BIMZELX Navigate^® TERMS OF USE

Please note: These Terms of Use do not replace or change the HIPAA Business Associates Agreement (BAA) currently in place between your practice and Careform LLC.

These Terms of Use contain an exclusive jurisdiction clause, an arbitration clause, indemnification obligations, disclaimers of warranties and limitations of liability. Please review these Terms of Use in their entirety.

THIS IS AN AGREEMENT BETWEEN YOU ("Licensee", “you”, “your”) AND CAREFORM LLC, LP AND CAREFORM LLC (collectively, "Careform LLC", “we”, “our”). BY USING THE CAREFORM LLC WEB PORTAL OR BIMZELX Navigate^® SOFTWARE AND/OR SERVICES (“PRODUCT”) AND/OR ACKNOWLEDGING ANY ACCEPTANCE OF THESE TERMS OF USE, YOU ACCEPT AND AGREE TO THESE TERMS OF USE.

Careform LLC reserves the right, at our discretion, to change, modify, add, or remove portions of these Terms of Use at any time. Please check these Terms of Use periodically for changes. Your continued use of the Product after the posting of changes to these Terms of Use will mean you agree to abide by those changes. Any amendment to these Terms of Use by you must be agreed to by Careform LLC in writing.

Program Enrollment / Product License

ENROLLMENT IN PROGRAM.
By using this Product, including the Software, and Hardware defined below, Licensee enrolls in the BIMZELX Navigate^® (the "Program"). While enrolled in the Program, Licensee is granted a limited license, as described below, to use the Product solely for the purpose of tracking BIMZELX^® products and inventory and for certain benefit investigation and fulfillment services, if applicable. The Product cannot, and Licensee agrees will not, be used for tracking other pharmaceutical products or otherwise as an inventory system. There shall be NO payment due to Careform LLC from Licensee under these Terms of Use including for usage of the Product and for support and services provided by Careform LLC related to the Product hereunder. The Product is only intended for use by U.S. residents. Licensee acknowledges and agrees that the costs for the Product are part of the costs for the purchase of BIMZELX^® products as part of the Program. Enrollment in the Program shall be ongoing until identified as terminated (for any reason or no reason) by Careform LLC or UCB, Inc. or its affiliates or subsidiaries (“UCB, Inc.”).

GRANT OF LICENSE.
Licensee is granted a limited license to use the Product, which includes certain Software and Hardware, as defined below, solely in connection with the Program as long as Licensee remains a participant in the Program. Careform LLC reserves all rights not expressly granted to Licensee.

Careform LLC may create, from time to time, updated versions of the Software. Careform LLC reserves the right to make changes to or improvements in any aspect of the Software at any time without prior notice to Licensee and without an obligation to supply such changed and/or improved Software to Licensee.

OWNERSHIP OF PRODUCT; DATA.
The Product, including the Software accessible through the Product, and all intellectual property rights included in or associated with the Product, including but not limited to patents, copyrights, trademarks and service marks, are owned or licensed by Careform LLC, and all right, title and interest in and to the Product remains with Careform LLC or its licensors. Except as ordinarily occurs when a content is downloaded to your computer in the normal course of operations, material from the Product may not be copied, distributed, re-published, uploaded, posted, modified, reverse engineered, or transmitted in any manner without our prior written consent. Certain content may be licensed from third parties and all such third-party content and intellectual property rights related to such content belong to the respective third parties. In any event, you may not remove any copyright, trademark or other intellectual property or proprietary notice or legend contained on the Product or in the content. As between Careform LLC and Licensee, ownership of Licensee’s customer and clinical data is with Licensee as set forth in that certain Business Associate Agreement (“BAA”) between Careform LLC and Licensee; provided that Careform LLC shall have the rights to use data as specified in the governing BAA between Careform LLC and Licensee.

ADDITIONAL TERMS.
If Licensee is accessing these Terms of Use from an administrator account, then Licensee hereby represents and warrants that Licensee is acting on behalf of the [clinic] entity employing/engaging Licensee, and that such entity is bound by all of the terms set forth herein, including but not limited to the Additional Terms set forth in Exhibit A below.

USE RESTRICTIONS.
Licensee may not distribute copies of the Software to others. Licensee may not modify, adapt, translate, reverse engineer, decompile, disassemble, or create derivative works of the Product without the prior written consent of Careform LLC. Licensee is only permitted to use the Product as specified herein.

ASSIGNMENT AND TRANSFER RESTRICTIONS.
The Product is licensed only to the Licensee and may not be transferred or assigned to anyone without the prior written agreement of Careform LLC. Any authorized transferee or assignee of the Product shall be bound by the terms and conditions of this Agreement. In no event may Licensee transfer, assign, rent, lease, sell, or otherwise dispose of Product, in part or in whole, on a temporary or permanent basis except as expressly provided herein.

LICENSEE COMPLIANCE; INDEMNITY.
Licensee represents that all of Licensee's operations within the Program are in full compliance with all applicable Federal, State, and Local laws and regulations, including those required by HIPAA. Licensee shall be solely responsible for the supervision, management, and control of Licensee's use of the Product, and related products and documentation. ALL INVENTORY INFORMATION, PATIENT AND/OR USER INFORMATION IN THE PRODUCT IS PROVIDED BY AND THROUGH LICENSEE AND CAREFORM LLC SHALL HAVE NO LIABILITY FOR ANY SUCH INVENTORY INFORMATION (INCLUDING ALL BAR CODE INFORMATION) AND/OR THE ACCURACY OR INACCURACY OF SUCH INFORMATION. Licensee hereby indemnifies and holds harmless Careform LLC, UCB, Inc., and their respective affiliates, officers, employees and agents (the “Indemnified Parties”) from and against any loss, liability, damages, costs, or expenses suffered or incurred by the Indemnified Parties at any time as a result of any claim, action, or proceeding arising out of or relating to: (i) Licensee's use, operation, or implementation of the Product; (ii) Licensee’s breach of any provision of these Terms of Use; (iii) medical care provided (or any failure or omission to provide care) to any patient in your system even if the Product is used in connection with such care; and/or (iv) any negligence (gross or otherwise) or willful misconduct of Licensee.

TERMINATION.
These Terms of Use are effective until terminated. Upon termination, the Licensee shall cease all use of the Product. Upon termination of these Terms of Use, Licensee shall additionally return the Hardware to Careform LLC within five business days. Careform LLC reserves the right to send an agent to the place of business of the Licensee to retrieve the Hardware if it is not returned within five business days of termination of these Terms of Use. Careform LLC will use commercially reasonable efforts to retain data associated with the Licensee for at least fifteen (15) calendar days following termination of the agreement. The provisions of Sections 3, 7, 8, 12, 14, 16, 17 and 18 shall survive termination. In addition to the termination rights specified above:

SUPPORT
Careform LLC will use commercially reasonable efforts to provide set-up, troubleshooting, and maintenance service associated with the Product. Upon contact of Careform LLC by the Licensee regarding a service issue via the provided contact information, Careform LLC will use commercially reasonable efforts to respond to Licensee's inquiry to develop an action plan for addressing the service issue within three business days.

NOTICE AND CONSENT TO RECORDING.
If and to the extent the Product includes benefit investigation services provided by Careform LLC, then Licensee acknowledges and agrees that in connection with such benefit investigation services, it will be necessary for Careform LLC to monitor business-related telephone calls and retrieve recorded business-related conversations as necessary. The Careform LLC monitored lines will be used as a training vehicle and to ensure accuracy, quality control and consistency as a normal and regular business practice. The recordings will be used to clarify any discrepancies, resolve any disputes pertaining to a particular business-related telephone conversation and to address benefit investigation issues.

EXPORT LAW.
Licensee may not export all or any portion of the Product in violation of applicable export laws and regulations.

CONFIDENTIALITY.
Licensee understands and acknowledges that the Product comprises valuable assets and trade secrets of Careform LLC in which Careform LLC claims exclusive proprietary rights and interest. Without prior written consent from Careform LLC, Licensee agrees not to, and will not permit its employees or agents or independent contractors to use, disclose, provide, or otherwise make available any non-public or confidential materials, documents, specifications, computer screens, computer screen layout, computer screen fields, computer screen input and output fields, database schema, computer code or the like (no matter in what media or form it is embodied) that is received from Careform LLC or Careform LLC' agent or independent contractors to any person, other than Licensee's employees or agents or its contractor(s) having a bona fide need for access. Licensee shall have no obligation of confidentiality with regard to information which is:

U.S.GOVERNMENT RESTRICTED RIGHTS.
The Software and Product are provided with RESTRICTED RIGHTS. Use, duplication, or disclosure by the Government is subject to restrictions set forth in FAR Sections 52-227-14 and 52-227-19 or DFARS Section 52.227-7013(C)(1)(ii), as applicable. Contractor/manufacturer is: ConnectiveRx, 6000 Park Lane, Pittsburgh, PA 15275.

DISCLAIMERS OF WARRANTY AND LIABILITY.
Licensee expressly acknowledges and agrees that use of the Product is at Licensee's sole risk. The PRODUCT IS provided "AS IS" and without warranty of any kind and CAREFORM LLC EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESS AND IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, TITLE, NON-INFRINGEMENT AND FITNESS FOR A PARTICULAR PURPOSE. CAREFORM LLC DOES NOT WARRANT THAT THE FUNCTIONS CONTAINED IN THE PRODUCT WILL MEET LICENSEE'S REQUIREMENTS, OR THAT THE OPERATION AND RESULTS OF THE PRODUCT WILL BE UNINTERRUPTED OR ERROR-FREE, OR THAT DEFECTS IN THE PRODUCT WILL BE CORRECTED. NO ORAL OR WRITTEN INFORMATION OR ADVICE GIVEN BY CAREFORM LLC OR ITS AUTHORIZED REPRESENTATIVE SHALL CREATE A WARRANTY OR IN ANY WAY INCREASE THE SCOPE OF THIS WARRANTY.

Moreover, CAREFORM LLC DOES NOT WARRANT AND EXPRESSLY DISCLAIMS ANY WARRANTIES THAT THE EXERCISE OF LICENSE RIGHTS PURSUANT TO THIS AGREEMENT WILL NOT INFRINGE ANY CURRENT OR FUTURE INTELLECTUAL PROPERTY RIGHTS OWNED BY PERSONS OTHER THAN CAREFORM LLC. Careform LLC makes no representation regarding the possibility of any such infringement by use of the Product, either alone or when combined with products other than the Product. The parties hereby agree that Careform LLC has no duty to investigate or to warn Licensee of any such possibility of infringement by use of the Product when used alone or when combined with entities other than the Product.

CAREFORM LLC AND UCB, INC. AND THEIR RESPECTIVE AFFILIATES, DIRECTORS, OFFICERS, EMPLOYEES AND AGENTS, WILL NOT BE LIABLE TO LICENSEE FOR ANY INCIDENTAL, INDIRECT, SPECIAL, OR CONSEQUENTIAL DAMAGES (INCLUDING DAMAGES FOR LOSS OF BUSINESS PROFITS, BUSINESS INTERRUPTION, LOSS OF BUSINESS INFORMATION, AND THE LIKE) ARISING OUT OF THE USE, MISUSE OR INABILITY TO USE THE PRODUCT, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

LICENSEE UNDERSTANDS THAT ANY SERVICES (INCLUDING SUPPORT) AND OTHER MATERIALS ARE PROVIDED ON AN “AS IS” BASIS, WITHOUT ANY WARRANTY OF ANY KIND. LICENSEE WILL REVIEW, MODIFY AND VALIDATE ALL INFORMATION FOR CLINICAL AND OTHER CORRECTNESS AND APPROPRIATENESS IN YOUR ENVIRONMENT BEFORE ANY USE. CAREFORM LLC AND UCB, INC. AND ALL OTHERS ASSOCIATED IN ANY WAY WITH THE PRODUCTS HAVE NO RESPONSIBILITY FOR MEDICAL CARE PROVIDED (OR ANY FAILURE OR OMISSION TO PROVIDE CARE) TO ANY PATIENT IN YOUR SYSTEM EVEN IF SUCH PRODUCT IS USED IN CONNECTION WITH SUCH CARE, AND INSTEAD LICENSEE WILL BE SOLELY RESPONSIBLE FOR SUCH CARE. LICENSEE HEREBY AGREES TO WAIVE ANY CLAIMS YOU MAY HAVE AGAINST CAREFORM LLC AND UCB, INC. AND ALL OTHERS ASSOCIATED WITH THE PRODUCTS WITH RESPECT THERETO. CAREFORM LLC MAY REQUIRE LICENSEE TO AGREE TO ADDITIONAL TERMS IN ORDER TO ACCESS ADDITIONAL FUNCTIONALITY IN THE PRODUCTS.

PROHIBITED ACTIVITIES.
Licensee may not use any device, software or routine, including but not limited to any viruses, trojan horses, worms, time bombs or other malicious code, intended to damage or interfere with the proper working of the Products or to surreptitiously intercept or expropriate any system, data or information from the Products. Licensee may not take any action which imposes an unreasonable or disproportionately large load on our infrastructure, including but not limited to denial of service attacks, "spam" or any other such unsolicited overload technique.

GOVERNING LAW, ARBITRATION AND JURISDICTION.
You recognize that, although the Internet can be accessed from anywhere in the world, the Software is located in the Commonwealth of Pennsylvania, United States of America, and that when you access the Software, you are doing so in the Commonwealth of Pennsylvania, United States of America. These Terms of Use shall be governed by and construed in accordance with the internal substantive laws of the Commonwealth of Pennsylvania without giving effect to any principles of conflict of law and the federal laws of the United States of America. ANY CONTROVERSY OR CLAIM ARISING OUT OF OR RELATING TO THESE TERMS OF USE, OR THE BREACH THEREOF, BROUGHT BY YOU SHALL BE SETTLED BY ARBITRATION ADMINISTERED BY THE AMERICAN ARBITRATION ASSOCIATION UNDER ITS COMMERCIAL ARBITRATION RULES, AND JUDGMENT ON THE AWARD RENDERED BY THE ARBITRATOR(S) MAY BE ENTERED IN ANY COURT HAVING JURISDICTION THEREOF. THERE IS NO JUDGE OR JURY IN ARBITRATION. HOWEVER, AN ARBITRATOR CAN AWARD THE SAME DAMAGES AND RELIEF AS A COURT. LICENSEE FURTHER AGREES THAT ANY ARBITRATION ACTION BROUGHT BY YOU ARISING OUT OF OR RELATING TO THESE TERMS OF USE OR THE PRODUCT SHALL BE FILED ONLY IN ALLEGHENY COUNTY, PENNSYLVANIA, AND YOU HEREBY CONSENT AND SUBMIT TO THE PERSONAL JURISDICTION AND VENUE IN ALLEGHENY COUNTY, PENNSYLVANIA.

MISCELLANEOUS.
Headings are for reference purposes only. Careform LLC failure to exercise or enforce any right or provision of the Terms of Use shall not constitute a waiver of such right or provision. If any provision of these Terms of Use shall be unlawful, void, or for any reason unenforceable, then that provision shall be deemed severable from these Terms of Use and shall not affect the validity and enforceability of any remaining provisions. Recognizing the global nature of the Internet, you agree to comply with all local rules regarding online conduct and acceptable materials. Specifically, you agree to comply with all applicable laws regarding the transmission of technical or other data exported from the United States or the country in which you reside. These Terms of Use, and any web pages or other documents incorporated by reference, set forth the entire understanding and agreement between us with respect to the subject matter hereof.

CONTACT.
Should Licensee have any questions concerning this Agreement, or if Licensee desires to contact Careform LLC for any reason, please contact us in writing:

ConnectiveRx
6000 Park Lane
Pittsburgh, PA 15275

Licensee should print a copy of these Terms of Use for your records. Please note, however, that these Terms of Use may be updated and amended by us from time to time as provided herein.

August 23, 2018

Version 1.0

EXHIBIT A

ADDITIONAL TERMS

BENEFIT INVESTIGATION. If and to the extent the Product includes benefit investigation services provided by Careform LLC, the Licensee and the [clinic] entity employing/engaging Licensee hereby authorize Careform LLC to act as an agent of Licensee and entity in conducting such benefit investigation services, including but not limited to contacting provider offices on behalf of Licensee and entity to confirm applicable patient eligibility.

ELECTRONIC SIGNATURES. To the extent applicable, you will comply with, U.S. 21 C.F.R. Part 11, and the Health Insurance Portability and Accountability Act (the “HIPAA”), including without limitation, preventing unauthorized access to the data as well as the accounts containing eSignature capabilities by maintaining physical security of the computers and ensuring that you and your personnel maintain the confidentiality of their passwords, and to allow only those individuals authorized and qualified to sign prescriptions to have access to accounts with eSignature capabilities and to have procedures and safeguards in place to prevent unauthorized access to an eSignature enabled account. You will also develop and implement policies and procedures to initially at the time of employment or at the time such person is granted access to accounts with eSignature capabilities, and periodically thereafter, to verify such person’s identity, to determine that such persons have the appropriate training and education to complete the tasks related to such accounts, to review password assignments and usage, and to conduct authority checks to verify that only authorized persons can use, access, sign, or alter a record within accounts with eSignature capabilities, and will also enforce any violation of policies regarding access to accounts with eSignature capabilities as well as the use of eSignatures. You shall also comply with our instructions for data entry into the system, as provided by us from time to time through the Product (including any third party electronic signature functionality we utilize, such as DocuSign). You will also certify to the Federal Food and Drug Administration (“FDA”) that the electronic signatures of your personnel using the Product are the legally binding equivalent of handwritten signatures, and that such personnel attest to the accuracy and completeness of the data entered. You also agree to ensure access to your source records and documentation supporting 21 CFR Part 11 compliance, during and after the term of this Agreement, by Careform LLC representatives and/or FDA or other government entities for auditing purposes.

 

 

 

Suicidal Ideation and Behavior

Suicidal ideation and behavior, including a completed suicide, have occurred in subjects treated with BIMZELX^® (bimekizumab-bkzx). Prior to prescribing BIMZELX, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional, as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes.

Infections

BIMZELX may increase the risk of infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves.

Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients for signs and symptoms of active TB during and after treatment.

Liver Biochemical Abnormalities

Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase and bilirubin at baseline, periodically during treatment with BIMZELX, and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis.

Inflammatory Bowel Disease

Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.

Immunizations

Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX.

MOST COMMON ADVERSE REACTIONS

Most common adverse reactions (≥1%) are upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex infections, acne, folliculitis, other Candida infections, and fatigue.