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1.181 "ROW Market" means China and Japan.
1.182 "Royalty Product" means any Licensed Capsid Product or Licensed Ophthalmology Product, that, in each case, is sold by AbbVie, its Affiliates, or Sublicensees in the Territory to Third Parties (including wholesalers and Distributors).
1.183 "Royalty Term" means, with respect to each Royalty Product and each country in the Territory, the period beginning on the date of the First Commercial Sale of such Royalty Product in such country and ending on the latest to occur of: (a) the expiration, invalidation, irretrievable lapse, revocation, cancellation,...
1.184 "Sales and Marketing Costs" means those FTE Costs (charged in accordance with Section 9.15) and the Out-of-Pocket Costs, incurred by AbbVie or any of its Affiliates in accordance with Accounting Standards, that are specifically identifiable or reasonably allocable to the sales and marketing of the ALS Product in ...
(a) activities directed to the advertising and marketing of the ALS Product;
(b) launch meetings;
(c) advertising and public relations agencies, including development and distribution of selling and advertising and promotional materials relating to the use of the ALS Product, field literature, direct to consumer advertising campaigns, media/journal advertising, distribution of such advertising and promotional mater...
(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 the ALS Product, promotional literature, promotional materials, and other selling materials, including shipment costs of the same to AbbVie's central distribution facility and from AbbVie's central distribution facility to a Party's sales force personnel;
(g) transporting, housing and maintaining sales representatives for training and the costs of all training materials used for such purpose;
(h) developing and performing market research programs;
(i) developing and administering reimbursement programs;
(j) program costs for support of developing information and data specifically intended for national accounts, managed care organizations, Regulatory Authorities (e.g., federal, state and local), and other group purchasing organizations, including pull through activities;
(k) selling by Third Party independent contractors engaged by Parties as permitted by this Agreement;
(l) operation and maintenance of the sales representatives that promote the ALS Product (including payments made to Capsida pursuant to the Co-Promotion Agreement), sales bulletins and other communications, sales meetings, specialty sales forces, call reporting and other monitoring and tracking costs, district and regi...
(m) call center set up, maintenance and operation for personnel used in connection therewith; and
(n) establishing and conducting one (1) or more training facilities for potential users of the ALS Product, including trainer costs, facility costs, supplies and user costs.
With respect to the ALS Product, Sales and Marketing Costs shall include costs of such activities that are incurred at any time during the Profit-Share Period with respect to the ALS Product (including prior to any Regulatory Approval of the ALS Product).
1.185 "Screening Period" means (a) with respect to Research Stage One, the period from the Original Agreement Effective Date until the earlier of: (i) the second (2nd) anniversary of the Original Agreement Effective Date and (ii) the date that the final individual Capsid-cargo characterization set forth in Section 2.3....
1.186 "SCS" means suprachoroidal administration.
1.187 "Selection Period" means, with respect to each opportunity for AbbVie to make an election under Article 2 for a Target and a Research Stage, the period commencing on the date that Capsida delivers to AbbVie the applicable Data Package for such Target and Research Stage and ending on the earlier of: (a) the later ...
1.188 "Senior Officer" means, with respect to Capsida, its Chief Executive Officer and with respect to AbbVie, its Chief Scientific Officer.
1.189 "Sublicensee" means with respect to each Party, a Person, other than an Affiliate or a Distributor, that is granted a sublicense (or further right of reference), by such Party or its Affiliate under the grants in Section 8.1 or Section 8.2, as provided in Section 8.3, or, in the case of Capsida, a license under t...
1.190 "Target" means each of α-syn, Tau and TDP-43.
1.191 "Target Capsid Profile" means, with respect to a Target, the Initial Target Capsid Profile for such Target and, if AbbVie exercises the Initial Capsid Program Option with respect to α-syn or Tau, the Additional Target Capsid Profile for such Target. References to Target Capsid Profile for a Target with respect to...
1.192 "Target Component" means (a) a human gene sequence identified by a GenBank accession number (or identified by similar information that uniquely identifies such gene sequence) or any variant thereof and (b) any protein expressed therefrom and any variant thereof in each case, that when bound to, activated, inhibit...
1.193 "Target Product Profile" means, with respect to a Target, the Initial Target Product Profile for such Target and, if AbbVie exercises the Initial Capsid Program Option with respect to α-syn or Tau, the Additional Target Product Profile for such Target. References to Target Product Profile for a Target with respec...
1.194 "Tau" means the microtubule-associated protein tau gene designated MAPT (as exemplified by NCBI Reference Sequence Database record NG_007398) including all DNA haplotypes, gene duplications, polymorphisms, mutations or allelic variants of the MAPT locus, all mRNA products derived from the complete or partial MAPT...
1.195 "TDP-43" means the Transactive response DNA binding Protein 43 kDa (TDP-43) gene designated TARDBP (as exemplified by NCBI Reference Sequence Database record NG-008734) including all DNA haplotypes, gene duplications, polymorphisms, mutations or allelic variants of the TARDBP locus, all mRNA products derived from...
1.196 "Terminated Territory" means, with respect to a particular Program, each country with respect to which this Agreement is terminated in respect of such Program by either Party pursuant to Section 14.2.1 or AbbVie pursuant to Section 14.2.2, in either case, if such termination applies to one (1) or more countries, ...
1.197 "Territory" means all of the countries in the world, including their respective territories and possessions, excluding, with respect to a particular Program, any Terminated Territory in respect of such Program.
1.198 "Third Country" or "Third Countries" means a country outside the EEA or a country not deemed to provide an adequate level of protection for Personal Data by the European Commission.
1.199 "Third Party" means any Person other than Capsida, AbbVie and their respective Affiliates.
1.200 "Third Party Managed Patents" means Existing NP Patents or Existing OP Patents, as applicable, for which neither Capsida nor any of its Affiliates has the first right to control Prosecution and Maintenance as of the Original Agreement Effective Date.
1.201 "Third Party Right" means any Patent, trade secret or other intellectual property right (but not any Trademark) of a Third Party in any country in the Territory.
1.202 "Trademark" means any mark, word, name, symbol, color, shape, designation or any combination thereof, including any trademark, service mark, trade name, brand name, sub-brand name, trade dress, product configuration, program name, delivery form name, certification mark, collective mark, logo, tagline, slogan, des...
1.203 "Trademark 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 AbbVie or any of its Affiliates in ac...
1.204 "United States" or "U.S." means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico).
1.205 "Valid Claim" means a claim of (a) any issued and unexpired Patent whose validity, enforceability or patentability has not been affected by (i) irretrievable lapse, abandonment, revocation, cancellation, dedication to the public or disclaimer or (ii) a holding, finding or decision of invalidity, unenforceability ...
1.206 "wAMD" means wet age-related macular degeneration of early, intermediate, or advanced classification.
INDEX OF ADDITIONAL DEFINED TERMS
Term
α-syn Program Option
AbbVie
AbbVie Background Know-How for ALS
AbbVie Background Know-How for Ophthalmology Research Program
AbbVie Background Know-How for Research Program
AbbVie Background Patents for ALS
AbbVie Background Patents for Ophthalmology Research Program
AbbVie Background Patents for Research Program
AbbVie Indemnitees
AbbVie Materials
AbbVie Methods
AbbVie Ophthalmology Materials
AbbVie Reserved Field
Acquired Third Party
Acquirer
Acquirer IP
Acquiring Entity
Additional Capsid Program Option
Additional Target Capsid Profile
Additional Target Product Profile
ADR
Agreement
ALS
ALS Cargo
ALS Commercialization Plan
ALS Development Plan and Budget
ALS Milestone Event
ALS Milestone Payments
ALS Reversion Royalty Term
Amount
Auditor
Back-Up Capsids
Biosimilar Application
Breaching Party
Build and Platform Development Research Stage
CalTech IP
Capsid Exclusive License
Capsid Patent
Capsid Program Research Plan
Capsida
Capsida Indemnitees
Capsida NP Regulatory Filings
Capsida OP Regulatory Filings
Change of Control Party
Co-Development Costs
Collaboration Program Option
Collaboration Program Research Plan
Commercial Scale-Up Transition Event
Confidential Information
Conversion Date
Co-Promotion Agreement
Co-Promotion Option
Co-Promotion Option Exercise Notice
Co-Promotion Product
Co-Promotion Readiness Plan
Data Breach
Defense Proceeding