Member Rules
Version 6.3, October 2022
Whereas:
1.1 Sphera has developed a Substance Compliance Platform (BOMcheck.com including all Sphera owned sub and associated domains) which enables Members to upload their substances declaration data to one location for all participating parties to access.
1.2 The Member wishes to access the Platform and upload their substances declarations data.
1.3 A Member who wishes to join the Platform must appoint an Authorised Individual with the authority to access the Platform and upload Data on behalf of the Member. When a company becomes a Member of the Platform, Sphera will check the identity of the Member and validate the email address of the Authorised Individual which will allow authorised electronic signatures for the Authorised Individual. This electronic signature will be attached to all Data that the Authorised Individual will upload to the Platform on behalf of the Member. This ensures Sphera BOMcheck services comply with Title 21 CFR Part 11 of the US Code of Federal Regulations, which defines criteria under which the FDA accept:
"electronic records and electronic signatures as trustworthy, reliable and equivalent to paper records and handwritten signatures executed on paper."
These Member Rules set out the terms and conditions for a company to become a Member of Sphera's BOMcheck Platform.
1. Interpretation
1.1 In these Member Rules, unless the context requires otherwise:
"Authorised Individual" means the Member employee who the Member appoints with the authority to access the Platform and upload Data on behalf of the Member;
"Data" means the Member’s substance declarations data that the Member wishes to make available to participating manufacturers;
"Platform" means the Sphera BOMcheck Substance Compliance Platform located accessible from sphera.BOMcheck.com;
"Sphera" means Sphera Compliance Limited, a company registered in England and Wales with number 9701701 whose registered office is at 4 Coleman Street, 6th Floor, London, England, EC2R 5AR
"Member" means a company who joins the Platform subject to the terms and conditions in these Member Rules and who has paid the annual subscription fee by credit card, wire transfer or by invoice.
"Membership" means a Member's authorised participation in the Platform.
2. Admission of Members
2.1 The Member will appoint an Authorised Individual who will have the authority to access the Platform and upload Data on behalf of the Member. This appointment will be confirmed on the Member’s application form.
2.2 The Authorised Individual will complete an on-line application form for Membership of the Platform. The application form requires the Authorised Individual to confirm that the Member has read, understood and agrees to abide by all of these Member Rules and that the Authorised Individual has read, understood and freely consents to the use and transfer of Personal Data in accordance with the Rules. A copy of these Member Rules is posted can be found at https://sphera.bomcheck.com/legal/member-rules.
2.3 The application form requires the Authorised Individual to confirm that pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations the Member intends that all electronic signatures provided by the Authorised Individual are the legally binding equivalent of traditional handwritten signatures.
2.4 The Member acknowledges that it will be entitled to the benefits of Membership and will be bound by these Member Rules from the date of the first occasion when the Member pays the subscription fee by credit card.
2.5 When the Authorised Individual completes an application to join the Platform a document containing the Member’s application details is generated in pdf format. The Authorised Individual will sign a paper copy of this pdf document and return it by fax or e-mail to Sphera within 14 days. Sphera reserves the right to suspend or terminate a Membership if the Member’s signed application document is not received at Sphera's offices within 14 days of the first occasion when the Member pays the annual subscription fee by credit card.
2.6 Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, the Member authorises Sphera to submit a paper copy of the application form document, signed by the Authorised Individual, to the US FDA, Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.
2.7 All applicants for Membership will include a valid D-U-N-S® number on their application form. A D-U-N-S® number is a unique nine-digit identification number which provides unique identifiers of single business entities, while linking corporate family structures together. The D-U-N-S® number system is administered by Dun & Bradstreet and is available at www.dnb.com.
2.8 Sphera will check the identity of the Member by verifying the Member’s D-U-N-S® number against the company name and address details. Sphera reserves the right to suspend or terminate a Membership if Sphera finds, or has reasonable cause to suspect, that any details on the Members application document are inaccurate or incomplete.
2.9 The Authorised Individual will have a unique company e-mail address. Applications for Membership which include a generic e-mail addresses (e.g. info@supplier.com) will not be accepted by Sphera. Sphera will validate the e-mail address of the Authorised Individual and will establish an electronic signature for the Authorised Individual. This electronic signature will be attached to all Data that the Authorised Individual will upload to the Platform on behalf of the Member.
3. Use of Platform
3.1 In consideration of, and subject to, the Member complying with its obligations set out in these Member Rules, Sphera hereby grants to the Member a single-user, non-exclusive, non-transferable licence to access the Platform and upload Data to the Platform during the term in accordance with these Member Rules.
3.2 Sphera will provide the Authorised Individual with a login (which will be the Authorised Individual’s business e-mail address) and password to enable the Authorised Individual to access the Platform and upload the Member’s Data to the Platform. The Authorised Individual will change their password at the end of each quarter.
3.3 Sphera will use reasonable endeavours to provide access to the Platform on a continuous basis, subject to the terms of these Member Rules. If the Platform becomes unavailable or is inoperative, in full or in part for any reason, Sphera will use reasonable endeavours to rectify faults or problems or restore the Platform to full operational capacity as soon as reasonably practicable. The Member acknowledges that the Platform may be unavailable during such times.
3.4 The Platform was developed under the consideration of the highest appropriate technical information security principles available on the market. For the purpose of improving security, Sphera reserves all rights to further update the Platform security in line with appropriate standards of information technology. Sphera shall notify the Member of any significant reduction in services to improve the system’s security within a reasonable period of time.
3.5 The Member acknowledges that use of the Platform by manufacturers is at the manufacturers' option and that in selecting a supplier, a manufacturer exercises its own skill and judgement. As a consequence, Sphera makes no warranties (express or implied) as to the likelihood of any manufacturer procuring products from the Member. 4 Member obligations and restrictions.
4.1 The Member undertakes to take all necessary steps to ensure that the Authorised Individual does not divulge their password to any other person or allow any other person access to the Platform. If the Member becomes aware or suspects that the Authorised Individual’s password has been disclosed to any other person, or unauthorised access has taken place, the Member will report this immediately to Sphera so that the password can be changed and/or another Member employee appointed as the Authorised Individual.
4.2 The Member accepts and acknowledges that any failure by the Member to comply with Member Rule 4.1 will result in suspension of the Members access to the Platform by Sphera and the Member will not regain access to the Platform, unless it has been authorised to do so by Sphera.
4.3 The Member undertakes to ensure that the Authorised Individual will change their password at the end of each quarter.
4.4 The Member will maintain the appointment of an individual Member employee as the Authorised Individual at all times. The Member will inform Sphera immediately if there is a need to appoint another employee as the Authorised Individual for any reason.
4.5 The Member acknowledges that it is entirely responsible for all access to the Platform that is facilitated by the Authorised Individual’s login and password (whether such access is with or without the Member’s consent). Unless provided for otherwise below, Sphera will not be liable for any loss that the Member may incur as a result of someone else using the Authorised Individual’s login and password, either with or without the Member’s knowledge. Sphera will, within the limitations set out in Member Rule 10, be liable if the unauthorised use of the Authorised Individual’s login and password is due to Sphera’s intentional or grossly negligent conduct.
4.6 In the event of negligence or wilful misconduct of the Member, the Member may be held liable for losses incurred by Sphera due to someone else using the Authorised Individual’s login and password. For the avoidance of doubt, the Member will not be liable for any loss of Data caused by any third party outside the Member’s sphere and not attributable to the Member.
4.7 For the avoidance of doubt, Sphera will not be liable under any circumstances for any unauthorised access to the Data via the Platform in circumstances where the Member had not maintained the appointment of an individual Member employee as the Authorised Individual at all times, or an Authorised Individual had disclosed the password to any other person or allowed access to any other person.
5. Data Protection and Accuracy
5.1 The Member warrants that it has obtained and will maintain all consents, authorisations, licences and approvals necessary to allow:
5.1.1 the uploading of the Data to the Platform;
5.1.2 Sphera to distribute the Data via the Platform; and
5.1.3 manufacturers to use the Data.
5.2 The Member will use all reasonable endeavours to ensure that the Data uploaded to the Platform is accurate, current, and complete and is supplied in a timely manner in accordance with requests from the Platform.
5.3 The Member will promptly notify Sphera if it has, or has reason to believe that it has, contributed inaccurate, incomplete or misleading Data, and will then upload the corrected Data onto the Platform as soon as is reasonably practicable.
5.4 In the event that any error in the Data is notified to the Member by Sphera or a third party, the Member will correct such error as soon as is reasonably practical.
5.5 Sphera is responsible for the system functionality, but has no responsibility for the Data content entered by the Member. In any case Sphera can provide traceability of Data origin through identification of the Data providing Member and the Data input / modification date.
5.6 Under consideration of Member Rule 4.5, Sphera will take adequate measures to ensure that the Data that the Member provides into the Platform can only be completed, changed or in any other way modified by the Member.
5.7 Sphera will not use any other means to distribute the Member’s Data except via the Platform. Sphera will not provide the Member’s Data to any party who has not signed a Manufacturer’s Agreement to use the Platform. Sphera will not in any way sell, transfer, (sub-)license or otherwise commercially exploit the Data provided into the Platform.
5.8 Sphera will treat any Data in the Platform as strictly confidential and will not access the Member’s account unless instructed to do so by the Member. Exception to this is system statistics calculation such as e.g. number of Regulatory Compliance Declarations, number of Full Materials Declarations etc. Furthermore Sphera’s internal access to Data is restricted to specially selected persons that may need access under supervision of security personnel for system maintenance purposes.
5.9 Without prejudice to the confidentiality restrictions in Member Rule 5.8, Sphera is entitled to review any Data provided into the Platform in order to check whether these Data have been provided in compliance to these Member Rules; Sphera will only review such Data if there are indications that a Member does not comply with these Member Rules.
6. Term and Termination of Membership
6.1 Membership will commence on the date of the first occasion when the Member pays the annual subscription fee by credit card and will continue for an initial period of twelve (12) months ("Initial Period") unless terminated earlier in accordance with these Member Rules. Following the Initial Period, either Sphera or the Member may terminate the Membership for convenience on three (3) months' written notice.
6.2 Sphera can terminate a Membership immediately by notice in writing if:
6.2.1 the Member’s signed application document is not received at Sphera’s offices within 14 days of the first occasion when the Member pays the annual subscription fee by credit card;
6.2.2 Sphera finds, or has reasonable cause to suspect, that any details on the Member’s application document are inaccurate or incomplete;
6.2.3 the Member fails to make payments by credit card within 14 days of the due date;
6.2.4 the Member commits a material breach of any of its obligations under these Member Rules which is incapable of remedy;
6.2.5 the Member is in material breach or continuing breach of any of its obligations under these Member Rules and fails to remedy the breach (if capable of remedy) within a period of 14 days after receiving written notice from Sphera;
6.2.6 the Member becomes subject to an administration order; a receiver or administrative receiver or similar is appointed over, or an encumbrancer takes possession of any of the Member’s assets or property; or the Member enters into an arrangement or composition with its creditors, ceases or threatens to cease to carry on business, becomes insolvent; or any similar event occurs in any other relevant jurisdiction.
6.3 Upon termination of a Membership in accordance with Member Rule 6, Sphera will disable the Member’s login and password and the Member will immediately cease accessing and using the Platform.
6.4 Any Member will, upon ceasing to be a Member of the Platform, forfeit all rights to any claim to a refund of the annual subscription fee.
6.5 Sphera will not be liable for any loss (including indirect or consequential), damage, delay, loss of market, costs or expenses of whatsoever nature or kind and howsoever sustained or occasioned by the Member by virtue of the termination of their Membership under Member Rule 6.
6.6 Termination of a Membership will be without prejudice to the accrued rights of Sphera and the Member and will not affect any rights or liabilities of Sphera or, subject to Member Rule 6.4, the Member existing prior to the date of termination.
6.7 Any provision of these Member Rules which expressly or by implication is intended to come into force on or after termination of a Membership will remain in full force and effect notwithstanding the termination.
7. Financial Matters
7.1 The Member will pay the annual subscription fee at the rates published by Sphera from time to time on sphera.BOMcheck.com.
7.2 All annual subscription fees and other sums payable under these Member Rules by Members to Sphera will be paid by credit card on sphera.BOMcheck.com or by wire transfer using Bank details supplied by Sphera or by invoice.
7.3 All sums quoted or charged are exclusive of Value Added Tax ("VAT"). The Member will be responsible for paying VAT.
8. Warranties
8.1 Sphera and the Member warrant to each other that:
8.1.1 it has full capacity and authority to perform its obligations pursuant to these Member Rules;
8.1.2 it will discharge its obligations under these Member Rules with all due skill, care, and diligence and in accordance with its own established internal procedures; and
8.1.3 it has obtained and will keep in force all necessary consents, licences and permissions to enable it to perform its obligations pursuant to these Member Rules.
9. Intellectual Property
9.1 The Member acknowledges that Sphera has spent and continues to spend considerable time and resources on the selection and arrangement of the Platform as an original intellectual creation. Accordingly, Sphera owns the copyright, database rights and all other intellectual property rights in the selection and arrangement of the Platform and in the electronic materials necessary for its operation (without prejudice to the rights of the various suppliers in the Platform).
9.2 The Member acknowledges that the intellectual property rights subsisting in or used in connection with the Platform (including the manner in which it is presented or appears) and all information, documentation and manuals relating thereto are (unless another owner is specified therein) the property of Sphera or such other third party as the case may be (the "Owner") and the Member will not during or at any time after the expiry of their Membership in any way question or dispute ownership by Sphera or the Owner, as the case may be, of any such rights.
9.3 The Member will not during or after the termination of its Membership abuse or permit the abuse of such Sphera or Owner intellectual property rights nor adopt any trade mark, trade name or commercial designation that includes or is similar to or may be mistaken for the whole or any part of any trade mark, trade name or commercial designation used by Sphera.
9.4 Any trademarks or logos (the “Trademarks”) displayed on the Platform are either the property of, or used with permission by Sphera. The Member acknowledges that any Trademarks displayed on the Platform may not be used without the written permission of Sphera or such third party that may own the Trademarks.
10. Limitation of Liability
10.1 Subject to Member Rule 10.3, the total aggregate liability of Sphera to the Member, and vice versa, arising in connection with the performance of these Member Rules will not exceed one million euros (€1,000,000) in any twelve (12) month period. Notwithstanding the foregoing, Sphera will not be liable to the Member, and vice versa, for loss of profits, business, contracts or for any indirect or consequential loss caused in any way by any act or omission committed in connection with these Member Rules (whether arising from negligence, breach of contract, statutory duty or otherwise).
10.2 Nothing in these Member Rules is intended and nor will it be construed as an attempt by either Sphera or the Member to exclude or limit its liability for any liability which cannot be excluded or limited under applicable law, including without limitation its liability for death or personal injury caused by its negligence or for its fraudulent misrepresentation.
10.3 The Member will at all times during and after the term of its Membership, on written demand indemnify Sphera and keep Sphera indemnified against all losses, costs, damages, expenses and other liabilities (including legal fees) incurred by Sphera arising from any breach by the Member of Member Rule 4.1 and Member Rule 9.
11. No Partnership
11.1 Nothing in these Member Rules is intended to or will operate to create a partnership or joint venture of any kind between Sphera and the Member, or to authorise any one to act as agent for the other. Neither Sphera nor the Member will have authority to act in the name or on behalf of or otherwise to bind the other in any way (including but not limited to the making of any representation or warranty, the assumption of any obligation or liability and the exercise of any right or power).
12. Antitrust Guidelines
12.1 Sphera and the Member acknowledge that industry forums which are designed to share information can give rise to “Antitrust risk”, in particular in relation to allegations of collusion by participants in the same market. Accordingly, Sphera and the Member agree to comply with the Antitrust Guidelines contained in Schedule 1.
13. Notices
13.1 Any notice to be given under these Member Rules by either Sphera or the Member will be in writing and signed by or on behalf of the party giving it and will be served by delivering it personally or by sending it by pre-paid recorded delivery or registered post or by fax to the address and for the attention of the relevant party. Any such notice will be deemed to have been received:
- if delivered personally, at the time of delivery;
- in the case of pre-paid recorded delivery or registered post, forty eight (48) hours from the date of posting; and
- in the case of fax, at the time of transmission.
13.2 For the avoidance of doubt, operational communications may be by e-mail, but any notice of failure, breach or termination will be subject to the provisions of Member Rule 14.1.
14. Assignment
14.1 The Membership and all the rights, benefits and obligations of the Member may not be assigned, transferred or novated without the prior written consent of Sphera.
15. Severability
15.1 If any of the terms in these Member Rules are judged to be illegal or unenforceable, that term will, to that extent, be deemed not to form part of the Member Rules and the enforceability of the remainder will not be affected.
16. Force Majeure
16.1 Neither Sphera nor the Member will be liable to the other party for any delay in or any failure to perform its obligations (other than payment of money) as a result of any act of god, war, terrorism, riot, or civil commotion but only to the extent that the same was not caused by the party seeking relief. If such delay or failure continues for at least sixty (60) days, either Sphera or the Member will be entitled to terminate the Membership by notice in writing.
17. Entire Agreement
17.1 These Member Rules constitute the entire agreement between Sphera and the Member and supersede all prior agreements and understandings between Sphera and the Member in connection with the subject matter hereof.
18. No Waiver
18.1 No forbearance or delay by either Sphera or the Member in enforcing its respective rights will prejudice or restrict the rights of Sphera or the Member, and no waiver of any such rights or of any breach of any contractual terms will be deemed to be a waiver of any other right or of any later breach.
19. Applicable Law and Jurisdiction
19.1 These Member Rules and all rights and obligations of the Member and Sphera hereto will be governed and construed in accordance with the laws of England and Wales and the Member and Sphera hereby submit to the non-exclusive jurisdiction of the English courts as regards any claim, dispute or matter arising out of or relating to these Member Rules and their implementation or effect.