text stringlengths 1 5.46k |
|---|
1.23 "Calendar Quarter" means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 or October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or Oct... |
1.24 "Calendar Year" means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the... |
1.25 "CalTech License Agreement" means the License Agreement between Capsida and the California Institute of Technology effective as of August 5, 2019 and as amended effective September 1, 2020. |
1.26 "Capsid" means an engineered or naturally occurring adeno-associated virus (AAV)-based capsid protein or proteins (or the encoding nucleic acid sequence(s) thereof), that is capable of encapsulating one or more polynucleotides, whether single stranded (ss) or self-complementary (sc), and delivering such polynucleo... |
1.27 "Capsid Program Capsid" means any of the Capsids that AbbVie selects as Selected Capsids for α-syn or Tau pursuant to Section 2.3.8. |
1.28 "Capsid Program Option" means the Initial Capsid Program Option and, if any, the Additional Capsid Program Option. |
1.29 "Capsid Program Option Period" means the Initial Capsid Option Period(s) and, if any, the Additional Capsid Program Option Period. |
1.30 "Capsid Research Program" means all activities to be conducted by the Parties under the Capsid Program Research Plan and, if applicable, the RP2 Plan. |
1.31 "Capsida Background IP" means Capsida Background Know-How and Capsida Background Patents. |
1.32 "Capsida Background Know-How" means all information (including regulatory data, Know-How relating to Manufacture of Capsids, files, approvals and other documentation) and other Know-How owned or Controlled by Capsida or any of its Affiliates (a) as of the Original Agreement Effective Date or (b) after the Original... |
1.33 "Capsida Background Patents" means all Patents owned or Controlled by Capsida or any of its Affiliates and issued or filed (a) on or before the Original Agreement Effective Date or (b) after the Original Agreement Effective Date, in each case ((a) and (b)), that are necessary or reasonably useful (or, with respect... |
1.34 "Capsida Managed Patents" means Existing NP Patents or Existing OP Patents, as applicable, for which Capsida or any of its Affiliates has the first right to control Prosecution and Maintenance as of the Original Agreement Effective Date. |
1.35 "Capsida Platform" means (a) Capsida's proprietary processes for the design and genetic engineering of Capsids to, among other things, (i) selectively deliver polynucleotides across the blood-brain barrier or to the central nervous system or to the spinal cord following delivery, (ii) express such polynucleotides ... |
1.36 "Capsida Platform IP" means Capsida Platform Know-How and Capsida Platform Patents. |
1.37 "Capsida Platform Know-How" means any Know-How specifically directed to the Capsida Platform and 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 Per... |
1.38 "Capsida Platform Patent" means any Patents Controlled by Capsida or any of its Affiliates as of the Original Agreement Effective Date or the Effective Date or at any time during the Term that specifically claim Capsida Platform Know-How; provided, however, Capsida Platform Patents shall not include any Patent tha... |
1.39 "Capsida Sales" means, with respect to the ALS Reversion Product for any period, the total amount billed or invoiced on sales of such ALS Reversion Product during such period by Capsida, its Affiliates, or Sublicensees in the Territory to Third Parties (including wholesalers and Distributors), in bona fide arm's l... |
(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 ALS Reversion Product; |
(f) any consideration actually paid or payable by Capsida, its Affiliates or their respective Sublicensees for any Delivery System related to a billed or invoiced sale of such ALS Reversion Product, where for purposes of this Capsida Sales definition, a "Delivery System" means any delivery system comprising equipment, ... |
(g) any invoiced amounts from a prior period which are not collected and are written off by Capsida, 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 ALS Reversion 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 ALS Reversion Product; and |
(j) any other similar and customary deductions that are consistent with Accounting Standards, but which are not duplicative of the above deductions. |
Capsida Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical or regulatory purposes. Capsida Sales shall include the amount or fair market value of all other consideration received by Capsida, its Affiliates or Sublicensees in respect of such ALS Reversion Product, wheth... |
Subject to the above, Capsida Sales shall be calculated in accordance with the standard internal policies and procedures of Capsida, its Affiliates or its or their Sublicensees, which must be in accordance with Accounting Standards. |
For purposes of calculating Capsida Sales, all Capsida Sales shall be converted into Dollars in accordance with Section 9.17. |
In the event the ALS Reversion Product is a Combination Product, the Capsida Sales for such Combination Product shall be calculated as follows: |
(i) If Capsida, its Affiliate, or Sublicensee separately sells in such country or other jurisdiction (A) a Mono Product and (B) gene therapy products containing as their sole active ingredients the other active moiety(ies) in such Combination Product, the Capsida Sales attributable to such Combination Product shall be ... |
(ii) If Capsida, 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 Capsida Sales attributable to such Combination Product shall be determined by the Partie... |
1.40 "Cargo IP" means Cargo Know-How and Cargo Patents. |
1.41 "Cargo Know-How" means any Know-How that is specifically directed to any (a) AbbVie platform for the generation of AbbVie Cargo or AbbVie Ophthalmology Cargo, (b) AbbVie Cargo, AbbVie Ophthalmology Cargo or Exploitation thereof (subject to the last sentence of this definition), (c) α-syn, Tau, or TDP-43 (or any ta... |
1.42 "Cargo Patent" means any Patent that specifically claims Cargo Know-How. Cargo Patents shall not include any Patent that specifically claims (a) the Capsida Platform (whether or not in combination with AbbVie Cargo, the AbbVie Ophthalmology Cargo or another molecule(s)), (b) one (1) or more Licensed Products, (c) ... |
1.43 "cGMP" means the current Good Manufacturing Practices as provided for (and as amended from time to time) in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Harmonized Tripartite Guideline, Good Manufacturing Practice Guide for Active P... |
1.44 "Change of Control" means, with respect to a Party (a) the acquisition of beneficial ownership, directly or indirectly, by any Third Party of securities or other voting interest of such Party (or, if applicable, a parent of such Party) representing a majority or more of the combined voting power of such Party's (o... |
1.45 "Clinical Trial" means any human clinical trial of a Licensed Product or of a Licensed Ophthalmology Product. |
1.46 "CMC Activities" means the chemistry, manufacturing and controls activities required or otherwise conducted under or in connection with the Agreement. |
1.47 "Co-Promotion Option Period" means, with respect to an ALS Product, the ninety (90)-day period commencing upon delivery by AbbVie of notice of the anticipated submission date for a BLA for such ALS Product in the United States pursuant to Section 6.3.3, during which period Capsida shall have the right to exercise ... |
1.48 "Collaboration Program Capsid" means any of the Capsids that AbbVie selects as Selected Capsids for TDP-43 pursuant to Section 2.3.8. |
1.49 "Collaboration Program Option Period" means the time period commencing on the Effective Date and ending the later of (a) sixty (60) days following delivery by Capsida to AbbVie of the Final Data Package for the Collaboration Program Research Plan and (b) fifty (50) days after AbbVie's receipt of such other informa... |
1.50 "Collaboration Research Program" means all activities to be conducted by the Parties under the Collaboration Program Research Plan. |
1.51 "Combination Product" means (a) a Licensed Product that is sold with one (1) or more other active moieties in addition to the applicable Licensed Capsid and any AbbVie Cargo, or (b) a Licensed Ophthalmology Product that is sold with one (1) or more other active moieties in addition to the applicable Licensed Ophth... |
1.52 "Commercialization" means any and all activities related to the preparation for sale of, offering for sale of or sale of a Licensed Product or a Licensed Ophthalmology Product, including activities related to marketing, promoting, distributing and importing such Licensed Product or Licensed Ophthalmology Product, ... |
1.53 "Commercially Reasonable Efforts" means (a) with respect to the efforts and resources to be expended, or considerations to be undertaken, by AbbVie with respect to any objective, activity or decision to be undertaken with respect to the Research, Development, Manufacture or Commercialization of a Licensed Product ... |
1.54 "Control" means, with respect to any item of Know-How, 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 8.1 or S... |
1.55 "Converted Trial" means an Adaptive Trial that is modified to meet and otherwise satisfies the criteria for a Registrational Trial based on pre-specified analyses following an analysis of interim data from subjects in such Adaptive Trial. For clarity, an Adaptive Trial shall only constitute a Converted Trial if, f... |
1.56 "Corporate Names" means the Trademarks and logos identified on Schedule 1.56 and such other names and logos as Capsida may designate in writing from time to time. |
1.57 "CPI" means (a) with respect to FTEs in the United States the Consumer Price Index – All Urban Consumers, 1982-84=100, by the United States Department of Labor, Bureau of Statistics (or its successor equivalent index), or (b) an equivalent index in a foreign country applicable to FTEs in such country, accounting i... |
1.58 "CPI Adjustment" means the percentage increase or decrease, if any, in the CPI applicable to such personnel for the twelve (12) months ending June 30 of the Calendar Year prior to the Calendar Year for which the adjustment is being made. |
1.59 "dAMD" means dry age-related macular degeneration of early, intermediate or advanced classification. |
1.60 "Data Package" means, with respect to an activity pursuant to the applicable Plan, upon the completion of such activity, the delivery of (a) a data package that includes the Results (excluding raw sequence data except for Selected Capsids or Selected Ophthalmology Capsids, as applicable) from such activity and (b)... |
1.61 "Data Protection Laws" means any law, statute, declaration, decree, directive, legislative enactment, order, ordinance, regulation, rule or other binding restriction (as amended, consolidated or re-enacted from time to time) which relates to the protection of individuals with regards to the Processing of Personal ... |
1.62 "Detail" means, with respect to a Co-Promotion Product in the United States, a contact between a sales representative and a physician or other medical professional licensed to prescribe drugs, as will be further defined in the Co-Promotion Agreement and as measured by each Party's internal recording of such activi... |
1.63 "Development" means any research and development activities, including, as applicable, biodistribution and transduction studies and tissue distribution across species, translational (target engagement, biomarker) studies, toxicology and tolerability studies, additional pharmacology (efficacy) studies, statistical ... |
1.64 "Development Costs" means the FTE Costs (charged in accordance with Section 9.15) and the Out-of-Pocket Costs incurred by or on behalf of AbbVie or any of its Affiliates, or by Capsida or any of its Affiliates that are specifically identifiable or reasonably allocable to Development activities with respect to any ... |
(a) pre-clinical and non-clinical activities such as biodistribution, toxicology and formulation development, test method development, stability testing, quality assurance, quality control development and statistical analysis; |
(b) Clinical Trials (including aspects of such Clinical Trials involving any comparator product or co-administered agent), including (i) the preparation for and conduct of clinical studies including follow-up and long-term extension studies as required for gene therapy products by Regulatory Authorities or Applicable L... |
(c) the preparation of a regulatory dossier to support obtaining or maintaining any Regulatory Approval (including any label expansion) for any Licensed Product in the Territory, but excluding the preparation of any Regulatory Approval Application and any filing fees in connection with the filing of applications for an... |
(d) (i) Manufacturing Costs for any ALS Product for use in clinical studies or other Development activities for such ALS Product; (ii) the manufacture, purchase or packaging of comparator products, co administered agents or placebos for use in clinical studies for any ALS Product (with the manufacturing costs for compa... |
(e) Costs for the development of the Manufacturing process for an ALS Product, scale-up, manufacturing process validation, including validation batches, manufacturing improvements, and qualification and validation of Third Party contract manufacturers, in each case unless otherwise agreed by the Parties in a supply agr... |
(f) Costs associated with recall, withdrawal or field corrections of an ALS Product in connection with the Development of such ALS Product, except to the extent such costs arise from either Party's (i) gross negligence, recklessness, willful misconduct or (ii) breach of this Agreement, the Co-Promotion Agreement, the c... |
1.65 "Distributor" means any Person appointed by AbbVie or Capsida, as applicable, or any of its Affiliates or its or their Sublicensees to distribute, market and sell Licensed Product, Licensed Ophthalmology Product or the ALS Reversion Product, as applicable, with or without packaging rights, in one or more countries... |
1.66 "Distribution Costs" means, to the extent not included in Manufacturing Costs, the FTE Costs (charged in accordance with Section 9.15) incurred, and the direct Out-of-Pocket Costs incurred by AbbVie or any of its respective Affiliates during the Term and pursuant to this Agreement that are specifically identifiabl... |
(a) handling and transportation to fulfill orders (excluding such costs, if any, treated as a deduction in the definition of Net Sales); |
(b) customer services, including order entry, billing and adjustments, inquiry and credit and collection; and |
(c) direct costs of storage and distribution of such ALS Product. |
The Parties may, if appropriate, agree in writing that Distribution Costs be determined on the basis of a specified annual charge or as a percentage of Net Sales. |
1.67 "DME" means diabetic macular edema. |
1.68 "DOJ" has the meaning set forth in the definition of "HSR Filing". |
1.69 "Dollars" or "$" means United States Dollars. |
1.70 "DR" means diabetic retinopathy inclusive of background diabetic retinopathy and proliferative diabetic retinopathy. |
1.71 "EEA" means the European Economic Area. |
1.72 "EMA" means the European Medicines Agency and any successor agency thereto. |
1.73 "European Union" means the economic, scientific and political organization of member states as it may be constituted from time to time. |
1.74 "Exercise Notice" means written notice by AbbVie to Capsida exercising any Initial Capsid Program Option, the Additional Capsid Program Option, the Collaboration Program Option or any Ophthalmology Program Option. |
1.75 "Existing Capsids" means the Capsids set forth on Schedule 1.75. |
1.76 "Existing In-License Agreement" means any license or other agreement between Capsida or any of its Affiliates, on the one hand, and a Third Party, on the other hand, existing as of the Original Agreement Effective Date regarding any Third Party intellectual property rights licensed to AbbVie hereunder, including t... |
1.77 "Exploit" means to make, have made, import, use, sell or offer for sale, including to Research, Develop, Commercialize, register, modify, enhance, improve, Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), formulate, optimize, have used, export, transport, distribute, promote, marke... |
1.78 "Expression Elements" means (a) a gene expression cassette comprising one or more regulatory elements associated with the targeting, transduction or expression of a protein, peptide or polynucleotide, which may include one (1) or more promoters, enhancers, introns, or other transcriptional or post-transcriptional ... |
1.79 "FDA" means the United States Food and Drug Administration and any successor agency thereto. |
1.80 "FFDCA" means the United States Federal Food, Drug, and Cosmetic Act, as set forth at 21 U.S.C. ch. 9 §301 et seq., 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). |
1.81 "Field" means all human and non-human diagnostic, prophylactic and therapeutic uses. |
1.82 "Final Data Package" means, with respect to each Research Stage and each Target that is included in such Research Stage, upon completion of the Research Program and the associated CMC Activities and either: (i) the JGC's determination that a Research Product from such Research Stage directed to such Target meets t... |
1.83 "Final Ophthalmology Data Package" means, with respect to each Route of Administration, upon completion of the Ophthalmology Research Plan for such Route of Administration and the applicable activities thereunder (including completion resulting from the expiration of the seventy-five (75) month period in clause (c... |
1.84 "First Commercial Sale" means, with respect to a (a) Licensed Product or ALS Reversion Product and a country, the first sale for monetary value of such Licensed Product or ALS Reversion Product, as applicable, in such country by AbbVie, its Affiliates or its or their Sublicensees to a Third Party after all Regulat... |
1.85 "FTC" has the meaning set forth in the definition of "HSR Filing". |
1.86 "FTE" means the equivalent of the work of one (1) employee full time for one (1) Calendar Year (consisting of at least a total of one thousand eight hundred (1800) hours per Calendar Year) of work performing applicable Exploitation activities. Any person who devotes less than one thousand eight hundred (1800) hour... |
1.87 "FTE Costs" means, with respect to a Party and an activity for any period, the applicable FTE Rate multiplied by the applicable number of FTEs of such Party performing such activity during such period. |
1.88 "FTE Rate" means the applicable rate(s) set forth on Schedule 1.88, such rates to be adjusted annually (with the first of such adjustments to be made as of January 1, 2022 and each subsequent Calendar Year thereafter, but such adjustment determined no later than the preceding September 30) with respect to the FTEs... |
1.89 "Future Capsida In-License Agreement" means any license or other agreement between Capsida or any of its Affiliates, on the one hand, and a Third Party, on the other hand, that after the Effective Date is entered into pursuant to (a) Section 8.4.2(a)(i) or (b) Section 8.4.2(b) only from and after the date that suc... |
1.90 "GA" means geographic atrophy secondary to age-related macular degeneration. |
1.91 "Glaucoma" means open-angle, angle-closure glaucoma, high tension glaucoma, normal-tension glaucoma, secondary glaucoma, pigmentary glaucoma, neovascular glaucoma, childhood glaucoma, pseudoexfoliation syndrome, and irido corneal endothelial syndrome. |
1.92 "Good Reason" means, with respect to a decision by AbbVie to not exercise the Collaboration Program Option or to terminate the Agreement with respect to the Collaboration Research Program or the ALS Product, that such decision was based on AbbVie's bona fide, good faith determination in accordance with AbbVie's st... |
1.93 "Government Official" means (a) any Person employed by or acting on behalf of a government, government-controlled agency or entity or public international organization, (b) any political party, party official or candidate, (c) any Person who holds or performs the duties of an appointment, office or position create... |
1.94 "Highly Sensitive Know-How" means, to the extent not generally in the public domain (e.g., via publications, patents), (a) Capsida's proprietary processes for the design and genetic engineering of Capsids to, among other things, selectively deliver polynucleotides across the blood-brain barrier or to the central n... |
1.95 "HSR Act" means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as codified at 15 U.S.C. §18a, as may be amended from time to time, and the rules and regulations promulgated thereunder, or foreign equivalent thereof under Applicable Law (including all additions, supplements, extensions and modifications ... |
1.96 "HSR Clearance" means, with respect to this Agreement, the expiration or termination of all applicable waiting periods and requests for information (and any extensions thereof) under the HSR Act. |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.