 shall be reduced to * of the amount that would otherwise have been due for such Calendar Quarter pursuant to Section 6.3.

(iv) If the Indevus Sales Force delivers less than or equal to * of the Quarterly Indevus Details set forth in Section 5.5(b) for such Deficient Quarter, at Esprit’s election, (A) the Copromotion Period shall terminate and the Indevus Sales Force shall, at Esprit’s election, cease all Details and (B) * pursuant to Section 6.3 for such Deficient Quarter or thereafter.

(e) The actual number of Details made by the Indevus Sales Force to Target Prescribers during each Calendar Quarter shall be determined and reported in accordance with a call reporting system provided by Esprit to Indevus under this Agreement during the Copromotion Period.

5.6 Promotional Materials and Activities. During the Copromotion Period, and in compliance with Law, Esprit shall have the sole right to create and develop the Promotional Materials with, during the Copromotion Period, input and participation from the Marketing Committee, subject to Section 5.6(a). During the Copromotion Period, prior to finalizing such Promotional Materials and promotional activities, each Party shall include the other Party in its internal circulation of information regarding such promotional materials and activities during the development of such Promotional Materials and any event related materials and upon the finalization of such materials.

(a) Neither Party shall produce (other than as concepts for consideration by the other Party), distribute or otherwise use any Promotional Materials that have not been approved in advance by the Development Committee for purposes of determining compliance with Law and agreed upon standard operating procedures of each Party. Prior to the NDA Transfer Date, Promotional Materials shall be submitted to Indevus’ internal regulatory compliance personnel for timely review pursuant to applicable internal standard operating procedures, for an assessment of compliance with Law and shall be subject to Indevus’ approval solely with respect to compliance with Law. Such assessment shall be provided to both Parties. Each Party shall limit its statements, discussions and claims regarding Products, including those as to safety and efficacy, to those that are consistent with the Product Labeling and the Promotional Materials. Neither Party shall add, delete, modify or distort claims of safety or efficacy in the Detailing of Products, nor shall it make any changes (including underlining or otherwise highlighting any language or adding any notes thereto) or alter the presentation order or format in the Promotional Materials.

(b) Esprit shall own all right, title and interest in and to the copyrights in all marketing, sales, advertising or Promotional Materials relating to the Products in the Field in the Territory (“ Territory Copyrighted Works ”). Indevus shall execute all documents and take all actions as are reasonably requested by Esprit to vest title to such Territory Copyrighted

 

* CONFIDENTIAL TREATMENT REQUESTED

33

 


Works in Esprit. Esprit shall be responsible, at its expense, for searching, clearing and filing applications for registration of all such Territory Copyrighted Works. To the extent such materials include or incorporate original works of authorship created by Indevus prior to the Effective Date, Indevus shall not use, or make any proprietary claim with regard to, those pre-existing materials separate and apart from their use and inclusion in Territory Copyrighted Works relating to Products.

(c) Subject to Section 5.6(b), Esprit and Indevus shall retain all rights, including all copyrights and trademarks, to all of their respective programs and materials existing as of the Effective Date in all formats (including print, video, audio, digital, and computer formats) regarding sales training, patient education and disease management programs owned or licensed by each at the time such materials are shared with the other Party, as well as any modifications of such programs each may develop in the future that are not specific to Products in the Field. Esprit and Indevus shall, from time to time, each notify the other as to the identity of such proprietary programs. In addition, all new programs that are not specific to Products in the Field that are jointly developed by Esprit and Indevus pursuant to this Agreement shall be jointly owned by Esprit and Indevus, and each Party shall have the right to use such jointly developed programs free of charge after the expiration of the Agreement Term.

(d) Esprit shall be the primary Party responsible for preparing all submissions with the FDA regarding approval of all Promotional Materials that require FDA approval; provided that prior to the NDA Transfer Date Indevus shall be responsible for filing all such submissions and participating with Esprit in any interactions with the FDA regarding such matters. After the NDA Transfer Date, Esprit shall be responsible for all submissions and interactions with the FDA regarding approval of all Promotional Materials that require FDA approval.

(e) Except as otherwise prohibited by Law, during the Copromotion Period, all Promotional Materials used by Indevus in connection with the Promotion of Products under this Agreement shall be only those supplied by Esprit. Indevus may display on such Promotional Materials the Indevus Logo; provided that the trademark of and specified by Esprit (or any person or entity to which Esprit assigns or sublicenses rights hereunder) shall appear to the left of and/or above the Indevus Logo. Indevus shall not use any representations of any mark of Esprit other than those supplied by Esprit in Promotional Materials. Solely to the extent required by Law, all Promotional Materials used by Esprit will indicate that a Product is sold under license from Indevus and promoted by Esprit or any such Affiliate, as directed by Esprit. All promotional materials used by Indevus in connection with the Promotion of Products under this Agreement shall indicate that the Trademarks (except for the Indevus Logo) are owned by Esprit or any such Affiliate, as directed by Esprit. Notwithstanding anything to the contrary in this Section 5.6(e), except to the extent required by Law, in no event shall any packaging, trade dress, journal advertising and sales aids, or FDA approved Product Labeling display any mark of Indevus.

(f) Within ninety (90) days after the expiration or termination of this Agreement, each Party shall return (unless prohibited by Law), or otherwise dispose of in accordance with instructions from the other Party, all remaining Promotional Materials provided by the other Party and will provide the other Party with a certified statement that all remaining Promotional Materials have been returned or otherwise properly disposed of and that the Party is no longer in possession or control of any such Promotional Materials in any form or fashion.

 

34

 


5.7 Samples. The following terms shall apply to any Samples in the Territory:

(a) Esprit shall distribute to each Party Samples to be used by the Sales Forces. All supply and costs of Samples shall be subject to the provisions of Article 14.

(b) Each Party shall receive and use such Samples in accordance with the Promotion Plan and Laws. The quantity of Samples to be provided to each Party and the method of distribution shall be determined by Esprit; provided , that the number of Samples provided to a Party shall be consiste


 
SITE SEARCH

AGREEMENTS / CONTRACTS

Document Title:

Entire Document: (optional)

Governing Law:(optional)


Try our advanced search >>
 

CLAUSES

Search Contract Clauses >>

Browse Contract Clause Library>>

Get Email Updates
Email:
This is only a partial view of this document. We have millions of legal documents and clauses drafted by top law firms. learn more search for free browse for free learn more