AMENDMENT NO. 1 TO THE LICENCE AGREEMENT (MACULIA)
PORTIONS OF THIS EXHIBIT IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Ref. SU:
Ref. SATT LUTECH: LIC3-2015-0012-AV01 (ST00025)
AMENDMENT NO. 1 TO THE LICENCE AGREEMENT
(MACULIA)
BETWEEN:
· BIOPHYTIS, a public limited company with a share capital of 2,692,682 euro, having its registered office at 00 Xxxxxx xx x’Xxxxx - 00000 Xxxxx, registered with the Paris Trade and Companies Register, under number B 492 002 225, represented by Xxxxxxxxx XXXXXXX, its Managing Director, duly authorised for this purpose,
Hereinafter referred to as “BIOPHYTIS”,
ON THE ONE HAND,
AND
· SORBONNE UNIVERSITE, a public scientific, cultural and professional institution, having its registered office at 00 xxx xx x’Xxxxx xx xxxxxxxx, 00000 PARIS, whose SIRET number is 130 023 385 00011, represented by its President, Xx Xxxx XXXXXXX, duly authorised for this purpose,
Hereinafter referred to as “SORBONNE UNIVERSITE” or “SU”,
CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE (CNRS, National Centre for Scientific Research), a public scientific and technological institution, having its registered office at 0, xxx Xxxxxx-Xxxx - 00000 Xxxxx cedex 16 - France, whose SIRET number is 197 517 220 00012, represented by its Chairman, Xx Xxxxxxx Xxxxx, duly authorised for this purpose,
Hereinafter referred to as “CNRS”,
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM, French National Institute of Health and Medical Research), a public scientific and technological institution, having its registered office at 000, Xxx xx Xxxxxxx - 00000 Xxxxx Cedex 13 whose SIRET number is 180 0360 48 000 15, represented by its Managing Director, Xx Xxxxxx XXXXX, duly authorised for this purpose,
Hereinafter referred to as “INSERM”,
CNRS and INSERM having given SU signature mandate for the purposes of this amendment 1,
SU, CNRS and INSERM being hereinafter referred to collectively as the “ESTABLISHEMENTS”,
ON THE OTHER HAND,
AND IN THE PRESENCE OF:
· SATT Paris - Ile de France - Compiègne - Oise, whose trade name is “SATT LUTECH”, a simplified joint stock company, having its registered office at 4 - 4bis xxx xx Xxxxxxxxx- 00000 Xxxxx, registered with the Paris Trade and Companies Register under number B 000 000 000, represented by its Chairman, Xx Xxxxxxx XXXXXX, duly authorised for this purpose,
Hereinafter referred to as “SATT LUTECH”,
Acting in its capacity as representative of the ESTABLISHMENTS for the negotiation and monitoring of the performance of this amendment 1, the rights and obligations vested in SATT LUTECH in application of this amendment which may at any time be transferred to the ESTABLISHMENTS or to any third party appointed by the ESTABLISHMENTS as agent instead of SATT LUTECH, without BIOPHYTIS being able to object thereto,
The ESTABLISHMENTS and BIOPHYTIS being hereinafter jointly referred to as the “PARTIES” and individually as the “PARTY”.
SATT LUTECH, the ESTABLISHMENTS and BIOPHYTIS being hereinafter jointly referred to as “SIGNATORIES” and individually as “SIGNATORY”.
WHEREAS:
Pierre et Xxxxx Xxxxx Université (UPMC), CNRS, INSERM and BIOPHYTIS, in the presence of SATT LUTECH, entered into an effective operating agreement on 28 May 2015 for the operation of a patent family of which the PARTIES are co-owners (the “Licence Agreement”).
It being recalled that pursuant to Decree No. 2017-596 of 21 April 2017 establishing the University called “Sorbonne Université” bringing together the universities of Paris-IV (Université Paris-Sorbonne) and Paris-VI (Université Pierre et Xxxxx Xxxxx - UPMC), Sorbonne Université replaced the two pre-existing universities from 1st January 2018 and took over, consequently, all of the rights and obligations of Paris-IV and Paris-VI, without it being necessary to sign an amendment to the aforementioned agreements.
The SIGNATORIES wish to enter into an amendment to the Licence Agreement (“Amendment No. 1”) in order to include a new patent (number 5 as specified in the appendix) in addition to the patent families licensed to BIOPHYTIS pursuant to the Licence Agreement, and also incorporate a definition of “reasonable business efforts”.
NOW THEREFORE, IT HAS BEEN AGREED AS FOLLOWS:
ARTICLE 1: MODIFICATION OF THE LICENCE AGREEMENT
1.1 A new Article 1.7bis is added in “Article 1 - DEFINITIONS” as follows:
“1.7bis REASONABLE BUSINESS EFFORTS means the level of effort and resources comparable to the standard practised by companies of the same size as BIOPHYTIS for the development and marketing of products similar to the PRODUCTS, a similar stage of development or marketing, taking into account in particular the scientific, technical, clinical, regulatory, normative, manufacturing, safety or performance constraints of the product concerned, the level of competition of the relevant market in general or, for a given application or indication, changes in the strategy, particularly clinical or regulatory, justified by the return of a regulatory authority, likely to affect the development or marketing of the PRODUCT or by compliance with the standards of the relevant industry in the PRODUCTS, etc. (ex. certification, certification, etc.), likely to affect the development or marketing of the PRODUCT or significant changes in the conditions of the markets envisaged, likely to affect the potential of the PRODUCT.”
1.2 Article 4.3 is amended and replaced as follows:
“4.3 BIOPHYTIS shall promptly inform SATT LUTECH, acting on behalf of the ESTABLISHMENTS, of any decision taken by BIOPHYTIS itself or any of the LICENSEES, not to continue the development and/or launch on the market of any PRODUCT in any country of the TERRITORY or the operation of all or part of the PATENTS. Where applicable, the ESTABLISHMENTS or SATT LUTECH acting on behalf of the latter shall have the right to withdraw from BIOPHYTIS the exclusivity granted in the country/countries in question or with regard to the rights not operated.
The ESTABLISHMENTS, or the LUTECH SATT acting on behalf of the latter, may withdraw from BIOPHYTIS the exclusivity granted pursuant to Article 2.1 above, if for two (2) consecutive years and with regard to the projections provided pursuant to Article 4.2 above, BIOPHYTIS has not put in place any means necessary for the development and marketing, directly or indirectly, of PRODUCTS.
Finally, in the event that the fees received (excluding guaranteed minimum) from BIOPHYTIS pursuant to the LICENCE AGREEMENT, on NET SALES and INDIRECT INCOME, represent an annual total of less than or equal to [****] euro excluding taxes (€[****] excluding tax), for a period of two (2) consecutive accounting years, SATT LUTECH, acting on behalf of the ESTABLISHMENTS, may notify BIOPHYTIS by registered letter with acknowledgement of receipt of the immediate and automatic conversion of the exclusive rights object of the LICENCE AGREEMENT into non-exclusive rights. It is however agreed between the PARTIES that in the event referred to in this paragraph, the conversion of the exclusive rights granted into non-exclusive rights shall be suspended provided that BIOPHYTIS demonstrates that it has provided over the period in question REASONABLE BUSINESS EFFORTS and that it pays SATTLUTECH PRODUCT-per-PRODUCT (i.e. MEDICATION PRODUCTS on the one hand and NUTRACETICAL PRODUCTS on the other hand), a lump sum equal to the difference between the threshold of [****] euro excluding taxes (€[****] excluding tax) due annually as indicated above and the fees already paid by BIOPHYTIS to SATT LUTECH, acting on behalf of the ESTABLISHMENTS, pursuant to Article 5.2 of the AGREEMENT and for the period in question. By
express agreement between the PARTIES, this paragraph may be implemented at any time during the term of the LICENCE AGREEMENT, from the expiry of a period of six (6) months following the issuance of a first Marketing Authorisation (MA) (or any other equivalent authorisation issued outside Europe by any health authority before any MA) in respect of any PRODUCT, and in any event no later than the 2026 financial year.”
1.3 Appendix 1 to the Licence Agreement is deleted and replaced by Appendix 1a annexed to this Amendment No. 1 which includes the new patent.
ARTICLE 2: INTANGIBILITY OF UNMODIFIED CLAUSES
All other provisions of the Licence Agreement, not amended by Amendment No. 1, shall remain in full force and effect.
ARTICLE 3: EFFECTIVE DATE
As from its date of signature by the last of the SIGNATORIES, this Amendment No. 1 is deemed to have entered into force retroactively to the filing date of the patent application added by this Amendment No. 1, namely 26 December 2019.
ARTICLE 4: ELECTRONIC SIGNATURE
The Parties agree that the execution of this Amendment No. 1 by the renowned electronic signature service Yousign shall have the same force and effect as the exchange of original signatures, and that in any proceeding arising out of or in connection with this Amendment No. 1, each Party hereby waives any right to raise a defence or waiver based on the signature of this Amendment No. 1 by means of such electronic signature service or digital backup or retention of this Amendment No. 1.
IN WITNESS WHEREOF, the SIGNATORIES, by their respective duly authorised representatives on the date indicated below, have signed this Amendment No. 1 and each shall hold a true electronic copy, a version of which may be printed for registration with the National Patent Register.
Done on 17/12/2020 on behalf of BIOPHYTIS
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/s/ Xxxxxxxxx Xxxxxxx |
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Signed by Xxxxxxxxx XXXXXXX, Managing Director
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Signed and certified by yousign |
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Done on 17/12/2020 on behalf of Sorbonne Université
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/s/ Xxxxx Xxxxxx |
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Signed by Xxxxx XXXXXX, Director of Development and Research - FSI acting by delegation of J. CHAMBAZ, President
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Signed and certified by yousign |
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Done on 17/12/2020 on behalf of SATT LUTECH
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/s/ Xxxxxxx Xxxxxx |
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Signed by Xxxxxxx XXXXXX, Chairman
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Signed and certified by yousign |
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Appendix 1a - List of Patents
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