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WHEREAS, HotSpot Controls (as defined herein) certain intellectual property rights with respect to Licensed Compounds (as defined herein) and Licensed Products (as defined herein) in the Territory (as defined herein); and |
WHEREAS, HotSpot wishes to grant, and AbbVie wishes to take, an exclusive option to an exclusive license under such intellectual property rights to Exploit (as defined herein) Licensed Compounds and Licensed Products in the Territory, in each case in accordance with the terms and conditions set forth below. |
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows: |
ARTICLE 1 DEFINITIONS |
Unless otherwise specifically provided herein, the following terms shall have the following meanings: |
1.1 "AbbVie" has the meaning set forth in the preamble hereto. |
1.2 "AbbVie Cost-Sharing Plan and Budget" means AbbVie's reasonably detailed, bona fide, good faith Development plan and non-binding budget for anticipated global Clinical Studies of a Licensed Product in the first Indication through the date of First Commercial Sale of the Licensed Product in the first Indication in t... |
1.3 "AbbVie Grantback Know-How" means, as used in connection with a Grantback Product and any related grantback license provided in Section 12.7.1(c) (Termination in Entirety) or 12.9.2 (Termination of Terminated Territory), that certain AbbVie Know-How that is (a) Controlled by AbbVie or any of its Affiliates as of th... |
1.4 "AbbVie Grantback Patents" means, as used in connection with a Grantback Product and any related grantback license provided in Section 12.7.1(c) (Termination in Entirety) or 12.9.2 (Termination of Terminated Territory), those certain AbbVie Patents that are (a) Controlled by AbbVie or any of its Affiliates as of th... |
1.5 "AbbVie Indemnitees" has the meaning set forth in Section 11.2 (Indemnification of AbbVie). |
1.6 "AbbVie Know-How" means any and all Information that is (a) conceived, reduced to practice, discovered, developed or otherwise made by or on behalf of AbbVie or its Affiliates or its or their Sublicensees in the course of activities conducted under this Agreement, and (b) not generally known, but excluding any Info... |
1.7 "AbbVie Patents" means all Patents that claim inventions that are conceived, reduced to practice, discovered, developed or otherwise made by or on behalf of AbbVie or its Affiliates or its or their Sublicensees in the course of activities conducted under this Agreement, but excluding any Joint Patents. |
1.8 "AbbVie Platform Technology" means any proprietary technology that is (a) Controlled by AbbVie or any of its Affiliates during the Term, and (b) generally applicable to one (1) or more of AbbVie's compounds or products in addition to a Licensed Product or a Licensed Compound (including manufacturing technology or f... |
1.9 "Acceptance" means, with respect to a Drug Approval Application, receipt of written notice from the applicable Regulatory Authority indicating that such Drug Approval Application has been accepted for filing and further review. |
1.10 "Accounting Standards" means, with respect to a Party, that such Party shall maintain records and books of accounts in accordance with (a) United States Generally Accepted Accounting Principles, or (b) to the extent applicable, International Financial Reporting Standards as issued by the International Accounting S... |
1.11 "Acquiring Party" has the meaning set forth in Section 6.9.2 (Change in Control of HotSpot). |
1.12 "Additional Shared Development Costs" has the meaning set forth in Section 5.3.7 (HotSpot Cost-Sharing Option). |
1.13 "Adjacent Target" means any of interferon regulatory factor 3 (uniprot: Q14653) and interferon regulatory factor 7 (uniprot: Q92985). |
1.14 "ADR" has the meaning set forth in Section 13.7.1 (General). |
1.15 "Adverse Ruling" has the meaning set forth in Section 12.2.1 (Material Breach). |
1.16 "Affiliate" means, with respect to a Party, any Person that, directly or indirectly through one (1) or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, "control" and, with correlative meanings, the terms "controlled by" and "under common c... |
1.17 "Agreement" has the meaning set forth in the preamble hereto. |
1.18 "Alliance Manager" has the meaning set forth in Section 2.3.6 (Alliance Manager). |
1.19 "Annual Net Sales" means the annual Net Sales of the relevant Licensed Product in a Calendar Year. |
1.20 "Antitrust/FDI Review Period" has the meaning given in Section 4.3.1 (Antitrust Clearances). |
1.21 "Antitrust Law" means the Sherman Antitrust Act of 1890, the Clayton Antitrust Act of 1914, the HSR Act and the Federal Trade Commission Act of 1914, each as amended, and all other Applicable Law, whether federal, state, or foreign, that is designed or intended to prohibit, restrict or regulate actions having the ... |
1.22 "Applicable Expiration Date" means the Stage 1 License Option Expiration Date, Stage 2 License Option Expiration Date, Stage 3 License Option Expiration Date, Stage 4 License Option Expiration Date, or Final License Option Expiration Date, as applicable. |
1.23 "Applicable Law" means federal, state, local, national and supra-national laws, statutes, rules, and regulations, including any rules, regulations, regulatory guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges or major securities listing organizations, that may be ... |
1.24 "Audit Arbitrator" has the meaning set forth in Section 7.17 (Audit Dispute). |
1.25 "Bankruptcy Code" has the meaning set forth in Section 12.6.1 (Rights in Bankruptcy). |
1.26 "Bayh-Dole Act" means the Patent and Trademark Law Amendments Act of 1980, codified at 35 U.S.C. §§ 200-212, as amended, as well as any regulations promulgated pursuant thereto, including in 37 C.F.R. Part 401. |
1.27 "Board of Directors" has the meaning set forth Section 1.35.1 (Change in Control). |
1.28 "Breaching Party" has the meaning set forth in Section 12.2.1 (Material Breach). |
1.29 "Business Day" means a day other than a Saturday or Sunday on which banking institutions in Chicago, Illinois, Hamilton, Bermuda, or New York City, New York are open for business. |
1.30 "Calendar Half" means each successive period of six (6) calendar months commencing on January 1 or July 1, except that the first Calendar Half of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1 or July 1 after the Effective Date, and the last Ca... |
1.31 "Calendar Quarter" means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and 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 Oc... |
1.32 "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 th... |
1.33 "CDA" means that certain Bilateral Confidential Disclosure Agreement by and between AbbVie and HotSpot dated August 3, 2021, as amended. |
1.34 "Centralized Approval Procedure" means the procedure through which a MAA filed with the EMA results in a single marketing authorization valid throughout the European Union. |
1.35 "Change in Control" with respect to a Party, shall be deemed to have occurred if any of the following occurs after the Effective Date: |
1.35.1 any "person" or "group" (as such terms are defined below) acquires or becomes the "beneficial owner" (as defined below), directly or indirectly, of (a) shares of capital stock or other interests (including partnership interests) of such Party then outstanding and normally entitled (without regard to the occurren... |
1.35.2 such Party enters into a merger, consolidation or similar transaction with another Person (whether or not such Party is the surviving entity) and as a result of such merger, consolidation or similar transaction (a) the members of the Board of Directors of such Party immediately prior to such transaction constitu... |
1.35.3 such Party sells or transfers to any Third Party, in one (1) or more related transactions, properties or assets representing all or substantially all of such Party's total assets to which this Agreement relates; or |
1.35.4 the holders of capital stock of such Party approve a plan or proposal for the liquidation or dissolution of such Party. |
For the purpose of this definition of Change in Control, (a) "person" and "group" have the meanings given such terms under Section 13(d) and 14(d) of the United States Securities Exchange Act of 1934 and the term "group" includes any group acting for the purpose of acquiring, holding or disposing of securities within t... |
1.36 "Clinical Program Data" means all Information with respect to any Licensed Compound or Licensed Product that is made, collected, or otherwise generated under or in connection with Clinical Studies, including any raw data, reports, and results with respect thereto. |
1.37 "Clinical Studies" means clinical tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain any Regulatory Approval for a Licensed Product for one (1) or more Indications, including tests or studies that are intended to ex... |
1.38 "CMC" means chemistry, manufacturing, and controls. |
1.39 "Collaboration Compounds" means (a) the HotSpot Existing Compounds, (b) the Research Compounds, (c) all compounds that are (i) Directed To the Collaboration Target and (ii) developed by or on behalf of AbbVie (either solely or together with HotSpot) in the course of activities performed by or on behalf of AbbVie u... |
1.40 "Collaboration DELs" means the Project DELs, the DELs denominated by HotSpot as DELs 5 through 11, and any other DEL created by or on behalf of HotSpot prior to or during the Research Term that includes a Compound. |
1.41 "Collaboration Product" means any product containing any Collaboration Compound, alone or in combination with one or more other active ingredients in any and all forms, in current and future formulations, dosage forms and strengths, and delivery modes. For clarity, a Collaboration Product that contains the same Co... |
1.42 "Collaboration Program" means HotSpot's Development program for compounds Directed To the Collaboration Target existing as of the Effective Date or at any time during the Term. Upon AbbVie's exercise of the License Option, the Collaboration Program shall be the Licensed Program. |
1.43 "Collaboration Target" means interferon regulatory factor 5 (uniprot: Q13568). |
1.44 "Combination Product" means a Licensed Product that (a) is comprised of or contains one (1) or more Licensed Compounds as an active ingredient together with one (1) or more other active ingredients, whether in the same or different formulations, and (b) is sold as a fixed-dose or is sold in separate doses as one (... |
1.45 "Commercialization" means any and all activities related to the preparation for sale of, offering for sale of, or sale of a Licensed Compound or Licensed Product, including activities related to marketing, promoting, distributing, importing and exporting such Licensed Compound or Licensed Product, and, for purpose... |
1.46 "Commercially Reasonable Efforts" means (a) with respect to the efforts and resources to be expended by AbbVie with respect to any objective, activity or decision to be undertaken with respect to the Development or Commercialization of a Licensed Compound or a Licensed Product, the reasonable efforts and resources... |
1.47 "Competing Product" means any molecule, compound or other therapeutic Directed To the Collaboration Target, other than Compounds or Products. |
1.48 "Competitive Program" has the meaning set forth in Section 6.9.2 (Change in Control of HotSpot). |
1.49 "Completion" means: (a) with respect to Stage 1 Activities, as determined by the JGC, the point at which the contemplated Stage 1 Activities assigned to HotSpot as set forth in Schedule 1.75 (Initial Development Plan and Budget) have been completed, (b) with respect to Stage 2 Activities, as determined by the JGC,... |
1.50 "Compound" means a Collaboration Compound or Licensed Compound, as applicable. |
1.51 "Compulsory Sublicense" means a sublicense by AbbVie to a Third Party (a "Compulsory 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) under an order, decree or gran... |
1.52 "Compulsory Sublicensee" has the meaning set forth in Section 1.51 (Compulsory Sublicense). |
1.53 "Confidential Information" means any Information provided orally, visually, in writing, electronically or in any other form by or on behalf of one (1) Party (or an Affiliate or representative of such Party) to the other Party (or to an Affiliate or representative of such Party) in connection with this Agreement, w... |
1.54 "Control" means, (a) with respect to any item of Information, material, Patent, or other property right, the possession of the right, whether directly or indirectly, and whether by ownership, license, covenant not to sue or otherwise (other than by operation of the license and other grants in Section 6.1 (Grants t... |
In the event of a Change in Control of either Party, the rights to Information, Patents, and other proprietary rights: (a) Controlled by a Third Party permitted assignee of a Party that were Controlled by such assignee immediately prior to such assignment; or (b) Controlled by an Affiliate of a Party who becomes an Aff... |
1.55 "Convicted Entity" has the meaning set forth in Section 10.4.4 (Debarment and Exclusion). |
1.56 "Convicted Individual" has the meaning set forth in Section 10.4.4 (Debarment and Exclusion). |
1.57 "Corporate Names" means the Trademarks and logos identified on Schedule 1.57 (Corporate Names) and such other names and logos as HotSpot may designate in writing from time to time. |
1.58 "Cost-Sharing Option" has the meaning set forth in Section 5.3.2 (HotSpot Cost-Sharing Option). |
1.59 "Cost-Sharing Option Exercise Notice" means HotSpot's written notice to AbbVie exercising the Cost-Sharing Option. |
1.60 "Cost-Sharing Option Package" has the meaning set forth in Section 5.3.1 (HotSpot Cost-Sharing Option). |
1.61 "Cost-Sharing Option Period" has the meaning set forth in Section 5.3.2 (HotSpot Cost-Sharing Option). |
1.62 "Cost-Sharing Period" means the period beginning on commencement of the first Phase II Study for the first Licensed Product and continuing through the Term. |
1.63 "Cost-Sharing Royalty" has the meaning set forth in Section 7.6.1(b) (Royalty Rates). |
1.64 "Cure Period" has the meaning set forth in Section 12.2.1 (Material Breach). |
1.65 "Data Security and Privacy Laws" means all Applicable Law relating to the privacy, Processing, and security of Personal Data. |
1.66 "Debarred Entity" has the meaning set forth in Section 10.4.2 (Debarment and Exclusion). |
1.67 "Debarred Individual" has the meaning set forth in Section 10.4.1 (Debarment and Exclusion). |
1.68 "Default Notice" has the meaning set forth in Section 12.2.1 (Material Breach). |
1.69 "Deferral Notice" has the meaning set forth in Section 5.3.6 (HotSpot Cost-Sharing Option). |
1.70 "Deferred Shared Development Costs" has the meaning set forth in Section 5.3.6 (HotSpot Cost-Sharing Option). |
1.71 "DELs" means DNA-encoded libraries. |
1.72 "Determined Royalty" has the meaning set forth in Section 12.11.2 (Reverse Royalty). |
1.73 "Development" means all activities related to research, discovery, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, Clinical Studies, inc... |
1.74 "Development Plan Activities" means the Development and Manufacturing activities set forth in the Development Plan and Budget to be performed by HotSpot. |
1.75 "Development Plan and Budget" means the mutually agreed upon written development plan and budget that sets forth in reasonable detail: (a) all Development activities to be performed during the period commencing on the Effective Date through the completion of (i) the first multiple ascending dose study sponsored by... |
1.76 "Directed To" means, with respect to any compound and the Collaboration Target, that the inhibition/degradation, selectivity and cell-based activity criteria are met as follows: |
For an antagonist, the criteria listed below in (a), (b) and (c) apply: |
(a) Inhibition of Collaboration Target dimerization with an IC50 </= 200 nM as measured in the biochemical alpha-lisa assay; and |
(b) Demonstration of selectivity for the Collaboration Target as demonstrated by (x) at least a 10x higher IC50 for IRF3 (>/= 10x selective) and (y) at least 50x higher IC50 for other IRF transcriptional factor family members (>/= 50x selective) versus the Collaboration Target in similar assay formats; and |
(c) Inhibition of Collaboration Target-mediated cellular activity with an IC50 </= 500 nM as measured by R848-induced TNFa production. |
For a degrader, the criteria listed below in (d) and (e) apply: |
(d) Degradation of the Collaboration Target with a cellular DC50 </= 200 nM; and |
(e) Demonstration of selectivity for Collaboration Target degradation as demonstrated by (x) at least a 10x higher DC50 for IRF3 (>/= 10x selective) and (y) at least 50x higher DC50 for other IRF transcriptional factor family members (>/= 50x selective) versus the Collaboration Target in similar assay formats. |
1.77 "Disclosure Letter" means a letter to be delivered by HotSpot to AbbVie with each final and complete Information Report and Final Data Package, which letter sets forth (a) any updated disclosures against HotSpot's representations or warranties contained in Section 10.2 (Additional Representations and Warranties of... |
1.78 "Dispute" has the meaning set forth in Section 13.7 (Dispute Resolution). |
1.79 "Distributor" has the meaning set forth in Section 6.5 (Distributorships). |
1.80 "Dollars" or "$" means United States Dollars. |
1.81 "Drug Approval Application" means a New Drug Application ("NDA") as defined in the FFDCA, or any corresponding foreign application in the Territory, including, with respect to the European Union, a Marketing Authorization Application (a "MAA") filed with the EMA pursuant to the Centralized Approval Procedure or wi... |
1.82 "Effective Date" has the meaning set forth in the preamble hereto. |
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