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Amendment 2 to the License Agreement entered into by AnalytiCon Discovery GmbH and Pharvaris NV on 31 st March 2016, This Amendment 2 is made between Pharvaris Netherlands BV Emmy Noetherweg 2, 2333 BK Leiden, The Nether

Key Takeaway: Pharvaris NV and BRAIN Biotech have signed Amendment 2 to a License Agreement originally dated March 31, 2016. This amendment clarifies terms regarding the payment obligations connected to Royalty-Bearing Products, including several specific compounds like deucrictibant (PHVS121). Additionally, the agreement involves the transfer of rights related to revenue from Pharvaris to Royalty Pharma Investments. The amendment is set to take effect upon execution of a related Consent Letter.

Market Sentiment Analysis

POSITIVE FACTORS

  • The amendment clarifies payment obligations, reducing ambiguity.
  • Royalty-Bearing Products include specific compounds with growth potential.
  • Collaboration between Pharvaris and BRAIN Biotech indicates robust strategic alignment.

Full Press Release Details

AnalytiCon Discovery GmbH and Pharvaris NV on 31st March 2016,
This Amendment 2 is made between
Pharvaris Netherlands BV
Emmy Noetherweg 2, 2333 BK Leiden, The Netherlands
Darmst dter Str. 34 - 36, 64673 Darmstadt, Germany
BRAIN Biotech and Pharvaris in the following also referred to individually as Party
or collectively as Parties
This Amendment 2 to License Agreement ( Amendment 2 ) is dated as of September 20, 2024 by and between Pharvaris Netherlands BV, a company with limited liability incorporated in the Netherlands ( Pharvaris ), and BRAIN Biotech AG, a stock corporation incorporated in Germany ( BRAIN Biotech ). Capitalized terms used and not defined in this Amendment 2 have the meanings assigned to them in the License Agreement.
WHEREAS, Pharvaris NV (FKA Pharvaris BV) and AnalytiCon Discovery GmbH ( AnalytiCon ) have entered into that certain License Agreement, dated as of March 31, 2016, as assumed by Pharvaris which replaced Pharvaris NV by way of an Assumption of Contract dated as of January 21/23, 2020 and as amended by that certain Amendment 1, dated as of January 9, 2021 ( Amendment 1 ; the License Agreement, as amended from time to time, the License Agreement );
WHEREAS, AnalytiCon has transferred the License Agreement to BRAIN Biotech by way of a merger between AnalytiCon and BRAIN Biotech, effective as of June 6, 2024;
WHEREAS, BRAIN Biotech has proposed to sell, transfer and assign its right, title and interest in the payments BRAIN Biotech receives from Pharvaris pursuant to Section 5.3 of the License Agreement (subject to, as the case may be, reductions pursuant to Sections 5.5, 5.6, 6.4.4, 10.3.3, and 12.2.4 of, or otherwise pursuant to and in accordance with, the License Agreement) to Royalty Pharma Investments 2019 ICAV, an Irish collective asset-management vehicle ( Royalty Pharma ) on terms and conditions customary for such a monetization transaction, including the grant for the benefit of Royalty Pharma of a security interest in the License Agreement (the RP Monetization ); and
WHEREAS, at the occasion of, but independently from, the RP Monetization, the Parties desire to amend the License Agreement to clarify certain terms related to the duration of the Pharvaris payment obligations under the License Agreement, as set forth herein.
NOW, THEREFORE, in consideration of the foregoing and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby amend the License Agreement and agree as follows:
I.After Section 1.27, the following new Section 1.27A is hereby added:
1.27A Royalty-Bearing Product(s) shall mean any Licensed Product containing a compound within the scope of the Markush general formula (I) of claim 1 of US Patent No. 10,836,748. Each of deucrictibant (PHVS121), PHVS416 and PHVS719 is a Royalty-Bearing Product.
II.In Sections 1.13, 1.17, 1.22, 5.2, 5.3, 5.6, and 6.1 the words Licensed Product(s) (or corollary phrases Licensed Product or Licensed Products as applicable) are replaced by the words Royalty-Bearing Product(s) (or corollary phrases Royalty-Bearing Product or Royalty-Bearing Products as applicable).
III.Section 1.28 is reworded as follows:
1.28 Sublicensee shall mean such a Third Party which receives a commercial sublicense from Pharvaris under the Exclusive License to develop, market and sell Licensed Products(s) on its own account (and, if applicable, which is obligated to make payments to Pharvaris on the basis of royalty payments on Net Sales of Royalty-Bearing Product(s)).
IV.Section 4.2 is reworded as follows:
The Exclusive License includes the right of Pharvaris to grant sublicenses within the scope of the Exclusive License to its Affiliates or Third Parties to develop, market and sell Licensed Product(s) on its own account (if applicable, on the basis of royalty payments by Pharvaris to AnalytiCon on Net Sales of Royalty-Bearing Product(s) by such Sublicensees as further defined in this Agreement).
V.In Section 5.4, the words Product are replaced by words Royalty-Bearing Product containing deucrictibant , and the words Backup Product are replaced by the words Royalty-Bearing Product not containing deucrictibant .
VI.In Section 5.5, the words Product are replaced by the words Royalty-Bearing Product .
VII.Section 5.7.2 is reworded as follows:
The Term of royalty payments with respect to each Royalty-Bearing Product shall be the Term with respect to such Royalty-Bearing Product.
VIII.In the first sentence of Section 10.1, the words the expiry of the last Patent of the Licensed IP (the Term ). are replaced by the following words:
(a) with respect to each Royalty-Bearing Product, the Expiration of the last Valid Claim of a Royalty-Bearing Patent that claims such Royalty-Bearing Product, on a Royalty-Bearing Product-by-Royalty-Bearing Product basis, and (b) with respect to each Licensed Product that is not a Royalty-Bearing Product, the Expiration of the last Valid Claim of a Non-Royalty-Bearing Patent that claims such Licensed Product, on a Licensed Product-by-Licensed Product basis (the Term ).
IX.At the end of Section 10.1, the following new paragraphs are added:
Valid Claim means a claim of a Patent, including as such claim may be extended, whether through a patent term extension, supplementary protection certificate or otherwise, that has not expired, lapsed, been cancelled, abandoned or waived, or been dedicated to the public, disclaimed, rejected or held unenforceable, invalid, revoked or cancelled by a court or administrative agency of competent jurisdiction in an order or decision from which no appeal has been or can be taken, including through opposition, re-examination, reissue, disclaimer, inter partes review, inter partes review post grant procedures or similar
proceedings, and that has not otherwise become, or turned out to be, ineffective in whatever form and on whatever legal grounds. Expiration means any of the cases of ineffectiveness addressed in the preceding sentence.
Royalty-Bearing Patent means (a) US Patent No. 10,836,748 and (b) any patent or patent application (including any international patent or patent application) that shares a common priority with US Patent No. 10,836,748. The Patents listed on Schedule A are the Royalty-Bearing Patents that exist as of the date of this Amendment 2.
Non-Royalty-Bearing Patent means any Patent owned or controlled by Pharvaris that claims a Licensed Product that is not a Royalty-Bearing Product.
X.The schedule attached hereto as Schedule A is hereby appended to, and incorporated into, the License Agreement as a new Schedule A.
XI.The License Agreement shall stay in force to the extent not explicitly amended by this Amendment 2.
XII.This Amendment 2 shall only come into effect (and, subject to the terms and conditions of the License Agreement, remain in effect) upon the condition that the Consent Letter, as specified in Exhibit D-2 to the Royalty Purchase Agreement between Brain Biotech and Royalty Pharma, is duly executed and becomes effective among Brain Biotech, Pharvaris, and Royalty Pharma.
Remainder of page blank; signature page follows.
IN WITNESS THEREOF, the Parties hereto have caused this Amendment 2 to be executed in duplicate by their respective duly authorized representatives.
Date / Place 9/20/2024 Date / Place 9/20/2024
BRAIN Biotech AG Pharvaris Netherlands BV, represented by its sole board member Pharvaris NV(Pharvaris)
(BRAIN Biotech) (Pharvaris)
/s/ Adriaan Moelker /s/ Berndt Modig
Adriaan Moelker Berndt Modig
Member of the Management Board Chief Executive Officer
Date / Place 9/20/2024
BRAIN Biotech AG
(BRAIN Biotech)
/s/ Michael Schneiders
Michael Schneiders
Member of the Management Board
Signature Page to Amendment 2
Country Application no. Publ. no. appl. Grant/Registration No. Publication of grant/ registration
Argentina 20180103444 AR113839 A1
Taiwan 107141872 202017916 I768156B 6/21/2022
Uruguay 37981
WIPO PCT/EP2018/082338 WO 2019/101906 A1
Australia 2018371186 2018371186 AU2018371186B 8/25/2022
Brazil BR 11 2020 010298 9 BR 11 2020 010298-9 A2
Canada 3,082,948
China 201880076162.X WO 2019/101906 A1 CN111433196B 06.06.2023
Macao J/007322 J/007322 18.10.2023 / 26.09.2023
Colombia NC2020/0006205 NC2020/0006205 CO 42230 22.02.2024 / 15.04.2024
Eurasia (EAPO) EA 202091256 EA43330 5/15/2023
Armenia AM/EA 43330 5/15/2023
Azerbaijan AZ/EA 43330 5/15/2023
Belarus BY/EA 43330 5/15/2023
Kazakhstan KG/EA 43330 5/15/2023
Kyrgyz Republic KZ/EA 43330 5/15/2023
Russian Federation RU/EA 43330 5/15/2023
Tajikistan TJ/EA 43330 5/15/2023
Country Application no. Publ. no. appl. Grant/Registration No. Publication of grant/ registration
Turkmenistan TM/EA 43330 5/15/2023
Europe (EPC) EP 18 818 992.2 3713928 EP3713928B1 1/12/2022
Albania AL/EP3713928 1/12/2022
Austria AT/EP3713928 1/12/2022
Bosnia and Herzegovina BA/EP3713928 1/12/2022
Belgium BE/EP3713928 1/12/2022
Bulgaria BG/EP3713928 1/12/2022
Switzerland CH/EP3713928 1/12/2022
Cyprus CY/EP3713928 (CY1125348T1) 1/12/2022
Czech Republic CZ/EP3713928 1/12/2022
Germany DE/EP3713928 1/12/2022
Denmark DK/EP3713928 (DK3713928T3) 1/12/2022
Estonia EE/EP3713928 1/12/2022
Spain ES/EP3713928 (ES2908409T3) 1/12/2022
Finland FI/EP3713928 1/12/2022
France FR/EP3713928 1/12/2022
United Kingdom GB/EP3713928 1/12/2022
Greece GR/EP3713928 (GR3110122) 1/12/2022
Hong Kong HK 62020021917.3 HK40031700 HK40031700 14.04.2022
Croatia HR/EP3713928 (HRP20220429) 1/12/2022
Country Application no. Publ. no. appl. Grant/Registration No. Publication of grant/ registration
Hungary HU/EP3713928 (HU/E058217) 1/12/2022
Ireland IE/EP3713928 1/12/2022
Iceland IS/EP3713928 1/12/2022
Italy IT/EP3713928 1/12/2022
Liechtenstein LI/EP3713928 1/12/2022
Lithuania LT/EP3713928 (LT3713928T) 1/12/2022
Luxembourg LU/EP3713928 1/12/2022
Latvia LV/EP3713928 1/12/2022
Morocco MA50804B1 1/12/2022
Monaco MC/EP3713928 1/12/2022
Montenegro ME/EP3713928 1/12/2022
North Macedonia MK/EP3713928 1/12/2022
Malta MT/EP3713928 1/12/2022
Netherlands NL/EP3713928 1/12/2022
Norway NO/EP3713928 1/12/2022
Poland PL/EP3713928 (PL3713928T3) 1/12/2022
Portugal PT/EP3713928 (PT3713928T) 1/12/2022
Romania RO/EP3713928 1/12/2022
Serbia RS63087B1 1/12/2022
Sweden SE/EP3713928 1/12/2022
Country Application no. Publ. no. appl. Grant/Registration No. Publication of grant/ registration
Slovenia SI/EP3713928 (SI3713928T1) 1/12/2022
Slovakia SK/EP3713928 1/12/2022
San Marino SM/EP3713928 (SMT20220154) 1/12/2022
Tunisia EP3713928 (TN/P/2022/0094) 1/12/2022
T rkiye TR/EP3713928 1/12/2022
Europe (EPC) 21 213 719.4 3998259
Indonesia P00202004204 IDP000082558 08/18/2022
Israel 274883 IL274883 10/2/2023
India 202017023470 IN419052 1/24/2023
Japan 2020-545875 JP7164619 11/1/2022
Republic of Korea 10-2020-7017972 KR10-2413321 6/22/2022
Mexico MX/a/2020/005287 MX398255 12/8/2022
Nigeria NG/PT/C/2020/4568 WO 2019/101906 A1 RP NG/PT/C/2020/4568 11/22/2022
New Zealand 764304 NZ764304 5/31/2024 / 5/24/2024
Philippines 1/2020/550683
Singapore 11202004653T SG11202004653T 8/27/2024
United States of America 16/861,131 US 2020/0255405 A1 US10,836,748B2 11/17/2020
United States of America 17/033,347 US 2021/0017158 A1 US11,261,173B2 3/1/2022
Country Application no. Publ. no. appl. Grant/Registration No. Publication of grant/ registration
United States of America 17/578,161 US 2022/0135543 A1 US11,820,756B2 11/21/2023
South Africa 2020/03039 ZA2020/03039 11/24/2021

Frequently Asked Questions

What is Amendment 2 to the License Agreement?

Amendment 2 is an update to the License Agreement between Pharvaris and BRAIN Biotech, detailing changes as of September 20, 2024.

What is a Royalty-Bearing Product?

A Royalty-Bearing Product includes any Licensed Product containing compounds under US Patent No. 10,836,748, such as deucrictibant.

What is the role of Royalty Pharma in this agreement?

Royalty Pharma Investments 2019 ICAV will receive payments from BRAIN Biotech under the License Agreement, as part of a monetization transaction.

When will Amendment 2 take effect?

Amendment 2 will take effect upon the execution of a Consent Letter among BRAIN Biotech, Pharvaris, and Royalty Pharma.

How does Amendment 2 affect payment obligations?

Amendment 2 clarifies the duration of Pharvaris' payment obligations under the License Agreement for Royalty-Bearing Products.

Last updated: Sep 20, 2024