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1.96 "First Commercial Sale" means, with respect to a Licensed Product and a country or other jurisdiction, the first sale for monetary value for use or consumption by the end user of such Licensed Product in such country or other jurisdiction after all necessary Regulatory Approvals for such Licensed Product have been... |
1.97 "Foreign Investment Law" means any public interest, foreign investment or national security laws, rules or regulations in any jurisdiction enacted or amended at any time after the Effective Date. |
1.98 "FTE" means the equivalent of the work of one (1) full-time employee of a Party or its Affiliates for one (1) year (consisting of one thousand eight hundred (1800) hours per year) in directly conducting activities under this Agreement. For clarity, FTE shall not include the work of general corporate or administrat... |
1.99 "FTE Cost" means the FTE Rate multiplied by the number of FTEs to be performing relevant activities under this Agreement. |
1.100 "FTE Rate" means three hundred and seventy-five thousand Dollars ($375,000) per FTE per year (as of the Effective Date). Commencing on January 1, 2025, the FTE Rate shall be changed annually to reflect any year-to-year percentage change in the Consumer Price Index National Average, as published by the U.S. Depart... |
1.101 "Genentech License" has the meaning set forth in Section 11.2.25 (Additional Representations and Warranties of Parvus). |
1.102 "Good Clinical Practices" or "GCP" means Good Clinical Practice as promulgated by the FDA under and in accordance with the FFDCA, Title 21, Parts 312 of the U.S. Code of Federal Regulations, and the guidelines and standards published by the FDA that relate thereto as may be amended from time-to-time, or any succe... |
1.103 "Good Laboratory Practices" or "GLP" means the FDA's standards for conducting non-clinical laboratory studies contained in 21 C.F.R. Part 58, and any equivalent standards promulgated by the EMA. |
1.104 "Good Manufacturing Practices" or "GMP" or "cGMP" means the current Good Manufacturing Practices as provided for (and as amended from time to time) in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Harmonized Tripartite Guideline, Go... |
1.105 "Governmental Authority" means any multinational, federal, national, state, provincial, local or other entity, office, commission, bureau, agency, political subdivision, instrumentality, branch, department, authority, board, court, arbitral or other tribunal exercising executive, judicial, legislative, police, re... |
1.106 "Grantback Product" means any Licensed Product (a) for which AbbVie's license rights under Section 6.1 (Grants to AbbVie on the Effective Date) have terminated, (b) for which a Phase II Study or later stage Clinical Study has been initiated or that is, as of the date of termination, the subject of Development or ... |
1.107 "HSR Act" means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. |
1.108 "IBD" means conditions characterized by chronic inflammation of the gastrointestinal tract, including Crohn's disease and ulcerative colitis. |
1.109 "IBD-Associated Antigen" means (a) flagellin, (b) any other gut microbial antigen and (c) any other antigen that produces a result of statistically significant higher antibody titers in a population of IBD patients (P < 0.05) as compared to a population of healthy subjects, as demonstrated in a Qualified Immunoas... |
1.110 "ICF" has the meaning set forth in Section 3.5.2 (Regulatory Matters Prior to License Option Exercise). |
1.111 "In-License Agreement" means (a) the UTI/MGH License, or (b) any agreement between Parvus and a Third Party entered into after the Effective Date in accordance with Sections 6.8.1 (In-License Agreements) or 6.8.2 (In-License Agreements) and for which AbbVie has exercised its right to obtain a sublicense or other ... |
1.112 "In-Licensed Patents" has the meaning set forth in Section 11.2.5 (Additional Representations and Warranties of Parvus). |
1.113 "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 r... |
1.114 "IND-Enabling Studies" mean the studies required to demonstrate safety, efficacy and quality of a compound that will satisfy applicable regulatory requirements and that meet the standard necessary for submission as part of an IND filing with the FDA to allow dosing of such compound in humans, including GLP toxico... |
1.115 "Indemnification Claim Notice" has the meaning set forth in Section 12.3 (Notice of Claim). |
1.116 "Indemnified Party" has the meaning set forth in Section 12.3 (Notice of Claim). |
1.117 "Indication" means, with respect to a Licensed Product, a use to which such Licensed 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, or for the relief of symptoms associated with a recogn... |
1.118 "Indirect Taxes" has the meaning set forth in Section 7.11 (Indirect Taxes). |
1.119 "Inflation Reduction Act" means P.L. 117-169 (Aug. 16, 2022), as codified at 42 U.S.C. § 1320f, 42 U.S.C. § 1395w-3a and 42 U.S.C. § 1395w-114a (inter alia), as it may be amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, ... |
1.120 "Information" means all knowledge and data of a technical, scientific, business and other nature, including inventions, know-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedur... |
1.121 "Information Report" means each of the Stage 1 Information Report and the Stage 2 Information Report. |
1.122 "Initial Review Period" has the meaning set forth in Section 3.2.3 (Periodic Reports; Information Reports and License Option Exercise Data Package). |
1.123 "Invoiced Party" has the meaning set forth in Section 7.7 (Other Invoiced Amounts). |
1.124 "Invoicing Party" has the meaning set forth in Section 7.7 (Other Invoiced Amounts). |
1.125 "Joint Governance Committee" or "JGC" has the meaning set forth in Section 2.1.1 (Joint Governance Committee—Formation). |
1.126 "Joint IP" has the meaning set forth in Section 8.1.3 (Ownership of Joint Patents and Joint Know-How). |
1.127 "Joint Know-How" means any and all Information that is first conceived, reduced to practice, discovered, developed, created, generated or otherwise made under this Agreement, jointly by or on behalf of Parvus or its Affiliates, on the one hand, and AbbVie or its Affiliates or its or their Sublicensees, on the oth... |
1.128 "Joint Patents" means all Patents that claim inventions that are first conceived, reduced to practice, discovered, developed, created, generated or otherwise made under this Agreement jointly by or on behalf of Parvus or its Affiliates, on the one hand, and AbbVie or its Affiliates or its or their Sublicensees, o... |
1.129 "Knowledge" means the actual knowledge of the Chief Executive Officer, the Chief Scientific Officer, the Executive Vice President of Research and Development, the Vice President of Technical Operations, the Vice President of CMC of Parvus or any personnel holding positions equivalent to such job titles, and Brend... |
1.130 "License Option" has the meaning set forth in Section 4.1 (License Option Grant to AbbVie). |
1.131 "License Option Effective Date" means the date upon which AbbVie delivers to Parvus the Exercise Notice in accordance with the terms of this Agreement; provided that, if AbbVie reasonably determines in good faith prior to the delivery of the Exercise Notice that the transactions to be consummated upon the exercis... |
1.132 "License Option Exercise Data Package" means the complete data package containing all data (including all raw data to the extent not previously provided to AbbVie), findings, information, analyses, and results of the research and development activities performed in connection with the Research and Development Pla... |
1.133 "License Option Exercise Payment" has the meaning set forth in Section 7.2.1 (Option Exercise Payment). |
1.134 "License Option Period" means the period commencing on the Effective Date and ending on the Applicable Expiration Date. |
1.135 "Licensed Compound" means (a) (i) PVT401, (ii) any other DRB4 Navacim, (iii) any DRB3 Navacim and (iv) any other molecule, compound or product, in each case ((ii)-(iv)) conjugated with Surface-Antigen MHCs that contain an IBD-Associated Antigen, and (b) any modifications, enhancements, improvements, derivatives o... |
1.136 "Licensed Product" means any product comprising or containing a Licensed Compound, alone or in combination with one or more other active ingredients, in any and all forms, presentations, current and future formulations, dosage forms and strengths, and delivery modes. For clarity, a Licensed Product that contains ... |
1.137 "Losses" has the meaning set forth in Section 12.1 (Indemnification of Parvus). |
1.138 "MAA" has the meaning set forth in Section 1.75 (Definition of Drug Approval Application). |
1.139 "Major Market" means the (i) United States, (ii) European Market or (iii) the rest of the world other than the United States and the European Market, as applicable. |
1.140 "Major European Market" means the United Kingdom, Germany, France, Italy and Spain. |
1.141 "Manufacture" and "Manufacturing" means all activities related to the synthesis, scale-up, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping, and holding of a Licensed Compound, any Licensed Product, or any intermediate thereof, including process development... |
1.142 "Manufacturing Process" has the meaning set forth in Section 5.5 (Technology Transfer). |
1.143 "Manufacturing Technology Transfer" has the meaning set forth in Section 5.5 (Technology Transfer). |
1.144 "Maximum Fair Price" has the meaning set forth in Section 1191(c)(3) of the Social Security Act. |
1.145 "MHC" means major histocompatibility complex. |
1.146 "Mono Product" has the meaning set forth in Section 1.148 (Definition of Net Sales). |
1.147 "Navacim" means a proprietary iron oxide nanoparticle encapsulated in a polymer coating and conjugated with Surface-Antigen MHCs, that triggers or is intended to trigger endogenous generation of regulatory T cells and Tr1 cells to provide organ specific immunoregulation and bystander immunity without impairing no... |
1.148 "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 in the Territory to Third Parties (including wholesalers or Distributors), in bona fide arm's length transaction... |
(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 (excluding taxes when assessed on income derived from sales); |
(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; |
(f) any consideration actually paid or payable for any Delivery System related to a billed or invoiced sale of such Licensed Product, where, for the purposes of this Net Sales definition, a "Delivery System" means any delivery system designed to assist in the administration of such Licensed Product; |
(g) any invoiced amounts from a prior period which are not collected and are written off by AbbVie or its Affiliates, including bad debts; provided that such amounts are included as Net Sales if and when collected at a later time; |
(h) 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 the Licensed Products; |
(i) 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 |
(j) any other similar and customary deductions that are consistent with Accounting Standards, but which may not be duplicative of the deductions specified in clauses (a) – (i) above. |
Net Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory, or governmental purposes. Net Sales shall not include sales between or among AbbVie, its Affiliates, or Sublicensees. |
Subject to the above, Net Sales shall be calculated in accordance with the Accounting Standards, consistently applied. |
For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 7.8 (Mode of Payments; Offsets). |
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) a product containing as its sole active ingredient a Licensed Compound contained in such Combination Product (the "Mono Product") and (ii) products containing as their sole active ingredients the other active ingred... |
(b) If AbbVie, its Affiliate, or Sublicensee separately sells in such country or other jurisdiction the Mono Product but does not separately sell in such country or other jurisdiction products containing as their sole active ingredients the other active ingredient in such Combination Product, the Net Sales attributable... |
(c) If AbbVie, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction the Mono Product but do separately sell products containing as their sole active ingredients the other active ingredients contained in such Combination Product, the Net Sales attributable to such Combination Pro... |
(d) If AbbVie, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction both the Mono Product and the other active ingredient or ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be determined by the Parties in good faith based on ... |
For clarity, AbbVie shall not treat sales of a Licensed Product comprising a Licensed Compound as its sole active ingredient delivered via a device (e.g., autoinjectors) as a Combination Product for purposes of calculating Net Sales hereunder. |
1.149 "Neutral" has the meaning set forth in Schedule 14.7.3 (ADR Procedures). |
1.150 "Non-Acting Party" has the meaning set forth in Section 7.9 (Withholding Taxes). |
1.151 "Novartis License" has the meaning set forth in Section 11.2.25 (Additional Representations and Warranties of Parvus). |
1.152 "Option Antitrust Consents" has the meaning set forth in Section 4.3.1 (Antitrust Clearances). |
1.153 "Option Continuation Notice" means AbbVie's written notice to Parvus extending the License Option Period prior to the Stage 1 License Option Expiration Date or Stage 2 License Option Expiration Date, as applicable. |
1.154 "Option Continuation Payment" has the meaning given in Section 7.2.2 (Option Continuation Payments) |
1.155 "Option Foreign Investment Consents" has the meaning set forth in Section 4.3.1 (Antitrust Clearances). |
1.156 "Other Arising IP Infringement" has the meaning set forth in Section 8.3.1 (Enforcement of IP–Notice). |
1.157 "Other Arising Patents" has the meaning given in Section 8.2.2(a) (Prosecution and Maintenance of Other Arising Patents). |
1.158 "Other IBD-Associated Antigen" has the meaning set forth in Section 1.109 (IBD-Associated Antigen). |
1.159 "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 a Party (or its Affiliate) directly incurred in the conduct of any applicable activities under this Agreement, including costs for inde... |
1.160 "Owned Patents" has the meaning set forth in Section 11.2.5 (Additional Representations and Warranties of Parvus). |
1.161 "Party" and "Parties" has the meaning set forth in the preamble hereto. |
1.162 "Parvus" has the meaning set forth in the preamble hereto. |
1.163 "Parvus Indemnitees" has the meaning set forth in Section 12.1 (Indemnification of Parvus). |
1.164 "Parvus Licensed Know-How" means Information that is Controlled by Parvus or any of its Affiliates as of the Effective Date or at any time during the Term and that (a) is not generally known and (b) is necessary or useful to Exploit the Licensed Compounds or Licensed Products in the Field in the Territory, and in... |
1.165 "Parvus Licensed Materials" means all Biological and Chemical Materials that are controlled by Parvus or any of its Affiliates as of the Effective Date or at any time during the Term and that are necessary or useful to Exploit the Licensed Compounds or Licensed Products in the Field in the Territory. The Parvus L... |
1.166 "Parvus Licensed Patents" means all Patents that are (a) Controlled by Parvus or any of its Affiliates as of the Effective Date or at any time during the Term, and (b) necessary or useful to Exploit the Licensed Compounds or Licensed Products in the Field in the Territory, including any Parvus Platform Patent nec... |
1.167 "Parvus Platform IP" means all Parvus Platform Know-How and Parvus Platform Patents. |
1.168 "Parvus Platform Know-How" means any Information that Covers Parvus Platform Technology generally and does not specifically Cover, disclose, reference, or apply to a Licensed Compound, Licensed Product or a Unique Component thereof. |
1.169 "Parvus Platform Patent" means any Patent that contains an issued or pending claim that Covers Parvus Platform Technology generally and does not specifically Cover, claim, disclose, reference or apply to a Licensed Compound, a Licensed Product or a Unique Component thereof. Schedule 1.166 (Parvus Licensed Patents... |
1.170 "Parvus Platform Technology" means Parvus' proprietary technology relating to the discovery, design, modification, synthesis and Manufacture of Navacims and other modified nanoparticles containing Surface-Antigen MHCs, including (a) the Navacim iron oxide nanoparticle core and other nanoparticle cores, (b) polyme... |
1.171 "Patents" means (a) all national, regional and international patents and patent applications, including provisional patent applications and rights to claim priority from any of such patents or applications, (b) all patent applications filed either from such patents, patent applications or provisional applications... |
1.172 "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... |
1.173 "Personal Data" means (a) all information identifying, or in combination with other information, identifiable to an individual, including pseudonymized (key-coded) Clinical Program Data containing such information; and (b) any other information that is governed, regulated or protected by one or more Data Security... |
1.174 "Phase I Study" means a human clinical trial of a compound, the principal purpose of which is a preliminary determination of safety, tolerability, pharmacological activity or pharmacokinetics in healthy individuals or patients or similar clinical study prescribed by the Regulatory Authorities, including the trial... |
1.175 "Phase II Study" means a human clinical trial of a compound, the principal purpose of which is a determination of safety and efficacy in the target patient population, which is prospectively designed to generate sufficient data that may permit commencement of pivotal clinical trials, or a similar clinical study p... |
1.176 "Phase III Study" means a human clinical trial of a pharmaceutical product on a sufficient number of subjects in an indicated patient population that is designed to establish that a Licensed Compound or Licensed Product is safe and efficacious for its intended use and to determine the benefit/risk relationship, w... |
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