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1.93 "Joint Know-How" has the meaning set forth in Section 7.1.2 (Ownership of Joint Patents and Joint Know-How). |
1.94 "Joint Patents" has the meaning set forth in Section 7.1.2 (Ownership of Joint Patents and Joint Know-How). |
1.95 "Late Phase Development Activities" means the activities described in the Development Plan as "Late Phase Development Activities." Late Phase Development Activities shall be Development Activities pursuant to the Development Plan in the event AbbVie requests completion of such activities as further described in Se... |
1.96 "LIBOR" means the London Interbank Offered Rate for deposits in United States Dollars having a maturity of one (1) month published by the British Bankers' Association, as adjusted from time to time on the first London Business Day of each month. |
1.97 "Licensed Compound" means (a) the fusion protein known as ALPN-101 and (b) any other molecule that (i) is owned or Controlled by Licensor or its Affiliates as of the Effective Date or at any time during the Term and (ii) binds to, or directly modulates or targets ICOS with greater than ten percent (10%) of the wil... |
1.98 "Licensed Product" means any product, or portion thereof, containing a Licensed Compound, alone or in combination with one (1) or more Other Active Ingredients, in any and all forms, presentations, delivery systems, dosages and formulations. |
1.99 "Licensor" has the meaning set forth in the preamble hereto. |
1.100 "Licensor Acquirer" means any Person that becomes an Independent Affiliate of Licensor due to and upon a Change in Control of Licensor. |
1.101 "Licensor Indemnitees" has the meaning set forth in Section 11.1 (Indemnification of Licensor). |
1.102 "Licensor Know-How" means all Information that is (a) owned or Controlled by Licensor or any of its Affiliates as of the Effective Date or at any time during the Term, (b) not generally known and (c) necessary or reasonably useful for the Development, Manufacture, Commercialization or Exploitation of any Licensed... |
1.103 "Licensor Patents" means all of the Patents that are (a) Controlled by Licensor or any of its Affiliates as of the Effective Date or at any time during the Term and (b) that claim any Licensed Compound, any Licensed Product or any composition containing a Licensed Compound, or the Development, Manufacture, Commer... |
1.104 "Licensor Platform Patents" means all of the Licensor Patents that are not Licensor Product Patents. |
1.105 "Licensor Product Patents" means all of the Licensor Patents that (a) as of the Option Effective Date, claim (i) any molecule or product containing the same or substantially the same amino acid sequence of the ICOS-binding portion(s) of a Licensed Compound, (ii) any composition containing such molecule or product... |
1.106 "Licensor Prosecution Countries" has the meaning set forth in Section 7.2 (Maintenance and Prosecution of Licensor Product Patents). |
1.107 "Losses" has the meaning set forth in Section 11.1 (Indemnification of Licensor). |
1.108 "MAA" has the meaning set forth in the definition of Drug Approval Application. |
1.109 "Major Market" means each of the United States, United Kingdom, Germany, France, Spain and Italy. |
1.110 "Manufacture" and "Manufacturing" means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping and holding of the Licensed Compound, any Licensed Product or any intermediate thereof, including process development, process ... |
1.111 "Manufacturing Process" has the meaning set forth in Section 5.5.2 (Manufacturing Technology Transfer Upon AbbVie's Request). |
1.112 "Manufacturing Technology Transfer" has the meaning set forth in Section 5.5.2 (Manufacturing Technology Transfer Upon AbbVie's Request). |
1.113 "Material Amendment" means any material amendment or other modification to the Development Plan, including (a) a change to the scope, timing or resource allocation of any Development Activities that would result in an increase in the timeline included in such Development Plan, (b) budgetary changes that, together... |
1.114 "Mono Product" has the meaning set forth in the definition of "Net Sales." |
1.115 "Net Sales" means, with respect to a Licensed Product for any period, the total amount billed or invoiced on sales of such Licensed Product during such period by AbbVie, its Affiliates or Sublicensees (each, a "Selling Party") in the Territory to Third Parties (including wholesalers or distributors) in bona fide ... |
(a) trade, cash and quantity discounts; |
(b) price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to governmental authorities or other payees; |
(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) amounts repaid or credited by reason of rejections, defects, return goods allowance, recalls or returns, or because of retroactive price reductions, including rebates or wholesaler charge backs; |
(e) the portion of administrative fees paid during the relevant time period to group purchasing organizations, pharmaceutical benefit managers or Medicare Prescription Drug Plans relating to such Licensed Product; |
(f) any consideration actually paid or payable for any Delivery System related to a billed or invoiced sale of such Licensed Product, where for purposes of this Net Sales definition, a "Delivery System" means any delivery system designed to assist in the administration of such Licensed Product; |
(g) any invoiced amounts from a prior period which are not collected and are written off by the Selling Party, including bad debts, up to a limit of three percent (3%) of such total amount billed or invoiced; |
(h) 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 such Licensed Product by the Selling Party in a manner consistent with the such party's accounting policies across its ot... |
(i) freight, insurance, import/export 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 Licensed Product; and |
(j) any other similar and customary deductions that are consistent with Accounting Standards, but which may not be duplicative of the deductions specified in clauses (a) – (j) above. |
Net Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory, or governmental purposes. Net Sales shall include the amount or fair market value of all other consideration received by the Selling Party in respect of the Licensed Product, whether such consideration... |
Net Sales shall be calculated in accordance with the standard internal policies and procedures of the Selling Party, which must be in accordance with Accounting Standards. |
For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 6.8 (Mode of Payment; Offsets). |
In the event that a Licensed Product is sold in any country or other jurisdiction in the form of a Combination Product, the Net Sales for such Combination Product shall be calculated as follows: |
(i) If a product containing as its sole active ingredient a Licensed Compound contained in such Combination Product (the "Mono Product") and products containing as their sole active ingredients Other Active Ingredients in such Combination Product are separately sold in such country or other jurisdiction, the Net Sales ... |
(ii) If the Mono Product is separately sold in such country or other jurisdiction, but products containing as their sole active ingredients Other Active Ingredients in such Combination Product are not separately sold in such country or other jurisdiction, the Net Sales attributable to such Combination Product shall be ... |
(iii) If the Mono Product is not separately sold in such country or other jurisdiction, but products containing as their sole active ingredients Other Active Ingredients contained in such Combination Product are separately sold in such country or other jurisdiction, the Net Sales attributable to such Combination Produc... |
(iv) If both the Mono Product and Other Active Ingredients or ingredients in such Combination Product are not separately sold in such country or other jurisdiction, the Parties shall negotiate in good faith to determine the Net Sales attributable to such Combination Product. If the Parties cannot agree on such Net Sale... |
1.116 "New License Agreement" has the meaning set forth in Section 4.7 (Sublicense Survival). |
1.117 "Non-Breaching Party" has the meaning set forth in Section 12.2.1 (Material Breach). |
1.118 "Option" has the meaning set forth in Section 4.1 (AbbVie Option). |
1.119 "Option Effective Date" means the date upon which AbbVie delivers to Licensor the Option Exercise Notice with respect to the Option in accordance with Section 13.8 (Notices); provided that, if AbbVie reasonably determines in good faith prior to the delivery of the Option Exercise Notice for the Option that the tr... |
1.120 "Option Exercise Data Package" means a data package containing the information set forth on Schedule 1.120 (Option Exercise Data Package). |
1.121 "Option Exercise Data Package Trigger Event" has the meaning set forth on Schedule 1.121 (Option Exercise Data Package Trigger Event). |
1.122 "Option Exercise Fee" has the meaning set forth in Section 6.4 (Option Exercise Fee). |
1.123 "Option Exercise Notice" has the meaning set forth in Section 4.2 (Option Exercise). |
1.124 "Option Exercise Period" means the period of time beginning on the Effective Date and, subject to Section 4.2 (Option Exercise) and Section 4.3 (HSR), ending ninety (90) days following the date that Licensor provides AbbVie with the Option Exercise Data Package; provided that, if Licensor has not provided AbbVie ... |
1.125 "Other Active Ingredient" means any component that provides pharmacological activity or other direct therapeutic effect in the Field or that therapeutically affects the structure or any function of the body whereby such component is not Controlled by Licensor. |
1.126 "Other Licensed Molecules" has the meaning set forth in Section 1.97 (Licensed Compound). |
1.127 "Party" and "Parties" has the meaning set forth in the preamble hereto. |
1.128 "Patents" means (a) all national, regional and international patents and patent applications, including provisional patent applications and rights to claim priority from any of such patents or patent applications, (b) all patent applications filed either from such patents, patent applications or provisional appli... |
1.129 "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 polit... |
1.130 "Personal Data" means (a) all information identifying, or in combination with other information, identifiable to an individual, including pseudonymized (key-coded) Clinical Data containing such information; and (b) any other information that is governed, regulated or protected by one or more Data Security and Pri... |
1.131 "Phase 0" means an exploratory, first-in-human trial conducted in accordance with the FDA 2006 Guidance on Exploratory Investigational New Drug Studies (or the equivalent in any country or other jurisdiction outside of the United States) and designed to expedite the development of therapeutic or imaging agents by... |
1.132 "Phase I" means a human clinical trial of a Licensed Compound or Licensed Product, the principal purpose of which is a preliminary determination of safety, tolerability, pharmacological activity or pharmacokinetics in healthy individuals or patients or similar clinical study prescribed by the Regulatory Authoriti... |
1.133 "Phase II" means a human clinical trial of a Licensed Compound or Licensed Product, the principal purpose of which is a determination of safety and efficacy in the target patient population, which is prospectively designed to generate sufficient data that may permit commencement of pivotal clinical trials, or a s... |
1.134 "Phase II SLE Clinical Study" means a Phase II of a Licensed Compound or Licensed Product for the treatment of SLE that has the minimum characteristics set forth in the Development Plan. |
1.135 "Phase III" means a human clinical trial of a Licensed Compound or Licensed Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a Licensed Compound or Licensed Product is safe and efficacious for its intended use and to determine the benefit/risk relati... |
1.136 "PHSA" means the United States Public Health Service Act, as amended from time to time. |
1.137 "Privacy and Security Obligations" has the meaning set forth in Section 10.2.22 (Additional Representations and Warranties of Licensor). |
1.138 "Processing" (or its conjugates) means any operation or set of operations that is performed upon Personal Data, whether or not by automatic means, such as collection, recording, organization, storage, adaptation or alternation, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise m... |
1.139 "Product Information" has the meaning set forth in Section 9.1 (Product Information). |
1.140 "Product Infringement" has the meaning set forth in Section 7.3.1 (Enforcement of Licensor Patents). |
1.141 "Product Labeling" means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority-approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and ... |
1.142 "Product Trademarks" means the Trademark(s) to be used by AbbVie or its Affiliates or its or their respective Sublicensees for the Development, Commercialization or Exploitation of Licensed Products in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (exclu... |
1.143 "Proposed In-Licensed Rights" has the meaning set forth in Section 4.8.1 (In-License Agreements Prior to Option Exercise). |
1.144 "Regulatory Approval" means, with respect to a country or other jurisdiction in the Territory, the approvals (including Drug Approval Applications), licenses, registrations or authorizations of any Regulatory Authority necessary to Commercialize a Licensed Product in such country or other jurisdiction, including,... |
1.145 "Regulatory Authority" means any applicable supra-national, federal, national, regional, state, provincial or local governmental or regulatory authority, agency, department, bureau, commission, council or other entities (e.g., the FDA and EMA) regulating or otherwise exercising authority with respect to activitie... |
1.146 "Regulatory Data" has the meaning set forth in Section 5.3 (Regulatory Matters). |
1.147 "Regulatory Documentation" means all (a) applications (including all INDs and Drug Approval Applications), registrations, licenses, authorizations and approvals (including Regulatory Approvals), (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official con... |
1.148 "Regulatory Exclusivity" means, with respect to any country or other jurisdiction in the Territory, an additional market protection, other than Patent protection or other patent-related exclusivity, granted by a Regulatory Authority in such country or other jurisdiction which confers an exclusive Commercializatio... |
1.149 "Royalty Term" means, with respect to each Licensed Product and each country or other jurisdiction in the Territory, the period beginning on the date of the First Commercial Sale of such Licensed Product in such country or other jurisdiction, and ending on the later to occur of (a) the expiration, invalidation, r... |
1.150 "Safety Data Exchange Agreement" has the meaning set forth in Section 5.4.1 (Safety Data Exchange Agreement). |
1.151 "Second Request" has the meaning set forth in Section 12.6 (Termination of Failure or Delay to Obtain HSR Clearance). |
1.152 "Selling Party" has the meaning set forth in the definition of "Net Sales." |
1.153 "Senior Officer" means, with respect to Licensor, its Chief Executive Officer, President, Chief Financial Officer or any of their designees, and with respect to AbbVie, its Chief Scientific Officer or his/her designee. |
1.154 "SLE" means systematic lupus erythematosus. |
1.155 "Sublicense Agreement" has the meaning set forth in Section 4.6 (Sublicenses). |
1.156 "Sublicensee" means a Person, other than an Affiliate, that is granted a sublicense by AbbVie under the grants in Section 4.4.1 (License Grants to AbbVie) as provided in Section 4.6 (Sublicenses), excluding any Third Party to which AbbVie or its Affiliate has granted such sublicense as a result of a settlement fo... |
1.157 "Successful Completion of the Bridging Study" means the achievement of the success criteria set forth on Schedule 1.157 (Bridging Study Success Completion Criteria). |
1.158 "Term" has the meaning set forth in Section 12.1 (Term). |
1.159 "Terminated Territory" means each (a) Major Market with respect to which this Agreement is terminated by Licensor pursuant to Section 12.2.2 (Material Breach Related to Diligence in a Major Market), (b) each country or other jurisdiction with respect to which this Agreement is terminated by AbbVie pursuant to Sec... |
1.160 "Territory" means the entire world. |
1.161 "Third Party" means any Person other than Licensor, AbbVie and their respective Affiliates. |
1.162 "Third Party Claims" has the meaning set forth in Section 11.1 (Indemnification of Licensor). |
1.163 "Third Party Payments" has the meaning set forth in Section 6.6.3(c) (Reductions). |
1.164 "Third Party Provider" has the meaning set forth in Section 13.1 (Subcontracting). |
1.165 "Trademark" means any word, name, symbol, color, designation or device or any combination thereof that functions as a source identifier, including any trademark, trade dress, brand mark, service mark, trade name, brand name, logo, business symbol or domain names, whether or not registered, and any registrations t... |
1.166 "United States" or "U.S." means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico). |
1.167 "Valid Claim" means (a) 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, cancellation, dedication to the public or disclaimer; or (ii) a holding, finding or decision of invali... |
1.168 "Voting Stock" has the meaning set forth in the definition of "Change in Control." |
1.169 "Withholding Amount" has the meaning set forth in Section 6.9.1 (Withholding Taxes). |
1.170 "Withholding Party" has the meaning set forth in Section 6.9.1 (Withholding Taxes). |
1.171 "Withholding Tax Action" has the meaning set forth in Section 6.9.2 (Withholding Taxes). |
1.172 "Working Group" has the meaning set forth in Section 3.1.9(a) (Working Groups). |
ARTICLE 2 LICENSOR ACTIVITIES |
2.1 Pre-Option Development. |
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