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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... |
(ii) if such dispute is related to a Collaboration Program for which AbbVie has exercised its Option, such dispute shall be finally and definitively resolved by the Senior Officer of AbbVie, provided, that Licensor's written consent shall be required for any proposed amendment to the Post Exercise Development Plan that... |
(iii) if such dispute is related to Additional Licensor Development Activities for which AbbVie has not exercised the AbbVie Opt In in accordance with Section 3.3.4, such dispute shall be finally and definitively resolved by the Senior Officer of Licensor; and |
(iv) if such dispute is related to any activities for an Additional Indication under Additional Licensor Development Activities following AbbVie's exercise of the AbbVie Opt In in accordance with Section 3.3.4, such dispute shall be finally and definitively resolved by the Senior Officer of AbbVie. |
(b) Disputes arising between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith, and that are outside of the jurisdiction of the JSC and not within a Party's sole decision-making authority, shall be resolved pursuant to Section 13.7. |
2.4.4 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 a Joint Committee unless such delegation or vesting of rights is expressly provided for in this Agreement or the Part... |
2.4.5 Alliance Manager. Each Party shall appoint a person(s) who shall oversee contact between the Parties for all matters between meetings of each Joint Committee and shall have such other responsibilities as the Parties may agree in writing after the Effective Date (each, an "Alliance Manager"). Each Party may replac... |
2.5 Discontinuation of Participation on a Committee. Subject to Sections 2.2.3 and 2.3.3, each Joint Committee shall continue to exist until the first to occur of: (a) the Parties mutually agreeing to disband the Joint Committee; or (b) Licensor providing to AbbVie written notice of its intention to disband and no long... |
2.6 Interactions Between a Committee and Internal Teams. The Parties recognize that each Party possesses an internal structure (including various committees, teams and review boards) that will be involved in administering such Party's activities under this Agreement. Nothing contained in this Article shall prevent a Pa... |
2.7 Working Groups. From time to time, a Joint Committee may establish and delegate duties to sub-committees or directed teams (each, a "Working Group") on an "as-needed" basis to oversee particular projects or activities (for example, joint project team, joint finance group, and/or joint intellectual property group). ... |
2.8 Information. Each Party shall keep the Joint Committees informed as to its efforts and activities with respect to the Development, Manufacture and Commercialization of the Licensed Antibodies and Licensed Products, including by providing such Information as the other Party may reasonably request from time to time. |
2.9 Expenses. Each Party shall be responsible for all travel and related costs and expenses for its members and other representatives to attend meetings of, and otherwise participate on, a Committee or other Working Group. |
ARTICLE 3. DEVELOPMENT AND REGULATORY |
3.1 Pre Exercise Development Plan and Activities. |
3.1.1 Pre Exercise Development Plan and Budget. Either Party, directly or through its representatives on the JDC, may propose amendments to the Pre Exercise Development Plan and Budget from time to time as appropriate, including in light of changed circumstances. Any and all such amendments shall be subject to approval... |
3.1.2 Pre Exercise Development Activities. Licensor shall perform the Pre Exercise Development Activities (including providing to AbbVie the reports specified in the Pre Exercise Development Plan and Budget), and shall do so in accordance with the Pre Exercise Development Plan and Budget by allocating such time, effort... |
3.1.3 PoC Trial Reports. Within fifteen (15) days after database lock of the PoC Trial for each Collaboration Program pursuant to the applicable Pre-Exercise Development Plan and Budget, Licensor shall provide or make available to AbbVie all raw Clinical Data generated in such PoC Trial that are available to Licensor. ... |
3.2 Post Exercise Development Plan and Budget and Activities. |
3.2.1 Post Exercise Development Plan and Budget. Promptly following the Option Exercise Date for the applicable Collaboration Program, AbbVie shall prepare and present to the JDC for review and approval an updated global Development Plan and Budget for each Collaboration Program (the "Post Exercise Development Plan and... |
3.2.2 Amendments. Either Party, through its representatives on the JDC, may propose amendments to a Post Exercise Development Plan and Budget at any time. Following the Option Exercise Date for the Collaboration Program to which a given Post Exercise Development Plan and Budget relates, amendments to such Post Exercise... |
3.2.3 Diligence. Each Party shall use Commercially Reasonable Efforts to perform the responsibilities assigned to it under each Post Exercise Development Plan and Budget. |
3.2.4 Country-Specific Development Activities. After the applicable Option Exercise Date, AbbVie may, at its initial expense, conduct Country-Specific Development Activities. |
3.2.5 Incorporation of AbbVie Independent New Technology. In the event AbbVie proposes to incorporate or use with a Licensed Antibody or Licensed Product any AbbVie Independent New Technology, AbbVie will provide to Licensor a written proposal describing the AbbVie Independent New Technology it proposes to employ and i... |
3.3 Additional Licensor Development Activities. |
3.3.1 If Licensor proposes to the JDC an amendment to a Development Plan and Budget to include Development activities designed to support the filing of Drug Approval Applications and the obtaining of Regulatory Approvals for a Licensed Product in an Additional Indication not covered by a Post Exercise Development Plan ... |
3.3.2 Prior to AbbVie's exercise of its Option for both Collaboration Programs, Licensor may conduct Clinical Studies within the Additional Licensor Development Activities only using an Antibody set forth on Schedule 3.3.2 and no other Licensed Antibody. After AbbVie's exercise of its Option for both Collaboration Prog... |
3.3.3 If, at any time, AbbVie believes that an Additional Licensor Development Activity would adversely affect a Licensed Antibody or Licensed Product included in a Development Plan and Budget or being Developed or Commercialized by AbbVie or its commercial prospects, AbbVie may notify Licensor and Licensor will not un... |
3.3.4 For each Additional Indication pursued under an Additional Licensor Development Activity, if AbbVie has exercised the Option in accordance with Section 5.1.1 with respect to the applicable Collaboration Program, AbbVie shall have the right (the "AbbVie Opt In"), exercisable by written notice to Licensor at any ti... |
3.3.5 Licensor Right to Conduct Non-Clinical Research with Licensed Antibodies. Without limiting Licensor's rights under Sections 3.3.1 through 3.3.4 above, Licensor shall have the right at its sole cost to conduct non-clinical research outside the Pre-Exercise Development Plan and Budget with respect to Licensed Antib... |
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