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1.176 "Losses" has the meaning set forth in Section 11.1. |
1.177 "Major European Market" means each of the United Kingdom, France, Germany, Italy and Spain. |
1.178 "Manufacture", "Manufactured" and "Manufacturing" means all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, shipping and holding of any Licensed Product, including any Calibr Component or any intermediate thereof, including process development, process quali... |
1.179 "Manufacturing Process" has the meaning set forth in Section 5.3.1. |
1.180 "Manufacturing Technology Transfer" has the meaning set forth in Section 5.3.1. |
1.181 "Merck" means Merck Sharp & Dohme Corp. |
1.182 "Merck Agreement" means that certain Drug Discovery Collaboration and License Option Agreement, dated January 1, 2012 between Merck and Calibr. |
1.183 "Milestone Events" has the meaning set forth in Section 7.5. |
1.184 "Milestone Payments" has the meaning set forth in Section 7.5. |
1.185 "Mixed Patent" means, subject to Section 8.3.2(a), any Calibr Patent that includes (a) at least one (1) claim that claims a Licensed Product or Exploitation thereof and (b) at least one (1) claim that generally claims (i) a Calibr Component or the sCAR-T Platform or the Exploitation thereof (i.e., the claim does ... |
1.186 "Mono CD19 Product" has the meaning set forth in the definition of Calibr Sales. |
1.187 "mRNA Data Package" means a data package prepared by Calibr in a form reasonable under the circumstances setting forth the research activities conducted by or on behalf of Calibr or its Affiliates under the mRNA Work Plan and the Information generated in connection with the same, including: (a) a written report s... |
1.188 "mRNA Work Plan" has the meaning set forth in Section 2.3.2. |
1.189 "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, subject to Section 7.7, Sublicensees in the Territory to Third Parties (including wholesalers or Distributors), in bona fide... |
1.189.1 trade, cash and quantity discounts; |
1.189.2 price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to Governmental Authorities or other payees; |
1.189.3 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; |
1.189.4 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; |
1.189.5 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; |
1.189.6 any consideration actually paid or payable for any Delivery System related to a billed or invoiced sale of such Licensed Product; provided, that for clarity, any consideration actually paid or payable for any Delivery System related to a billed or invoiced sale of a Licensed Product shall only be deducted once ... |
1.189.7 any invoiced amounts from a prior period that are not collected and are written off by AbbVie, its Affiliates or Sublicensees, including bad debts; |
1.189.8 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 such Licensed Product; |
1.189.9 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 |
1.189.10 any other similar and customary deductions that are consistent with the Accounting Standards, but which may not be duplicative of the deductions specified in Section 1.189.1 through Section 1.189.9. |
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 such Licensed Product, whet... |
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 the Accounting Standards. |
For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 7.12. |
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, (i) the Single Agent Product and (ii) products containing as their sole active ingredients the other Active Agents in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated b... |
(b) If AbbVie, its Affiliate or Sublicensee separately sells in such country or other jurisdiction the Single Agent Product but does not separately sell in such country or other jurisdiction products containing as their sole active ingredients the other Active Agents in such Combination Product, the Net Sales attributa... |
(c) If AbbVie, its Affiliates and Sublicensees do not separately sell in such country or other jurisdiction the Single Agent Product but do separately sell products containing as their sole active ingredients the other Active Agents contained in such Combination Product, the Net Sales attributable to such Combination P... |
(d) If AbbVie, its Affiliates and Sublicensees do not separately sell in such country or other jurisdiction both the Single Agent Product and the other Active Agents in such Combination Product, the Net Sales attributable to such Combination Product shall be determined by the Parties in good faith based on the relative... |
1.190 "New Platform Exclusivity Period" means the time period commencing on the A&R Effective Date and ending on the earliest of (a) ninety (90) days after the Acceptance Date for: (i) the mRNA Data Package; (ii) the In-Situ Data Package; (iii) the PRLR Phase I Data Package; (iv) if AbbVie exercises the CD19 Autoimmune... |
1.191 "Non-Breaching Party" has the meaning set forth in Section 12.2.1(a). |
1.192 "Notice Period" has the meaning set forth in Section 12.2.1(a). |
1.193 "Offsetable Payments" means any of the following: (a) any option payments payable under Section 2.1.5(a), Section 3.1.2 or Section 3.2.2, or payments payable under Section 2.1.6 in connection with exercise of an Existing Target ROFN, (b) any Milestone Payments payable under Section 7.5, (c) any royalty payments p... |
1.194 "Opt-In" means the 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. |
1.195 "Opt-Out" means 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). |
1.196 "Option Effective Date" means (a) with respect to a Target Option, the date upon which AbbVie delivers to Calibr the Exercise Notice with respect to such Target Option in accordance with Section 2.1.5(a), (b) with respect to the CD19 License Option, the date upon which AbbVie delivers to Calibr the Exercise Notic... |
1.197 "Option Patents" has the meaning set forth in Section 8.3.2(a). |
1.198 "Option Target" has the meaning set forth in Section 2.1.5(a). |
1.199 "Option Target Period" means the time period commencing on the Original Effective Date and ending on the tenth (10th) anniversary thereof. |
1.200 "Original Effective Date" means August 13, 2018. |
1.201 "Original Execution Date" has the meaning set forth in the recitals hereto. |
1.202 "Original License Agreement" has the meaning set forth in the recitals hereto. |
1.203 "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 AbbVie (or its Affiliate) or Calibr (or its Affiliate) directly incurred in the conduct of any applicable activities under this Agreeme... |
1.204 "Party" and "Parties" have the meaning set forth in the preamble hereto. |
1.205 "Patent Challenge" has the meaning set forth in Section 12.2.4. |
1.206 "Patents" means: (a) all national, regional and international 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 either of these, inclu... |
1.207 "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... |
1.208 "Personal Data" means any data that identifies or could identify a natural person. |
1.209 "Phase I Clinical Trial" means a human clinical trial of a product in any country, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, that would satisfy the requirements of 21 C.F.R. 312.21(a), or a similar clinical trial prescribed by the relevant Regulato... |
1.210 "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). |
1.211 "Platform Extension Payment" has the meaning set forth in Section 7.3. |
1.212 "Platform Improvement Plan" has the meaning set forth in Section 2.3.2. |
1.213 "Platform Improvements" means any and all modifications, enhancements and improvements to the sCAR-T Platform acquired (whether by license or otherwise), or conceived, discovered, developed or otherwise made by or on behalf of Calibr or any of its Affiliates (a) during the period commencing on the Original Effect... |
1.214 "Platform Option" has the meaning set forth in Section 3.2.1. |
1.215 "Platform Option Bringdown Date" has the meaning set forth in Section 10.2.5. |
1.216 "Platform Option Extension Fee" has the meaning set forth in Section 7.2. |
1.217 "Platform Option Period" means the time period commencing on the A&R Effective Date and, subject to Section 2.10.6, ending ninety (90) days after the expiration of the New Platform Exclusivity Period. |
1.218 "Platform Patents" has the meaning set forth in Section 8.3.2(a). |
1.219 "Platform Research Activities" has the meaning set forth in Section 2.3.1. |
1.220 "Platform Technology Transfer Product" has the meaning set forth in the definition of Technology Transfer Product. |
1.221 "Pre-Transaction Entities" has the meaning set forth in Section 13.3.2. |
1.222 "PRLR" means prolactin receptor. |
1.223 "PRLR Interim Research Plan" has the meaning set forth in Section 1.273. |
1.224 "PRLR Phase I Data Package" means a data package prepared by Calibr in a form reasonable under the circumstances setting forth the Development activities conducted by or on behalf of Calibr or its Affiliates under the PRLR Switch Plan, and Information generated in connection with the same, including: (a) a summar... |
1.225 "PRLR Switch Plan" means the Development plan and budget with respect to the Phase I Clinical Trial of a PRLR Switch Product attached hereto as Schedule 1.225, as the same may be amended from time to time in accordance with the terms herein. |
1.226 "PRLR Switch Product" means any biopharmaceutical product comprising (a) a sCAR-T or vector encoding the chimeric proteins expressed by a sCAR-T that is Directed to PRLR and (b) one (1) or more Switches Directed to PRLR. |
1.227 "PRLR Switch Program" means all Development activities pursuant to the PRLR Switch Plan or PRLR Interim Research Plan. |
1.228 "Processing" has the meaning given to such term in the Data Protection Laws, and "Process" and "Processed" shall be construed accordingly. |
1.229 "Product Information" has the meaning set forth in Section 9.1.1. |
1.230 "Product Patent" means (a) after the Inclusion Date with respect to a Target, any Calibr Patent, other than any Mixed Patent, that specifically claims the composition of matter, manufacture or use of a Licensed Product Directed to such Target or the Exploitation of any such Licensed Product, (b) after AbbVie exer... |
1.231 "Product Trademarks" has the meaning set forth in Section 8.10.1 |
1.232 "Program Product Inventions" has the meaning set forth in Section 8.1.3. |
1.233 "Program Product Patents" has the meaning set forth in Section 8.1.3. |
1.234 "Prosecuting Party" has the meaning set forth in Section 8.3.4. |
1.235 "Receiving Party" has the meaning set forth in Section 9.1.1. |
1.236 "Registration Study" means, with respect to a Licensed Product, a human clinical trial (whether or not designated a phase III clinical trial) for such Licensed Product on a sufficient number of subjects, the results of which, together with prior data and information concerning such Licensed Product, are intended ... |
1.237 "Regulatory Approval" means, with respect to a country in the Territory, any and all approvals (including approvals of BLAs), licenses, registrations or authorizations of any Regulatory Authority necessary to commercially distribute, sell and market a Licensed Product or a CD19 Product in such country, including,... |
1.238 "Regulatory Authority" means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of Licensed Products in th... |
1.239 "Regulatory Documentation" means: all (a) applications (including all INDs and BLAs), registrations, licenses, authorizations and approvals (including Regulatory Approvals) and (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relat... |
1.240 "Regulatory Exclusivity Period" means, with respect to a Licensed Product or a CD19 Product in any country in the Territory, a period of exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country that prevents a Third Party from referencing the L... |
1.241 "Research Target" means any Selected Target (unless and until it becomes a Failed Target), Substitute Target, Option Target or Included Existing Target, in each case from and after the applicable Inclusion Date with respect thereto. |
1.242 "Research Target Product" means a product generated and Developed by Calibr under the Target Research Plan, the PRLR Switch Plan or the SST Switch Plan and solely comprising: (a) an sCAR-T or a vector encoding the chimeric protein of an sCAR-T, and, if applicable, an Additional Gene expressed by such sCAR-T; and ... |
1.243 "Reversion Data" has the meaning set forth in Section 12.4.2(a). |
1.244 "Reversion Product" means a Licensed Product with respect to which this Agreement is terminated and that is or was the subject of Exploitation by or on behalf of AbbVie in the Territory as of the effective date of termination of this Agreement that (a) is not Directed to an AbbVie Target and (b) is solely compris... |
1.245 "Reviewable Data Package" means any Data Package, CD19 Data Package, CD19 Autoimmune Data Package, In-Situ Data Package, mRNA Data Package, PRLR Phase I Data Package, or SST Phase I Data Package. |
1.246 "ROFN Notice" has the meaning set forth in Section 2.1.6(b). |
1.247 "Royalty Term" means, with respect to each Licensed Product (unless and until AbbVie exercises the Platform Option) or CD19 Product and each country in the Territory, the time period commencing on the date of the First Commercial Sale of such Licensed Product or CD19 Product, as applicable, in such country and en... |
1.248 "sCAR-T" means, with respect to a Target(s), a chimeric antigen receptor T-cell expressing (a) a chimeric protein comprising (i) an extracellular domain that specifically binds to a Switch, (ii) a transmembrane region and (iii) an intracellular signaling domain and (b) optionally one (1) or more Additional Genes,... |
1.249 "sCAR-T Platform" means Calibr's cell therapy platform employing sCAR-Ts and Switches, including, subject to Section 4.2.1, any Platform Improvements. |
1.250 "sCAR-T Platform IP" means the sCAR-T Platform Know-How and sCAR-T Platform Patents. |
1.251 "sCAR-T Platform Know-How" means any Information Controlled by Calibr or any of its Affiliates as of the Original Execution Date or during the Term that is solely related to the sCAR-T Platform. For clarity, sCAR-T Platform Know-How shall not include any Information with respect to CD19, any Research Target or an... |
1.252 "sCAR-T Platform Patents" means any Patents Controlled by Calibr or any of its Affiliates as of the Original Execution Date or at any time during the Term that claim sCAR-T Platform Know-How. |
1.253 "Scripps-Research Personnel" means employees of The Scripps Research Institute that (a) are not employed through its Calibr-Division, (b) do not conduct any Development activities under this Agreement, including any activities in connection with any activities under the Target Research Plan, mRNA Work Plan, In-Si... |
1.254 "Second Solid Tumor Switch Program" means all Development activities pursuant to the SST Switch Plan for the Second Solid Tumor Target. |
1.255 "Second Solid Tumor Target" means LIV1 or BMPR1, as selected by AbbVie and notified to Calibr. |
1.256 "Selected Target" has the meaning set forth in Section 2.1.3. |
1.257 "Senior Officer" means, (a) with respect to Calibr, its Chief Operating Officer, and (b) with respect to AbbVie, its Chief Scientific Officer, or his or her designee. |
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