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1.265 "Valid Claim" means (a) a claim of any issued and unexpired Patent whose validity, enforceability, or patentability has not been affected by (i) an irretrievable lapse, abandonment, revocation, cancellation, dedication to the public, or disclaimer or (ii) a holding, finding, or decision of invalidity, unenforceab... |
1.266 "Valuation Expert" has the meaning set forth in Section 12.11.1 (Reverse Royalty). |
1.267 "Valuation Notice" has the meaning set forth in Section 12.11.1 (Reverse Royalty). |
1.268 "Voting Stock" has the meaning set forth in Section 1.35.1 (Change in Control). |
1.269 "Wind Down Period" means, in the event of termination in a Terminated Territory with respect to a Licensed Product during the Cost-Sharing Period, the period during which AbbVie continues to conduct one or more Clinical Studies with respect to such Licensed Product with respect to such Terminated Territory pursua... |
1.270 "Withholding Amount" has the meaning set forth in Section 7.13 (Withholding Taxes). |
1.271 "Withholding Party" has the meaning set forth in Section 7.13 (Withholding Taxes). |
1.272 "Working Group" has the meaning set forth in Section 2.2 (Working Groups). |
ARTICLE 2 COLLABORATION MANAGEMENT |
2.1. Joint Governance Committee. |
2.1.1. Formation. Within thirty (30) days after the Effective Date, the Parties shall establish a joint governance committee (the "Joint Governance Committee" or "JGC") to serve as the oversight and decision-making body for the activities to be conducted by the Parties pursuant to this Agreement, as more fully describe... |
2.1.2. Responsibilities. The JGC shall perform the following functions, subject to the final decision-making authority of the respective Parties as set forth in Section 2.3.4 (Decision Making): |
(a) oversee the Parties' activities and progress under the Development Plan and Budget; |
(b) periodically (no less often than annually) review and serve as a forum for discussing the Development Plan and Budget, and review and determine whether to approve amendments or extensions thereto; |
(c) discuss nomination and selection of the Lead Development Candidate Compound; |
(d) review and determine whether to approve GLP toxicology protocols, single ascending dose Phase I Study protocols and clinical site selection, manufacturing specifications and the contents of INDs; |
(e) if AbbVie exercises the License Option, serve as a collaborative forum for discussions and coordination of AbbVie's Development of the Licensed Compounds and Licensed Products in the Territory; |
(f) if HotSpot exercises the Cost-Sharing Option, review and discuss, for informational purposes only, any questions that HotSpot may reasonably have with respect to (i) the Development of Licensed Products, and (ii) the Shared Cost Report; |
(g) serve as an initial forum for discussion of, and attempt to resolve, any issues or Disputes that may arise in a Working Group or otherwise under this Agreement; |
(h) coordinate the Parties' activities under this Agreement, including oversight of the Working Groups; |
(i) assign responsibilities that may fall within the purview of more than one (1) Working Group to a particular Working Group; and |
(j) 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. |
For clarity, the JGC shall not have any authority beyond the specific matters set forth in this Section 2.1.2 (Responsibilities), and in particular shall not have any power to amend or modify the terms of this Agreement or waive a Party's compliance with this Agreement or to decide or resolve any issues other than thos... |
2.2. Working Groups. From time to time, the JGC may establish and delegate duties to other committees or directed teams (each, a "Working Group") on an "as-needed" basis to oversee particular projects or activities (for example CMC, clinical Development, non-clinical Development, or Joint IP). The JGC shall establish a... |
2.3. General Provisions Applicable to the JGC. |
2.3.1. Composition. The JGC shall consist of three (3) representatives from each of the Parties, each with the requisite experience and seniority to enable such person to make decisions on behalf of the Parties with respect to the issues falling within the jurisdiction of the JGC. From time to time, each Party may subs... |
2.3.2. Meetings and Minutes. The JGC shall meet quarterly, or in each case as otherwise agreed to by the Parties, with the location of such meetings alternating between locations designated by HotSpot and locations designated by AbbVie. Alternatively, the JGC may meet by means of teleconference, videoconference or othe... |
2.3.3. 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. R... |
2.3.4. Decision Making. If a Working Group cannot, or does not, reach consensus on an issue at a meeting or within a period of ten (10) Business Days thereafter, then either Party may refer the issue, in writing (which may be via e-mail) to the JGC for resolution, in which case a special meeting of the JGC will be call... |
(a) prior to the License Option Effective Date, |
(i) HotSpot shall have final decision-making authority with respect to the conduct of activities performed pursuant to the Development Plan and Budget, provided that (A) any conduct that would materially affect the information AbbVie would receive in any Information Report or the Final Data Package, and (B) all amendme... |
(ii) AbbVie shall have final decision-making authority with respect to (A) selecting the Lead Development Candidate Compound, (B) after AbbVie assumes responsibility for Manufacturing, the approval of Manufacturing specifications, and (C) the approval of the clinical trial protocol for each of the first Phase Ib Study ... |
(iii) neither Party shall have final decision-making authority with respect to approval of GLP toxicology protocols, single ascending dose Phase I Study protocols and clinical site selection, the approval of the clinical trial protocol for the first multiple ascending dose Phase I Study of the first Licensed Product in... |
(b) on and after the License Option Effective Date, AbbVie shall have final decision-making authority with respect to all matters within the jurisdiction of the JGC; |
provided that, in no event shall the decision-making process under this Section 2.3.4 (Decision-Making) exceed forty-five (45) Business Days from the date a dispute was first discussed at a meeting of a Working Group. Disputes arising between the Parties in connection with or relating to this Agreement or any document ... |
2.3.5. 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 or a Working Group unless such delegation or vesting of rights is expressly provided for in this Agreement o... |
2.3.6. Alliance Manager. Each Party shall appoint an employee who shall (a) oversee contact between the Parties for all matters between meetings of the JGC, (b) be the primary contact between the Parties after disbandment of the JGC, and (c) have such other responsibilities as the Parties may agree in writing after the... |
2.4. Discontinuation of the JGC or Working Groups. |
2.4.1. Discontinuation of the JGC. If AbbVie does not exercise the License Option during the License Option Period, then, the JGC shall disband upon the expiration of the License Option Period. If AbbVie exercises the License Option and (a) HotSpot does not exercise the Cost-Sharing Option, then, subject to Section 13.... |
2.4.2. Discontinuation of Working Groups. Subject to Section 13.2.2 (Change in Control of HotSpot), each Working Group shall continue to exist until the first to occur of: (a) the Parties mutually agreeing to disband the Working Group; or (b) the JGC disbanding in accordance with Section 2.4.1 (Discontinuation of the J... |
2.4.3. Discontinuation Upon Change of Control. Additionally, in the event of a Change in Control of HotSpot, AbbVie shall have the right at any time and for any reason, effective upon written notice, to disband the JGC or one (1) or more Working Groups pursuant to Section 13.2.2 (Change in Control of HotSpot). |
2.5. Interactions Between the JGC or a Working Group 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 s... |
2.6. 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 in, the JGC or any Working Group. |
ARTICLE 3 INITIAL DEVELOPMENT |
3.1. Development Plan and Budget. The Development Plan and Budget shall be designed and implemented to enable HotSpot to deliver one (1) Lead Development Candidate Compound that is ready to commence a Phase Ib Study or Phase II Study and ultimately to support the filing of Drug Approval Applications and obtaining of Re... |
3.2. Performance of the Development Plan and Budget. |
3.2.1. Except as otherwise expressly set forth in Section 3.7 (AbbVie Development Activities Prior to License Option Effective Date) and Section 3.10 (Completion of Development Plan Activities after License Option Effective Date), HotSpot shall be responsible for, and shall perform, the Development Plan Activities allo... |
3.2.2. HotSpot shall have the right to subcontract its Development Plan Activities (including Manufacturing activities in support of the Development Plan Activities and HotSpot's obligations under Section 3.8 (Manufacturing Prior to License Option Effective Date)) to a Third Party (a) listed in Schedule 3.2.2 (Approved... |
3.2.3. HotSpot shall, and shall cause its Affiliates and subcontractors to, maintain in good scientific manner, complete and accurate books and records pertaining to all Development Plan Activities, in sufficient detail to verify compliance with its obligations under this Agreement and which books and records shall (a)... |
3.2.4. If AbbVie reasonably believes HotSpot is in material breach of its obligations (a) to perform any Development Plan Activities in accordance with this Agreement or the Development Plan and Budget (including meeting the minimum number of FTEs), or (b) to use Commercially Reasonable Efforts to perform the Developme... |
3.3. Amendments to the Development Plan and Budget. Either Party, directly or through its representatives on the JGC, may propose amendments to the then-current Development Plan and Budget at any time, including in light of changed circumstances. If the Parties mutually agree to amend the Development Plan and Budget to... |
3.4. Interim Development Reports. Within thirty (30) days following the end of each Calendar Half, HotSpot shall provide to the JGC and AbbVie (a) a detailed written report, in a format to be agreed upon by the Parties, summarizing HotSpot's Development Plan Activities that shall contain sufficient detail to enable the... |
3.5. Information Reports and Final Data Package. |
3.5.1. HotSpot shall deliver to AbbVie, within thirty (30) days after the Completion of (a) the Stage 1 Activities in accordance with the Development Plan and Budget, the Stage 1 Information Report and a draft Disclosure Letter, (b) the Stage 2 Activities in accordance with the Development Plan and Budget, the Stage 2 ... |
3.5.2. AbbVie shall have (a) thirty (30) days after the date HotSpot provides an Information Report and (b) sixty (60) days after the date HotSpot provides the Final Data Package (the time period in each of clauses (a) and (b), as applicable, the "Initial Review Period") in which to review such Information Report or Fi... |
3.5.3. Any request for additional Information or clarification pursuant to Section 3.5.2 (Information Reports and Final Data Package) shall be limited to (a) Information or clarification that is necessary or reasonably useful for AbbVie to evaluate the applicable Information Report or Final Data Package, or (b) to help... |
3.5.4. Following delivery of the Final Data Package and any time prior to the License Option Effective Date, the Parties, directly or through their representatives on the JGC, shall discuss in good faith whether to amend the Development Plan and Budget to include a first Phase Ib Study or first Phase II Study of the fi... |
3.6. Expenses. Except as otherwise expressly set forth in Section 3.3 (Amendments to the Development Plan and Budget) and Section 3.10 (Completion of Development Plan Activities after License Option Effective Date), HotSpot shall be solely responsible for and shall bear (a) all costs and expenses incurred by or on beha... |
3.7. AbbVie Development Activities Prior to License Option Effective Date. At any time prior to the License Option Effective Date, the Parties may discuss, directly or through representatives on the JGC, and mutually agree in writing for AbbVie to perform certain supplemental Development activities in respect of the Co... |
3.8. Manufacturing Prior to License Option Effective Date. Prior to the License Option Effective Date and subject to Section 3.10 (Completion of Development Plan Activities after License Option Effective Date), HotSpot shall (a) Manufacture (or cause to be Manufactured), a supply of drug product and placebo to support ... |
3.9. Regulatory Matters Prior to License Option Effective Date. Prior to the License Option Effective Date, the following shall apply: |
3.9.1. HotSpot shall have the sole right and responsibility to prepare, obtain and maintain all INDs necessary to perform the Development Plan Activities under the Development Plan and Budget, and to conduct communications with the applicable Regulatory Authorities with respect to such INDs; provided that the form and ... |
3.9.2. Subject to the immediately following sentence, HotSpot shall provide AbbVie with (a) access to or copies of all material written or electronic correspondence (other than regulatory filings) relating to the Development of Collaboration Compounds or Collaboration Products received by HotSpot or its Affiliates from... |
3.9.3. HotSpot shall provide AbbVie with prior written notice, to the extent HotSpot or its Affiliates 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 Collaboration Product, within two (2) Bu... |
3.10. Completion of Development Plan Activities after License Option Effective Date. If the License Option Effective Date occurs prior to completion of the Development Plan Activities, then, except as otherwise directed in writing by AbbVie, HotSpot shall be responsible, at its sole cost and expense, for completing (a)... |
ARTICLE 4 LICENSE OPTION |
4.1. License Option Grant to AbbVie. HotSpot hereby grants to AbbVie an exclusive (including with regard to HotSpot and its Affiliates) option to obtain an Exclusive License (the "License Option"), exercisable by AbbVie in its sole discretion during the License Option Period as set forth in Section 4.2 (Exercise of the... |
4.2. Exercise of the License Option. At any time during the License Option Period, AbbVie shall have the right to exercise the License Option by delivering to HotSpot the License Option Exercise Notice, provided that: |
4.2.1. in order to retain the License Option following the Stage 1 License Option Expiration Date and extend the right to exercise the License Option until the Stage 2 License Option Expiration Date, AbbVie shall (a) deliver a License Option Extension Notice to HotSpot prior to the Stage 1 License Option Expiration Dat... |
4.2.2. AbbVie shall only have the right to exercise the License Option during the period beginning the day after the Stage 2 License Option Expiration Date and ending on the Stage 3 License Option Expiration Date if AbbVie (a) delivers a License Option Extension Notice to HotSpot prior to the Stage 2 License Option Exp... |
4.2.3. AbbVie shall only have the right to exercise the License Option during the period beginning the day after the Stage 3 License Option Expiration Date and ending on the Stage 4 License Option Expiration Date if AbbVie (a) delivers a License Option Extension Notice to HotSpot prior to the Stage 3 License Option Exp... |
4.2.4. AbbVie shall only have the right to exercise the License Option during the period beginning the day after the Stage 4 License Option Expiration Date and ending on the Final License Option Expiration Date if AbbVie (a) delivers a License Option Extension Notice to HotSpot prior to the Stage 4 License Option Expir... |
4.3. Antitrust Clearances. |
4.3.1. If AbbVie reasonably determines in good faith prior to the delivery of the License Option Exercise Notice that the transaction to be consummated upon the exercise of the License Option requires AbbVie to (a) file, or cause to be filed, any documents to consummate the transactions contemplated in connection with ... |
(a) In furtherance of this Section 4.3.1 (Antitrust Clearances), and unless agreed otherwise by mutual consent, AbbVie and HotSpot shall use reasonable best efforts to prepare and file any filing required to obtain such Option Antitrust Consents or Option Foreign Investment Consents promptly after delivery of the Licen... |
(b) AbbVie shall be responsible for all filing fees in connection with any necessary filing(s) to be made pursuant to this Section 4.3.1 (Antitrust Clearances). With the exception of filing fees, each Party shall be responsible for its own costs and expenses, including attorneys' fees, incurred by it in connection with... |
4.3.2. AbbVie and HotSpot shall each use reasonable best efforts to resolve as promptly as practicable any objections that may be asserted by any Governmental Authority with respect to the transactions notified in any Option Antitrust Consent or Option Foreign Investment Consent listed in the License Option Exercise No... |
4.3.3. Each Party shall use its best efforts to cooperate with the other Party and furnish to the other Party, or such other Party's legal advisers, in accordance with any Applicable Law, any and all information required to prepare and submit any necessary filing(s) to be made after obtaining any Option Antitrust Conse... |
4.4. Termination of License Option. If (a) upon the expiration of the License Option Period AbbVie has not delivered the License Option Exercise Notice pursuant to Section 4.2 (Exercise of the License Option), (b) AbbVie does not pay the applicable Option Extension Payment within thirty (30) days after the then-current... |
ARTICLE 5 DEVELOPMENT AND COMMERCIALIZATION AFTER LICENSE OPTION EXERCISE |
5.1. In General. |
5.1.1. From and after the License Option Effective Date, AbbVie (itself or through its Affiliates or Sublicensees or its or their designees) shall (a) have the Exclusive License and the Collaboration Program shall become the Licensed Program, (b) subject to HotSpot's obligations under Section 3.10 (Completion of Develo... |
5.1.2. If AbbVie exercises the License Option in accordance with Section 4.2 (Exercise of the License Option) prior to HotSpot's completion of all Development Plan Activities set forth in the Development Plan and Budget, then (a) any previously unpaid Option Extension Payments shall automatically convert into the miles... |
5.1.3. In the case of any agreement with any Third Party that relates to the conduct of the Development Plan and Budget, HotSpot shall promptly identify such agreement and provide a copy thereof to AbbVie. Upon the License Option Effective Date, (a) HotSpot shall promptly transfer and make available to AbbVie all HotSp... |
5.2. Diligence. From and after the License Option Effective Date, AbbVie shall use Commercially Reasonable Efforts to (a) Develop and obtain Regulatory Approval for one (1) Licensed Product in one (1) Indication in the United States and in three (3) of the European Major Markets; and (b) Commercialize one (1) Licensed ... |
5.3. HotSpot Cost-Sharing Option. |
5.3.1. Promptly following (but in no case later than forty-five (45) days after) the earlier of (a) the date on which all of the Phase II Studies for the first Licensed Product in the first Indication are completed and (b) the date on which the first Phase III Study for the first Licensed Product in the first Indicatio... |
5.3.2. During the period beginning on the date on which AbbVie delivers to HotSpot the Cost-Sharing Option Package and ending forty-five (45) days thereafter (the "Cost-Sharing Option Period"), HotSpot shall have a one-time right to elect to share in the Shared Development Costs of all Licensed Compounds and Licensed P... |
5.3.3. During the Cost-Sharing Period, (a) HotSpot and AbbVie shall each bear its Pro Rata Percentage of all Shared Development Costs for each Licensed Compound and Licensed Product, and (b) HotSpot shall, subject to the terms and conditions of this Section 5.3 (HotSpot Cost-Sharing Option) and Section 7.6.3 (Royalty R... |
5.3.4. If HotSpot exercises the Cost-Sharing Option, within forty-five (45) days after the end of each Calendar Quarter thereafter, AbbVie shall provide to HotSpot a summary report of the Shared Development Costs incurred by AbbVie during such Calendar Quarter (or, with respect to the first such report, since the comme... |
5.3.5. During the Cost-Sharing Period, AbbVie shall deliver to HotSpot the AbbVie Cost-Sharing Plan and Budget at least once per Calendar Year, regardless of whether any changes have been made thereto. Notwithstanding the following, AbbVie may amend the AbbVie Cost-Sharing Plan and Budget in its sole discretion from ti... |
5.3.6. In the event AbbVie provides to HotSpot a Shared Cost Report demonstrating that the Shared Development Costs for the Licensed Compounds and Licensed Products incurred in respect of Development activities and Indications set forth in the Initial AbbVie Cost-Sharing Plan and Budget in a given Calendar Year exceede... |
5.3.7. During the Cost-Sharing Period, in the event AbbVie elects to perform additional Development activities (e.g., a new Clinical Study or additional Development activities for a new Indication) not set forth in the Initial AbbVie Cost-Sharing Plan and Budget, then HotSpot shall elect to either (a) reimburse AbbVie ... |
5.4. Manufacturing after License Option Effective Date. Subject to Section 3.10 (Completion of Development Plan Activities after License Option Effective Date), AbbVie shall have the sole right, at AbbVie's expense, to Manufacture (or have Manufactured) a supply of the Licensed Compounds and Licensed Products in the Te... |
5.5. Manufacturing Supplies Transfer. Following the License Option Effective Date, or as otherwise agreed upon by the Parties, at a time reasonably requested by AbbVie in writing in advance with respect to any Licensed Compound and Licensed Product, HotSpot shall, at HotSpot's sole cost and expense, effect a full trans... |
5.6. Manufacturing Technology Transfer. Following the License Option Effective Date, or as otherwise agreed upon by the Parties, at a time reasonably requested by AbbVie in writing in advance with respect to any Licensed Compound and Licensed Product (but no later than the completion of HotSpot's Manufacturing of Licen... |
5.6.1. With respect to the Manufacturing Technology Transfer, HotSpot shall provide, and shall use Commercially Reasonable Efforts to cause its Affiliates and Third Party contract manufacturers to provide (including by using Commercially Reasonable Efforts to negotiate contractual obligations for such Third Party manuf... |
(a) HotSpot shall make available, and shall use Commercially Reasonable Efforts to cause its Affiliates and Third Party contract 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 i... |
(b) HotSpot shall (i) grant, and hereby grants, to AbbVie a license to use all materials (including regulatory starting materials, API, drug product, placebos, and Excipients) used by HotSpot or any of its Affiliates or Third Party contract manufacturers to Manufacture, or relating thereto, the applicable Licensed Comp... |
(c) HotSpot shall cause all appropriate employees and representatives of HotSpot and its Affiliates, and shall use Commercially Reasonable Efforts to cause all appropriate employees and representatives of its Third Party contract manufacturers, to meet with (including by using Commercially Reasonable Efforts to negotia... |
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