CERTAIN INFORMATION IDENTIFIED BY BRACKETED ASTERISKS ([* * *]) HAS BEEN OMITTED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. AMENDMENT NO. I TO LICENSE AGREEMENT
Exhibit 10.8
CERTAIN INFORMATION IDENTIFIED BY BRACKETED ASTERISKS ([* * *]) HAS BEEN OMITTED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
AMENDMENT NO. I TO LICENSE AGREEMENT
THIS AMENDMENT NO I (the Amendment) is made as of August 15, 2017 (the Amendment Effective Date) by and between KUROS BIOSCIENCES AG (formerly Cytos Biotechnology, LTD), a company registered in Switzerland whose registered office is at Xxxxxxxxxxx 00, 0000 Xxxxxxxxx, Xxxxxxxxxxx (“Licensor”), and CHECKMATE PHARMACEUTICALS, INC., having its registered office at Xxx Xxxxxxxx, 00xx Xxxxx, Xxxxxxxxx, XX 00000, XXX, (“Checkmate”). Licensor and Checkmate may be referred to herein as a “Party” or, collectively, as “Parties”.
WHEREAS
| (A) | Licensor and Checkmate entered into a License Agreement dated June 17, 2015 (the Agreement). |
| (B) | Pursuant to Section 13.8 (titled “Entire Agreement of the Parties, Amendment”) of the Agreement, the Agreement may be amended only by the written agreement of the Parties. |
| (C) | Licensor and Checkmate desire to amend the Agreement to classify Qb VLP Cancer Vaccines in the Field as Licensed Compounds Series 4 and to mutually agree on the financial terms of Licensed Compounds Series 4 in accordance with the provisions of this Amendment. |
| (D) | Additional IP required to develop Qb VLP Cancer Vaccines shall be included in Schedule 1.42 and the full cost for the prosecution of these patents shall be borne by Checkmate. |
NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, Licensor and Checkmate agree as follows:
| 1. | Qb VLP Cancer Vaccines definition |
It is hereby agreed that the below Clause 1.55a will be added to Article I of the Agreement.
1.55a “Qb VLP Cancer Vaccine” means any Qb VLP, including CYT003, covalently conjugated or co-formulated with any tumor antigen and delivered by subcutaneous, intramuscular, or intradermal injection or other route of vaccination, but specifically excluding intra-tumoral adminstration.
| 2. | Modification of 1.36 Licensed Compounds |
It is hereby agreed that in Clause I .36 the text
“belonging to one of the three following series” will be replaced with “belonging to one of the four following series”
And l.36(a) will change from “Series I: CYT003 (further described in Schedule 1.18)” to “Series I: CYT003 (further described in Schedule 1.18) but excluding Licensed Compounds in Series 4 (as defined in 1.36(d))
and, in 1.36(c) “(other than those in Series I and 2)” will be replaced by “(other than those in Series 1, 2 and 4)”.
Also, the following Clause 1.36(d) will be added at the end of Clause 1.36
“(d) Series 4: any Qb VLP Cancer Vaccine
| 3. | Modification of 1.37 Licensed Compound Series |
It is hereby agreed that in Clause 1.37 the text
“referred to individually in 1.36(a), (b) and (c)”
will be replaced with
“referred to individually in 1.36(a), (b), (c) and (d)”
| 4. | Addition of Development Milestones for Licensed Compounds Series 4: |
It is hereby agreed that the following table will be added to the end of Clause 5.2.1.
| Development Milestones: Licensed Compound Series 4 (l.36(d)) | Payment (all in USD) | |
|
Dosing of the first patient in the first Phase I clinical trial |
[***] | |
|
Dosing of the first patient in the first Phase 2 clinical trial |
[***] | |
|
Dosing of the first patient in the first Phase 3 clinical trial |
[***] | |
|
Upon the first New Drug Application filing with the FDA for regulatory approval in the United States |
[***] | |
|
Upon the first MAA filing for regulatory approval in the European Union |
[***] | |
|
Upon the first MAA filing for regulatory approval in the first of: China or Japan |
[***] | |
|
Upon the first approval ofa New Drug Application in the United States |
[***] | |
|
Upon the first approval of an MAA in the European Union |
[***] | |
|
Upon the first approval of an MAA in the first of: China or Japan |
[***] | |
| 5. | Milestones for Additional Products in Licensed Compound Series 4. |
It is hereby agreed that the current Clause 5.2.2 is replaced by
“5.2.2 Each milestone payment in this Section 5.2 shall be payable only upon the first achievement of such milestone for the first Licensed Product from the same Licensed Compound Series and no amounts shall be due for subsequent or repeated achievements of such milestone in with Licensed Products from such Licensed Compound Series, except for Licensed Products in Licensed Compound Series 4. For Licensed Products in Licensed Compound Series 4 each milestone payment shall be as stated in Section 5.2.1 for the first Licensed Products in Licensed Compound Series 4, milestone payments shall be reduced by [***] for the second Licensed Products in Licensed Compound Series 4, and shall be reduced by [***] for the third Licensed Products in Licensed Compound Series 4. For subsequent Licensed Products in Licensed Compound Series 4 no milestone payments shall be payable. For purposes of clarity, each milestone payment in this Section 5.2 shall be payable only one time irrespective of the number of indications pursued for such Licensed Product in Licensed Compound Series 1, 2, and 3. For Licensed Products in Licensed Compound Series 4 each milestone payment may be payable up to 3 times with milestone payments for the second and third Licensed Products being reduced as described in this Section 5.2.2.”
| 6. | Modification of Clause 5.2.3 |
It is hereby agreed to replace the current text of clause 5.2.3 with the following:
5.2.3 Milestones payments will be made on the first achievement of each milestone listed in Section 5.2.1 for Licensed Products in Licensed Compound Series I, 2 and 3. Milestone payments will be paid on the first, second and third achievement of each milestone listed in Section 5.2.1 for Licensed Products in Licensed Compound Series 4, with milestones for the second and third achievement of said milestone being reduced as described in Section 5.2.2.”
| 7. | Royalty Payments |
The Royalty Payments for Licensed Products in Licensed Compound Series 4 shall be the same as the royalty payments for Licensed Compound Series 2 set forth in the Agreement in Section 5.3 with the exception that only the first three Licensed Products in Licensed Compound Series 4 reaching the market shall be eligible for Royalty payments. For clarity, no Royalties are due for the fourth and any subsequent Qb VLP Cancer Vaccine Licensed Product reaching the market. Therefore, it is hereby agreed that in Section 5.3.1 the table will be replaced with the table below:
| Net Sales in the Territory of all Licensed Products in a calendar year |
Licensed Compound Series 1 |
Licensed Compound Series 2 |
Licensed Compound Series 3 |
Licensed Compound Series 4 | ||||
| [***] |
[***] | [***] | [***] | [***] | ||||
|
[***] |
[***] | [***] | [***] | [***] | ||||
|
[***] |
[***] | [***] | [***] | [***] |
It is also hereby agreed to add the following to the end of Section 5.3.1:
“For Licensed Products in Licensed Compound Series 1, 2 and 3 royalties are payable on all Licensed Product Net Sales, however for Licensed Products in Licensed Compound Series 4 royalties are payable only on Net Sales of the first three Licensed Products in Licensed Compound Series 4.”
| 8. | Addition of patents to Schedule 1.42 |
It is hereby agreed to add the patents listed in Schedule I of this Amendment to Schedule 1.42 of the Agreement.
| 9. | Existing terms and conditions |
Except as otherwise expressly amended by this Amendment No. 1, the terms and conditions of the Agreement shall remain in full force and effect, and neither Party waives any right under the Agreement herein.
| 10. | Counterparts |
This Amendment may be executed in any number of counterparts, each such counterpart shall be deemed to be an original instrument. and all such counterparts together shall constitute but one agreement. Any such counterpart may contain one or more signature pages.
Remainder of page left blank intentionally
SIGNED by the Parties or their duly authorized officers on the dates set forth below, to be effective on the date set forth above.
| KUROS BIOSCIENCES AG |
CHECKMATE PHARMACEUTICALS, INC | |||||||
| Date: August 15, 2017 | Date: August 16, 2017 | |||||||
| By: | /s/ Xxxxxxxx Xxxxxx | By: | /s/ Xxxxxx X. Xxxxx | |||||
| Name: Xxxxxxxx Xxxxxx | Name: Xxxxxx X. Xxxxx | |||||||
| Title: CDO | Title: CEO | |||||||
5
Schedule 1
Remainder of page left blank intentionally
| Kuros Biosciences AGG | 14.08.2017 |
| Patent Family: | In Vivo Activation of Antigen Presenting Xxxxx for Enhancement of Immune Respond Induced by VLPs | |
| Applicant: | Kuros Biosciences AG | |
| Inventors: | Xxxxxx X. Xxxxxxxx, Xxxxxxxxx Xxxxxxx, Tazlo Stornl |
| Kuros Reference No. |
Country | Application Type |
Application Date |
Application No. |
Priority Country |
Earliest Priority Date |
Earliest Priority No. |
Additional Priorities |
Publication Date |
Publication No. |
Grant Date |
Patent No. |
Status | |||||||||||||
| P1009EPOO |
EP |
PCT Based with Priority | 16.09.2002 | 2783338.3 | US | 14.09.2001 | 60/318,967 | 27.03.2003 | 1425040 | Pending | ||||||||||||||||
| P1009JPOO |
JP |
PCT Based with Priority | 16.09.2002 | 2003-528574 | US | 14.09.2001 | 60/318,967 | 17.03.2005 | 2005-507388 | 21.08.2009 | 4360906 | Granted | ||||||||||||||
| P1009PCOO |
PC |
With Priority | 16.09.2002 | PCT/1802/04252 | US | 14.09.2001 | 60/318,967 | 27.03.2003 | W02003/024480A2 | Closed | ||||||||||||||||
| P1009US04 |
us |
Continuation | 20.12.2012 | 14/567,945 | US | 14.09.2001 | 60/318,967 | 12.11.2015 | US2015-0320855 | Pending |
| Kuros Biosciences AGG | 14.08.2017 |
| Patent Family: | Molecular Antigen Array | |
| Applicant: | Kuros Biosciences AG | |
| Inventors: | Xxxxxxxx Xxxxxx, Xxxxxx Xxxxxxxx, Xxxxx Tissct, Xxxxxxx Xxxxxx, Franziska Xxxxxxx, Xxxxx Xxxxxx, Xxxxxxxxx Plossek |
| Kuros Reference No. |
Country | Application Type |
Application Date |
Application No. |
Priority Country |
Earliest Priority Date |
Earliest Priority No. |
Additional Priorities |
Publication Date |
Publication no. |
Grant Date |
Patent No. |
Status | |||||||||||||
| P1011AU00 | AU | PCT Based with Priority | 21.01.2002 | 2002226263 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
28.06.2007 | 2002228263 | Granted | |||||||||||||||
| P1011AU01 | AU | Divisional | 21.01.2002 | 2007202761 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
06.05.2010 | 2007202761 | Granted | |||||||||||||||
| P1011BR00 | BR | PCT Based with Priority | 21.01.2002 | X00000000-5 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
Xxxxxxx | |||||||||||||||||
| X0000XX00 | XX | PCT Based with Priority | 21.01.2002 | 2,433,316 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
13.08.2013 | 2433316 | Granted | |||||||||||||||
| P1011CHEP | CH | Validated after EPC | 21.01.2002 | 2710211 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
25.07.2002 | 1370290 | 01.06.2016 | 1370290 | Granted | |||||||||||||
| P1011CN00 | CN | PCT Based with Pnortty | 21.01.2002 | 02803869.X | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
07.04.2004 | 1487840A | 21.02.2007 | ZL02803869.X | Granted | |||||||||||||
| P1011JP01 | JP | Divisional | 21.01.2002 | 2008-274671 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
18.06.2009 | 2009-132689 | 11.01.2013 | 5175160 | Granted |
| Kuros Biosciences AGG |
14.08.2017 |
| Kuros Reference No. |
Country | Application Type |
Application Date |
Application No. |
Priority Country |
Earliest Priority Date |
Earliest Priority No. |
Additional Priorities |
Publication Date |
Publication no. |
Grant Date |
Patent No. |
Status | |||||||||||||
| P1011JP03 | JP | Divisional | 21.01.2002 | 2015-094858 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
19.11.2015 | 2015-205881 | Xxxxxx | |||||||||||||||
| X0000XXXX | XX | Validated after EPC | 21.01.2002 | 2710211 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
25.07.2002 | 1370290 | 01.06.2016 | 1370290 | Granted | |||||||||||||
| X0000XX00 | PC | With Priority | 21.01.2002 | PCT/IB02/00166 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
25.07.2002 | WO2002/056905A2 | Closed | |||||||||||||||
| P1011RU01 | RU | PCT Based with Prionty | 21.01.2002 | 2003125363 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
27.03.2007 | 2295973 | Granted | |||||||||||||||
| P1011RU01 | RU | Divisional | 21.01.2002 | 2206141850 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
10.01.2012 | 2438701 | Granted | |||||||||||||||
| P1011US04 | US | With Priority | 18.01.2002 | 10/050,902 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
18.09.2003 | 2003/0175290A1 | 04.09.2007 | 7,264,810 | Granted | |||||||||||||
| P1011US09 | US | Continuation | 17.01.2017 | 151407920 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
Pend ng | |||||||||||||||||
| P1001DEEP | DE | Validated after EPC | 21.01.2002 | 2710211 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
25.07.2002 | 1370290 | 01.06.2016 | 1370290 | Granted |
| Kuros Biosciences AGG |
14.08.2017 |
| Kuros Reference No. |
Country | Application Type |
Application Date |
Application No. |
Priority Country |
Earliest Priority Date |
Earliest Priority No. |
Additional Priorities |
Publication Date |
Publication no. |
Grant Date |
Patent No. |
Status | |||||||||||||
| P1011EP00 | EP | PCT Based with Prionty | 21.01.2002 | 2710211 | US | 19.01,2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
25.07.2002 | 1370290 | 01.06.2016 | 1370290 | Granted | |||||||||||||
| X0000XX00 | EP | Divisional | 21.01.2002 | 10012605.1 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
14.09.2011 | 2364727 | Xxxxxxx | |||||||||||||||
| X0000XXXX | XX | Validated after EPC | 21.01.2002 | 2710211 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
25.07.2002 | 1370290 | 01.06.2016 | 1370290 | Granted | |||||||||||||
| P1011GBEP | GB | Validated attar EPC | 21.01.2002 | 2710211 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
26.07.2002 | 1370200 | 01.06.2016 | 1370290 | Granted | |||||||||||||
| P1010IEEP | IE | Validated attar EPC | 21.01.2002 | 2710211 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
25.07.2002 | 1370290 | 01.06.2016 | 1370290 | Granted | |||||||||||||
| P1011IN00 | IN | PCT Based with Priority | 21.01.2002 | 1120/CHENP/2003 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
07.01.2009 | 227435 | Granted | |||||||||||||||
| P1011IN01 | IN | Divisional | 21.01.2002 | 1503/CHENP/2008 | US | 19.01.2001 | 60/262.379 | 60/288.549 (04.05.2001); 60/326.998 (05.10.2001); 60/331.045 (07.11.2001); |
18.03.2011 | 246862 | Granted |
