Conditions générales de vente & de livraison de Servier (Suisse) S.A.
Entrée en vigueur : 04.09.2024
1. Principes de base
1.1. L’acceptation et l’exécution des ventes de biens et services (ci-après dénommés les « produits ») par Servier (Suisse) SA (ci-après dénommé le « vendeur ») à un client (ci-après dénommé l’« acheteur ») sont exclusivement régies par les présentes conditions générales de vente et de livraison (« CGVL »). Les conditions générales font partie intégrante du contrat de vente entre l’acheteur et le vendeur. Les conditions d’achat dérogatoires ou contraires émanant de l’acheteur ne sont pas reconnues, à moins que le vendeur n’ait donné son accord expressément et par écrit.
1.2. Nous nous réservons le droit de modifier ou de compléter à tout moment et à notre guise ces conditions générales de vente sans que cela puisse ouvrir de quelconques droits à l’acheteur. Les conditions générales de vente modifiées ou complétées s’appliquent à toutes les commandes passées par l’acheteur dès leur publication sur le site web www.servier.ch.
1.3. La version des CGVL publiée en français sur le site internet www.servier.ch fait foi.
2. Contrats, prix, commandes
2.1. Toute commande doit passer par l’adresse email suivante commande.ch@servier.com ou par EDI le cas échéant.
2.2. Un contrat est conclu lorsque la commande a été confirmée par écrit (y inclus par email) par le vendeur ou par la livraison.
2.3. Les listes de prix, devis et offres du vendeur sont données sous réserve de modifications et sans engagement, à moins que le vendeur ne les ait qualifiées de contraignantes expressément et par écrit.
2.4. Les prix et frais appliqués sont ceux en vigueur le jour de la conclusion du contrat. Les prix et frais s’entendent hors TVA.
2.5. Il est rappelé à l’acheteur qu’il est tenu de répercuter sur le débiteur de la rémunération d’éventuels avantages directs ou indirects en relation avec des produits thérapeutiques remboursés par l’assurance obligatoire en conformité avec l’article 56 de la loi fédérale sur l’assurance-maladie.
2.6 En tout état de cause, l’Utilisateur s’engage à conserver et recopier chaque mention de droit d’auteur ou de droit de propriété indiquée dans tout élément du Site qu’il utilise.
2.7 L’acheteur s’engage à céder ou revendre les produits exclusivement dans leur emballage d’origine non modifié.
3. Livraisons et facturation
3.1 Les livraisons se font à l’adresse indiquée par l’acheteur. Les frais de transport applicables sont chargés par livraison.
3.2 La facture libellée en CHF est établie lorsque la marchandise quitte les entrepôts de stockage du vendeur. Le délai de paiement est de 30 jours à compter de la date de la facture sauf dispositions particulières.
4. Retours
4.1 Les produits ne sont ni repris ni échangés.
4.2 Les retours de marchandises sont acceptés uniquement dans les cas spécifiques suivants sous condition de l’approbation écrite préalable (y inclus par email) du vendeur :
- 2.1 Si la marchandise est endommagée à la réception
- Le retour doit se faire immédiatement par le même canal que celui utilisé pour la livraison.
- Les conditions de transport GDP sont nécessaires et doivent être confirmées.
- 2.2 En cas d’erreur de livraison
- Le retour doit se faire immédiatement par le même canal que celui utilisé pour la livraison.
- Les marchandises sont remplacées par les marchandises ou quantités commandées appropriées.
- Les conditions de stockage et de transport GDP sont nécessaires et doivent être confirmées.
5. Dommages et intérêts
5.1 Le vendeur décline toute responsabilité par rapport à des dommages causés à l’acheteur à l’exception d’un dommage créé par un comportement intentionnel ou une négligence grave de sa part.
5.2 Le vendeur n’est pas responsable envers l’acheteur ou une autre personne des dommages indirects ainsi que des dommages non prévisibles au moment de la conclusion du contrat, des dommages consécutifs, des pertes de gains ou de bénéfices.
5.3 En cas de force majeure, le vendeur est exempté de ses obligations contractuelles pendant la durée de l’événement perturbateur et de ses répercussions, excluant toute responsabilité relative aux dommages résultant de retard de livraison. Sont considérées comme force majeure les catastrophes naturelles, les guerres, les grèves, les interventions de l’administration et tous les autres obstacles à la production et à la distribution qui ne sont pas imputables à Servier (Suisse) SA.
6. Prévention de la corruption
6.1.Aux fins des présentes conditions générales, les mots et expressions commençant par une majuscule ont la signification suivante :
«Agent public» désigne (a) tout dirigeant, employé, directeur, responsable, consultant, agent ou représentant, nommé ou élu, de tout ou partie d’un gouvernement (central, fédéral, d’état ou provincial), d’un ministère, d’un département, d’un organisme, d’une agence, d’un organe, de toute organisation internationale publique ou de toute entité, agence, hôpital ou entreprise ou d’une coentreprise/société de personnes (notamment un associé ou actionnaire d’une telle entreprise) détenue ou contrôlée par un État; et (b) toute personne agissant pour ou au nom de : (i) tout ou partie d’un gouvernement, ministère, organisme, département, collectivité, juridiction, agence ou organe ; ou (ii) toute organisation internationale publique ; ou (iii) tout parti politique ou responsable ou candidat à un mandat au sein d’un parti politique et, (c) toute personne ayant compétence pour prescrire, recommander, administrer ou fournir des produits pharmaceutiques, et étant employée dans des hôpitaux ou établissements publics.
«Avantage» désigne tout avantage financier ou autre, paiement, don, promesse ou cession de quelle que valeur que ce soit.
«Lois Anticorruption» désigne l’ensemble des lois, règles, réglementations et autres mesures ayant force obligatoire en matière de prévention et de répression de la corruption, du trafic d’influence, du blanchiment d’argent, de la fraude ou de pratiques similaires, en ce notamment compris, le code pénal français et la loi française relative à la transparence, à la lutte contre la corruption et à la modernisation de la vie économique (Sapin II), ainsi que, lorsqu’ils sont applicables, le «Foreign Corrupt Practices Act» (FCPA) et le UK Anti-Bribery Act (UKBA), et toute autre loi à laquelle est soumis le contrat, tels que modifiés périodiquement le cas échéant.
«Représentants» désigne l’Acheteur et ses actionnaires, dirigeants, administrateurs, employés, filiales, agents et tous sous-traitants, co-contractants ou autre(s) personne(s) agissant pour leur compte.
6.2. Les obligations stipulées dans le présente article 6 sont essentielles pour le Vendeur.
6.3. L’Acheteur déclare, garantit et s’engage dans le cadre de l’exécution du présent contrat ou de toute autre question en découlant ou s’y rapportant, qu’il se conforme aux Lois Anticorruption applicables, et notamment que (a) il ne proposera ou n’offrira aucun avantage, de quelque nature que ce soit, directement ou indirectement, à toute personne physique ou morale, publique ou privée (notamment mais non exclusivement à tout Agent du gouvernement) afin qu’elle accomplisse ou s’abstienne d’accomplir un acte en violation des Lois Anticorruption applicables ; (b) il ne sollicitera ou ne demandera aucun avantage, de quelque nature que ce soit, directement ou indirectement, afin d’accomplir ou s’abstenir d’accomplir un acte en violation des Lois Anticorruption applicables.
6.4. L’Acheteur déclare avoir connaissance du code de conduite de l’Acheteur et s’engager à le respecter.
6.5. L’Acheteur déclare et garantit qu’il a mis en place et qu’il appliquera (a) des politiques et procédures adéquates en matière d’éthique, de conduite professionnelle et plus largement de conformité aux Lois Anticorruption applicables ; (b) des formations appropriées relatives aux Lois Anticorruption applicables (c) des procédures d’évaluation de la conformité appropriées vis-à-vis des Représentants avec lesquels il entretient des relations.
6.6. L’Acheteur s’engage également à obtenir de ses Représentants des déclarations et des garanties quant à l’exactitude et à l’exhaustivité des informations obtenues de leur part pour réaliser son évaluation des risques de non-conformité.
6.7. L’Acheteur déclare, garantit et s’engage en son nom et au nom de ses Représentants à : (a) tenir des livres et registres exacts et complets et à mettre en place des contrôles internes suffisants, dont le niveau de qualité permet la vérification de ses livres et registres par un cabinet d’experts-comptables ou de comptables agréés ; (b) conserver ses livres et registres pendant au moins cinq (5) ans après l’expiration ou la résiliation du présent contrat, sous réserve des exigences de la législation applicable.
6.8. L’Acheteur s’engage à notifier immédiatement à SERVIER (i) toute violation de la présente clause et (ii) toute réclamation, enquête ou procédure relative à toute violation des Lois Anticorruption entamée à son encontre.
6.9. L’Acheteur accepte de se soumettre régulièrement à des procédures d’évaluation de la conformité conduites par le Vendeur ou un tiers désigné à cette fin et garantit que toutes les informations d’ores et déjà fournies au Vendeur dans ce cadre sont exactes et complètes.
6.10. L’Acheteur s’engage à communiquer toute information que le Vendeur peut raisonnablement exiger pour s’assurer du respect de sa part des garanties, engagements et/ou déclarations visés par la présente clause, dans un format électronique utilisable et dans la même langue que le présent contrat, accompagnées d’une garantie d’exactitude et d’exhaustivité.
6.11. L’Acheteur accepte de se soumettre à des audits de conformité et d’apporter son assistance dans le cadre de tels audits conduits par le Vendeur, ou par un tiers désigné par le Vendeur (ci-après « l’Auditeur »). Un tel audit de conformité sera réalisé sur notification écrite adressée à l’Acheteur, avec un délai ne pouvant être inférieur à dix (10) jours. Dans le cadre de cet audit, l’Acheteur s’engage à autoriser le Vendeur ou l’Auditeur à organiser des entretiens, consulter ses livres et registres, et, de manière plus générale, toutes informations et documentations demandées relatives à la conformité ainsi qu’à en fournir la copie sur demande. L’Acheteur s’engage à faire tout ce qui est raisonnablement possible pour permettre au Vendeur ou l’Auditeur d’avoir accès aux livres et registres de ses Représentants, si un tel accès est raisonnablement nécessaire aux fins de l’audit. À titre de précision, l’accès s’entend également de la remise, sur demande, de toutes copies de documents de Représentants.
6.12. L’Acheteur déclare, garantit et s’engage à coopérer dans le cadre de toute inspection ou enquête entreprise par toute agence ou autorité publique ou gouvernementale et à exiger la même obligation de la part de tout Représentant à quelque niveau que ce soit.
6.13. L’Acheteur s’engage à obtenir de ses Représentants qu’ils se conforment aux exigences de la présente clause et notamment aux Lois Anticorruption applicables.
6.14. En cas de violation de la présente clause par l’Acheteur, sans préjudice de toute autre voie de recours expressément prévue dans le présent contrat ou de tout droit et recours dont il peut se prévaloir, le Vendeur est en droit de :
(i) suspendre le présent contrat jusqu’à ce que des mesures correctives appropriées soient mises en place par l’Acheteur, sans que le Vendeur ne soit tenu de verser une quelconque indemnité à l’Acheteur au titre de toute perte ou préjudice qui résulterait d’une telle suspension,
(ii) et/ou résilier le présent contrat ainsi que tout autre relation commerciale avec l’Acheteur, avec effet immédiat, sans que le Vendeur ne soit tenu de verser une quelconque indemnité à l’Acheteur au titre de toute perte ou préjudice qui résulterait d’une telle résiliation.
6.15. L’Acheteur s’engage à indemniser et garantir le Vendeur contre toutes plaintes, réclamations, sanctions, coûts et dépenses liés, directement ou indirectement, à toute violation du présent article ou des Lois Anticorruption par l’Acheteur ou toute personne agissant en son nom ou pour son compte.
7. Divers
7.1. Si le contrat de vente entre l’Acheteur et le Vendeur concerne le produit Onivyde, les dispositions de l’appendice 1 s’appliquent également. Les dispositions de l’appendice 1 s’appliquent exclusivement aux produits Onivyde.
7.2. Si le contrat de vente entre l’Acheteur et le Vendeur concerne le produit Lonsurf, les dispositions de l’appendice 2 sont également applicables. Les dispositions de l’annexe 2 s’appliquent exclusivement aux produits Lonsurf.
7.3. Si certaines dispositions du contrat ou des présentes CGVL s’avéraient d’elles-mêmes ou par la suite non applicables ou irréalisables, ou accusaient des lacunes, la validité des autres dispositions n’en serait aucunement entravée. Dans ce cas, la loi remplace rétroactivement la disposition non applicable. À la place de la disposition non applicable, ou pour pallier une lacune, s’applique alors rétrospectivement la réglementation qui, dans un cadre légal, se rapproche le plus de ce que les deux parties ont souhaité ou auraient souhaité selon l’esprit et l’objet du contrat, si elles avaient considéré cette question.
8. Questions médicales
8.1 Pour toutes questions médicales, merci de vous adresser à medical.ch@servier.com.
9. Effets indésirables ou défaut de qualité
9.1 Pour signaler un effet indésirable ou un défaut de qualité d’un médicament, cosmétique ou dispositif médical du vendeur, merci de vous adresser à safety.ch@servier.com.
10. Confidentialité et Protection des données
10.1 Le vendeur et l’acheteur s’engagent à ne pas divulguer à des tiers des informations non-publiques concernant les conditions du contrat (y compris des prix non-publics et des rabais) ainsi que des secrets commerciaux et d’entreprise de l’autre partie dont ils ont connaissance dans le cadre de ce rapport de droit.
10.2 Le vendeur et l’acheteur traitent toutes les données personnelles dont ils ont connaissance dans le cadre de ce rapport de droit conformément aux lois et règlements applicables en matière de protection des données personnelles.
11. Droit applicable, for juridique
11.1 Les droits et obligations des parties découlant des présentes CGVL sont soumis au droit matériel suisse à l’exclusion de la Convention de Vienne sur la vente internationale de marchandises.
11.2 Tout litige ne pouvant pas être résolu à l’amiable sera exclusivement traité par les tribunaux compétents de Genève.
Appendices
Appendix 1
SPECIFIC CONDITIONS ONIVYDE
These additional specific conditions (« Specific Conditions ») are only applicable to agreements between Servier and Purchaser to the extent they relate to Onivyde products.
In case of contradiction, the Specific Conditions stated in this Appendix 1 prevail over any other agreement, with regard to the Onivyde products.
PREAMBLE
Pursuant to a License and Collaboration Agreement dated September 23, 2014, (hereinafter referred to as the “License and Collaboration Agreement”) SERVIER has exclusive rights from IPSEN to co-develop and commercialize Onivyde product in certain countries.
Therefore, in addition to the terms and conditions stated in the AVL, according to the License and Collaboration Agreement with IPSEN and its partner namely PharmaEngine, SERVIER has obligations imposed by IPSEN and PharmaEngine to pass on to its distributors for Onivyde products distribution.
The said imposed obligations by IPSEN and PharmaEngine are:
I – DEFINITIONS
Partner: means Ipsen and Ipsen’s partner (namely PharmaEngine).
Confidential Information: means all Know-How or other confidential or proprietary information of a Party that is disclosed (whether in written, graphic, oral, electronic or other form) by or on behalf of such Party to the other Party pursuant to the agreement, including information regarding a Party’s or its licensor’s technology, products, business, business plans, financial status, biological substances, chemical substances, formulations, techniques, methodology, equipment, sources of supply and patent positioning.
Commercially Reasonable Efforts: shall mean, with respect to the Purchaser, a level of efforts and resources, not less than reasonable efforts and resources, that is consistent with the efforts and resources that SERVIER typically devotes to its own internally discovered products, to which it solely owns all rights without financial obligations to any licensor, of similar market potential at a similar stage in the development or product life thereof, including issues of safety and efficacy, product profile, difficulty in developing, competitiveness of alternative third party products in the marketplace, the regulatory requirements involved.
Know-How: means any technical, scientific and business information, data and materials, including all information, data and materials, analyses, trade secrets, whether or not patentable, including documents and other media (including paper, notebooks, books, files, ledgers, records, tapes, discs, diskettes, CD-ROM, trays and containers and any other media developed containing or storing any of the foregoing related to Onivyde.
Regulatory Authorities: means any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the testing, approval, manufacture, use, storage, import, promotion, marketing or sale of a product in a country, including the United States Food and Drug Administration, European Medicines Agency or the Department of Health of the United States.
Regulatory Documentation: means with respect to Onivyde, all investigational new drugs (IND), new drug applications, and other regulatory applications submitted to any Regulatory Authority, copies of related regulatory approvals, regulatory materials, drug dossiers, master files (including drug master files, as defined in the United States and any non-United States equivalents), and any other reports, records, regulatory correspondence, meeting minutes, telephone logs, and other materials relating to Regulatory Approval of Onivyde (including any underlying safety and effectiveness data whether or not submitted to any Regulatory Authority), or required to manufacture, distribute or sell Onivyde including any information that relates to pharmacology, toxicology, chemistry, manufacturing and controls data, batch records, safety and efficacy, and any safety database required to be maintained for Regulatory Authorities.
Regulatory Filings: means any drug approval application, notification or other submission made to or with a Regulatory Authority that is necessary or reasonably desirable to develop, manufacture or commercialize Onivyde in the licensed product field in a particular country or regulatory jurisdiction, whether made before or after receipt of relevant marketing authorization in the country or regulatory jurisdiction, and any approval resulting from any such application is a “Regulatory Approval”. The term “Regulatory Filings” shall include all amendments and supplements to any of the foregoing and all proposed labels, labeling, package inserts, monographs and packaging for Onivyde in a particular country.
II – CONFIDENTIALITY
The obligation of confidentiality as stated in Article 10.1 of the AVL must be read in the light of the following elements:
2.1 Confidential Information: shall mean (i) all Know-How (technical, scientific and business information, data, and materials) or (ii) other confidential or proprietary information furnished by SERVIER and/or IPSEN to the Purchaser and that is not generally available to the public or independently known by the Purchaser and (iii) all information controlled by SERVIER (meaning any and all information from IPSEN) and (iv) all Confidential Information disclosed by a Party or any of its Affiliates to the other Party or any of its Affiliates during the Term shall not be used by the receiving Party or any of its Affiliates except in connection with the activities contemplated by the agreement, shall be maintained in confidence by the receiving Party and its Affiliates (except to the extent disclosure is reasonably necessary for research, development, manufacture or commercialization of Onivyde as contemplated hereunder, for the filing, prosecution and/or maintenance of patent rights for which such receiving Party is responsible, or to enforce the provisions of the agreement), and shall not otherwise be disclosed by the receiving Party or its Affiliates to any person that is not a Party or one of its Affiliates (except as set forth in the remainder of this present Article), without the prior written consent of the disclosing Party, except to the extent that the Confidential Information:
(a) was known or used by the receiving Party or any of its Affiliates prior to its date of disclosure to the receiving Party;
(b) either before or after the date of the disclosure to the receiving Party hereunder is lawfully disclosed to the receiving Party or any of its Affiliates by sources other than the disclosing Party rightfully in possession of the Confidential Information;
(c) either before or after the date of the disclosure to the receiving Party hereunder becomes published or generally known to the public through no fault or omission on the part of the receiving Party;
(d) is independently developed by or for the receiving Party or any of its Affiliates without reference to or reliance upon the Confidential Information; or
(e) is required to be disclosed by the receiving Party to comply with applicable laws, including the rules of the U.S. Securities and Exchange Commission or any stock exchange, or to defend or prosecute litigation or to comply with legal process provided that the receiving Party provides prior written notice of such disclosure to the disclosing Party (to the extent feasible) and only discloses Confidential Information of the other Party to the extent necessary for such legal compliance or litigation purpose.
2.2 Employee, Director, Consultant and Advisor Obligations. Each Party agrees that it and its Affiliates shall provide Confidential Information received from the other Party only to the receiving Party’s respective employees, directors, consultants, agents and advisors, and to the employees, directors, consultants, agents and advisors of the receiving Party’s Affiliates, who have a need to know such Confidential Information to assist the receiving Party in fulfilling its obligations under the Agreement and who are bound by obligations of confidentiality and non-use that are at least as restrictive as those set forth in this agreement. Each Party shall remain responsible for any failure by any of such Party’s Affiliates, employees, directors, consultants, agents and advisors to treat such Confidential Information as required under Article 2.1.
2.3 Other Disclosures. Notwithstanding anything in the agreement to the contrary, each Party shall have the right to disclose Confidential Information and/or the terms of the agreement (as applicable):
(a) to investors, potential investors, lenders, potential lenders, acquirers, potential acquirers, investment bankers and other third parties in connection with financing, partnering and acquisition activities, solely under obligations of confidentiality and non-use that are at least as restrictive as those set forth in this Article 2;
(b) to sublicensees, potential sublicensees, collaborators, potential collaborators and third-party contractors for purposes of engaging in the research, development, manufacture or commercialization of Onivyde as contemplated hereunder, solely under obligations of confidentiality and non-use that are at least as restrictive as those set forth in this Article 2;
(c) as required by applicable laws, including rules of the U.S. Securities and Exchange Commission or similar regulatory agency in a country other than the USA or of any stock exchange or other securities trading institution; and
(d) SERVIER is expressly authorized to provide IPSEN with any Confidential Information communicated by the Purchaser or its affiliates for the performance of the agreement and on Onivyde.
2.4 Confidentiality Term. The confidentiality and restricted use obligations shall apply until the Confidential Information enters into the public domain other than through the breach of the Purchaser.
2.5 Any redacted version of the agreement with the Purchaser (redacted as the Purchaser may reasonably determine to protect confidential or commercially sensitive information) must be available to IPSEN.
III – AUDIT – INFORMATION TRANSFER – ONGOING DISCLOSURES
Purchaser must comply with requests for information regarding all activities conducted under the Know-How disclosure requirements. Further, Purchaser must allow access to all documentation needed for audits.
IV – DEBARMENT/ ANTI-CORRUPTION/ COMPLIANCE
Anticorruption obligation as stated in Article 6 of the AVL must be read in the light of the following elements:
To its knowledge, Purchaser will not (i) employ or use any contractor or consultant that employs any individual or entity debarred by the United States Food and Drug Administration (FDA) (or subject to a similar sanction of European Medicines Agency (EMA)) or (ii) employ any individual who or entity that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMA), in each of clauses (i) and (ii) in the conduct of its activities under the agreement.
V – TERMINATION AND EFFECT OF TERMINATION
At SERVIER’s request, the agreement, and all rights and obligations thereunder, shall be transferred to Partner or its designee, which the Purchaser hereby acknowledges and agrees.
5.2 In case of expiration or termination of SERVIER’s rights with respect to Onivyde in any country, at SERVIER’s request, either the agreement and all rights and obligations thereunder, shall be transferred to SERVIER’s designee, which Purchaser hereby acknowledges and agrees, or it shall terminate in such country effective upon expiration or termination of SERVIER’s rights.
5.3 To avoid disruption in the availability of Onivyde to patients, then to the extent requested by SERVIER, the Purchaser shall continue to distribute Onivyde, in accordance with the terms and conditions of the agreement, until twelve (12) months after the date on which SERVIER notifies the Purchaser in writing that SERVIER has secured another distributor or licensee for Onivyde in such country, but in no event more for than twenty-four (24) months after the effective date of any expiration or termination of the agreement (the “Wind-down Period”); provided that the Purchaser shall cease such activities, or any portion thereof, in a given country upon less than 60 days days’ notice by SERVIER requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of the agreement, during the Wind-down Period, subcontractors’ rights with respect to Onivyde (including Onivyde Trademarks) shall be non-exclusive. Within less than 30 days of expiration of the Wind-down Period, the Purchaser shall notify SERVIER of any quantity of Onivyde remaining in its inventory and SERVIER shall have the option, upon notice to Purchaser, to repurchase any such quantities of Onivyde from Purchaser at the price paid by the Purchaser for such Onivyde.
5.4 Licenses: Effective as of the date of expiration of the Wind-down Period, the Purchaser shall either (i) grant to SERVIER an exclusive, worldwide, royalty-free license, with the right to grant sublicenses, under any patents rights owned or controlled by the Purchaser related to Onivyde (including improvements) for the sole purposes of making, using, developing, importing, selling, distributing, marketing and promoting Onivyde, or (ii) ,at Purchaser‘s election, assign such patent rights to SERVIER or its designee.
5.5 Return of materials: Within thirty (30) days after the end of the Wind-down Period upon request by SERVIER, the Purchaser shall, at Partner’s costs either return to SERVIER or destroy all tangible items comprising, bearing or containing Onivyde trademarks, trade names, patents, copyrights, designs, drawings, formulas or other data, photographs, samples, literature, sales and promotional aids and Confidential Information of SERVIER, that is in the Purchaser’s possession, subject to the Purchaser’s right to keep one copy for archiving purposes. Effective upon the end of the Wind-down Period, the Purchaser shall cease to use all trademarks and trade names of SERVIER (including the Onivyde Trademarks) in the Territory, and all rights granted to the Purchaser hereunder with respect to the Onivyde in the Territory shall terminate.
VI – DILIGENCE OBLIGATIONS
Purchaser shall use Commercially Reasonable Efforts regarding its activities on Onivyde.
For the avoidance of doubt, Purchaser shall use Commercially Reasonable Efforts to commercialize Onivyde.
Purchaser obligations to use Commercially Reasonable Efforts under Article 6 hereof shall require and shall be deemed to be satisfied: if Purchaser uses Commercially Reasonable Efforts to commercialize Onivyde for each indication for which Onivyde has been developed.
VII – REGULATORY ISSUES
Notwithstanding article 3 “Audit – Information Transfer – Ongoing Disclosures”, Purchaser shall permit any relevant Regulatory Authority to inspect any such Regulatory Documentation upon reasonable notice to the Purchaser.
Purchaser shall also permit SERVIER and/or IPSEN, upon reasonable notice, during regular business hours, to inspect any such Regulatory Documentation; provided SERVIER and/or IPSEN shall use reasonable efforts to limit such inspections by SERVIER and/or IPSEN to a moderate frequency reasonably necessary or desirable in order to facilitate SERVIER’s development and commercialization of Onivyde. SERVIER and/or IPSEN does not anticipate that it would require more than two (2) of such inspections conducted by SERVIER and/or IPSEN in a Calendar Year.
Purchaser must comply with requests for all information needed for regulatory approvals and audits by IPSEN. Further, Purchaser must execute, where necessary, documentation needed for IPSEN to exercise its right of reference.
VIII – COMMUNICATION WITH REGULATORY AUTHORITIES
Purchaser must comply with all requests for information/documentation regarding communications with Regulatory Authorities.
IX – SUPPLY- RECALLS
If any Regulatory Authority threatens, initiates or advises any action to remove Onivyde from the market in any country of the world, Purchaser must comply with all requests for information with respect to recalls.
SERVIER and/or Partner shall decide whether to recall or withdraw Onivyde in the Territory and shall undertake any such recall or withdrawal in the Territory at its own cost and expense.
Further, if the Purchaser is asked to issue a « Dear Doctor » letter or its equivalent regarding use of Onivyde, it must inform SERVIER within two (2) calendar days (or sooner if required by all and any applicable laws, rules, regulations, orders and assimilated instruments), who bears the burden of reporting to Partner.
Purchaser must inform SERVIER of any sublicenses, the latter who then bears the burden of reporting to Partner.”
Purchaser shall not be entitled to disclose or publish any information relating to Onivyde (e.g. press release, etc.) or Confidential Information of SERVIER without SERVIER’s prior written consent, in its sole discretion.
The Purchaser agrees that all Onivyde marketing materials, global marketing and commercialization actions shall comply with SERVIER’s instructions and documentation regarding Onivyde.
XII – OWNERSHIP OF RESULTS/ INTELLECTUAL PROPERTY
SERVIER shall own any intellectual property rights deriving from the activities conducted by Purchaser under this agreement. If pursuant to applicable law, the ownership of such intellectual property vests in the Purchaser, then Purchaser shall hereby irrevocably assign all of its right to such intellectual property rights to SERVIER and shall execute all deeds or other documents evidencing such transfer of ownership.
XIII – EXCHANGE OF DATA, KNOW-HOW AND CUSTOMER DATA
For the purpose of this article, “Control” or “Controlled” means with respect to any Know-How, patent right or other intellectual property right, the possession (whether by license (other than pursuant to this agreement) or ownership, or control over an Affiliate with such a license or ownership) by a Party of the ability to grant to the other Party access or a license as provided herein without violating the terms of any agreement or arrangement with any third party existing before or after the Effective Date.
During the term of this Agreement, Purchaser shall provide to SERVIER all Purchaser’s information, data and Know-How relating to Onivyde that is Controlled by Purchaser or its Affiliates and is generated during the term of this Agreement, in each case every six (6) months, and promptly upon any request by SERVIER. Purchaser shall provide the same in electronic form to the extent the same exists in electronic form, and shall provide copies or an opportunity to inspect (and copy) for all other materials comprising such Know-How. Any such Know-How shall be provided in the original language in which Know-How was generated, provided that, if such original language is not English, then the Purchaser shall also provide English translations thereof. The Parties will cooperate and reasonably agree upon formats and procedures to facilitate the orderly and efficient communication of such Know-How. SERVIER will be entitled to provide access to such Know-How to its Partners for Onivyde.
Regarding data and Know-How, Purchaser shall promptly provide to SERVIER a copy of all data, information and Know-How pertaining to Onivyde and SERVIER shall have the right to use and disclose them. In addition, all data, information and Know-How to the extent solely related to Onivyde shall be deemed Confidential Information of SERVIER (or its designee) and not Confidential Information of the Purchaser.
Regarding customer data, the Purchaser shall, upon written request from SERVIER, provide SERVIER with copies of customer lists, customer data and other customer information relating to Onivyde (except as prevented by the Applicable Laws and regulations relating to the protection of personal information), which SERVIER shall have the right to use and disclose.
XIV – TRANSITION OBLIGATIONS ON TERMINATION
Term and termination obligation as stated in Article V of this agreement must be read in the light of the following elements:
In case of expiration or termination of SERVIER’s rights with respect to Onivyde in any country, at SERVIER’s request, all rights and obligations thereunder relating to Onivyde, shall be transferred to SERVIER’s designee, which Purchaser hereby acknowledges and agrees, or it shall terminate in such country effective upon expiration or termination of SERVIER’s rights.
XV – RIGHT OF REFERENCE TO REGULATORY FILINGS
Purchaser shall grant to SERVIER, its Affiliates and their partners, including the Partner, the right to cross-reference, have access and use Purchaser’s Regulatory Filings related to Onivyde and use any data therein in connection with Onivyde.
APPENDIX 2
SPECIFIC CONDITIONS LONSURF
WHEREAS
WHEREAS, pursuant to a development and commercialization agreement entered into on June 12th, 2015 between SERVIER and Taiho Pharmaceutical Co. Ltd the (“Taiho Agreement”), SERVIER has exclusive rights to co-develop and commercialize the TAS-102 (Trifluridine and tipiracil as hydrochloride) (the “ Taiho Product”) in certain countries, among which Switzerland.
WHEREAS SERVIER markets and wants to have the Taiho Product marketed in Switzerland.
1. CONFIDENTIALITY/PUBLICATION
It is agreed between the Parties that Purchaser shall not be entitled to disclose nor publish any information relating to the Taiho Product without SERVIER’s prior written consent, in its sole discretion.
2. INSPECTION
SERVIER and/or its appointed nominees shall have the right to inspect, the premises of Purchaser, the Products and the Taiho Product, its warehouses, and any documents, procedures pertaining thereto in order to control the full and complete compliance by Purchaser of its contractual undertakings. Such audit shall be performed during normal business hours and after a five (5) working day prior notice to Purchaser.
3. TERMINATION CLAUSE (SPECIFIC FOR LONSURF)
Moreover, SERVIER shall be entitled to terminate this agreement with immediate effect at any time, without any damage or indemnity of any kind being due, if:
A – based upon all relevant scientific data, there are safety and public health issues relating to the Taiho Product such that the medical benefit/risk ratio of such Taiho Product is sufficiently unfavorable as to materially compromise the welfare of patients so that the use in patients is no longer justifiable and that such issues are unlikely to be reversed within a reasonable period of time with a commercially reasonable level of investment, as determined by SERVIER in its sole discretion, subject a thirty (30) days’ written notice to Purchaser or within a shorter period if required under applicable laws.
B – SERVIER may terminate this agreement at any time with a thirty (30) days’ prior notice to Purchaser and immediately for safety reasons related to the Taiho Product or decided by SERVIER as a precautionary measure.
C – In case of expiration or termination of SERVIER’s rights with respect to the Taiho Product in any country (including Switzerland), at SERVIER’s request, Purchaser’s rights and obligations thereunder, shall be transferred to Taiho or its designee, which Purchaser hereby unconditionally acknowledges and agrees. If SERVIER does not make such a request, the terms of the present agreement shall terminate upon expiration or termination of SERVIER’s rights.
D – In case the Taiho Product is withdrawn from any market by SERVIER or by any governmental decision or for patient safety purposes, as a precautionary measure.
SERVIER shall, however, reimburse Purchaser, at the price agreed between the Parties as stated in clause 2.4 of the AVL, for the remaining stock in Purchaser’s warehouse(s) as well as possible returns from the customers.
E- Moreover, to avoid disruption in the availability of Taiho Product to patients, if this agreement is terminated, then to the extent requested by SERVIER, Purchaser shall continue to distribute the Taiho Product to patients, in accordance with the terms and conditions of the agreement, until twelve (12) months after the date on which SERVIER notifies Purchaser in writing that SERVIER has secured an alternative partner for the Taiho Product in the Territory, but in no event more than twenty-four (24) months after the effective date of any expiration or termination of the agreement (the “Wind-down Period”). Purchaser shall cease its activities in relation with the import, storage, distribution and sale of the Taiho Product, or any portion thereof, in Switzerland upon a sixty (60) days’ notice by SERVIER requesting that such activities (or portion thereof) be ceased.
Each Party shall use reasonable efforts to cooperate with the other and/or its designee to effect a smooth and orderly transition in ongoing operations in Switzerland during the Wind-down Period and to conduct in an expeditious manner any activities to be conducted under this clause 3. Without limiting the foregoing, Purchaser shall, upon written request from SERVIER, provide SERVIER with copies of information relating to the Taiho Product in Switzerland in its possession (except as prevented by applicable laws and regulations), which SERVIER shall have the right to use and disclose.
If during the term of the agreement, Purchaser acquires the right to distribute, sell or promote any Competing Product, and thereafter commences to distribute, sell or promote such Competing Product, in Switzerland, or in any country where (i) SERVIER, its affiliated companies or a contractor distributes, sells or promotes the Taiho Product, (ii) there is an issued composition of matter patent within the Taiho patent covering the Taiho Product, or (iii) regulatory exclusivity is available for the Taiho Product (or would be available for the Taiho Product, were SERVIER to pursue registration of the Taiho Product in such country), SERVIER shall have the right to terminate the agreement upon ninety (90) days’ written notice to Purchaser. As used herein, “Competing Product” shall mean a product which is approved in the same indication as the Taiho Product.
4. AUDIT
SERVIER, and Taiho or their Affiliates and/or their respective external auditors shall have the right, upon reasonable written notice to Purchaser, and during normal business hours, to inspect Purchaser, its and any of its subcontractors site and facility and any records (including books of account) relating thereto and/or to the performance of the agreement ( and make copies of the same) at least once per year, or more often with cause, to verify their respective compliance with the agreement and all applicable laws and local regulations, including current standards for pharmacovigilance practice, if applicable. Purchaser, and its subcontractors, shall permit the auditor, at any time, to have access to any data records and reports relating to the Taiho Product complaints and/or batch recalls and pharmacovigilance. SERVIER and/or external auditor will be authorized to visit Purchaser’s premises, subject to reasonable period notice. Books of accounts shall be kept for at least three (3) years following the end of the calendar quarter to which they pertain.
Further to such audits, SERVIER may issue a report and if applicable a corresponding corrective action plan to be implemented immediately by SERVIER, at Purchaser’s sole cost and expense.
5. ANTI-CORRUPTION
Purchaser represents and warrants that it has not been debarred, and is not subject to debarment, pursuant to Section 306 of the United States Federal Food, Drug and Cosmetics Act and/or to similar laws of Switzerland and that it shall not involve in the activities contemplated in the Agreement any employee that has been debarred and is not subject to debarment.