text stringlengths 1 5.46k |
|---|
1.2 "AbbVie Default Notice" has the meaning set forth in Section 13.2.2 (Termination for Material Breach–Material Breach by AbbVie). |
1.3 "AbbVie Grantback Know-How" means, as used in connection with a Grantback Product and any related grantback license provided in Section 13.6.1(c) (Effects of Termination of this Agreement in the Entirety) or 13.7.2 (Effects of Termination of Terminated Territory), that certain AbbVie Know-How that is (a) Controlled... |
1.4 "AbbVie Grantback Patents" means, as used in connection with a Grantback Product and any related grantback license provided in Section 13.6.1(c) (Effects of Termination of this Agreement in the Entirety) or 13.7.2 (Effects of Termination of Terminated Territory), those certain AbbVie Patents that (a) are Controlled... |
1.5 "AbbVie Indemnitees" has the meaning set forth in Section 12.2 (Indemnification of AbbVie). |
1.6 "AbbVie Know-How" means any and all Information that is (a) first conceived, reduced to practice, discovered, developed, created, generated or otherwise made by or on behalf of AbbVie or its Affiliates or its or their Sublicensees under this Agreement, and (b) not generally known, but excluding any Information comp... |
1.7 "AbbVie Patents" means all Patents that claim inventions that are first conceived, reduced to practice, discovered, developed, created, generated or otherwise made by or on behalf of AbbVie or its Affiliates or its or their Sublicensees under this Agreement, but excluding any Joint Patents. |
1.8 "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 Sta... |
1.9 "Acquiring Party" has the meaning set forth in Section 6.7.2 (Change in Control of Parvus). |
1.10 "Acting Party" has the meaning set forth in Section 7.9 (Withholding Taxes). |
1.11 "ADR" has the meaning set forth in Section 14.7.1 (Dispute Resolution – General). |
1.12 "Adverse Ruling" has the meaning set forth in Section 13.2.1 (Termination for Material Breach – Material Breach by Parvus). |
1.13 "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... |
1.14 "Agreement" has the meaning set forth in the preamble hereto. |
1.15 "Alliance Director" has the meaning set forth in Section 2.3.6 (Alliance Director). |
1.16 "Amount" has the meaning set forth in Section 7.9 (Withholding Taxes). |
1.17 "Annual Net Sales" means the annual Net Sales of the relevant Licensed Product in a Calendar Year. |
1.18 "Antitrust Law" means the Sherman Antitrust Act of 1890, the Clayton Antitrust Act of 1914, the HSR Act, 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 pur... |
1.19 "Antitrust/FDI Review Period" has the meaning given in Section 4.3.1 (Antitrust Clearances). |
1.20 "Applicable Expiration Date" means the Stage 1 License Option Expiration Date, the Stage 2 License Option Expiration Date, or the Final License Option Expiration Date, as applicable. |
1.21 "Applicable Indication" means Crohn's Disease or Ulcerative Colitis. |
1.22 "Applicable Law" means federal, state, local, national and supra-national laws, statutes, rules, orders, decrees and regulations, including any rules, regulations, regulatory guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges or major securities listing organizatio... |
1.23 "Arising IP" has the meaning set forth in Section 8.1.1 (Ownership of Technology Generally). |
1.24 "Arising Patents" has the meaning set forth in Section 8.1.1 (Ownership of Technology Generally). |
1.25 "Audit Arbitrator" has the meaning set forth in Section 7.14 (Audit Dispute). |
1.26 "Bankruptcy Code" has the meaning set forth in Section 13.5.1 (Rights in Bankruptcy). |
1.27 "Bayh-Dole Act" means the Patent and Trademark Law Amendments Act of 1980, as amended, 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. |
1.28 "Biological and Chemical Materials" means chemical and biological materials, reagents, products, components or compositions, including plasmids, DNA fragments, DNA sequences and maps, clones, enzymes, oligonucleotides, small molecules, cell lines, proteins, peptides, antibodies, MHC tetramers and combinations ther... |
1.29 "Biosimilar Application" has the meaning set forth in Section 8.3.7(a) (Biosimilar Applicants). |
1.30 "Biosimilar Product" means, with respect to a Licensed Product and on a country-by-country basis, a biologic product (a) whose regulatory approval, or whose application for such regulatory approval, relies in whole or in part on a prior Regulatory Approval granted to a Licensed Product; (b) whose regulatory approv... |
1.31 "Board of Directors" has the meaning set forth in Section 1.37(a) (Definition of Change in Control). |
1.32 "Business Day" means a day other than (i) a Saturday, (ii) a Sunday or (iii) a day on which banking institutions in Chicago, Illinois or San Francisco, California are closed for business. |
1.33 "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... |
1.34 "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 the... |
1.35 "CDA" means that certain Bilateral Confidentiality Disclosure Agreement by and between the Parties dated December 5, 2023, as amended from time to time. |
1.36 "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. |
1.37 "Change in Control," with respect to a Party, shall be deemed to have occurred if any of the following occurs after the Effective Date: |
(a) 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 occurrence ... |
(b) 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 constitute ... |
(c) 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 |
(d) 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, as amended, and the term "group" includes any group acting for the purpose of acquiring, holding or disposing of securi... |
Notwithstanding anything to the contrary in the foregoing, Parvus' initial public offering of common stock registered under the Securities Act of 1933, as amended, in the U.S., or registered under foreign Applicable Laws pertaining to the regulation of publicly traded securities in a foreign jurisdiction, or any follow... |
1.38 "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. |
1.39 "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 pharmaceutical product, including a Licensed Product, for one (1) or more Indications, including tes... |
1.40 "CMC" means chemistry, manufacturing, and controls. |
1.41 "Combination Product" means a Licensed Product that 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 (a) is sold as a fixed-dose or (b) is sold in separate doses in a sing... |
1.42 "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 interacting ... |
1.43 "Commercially Reasonable Efforts" means (a) with respect to the efforts and resources to be expended by AbbVie with respect to (i) any objective, activity or decision to be undertaken with respect to the Development of a Licensed Product, the reasonable efforts and resources to accomplish such objective, activity ... |
1.44 "Competing Product" means any molecule, compound or product that (i) is conjugated with Surface-Antigen MHCs that contain an IBD-Associated Antigen and (ii) directly or indirectly suppresses inflammatory cell function or otherwise modulates immune tolerance, in the Field in the Territory. |
1.45 "Competitive Program" has the meaning set forth in Section 6.7.2 (Change in Control of Parvus). |
1.46 "Completion of Stage 1 Activities" means, with respect to a Licensed Compound, (a) completion of all those activities identified as Stage 1 Activities in the Research and Development Plan, (b) nomination of such Licensed Compound as a Development Candidate, and (c) satisfaction of the following CMC criteria: (i) a... |
1.47 "Completion of Stage 2 Activities" means, with respect to a Development Candidate, (a) completion of all those activities identified as Stage 2 Activities in the Research and Development Plan, and (b) dosing of the third subject in the first Phase I Study for the Licensed Product comprising or containing such Deve... |
1.48 "Component" means, with respect to a Licensed Compound, each of (i) the nanoparticle core, (ii) the polymer coating(s) on the nanoparticle core, (iii) the linker(s) and (iv) the Surface-Antigen MHC and each component of the Surface-Antigen MHC, including each of the antigen (including any IBD-Associated Antigen), ... |
1.49 "Compulsory Sublicense" means a sublicense by AbbVie or any Affiliate thereof to a Third Party (a "Compulsory Sublicensee") under the grants in Section 6.1 (Grants to AbbVie on the Effective Date) or 6.2 (Grants to AbbVie on the License Option Effective Date) as provided in Section 6.3 (Sublicenses), under an orde... |
1.50 "Compulsory Sublicensee" has the meaning set forth in Section 1.49 (Definition of Compulsory Sublicense). |
1.51 "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... |
1.52 "Contracting Party" has the meaning set forth in Section 6.8.2(c) (In-License Agreements). |
1.53 "Control" (and its conjugates) 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 ... |
1.54 "Convicted Entity" has the meaning set forth in Section 11.4.4 (Debarment and Exclusion). |
1.55 "Convicted Individual" has the meaning set forth in Section 11.4.4 (Debarment and Exclusion). |
1.56 "Corporate Names" means the Trademarks and logos identified on Schedule 1.56 (Corporate Names) and such other names and logos as Parvus may designate in writing from time to time. |
1.57 "Cover" (or its conjugates) means (a) as to a compound, product or technology and a Patent, that, in the absence of a license granted under, or ownership of, such Patent, the making, using, selling, offering for sale or importation of such compound, product or technology would infringe, or contribute to or induce ... |
1.58 "Crohn's Disease" means a spectrum of clinical and pathological processes manifested by focal asymmetric, transmural, and occasionally granulomatous inflammation which can affect any segment of the gastrointestinal tract. |
1.59 "Data Breach" has the meaning set forth in Section 9.1.3 (Security Breach Notification). |
1.60 "Data Security and Privacy Laws" means all Applicable Laws relating to the privacy, Processing and security of Personal Data. |
1.61 "Debarred Entity" has the meaning set forth in Section 11.4.2 (Debarment and Exclusion). |
1.62 "Debarred Individual" has the meaning set forth in Section 11.4.1 (Debarment and Exclusion). |
1.63 "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, sta... |
1.64 "Development Candidate" means each Licensed Compound that is selected by the JGC to advance to Stage 2 Activities during or prior to Completion of Stage 1 Activities; provided, that with respect to a Licensed Compound that comprises a DRB3 Navacim, a "Development Candidate" means such Licensed Compound that is sel... |
1.65 "Disclosure Letter" means a letter to be delivered by Parvus to AbbVie with each final and complete Information Report and License Option Exercise Data Package, which letter sets forth, subject to the provisions of Section 11.6 (Bring Down Limitations), (a) any disclosures against Parvus' representations and warra... |
1.66 "Dispute" has the meaning set forth in Section 14.7 (Dispute Resolution). |
1.67 "Distributor" has the meaning set forth in Section 6.4 (Distributorships). |
1.68 "Dollars" or "$" means United States Dollars. |
1.69 "DRB3 Navacim" means any Navacim-containing the HLA-DRB3 protein. |
1.70 "DRB3 Plan Activities" has the meaning set forth in Section 3.1.1 (Performance of the Research and Development Plan). |
1.71 "DRB3 Product" means any Licensed Product comprising or containing a DRB3 Navacim. |
1.72 "DRB4 Development Candidate" means a Development Candidate comprising a DRB4 Navacim. |
1.73 "DRB4 Navacim" means any Navacim-containing the HLA-DRB4 protein. |
1.74 "DRB4 Product" means any Licensed Product comprising or containing a DRB4 Navacim. |
1.75 "Drug Approval Application" means a Biologics License Application as defined in the PHSA, 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... |
1.76 "EEA" means the European Economic Area. |
1.77 "Effective Date" has the meaning set forth in the preamble hereto. |
1.78 "EMA" means the European Medicines Agency and any successor agency(ies) or authority having substantially the same function. |
1.79 "EU3" means any three (3) of the Major European Markets. |
1.80 "European Market" means all members of the European Union and the United Kingdom. |
1.81 "European Union" means the economic, scientific, and political organization of member states known as the European Union, as its membership may be altered from time to time, and any successor thereto. |
1.82 "Excess Efforts" has the meaning set forth in Section 5.5.1(g) (Technology Transfer). |
1.83 "Excluded Antigen" means any antigen listed on Schedule 1.83 (Excluded Antigens). |
1.84 "Excluded Entity" has the meaning set forth in Section 11.4.3 (Debarment and Exclusion). |
1.85 "Excluded Individual" has the meaning set forth in Section 11.4.3 (Debarment and Exclusion). |
1.86 "Excluded Intellectual Property" has the meaning set forth in Section 14.4.2 (Assignment). |
1.87 "Exclusive License" has the meaning set forth in Section 6.2.1 (Grants to AbbVie on the License Option Effective Date). |
1.88 "Exercise Notice" means AbbVie's written notice to Parvus exercising the License Option during the License Option Period. |
1.89 "Existing Parvus Licensed Patents" has the meaning set forth in Section 1.166 (Definition of Parvus Licensed Patents). |
1.90 "Exploit" (or its conjugates) means to make, have made, import, export, use, sell, or offer for sale, including to Develop, Commercialize, register, modify, enhance, improve, Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), formulate, optimize, have used, export, transport, distrib... |
1.91 "FDA" means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function. |
1.92 "FDA's Disqualified/Restricted List" has the meaning set forth in Section 11.4.5 (Debarment and Exclusion). |
1.93 "FFDCA" means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto). |
1.94 "Field" means all human and non-human uses. |
1.95 "Final License Option Expiration Date" means, subject to Section 3.2.3 (Periodic Reports; Information Reports and License Option Exercise Data Package), the date of expiration of the Initial Review Period with respect to the License Option Exercise Data Package, as such date may be extended pursuant to Section 3.2... |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.