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1.177 "Phase IV Study" means a post-marketing, human clinical trial for any pharmaceutical product for a country or jurisdiction in the Territory with respect to any Indication as to which all Regulatory Approvals have been received or for a use that is the subject of an investigator-initiated study program. |
1.178 "Potential IBD-Associated Antigen" means, at a given point in time, an antigen (other than flagellin, any other gut microbial antigen and any Excluded Antigen) which has not been determined to be an Other IBD-Associated Antigen as of such time and for which there is a basis to reasonably believe (based on a Party... |
1.179 "Price Applicability Period" has the meaning set forth in Section 1191(b)(2) of the Social Security Act. |
1.180 "Pricing and Reimbursement Approval" means such approval, agreement, determination or decision establishing prices for a Licensed Product that can be charged to consumers or will be reimbursed by Governmental Authorities in a country or other jurisdiction in the Territory where Governmental Authorities of such co... |
1.181 "Privacy and Security Obligations" has the meaning set forth in Section 9.1.1 (Data Privacy and Security). |
1.182 "Processing" (or its conjugates) means any operation or set of operations that is performed upon Personal Data, whether or not by automatic means, such as collection, recording, organization, storage, adaptation or alternation, retrieval, consultation, use, disclosure by transmission, dissemination, or otherwise ... |
1.183 "Product Information" has the meaning set forth in Section 10.1 (Product Information Confidentiality Obligations). |
1.184 "Product Infringement" has the meaning set forth in Section 8.3.1 (Enforcement of IP–Notice). |
1.185 "Product IP" means all Product Know-How, Product Materials and Product Patents. For clarity, a non-exhaustive listing of all Patents and Patent applications comprising Product IP and categories of Information within Product IP existing as of the Effective Date is set forth in Schedule 1.185 (Product IP), which Sc... |
1.186 "Product Know-How" means all Parvus Licensed Know-How and Joint Know-How that specifically relates to the making, using or selling of a Licensed Compound or Licensed Product in its entirety, or any Unique Component thereof. |
1.187 "Product Labeling" means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority-approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and ... |
1.188 "Product Materials" means all Parvus Licensed Materials that specifically relate to a Licensed Compound or Licensed Product in its entirety, or any Unique Components thereof. |
1.189 "Product Patents" means all Parvus Licensed Patents and Joint Patents that specifically Cover, claim, disclose, reference or apply to the composition, making or using of a Licensed Compound or Licensed Product in its entirety or Unique Component thereof. Schedule 1.166 (Parvus Licensed Patents) indicates the Parv... |
1.190 "Product Trademarks" means the Trademark(s) to be used by AbbVie or its Affiliates or its or their respective Sublicensees for the Exploitation of Licensed Products in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (excluding, in any event, any trademarks... |
1.191 "Program Materials" has the meaning set forth in Section 5.3 (Licensed Compound and Licensed Product Supply). |
1.192 "Proposed Future In-Licensed Rights" has the meaning set forth in Section 6.8.3 (In-License Agreements). |
1.193 "PVT401" means the DRB4 Product under Development and referred to by Parvus as of the Effective Date as "PVT401", as described in further detail in Schedule 1.193 (PVT401). |
1.194 "Qualified Immunoassay Test" or "QIT" means an immunoassay test conducted by a Third Party laboratory service company to determine whether an antigen satisfies the criteria to constitute an Other IBD-Associated Antigen. |
1.195 "Regulatory Approval" means, with respect to a country or other jurisdiction in the Territory, the approvals (including Drug Approval Applications), licenses, registrations, or authorizations of any Regulatory Authority necessary to Commercialize a Licensed Compound or Licensed Product in such country or other ju... |
1.196 "Regulatory Authority" means any applicable supra-national, federal, national, regional, state, provincial, or local Governmental Authority or regulatory authority, agency, department, bureau, commission, council, or other entities (e.g., the FDA and EMA) regulating or otherwise exercising authority with respect ... |
1.197 "Regulatory Data" has the meaning given in Section 5.6.3 (Regulatory Matters after License Option Exercise). |
1.198 "Regulatory Documentation" means all (a) applications (including all INDs and Drug Approval Applications), registrations, licenses, authorizations, and approvals (including Regulatory Approvals), (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official co... |
1.199 "Regulatory Exclusivity" means, with respect to a Licensed Product and any country or other jurisdiction in the Territory, an additional market protection, other than Patent protection or Patent-related exclusivity, granted by a Regulatory Authority in such country or other jurisdiction which confers an exclusive... |
1.200 "Related Third Party IP" has the meaning given in Section 6.8.1 (In-License Agreements). |
1.201 "Required QIT" has the meaning given in Section 6.9.1 (IBD-Associated Antigen Immunoassay Testing). |
1.202 "Research and Development Plan" means the mutually agreed upon written plan for the Licensed Compounds and Licensed Products that sets forth all Development, Manufacturing and regulatory activities to be performed by Parvus ("Research and Development Plan Activities") with respect to such Licensed Compounds and L... |
1.203 "Research and Development Plan Activities" has the meaning given in Section 1.202 (Definition of Research and Development Plan). |
1.204 "Research Term" means the period commencing on the Effective Date and ending upon the earlier of (x) completion by Parvus of all of the Research and Development Plan Activities and (y) AbbVie's exercise of the License Option, provided, that, in the case of this clause (y), AbbVie elects to assume all remaining ac... |
1.205 "Reverse Royalty Term" means, with respect to each Grantback Product that is the subject of a license pursuant to Section 13.6.1(c) (Effects of Termination of this Agreement in the Entirety) or 13.7.2 (Effects of Termination of Terminated Territory) and each country or other jurisdiction in the Terminated Territo... |
1.206 "Royalty Term" means, on a Licensed Product-by-Licensed Product and a country-by-country or other jurisdiction-by-other jurisdiction basis, the period beginning on the date of the First Commercial Sale of a Licensed Product in such country or other jurisdiction, and ending on the latest to occur of (a) the expira... |
1.207 "Selected Drug" means a drug selected under the Drug Price Negotiation Program, as described in Section 1192 of the Social Security Act. |
1.208 "Senior Officer" means, with respect to Parvus, its Chief Executive Officer, and with respect to AbbVie, its Chief Scientific Officer or his/her designated direct reports. |
1.209 "Significant Biopharmaceutical Company" means, with respect to a Change in Control of Parvus, (a) any pharmaceutical, biotechnology, medical device or diagnostic company which together with its Affiliates has, as of the date of execution of a definitive agreement for such Change in Control, capabilities and exper... |
1.210 "Social Security Act" means the Social Security Act of 1935 as set forth in Title 42, Chapter 7 of the United States Code, as amended, and any successor statute thereto, as interpreted by the rules and regulations issued thereunder, in each case as in effect from time to time. |
1.211 "Stage 1 Activities" means those activities identified as Stage 1 Activities in the Research and Development Plan. |
1.212 "Stage 1 Information Report" means a report that sets forth the results of all research, development and CMC activities conducted by or on behalf of Parvus concerning any Licensed Compound or Licensed Product for the period beginning on the Effective Date and through the Completion of the Stage 1 Activities, as s... |
1.213 "Stage 1 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 Stage 1 Information Report. |
1.214 "Stage 2 Activities" means those activities identified as Stage 2 Activities in the Research and Development Plan. |
1.215 "Stage 2 Information Report" means a report that sets forth the results of all research, development and CMC activities conducted by or on behalf of Parvus concerning any Licensed Compound or Licensed Product for the period beginning on the Effective Date and through the Completion of the Stage 2 Activities, as s... |
1.216 "Stage 2 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 Stage 2 Information Report. |
1.217 "Sublicensee" means a Person, other than an Affiliate or a Distributor, that is granted a sublicense by AbbVie under the grants in Section 6.1 (Grants to AbbVie on the Effective Date) and 6.2 (Grants to AbbVie on the License Option Effective Date) as provided in Section 6.3 (Sublicenses), excluding (a) any Third ... |
1.218 "Surface-Antigen MHC" means a fusion protein complex consisting of an antigen, a human MHC and a dimerization domain. |
1.219 "Surface-Antigen MHC Density" means (a) the number of Surface-Antigen MHCs per unit external surface area of the polymer coating of a Navacim nanoparticle core or (b) the number of Surface-Antigen MHCs per Navacim. |
1.220 "Tax Action" has the meaning set forth in Section 7.9 (Withholding Taxes). |
1.221 "Technical or Scientific Infeasibility" means that a Licensed Product for the Indication for which it is being studied is determined by the JGC: (i) to be unsafe, based on results of testing, or (ii) otherwise not suitable for Development or Manufacture for technical or scientific reasons. |
1.222 "Term" has the meaning set forth in Section 13.1 (Term). |
1.223 "Terminated Territory" means (a) any Major Market, if this Agreement is terminated in such Major Market by AbbVie pursuant to Section 13.3.2 (Additional Termination Rights by AbbVie – For Convenience), or (b) the entire Territory, if this Agreement is terminated in its entirety. |
1.224 "Territory" means worldwide. |
1.225 "Testing Party" has the meaning set forth in Section 6.9.1 (IBD-Associated Antigen Immunoassay Testing). |
1.226 "Third Party" means any Person other than Parvus, AbbVie and their respective Affiliates. |
1.227 "Third Party Claims" has the meaning set forth in Section 12.1 (Indemnification of Parvus). |
1.228 "Third Party Infringement Claim" has the meaning set forth in Section 8.4.1(a) (Infringement Claims by Third Parties—Prior to License Option Effective Date). |
1.229 "Trademark" means any trademark, trade dress, brand mark, service mark, trade name, brand name, logo, business symbol or domain name, or any word, name, symbol, color, designation or device or any combination thereof that functions as a source identifier, whether or not registered, and any registrations thereof o... |
1.230 "Transition Agreement" has the meaning set forth in Section 13.8.1 (Transition Agreement and Other Performance Obligations). |
1.231 "Trial Master File" means the documents maintained at clinical research sites and by Parvus during the course of Clinical Studies for any Licensed Product, which enable the conduct of a Clinical Study and the quality of the data produced to be evaluated, proving that the study was conducted by the investigator an... |
1.232 "Ulcerative Colitis" means a chronic inflammatory condition characterized by relapsing and remitting episodes of inflammation limited to the mucosal layer of the colon, and that almost invariably involves the rectum and often involves more proximal portions of the colon in a continuous fashion. |
1.233 "Unfinished Research and Development Plan Activities" has the meaning set forth in Section 3.6 (Completion of Research and Development Plan Activities after License Option Exercise). |
1.234 "Unique Component" means with respect to a Licensed Compound, (i) the antigen Component, and (ii) any combination of Components that includes the antigen Component. For purposes of this definition, each Component shall include Variants of such Components. |
1.235 "United States" or "U.S." means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico). |
1.236 "UTI/MGH License" means the Amended and Restated Licensed Agreement, dated April 10, 2017, by and among (a) Parvus, (b) UTI Limited Partnership ("UTI"), by its general partner, University Technologies International Inc., having an office and place of business at Suite 100, 3553 31st Street NW, Calgary, Alberta, T... |
1.237 "Valid Claim" means (a) a claim of any issued and unexpired Patent whose validity, enforceability, or patentability has not been affected by any of the following: (i) irretrievable lapse, abandonment, revocation, cancellation, dedication to the public, or disclaimer; or (ii) a holding, finding, or decision of inv... |
1.238 "Variant" means, with respect to: |
(a) an antigen Component, any other antigen that (i) contains between nine (9) and twenty (20) amino acids, or (ii) has a sequence identity of at least eighty percent (80%) relative to the reference antigen Component; |
(b) an antigen-MHC linker Component, any other antigen-MHC linker that (i) contains between seven (7) and seventeen (17) amino acids, or (ii) has a sequence identity of at least seventy percent (70%) relative to the reference antigen-MHC linker Component; |
(c) an MHC Component, any other MHC wherein the MHC alpha chain or MHC beta chain, as applicable, (i) contains between one-hundred and eighty (180) and two-hundred and thirty-five (235) amino acids, or (ii) has a sequence identity of at least eighty percent (80%) relative to the MHC alpha chain or MHC beta chain, as ap... |
(d) a dimerization domain Component, any other dimerization domain that (i) contains between one-hundred and eighty (180) and two-hundred and thirty-five (235) amino acids, or (ii) has a sequence identity of at least ninety-five percent (95%) relative to the reference dimerization domain Component; |
(e) an alpha chain or beta chain linker Component, any other alpha chain or beta chain linker Component that (i) contains between zero (0) and twenty-five (25) amino acids, or (ii) has a sequence identity of at least seventy percent (70%) relative to the reference alpha or beta chain linker Component; and |
(f) Surface-Antigen MHC Density, any other Surface-Antigen MHC Density that (i) is in the range of between one-twentieth (0.05) and twenty-five (25) Surface-Antigen MHC(s) per one hundred square nanometers (100 nm2) of the external surface area of the polymer coating of a Navacim nanoparticle core or (ii) is between te... |
1.239 "Voting Stock" has the meaning set forth in Section 1.37(a) (Change in Control). |
1.240 "Withholding Party" has the meaning set forth in Section 7.9 (Withholding Taxes). |
1.241 "Working Group" has the meaning set forth in Section 2.2 (Working Groups). |
ARTICLE 2 COLLABORATION MANAGEMENT |
2.1 Joint Governance Committee. |
2.1.1 Formation. Within thirty (30) days after the Effective Date, the Parties shall establish a joint governance committee (the "Joint Governance Committee" or "JGC") to serve as the oversight and decision-making body for the activities to be conducted by the Parties pursuant to this Agreement, as more fully described... |
2.1.2 Responsibilities. The JGC shall perform the following functions, subject to the final decision-making authority of the respective Parties as set forth in Section 2.3.4 (General Provisions Applicable to the JGC—Dispute Resolution): |
(a) oversee the Parties' activities and progress under the Research and Development Plan; |
(b) discuss Research and Development Plan Activities; |
(c) periodically (no less often than annually) review and serve as a forum for discussing the Research and Development Plan, and review and approve any proposed material amendments thereto; |
(d) discuss the content and scope of results, information and data to be included in an Information Report or the License Option Exercise Data Package; |
(e) discuss, nominate and select each Development Candidate; |
(f) discuss pre-Clinical Study protocols, IND-Enabling Study protocols, Phase I Study protocols, clinical site selection, manufacturing specifications, contents of INDs, and regulatory plans, correspondence and scheduled meetings as set forth in Sections 3.5.3 (Regulatory Matters Prior to License Option Exercise) and 3... |
(g) serve as an initial forum for discussion of, and attempt to resolve, any issues or disputes that may arise in a Working Group or otherwise under this Agreement; |
(h) coordinate the Parties' activities during the Research Term under this Agreement, including oversight of the Working Groups; |
(i) discuss and determine whether a Technical or Scientific Infeasibility exists; |
(j) discuss the entry into any agreements with Third Party subcontractors pursuant to Section 3.1.2 (Performance of the Research and Development Plan); |
(k) assign responsibilities that may fall within the purview of more than one (1) Working Group to a particular Working Group; and |
(l) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement. |
For clarity, the JGC shall not have any authority beyond the specific matters set forth in this Section 2.1.2 (Joint Governance Committee—Responsibilities), and in particular shall not have any power to amend or modify the terms of this Agreement or waive a Party's compliance with this Agreement or to decide or resolve... |
2.2 Working Groups. From time to time, the JGC may establish and delegate duties to other committees or directed teams (each, a "Working Group") on an "as-needed" basis to oversee particular projects or activities (such as, for example, CMC, clinical Development, pre-clinical and other non-clinical Development, biomark... |
2.3 General Provisions Applicable to the JGC. |
2.3.1 Composition. The JGC shall consist of three (3) representatives from each of the Parties, each with the requisite experience and seniority to enable such person to make decisions on behalf of the Parties with respect to the issues falling within the jurisdiction of the JGC. From time to time, each Party may subst... |
2.3.2 Meetings and Minutes. The JGC shall meet quarterly, or in each case as otherwise agreed to by the Parties, with the location of such meetings alternating between locations designated by Parvus and locations designated by AbbVie. Alternatively, the JGC may meet by means of teleconference, videoconference or other ... |
2.3.3 Procedural Rules. The JGC shall have the right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with this Agreement. A quorum of the JGC shall exist whenever there is present at a meeting at least two (2) representatives appointed by each Party. R... |
2.3.4 Dispute Resolution. If a Working Group cannot, or does not, reach consensus on an issue at a meeting or within a period of ten (10) Business Days thereafter, then the dispute shall be referred, in writing (which may be via e-mail) to the JGC for resolution and a special meeting of the JGC may be called for such p... |
(a) Parvus shall have final decision-making authority with respect to the conduct of activities assigned to Parvus under the Research and Development Plan other than (i) any activities that would materially affect the Information AbbVie would receive in any Information Report or the License Option Exercise Data Package... |
(b) AbbVie shall have final decision-making authority with respect to the nomination and selection of Development Candidates; and |
(c) Neither Party shall have final decision-making authority with respect to a dispute over any other decision to be made by the JGC, which dispute shall be resolved by mutual agreement of the Parties. Such decisions include the determinations of (i) whether the activities under the Research and Development Plan have b... |
2.3.5 Limitations on Authority. Each Party shall retain the rights, powers, and discretion granted to it under this Agreement and no such rights, powers, or discretion shall be delegated to or vested in the JGC or a Working Group unless such delegation or vesting of rights is expressly provided for in this Agreement or... |
2.3.6 Alliance Director. Each Party shall appoint an employee who shall (a) oversee contact between the Parties for all matters between meetings of the JGC, (b) be the primary contact between the Parties after disbandment of the JGC, and (c) have such other responsibilities as the Parties may agree in writing after the... |
2.4 Discontinuation of the JGC or Working Groups. |
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