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Unless otherwise specifically provided herein, the following terms shall have the following meanings: |
1.1 "A&R Disclosure Schedules" has the meaning set forth in Section 10.2.2. |
1.2 "A&R Effective Date" has the meaning set forth in the preamble hereto. |
1.3 "AbbVie" has the meaning set forth in the preamble hereto. |
1.4 "AbbVie Consideration Period" has the meaning set forth in Section 2.1.6(d). |
1.5 "AbbVie Development Cost Report" has the meaning set forth in Section 3.3.4. |
1.6 "AbbVie Development Costs" means, with respect to a Cost-Share Product, the FTE Costs and the Out-of-Pocket Costs incurred by or on behalf of AbbVie or any of its Affiliates, commencing on the date on which the relevant Cost-Sharing Option Period begins, in accordance with the Accounting Standards and this Agreemen... |
1.7 "AbbVie Grantback IP" means, with respect to any Reversion Product, (a) any Program Product Inventions that are necessary or reasonably useful for the Exploitation of such Reversion Product and (b) any Program Product Patents that claim any Program Product Inventions described in the foregoing clause (a). |
1.8 "AbbVie Indemnitees" has the meaning set forth in Section 11.2. |
1.9 "AbbVie Independent Information" means any Information owned or otherwise controlled by AbbVie or its Affiliates that is generated independently of this Agreement and without use of Calibr IP. |
1.10 "AbbVie IP" means AbbVie Know-How and AbbVie Patents. |
1.11 "AbbVie Know-How" means any and all (a) Information Controlled by AbbVie or any of its Affiliates as of the Original Execution Date or at any time during the Term, other than any AbbVie Sole Inventions, Program Product Inventions or Joint Know-How, that is reasonably necessary or useful for the Development of a Re... |
1.12 "AbbVie Materials" has the meaning set forth in Section 2.7. |
1.13 "AbbVie Patents" means any and all (a) Patents Controlled by AbbVie or any of its Affiliates as of the Original Execution Date or at any time during the Term, other than any AbbVie Sole Patents, Program Product Patents or Joint Patents, that are reasonably necessary or useful for the Development of a Research Targ... |
1.14 "AbbVie Platform Improvement IP" means any and all modifications, enhancements and improvements to the sCAR-T Platform (or any Calibr Component) conceived, discovered, developed or otherwise made by or on behalf of AbbVie or any of its Affiliates under this Agreement to the extent such modification, enhancement or... |
1.15 "AbbVie Sensitive Information" has the meaning set forth in Section 9.6.1. |
1.16 "AbbVie Sole Inventions" has the meaning set forth in Section 8.1.1. |
1.17 "AbbVie Sole Patents" has the meaning set forth in Section 8.1.1. |
1.18 "AbbVie Target" means any Research Target excluding any Research Target (a) for which, as of the Inclusion Date for such Research Target, Calibr or any of its Affiliates had performed any in vivo assay with respect to any biopharmaceutical product Directed to such Research Target for any of the indications for whi... |
1.19 "AbbVie Target Information" means, with respect to an AbbVie Target, (a) the identity of such AbbVie Target, (b) the indications for which the Parties are conducting activities under the Target Research Plan for such AbbVie Target, (c) the sequences of such AbbVie Target and any potential post-translational modifi... |
1.20 "Academic Collaborations" has the meaning set forth in Section 4.7.4. |
1.21 "Academic Collaborator" means any Third Party that Calibr licenses, authorizes, appoints, or otherwise assists or enables in connection with an Academic Collaboration. |
1.22 "Acceptance Date" means, with respect to a Reviewable Data Package, (a) if AbbVie does not request that such Reviewable Data Package be updated with any missing information or data pursuant to Section 2.10.4, the date AbbVie receives such Reviewable Data Package and (b) if AbbVie requests that such Reviewable Data... |
1.23 "Accounting Standards" means, with respect to a Party or its Affiliates or its or their (sub)licensees, United States generally accepted accounting principles, consistently applied. |
1.24 "Acquirer IP" has the meaning set forth in Section 13.3.2. |
1.25 "Acquiring Entities" has the meaning set forth in Section 13.3.2. |
1.26 "Acquisition Party" has the meaning set forth in Section 13.3.2. |
1.27 "Acquisition Transaction" has the meaning set forth in Section 13.3.2. |
1.28 "Act" has the meaning set forth in the definition of Change of Control. |
1.29 "Active Agent" means any molecule, active pharmaceutical ingredient, antibody, recombinant protein, gene therapy, nucleic acid sequence, or small molecule-induced or protein-induced agent other than a Calibr Component that is (a) an active pharmaceutical or biological agent and (b) not proprietary to Calibr. |
1.30 "Adaptive Trial" means a human clinical trial that does not meet the criteria for a Registration Study at the time such human clinical trial is Initiated and includes a prospectively planned opportunity for such human clinical trial to be modified based on interim analyses to change to a Registration Study followi... |
1.31 "Additional Gene" means, with respect to a vector that encodes the chimeric protein expressed by a sCAR-T that is part of any Licensed Product, any other gene or functional domain encoded by such vector. |
1.32 "Affiliate" means, with respect to a Person, any Person that, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with such first Person at any time for so long as such Person controls, is controlled by or is under common control with such first Per... |
1.33 "Agreement" has the meaning set forth in the preamble hereto. |
1.34 "Agreement Data" has the meaning set forth in Section 10.4. |
1.35 "Alliance Managers" has the meaning set forth in Section 6.6. |
1.36 "Antibody-Based Protein" means a protein that is an antibody, a fragment of an antibody, or an alternative scaffold designed to provide specific binding to a Target. |
1.37 "Applicable Law" means those laws, rules and regulations of any Governmental Authority, including any rules, regulations, regulatory guidelines or other requirements of Regulatory Authorities, that may be in effect from time to time and applicable to a particular activity hereunder. |
1.38 "Auditor" has the meaning set forth in Section 7.16.2. |
1.39 "Bayh Dole Act" means the Patent and Trademark Law Amendments Act of 1980, as amended, codified at 35 USC §§ 200-212, as may be amended from time to time, together with any rules, regulations, executive orders and requirements promulgated thereunder, including in 37 C.F.R. Part 401, (including all additions, suppl... |
1.40 "Bayh Dole Act Filings" has the meaning set forth in Section 10.2.1(o). |
1.41 "Biosimilar Application" has the meaning set forth in Section 8.5.1. |
1.42 "Biosimilar Product" means, with respect to a particular Licensed Product in a particular country in the Territory, any pharmaceutical product that: (a) is claimed to be biosimilar to or interchangeable with such Licensed Product and whose BLA relies in whole or in part on a prior BLA granted to such Licensed Prod... |
1.43 "BLA" means (a) a Biologics License Application as described in 21 C.F.R. §601.2, or equivalent application in any applicable foreign jurisdiction in the Territory, including, with respect to the European Union, a marketing authorization application filed with the EMA pursuant to the centralized approval procedure... |
1.44 "BMPR1" means bone morphogenetic protein receptor type 1B. |
1.45 "Board of Directors" has the meaning set forth in the definition of Change of Control. |
1.46 "Breaching Party" has the meaning set forth in Section 12.2.1(a). |
1.47 "Business Day" means a day other than a Saturday or Sunday or a day on which banking institutions in Chicago, Illinois are permitted or required to be closed. |
1.48 "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 Original Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July... |
1.49 "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 Original Effective Date and end on December 31 of the year in which the Original Effective Date occurs and the last Ca... |
1.50 "Calibr" has the meaning set forth in the preamble hereto. |
1.51 "Calibr-Division" means (a) the Scripps Research Institute's drug discovery division with an address at 11119 N Torrey Pines Rd, La Jolla, CA 92037 as of the A&R Effective Date and (b) any other operational division within the Scripps Research Institute or entity acting on behalf of the Scripps Research Institute'... |
1.52 "Calibr CD19 Patents" has the meaning set forth in Section 8.3.2(b). |
1.53 "Calibr Component" means any of the following: (a) a sCAR-T, (b) a vector encoding the chimeric protein expressed by a sCAR-T or (c) a Switch, in each case (a) through (c), that is either (i) a component or part of any Research Target Product or (ii) otherwise generated through the use of the sCAR-T Platform under... |
1.54 "Calibr Development Costs" means the FTE Costs and the Out-of-Pocket Costs incurred by or on behalf of Calibr or any of its Affiliates in accordance with the Accounting Standards and this Agreement, that are specifically attributable or reasonably allocable to the performance of the Development activities under th... |
1.55 "Calibr Indemnitees" has the meaning set forth in Section 11.1. |
1.56 "Calibr IP" means Calibr Know-How and Calibr Patents. |
1.57 "Calibr IP Indemnity Claim" has the meaning set forth in Section 11.2. |
1.58 "Calibr Know-How" means (a) any and all Information Controlled by Calibr or any of its Affiliates as of the Original Execution Date or at any time during the Term, that is reasonably necessary or useful for the Exploitation of a Licensed Product or the sCAR-T Platform and that was generated, developed or optimized... |
1.59 "Calibr Negotiation Option" has the meaning set forth in Section 12.4.2(b). |
1.60 "Calibr Patent" means (a) any and all Patents Controlled by Calibr or any of its Affiliates as of the Original Execution Date or at any time during the Term that are reasonably necessary or useful for the Exploitation of a Licensed Product and that claim or cover any inventions generated through the Calibr-Divisio... |
1.61 "Calibr Regulatory Documentation" has the meaning set forth in Section 10.2.1(h). |
1.62 "Calibr Sales" means, with respect to a CD19 Product for any period, the total amount billed or invoiced on sales of such CD19 Product during such period by Calibr, its Affiliates or (sub)licensees in the Territory to Third Parties (including wholesalers or Distributors), in bona fide arm's length transactions, le... |
1.62.1 trade, cash and quantity discounts; |
1.62.2 price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to governmental authorities or other payees; |
1.62.3 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; |
1.62.4 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; |
1.62.5 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 CD19 Product; |
1.62.6 any consideration actually paid or payable for any Delivery System related to a billed or invoiced sale of such CD19 Product; provided, that for clarity, any consideration actually paid or payable for any Delivery System related to a billed or invoiced sale of a CD19 Product shall only be deducted once for Calib... |
1.62.7 any invoiced amounts from a prior period that are not collected and are written off by Calibr, its Affiliates or (sub)licensees, including bad debts; |
1.62.8 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 of such CD19 Product; |
1.62.9 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 CD19 Product; and |
1.62.10 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 1.62.1 through Section 1.62.9. |
Calibr Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory or governmental purposes. Calibr Sales shall include the amount or fair market value of all other consideration received by Calibr, its Affiliates or (sub)licensees in respect of such CD19 Product, w... |
Subject to the above, Calibr Sales shall be calculated in accordance with the standard internal policies and procedures of Calibr, its Affiliates or its or their (sub)licensees, which must be in accordance with the Accounting Standards. |
For purposes of calculating Calibr Sales, all Calibr Sales shall be converted into Dollars in accordance with Section 7.12. |
In the event a CD19 Product is a Combination Product, the Net Sales for such Combination Product shall be calculated as follows: |
(a) If Calibr, its Affiliate or (sub)licensees separately sells in such country or other jurisdiction, (i) a product containing as its sole active ingredients the sCAR-T and Switch Directed to CD19 contained in such Combination Product (the "Mono CD19 Product") and (ii) products containing as their sole active ingredie... |
(b) If Calibr, its Affiliate or (sub)licensees separately sells in such country or other jurisdiction the Mono CD19 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 Calibr, its Affiliate and (sub)licensees do not separately sell in such country or other jurisdiction the Mono CD19 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 Pro... |
(d) If Calibr, its Affiliate and (sub)licensees do not separately sell in such country or other jurisdiction both the Mono CD19 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 f... |
1.63 "Calibr Sole Inventions" has the meaning set forth in Section 8.1.1. |
1.64 "Calibr Sole Patents" has the meaning set forth in Section 8.1.1. |
1.65 "Category 1 Target" means each of PRLR, LIV1 and BMPR1 (in each case, unless and until it becomes a Failed Target). |
1.66 "Category 2 Target" means any Research Target that is not a Category 1 Target. |
1.67 "CD19" means B-lymphocyte antigen Cluster of Differentiation 19. Entrez Gene ID:930. HGNC ID: HGNC:1633. |
1.68 "CD19 Autoimmune 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 CD19 Autoimmune Subplan and the Information generated in connection with the same, including: ... |
1.69 "CD19 Autoimmune Option" means the option to amend the CD19 Plan to include the Initial CD19 Autoimmune Subplan. |
1.70 "CD19 Autoimmune Option Fee" has the meaning set forth in Section 7.3. |
1.71 "CD19 Autoimmune Program" means all Development activities pursuant to the CD19 Autoimmune Subplan. |
1.72 "CD19 Autoimmune Subplan" means the portion of the CD19 Plan with respect the Development of CD19 Products for an autoimmune disease designated by AbbVie, including (a) preclinical activities with respect to the use of CD19 Products in additional autoimmune indications and settings and (b) a Phase I Clinical Trial... |
1.73 "CD19 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 CD19 Plan (excluding the CD19 Autoimmune Subplan, if applicable) and the Information generated in connect... |
1.74 "CD19-JDC" or "CD19 Platform Proof-of-Principle Joint Development Committee" has the meaning set forth in Section 6.2. |
1.75 "CD19 License Option" has the meaning set forth in Section 3.1.1. |
1.76 "CD19 License Option Fee" means (a) if AbbVie exercises the CD19 License Option before the CD19 Autoimmune Data Package Acceptance Date, Fifteen Million Dollars ($15,000,000) and (b) if AbbVie exercises the CD19 License Option after the CD19 Autoimmune Data Package Acceptance Date, Twenty Million Dollars ($20,000,... |
1.77 "CD19 License Option Period" means, subject to Section 2.10.5, the time period commencing on the Original Execution Date and ending (a) if AbbVie does not exercise the CD19 Autoimmune Option before the first (1st) anniversary of the A&R Effective Date, ninety (90) days after the Acceptance Date for the CD19 Data P... |
1.78 "CD19 Licensed Product" has the meaning set forth in the definition of Licensed Product. |
1.79 "CD19 Option Bringdown Date" has the meaning set forth in Section 10.2.2. |
1.80 "CD19 Plan" means the Development plan with respect to CD19 attached hereto as Schedule 1.80, as the same may be amended from time to time in accordance with the terms hereof. For clarity, (a) unless and until AbbVie exercises the CD19 Autoimmune Option, the CD19 Plan does not include any (i) preclinical activitie... |
1.81 "CD19 Product" means any biopharmaceutical product comprised of (a) a sCAR-T or vector encoding the chimeric proteins expressed by a sCAR-T that is Directed to CD19 and (b) one (1) or more Switches Directed to CD19. |
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