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1.97 "Knowledge" means, with respect to Mission, the good faith understanding of the facts and information of the chief executive officer, the chief financial officer, the chief business officer and the Mission employee lead patent attorney of Mission as at the Effective Date, in each case, after due inquiry of each su... |
1.98 "Licensed Compound" means a Collaboration Compound, that is a DUB Hit in relation to the applicable Exclusively Licensed DUB. |
1.99 "Licensed Product" means any product that contains or comprises a Collaboration Compound or an AbbVie Compound that is a DUB Hit in relation to the applicable Exclusively Licensed DUB, alone or in combination with one or more other active ingredients in any and all forms, in current and future formulations, dosage... |
1.100 "Loss of Market Share" means an event where, with respect to a particular Licensed Product in a particular country: (a) one or more Generic Products of such Licensed Product is or are sold in such country by a Third Party; and (b) the market penetration of such Generic Products in such country is equal to or grea... |
1.101 "Major European Countries" means France, Germany, Italy, Spain and the United Kingdom. |
1.102 "Major Market" means the U.S. and the Major European Countries. |
1.103 "Manufacture" and "Manufacturing" means all activities related to the production, manufacture, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping, and holding of a Licensed Compound, any Licensed Product, or any intermediate thereof, including process development, process qualif... |
1.104 "Material Amendment" has the meaning set forth in Section 2.1(f). |
1.105 "Mission" has the meaning set forth in the preamble hereto. |
1.106 "Mission Background IP" means, collectively, Mission Background Know-How and Mission Background Patents. |
1.107 "Mission Background Know-How" means all Know-How that: (i) is Controlled by Mission on the Effective Date; or (ii) which either Party uses in the course of performing its obligations under this Agreement after the Effective Date and prior to the completion of the Stage 2 Period; and that is, in each case, necessa... |
1.108 "Mission Background Patents" means all Patents that are Controlled by Mission that: (i) on the Effective Date and that, but for the licenses granted to AbbVie under this Agreement, would be infringed by AbbVie or its Affiliates or Sublicensees by the conduct of the Research Plan or the Exploitation of any DUB Hit... |
1.109 "Mission Claims" has the meaning set forth in Section 11.2. |
1.110 "Mission Compound" means any molecule directed to a DUB that (a) originates from Mission's Compound Library, or (b) is otherwise acquired, discovered or invented by Mission independently of the Collaboration, other than non-proprietary compounds in the public domain. |
1.111 "Mission's Compound Library" means the collection of molecules that is Controlled by Mission as of the Effective Date or at any time during the Term, including any molecules not synthesized as of the Effective Date but documented in Patents or laboratory notebooks of Mission. |
1.112 "Mission Derived Compound" means any (a) analog or derivative of a Mission Compound directed to a DUB that is identified by or on behalf of either Party under the Collaboration either (i) using any Mission Know-How or (ii) for which the identification of such analog or derivative, but for the licenses granted to ... |
1.113 "Mission Indemnitees" has the meaning set forth in Section 11.2. |
1.114 "Mission IP" means, collectively, Mission Background IP, Mission Product IP, Mission Program IP and Mission's interest in Joint Program IP. |
1.115 "Mission Know-How" means all Mission Background Know-How, Mission Product Know-How, Mission Program Know-How and Joint Program Know-How. |
1.116 "Mission Patents" means all Mission Background Patents, Mission Product Patents, Mission Program Patents and Joint Program Patents. |
1.117 "Mission Patent Countries" means those countries set forth on Schedule 1.117 attached hereto. |
1.118 "Mission Product IP" means, collectively, Mission Product Know-How and Mission Product Patents. |
1.119 "Mission Product Know-How" means all Mission Program Know-How directed to (i) the composition of matter of a Licensed Compound or (ii) the use of a Licensed Compound. |
1.120 "Mission Product Patents" means all Mission Program Patents or Mission's interest in any Joint Program Patents, in either case, Directed to a Licensed Compound. For the purposes of this definition, a composition of matter claim shall be limited to the chemical structure of a molecule, and, for clarity, expressly ... |
1.121 "Mission Program IP" means, collectively, Mission Program Know-How and Mission Program Patents. |
1.122 "Mission Program Know-How" means any and all Know-How that is developed or invented after the Effective Date solely by or on behalf of Mission in the performance of activities under this Agreement. Mission Program Know-How expressly excludes Joint Program Know-How. |
1.123 "Mission Program Patents" means all Patents Controlled by Mission after the Effective Date that cover Mission Program Know-How, but excluding Joint Program Patents and Mission Background Patents. Where Mission files a Mission Program Patent that covers both Mission Background Know-How and Mission Program Know-How... |
1.124 "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 in the Territory to Third Parties (including wholesalers or distributors), in bona fide arm's length transaction... |
(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, to the extent such consideration is separately itemized on the invoice to the purchaser, where for purposes of this Net Sales definition, a "Delivery System" means any delivery system de... |
(g) any invoiced amounts from a prior period which are not collected and are written off by AbbVie or its Affiliates, including bad debts; |
(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 the Licensed Products; |
(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 (a) – (i) 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 AbbVie, its Affiliates or Sublicensees in respect of the Licensed Product, wheth... |
Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of AbbVie, its Affiliates, or Sublicensees, 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. |
In the event that a Licensed Product is sold in any country or other jurisdiction in the form of a Combination Product, the Parties shall negotiate in good faith to determine what portion of the net sales of such Combination Product in such country or other jurisdiction shall be treated as "Net Sales" under this Agreem... |
1.125 "Neutral" has the meaning set forth in Section 12.1(d)(i). |
1.126 "New Initially Selected DUB" has the meaning set forth in Section 12.1(d)(iv)(1). |
1.127 "New Selected DUB" has the meaning set forth in Section 12.1(d)(iv)(2). |
1.128 "Non-Breaching Party" has the meaning set forth in Section 9.4(a)(i). |
1.129 "Nominated Pre-Selected DUB" has the meaning set forth in Section 3.2(a). |
1.130 "Other Indication" means any Indication other than the Alzheimer's disease Indication. For clarity, Other Indication includes the Parkinson's disease Indication. |
1.131 "Other Mission Patents" has the meaning set forth in Section 7.4(a). |
1.132 "Party" and "Parties" has the meaning set forth in the preamble hereto. |
1.133 "Patents" means (a) all patents and patent applications, including provisional patent applications, (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from any of these, including divisionals, continuations, continua... |
1.134 "Patent Challenge" has the meanings as set forth in Section 7.9(a) (for the purposes of ARTICLE 7) and Section 9.5 (for the purposes of ARTICLE 9). |
1.135 "Patent Contact" has the meaning set forth in Section 7.10. |
1.136 "Patent Prosecution Costs" means the direct out-of-pocket costs (including the reasonable fees and expenses incurred to outside counsel and other Third Parties, including filing, prosecution and maintenance fees incurred to Governmental Authorities) recorded as an expense by a Party or any of its Affiliates (in a... |
1.137 "Person" means any individual, firm, corporation, partnership, limited liability company, trust, business trust, joint venture company, governmental authority, association or other entity. |
1.138 "Phase 1 Clinical Study" means a Clinical Study of a Licensed Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Licensed Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Studies. |
1.139 "Phase 2 Clinical Study" means a Clinical Study of a Licensed Product that utilizes the pharmacokinetic and pharmacodynamic information obtained from one or more previously conducted Clinical Study(s) that is designed to (i) confirm the optimal manner of use of such Licensed Product (dose and dose regimens) in th... |
1.140 "Phase 3 Clinical Study" means a Clinical Study of a Licensed Product on sufficient numbers of patients that is designed to establish that such Licensed Product is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with such Licensed Product in... |
1.141 "Pre-Selected DUBs" means the pre-selected DUBs set forth on Schedule 1.141 attached hereto. For clarity, the Pre-Selected DUBs do not include Initially Excluded DUBs. |
1.142 "Pre-Selected DUB Nomination Notice" has the meaning set forth in Section 3.2(a) |
1.143 "Prior CDA" means the Mutual Confidential Disclosure Agreement entered into by AbbVie and Mission effective as of February 16, 2015, as amended on February 1, 2018. |
1.144 "Product Information" has the meaning set forth in Section 8.1. |
1.145 "Product Specific Infringement Action" has the meaning set forth in Section 7.6(b). |
1.146 "Prohibited Programs" has the meaning set forth in Section 4.10(g)(iii). |
1.147 "Proposed Future In-Licensed Rights" has the meaning set forth in Section 4.11. |
1.148 "Prosecute" or "Prosecution" has the meaning set forth in Section 7.2. |
1.149 "Prosecuting Party" has the meaning set forth in Section 7.4(c). |
1.150 "Regulatory Approval" means with respect to a country, extra-national territory, province, state, or other regulatory jurisdiction, any and all approvals, licenses, registrations or authorizations of any Regulatory Authority necessary in order to commercially distribute, sell, manufacture, import, export or marke... |
1.151 "Regulatory Authority" means, with respect to a particular country, extra-national territory, province, state, or other regulatory jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval and/or, to the extent required for such country, extra-national territory, province, state... |
1.152 "Regulatory Exclusivity" means, with respect to any country or other jurisdiction in the Territory, an additional market protection, other than Patent protection, granted by a Regulatory Authority in such country or other jurisdiction which confers an exclusive Commercialization period during which AbbVie or its ... |
1.153 "Regulatory Materials" means regulatory applications (including Drug Approval Applications), submissions, dossiers, notifications, registrations, Regulatory Approvals and/or other filings made to or with, or other approvals granted by, a Regulatory Authority that are necessary or reasonably desirable in order to ... |
1.154 "Replaced Initially Selected DUB" has the meaning set forth in Section 12.1(d)(iv)(1). |
1.155 "Replaced Selected DUB" has the meaning set forth in Section 12.1(d)(iv)(2). |
1.156 "Required License" has the meaning set forth in Section 6.3(e). |
1.157 "Research Plan" means the plan for research to be undertaken by or on behalf of the Parties pursuant to this Agreement, an initial version of which is set forth in Schedule 1.157, as amended from time to time in accordance with this Agreement. |
1.158 "Research Program" has the meaning set forth in Section 3.1. |
1.159 "Restricted AbbVie Compound" means any AbbVie Derived Compound that, following a DUB Selectivity Screen, is not a DUB Hit. |
1.160 "Restricted Mission Compound" means any Mission Compound or Mission Derived Compound that is neither (i) a DUB Hit, nor (ii) an Unrestricted Mission Compound. |
1.161 "Royalty Term" means, with respect to each Licensed Product and each country in the Territory, the period beginning on the date of the First Commercial Sale of such Licensed Product in such country, and ending upon the later of (a) the expiration, invalidation or abandonment of the last Mission Product Patent or ... |
1.162 "Selected DUB" has the meaning set forth in Section 3.2(b). |
1.163 "Selected DUB Exchange" has the meaning set forth in Section 12.1(d)(iv)(2). |
1.164 "Stage 1" has the meaning set forth in Section 3.2(a). |
1.165 "Stage 1A" has the meaning set forth in Section 3.2(a). |
1.166 "Stage 1B" has the meaning set forth in Section 3.2(a). |
1.167 "Stage 2" has the meaning set forth in Section 3.3(a). |
1.168 "Stage 1B DUB Failure" has the meaning set forth in Section 9.3(a). |
1.169 "Stage 1 Fee" has the meaning set forth in Section 3.2(b). |
1.170 "Stage 1 Period" has the meaning set forth in Section 3.2(b). |
1.171 "Stage 1A DUB Failure" has the meaning set forth in Section 9.3(a). |
1.172 "Stage 1A Minimum Deliverables" has the meaning set forth in the Research Plan. |
1.173 "Stage 1A Period" has the meaning set forth in Section 3.2(a). |
1.174 "Stage 1B Minimum Deliverables" has the meaning set forth in the Research Plan. |
1.175 "Stage 2 Commencement Date" has the meaning set forth in Section 3.2(b). |
1.176 "Stage 2 Option" has the meaning set forth in Section 3.3(b). |
1.177 "Stage 2 Period" has the meaning set forth in Section 3.3(b). |
1.178 "Sublicensee" means any Third Party granted a sublicense by AbbVie to the rights licensed by Mission to AbbVie under Section 4.1. |
1.179 "Suitable Biochemical Assay" has the meaning set forth in the definition of "Binds", and for clarity, includes the assays set forth in Schedule 1.179. |
1.180 "Term" has the meaning set forth in Section 9.1. |
1.181 "Terminated Compounds" has the meaning set forth in Section 9.8(a)(i). |
1.182 "Terminated DUB" has the meaning set forth in Section 9.8(a). |
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