General Terms and Conditions of Business (GTCB) for Consulting and Provision of Additional Services of Phact GmbH

§1 Validity of the GTCB

(1) These General Terms and Conditions of Business apply for consulting and provision of additional services as well as training and further education in the fields of drug approval and registration, quality, quality management, good manufacturing practice and other regulated fields in the pharmaceutical sector, active ingredients and medical devices of the Phact GmbH (Offeror). Detailed descriptions and contents of the services to be provided on the basis of this GTCB are set forth in the respective contracts.

(2) These GTCB shall not apply for digital services provided by Phact GmbH. The General Terms and Conditions for Ordering and Use of Digital Services of Phact GmbH shall apply for the provision of digital services.

(3) The scope of these GTCB is limited to business with Enterprises as Clients. An enterprise is a natural person or a legal entity or a partnership with legal capacity, that acts in the exercise of their commercial or independent professional occupation when concluding a legal transaction.

(4) The Offeror is prepared to conclude a contract only on the basis of these General Terms and Conditions of Business for consulting and provision of services. Deviating General Terms and Conditions of Business of the Client will not be recognised unless the Offeror has expressly consented to them. Deviating General Terms and Conditions of Business of the Client will not apply even when the Offeror is aware of these while rendering his services.

§2 Offers and Conclusion Contract

The offers of the Offeror are subject to change. A contract will only be concluded with the Offeror’s written confirmation of the relevant order. Changes to the contract must be in writing.

§3 Provision of Services and Deadlines

(1) Unless otherwise agreed, the manner and scope of the provision of services will agreed in the relevant order.

(2) The services will be provided according to the principles of proper professional practice.

(3) The location of the provision of services is the headquarters of the Offeror, unless otherwise agreed to in individual cases.

(4) The Offeror shall designate a contact person (project manager) for the duration of the provision of services. If there is a change in the contact person, the Offeror will ensure that the new contact person is instructed from the beginning of his/her activity about the order and its current status.

(5) The Offeror will determine – according to the subject of the contract – the manner in which the services are provided The Offeror will deploy appropriately qualified employees for the provision of services. In particular, the Client is not authorised to impart instructions to the Offeror or the employees commissioned by him to provide the services.

(6) The engagement of third parties by the Offeror for providing the service requires the prior written approval of the Client.

(7) If documentation is agreed to, the Offeror shall provide such documents in the content and format defined in the order. Electronic transmission of documentation is sufficient, no hard copies are required.

(8) To the extent that performance deadlines are agreed to, these will only apply subject to the fulfilment of the obligations cited in §4 for the participation of the Client and subject to the contractual compliance of obligations by any third parties.

§4 Obligations and Participation of the Client

(1) The Client shall provide the employees of the Offeror with all information, data and documents etc. that are required for the performance of the service, completely, correctly, on time, and free of charge, insofar as the Offeror is not obligated to provide these. Furthermore, the Client will ensure that these are updated. The Offeror may rely on the completeness and correctness of the documents provided, unless he is aware, or is expected to be aware, of anything to the contrary.

(2) The Client is obligated to support the Offeror to the extent required and – if it is agreed that a work activity will be carried out at the production site of the Client or one of his providers (e.g. contract manufacturer, contract laboratories) or suppliers (e.g. active ingredients, auxiliary materials, packaging materials) – to provide any infrastructure necessary for the proper performance of the agreed services (e.g. access to premises and systems, work places with electricity, telephone and internet connections).

(3) The Client will designate a competent contact person for the duration of the provision of the service, who can make binding decisions for the Client during the performance of the contract. This person must be available for exchanging necessary information and to participate in the decisions required for the performance of the contract. If there is a change in the contact person, the Client will ensure that the successor is given full instructions about the order and its current status, from the beginning of their activity. The Client will also designate a new contact person also if the existing contact person takes long-term sick leave or is unavailable for an extended period of tie for other reasons.

(4) If third-party services (e.g. texts, pictures, photos) or standard software of third party providers are to be incorporated into the services of the Offeror or taken into account, the Client will procure these at his own cost and provide them to the Offeror. If the material submitted by the Client needs to be converted into another format, the Client shall assume the relative costs incurred. The Client shall independently perform all relevant conditions for third-party services and, if applicable, any contract and/or licence extensions required.

(5) The Offeror shall not be obligated to procure third-party services, unless this is expressly agreed to in the order. In this case, in so far as contracts for external services are concluded on behalf of and for the account of the Offeror in individual cases, the Client will be obligated to release the Offeror, internally, of all and any liabilities that arise from the conclusion of such contracts.

(6) The Client is responsible and shall ensure that any material made available by him, including third-party services, do not violate statutory or regulatory provisions (e.g. data protection or competition law) and are free from third party rights (in particular, copyrights, trademark rights, technical intellectual property rights) that could limit the intended use.

(7) The Client will assume the coordination of the services by its own employees and third parties authorised by him which are directly or indirectly connected with the order. He shall also ensure that for the provision of their services to the Offeror, the latter cooperate in such a way that the Offeror is not impeded or hindered.

(8) The Client shall ensure, within the scope of his responsibilities, that the reconstruction of the data provided by him and the data transferred to him by the Offeror, is possible with reasonable efforts. In this respect, he is responsible for regularly backing up the data. Additionally the Client shall guarantee that his systems affected by the respective order are appropriately secure, in accordance with the state of the art (e.g. against computer viruses, trojans, spyware, other malware and hacker attacks).

(9) The Client must keep any access data provided to him by the Offeror (e.g. user name, password etc.) protected against access by third parties, so that the systems and applications of the Offeror cannot be accessed by third parties.

(10) All participation of the Client must be on time, complete and free of charge for the Offeror.

(11) For the Offeror to properly provide the service, it is imperative that Client provides its participation services in a timely and qualified manner, when requested to do so by the Offeror. No request is necessary if the due date for the participation services arises from or is determined by the respective order or deadline/project plan, and the participation services are to be provided on an ongoing basis (e.g. the operation of systems that the Offeror has to access).

(12) If delays or extra expenses arise because the Client does not participate properly or in a timely manner, the Offeror can – irrespective of further statutory rights – demand changes to the schedule and, if necessary, to the agreed remuneration.

§5 Rights of Use, Intellectual Property

(1) “Work results” are the documentation agreed to in the order, that the Offeror transmits to the Client in writing, in a machine readable or other form of presentation.

(2) The Offeror reserves ownership of the work results until they are paid for in full.

(3) The rights of the Offeror or the original rights holder to their own work (e.g. presentation documents, templates, graphics) and other protected works, that are incorporated into the contractual cooperation for creating the work results, will in any case remain unaffected, and these may not, in particular, be changed, edited, copied or distributed, in whole or in part, either in the original or in reproduction, without the consent of the Offeror or the original rights owner.

§6 Remuneration, Payment Terms, Legal Reservations

(1) The price for the provision of services and the conditions for travel (e.g. carriage class for plane and train travel) shall be agreed in the relevant order. Unless otherwise agreed, the remuneration for services that the Offeror provides to the Client will made according to the prices and conditions agreed in the respective order.

(2) All prices are exclusive of statutory VAT at the applicable rate. If, during the billing period, the value added tax changes, the billing periods with the respectively applicable rate of VAT will be considered separately.

(3) Unless otherwise agreed, the services provided will be billed monthly for the preceding month. Documentation of the activities will be attached to the invoice. Travel and accommodation expenses will be calculated in accordance with the statutory maximum rates. Travel time shall be calculated at 50% of the agreed hourly rate for the service.

(4) Payments will be made to the Offeror at the latest (14) calendar days after receipt of the invoice without deduction, unless any differing terms of payment are stated on the invoice.

(5) If the Client falls behind with his payments, the Offeror will be entitled to stop or defer the additional services irrespective of further rights, until the payment is made.

§7 Liability, Limitation of Liability

(1) Any information given by the Offeror and/or the employees over the phone is not binding.

(2) The liability of the Offeror for slight negligence is excluded; furthermore liability is excluded in so far as it is allowed by law. In particular, liability for indirect damages is hereby excluded.

§8 Contract termination, notice of termination

(1) The contract will end with the fulfilment of the agreed services, upon expiry of the agreed or by notice of termination.

(2) If a contract runs for an indefinite period, it can, unless otherwise agreed, be terminated by either contractual party at any time.

(3) If the Offeror terminates the contract, any actions will still be carried out that are still reasonable to expect and cannot be delayed (e.g. submission deadline of an application for approval).

(4) Notice of termination must be made in writing.

§9 Confidentiality

(1) The Offeror is obligated to keep secret all activities, information and documents that he becomes aware of from the Client in connection with the provision of services.

(2) The obligation to confidentiality and non-use of the mutually exchanged information will lapse, if it

  • was demonstrably known to the informed contractual party before it was divulged,

  • was known or generally available to the public before it was divulged,

  • was known or generally available to the public after it was divulged, without the participation or fault of the informed contractual party,

  • must be disclosed for reasons of a binding regulatory or judicial order or a compulsory statutory provision, provided the other party is promptly informed in writing about the disclosure beforehand.

(3) All information that confided to a contractual party will remain property of the disclosing party. Each party is obligated to either return to the other party, or destroy, all documents, drawings, data, presentations or similar things at the latest with the expiry of this non-disclosure agreement.

(4) The contractual parties will be released from this confidentiality obligation if, data have to be disclosed on the basis of statutory obligations or an order of a court or a public authority.

§ 10 Data protection

(1) During the initiation, conclusion, processing and reverse processing of a contract, data will be collected, stored and processed by the Offeror within the framework of the statutory provisions.

(2) If personal data about employees or business partners of the Client is exchanged between the Client and the Offeror, the Client shall obtain any consents required from his respective employees or business partners for the data processing.

(3) The Client agrees that any necessary personal data of his contact person will be processed by the Offeror for the development of the business relationship.

(4) Further information about data protection is contained in our privacy statement.

§11 Retention Requirements, Right of Return and Retention Rights to Work Results and Documents.

(1) At the request of the Client, within a reasonable time, the Offeror will return all documents passed on to him for the provision of the agreed service. The Offeror is authorised to make copies of these documents and to keep them.

(2) The Offeror has the right to refuse to return the documents and the work results until the payment in full of the agreed services.

§12 Choice of Law, Place of Jurisdiction, Final Provisions

(1) Exclusively Swiss Law is applicable to the Contracts between the Offeror and the Client; the provisions of the United Nations Convention on Contracts for the International Sale of Goods (CISG, “UN Sale of Goods Law”) is excluded.

(2) The place of jurisdiction is Duggingen (Canton Basel-Landschaft, Switzerland). The Offeror is also entitled to sue the Client at a territorially competent court at the headquarters or domicile of the Client.

(3) Should one or more of provisions of these GTCB be, or become, ineffective, the efficacy of the other provisions shall remain unaffected.

Phact GmbH, Christoph Merian-Ring 11, 4153 Reinach BL/Switzerland.

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