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(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... |
3.4 Development and Regulatory Diligence. With respect to a given Collaboration Program for which AbbVie has exercised its Option, AbbVie shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for a Licensed Product for such Collaboration Program in the Major Markets. For clarity, it is ack... |
3.5 Pre-Clinical and Clinical Supply of Licensed Antibodies or Licensed Products; Subcontracting. |
3.5.1 Supply Prior to Option Exercise. Licensor shall be responsible for obtaining the quantities of Licensed Antibodies or Licensed Products and placebo (a) needed by Licensor to carry out the Pre Exercise Development Plan and Budget or (b) as reasonably requested by AbbVie to perform activities outside the Pre Exerci... |
3.5.2 Manufacture. Licensor shall Manufacture all Licensed Antibodies or Licensed Products and placebo delivered by it pursuant to Section 3.5.1 pursuant to GMP, to the extent applicable. |
3.5.3 Supply Following Option Exercise; Manufacturing Technology Transfer. Following AbbVie's exercise of its Option with respect to a given Collaboration Program and successful completion of the Manufacturing Technology Transfer described below, AbbVie will assume responsibility for the Manufacture of all Licensed Ant... |
(a) make available, to AbbVie (or its designated Third Party manufacturer, as applicable) from time to time as AbbVie may request, all Manufacturing-related Licensor Background Know-How, Licensor Program Know-How, Joint Program Know-How, Information and materials relating to the Manufacturing Process not transferred to... |
(b) cause all appropriate employees and representatives of Licensor and its Affiliates and all appropriate employees and representatives of its Third Party manufacturers to meet with, employees or representatives of AbbVie (or its designated Third Party manufacturer, as applicable) at the applicable manufacturing facil... |
(c) Without limiting the generality of clause (b) above, cause all appropriate analytical and quality control laboratory employees and representatives of Licensor and its Affiliates and all appropriate analytical and quality control employees and representatives of its Third Party manufacturers to meet with, employees ... |
(d) provide such other assistance as AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) may reasonably request to enable AbbVie's Third Party manufacturer to use and practice the Manufacturing Process and otherwise to Manufacture Licensed Antibodies and Licensed Products. |
3.5.4 Acquisition of Licensed Product for Phase III Clinical Studies. For clarity, AbbVie shall be responsible for securing all quantities of Licensed Products necessary for the conduct of the Phase III Clinical Studies and other Development Activities under the Post Exercise Development Plan and Budget, provided that ... |
3.5.5 Subcontracting. Each Party shall have the right to subcontract any of its Party Development Activities to a Third Party (a "Third Party Provider"); provided that (a) Licensor shall keep AbbVie reasonably informed with respect to any material activities Licensor intends to subcontract and shall furnish AbbVie with... |
3.6 Supply of Technology for Development Purposes. |
3.6.1 Immediately after the Option Exercise Date, Licensor shall, and shall cause its Affiliates to, without additional compensation, disclose and make available to AbbVie, such Regulatory Documentation, Licensor Background Know-How, Licensor Program Know-How, Joint Program Know-How with respect to the Licensed Antibod... |
3.6.2 Immediately after Option Exercise Date, Licensor, without additional compensation, shall provide AbbVie with all reasonable assistance required in order to transfer to AbbVie the Regulatory Documentation, Licensor Background Know-How, Licensor Program Know-How, Joint Program Know-How, and other Information requir... |
3.6.3 Any Out-of-Pocket Costs and FTE Costs incurred by the Parties in performing activities pursuant to this Section 3.6, and if any supplies of Licensed Antibodies or Licensed Product are transferred to AbbVie in connection with such activities, the Manufacturing Cost of such materials, shall be included as Developme... |
3.7 Development Costs. |
3.7.1 Development Costs Sharing: |
(a) Pre Exercise Development Activities. Licensor shall be solely responsible for and shall bear all Development Costs (i) incurred by it and its Affiliates in connection with the performance of the Pre Exercise Development Activities for each Collaboration Program through the Option Exercise Date, including any Contin... |
(b) Core Development Costs Relating to Post Exercise Development Activities. Subject to Section 3.7.1(f), each Party shall bear fifty percent (50%) of all Core Development Costs incurred in connection with the performance of Post Exercise Development Activities. Within sixty (60) days after the end of each Calendar Qua... |
(c) Country-Specific Development Costs. AbbVie shall initially be responsible for the Country-Specific Development Costs. Following Regulatory Approval for any Licensed Product in a country outside the Major Markets, AbbVie shall invoice Licensor for fifty percent (50%) of the Country-Specific Development Costs incurre... |
(d) Development Costs Relating to Additional Licensor Development Activities. Licensor shall bear one hundred percent (100%) of all Development Costs for Additional Licensor Development Activities unless AbbVie exercises the AbbVie Opt In, in which case AbbVie shall reimburse costs for the applicable Additional Licenso... |
(e) Development Costs for Second Generation Products and Additional Indications. |
(i) If Licensor has not exercised a Licensor Opt Out with respect to a particular Collaboration Program, Licensor shall remain responsible for fifty percent (50%) of all Development Costs for all Second Generation Products and Additional Indications (including Additional Indications for such Second Generation Products)... |
(ii) Reports of Ongoing Second Generation and Additional Indication Development Costs; Payment Default. For so long as Licensor has the right to maintain an Adjusted Royalty Rate for a Second Generation or Additional Indication under Section 6.5.2(b), then within sixty (60) days after the end of each Calendar Quarter, ... |
(iii) Calculation of Licensor's Proportionate Share. For purposes of this Section 3.7.1(e) (and Section 6.5.2(b)(ii)), "Licensor's Proportionate Share" of the applicable Additional Development Costs shall mean (x) the quotient of the Incremental Royalty for the applicable Collaboration Program, divided by nine percent ... |
(f) Costs of Combination Studies. If a Clinical Study involving a Licensed Product involves the use of such Licensed Product in combination with another product of AbbVie or its Affiliate, then unless otherwise agreed by the Parties, no more than fifty percent (50%) of the Out-of-Pocket Costs and Manufacturing Costs at... |
(g) No Double Counting. For clarity, no item shall be included in both Development Costs and Allowable Expenses, or otherwise be double counted in determining costs to be shared. |
3.7.2 Licensor Development Opt Out. Licensor, may, upon 90 days' advance written notice to AbbVie, opt out of sharing Development Costs incurred in connection with the performance of AbbVie Post Exercise Development Activities one or both Collaboration Programs (a "Licensor Development Opt Out"), in which case, (i) Lic... |
3.7.3 Reports. Each Party shall report to the other Party, within forty-five (45) days after the end of each Calendar Quarter, the Development Costs incurred by such Party during such Calendar Quarter; provided that AbbVie shall not be required to report its Development Costs incurred in connection with a Collaboration... |
3.8 Regulatory Matters. |
3.8.1 Pre Exercise Regulatory Activities: Prior to the Option Exercise Date for a given Collaboration Program or, for any AbbVie Opt In Product prior to AbbVie's exercise of the AbbVie Opt In, the following shall apply with respect to such Collaboration Program or Licensed Product: |
(a) Licensor shall have the sole right and responsibility to prepare, obtain and maintain all INDs necessary to perform its obligations under the Pre Exercise Development Plan and Budget, and to conduct communications with the applicable Regulatory Authorities with respect to such INDs; provided that Licensor must secu... |
(b) Subject to the immediately following sentence, Licensor shall provide AbbVie with (i) access to or copies of all material written or electronic correspondence (other than regulatory filings) relating to the Development or Commercialization of Licensed Antibodies or Licensed Products received by Licensor or its Affi... |
(c) Licensor shall provide AbbVie with prior written notice, to the extent Licensor has advance knowledge, of any scheduled meeting, conference, or discussion (including any advisory committee meeting) with a Regulatory Authority in the Territory relating to a Licensed Product, within two (2) Business Days after Licens... |
3.8.2 Post Exercise Regulatory Activities. Effective on the Option Exercise Date for a given Collaboration Program, or (b) the AbbVie Opt In Exercise Date for an AbbVie Opt In Product, the following shall apply with respect to such Collaboration Program or AbbVie Opt In Product, as applicable: |
(a) Promptly after the Option Exercise Date for a given Collaboration Program or the AbbVie Opt In Exercise Date for a given AbbVie Opt In Product, Licensor shall transition to AbbVie all INDs for Licensed Antibodies and Licensed Products in such Collaboration Program or for such AbbVie Opt In Product. All Regulatory D... |
(b) As between the Parties, AbbVie shall have the sole right to prepare, obtain, and maintain the Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other regulatory approvals and other submissions, and to conduct communications with the Regulatory Authorities, for Licensed ... |
(c) AbbVie shall provide Licensor with an opportunity to review and comment on all INDs, pre-meeting submissions, Drug Approval Applications, material labeling supplements, Regulatory Authority meeting requests, core data sheets and other material regulatory submissions (collectively, "Major Regulatory Filings") in the... |
(d) AbbVie shall provide Licensor with prior written notice, to the extent AbbVie has advance knowledge, of any scheduled meeting, conference, or discussion (including any advisory committee meeting) with a Regulatory Authority in the Major Markets relating to a Licensed Product, within two (2) Business Days after AbbV... |
(e) AbbVie shall make every reasonable effort to notify Licensor promptly following its determination that any event, incident, or circumstance has occurred that may result in the need for an application withdrawal during the review period, recall, market suspension, or market withdrawal of a Licensed Product in the Te... |
3.8.3 Regulatory Data. |
(a) Licensor shall promptly provide to AbbVie copies of or access to non-clinical data and Clinical Data, and other Information, results, and analyses with respect to any Development activities and Additional Licensor Development Activities, that are Controlled by Licensor or any of its Affiliates (collectively, "Regul... |
(b) Licensor shall support AbbVie, as may be reasonably necessary or appropriate, in obtaining Regulatory Approval for the Licensed Antibody or Licensed Products, including providing necessary documents or other materials required by Applicable Law to obtain Regulatory Approvals, in each case in accordance with the ter... |
3.9 Compliance. Each Party shall perform or cause to be performed, any and all of its Party Development Activities and the Additional Licensor Development Activities in good scientific manner and in compliance with all Applicable Law. |
3.10 Records. |
3.10.1 Licensor shall, and shall ensure that its Third Party Providers, maintain records in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, and in compliance with Applicable Law, which shall be complete and accurate and shall properly reflect all work done and results ach... |
3.10.2 AbbVie shall have the right, during normal business hours and upon reasonable notice, to inspect and copy all records of Licensor maintained pursuant to Section 3.10.1. AbbVie shall maintain such records and the information disclosed therein in confidence in accordance with ARTICLE 9. |
3.10.3 Without limiting Section 7.1.5(b), within thirty (30) days following the end of each Calendar Quarter during which the Parties are conducting Party Development Activities, each Party shall provide to the other access to or copies of written reports of such Development activities as such Party produces in the ord... |
3.11 Human Samples. All human samples collected and retained in connection with Clinical Studies involving a Licensed Antibody or Licensed Product that are performed under a Development Plan and Budget or for which costs are shared as Allowable Expenses (together with compilations of Information comprising annotations ... |
ARTICLE 4. COMMERCIALIZATION |
4.1 In General. AbbVie (itself or through its Affiliates or Sublicensees) shall have the sole right to Commercialize Licensed Antibodies and Licensed Products in the Territory. |
4.2 Commercialization Plan. |
4.2.1 If Licensor has not exercised the Licensor Opt Out with respect to a given Collaboration Program, the Commercialization of the Licensed Products for such Collaboration Program shall be conducted pursuant to a multi-year plan and budget approved by the JCC (each, a "Commercialization Plan and Budget"). For all Lic... |
4.2.2 Each Commercialization Plan and Budget shall include a high-level overview of: (a) general strategies for the promoting, detailing, marketing, and distributing of the Licensed Products, (b) overview of pre-launch Commercialization activities and the expected date of launch, (c) the nature of promotional activitie... |
4.2.3 The JCC shall review each Commercialization Plan and Budget within sixty (60) days after receipt and, thereafter, at least annually, and shall review amendments thereto made by AbbVie. AbbVie shall provide to the JCC the Commercialization Plan and Budget for the next succeeding year no later than December 1 of ea... |
4.3 Diligence. AbbVie shall use Commercially Reasonable Efforts to Commercialize a Licensed Product for the Alzheimer's Indication in the Major Markets following exercise of its Option with respect to the corresponding Collaboration Program and the receipt of Regulatory Approval therefor in the Major Markets; provided ... |
4.4 Compliance with Applicable Law. Each Party shall, and shall cause its Affiliates to, comply with all Applicable Law with respect to the Commercialization of Licensed Products. |
4.5 Booking of Sales; Distribution. AbbVie shall have the sole right to invoice and book sales, establish all terms of sale (including pricing and discounts) and warehousing, and distribute the Licensed Products in the Territory and to perform or cause to be performed all related services. AbbVie shall handle all retur... |
4.6 Product Trademarks. Subject to Section 4.7, AbbVie shall have the sole right to determine and own the Product Trademarks to be used with respect to the Exploitation of the Licensed Products on a worldwide basis. Subject to any pre-existing Trademarks Licensor may have, Licensor shall not, and shall not permit its A... |
4.7 Markings. To the extent required by Applicable Law in a country or other jurisdiction in the Territory, the promotional materials, packaging, and Product Labeling for the Licensed Products used by AbbVie and its Affiliates in connection with the Licensed Products in such country or other jurisdiction shall contain ... |
4.8 Commercial Supply of Licensed Antibodies or Licensed Products. As between the Parties, AbbVie shall have the sole right, and shall be solely responsible for, at its initial expense (but includable in Allowable Expenses and ROW Profit, as applicable), having Manufactured and supplied the Licensed Antibody and Licens... |
ARTICLE 5. GRANT OF RIGHTS |
5.1 Option Grants to AbbVie. |
5.1.1 Licensor hereby grants, on a Collaboration Program-by-Collaboration Program basis, to AbbVie the exclusive right, but not the obligation, to obtain the licenses set forth in Section 5.2.2 (the "Option"). AbbVie shall have the right to exercise its Option with respect to a Collaboration Program by providing writte... |
5.1.2 For purposes of clarity, AbbVie, in its sole discretion, shall have the right to exercise its Option with respect to each Collaboration Program on a Collaboration Program-by-Collaboration Program basis as set forth in Section 5.1.1. |
5.2 License Grants to AbbVie. |
5.2.1 Upon the Effective Date, Licensor (on behalf of itself and its Affiliates) hereby grants to AbbVie a non-exclusive, royalty-free license, with the right to grant sublicenses in accordance with Section 5.4, under the Licensor Background Patents, the Licensor Background Know-How, Licensor Program Patents, Licensor ... |
5.2.2 Upon the Option Exercise Date with respect to a given Collaboration Program, Licensor (on behalf of itself and its Affiliates) hereby grants to AbbVie, with respect to such Collaboration Program: |
(a) an exclusive (including with regard to Licensor and its Affiliates) license (or sublicense), with the right to grant sublicenses in accordance with Section 5.4, under the Licensor Background Patents, the Licensor Background Know-How, Licensor Program Patents, Licensor Program Know-How, and Licensor's interests in t... |
(b) an exclusive (including with regard to Licensor and its Affiliates) license and right of reference, with the right to grant sublicenses and further rights of reference in accordance with Section 5.4, under the Regulatory Approvals and any other Regulatory Documentation that Licensor or its Affiliates may Control wi... |
(c) subject to Section 7.1.6, a non-exclusive license, with the right to grant sublicenses in accordance with Section 5.4, to use Licensor's Corporate Names solely as required by Applicable Law to Exploit the Licensed Antibodies or Licensed Products in the Field in the Territory and for no other purpose. |
5.2.3 The grants set forth in Section 5.2.2 will automatically come into full force and effect on the Option Exercise Date for such Collaboration Program without any further action required by either Party under this Agreement. |
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