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1.28 "Breaching Party" has the meaning set forth in Section 12.2.1 (Material Breach). |
1.29 "Bridging Study" means a supplemental Clinical Study intended to confirm the comparable pharmacokinetic (PK) characteristics between the IV and SC routes of administration of ALPN-101, as such Clinical Study is described in the Development Plan. |
1.30 "Business Day" means a day other than a Saturday or Sunday on which banking institutions in Chicago, Illinois are open for business. |
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 the... |
1.33 "CDA" means that certain Mutual Nondisclosure Agreement by and between AbbVie Inc. and Alpine Immune Sciences, Inc. dated November 25, 2018, as may be amended from time to time. |
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 Licensor, 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 but excluding any group of stockholders currently represented on Licensor's Board of Directors) (a) is or becomes the "beneficial owner" (as defined below), directly or indirectly, of shares of capital stock or other interests (including partnership intere... |
1.35.2 Licensor enters into a merger, consolidation or similar transaction with another Person (whether or not Licensor is the surviving entity) and as a result of such merger, consolidation or similar transaction (a) the members of the Board of Directors of Licensor immediately prior to such transaction constitute les... |
1.35.3 Licensor sells or transfers to any Third Party, in one (1) or more related transactions, properties or assets representing all or substantially all of Licensor's total assets to which this Agreement relates, excluding any assignment or transfer to any Third Party of Licensor's rights to receive royalty or other ... |
1.35.4 the holders of capital stock of Licensor approve a plan or proposal for the liquidation or dissolution of Licensor. |
1.35.5 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 w... |
1.36 "Clinical Data" means all Information with respect to any Licensed Compound or Licensed Product and made, collected or otherwise generated under or in connection with Clinical Studies, including any data (including raw data), reports and results with respect thereto. |
1.37 "Clinical Studies" means Phase 0, Phase I, Phase II, Phase III and such other 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 Compound or Licensed Product for one (1) or mor... |
1.38 "CMC Working Group" has the meaning set forth in Section 3.1.9(b) (CMC Working Group). |
1.39 "Combination Product" means a Licensed Product containing one (1) or more Licensed Compounds and one (1) or more Other Active Ingredients. By way of example, and not meant to limit the foregoing definition, a Combination Product includes: |
1.39.1 a Licensed Product that contains (a) one (1) or more Licensed Compounds and (b) one (1) or more Other Active Ingredients, such as an antibody, or an antibody fragment or a binding protein that can modulate function, and, in the case of (a) and (b), are either, for example, in the same formulation, co-administere... |
1.39.2 a Licensed Product that contains (a) one (1) or more Licensed Compounds and (b) one (1) or more Other Active Ingredients, for example, (i) one component of such Licensed Product is the ICOS ligand binding portion of the Licensed Compound and (ii) a second component of such Licensed Product is a portion or compon... |
1.40 "Commercialization" means any and all activities directed to the preparation for sale of, offering for sale of, or sale of a Licensed Product, including activities related to marketing, promoting, distributing, importing and exporting such Licensed Product, and interacting with Regulatory Authorities or other gove... |
1.41 "Commercially Reasonable Efforts" means, with respect to the performance of Development, Commercialization or Manufacturing activities with respect to the Licensed Compound or a Licensed Product by a Party, the carrying out of such activities using efforts and resources comparable to the efforts and resources that... |
1.42 "Competing Product" means any product (a) that is labeled, advertised, marketed, promoted or intended for use in the Territory for the diagnosis, treatment, palliation or prevention of any autoimmune Indication and (b) that binds to, or directly modulates or targets, ICOS or CD28 with greater than ten percent (10%... |
1.43 "Competitive Activities" has the meaning set forth in Section 2.4 (Exclusivity). |
1.44 "Confidential Information" means any Information or data provided orally, visually, in writing or 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, whether prior to... |
1.45 "Control" means, subject to Section 4.8 (In-License Agreements), with respect to any item of Information, Regulatory Documentation, 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 ... |
1.46 "Convicted Entity" has the meaning set forth in Section 10.2.16(d) (Additional Representations and Warranties of Licensor). |
1.47 "Convicted Individual" has the meaning set forth in Section 10.2.16(d) (Additional Representations and Warranties of Licensor). |
1.48 "Data Breach" has the meaning set forth in Section 8.3 (Security Breach Notification). |
1.49 "Data Security and Privacy Laws" means all Applicable Laws relating to the privacy, Processing and security of Personal Data. |
1.50 "Debarred Entity" has the meaning set forth in Section 10.2.16(b) (Additional Representations and Warranties of Licensor). |
1.51 "Debarred Individual" has the meaning set forth in Section 10.2.16(a) (Additional Representations and Warranties of Licensor). |
1.52 "Default Notice" has the meaning set forth in Section 12.2.1 (Material Breach). |
1.53 "Development" means all activities related to research, 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, including Manu... |
1.54 "Development Activities" has the meaning set forth in Section 2.1.1 (Development Plan and Activities). |
1.55 "Development Plan" means the development plan set forth on Schedule 2.1.1 (Development Plan), as such development plan may be amended from time to time in accordance with this Agreement. |
1.56 "Dispute" has the meaning set forth in Section 13.7 (Dispute Resolution). |
1.57 "DOJ" means the Antitrust Division of the United States Department of Justice, and any successor entity thereto. |
1.58 "Dollars" or "$" means United States Dollars. |
1.59 "Drug Approval Application" means a Biologics License Application (a "BLA") 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 Proce... |
1.60 "Effective Date" means the effective date of this Agreement as set forth in the preamble hereto. |
1.61 "EMA" means the European Medicines Agency and any successor agency(ies) or authority having substantially the same function. |
1.62 "European Union" or "E.U." 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. |
1.63 "Excluded Entity" has the meaning set forth in Section 10.2.16(c) (Additional Representations and Warranties of Licensor). |
1.64 "Excluded Individual" has the meaning set forth in Section 10.2.16(c) (Additional Representations and Warranties of Licensor). |
1.65 "Existing Patents" means (a) as of the Effective Date, all Licensor Patents existing as of the Effective Date and (b) as of the date of delivery by Licensor to AbbVie of the Option Exercise Data Package, all Licensor Patents existing as of such date of delivery. |
1.66 "Existing Regulatory Documentation" means the Regulatory Documentation Controlled by Licensor or any of its Affiliates as of the Effective Date or at any time during the Term prior to the Option Effective Date. |
1.67 "Exploit" or "Exploitation" means to make, have made, import, have imported, export, have exported, use, have used, sell, have sold, offer for sale or otherwise exploit, including to research, Develop, Commercialize, register, modify, enhance, improve, Manufacture, have Manufactured, hold, keep (whether for dispos... |
1.68 "FDA" means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function. |
1.69 "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). |
1.70 "Field" means all human and non-human diagnostic, prophylactic and therapeutic uses. |
1.71 "First Commercial Sale" means, with respect to a Licensed Product and a country, the first sale for monetary value for use or consumption by the end user of such Licensed Product in such country after all Regulatory Approvals for such Licensed Product has been obtained in such country. Sales prior to receipt of al... |
1.72 "FTC" means the United States Federal Trade Commission, and any successor entity thereto. |
1.73 "FTE" means the equivalent of the work of one (1) employee full time for one (1) Calendar Year (consisting of at least a total of eighteen hundred (1800) hours per Calendar Year) of work performing Development or Manufacturing activities for a Licensed Compound or Licensed Product. No additional payment shall be m... |
1.74 "FTE Costs" means, with respect to Licensor for any period, the FTE Rate multiplied by the applicable number of FTEs of Licensor performing Development or Manufacturing activities during such period in accordance with the Development Plan. |
1.75 "FTE Rate" has the meaning set forth in Section 5.5.2 (Manufacturing Technology Transfer Upon AbbVie's Request). |
1.76 "HSR Act" means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder. |
1.77 "HSR Clearance" means the earlier of (a) notification to the Parties from the FTC or DOJ of early termination of the applicable waiting period under the HSR Act with respect to the HSR Filings, or (b) expiration of the applicable waiting period under the HSR Act with respect to the HSR Filings; provided, however, ... |
1.78 "HSR Extension Period" has the meaning set forth in Section 4.3.1 (HSR). |
1.79 "HSR Filings" means the filings by Licensor and AbbVie with the FTC and the DOJ of a Notification and Report Form for Certain Mergers and Acquisitions (as that term is defined in the HSR Act) with respect to the matters set forth in this Agreement, together with all required documentary attachments thereto. |
1.80 "In-License Agreement" means any agreement between Licensor or its Affiliate, on one hand, and a Third Party on the other hand under which AbbVie is granted a sublicense or other right under this Agreement as provided in Section 4.8 (In-License Agreements). |
1.81 "IND" means an application filed with a Regulatory Authority for authorization to commence Clinical Studies, including (a) an Investigational New Drug Application as defined in the FFDCA or any successor application or procedure filed with the FDA, (b) any equivalent of a United States IND in other countries or re... |
1.82 "Indemnification Claim Notice" has the meaning set forth in Section 11.3 (Notice of Claim). |
1.83 "Indemnified Party" has the meaning set forth in Section 11.3 (Notice of Claim). |
1.84 "Independent Affiliate" means, with respect to a Change in Control of Licensor, an Affiliate of Licensor that was not an Affiliate of Licensor prior to such Change in Control and is not a successor in interest to any Affiliate of Licensor that was an Affiliate of Licensor prior to such Change in Control. |
1.85 "Indication" means, with respect to a product, a use to which such product is intended to be put for the treatment, prevention or cure of a distinct recognized disease or condition, or of a manifestation of a recognized disease or condition, which, if approved in the U.S., would be reflected in the "Indications an... |
1.86 "Indirect Taxes" has the meaning set forth in Section 6.10 (Indirect Taxes). |
1.87 "Information" means all knowledge of a technical, scientific, business and other nature, including know-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs,... |
1.88 "Initial Development Plan" has the meaning set forth in Section 2.1.1 (Development Plan and Activities). |
1.89 "Initiation" or "Initiate" means, with respect to a Clinical Study, the first enrollment of the first human subject in such Clinical Study. |
1.90 "Intellectual Property" has the meaning set forth in Section 12.5.1 (Applicability of 11 U.S.C. § 365(n)). |
1.91 "Joint Governance Committee" or "JGC" has the meaning set forth in Section 3.1.1 (Formation). |
1.92 "Joint Intellectual Property Rights" has the meaning set forth in Section 7.1.2 (Ownership of Joint Patents and Joint Know-How). |
1.93 "Joint Know-How" has the meaning set forth in Section 7.1.2 (Ownership of Joint Patents and Joint Know-How). |
1.94 "Joint Patents" has the meaning set forth in Section 7.1.2 (Ownership of Joint Patents and Joint Know-How). |
1.95 "Late Phase Development Activities" means the activities described in the Development Plan as "Late Phase Development Activities." Late Phase Development Activities shall be Development Activities pursuant to the Development Plan in the event AbbVie requests completion of such activities as further described in Se... |
1.96 "LIBOR" means the London Interbank Offered Rate for deposits in United States Dollars having a maturity of one (1) month published by the British Bankers' Association, as adjusted from time to time on the first London Business Day of each month. |
1.97 "Licensed Compound" means (a) the fusion protein known as ALPN-101 and (b) any other molecule that (i) is owned or Controlled by Licensor or its Affiliates as of the Effective Date or at any time during the Term and (ii) binds to, or directly modulates or targets ICOS with greater than ten percent (10%) of the wil... |
1.98 "Licensed Product" means any product, or portion thereof, containing a Licensed Compound, alone or in combination with one (1) or more Other Active Ingredients, in any and all forms, presentations, delivery systems, dosages and formulations. |
1.99 "Licensor" has the meaning set forth in the preamble hereto. |
1.100 "Licensor Acquirer" means any Person that becomes an Independent Affiliate of Licensor due to and upon a Change in Control of Licensor. |
1.101 "Licensor Indemnitees" has the meaning set forth in Section 11.1 (Indemnification of Licensor). |
1.102 "Licensor Know-How" means all Information that is (a) owned or Controlled by Licensor or any of its Affiliates as of the Effective Date or at any time during the Term, (b) not generally known and (c) necessary or reasonably useful for the Development, Manufacture, Commercialization or Exploitation of any Licensed... |
1.103 "Licensor Patents" means all of the Patents that are (a) Controlled by Licensor or any of its Affiliates as of the Effective Date or at any time during the Term and (b) that claim any Licensed Compound, any Licensed Product or any composition containing a Licensed Compound, or the Development, Manufacture, Commer... |
1.104 "Licensor Platform Patents" means all of the Licensor Patents that are not Licensor Product Patents. |
1.105 "Licensor Product Patents" means all of the Licensor Patents that (a) as of the Option Effective Date, claim (i) any molecule or product containing the same or substantially the same amino acid sequence of the ICOS-binding portion(s) of a Licensed Compound, (ii) any composition containing such molecule or product... |
1.106 "Licensor Prosecution Countries" has the meaning set forth in Section 7.2 (Maintenance and Prosecution of Licensor Product Patents). |
1.107 "Losses" has the meaning set forth in Section 11.1 (Indemnification of Licensor). |
1.108 "MAA" has the meaning set forth in the definition of Drug Approval Application. |
1.109 "Major Market" means each of the United States, United Kingdom, Germany, France, Spain and Italy. |
1.110 "Manufacture" and "Manufacturing" means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping and holding of the Licensed Compound, any Licensed Product or any intermediate thereof, including process development, process ... |
1.111 "Manufacturing Process" has the meaning set forth in Section 5.5.2 (Manufacturing Technology Transfer Upon AbbVie's Request). |
1.112 "Manufacturing Technology Transfer" has the meaning set forth in Section 5.5.2 (Manufacturing Technology Transfer Upon AbbVie's Request). |
1.113 "Material Amendment" means any material amendment or other modification to the Development Plan, including (a) a change to the scope, timing or resource allocation of any Development Activities that would result in an increase in the timeline included in such Development Plan, (b) budgetary changes that, together... |
1.114 "Mono Product" has the meaning set forth in the definition of "Net Sales." |
1.115 "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 Sublicensees (each, a "Selling Party") in the Territory to Third Parties (including wholesalers or distributors) in bona fide ... |
(a) trade, cash and quantity discounts; |
(b) price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to governmental authorities or other payees; |
(c) 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; |
(d) 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; |
(e) 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; |
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