Preliminary Remarks
ZOLL Medical UK Limited (the "Company") specializes in the development and marketing of medical devices and sells in the United Kingdom, among other things, the LifeVest® wearable cardioverter defibrillator (hereinafter: "LifeVest WCD").
LifeVest WCD is a technically complex medical device that automatically initiates a treatment mode, for example in the event of ventricular tachycardia or ventricular fibrillation. If the patient is unable to respond e.g. because s/he is unconscious, LifeVest WCD automatically defibrillates the patient. The LifeVest WCD is applied and used by the patients in their daily lives independently on the body. However, LifeVest WCD can fulfill its life-saving function only if proper use by the patient is ensured at all times. Therefore, in addition to careful reading and following of the instructions for use as well as the initial instructions by medical experts, comprehensive practical instruction and advice for the patient is im¬portant (hereinafter: "Training"). If necessary, patients are also trained again during the use of the LifeVest WCD (hereinafter: "Follow-up Training").
You have the necessary technical expertise with regard to the application of LifeVest WCD on the patient. The Company wants to use your expertise to ensure the highest possible quality in respect of the Services (as defined below) provided in respect of patients who use of LifeVest WCD.
Any engagement of you by the Company in respect of the provision of the Services will be subject to these GTC. Hereinafter, you will be referred to as the "Consultant".
PART 1: GENERAL PROVISIONS
1. Object of the activity
1.1 The Consultant shall provide the following services and warrants that s/he has the necessary expertise in respect of the same:
· Training
· Follow-up Training
· Replacement parts deliveries
· Obtaining additional documents required for order processing (as notified by the Company from time to time)
(together, the "Services" and each a "Service").
2. Information about Training/conclusion of the Order
2.1 The Company will include details of the current Company's requirements for Services ("Current Service Requirements") on its online communication platform, including the specific details of the Services to be provided, the place of the patient's residence/clinic, the contact person and the latest possible completion date.
2.2 The Consultant is entirely free to make an offer to the Company in respect of all or some of the Current Service Requirements, based on his/her own plans and scheduling and business considerations. The Consultant is not obliged to submit an offer to the Company for the performance of any or all of the Current Service Requirements.
2.3 The Company shall be free to decide whether to accept the Consultant's offer; this shall apply in particular if several consultants submit offers for the same Service. In this case, the Company shall be free to decide which consultant is commissioned to provide the Service.
2.4 Any acceptance by the Company of the Consultant's offer is subject to the condition precedent that the Consultant has the necessary qualifications in accordance with section 4 of the GTC and complies with the obligations set out therein and also has the operating equipment required pursuant to section 5 of the GTC at his/her disposal.
2.5 Once the Company has accepted the Consultant's offer, the order for the relevant Service(s) becomes binding subject to the remaining terms of these GTC ("Order").
3. Performance of services by the Consultant
3.1 The Consultant shall be free to cancel an Order at any time. If an Order is cancelled by the Consultant, there shall be no entitlement to a fee; this shall also apply if the Consultant is prevented from rendering the Services due to illness unless the Consultant finds a suitable substitute who is able to provide the Services on his/her behalf while the Consultant is ill. The Company shall be notified without undue delay about any cancellation; a cancellation at an inopportune time, for which the Consultant is responsible, in particular shortly before the expiry of the latest possible completion date for the provision of the Services, may entitle the Company to claim damages.
3.2 The Company may cancel an Order at any time if the Service ordered is no longer required due to circumstances for which the Company is not responsible, such as the death of the patient or termination of the corresponding order with the Company. In this case, the Consultant shall not be entitled to payment unless s/he can prove that s/he has already started processing the Order (start of the journey to the patient, at the earliest), in which case the Company shall pay the Consultant pro-rata for Services already provided at the time of cancellation.
3.3 The Consultant shall store the equipment and materials required for the performance of the Services in his/her home in a secure and proper manner (theft-proof, hygienic, dry, dark and at room temperature); special care must be taken to ensure that the fabric vests are available in sufficient numbers and in a range of sizes. The Consultant is entitled, but not obliged, to also store the LifeVest WCD packages in sufficient quantity to meet future demand for expected Training so as to achieve greater flexibility in the timing of the delivery of the Services. To the extent that the Consultant decides to store the LifeVest WCD packages or any other property of the Company in connection with the provision of the Services ("Company Equipment"), the Consultant acknowledges that all Company Equipment is and remains the sole property of the Company or that the Company has the exclusive right to make dispositions on them, and commits to return all Company Equipment to the Company upon the Company's request. In addition, the Consultant undertakes to make use of the Company Equipment solely for the purpose of providing the Services and to treat the Company Equipment with due care, and to protect it against deterioration and loss, and to refrain from making it available to third parties without the Company's prior written consent.
3.4 The Consultant may provide the Services herself/himself or through suitable third parties. Suitable third parties are those who have the required qualification as notified by the Company to the Consultant from time to time and who shall enter into direct undertakings with the Company in respect of confidentiality and ownership of intellectual property rights as requested by the Company. The required qualification must be demonstrated by a certification issued by the Company. In the event of the Consultant’s inability to perform the contracted Services, the Consultant will inform the Company immediately, stating the expected duration of the inability. The Consultant is free to determine the timing and location of the provision of the Services in a way to ensure that optimal efficiency of the Services is achieved. The Consultant may delegate the performance of the Services, in whole or in part, to others or use others for their fulfillment, provided they have the necessary qualifications/certifications. The Company must be notified of this in good time in advance. In the event that the Consultant uses third parties to provide the contracted Services, s/he shall be solely liable for any fees payable to such third parties, taxes, National Insurance and social insurance contributions (if any) charged or payable in respect of the engagement of such third parties. The Consultant shall be liable at all times for the actions and/or omissions of any third party engaged by him/her in the provision of the contracted Services as if they were the Consultant's own actions and/or omissions.
3.5 The Consultant shall provide his/her services in his/her own name and for his/her own account. S/he shall provide his/her services as an independent contractor. S/he shall not be authorized to represent the Company in legal transactions or assume any duties or liabilities on the Company's behalf.
3.6 The Consultant is not subject to any instructions or directions from the Company regarding working hours, division of working hours, etc. when carrying out his/her activities. If necessary, s/he shall agree the place and time of performance with the patient and/or the clinic save that the Services must be provided prior to the latest possible completion date as communicated by the Company to the Consultant.
3.7 The Consultant shall not be entitled to sickness benefits or paid annual leave.
3.8 The Consultant acknowledges that s/he has no rights of his/her own with regard to patient data and that s/he may neither transfer nor disclose such data to third parties.
3.9 The Company, being a healthcare company, is committed to the well-being and health of patients; as such ethical and lawful conduct is of utmost importance to the Company in achieving this goal. The Consultant represents and warrants that s/he will strictly comply with all applicable legal requirements in respect of the cooperation with healthcare companies in the course of his/her activities, in particular any laws and regulations relating to advertising in the healthcare sector, including any applicable codes of conducts of the industry, and any codes of professional conduct and regulations applicable to the Consultant.
3.10 Furthermore, the Consultant represents and warrants that by accepting and performing the activities under an Order, including receipt of the fee for the Services, no ongoing business relationships is created between the Company and the Consultant or, if applicable, his/her employer. For the avoidance of doubt, the Company reiterates that the opportunity offered to the Consultant to bid for and provide the Services and the corresponding potential earnings, is not provided in the expectation that the Consultant or the Consultant's employer will consider, recommend, prescribe or purchase the LifeVest WCD or any other Company products as part of any future procurement and prescription decisions.
3.11 All intellectual property rights of any kind, including, without limitation, copyrights, trademarks, patents, design rights, goodwill, look and feel, moral rights, know-how, and any other intangible right relating to intellectual property (“Intellectual Property Rights”) in the LifeVest WCD, and the Company Equipment are the Company’s property, and the Consultant undertakes not to make any direct or indirect use of them other than in accordance with the terms of these GTC. If the Consultant creates any materials, developments, improvements or inventions relating to the LifeVest WCD, the Company’s Intellectual Property Rights and/or confidential information (“Consultant Materials”), then such Consultant Materials shall be the sole property of the Company. In consideration for the fees paid and payable under these GTC, the Consultant hereby irrevocably assigns to Company all of Consultant’s rights, title, interest (including all Intellectual Property Rights) in the Consultant Materials and the Consultant shall, at the request of the Company, execute all such deeds and documents and do all such acts as may be necessary to secure the vesting in the Company, and registration, of all rights assigned by this section and, shall provide all such assistance as may be required by the Company in connection with bringing or defending any proceedings relating to any of the rights assigned. Consultant agrees to provide a non-exclusive, royalty-free, perpetual license to Company and its affiliates to use Consultant’s Intellectual Property Rights to the extent necessary to make, use, and/or reproduce the Consultant Materials.
3.12 The Consultant shall not whilst s/he is providing the Services to the Company under an Order at the same time be engaged by or provide services to any other provider of a WCD (Wearable Cardioverter Defibrillator) System ("Competitor"), either directly or indirectly, which are identical or similar to the Services.
3.13 The Consultant shall not for a period of three (3) months after completion of an Order be engaged by or provide services to any Competitor, either directly or indirectly, which are identical or similar to the Services.
4. Qualification and duties of the Consultant
4.1 The Consultant must have the necessary qualifications to provide the Services (as determined and notified by the Company).
4.2 In order to be able to properly perform the Services in accordance with section 1 of these GTC, the Consultant must have familiarized her-/himself with the contents of the consultation and instructions specified in Part 2 of the GTC. Software made available to the Consultant to enable the Company to fulfill its technical and legal obligations regarding IT security and data protection must be implemented and used by the Consultant.
5. Consultant's operating equipment
5.1 The Consultant represents and warrants that, in addition to the software specified in Part 2 of the GTC and made available to the Consultant by the Company, s/he has the following minimum operating equipment of her/his own, which is required for the proper performance of the Services:
· Motor vehicle for travelling to the patient;
· Software that meets the current state of the art and is always used in the latest version;
· Work space with lockable storage (cabinet/table) for safe storage of data carriers and/or documents;
· Document shredder;
· Suitable storage space for the fulfillment of the storage obligations mentioned in bulletpoint 3;
· Smartphone with the capability to use the latest mobile applications, in particular to use the Company's communication platform and associated programs and applications.
5.2 The operating equipment and resources mentioned above do not have to be used exclusively for the provision of Services to the Company, as long as it is made sure that any use for other clients or for private use does not impair their use to fulfil an Order.
6. Term
The provisions of these GTC shall apply exclusively to any Order and their application shall end automatically upon completion of the relevant Order.
7. Fee/expenses
7.1 The consultant shall receive the fee negotiated between the parties for the Services performed as part of an Order. The fee shall cover all Services performed by the Consultant and there will be no separate reimbursement of expenses, in particular travel expenses.
7.2 The Consultant shall issue a written invoice to the Company in a timely manner and at the latest (a) within three (3) months of the relevant Services under an Order having been completed; or (b) by the end of the year in which the relevant Service were performed, whichever occurs earlier. The foregoing shall not apply in respect of Services provided under an Order which completed in December, which must be invoiced at the latest by 31 January of the following year. Any invoices received late may not be paid by the Company.
7.3 The fee shall be paid only upon presentation of a valid invoice; it shall become due four weeks after receipt of the invoice.
7.4 The fee shall be paid plus statutory VAT provided that the Consultant issues a valid VAT invoice. If it turns out that the Consultant was not/is not entitled to charge VAT, the Consultant shall reimburse the Company without undue delay for any VAT wrongly shown on an invoice and paid by the Company.
7.5 The Consultant shall be solely responsible for the payment of all taxes and levies arising from or applicable to the provision of the Services by the Consultant and any insurance premiums for insurance policies taken out by the Consultant in respect thereof. The Company shall not be liable to the Consultant for any back payments.
7.6 The Consultant confirms vis-à-vis the Company that he/she is in possession of all valid licences, permits or authorizations required in order to provide the Services and has registered as a sole trader with HMRC (if required).
8. Confidentiality and Data protection
8.1 The Consultant shall keep all information (including business, technical, and proprietary information and inventions, research, technology, designs, drawings, formulas, product specifications, and know-how) disclosed by or on behalf of Company to Consultant or which the Consultant has obtained on the occasion of or during the performance of his/her activities in connection with an Order that (a) is identified as “confidential” or “proprietary” or (b) should be reasonably understood as confidential or proprietary due to its nature and the circumstances of its disclosure ("Confidential Information") strictly confidential and shall not use such information for his/her own benefit or the benefit of any third parties. The Consultant may disclose the Confidential Information, where such disclosure is required for the proper fulfillment of the tasks assigned to her/him or in the event that disclosure has been expressly permitted in writing by the Company. The Consultant is prohibited from using the Confidential Information for any purposes other than the fulfilment of the Order and shall not make the Confidential Information available to third parties, or otherwise use the Confidential Information without the Company's prior written consent.
8.2 The Consultant shall treat all Company Equipment in his/her possession, as well as all documents, including files as well as electronically stored data and data sets and other records relating to the Company's business operations, in particular any printed material, instruments, drawings, notes and drafts as well as copies or transcripts, in such a manner so as to ensure that they cannot fall into the hands of unauthorized third parties.
8.3 The duty of confidentiality does not apply to any information:
· which is already public at the time of disclosure by the Company;
· which becomes public after disclosure by the Company, without this resulting from a breach of confidentiality by the Consultant,
· which the Company has expressly approved for disclosure in writing,
· which the Consultant has received from other sources, lawfully and without confidentiality restrictions, provided that the third party who provided such information did not violate contractual agreements, statutory provisions or official orders in disclosing such information,
· which are developed by the Consultant independently without access to the Company's confidential information,
· which have to be disclosed due to legal requirements, including court orders. To the extent permitted, the Consultant will notify the Company of any obligation to disclose as early as possible and shall take such action as the Company may reasonably request to avoid or limit the disclosure and in relation to the content of the disclosure provide the best possible support in dealing with the disclosure obligation.
8.4 The Consultant is advised that in the course of her/his activities s/he must process personal data and special categories of personal data within the meaning of the UK GDPR, in particular through data collection, use, storage and transmission in strict compliance with the data protection agreement in the Annex ("DPA") and all applicable data protection laws.
8.5 The Consultant acknowledges that s/he has no rights to patient data and that s/he may not transfer such data to third parties or disclose such data to third parties.
8.6 The Consultant shall indemnify the Company and any of its affiliates (together, the "Indemnified Parties") on demand from and against any and all claims, demands, costs, proceedings, interest, fines and penalties, damages, direct and indirect losses, expenses (including reasonable legal or professional expenses) and liabilities ("Loss") of whatsoever nature incurred or suffered by the Indemnified Parties which arise (either directly or indirectly) out of, or in any way in connection with the breach by the Consultant of this section 8.
8.7 The Consultant acknowledges that the unauthorised disclosure or use of the Company's confidential information or personal data provided by the Company in connection with the Order could cause irreparable damage to the Company's business and goodwill for which damages are unlikely to be an adequate remedy and accordingly confirms that the Company is entitled to seek an injunction, specific performance or any other equitable relief in respect of any threatened, anticipated or actual breach of this section 8.
8.8 This section 8 shall continue to apply and survive the completion of an Order.
9. Return of property and documents
Upon the Company's request, the Consultant shall return to the Company all electronic files and other data and documents, correspondence, records, drafts as well as any software provided by the Company in connection with the Order and delete all files and other data as well as software and applications on any of her/his computers and other mobile devices. Upon the Company's request, the Consultant shall hand over to the Company any and all other items belonging to the Company or provided to him/her by the Company for use. There shall be no right of retention in this respect.
10. Approvals
The Consultant represents and warrants that the provision of the Services pursuant to the Order will not put the Consultant in breach of any obligations that s/he owes to a third party, including any employer and the Consultant shall indemnify the Indemnified Parties on demand from and against any and all Loss of whatsoever nature incurred or suffered by the Indemnified Parties arising from a breach by the Consultant of this representation and warranty.
PART 2: PERFORMANCE SPECIFICATION
11. Consultant's tasks
11.1 The Consultant's task is to instruct the respective patient in the operation and use of the LifeVest WCD in such a way that the patient is enabled to use the vest correctly, ensuring its proper functioning and optimal protection of the patient's life.
11.2 The Consultant may freely decide the way in which this task is achieved, and in doing so shall make use of her/his knowledge and adjust her/his approach to the respective patient and their previous knowledge or intellectual abilities in such a way that the aforementioned goals can be optimally achieved. However, during consultation, the Consultant shall observe the general abstract objectives of the consultation (see section 12 below) as well as the technical and medical specifications for the vest itself (section 13 below).
12. General objectives of the consultation
12.1 The Consultant is not subject to the Company's instructions regarding working hours, work schedule etc. in connection with his/her the performance of the Services. However, s/he is required to follow certain substantive guidelines regarding the manner of patient instruction to ensure that patients are property and timely instructed. To this end, the Consultant shall observe the general objectives of the consultation, as well as the technical and medical requirements for the vest itself:
· The focus must be on the benefit of the product for the patient - this is paramount.
· The actual safety aspect, functionality and quality of the LifeVest WCD should always be ad¬dressed.
· Permanent protection can be guaranteed only if the LifeVest WCD is worn regularly/ permanently and in the correct way. This should be clearly emphasized to the patient.
12.2 The Consultant is free to determine the course and duration of the consultation provided s/he adheres to the general objectives set out in this section 12. The Consultant may use experiences from previous work shadowing; however, s/he is not obliged to align his his/her own instructions entirely or partially with any consultations in which s/he participated during any observation period.
13. Contents of consulting
The content to be conveyed in the consultation is derived from the individual Order.
14. Use of the Company's software
In order to meet the high technical and legal requirements for processing and transmission of patient and health data, the Consultant is given access to a secure communication platform. Instructions for setup and use are provided to the Consultant. The Consultant shall install the associated software and/or app on her/his notebook or smartphone and shall communicate with the Company exclusively via this communication platform, using the associated software or app.
15. Training
The Company shall enable the Consultant to participate in training courses and workshops, in particular on data protection and the use of provided software.
PART 3: LIABILITY AND FINAL PROVISIONS
16. The Consultant shall be liable vis-à-vis the Company for any damage caused by the Consultant, his/her employees or any third parties (subcontractors) engaged by the Consultant in the performance of the Services.
17. Amendments or additions to these GTC must be made in writing to be valid. This also applies to the waiver of this written form requirement.
18. If individual provisions of these GTC are or become invalid as a whole or in part, this shall not affect the validity of the remaining provisions.
19. English law shall apply to all legal disputes concerning these GTC as well as claims arising under and in connection with these GTC or any Order. The Company and the Consultant each irrevocably agree that the courts of England have exclusive jurisdiction to settle any dispute arising out of or in connection with these GTC, an Order or any non-contractual obligation arising out of or in connection with them.
20. The activities within the scope of the Order shall be carried out exclusively on the basis of these GTC. The Consultant's terms and conditions, if any, shall not apply to the Order, even if the Company does not expressly object to their validity or application. Deviating or contradictory terms and conditions hence shall only apply if they have been accepted in writing by the Company.