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(h) establish secure access methods (including secure databases) for each Party to access the Confidential Information of the other Party; and |
(i) 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. |
3.1.3 Meetings and Minutes. The JGC shall meet quarterly, or as otherwise agreed to by the Parties, with the location of such meetings alternating between locations designated by Licensor and locations designated by AbbVie. The chairperson of the JGC shall be responsible for calling meetings on no less than fifteen (15... |
3.1.4 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 one (1) representative appointed by each Party. Re... |
3.1.5 Dispute Resolution. |
(a) If the JGC cannot, or does not, reach consensus on an issue at a meeting or within a period of ten (10) Business Days thereafter or such other period as the Parties may agree, then the dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issu... |
(b) If the Senior Officers are not able to agree on the resolution of any such issue within thirty (30) days after such issue was first referred to them, then the status quo shall prevail; provided that (i) Licensor shall have final decision-making authority with respect to any amendment to the Development Plan that is... |
3.1.6 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 unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressl... |
3.1.7 Alliance Manager. Each Party shall appoint a person who shall oversee contact between the Parties for all matters between meetings of each JGC and shall have such other responsibilities as the Parties may agree in writing after the Effective Date (each, an "Alliance Manager"). Each Party may replace its Alliance ... |
3.1.8 Discontinuation of the JGC. AbbVie may disband the JGC, at its sole discretion, after the Option Effective Date upon written notice to Licensor. Once AbbVie has provided such written notice, the JGC shall be terminated and shall have no further rights or obligations under this Agreement, and thereafter, (a) any r... |
3.1.9 Working Groups. |
(a) From time to time, the JGC 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. Each Working Group shall be constituted and shall operate as the JGC determines; provided that each Working Group shall hav... |
(b) CMC Working Group. Subject to Section 3.1.9(a) (Working Groups), the JGC shall establish a CMC Working Group (the "CMC Working Group") promptly after the JGC's formation that shall be responsible for Manufacturing and supply matters delegated to it by the JGC. The CMC Working Group shall consist of an equal (and ag... |
3.1.10 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, the JGC or other Working Groups. |
ARTICLE 4 OPTION AND OPTION EXERCISE |
4.1 AbbVie Option. Effective as of the Effective Date, Licensor hereby grants, and shall cause its Affiliates to hereby grant, to AbbVie an exclusive option to obtain an exclusive (including with regard to Licensor and its Affiliates) license, with the right to grant sublicenses through multiple tiers, under the Licens... |
4.2 Option Exercise. AbbVie may, in its sole discretion, exercise the Option at any time prior to the expiration of the Option Exercise Period, subject to Section 4.3 (HSR), by providing written notice of such to Licensor ("Option Exercise Notice"). Promptly following the Option Exercise Data Package Trigger Event, Lic... |
4.3 HSR. |
4.3.1 If AbbVie reasonably determines in good faith prior to the delivery of the Option Exercise Notice for the Option that the transactions to be consummated upon the exercise of the Option requires HSR Filings and AbbVie wishes to provide an Option Exercise Notice for the Option, AbbVie shall provide the Option Exerc... |
4.3.2 In connection with the Parties' activities under this Section 4.3 (HSR), AbbVie and Licensor shall each use commercially reasonable efforts to resolve as promptly as practicable any objections that may be asserted by the FTC or the DOJ with respect to the transactions notified in the HSR Filings. Nothing in this ... |
4.3.3 AbbVie shall be responsible for all filing fees in connection with the filing of submissions to the FTC and DOJ under the HSR Act, and each Party shall be responsible for its costs and expenses, including attorneys' fees, incurred by it in preparing submissions or responses or responding to any Second Request or ... |
4.3.4 Tolling of Obligations. If the exercise by AbbVie of the Option under Section 4.2 (Option Exercise) requires the making of filings under the HSR Act, then all rights and obligations related to the exercise of the Option (including payment of any Option Exercise Fee) and the granting of any licenses in connection ... |
4.4 Effects of Option Exercise. Effective upon the Option Effective Date: |
4.4.1 License Grants to AbbVie. Licensor hereby grants, and shall cause its Affiliates (subject to Section 13.4 (Assignment)) to grant, to AbbVie an exclusive license (including with regard to Licensor and its Affiliates except with respect to the retained rights set forth in Section 4.5 (Post-Option Licensor Developme... |
4.4.2 Transfer of Regulatory Documentation. As of the Option Effective Date, Licensor hereby assigns to AbbVie all of its rights, title and interests in and to all Existing Regulatory Documentation (including any existing Regulatory Approvals). Licensor shall duly execute and deliver, or cause to be duly executed and d... |
4.4.3 Right of Reference. Licensor hereby grants to AbbVie, its Affiliates and sublicensees, an exclusive license and right of reference (including with regard to Licensor and its Affiliates), with the right to grant sublicenses and further rights of reference through multiple tiers, under all Regulatory Approvals and ... |
4.5 Post-Option Licensor Development Activities. Within sixty (60) days following the Option Effective Date, AbbVie may, in its sole discretion, request that Licensor finish performing the Development Activities and, upon any such request, Licensor shall finish performing such Development Activities, at Licensor's sole... |
4.6 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 to AbbVie under Section 4.4.1 (License Grants to AbbVie) to its Affiliates and other Persons; provided that any such sublicenses ... |
4.7 Sublicense Survival. As of and following the Option Effective Date, upon termination of this Agreement for any reason other than by AbbVie pursuant to Section 12.3 (Termination Right by AbbVie for Convenience), upon the request of any Sublicensee of AbbVie, Licensor shall enter into a direct license with such Subli... |
4.8 In-License Agreements. |
4.8.1 In-License Agreements Prior to Option Exercise. If Licensor or its Affiliate enters into an agreement with a Third Party prior to the Option Effective Date under which Licensor or its Affiliate obtains a license or rights to Patents or know-how that are necessary or useful for the Exploitation of any Licensed Com... |
4.8.2 Procedure for In-License Agreements Following Option Exercise. Following the Option Effective Date, if Licensor or its Affiliate is planning to enter into an agreement with a Third Party under which Licensor or its Affiliate obtains a license or rights to Patents or know-how that are necessary or useful for the E... |
4.8.3 In-License Agreements Following Option Exercise. Following the Option Effective Date, if Licensor or any of its Affiliates becomes a party to a license, sublicense or other agreement for additional rights, with the right to sublicense, that are necessary or useful for the Exploitation of the Licensed Compound or ... |
4.9 No Implied Licenses. No Party shall be deemed by estoppel or implication to have granted to the other Party any other licenses or right with respect to any intellectual property that are not expressly granted herein. |
ARTICLE 5 POST-OPTION ACTIVITIES |
5.1 Technology Transfer. Promptly following the Option Effective Date, but in no event later than sixty (60) days thereafter, Licensor shall, at its sole cost and expense, use reasonable good faith efforts to disclose and transfer to AbbVie or its designee, in whatever form AbbVie may reasonably request, all Licensor K... |
5.2 Development. |
5.2.1 General. Following the Option Effective Date, subject to the terms of this Agreement, AbbVie (itself or through its Affiliates, Sublicensees or Third Party Providers) shall have sole authority over the Development of the Licensed Compound and Licensed Products. At AbbVie's request, Licensor shall provide reasonab... |
5.2.2 Reporting. Following the Option Effective Date, and until the First Commercial Sale of a Licensed Product in a Major Market, AbbVie shall provide to Licensor, following disbandment of the JGC, reports within thirty (30) days after each Calendar Quarter summarizing the key Development activities undertaken and sum... |
5.3 Regulatory Matters. |
5.3.1 During the Term following the Option Effective Date, except to the extent that Licensor is performing any regulatory activities in connection with Development Activities under Section 4.5 (Post-Option Exercise Licensor Development Activities), subject to the terms of this Agreement (including Section 5.7 (AbbVie ... |
5.3.2 During the Term following the Option Effective Date, all Regulatory Documentation (including all Regulatory Approvals and Product Labeling) relating to the Licensed Compound or Licensed Products in the Field in the Territory shall be owned by, and shall be the sole property and held in the name of, AbbVie or its ... |
5.3.3 During the Term following the Option Effective Date, Licensor shall promptly provide to AbbVie copies of or access to all non-clinical data and Clinical Data, and other Information, results and analyses with respect to any Development Activities that are Controlled by Licensor or any of its Affiliates (collective... |
5.3.4 During the Term following the Option Effective Date, Licensor shall support AbbVie and its Affiliates as may be reasonably necessary or appropriate, in obtaining all Regulatory Approvals for the Licensed Products, including providing necessary documents or other materials required by Applicable Law to obtain all ... |
5.4 Safety Data Exchange Agreement. |
5.4.1 Within ninety (90) days after the Option Effective Date, the Parties shall enter into a safety data exchange agreement (the "Safety Data Exchange Agreement") to initiate a process for the exchange of adverse event safety data in a mutually agreed format, including those that occur during Clinical Studies and post... |
5.4.2 Notwithstanding the forgoing, if any adverse event safety data is received or otherwise generated by a Party prior to the execution of the Safety Data Exchange Agreement, such Party shall, within four (4) days of receiving or otherwise generating such data, provide such data to the other Party by email to: (a) if... |
5.5 Manufacturing. |
5.5.1 Manufacturing Activities. During the Term following the Option Effective Date and the completion of Manufacturing Technology Transfer, except to the extent that Licensor is performing any Manufacturing activities under Section 4.5 (Post-Option Exercise Licensor Development Activities), AbbVie (itself or through i... |
5.5.2 Manufacturing Technology Transfer Upon AbbVie's Request. AbbVie shall have the right, following the interim analysis as described in the Development Plan through the date that is three (3) years following the date of the Option Exercise Notice, to require Licensor to effect a full transfer to AbbVie or its design... |
(a) Licensor shall make available, and shall use commercially reasonable efforts to cause its Third Party manufacturers to make available (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effec... |
(b) Licensor shall cause appropriate employees and representatives of Licensor and its Affiliates to meet with, and shall use commercially reasonable efforts to cause appropriate employees and representatives of its Third Party manufacturers to meet with (including by using commercially reasonable efforts to negotiate ... |
(c) Without limiting the generality of clause (b) above, Licensor shall cause appropriate analytical and quality control laboratory employees and representatives of Licensor and its Affiliates to meet with, and shall use commercially reasonable efforts to cause appropriate analytical and quality control employees and r... |
(d) Licensor shall take such steps, and shall use commercially reasonable efforts to cause its Third Party manufacturers to take such steps (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Eff... |
(e) Licensor shall provide, and shall use commercially reasonable efforts to cause its Third Party manufacturers to provide (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), su... |
(f) The first two hundred (200) FTE hours of assistance provided by Licensor to AbbVie under this Section 5.5.2 (Manufacturing Technology Transfer Upon AbbVie's Request) and Section 5.5.3 (Subsequent Manufacturing Technology Transfer) shall be provided without charge. If AbbVie requests any such assistance in excess of... |
5.5.3 Subsequent Manufacturing Technology Transfer. Without limiting the foregoing, during the five (5) years following AbbVie's request for the Manufacturing Technology Transfer pursuant to Section 5.5.2 (Manufacturing Technology Transfer Upon AbbVie's Request), in the event that there is any invention, discovery or i... |
5.6 AbbVie Commercialization. During the Term following the Option Effective Date, subject to Section 5.7 (AbbVie Diligence), |
5.6.1 Commercialization Activities. AbbVie (itself or through its Affiliates, Sublicensees or Third Party Providers) shall be solely responsible for, at its sole cost and expense, the Commercialization of the Licensed Products in the Field in the Territory. |
5.6.2 Booking of Sales; Distribution. AbbVie (itself or through its Affiliates, Sublicensees or Third Party Providers) shall be solely responsible for, at its sole cost and expense, invoicing and booking sales, establishing all terms of sale (including pricing and discounts) and warehousing, and distributing the Licens... |
5.6.3 Product Trademarks. AbbVie shall be solely responsible for, at its sole cost and expense, determining the Product Trademarks to be used with respect to the Exploitation of the Licensed Products on a worldwide basis and AbbVie shall own such Product Trademarks. |
5.6.4 Commercialization Reports. No less than ninety (90) days prior to the anticipated First Commercial Sale of the first Licensed Product in a Major Market and each anniversary of the First Commercial Sale thereafter for the next five (5) years, AbbVie shall provide Licensor with a written high-level report that summ... |
5.7 AbbVie Diligence. |
5.7.1 During the Term as of and following the Option Effective Date, AbbVie (itself or through its Affiliates, Sublicensees or Third Party Providers) shall use Commercially Reasonable Efforts to (a) Develop and seek Regulatory Approval for one (1) Licensed Product in one (1) Indication in each of the United States and ... |
5.7.2 Licensor acknowledges and agrees that, in addition to the foregoing, (a) AbbVie shall have the right to satisfy its diligence obligations under this Section 5.7 (AbbVie Diligence) through its Affiliates or Sublicensees, and (b) nothing in this Section 5.7 (AbbVie Diligence) is intended, or shall be construed, to ... |
5.7.3 In the event that AbbVie decides to discontinue its diligence obligations under this Section 5.7 (AbbVie Diligence) with respect to a Licensed Product in favor of another Licensed Product, its diligence obligations under this Section 5.7 (AbbVie Diligence) shall cease with respect to such initial Licensed Product... |
5.7.4 Licensor further acknowledges that AbbVie is in the business of Exploiting products and nothing in this Agreement shall be construed as restricting such business or imposing on AbbVie the duty to Exploit any Licensed Product for which royalties are payable hereunder to the exclusion of, or in preference to, any o... |
5.8 Compliance with Applicable Law. AbbVie shall perform its activities under this ARTICLE 5 (Post-Option Activities) in compliance with all Applicable Law. |
ARTICLE 6 PAYMENTS AND RECORDS |
6.1 Upfront Payment. No later than fifteen (15) days following the Effective Date, AbbVie shall pay Licensor an upfront amount equal to Sixty Million Dollars ($60,000,000). Such payment shall be noncreditable against any other payments due hereunder. |
6.2 Development Milestones by Licensor. 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 the amounts set forth below within sixty (60) days after the first achievement of each of the following... |
Development Milestone |
The later of (a) Initiation of Phase II SLE Clinical Study and (b) the last day of the first Calendar Quarter in Calendar Year 2021 |
Decision by the JGC to approve a Material Amendment expanding the Phase II SLE Clinical Study to twenty-four (24) weeks |
Successful Completion of a Bridging Study |
Each milestone payment in this Section 6.2 (Development Milestones by Licensor) shall be payable only upon the first achievement of such milestone and no amounts shall be due for subsequent or repeated achievements of such milestone, whether for the same or a different Licensed Compound or Licensed Product. The maximum... |
6.3 Development Milestones by AbbVie. 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 the amounts set forth below within sixty (60) days after the first achievement of each of the following m... |
Development Milestone |
Initiation of the first Phase III for a Licensed Product for an Indication other than aGVHD |
Acceptance of a BLA submission for a Licensed Product in the U.S. for an Indication other than aGVHD |
First Commercial Sale of a Licensed Product in the U.S. for an Indication other than aGVHD |
First Commercial Sale of a Licensed Product in a Major Market other than the U.S. for an Indication other than aGVHD |
Each milestone payment in this Section 6.3 (Development Milestones by AbbVie) shall be payable only upon the first achievement of such milestone and no amounts shall be due for subsequent or repeated achievements of such milestone, whether for the same or a different Licensed Compound or Licensed Product. The maximum a... |
6.4 Option Exercise Fee. Within thirty (30) days after the Option Effective Date, AbbVie shall pay Licensor a one-time payment of Seventy-Five Million Dollars ($75,000,000) (the "Option Exercise Fee"). |
6.5 Sales-Based Milestones. In partial consideration of the rights granted by Licensor to AbbVie hereunder, subject to Section 6.5 (Sales-Based Milestones), in the event that the Net Sales of a particular Licensed Product made by AbbVie or any of its Affiliates or Sublicensees in a given Calendar Year exceeds a thresho... |
Annual Net Sales Milestone Threshold |
Greater than or equal to $500 million but less than $1 billion |
Greater than or equal to $1 billion but less than $2 billion |
Greater than or equal to $2 billion |
Notwithstanding anything contained in Section 6.5 (Sales-Based Milestones), each milestone payment in this Section 6.5 (Sales-Based Milestones) shall be payable only upon the first achievement of such milestone in a Calendar Year, and no amounts shall be due for subsequent or repeated achievements of such milestone in ... |
6.6 Royalties. |
6.6.1 Royalty Rates. As further consideration for the rights granted to AbbVie hereunder, subject to Section 6.6.3 (Reductions), commencing upon the First Commercial Sale of a Licensed Product in the Territory, on a Licensed Product-by-Licensed Product and country-by-country or other jurisdiction-by-other jurisdiction ... |
Net Sales in the Territory of each Licensed Product in a Calendar Year |
For that portion of aggregate Net Sales of each Licensed Product in the Territory during a Calendar Year less than One Billion Dollars ($1,000,000,000) |
For that portion of aggregate Net Sales of each Licensed Product in the Territory during a Calendar Year equal to or greater than One Billion Dollars ($1,000,000,000) but less than One and a Half Billion Dollars ($1,500,000,000) |
For that portion of aggregate Net Sales of each Licensed Product in the Territory during a Calendar Year equal to or greater than One and a Half Billion Dollars ($1,500,000,000) |
With respect to each Licensed Product in each country or other jurisdiction in the Territory, from and after the expiration of the Royalty Term for such Licensed Product in such country or other jurisdiction, Net Sales of such Licensed Product in such country or other jurisdiction shall be excluded for purposes of calc... |
6.6.2 Royalty Term. AbbVie shall have no obligation to pay any royalty with respect to Net Sales of any Licensed Product in any country or other jurisdiction in the Territory after the Royalty Term for such Licensed Product in such country or other jurisdiction in the Territory has expired. |
6.6.3 Reductions. Notwithstanding the foregoing: |
(a) from and after the date on which a Licensed Product is sold in a particular country or other jurisdiction in the Territory and is both (i) not covered by a Valid Claim of a Licensor Patent described in clause (a) of Section 1.149 ("Royalty Term") and (ii) not subject to Regulatory Exclusivity in such country or oth... |
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