Clinical Trial Supply – Bionical Emas’ Portal Terms of Use for Healthcare Practitioners and Institution Only

Definitions

• In these Terms (as defined below), the following words and phrases shall have the following meanings:

Applicable Laws: all applicable laws, statutes, regulations and regulatory requirements from time to time in force.

Bionical Emas: the company which is contracted by the Sponsor to supply Product(s) to the Institution for the purpose of the Study, and which is Bionical Limited, a company registered in England and Wales under registration number 07059600 and whose registered office and main trading office is at the Piazza, Mercia Marina, Findern Lane, Willington DE65 6DW, UK or Bionical Emas, Inc. (an affiliate of Bionical Limited) whose trading office is 200 Grove Road, Suite A, Paulsboro, NJ 08066.

Bionical Emas’ Portal: Bionical Emas’ online clinical trial supply portal that allows Users to submit Requests.

Confidential Information: any information of a confidential nature concerning the business, affairs, customers, clients, patients or suppliers of Bionical Emas and/or Sponsor including but not limited to information relating to Bionical Emas’ and/or Sponsor’s operations, processes, plans, products, know-how, designs, trade secrets, software, market opportunities and customers.

Designated Delivery Address: the address of Institution where Products are to be delivered as selected by User on Bionical Emas’ Portal (and which address shall be licensed and regulated by the applicable regulatory authority to receive Products).

Institution: a hospital or other institution authorised by the Sponsor to receive Products for use in the applicable Study, and who is licensed and regulated by the applicable regulatory authority to acquire and receive such Products.

Intellectual Property Rights: patents, utility models, rights to inventions, copyright and neighbouring and related rights, trade marks, business names and domain names, rights in get-up and trade dress, goodwill and the right to sue for passing off, rights in designs, database rights, rights to use, and protect the confidentiality of, Confidential Information, and all other intellectual property rights, in each case whether registered or unregistered and including all applications and rights to apply for and be granted, renewals or extensions of, and rights to claim priority from, any rights and all similar or equivalent rights or forms of protection that subsist or will subsist now or in the future in any part of the world.

Parameters: shall mean the Product specification, which may include, but is not limited, Product quantity and order frequency, as determined solely by the Sponsor.

Personal Data: shall mean any information (direct or indirect) that relates to an individual from which that individual can be identified, and which is processed by Bionical Emas.

Products: shall mean the licensed and unlicensed pharmaceutical or healthcare products including, but not limited to, pharmaceutical compounds, drugs, medical equipment, supplies and ancillary items as set forth on Bionical Emas’ Portal.

Request: Request for Products submitted by a User on behalf of the Institution via Bionical Emas’ Portal and solely for use in the applicable Sponsor Study.

Sponsor: the sponsor of the applicable Study.

Study: the applicable clinical trial as set forth on Bionical Emas’ Portal.

User: means any person that accesses and uses Bionical Emas’ Portal on behalf of Institution. For the avoidance of doubt, User shall not include Sponsor.

Terms: shall mean these Clinical Trial Supply – Bionical Emas’ Portal Terms of Use for Healthcare Practitioners and Institution Only.

Access and Use of Bionical Emas’ Portal

• In order to access and use Bionical Emas’ Portal, User hereby accepts these Terms. User’s confirmation of these Terms during registration of User’s account on Bionical Emas’ Portal and User’s access and use of Bionical Emas’ Portal constitutes User’s agreement to these Terms.
• User shall be solely responsible for bringing these Terms to the attention of the Institution. For the avoidance of doubt, by using Bionical Emas’ Portal, User hereby warrants and represents that it has the authority to: (a) in accordance with applicable laws, which User is responsible for checking, procure Products; (b) submit Requests on behalf of Institution; and (c) agree to these Terms on behalf of itself and the Institution. Any reference to User in these Terms shall be deemed to include a reference to Institution.
• For the avoidance of doubt, these Terms shall not apply to Sponsor or any individual who accesses Bionical Emas’ Portal on behalf of Sponsor.

Supply of Products

• User hereby acknowledges that pursuant to a contract between Sponsor and Bionical Emas and subject to these Terms, Sponsor has instructed Bionical Emas to supply Products to Institution pursuant to User’s Request and solely in connection with the Study. For the avoidance of doubt, User shall not be deemed to be Bionical Emas’ customer and any Requests Bionical Emas fulfils is strictly pursuant to its contract with the Sponsor, which Bionical Emas understands is in connection with a contract that Sponsor has with Institution and/or User in relation to the Study.
• To the extent that the Sponsor has authorised Institution to order Product from Bionical Emas, User’s may submit Requests for the Products. Provided that the Request does not exceed the Parameters, Bionical Emas may fulfil such Request.
• If Bionical Emas agrees to fulfil User’s Request, it will be confirmed via Bionical Emas’ Portal and User shall be able to track the progress of such Request.
• If User’s Request is not within the Parameters, Bionical Emas may liaise with the Sponsor and the Sponsor shall decide whether such Request can be fulfilled by Bionical Emas. Bionical Emas may only fulfil such Request that is not within the Parameters provided that Sponsor has given authority to Bionical Emas to do so.
• For the avoidance of doubt, Bionical Emas’ confirmation of a Request shall not form a legally binding contract between Bionical Emas and Institution and/or the User. Notwithstanding confirmation of a Request, Bionical Emas shall not be bound to Institution and/or User to fulfil such Request and a Request confirmed by Bionical Emas may be cancelled at any time by Bionical Emas and for any reason.
• The Products made available for User on Bionical Emas’ Portal have been solely decided by Sponsor and are solely made available for the applicable Study and Bionical Emas has no authority to add and/or remove Products and/or change the Parameters without the authority of Sponsor. In the event User requires additional Products or Products that differ from the Parameters (“Additional Products”) in connection with the Study, User shall  contact Sponsor who retains sole authority for approving or rejecting requests for Additional Products. To the extent a User contacts Bionical Emas for Additional Products. Bionical Emas’ shall forward such request to Sponsor for Sponsor’s consideration.
• Save for any assistance related to User’s use of Bionical Emas’ Portal as set forth herein, Bionical Emas shall not provide any support, either financial or otherwise to User and/or Institution.

Quality and Compliance

• User acknowledges and agrees that access to Bionical Emas’ Portal has been granted following Bionical Emas’ confirmation that Institution holds the necessary licences, consents, and authorisations to acquire and receive Product. Pursuant to law applicable to Bionical Emas, Bionical Emas may be required to periodically review Institution’s licences, consents, and authorisations, and User hereby acknowledges that to the extent that Bionical Emas is unable to qualify Institution in accordance with applicable laws and Bionical Emas’ policies, User’s access to submit Requests for the applicable Study may be suspended.
• Notwithstanding clause 4.1, Institution and User warrant and represent that it shall immediately notify Bionical Emas, in writing, if the licence, consent or authorisation referred to in clause 4.1 is revoked, suspended or otherwise conditioned.
• User and Institution warrant and represent that use of the Products shall solely be in connection with the applicable Study and Institution and User shall use, handle, store the Products in accordance with: (a) the applicable Study protocol; (b) the applicable Study’s clinical trial agreement; (c) applicable laws; and (d) the instructions of Sponsor (“Requirements”). In addition to the foregoing, Institution and User shall report adverse events arising from use of the Product in accordance with the Requirements.
• In the event of a recall of Products, Institution and User shall act on and comply with the instructions of Bionical Emas and/or Sponsor in a timely

Price and Delivery

• All confirmed Requests shall be supplied by Bionical Emas free of charge.
• For each Request, User shall select, on Bionical Emas’ Portal, the applicable Designated Delivery Address. The addresses set forth on Bionical Emas’ Portal are the delivery addresses as notified by Sponsor to Bionical Emas and as qualified by Bionical Emas (as set forth in clause 4.1). To the extent User wishes to add an additional delivery address, User shall notify Bionical Emas of the revised delivery address prior to submission of the applicable Request. Any new delivery addresses, to the extent not previously qualified by Bionical Emas, shall be subject to qualification, as set forth in clause 4.1.
• Unless otherwise agreed by Bionical Emas or instructed by the Sponsor, Bionical Emas shall deliver Products to the Designated Delivery Address. User shall be solely liable for ensuring that the Designated Delivery address selected for each Request is the correct address.
• For the avoidance of doubt, any timeframes (if any) communicated by Bionical Emas to User and/or Institution shall be deemed to be estimates only.
• Either Institution or User shall notify Bionical Emas within one (1) business day of delivery if (a) Products are defective; and (b) Products have been supplied not in accordance with the quantity set forth in the confirmed Request. For the avoidance of doubt, Bionical Emas shall have no liability to Institution and/or User for supply of defective Product or supply of incorrect quantity of Product and Bionical Emas shall liaise with the Sponsor to determine the next steps, if any.

Bionical Emas’ Portal Use and Access Conditions

• Bionical Emas hereby grants User a non-exclusive, non-transferable right to access and use Bionical Emas’ Portal for the sole purpose of submitting Requests (and all activities related thereto) provided that User complies with these Terms.
• User hereby warrants and represents that, it shall not, nor shall instruct or allow a third party to do any of the following in relation to Bionical Emas’ Portal:
  • modify the code in any way;
  • manipulate or interfere with any security features of Bionical Emas’ Portal or attempt to do so;
  • transmit any harmful software code including, but not limited to, viruses;
  • access Bionical Emas’ Portal to build a competitive and/or similar product;
  • reverse engineer Bionical Emas’ Portal; or
  • interfere with or disrupt the integrity or performance of Bionical Emas’ Portal.

• User agrees that the username and password to Bionical Emas’ Portal (“Access Credentials”) are personal to User only and User warrants and represents that it shall, at all times, keep such Access Credentials confidential and not share the Access Credentials with any third party, including, but not limited to personnel at the Institution. If any third party requires access to Bionical Emas’ Portal, User shall instruct such third party to contact Bionical Emas and/or Sponsor directly.
• Any violation or suspected violation of clause 6.2 and/or 6.3 may result in suspension of User’s account on Bionical Emas’ Portal.
• All Intellectual Property Rights in or to Bionical Emas’ Portal are owned by Bionical Emas or the relevant third-party owner. User hereby acknowledges and agrees that it will not acquire in any way any title, rights of ownership, or Intellectual Property Rights of whatever nature to Bionical Emas’ Portal (or any part) and no Intellectual Property Rights to Bionical Emas’ Portal are transferred or licensed as a result of these Terms or access to the Bionical Emas’ Portal.
• BIONICAL EMAS DOES NOT MAKE ANY WARRANTY OF ANY KIND, WHETHER EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, AND BIONICAL EMAS SPECIFICALLY DISCLAIM ALL IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABLLITY OR, FITNESS FOR A PARTICULAR PURPOSE, TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW. BIONICAL EMAS DOES NOT GUARANTEE THAT BIONICAL EMAS’ PORTAL WILL BE AVAILABLE, ERROR-FREE, OR WILL MEET ANY REQUIREMENTS.
• In order to provide access to User to Bionical Emas’ Portal, Bionical Emas requires User’s Personal Data. Personal Data may be provided to Bionical Emas by Sponsor on behalf of User or by User directly to Bionical Emas. In either case, User hereby acknowledges that Bionical Emas is acting as a data processor of User’s Personal Data on behalf of the Sponsor who is the data controller.
• In relation to any Personal Data processed by Bionical Emas in connection with these Terms, Bionical Emas’ privacy policy (available at: https://bionicalemas.com/privacy-policy/) sets forth the Personal Data that Bionical Emas collects, how and why it collects, stores, use and shares such information, User’s rights in relation to it and how to contact Bionical Emas and supervisory authorities if User has a query or complaint related to Personal Data.

Limitation of Liability, Indemnity and Insurance

• Nothing in these Terms shall limit or exclude a party’s liability for: (a) death or personal injury caused by its negligence or the negligence of its employees, agents or subcontractors; (b) fraud or fraudulent misrepresentation; or (c) any matter in respect of which it would be unlawful to exclude or restrict liability.
• Subject to clause 7.1, Bionical Emas shall under no circumstances be liable to Institution or User, whether in contract, tort (including negligence), breach of statutory duty, or otherwise, for any loss of profit, or any indirect  or consequential loss arising under or in connection with these Terms.
• Whilst it is the parties intention that Bionical Emas’ fulfilment of a Request does not constitute a legally binding contract between Bionical Emas and Institution and/or User (as set forth in clause 3 hereto), in the event a court (having appropriate jurisdiction) determines there to be a formation of a legally binding contract as a result of these Terms, the liability clause in this clause 7 shall apply. Subject to clause 7.1, to the maximum extent permitted by applicable law, in no event shall the collective, aggregate liability (whether based on contract, tort or otherwise) of Bionical Emas to Institution and User under these Terms exceed £100.
• Institution and User shall jointly and severally indemnify Bionical Emas against all liabilities, costs, expenses, damages and losses (including but not limited to any direct, indirect or consequential losses, loss of profit, loss of reputation and all interest, penalties and legal costs (calculated on a full indemnity basis) and all other professional costs and expenses) suffered or incurred by Bionical Emas arising out of or in connection with any claim made against Bionical Emas by a third party (including but not limited to a Study participant) for death, personal injury or damage to property arising out of or in connection with Institution’s and/or User’s treatment, handling or use of Products or conduct of the Study not in accordance with the Requirements.
• Subject to clause 7.1, Bionical Emas accepts no responsibility and will not be liable for any losses; costs, damages, or other expenses arising out of: (a) the design, content, or implementation of the Study; (b) the quality or manufacture of Products; or (c) any injury to persons (including Study participants) or damage to personal property resulting from the

Confidentiality

• User undertakes that it shall not, at any time, disclose to any person any Confidential Information disclosed by Bionical Emas, except as permitted by clause 2.
• User may disclose the other party’s Confidential Information: (a) to Institution’s employees, officers, agents or consultants who need to know this information for the purposes of exercising the party’s rights or carrying out its obligations under or in connection with these Terms; and (b) as may be required by law, a court of competent jurisdiction or any regulatory authority.
• Bionical Emas reserves all rights in the Confidential Information. No rights or obligations in respect of Bionical Emas’ Confidential Information other than those expressly stated in these Terms are granted to User or to be implied from these

Termination

• User’s right to access and use Bionical Emas’ Portal may be revoked by Bionical Emas at any time and for any reason, including, but not limited to, if:
  1. Sponsor instructs Bionical Emas to cease supply of Products, including but not limited, cease supply of Products to the Institution only; and/or
  2. Institution or Sponsor (on behalf of Institution) fails to submit information and/or documents required and requested by Bionical Emas pursuant to clause 4.1;
  3. User breaches these Terms or Bionical Emas suspects that a breach of these Terms has or will be committed.
• Bionical Emas may terminate these Terms for any reason and without notice to User. Upon termination of these Terms, User’s licence to access Bionical Emas’ Portal shall immediately cease. Any confirmed Requests as of the date of termination shall, at the sole discretion of Bionical Emas, either be cancelled or fulfilled.
• Clauses which expressly or by implication survive termination of a Contract shall continue in full force and effect.

General

• Bionical Emas may at any time assign, transfer, charge, subcontract or deal in any other manner with all or any of its rights or obligations under these Terms. Neither Institution nor User may assign, transfer, charge, subcontract or deal in any other manner with any or all of its rights or obligations under these Terms without Bionical Emas’ prior written consent.
• Any notice or other communication given to a party in connection with these Terms shall be in writing, addressed to (a) Bionical Emas, at its registered office as set forth herein; and (b) Institution and/or User to any of the addresses linked to Institution and/or User on Bionical Emas’ Portal.
• If any provision of these Terms is held by any regulatory authority or court to be invalid or unenforceable in whole or in part, the validity of the other provisions of these Terms and the remainder of the provision in question shall not be affected.
• No waiver by Bionical Emas of any breach of these Terms by Institution or User shall be considered as a waiver of any subsequent breach of the same or any other provision.
• Bionical Emas may modify these Terms at any time and without notice. Any revised terms shall be displayed on Bionical Emas’ Portal.
• Regardless of the place of formation of these Terms or delivery of the Products, these Terms shall be governed by and interpreted in accordance with the laws of England and Wales and the parties agree to submit to the exclusive jurisdiction of the English courts.