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(d) Without limiting the generality of Section 5.6.1(c) (Manufacturing Technology Transfer), HotSpot shall cause all appropriate analytical and quality control laboratory employees and representatives of HotSpot and its Affiliates, and shall use Commercially Reasonable Efforts to cause all appropriate analytical and qu... |
(e) HotSpot shall take such steps, and shall use Commercially Reasonable Efforts to cause its Affiliates and Third Party contract 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... |
(f) 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 manufacturers to do so under agreements entered into on and aft... |
5.7. Regulatory Matters after License Option Effective Date. On and after the License Option Effective Date, the following shall apply: |
5.7.1. From and after the License Option Effective Date, AbbVie shall have the sole right to prepare, obtain, and maintain the Drug Approval Applications (including the setting of the overall regulatory strategy therefor), all other Regulatory Approvals and other submissions, and to conduct communications with the Regu... |
5.7.2. All Regulatory Documentation (including all Trial Master Files, Regulatory Approvals and Product Labeling) relating to a Licensed Compound or Licensed Product with respect to the Territory shall be owned by, and shall be the sole property and held in the name of, AbbVie or its Affiliate, Sublicensee or its or th... |
5.7.3. Effective as of the License Option Effective Date, HotSpot hereby assigns to AbbVie all of HotSpot's and its Affiliates' right, title, and interest in and to all Regulatory Documentation (including all Trial Master Files and Regulatory Approvals) relating to any Licensed Compound or Licensed Product that is exis... |
5.7.4. From and after the License Option Effective Date, AbbVie shall have the sole right to determine and initiate all recalls, market suspensions or market withdrawals undertaken with respect to the Licensed Compounds and Licensed Products, and AbbVie (itself or through its Affiliates or Sublicensees or its or their ... |
5.8. Records and Reports. AbbVie shall, and shall cause its Affiliates and Sublicensees to, maintain books and records pertaining to Development and Commercialization activities conducted by or on behalf of AbbVie, in each case in accordance with AbbVie's standard records retention policies. If HotSpot exercises the Co... |
5.9. Booking of Sales; Distribution. AbbVie (itself or through its Affiliates or Sublicensees or its or their designee(s)) shall have the sole right to invoice and book sales, establish all terms of sale (including pricing and discounts) and warehousing, and distribute Licensed Products in the Territory and to perform ... |
5.10. Product Trademarks. AbbVie (itself or through its Affiliates or Sublicensees or its or their designee(s)) shall have the sole right to determine and AbbVie (itself or through its Affiliates or Sublicensees or its or their designee(s)) shall own the Product Trademarks in the Territory to be used with respect to th... |
ARTICLE 6 GRANT OF RIGHTS |
6.1. Grants to AbbVie on the Effective Date. HotSpot (on behalf of itself and its Affiliates) hereby grants to AbbVie on the Effective Date and during the License Option Period, a non-exclusive, royalty-free license, with the right to sublicense in accordance with Section 6.4 (Sublicenses), under the HotSpot Know-How, ... |
6.2. Grants to HotSpot on the Effective Date. |
(a) AbbVie (on behalf of itself and its Affiliates) hereby grants to HotSpot and its Affiliates on the Effective Date and during the License Option Period, a non-exclusive, non-sublicensable (except to subcontractors in accordance with Schedule 3.2.2 (Approved Subcontractors)), royalty-free license under the AbbVie Kno... |
6.3. Grants to AbbVie on the License Option Effective Date. Subject to Section 4.3 (Antitrust Clearances) and Section 6.7 (Retention of Rights), HotSpot (on behalf of itself and its Affiliates) hereby grants to AbbVie, effective as of the License Option Effective Date: |
6.3.1. an exclusive (including with regard to HotSpot and its Affiliates, except as required to conduct Unfinished Development Plan Activities), royalty-bearing license, with the right to sublicense in accordance with Section 6.4 (Sublicenses), under the HotSpot Know-How, HotSpot Patents and HotSpot's interests in the ... |
6.3.2. subject to the assignments contemplated by Section 5.7 (Regulatory Matters after License Option Effective Date), an exclusive (including with regard to HotSpot and its Affiliates, except as provided in Section 5.7 (Regulatory Matters after License Option Effective Date)) license and right of reference, with the ... |
6.3.3. subject to Section 8.1.6 (Ownership of Corporate Names) and Section 9.4 (Use of Name), a non-exclusive license, with the right to grant sublicenses in accordance with Section 6.4 (Sublicenses), to use HotSpot's Corporate Names solely as required to Exploit the Licensed Compounds and Licensed Products in the Fiel... |
6.3.4. a non-exclusive license, with the right to grant sublicenses in accordance with Section 6.4 (Sublicenses), under the HotSpot Program Data to Exploit Licensed Compounds and Licensed Products in the Field in the Territory. |
6.4. 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 6.1 (Grants to AbbVie on the Effective Date) and Section 6.3 (Grants to AbbVie on the License Option Effective Date),... |
6.5. Distributorships. AbbVie shall have the right, in its sole discretion, to appoint its Affiliates, and AbbVie and its Affiliates shall have the right, in their sole discretion, to appoint any other Persons, in the Territory to Commercialize a Licensed Product (with or without packaging rights), in circumstances whe... |
6.6. Co-Promotion Rights. For 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 with or without AbbVie in all or any part of the Territory. |
6.7. Retention of Rights. |
6.7.1. Notwithstanding the Exclusive License, HotSpot retains the right to practice under the HotSpot Know-How and HotSpot Patents solely as necessary to perform the Unfinished Development Plan Activities. |
6.7.2. Nothing in this Agreement shall be construed as conferring, expressly or by implication, estoppel or otherwise, and license, right or immunity under any Patent or Information Controlled by a Party or any of its Affiliates, other than as expressly provided herein. Except as expressly provided in this Agreement, H... |
6.8. Confirmatory Patent License. HotSpot shall, if requested to do so by AbbVie, as promptly as practicable 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... |
6.9. Exclusivity. |
6.9.1. HotSpot Exclusivity. During the Term, HotSpot shall not, and shall cause its Affiliates not to (a) directly or indirectly, Develop, Commercialize, Manufacture, or otherwise Exploit any Competing Product, Compound or Product in the Field in any country or other jurisdiction in the Territory, or (b) license, autho... |
6.9.2. Change in Control of HotSpot. If, as a result of a Change in Control of HotSpot, HotSpot or any of its Affiliates merges or consolidates with, or is acquired by, a Third Party (the "Acquiring Party") that is engaged in activities, as of the date of such Change in Control, that would otherwise constitute a breach... |
6.9.3. Obligations of Acquiring Party with Competing Program. If a Change in Control of HotSpot occurs in which the Acquiring Party is engaged in a Competitive Program as of the date of such Change in Control, or if HotSpot acquires a Third Party engaged in a Competitive Program, or if the Acquiring Party commences a n... |
6.9.4. Acquisitions by HotSpot. HotSpot shall not be in breach of Section 6.9.1 (HotSpot Exclusivity) if HotSpot acquires a Third Party engaged in a Competitive Program as of the date of such acquisition, provided that (a) HotSpot notifies AbbVie in writing within thirty (30) days of such acquisition, and either termin... |
6.9.5. AbbVie Competing Products. If, at any time during the Term, AbbVie or any of its Affiliates is Exploiting a Competing Product, then AbbVie (a) shall ensure that all activities with respect to such Competing Product at any time during the Term (i) do not use, incorporate or reference, and are not based on, covere... |
6.9.6. Acknowledgement. Each Party acknowledges and agrees that (a) this Section 6.9 (Exclusivity) has been negotiated by the Parties, (b) the time limitations on activities set forth in this Section 6.9 (Exclusivity) are reasonable, valid and necessary in light of the Parties' circumstances and necessary for the adequ... |
6.10. In-License Agreements. |
6.10.1. Prior to the License Option Effective Date, HotSpot shall have the sole right, but not the obligation, at its sole cost and expense, to enter into any agreement with a Third Party related to Information, Regulatory Documentation, materials, Patents, or other intellectual other property rights Controlled by such... |
(a) if such Related Third Party IP is solely related to a Compound or a Product or the Exploitation thereof (and not, for example, to HotSpot Platform Technology or any other compounds or products Controlled by HotSpot), then HotSpot shall not enter into any agreement in connection therewith without AbbVie's prior writ... |
(b) if such Related Third Party IP is related both to (i) a Compound or a Product or the Exploitation thereof, and (ii) HotSpot Platform Technology or any other compounds or products Controlled by HotSpot, then (A) HotSpot shall ensure that any agreement executed in connection therewith is sublicensable to AbbVie and i... |
6.10.2. On and after the License Option Effective Date: |
(a) AbbVie shall have the sole right, but not the obligation, to negotiate and obtain a license or other right from such Third Party for AbbVie and its Affiliates and its and their Sublicensees to Exploit Licensed Compounds and Licensed Products in such country or other jurisdiction, including in connection with settle... |
(b) HotSpot shall have the sole right, but not the obligation, to negotiate and obtain a license or other right from such Third Party solely with respect to HotSpot Platform Technology or any other compounds or products Controlled by HotSpot or the Exploitation thereof. |
6.10.3. If HotSpot or any of its Affiliates, after the Effective Date, becomes a party to a license, sublicense or other agreement, with the right to sublicense, in respect of Related Third Party IP under Section 6.10.1(a) or Section 6.10.1(b) (In-License Agreements), then HotSpot shall inform AbbVie and shall provide ... |
(a) (i) AbbVie shall bear a portion of license fees, milestones, royalties, or other payments owed in connection with such Proposed Future In-Licensed Rights to the extent attributable to the Development, Manufacturing, and Commercialization of a Compound or Product by AbbVie, its Sublicensees, and its and their Affili... |
6.10.4. HotSpot shall be solely responsible for any license fees, milestones, royalties, or other payments owed to Third Parties under or in connection with any In-License Agreement existing as of the Effective Date (whether or not any such In-License Agreement is disclosed to AbbVie prior to the Effective Date). |
6.11. HotSpot DNA Encoded Libraries (DELs). For clarity, the Exclusive License shall not, and nothing in this Agreement shall be construed to, give AbbVie or its Affiliates (a) the right to directly access or search the full compound collections from HotSpot's DELs, (b) subject to Section 8.2 (HotSpot Screening Obligat... |
ARTICLE 7 PAYMENTS AND RECORDS |
7.1. One-Time Payments. |
7.1.1. Upfront Payment. No later than fifteen (15) Business Days following the Effective Date, AbbVie shall pay HotSpot a one-time upfront amount equal to Forty Million Dollars ($40,000,000) in consideration of the License Option. |
7.1.2. Option Exercise Payment. In the event that AbbVie exercises the License Option, AbbVie shall pay HotSpot a one-time payment of Sixty Million Dollars ($60,000,000) (the "Option Exercise Payment") within thirty (30) days of the License Option Effective Date. |
7.1.3. Option Extension Payments. |
(a) In the event that AbbVie elects to retain the License Option until the Stage 2 License Option Expiration Date in accordance with Section 4.2.1 (Exercise of the License Option), AbbVie shall pay HotSpot a one-time, payment of Twenty Million Dollars ($20,000,000) ("First Option Extension Payment") within thirty (30) ... |
(b) In the event that AbbVie extends the Applicable Expiration Date of the License Option Period from the Stage 2 License Option Expiration Date to the Stage 3 License Option Expiration Date in accordance with Section 4.2.2 (Exercise of the License Option), AbbVie shall pay HotSpot a one-time payment of Fifteen Million... |
(c) In the event that AbbVie further extends the Applicable Expiration Date of the License Option Period from the Stage 3 License Option Expiration Date to the Stage 4 License Option Expiration Date in accordance with Section 4.2.3 (Exercise of the License Option), AbbVie shall pay HotSpot a one-time payment of Ten Mil... |
(d) In the event that AbbVie further extends the Applicable Expiration Date of the License Option Period from the Stage 4 License Option Expiration Date to the Final License Option Expiration Date in accordance with Section 4.2.4 (Exercise of the License Option), AbbVie shall pay HotSpot a one-time payment of Thirty Mi... |
7.2. Research and Development Milestones. |
7.2.1. If AbbVie exercises the License Option prior to paying all of the Option Extension Payments, then, in partial consideration of the rights granted by HotSpot to AbbVie hereunder and subject to the terms and conditions set forth in this Agreement, any Option Extension Payment that has not been paid to HotSpot shal... |
No. Research and Development Milestone Event Research and Development Milestone Payment |
1. Completion of Stage 1 Activities Twenty Million Dollars ($20,000,000) |
2. Completion of Stage 2 Activities Fifteen Million Dollars ($15,000,000) |
3. Completion of Stage 3 Activities Ten Million Dollars ($10,000,000) |
4. Completion of Stage 4 Activities Thirty Million Dollars ($30,000,000) |
7.2.2. For clarity, each Research and Development Milestone Payment shall be payable (a) only if AbbVie has not paid the corresponding Option Extension Payment to HotSpot prior to AbbVie's exercise of the License Option, and (b) only after first achievement of the corresponding Research and Development Milestone Event;... |
7.2.3. Notwithstanding the foregoing, if AbbVie exercises the License Option prior to the occurrence of one (1) or more of the Research and Development Milestone Events, then (a) the next Research and Development Milestone Payment for which AbbVie has not paid to HotSpot the corresponding Option Extension Payment shall... |
7.3. Development and Regulatory Milestones. |
7.3.1. If AbbVie exercises the License Option, in partial consideration of the rights granted by HotSpot to AbbVie hereunder and subject to the terms and conditions set forth in this Agreement, AbbVie shall pay to HotSpot the following one-time milestone payments, each within sixty (60) days after the corresponding mil... |
No. Milestone Event Milestone Payment |
1. First patient dosed in AbbVie's (or its Affiliate's or Sublicensee's) first Phase III Study for the first Licensed Product in the United States for the first Indication Seventy-Five Million Dollars ($75,000,000) |
2. Acceptance by the FDA of AbbVie's (or its Affiliate's or Sublicensee's) first Drug Approval Application for the first Licensed Product for the first Indication Fifty Million Dollars ($50,000,000) |
3. Acceptance by the EMA of AbbVie's (or its Affiliate's or Sublicensee's) first Drug Approval Application for the first Licensed Product for the first Indication Thirty-Five Million Dollars ($35,000,000) |
7.3.2. Each milestone payment in Section 7.3.1 (Development and Regulatory Milestones) shall be payable only after first achievement of the corresponding milestone event and no amounts shall be due for subsequent or repeated achievements of any milestone event. The maximum aggregate amount payable by AbbVie pursuant to... |
7.3.3. If Milestone Event No. 2 in Section 7.3.1 (Development and Regulatory Milestones) is achieved prior to achievement of Milestone Event No. 1 in Section 7.3.1 (Development and Regulatory Milestone), then Milestone Event No. 1 shall be deemed to have been achieved upon the achievement of Milestone Event No. 2. |
7.4. Commercial Milestones. If AbbVie exercises the License Option, in partial consideration of the rights granted by HotSpot to AbbVie hereunder and subject to the terms and conditions set forth in this Agreement, AbbVie shall pay to HotSpot the following one-time milestone payments, each within sixty (60) days after ... |
No. Milestone Event Milestone Payment |
1. First Commercial Sale for the first Indication for the first Licensed Product in the United States Sixty Million Dollars ($60,000,000) |
2. First Commercial Sale following receipt of all Regulatory Approvals for the first Licensed Product for the first Indication in three (3) of the European Major Markets Forty Million Dollars ($40,000,000) |
Each milestone payment in this Section 7.4 (Commercial Milestones) shall be payable only after first achievement of the corresponding milestone event and no amounts shall be due for subsequent or repeated achievements of any milestone event. The maximum aggregate amount payable by AbbVie pursuant to this Section 7.4 (C... |
7.5. Sales-Based Milestones. If AbbVie exercises the License Option, in partial consideration of the rights granted by HotSpot to AbbVie hereunder, AbbVie shall pay to HotSpot the following one-time milestone payments, each within sixty (60) days after the end of the Calendar Year in which the corresponding milestone e... |
No. Milestone Event Milestone Payment |
1. First time Annual Net Sales for the first Licensed Product exceed Five Hundred Million Dollars ($500,000,000) Twenty-Five Million Dollars ($25,000,000) |
2. First time Annual Net Sales for the first Licensed Product exceed One Billion Dollars ($1,000,000,000) Fifty Million Dollars ($50,000,000) |
3. First time Annual Net Sales for the first Licensed Product exceed Two Billion Dollars ($2,000,000,000) Seventy-Five Million Dollars ($75,000,000) |
4. First time Annual Net Sales for the first Licensed Product exceed Three Billion Dollars ($3,000,000,000) One Hundred Million Dollars ($100,000,000) |
5. First time Annual Net Sales of the first Licensed Product exceed Four Billion Dollars ($4,000,000,000) One Hundred Twenty-Five Million Dollars ($125,000,000) |
Each milestone payment in this Section 7.5 (Sales-Based Milestones) shall be payable only upon the first achievement of such milestone by the first Licensed Product in a Calendar Year, and no amounts shall be due for subsequent or repeated achievements of any milestone event in subsequent Calendar Years. Subject to the... |
7.6. Royalties. |
7.6.1. Royalty Rates. |
(a) As further consideration for the rights granted to AbbVie hereunder, subject to Sections 7.6.1(b) (Royalty Rates) and 7.6.4 (Compulsory or Settlement Sublicensee Royalties) during the Royalty Term, AbbVie shall pay to HotSpot, on a Licensed Product-by-Licensed Product basis, a royalty on incremental Annual Net Sale... |
Annual Net Sales of a Licensed Product Royalty Rate |
For that portion of Annual Net Sales of a Licensed Product in the Territory less than or equal to One Billion Dollars ($1,000,000,000) 8% |
For that portion of Annual Net Sales of a Licensed Product in the Territory greater than One Billion Dollars ($1,000,000,000) but less than or equal to Two Billion Dollars ($2,000,000,000) 9% |
For that portion of Annual Net Sales of a Licensed Product in the Territory greater than Two Billion Dollars ($2,000,000,000) but less than or equal to Three Billion Dollars ($3,000,000,000) 11% |
For that portion of Annual Net Sales of a Licensed Product in the Territory greater than Three Billion Dollars ($3,000,000,000) 13% |
(b) In the event HotSpot exercises the Cost-Sharing Option and funds its Pro Rata Percentage of Shared Development Costs in accordance with Section 5.3 (HotSpot Cost-Sharing Option), then, subject to Section 7.6.4 (Compulsory or Settlement Sublicensee Royalties), the royalty rates set forth in Section 7.6.1(a) (Royalty... |
Annual Net Sales of a Licensed Product Royalty Rate |
For that portion of Annual Net Sales of a Licensed Product in the Territory less than or equal to One Billion Dollars ($1,000,000,000) 13% |
For that portion of Annual Net Sales of a Licensed Product in the Territory greater than One Billion Dollars ($1,000,000,000) but less than or equal to Two Billion Dollars ($2,000,000,000) 14% |
For that portion of Annual Net Sales of a Licensed Product in the Territory greater than Two Billion Dollars ($2,000,000,000) but less than or equal to Three Billion Dollars ($3,000,000,000) 16% |
For that portion of Annual Net Sales of a Licensed Product in the Territory greater than Three Billion Dollars ($3,000,000,000) 18% |
7.6.2. 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 after the Royalty Term for such Licensed Product in such country or other jurisdiction has expired. |
7.6.3. Royalty Reductions. Notwithstanding anything herein to the contrary, with respect to royalties under Section 7.6.1 (Royalty Rates), the following shall apply: |
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