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1.97 "HSR Filing" means (a) filings by Capsida and AbbVie with the United States Federal Trade Commission (the "FTC") and the Antitrust Division of the United States Department of Justice (the "DOJ") of a Notification and Report Form for Certain Mergers and Acquisitions (as that term is defined in the HSR Act) with res... |
1.98 "IC" means intracameral administration. |
1.99 "In-License Agreement" means any Existing In-License Agreement and any Future Capsida In-License Agreement, in each case, as amended from time to time to the extent permitted under this Agreement. |
1.100 "Included FTE Costs and Expenses" means the sum of (a) all costs and expenses for the employee performing any Research, Development or Manufacturing, as applicable, activities hereunder, including salaries, wages, bonuses, commissions, benefits, profit sharing, stock option grants, FICA costs and other similar ex... |
1.101 "IND" means (a) an investigational new drug application filed with the FDA for authorization to commence clinical studies and its equivalent in other countries or regulatory jurisdictions and (b) all supplements and amendments that may be filed with respect to the foregoing. |
1.102 "Independent IP" means any intellectual property or proprietary right of an Acquiring Entity conceived, discovered, generated, created, developed, or acquired after the Change of Control or Acquirer IP, provided that such Acquirer IP or other intellectual property or proprietary right: (a) is not conceived, disco... |
1.103 "Inflation Reduction Act" means 42 U.S.C. §§ 1320f et seq. and all its subsequent amendments and replacements. |
1.104 "Initial Capsid Option Period" means, with respect to each of α-syn and Tau, the time period commencing on the Original Agreement Effective Date and ending the later of (a) sixty (60) days following the delivery by Capsida to AbbVie of the Final Data Package for Research Stage One for such Target and (b) fifty (5... |
1.105 "Initial Capsid Program Option" means the α-syn Program Option or Tau Program Option. |
1.106 "Initial Target Capsid Profile" means, with respect to each Target, the initial target capsid profile for such Target set forth in the applicable Research Plan. |
1.107 "Initial Target Product Profile" means, with respect to each Target, the initial target product profile for such Target set forth in the applicable Research Plan. |
1.108 "IVT" means intravitreal administration. |
1.109 "Joint Governance Committee" or "JGC" has the meaning set forth in Section 7.1. |
1.110 "Know-How" means all inventions and 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, comput... |
1.111 "Knowledge" means, with respect to Capsida, the knowledge of the Chief Business Officer, VP of Technology, VP of Research and Chief Manufacturing Officer or internal legal counsel of Capsida or any of its Affiliates or any personnel holding positions equivalent to such job titles after performing a reasonably dil... |
1.112 "Legal Dispute" means any dispute, controversy or claim related to compliance with this Agreement or the validity, breach, termination or interpretation of this Agreement. |
1.113 "Licensed Capsid" means any Licensed Capsid Program Capsid or any Licensed Collaboration Program Capsid. |
1.114 "Licensed Capsid Product" means any Licensed Product containing a Licensed Capsid Program Capsid. |
1.115 "Licensed IP" means the Capsida Background IP, the Capsida Platform IP, and Capsida's interest in any Program IP, Joint IP and Manufacturing IP. |
1.116 "Licensed Ophthalmology Capsid" means each Selected Ophthalmology Capsid for a Route of Administration for which AbbVie has issued an Exercise Notice for such Route of Administration. |
1.117 "Licensed Ophthalmology Product" means any product containing a Licensed Ophthalmology Capsid and one (1) or more AbbVie Ophthalmology Cargo directed to any Final Selected Ophthalmology Target. For clarity, a Licensed Ophthalmology Product that contains both the same Licensed Ophthalmology Capsid and AbbVie Ophth... |
1.118 "Licensed Product" means any product containing a Licensed Capsid and one or more AbbVie Cargo directed to a Licensed Target. For clarity, a Licensed Product that contains both the same Licensed Capsid and AbbVie Cargo, but in a different form, formulation, dosage form/strength or delivery mode, whether or not in... |
1.119 "Major European Market" means the United Kingdom, Germany, France, Italy and Spain. |
1.120 "Major Market" means the United States and each Major European Market. |
1.121 "Manufacture" and "Manufacturing" means all activities related to the making, having made, production, manufacture, processing, filling, finishing, packaging, labeling, shipping and holding of any product (including a Licensed Product or a Licensed Ophthalmology Product) or any intermediate of any of the foregoin... |
1.122 "Manufacturing Cost" means, to the extent specifically identifiable or reasonably allocable to any Licensed Product or Licensed Ophthalmology Product, the fully burdened manufacturing cost (including as applicable, Manufacturing, indirect labor (including allocations of costs for supervisory services, occupancy a... |
1.123 "Manufacturing IP" means Manufacturing Know-How and Manufacturing Patents. |
1.124 "Manufacturing Know-How" means all Know-How specifically related to the Manufacture of Capsids that is conceived, discovered, generated, created, developed or otherwise made by or on behalf of a Party or any of its Affiliates, alone or jointly with the other Party or any of its Affiliates or any other Person, in ... |
1.125 "Manufacturing Patents" means any Patents that specifically claim Manufacturing Know-How. Manufacturing Patents exclude any Cargo Patents and any Capsida Platform Patents. |
1.126 "Marketing Authorization Application" has the meaning set forth in the definition of "Regulatory Approval Application". |
1.127 "Medical Affairs Costs" means those FTE Costs (charged in accordance with Section 9.15) incurred and the Out-of-Pocket Costs incurred by AbbVie or any of its Affiliates in accordance with Accounting Standards after the Effective Date and during the Term and pursuant to this Agreement that are specifically identif... |
1.128 "Net Profits" and, with correlative meaning, "Net Losses", means, with respect to the ALS Product for a given period during the Profit Share Term, Net Sales of such ALS Product in the Territory in such period less Allowable Expenses with respect to such ALS Product related to such period in the Territory. |
1.129 "Net Sales" means, with respect to a Royalty Product for any period, the total amount billed or invoiced on sales of such Royalty Product during such period by AbbVie, its Affiliates, or Sublicensees in the Territory to Third Parties (including wholesalers and Distributors), in bona fide arm's length transactions... |
(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 Royalty Product; |
(f) any consideration actually paid or payable by AbbVie, its Affiliates or their respective Sublicensees for any Delivery System related to a billed or invoiced sale of such Royalty Product, where for purposes of this Net Sales definition, a "Delivery System" means any delivery system comprising equipment, instrumenta... |
(g) any invoiced amounts from a prior period which are not collected and are written off by AbbVie, its Affiliates or Sublicensees, 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) to the extent reasonably allocable to sales of such Royalty Product; |
(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 Royalty Product; and |
(j) any other similar and customary deductions that are consistent with Accounting Standards, but which are not duplicative of the above deductions. |
Net Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical or regulatory 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 such Royalty Product, whether such conside... |
Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of AbbVie, its Affiliates, or its or their 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 9.17. |
In the event a Royalty Product is a Combination Product, the Net Sales for such Combination Product shall be calculated as follows: |
(i) If AbbVie, its Affiliate, or Sublicensee separately sells in such country or other jurisdiction, (A) a gene therapy product containing as its sole active ingredient, (x) with respect to a Licensed Product, the Licensed Capsid and AbbVie Cargo contained in such Combination Product, or (y) with respect to a Licensed ... |
(ii) If AbbVie, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction both the Mono Product and gene therapy products containing the other active moiety(ies) in such Combination Product, the Net Sales attributable to such Combination Product shall be determined by the Parties in ... |
1.130 "Ophthalmology Program Capsid" means any Capsid screened, generated, developed, engineered, optimized or used by or on behalf of Capsida under or in connection with the Ophthalmology Research Program. |
1.131 "Ophthalmology Program Option" means each of the IVT Option, the SCS Option and the IC Option. |
1.132 "Ophthalmology Program Option Period" means, in respect of the applicable Ophthalmology Program Option, the time period commencing on the Effective Date and ending on the later of (a) ninety (90) days following the delivery by Capsida to AbbVie of the Final Ophthalmology Data Package for the relevant Route of Adm... |
1.133 "Ophthalmology Research Program" means all activities to be conducted by the Parties under the Ophthalmology Research Plan. |
1.134 "Ophthalmology Research Stage" means each of the Build and Platform Development Research Stage, Initial Library Screening Research Stage, First Pooled Candidate Identification Studies Research Stage, Variant Optimization Research Stage, Secondary Pooled Ophthalmology CIS Research Stage, Final Variant Optimization... |
1.135 "Ophthalmology Rights" has the meaning given to it in the preamble hereto. |
1.136 "Ophthalmology Selection Period" means, with respect to each opportunity for AbbVie to make an election under Article 2A for a Route of Administration, the period commencing on the date that Capsida delivers to AbbVie the applicable Data Package for a such Route of Administration and ending on the earlier of: (a)... |
1.137 "Ophthalmology Target" means a set of one (1) or more Target Components that are associated with one (1) or more AbbVie Indications. Each Ophthalmology Target shall constitute a single Ophthalmology Target regardless of the number of Target Components. Only the set of Target Components that constitute the Ophthal... |
1.138 "Ophthalmology Target Capsid Profile" means, with respect to each Route of Administration, the target Capsid profile for such Route of Administration as agreed by the Parties and as set forth in the Ophthalmology Research Plan. |
1.139 "Ophthalmology Transferred Materials" has the meaning set forth in Section 2.12.1. |
1.140 "Opt-In" means opting into the jurisdiction of Unified Patent Court, such as through withdrawal under Article 83(4) of the Agreement on a Unified Patent Court between the participating Member States of the European Union (2013/C 175/01) of the Opt-Out of a Patent. |
1.141 "Opt-Out" means opting out of the jurisdiction of Unified Patent Court, such as the opt-out of a Patent from the exclusive competence of the Unified Patent Court under Article 83(3) of the Agreement on a Unified Patent Court between the participating Member States of the European Union (2013/C 175/01). |
1.142 "Optimization and Screening Activities" means the activities conducted pursuant to Section 2.3 or Section 2.13, as applicable. |
1.143 "Option" means a Capsid Program Option, the Collaboration Program Option, the IC Option, the IVT Option, or the SCS Option, as applicable. |
1.144 "Option Exercise Date" means the date upon which AbbVie exercises any Option pursuant to Section 3.3. |
1.145 "Option Period" means a Capsid Program Option Period, the Collaboration Program Option Period or an Ophthalmology Program Option Period, as applicable. |
1.146 "Original Neurology Rights" has the meaning given to it in the preamble hereto. |
1.147 "Out-of-Pocket Costs" means costs and expenses paid to Third Parties (or payable to Third Parties and accrued in accordance with the Accounting Standards consistently applied) by a Party (or its Affiliate) directly incurred in the conduct of any applicable activities under this Agreement, including costs for inde... |
1.148 "Patent Costs" means those FTE Costs (charged in accordance with Section 9.15) and 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) incurred by a Party or any of its Affiliates in acco... |
1.149 "Patents" means: (a) all national, regional and international patents and patent applications, including provisional patent applications and rights to claim priority from any of these patents or applications; (b) all patent applications filed either from such patents, patent applications or provisional applicatio... |
1.150 "Permitted Uses" means (a) with respect to each item of a Party's Transferred Materials, the specific uses of such Transferred Material set forth in a Plan, (b) with respect to AbbVie as the receiving Party, the Exploitation of Licensed Capsids, Licensed Ophthalmology Capsids, Licensed Products, and Licensed Opht... |
1.151 "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... |
1.152 "Personal Data" means any data that identifies or could identify a living person and does not include anonymized, key-coded data. |
1.153 "PHSA" means the Public Health Service Act as set forth at 42 U.S.C. Chapter 6A, as may be amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto). |
1.154 "Plan" means each of the Capsid Program Research Plan, the RP2 Plan, the Collaboration Program Research Plan, the POC Plan, and the Ophthalmology Research Plan, as applicable. |
1.155 "POC Studies" means, (a) with respect to Licensed Capsid Products or Licensed Ophthalmology Products, Clinical Trials conducted prior to the start of the first Registrational Trial for such product and (b) with respect to the ALS Product, Clinical Trials conducted under the POC Plan. |
1.156 "Pool Testing" has the meaning set forth in the applicable Research Plan or the Ophthalmology Research Plan, as applicable. |
1.157 "Possession" means with respect to a Party, Controlled by such Party or its Affiliates and in the possession of such Party, its Affiliate, or its or their contractors, consultants or agents. Possession shall not be deemed to require the disclosure or contribution of any Independent IP for the applicable selection... |
1.158 "Processing" has the meaning given to such term in the Data Protection Laws, and "Process" and "Processed" shall be construed accordingly. |
1.159 "Product-Specific IP" means (a) all Patents included in the Licensed IP that specifically cover, and (b) all other Licensed IP specifically relating to, in each case ((a) and (b)), Licensed Capsid(s), Licensed Product(s), Licensed Ophthalmology Capsid(s), Licensed Ophthalmology Product(s) or the Exploitation ther... |
1.160 "Profit Share Term" means, with respect to the ALS Product, the period beginning on the Option Exercise Date with respect to the Collaboration Program Option and continuing for so long as the ALS Product is being Exploited in the Territory by or on behalf of AbbVie pursuant to this Agreement. |
1.161 "Program" means (a) the rights and activities under this Agreement with respect to the Original Neurology Rights, including the Research Programs, POC Plan, and Program Capsids, Reserved Capsids, Selected Capsids, Licensed Capsids and Licensed Products (the "Neurology Program") or (b) the rights and activities un... |
1.162 "Program Capsid" means any Capsid screened, generated, developed, engineered or used by or on behalf of Capsida under or in connection with the Research Program. |
1.163 "Program IP" means the Program Know-How and the Program Patents. |
1.164 "Program Know-How" means all Know-How that is conceived, discovered, generated, created, developed or otherwise made by or on behalf of a Party or any of its Affiliates, either alone or jointly with the other Party or any of its Affiliates or any other Person, under (a) the Research Program or the POC Plan, inclu... |
1.165 "Program Patents" means any Patents that specifically claim Program Know-How. Program Patents exclude any Manufacturing Patents, Cargo Patents and any Capsida Platform Patents. For clarity, Program Patents shall include all Patents claiming inventions that are conceived, discovered, generated, created, developed ... |
1.166 "Prosecution and Maintenance" or "Prosecute and Maintain" means, with regard to a Patent, the preparation, filing, prosecution and maintenance of such Patent. For clarification, "Prosecution and Maintenance" or "Prosecute and Maintain" shall not include any Defense Proceedings or other enforcement actions taken w... |
1.167 "Registrational Trial" means, with respect to a Milestone Product, a Clinical Trial (whether or not designated a phase 3 clinical trial) for such Milestone Product with a sufficient number of subjects, (a) the results of which, together with prior data and information concerning such Milestone Product, are intend... |
1.168 "Regulatory Approval" means, with respect to a country or other jurisdiction in the Territory, all approvals (including approvals of Regulatory Approval Applications), licenses, registrations, or authorizations of any Regulatory Authority necessary to commercially distribute, sell and market a product in such cou... |
1.169 "Regulatory Approval Application" means a BLA or any corresponding foreign application in the Territory, including, with respect to the European Union, a marketing authorization application filed with the EMA pursuant to the centralized approval procedure or with the applicable Regulatory Authority of a country i... |
1.170 "Regulatory Authority" means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils, governmental authorities or other government entities regulating or otherwise exercising authority with respect to the Exploitation ... |
1.171 "Regulatory Documentation" means: all (a) applications (including all INDs and Regulatory Approval Applications), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and offic... |
1.172 "Regulatory Exclusivity Period" means, with respect to each Licensed Product, ALS Reversion Product or Licensed Ophthalmology Product in any country in the Territory, a period of exclusivity (other than Patent-related exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country ... |
1.173 "Regulatory Expenses" means those FTE Costs (charged in accordance with Section 9.15) and the Out-of-Pocket Costs (including filing, user, maintenance and other fees paid to Regulatory Authorities) incurred by or on behalf of AbbVie or any of its Affiliates in accordance with Accounting Standards that are specifi... |
1.174 "Regulatory Filing" means, with respect to a product, any documentation comprising any filing or application with any Regulatory Authority with respect to such product, or its use or potential use in the Field, including any such document submitted to or received from any Regulatory Authority, as well as any regi... |
1.175 "Research" means research, discovery and any non-clinical and pre-clinical activities relating to a Capsid, which, (a) with respect to the Research Program shall be up to but not including any IND-enabling studies and (b) with respect to the Ophthalmology Research Program shall be up to and including AbbVie's sel... |
1.176 "Research Program" means the Capsid Research Program and the Collaboration Research Program. |
1.177 "Research Stage" means Research Stage One and, if AbbVie exercises the Initial Capsid Program Option with respect to α-syn or Tau, Research Stage Two. For clarity, unless and until AbbVie exercises the Initial Capsid Program Option with respect to α-syn or Tau, Research Stage means Research Stage One. |
1.178 "Results" means all data, analyses, conclusions and other information and other Know-How generated under or in connection with, or otherwise resulting from, the Research Program, the POC Plan or the Ophthalmology Research Plan, as applicable, excluding Highly Sensitive Know-How and raw sequence data other than Se... |
1.179 "Reversion IP" means (a) (i) Know-How that (A) is owned or Controlled by AbbVie or any of its Affiliates as of the Effective Date and is conceived, discovered, generated, created, developed, acquired or otherwise made outside of the Research Program and (B) is not generally known, (ii) the Cargo Know-How, and (ii... |
1.180 "Route of Administration" means IC, IVT or SCS, as applicable. |
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