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Initiation of a Phase IIa Study $10,000,000 $10,000,000 |
Initiation of the first Phase IIb Study $15,000,000 $12,500,000 |
Initiation of a Phase III Study $25,000,000 $20,000,000 |
For a second Indication |
Initiation of the first Phase IIb Study $15,000,000 $12,500,000 |
Initiation of a Phase III Study $25,000,000 $20,000,000 |
For a third Indication |
Initiation of the first Phase IIb Study $15,000,000 $12,500,000 |
Initiation of a Phase III Study $25,000,000 $20,000,000 |
Regulatory Milestone Payments |
Milestone Event D3 Receptor Product Vraylar Indication Non-Vraylar Indication |
Acceptance of the NDA in the United States for a first Indication $20,000,000 $25,000,000 $12,500,000 |
Regulatory Approval in the United States for a second Indication $17,500,000 $22,500,000 $10,000,000 |
Regulatory Approval in the United States for a third Indication $8,750,000 $12,500,000 $5,500,000 |
First Commercial Sale in the United States $35,000,000 $45,000,000 $22,000,000 |
First Commercial Sale in Japan $5,000,000 $7,500,000 $2,500,000 |
Total Potential Development and Regulatory Milestone Payments $216,250,000 $220,000,000 $160,000,000 |
Each milestone payment in this Section 6.2 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. With respect to the regulatory milestones for th... |
6.3 Sales-Based Milestones. |
6.3.1. In partial consideration of the license rights granted by Richter to AbbVie hereunder, subject to Sections 6.3.2, in the event that the Net Sales of a particular Licensed Product made by AbbVie or any of its Affiliates or Sublicensees in the AbbVie Territory in a given consecutive twelve (12)-month period exceed... |
Threshold Annual Net Sales Levels Payment Amount |
$500,000,000 $25,000,000 |
$1,000,000,000 $25,000,000 |
6.3.2. Notwithstanding anything contained in Section 6.3.1, (a) the Annual Net Sales Milestone Threshold set forth in the first row of the Annual Net Sales-Based Milestone Table only applies with respect to Net Sales of a particular Licensed Product made by AbbVie or any of its Affiliates or Sublicensees in the AbbVie ... |
6.3.3. Notwithstanding anything contained in Section 6.3.1, and subject to Section 6.3.2, each milestone payment in this Section 6.3.3 shall be payable with respect to each Licensed Product only upon the first achievement of such milestone in a twelve (12)-month period, and no amounts shall be due for subsequent or rep... |
6.4 Royalties. |
6.4.1. Royalty Rates. As further consideration for the rights granted to AbbVie hereunder, commencing upon the First Commercial Sale of a Licensed Product in the AbbVie Territory, on a Licensed Product-by-Licensed Product basis, AbbVie shall pay to Richter a royalty on Net Sales of each Licensed Product in the AbbVie T... |
Net Sales in the AbbVie Territory of each D3 Receptor Product in a Calendar Year Royalty Rate |
For that portion of aggregate Net Sales of each D3 Receptor Product in the AbbVie Territory during a Calendar Year less than or equal to Five Hundred Million Dollars ($500,000,000) 14% |
For that portion of aggregate Net Sales of each D3 Receptor Product in the AbbVie Territory during a Calendar Year greater than Five Hundred Million Dollars ($500,000,000) 16% |
Net Sales in the AbbVie Territory of each Pro-metabolite Product in a Calendar Year Royalty Rate |
For that portion of aggregate Net Sales of each Pro-metabolite Product in the AbbVie Territory during a Calendar Year less than or equal to Five Hundred Million Dollars ($500,000,000) 16% |
For that portion of aggregate Net Sales of each Pro-metabolite Product in the AbbVie Territory during a Calendar Year greater than Five Hundred Million Dollars ($500,000,000) 18% |
With respect to each Licensed Product in each country or other jurisdiction in the AbbVie 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 ... |
6.4.2. Reductions. Notwithstanding the foregoing: |
(a) in the event that one or more Generic Products are being sold in any country or other jurisdiction in the AbbVie Territory and such Generic Products collectively captures twenty percent (20%) or more of the relevant market share in volume of Licensed Product sold in any particular country or other jurisdiction in t... |
(b) in the event that AbbVie enters into an agreement with a Third Party in order to obtain a Necessary Third Party License in a particular country or other jurisdiction pursuant to Section 5.9.1, or is subject to a court decision which finds that AbbVie infringes such Patent or intellectual property right, AbbVie shal... |
(c) in the event that a court or a governmental agency of competent jurisdiction requires AbbVie or any of its Affiliates or Sublicensees to grant a compulsory license to a Third Party permitting such Third Party to make and sell a Licensed Product in a country or other jurisdiction in the AbbVie Territory, then, for t... |
(d) in the event that, and in such case from and after the date on which, a Licensed Product is Exploited in a country or other jurisdiction and (i) does not retain or otherwise maintain Regulatory Exclusivity in such country or other jurisdiction, or (ii) is not covered by one or more Valid Claims of a Richter Patent ... |
(e) AbbVie shall have the right to offset costs against payments to Richter in accordance with Section 7.4 and Section 7.5.5 and agrees that the aggregate of such offsets shall not exceed fifty percent (50%) with respect to claims, suits and proceedings in the AbbVie Territory. |
6.4.3. Mechanics of Adjustments. Any adjustments pursuant to Section 6.4.2 shall apply only to the relevant Licensed Product in the relevant country and, with respect to royalties under Section 6.4.1, shall be allocated pro rata across each of the royalty tiers in the relevant Calendar Quarter. |
6.5 Royalty Payments and Reports. |
(a) Within thirty (30) days after the end of each Calendar Quarter after the First Commercial Sale in the AbbVie Territory, AbbVie shall deliver to Richter a report (a "Quarterly Royalty Report") setting forth (i) the Net Sales on a Licensed Product-by-Licensed Product and country-by-country basis for such Calendar Qua... |
(b) After receipt of the Quarterly Royalty Report, Richter shall invoice AbbVie for the amount of royalties due from AbbVie in accordance with the Quarterly Royalty Report and AbbVie shall pay such royalties in accordance with Section 6.6 within the later of sixty (60) days after the end of the applicable Calendar Quar... |
6.6 Mode of Payment; Offsets. All payments to either Party under this Agreement shall be made by deposit of Dollars in the requisite amount to such bank account as the receiving Party may from time to time designate by notice to the paying Party. For the purpose of calculating any sums due under, or otherwise reimbursa... |
6.7 Accounting Procedures. For purposes of determining Development Costs, any expense allocated by either Party to a particular expense category of Development Costs shall not also be allocated to another category under Development Costs. Each Party shall determine Development Costs using its standard accounting proced... |
6.8 Withholding Taxes. Where any sum due to be paid to either Party hereunder is subject to any withholding or similar tax, the Parties shall use their commercially reasonable efforts to do all such acts and things and to sign all such documents as will enable them to take advantage of any applicable double taxation ag... |
6.9 Indirect Taxes. All payments are exclusive of value added taxes, sales taxes, consumption taxes and other similar taxes (the "Indirect Taxes"). If any Indirect Taxes are chargeable in respect of any payments, the paying Party shall pay such Indirect Taxes at the applicable rate in respect of such payments following... |
6.10 Interest on Late Payments. If any payment due to either Party under this Agreement is not paid when due, then such paying Party shall pay interest thereon (before and after any judgment) at an annual rate (but with interest accruing on a daily basis) of one hundred (100) basis points above SOFR, such interest to r... |
6.11 Financial Records. Each Party shall, and shall cause its Affiliates to, keep complete and accurate books and records pertaining to reimbursable Development Costs, Net Sales of Licensed Products, as applicable, and Development of the Licensed Compounds or Licensed Products, including books and records of actual exp... |
6.12 Audit. At the request of the other Party, each Party shall, and shall cause its Affiliates to, permit an independent public accounting firm of internationally recognized standing designated by the other Party and reasonably acceptable to the audited Party, at reasonable times during normal business hours and upon ... |
[SIGNATURE PAGE FOLLOWS.] |
This Agreement is executed by the authorized representatives of the Parties as of the Execution Date. |
GEDEON RICHTER PLC. ABBVIE GLOBAL ENTERPRISES LTD. |
By: By: |
Name: Gábor Orbán Name: Jonathan C. Clipper |
Title: CEO Title: Director |
For purposes of Section 5.10 only: |
GEDEON RICHTER USA, INC. ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED |
By: By: |
Name: Warren Czerniak Name: Francis Bates |
Title: President Title: Director |
This Agreement is executed by the authorized representatives of the Parties as of the Execution Date. |
GEDEON RICHTER PLC. ABBVIE GLOBAL ENTERPRISES LTD. |
By: By: |
Name: Gábor Orbán Name: Jonathan C. Clipper |
Title: CEO Title: Director |
For purposes of Section 5.10 only: |
GEDEON RICHTER USA, INC. ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED |
By: By: |
Name: Warren Czerniak Name: Francis Bates |
Title: President Title: Director |
Schedule 1.54 |
Corporate Names |
(a) In case of Richter: |
• full corporate name in English: Chemical Works of Gedeon Richter Plc. |
• abbreviated corporate name in English: Gedeon Richter Plc. |
• full corporate name in Hungarian: Richter Gedeon Vegyészeti Gyár Nyilvánosan Működő Rt. |
• abbreviated corporate name in Hungarian: Richter Gedeon Nyrt. |
99450416_50 |
Schedule 1.59 |
D3 Receptor Discovery Program Plan |
Program Overview and Objectives |
There is a growing body of evidence, including clinical observations with Vraylar® that suggest the dopamine D3 receptor (D3R) plays a critical role in several brain disorders. To date, however, there has been a lack of highly selective D3R compounds that can be used to explore the significance of D3R signaling and the... |
The aim of this program is to identify and develop CNS-penetrant dopamine D3R selective compounds that can be used to clinically test the role of D3R in neuropsychiatric diseases. Using novel medicinal chemistry approaches, i.e., computational docking and free energy perturbation analysis as well as the crystal structu... |
Status |
The initial chemical strategy for this program relied on the literature of D3 receptor ligands, experience from previous in-house D3 receptor programs and a pharmacophore model. Approximately 400 compounds (listed in Schedule 1.56) have thus far been synthesized based on this 'modular' approach (i.e., combination of he... |
Further optimization of 70022302 is focused on selection of analogues with improved brain to plasma (B/P) ratio while maintaining or exceeding in vitro hD3R binding affinity, functional potency and selectivity vs hD2R and other targets. Compound 70024303 emerged as one the promising compounds in the spiro-indolinone se... |
In addition to these activities, efforts to identify D3R partial agonists have progressed based on the use of dichlorophenylpiperazine and other head groups that appear to have partial agonistic attributes. The screening of novel head groups suitable for further derivatization towards the synthesis of partial agonists ... |
The Discovery Program Plan to identify D3 Receptor Compounds comprises the following key activities: 1. Compound screening and evaluation 2. Preclinical characterization of compounds 3. Selection and characterization of Lead Compounds and Backup compounds for candidate nomination 4. IND enabling studies |
The studies conducted to support this D3 Receptor Discovery Program Plan will be conducted, with AbbVie's prior written consent (not to be unreasonably withheld, delayed or conditioned), at mutually-agreed-upon vendors, service provides, CROs or CMOs. Gedeon Richter will be responsible for managing day-to-day project m... |
Screening & Identification |
Gedeon Richter Activities and Deliverables |
• Screening to identify hits • Competitive in vitro radioligand based receptor binding assays to identify compounds that bind to the human dopamine D3R, and determine selectivity vs hD2L receptor (both receptors expressed in CHO-K1 cells) |
• In silico modeling of D2R/D3R occupancy to identify compounds with: • Docking models on most up-to-date crystal structures combined with pharmacophore fitting screen. Artificial intelligence-based design platform combined with Gedeon Richter's prior experience with the target. • In vitro screen of compounds for each ... |
• In vitro characterization in target primary cells: Intracellular Ca2+ signal detection in cultured neurons derived from induced pluripotent stem cells (iPSC-Ns) (as needed) |
The overall goal of the above activities is to identify and prioritize D3R Modulators as defined in the Agreement. |
Preclinical Characterization of D3R Modulators |
Gedeon Richter Activities and Deliverables |
• Compound evaluation in rodent model • BBB penetration o Deliverable: Determine the brain/plasma ratio of drug after various dosing regimens o Methods: ■ Detailed pharmacokinetic (PK) characterization of the compounds is performed in rats and/or mice ■ Single dose of the compound is administered parenterally and orall... |
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