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(g) Standards of Conduct. AbbVie shall, and shall cause its Affiliates to, perform, and shall use reasonable efforts to ensure that its Sublicensees and Third Party contractors perform, its Development activities with respect to Licensed Compounds and Licensed Product in good scientific manner, and in compliance with t... |
5.2 Commercialization. |
(a) Commercialization Responsibility. As between AbbVie and Mission, following payment of the Exclusively Licensed DUB Fee, AbbVie shall have the sole right, responsibility and obligation for Commercialization of Licensed Products in the Field in the Territory, at its cost and expense, and shall have the sole decision-... |
(b) Commercialization Diligence. AbbVie by itself and/or through its Affiliates and Sublicensees shall use Commercially Reasonable Efforts to Commercialize at least one (1) Licensed Product that knocks down or inhibits tau, and at least one (1) Licensed Product that knocks down or inhibits α-synuclein in the Field thro... |
(c) Commercialization Report. At each semi-annual meeting of the JGC (or after dissolution of the JGC, at least once per Calendar Year, through the Alliance Managers or other designees of the Parties), AbbVie shall provide to Mission a written report that summarizes the Commercialization activities performed by AbbVie,... |
(d) Standards of Conduct. AbbVie shall, and shall cause its Affiliates and Sublicensees to, comply with all Applicable Law with respect to the Commercialization of Licensed Products in the Territory. |
(e) Licensed Product Trademarks and INN. AbbVie shall be solely responsible for the selection (including the creation, searching and clearing), registration, maintenance, policing and enforcement of all trademarks, and for the selection and obtainment of the International Nonproprietary Name nomenclature, in each case,... |
(f) Use of Third Parties. AbbVie may retain Third Party contractors to perform Commercialization activities subject to the terms of this Agreement. Any such Third Party contractor performing Commercialization activities hereunder shall not be Debarred/Excluded and shall enter into a written agreement with AbbVie that i... |
5.3 Manufacture. |
(a) Manufacturing Responsibility. As between AbbVie and Mission, AbbVie shall have the sole right, responsibility and obligation for the Manufacture (including having a Third Party Manufacture on its behalf, if applicable) of all Licensed Compounds and Licensed Products (including all such manufacturing for use in Clin... |
(b) Third Party Manufacturing. AbbVie may exercise any of its Manufacturing rights with respect to Compounds and Licensed Products through one or more Third Party manufacturers, provided that the Third Party manufacturer is not Debarred/Excluded and enters into a written agreement containing obligations of confidential... |
ARTICLE 6 PAYMENTS |
6.1 Upfront Payment. AbbVie shall pay Mission a non-creditable, non-refundable, one-time upfront payment of Twenty Million Dollars ($20,000,000) within thirty (30) days after the Effective Date. |
6.2 Development Milestone Payments for Licensed Product. |
(a) On an Exclusively Licensed DUB-by-Exclusively Licensed DUB basis, subject to Section 6.2(b), AbbVie shall pay to Mission each of the non-creditable, one-time milestone payments described in the tables below within thirty (30) days after the first achievement by AbbVie or its Affiliates or Sublicensees of each of th... |
Table 6.2.1 – Phase 1 Milestone |
Milestone Event: Initiation of the first Phase 1 Clinical Study of a Licensed Product |
Milestone Payment: Ten Million Dollars ($10,000,000) |
Table 6.2.2 – Alzheimer's Indication |
Milestone Event: Initiation of the first Phase 2 Clinical Study of a Licensed Product for the Alzheimer's Indication |
Milestone Payment: Licensed Compound: Twenty Million Dollars ($20,000,000) |
Milestone Payment: AbbVie Compound: Ten Million Dollars ($10,000,000) |
Milestone Event: Initiation of the first Phase 3 Clinical Study of a Licensed Product for the Alzheimer's Indication |
Milestone Payment: Licensed Compound: Fifty Million Dollars ($50,000,000) |
Milestone Payment: AbbVie Compound: Twenty-Five Million Dollars ($25,000,000) |
Milestone Event: First Commercial Sale in the U.S. of a Licensed Product for the Alzheimer's Indication |
Milestone Payment: Licensed Compound: Two Hundred Twenty-Five Million Dollars ($225,000,000) |
Milestone Payment: AbbVie Compound: One Hundred Million Dollars ($100,000,000) |
Milestone Event: First Commercial Sale in the EU of a Licensed Product for the Alzheimer's Indication |
Milestone Payment: Licensed Compound: One Hundred Fifteen Million Dollars ($115,000,000) |
Milestone Payment: AbbVie Compound: Fifty Million Dollars ($50,000,000) |
Milestone Event: First Commercial Sale in Japan of a Licensed Product for the Alzheimer's Indication |
Milestone Payment: Licensed Compound: Twenty-Five Million Dollars ($25,000,000) |
Milestone Payment: AbbVie Compound: Twelve Million Five Hundred Thousand Dollars ($12,500,000) |
Table 6.2.3 – First Other Indication |
Milestone Event: Initiation of the first Phase 2 Clinical Study of a Licensed Product for the first Other Indication |
Milestone Payment: Licensed Compound: Ten Million Dollars ($10,000,000) |
Milestone Payment: AbbVie Compound: Five Million Dollars ($5,000,000) |
Milestone Event: Initiation of the first Phase 3 Clinical Study of a Licensed Product for the first Other Indication |
Milestone Payment: Licensed Compound: Twenty-Five Million Dollars ($25,000,000) |
Milestone Payment: AbbVie Compound: Twelve Million Five Hundred Thousand Dollars ($12,500,000) |
Milestone Event: First Commercial Sale in the U.S. of a Licensed Product for the first Other Indication |
Milestone Payment: Licensed Compound: One Hundred Twenty-Five Million Dollars ($125,000,000) |
Milestone Payment: AbbVie Compound: Fifty Million Dollars ($50,000,000) |
Milestone Event: First Commercial Sale in the EU of a Licensed Product for the first Other Indication |
Milestone Payment: Licensed Compound: Sixty-Five Million Dollars ($65,000,000) |
Milestone Payment: AbbVie Compound: Twenty-Five Million Dollars ($25,000,000) |
Milestone Event: First Commercial Sale in Japan of a Licensed Product for the first Other Indication |
Milestone Payment: Licensed Compound: Ten Million Dollars ($10,000,000) |
Milestone Payment: AbbVie Compound: Five Million Dollars ($5,000,000) |
{Remainder of this page intentionally left blank – followed by Table 6.24} |
Table 6.2.4 – Second Other Indication |
Milestone Event: Initiation of the first Phase 2 Clinical Study of a Licensed Product for the second Other Indication |
Milestone Payment: Licensed Compound: Five Million Dollars ($5,000,000) |
Milestone Payment: AbbVie Compound: Two Million Five Hundred Thousand Dollars ($2,500,000) |
Milestone Event: Initiation of the first Phase 3 Clinical Study of a Licensed Product for the second Other Indication |
Milestone Payment: Licensed Compound: Twelve Million Five Hundred Thousand Dollars ($12,500,000) |
Milestone Payment: AbbVie Compound: Six Million Three Hundred Thousand Dollars ($6,300,000) |
Milestone Event: First Commercial Sale in the U.S. of a Licensed Product for the second Other Indication |
Milestone Payment: Licensed Compound: Sixty-Two Million Five Hundred Thousand Dollars ($62,500,000) |
Milestone Payment: AbbVie Compound: Twenty-Five Million Dollars ($25,000,000) |
Milestone Event: First Commercial Sale in the EU of a Licensed Product for the second Other Indication |
Milestone Payment: Licensed Compound: Thirty-Two Million Five Hundred Thousand Dollars ($32,500,000) |
Milestone Payment: AbbVie Compound: Twelve Million Five Hundred Thousand Dollars ($12,500,000) |
Milestone Event: First Commercial Sale in Japan of a Licensed Product for the second Other Indication |
Milestone Payment: Licensed Compound: Five Million Dollars ($5,000,000) |
Milestone Payment: AbbVie Compound: Two Million Five Hundred Thousand Dollars ($2,500,000) |
(b) Skipped Milestones. In the event that a milestone event for Initiation of a first Clinical Study of a Licensed Product for a given Indication set forth in Tables 6.2.1, 6.2.2, 6.2.3 or 6.2.4 has not been achieved at the time of achievement of a milestone event for Initiation of a first Clinical Study of a Licensed ... |
(c) Milestone Payment Conditions. |
(i) The milestone payment set forth in Table 6.2.1 shall be payable once per Exclusively Licensed DUB at the time the first Phase 1 Study in respect of such Exclusively Licensed DUB is Initiated. |
(ii) Each of the milestone payments set forth in Tables 6.2.2, 6.2.3 and 6.2.4 shall be payable once per Exclusively Licensed DUB in respect of the first Licensed Product directed to such Exclusively Licensed DUB to achieve the applicable milestone event, regardless of the number of Licensed Products directed to such E... |
(iii) In the event that the first Licensed Product directed to a given Exclusively Licensed DUB to achieve the applicable milestone event is directed to more than one Exclusively Licensed DUB, the applicable milestone payment set forth in Tables 6.2.1, 6.2.2, 6.2.3 and 6.2.4 shall only be payable in respect of one Excl... |
(iv) The milestone payments set forth in Tables 6.2.3 and 6.2.4 shall not be payable in respect of more than two (2) Other Indications per Exclusively Licensed DUB if the first Licensed Product directed to such Exclusively Licensed DUB to achieve the milestone events in Table 6.2.2 is for the Alzheimer's Indication, an... |
(v) Different stages or severity of an Indication shall not be separate Indications for the purposes of this Agreement. For example, in the event that a Licensed Product achieves the milestone events in Tables 6.2.2, 6.2.3 or 6.2.4 for patients with mild Alzheimer's or early on-set Alzheimer's in the Alzheimer's Indica... |
(vi) If a Licensed Product containing or comprised of an AbbVie Compound (an "AC Licensed Product") is the first Licensed Product directed to an Exclusively Licensed DUB to achieve any of the milestone events in Tables 6.2.2 6.2.3 and/or 6.2.4, and if a Licensed Product containing or comprised of a Licensed Compound di... |
6.3 Royalty Payments to Mission. |
(a) General. Subject to the other provisions of this Section 6.3, AbbVie shall pay to Mission royalties based on the Net Sales of each Licensed Product during the applicable Royalty Term for such Licensed Product. The royalty payable with respect to each particular Licensed Product shall be based on the level of Net Sa... |
(b) Royalty on Licensed Products Containing an AbbVie Compound. For each Licensed Product that contains or is comprised of an AbbVie Compound, AbbVie shall pay to Mission a royalty on Net Sales of such Licensed Product sold by AbbVie or its Affiliates or Sublicensees, on a Licensed Product-by-Licensed Product basis, ba... |
Table 6.3(b) |
Annual Net Sales (Determined Separately for Each Licensed Product Containing an AbbVie Compound): For that portion of annual worldwide Net Sales less than One Billion Dollars ($1,000,000,000) |
Royalty Rate for each Licensed Product Containing an AbbVie Compound: Three Percent (3%) |
Annual Net Sales (Determined Separately for Each Licensed Product Containing an AbbVie Compound): For that portion of annual worldwide Net Sales equal to or greater than One Billion Dollars ($1,000,000,000) but less than Three Billion Dollars ($3,000,000,000) |
Royalty Rate for each Licensed Product Containing an AbbVie Compound: Four Percent (4%) |
Annual Net Sales (Determined Separately for Each Licensed Product Containing an AbbVie Compound): For that portion of annual worldwide Net Sales equal to or greater than Three Billion Dollars ($3,000,000,000) but less than Five Billion Dollars ($5,000,000,000) |
Royalty Rate for each Licensed Product Containing an AbbVie Compound: Five Percent (5%) |
Annual Net Sales (Determined Separately for Each Licensed Product Containing an AbbVie Compound): For that portion of annual worldwide Net Sales equal to or greater than Five Billion Dollars ($5,000,000,000) |
Royalty Rate for each Licensed Product Containing an AbbVie Compound: Six Percent (6%) |
(c) Royalty on Licensed Products Containing a Licensed Compound. For each Licensed Product that contains or is comprised of a Licensed Compound, AbbVie shall pay to Mission a royalty on Net Sales of such Licensed Product sold by AbbVie or its Affiliates or Sublicensees, on a Licensed Product-by-Licensed Product basis, ... |
Table 6.3(c) |
Annual Net Sales (Determined Separately for Each Licensed Product Containing a Licensed Compound): For that portion of annual worldwide Net Sales less than One Billion Dollars ($1,000,000,000) |
Royalty Rate for each Licensed Product Containing a Licensed Compound: Seven Percent (7%) |
Annual Net Sales (Determined Separately for Each Licensed Product Containing a Licensed Compound): For that portion of annual worldwide Net Sales equal to or greater than One Billion Dollars ($1,000,000,000) but less than Three Billion Dollars ($3,000,000,000) |
Royalty Rate for each Licensed Product Containing a Licensed Compound: Eight Percent (8%) |
Annual Net Sales (Determined Separately for Each Licensed Product Containing a Licensed Compound): For that portion of annual worldwide Net Sales equal to or greater than Three Billion Dollars ($3,000,000,000) but less than Five Billion Dollars ($5,000,000,000) |
Royalty Rate for each Licensed Product Containing a Licensed Compound: Nine Percent (9%) |
Annual Net Sales (Determined Separately for Each Licensed Product Containing a Licensed Compound): For that portion of annual worldwide Net Sales equal to or greater than Five Billion Dollars ($5,000,000,000) |
Royalty Rate for each Licensed Product Containing a Licensed Compound: Ten Percent (10%) |
(d) Royalty Term. Royalties payable by AbbVie to Mission under this Section 6.3 shall be paid on a Licensed Product-by-Licensed Product and country-by-country basis during the Royalty Term. AbbVie shall have no obligation to pay any royalty with respect to Net Sales of a particular Licensed Product in a particular coun... |
(e) Third Party Payments. In the event that (i) AbbVie determines, acting reasonably, following consultation with Mission and taking into consideration Mission's reasonable suggestions, that any Third Party Patent license that covers the composition of matter as such or use of a Collaboration Compound in the relevant I... |
(f) Generic Products. If, during the Royalty Term with respect to a Licensed Product that contains a Licensed Compound and with respect to a particular country, one or more Generic Products of such Licensed Product are sold in such country, then during each Calendar Quarter in which there is Loss of Market Share with r... |
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