Janssen AccessPlus Terms and Conditions:

Janssen AccessPlus (AccessPlus) is supported by Janssen-Cilag Pty Ltd (291887) (Janssen) and administered by Atlantis Healthcare Limited (834483) (Atlantis).

Enrolment in AccessPlus

The compassionate supply of Janssen medicine through AccessPlus is subject to your understanding, agreement and compliance with the following Terms and Conditions:

1. The medicine supplied is only to be prescribed and used for the specific AccessPlus enrolled patient for which it is requested and supplied (Enrolled Patient), and cannot be transferred to any other patient;
2. Supply of any medicine to any patient through AccessPlus is subject to review and approval by Janssen, at its sole discretion. Janssen may refuse to supply any medicine through AccessPlus.
3. You have obtained all approvals, including where applicable any additional authorisation, required to supply the relevant medicine to the Enrolled Patient;
4. If the patient stops treatment, you will update the patient record in the AccessPlus portal, or notify via 0800 462 486.
5. Prior to prescribing the medicine, you acknowledge and agree that:
   1. you have read and understood the Medicine Information for the medicine approved by the New Zealand Medicines and Medical Devices Safety Authority;
   2. you have discussed with your patient the potential risks and nature of side effects of the relevant medicine;
   3. you have explained to your patient that Janssen will supply the medicine on a shared cost basis (i.e. Janssen will supply every other dose free-of-charge, as advised by Janssen), and there will be ongoing costs of treatment with the medicine should the patient choose to continue. An Enrolled Patient will be required to pay for each alternate dose of the relevant medicine;
   4. if the drug is not approved in New Zealand for the indication you have prescribed, your patient has been informed and you have discussed the implications of this with your patient before accessing supply through AccessPlus; and
   5. you have obtained informed patient consent where applicable before accessing supply through AccessPlus.
6. You acknowledge and agree that Janssen does not recommend use of its medicines outside of the approved indications or dosages. To the extent you request medicine for Enrolled Patients for unapproved use or dosing regimens, any such decision is at your discretion and you have discussed this decision with the relevant Enrolled Patient.
7. Subject to clause 8, the medication will continue to be provided on a cost-share basis by Janssen to the Enrolled Patient for as long as the patient is judged to benefit clinically from the treatment and until the medicine is available to those patients through a formal funding mechanism, such as listing on the relevant PHARMAC pharmaceutical schedule or other relevant formulary.
8. Janssen reserves the right to discontinue or suspend supply for factors that may be out of its control including but not limited to if the medication is deregistered or discontinued, there is a safety issue or any regulator action or in the event of limited or no availability of the medication.
9. You shall advise each Enrolled Patient of the fact that Janssen cannot guarantee ongoing free supply of this medicine and that the ongoing use of this medicine will be a financial cost borne solely by the Enrolled Patient
10. You may terminate this arrangement at any time on notice to Atlantis. You understand that if you terminate the arrangement, all of your Enrolled Patients will cease to receive medicine through the AccessPlus program unless enrolled by an alternate doctor.
11. All adverse events and medicine complaints must be reported via fax to Janssen Drug Safety on +61 2 9888 9817, email to LSO_AUST@its.jnj.com or directly to a Janssen Representative. You understand that Atlantis is legally obliged to pass on details of any adverse events that it becomes aware of, to Janssen. You understand that Janssen (or an authorised third party) may contact you for the purpose of an adverse event follow up.
12. You agree to indemnify and hold harmless Janssen against any loss, claim, liability or damage of any kind in relation to the accuracy or completeness of any information given, or any representations made to the Enrolled Patient arising out of or relating to the above obligations and the dispensing of the medicine to the Enrolled Patient.
13. You have read and understand and agree with the terms of the Privacy Statement set out below.
14. Janssen may update, improve or otherwise modify the AccessPlus services from time to time in which case these Terms and Conditions may need to be changed. Janssen will use reasonable endeavours to ensure you are notified of such changes. Your subsequent continued use of AccessPlus after such changes have been made will constitute acceptance of the new Terms and Conditions.

Use of the AccessPlus portal

15. AccessPlus is available to you through an online portal (the Portal) through which you can enroll and manage patients and your own information.
16. You will be provided with a username and be prompted to choose a password. You must treat these login credentials as confidential. You must not disclose them to any third party.
17. Janssen and Atlantis have the right to disable any username or password or suspend or terminate access to the Portal, at any time, if you breach any of these Terms and Conditions.
18. If you know or suspect that anyone other than you knows your login credentials, you must promptly notify Atlantis at the contact details below.

Privacy Statement

By accepting these Terms and Conditions you acknowledge and agree that:

1. Janssen has engaged Atlantis to manage, deliver and administer the AccessPlus program; and
2. in order to register for and enroll patients in AccessPlus you need to provide Atlantis with personal information for yourself and any Enrolled Patient (which includes Enrolled Patient medical information); and
3. you have obtained the consent of the relevant Enrolled Patient to provide such information to Atlantis for the purposes of receiving medicine through AccessPlus.

You consent to the personal information you provide being collected and used by Atlantis (and any contracted service provider in its place) for the purpose of arranging, managing and administering the AccessPlus program. You understand that Atlantis shall collect, use, disclose and store your personal information in accordance with its privacy policy attached at Annexure A and of New Zealand privacy law.

You understand that unless you ask Janssen or Atlantis not to, Atlantis may contact you to obtain feedback on your experience of AccessPlus. Atlantis will provide certain de-identified aggregate data to Janssen in respect of feedback and the program for the purposes of analysing trends, drive program improvement, conducting research and publication of such findings at health care professional educational symposium. You understand that any such publication will not identify you individually.

If you have any queries about how Atlantis handles your personal information, or if you would like to access or update your personal information, please contact Atlantis on 0800 462 486.
For more information on how Janssen handles your personal information, please refer to Janssen's privacy policy https://www.janssen.com/newzealand/privacy. If you would like further information please contact Janssen Customer Services on 0800 800 806.

ANNEXURE A _ Atlantis Privacy Policy

https://atlantishealthcare.com/en-us/privacy-notice

https://atlantishealthcare.com/en-us/terms-conditions