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1.184 "Phase IV Costs" means those FTE Costs (charged in accordance with Section 6.4.4) and the Out-of-Pocket Costs recorded as an expense in accordance with Accounting Standards by or on behalf of a Party or any of its Affiliates after the Effective Date, during the Term of and pursuant to this Agreement, that are spe... |
1.185 "Phase IV Study" means: (a) a post-approval clinical study for a Licensed Product with respect to any Indication for which Regulatory Approval has been received or that is required or agreed to be conducted as a condition of receiving Regulatory Approval in a country; as well as (b) any marketing study, epidemiol... |
1.186 "PHSA" means the United States Public Health Service Act, as amended from time to time. |
1.187 "PMDA" means Japan's Pharmaceuticals and Medical Devices Agency and any successor agency(ies) or authority having substantially the same function. |
1.188 "PoC Trial" means the proof of concept (PoC) clinical study meeting the parameters described in Schedule 1.188. |
1.189 "PoC Trial Report" has the meaning set forth in Section 3.1.3. |
1.190 "Post Exercise Development Activities" has the meaning set forth in Section 3.2.1. |
1.191 "Post Exercise Development Plan and Budget" has the meaning set forth in Section 3.2.1. |
1.192 "Pre Exercise Development Activities" means the Party Development Activities set forth in each Pre Exercise Development Plan and Budget to be performed by Licensor (or, pursuant to Section 3.1.2, AbbVie) prior to expiration of the Option Exercise Period. |
1.193 "Pre Exercise Development Plan and Budget" means the Development Plan and Budget covering the Pre Exercise Development Activities for the CD33 Collaboration Program attached hereto as Schedule 1.193 Part 1 and the Development Plan and Budget covering the Pre Exercise Development Activities for the Trem2 Collabora... |
1.194 "Product Information" has the meaning set forth in Section 9.1. |
1.195 "Product Infringement" has the meaning set forth in Section 7.3.1. |
1.196 "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 ... |
1.197 "Product Trademarks" means the product specific Trademark(s) to be used by AbbVie or its Affiliates or its or their respective Sublicensees for the Development or Commercialization of Licensed Products in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (ex... |
1.198 "Program Costs" has the meaning set forth in Section 6.5.2(a). |
1.199 "Prosecuted Infringements" has the meaning set forth in Section 7.3.1. |
1.200 "Regulatory Approval" means, with respect to a country or other jurisdiction in the Territory, all approvals (including Drug Approval Applications), licenses, registrations, or authorizations of any Regulatory Authority necessary to Commercialize a Licensed Antibody or Licensed Product in such country or other ju... |
1.201 "Regulatory Authority" means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory authority, agency, department, bureau, commission, council, or other entities (e.g., the FDA, EMA and PMDA) regulating or otherwise exercising authority with respect to a... |
1.202 "Regulatory Data" has the meaning set forth in Section 3.8.3(a). |
1.203 "Regulatory Documentation" means all (a) applications (including all INDs and Drug Approval Applications and other Major Regulatory Filings), registrations, licenses, authorizations, and approvals (including Regulatory Approvals), (b) correspondence, materials and reports submitted to or received from Regulatory ... |
1.204 "Regulatory Exclusivity" means, with respect to any country or other jurisdiction in the Territory, an additional market protection, other than Patent protection, granted by a Regulatory Authority in such country or other jurisdiction which confers an exclusive Commercialization period during which AbbVie or its ... |
1.205 "Regulatory Expenses" means those FTE Costs (charged in accordance with Section 6.4.4) incurred and the Out-of-Pocket Costs (including filing, user, maintenance and other fees paid to Regulatory Authorities) recorded as an expense in accordance with Accounting Standards by or on behalf of AbbVie or any of its Aff... |
1.206 "Repayment Amount" has the meaning set forth in Section 3.7.1(b). |
1.207 "Reverse Royalty Term" means, with respect to each Licensed Product for which a royalty is due under Section 12.8, and each country or other jurisdiction in a Terminated Program, the period beginning on the date of the First Commercial Sale of such Licensed Product in such country or other jurisdiction after term... |
1.208 "ROW" means all regions, countries and territories other than the United States. |
1.209 "ROW Profit" means, with respect to the Licensed Products, the Net Sales of the Licensed Products in the ROW by AbbVie and its Affiliates (but excluding Net Sales of a Sublicensee) plus Other Income received in connection with the Licensed Products in the ROW less the following allocable to such Net Sales: (a) Ma... |
1.210 "ROW Profit Threshold" has the meaning set forth in Section 6.3.2(b). |
1.211 "Royalty Term" means, with respect to each Licensed Product and each country or other jurisdiction in the Territory, the period beginning on the date of the First Commercial Sale of such Licensed Product in such country or other jurisdiction, and ending on the later to occur of (a) the expiration, invalidation or... |
1.212 "Sales and Marketing Costs" means those FTE Costs (charged in accordance with Section 6.4.4) incurred and the Out-of-Pocket Costs, including costs for independent contractors engaged as permitted under this Agreement, recorded as an expense by a Party or any of its Affiliates in accordance with Accounting Standar... |
(a) activities directed to the advertising and marketing of a Licensed Product, including the use of AbbVie's global marketing personnel or marketing personnel specifically allocated to countries in the United States; |
(b) launch meetings; |
(c) advertising and public relations agencies, including development and distribution of selling and advertising and promotional materials relating to the use of a Licensed Product, field literature, direct-to-consumer advertising campaigns, media/journal advertising, distribution of such advertising and promotional ma... |
(d) peer-to-peer activities such as lunch and dinner meetings; |
(e) speakers programs, including training of such speakers; |
(f) developing, obtaining, and providing training packages for a Licensed Product, promotional literature, promotional materials, and other selling materials, including shipment costs of the same to AbbVie's central distribution facility and from a Party's central distribution facility to its sales force personnel; |
(g) transporting, housing and maintaining sales representatives for training and the costs of all training materials used for such purpose; |
(h) developing and performing market research; |
(i) developing reimbursement programs; |
(j) developing information and data specifically intended for national accounts, managed care organizations, governmental agencies (e.g., federal, state and local), and other group purchasing organizations, including pull-through activities; |
(k) selling by Third Party independent contractors engaged by AbbVie as permitted by this Agreement; |
(l) operation and maintenance of the sales representatives that promote a Licensed Product in the Territory, sales bulletins and other communications, sales meetings, specialty sales forces, call reporting and other monitoring/tracking costs, district and regional sales management, home office personnel who support the... |
(m) call center set-up, maintenance and operation for personnel used in connection therewith; and |
(n) establishing and conducting one (1) or more training facilities for potential users of the Licensed Products, including trainer costs, facility costs, supplies and user costs. |
Sales and Marketing Costs shall include costs of such activities that are incurred at any time after the Effective Date and during the Term of this Agreement (including prior to Regulatory Approval of a Licensed Product in any country, region or other jurisdiction in the Territory). |
1.213 "Second Additional Repayment Amount" has the meaning set forth in Section 3.7.1(e). |
1.214 "Second Generation Product" has the meaning set forth in Section 6.5.2(b). |
1.215 "Second Repayment Amount" has the meaning set forth in Section 3.7.1(b). |
1.216 "Segregate" means, with respect to a Licensor Competing Product or AbbVie Competing Product, as applicable, to use Commercially Reasonable Efforts to segregate the Development and Commercialization activities relating to such product, as applicable, in the Field from Development and Commercialization activities w... |
1.217 "Senior Officer" means, with respect to Licensor, its Chief Executive Officer or his/her designee, and with respect to AbbVie, its Chief Strategy Officer or his/her designee. |
1.218 "Significant Pharmaceutical Company" has the meaning set forth in Section 13.2.1(b). |
1.219 "Sublicensee" means a Person, other than an Affiliate or a Distributor, that is granted (directly or indirectly) a sublicense by AbbVie or its Affiliate under the grants in Section 5.2 as provided in Section 5.4 or other rights to Develop or Commercialize a Licensed Antibody or Licensed Product; provided that a D... |
1.220 "Term" has the meaning set forth in Section 12.1.2. |
1.221 "Terminated Antibody" has the meaning set forth in Section 12.8.1(f). |
1.222 "Terminated Product" has the meaning set forth in Section 12.8.1(f). |
1.223 "Terminated Program" means (a) with respect to the termination of this Agreement for a Collaboration Program pursuant to Sections 12.2 or 12.5, the Collaboration Program subject to such termination, (b) upon expiration of the Option Period for a Collaboration Program for which AbbVie has not previously delivered ... |
1.224 "Terminated Target" has the meaning set forth in Section 12.8.1(f). |
1.225 "Territory" means the entire world. |
1.226 "Third Party" means any Person other than Licensor, AbbVie and their respective Affiliates. |
1.227 "Third Party Claims" has the meaning set forth in Section 11.1. |
1.228 "Third Party Payments" has the meaning set forth in Section 6.5.4(b). |
1.229 "Third Party Provider" has the meaning set forth in Section 3.5.5. |
1.230 "Third Party Technology" has the meaning set forth in Section 5.7. |
1.231 "Trademark" means any word, name, symbol, color, designation or device or any combination thereof that functions as a source identifier, including any trademark, trade dress, brand mark, service mark, trade name, brand name, logo, business symbol or domain names, whether or not registered. |
1.232 "Trademark Costs" means those FTE Costs of in-house legal counsel and related personnel (charged in accordance with Section 6.4.4) incurred and the Out-of-Pocket Costs (including the reasonable fees and expenses paid to outside counsel and other Third Parties, and filing and maintenance fees paid to governmental ... |
1.233 "Trem2" means a receptor protein known as "triggering receptor expressed on monocytes 2" (Trem-2") described in UniProtKB-Q9NZC2 (TREM2_Human). In addition to the amino acid sequence described in UniProtKB-Q9NZC2 (TREM2_Human), Trem2 shall be deemed to include isoforms, alternatively spliced forms and post-transl... |
1.234 "United States" or "U.S." means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico). |
1.235 "US Net Profits" and, with correlative meaning, "US Net Losses", means, with respect to the Licensed Products: Net Sales of the Licensed Products in the United States by AbbVie and its Affiliates (and not by its Sublicensees) (a) plus Other Income received in connection with the Licensed Products in the United St... |
1.236 "Valid Claim" means a claim of any issued and unexpired Patent whose validity, enforceability, or patentability has not been affected by any of the following: (a) irretrievable lapse, abandonment, revocation, dedication to the public, or disclaimer; or (b) a holding, finding, or decision of invalidity, unenforcea... |
1.237 "Voting Stock" has the meaning set forth in the definition of "Change in Control." |
1.238 "Withholding Party" has the meaning set forth in Section 6.9. |
1.239 "Working Group" has the meaning set forth in Section 2.7. |
ARTICLE 2. COLLABORATION MANAGEMENT |
2.1 Joint Steering Committee. |
2.1.1 Formation. As soon as practical, but no later than fifteen (15) days after the Effective Date, the Parties shall establish a joint steering committee (the "Joint Steering Committee" or "JSC"), which shall (a) oversee the Development, Commercialization, and other Exploitation of the Licensed Antibody or Licensed P... |
2.2 Joint Development Committee. |
2.2.1 Formation. As soon as practical, but no later than fifteen (15) days after the Effective Date, the Parties shall establish a joint development committee (the "Joint Development Committee" or "JDC"). The JDC shall consist of three (3) representatives from each of the Parties, each with the requisite seniority to e... |
2.2.2 Specific Responsibilities. The JDC shall meet at least semi-annually, or as otherwise agreed to by the Parties, and such meetings may be conducted by telephone, video-conference or in person as determined by the JDC members, provided that with respect to in person meetings, unless otherwise agreed the location of... |
(a) periodically (no less often than annually) review and serve as a forum for discussing each Pre Exercise Development Plan and Budget, and review and approve amendments thereto, which approval will be reflected in the applicable minutes of the JDC meeting; |
(b) serve as a forum for discussing and oversee the conduct of Pre Exercise Development Activities; |
(c) periodically (no less often than annually) review and approve each Post Exercise Development Plan and Budget, and review and approve amendments thereto, which approval will be reflected in the applicable minutes of the JDC meeting; |
(d) serve as a forum for discussing the conduct of the applicable Country-Specific Development Activities; |
(e) serve as a forum for discussing and oversee the conduct of Additional Licensor Development Activities; |
(f) serve as a forum for reviewing and approving strategies for obtaining Regulatory Approvals including approving use of consultants, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products in the Territory; |
(g) establish secure access methods (such as secure databases) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this Agreement; and |
(h) 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. |
2.2.3 Disbandment. Unless otherwise mutually agreed in writing, (a) upon the earlier of (i) Licensor Opt Out for a Collaboration Program or (ii) Regulatory Approval of the first Licensed Product for a Collaboration Program if AbbVie contemplates no further Development Activities for such Collaboration Program, the JDC ... |
2.3 Joint Commercialization Committee. |
2.3.1 Formation. Within thirty (30) days after initiation of the first Phase III for a Licensed Product in a Collaboration Program for which Licensor has not exercised a Licensor Opt Out, the Parties shall establish a joint commercialization committee (the "Joint Commercialization Committee" or "JCC", and collectively ... |
2.3.2 Specific Responsibilities. The JCC shall meet at least semi-annually, or as otherwise agreed to by the Parties, and such meetings may be conducted by telephone, video-conference or in person as determined by the JCC members, provided that with respect to in person meetings, unless otherwise agreed the location of... |
(a) discuss the global strategy for the Commercialization of the Licensed Products; |
(b) periodically (no less often than annually) review and approve the Commercialization Plan and Budget and amendments thereto; |
(c) oversee at a high level all Commercialization activities in the Territory with respect to the Licensed Products; |
(d) 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. |
2.3.3 Disbandment. Unless otherwise mutually agreed in writing, (a) if a Licensor Opt Out is exercised for a Collaboration Program, the JCC shall have no further responsibilities with respect to such Collaboration Program and (b) if a Licensor Opt Out is exercised for both of the Collaboration Programs, the JDC shall d... |
2.4 General Provisions Applicable to Joint Committees. |
2.4.1 Meetings and Minutes. Meetings of any Joint Committee may be called by either Party on no less than thirty (30) Business Days' notice. Each Party shall make all proposals for agenda items and shall provide all appropriate information with respect to such proposed items at least ten (10) Business Days in advance o... |
2.4.2 Procedural Rules. Each Joint Committee 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; provided that such rules shall not be subject to a deciding vote of either Party under Section 2.4.3 below. A quorum ... |
2.4.3 Joint Committee Dispute Resolution. |
(a) If a Joint Committee (other than the JSC) 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 to the JSC for resolution and a special meeting of the JSC may be called for such purpose. If the JSC cannot, or does no... |
(i) if such dispute is related to a Collaboration Program for which AbbVie has not exercised its Option, such dispute shall be finally and definitively resolved by the Senior Officer of Licensor; provided, that the following amendments to the Pre Exercise Development Plan and Budget shall be subject to AbbVie's written... |
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