Subscriptions Terms & Conditions

Knowledge Subscription, BSOL and Compliance Navigator Terms and Conditions

SUBSCRIPTION TO THE SERVICES IS GOVERNED BY THESE TERMS AND CONDITIONS (THE “TERMS”). EXECUTING OR INDICATING ACCEPTANCE OF AN ORDER FORM FOR ACCESS TO THE SERVICES CREATES A BINDING AGREEMENT BETWEEN THE PARTIES NAMED IN THE ORDER FORM. DEFINITION AND INTERPRETATION

1. DEFINITION AND INTERPRETATION

1. 1 The following definitions apply to these Terms:

Agreement: the agreement for Client’s use of the Services formed when the Order Form and these Terms are taken together.

Authorised Users: those fixed number of Client employees, agents and independent contractors authorised to use the Services as set out in the Order Form.

BSI: BSI Standards Limited a company incorporated in England and Wales (company number 07864997), whose registered office is 389 Chiswick High Road, Chiswick, London, WE 4AL.

BSOL: the British Standards Online service which allows the Client Authorised User to access to British and international standards documents, with search, browse, and email alerting features.

Business Day: a day other than a Saturday, Sunday or public holiday in England when banks in London are open for business.

Business Hours: 9.00 am to 5.00 pm each Business Day.

Client: the organisation who subscribes to the use of a Service via an Order Form and agrees to be bound by these Terms.

Client Data: the data provided by the Client during its use of the Service and for the purpose of facilitating the use of the Service.

Compliance Navigator: the online solution provided by BSI for the management of medical device compliance with relevant standards, EU & US regulatory information, and applicable guidance.

Data Protection Legislation: as applicable (i) EU Data Protection Laws, (ii) UK Data Protection Laws, and (iii) all other applicable laws relating to the Processing of Personal Data and privacy that may exist in any relevant jurisdiction from time to time, along with the guidance and codes of practice issued by the relevant supervising authority from time to time.

Documents: the documents made available to the Client by BSI as part of the Client’s subscription to the Service.

Effective Date: as detailed in the Order Form.

EU Data Protection Laws: all laws and regulations of the European Union, the European Economic Area and their member states applicable to the processing of Personal Data under this Agreement, including (where applicable) the GDPR.

Fees: the fees specified in the Order Form for Client’s subscription to the named Service.

GDPR: the General Data Protection Regulation (Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of Personal Data and on the free movement of such data). “Controller”, “Personal Data”, “Personal Data Breach” “Process/Processing” “Data Subjects” and “Processor” will have the meaning ascribed to them in the GDPR.

Initial Subscription Term: the period specified in the Order Form.

Intellectual Property Rights: any and all present and future, patents, inventions, know- how, trade secrets and other confidential information, trademarks, service marks, logos, emblems, badges, mascots, insignia, identifying music and sounds, get-up, domain names, business names, trade names, moral rights, performance rights, registered designs, copyrights, database rights, design rights and other intellectual property rights of whatever nature, in each case whether registered or unregistered and including applications for registration, and all rights or forms of protection having equivalent or similar effect anywhere in the world.

Knowledge Subscription: the BSI Knowledge subscription service which allows the Client to access British and international standard documents, with search, browse, and email altering features.

Order Form: the document, completed as part of the subscription to the Service containing Client specific information, such as the Fees and Subscription Term and which incorporate these Terms by reference. Renewal Term: the period described in clause 10.1.

Service: the BSOL, Knowledge Subscription or Compliance Navigator service. Subscriptions: the user subscriptions purchased by the Client pursuant to clause 7.1 which entitle Authorised Users to access and use the Services and the Documents in accordance with the Agreement. Subscription Term: The Initial Term or a Renewal Term.

UK Data Protection Laws: the GDPR as transposed into United Kingdom national law by operation of section 3 of the European Union (Withdrawal) Act 2018 and as amended by the Data Protection, Privacy and Electronic Communications (Amendments etc.) (EU Exit) Regulations 2019 (as amended by the Data Protection, Privacy and Electronic Communications (Amendments etc) (EU Exit) Regulations 2020) ("UK GDPR"), together with the UK Data Protection Act 2018 and other data protection or privacy legislation in force from time to time in the United Kingdom.

User Guide: the user guide and related documents designed to assist the Client to use the Services.

Virus: any code or malware whose purpose is to disable a computer or network or adversely affect its performance such as a computer virus, worm, 'trojan horse', back door or similar item which may impair or otherwise adversely affect the operation of any computer or network, prevent or hinder access to any program or data, impair the operation of any program or the reliability of any data (whether by re-arranging within the computer or any storage medium or device, altering or erasing, the program or data in whole or part or otherwise).

1.2 The clause headings in these Terms are included for convenience only and shall not affect the interpretation of these Terms.

1.3 A reference to a statute or statutory provision is a reference to it as amended or re-enacted. A reference to a statute or statutory provision includes all subordinate legislation made under that statute or statutory provision.

1.4 Any words following the terms including, include, in particular, for example or any similar expression shall be interpreted as illustrative and shall not limit the sense of the words preceding those terms.

1.5 In the event of a conflict between these Terms and the Order Form, these Terms shall prevail.

2. SUBSCRIPTIONS

2.1 For each Subscription, BSI hereby grants to the Client a non-exclusive, revocable, non-transferable right, without the right to grant sub licenses, to permit the Authorised Users to use the Services and the Documents during the Subscription Term solely for the Client's internal business operations.

2.2 BSI will ensure that the Client can access the Services either by issuing the Client a password or the means to self-register to access the Services for each Authorised User.

2.3 In relation to the Authorised Users, the Client undertakes that:

2.3.1 the maximum number of Authorised Users that it permits to access and use the Services and the Documents shall not exceed the number of users specified in the Order Form;

2.3.2 unless a Subscription is specified to be an institutional login tied to an IP address, it shall procure that each Authorised User’s login details remains personal to such user and is never shared with any other party for accessing the Services and/or Documents;

2.3.3 unless a User Subscription is specified to be an institutional login tied to an IP address, it shall maintain a written, up to date list of current Authorised Users and provide such list to BSI within 5 Business Days of BSI's written request;

2.3.4 it shall permit BSI or BSI's designated auditor to audit the Client’s use of the Services in order to confirm compliance with the Agreement. Each such audit may be conducted no more than once per quarter, at BSI's expense, and this right shall be exercised with reasonable prior notice, in such a manner as not to substantially interfere with the Client's normal conduct of business; and

2.3.5 it shall procure and be liable for each Authorised User’s acceptance and compliance with any additional user terms (the “User Terms”) that BSI makes available to an individual user of its Service platforms.

2.4 The Client shall not:

2.4.1 except as may be allowed by any applicable law which is incapable of exclusion by agreement between the parties and except to the extent expressly permitted under the Agreement:

(a) attempt to copy, scan, modify, duplicate, create derivative works from, frame, mirror, publish, republish, download, license, sell, lease, give, disseminate, assign (directly or indirectly), display, transmit, or distribute all or any portion of the Services and/or Documents (as applicable) in any form or media or by any means; or (b) attempt to de-compile, reverse compile, disassemble, reverse engineer or otherwise reduce to human-perceivable form all or any part of the software; or

2.4.2 access all or any part of the Services and Documents in order to build a product or service which competes with the Services and/or the Documents; or

2.4.3 use the Services to provide services to third parties; or

2.4.4 subject to clause 16.1, license, sell, rent, lease, transfer, assign, distribute, display, disclose, or otherwise commercially exploit, or otherwise make the Services and/or Documents available to any third party except the Authorised Users, or

2.4.5 remove any proprietary legends or markings, including, but not limited to, copyright notices, electronically encoded information, watermarks or any specific markings of BSI; or

2.4.6 attempt to obtain, or assist third parties in obtaining, access to the Services and/or Documents, other than as provided under this clause 2.

2.5 The Client shall use all reasonable endeavours to prevent any unauthorised access to, or use of, the Services and, in the event of any such unauthorised access or use, promptly notify BSI.

2.6 The Client acknowledges that neither they nor any Authorised Users have any ownership rights conferred upon them whatsoever in respect of the Services or Documents.

3. SERVICES

3.1 BSI shall, during the Subscription Term, provide the Services and make the Documents available to the Client and subject to the terms of the Agreement.

3.2 BSI shall use reasonable endeavours to make the Services available 24 hours a day, seven days a week, except for:

3.2.1 planned maintenance; and

3.2.2 unscheduled maintenance performed outside Business Hours.

3.3 BSI reserves the right to make changes to any part of the Service that it deems necessary or useful without any notification to the Client.

4. CLIENT DATA

4.1 As between the parties, the Client shall own all right, title and interest in and to all of the Client Data.

4.2 Each party warrants that for the purposes of the Agreement it:

4.2.1 shall comply with the provisions of the Data Protection Legislation, including without limitation that it:

(a) shall use Personal Data in accordance with the permissions or consents obtained from the Data Subjects or such other lawful basis as allowed under applicable Data Protection Legislation;

(b) shall communicate to the other party the terms of any permissions or consents (where used as the lawful basis for data processing) obtained from the Data Subjects;

(c) shall have in place appropriate technical and organisational security measures against unauthorised or unlawful Processing of Personal Data and against accidental loss or destruction of, or damage to, Personal Data and shall take all reasonable steps to ensure the reliability of its personnel who have access to such Personal Data and to impose obligations of confidentiality upon such personnel and to ensure that such personnel are aware of their responsibilities under the Data Protection Legislation;

(d) shall not transfer Personal Data outside the United Kingdom or the European Economic Area save in accordance with the Data Protection Legislation; and

(e) shall comply with any request or notice it receives from a Data Subject in its capacity as a Controller

4.2.2 shall upon request provide such assistance as is reasonably necessary to the other party to enable that party to comply with its obligations as a Controller;

4.2.3 shall inform the other party as soon as reasonably practicable of the discovery of any actual or suspected data-breach relating to the Processing of Personal Data in connection with the Agreement;

4.2.4 shall, except to the extent prohibited by applicable law, inform the other party upon receipt of a complaint from a data subject or if approached by any regulatory body in connection with its compliance with the Data Protection Legislation in connection with the Agreement; and

4.2.5 shall, except to the extent prohibited by applicable law, consult the other party in good faith as to the timing, manner and content of any response to a complaint from a data subject or approach by any regulatory body in connection with compliance with the Data Protection Legislation in connection with the Agreement.

5. BSI’S OBLIGATIONS

5.1 BSI undertakes that the Services will be performed with reasonable skill and care. BSI:

5.1.1 does not warrant that the Client's use of the Services will be uninterrupted or error-free; or that the Services, Documents and/or the information obtained by the Client through the Services will meet the Client's requirements;

5.1.2 provides no warranties in respect of the accuracy of the Documents and/or their contents; and

5.1.3 is not responsible for any delays, delivery failures, or any other loss or damage resulting from the transfer of data over communications networks and facilities, including the internet, and the Client acknowledges that the Services and Documents may be subject to limitations, delays and other problems inherent in the use of such communications facilities.

6. CHARGES AND PAYMENT

6.1 The Client shall pay the Fees, which are non-refundable, to BSI for the Subscriptions, in accordance with this clause 6 and the Order Form.

6.2 The Client shall pay the Fees within 30 days from the date of the invoice.

6.3 If BSI has not received payment within 30 days of the due date, without prejudice to any other rights and remedies:

6.3.1 BSI may, without liability to the Client, disable the Client's password, account and access to all or part of the Services and BSI shall be under no obligation to provide any or all of the Services while the amounts due remain unpaid; and

6.3.2 interest shall accrue on a daily basis on such due amounts at an annual rate of 3 percent over the then current base lending rate of Barclays Bank plc (or its successor) from time to time, commencing on the due date and continuing until fully paid, whether before or after judgment.

6.4 The Fees do not include, and the Client is solely responsible for, all applicable taxes including, value added tax and other sales taxes.

6.5 BSI shall be entitled to increase the Fees at the start of each Renewal Term upon 60 days' prior notice to the Client and the Order Form shall be deemed to have been amended accordingly.

6.6 The Client shall only be entitled to decrease the number of Authorised Users under a Subscription by providing BSI with notification, in writing, at least 30 days before the end of the Initial Subscription Term or any Renewal Term.

7. PROPRIETARY RIGHTS

7.1 The Client acknowledges and agrees that BSI and/or its licensors own all Intellectual Property Rights in the Services and the Documents. Except as expressly stated herein, the Agreement does not grant the Client any rights to, under or in, any patents, copyright, database right, trade secrets, trade names, trademarks (whether registered or unregistered), or any other rights or licences in respect of the Services or the Documents.

7.2 BSI may impose security measures it reasonably deems appropriate to ensure compliance with the Agreement, including but not limited to covert and overt copy-detection; licence awareness technology and encoding of requestor/user information in printed and electronic formats. Any attempt to circumvent such access restrictions or any other of BSI's security measures will be considered a material breach of the Agreement.

7.2.1 The Client acknowledges that the Client is not authorised to transmit the Documents electronically or by any other means in any form to any party who is not an Authorised User.

7.3 The Client may make a reasonable number of copies of the User Guide, provided all such copies include all legends, copyright and other proprietary notices that appear on the original User Guide.

7.4 BSI may use software, programs or access management tools to verify the Client’s compliance with the Agreement.

8. CONFIDENTIALITY

8.1 Each party may be given access to confidential information from the other party in order to perform its obligations under the Agreement. A party's confidential information shall not be deemed to include information that:

8.1.1 is or becomes publicly known other than through any act or omission of the receiving party;

8.1.2 was in the other party's lawful possession before the disclosure;

8.1.3 is lawfully disclosed to the receiving party by a third party without restriction on disclosure; or

8.1.4 is independently developed by the other party, and such independent development can be shown by written evidence.

8.2 Subject to clause 8.3, each party shall hold the other's confidential information in confidence and not make the other's confidential information available to any third party, or use the other's confidential information for any purpose other than the implementation of the Agreement.

8.3 A party may disclose confidential information to the extent such confidential information is required to be disclosed by law, by any governmental or other regulatory authority or by a court or other authority of competent jurisdiction, provided that, to the extent it is legally permitted to do so, it gives the other party as much notice of such disclosure as possible and, where notice of disclosure is not prohibited and is given in accordance with this clause 8.3, it takes into account the reasonable requests of the other party in relation to the content of such disclosure.

8.4 The content of this clause 8 shall survive termination of the Agreement, however arising.

9. LIMITATION OF LIABILITY

9.1 Except as expressly and specifically provided under the Agreement:

9.1.1 the Client assumes sole responsibility in connection with its use of the Services and/or Documents, and for conclusions drawn from such use;

9.1.2 the Client assumes sole responsibility for results obtained from the use of the Services and the Documents by the Client, and for conclusions drawn from such use. BSI shall have no liability for any damage caused by errors or omissions in any information, instructions or scripts provided to BSI by the Client in connection with the Services, or any actions taken by BSI at the Client's direction;

9.1.3 BSI shall not be liable for any damage caused or costs incurred through the use of the content of the Documents and/or Services. The Client assumes responsibility to conduct the necessary research and confirmations and should not rely solely on the contents of the Documents alone;

9.1.4 all warranties, representations, conditions and all other terms of any kind whatsoever implied by statute or common law are, to the fullest extent permitted by applicable law, excluded from the Agreement; and

9.1.5 the Services and the Documents are provided to the Client on an "as is" basis.

9.2 Nothing in the Agreement limits any liability which cannot legally be limited, including, but not limited to, liability for:

9.2.1 death or personal injury caused by negligence; or

9.2.2 fraud or fraudulent misrepresentation.

9.3 Subject to clause 9.2:

9.3.1 BSI shall not be liable whether in tort (including for negligence or breach of statutory duty), contract, misrepresentation, restitution or otherwise for any loss of profits, loss of business, depletion of goodwill and/or similar losses or loss or corruption of data or information, or pure economic loss, or for any special, indirect or consequential loss, costs, damages, charges or expenses however arising; and

9.3.2 BSI's total aggregate liability in contract, tort (including negligence or breach of statutory duty), misrepresentation, restitution or otherwise, arising in connection with the Agreement shall be limited to the total Fees paid for the Subscription to the Service during the 12 months immediately preceding the date on which the claim arose.

9.4 BSI is not aware of any inherent risk of viruses in the pdf files forming the Documents at the time they are downloaded. BSI has exercised due diligence to ensure, so far as practicable, that such files do not contain such viruses.

9.5 The terms implied by sections 13 to 15 of the Sale of Goods Act 1979 and sections 3 and 4 of the Supply of Goods and Services Act 1982 are, to the fullest extent permitted by law, excluded from the Agreement.

9.6 This clause 9 shall survive termination of the Agreement.

10. TERM AND TERMINATION

10.1 The Agreement shall, unless otherwise terminated as provided in this clause 10, commence on the Effective Date and continue for the Initial Subscription Term and, thereafter, shall automatically renew for a successive renewal term equal to the Initial Subscription Term, but in no event less than 12 months (each a “Renewal Term”), unless either party notifies the other party of termination, in writing, at least 30 days before the end of the Initial Subscription Term or any Renewal Term, in which case the Agreement shall terminate upon the expiry of the applicable Initial Subscription Term or Renewal Term.

10.2 Without affecting any other right or remedy available to it, either party to the Agreement may terminate it with immediate effect by giving written notice to the other party if:

10.2.1 the other party commits a material breach of any term of the Agreement which breach is irremediable or (if such breach is remediable) fails to remedy that breach within a period of 30 days after being notified in writing to do so;

10.2.2 the other party takes any step or action in connection with its entering administration, provisional liquidation, bankruptcy or any composition or arrangement with its creditors (other than in relation to a solvent restructuring), being wound up (whether voluntarily or by order of the court, unless for the purpose of a solvent restructuring), having a receiver appointed to any of its assets or ceasing to carry on business or, if the step or action is taken in another jurisdiction, in connection with any analogous procedure in the relevant jurisdiction;

10.2.3 the other party suspends, or threatens to suspend, or ceases or threatens to cease to carry on all or a substantial part of its business; or

10.2.4 in the event of any governmental prohibition or required alteration of the Documents or Services.

10.3 In addition to any of the remedies available to BSI at law or in equity, BSI may immediately and without notice terminate, suspend, restrict or limit access to any or all of the Services and/or Documents or require additional user registration or authentication information if:

10.3.1 BSI has reasonable evidence of the Client's breach of BSI's or its licensor’s Intellectual Property Rights or fraudulent or illegal use of the Documents and/or Services;

10.3.2 BSI determines that the Client has allowed or permitted access to the Services in violation of the Agreement; or

10.3.3 it is required to do so by any legal or regulatory authority.

10.4 Without affecting any other right or remedy available to it, BSI may terminate the Agreement with immediate effect by giving written notice to the Client if the Client fails to pay any amount due under the Agreement, within 30 days of receiving an invoice.

10.5 Notwithstanding any termination or suspension of the Agreement in relation to all or any part of the Documents and/or Services, all Terms will continue to apply to any Documents or Services not so terminated, and in particular, but without limitation, the Client shall not be relieved from any liability incurred prior to such termination or suspension, or for payment for any Documents or Services not affected by any such termination or suspension.

10.6 On termination of the Agreement:

10.6.1 all licences granted under the Agreement shall immediately terminate and the Client shall immediately cease all use of the Services and/or the Documents;

10.6.2 the Client shall make no further use of the Documents and shall ensure that all copies of the Documents and/or extracts copied (whether in electronic or hard copy form) are destroyed and deleted (including but not limited to data, software, hard copy documents and any other documentation) and purge any Documents from all electronic media or document to which they have been copied;

10.6.3 the Client shall provide written notice to BSI certifying that they have complied with this clause 10.6; and

10.6.4 any provision of the Agreement that expressly or by implication is intended to come into or continue in force on or after termination of the Agreement shall remain in full force and effect.

10.7 Termination of the Agreement shall not affect any of the rights, remedies, obligations or liabilities of the parties that have accrued up to the date of termination, including the right to claim damages in respect of any breach of the Agreement which existed at or before the date of termination.

11. FORCE MAJEURE

BSI shall have no liability to the Client under the Agreement if it is prevented from or delayed in performing its obligations under the Agreement, or from carrying on its business, by acts, events, omissions or accidents beyond its reasonable control, including, without limitation, strikes, lock-outs or other industrial disputes (whether involving the workforce of BSI or any other party), failure of a utility service or transport or IT or telecommunications network, act of God, war, riot, civil commotion, malicious damage, compliance with any law or governmental order, rule, regulation or direction, accident, breakdown of plant or machinery, fire, flood or storm provided that the Client is notified of such an event and its expected duration.

12. VARIATION

BSI may vary the Agreement from time to time on giving the Customer at least 7 days’ notice in writing provided that any variation required by applicable law will be effective immediately.

13. WAIVER

No failure or delay by a party to exercise any right or remedy provided under the Agreement or by law shall constitute a waiver of that or any other right or remedy, nor shall it prevent or restrict the further exercise of that or any other right or remedy. No single or partial exercise of such right or remedy shall prevent or restrict the further exercise of that or any other right or remedy.

14. SEVERANCE

14.1 If any provision or part-provision of the Agreement is or becomes invalid, illegal or unenforceable, it shall be deemed deleted, but that shall not affect the validity and enforceability of the rest of the Agreement.

15. ENTIRE AGREEMENT

15.1 The Agreement constitutes the entire agreement between the parties and supersedes and extinguishes all previous agreements, promises, assurances, warranties, representations and understandings between them, whether written or oral, relating to its subject matter.

15.2 Each party acknowledges that in entering into the Agreement it does not rely on, and shall have no remedies in respect of, any statement, representation, assurance or warranty (whether made innocently or negligently) that is not set out in the Agreement.

16. ASSIGNMENT

16.1 The Client shall not, without the prior written consent of BSI, assign, transfer, charge, deal in any other manner with or sub-contract all or any of its rights or obligations under the Agreement, such consent may be withheld in BSI's sole discretion and subject to any necessary recalculation of the Fees.

16.2 The Client shall not grant affiliates, subsidiaries or successors-in-interest any right to use the Documents or Services without the prior written consent of BSI, which may be withheld at BSI's sole discretion, and subject to any necessary recalculation of the Fees.

16.3 BSI may at any time assign, transfer, charge, deal in any other manner with or sub-contract all or any of its rights or obligations under the Agreement.

17. NO PARTNERSHIP OR AGENCY

Nothing in the Agreement is intended to or shall operate to create a partnership between the parties, or authorise either party to act as agent for the other, and neither party shall have the 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).

18. THIRD PARTY RIGHTS

The Agreement does not confer any rights on any person or party, other than the Parties to the Agreement and, where applicable, their successors and permitted assigns.

19. NOTICES

19.1 Any notice required to be given under the Agreement shall be in writing and shall be delivered by hand or sent by pre-paid first-class post, recorded delivery or email to the other party at its address set out in the Agreement, or such other address as notified by that party for such purposes during the Subscription Term.

19.2 A correctly addressed notice sent by pre-paid first-class post or recorded delivery shall be deemed to have been received on the second Business Day after posting. A notice sent by email shall be deemed to have been received at the time of transmission (as shown by the time sent in respect of an email).

20. GOVERNING LAW

The Agreement and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) shall be governed by and construed in accordance with the law of England and Wales.

21. JURISDICTION

Each party irrevocably agrees that the courts of England and Wales shall have exclusive jurisdiction to settle any dispute or claim arising out of or in connection with the Agreement or its subject matter or formation (including non-contractual disputes or claims).

Any enquiries relating to these Terms and Conditions should be addressed to:

BSI Licensing Department, BSI Standards Limited

389 Chiswick High Road, London, W4 4AL, United Kingdom

Tel: +44 (0) 20 8996 7070

Email: copyright@bsigroup.com