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(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) – (i) above. |
Net Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory, or governmental purposes. Net Sales shall not include sales between or among AbbVie, its Affiliates, or Sublicensees; provided that such transfer is intended for further sale, transfer, lease, exchange... |
Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of AbbVie, its Affiliates, or Sublicensees, and, where applicable, Accounting Standards. |
For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 7.12 (Mode of Payment; Offsets). |
In the event a Licensed Product is a Combination Product, the Net Sales for such Combination Product shall be calculated as follows: |
(a) If AbbVie, its Affiliate, or Sublicensee separately sells in such country or other jurisdiction, (A) a product containing as its sole active ingredient a Licensed Compound contained in such Combination Product (the "Mono Product") and (B) products containing as their sole active ingredients the other active ingredi... |
(b) If AbbVie, its Affiliate, or Sublicensee separately sells in such country or other jurisdiction the Mono Product but does not separately sell in such country or other jurisdiction products containing as their sole active ingredients the other active ingredient in such Combination Product, the Net Sales attributable... |
(c) If AbbVie, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction the Mono Product but do separately sell products containing as their sole active ingredients the other active ingredients contained in such Combination Product, the Net Sales attributable to such Combination Pro... |
(d) If AbbVie, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction both the Mono Product and the other active ingredient or ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be determined by the Parties in good faith based on ... |
1.175 "Neutral" has the meaning set forth in Schedule 13.7.3 (ADR Procedures). |
1.176 "Non-Breaching Party" has the meaning set forth in Section 12.2.1 (Material Breach). |
1.177 "Option Antitrust Consents" has the meaning set forth in Section 4.3.1 (Antitrust Clearances). |
1.178 "Option Exercise Payment" has the meaning set forth in Section 7.1.2 (Option Exercise Payment). |
1.179 "Option Extension Payment" means each of the First Option Extension Payment, Second Option Extension Payment, Third Option Extension Payment, and Fourth Option Extension Payment. |
1.180 "Option Foreign Investment Consents" has the meaning set forth in Section 4.3.1 (Antitrust Clearances). |
1.181 "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) that are directly incurred in the conduct of any applicable activities under this Agreement, including costs... |
1.182 "Overlap Compound" has the meaning set forth in Section 8.2 (HotSpot Screening Obligation). |
1.183 "Overlap Patents" has the meaning set forth in Section 8.3.4 (Prosecution and Maintenance of Overlap Patents). |
1.184 "Owned Patents" has the meaning set forth in Section 10.2.5 (Additional Representations and Warranties of HotSpot). |
1.185 "Party" and "Parties" has the meaning set forth in the preamble hereto. |
1.186 "Patent Roadmap" has the meaning set forth in Section 8.3.1 (Patent Roadmap). |
1.187 "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 applications, (b) all patent applications filed either from such patents, patent applications or provisional applications... |
1.188 "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... |
1.189 "Personal Data" means (a) all information identifying, or in combination with other information, identifiable to an individual, including pseudonymized (key-coded) Clinical Program Data containing such information; and (b) any other information that is governed, regulated or protected by one (1) or more Data Secu... |
1.190 "Phase I Study" means a human clinical trial of a Compound or Product, the principal purpose of which is a preliminary determination of safety, tolerability, pharmacological activity or pharmacokinetics in healthy individuals or patients, or a similar clinical study prescribed by the Regulatory Authorities, inclu... |
1.191 "Phase Ib Study" means a Phase I Study of a Compound or Product that (a) provides for the first introduction of a Compound or Product into patients having the disease of interest with the primary purpose of determining safety, tolerability, pharmacologic activity, and pharmacokinetics of a Compound or Product, in... |
1.192 "Phase II Study" means a human clinical trial of a Compound or 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 similar clini... |
1.193 "Phase III Study" means a human clinical trial of a Compound or Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a Compound or Product is safe and efficacious for its intended use and to determine the benefit/risk relationship, warnings, precautions,... |
1.194 "Phase IV Study" means a post-marketing, human clinical trial for any Licensed Product for a country or jurisdiction in the Territory with respect to any Indication as to which all Regulatory Approvals have been received or for a use that is the subject of an investigator-initiated study program. |
1.195 "Powder Libraries" means all compound libraries Controlled by HotSpot or its Affiliates as of the Effective Date or during the Research Term that are not DNA-tagged or encoded and that contain a Compound. |
1.196 "Price Applicability Period" has the meaning set forth in Section 1191(b)(2) of the Social Security Act. |
1.197 "Pricing and Reimbursement Approval" means such approval, agreement, determination or decision establishing prices for a Licensed Product that can be charged to consumers or will be reimbursed by Governmental Authorities in a country or other jurisdiction in the Territory where Governmental Authorities of such co... |
1.198 "Privacy and Data Security Obligations" has the meaning set forth in Section 10.2.17 (Additional Representations and Warranties of HotSpot). |
1.199 "Pro Rata Percentage" has the meaning set forth in Section 5.3.3 (HotSpot Cost-Sharing Option). |
1.200 "Processing" 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 making available, al... |
1.201 "Product" means a Collaboration Product or Licensed Product, as applicable. |
1.202 "Product Information" has the meaning set forth in Section 9.1 (Product Information). |
1.203 "Product Infringement" has the meaning set forth in Section 8.4.1 (Notice). |
1.204 "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 ... |
1.205 "Product Trademarks" means the Trademark(s) to be used by AbbVie or its Affiliates or its or their respective Sublicensees for the Exploitation of Licensed Products in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (excluding, in any event, any Trademarks... |
1.206 "Project DELs" has the meaning given in Schedule 10.2 (Disclosures to Additional Representations and Warranties of HotSpot). |
1.207 "Proposed Future In-Licensed Rights" has the meaning set forth in Section 6.10.3 (In-License Agreements). |
1.208 "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 Compound or Licensed Product in such country or other ju... |
1.209 "Regulatory Authority" means any applicable supra-national, federal, national, regional, state, provincial, or local Governmental Authority or regulatory authority, agency, department, bureau, commission, council, or other entities (e.g., the FDA and EMA) regulating or otherwise exercising authority with respect ... |
1.210 "Regulatory Data" has the meaning set forth in Section 5.7.3 (Regulatory Matters after License Option Effective Date). |
1.211 "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 co... |
1.212 "Regulatory Exclusivity" means, with respect to a Licensed Product and any country or other jurisdiction in the Territory, an additional market protection, other than Patent protection or Patent-related exclusivity, granted by a Regulatory Authority in such country or other jurisdiction which confers an exclusive... |
1.213 "Related Third Party IP" has the meaning given in Section 6.10.1 (In-License Agreements). |
1.214 "Research and Development Milestone Event" has the meaning set forth in Section 7.2.1 (Research and Development Milestones). |
1.215 "Research and Development Milestone Payment" has the meaning set forth in Section 7.2.1 (Research and Development Milestones). |
1.216 "Research Compounds" means all compounds, other than HotSpot Existing Compounds or HotSpot Existing Mature Program Compounds, that are (a) Controlled by HotSpot or its Affiliates during the Research Term, and (b) Directed To the Collaboration Target. |
1.217 "Research Term" means the period beginning on the Effective Date and ending on the earlier of (a) completion of all activities under the Development Plan and Budget (as amended) and delivery of the Final Data Package by HotSpot to AbbVie and (b) the License Option Effective Date. |
1.218 "Reverse Royalty Term" means, with respect to each Grantback Product that is the subject of a license pursuant to Section 12.7.1 (Termination in Entirety) or Section 12.9.2 (Termination of Terminated Territory) and each country or other jurisdiction in the Terminated Territory, the period beginning on the date of... |
1.219 "Royalty-Bearing Patent" means a HotSpot Patent or Joint Patent that includes a Valid Claim that claims (a) the composition of matter of the Licensed Compound contained in the Licensed Product in such country or jurisdiction or (b) any method of therapeutic use for an Indication for which the Licensed Product has... |
1.220 "Royalty Term" means, on a Licensed Product-by-Licensed Product and a country-by-country or other jurisdiction-by-other jurisdiction basis, the period beginning on the date of the First Commercial Sale of a Licensed Product in such country or other jurisdiction, and ending on the latest to occur of (a) the expira... |
1.221 "Scheduled Deliverables" has the meaning given in Schedule 10.2 (Disclosures to Additional Representations and Warranties of HotSpot). |
1.222 "Scheduled Litigation" means that certain litigation identified in Schedule 10.2 (Disclosures to Additional Representations and Warranties of HotSpot). |
1.223 "Scheduled Third Party" has the meaning given in Schedule 10.2 (Disclosures to Additional Representations and Warranties of HotSpot). |
1.224 "Scheduled Third Party Agreement" means that certain agreement identified in Schedule 10.2 (Disclosures to Additional Representations and Warranties of HotSpot). |
1.225 "Scheduled Third Party Exclusive Field" has the meaning given in Schedule 10.2 (Disclosures to Additional Representations and Warranties of HotSpot). |
1.226 "Second Option Extension Payment" has the meaning set forth in Section 7.1.3(b) (Option Extension Payments). |
1.227 "Selected Drug" means a drug selected under the Drug Price Negotiation Program, as described in Section 1192 of the Social Security Act. |
1.228 "Senior Officer" means with respect to HotSpot, its Chief Executive Officer, and with respect to AbbVie, its Chief Scientific Officer or his/her designated direct reports; provided that upon a Change in Control of HotSpot, HotSpot may designate as a new Senior Officer (a) if such Change in Control is to a Large P... |
1.229 "Series 1" means the lead chemical series based on a common scaffold denominated by HotSpot as "IRF5 Series 1" as of the Effective Date. |
1.230 "Series 2/3" means the lead chemical series based on a common scaffold denominated by HotSpot as "IRF5 Series 2/3" as of the Effective Date. |
1.231 "Series 4" means the lead chemical series based on a common scaffold denominated by HotSpot as "IRF5 Series 4" as of the Effective Date. |
1.232 "Settlement Sublicense" means a sublicense by AbbVie to a Third Party (a "Settlement Sublicensee") under the grants in Section 6.1 (Grants to AbbVie on the Effective Date) and Section 6.3 (Grants to AbbVie on the License Option Effective Date) as provided in Section 6.4 (Sublicenses) as a result of a settlement i... |
1.233 "Settlement Sublicensee" has the meaning set forth in Section 1.232 (Settlement Sublicense). |
1.234 "Shared Cost Report" has the meaning set forth in Section 5.3.4 (HotSpot Cost-Sharing Option). |
1.235 "Shared Development Costs" means, with respect to a Licensed Compound or Licensed Product, the FTE Costs and Out-of-Pocket Costs incurred by or on behalf of AbbVie or any of its Affiliates in accordance with Accounting Standards, this Agreement, and the AbbVie Cost-Sharing Plan and Budget, that are specifically a... |
1.236 "Social Security Act" means the Social Security Act of 1935 as set forth in Title 42, Chapter 7 of the United States Code, as amended, and any successor statute thereto, as interpreted by the rules and regulations issued thereunder, in each case as in effect from time to time. |
1.237 "SOFR" means the Secured Overnight Financing Rate for a thirty (30)-day term published by US Federal Reserve Bank of New York, as adjusted from time to time on the first New York business day of each month. |
1.238 "Stage 1 Activities" means those activities identified as Stage 1 Activities in the Development Plan and Budget, which generally shall include all activities conducted from the Effective Date through the completion of lead generation and initiation of lead optimization in accordance with the Development Plan and ... |
1.239 "Stage 1 Information Report" means a report that sets forth the information listed on Schedule 1.239 (Stage 1 Information Report), including, without limitation, the results of the Stage 1 Activities. |
1.240 "Stage 1 License Option Expiration Date" means, subject to Section 3.5.2 (Information Reports and Final Data Package), the forty-fifth (45th) day following HotSpot's delivery of the Stage 1 Information Report to AbbVie that contains all of the information required to be therein. |
1.241 "Stage 2 Activities" means those activities identified as Stage 2 Activities in the Development Plan and Budget, which generally shall include all activities conducted from Completion of Stage 1 Activities through the nomination of the Lead Development Candidate Compound in accordance with the criteria set forth ... |
1.242 "Stage 2 Information Report" means a report that sets forth the information listed on Schedule 1.242 (Stage 2 Information Report), including, without limitation, the results of the Stage 2 Activities. |
1.243 "Stage 2 License Option Expiration Date" means, subject to Section 3.5.2 (Information Reports and Final Data Package), the forty-fifth (45th) day following HotSpot's delivery of the Stage 2 Information Report to AbbVie that contains all of the information required to be therein. |
1.244 "Stage 3 Activities" means those activities identified as Stage 3 Activities in the Development Plan and Budget, which shall include all the activities conducted from the Completion of Stage 2 Activities through the dosing of the first animal in the first in vivo GLP toxicology study. |
1.245 "Stage 3 Information Report" means a report that sets forth the information listed on Schedule 1.245 (Stage 3 Information Report), including, without limitation, the results of the Stage 3 Activities. |
1.246 "Stage 3 License Option Expiration Date" means, subject to Section 3.5.2 (Information Reports and Final Data Package), the forty-fifth (45th) day following HotSpot's delivery of the Stage 3 Information Report to AbbVie that contains all of the information required to be therein. |
1.247 "Stage 4 Activities" means those activities identified as Stage 4 Activities in the Development Plan and Budget, which shall include all the activities conducted from the Completion of Stage 3 Activities through IND Acceptance for the first Licensed Product. |
1.248 "Stage 4 Information Report" means a report that sets forth the information listed on Schedule 1.248 (Stage 4 Information Report), including, without limitation, the results of the Stage 4 Activities. |
1.249 "Stage 4 License Option Expiration Date" means, subject to Section 3.5.2 (Information Reports and Final Data Package), the forty-fifth (45th) day following HotSpot's delivery of the Stage 4 Information Report to AbbVie that contains all of the information required to be therein. |
1.250 "Sublicensee" means a Person, other than an Affiliate or a Distributor, that is granted a sublicense by AbbVie under the grants in Section 6.1 (Grants to AbbVie on the Effective Date) or Section 6.3 (Grants to AbbVie on the License Option Effective Date) as provided in Section 6.4 (Sublicenses), excluding (a) any... |
1.251 "Term" has the meaning set forth in Section 12.1.1 (Term). |
1.252 "Terminated Territory" means (a) the United States, if this Agreement is terminated in the United States by HotSpot pursuant to Section 12.2.2 (Material Breach Related to Diligence in Specific Countries) or by AbbVie pursuant to Section 12.3.2 (For Convenience), (b) Europe if this Agreement is terminated in the E... |
1.253 "Termination Product" has the meaning set forth in Section 1.116 (Grantback Product). |
1.254 "Territory" means worldwide, excluding any Terminated Territory. |
1.255 "Third Option Extension Payment" has the meaning set forth in Section 7.1.3(c) (Option Extension Payments). |
1.256 "Third Party" means any Person other than HotSpot, AbbVie and their respective Affiliates. |
1.257 "Third-Party Claims" has the meaning set forth in Section 11.1 (Indemnification of HotSpot). |
1.258 "Third-Party Infringement Claim" has the meaning set forth in Section 8.5.1 (Prior to License Option Effective Date). |
1.259 "Trademark" means any trademark, trade dress, brand mark, service mark, trade name, brand name, logo, business symbol or domain name, or any word, name, symbol, color, designation or device or any combination thereof that functions as a source identifier, whether or not registered, and any registrations thereof o... |
1.260 "Transition Agreement" has the meaning set forth in Section 12.10.3 (Other Effects of Termination). |
1.261 "Trial Master File" means the documents maintained at clinical research sites and by HotSpot during the course of Clinical Studies for any Licensed Product, which enable the conduct of a Clinical Study and the quality of the data produced to be evaluated, proving that the study was conducted by the investigator a... |
1.262 "Unfinished Development Plan Activities" has the meaning set forth in Section 3.10 (Completion of Development Plan Activities after License Option Effective Date). |
1.263 "Unfinished Manufacturing Activities" has the meaning set forth in Section 3.10 (Completion of Development Plan Activities after License Option Effective Date). |
1.264 "United States" or "U.S." means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico). |
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