COLLABORATION AGREEMENT between REATA PHARMACEUTICALS, INC. and ABBOTT PHARMACEUTICALS PR LTD. Dated as of December 9, 2011
Exhibit 10.29
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
EXECUTION COPY
between
REATA PHARMACEUTICALS, INC.
and
XXXXXX PHARMACEUTICALS PR LTD.
TABLE OF CONTENTS
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Page |
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ARTICLE 1 |
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DEFINITIONS |
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11 |
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ARTICLE 2 |
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COLLABORATION OVERVIEW; GOVERNANCE |
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46 |
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2.1 |
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Overview of Collaboration |
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46 |
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2.2 |
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General Principles Governing the Collaboration |
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47 |
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2.3 |
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Joint Executive Committee |
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48 |
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2.4 |
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Joint Research and Development Incubator |
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48 |
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2.5 |
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Joint Development Committees |
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49 |
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2.6 |
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Joint Supply Committee |
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50 |
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2.7 |
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Joint Marketing Committee |
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51 |
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2.8 |
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Joint Patent Committee |
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52 |
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2.9 |
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General Provisions Applicable to Committees |
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53 |
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2.10 |
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Good Faith |
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54 |
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2.11 |
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Appointment of Alliance Managers |
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54 |
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2.12 |
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Discontinuation of Participation on a Committee |
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55 |
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2.13 |
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Possession Arrow Decision Making |
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55 |
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ARTICLE 3 |
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RESEARCH PROGRAM |
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55 |
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3.1 |
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Research Collaboration; Discovery Research Plan |
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55 |
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3.2 |
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Unilateral Discovery |
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56 |
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3.3 |
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Initial Information-Sharing |
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56 |
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3.4 |
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New Information Sharing and Designation of Lead Compound |
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56 |
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3.5 |
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Compliance |
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57 |
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3.6 |
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Records |
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57 |
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ARTICLE 4 |
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EXPLORATORY DEVELOPMENT PROGRAM |
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57 |
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4.1 |
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General Scope |
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57 |
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4.2 |
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Elements of Exploratory Development Program |
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57 |
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4.3 |
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Joint Exploratory Development |
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61 |
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4.4 |
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Unilateral Exploratory Development |
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65 |
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4.5 |
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Exploratory Development Records and Reports |
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67 |
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4.6 |
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Relationship with Existing Agreement |
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67 |
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Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
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ARTICLE 5 |
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PRODUCT DEVELOPMENT |
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69 |
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5.1 |
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General |
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69 |
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5.2 |
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Formation of JDC and JMC |
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69 |
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5.3 |
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Elements of Product Development Program |
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69 |
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5.4 |
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Opt-Out After Designation of Product Candidate and Selection of Indication for Development |
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69 |
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5.5 |
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Joint Product Development |
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70 |
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5.6 |
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Unilateral Product Development |
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78 |
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5.7 |
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Development of a Product Candidate in Additional Indication(s) |
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88 |
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5.8 |
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Unilateral Development of Any Additional Product Candidate for an Active Indication |
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91 |
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5.9 |
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Development Records and Reports |
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91 |
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5.10 |
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Unilateral Acquired AIMs |
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92 |
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ARTICLE 6 |
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REGULATORY MATTERS |
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92 |
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6.1 |
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Regulatory Filings and Approvals |
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92 |
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6.2 |
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Regulatory Costs |
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94 |
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6.3 |
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Data Sharing |
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95 |
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6.4 |
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Product Withdrawals and Recalls |
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95 |
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6.5 |
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Pharmacovigilance |
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96 |
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6.6 |
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Standards of Conduct |
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96 |
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ARTICLE 7 |
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COMMERCIALIZATION OF JOINT PRODUCTS |
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96 |
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7.1 |
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Commercialization of Joint Products in a Commercialization Territory |
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96 |
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7.2 |
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Commercial Summit Meeting |
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96 |
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7.3 |
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Determination of LCP and SCP |
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97 |
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7.4 |
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Commercialization Plan |
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99 |
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7.5 |
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Commercial Readiness |
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101 |
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7.6 |
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Role of the Lead Commercialization Party |
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102 |
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7.7 |
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Co-Promotion by the SCP |
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103 |
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7.8 |
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PDE Shortfalls |
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105 |
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7.9 |
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Trademarks and Markings |
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106 |
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7.10 |
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Commercialization Reports |
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106 |
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7.11 |
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Commercialization Standards of Conduct |
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106 |
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Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
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ARTICLE 8 |
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COMMERCIALIZATION OF UNILATERAL PRODUCTS |
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107 |
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8.1 |
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Rights of Unilateral Party |
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107 |
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8.2 |
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Commercialization Plans |
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107 |
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8.3 |
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Where Unilateral Product is also a Joint Product |
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107 |
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8.4 |
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Sales and Distribution |
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108 |
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8.5 |
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Compliance with Applicable Law |
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108 |
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ARTICLE 9 |
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MANUFACTURE AND SUPPLY |
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108 |
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9.1 |
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Supply for the Research Collaboration and Development Programs |
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108 |
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9.2 |
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Manufacturing Plan for Joint Products |
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109 |
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9.3 |
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Supply of Unilateral Products |
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109 |
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9.4 |
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Technology Transfer |
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110 |
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9.5 |
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Launch Product Volume; Product Supply Volume; Supply |
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112 |
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9.6 |
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Manufacturing Standards of Conduct |
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112 |
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9.7 |
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Subcontracting |
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112 |
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9.8 |
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Manufacturing Records and Reports |
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112 |
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ARTICLE 10 |
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LICENSES AND EXCLUSIVITY |
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113 |
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10.1 |
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License Grants |
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113 |
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10.2 |
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Sublicenses and Subcontracting |
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115 |
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10.3 |
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Negative Covenant |
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116 |
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10.4 |
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No Implied Licenses |
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117 |
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10.5 |
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Access to Regulatory Documentation and Cooperation |
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117 |
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10.6 |
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Exclusivity |
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117 |
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ARTICLE 11 |
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FINANCIALS |
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118 |
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11.1 |
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Upfront Amount |
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118 |
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11.2 |
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Development Costs |
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118 |
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11.3 |
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Profit Sharing for Joint Products in the Profit Share Region |
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119 |
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11.4 |
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Royalties |
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121 |
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11.5 |
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Mode of Payment |
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123 |
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11.6 |
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Taxes |
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123 |
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11.7 |
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Interest on Late Payments |
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125 |
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Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
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11.8 |
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Financial Records |
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125 |
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11.9 |
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Audit |
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125 |
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11.10 |
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Audit Dispute |
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125 |
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11.11 |
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Confidentiality |
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126 |
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11.12 |
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Diagnostic or Veterinary Products |
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126 |
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ARTICLE 12 |
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INTELLECTUAL PROPERTY |
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126 |
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12.1 |
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Ownership of Inventions |
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126 |
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12.2 |
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Maintenance and Prosecution of Patents |
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128 |
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12.3 |
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Enforcement of Patents |
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132 |
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12.4 |
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Infringement Claims by Third Parties |
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134 |
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12.5 |
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Defense of Collaboration Patents |
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136 |
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12.6 |
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Third Party Licenses |
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136 |
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12.7 |
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Patent Marking |
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137 |
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12.8 |
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Personnel Obligations |
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138 |
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12.9 |
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Trademarks, Corporate Logos and other Intellectual Property Rights |
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138 |
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ARTICLE 13 |
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REPRESENTATIONS AND WARRANTIES; COVENANTS |
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140 |
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13.1 |
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Mutual Representations and Warranties |
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140 |
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13.2 |
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Additional Representations of Reata |
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141 |
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13.3 |
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DISCLAIMER OF WARRANTIES |
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145 |
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ARTICLE 14 |
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INDEMNIFICATION |
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145 |
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14.1 |
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Indemnification by Reata |
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145 |
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14.2 |
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Indemnification by Abbott |
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146 |
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14.3 |
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Certain Losses |
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146 |
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14.4 |
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Notice of Claim |
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147 |
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14.5 |
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Control of Defense |
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147 |
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14.6 |
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Special, Indirect, Consequential and Other Losses |
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148 |
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14.7 |
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Insurance |
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149 |
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ARTICLE 15 |
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CONFIDENTIALITY |
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149 |
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15.1 |
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Confidentiality Obligations |
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149 |
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15.2 |
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Permitted Disclosures |
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150 |
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15.3 |
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Use of Name |
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151 |
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15.4 |
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Public Announcements |
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151 |
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15.5 |
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Publications |
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152 |
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Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
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ARTICLE 16 |
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16.1 |
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Term |
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153 |
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16.2 |
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Termination by Mutual Agreement |
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153 |
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16.3 |
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Rights in Bankruptcy |
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153 |
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16.4 |
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Material Breach |
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153 |
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16.5 |
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Remedies Other Than Termination |
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154 |
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ARTICLE 17 |
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MISCELLANEOUS |
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154 |
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17.1 |
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Force Majeure |
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154 |
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17.2 |
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Export Control |
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155 |
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17.3 |
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Assignment |
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155 |
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17.4 |
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Severability |
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156 |
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17.5 |
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Governing Law; Service |
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157 |
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17.6 |
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Dispute Resolution |
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157 |
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17.7 |
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Notices |
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159 |
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17.8 |
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Change of Control |
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160 |
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17.9 |
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Entire Agreement |
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164 |
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17.10 |
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English Language |
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164 |
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17.11 |
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Equitable Relief |
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164 |
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17.12 |
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Waiver and Non-Exclusion of Remedies |
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165 |
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17.13 |
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No Benefit to Third Parties |
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165 |
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17.14 |
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Further Assurance |
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165 |
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17.15 |
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Relationship of the Parties |
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165 |
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17.16 |
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Counterparts; Facsimile Execution |
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165 |
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17.17 |
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References |
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166 |
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17.18 |
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Construction |
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166 |
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Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
T HIS C OLLABORATION A GREEMENT (this “ Agreement ”) is entered into as of December 9, 2011 (the “ Effective Date ”) by and between R EATA P HARMACEUTICALS , I NC . , a Delaware corporation having its principal place of business at 0000 Xxxxxxx Xxxxx, Xxxxx 000, Xxxxxx, Xxxxx 00000 (“ Reata ”), and A BBOTT P HARMACEUTICALS PR LTD . , a Bermuda corporation having its principal place of business at 2 KM 58.2, Xxxxx Xxxxxx, Barceloneta 00617, Puerto Rico (“ Abbott ”). Reata and Abbott are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties ”.
B ACKGROUND
Abbott, together with its Affiliates (as defined herein), is a global pharmaceutical company with expertise in the development, manufacture and commercialization of human therapeutic products.
Reata is a biotechnology company with expertise and experience in the identification and development of product candidates containing Targeted AIMs (as defined herein) for use in multiple indications, and that controls intellectual property rights with respect to such Targeted AIMs.
Reata and Abbott are parties to a License Agreement, dated as of September 21, 2010 (the “ Bardoxolone License Agreement ”), under which Abbott obtained the right to develop and commercialize one of such Targeted AIMs, bardoxolone methyl, and certain back-up and follow-on compounds thereof, for use in the Previously Licensed Field (as defined herein) in certain countries and territories outside the U.S.
Abbott and Reata now desire to collaborate to establish a broad, worldwide, strategic collaboration for the joint research, development and, if successful, regulatory approval and commercialization of Targeted AIMs in fields of use other than in the Previously Licensed Field, under terms and conditions set forth herein.
Abbott and Xxxxx intend that their collaboration hereunder will utilize Xxxxxx’x position as a large, multi-national pharmaceutical company and Reata’s experience and expertise in discovery and development of Targeted AIMs while taking into account the Parties’ respective current and future aspirations, including Xxxxx’s strategic goal to further develop its global clinical development and commercial capabilities.
N OW T HEREFORE , in consideration of the foregoing premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
ARTICLE 1
DEFINITIONS
1.1 “ Abbott Excluded AIM ” means any Targeted AIM (a) that is acquired (or rights to which are acquired) by Abbott or any of its Affiliates from a Third Party after the Effective Date and that has not been clinically developed or commercialized in the New Collaboration Field as of the time of such acquisition or (b) that is owned by an Acquiring Affiliate or Acquired Affiliate of Abbott, or to which an Acquiring Affiliate or Acquired Affiliate of Abbott otherwise has rights, as of the time such Affiliate became an Affiliate of Abbott and that has not been clinically developed or commercialized in the New Collaboration Field as of the time such Affiliate became an Affiliate of Abbott.
1.2 “ Abbott Know-How ” means all Information (including Regulatory Data) Controlled by Abbott or any of its Affiliates as of the Effective Date or at any time during the Term that is not generally known and is reasonably necessary or useful for the Development, Manufacture, or Commercialization of a Product in the New Collaboration Field, but excluding any Information to the extent covered or claimed by or comprising published Abbott Patents or Joint Patents, or any Joint Know-How.
1.3 “ Abbott Patents ” means all of the Patents Controlled by Abbott or any of its Affiliates as of the Effective Date or at any time during the Term that are reasonably necessary or useful (or, with respect to patent applications, would be reasonably necessary or useful if such patent applications were to issue as patents) for the Development, Manufacture or Commercialization of a Product in the New Collaboration Field, but excluding any Joint Patents.
1.4 “ Acquired Affiliate ” means, with respect to a Party, a Person (a) with respect to which such Party acquires control (as defined in Section 1.8) after the Effective Date and (b) that was a Third Party at the time of such acquisition.
1.5 “ Acquired AIM ” means any Targeted AIM that comes into the Control of (or is otherwise Controlled by) a Party or any of its Affiliates after the Effective Date and during the Exclusivity Period as a result of: (a) the in-license or acquisition of rights to such Targeted AIM from a Third Party by such Party or any of its Affiliates after the Effective Date and during the Exclusivity Period, including any Abbott Excluded AIM; or (b) any Person that owns or otherwise has rights to such Targeted AIM becoming an Affiliate of such Party after the Effective Date and during the Exclusivity Period for any reason, including pursuant to a Change of Control, including any Abbott Excluded AIM, but excluding (i) any Exempt AIM, and (ii) any Divested AIM.
1.6 “ Acquiring Affiliate ” means, with respect to a Party, a Person that (a) acquires control (as defined in Section 1.8) of such Party after the Effective Date and (b) was a Third Party at the time of such acquisition.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
1.7 “ Active Indication ” means an Indication in the New Collaboration Field, with respect to which, at the time of determination, either Party or both Parties are conducting Development or Commercialization activities under this Agreement (including Unilateral Development or unilateral Commercialization of a Royalty Product).
1.8 “ Affiliate ” means, with respect to any Person, any other Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with such first Person. For purposes of this definition, “control” and, with correlative meanings, the terms “controlled by” and “under common control with” shall mean: (a) the possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise; or (b) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity). Neither of the Parties to this Agreement shall be deemed to be an “Affiliate” of the other solely as a result of their entering into this Agreement. ‘Affiliates’ of a Party include Persons that are Affiliates of such Party as of the Effective Date and Persons that become Affiliates of such Party after the Effective Date, including pursuant to a Change of Control.
1.9 “ Applicable Law ” means applicable laws, rules, and regulations, including any rules, regulations, guidelines, or other requirements of the Regulatory Authorities, that may be in effect from time to time.
1.10 “ Xxxx-Xxxx Act ” shall mean the Patent and Trademark Law Amendments Act of 1980, as amended, codified at 35 U.S.C. §§ 200-212, as amended, as well as any regulations promulgated pursuant thereto, including in 37 C.F.R. Part 401.
1.11 “ Business Day ” means a day other than a Saturday or Sunday on which banking institutions in New York, New York are open for business.
1.12 “ Calendar 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 the first Calendar Quarter for the first Calendar Year shall extend from the Effective Date to the first of March 31, June 30, September 30 and December 31 to occur thereafter.
1.13 “ Calendar Year ” means (a) the period commencing on the Effective Date and ending on December 31 of the calendar year during which the Effective Date occurs, and (b) each successive period beginning on January 1 and ending twelve (12) consecutive calendar months later on December 31.
1.14 “ Cardiovascular Indication ” means the prevention, treatment, or amelioration of any cardiovascular disease or condition, including atherosclerosis, heart failure, myocardial infarction, acute coronary syndrome, myocarditis, angina, restenosis, aneurysms, vasculitis, complications of vascular surgery and heart surgery, thrombosis, phlebitis, peripheral vascular disease, and hypertension.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
1.15 “ Clinical Data ” means all data with respect to Products or New Collaboration Compounds made, collected, or otherwise generated under or in connection with Clinical Studies or Phase IV Studies, including any data, reports, and results with respect thereto.
1.16 “ Clinical Studies ” means Phase I, Phase II, Phase III, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approval for a Product or New Collaboration Compound for an Indication.
1.17 “ CMC Development ” means those Manufacturing activities and regulatory activities designed to support preparation of the Chemistry, Manufacturing and Controls sections of any Drug Approval Application, including manufacturing process development and scale-up, bulk production and fill/finish work associated with the supply of New Collaboration Compounds or Products for Non-Clinical Studies and Clinical Studies, and related quality assurance technical support activities, as well as validation and qualification of commercial manufacturing processes.
1.18 “ Combination Product ” shall mean a Product that is comprised of or contains any New Collaboration Compound as an active pharmaceutical ingredient together with one or more other active pharmaceutical ingredients and is sold either as a fixed dose or as separate doses in a single package.
1.19 “ Commercialization ” means any and all activities directed to the preparation for sale of, offering for sale of, or sale of a Product, including activities related to marketing, promoting, distributing, and importing such Product, conducting Medical Affairs Activities, conducting Phase IV Studies, and interacting with Regulatory Authorities regarding the foregoing. When used as a verb, “ to Commercialize ” and “ Commercializing ” shall mean to engage in Commercialization, and “ Commercialized ” has a corresponding meaning.
1.20 “ Commercialization Costs ” means, with respect to a Joint Product for a Profit Share Region for any period, (i) the direct out-of-pocket costs paid to Third Parties recorded as an expense in accordance with GAAP and (ii) internal costs for field-based medical liaisons, in each case ((i) and (ii)) that are incurred by or on behalf of a Party or any of its Affiliates after the Effective Date and during the Term and that are specifically identifiable or reasonably allocable to the Commercialization of such Joint Product hereunder in the applicable Profit Share Region for such period. Except in the case of Commercialization Costs incurred in accordance with clauses (a), (e), (n), (o), and (p) below, Commercialization Costs shall be limited to Commercialization activities that are consistent with the applicable Commercialization Plan; provided, however, that such costs shall be included in “Commercialization Costs” only to the extent less than or equal to the amounts set forth in the applicable Commercialization Plan for the applicable activity. Subject to the foregoing, Commercialization Costs shall include:
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(a) Manufacturing Costs attributable to the Manufacture of Product (including inventory and safety stock) for commercial sale or distribution (including Samples) in the Profit Share Region for such Joint Product and incurred in accordance with the applicable Manufacturing Plan (including inventories of Joint Product Manufactured in anticipation of launch but for which Regulatory Approval is not obtained);
(b) Sales and Marketing Costs;
(c) costs associated with Medical Affairs Activities;
(d) Distribution Costs;
(e) Third Party Payments, subject to Section 12.6;
(f) Trademark Costs;
(g) costs of patient assistance and indigent/expanded access programs;
(h) import duties and similar charges for such Joint Product sold in the Profit Share Region, to the extent not recovered as a Manufacturing Cost;
(i) costs of conducting advisory board meetings or other consultant programs, the purpose of which is to obtain advice and feedback related to Commercialization of such Product in the Profit Share Region;
(j) Regulatory Costs;
(k) costs of Phase IV Studies;
(l) Patent Costs;
(m) Technology Transfer costs incurred in accordance with Section 9.4;
(n) Losses incurred in connection with Third Party Claims described in Section 14.3 to the extent such Losses are to be included in Commercialization Costs in accordance with such Section;
(o) costs of recalls, market suspensions and market withdrawals of such Joint Product incurred as Commercialization Costs incurred in accordance with Section 6.4;
(p) Exit Costs; and
(q) any other cost designated as a Commercialization Cost in this Agreement.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Commercialization Costs shall include the foregoing costs which are incurred after the Effective Date and prior to the First Commercial Sale of such Joint Product in the Profit Share Region (pre-launch costs). To the extent that any of the foregoing costs apply to both the Profit Share Region for a Joint Product and the Royalty Region for a Unilateral Product, such costs shall be reasonably allocated between the Profit Share Region and the Royalty Region by the applicable JMC based on the market size in the respective regions. Notwithstanding the foregoing, Commercialization Costs shall exclude: (i) costs directly relating to Sales Representatives and their direct managers and trainers, including salary, benefits, incentive compensation, and automobile allowances, and otherwise to the direct conduct of Details, in each case except to the extent included in PDE Costs; (ii) costs incurred solely with respect to Commercialization of a Unilateral Product in a Royalty Region; (iii) Development Costs; (iv) income tax liabilities of either Party; (v) corporate overhead costs of either Party, except and only to the extent reasonably and directly allocable to the applicable Joint Product in the applicable Profit Share Region, in accordance with GAAP; and (vi) Commercialization costs and regulatory costs incurred prior to the Effective Date.
1.21 “ Commercialization Territory ” means (a) as to the U.S./Europe/Japan Region, each of (i) the U.S.; (ii) Europe; and (iii) Japan; and (b) as to the ROW Region, each of (i) China, Korea, Taiwan, Philippines, Indonesia, Singapore, Malaysia, Thailand, and Vietnam collectively (the “ Asia Territory ”); (ii) South America, Central America (including Mexico), and the Caribbean islands (including Puerto Rico and the U.S. Virgin Islands) collectively (“ Latin America ”); and (iii) all other countries within the ROW Region collectively (the “ ROW Territory ”).
1.22 “ Commercially Reasonable Efforts ” means, with respect to the performance of Development, Commercialization, or Manufacturing activities with respect to a New Collaboration Compound or a Product by a Party, the carrying out of such activities using efforts and resources comparable to the efforts and resources that such Party would typically devote to products of similar market potential at a similar stage in development or product life, taking into account all scientific, commercial, and other factors that the Party would take into account, including issues of safety and efficacy, expected and actual cost and time to develop, expected and actual profitability (including royalties and other payments required hereunder), expected and actual competitiveness of alternative Third Party products (including generic products) in the marketplace, the nature and extent of expected and actual market exclusivity (including patent coverage and Regulatory Exclusivity), the expected likelihood of regulatory approval, the expected and actual reimbursability and pricing, and the expected and actual amounts of marketing and promotional expenditures required. “Commercially Reasonable Efforts” shall be determined on a country-by-country (or region-by-region, where applicable) and indication-by-indication basis, except that the Party may consider the impact of its efforts and resources expended with respect to any country (or region) on any other country (or region).
1.23 “ Committee ” means, individually and collectively, the Joint Executive Committee, the Joint Research and Development Incubator, the Joint Development Committee(s), the Joint Supply Committee, the Joint Marketing Committee(s), the Joint Patent Committee, or any other subcommittee established under Article 2, as applicable. The Existing JDC and the Existing JMC shall not be Committees hereunder.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
1.24 “ Completion Notice ” means, with respect to any Development activities under a Unilateral Plan, a report (which is not required to be the final study report) delivered after the datalock for the applicable Clinical Study set forth in such Unilateral Plan that summarizes the Clinical Data and other Information resulting from or with respect to such Development activities as currently as practicable as of the date of delivery of such report.
1.25 “ Control ” means, with respect to any item of Information, Regulatory Documentation, material, Patent, or other intellectual property right, possession of the right, whether directly or indirectly, and whether by ownership, license or otherwise (other than by operation of the license and other grants in Section 10.1), to grant a license, sublicense or other right (including the right to reference Regulatory Documentation) to or under such Information, Regulatory Documentation, material, Patent, or other intellectual property right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party. “ Controls ” and “ Controlled ” have corresponding meanings.
1.26 “ Co-Promotion ” or “ Co-Promote ” means those Detailing activities undertaken with respect to a Co-Promotion Product conducted by or on behalf of either Party or its Affiliates in accordance with the applicable Co-Promotion Agreement and Commercialization Plan to encourage appropriate prescribing of such Co-Promotion Product.
1.27 “ Dartmouth ” shall mean Trustees of Dartmouth College.
1.28 “ Detail ” means that part of an in-person, face-to-face sales call during which a Sales Representative, who is trained and knowledgeable with respect to a pharmaceutical product, including its product label and insert and the use of the applicable Promotional Materials, makes a presentation of such product to a physician or other medical professional with prescribing authority such that the relevant characteristics of such product are described by the Sales Representative in accordance with Applicable Law and in a fair and balanced manner that is customary in the industry for the purpose of promoting the prescription pharmaceutical product. The following shall not constitute a “Detail” except as otherwise set forth herein: (a) any activities performed by medical information scientists, market development specialists, managed care account directors and other personnel who are not conducting face-to-face sales calls; (b) E-details; (c) presentations made at conventions or to any group of more than five (5) physicians or other medical professionals with prescribing authority; or (d) a mere delivery of Samples without discussion with a medical professional about the product. When used as a verb, “ Detail ” means to perform a Detail. Details shall be measured by each Party’s internal recording of such activity; provided that such measurement shall be on the same basis as the recording Party’s measurement for its Sales Representatives’ Detailing of such recording Party’s other products, consistently applied. If a Party has no other marketed products, it will establish a reasonable basis of internal recording of Details consistent with industry standards in the global pharmaceutical industry.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
1.29 “ Development ” means all activities related to research, preclinical testing and other Non-Clinical Studies, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, other CMC Development, Clinical Studies, including Manufacturing in support thereof, development and identification of biomarkers, diagnostics and companion tools, statistical analysis and report writing, the preparation and submission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all other activities reasonably necessary or useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval. When used as a verb, “ Develop ” shall mean to engage in Development. Development shall exclude Phase IV Studies.
1.30 “ Development Candidate ” means any Lead Compound selected for IND- enabling Non-Clinical Studies and potentially for Clinical Studies in one or more Indications or as otherwise designated by the JRDI, but which has not yet been designated as a Product Candidate. The Development Candidates selected as of the Effective Date are set forth in Schedule 1.30 .
1.31 “ Development Costs ” means, for any period, (i) the direct out-of-pocket costs paid to Third Parties recorded as an expense in accordance with GAAP; and (ii) with respect to a Development Plan, any internal costs expressly agreed by the Parties and set forth in such Development Plan to be included as a Development Cost, in each case ((i) and (ii)) incurred by or on behalf of a Party or any of its Affiliates after the Effective Date and during the Term and that are specifically identifiable or reasonably allocable to Development activities for such period. Except in the case of Development Costs incurred in accordance with clauses (g) and (h) below, Development Costs shall be limited to Development activities that are consistent with the applicable Development Plan; provided, however, that such costs shall be included in “Development Costs” only to the extent less than or equal to the amounts set forth in the applicable Development Plan for the applicable activity (subject to permitted overruns pursuant to Section 11.2(b)). Subject to the foregoing, Development Costs shall include such costs in connection with the following activities, as applicable:
(a) pre-clinical activities and Non-Clinical Studies such as toxicology and formulation development, test method development, stability testing, quality assurance, quality control development and statistical analysis;
(b) Clinical Studies for a Product, including (i) the preparation for and conduct of such Clinical Studies; (ii) data collection and analysis and report writing; and (iii) clinical laboratory work;
(c) Manufacturing Costs for (i) a Product for use in Clinical Studies or other Development activities for such Product; (ii) the manufacture, purchase or packaging of comparators or placebo for use in Clinical Studies for a Product (with the manufacturing costs for comparators or placebo to be determined in the same manner as Manufacturing Costs are determined for such Product) and (iii) costs and expenses of disposal of drugs and other supplies used in such Clinical Studies or other Development activities;
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(d) Technology Transfer costs incurred in accordance with Section 9.4;
(e) Patent Costs;
(f) Study Trademark Costs;
(g) Third Party Payments, subject to Section 12.6;
(h) Losses incurred in connection with Third Party Claims described in Section 14.3 to the extent such Losses are to be included in Development Costs in accordance with such Section;
(i) Regulatory Costs;
(j) Costs for CMC Development, the development of the Manufacturing process for a Product, scale-up, Manufacturing process validation, Manufacture of registration batches, Manufacturing improvements, and qualification and validation of Third Party contract manufacturers; and
(k) any other cost designated as a Development Cost in this Agreement.
Notwithstanding the foregoing, Development Costs shall exclude: (i) any Manufacturing Costs for commercial supply of any Product; (ii) income tax liabilities of either Party; and (iii) corporate overhead costs of either Party, except and only to the extent reasonably and directly allocable to the applicable Joint Product in the applicable Profit Share Region, or applicable Development Candidate under the Joint Exploratory Development Plan, in accordance with GAAP.
1.32 “ Development Plan ” means, individually and collectively, the Joint Exploratory Development Plan, any Unilateral Exploratory Development Plan or any Product Development Plan.
1.33 “ Development Region ” means each of: (a) the U.S., Europe and Japan collectively (the “ U.S./Europe/Japan Region ”) and (b) all other countries in the Territory collectively (the “ ROW Region ”).
1.34 “ Distribution Costs ” means those costs and expenses incurred by or on behalf of a Party or any of its Affiliates, after the Effective Date and during the Term and pursuant to this Agreement and that are directly and reasonably allocable to the distribution of a Product and consistent with industry standards for a company of the size of such Party, including: (a) handling and transportation to fulfill orders with respect to a Product; (b) customer services, including order entry, billing and adjustments, inquiry and credit and collection with respect
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
to a Product; (c) reasonable and customary fees and other amounts payable to distributors (to the extent not taken into account in determining Net Sales); and (d) costs of storage and distribution of Products, but in each case excluding such costs to the extent they are treated as a deduction in the definition of Net Sales. For clarity, Distribution Costs shall exclude (i) corporate overhead costs of either Party, except and only to the extent reasonably and directly allocable to the applicable Joint Product in the applicable Profit Share Region, in accordance with GAAP, or (ii) costs incurred by a Party in connection with the build-out of such Party’s facilities or equipment, unless and to the extent such facility or equipment is dedicated to the distribution of a Product or Products, but excluding any excess capacity of such facility.
1.35 “ Divested AIM ” means any Targeted AIM that (a) is owned by an Acquiring Affiliate or Acquired Affiliate of a Party, or to which an Acquiring Affiliate or Acquired Affiliate of a Party otherwise has rights, as of the time such Affiliate became an Affiliate of such Party, (b) any Governmental Authority requires or recommends be divested by such Affiliate as a condition to the consummation of the transaction pursuant to which such Affiliate became an Affiliate of such Party, and (c) is actually divested by such Affiliate in accordance with such requirement or recommendation of such Governmental Authority.
1.36 “ Dollars ” or “ $ ” shall mean United States Dollars.
1.37 “ Drug Approval Application ” means a New Drug Application (an “ NDA ”) as defined in the FFDCA and the regulations promulgated thereunder (including all additions, supplements, extensions, and modifications thereto), or any corresponding foreign application in the Territory, including, with respect to the European Union, a Marketing Authorization Application (a “ MAA ”) filed with the EMA pursuant to the centralized approval procedure or with the applicable Regulatory Authority of a country in Europe with respect to the mutual recognition or any other national approval procedure.
1.38 “ EMA ” means the European Medicines Agency and any successor agency thereto.
1.39 “ Europe ” means Albania, Andorra, Austria, Armenia, Azerbaijan, Belarus, Belgium, Bosnia & Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Macedonia, Malta, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, U.K., Vatican City and Canada.
1.40 “ European Major Market Countries ” means, collectively, Germany, France, Italy, Spain and the United Kingdom.
1.41 “ Excusable Delay ” means, with respect to a Party’s assigned activities under a Development Plan, the delay of such activities as a result of: (a) the material non-performance or delay of the other Party of activities assigned to it under the same Development Plan or the Discovery Research Plan or any other Development Plan, which activities are reasonably
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
necessary to be performed by the other Party for the first Party to conduct such activities under such Development Plan; (b) the need to obtain or analyze data from any other Clinical Study with respect to the applicable Indication or New Collaboration Compound, which data is reasonably necessary for such Party to plan or conduct such activities under such Development Plan; or (c) matters outside of the reasonable control of the first Party ( e.g. , regulatory delay, or other delay caused by any Third Party outside of the reasonable control of the first Party).
1.42 “ Exempt AIM ” means, with respect to a Party, any Targeted AIM (a) that is owned by an Acquiring Affiliate of such Party, or to which an Acquiring Affiliate of such Party otherwise has rights, in each case as of the time such Acquiring Affiliate becomes an Acquiring Affiliate of such Party and (b) for which a Phase IIb or later Clinical Study has been commenced in the New Collaboration Field as of the time such Acquiring Affiliate becomes an Acquiring Affiliate of such Party.
1.43 “ Existing JDC ” means the JDC established under the Bardoxolone License Agreement.
1.44 “ Existing JMC ” means the JMC established under the Bardoxolone License Agreement.
1.45 “ Existing Lead Compounds ” means the Lead Compounds existing as of the Effective Date, as set forth in Schedule 1.45 .
1.46 “ Exit Costs ” means, with respect to a Joint Product, the reasonable and direct costs incurred by a Party and its Affiliates in connection with the significant reduction of Commercialization resources or Manufacturing resources of such Party and its Affiliates as a result of the cessation of, or a significant reduction in, Commercialization or Manufacturing activities with respect to such Joint Product for a Profit Share Region in accordance with the terms of this Agreement, including termination costs with respect to Sales Representatives; provided that (a) such Commercialization resources and Manufacturing resources were acquired or established by such Party or its Affiliates consistently with the applicable Commercialization Plan and Manufacturing Plan, respectively, and (b) such Party uses commercially reasonable efforts to minimize such costs.
1.47 “ Exploit ” means to make, have made, import, use, sell, or offer for sale, including to research, develop, commercialize, register, manufacture, have manufactured, hold, or keep (whether for disposal or otherwise), have used, export, transport, distribute, promote, market, or have sold or otherwise dispose of. “ Exploitation ” shall mean the act of Exploiting a product or process.
1.48 “ FDA ” means the United States Food and Drug Administration and any successor agency thereto.
1.49 “ FFDCA ” means the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
1.50 “ First Commercial Sale ” means, with respect to a pharmaceutical product and a country, the first sale for monetary value for use or consumption by the end user of such product in such country after Regulatory Approval for such product has been obtained in such country. Sales prior to receipt of Regulatory Approval for such product, such as so-called “treatment IND sales,” “named patient sales,” and “compassionate use sales,” shall not be construed as a First Commercial Sale.
1.51 “ FirstGen Targeted AIM ” means any Targeted AIM: (a) that is Controlled by Reata or any of its Affiliates as of the Effective Date and that is derived from oleanolic acid or generated using oleanolic acid (or a metabolite of oleanolic acid) as a starting material, but excluding bardoxolone methyl; (b) that is Controlled by Abbott or any of its Affiliates as of the Effective Date and that is derived from oleanolic acid or generated using oleanolic acid (or a metabolite of oleanolic acid) as a starting material; (c) that is invented solely by or on behalf of either Party, or jointly by or on behalf of the Parties, during the Exclusivity Period but prior to the [***]th anniversary of the Effective Date and is derived from oleanolic acid or generated using oleanolic acid (or a metabolite of oleanolic acid) as a starting material; or (d) that is invented solely by or on behalf of either Party, or jointly by or on behalf of the Parties, during the Exclusivity Period but after the [***]th anniversary of the Effective Date, is derived from oleanolic acid or generated using oleanolic acid (or a metabolite of oleanolic acid) as a starting material, and the composition of matter of which is claimed by any claim included in any Reata Patent existing as of the [***]th anniversary of the Effective Date. If Abbott or its Affiliates invents (either solely or jointly with Reata or its Affiliates) any Targeted AIM that would otherwise constitute a FirstGen Targeted AIM under clause (c) or (d) above and Abbott believes in good faith that such newly invented Targeted AIM constitutes a significant improvement in physical or chemical properties or other characteristics as compared to then-existing FirstGen Targeted AIMs, then Abbott may request that Reata designate such newly-invented Targeted AIM as a NextGen Targeted AIM. Reata shall consider such request reasonably and in good faith and may designate such newly-invented Targeted AIM as a NextGen Targeted AIM in Reata’s reasonable discretion.
1.52 “ GAAP ” means United States generally accepted accounting principles consistently applied.
1.53 “ Generic Product ” means, with respect to a Product, any pharmaceutical product that: (a) is sold by a Third Party under a Drug Approval Application granted by a Regulatory Authority to such Third Party, which Third Party is not a licensee or sublicensee of one of the Parties or their Affiliates, or any of their licensees or sublicensees, and has not obtained such Product from a chain of distribution including one of the Parties, its Affiliates or any of their licensees or sublicensees, (b) contains the applicable New Collaboration Compound as an active pharmaceutical ingredient (or the same active moiety); and (c) is approved in reliance, in whole or in part, on the prior approval of such Product as determined by the applicable Regulatory Authority (pursuant to 21 U.S.C. 355(b)(2), an ANDA, a separate NDA, compendia listing, other drug approval application or otherwise, including foreign equivalents of the foregoing). A Product licensed or produced by one of the Parties ( i.e. , an authorized generic product) will not constitute a Generic Product.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
1.54 “ GMPs ” means the then-current good manufacturing practices required by the FDA, as defined in 21 C.F.R. Parts 210 and 211 and the regulations promulgated thereunder, for the manufacture and testing of pharmaceutical materials, and comparable laws or regulations applicable to the manufacture and testing of pharmaceutical materials in jurisdictions outside the U.S., as they may be updated from time to time. GMPs shall include applicable quality guidelines promulgated under the International Conference on Harmonization.
1.55 “ Governmental Authority ” means any multi-national, federal, state, local, municipal or other government authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).
1.56 “ Humira-Related Product ” means any Product containing a Product Candidate that is designated to be Developed pursuant to Section 4.2(e)(ii) for an Indication for which Humira has received regulatory approval in any country within the U.S./EU/Japan Region at the time of such designation as a Product Candidate.
1.57 “ IND ” means an investigational new drug application filed with the FDA for authorization to commence Clinical Studies in the U.S. and an equivalent application filed with the applicable Regulatory Authority in other countries or regulatory jurisdictions.
1.58 “ Indication ” means any disease or condition that can be treated, prevented or cured or the progression of which can be delayed and for which a Product is specifically Developed in order to obtain Regulatory Approval for use of such Product pursuant to an approved label claim.
1.59 “ Information ” means all technical, scientific, and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, including: biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols; assays and biological methodology; (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form now known or hereafter developed.
1.60 “Indication Survey Study ” or “ISS” means a Clinical Study of a Development Candidate which is in general relatively short in duration and small in size conducted for a particular Indication and which is reasonably designed to provide initial evidence of efficacy. An Indication Survey Study is intended only to demonstrate the suitability of treating a particular Indication using Targeted AIMs in general or to provide initial evidence of the efficacy of treating a particular Indication with a specific Development Candidate, and is not required to be (but is not prohibited from being) a pivotal trial or dose-ranging study or to
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
otherwise provide data sufficient to support any Regulatory Filing or Regulatory Approvals for a Development Candidate or Product Candidate. In general, the Parties intend for a typical Indication Survey Study to be a Phase IIa Study involving no more than two hundred (200) patients with a treatment period of no more than twelve (12) months. The Parties acknowledge that an actual ISS may be designed to be a more robust Clinical Study than as described in this Section 1.60.
1.61 “ Initial Studies Period ” means the period commencing on the Effective Date and ending on the earlier of: (a) [***]; and (b) the date on which [***].
1.62 “ Joint Plan ” means, individually and collectively, each Joint Pre-Phase IIb Plan, each Joint Phase IIb Plan, and each Joint Phase III Plan.
1.63 “ Knowledge ” means the actual knowledge of the chief executive officer, the president, the executive vice-president, any vice president, including the vice president for research, the vice president for product development, the vice president for clinical development, and the vice president for intellectual property, the head of regulatory affairs, the senior patent counsel, the general counsel, or the chief medical officer of a Party, or any personnel holding positions equivalent to such job titles (but only to the extent such positions exist at such Party).
1.64 “ Lead Compound ” means any New Collaboration Compound that: (a) is identified on Schedule 1.45 ; or (b) is designated as a Lead Compound by the JRDI after the Effective Date, in each case that has not yet been designated as a Development Candidate.
1.65 “ Lead Development Party ” or “ LDP ” means, with respect to each particular stage of Development of a Development Candidate or Product Candidate in the applicable Development Region or Commercialization Territory, as the case may be, the Party designated as the lead Development Party therefor pursuant to Section 4.3(e), 4.4(d), 5.5(a)(vii), 5.5(b)(iii), 5.5(d)(iv), 5.6(a)(iv), 5.6(b)(ii), or 5.6(d)(iv).
1.66 “ Lead Regulatory Party ” or “ LRP ” means, with respect to each particular stage of Development of a Development Candidate or Product Candidate in the applicable Development Region or Commercialization Territory, as the case may be, the Party designated as the lead Regulatory Party therefor pursuant to Section 4.3(e), 4.4(d), 5.5(a)(vii), 5.5(b)(iii), 5.5(d)(iv), 5.6(a)(iv), 5.6(b)(ii), or 5.6(d)(iv).
1.67 “ LIBOR ” shall mean the London Interbank Offered Rate for deposits in United States Dollars having a maturity of one month published by the British Bankers’ Association, as adjusted from time to time on the first London business day of each month.
1.68 “ Manufacture ” and “ Manufacturing ” shall mean all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, shipping, and holding of New Collaboration Compounds (including Lead Compounds, Development Candidates and Product Candidates) and Products, or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality assurance, and quality control.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
1.69 “ Manufacturing Costs ” means costs and expenses of Manufacturing a New Collaboration Compound or a Product which is either: (a) supplied to a Party by a Third Party; or (b) Manufactured directly by a Party or its Affiliate, in each case to the extent such costs are directly and reasonably allocable to the Development or Commercialization of such New Collaboration Compound or Product in the Territory, as further described below and in accordance with GAAP. Manufacturing Costs shall be (i) included in Commercialization Costs as (A) Product is sold, (B) Product is distributed as Samples or (C) incurred or accrued by the Manufacturing Party in connection with write-offs of inventory, or (ii) Development Costs as such costs are incurred, as the case may be. In the event that a Party performs any of its Manufacturing and supply obligations through one or more Affiliates, any inter-company amounts or fees paid for any such services or Product or any intermediate used therein by such Party shall not be included in calculating Manufacturing Costs and only those costs directly incurred by such Affiliate shall be so included. To the extent that any Manufacturing Costs apply to both the Profit Share Region for a Joint Product and the Royalty Region for a Unilateral Product, such costs shall be reasonably allocated between the Profit Share Region and the Royalty Region by the JSC based on the market size in the respective regions.
For costs in subsection (a), Manufacturing Costs means: (i) the amount paid to such a Third Party (excluding any Third Party Payments); plus (ii) the relevant Manufacturing Party’s reasonable out-of-pocket costs to Third Parties, incurred or accrued (including any prepayments) by the Manufacturing Party in connection therewith, including costs associated with inventory write-offs, variances, Manufacturing process improvements, storage, freight, Manufacturing scale-up, Manufacturing site qualification, materials, quality assurance and quality control (including testing), supply chain management, capital equipment depreciation charges, similar activities comprising the Manufacturing Party’s oversight of the Manufacturing process of the Third Party, and any unrecoverable value-added tax or similar tax due for amounts paid to such Third Party.
For costs in subsection (b), Manufacturing Costs shall be calculated in accordance with Schedule 1.69 .
Manufacturing Costs shall include costs of such activities that are undertaken at any time during the Term of this Agreement (including Manufacturing activities relating to the Commercialization of a Product that are undertaken prior to the initial Regulatory Approval of such Product).
1.70 “ MAA ” has the meaning set forth in the definition of “Drug Approval Application.”
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
1.71 “ Material Adverse Effect ” means a material adverse effect on (a) the development, manufacturing or commercialization of bardoxolone methyl under the Bardoxolone License Agreement or (b) the Development, Manufacturing or Commercialization of a then-existing Joint Product or Unilateral Product under this Agreement; provided that loss of sales, loss of profit, loss of market share, reduced pricing or any other competitive effect on an existing Joint Product or Unilateral Product as a result of such activity shall not in and of itself constitute a material adverse effect on the Development, Manufacturing or Commercialization of such existing Joint Product or Unilateral Product.
1.72 “ Material Amendment ” means any amendment to a Joint Plan or any work plan or protocol under the Joint Exploratory Development Plan that (a) adds, deletes, discontinues (except for discontinuance for a reason set forth below in clause (f)) or materially changes a Clinical Study under such Joint Plan or the Joint Exploratory Development Plan or any other material Development activity under such Joint Plan or the Joint Exploratory Development Plan; (b) materially alters the nature or scope of a Party’s obligations under such Joint Plan or the Joint Exploratory Development Plan; (c) changes the budget in such Joint Plan or the Joint Exploratory Development Plan by more than [***] percent ([***]%) as compared to the budget last agreed on by the Parties mutually; (d) materially changes any timeline for performing any Clinical Study under such Joint Plan or the Joint Exploratory Development Plan or any other material Development activity under such Joint Plan or the Joint Exploratory Development Plan as compared to the timeline last agreed on by the Parties mutually; (e) could reasonably be expected to have a Material Adverse Effect; or (f) could reasonably be expected to present a Safety Risk.
1.73 “ Medical Affairs Activities ” means the coordination of medical information requests and field-based medical liaisons with respect to Products that have been commercially launched in the applicable country.
1.74 “ Metabolic Indication ” means the prevention, treatment, or amelioration of any of the following metabolic diseases or conditions: type II diabetes, insulin resistance, complications of diabetes (including retinopathy, neuropathy, and ulcers), obesity, metabolic syndrome, hypercholesterolemia, and hyperlipidemia.
1.75 “ Net Sales ” means, with respect to a Product for any period in any country in the Territory, the total amount billed or invoiced on sales of such Product during such period by a Party or its Affiliates, or sublicensees (but in the case of sublicensees, only with respect to sales of Unilateral Products in a country in the applicable Royalty Region(s)) in such country in the Territory to Third Parties (including wholesalers or distributors) in bona fide arm’s length transactions, less the following deductions, in each case to the extent such deductions relate specifically to such Product in such country and are actually allowed and taken by such Third Parties and are not otherwise recovered by or reimbursed to the selling Party, its Affiliates, or sublicensees:
(a) trade, cash and quantity discounts;
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(b) price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to Governmental Authorities;
(c) taxes on sales (such as sales, value added, or use taxes) to the extent added to the sale price and set forth separately as such in the total amount invoiced;
(d) freight, insurance, and other transportation charges to the extent added to the sale price and set forth separately as such in the total amount invoiced, as well as any fees for services provided by wholesalers and warehousing chains related to the distribution of such Product;
(e) amounts repaid or credited by reason of rejections, defects, one percent (1%) return goods allowance, recalls or returns, or because of retroactive price reductions, including rebates or wholesaler charge backs;
(f) that portion of the annual fee on prescription drug manufacturers imposed by the Patient Protection and Affordable Care Act, Pub. L. No. 111-148 (as amended) and reasonably allocable to sales of the Product;
(g) the portion of administrative fees (which fees shall be consistent with the requirements set forth in 42 C.F.R. 1001.952(j) or any successor regulation) paid during the relevant time period to group purchasing organizations, pharmaceutical benefit managers relating specifically to such Product;
(h) any consideration actually paid or payable for any Delivery System related to a billed or invoiced sale of such Product, where for purposes of this Net Sales definition, a “Delivery System” shall mean any delivery system comprising equipment, instrumentation, one or more devices, or other components designed to assist in the administration of such Product. To the extent that the Delivery System and Product are sold as one product, the deduction from Net Sales shall be calculated using the methodology spelled out for a Combination Product involving either a Joint Product or a Unilateral Product as described below;
(i) any invoiced amounts from a prior period that are written off or reserved as not collectable by the Party, its Affiliates or its sublicensees, including bad debts; and
(j) any other similar and customary deductions that are consistent with GAAP.
Net Sales shall include the amount or fair market value of all other consideration received by the selling Party, its Affiliates, or sublicensees in respect of such Product, whether such consideration is in cash, payment in kind, exchange, or other form. Net Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory, or governmental purposes so long as such transfer or disposition is made at or below cost. Net Sales shall not include sales between or among the selling Party, its Affiliates, or sublicensees so long as such Affiliates or sublicensees are not end-users of such Product. Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of the selling Party, its Affiliates, or sublicensees, which must be in accordance with GAAP.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Net Sales for a Joint Product in a Profit Share Region for a period shall include all Sublicense Revenues received by the Parties for such Joint Product in such Profit Share Region for such period.
In the event a Combination Product is a Joint Product sold in the Profit Share Region, unless otherwise agreed in writing by the Parties, Net Sales for such Combination Product shall be calculated in the same manner as all other Products (i.e., Net Sales shall include the entire invoiced amount of the Combination Product), and the incremental costs associated with such other active ingredient or delivery device shall be included as an element of Manufacturing Costs.
In the event a Combination Product is a Unilateral Product sold in the Royalty Region, the Net Sales for such Combination Product will be calculated as follows:
(i) If the selling Party, its Affiliate, or sublicensee separately sells in such country, (x) a Product containing as its sole active ingredient a New Collaboration Compound contained in such Combination Product (the “ Mono Product ”) and (y) products containing as their sole active ingredients the other active ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B) where: A is the selling Party’s (or its Affiliate’s or sublicensee’s, as applicable) average Net Sales price during the period to which the Net Sales calculation applies for the Mono Product in such country and B is the selling Party’s (or its Affiliate’s or sublicensee’s, as applicable) average Net Sales price during the period to which the Net Sales calculation applies in such country, for products that contain as their sole active ingredients the other active ingredients in such Combination Product.
(ii) If the selling Party, its Affiliate, or sublicensee separately sells in such country the Mono Product but does not separately sell in such country products containing as their sole active ingredients the other active ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction A/C where: A is the selling Party’s (or its Affiliate’s or sublicensee’s, as applicable) average Net Sales price during the period to which the Net Sales calculation applies for the Mono Product in such country, and C is the selling Party’s (or its Affiliate’s or sublicensee’s, as applicable) average Net Sales price in such country during the period to which the Net Sales calculation applies for such Combination Product.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(iii ) If the selling Party, its Affiliates, and sublicensees do not separately sell in such country the Mono Product but do separately sell products containing as their sole active ingredients the other active ingredients contained in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction (D-E)/D where: D is the average Net Sales price during the period to which the Net Sales calculation applies for such Combination Product in such country and E is the average Net Sales price during the period to which the Net Sales calculation applies for products that contain as their sole active ingredients the other active ingredients in such Combination Product.
(iv ) If the selling Party, its Affiliates, and sublicensees do not separately sell in such country both the Mono Product and the other active ingredient or ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be determined by the Parties in good faith based on the relative fair market value of such Mono Product and such other active ingredient or ingredients. If the Parties cannot agree on such relative value, the dispute shall be resolved pursuant to Section 17.6(d).
1.76 “ New Collaboration Compound ” means any Targeted AIM that:
(a ) is (i) a FirstGen Targeted AIM; (ii) Controlled by Reata or any of its Affiliates as of the Effective Date other than a FirstGen Targeted AIM and bardoxolone methyl, (iii) Controlled by Abbott or any of its Affiliates as of the Effective Date other than a FirstGen Targeted AIM; or (iv) Controlled by either Party or any of its Affiliates (or jointly by the Parties or any of their respective Affiliates) during the Exclusivity Period (including (A) any Acquired AIM and (B) any Targeted AIM discovered by or on behalf of either Party or any of its Affiliates or jointly by or on behalf of the Parties or any of their respective Affiliates during the Exclusivity Period), other than an Exempt AIM and a Divested AIM; and
(b) has not been removed from the pool of Targeted AIMs available for Development under this Agreement pursuant to Section 4.6. For clarity, none of bardoxolone methyl, any Exempt AIM and any Divested AIM shall constitute a New Collaboration Compound.
1.77 “ New Collaboration Compound Pool ” means all New Collaboration Compounds.
1.78 “ New Collaboration Field ” means all human and non-human diagnostic, prophylactic and therapeutic uses of the Products in all Indications other than an Indication included in the Previously Licensed Field.
1.79 “ NextGen Targeted AIM ” means any New Collaboration Compound that is not a FirstGen Targeted AIM.
1.80 “ Non-Clinical Studies ” means all non-human tests and studies of New Collaboration Compounds (including Lead Compounds, Development Candidates and Product Candidates) and Products.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
1.81 “ Non-Participating Party ” means (a) with respect to any Unilateral Plan, the Party that does not conduct Development activities under such Unilateral Plan or (b) with respect to a Unilateral Product in the applicable Royalty Region, the Party that is not Developing or Commercializing such Unilateral Product in such Royalty Region.
1.82 “ Operating Profit (or Loss) ” means, with respect to a Joint Product for a given period of time, Net Sales of such Joint Product in the applicable Profit Share Region during such period, less the Commercialization Costs incurred in connection with the Commercialization of such Joint Product in or for such Profit Share Region during such period. Operating Profit (or Loss) shall be determined prior to application of any income taxes, and if such terms are used individually, “ Operating Profit ” shall mean a positive Operating Profit (or Loss), and “ Operating Loss ” shall mean a negative Operating Profit (or Loss).
1.83 “ Orange Book ” means the publication Approved Drug Products with Therapeutic Equivalence Evaluations that identifies drug products approved on the basis of safety and effectiveness by the FDA under the FFDCA.
1.84 “ Participating Party ” means (a) with respect to any Unilateral Plan, the Party conducting Development activities under such Unilateral Plan or (b) with respect to a Unilateral Product in the applicable Royalty Region, the Party that is Developing or Commercializing such Unilateral Product in such Royalty Region.
1.85 “ Patent Costs ” means the direct out of pocket costs (including the reasonable fees and expenses paid to outside counsel and other Third Parties, and filing and maintenance fees paid to Governmental Authorities) recorded as an expense by a Party or any of its Affiliates in accordance with GAAP after the Effective Date, during the Term of and pursuant to this Agreement, (i) in connection with the prosecution and maintenance of rights, including costs of patent interference, opposition, reissue, or re-examination proceedings and filing and registration fees with respect to the Reata Patents, Xxxxxx Patents, or Joint Patents, and (ii) the costs of litigation (enforcement or defense) or other proceedings, under the Reata Patents, Xxxxxx Patents and Joint Patents, in each case only to the extent related to a Joint Product in the applicable Profit Share Territory and not reimbursed by a Third Party.
1.86 “ Patents ” mean (i) all national, regional and international patents and patent applications, including provisional patent applications, (ii) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in- part, provisionals, converted provisionals and continued prosecution applications, (iii) any and all patents that have issued or in the future issue from the foregoing patent applications ((i) and (ii)), including utility models, xxxxx patents and design patents and certificates of invention, (iv) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((i), (ii), and (iii)) and (v) any similar rights, including so-called pipeline protection or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any of such foregoing patent applications and patents.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
1.87 “ PDE ” means, with respect to a Product, (i) a primary Detail equivalent where (A) a Detail during a sales call in which the Product receives greater emphasis than that given any other product during the sales call has a value of 1.0 primary Detail equivalents, and (B) a Detail during a sales call in which the Product receives emphasis that is less than the emphasis received by one (but no more than one) other product has a value of 0.5 primary Detail equivalents (it being agreed by the Parties that any Detail during a sales call in which the Product receives emphasis that is less than the emphasis received by more than one other product, and any Detail during a sales call in which more than two (2) other products are presented with the Product, has a value of 0.0 primary Detail equivalents) or (ii) for a country in which the tracking of Details in the manner set forth in the foregoing clause (i) is impractical, such method of tracking as the Parties may agree and consistent with the customary practice in such country.
1.88 “ PDE Costs ” means, with respect to a Party for any period for any Joint Product in a country in the applicable Profit Share Region, (a) the lesser of (i) the number of PDEs actually performed by such Party during such period for such Joint Product in such country and (ii) the number of PDEs required to be performed by such Party during such period for such Joint Product in such country in accordance with the applicable Commercialization Plan; multiplied by (b) the applicable PDE Rate for such country during such period.
1.89 “ PDE Rate ” means, with respect any country or region, the amount determined by the Parties at the first Commercial Summit that addresses Detailing in such country or region, increased or decreased on January 1 of each Calendar Year thereafter to correspond with the total percentage change in the inflation index for such country or region determined by the Parties at such Commercial Summit.
1.90 “ Person ” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.
1.91 “ Phase I ” means a human clinical trial of a Product or a New Collaboration Compound, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients or similar clinical study prescribed by the Regulatory Authorities, including the trials referred to in 21 C.F.R. §312.21(a), as amended.
1.92 “ Phase II ” means a human clinical trial of a Product or a New Collaboration Compound, the principal purpose of which is a determination of safety and efficacy in the target patient population or a similar clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(b), as amended.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
1.93 “ Phase IIa ” means a Phase II that utilizes the pharmacokinetic and pharmacodynamic information obtained from one or more previously conducted Phase I or other Phase IIa in order to confirm the optimal manner of use of the applicable Product or New Collaboration Compound (dose and dose regimes) and to better determine safety and efficacy.
1.94 “ Phase IIb ” means a Phase II designed to support and immediately precede the initiation of a Phase III without any further Phase II, on a sufficient number of patients that is designed to provide a preliminary determination of safety and efficacy of the applicable Product or New Collaboration Compound in the target patient population over a range of dose and dose regimes.
1.95 “ Phase III ” means a human clinical trial of a Product or New Collaboration Compound on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use and to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support marketing approval of such Product or New Collaboration Compound, including all tests and studies that are required by the FDA from time to time, pursuant to Applicable Law or otherwise.
1.96 “ Phase IV Study ” means a post-marketing human clinical study for a Product with respect to any Indication with respect to which Regulatory Approval has been received or for a use that is the subject of an investigator-initiated study program.
1.97 “ Possession Arrow Decision ” means a decision specified in Section 4.2(e)(ii)(3) or Section 5.5(a)(ii)(2)(B) which is to be resolved in accordance with Section 2.13.
1.98 “ Previously Licensed Compound ” means bardoxolone methyl or any Targeted AIM that is a Collaboration Compound or a Backup Compound under the Bardoxolone License Agreement. Any Targeted AIM that is returned to the New Collaboration Compound Pool pursuant to Section 4.6 shall thereafter no longer be a Previously Licensed Compound. As of the Effective Date, the only Previously Licensed Compound under the Bardoxolone License Agreement is bardoxolone methyl.
1.99 “ Previously Licensed Field ” means each of the Renal Indication, the Cardiovascular Indication, and the Metabolic Indication. The Previously Licensed Field does not include any Indication not included in the Renal Indication, the Cardiovascular Indication, or the Metabolic Indication, including the prevention, treatment, or amelioration of: (i) any forms of cancer; (ii) any forms of organ failure (other than renal failure or heart failure); (iii) respiratory disorders; (iv) allergies and autoimmune diseases (other than lupus nephritis); (v) neurological, psychiatric, or neuropsychiatric disorders (other than diabetic neuropathy); (vi) infectious diseases; (vii) skin diseases (other than diabetic ulcers); (viii) gastrointestinal disorders; (ix) bone or cartilage disorders; (x) musculoskeletal disorders; (xi) eye diseases (other than diabetic retinopathy); (xii) human immunodeficiency virus-associated complications; and (xiii) sepsis.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
1.100 “ Product ” means any product containing a New Collaboration Compound, in oral forms and all other forms, formulations and delivery modes, including Combination Products, but excluding any combination of a New Collaboration Compound and a Previously Licensed Compound or any compound, composition or product owned or controlled by a Party or any of its Affiliates that is not a New Collaboration Compound.
1.101 “ Product Candidate ” means any Development Candidate selected for further Development in an Indication with the goal of supporting Regulatory Approval for such Development Candidate in such Indication.
1.102 “Product Development Plan” means, with respect to a given Product Candidate, any Pre-Phase IIb Plan, Phase IIb Plan, Phase III Plan, or Additional Indication Plan (whether unilateral or joint).
1.103 “ Product Labeling ” means, with respect to a Product in a country in the Territory, (i) the Regulatory Authority-approved full prescribing information for such Product for such country, including any required patient information and (ii) all labels and other written, printed or graphic matter upon a container, wrapper or any package insert utilized with or for such Product in such country.
1.104 “ Product Trademarks ” means the Trademark(s) to be used in connection with the Commercialization of Products in the Territory and any registrations thereof or any pending applications relating thereto (excluding, in any event, any trademarks, service marks, names or logos that include any corporate name or logo of the Parties or their Affiliates).
1.105 “ Promotional Materials ” means all Sales Representative training materials and all written, printed, graphic, electronic, audio or video matter, including journal advertisements, sales visual aids, leave behind items, formulary binders, reprints, direct mail, direct-to-consumer advertising, internet postings, internet sites, broadcast advertisements and sales reminder aides (for example, note pads, pens and other such items) intended for use or used by either Party or its Affiliates or sublicensees in connection with any promotion of a Product.
1.106 “ Protected Period ” means the period commencing upon the Effective Date and ending on [***].
1.107 “ Reata Know-How ” means all Information (including Regulatory Data) Controlled by Reata or any of its Affiliates as of the Effective Date or at any time during the Term that is not generally known and is reasonably necessary or useful for the Development, Manufacture, or Commercialization of a Product in the New Collaboration Field, but excluding any Information to the extent covered or claimed by or comprising published Reata Patents or Joint Patents or any Joint Know-How.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
1.108 “ Reata Patents ” means all of the Patents Controlled by Reata or any of its Affiliates as of the Effective Date or at any time during the Term that are reasonably necessary or useful (or, with respect to patent applications, would be reasonably necessary or useful if such patent applications were to issue as patents) for the Development, Manufacture or Commercialization of a Product in the New Collaboration Field, but excluding: (a) any Joint Patents; (b) subject to Section 12.6(b), the Patents licensed by UT and Dartmouth to Reata under the UT 2006 Agreement; and (c) subject to Section 12.6(b), the Patents licensed by UT and Dartmouth to Reata under the UT 2004 Agreement.
1.109 “ Regulatory Approval ” means, with respect to a Product in a country in the Territory, any and all approvals (including Drug Approval Applications), licenses, registrations, or authorizations of any Regulatory Authority necessary to commercially distribute, sell, or market such Product in such country, including, where applicable, (i) pricing or reimbursement approval in such country, (ii) pre- and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto), and (iii) labeling approval.
1.110 “ Regulatory Authority ” means any applicable supra-national, federal, national, regional, state, provincial, or local regulatory agencies, departments, bureaus, commissions, councils, or other government entities regulating or otherwise exercising authority with respect to the Exploitation of New Collaboration Compounds or Products in the Territory.
1.111 “ Regulatory Costs ” means the direct out-of-pocket costs paid to Third Parties recorded as an expense in accordance with GAAP, in each case incurred by or on behalf of a Party or any of its Affiliates after the Effective Date and during the Term in accordance with the applicable Development Plan, or Commercialization Plan, as applicable, that are specifically identifiable or reasonably allocable to costs and expenses incurred to prepare Regulatory Documentation to obtain or maintain Regulatory Approval and to comply with post-Regulatory Approval requirements of a Regulatory Authority, including FDA user and other fees, reporting and regulatory affairs activities.
1.112 “ Regulatory Data ” means non-clinical data, Clinical Data, results and analyses with respect to any Development activities conducted by or on behalf of a Party or any of its Affiliates that are Controlled by such Party or any of its Affiliates, including any such data, results and analyses Controlled by such Party or any of its Affiliates and resulting from or relating to Unilateral Discovery or Unilateral Development.
1.113 “ Regulatory Documentation ” means all: (a) applications (including all INDs and Drug Approval Applications), registrations, licenses, authorizations, and approvals (including Regulatory Approvals); and (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all regulatory drug lists, advertising and promotion documents, adverse event files, and complaint files, in each case ((a) and (b)) relating to a New Collaboration Compound or Product.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
1.114 “ Regulatory Exclusivity ” means, with respect to any country of the Territory, an additional market protection, other than Patent protection, granted by a Regulatory Authority in such country which confers an exclusive Commercialization period during which a Party or its Affiliates or sublicensees have the exclusive right to market, price, and sell a Product in such country through a regulatory exclusivity right, such as new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity, or any applicable data exclusivity.
1.115 “ Related Indications ” means, (a) with respect to each Initial Indication as of the Effective Date, those Indications identified as Related Indications with respect thereto in the Joint Exploratory Development Plan, as the same may be amended from time to time by the JEC, and (b) with respect to any other Indication, those other Indications that are determined to be related to such Indication by the JEC pursuant to Section 4.2(e)(ii).
1.116 “ Renal Indication ” means the prevention, treatment, or amelioration of any renal disease or condition, including renal insufficiency, chronic kidney disease, acute kidney failure, ischemia-reperfusion injury of the kidney, glomerulonephritis, and all other forms of nephritis (whether acute or chronic).
1.117 “ Research Term ” means the period of time that commences upon the Effective Date and ends on [***], as may be extended by mutual agreement of the Parties pursuant to Section 3.2.
1.118 “ Royalty Term ” means, with respect to each Unilateral Product and each country in the applicable Royalty Region, the period beginning on the date of the First Commercial Sale of such Unilateral Product in such country, and ending on the latest to occur of (i) the expiration of the last-to-expire Xxxxxx Patent, Reata Patent or Joint Patent that includes a Valid Claim that covers such Unilateral Product in such country; (ii) the expiration of Regulatory Exclusivity in such country for such Unilateral Product; and (iii) the fifteenth (15 th ) anniversary of the First Commercial Sale of such Unilateral Product in such country, provided that, in the event a Generic Product is sold in such country, the Royalty Term shall end on the later of: (A) the last day of the first Calendar Quarter in which unit sales of all Generic Products in such country exceed fifty percent (50%) of the sum of unit sales of such Unilateral Product and all Generic Products in such country during such Calendar Quarter; and (B) the fifteenth (15 th ) anniversary of the First Commercial Sale of such Unilateral Product in such country.
1.119 “ Safety Risk ” means, with respect to a Clinical Study of a Product, Product Candidate or Development Candidate anywhere in the Territory, a substantial and unwarranted safety risk (in light of the perceived benefit to be conferred by such Product, Product Candidate or Development Candidate) associated with the design of or possible results of such Clinical Study, based on the administration of such Product, Product Candidate or Development Candidate in a new dosage, dosage form or in a patient population not previously studied in a Clinical Study performed with respect to such Product, Product Candidate or Development Candidate by a Party under a Development Plan.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
1.120 “ Sales and Marketing Costs ” means, with respect to a Joint Product in the applicable Profit Share Territory for any period, the direct out-of-pocket costs paid to Third Parties recorded as an expense in accordance with GAAP that are incurred by or on behalf of a Party or any of its Affiliates after the Effective Date and during the Term and that are specifically identifiable or reasonably allocable to the marketing and promotion of such Joint Product in the applicable Profit Share Territory for such period. Subject to the foregoing, Sales and Marketing Costs shall include costs incurred in connection with the following activities (but in each case only to the extent specifically identifiable or reasonably allocable to the marketing and promotion of such Joint Product in the applicable Profit Share Territory):
(a) activities directed to the advertising and marketing of such Joint Product, in the applicable countries in the Territory;
(b) launch meetings;
(c) advertising and public relations agencies, including development and distribution of Promotional Materials, field literature, direct-to-consumer advertising campaigns, media/journal advertising, exhibiting at seminars and conventions, convention costs, and promotional premiums;
(d) peer-to-peer activities such as lunch and dinner meetings;
(e) speakers programs, including training of such speakers;
(f) developing, obtaining, and providing training packages for such Joint Product;
(g) PDE Costs;
(h) developing and performing market research;
(i) developing reimbursement programs;
(j) developing information and data specifically intended for national accounts, managed care organizations, governmental agencies (e.g., federal, state and local), and other group purchasing organizations, including pull-through activities;
(k) establishing and conducting one or more training facilities for potential users of such Joint Product, including trainer costs, facility costs, supplies and user costs; and
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(l) call center set-up, maintenance and operation for personnel used in connection therewith.
Sales and Marketing Costs shall exclude costs directly relating to Sales Representatives and their direct managers and trainers, including salary, benefits, incentive compensation, and automobile allowances, and otherwise to the direct conduct of Details, in each case except to the extent included in PDE Costs.
1.121 “ Sales Representative ” means a pharmaceutical sales representative employed or contracted (as permitted by the terms of this Agreement) by either Party to conduct Details with respect to the Products in accordance with the terms of this Agreement.
1.122 “ Samples ” means Product packaged and distributed as a complimentary trial for use by patients and free goods provided for this purpose through coupons or other mechanisms.
1.123 “ Senior Officer ” means, with respect to Reata, its Chief Executive Officer, and with respect to Abbott, its Executive Vice President, Pharmaceutical Products Group.
1.124 “ Study Trademark” means the Trademark(s), if any, to be used to name any Clinical Study for a New Collaboration Candidate or Product and any registrations thereof or any pending applications relating thereto (excluding, in any event, any trademarks, service marks, names or logos that include any corporate name or logo of the Parties or their Affiliates).
1.125 “ Study Trademark Costs ” means the direct out-of-pocket costs (including the reasonable fees and expenses paid to outside counsel and other Third Parties, and filing and maintenance fees paid to Governmental Authorities) recorded as an expense by a Party or any of its Affiliates in accordance with GAAP after the Effective Date, during the Term of and pursuant to this Agreement that are specifically identifiable or reasonably allocable to the Study Trademarks, including (a) expenses incurred in clearance, filing, registration and maintenance; and (b) expenses incurred in connection with any proceedings related to a Study Trademark, including actions to enforce or defend against challenges or objections to the use or registration of such Study Trademark.
1.126 “ Targeted AIM ” means any small molecule that activates the Nrf1 or the Nrf2/Keap 1 pathways as its primary mechanism of action.
1.127 “ Territory ” means all countries and territories of the world.
1.128 “ Third Party ” means any entity other than Reata or Abbott or an Affiliate of either of them.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
1.129 “ Third Party License ” means (a) a license agreement entered into, or to be entered into, by and between a Party or its Affiliate or sublicensee, on the one hand, and a Third Party on the other hand, after the Effective Date to license intellectual property of the Third Party that is reasonably necessary or useful for the Development, Manufacture or Commercialization of any New Collaboration Compound or Product or (b) a license agreement between an Affiliate of a Party that becomes an Affiliate of such Party after the Effective Date, on the one hand, and a Third Party on the other hand, entered into prior to the date that such Affiliate becomes an Affiliate of such Party, to license intellectual property of the Third Party that is reasonably necessary or useful for the Development, Manufacture or Commercialization of any New Collaboration Compound or Product, except in each case ((a) and (b)) for Other Third Party License Agreements.
1.130 “ Third Party Payment ” means any payment (including upfront payments, milestones and royalties) to any Third Party in respect of any Third Party License that is reasonably allocable to the Development, Manufacture or Commercialization of any New Collaboration Compound or Product.
1.131 “ Trademark ” shall include any word, name, symbol, color, designation or device or any combination thereof that functions as a source identifier, including any trademark, trade dress, service mark, trade name, logo, design mark or domain name, whether or not registered.
1.132 “ Trademark Costs ” means the direct out-of-pocket costs (including the reasonable fees and expenses paid to outside counsel and other Third Parties, and filing and maintenance fees paid to Governmental Authorities) recorded as an expense by a Party or any of its Affiliates in accordance with GAAP after the Effective Date, during the Term of and pursuant to this Agreement that are specifically identifiable or reasonably allocable to the Product Trademarks, including (a) expenses incurred in clearance, filing, registration and maintenance; and (b) expenses incurred in connection with any proceedings related to a Product Trademark, including actions to enforce or defend against challenges or objections to the use or registration of such Product Trademark.
1.133 “ Unilateral Acquired AIM ” means, with respect to a Party, (a) any Acquired AIM Controlled by such Party or any of its Affiliates for which a Phase IIb or later Clinical Study had been commenced in the New Collaboration Field as of the time such Acquired AIM came into the Control of such Party or its Affiliate and (b) any Acquired AIM Controlled by an Acquired Affiliate of such Party as of the time such Acquired Affiliate became an Acquired Affiliate of such Party for which a Phase IIb or later Clinical Study had been commenced in the New Collaboration Field as of the time such Acquired Affiliate became an Acquired Affiliate of such Party.
1.134 “ Unilateral Development ” means Development activities conducted by or on behalf of a Party or any of its Affiliates under a Unilateral Plan.
1.135 “ Unilateral Material Amendment ” means, with respect to a Unilateral Plan, an amendment to such plan proposed by the applicable Participating Party that proposes to conduct any Development activity that: (a) materially alters the Indication to which the plan is then targeted; (b) could reasonably be expected to have a Material Adverse Effect; and (c) could reasonably be expected to present a Safety Risk.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
1.136 “ Unilateral Plan ” means, individually and collectively, each Unilateral Exploratory Development Plan, each Unilateral Pre-Phase IIb Plan, each Unilateral Phase IIb Plan, each Unilateral Phase III Plan and each Additional Indication Plan.
1.137 “ U.S. ” means the United States of America, including all possessions and territories thereof except Puerto Rico and the U.S. Virgin Islands.
1.138 “ UT ” shall mean the Board of Regents of The University of Texas System and The University of Texas M.D. Xxxxxxxx Cancer Center.
1.139 “ UT 2004 Agreement ” shall mean that certain Exclusive Patent License Agreement among UT, Dartmouth, and Reata Discovery, Inc. dated July 15, 2004, a redacted copy of which has been provided to Abbott, as may be amended, supplemented, or restated from time to time.
1.140 “ UT 2006 Agreement ” shall mean that certain Patent and Technology License Agreement among UT, Dartmouth and Reata, dated February 7, 2006.
1.141 “ Valid Claim ” means a claim of any issued and unexpired patent whose validity, enforceability, or patentability has not been affected by any of the following: (i) irretrievable lapse, abandonment, revocation, dedication to the public, or disclaimer, or (ii) a holding, finding, or decision of invalidity, unenforceability, or non-patentability by a court, governmental agency, national or regional patent office, or other appropriate body that has competent jurisdiction, such holding, finding, or decision being final and unappealable or unappealed within the time allowed for appeal.
1.142 Terms Defined in the Agreement.
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Term |
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Section Defined |
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Abbott |
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Preamble |
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Abbott CoC |
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17.8(b) |
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Abbott Parent |
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17.8(d) |
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Academic Research Agreements |
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13.2(g) |
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Additional Amount |
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11.6(b) |
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Additional Indication(s) |
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5.7 |
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
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Additional Indication Activities |
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5.7 |
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Additional Indication Plan |
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5.7(a)(iii)(1) |
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Adjusted Required PDEs |
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7.7(c)(iii) |
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ADR |
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17.6(a) |
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Adverse Ruling |
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16.4(b) |
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Aggregate Payments |
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11.6(b) |
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Agreement |
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Preamble |
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AIM Acquiring Party |
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5.10 |
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Alliance Manager |
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2.11 |
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Alternative Indication |
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4.2(e)(ii)(1) |
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Anticipated Launch Date |
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7.4(b) |
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Arbitrator |
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11.10 |
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Asia Territory |
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1.21 |
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Bardoxolone License Agreement |
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Preamble |
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Breaching Party |
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16.4(a) |
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Change of Control |
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17.8(d) |
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Collaboration Patents |
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12.3(a) |
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Commercial Summit |
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7.2 |
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Commercialization Plan |
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7.4(a) |
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Committed Sales Force |
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7.5(a) |
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Confidential Information |
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15.1 |
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Contracting Third Party |
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10.2(c) |
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Co-Promotion Agreement |
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7.7(c)(i) |
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
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Co-Promotion Product |
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7.7(a) |
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CREATE Act |
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12.1(e) |
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Current Products |
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5.10 |
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Default Notice |
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16.4(a) |
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Discovery Research Activities |
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3.1(a) |
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Discovery Research Plan |
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3.1(a) |
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Dispute |
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17.6 |
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Effective Date |
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Preamble |
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Effective Date AIMs |
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13.2(b) |
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Election Notice |
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5.10(a) |
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Entity |
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17.8(d) |
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EOP2 Meeting |
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5.5(c)(i) |
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EOP3 Election Notice |
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5.6(e)(i) |
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EOP3 Notification |
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5.6(e)(i) |
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EOP3 Opt-In |
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5.6(e)(i) |
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Exclusivity Period |
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10.6(a) |
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Existing Patents |
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13.2(a) |
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Existing Reata License |
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12.6(b) |
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Exploratory Development Activities |
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4.2 |
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Exploratory Development Program |
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2.1(b) |
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Exploratory Non-Performing Party |
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4.3(d) |
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Exploratory Step-In Party |
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4.3(d) |
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FCPA |
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7.11 |
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
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Field Infringement |
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12.3(d) |
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Final Launch Readiness Meeting |
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7.5(c) |
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First Indication |
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4.2(e)(ii)(1) |
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Fixed Indications |
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4.3(b) |
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Flexible Indications |
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4.3(b) |
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Follow-On Product Candidate |
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5.8(a) |
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Humira-Related Indications |
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11.3(a) |
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Indemnification Claim Notice |
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14.4 |
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Indemnified Party |
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14.4 |
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Initial Indications |
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4.3(b) |
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Initial Launch Readiness Meeting |
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7.5(b) |
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Initial Product Candidate |
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5.8(a) |
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Initial Shortfall Party |
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7.5(b) |
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JDC |
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2.5(a) |
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JRDI |
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2.4(a) |
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JEC |
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2.3(a) |
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JEDP Budget Cap |
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4.3(f)(i) |
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JMC |
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2.7(a) |
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Joint Exploratory Development |
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4.3(a) |
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Joint Exploratory Development Indications |
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4.3(b) |
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Joint Exploratory Development Plan |
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4.3(a) |
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Joint Intellectual Property Rights |
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12.1(b) |
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Joint Know-How |
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12.1(b) |
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
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Joint Patents |
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12.1(b) |
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Joint Phase IIb Development |
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5.5(b)(ii) |
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Joint Phase IIb Plan |
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5.5(b)(ii) |
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Joint Phase III Plan |
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5.5(d)(iii) |
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Joint Pre-Phase IIb Development |
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5.5(a)(iii) |
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Joint Pre-Phase IIb Plan |
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5.5(a)(iii) |
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Joint Product |
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5.5(d)(iii) |
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Joint Product Infringement |
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12.3(b) |
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JPC |
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2.8(a) |
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JSC |
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2.6(a) |
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Latin America |
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1.21 |
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Launch Period |
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7.8(a) |
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Lead Commercialization Party or LCP |
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7.2 |
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Lead Manufacturing Party or LMP |
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9.2(d) |
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Losses |
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14.1 |
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MAA |
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1.37 |
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Manufacturing Plan |
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9.2(a) |
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Manufacturing Process |
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9.4 |
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Mono Product |
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1.75(i) |
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MSL Agreement |
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7.7(d) |
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NDA |
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1.37 |
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New Company |
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17.8(d) |
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Non-Breaching Party
42
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16.4(a)
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Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
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Non-Participating Exploratory Party |
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4.4(c) |
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Non-Participating Phase IIb Party |
|
5.6(b)(i) |
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Non-Participating Phase III Party |
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5.6(d)(i) |
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Non-Participating Pre-Phase IIb Party |
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5.6(a)(i) |
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Non-Performing Party |
|
5.5(e) |
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Non-Proposing Party |
|
5.7(a)(iii) |
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Opt-Out Notice |
|
5.4(b) |
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Other Abbott Business |
|
17.8(d) |
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Other Third Party License Agreements |
|
12.6(c) |
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Overage Amount |
|
5.5(g) |
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Overage Recoupment Amount |
|
5.5(g) |
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Owned Patents |
|
13.2(c) |
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Participating Exploratory Party |
|
4.4(b) |
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Participating Phase IIb Party |
|
5.6(b)(i) |
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Participating Phase III Party |
|
5.6(d)(i) |
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Participating Pre-Phase IIb Party |
|
5.6(a)(i) |
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Party or Parties |
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Preamble |
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Party Readiness Plan |
|
7.5(a) |
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Payer Party |
|
11.6(a) |
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Payer Party Withholding Tax Action |
|
11.6(b) |
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Payment |
|
11.6(a) |
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|
Phase IIb Development |
|
5.5(b)(i)(1) |
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|
Phase IIb Plan |
|
5.5(b)(i)(1) |
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
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Phase III Opt-Out |
|
5.5(d)(ii) |
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Phase III Plan |
|
5.5(d)(i) |
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Post-Approval Cap |
|
5.5(g) |
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Post-Approval Commitments |
|
5.5(g) |
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|
Pre-Phase IIb Development |
|
5.5(a)(ii)(1) |
|
|
|
Pre-Phase IIb Election Notice |
|
5.6(a)(vi) |
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|
Pre-Phase IIb Notification |
|
5.6(a)(vi) |
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|
Pre-Phase IIb Opt-In |
|
5.6(a)(vi) |
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|
Pre-Phase IIb Opt-In Payment |
|
5.6(a)(vi) |
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Pre-Phase IIb Plan |
|
5.5(a)(ii)(1) |
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|
Pre-Phase III Election Notice |
|
5.6(c)(iv) |
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Pre-Phase III Notification |
|
5.6(c)(iv) |
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Pre-Phase III Opt-In |
|
5.6(c)(iv) |
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Pre-Phase III Opt-In Payment |
|
5.6(c)(iv) |
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|
|
Principles |
|
2.2(b) |
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|
Product Development Program |
|
2.1(c) |
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|
Profit Share Region |
|
5.5(d)(iii) |
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|
Projected Product Supply Volume |
|
9.5 |
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|
Proprietary Pharmaceutical Business |
|
17.8(d) |
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Proposed Terms |
|
17.6(d)(ii) |
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Proposing Party |
|
5.7(a)(iii) |
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|
Prosecuting Party |
|
12.3(d) |
|
|
|
Purchase Price |
|
5.10(d) |
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
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|
Reata |
|
Preamble |
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|
Reata CoC |
|
17.8(a) |
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|
Reata Cost Cap |
|
4.3(f)(ii) |
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|
Receiving Party |
|
11.6(a) |
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Recoupment Amount |
|
5.7(a)(iii)(3) |
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|
Replaced PDEs |
|
7.5(b) |
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|
|
Required PDEs |
|
7.8 |
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|
|
Research Collaboration |
|
3.1(a) |
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|
|
Research Results |
|
3.4 |
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ROW Territory |
|
1.21 |
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|
Royalty Region |
|
5.6(d)(i) |
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Sales Force Shortfall |
|
7.5(b) |
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Selecting Party |
|
7.3(c)(i) |
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Shortfall Party |
|
7.8 |
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Shortfall Period |
|
7.5(b) |
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|
|
Spin Off Transaction |
|
17.8(d) |
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|
|
Statement Cut-Off Date |
|
5.6(e)(i) |
|
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|
Step-In Party |
|
5.5(e) |
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Sublicense Revenue |
|
7.3(e) |
|
|
|
Supplementing Party |
|
7.5(b) |
|
|
|
Support Memorandum |
|
17.6(d)(ii) |
|
|
|
Supporting Commercialization Party or SCP |
|
7.2 |
|
|
|
Technology Transfer |
|
9.4 |
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
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Term |
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16.1 |
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Third Party Agreement |
|
10.2(c) |
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Third Party Claims |
|
14.1 |
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|
Threshold Amount |
|
11.6(c) |
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|
Unilateral Discovery |
|
3.2 |
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|
Unilateral Discovery Plan |
|
3.2 |
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Unilateral Exploratory Development |
|
4.4(a) |
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Unilateral Exploratory Development Plan |
|
4.4(b) |
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|
Unilateral Phase IIb Development |
|
5.6(b)(i) |
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|
Unilateral Phase IIb Plan |
|
5.6(b)(iii) |
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|
Unilateral Phase III Development |
|
5.6(d)(i) |
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|
Unilateral Phase III Plan |
|
5.6(d)(ii) |
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|
Unilateral Pre-Phase IIb Development |
|
5.6(a)(i) |
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|
Unilateral Pre-Phase IIb Plan |
|
5.6(a)(ii) |
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Unilateral Product |
|
5.6(d)(i) |
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|
Unilateral Product Infringement |
|
12.3(c) |
ARTICLE 2
C OLLABORATION O VERVIEW ; G OVERNANCE
(a) a research collaboration, for the purpose, inter alia, of characterizing New Collaboration Compounds and designating Lead Compounds, under the direction of the Joint Research and Development Incubator, and in accordance with a research plan agreed upon by the Parties, as further set forth in Article 3;
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(b) an exploratory Development program (the “Exploratory Development Program” ) encompassing the following activities: (i) the characterization of Lead Compounds and designation of Lead Compounds as Development Candidates; (ii) the conduct of Phase I Clinical Studies with respect to such Development Candidates; (iii) the conduct of Indication Survey Studies in various Indications, including the Initial Indications (as described in Section 4.3(c)) with respect to such Development Candidates; and (iv) the evaluation of the results of Indication Survey Studies and such Development Candidates in order to determine which Development Candidates should be designated as Product Candidates for further Development in a selected Indication and, where successful, seeking and obtaining Regulatory Approval, as further set forth in Article 4;
(c) on a Product Candidate-by-Product Candidate basis, at the time of designation of a Development Candidate as a Product Candidate for its selected Indication, a later stage development program for each such Product Candidate (each, a “Product Development Program” ) which includes all Clinical Studies and Non-Clinical Studies for such Product Candidate with the goal of obtaining Regulatory Approval for Products containing such Product Candidate, in each case under the oversight of the applicable JDC and in accordance with Article 5 and the other terms of this Agreement; and
(d) for jointly-funded Products, shared Commercialization and profit sharing of such Products within a Profit Share Region under the oversight of the applicable JMC and the JEC, and pursuant to a Commercialization Plan, in accordance with Articles 7 and 11 and the other terms of this Agreement; and for unilaterally-funded Products, unilateral Commercialization of such Products in the Royalty Regions, with a royalty paid to the non- funding party, as set forth in Articles 8 and 11 and the other terms of this Agreement.
2.2 General Principles Governing the Collaboration.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
2.3 Joint Executive Committee.
[***].
2.4 Joint Research and Development Incubator .
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
with this Agreement) to participate in the discussions and meetings of the JRDI, provided that such participants are involved in activities related to the Research Collaboration and shall have no voting authority at the JRDI. The JRDI shall have a chairperson, who shall serve for a term of one year, and who shall be selected alternately, on an annual basis, by Reata or Xxxxxx. The initial chairperson shall be selected by Xxxxx. The role of the chairperson shall be to convene and preside at meetings of the JRDI, to prepare and circulate agendas and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JRDI representatives. The JRDI shall have a vice chairperson, who shall serve for a term of one year (and who then shall serve as chairperson), and who shall be selected alternately, on an annual basis, by Xxxxxx or Reata. The initial vice chairperson shall be selected by Xxxxxx. The role of the vice chairperson shall be to consult with and assist the chairperson in the carrying out of the chairperson’s duties.
[***].
2.5 Joint Development Committees .
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Product Candidate shall be selected by Xxxxxx, with the initial chairperson for each later Product Candidate to be selected by alternating Parties. The role of the chairperson shall be to convene and preside at meetings of the applicable JDC, to prepare and circulate agendas and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JDC representatives. Each JDC shall have a vice chairperson, who shall serve for a term of one year (and who then shall serve as chairperson), and who shall be selected alternately, on an annual basis, by Xxxxxx or Reata. The initial vice chairperson for the JDC for the first Product Candidate shall be selected by Xxxxxx, and the initial chairperson for the JDC for the second Product Candidate shall be selected by Reata, with the initial chairperson for each later Product Candidate to be selected by alternating Parties. The role of the vice chairperson shall be to consult with and assist the chairperson in the carrying out of the chairperson’s duties.
[***].
.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
with this Agreement) to participate in the discussions and meetings of the JSC, provided that such participants are involved in activities related to Product Candidates or Products and shall have no voting authority on the JSC. The JSC shall have a chairperson, who shall serve for a term of one year, and who shall be selected alternately, on an annual basis, by Reata or Xxxxxx. The initial chairperson for the Joint Supply Committee shall be selected by Xxxxxx. The role of the chairperson shall be to convene and preside at meetings of the JSC, to prepare and circulate agendas and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JSC representatives. The JSC shall have a vice chairperson, who shall serve for a term of one year (and who then shall serve as chairperson), and who shall be selected alternately, on an annual basis, by Xxxxxx or Reata. The initial vice chairperson for the Joint Supply Committee shall be selected by Reata. The role of the vice chairperson shall be to consult with and assist the chairperson in the carrying out of the chairperson’s duties.
[***].
2.7 Joint Marketing Committee .
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
term of one year (and who then shall serve as chairperson), and who shall be selected alternately, on an annual basis, by Xxxxxx or Reata. The initial vice chairperson for the JMC for the first Product Candidate shall be selected by Xxxxx, and the initial chairperson for the JMC for the second Product Candidate shall be selected by Xxxxxx, with the initial chairperson for JMC for each later Product Candidate to be selected by alternating Parties. The role of the vice chairperson shall be to consult with and assist the chairperson in the carrying out of the chairperson’s duties.
[***].
[***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
2.9 General Provisions Applicable to Committees.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
cannot, or does not, reach consensus on an issue within a period of [***] Business Days or such other period as the Parties may agree, then, with respect to any provision of this Agreement that specifically provides for the resolution of certain disputes in the JEC in a particular manner, the procedures in such provision shall apply, and with respect to any other dispute in the JEC, the dispute resolution provisions set forth in Section 17.6 shall apply. Any provision in the Agreement that refers to the approval, authorization, determination, decision, selection, designation, allocation or similar action by a Committee with respect to a matter shall be deemed to mean the approval, authorization, determination, decision selection, designation, allocation or similar action by such Committee with respect to such matter subject to the dispute resolution procedures of this Section 2.9(d), whether or not explicitly stated.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
2.13 Possession Arrow Decision Making .
(a) The Parties shall alternate in making all Possession Arrow Decisions hereunder, with such alternation being made solely by the order of occurrence of such Possession Arrow Decision, regardless of the nature of such Possession Arrow Decision. The Party making a Possession Arrow Decision shall exercise reasonable good faith judgment consistent with the Principles. [***] shall have the right to make the first Possession Arrow Decision.
(b) The Parties’ Alliance Managers shall, collectively, be responsible for the record keeping as to the Parties’ exercise of their respective Possession Arrow Decision making authorities. At any time a Party exercises such Possession Arrow Decision making authority, such Party shall provide written notification to the other Party and the Parties’ Alliance Managers of such decision, the date such decision was made through such Possession Arrow Decision making authority, and the identity of the Party exercising such Possession Arrow Decision making authority. The Alliance Managers shall record such information and shall provide a copy of such information to the JEC for its record and information. At each regular meeting of the JEC, the JEC shall review the list of Possession Arrow Decisions made by the Parties since its last meeting to ensure its accuracy.
ARTICLE 3
3.1 Research Collaboration; Discovery Research Plan.
(a) The Parties shall conduct a research collaboration (the “ Research Collaboration ”) to: (i) characterize the New Collaboration Compounds with the goal of identifying and designating Lead Compounds in addition to the Existing Lead Compounds for pursuit as potential Development Candidates under the Exploratory Development Program; and (ii) conduct research to discover NextGen Targeted AIMs (the activities under clauses (i) and (ii) collectively, “ Discovery Research Activities ”); all in accordance with a research plan agreed upon by the Parties and attached hereto as Schedule 3.1 (as the same may be amended from time to time in accordance with the terms hereof, the “ Discovery Research Plan ”).
(b) Each Party shall perform the Discovery Research Activities assigned to it in the Discovery Research Plan, and shall do so in accordance with the Discovery Research Plan by allocating sufficient time, effort, equipment, and skilled personnel to complete such Discovery Research Activities successfully and promptly. The Parties understand and acknowledge that neither Party can guarantee the outcome or results of any Discovery Research Activities under the Discovery Research Plan.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(c) Each Party shall be responsible for all costs in connection with the performance of the activities assigned to it under the Discovery Research Plan, and such costs shall not count towards the Cap, in each case unless otherwise agreed by the Parties.
(d) Either Party may propose an amendment to its activities under the Discovery Research Plan by submitting such proposed amendment to the JRDI for its review and comment. The proposing Party shall consider the JRDI’s comments in good faith, [***]. For clarity, any amendment proposed by a Party that would delete, change the nature of, reduce or add to the activities then-assigned to the other Party under the Discovery Research Plan [***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Compound should be designated as a Lead Compound, such matter shall be referred to the JEC for resolution. If the JEC cannot resolve such matter within a [***]-day period, then such matter shall be referred to the Senior Officers of the Parties for resolution. If such Senior Officers cannot resolve such matter within a [***]-day period, then: (a) [***] or (b) [***]; provided that in each case each Party’s rights to conduct Development with respect to any such Lead Compound shall be only as set forth under the Exploratory Development Program and Product Development Program under Articles 4 and 5.
ARTICLE 4
E XPLORATORY D EVELOPMENT P ROGRAM
(a) Characterization and Evaluation of Lead Compounds . Under the Exploratory Development Program, the Parties (either jointly or unilaterally) will conduct Non-Clinical Studies (such as in vivo pharmacodynamics studies, pharmacological studies and ADMET studies) to characterize Lead Compounds, to determine whether any such Lead Compounds should be designated as Development Candidates for IND-enabling Non-Clinical Studies and potentially for Clinical Studies. The plan for the initial undertaking to characterize the Existing Lead Compounds is set forth in the Joint Exploratory Development Plan. The Parties anticipate that the characterization of other Lead Compounds (beyond those identified in Schedule 1.45 ), as they become designated as such, will also be conducted, either jointly as part of an amended Joint Exploratory Development Plan in accordance with Section 4.3(a), or unilaterally as part of a Unilateral Exploratory Development Plan in accordance with Section 4.4.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(e) Phase I and Phase II Clinical Studies .
(i) Phase I and Phase II Clinical Studies for Each Development Candidate. The Parties (jointly or unilaterally) may Develop each Development Candidate in Phase I Clinical Studies for which an IND has been filed. The JRDI shall evaluate the results obtained from such Phase I Clinical Studies and determine whether to further Develop such Development Candidate in Indication Survey Studies as described in Section 4.2(e)(ii) below or other Phase II Clinical Studies to further characterize such Development Candidate prior to it being designated, if at all, as a Product Candidate.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(1) if such Development Candidate is a FirstGen Targeted AIM that has been Developed under a Joint Exploratory Development Plan directly preceding such determination (or Developed by Reata in an Alternative Indication pursuant to this Section 4.2(e)(ii)(1)), Reata shall have the final decision-making authority on whether such Development Candidate shall be designated as a Product Candidate, and if so, the Indication for which it will be Developed and up to two (2) Indications as Related Indications thereof (except that the Related Indications for the Initial Indications as of the Effective Date shall be as set forth in the most current Joint Exploratory Development Plan, and may only be changed with the mutual agreement of both Parties), exercising reasonable good faith judgment consistent with the Principles. Notwithstanding the foregoing, if Xxxxxx proposed that such Development Candidate should be designated as a Product Candidate for a particular Indication (the “ First Indication ”), and Reata in the exercise of its final decision-making authority
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
determines not to confer Product Candidate status on such Development Candidate for such First Indication or any other then-eligible Indication, then at the time Reata exercises such final decision-making authority [***] must inform [***] in writing whether [***]. For the purpose of this Section 4.2(e)(ii)(1), Section 4.2(e)(ii)(2) and Section 4.2(e)(ii)(3), an “ Alternative Indication ” means, as to a given Development Candidate, either (A) any Initial Indication or any of its Related Indications, or (B) an Indication that is expected by the Parties, in good faith, on the basis of market data from a recognized provider such as IMS Health, to have anticipated aggregate annual Net Sales for the Product containing such Development Candidate in the Territory in any [***] ([***]) of the [***] full Calendar Years immediate following the launch date of such Product of at least [***] Dollars ($[***]) for such Calendar Year;
(2) if such Development Candidate is a NextGen Targeted AIM that has been Developed under a Joint Exploratory Development Plan directly preceding such determination (or Developed by Reata in an Alternative Indication pursuant to this Section 4.2(e)(ii)(2)), then [***]. Notwithstanding the foregoing, if [***] proposed that such Development Candidate should be designated as a Product Candidate for a First Indication, and [***] in the exercise of its final decision-making authority determines not to confer Product Candidate status on such Development Candidate for such First Indication or any other then-eligible Indication, then at the time [***] exercises such final decision-making authority [***] must inform [***] in writing [***];
(3) if such Development Candidate is a NextGen Targeted AIM that has been Developed under a Joint Exploratory Development Plan directly preceding such determination (or Developed by the decision-making Party in an Alternative Indication pursuant to this Section 4.2(e)(ii)(3)), then, after the Initial Studies Period, [***] shall have the final determination as to whether such Development Candidate shall be designated as a Product Candidate, and if so, the Indication for which it will be Developed [***]), exercising reasonable good faith judgment consistent with the Principles. Notwithstanding the foregoing, if at the time of such decision-making the other Party proposed that such Development Candidate should be designated as a Product Candidate for a First Indication, and the Party [***] in the exercise of its final decision-making authority determines not to confer Product Candidate status on such Development Candidate for such First Indication or any other then-eligible Indication, then at the time the decision-making Party exercises such final decision-making authority the decision-making Party must inform the other Party in writing [***];
(4) if such Development Candidate is a FirstGen Targeted AIM or NextGen Targeted AIM developed under a Party’s Unilateral Exploratory Development Plan, then the Participating Exploratory Party shall have the final decision- making authority on whether such Development Candidate shall be designated as a Product Candidate, and if so, the Indication(s) for which it will be Developed and [***];
provided that, in each case of (1), (2), (3) and (4) above, neither Party may exercise its final decision-making authority to determine to Develop a particular Product Candidate in more than [***] Indication without the other Party’s written consent, except as otherwise provided in Section 5.7. Once a Development Candidate is designated a Product Candidate, its further Development shall be governed by the applicable Joint Development Committee and in accordance with Article 5.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
4.3 Joint Exploratory Development .
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
such proposed amendment within a ([***])-day period, then such matter shall be referred to the JEC for resolution. If the JEC cannot resolve such matter within a [***]-day period, then such matter shall be referred to the Parties’ Senior Officers for resolution. If such Senior Officers cannot resolve such matter within a [***]-day period, then the following shall apply:
[***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
performing such Joint Exploratory Development activities within [***] days after receipt of such notice (and thereafter continue to perform such Joint Exploratory Development activities), the Exploratory Step-In Party shall have the right, at the Exploratory Step-In Party’s sole election, to assume and complete some or all of such Joint Exploratory Development activities (which shall include the right to designate a Development Candidate for use in an ISS for an Indication if a Development Candidate has not already been designated for use in such ISS to the extent the timeline for such designation has not been met), and all Development Costs incurred by the Exploratory Step-In Party and its Affiliates in performing such assumed Joint Exploratory Development activities shall be shared by the Parties in accordance with Section 4.3(f). If the Exploratory Step-In Party so elects to assume and complete any of the Joint Exploratory Development activities, to the extent requested by the Exploratory Step-In Party in writing and reasonably necessary for the conduct of such activities, the Exploratory Non-Performing Party shall assign (or cause its Affiliates to assign) to the Exploratory Step-In Party all agreements with any Third Party with respect to the conduct of such Exploratory Development Activities, including agreements with contract research organizations, clinical sites, and investigators, unless, with respect to any such agreement, such agreement (A) expressly prohibits such assignment, in which case the Exploratory Non-Performing Party shall cooperate with the Exploratory Step-In Party in all reasonable respects to secure the consent of the applicable Third Party to such assignment, or (B) covers products in addition to the New Collaboration Compound that is the subject of such Exploratory Development Activities, in which case the Exploratory Non-Performing Party shall cooperate with the Exploratory Step-In Party in all reasonable respects to facilitate the execution of a new agreement between the Exploratory Step-In Party and the applicable Third Party. In such event, with respect to all such Joint Exploratory Development activities that involve Clinical Studies, at the Exploratory Step-In Party’s option, the Exploratory Non- Performing Party shall transfer control to the Exploratory Step-In Party or its designee of such Clinical Studies and cooperate with the Exploratory Step-In Party to ensure a smooth and orderly transition thereof that will not involve any disruption of such Clinical Studies.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Development Plan; provided that such work plans (including protocols) shall be subject to approval by the JRDI. In the event the JRDI cannot agree on the work plan for a particular Non-Clinical Study or Clinical Study (or the protocol thereof) within a [***]-day period, then such matter shall be referred to the JEC for resolution. If the JEC cannot resolve such matter within a [***]-day period, then such matter shall be referred to the Parties’ Senior Officers for resolution. If such Senior Officers cannot resolve such matter within a [***])-day period [***]. In the event the JRDI cannot agree on any amendment of a particular work plan or protocol within a [***]-day period, then such matter shall be referred to the JEC for resolution. If the JEC cannot resolve such matter within a [***]-day period, then such matter shall be referred to the Parties’ Senior Officers for resolution. If such Senior Officers cannot resolve such matter within a [***]-day period, then, [***].
(f) Costs for Joint Exploratory Development.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
other Party shall have the right to conduct the remainder of such Exploratory Development Activities set forth under such Joint Exploratory Development Plan as Unilateral Exploratory Development in accordance with Section 4.4 (in which event the Joint Exploratory Development Plan thereafter shall be deemed a Unilateral Exploratory Development Plan) and solely fund such activities (and the non-funding Party would have the right to participate in the joint funding and Development of any Product Candidates arising therefrom in accordance with Article 5).
4.4 Unilateral Exploratory Development.
(i) Neither Party shall have the right to conduct Exploratory Development Activities for a particular New Collaboration Compound or for a particular Indication under Unilateral Exploratory Development without first having proposed such Exploratory Development Activity as a joint activity by means of an amendment to the Joint Exploratory Development Plan under Section 4.3(a), and only after the other, non-proposing Party declines to include such Exploratory Development Activity as part of the Joint Exploratory Development Plan.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(ii) Except as otherwise provided in Section 5.7, neither Party shall have the right to conduct Unilateral Exploratory Development using a Development Candidate that has been designated a Product Candidate without the other Party’s prior written approval.
(iii) Subject to the restrictions set forth in Sections 4.4(a)(i) and (ii) above, after the Protected Period [***].
(iv) In the event that Xxxxx decides not to co-fund activities under the Joint Exploratory Development Plan in excess of the JEDP Budget Cap in accordance with Section 4.3(f)(ii), [***].
(v) Subject to the restrictions set forth in Sections 4.4(a)(i) and (ii) above, [***] shall at all times during the Term have the right to (A) conduct Unilateral Exploratory Development with respect to any New Collaboration Compound or (B) use any New Collaboration Compound to conduct unilaterally any Clinical Studies under this Article 4 for any Indication other than a Joint Exploratory Development Indication.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(f) Opt-In Rights of the Non-Participating Exploratory Party . Any Development Candidate that is Developed under a Unilateral Exploratory Program shall be subject to the JEC’s review and approval as a Product Candidate under Section 4.2(e)(ii) before commencement of any Phase IIb Clinical Study with respect thereto. If so designated by the JEC as a Product Candidate, the Non-Participating Exploratory Party shall nonetheless have the right to participate in the joint funding and Development of such Product Candidate as provided in Article 5.
(a) The Targeted AIMs in the New Collaboration Compound Pool will be the source of both: (i) New Collaboration Compounds under this Agreement for Development and Commercialization in the New Collaboration Field in accordance with the terms of this Agreement on the one hand; and (ii) Collaboration Candidates, Collaboration Compounds, Backup Candidates and Backup Compounds under the Bardoxolone License Agreement for development and commercialization in the Previously Licensed Field on the other hand; provided that Reata shall not have the right to select a Unilateral Acquired AIM of Xxxxxx as a Collaboration Candidate or Backup Candidate under the Bardoxolone License Agreement without the prior written consent of Xxxxxx.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(b) Unless otherwise mutually agreed by the Parties, the selection of a Targeted AIM from the New Collaboration Compound Pool as a Collaboration Candidate, Collaboration Compound, Backup Candidate or Backup Compound under the Bardoxolone License Agreement will serve to remove such Targeted AIM from the New Collaboration Compound Pool and such Targeted AIM shall thereafter be governed solely by the Bardoxolone License Agreement and will not be eligible to be selected as a Development Candidate or Product Candidate under this Agreement, unless and until the Parties permanently discontinue development and commercialization of such Targeted AIM under the Bardoxolone License Agreement, in which event such Targeted AIM shall be returned to the New Collaboration Compound Pool and shall again be eligible to be selected as a Development Candidate or Product Candidate under this Agreement in accordance with the terms hereof.
(c) Unless otherwise mutually agreed by the Parties, the selection of a Targeted AIM in the New Collaboration Compound Pool as a Product Candidate for an Indication under this Agreement will make such Targeted AIM ineligible to be selected as a Collaboration Candidate, Collaboration Compound, Backup Candidate or Backup Compound under the Bardoxolone License Agreement and such Targeted AIM shall thereafter be governed solely by this Agreement and will not be eligible to be selected as a Collaboration Candidate, Collaboration Compound, Backup Candidate or Backup Compound under the Bardoxolone License Agreement, unless and until the Parties permanently discontinue Development and Commercialization of such Targeted AIM under this Agreement, in which event such Targeted AIM shall be returned to the New Collaboration Compound Pool and shall again be eligible to be selected as a Collaboration Candidate, Collaboration Compound, Backup Candidate or Backup Compound under the Bardoxolone License Agreement.
(d) As part of the Exploratory Development, the Parties may perform certain Exploratory Development Activities under the Exploratory Development Program with respect to a Targeted AIM prior to the time that such Targeted AIM is selected as a Product Candidate for an Indication under this Agreement. If such Targeted AIM is selected as a Collaboration Candidate, Collaboration Compound, Backup Candidate or Backup Compound under the Bardoxolone License Agreement prior to such Targeted AIM being selected as a Product Candidate under this Agreement, then: (i) any Development Costs incurred by the Parties for such Exploratory Development Activities for such Targeted AIM shall no longer be counted towards the Cap (and any previous inclusion of such amount will be reversed); and (ii) Reata shall reimburse Xxxxxx for Xxxxxx’x share of any Development Costs incurred by the Parties for such Exploratory Development Activities (including Unilateral Exploratory Development Activities) that has been borne by Xxxxxx in accordance with the terms hereof.
(e) Reata acknowledges and agrees that Xxxxxx has the right to select any Xxxxxx Excluded AIM(s) from the New Collaboration Compound Pool and develop, manufacture and commercialize such Xxxxxx Excluded AIM(s) for the Renal Indication, Cardiovascular Indication or Metabolic Indication subject to the terms of the Bardoxolone
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
ARTICLE 5
5.4 Opt-Out after Designation of Product Candidate and Selection of Indication for Development.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(b) Opt-Out Notice; Unilateral Development. Within [***] days of completion of such review by the JDC, either Party shall have the right to deliver to the other Party a written notice that it does not desire to pursue Development of such Product Candidate for the Indication selected for Development at such time (the “ Opt-Out Notice ”), in which event the other Party shall have the right to pursue, unilaterally, the further Development of such Product Candidate under a Unilateral Development Program as provided under and in accordance with Section 5.6, unless and until the opt-out Party later opts back in to such Unilateral Development Program in accordance with Section 5.6.
5.5 Joint Product Development.
(a) Readiness for Phase IIb Development. With respect to any Product that is subject to Joint Development pursuant to Section 5.4(c) above, the JDC for such Product Candidate shall discuss and determine whether the Product Candidate is ready for Phase IIb Clinical Studies, and if not, what additional Development activities are required prior to the conduct of a Phase IIb Clinical Study.
(ii) Pre-Phase IIb Development and Plan.
(1) If either Party’s representatives on the JDC are of the view that such Product Candidate is not ready for Phase IIb Clinical Studies, then the Parties shall not commence Phase IIb Clinical Studies for such Product Candidate at such time; and instead the JDC shall prepare a written plan setting forth: (A) the Development activities (including any additional Phase IIa Clinical Study or other Phase II Clinical Study) it believes should be conducted prior to a Phase IIb Clinical Study, or any Non-Clinical Studies to be conducted by the Parties for such Product Candidate with the goal of determining whether such Product Candidate should be further Developed in Phase IIb Clinical Studies, and related Manufacture and supply matters (such activities collectively, the “ Pre-Phase IIb Development ”), including the protocols for any such Clinical Studies or other such studies; (B) the allocation of the conduct of the activities under such Pre-Phase IIb Development between the Parties; (C) the timeline associated with such Pre-Phase IIb Development; and (D) the budget for such Pre-Phase IIb Development (the “ Pre-Phase IIb Plan ”). Any such Pre- Phase IIb Plan shall be effective upon approval of the JDC, either by the agreement of the JDC or, in the case of disagreement, as set forth in Section 5.5(a)(ii)(2) below.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(iii) Opting-Out of Pre-Phase IIb Development . Either Party shall have the right, during a period of [***] days after the determination of the Pre-Phase IIb Plan, to deliver to the other Party an Opt-Out Notice. If neither Party delivers such Opt-Out Notice within such period, such Pre-Phase IIb Development shall be deemed “ Joint Pre-Phase IIb Development ” and such Pre-Phase IIb Plan shall be deemed a “ Joint Pre-Phase IIb Plan ”. If either Party delivers such Opt-Out Notice, the other Party may conduct such Pre- Phase IIb Development unilaterally as provided under and in accordance with Section 5.6(a), and the Unilateral Pre-Phase IIb Plan may be amended in accordance with Section 5.6(a)(iii).
(vi) Decision to Commence Phase IIb Development . At the conclusion of Joint Pre-Phase IIb Development activities, the JDC shall again assess the readiness for such Product Candidate for further Development in Phase IIb Clinical Studies in accordance with this Section 5.5(a).
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(1) For any Product Candidate that is being jointly Developed and that has been determined by the applicable JDC to be ready for Development in Phase IIb Clinical Studies pursuant to Section 5.5(a)(i) or Section 5.5(a)(vi), the JDC shall prepare a written plan setting forth: (A) the Development activities (including the Phase IIb Clinical Study, any Non-Clinical Studies and potentially other Clinical Study(ies)) to be conducted by the Parties for such Product Candidate with the goal of determining whether such Product Candidate should be further Developed in Phase III Clinical Studies, and if so, obtaining the Clinical Data and other results necessary to meet the requirements of the Regulatory Authorities in order to commence Phase III Clinical Studies for such Product Candidate and related Manufacture and supply matters (such activities collectively, the “ Phase IIb Development ”), including the protocol for the proposed Phase IIb Clinical Study or other related such studies; (B) the allocation of the conduct of the activities under such Phase IIb Development between the Parties; (C) the timeline associated with such Phase IIb Development; and (D) the budget for such Phase IIb Development (the “ Phase IIb Plan ”). Any such Phase IIb Plan shall be effective upon approval of the JDC, either by the agreement of the JDC or, in the case of disagreement, as set forth in Section 5.5(b)(i)(2) below.
(2) If the JDC cannot agree on the Phase IIb Plan within a [***]-day period, then such matter shall be referred to the JEC for resolution. If the JEC cannot resolve such matter within a [***]-day period, then such matter shall be referred to the Parties’ Senior Officers for resolution. If such Senior Officers cannot resolve such matter within a [***]-day period, then the Phase IIb Clinical Study for such Product Candidate [***].
(ii) Opting-Out of Phase IIb Development . Either Party shall have the right, during a period of [***] days after the determination of the Phase IIb Plan, to deliver to the other Party an Opt-Out Notice. If neither Party delivers such Opt-Out Notice within such period, then such Phase IIb Development shall be deemed “ Joint Phase IIb Development ” and such Phase IIb Plan shall be deemed a “ Joint Phase IIb Plan ”. If either Party delivers such Opt-Out Notice, the other Party may conduct such Phase IIb Development unilaterally as provided under and in accordance with Section 5.6(b), and the Unilateral Phase IIb Plan may be amended in accordance with Section 5.6(b)(iii).
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(c) EOP2 Meeting; Briefing Package.
(i) EOP2 Meeting [***] (collectively, the “ EOP2 Meeting ”). Both Parties shall have the right to attend any EOP2 Meeting for a Product Candidate for an Indication under this Section 5.5(c)(i).
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(iii) Further Development Prior to Phase III Development. After reviewing the minutes of the EOP2 Meeting, if both Parties’ JDC representatives agree that such Product Candidate is ready for Phase III Clinical Studies in the applicable Indication, the Parties shall proceed under Section 5.5(d). If either Party’s representatives on the JDC are of the view that such Product Candidate is not ready for Phase III Clinical Studies, [***]. At the conclusion of such additional Development activities, the Parties shall again assess the readiness of such Product Candidate for further Development in a Phase III Clinical Study in accordance with this Section 5.5(c)(iii).
(1) If both Parties’ JDC representatives agree that a Product Candidate under a Joint Phase IIb Plan is ready for Phase III Clinical Studies in an Indication, then the JDC shall prepare a written Development plan and budget for the Phase III Development of such Product Candidate for such Indication with the goal of obtaining Regulatory Approval for the U.S./Europe/Japan Region and the ROW Region, which shall include a clinical plan and a protocol for such Phase III Clinical Study(ies) based on the EOP2 Meeting briefing package, incorporating any feedback received from each Regulatory Authority, as well as all other Development activities, including Non-Clinical Studies and CMC Development, that are required to support Regulatory Approval of the Product containing such Product Candidate in such Indication for the U.S./Europe/Japan Region and the ROW Region, and which Development plan shall assign responsibility for such Development activities between the Parties, and shall include the timeline and budget for such Development activities (the “ Phase III Plan ”).
(2) If the JDC cannot agree on such Phase III Plan within [***] days after both Parties’ JDC representatives agree that such Product Candidate is ready for Phase III Clinical Studies in an Indication, the matter shall be referred to the JEC for resolution. If the JEC cannot agree on such Phase III Plan within a [***]-day period, then such matter shall be referred to the Senior Officers of the Parties for resolution. If such Senior Officers cannot agree on such Phase III Plan within a [***]-day period, then [***].
(ii) Opting-Out of Phase III Development. Within [***] days after the determination of the Phase III Plan in accordance with Section 5.5(d)(i), each Party shall have the right to deliver to the other Party an Opt-Out Notice in which it notifies the other Party whether it desires to opt-out of the Development of the applicable Product Candidate under such Phase III Plan, which opt-out may be for the entire Territory or for the ROW Region only (the “ Phase III Opt-Out ”).
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(iii) Joint Products; Joint Phase III Plan . Any Development Region for which neither Party exercises its Phase III Opt-Out for a Product Candidate in an Indication is referred to as a “ Profit Share Region ” for such Product Candidate, and any Product containing such Product Candidate is referred to as a “ Joint Product ” with respect to such Development Region. For each Joint Product in each applicable Profit Share Region, the Parties shall conduct the Phase III Clinical Studies, as well as other Development activities required for Regulatory Approval, all in accordance with the applicable Phase III Plan (such Phase III Plan, the “ Joint Phase III Plan ”).
(iv) Lead Development Party; Lead Regulatory Party. With respect to a Joint Phase III Plan for a Joint Product in an Indication for a Profit Share Region, (A) the Party that was the Lead Development Party for Phase IIb Development for such Joint Product in such Indication shall remain the Lead Development Party for such Joint Product in such Indication in such Profit Share Region; and (B) the Party that was the Lead Regulatory Party for Phase IIb Development for such Joint Product in such Indication in such Region shall remain the Lead Regulatory Party with respect to the Development activities for such Joint Product in such Indication in such Profit Share Region up to and including the preparation, filing and approval of all Drug Approval Applications for such Joint Product in each Commercialization Territory, and thereafter the Lead Commercialization Party for such Joint Product in each Commercialization Territory (as determined in accordance with Section 5.6(e)(vi) or Section 7.3) shall be Lead Regulatory Party with respect to all other regulatory Development, Manufacturing and Commercialization activities with respect to such Joint Product in such Commercialization Territory thereafter.
(vi) Funding of Joint Phase III Plan. The Parties shall share equally (50/50) all Development Costs incurred by each Party in connection with the conduct of Development activities under such Joint Phase III Plan.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
to facilitate the execution of a new agreement between the Step-In Party and the applicable Third Party. In such event, with respect to all such Development activities that involve Clinical Studies, at the Step-In Party’s option, the Non-Performing Party shall transfer control to the Step-In Party or its designee of such Clinical Studies and cooperate with the Step-In Party to ensure a smooth and orderly transition thereof that will not involve any disruption of such Clinical Studies.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Operating Profit (or Loss) for such Product in the applicable Profit Share Region as otherwise set forth in Section 11.3 of this Agreement, to recoup one hundred percent (100%) (%) of the Overage Amount, plus a premium, by receiving (or retaining) a royalty equal to fifteen percent (15%) of the quarterly Net Sales of such Product in the applicable Profit Share Region (the “ Overage Recoupment Amount ”), until the aggregate amount of royalties received (or retained) by such Participating Party under this Section 5.5(g) equals two (2) times the total Overage Amount. The Overage Recoupment Amount shall be deducted from Net Sales of such Product in the Profit Share Region prior to determining Operating Profit (or Loss) of such Product in the Profit Share Region and shall not otherwise be taken into account in determining Operating Profit (or Loss). The funding Party shall provide to the other Party a written statement of all Overage Amounts incurred by it on a quarterly basis, and all such costs specified in such cost statements shall be subject to audit pursuant to Section 11.9.
5.6 Unilateral Product Development.
(a) Pre-Phase IIb Development.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(1) One hundred percent (100%) of such Participating Pre-Phase IIb Party’s Development Costs incurred in connection with such Unilateral Pre- Phase IIb Plan (even if such Non-Participating Pre-Phase IIb Party delivers its notice of election to opt back in prior to the completion of such activities); and
(2) If such Non-Participating Pre-Phase IIb Party was a Non-Participating Exploratory Party for the applicable Development Candidate, One hundred percent (100%) of such Participating Exploratory Party’s Development Costs incurred in connection with Unilateral Exploratory Development for the applicable Development Candidate;
with such aggregate payment (for (1) and (2)) (the “ Pre-Phase IIb Opt-In Payment ”) reflecting the reimbursement of such Non-Participating Pre-Phase IIb Party’s original fifty percent (50%) share of such Development Costs plus a premium of [***] percent ([***]%). All Development Costs incurred by a Participating Exploratory Party or Participating Pre-Phase IIb Party in connection with any Development activities under any Unilateral Exploratory Development Plan or Unilateral Pre-Phase IIb Plan and specified in any cost statement under this Section 5.6(a)(vi) shall be subject to audit pursuant to Section 11.9. In the event a Non-Participating Pre-Phase IIb Party does not elect to opt-in to Joint Phase IIb Development under this Section 5.6(a)(vi), it shall nonetheless have the right to exercise its Pre-Phase III Opt-In or EOP3 Opt-In with respect the applicable Product Candidate in the applicable Indication in accordance with the terms hereof.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(c) EOP2 Meeting; Briefing Package for Unilateral Products.
(ii) Briefing Package; Phase III Plan. Prior to any EOP2 Meeting for a Product Candidate under a Unilateral Phase IIb Plan for an Indication, the Participating Phase IIb Party shall prepare a briefing package, exercising reasonable good faith judgment consistent with the Principles, for submission to the applicable Regulatory Authority for such EOP2 Meeting. The Participating Phase IIb Party shall provide such briefing package to the JDC for review and comment, and shall consider in good faith all comments made by the Non- Participating Phase IIb Party’s representatives on the JDC. The Non-Participating Phase IIb Party shall not have the right to attend any EOP2 Meeting for a Product Candidate under a Unilateral Phase IIb Plan for an Indication under this Section 5.6(c)(ii).
(iv) Right to Opt Back In Prior to Phase III. The Non- Participating Phase IIb Party for a Product Candidate under a Unilateral Phase IIb Plan shall have the right to opt back in to the Development of such Product Candidate (the “ Pre-Phase III Opt-In ”) by providing the Participating Phase IIb Party with written notice of its exercise of such Pre-Phase III Opt-In (the “ Pre-Phase III Election Notice ”) within [***] days after receiving from the Participating Phase IIb Party: (A) a Completion Notice with respect to such Unilateral Phase IIb Development, (B) reasonable access to (with the ability to analyze and manipulate but not change) the electronic database that contains the Regulatory Data with respect to such Unilateral Phase IIb Development, and (C) a written statement of the costs that would need to be paid under clauses (1), (2) and (3) below by the Non-Participating Phase IIb Party if it elects to exercise its Pre-Phase III Opt-In ((A), (B) and (C) collectively, the “ Pre- Phase III Notification ”). In addition, the Participating Phase IIb Party promptly shall provide to the Non-Participating Phase IIb Party such additional Information and Regulatory Documentation with respect to the Development activities described in such Completion
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Notice as may be reasonably requested by the Non-Participating Phase IIb Party in order to evaluate such Development activities. The Participating Phase IIb Party shall provide the Pre- Phase III Notification to the Non-Participating Phase IIb Party promptly after completion of such Unilateral Phase IIb Development. Any Pre-Phase III Opt-In exercise shall become effective only if the Non-Participating Phase IIb Party pays the Participating Phase IIb Party an amount equal to the sum of the following (as applicable) within [***] days after its delivery of the Pre-Phase III Election Notice:
(1) one hundred percent (100%) of the Participating Phase IIb Party’s Development Costs incurred in connection with such Unilateral Phase IIb Plan (even if such Non-Participating Phase IIb Party delivers its notice of election to opt back in prior to the completion of such activities); and
(2) if such Non-Participating Phase IIb Party also has been a Non-Participating Pre-Phase IIb Party during any Unilateral Pre-Phase IIb Development for the applicable Product Candidate, one hundred percent (100%) of the Participating Pre- Phase IIb Party’s Development Costs incurred in connection with such Unilateral Pre-Phase IIb Party’s Development; and
(3) if such Non-Participating Phase IIb Party also has been a Non-Participating Exploratory Party during any Unilateral Exploratory Development for the applicable Product Candidate as a Development Candidate or Lead Compound, one hundred percent (100%) of the Participating Exploratory Party’s Development Costs incurred in connection with such Unilateral Exploratory Development;
with such aggregate payment (for (1), (2) and (3)) (the “ Pre-Phase III Opt-In Payment ”) reflecting the reimbursement of such Non-Participating Phase IIb Party’s original fifty percent (50%) share of such Development Costs plus a premium of one hundred percent (100%). All Development Costs incurred by a Participating Phase IIb Party in connection with any Development activities under any Unilateral Exploratory Development Plan or Unilateral Pre-Phase IIb Plan or Unilateral Phase IIb Plan and specified in any cost statement under this Section 5.6(c)(iv) shall be subject to audit pursuant to Section 11.9. In the event a Non- Participating Phase IIb Party does not elect to opt-in to Joint Phase III Development under this Section 5.6(c)(iv), it shall nonetheless have the right to exercise its EOP3 Opt-In with respect the applicable Product Candidate in the applicable Indication in accordance with the terms hereof.
(1) Where the Pre-Phase III Election Notice under Section 5.6(c)(iv) is received prior to the first data analysis (including any interim analysis as part of the statistical plan) of the Phase IIb Clinical Study, payment of the Pre-Phase III Opt-In Payment shall render such Product Candidate a Product Candidate Developed under a Joint Phase IIb Plan for all purposes, including joint decision making as to the readiness for Phase III Development and the Phase III Plan under Sections 5.5(c) and 5.5(d).
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(2) Where the Pre-Phase III Election Notice under Section 5.6(c)(iv) is not received prior to the first data analysis (including any interim analysis as part of the statistical plan) of the Phase IIb Clinical Study, payment of the Pre-Phase III Opt- In Payment shall not render such Product Candidate a Product Candidate Developed under a Joint Phase IIb Plan for purposes of determining the Phase III Plan, but rather shall ensure that such previously Non-Participating Phase IIb Party has the right, and the obligation, to participate in the ongoing joint funding of Phase III Development under Section 5.5(d); however, exercise of the Pre-Phase III Opt-In and payment of the Pre-Phase III Opt-In Payment shall render such Product Candidate a Product Candidate Developed under a Joint Phase IIb Plan for all purposes following the completion of the first Phase III Clinical Study.
(d) Phase III Clinical Development.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(e) Option to Convert a Unilateral Product into a Joint Product at the End of the first Phase III Clinical Study.
(i) EOP3 Opt-In and Notice. Subject to Section 5.6(e)(ii) below, for any particular Unilateral Product in a Royalty Region, a Party that has been the Non- Participating Phase III Party under the Unilateral Phase III Plan shall have the right to convert such Unilateral Product to a Joint Product in such Development Region after the completion of the first Phase III Clinical Study for such Unilateral Product (the “ EOP3 Opt-In ”) by providing the Participating Phase III Party with written notice of its exercise of such EOP3 Opt-In (the “ EOP3 Election Notice ” ) within [***] days after receiving from the Participating Phase III Party: (A) a Completion Notice with respect to such Phase III Clinical Study, (B) reasonable access to (with the ability to analyze and manipulate but not change) the electronic database that contains the Regulatory Data with respect to such Phase III Clinical Study and all other Development activities under the applicable Unilateral Phase III Plan, and (C) a written statement of the costs that would need to be paid under Section 5.6(e)(iii) below by the Non-Participating Phase III Party if it elects to exercise its EOP3 Opt-In incurred by the Participating Phase III Party through the last day of the Calendar Quarter immediately preceding the Calendar Quarter in which such statement is provided (such date, the “ Statement Cut-Off Date ”) ((A), (B) and (C) collectively, the “ EOP3 Notification ”). In addition, the Participating Phase III Party promptly shall provide to the Non-Participating Phase III Party such additional Information and Regulatory Documentation with respect to the Development activities described in such Completion Notice as may be reasonably requested by the Non-Participating Phase III Party in order to evaluate such Development activities. The Participating Phase III Party shall provide the EOP3 Notification to the Non-Participating Phase III Party promptly after completion of such first Phase III Clinical Study.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(A) in the event such Non-Participating Phase III Party also has been a Non-Participating Exploratory Party during any Unilateral Exploratory Development for the applicable Development Candidate (but only in the event not already paid), one hundred percent (100%) of the Participating Exploratory Party’s Development Costs incurred in connection with such Unilateral Exploratory Development Plan, with such payment reflecting the reimbursement of such Non-Participating Exploratory Party’s original fifty percent (50%) share of such Development Costs plus a premium of one hundred percent (100%);
(B) in the event such Non-Participating Phase III Party also has been a Non-Participating Pre-Phase IIb Party during any Unilateral Pre-Phase IIb Development for the applicable Product Candidate in the applicable Indication (but only in the event not already paid), one hundred percent (100%) of the Participating Pre-Phase IIb Party’s Development Costs incurred in connection with such Unilateral Pre-Phase IIb Plan, with such payment reflecting the reimbursement of such Non-Participating Pre-Phase IIb Party’s original fifty percent (50%) share of such Development Costs plus a premium of one hundred percent (100%);
(C) in the event such Non-Participating Phase III Party also has been a Non-Participating Phase IIb Party during the Phase IIb Development for the applicable Product Candidate in the applicable Indication, one hundred percent (100%) of the Participating Phase IIb Party’s Development Costs incurred in connection with such Unilateral Phase IIb Plan, with such payment reflecting the reimbursement of such Non-Participating Phase IIb Party’s original fifty percent (50%) share of such Development Costs plus a premium of one hundred percent (100%);
(D) one hundred fifty percent (150%) of the Participating Phase III Party’s total Development Costs incurred through the Statement Cut-Off Date in connection with its Unilateral Phase III Development activities under the Unilateral Phase III Plan for such Product Candidate in the Development Region for which the Non-Participating Phase III Party is exercising the EOP3 Opt-In, with such payment reflecting the reimbursement of such Party’s original fifty percent (50%) share of such Development Costs plus a premium of two hundred percent (200%); and
(E) fifty percent (50%) of the pre-launch commercialization costs (calculated in the same manner as Commercialization Costs, mutatis mutandis ) incurred by the Participating Phase III Party for such Product Candidate in such Development Region for such Indication and identified in the EOP3 Notification.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Phase III Plan for such Product Candidate in such Development Region during the period commencing on the day after the Statement Cut-Off Date and ending on the date of receipt of the EOP3 Election Notice, and the Non-Participating Phase III Party shall within [***] days of the receipt of such statement pay one hundred fity percent (150%) of such additional Development Costs set forth in such statement, with such payment reflecting the reimbursement of such Non-Participating Phase III Party’s original fifty percent (50%) share of such additional Development Costs plus a premium of two hundred percent (200%).
(vi) Conversion of Unilateral Product to Joint Product and Royalty Region to Profit Share Region. Upon the Participating Phase III Party’s receipt of the EOP3 Election Notice and the payment required pursuant to Section 5.6(e)(iii): (A) such Product shall cease to be a Unilateral Product in the applicable Development Region for which the Non-Participating Phase III Party is exercising the EOP3 Opt-In, and shall become a Joint Product in such Development Region; (B) such Development Region shall cease to be a Royalty Region and shall become a Profit Share Region; (C) the original Participating Phase III Party that has been conducting the Phase III Clinical Study for such Product Candidate shall have the right to be the Lead Commercialization Party for such Joint Product in such Profit Share Region; and (D) the Parties shall share equally (50/50) all future Development Costs for such Joint Product for such Indication for such Profit Share Region.
(ix) Opt-In Across Indications. Except as set forth in Section 5.7(a)(iii)(3), in the event a Non-Participating Party exercises its Pre-Phase II Opt-In, Pre-Phase III Opt-In or EOP3 Opt-In for a particular Product Candidate for any Indication (either an original Indication or an Additional Indication), such Non-Participating Party shall be deemed to have exercised such Pre-Phase II Opt-In, Pre-Phase III Opt-In or EOP3 Opt-In with respect to all Active Indications with respect to such Product Candidate (and shall be required to make opt-in payments in respect of all Development Costs and commercialization costs with respect thereto).
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
5.7 Development of a Product Candidate in Additional Indication(s). For each Product Candidate/Product that is being Developed or Commercialized by the Parties or a Party (either jointly or unilaterally) in an Active Indication, each Party shall have the right to propose to the JEC that the Parties jointly, or such Party unilaterally, undertake Development activities for that same Product Candidate/Product for one (1) or more additional Indications in the New Collaboration Field, whether a Related Indication or outside the Related Indications (such Indications, the “ Additional Indication(s) ” and such Development activities, the “ Additional Indication Activities ”), subject to the following:
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(1) The Proposing Party shall conduct all Additional Indication Activities in accordance with a written Development plan and budget (the “ Additional Indication Plan ”) to be proposed by such Proposing Party and approved by the applicable JDC, provided that, if such JDC cannot reach agreement on such plan within a [***]-day period, the matter shall be referred to the JEC for resolution. If the JEC cannot resolve such matter within a [***]-day period, then the matter shall be referred to the Senior Officers of the Parties for resolution. If such Senior Officers cannot resolve such matter within a [***])-day period, then [***];
(2) The Non-Proposing Party shall have the right to exercise its Pre-Phase IIb Opt-In under Section 5.6(a)(vi), its Phase IIb Opt-In under Section 5.6(c)(iv), and its EOP3 Opt-In under Section 5.6(e) with respect to such Additional Indication under the Additional Indication Plan on the substantially same terms and conditions as set forth in such Sections, mutatis mutandis ; and
(3) If the Non-Proposing Party does not participate in Phase III Clinical Studies for such Additional Indication under the Additional Indication Plan, then, if the Proposing Party obtains Regulatory Approval for such Additional Indication in the applicable Profit Share Region: (A) such Product shall be Commercialized as a single Product for all Indications in the applicable Profit Share Region as provided in Article 7; and (B) the Proposing Party shall have the right, in addition to all of its rights (and obligations) to receive (and bear) its share of Operating Profit (or Loss) for such Product in the applicable Profit Share Region as otherwise set forth in Section 11.3 of this Agreement, to recoup its Development Costs incurred in the Development of such Product in such Additional Indication, plus a premium, by receiving (or retaining) a royalty equal to fifteen percent (15%) of the quarterly Net Sales of such Product in all Indications in the applicable Profit Share Region (the “ Recoupment Amount ”), until the aggregate amount of royalties received (or retained) by such Proposing Party under this Section 5.7(a)(iii)(3) equals two (2) times the total
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Development Costs incurred by such Proposing Party in connection with the Additional Indication Activities to the extent not jointly funded by such Non-Proposing Party. The Recoupment Amount shall be deducted from Net Sales of such Product in the Profit Share Region prior to determining Operating Profit (or Loss) of such Product in the Profit Share Region and shall not otherwise be taken into account in determining Operating Profit (or Loss). The Proposing Party shall provide to the other Party a written statement of all Development Costs incurred by such Proposing Party in connection with any Additional Indication Activities promptly after obtaining Regulatory Approval for the applicable Additional Indication in the applicable Profit Share Region, and all such Development Costs specified in such cost statement under this Section 5.7(a)(iii)(3) shall be subject to audit pursuant to Section 11.9.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
5.8 Unilateral Development of Any Additional Product Candidate for an Active Indication.
(i) Such Party shall first propose the Development of such Follow-On Product Candidate in such Indication to the JDC which is overseeing the then-current Development of the Initial Product Candidate (or which oversaw the Development where such Initial Product Candidate is an approved Product), and such Party may conduct such Development unilaterally [***];
(ii) Unless the Parties otherwise agree, if a Participating Party is unilaterally Developing such Initial Product Candidate for the Active Indication (and such Initial Product Candidate is not being Developed for the Active Indication jointly by the Parties in any Development Region), the other Non-Participating Party may not commence any unilateral Clinical Study Development of a Follow-On Product Candidate in such Active Indication or any of its Related Indications [***];
(iii) Unless the Parties otherwise agree, if the Parties jointly are Developing such Initial Product Candidate for the Active Indication in any Development Region, [***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Agreement, or for such longer period as may be required by Applicable Law. Each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy any such records, except to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party. Each Party shall provide the applicable JDC and the other Party with such reports summarizing in reasonable detail its Development activities under this Article 5 and the results of such activities as such JDC or the other Party reasonably requests.
(a) within [***] months of the date on which such Unilateral Acquired AIM becomes a Unilateral Acquired AIM, such AIM Acquiring Party shall be required to elect one (1) of the following: (A) [***];
(b) if the First Commercial Sale of a Current Product has not occurred in the Profit Share Region and the AIM Acquiring Party elects [***];
(c) if the First Commercial Sale of a Current Product has occurred anywhere in the Profit Share Region, and the AIM Acquiring Party elects [***]; and
(d) if the AIM Acquiring Party elects [***].
ARTICLE 6
6.1 Regulatory Filings and Approvals .
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(b) Regulatory Responsibilities .
(i) As between the Parties, subject to Section 9.2(c)(iii), the Party designated in accordance with the provisions of this Agreement as the LRP with respect to a particular set of Development, Manufacturing or Commercialization activities for a particular Development Candidate, Product Candidate or Product in a particular country in the Territory shall have the right and responsibility (but subject to the other Party’s rights of participation as set forth herein) for preparing, obtaining, and maintaining Drug Approval Applications, other Regulatory Approvals and other submissions, and for conducting communications with the Regulatory Authorities, with respect to the specific activities for which it is designated as LRP.
(ii) All Regulatory Documentation (including all Regulatory Approvals and Product Labeling) relating to the applicable Development Candidate, Product Candidate or Product with respect to the applicable Development, Manufacturing, or Commercialization activities in the applicable countries shall be owned by the applicable LRP or its designee. The Party that is not the LRP with respect to the applicable Development Candidate, Product Candidate or Product for the applicable Development, Manufacturing, or Commercialization activities in the applicable countries shall assign to the LRP all of its right, title, and interest in and to the applicable Regulatory Documentation (including any existing Regulatory Approvals) with respect to the applicable Product or New Collaboration Compound in the applicable countries, including Regulatory Documentation with respect to activities for which such Party was the LRP in a previous stage of Development, subject to such Party’s right of access, reference and use of Regulatory Data and Regulatory Documentation pursuant to Section 6.3, Section 10.1 and Section 10.5.
(iii) For all Joint Products, the LRP shall provide the other Party with an opportunity to review and comment on all Regulatory Documentation for Joint Products in the applicable countries in the Profit Share Territory, and all proposed actions with respect thereto, prior to submission thereof or the taking of the action. The LRP shall provide the other Party with access to interim drafts of the Regulatory Documentation for Joint Products in the applicable countries in the Profit Share Territory via the access methods (such as secure databases) established by the applicable JDC, and the other Party shall provide its comments on the then-current drafts of such Regulatory Documentation or of proposed actions within [***] days ([***] for Drug Approval Applications), or such other longer period of time mutually agreed to by the Parties. In the event that a Regulatory Authority establishes a response deadline for a regulatory filing or action shorter than such ([***])-day (or [***]-day) period, the Parties shall work cooperatively to ensure the other Party has a reasonable opportunity for review and comment within such deadlines. The LRP shall consider in good faith any such comments of the other Party.
(iv) For all Joint Products, the LRP shall provide the other Party with (A) access to or copies of all material written or electronic correspondence (other than regulatory filings) relating to the Development or Commercialization of Joint Products in the applicable countries in the Profit Share Territory received by such Party or its Affiliates from, or forwarded by such Party or its Affiliates to, the Regulatory Authorities in the applicable countries, and (B) copies of all meeting minutes and summaries of all meetings, conferences, and discussions held by such Party or its Affiliates with the Regulatory Authorities relating to
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
such Joint Products in such applicable countries, including copies of all contact reports produced by such Party or its Affiliates, in each case ((A) and (B)) within [***] Business Days of its receipt, forwarding or production of the foregoing, as applicable. If such written or electronic correspondence received from a Regulatory Authority relates to the withdrawal, suspension, or revocation of a Regulatory Approval for a Joint Product, the prohibition or suspension of the supply of a Joint Product, or the initiation of any investigation, review, or inquiry by such Regulatory Authority concerning the safety of a Joint Product, such Party shall notify the other Party and provide the other Party with copies of such written or electronic correspondence as soon as practicable, but not later than [***] Business Day after receipt of such correspondence.
(v) For all Joint Products, the LRP shall provide the other Party with prior written notice, to the extent the LRP has advance knowledge, of any meeting, conference, or discussion (including any advisory committee meeting) with a Regulatory Authority in the applicable countries relating to the applicable Development, Manufacture, or Commercialization of a Joint Product in the Profit Share Territory, within [***] Business Days after the Party or its Affiliate first receives notice of the scheduling of such meeting, conference, or discussion (or within such shorter period as may be necessary in order to give the other Party a reasonable opportunity to attend such meeting, conference, or discussion). The other Party shall have the right to attend as an observer (but not participate in) all such meetings, conferences, and discussions.
(vi) For all Joint Products, the Party that is not the LRP shall support the LRP, as may be reasonably necessary, in obtaining and maintaining Regulatory Approval for Joint Products in the applicable countries in the Profit Share Territory, including providing necessary documents or other materials required by Applicable Law to obtain and maintain Regulatory Approval, in each case in accordance with the terms and conditions of this Agreement and any applicable Development Plan.
(vii) For any Joint Product in any particular Commercialization Territory, in the event a Party becomes the new Lead Regulatory Party, the other Party shall promptly provide to such new Lead Regulatory Party copies of or access to all non-clinical data, Clinical Data and other Information, results and analyses with respect to such Joint Product to the extent not already in possession of such new Lead Regulatory Party, as may be reasonably necessary for obtaining and maintaining Regulatory Approval for such Joint Product in such Commercialization Territory, including providing necessary documents or other materials required by Applicable Law to obtain and maintain Regulatory Approval.
(a) Regulatory Costs incurred by the Parties in connection with Development activities for a Product (and Development-related Manufacturing activities, including CMC Development for a Product) shall be allocated in the same manner as Development Costs for such Development activities for such Product.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(b) Regulatory Costs incurred by the Parties in connection with Commercialization activities for a Product (and Commercialization-related Manufacturing activities, including commercial supply activities for such Product): (i) shall be included as part of the Commercialization Costs in the Profit Share Region for such Product, if the Product is a Joint Product; and (ii) shall be solely borne by the Participating Party in the Royalty Region for such Product, if such Product is a Unilateral Product.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
sole responsibility of the Participating Party except to the extent that the recall or withdrawal is attributable to the negligence or willful misconduct of, or breach of this Agreement by, the Non-Participating Party, in which event the Non-Participating Party shall bear that portion of the recall expenses attributable thereto.
ARTICLE 7
C OMMERCIALIZATION OF J OINT P RODUCTS
7.1 Commercialization of Joint Products in a Commercialization Territory. The Parties shall Commercialize each Joint Product in the New Collaboration Field in a given Commercialization Territory within a Profit Share Region under the oversight of the JMC and the JEC, and pursuant to the Commercialization Plan applicable to each such Joint Product in the Profit Share Region. If a Joint Product receives Regulatory Approval for more than one Indication, Commercialization of such Joint Product for all Indications will be conducted pursuant to a single Commercialization Plan and led by a single LCP. In furtherance of the foregoing, each Party shall be obligated to (a) perform the number of PDEs for each Joint Product assigned to it in each applicable Commercialization Plan and (b) expend the amount of promotional funds with respect to each Joint Product required in each applicable Commercialization Plan, and each Party otherwise shall use Commercially Reasonable Efforts to Commercialize each Joint Product in the Profit Share Region pursuant to the applicable Commercialization Plan.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
each Commercial Summit the Parties shall discuss in good faith and attempt to agree upon a PDE Rate that will be applicable to each country in the Profit Share Region. If the Parties cannot agree upon the PDE Rate for any country in the Profit Share Region, the dispute shall be resolved pursuant to Section 17.6(d)(ii).
(i) In the U.S., Reata shall have the first right to be the LCP, and if Reata elects to be the LCP, Abbott shall have the right to be the SCP, with a right to Co- Promote such Joint Product in the U.S., at its election, as further provided in Section 7.7 below;
(ii) In Europe, Abbott shall have the first right to be the LCP, and if Abbott elects to be the LCP, Reata shall have the right to be the SCP, with the right to Co- Promote such Joint Product in any or all of the European Major Market Countries, at its election, as further provided in Section 7.7 below;
(iii) In Japan, Abbott shall have the first right to be the LCP, and if Abbott elects to be the LCP, Reata shall have the right to be the SCP, but if Reata is the SCP, it shall have no right to Co-Promote such Joint Product in Japan; and
(iv) If the ROW Region is a Profit Share Region, Abbott shall have the first right to be the LCP in all countries of the ROW Region, and if Abbott elects to be the LCP, Reata shall have the right to be the SCP, but if Reata is the SCP, it shall have no right to Co-Promote such Joint Product in any such countries.
(i) In the U.S. and Europe, Abbott shall have the first right to be the LCP in either the U.S. or Europe (or neither, but not both), and Reata shall have the right to be the SCP in whichever of such Commercialization Territories (if any) is selected by Abbott;
(ii) Reata shall have the first right to be the LCP in whichever (or both) of the U.S. or Europe for which Abbott has elected not to be the LCP pursuant to Section 7.3(b)(i) above, and Abbott shall have the right to be the SCP in such Commercialization Territory(ies) for which Reata has elected to be the LCP;
(iii) The SCP in the U.S. (whether Reata or Abbott) shall have right to Co-Promote in the U.S., at its election, as further provided in Section 7.7 below;
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(iv) If Abbott is the SCP in Europe, it shall have right to Co-Promote such Joint Product in any or all of the countries of Europe, at its election, as further provided in Section 7.7 below;
(v) If Reata is the SCP in Europe, it shall have the right to Co- Promote such Joint Product in any or all of the European Major Market Countries, at its election, as further provided in Section 7.7 below;
(vi) In Japan, Abbott shall have the first right to be the LCP, and if Abbott elects to be the LCP, Reata shall have the right to be the SCP, but if Reata is the SCP, it shall have no right to Co-Promote such Joint Product in Japan; and
(vii) If the ROW Region is a Profit Share Region, Abbott shall have the first right to be the LCP in all countries of the ROW Region, and if Abbott elects to be the LCP, Reata shall have the right to be the SCP, but if Reata is the SCP, it shall have no right to Co-Promote such Joint Product in any such countries.
(c) Third and Subsequent Joint Products . With respect to the third Joint Product and all subsequent Joint Products to reach such stage of Development and which are not Humira-Related Products:
(i) For the U.S. and Europe, beginning with Reata, the Parties shall alternate as to which has the first right to elect to be the LCP (the “ Selecting Party ”) in either (or neither) but not both of such Commercialization Territories; and the other Party shall have the right to be the SCP in such selected Commercialization Territory, if any;
(ii) The non-Selecting Party shall have the right to be the LCP in whichever (or both) of the U.S. or Europe for which the Selecting Party has elected not to be the LCP pursuant to Section 7.3(c)(i) above, and the Selecting Party shall have the right to be the SCP in such Commercialization Territory(ies) for which the non-Selecting Party has elected to be the LCP;
(iii) The SCP in the U.S. (whether Reata or Abbott) shall have right to Co-Promote such Joint Product in the U.S., at its election, as further provided in Section 7.7 below;
(iv) The SCP in Europe (whether Reata or Abbott) shall have right to Co-Promote such Joint Product in any or all of the countries of Europe, at its election, as further provided in Section 7.7 below;
(v) The non-Selecting Party shall have the first right to elect to be the LCP in up to two (2) of the following Commercialization Territories: (A) Japan, (B) the Asia Territory (if it is in the Profit Share Region), (C) Latin America (if it is in the Profit Share Region), and (D) the ROW Territory (if it is in the Profit Share Region). The Selecting Party shall have the right to be the LCP in whichever Commercialization Territories are not selected by the non-Selecting Party (and which are in Profit Share Regions). By way of example,
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
assuming the ROW Region is a Profit Share Region, if Abbott is the Selecting Party under Section 7.3(c)(i) and elects to be the LCP in the U.S., then Reata shall have the right to be the LCP in Europe pursuant to Section 7.3(c)(ii), and shall further have the first right to elect to be the LCP pursuant to this Section 7.3(c)(v) in two out of the following: Japan, Asia Territory, Latin America, and the ROW Territory. Continuing such example, if Reata exercises such first right by electing to be the LCP in Japan and the Asia Territory, then Abbott shall have the right to be the LCP in Latin America and the ROW Territory. In each Commercialization Territory, the Party that is not the LCP shall have the right to be the SCP, and shall have the right to Co- Promote the Joint Product in all countries of such Commercialization Territory, at its election and as further provided in Section 7.7 below.
(e) No Obligation to be LCP or SCP . Notwithstanding the foregoing Sections 7.3(a) through 7.3(d), but subject to Section 7.4, a Party having the right to be the LCP shall not be required to be the LCP in any given Commercialization Territory, and if it declines such right, the other Party shall have the right to be the LCP in such Commercialization Territory; it being understood that neither Party shall have the authority to require the other Party to be the LCP. Similarly, a Party having the right to be the SCP shall not be required to be the SCP in the applicable Commercialization Territory, and if it declines such right, the LCP shall, in addition to its role as the LCP, carry out those Commercialization responsibilities that would otherwise have been allocated to the SCP. If, as to any given Commercialization Territory for a Joint Product, neither Party desires to be the LCP, then the Parties, through the JMC, shall discuss the matter and endeavor to agree as to the use of one or more Third Parties to act as the LCP or otherwise take the lead role in the Commercialization of such Joint Product in such Commercialization Territory. Any payments made under any arrangement with any such Third Party to either Party in exchange for such Commercialization Rights, whether in the form of upfront payments, milestones, Net Sales of Joint Product, profit share or royalties shall be deemed “ Sublicense Revenue ” and shared equally by the Parties as part of the Operating Profit (or Operating Loss), and all costs incurred in connection with the establishment of such Third Party arrangement shall be Commercialization Costs.
(a) As further described in this section 7.4, the strategy for the commercial launch of, and subsequent Commercialization of, each Joint Product in each Commercialization Territory shall be described in a comprehensive plan (each such plan, and any revisions thereto, a “ Commercialization Plan ”) for such Commercialization Territory that describes: (a) the pre-launch, launch and subsequent Commercialization activities for such Joint Product in the Commercialization Territory
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(including promotional messaging, branding (including Product Trademarks), pricing, advertising, planning, marketing, sales force training); (b) key tactics for implementing those activities; (c) the responsibilities for implementing those activities assigned to each of the Parties; (d) the Detailing plan (including the number of Sales Representatives to be provided by the Parties and the number of PDEs required to be performed by the Parties in each applicable country in the Commercialization Territory during each Calendar Quarter); (e) Phase IV Studies and Medical Affairs Activities; (f) the brand elements for such Joint Product throughout the Profit Share Region, including the applicable key distinctive colors, logos, images, and symbols, and Trademarks (including the Product Trademarks) to be used in connection therewith (consistent with Section 7.9); and (g) a comprehensive budget of the projected costs for executing such activities for such Joint Product in the Commercialization Territory (which budget shall include required amounts of promotional funds to be expended by the Parties). The Parties may agree on a single Commercialization Plan to cover multiple Joint Products. Each Commercialization Plan and all subsequent revisions thereto shall contain the information described above in this Section 7.4(a) and any other information the JMC believes is necessary or useful for the successful commercial launch and subsequent Commercialization of such Joint Product. The Parties acknowledge that certain items of the Commercialization Plan may not be amenable to determination at the time the Commercialization Plan is initially drafted. In such event, the Parties shall amend such plan pursuant to Section 7.4(b) to include such items when appropriate. In the event of any inconsistency between a Commercialization Plan and this Agreement, the terms of this Agreement shall control.
(b) The applicable JMC shall develop for approval by the JEC a proposed Commercialization Plan for each Joint Product for each Commercialization Territory at least [***] months prior to the then-current date of expected First Commercial Sale for such Joint Product in the Commercialization Territory as determined by such JMC (such date, the “ Anticipated Launch Date ” for such Joint Product). In addition, the JMC shall prepare and provide to the JEC for approval by [***]of each year an updated Commercialization Plan for the following Calendar Year. The JMC may also prepare amendments to the Commercialization Plan from time to time during the Calendar Year. If the JMC or JEC cannot agree on any amendment to any such Commercialization Plan, the matter shall be resolved [***].
(c) In the event the JMC cannot agree on a Commercialization Plan (or any amendment thereto, including each annual update) to be submitted to the JEC within [***] days after consideration thereof, then such matter shall be referred to the JEC for resolution. In the event the JEC cannot agree on a Commercialization Plan (or any amendment thereto, including each annual update) within [***] days after consideration thereof, then such matter shall be referred to the Senior Officers of the Parties for resolution. If such Senior Officers cannot reach resolution on the matter within a [***])-day period [***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
7.7 Co-Promotion by the SCP .
(a) Co-Promotion Option. As and to the extent provided in Section 7.3, the SCP in a given Commercialization Territory in the Profit Share Region shall have the right to Co-Promote the Joint Product on the terms and conditions set forth in this Section 7.7. A Joint Product Co-Promoted under the same Product Trademark by both Parties under this Article 7 is referred to herein as a “ Co-Promotion Product .”
(c) Terms of Co-Promotion Agreement .
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Costs). Under the Co-Promotion Agreement, the LCP shall have the right to make all final decisions with respect to the Co-Promotion arrangement (consistent with the applicable Commercialization Plan), including call plans and assigned territories, the total number of PDEs required to be performed by the SCP (in accordance with Section 7.7(c)(ii)), the Promotional Materials to be used, the training and testing applicable to such Sales Representatives, and restrictions with respect to the ability of such Sales Representatives to Detail other products.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(a) if the Shortfall Party fails to perform [***] percent ([***]%) (but performs at least [***] percent ([***]%) of the Required PDEs in a country for any Calendar Quarter during the period commencing on the date of First Commercial Sale of such Joint Product in such country and ending [***] years after such date of First Commercial Sale (the “ Launch Period ”), then, not later than [***] days after the end of such Calendar Quarter, the Shortfall Party shall pay to the other Party an amount equal to (A) the difference between (i) the number of Required PDEs for such country for such Calendar Quarter, less (ii) the number of PDEs actually performed by the Shortfall Party for such country for such Calendar Quarter; multiplied by (B) the PDE Rate for such country for such Calendar Quarter, multiplied by (C) five (5);
(b) if the Shortfall Party fails to perform at least [***] percent ([***]%) of the Required PDEs in a country for [***] during the Launch Period, then, not later than [***] days after the end of [***], the Shortfall Party shall pay to the other Party an amount equal to (A) the difference between (i) the number of Required PDEs for such country for such Calendar Quarter, less (ii) the number of PDEs actually performed by the Shortfall Party for such country for such Calendar Quarter; multiplied by (B) the PDE Rate for such country for such Calendar Quarter, multiplied by (C) ten (10);
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(c) if the Shortfall Party fails to perform [***] percent ([***]%) (but performs at least [***] percent ([***]%) of the Required PDEs in a country for [***] after the Launch Period, then, not later than [***] days after the end of [***], the Shortfall Party shall pay to the other Party an amount equal to (A) the difference between (i) the number of Required PDEs for such country for such Calendar Quarter, less (ii) the number of PDEs actually performed by the Shortfall Party for such country for such Calendar Quarter; multiplied by (B) the PDE Rate for such country for such Calendar Quarter, multiplied by (C) two and one-half (2.5); and
(d) if the Shortfall Party fails to perform at least [***] percent ([***]%) of the Required PDEs in a country for [***] after the Launch Period, then, not later than [***] days after the end of [***], the Shortfall Party shall pay to the other Party an amount equal to (A) the difference between (i) the number of Required PDEs for such country for such Calendar Quarter, less (ii) the number of PDEs actually performed by the Shortfall Party for such country for such Calendar Quarter; multiplied by (B) the PDE Rate for such country for such Calendar Quarter, multiplied by (C) five (5).
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
anti-bribery laws. Each Party and its Affiliates shall have a system of internal accounting controls in place that are sufficient to provide reasonable assurances of compliance as required by the FCPA, and shall obtain certification from any permitted sublicensee or distributor it or its Affiliates may engage with respect to Joint Products to do the same, to bring any material non-compliance therewith (should it ever occur) by any of the foregoing entities to its attention, and to promptly remedy any such non-compliance. Each Party and its Affiliates shall maintain such controls throughout the Term and shall promptly notify the JMC in writing with respect to any material non-compliance regarding Commercialization of Joint Products.
ARTICLE 8
C OMMERCIALIZATION OF U NILATERAL P RODUCTS
8.1 Rights of Unilateral Party. The applicable Participating Party shall have the sole right to Commercialize Unilateral Products in the New Collaboration Field in any Royalty Region at its own cost and expense (except as otherwise expressly provided herein).
8.3 Where Unilateral Product is also a Joint Product. Where a Unilateral Product in a Royalty Region is also a Joint Product in a Profit Share Region:
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
ARTICLE 9
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
9.2 Manufacturing Plan for Joint Products .
(c) Manufacturing Responsibilities under the Manufacturing Plan. Unless the Parties agree in writing upon an alternate allocation of responsibility, the Parties agree that the Lead Manufacturing Party shall have primary operational responsibility for: (i) executing the Manufacturing Plan as in effect from time to time for the Profit Share Territory; (ii) the Manufacturing of Joint Product in accordance with the Manufacturing Plan; and (iii) the preparation of the CMC sections of the Drug Approval Applications for such Joint Product and any follow-on correspondence and discussions with the applicable Regulatory Authorities in connection therewith.
(d) Lead Manufacturing Party and Backup Supplier for Joint Product. Xxxxxx shall serve as the lead manufacturing Party for the commercial supply for the Profit Share Region (the “ Lead Manufacturing Party ” or “ LMP ”) of the first Joint Product. Reata shall serve as the LMP for the second Joint Product; thereafter, the Parties shall alternate as LMPs for subsequent Joint Products. The Party that is not the LMP shall have the right, but not the obligation, to serve as the backup supplier for a Joint Product.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(a) At the transferee Party’s reasonable request, the transferring Party shall make available, and shall use Commercially Reasonable Efforts to cause its Third Party manufacturers to make available (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), to the transferee Party (or its Affiliate or designated Third Party manufacturer, as applicable), all of the transferring Party’s Manufacturing Information and materials relating to the Manufacturing Process, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to materials to be used and control methods, that are reasonably necessary or useful to enable the transferee Party (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice the Manufacturing Process;
(b) At the transferee Party’s reasonable request, the transferring Party shall cause all appropriate employees and representatives of the transferring Party and its Affiliates to meet with, and shall use Commercially Reasonable Efforts to cause all appropriate employees and representatives of its Third Party manufacturers to meet with (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), employees or representatives of the transferee Party (or its Affiliate or designated Third Party manufacturer, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of the Manufacturing Process and with the training of the personnel of the transferee Party (or its Affiliate or designated Third Party manufacturer, as applicable) to the extent reasonably necessary or useful to enable the transferee Party (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice the Manufacturing Process;
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(c) Without limiting the generality of clause 9.4(b) above, at the transferee Party’s reasonable request, the transferring Party shall cause all appropriate analytical and quality control laboratory employees and representatives of the transferring Party and its Affiliates to meet with, and shall use Commercially Reasonable Efforts to cause all appropriate analytical and quality control laboratory employees and representatives of its Third Party manufacturers to meet with (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), employees or representatives of the transferee Party (or its Affiliate or designated Third Party manufacturer, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the transfer of all applicable analytical methods and the validation thereof (including, all applicable Information, methods, validation documents and other documentation, materials and sufficient supplies of all primary and other reference standards);
(d) At the transferee Party’s reasonable request, the transferring Party shall take such steps, and shall use Commercially Reasonable Efforts to cause its Third Party manufacturers to take such steps (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), as are reasonably necessary or useful to assist in reasonable respects the transferee Party (or its Affiliate or designated Third Party manufacturer, as applicable) in obtaining any necessary licenses, permits, or approvals from Regulatory Authorities with respect to the Manufacture of the Products and New Collaboration Compounds at the applicable facilities; and
(e) At the transferee Party’s reasonable request, the transferring Party shall provide, and shall use Commercially Reasonable Efforts to cause its Third Party manufacturers to provide (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), such other assistance as the transferee Party (or its Affiliate or designated Third Party manufacturer, as applicable) may reasonably request to enable the transferee Party (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice the Manufacturing Process and otherwise to Manufacture the Products and New Collaboration Compounds.
For each Joint Product, the reasonable out-of-pocket costs paid to Third Parties by or on behalf of the Parties in connection with each Technology Transfer, in each case incurred directly as a result of performing each Technology Transfer, shall be Development Costs or Commercialization Costs, as applicable.
For each Unilateral Product, the reasonable out-of-pocket costs paid to Third Parties by or on behalf of the Parties in connection with each Technology Transfer, in each case incurred directly as a result of performing each Technology Transfer, shall be borne by the Participating Party that requests such Technology Transfer.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
ARTICLE 10
L ICENSES A ND E XCLUSIVITY
(i) an exclusive (including with regard to Reata and its Affiliates) license (or sublicense), with the right to grant sublicenses in accordance with Section 10.2, under the Reata Patents, Reata Know-How and Reata’s interest in Joint Patents and Joint Know-How, to import, offer to sell and sell in the New Collaboration Field (A) those Joint Products in those countries of the Territory for which Xxxxxx is designated as LCP under and in accordance with the terms of this Agreement and (B) those Unilateral Products in those countries of the Territory for which Xxxxxx is the Participating Party under and in accordance with the terms of this Agreement;
(ii) an exclusive (including with regard to Reata and its Affiliates) license and right of reference, with the right to grant sublicenses and further rights of reference in connection with the grant of sublicenses in accordance with Section 10.2 under the grants in Section 10.1(a)(i), under the Regulatory Approvals and any other Regulatory Documentation that Reata or any of its Affiliates may Control with respect to New Collaboration Compounds or Products, to import, offer to sell and sell in the New Collaboration Field (A) those Joint Products in those countries of the Territory for which Abbott is designated as LCP under and in accordance with the terms of this Agreement and (B) those Unilateral Products in those countries of the Territory for which Abbott is the Participating Party under and in accordance with the terms of this Agreement;
(iii) a co-exclusive (together with Reata and its Affiliates) license (or sublicense), with the right to grant sublicenses in accordance with Section 10.2, under the Reata Patents, Reata Know-How and Reata’s interest in Joint Patents and Joint Know-How, to (A) Develop, Manufacture, have Manufactured, and obtain, maintain, and hold Regulatory Approvals for, New Collaboration Compounds and Products in the New Collaboration Field in the Territory and (B) Commercialize (other than importing, offering to sell or selling) Products in the New Collaboration Field in the Territory;
(iv) a co-exclusive (together with Reata and its Affiliates) license and right of reference, with the right to grant sublicenses and further rights of reference in connection with the grant of sublicenses in accordance with Section 10.2 under the grants in Section 10.1(a)(iii), under the Regulatory Approvals and any other Regulatory Documentation that Reata or any of its Affiliates may Control with respect to New Collaboration Compounds
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
or Products, to (A) Develop, Manufacture, have Manufactured, and obtain, maintain, and hold Regulatory Approvals for, New Collaboration Compounds and Products in the New Collaboration Field in the Territory and (B) Commercialize (other than importing, offering to sell or selling) Products in the New Collaboration Field in the Territory;
(v) subject to Sections 7.9, 8.3(b) and 12.9, a non-exclusive license, without the right to grant sublicenses, except in connection with the grant of sublicenses pursuant to Section 10.2 under the grants in Section 10.1(a), to use Reata’s corporate names solely as required to comply and solely in accordance with Sections 7.9 and 8.3(b) and for no other purpose; and
(vi) a non-exclusive license (or sublicense), with the right to grant sublicenses through multiple tiers, under the Reata Know-How from and after the end of the Exclusivity Period for any and all purposes in the New Collaboration Field except as expressly prohibited under this Agreement (including under Section 10.6).
(i) an exclusive (including with regard to Abbott and its Affiliates) license (or sublicense), with the right to grant sublicenses in accordance with Section 10.2, under the Abbott Patents, Abbott Know-How and Xxxxxx’x interest in Joint Patents and Joint Know-How, to import, offer to sell and sell in the New Collaboration Field (A) those Joint Products in those countries of the Territory for which Reata is designated as LCP under and in accordance with the terms of this Agreement and (B) those Unilateral Products in those countries of the Territory for which Reata is the Participating Party under and in accordance with the terms of this Agreement;
(ii) an exclusive (including with regard to Abbott and its Affiliates) license and right of reference, with the right to grant sublicenses and further rights of reference in connection with the grant of sublicenses in accordance with Section 10.2 under the grants in Section 10.1(b)(i), under the Regulatory Approvals and any other Regulatory Documentation that Abbott or any of its Affiliates may Control with respect to New Collaboration Compounds or Products, to import, offer to sell and sell in the New Collaboration Field (A) those Joint Products in those countries of the Territory for which Reata is designated as LCP under and in accordance with the terms of this Agreement and (B) those Unilateral Products in those countries of the Territory for which Reata is the Participating Party under and in accordance with the terms of this Agreement;
(iii) a co-exclusive (together with Abbott and its Affiliates) license (or sublicense), with the right to grant sublicenses in accordance with Section 10.2, under the Abbott Patents, Abbott Know-How and Xxxxxx’x interest in Joint Patents and Joint Know- How, to (A) Develop, Manufacture, have Manufactured, and obtain, maintain, and hold Regulatory Approvals for, New Collaboration Compounds and Products in the New Collaboration Field in the Territory and (B) Commercialize (other than importing, offering to sell or selling) Products in the New Collaboration Field in the Territory;
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(iv) a co-exclusive (together with Abbott and its Affiliates) license and right of reference, with the right to grant sublicenses and further rights of reference in connection with the grant of sublicenses in accordance with Section 10.2 under the grants in Section 10.1(b)(iii), under the Regulatory Approvals and any other Regulatory Documentation that Abbott or any of its Affiliates may Control with respect to New Collaboration Compounds or Products, to (A) Develop, Manufacture, have Manufactured, and obtain, maintain, and hold Regulatory Approvals for, New Collaboration Compounds and Products in the New Collaboration Field in the Territory and (B) Commercialize (other than importing, offering to sell or selling) Products in the New Collaboration Field in the Territory;
(v) subject to Sections 7.9, 8.3(b) and 12.9, a non-exclusive license, without the right to grant sublicenses, except in connection with the grant of sublicenses pursuant to Section 10.2 under the grants in Section 10.1(b), to use Xxxxxx’x corporate names solely as required to comply and solely in accordance with Sections 7.9 and 8.3(b) and for no other purpose; and
(vi) a non-exclusive license (or sublicense), with the right to grant sublicenses through multiple tiers, under the Abbott Know-How from and after the end of the Exclusivity Period for any and all purposes in the New Collaboration Field except as expressly prohibited under this Agreement (including under Section 10.6).
As used in this Section 10.1, “co-exclusive” shall mean that the Person granting the license and the licensee shall have the right to Exploit the intellectual property rights granted under such license (by itself or together with its Affiliates), but shall not have the right to further license (in the case of the Person granting the license) or sublicense (in the case of the licensee) such rights to a Third Party except in accordance with Section 10.2 below.
10.2 Sublicenses and Subcontracting .
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
whether such other Party desires to take on the activities proposed to be licensed or sublicensed (but the Participating Party shall be under no obligation to engage such other Party as the subcontractor); or (iii) in connection with the settlement of any Joint Product Infringement, Unilateral Product Infringement or Field Infringement pursuant to Section 12.3.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(a) During the Research Term and for a period of [***] years ([***]) thereafter (the “ Exclusivity Period ”), the Parties shall not, and shall cause their respective Affiliates not to, directly or indirectly (including by licensing, authorizing, appointing, or otherwise enabling any Third Party to do so), develop, manufacture or commercialize any Targeted AIM other than an Exempt AIM, or any product containing a Targeted AIM other than an Exempt AIM, in each case in the New Collaboration Field in the Territory except pursuant to the Parties’ activities under and in accordance with this Agreement.
(b) During the Term following the end of the Exclusivity Period, the Parties shall not, and shall cause their respective Affiliates not to, directly or indirectly (including by licensing, authorizing, appointing, or otherwise enabling any Third Party to do so), develop, manufacture or commercialize: (i) any Targeted AIM other than an Exempt AIM, or any product containing a Targeted AIM other than an Exempt AIM, in each case in an Active Indication or any Related Indication for an Active Indication, or (ii) any Targeted AIM that is part of the New Collaboration Compound Pool as of the end of the Exclusivity Period, or any product containing such a Targeted AIM, in each case ((i) and (ii)) in the New Collaboration Field in the Territory except pursuant to the Parties’ activities under and in accordance with this Agreement (including Section 5.7 and Section 5.8).
(c) Following the end of the Exclusivity Period, nothing herein shall restrict either Party or its Affiliates from, directly or indirectly (including by licensing, authorizing, appointing, or otherwise enabling any Third Party to do so), developing, manufacturing or commercializing Targeted AIMs that are not in the New Collaboration Compound Pool as of the end of the Exclusivity Period for any indication except a then-Active Indication or any Related Indication for a then-Active Indication, and nothing herein shall require the Parties to share Information with or coordinate such development, manufacturing or commercialization activities with the other Party.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(d) During the Term, each Party shall not, and shall cause its Affiliates not to, directly or indirectly (including by licensing, authorizing, appointing, providing Product or funding to, or otherwise enabling any Third Party to do so), conduct any Clinical Study with a New Collaboration Compound in which a product of the other Party or its Affiliate is used as a comparator except to the extent such a Clinical Study is required or recommended by a Regulatory Authority or as otherwise approved by the other Party.
ARTICLE 11
(i) Each Party shall promptly inform the other Party if such Party determines that it is likely to overspend or underspend by more than [***] percent ([***]%) its respective aggregate budgeted costs and expenses under the Joint Exploratory Development Plan or any Joint Plan for Development activities conducted thereunder and shall provide the other Party with a reasonably detailed explanation for such anticipated overspend or underspend. If the Parties agree, the budget set forth in the Joint Exploratory Development Plan or any Joint Plan for Development activities may be amended to address such overspend or underspend.
(ii) The portion of any overspend that is less than or equal to [***] percent ([***]%) of a Party’s respective aggregate budgeted costs and expenses set forth in the Joint Exploratory Development Plan or such Joint Plan, as applicable, shall be included in Development Costs and shared by the Parties in accordance with the terms hereof.
(iii) If a Party exceeds its aggregate budgeted costs and expenses by more than [***] percent ([***]%), the Party that has so exceeded its budget shall provide to the JEC a full explanation for exceeding such aggregate budgeted costs under the Joint Exploratory Development Plan or such Joint Plan, as applicable. If and to the extent that any such overspend in excess of [***] percent ([***]%) was outside the reasonable control of the applicable Party and not caused by the negligence or willful misconduct of, or breach of this Agreement by, such Party, then provided that the applicable Party has promptly notified the other Party of such overspend and used reasonable efforts to mitigate the size of such overspend, such overspend shall be included in Development Costs and shared by the Parties in accordance with the terms hereof.
(iv) To the extent that any overspend is not included in Development Costs as provided in Section 11.2(b)(iii), the Party that has exceeded its budget shall be solely responsible for the overspend.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
paid less than its share of Development Costs during such Calendar Quarter shall make reconciling payments to the other Party to achieve the appropriate allocation of Development Costs provided for herein.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
11.4 Royalties .
(i) For each Unilateral Product for which the Non-Participating Party has co-funded Phase III Development for the U.S./Europe/Japan Region only (i.e., such Product is a Joint Product in U.S./Europe/Japan Region and a Unilateral Product only in the ROW Region), the royalty rate applicable to Net Sales of such Unilateral Product shall be sixteen percent (16%).
(ii) For each Unilateral Product for which the Non-Participating Party has co-funded Phase IIb Development (or has exercised its Pre-Phase III Opt-In) but has not co-funded any further Development for such Unilateral Product, the royalty rate applicable to Net Sales of such Unilateral Product shall be thirteen percent (13%).
(iii) For each Unilateral Product for which the Non-Participating Party has co-funded Pre-Phase IIb Development (or has exercised its Pre-Phase IIb Opt-In) but has not co-funded any further Development for such Unilateral Product, the royalty rate applicable to Net Sales of such Unilateral Product shall be eight percent (8%).
(iv) For each Unilateral Product for which the Non-Participating Party has co-funded Exploratory Development but has not co-funded any further Development for such Unilateral Product, the royalty rate applicable to Net Sales of such Unilateral Product shall be six percent (6%).
(v) For each Unilateral Product for which the Non-Participating Party has not co-funded any Development activities (other than Unilateral Products containing a Unilateral Acquired AIM of the Participating Party), the royalty rate applicable to Net Sales of such Unilateral Product shall be five percent (5%).
(vi) For each Unilateral Product that contains a Unilateral Acquired AIM of the Participating Party, the royalty rate applicable to Net Sales of such Unilateral Product shall be five percent (5%).
(vii) For each Unilateral Product that becomes a Unilateral Product through an AIM Acquiring Party’s opting-out after the First Commercial Sale of such Product pursuant to Section 5.10(c), the royalty rate applicable to Net Sales of such Unilateral Product shall be twenty percent (20%).
(viii) In addition, for each Unilateral Product that is a Humira-Related Product and for which Abbott is the Participating Party, Abbott shall pay to Reata an additional royalty of three percent (3%) on Net Sales of such Unilateral Product for royalties payable under Sections 11.4(a)(i) or (ii) above, as the case may be.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(c) Adjustments to Royalties .
Provided, however, that regardless of the adjustment mechanisms of clauses (i) – (iv) above, the royalties that would otherwise be payable to the Non-Participating Party with respect to a Unilateral Product pursuant to Section 11.4(a) shall not be reduced by more than fifty percent (50%) in any given Calendar Quarter. Reductions in royalties pursuant to the adjustment mechanisms of clauses (i) – (iv) above that are not used to reduce the royalties due in a particular Calendar Quarter on account of the previous sentence shall be carried over to subsequent Calendar Quarters until fully used in accordance with clauses (i) – (iv) above.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(a) Deduction or Withholding of Tax. Any payments that are payable by one Party (the “ Payer Party ”) to the other Party (the “ Receiving Party ”) pursuant to this Agreement (each a “ Payment ”) shall not be reduced on account of any taxes unless required by Applicable Laws. The Payer Party shall deduct or withhold from the Payments any taxes that it is required by Applicable Laws to deduct or withhold on Receiving Party’s behalf. If any Payment is subject to a deduction or withholding of tax, the Receiving Party and Payer Party shall use commercially reasonable efforts to perform all acts (including by executing all appropriate documents) so as to enable Receiving Party to take advantage of any applicable double taxation agreement or treaty. In the event there is no applicable double taxation agreement or treaty, or if an applicable double taxation agreement or treaty reduces but does not eliminate such tax, Payer Party shall pay the applicable tax to the appropriate government
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
authority, shall deduct the amount paid from the amount due Receiving Party, and shall provide to Receiving Party evidence of such payment within [***] days following such payment. If Payer Party has not received evidence, in a form satisfactory to Payer Party, at least [***] days prior to the time that a Payment is due, of Receiving Party’s entitlement under an applicable treaty to a reduced rate or elimination of the applicable tax, Payer Party may withhold with respect to such Payment as if no double taxation agreement or treaty applied.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Arbitrator, which shall spell out the specific procedures that the Arbitrator shall perform in order to reach a decision. The Parties shall make available to the Arbitrator all working papers and supporting documents required by the Arbitrator to fulfill its obligations under the engagement letter. The decision of the Arbitrator shall be final and the costs of such arbitration as well as the initial audit shall be borne between the Parties in such manner as the Arbitrator shall determine. Not later than [***] days after such decision and in accordance with such decision, the audited Party shall pay the additional amounts, with interest as provided in Section 11.7, or the auditing Party shall reimburse such excess payments, as applicable.
ARTICLE 12
12.1 Ownership of Inventions .
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(i) The LCP with respect to a Joint Product shall have the sole right to make all filings for such Joint Product with Regulatory Authorities in the applicable Commercialization Territory with respect to Xxxxxx Patents, Reata Patents, and Joint Patents as required or allowed in connection with the Orange Book in the U.S. or under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents, provided that the LCP shall consult with the other Party and the JPC to determine the course of action with respect to such filings. The other Party shall (A) provide to the LCP all Information, including a correct and complete list of its Patents covering the applicable Joint Product or otherwise reasonably necessary or useful to enable the LCP to make such filings with Regulatory Authorities in the Commercialization Territory with respect to such Patents, and (B) cooperate with the LCP’s reasonable requests in connection therewith, including meeting any submission deadlines, in each case, to the extent required or permitted by Applicable Law.
(ii) The Participating Party with respect to a Unilateral Product shall have the sole right to make all filings for such Unilateral Product with Regulatory Authorities in the applicable Royalty Region with respect to Xxxxxx Patents, Reata Patents, and Joint Patents as required or allowed in connection with the Orange Book in the U.S. or under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents, provided that the Participating Party shall consult with the Non-Participating Party and the JPC to determine the course of action with respect to such filings. The Non- Participating Party shall (i) provide to the Participating Party all Information, including a correct and complete list of its Patents covering the applicable Unilateral Product or otherwise reasonably necessary or useful to enable the Participating Party to make such filings with Regulatory Authorities in the Royalty Region with respect to such Patents, and (ii) cooperate with the Participating Party’s reasonable requests in connection therewith, including meeting any submission deadlines, in each case, to the extent required or permitted by Applicable Law.
12.2 Maintenance and Prosecution of Patents .
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
requests and suggestions provided by Xxxxxx. Reata shall not initiate any such adversarial patent office proceeding relating to a Reata Patent in the Territory without first consulting Xxxxxx. In the event that Xxxxx decides not to prepare, file, prosecute, or maintain a Reata Patent in a country in the Territory, Reata shall provide reasonable prior written notice to Xxxxxx of such intention (which notice shall, in any event, be given no later than [***] days prior to the next deadline for any action that may be taken with respect to such Reata Patent in such country), and Xxxxxx shall thereupon have the option, in its sole discretion, to assume the control and direction of the preparation, filing, prosecution, and maintenance of such Reata Patent in such country on Xxxxx’s behalf. Upon Xxxxxx’x written acceptance of such option, Xxxxxx shall assume the responsibility and control for the preparation, filing, prosecution, and maintenance of such specific Reata Patent, as well as all costs that accrue in connection therewith. In such event, Reata shall reasonably cooperate with Xxxxxx in such country as provided under Section 12.2(c).
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(i) executing all papers and instruments, or requiring its employees or contractors to execute such papers and instruments, so as to (A) effectuate the ownership of intellectual property set forth in Sections 12.1(a) and 12.1(b), (B) enable the other Party to apply for and to prosecute Patent applications in the Territory, and (C) obtain and maintain any Patent extensions, supplementary protection certificates, and the like with respect to the Reata Patents, Xxxxxx Patents, and Joint Patents in the Territory, each of (A), (B), and (C) to the extent provided for in this Agreement;
(ii) consistent with this Agreement, assisting in any license registration processes with applicable Governmental Authorities that may be available in the Territory for the protection of a Party’s interests in this Agreement; and
(iii) promptly informing the other Party of any matters coming to such Party’s attention that may materially affect the preparation, filing, prosecution, or maintenance of any such Reata Patents, Xxxxxx Patents, or Joint Patents in the Territory.
In addition, each Party agrees to use reasonable efforts to promptly provide to the other Party notice and copies of (or citations to) any publications that such Party’s intellectual property personnel (and such Party’s scientific and technical personnel working with such intellectual property personnel) involved in either the intellectual property diligence review conducted by such Party in anticipation of executing this Agreement, or involved in the patent prosecution or enforcement related activities provided for in this Agreement, reasonably believe would constitute prior art required to be disclosed in any patent applications within the other Party’s Patent or Joint Patents (to the extent not already disclosed therein) to the extent such personnel become reasonably aware of such publications and their relationship to the other Party’s Patent or Joint Patents.
(d) Patent Term Extension and Supplementary Protection Certificate .
(i) Upon receiving Regulatory Approval for a Joint Product in any country in the Territory, the Parties shall coordinate the application for any patent term extension or supplementary protection certificates that may be available, and the Parties shall determine jointly, through their representatives on the JPC, for which Patent(s) the Parties shall apply for patent term extension for such Joint Product in the Profit Share Region. If the JPC cannot agree on the patents that should be the subject of the application for patent term extension in a particular country in the Profit Share Region within [***] days, subject to clause (iii) below the LCP shall have the right to determine for which Patent(s) the Parties shall apply for patent term extension or supplementary protection certificate for a particular Joint Product in the Profit Share Region. The LCP shall have the primary responsibility of applying
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
for any patent term extension or supplementary protection certificate for a particular Joint Product in the Profit Share Region. The LCP shall keep the other Party fully informed of its efforts to obtain such extension or supplementary protection certificate. The other Party shall provide prompt and reasonable assistance, as requested by the LCP, including by taking such action as patent holder as is required under any Applicable Law to obtain such patent extension or supplementary protection certificate. Expenses in regard to obtaining the extension or supplementary protection certificate for a Joint Product shall be Commercialization Costs.
(ii) The Participating Party shall have the right to determine for which Patent(s) it shall apply for patent term extension or supplementary protection certificate for a particular Unilateral Product in the applicable Royalty Region. The Participating Party shall have the primary responsibility of applying for any patent term extension or supplementary protection certificate for a particular Unilateral Product in the applicable Royalty Region. The Participating Party shall keep the Non- Participating Party fully informed of its efforts to obtain such extension or supplementary protection certificate. The Non- Participating Party shall provide prompt and reasonable assistance, as requested by the Participating Party, including by taking such action as patent holder as is required under any Applicable Law to obtain such patent extension or supplementary protection certificate. Expenses in regard to obtaining the extension or supplementary protection certificate for a Unilateral Product shall be borne solely by the Participating Party and shall not be Commercialization Costs.
(iii) Notwithstanding the foregoing, in the event that a particular Patent in a particular country claims the composition of matter of, or the method of making or using, multiple Products where for one (1) or more of such Products one Party is the LCP or Participating Party and for one (1) or more of such Products the other Party is the LCP or Participating Party, the Parties shall consult with each other as to for which Product the Parties shall apply for patent term extension or a supplementary protection certificate using such Patent in such country.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(g) Patents Licensed from Third Parties Each Party’s rights under this Section 12.3 with respect to any Collaboration Patent licensed to the other Party by a Third Party shall be subject to the rights of such Third Party to enforce such Collaboration Patent or defend against any claims that such Collaboration Patent is invalid or unenforceable.
12.4 Infringement Claims by Third Parties .
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Party may conduct and control the defense of any such claim, suit, or proceeding. Each Party shall keep the other Party reasonably informed of all material developments in connection with any such claim, suit, or proceeding. Each Party agrees to provide the other Party with copies of all pleadings filed in such action and to allow the other Party reasonable opportunity to participate in the defense of the claims. All out-of-pocket costs (including any payment made pursuant to a judgment or settlement) incurred by the LCP and the other Party in defending such claim shall constitute Commercialization Costs with respect to such Joint Product and be included in the calculation of Operating Profit or Loss. Any recoveries by the LCP of any sanctions awarded to the LCP and against a Third Party asserting a claim being defended under this Section 12.4 shall be applied as follows: such recovery shall be applied first to (i) reimburse the LCP for its reasonable out-of-pocket costs of defending such claim, and (ii) reimburse the other Party for its reasonable out-of-pocket costs of defending such claim (and to such extent shall not constitute Commercialization Costs). The balance of any such recoveries shall be included in Net Sales for the relevant Joint Product and included in the calculation of Operating Profit or Loss. In the event the claim is brought against a Joint Product in the Territory in a manner that would result in each Party controlling the defense of such claim in different countries of the world, then the Parties shall attempt to coordinate their efforts in conducting such defense through the JPC to form a joint defense strategy and plan of execution and to appoint one Party to lead such defense on the worldwide basis. In the absence of such an agreement, each Party shall have the right to take such action as it deems appropriate.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
12.5 Defense of Collaboration Patents .
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Costs for a particular New Collaboration Compound covered under the applicable Patents subject to such license (or, if such Patents cover more than one (1) New Collaboration Compounds, allocated by the JPC among the Development Costs for such New Collaboration Compounds), in each case prior to the First Commercial Sale of the Product containing such New Collaboration Compound. Thereafter, such Third Party Payments shall be included in Commercialization Costs for any Joint Product, or borne solely by the Participating Party for any Unilateral Product, subject to a royalty reduction as and to the extent provided in Section 11.4(c).
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
12.9 Trademarks, Corporate Logos and other Intellectual Property Rights .
(a) Ownership and Prosecution of Product Trademarks.
(i) With respect to each Joint Product in a Commercialization Territory, the LCP with respect to such Joint Product in such Commercialization Territory shall own all right, title, and interest to the Product Trademarks for such Joint Product in such Commercialization Territory, and shall be responsible for the clearance, registration, prosecution, and maintenance thereof; provided that the other Party shall have the right to provide input on the overall strategy for such registration, prosecution, and maintenance, and such LCP shall consider such input in good faith. The other Party shall provide all assistance and documents reasonably requested by the LCP in support of its prosecution, registration, and maintenance of the Product Trademarks.
(ii) With respect to each Unilateral Product in a Royalty Region, the Participating Party with respect to such Unilateral Product in such Royalty Region shall own all right, title, and interest to the Product Trademarks for such Unilateral Product in such Royalty Region, and shall be responsible for the clearance, registration, prosecution, and maintenance thereof.
(b) Enforcement of Product Trademarks.
(i) With respect to each Joint Product in a Commercialization Territory, the LCP with respect to such Joint Product in such Commercialization Territory shall have the first right to take such action as the LCP, after consultation with the other Party, deems necessary against a Third Party based on any alleged, threatened, or actual infringement, dilution, misappropriation, or other violation of, or unfair trade practices or any other like offense relating to, the Product Trademarks for such Joint Product in such Commercialization Territory by a Third Party. Subject to the foregoing, the other Party may elect at its expense to participate in the enforcement of such Product Trademarks. In the event that the LCP fails to assume responsibility for such enforcement, the other Party shall have the right to do so, with the LCP’s prior written consent, not to be unreasonably withheld.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(ii) With respect to each Unilateral Product in a Royalty Region, the Participating Party with respect to such Unilateral Product in such Royalty Region shall have the sole right to take such action as the Participating Party deems necessary against a Third Party based on any alleged, threatened, or actual infringement, dilution, misappropriation, or other violation of, or unfair trade practices or any other like offense relating to, the Product Trademarks for such Unilateral Product in such Royalty Region by a Third Party.
(i) With respect to each Joint Product in a Commercialization Territory, the LCP with respect to such Joint Product in such Commercialization Territory shall have the first right to defend against any alleged, threatened, or actual claim by a Third Party that the use or registration of the Product Trademarks for such Joint Product in such Commercialization Territory infringes, dilutes, misappropriates, or otherwise violates any Trademark or other right of such Third Party or constitutes unfair trade practices or any other like offense, or any other claims as may be brought by a Third Party against a Party in connection with the use of the Product Trademarks for such Joint Product in such Commercialization Territory. Subject to the foregoing, the other Party may elect at its expense to participate in the defense of the Product Trademarks. In the event that the LCP fails to assume responsibility for such defense, the other Party shall have the right to do so.
(ii) With respect to each Unilateral Product in a Royalty Region, the Participating Party with respect to such Unilateral Product in such Royalty Region shall have the sole right to defend against any alleged, threatened, or actual claim by a Third Party that the use or registration of the Product Trademarks for such Unilateral Product in such Royalty Region infringes, dilutes, misappropriates, or otherwise violates any Trademark or other right of such Third Party or constitutes unfair trade practices or any other like offense, or any other claims as may be brought by a Third Party against such Participating Party in connection with the use of the Product Trademarks for such Unilateral Product in such Royalty Region.
(d) The Trademark Costs incurred by each Party with respect to a Joint Product in the applicable Profit Share Region shall be included in Commercialization Costs. The Trademark Costs incurred by the Participating Party with respect to a Unilateral Product in the applicable Royalty Region shall be borne solely by the Unilateral Party. Any recoveries awarded to a Party in connection with an action under Section 12.9(b) or Section 12.9(c) shall be applied as follows: such recovery shall be applied first to reimburse the Parties for their Trademark Costs relating to such enforcement or defense, and any amounts remaining shall be allocated as follows: (x) for Joint Products, such amounts shall be deemed Net Sales of such Joint Product in the applicable Profit Share Region; and (y) for Royalty Products, such amounts shall be deemed Net Sales of the applicable Unilateral Product in the applicable Royalty Region.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(i) The LDP with respect to a Clinical Study under a Development Plan shall have the right (after consultation with the other Party in the case of the Joint Exploratory Development Plan or a Joint Plan) to select the Study Trademark, if any, with respect to such Clinical Study.
(ii) The provisions of Sections 12.9(a) through (d) shall apply to the ownership, clearance, prosecution, maintenance, enforcement and defense of Study Trademarks (and related Study Trademark Costs), mutatis mutandis , in each case with the applicable LDP substituted for the applicable LCP in each such provision and with applicable Study Trademark Costs allocated to Development Costs.
ARTICLE 13
R EPRESENTATIONS A ND W ARRANTIES ; C OVENANTS
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(a) All Reata Patents existing as of the Effective Date in the Territory (the “ Existing Patents ”) are listed on Schedule 13.2(a) . To Reata’s Knowledge, no issued patents included in the Existing Patents are invalid or unenforceable.
(b) There are no claims, judgments, or settlements against, or amounts with respect thereto (other than amounts owed to any patent office), owed by Reata or any of its Affiliates relating to the Existing Patents, or the Reata Know-How existing as of the Effective Date. As of the Effective Date, no claim or litigation has been brought or threatened by any Person alleging, and Xxxxx has no Knowledge of any claim, whether or not asserted, that (i) any issued patents included in the Existing Patents are invalid or unenforceable, or (ii) the disclosing, copying, making, assigning, or licensing of the inventions claimed by the Existing
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Patents, or the Reata Know-How, or the Development or Commercialization of Products containing any Effective Date AIMs as contemplated herein as of the Effective Date, violates or infringes, or would violate or infringe any intellectual property or proprietary right of any Person existing as of the Effective Date. “ Effective Date AIMs ” means New Collaboration Compounds Controlled by Reata or any of its Affiliates as of the Effective Date and claimed in any of the Reata Patents.
(c) Reata is the sole and exclusive owner of the Existing Patents listed on Schedule 13.2(a) (the “ Owned Patents ”) and the Reata Know-How existing as of the Effective Date free of any lien or claim of ownership by any Third Party and of any material encumbrance. Reata is entitled to grant the licenses specified herein. The Owned Patents constitute all of the Existing Patents.
(d) Reata has the right to use all Reata Know-How and the inventions claimed by Existing Patents that are necessary to conduct Joint Exploratory Development as set forth in the Joint Exploratory Development Plan existing as of the Effective Date. The Development or Commercialization of the Effective Date AIMs as contemplated herein is not subject as of the Effective Date to any other license or agreement to which Reata or any of its Affiliates is a party as of the Effective Date.
(e) During the Term, Reata shall not encumber or violate the rights granted to Xxxxxx hereunder with respect to the Reata Patents.
(f) To Reata’s Knowledge, the Existing Patents are being diligently prosecuted in the respective patent offices in accordance with Applicable Law. The Existing Patents have been filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment prior to the Effective Date.
(g) Reata has not previously assigned, transferred, licensed, conveyed, or otherwise encumbered its right, title, or interest under the Existing Patents or Reata Know-How in connection with the Development, Manufacture or Commercialization of the Effective Date AIMs (including by granting any covenant not to sue with respect thereto) (or any Patents or Information that would be Existing Patents or Reata Know-How but for such assignment, transfer, license, conveyance, or encumbrance) in the Territory in the New Collaboration Field, except (i) as provided in the agreements listed on Schedule 13.2(g) (the “ Academic Research Agreements ”) or (ii) where such assignment, transfer, license, conveyance, or encumbrance is terminated and no longer in force or effect, and it will not enter into any such agreements or grant any such right, title, or interest to any Person that is inconsistent with the rights and licenses granted to Xxxxxx under this Agreement.
(h) To Reata’s Knowledge, no Person is infringing or threatening to infringe the Existing Patents, or misappropriating or threatening to misappropriate the Reata Know- How existing as of the Effective Date.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(i) True, complete and correct copies (as of the Effective Date) of: (i) the file wrapper and other documents and materials relating to the prosecution, defense, maintenance, validity, and enforceability of the Owned Patents; (ii) the UT 2004 Agreement; (iii) the UT 2006 Agreement; and (iv) each of the Academic Research Agreements, in each case ((i), (ii), (iii) and (iv)) have been provided or made available to Xxxxxx prior to the Effective Date. As of the Effective Date, Xxxxx has disclosed to Xxxxxx (A) all material adverse information with respect to the safety and efficacy of the Existing Lead Compounds and the Development Candidates existing as of the Effective Date as to which Reata has Knowledge and (B) all material information and data with respect to RTA-408 and RTA-410 as to which Reata has Knowledge.
(j) To Reata’s Knowledge, the conduct of Joint Exploratory Development, Manufacturing of the Products containing the Effective Date AIMs (in the same formulation as they exist as of the Effective Date and using the same process as that used as of the Effective Date), and the Parties’ Commercialization of the Products containing the Effective Date AIMs as contemplated herein will not infringe any Patents or other intellectual property or proprietary right of any Person.
(k) To Reata’s Knowledge, the conception, development, and reduction to practice of the inventions claimed by the Existing Patents and Reata Know-How existing as of the Effective Date have not constituted or involved the misappropriation of trade secrets or other rights or property of any Person.
(l) To Reata’s Knowledge, in respect of the pending patent applications included in the Existing Patents, Reata has presented or will timely present all material references, documents, or information of which it and the inventors are aware to the relevant patent office, to the extent required by Applicable Law.
(m) The Existing Patents represent all Patents within Reata’s or its Affiliates’ Control relating to the Effective Date AIMs and the Products containing the Effective Date AIMs within the Territory as of the Effective Date.
(n) Each of the Existing Patents properly identifies each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Existing Patent is issued or such application is pending.
(o) Each Person who has or has had any rights in or to any Owned Patents, has assigned and has executed an agreement assigning its entire right, title, and interest in and to such Owned Patents to Reata.
(p) All rights in all inventions and discoveries, made, developed, or conceived by any employee or independent contractor of Reata during the course of their employment (or other retention) by Xxxxx, and relating to or included in Reata Know-How or that are the subject of one or more Existing Patents have been or will be assigned in writing to Reata.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(q) To Reata’s Knowledge, Reata has obtained the right (including under any Patents and other intellectual property rights) to use all Information and all other materials (including any formulations and manufacturing processes and procedures) developed or delivered by any Third Party under any agreements between Reata and any such Third Party with respect to the Effective Date AIMs as of the Effective Date, and Reata has the rights under each such agreement to transfer such Information or other materials to Xxxxxx and its designees and to xxxxx Xxxxxx the right to use such Know-How or other materials in the Development or Commercialization of the Effective Date AIMs or the Products containing the Effective Date AIMs as set forth in this Agreement.
(r) All information, documentation, and other materials furnished or made available by Reata upon the request of Xxxxxx during Xxxxxx’x period of diligence prior to the Effective Date or otherwise related to the transactions contemplated hereby are true, complete, and correct copies of what they purport to be in all material respects.
(s) Reata has made available to Xxxxxx true, complete and correct copies of all Regulatory Documentation relating to any New Collaboration Compound that has been submitted to or received from any Regulatory Authority as of the Effective Date.
(t) To Reata’s Knowledge, Reata and its Affiliates have conducted, and their respective contractors and consultants have conducted, prior to the Effective Date, all Development of the Effective Date AIMs or the Products containing the Effective Date AIMs in accordance with Applicable Law.
(u) As of the Effective Date there are no amounts that will be required to be paid to a Third Party as a result of the use of such Third Party’s Patents or other intellectual property rights for the Development or Commercialization of the Products containing the Effective Date AIMs that arise out of any agreement to which Reata is a party or, to Reata’s Knowledge, at all.
(v) Reata has caused all Persons who have performed research and development activities, Manufacturing process development activities or regulatory activities for Reata with respect to Targeted AIMs prior to the Effective Date to be under an obligation to assign (or, if Reata was unable to cause such Person to agree to such assignment obligation despite using commercially reasonable efforts to negotiate such assignment obligation, provide an exclusive license under) their rights in any inventions resulting therefrom (other than rights in inventions with respect to bardoxolone methyl) to Reata, except where Applicable Law requires otherwise.
(w) To Reata’s Knowledge, the information, documents and materials furnished to Xxxxxx in connection with its period of diligence prior to the Effective Date, do not, taken as a whole, (i) contain any untrue statement of a material fact or (ii) omit to state any material fact necessary to make the statements or facts contained therein, in light of the circumstances under which they were made, not misleading.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
ARTICLE 14
I NDEMNIFICATION
(a) the breach by Reata of this Agreement;
(b) the negligence or willful misconduct on the part of Reata or its Affiliates or their respective directors, officers, employees, and agents in performing its obligations under this Agreement;
(c) any actual or alleged infringement or misappropriation of any trademark or trade name right of any Third Party in connection with the use of Reata’s corporate name or logo in the Development or Commercialization of the Products in the Territory as permitted or required under this Agreement;
(d) any Manufacturing defect in a Product or a New Collaboration Compound Manufactured by or on behalf of Reata;
(e) the Development, Commercialization or Manufacture of Reata’s Unilateral Products in the applicable Royalty Regions;
(f) the Unilateral Development by or on behalf of Reata of a New Collaboration Compound that has not yet been Commercialized; or
(g) the Development, Commercialization or Manufacture of the Products or the New Collaboration Compounds owned or Controlled by Reata prior to the Effective Date anywhere in the world prior to the Effective Date by or on behalf of Reata or its Affiliates (or its or their contractors, licensees, or collaboration partners).
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
except, in the case of clauses (a)-(d), for those Losses for which Xxxxxx has an obligation to indemnify Reata pursuant to Section 14.2 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability for the Losses.
(a) the breach by Xxxxxx of this Agreement;
(b) the negligence or willful misconduct on the part of Xxxxxx or its Affiliates or their respective directors, officers, employees, and agents in performing its obligations under this Agreement;
(c) any actual or alleged infringement or misappropriation of any trademark or trade name right of any Third Party in connection with the use of Xxxxxx’x corporate name or logo in the Development or Commercialization of the Products in the Territory as permitted or required under this Agreement;
(d) any Manufacturing defect in a Product or a New Collaboration Compound Manufactured by or on behalf of Xxxxxx;
(e) the Development, Commercialization or Manufacture of Xxxxxx’x Unilateral Products in the applicable Royalty Regions; or
(f) the Unilateral Development by or on behalf of Xxxxxx of a New Collaboration Compound that has not yet been Commercialized.
except, in the case of clauses (a)-(d), for those Losses for which Reata has an obligation to indemnify Xxxxxx pursuant to Section 14.1 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability for the Losses.
\
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
ARTICLE 15
C ONFIDENTIALITY
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(a) is or hereafter becomes part of public domain by public use, publication, general knowledge or the like through no wrongful act, fault or negligence on the part of the receiving Party;
(b) can be demonstrated by documentation or other competent proof to have been in the receiving Party’s possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information;
(c) is subsequently received by the receiving Party from a Third Party who is not bound by any obligation of confidentiality with respect to such information;
(d) has been published by a Third Party or otherwise enters the public domain through no fault of the receiving Party in breach of this Agreement; or
(e) can be demonstrated by documentation or other competent evidence to have been independently developed by or for the receiving Party without reference to the disclosing Party’s Confidential Information.
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination and its principles are in the public domain or in the possession of the receiving Party.
(a) made in response to a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial and local governmental or regulatory body of competent jurisdiction or, if in the reasonable opinion of the receiving Party’s legal counsel, such disclosure is otherwise required by law, including by reason of filing with securities regulators; provided, however, that the receiving Party shall first have given notice to the disclosing Party and given the disclosing Party a reasonable opportunity to quash such order or to obtain a protective order or confidential treatment requiring that the Confidential Information and documents that are the subject of such order be held in confidence by such court or agency or, if disclosed, be used only for the purposes for which the order was issued; and provided, further, that the Confidential Information disclosed in response to such court or governmental order shall be limited to that information which is legally required to be disclosed in response to such court or governmental order;
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(b) made by or on behalf of the receiving Party to the Regulatory Authorities as required in connection with any filing, application or request for Regulatory Approval; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such protection is available;
(c) made by or on behalf of the receiving Party to a patent authority as may be reasonably necessary or useful for purposes of obtaining or enforcing a Patent; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such protection is available; or
(d) made by the receiving Party or its Affiliates or licensees or sublicensees to its or their attorneys, auditors, advisors, consultants or Contracting Third Party as may be necessary or useful in connection with the Development, Manufacturing or Commercialization of the New Collaboration Compounds or the Products, or otherwise in connection with the performance of its obligations or exercise of its rights as contemplated by this Agreement, or to potential or actual investors or acquirors as may be necessary or useful in connection with their evaluation of such potential or actual investment or acquisition; provided, however, that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this Article 15 (with a duration of confidentiality and non-use obligations as appropriate that is no less than [***] years from the date of disclosure).
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Party, such Party shall submit the proposed disclosure in writing to the other Party as far in advance as reasonably practicable (and in no event less than [***] Business Days prior to the anticipated date of disclosure) so as to provide a reasonable opportunity to comment thereon. Neither Party shall be required to seek the permission of the other Party to repeat any information regarding the terms of this Agreement or any amendment thereto that has already been publicly disclosed by such Party, or by the other Party, in accordance with this Section 15.4, provided such information remains accurate as of such time and provided the frequency and form of such disclosure are reasonable.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
ARTICLE 16
(a) If either Party (the “ Non-Breaching Party ”) believes that the other Party (the “ Breaching Party ”) has materially breached one or more of its material obligations under this Agreement, then the Non-Breaching Party may deliver notice of such material breach to the Breaching Party (a “ Default Notice ”).
(b) If the Breaching Party does not dispute that it has committed a material breach of one or more of its material obligations under this Agreement, then with respect to a breach of a payment obligation (including the failure by a Party to pay its share of Development Costs or to bear its share of an Operating Loss), if the Breaching Party fails to cure such breach within [***] days after receipt of the Default Notice, then, notwithstanding anything to
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
the contrary herein, upon the election of the Non-Breaching Party the New Collaboration Compound or Joint Product with respect to which such payment breach applies shall cease (unless and until the Breaching Party opts in to joint Development of such New Collaboration Compound as provided below) to be a jointly Developed New Collaboration Compound or Joint Product in the relevant Profit Share Region, as the case may be and thereafter shall be solely a New Collaboration Compound or Unilateral Product for which the Non-Breaching Party is the Participating Party with rights to continue to Develop and Commercialize unilaterally at its cost; provided, however, that the Breaching Party shall have the right to opt in to the joint Development of a New Collaboration Compound by (i) exercising its Pre-Phase II Opt-In, Pre-Phase III Opt-In or EOP3 Opt-In with respect to such Collaboration Compound, but only to the extent such opt-in rights have not expired in with respect to such New Collaboration Compound in accordance with Article 5 and (ii) paying to the Non-Breaching Party simultaneously with the applicable opt-in payment an amount equal to [***] percent ([***]%) of the original breached payment. The Breaching Party shall not have the right to opt-in to joint Development of any New Collaboration Compound after the Pre-Phase II Opt-In, Pre-Phase III Opt-In and EOP3 Opt-In for such New Collaboration Compound have expired.
(c) If the Breaching Party disputes that it has materially breached one of its material obligations under this Agreement, the dispute shall be resolved pursuant to Section 17.6. If, as a result of the application of such dispute resolution procedures, the Breaching Party is determined to be in material breach of one or more of its material obligations under this Agreement (an “ Adverse Ruling ”), then if the Breaching Party fails to complete the actions specified by the Adverse Ruling to cure such material breach within [***] days after such ruling with respect to a breach of a payment obligation, then the Non-Breaching Party shall have the remedy set forth in Section 16.4(b) (which shall not be an exclusive remedy), upon written notice to the Breaching Party. Subject to Section 16.5, exercise of the rights set forth in this Section 16.4 shall not limit remedies that may otherwise be available to the Non-Breaching Party in law or equity.
ARTICLE 17
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
control of the non-performing Party, including fires, floods, earthquakes, hurricanes, embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be declared or not), terrorist acts, insurrections, riots, civil commotion, strikes, lockouts or other labor disturbances (whether involving the workforce of the non-performing Party or of any other Person), acts of God or acts, omissions, or delays in acting by any Governmental Authority (except to the extent such delay results from the breach by the non-performing Party or any of its Affiliates of any term or condition of this Agreement). The non-performing Party shall notify the other Party of such force majeure within [***] days after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effect. The suspension of performance shall be of no greater scope and no longer duration than is necessary and the non- performing Party shall use commercially reasonable efforts to remedy its inability to perform.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
invalid, or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid, or unenforceable provision or by its severance herefrom, and (d) in lieu of such illegal, invalid, or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid, and enforceable provision as similar in terms to such illegal, invalid, or unenforceable provision as may be possible and reasonably acceptable to the Parties. To the fullest extent permitted by Applicable Law, each Party hereby waives any provision of law that would render any provision hereof illegal, invalid, or unenforceable in any respect.
(a) Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New York, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction. The Parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(d) Expert Panel Arbitration .
(i) Any Dispute pertaining to (A) the PDE Rate for a country or region or the applicable inflation index, (B) the terms of a Co-Promotion Agreement, (C) the terms of an MSL Agreement, (D) a Phase III Plan, or (E) whether a proposed amendment to a Unilateral Plan would be a Unilateral Material Amendment, in each case ((A)-(E)), shall be resolved pursuant to Section 17.6(d)(ii).
(ii) Any dispute to be resolved pursuant to this Section 17.6(d)(ii) shall take place pursuant to the following procedures: Promptly following receipt of any notice requiring dispute resolution pursuant to this Section 17.6(d)(ii), the Parties shall meet and discuss in good faith and agree on an expert panel to resolve the issue, which expert panel shall be neutral and independent of both Parties and all of their respective Affiliates, shall have significant experience and expertise in the substantive area in question, and shall have some experience in mediating or arbitrating issues relating to such agreements. If the Parties cannot agree on such expert panel within [***] days of request by a Party for arbitration, then each Party shall select one (1) expert for such panel and the two (2) experts selected by the Parties shall select a third expert for the panel, provided that all such three (3) experts must meet the foregoing criteria. Within [***] days after an arbitrator is selected (or appointed, as the case may be), each Party will deliver to both the expert panel and the other Party a detailed written proposal setting forth its proposed terms for the resolution for the matter at issue (the “ Proposed Terms ” of the Party) and a memorandum (the “ Support Memorandum ”) in support thereof, not exceeding [***] pages in length. The Parties will also provide the expert panel a copy of this Agreement, as may be amended at such time. Within [***] days after receipt of the other Party’s Proposed Terms and Support Memorandum, each Party may submit to the expert panel (with a copy to the other Party) a response to the other Party’s Support Memorandum, such response not exceeding [***] pages in length. Neither Party may have any other communications (either written or oral) with the expert panel other than for the sole purpose of engaging the expert panel or as expressly permitted in this Section 17.6(d)(ii); provided that the expert panel may convene a hearing if the expert panel so chooses to ask questions of the Parties and hear oral argument and discussion regarding each Party’s Proposed Terms. Within [***] days after the expert panel’s appointment, the expert panel will select one of the two Proposed Terms (without modification) provided by the Parties that the expert panel believes is most consistent with the intention underlying and agreed principles set forth in this Agreement. The decision of the expert panel shall be final, binding, and unappealable. The expert panel must select as the only method to resolve the matter at issue one of the two sets of Proposed Terms, and may not combine elements of both Proposed Terms or award any other relief or take any other action.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
If to Abbott, to:
Xxxxxx Laboratories
Pharmaceutical Products Group
000 Xxxxxx Xxxx Xxxx
Xxxxxx Park, IL 60064-3500
Attention: Executive Vice President
Facsimile: 000-000-0000
with a copy to (which shall not constitute notice):
Xxxxxx Laboratories
Building AP6D, D-364
000 Xxxxxx Xxxx Xxxx
Xxxxxx Park, IL 60064-3500
Attention: Executive Vice President, General Counsel and Secretary
Facsimile: 000-000-0000
If to Reata, to:
Reata Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxxx, Xxxxx 000
Irving, Texas 75063
Attention: Xxxx XxXxxxx
Facsimile: (000) 000-0000
with a copy to (which shall not constitute notice):
Xxxxxx LLP
0000 Xxxxxxx Xxxxxx
Palo Alto, CA 94304
Attention: Xxxxxxx X. Xxxxxx
Facsimile: (000) 000-0000
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(i) Section 4.2(e)(ii)(1) shall be amended to read in its entirety as follows: “If such Development Candidate is a FirstGen Targeted AIM or a NextGen Targeted AIM that has been Developed under a Joint Exploratory Development Plan directly preceding such determination and either (A) such Development Candidate is then eligible for designation as a Product Candidate in only one Indication, or (B) such Development Candidate is then eligible for designation as a Product Candidate in more than one Indication but only one Party believes that such Development Candidate should be designated as a Development Candidate in any eligible Indication, then in either case ((A) or (B)) [***].”
(ii) Section 4.2(e)(ii)(2) shall be amended to read in its entirety as follows: “If such Development Candidate is a FirstGen Targeted AIM or a NextGen Targeted AIM that has been Developed under a Joint Exploratory Development Plan directly preceding such determination and such Development Candidate is then eligible for designation as a Product Candidate in more than one Indication and each Party believes that such Development Candidate should be designated as a Product Candidate in a different Indication, then [***].”
(iii) Section 4.2(e)(ii)(3) shall be deleted in its entirety.
(iv) Section 1.97 shall be amended to replace the reference to Section 4.2(e)(ii)(3) with a reference to Section 4.2(e)(ii)(2).
(i) Section 1.51 shall be amended to read in its entirety as follows:
“ FirstGen Targeted AIM ” means any Targeted AIM: (a) that is Controlled by Reata or any of its Affiliates as of the Effective Date and that is derived from oleanolic acid or generated using oleanolic acid (or a metabolite of oleanolic acid) as a starting material, but excluding bardoxolone methyl; (b) that is Controlled by Abbott or any of its Affiliates as of the Effective Date and that is derived from oleanolic acid or generated using oleanolic acid (or a metabolite of oleanolic acid) as a starting material; or (c) that is invented solely by or on behalf of either Party, or jointly by or on behalf of the Parties, during the Exclusivity Period and is derived from oleanolic acid or generated using oleanolic acid (or a metabolite of oleanolic acid) as a starting material.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(ii) Section 4.2(e)(ii)(3) shall be amended to read in its entirety as follows:
“If such Development Candidate is a NextGen Targeted AIM that has been Developed under a Joint Exploratory Development Plan directly preceding such determination, then, after the Initial Studies Period:
(A) If either (x) such Development Candidate is then eligible for designation as a Product Candidate in only one Indication, or (y) such Development Candidate is then eligible for designation as a Product Candidate in more than one Indication but only one Party believes that such Development Candidate should be designated as a Development Candidate in any eligible Indication, then in either case ((x) or (y)) [***].
(B) If such Development Candidate is then eligible for designation as a Product Candidate in more than one Indication and each Party believes that such Development Candidate should be designated as a Product Candidate in a different Indication, then [***].”
(iii) Section 1.97 shall be amended to replace the reference to Section 4.2(e)(ii)(3) with a reference to Section 4.2(e)(ii)(3)(B).
(i) Section 5.5(a)(i) shall be amended to add the following at the end of such Section: “In the event the Parties’ representatives on the JDC cannot agree on whether to initiate Phase IIb Clinical Studies for a particular Product Candidate, then [***].”
(ii) Section 5.5(a)(ii) shall be amended to replace the words “either Party’s” in the first sentence thereof with the words “both Parties’”.
(iii) The third sentence of Section 5.5(b)(i)(2) shall be amended to read in its entirety as follows: “If such Senior Officers cannot resolve such matter within a [***].”
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(iv) Section 5.5(b)(vi) shall be amended to add the following at the end of the Section: “In the event the Parties’ representatives on the JDC cannot agree on whether such Product Candidate is ready to be Developed in a Phase III Clinical Study, then [***].”
(v) Section 5.5(b)(viii) shall be amended to replace the words “either (or both) Party’s” in the first sentence thereof with the words “both Parties’”.
(vi) The first sentence of Section 5.5(c)(i) shall be amended to read in its entirety as follows: “[***] (collectively, the “ EOP2 Meeting ”).”
(vii) The last sentence of Section 5.5(c)(ii) shall be amended to read in its entirety as follows: “If such Senior Officers cannot agree on such content within a [***]-day period, then [***].”
(viii) The last two sentences of Section 5.5(c)(iii) shall be amended to read in their entirety as follows: “If only one Party’s representatives on the JDC believe that such Product Candidate is ready for Phase III Clinical Studies, [***].”
(ix) Section 17.6(d)(i) shall be amended to read in its entirety as follows: “Any Dispute pertaining to (A) the PDE Rate for a country or region or the applicable inflation index, (B) the terms of a Co-Promotion Agreement, (C) the terms of an MSL Agreement, (D) a Phase III Plan, (E) a Phase IIb Plan, (F) the content of an EOP2 Meeting briefing package, or (G) whether a proposed amendment to a Unilateral Plan would be a Unilateral Material Amendment, in each case ((A)-(G)), shall be resolved pursuant to Section 17.6(d)(ii)
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
offering of the capital stock of an Entity or (y) a Spin Off Transaction in either case ((x) or (y)) constitute a Change of Control, require any consent or notice to the other Party, or violate, constitute a breach or default of or any loss of any rights or benefits under, or result in any right of termination, payment or cancellation of, this Agreement. As used herein, “Spin Off Transaction” means any transaction involving the following: (i) the distribution by Xxxxxx Laboratories, an Illinois corporation, or any successor thereof ( “Abbott Parent” ), to its shareholders of shares of a corporation (“ New Company” ), which New Company’s business operations comprise substantially either (A) the research (non-generic) based pharmaceutical business (the “ Proprietary Pharmaceutical Business ”) of Abbott Parent or (B) the business of Abbott Parent other than the Proprietary Pharmaceutical Business (the “Other Abbott Business” ), and (ii) any contribution or other transfer of the shares of Abbott or any Affiliate of Abbott to New Company or any Affiliate of New Company related to or in connection therewith; provided that this Agreement is not assigned, conveyed, or otherwise transferred, by operation of law or otherwise (including a transfer of shares of Abbott to New Company) to the New Company where it comprises the Other Abbott Business and not the Proprietary Pharmaceutical Business.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Both Parties agree to waive any requirement that the other (i) post a bond or other security as a condition for obtaining any such relief, and (ii) show irreparable harm, balancing of xxxxx, consideration of the public interest, or inadequacy of monetary damages as a remedy. Nothing in this Section 17.11 is intended, or should be construed, to limit either Party’s right to equitable relief or any other remedy for a breach of any other provision of this Agreement.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
[Signature Page Follows]
IN WITNESS W HEREOF , the Parties have executed this Collaboration Agreement by their duly authorized officers as of the date first written above.
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R EATA P HARMACEUTICALS , I NC . |
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A BBOTT P HARMACEUTICALS PR L TD . |
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By: |
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By: |
Name: |
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Name: |
Title: |
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Title: |
Signature Page to Collaboration Agreement
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
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Schedule 1.30 - |
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Development Candidates as of the Effective Date |
Schedule 1.45 - |
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Existing Lead Compounds |
Schedule 1.69 - |
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Manufacturing Costs for Product Manufactured by a Party |
Schedule 2.3 - |
|
Initial Members of the JEC |
Schedule 2.4 - |
|
Initial Members of the JRDI |
Schedule 3.1 - |
|
Discovery Research Plan |
Schedule 4.3(a) - |
|
Joint Exploratory Development Plan |
Schedule 11.3(b) - |
|
Form of Operating Profit/Loss Reconciliation Statement |
Schedule 13.2(a) - |
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Existing Patents |
Schedule 13.2(g) - |
|
Academic Research Agreements |
Schedule 15.4 - |
|
Joint Press Release |
Schedule 17.6(c) - |
|
ADR Procedures |
Schedule of Exceptions |
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
S CHEDULE 1.30
D EVELOPMENT C ANDIDATES AS OF THE E FFECTIVE D ATE
|
1. |
[***] |
|
2. |
[***] |
|
3. |
[***] |
|
4. |
[***] |
Note: TX designations are assigned in the corporate compound library of Reata. RTA numbers are assigned at approximately the time of designation as Development Candidate.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
S CHEDULE 1.45
E XISTING L EAD C OMPOUNDS
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[***] |
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[***] |
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[***] |
[***] |
|
[***] |
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
SCHEDULE 1.69
M ANUFACTURING C OSTS FOR P RODUCT M ANUFACTURED BY A P ARTY
“ Manufacturing Cost ” means, with respect to Product Manufactured by a Party or its Affiliate, a Party’s actual cost of Manufacturing a Product or a New Collaboration Compound, as the case may be, determined in accordance with GAAP, including the cost of Materials, Direct Labor and Benefits, and allocated Overhead (as such terms are defined below), the total expressed as Manufacturing Cost per unit of Product or New Collaboration Compound, as the case may be, Manufactured. Manufacturing Costs shall not include any site remediation or closure expenses and shall only include an amount with respect to overhead that has been prorated for the days of the year for which the Product or New Collaboration Compound, as the case may be, was Manufactured for Development or Commercialization hereunder.
For purposes of this Schedule, the terms below have the following meanings:
A. “Materials” means those items that form an integral and direct part of the Product or New Collaboration Compound, as the case may be, or are necessary for its production, as well as chemicals, intermediates, media, filters, one-way equipment, cartons, labels (if applicable), package inserts (if applicable) and shippers.
B. “Direct Labor and Benefits” means that portion of wages and related payroll taxes and employment benefits spent in the actual production of the Product or New Collaboration Compound, as the case may be, that can be identified with or charged to the Product or the New Collaboration Compound, as the case may be.
C. “Overhead” means all operating expenses incurred by and in support of all Manufacturing cost centers and quality operations. Overhead includes:
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• |
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wages for indirect labor, related payroll taxes and employee benefits; |
|
• |
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depreciation on specific assets used to Manufacture the Product or New Collaboration Compound; |
|
• |
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taxes; |
|
• |
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insurance; |
|
• |
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rent (paid at market rates); |
|
• |
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repairs and maintenance; |
|
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supplies, including gowning supplies; |
|
• |
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utilities; |
|
• |
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factory administration expenses; |
|
• |
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other similar cost elements of factory overhead; |
|
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an allocation of general and administrative overhead and the cost of manufacturing centers and quality operations, which allocation shall be made in a manner consistent with such allocations applied to other products made in the same production center with the same technology, and consistent with past practice; and |
|
• |
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an allocation of depreciation on assets being used in the same production center using the same technology, which allocation shall be made in a manner consistent with such allocations applied to other products made in the same production center with the same technology, and consistent with past practice.] |
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
The following expenses shall not be included in Manufacturing Cost
|
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idle capacity; and |
|
• |
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general and administrative costs not associated with the production process |
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
SCHEDULE 2.3
I NITIAL M EMBERS OF THE JEC
Reata
[***]
[***]
Abbott
[***]
[***]
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
SCHEDULE 2.4
INITIAL MEMBERS OF THE JRDI
Reata
[***]
[***]
[***]
[***]
Abbott
[***]
[***]
[***]
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
SCHEDULE 3.1
D ISCOVERY R ESEARCH P LAN
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
[***]
S CHEDULE 4.3( A )
J OINT E XPLORATORY D EVELOPMENT P LAN
4.3(a)(i) The plans for characterization of the Lead Compounds and Development Candidates existing as of the Effective Date are as follows:
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
[***]Pre-Clinical Assessment of Lead Compounds and Development Candidates
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[***] |
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
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[***] |
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
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Title |
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General Description |
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Estimated Start Date |
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Responsible Party |
[***] |
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[***] [***] [***] [***] [***] [***] [***] [***] [***] |
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[***] [***] [***] [***] [***] [***] [***] |
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4.3(a)(ii) The Initial Indications in which the Parties intend to conduct Indication Survey Studies are as follows: [***].
4.3(a)(iii) The general parameters of the Phase I studies and the Indication Survey Studies; including number of participants and duration of treatment are as follows:
Assumption: [***]
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General Description |
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Patient Population |
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Aprx # Patients |
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Expected Dosing |
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Potential Start Date |
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Responsible Party / |
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Phase I Studies |
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[***] |
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Assumption: [***]
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General Description |
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Patient Population |
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Aprx # Patients |
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Expected Dosing |
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Potential Start Date |
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Responsible Party / |
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Phase II (ISS) Studies – “Fixed Indications” |
|||||||||||
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Phase II (ISS) Studies – “Flexible” indications |
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[***] |
4.3(a)(iv) The Related Indications for the Initial Indications are as follows:
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
|
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Fixed Indications |
|
Related Indications |
[***] |
|
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] |
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[***] [***] [***] [***] |
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Flexible Indications |
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Related Indications |
[***] |
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[***] |
[***] |
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[***] |
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
[***]
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Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
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SCHEDULE 11.3( B )
FORM OF OPERATING PROFIT /LOSS RECONCILIATION STATEMENT
Calculation of Operating Profit or Operating Loss Example
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Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
SCHEDULE 13.2( A )
EXISTING PATENTS
Owned Patents:
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
SCHEDULE 13.2( G ) ACADEMIC
RESEARCH AGREEMENTS
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
SCHEDULE 15.4
JOINT PRESS RELEASE
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Abbott and Reata Pharmaceuticals Announce Agreement to Develop and Commercialize Next-Generation Antioxidant Inflammation Modulators
|
• |
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Agreement Calls for 50/50 Global Profit Share for Multiple New Molecules |
|
• |
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Companies Plan to Explore Broad Therapeutic Potential of AIM Class |
ABBOTT PARK, Ill. and IRVING, Texas, December XX, 2011 – Abbott and Reata Pharmaceuticals today announced that they have entered into a worldwide collaboration to jointly develop and commercialize Reata’s portfolio of second-generation oral antioxidant inflammation modulators (AIMs). The agreement is in addition to the partnership between the two companies announced in September 2010 in which Reata granted to Abbott exclusive rights to develop and commercialize its lead AIM compound, bardoxolone methyl, outside of the United States, excluding certain Asian markets.
The collaboration announced today is a global agreement and includes a large number of molecules in a broad range of therapeutic areas, including pulmonary, central nervous system disorders and immunology. Abbott and Reata will equally share costs and profits for all new AIMs in all newly licensed indications except for rheumatoid arthritis and select other autoimmune diseases, in which Abbott will take 70 percent of costs and profits and Reata will take 30 percent. The deal also includes a research agreement in which the companies will work together to discover new molecules that exhibit the same pharmacology as the AIMs already in Reata’s pipeline.
Abbott will make a one-time license payment of $400 million to Reata. The companies expect the first compound in this collaboration to enter into human clinical trials in 2012.
“We are excited to work with Abbott to develop this promising class of compounds,” Reata CEO Xxxxxx Xxxx said. “This deal helps Reata advance new molecules into clinical development in multiple important diseases and enables our company to build a global commercial presence.”
AIMs are potent activators of the transcription factor Nrf2. Activation of Nrf2 promotes the production of a wide range of antioxidant, detoxification, and anti-inflammatory genes. Activation of Nrf2 also inhibits NF- K B, a transcription factor that regulates many pro-inflammatory enzymes. Suppression of Nrf2 and activation of NF- K B have been associated with numerous chronic diseases, including multiple sclerosis, rheumatoid arthritis, chronic kidney disease, neurodegenerative disease and COPD. Therefore, agents that activate Nrf2 and inhibit NF- K B may be beneficial in the treatment of these chronic diseases.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
“This partnership allows Abbott to enhance its promising research pipeline across multiple therapeutic areas,” said Xxxx Xxxxxxx, M.D., senior vice president, pharmaceuticals, research and development, Abbott. “Accumulating data has established the potential for antioxidant inflammation modulators in neuroscience and immunology, and we look forward to expanding our knowledge through further research.”
Under an agreement reached in September 2010, Reata granted to Abbott exclusive rights to develop and commercialize its lead AIM compound, bardoxolone methyl, outside of the United States, excluding certain Asian markets. Reata retains U.S. development and commercialization rights. Reata and Abbott are currently conducting the BEACON study, a multi-national Phase 3 clinical trial of bardoxolone methyl in patients with stage 4 chronic kidney disease and type 2 diabetes.
About Reata Pharmaceuticals, Inc.
Reata Pharmaceuticals, Inc. is the leader in discovering and developing novel, oral anti- inflammatory drugs that activate Nrf2, the primary regulator of cellular antioxidant and detoxification enzymes, and suppress NFkB, the primary regulator of inflammatory genes. Reata is developing these compounds – called antioxidant inflammation modulators (AIMs) – with the goal of one day making them available to patients suffering from a broad range of diseases associated with inflammation and oxidative stress. Reata plans to build a stand-alone, fully integrated pharmaceutical company with a worldwide medical, commercial, and regulatory presence. For more information, please visit xxx.xxxxxxxxxxx.xxx.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacturing and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.
Reata Contacts
Xxxx Xxxxxxxxx or Xxxxx Xxxxxx, xxxx.xxxxxxxxx@xxxxxxxxxxxxxxxx.xxx , 000-000-0000; xxxxx.xxxxxx@xxxxxxxxxxxxxxxx.xxx , 212-845-4271
Investors: Xxxx Xxxxxx, xxxxxxx@xxxxxxxxxx.xxx, 000-000-0000
Abbott Contacts
Media: Xxxxxx Xxxxxx (000) 000-0000
Financial: Xxxxx Xxxxx (000) 000-0000
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
SCHEDULE 17.6( C )
Any Dispute referred to ADR under this Agreement shall be resolved as follows:
1. To begin an ADR proceeding, a Party shall provide written notice to the other Party of the Dispute to be resolved by ADR. Within [***] days after its receipt of such notice, the other Party may, by written notice to the Party initiating the arbitration, add additional issues to be resolved within the same ADR. Thereafter, no new issues can be added absent consent of the tribunal, which consent shall be granted for good cause. In assessing whether good cause exists for permitting the addition of new issues, the tribunal shall consider all relevant factors, including whether justice is served by allowing the addition of new issues, whether a Party unduly delayed in seeking to add a new issue, and whether the other Party would be unfairly prejudiced by the addition of the new issues. The ADR shall be administered by JAMS pursuant to the then-current JAMS Comprehensive Rules and Procedures, except as modified under this Schedule 17.6(c).
2. Within [***] days following the initiation of the ADR proceeding, the Parties shall select a mutually acceptable independent, impartial and conflicts-free neutral from the JAMS list of neutrals to preside in the resolution of all issues in this ADR proceeding. If the Parties are unable to agree on a mutually acceptable neutral within such period, each Party will select one independent, impartial and conflicts-free neutral (who does not need to be from the JAMS list) and, within [***] days thereafter, those two neutrals will select a third independent, impartial and conflicts-free neutral from the JAMS list of neutrals to preside as the chair of the panel of such three neutrals (such neutral(s), the “ Neutral ”). None of the neutrals selected may be current or former employees, officers or directors of either Party or its Affiliates. Furthermore, the following provisions shall supplement (but not replace) the provisions of the JAMS Comprehensive Rules and Procedures regarding neutrality:
(a) A person shall be deemed to have a conflict, and shall not be appointed as a Neutral absent the consent of both parties, if such person (i) has presided over an evidentiary hearing relating to, or issued a ruling on, the merits of a dispute, involving either Party; (ii) has conducted a mediation involving either Party, or (iii) has been retained to perform and has performed professional services for either Party within the last 10 years. The “merits of a dispute” are matters substantially related to the substance of the underlying claim, and do not include procedural or discovery-related matters;
(b) A person shall be deemed to have a conflict, and shall not be appointed as a Neutral absent consent of both parties, if such person previously served as a party-appointed arbitrator appointed by either Party, or by any party represented in a previous arbitration by one of the law firms representing either Party in any Dispute referred to ADR under this Agreement, if the governing rules of such arbitration did not require such arbitrator to be impartial and independent; and
(c) Neither Party nor any person acting on behalf of a Party may have any ex parte communications with any Neutral at any time before or during the proceedings. Notwithstanding JAMS Comprehensive Rules and Procedures, prohibited ex parte
communications shall include, advising the candidate of the general nature of the controversy and of the anticipated proceedings and to discuss the candidate’s qualifications, availability or independence in relation to the Parties.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
3. No earlier than [***]days or later than [***] days after selection, the Neutral shall hold a hearing to resolve each of the issues identified by the Parties.
4. At least [***] days prior to the hearing, each Party shall submit the following to the other Party and the Neutral:
(a) a copy of all exhibits on which such Party intends to rely in any oral or written presentation to the Neutral;
(b) a list of any witnesses such Party intends to call at the hearing, and a short summary of the anticipated testimony of each witness;
(c) a proposed ruling on each issue to be resolved, together with a request for a specific damage award or other remedy for each issue. The proposed ruling shall not contain any recitation of the facts or any legal arguments, and the proposed remedy shall not include any punitive damages. The proposed ruling and the proposed remedy collectively shall not exceed [***] per issue.
(d) a brief in support of such Party’s proposed rulings and remedies, provided that the brief shall not exceed [***] pages. This page limitation shall apply regardless of the number of issues raised in the ADR proceeding.
4. Each Party shall be entitled to [***] document requests and one deposition. The Neutral can permit additional discovery, subject to the limits specified below, where such discovery is reasonably calculated to lead to admissible evidence regarding liability or damages, and with respect to a request for an additional deposition, the necessity of an additional deposition shall be determined by the Neutral based upon the reasonable need for the requested information, the availability of other discovery options and the burdensomeness of the request on the opposing Parties and the witness. For such additional discovery, in no event shall a Party be permitted more than [***] interrogatories, [***] additional document requests (resulting in [***] total document requests) or more than [***] of the opposing Party (with all depositions limited to [***] day, up to [***] hours). No corporate representative deposition shall be permitted. Within [***] days of the service of document requests, the Parties shall agree to defined search terms in order to search for responsive electronic documents as efficiently and economically as possible. If the Parties cannot agree to such search terms, the Neutral shall meet with the Parties within [***] days thereafter and, at that meeting, determine the applicable search terms. No other discovery shall be permitted in any form. All discovery must be completed [***] days before the arbitration hearing.
4. The hearing shall be conducted on no more than [***] consecutive days and shall be governed by the following rules:
(a) Each party shall be entitled to [***] hours of hearing time to present its case. The Neutral shall determine whether each Party has had the [***] hours to which it is entitled.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(b) Each Party shall be entitled, but not required, to make an opening statement, to present regular and rebuttal testimony, documents, or other evidence, to cross-examine witnesses, and to make a closing argument. Cross-examination of witnesses shall occur immediately after their direct testimony, and cross-examination time shall be charged against the Party conducting the cross-examination.
(c) The Party initiating the ADR shall begin the hearing and, if it chooses to make an opening statement, shall address therein not only issues it raised but also any issues raised by the responding party. The responding party, if it chooses to make an opening statement, also shall address all issues raised in the ADR. Thereafter, the presentation of regular and rebuttal testimony and documents, other evidence, and closing arguments shall proceed in the same sequence.
(d) Except when testifying, witnesses shall be excluded from the hearing until closing arguments.
(e) Settlement negotiations, including any statements made therein, shall not be admissible under any circumstances.
(f) Affidavits prepared for purposes of the ADR hearing shall not be admissible.
(g) As to all other matters, the Neutral shall have sole discretion regarding the admissibility of any evidence.
5. Prior to the completion of the hearing, a Party may seek leave from the Neutral to modify its proposed rulings on one or more issues to be resolved. If the Neutral finds good cause for such modification, within [***] days following completion of the hearing, the Parties shall file a substitute proposed ruling on each issue for which the Neutral allows a modification, together with a request for a specific damage award or other remedy for each such issue. The proposed ruling shall not contain any recitation of the facts or any legal arguments, and the proposed remedy shall not include any punitive damages. The proposed ruling and the proposed remedy collectively shall not exceed [***] per issue.
6. Within [***] days following completion of the hearing, each Party may submit to the other Party and the Neutral a post-hearing brief in support of its proposed rulings and remedies, provided that such brief shall not contain or discuss any new evidence and shall not exceed [***] pages. This page limitation shall apply regardless of the number of issues raised in the ADR proceeding.
7. The Neutral shall rule on each disputed issue within [***] days following completion of the post-hearing briefing. Such ruling shall adopt in its entirety the proposed ruling and remedy of one of the Parties on each disputed issue but may adopt one party’s proposed rulings and remedies on some issues and the other Party’s proposed rulings and remedies on other issues. The Neutral shall not issue any written opinion or otherwise explain the basis of the ruling.
8. The Neutral shall be paid a reasonable fee plus expenses. These fees and expenses, along with the reasonable legal fees and expenses of the prevailing Party (including all expert witness fees and expenses), the fees and expenses of a court reporter, and any expenses for a hearing room, shall be paid as follows:
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
(a) If the Neutral rules in favor of one Party on all disputed issues in the ADR, the losing Party shall pay 100% of such fees and expenses.
(b) If the Neutral rules in favor of one Party on some issues and the other Party on other issues, the Neutral shall issue with the rulings a written determination as to how such fees and expenses shall be allocated between the Parties. The Neutral shall allocate fees and expenses in a way that bears a reasonable relationship to the outcome of the ADR, with the Party prevailing on more issues, or on issues of greater value or gravity, recovering a relatively larger share of its legal fees and expenses.
9. The rulings of the Neutral and the allocation of fees and expenses shall be binding, non- reviewable, and non-appealable, and may be entered as a final judgment in any court having jurisdiction.
10. Except as provided in paragraph 9 or as required by law, the existence of the Dispute, any settlement negotiations, the ADR proceeding, any submissions (including exhibits, testimony, proposed rulings, and briefs), and the rulings shall be deemed to be Confidential Information of both Parties. The Neutral shall have the authority to impose sanctions for unauthorized disclosure of Confidential Information.
11. All ADR proceedings shall be conducted in the English language and shall be conducted in New York, New York.
12. Each Party shall have the right to be represented by counsel in all aspects of any ADR proceeding.
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
SCHEDULE OF E XCEPTIONS
Section 13.2(a) : Reata makes no representation under the second sentence of Section 13.2(a) with respect to:
[***]
Section 13.2(c) and (o): Reference is made to PCT Application [***].
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
IN WITNESS WHEREOF, the Parties have executed this Collaboration Agreement by their duly authorized officers as of the date first written above.
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REATA PHARMACEUTICALS, INC. |
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XXXXXX PHARMACEUTICALS PR LTD. |
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By: |
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/s/ X. Xxxxxx Xxxx |
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By: |
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/s/ Xxxxxx X. Xxxxxxx |
Name: |
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X. Xxxxxx Xxxx |
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Name: |
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Xxxxxx X. Xxxxxxx |
Title: |
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President & CEO |
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Title: |
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Chief Financial Officer |
Signature Page to Collaboration Agreement
Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].