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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. |
5.3 Grants to Licensor. Upon the Effective Date, AbbVie grants to Licensor a non-exclusive, royalty-free license, without the right to grant sublicenses, under the AbbVie Program Patents, AbbVie Program Know-How, and AbbVie's interests in the Joint Program Patents and the Joint Program Know-How, to Develop and Manufact... |
5.4 Sublicenses. AbbVie shall have the right to grant sublicenses (or further rights of reference), through multiple tiers of sublicensees, under the licenses and rights of reference granted in Section 5.2, to its Affiliates and other Persons; provided that any such sublicenses shall be consistent with the terms and co... |
5.5 Distributorships. AbbVie shall have the right, in its sole discretion, to appoint its Affiliates, and except as provided in Section 5.4 above with respect to Sublicensees in Major Markets, AbbVie and its Affiliates shall have the right, in their sole discretion, to appoint any other Persons, in the Territory or in ... |
5.6 Co-Promotion Rights. For purposes of clarity, AbbVie and its Affiliates shall have the right, in their sole discretion, to co-promote the Licensed Products with any other Person(s), or to appoint one (1) or more Third Parties to promote the Licensed Products without AbbVie in all or any part of the Territory. |
5.7 Third Party Intellectual Property. With respect to any Third Party Information, inventions or Patents that are in-licensed or otherwise acquired by Licensor and fall within the definition of Licensor Background Know-How or Licensor Background Patents, including any Information, inventions or Patents that were in-li... |
5.7.1 In the case of Third Party Technology in-licensed by Licensor pursuant to an Existing In-License Agreement, (a) Licensor shall be solely responsible for any milestone payments, royalties or other amounts that become owing to such Third Party at any time prior to the Option Exercise Date for the Collaboration Prog... |
5.7.2 Licensor may not enter into any In-License Agreements on or after the Effective Date except in accordance with this Section 5.7.2 if such In-License would require the payment of any amounts by AbbVie or would limit AbbVie's Exploitation in accordance with this Agreement of the Licensed Product with respect to whi... |
5.7.3 To the extent that any such payments made by Licensor under an agreement to acquire Third Party Technology are not specifically attributable to the Exploitation of a Licensed Antibody or Licensed Product, but are attributable to the acquisition of rights to both (a) Third Party Technology used for the Licensed Pr... |
5.7.4 For clarity, regardless of whether Licensor has provided AbbVie with an option to do so pursuant to Section 5.7.2, AbbVie or its Affiliates may choose to enter into license agreements with Third Parties as necessary or useful for AbbVie and its Affiliates, and its and their Sublicensees to Develop, Manufacture, a... |
5.8 Retention of Rights. |
5.8.1 Notwithstanding the exclusive licenses granted to AbbVie pursuant to Section 5.2, Licensor retains the right to practice under the Licensor Background Patents, the Licensor Background Know-How, the Licensor Program Patents, the Licensor Program Know-How, Licensor's interests in the Joint Program Patents and the J... |
5.8.2 Except as expressly provided herein, AbbVie grants no other right or license, including any rights or licenses to the AbbVie Background Patents, the AbbVie Program Patents, the AbbVie Background Know-How, the AbbVie Program Know-How, the Regulatory Documentation, or any other Patent or intellectual property right... |
5.9 Confirmatory Patent License. Licensor shall if requested to do so by AbbVie immediately enter into confirmatory license agreements in the form or substantially the form reasonably requested by AbbVie for purposes of recording the licenses granted under this Agreement with such patent offices in the Territory as Abb... |
5.10 Exclusivity. |
5.10.1 Licensor Covenant. |
(a) During the Term, except under a Collaboration Program, Licensor shall not, and shall cause its Affiliates not to (i) directly or indirectly, develop, commercialize or manufacture any Antibody, either alone or in combination with any other therapeutically active ingredients (or any product incorporating such Antibod... |
(b) Notwithstanding the provisions of Section 5.10.1(a), if, during the Term, Licensor undergoes a Change in Control and the acquirer is either then commercializing a Licensor Competing Product in the Field, or has in Development any Licensor Competing Product in the Field, such Change in Control, and the commercializa... |
5.10.2 AbbVie Covenant. |
(a) During the Term, except under a Collaboration Program, AbbVie shall not, and shall cause its Affiliates not to (i) directly or indirectly, develop, commercialize or manufacture any Antibody, either alone or in combination with any other therapeutically active ingredients (or any product incorporating such Antibody)... |
(b) Notwithstanding the provisions of Section 5.10.2(a), if, during the Term, (i) AbbVie or any of its Affiliates acquires rights to an AbbVie Competing Product through an Acquisition, such Acquisition, and the commercialization of such AbbVie Competing Product in the Field thereafter, shall not constitute a breach of ... |
ARTICLE 6. PAYMENTS AND RECORDS |
6.1 Upfront Payment. AbbVie shall pay Licensor an upfront amount equal to Two Hundred Five Million Dollars ($205,000,000), Five Million Dollars ($5,000,000) of which shall be due no later than thirty (30) days following the Execution Date, with the remaining Two Hundred Million Dollars ($200,000,000) due on January 5, ... |
6.2 Development Milestones. In partial consideration of the rights granted by Licensor to AbbVie hereunder and subject to the terms and conditions set forth in this Agreement, AbbVie shall pay to Licensor a milestone payment within sixty (60) days after the achievement of each of the following milestones for the first ... |
6.2.1 upon AbbVie's exercise of its Option with respect to such Collaboration Program, Two Hundred and Fifty Million Dollars ($250,000,000); and |
6.2.2 upon the occurrence of both of the following (a) AbbVie's exercise of its Option with respect to such Collaboration Program and (b) Regulatory Approval of the first three (3) Additional Indications (on an Additional Indication by Additional Indication basis) to be obtained for a Licensed Product within such Colla... |
(i) One Hundred Million Dollars ($100,000,000) for the first such Additional Indication; |
(ii) Seventy-Five Million Dollars ($75,000,000) for the second such Additional Indication; and |
(iii) Fifty Million Dollars ($50,000,000) for the third such Additional Indication. |
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