Program Enrollment/Product License
GRANT OF LICENSE. Licensee is granted a limited license to use the Product, which includes certain Software, 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
Software - Subject to the foregoing, Careform LLC grants Licensee a non-exclusive, non-assignable, and non-transferable license to use Careform LLC's software program(s) as provided through the Product and its accompanying documentation (all hereinafter termed the "Software") subject to the terms herein.
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 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.
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.
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:
already known to Licensee; or
received by Licensee without confidentiality obligations or restrictions on use; or
independently developed by Licensee without access to such information; or
required to be disclosed pursuant to any statutory or regulatory provision or court order; or
publicly available information. The phrase "publicly available" shall mean readily accessible to the public in a written publication, and shall not include information which is only available by a substantial searching of the published literature, and information the substance of which must be pieced together from a plurality of different publications and sources.
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 is: Careform LLC, 400 Holiday Drive, Pittsburgh, PA 15220.
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.
CAREFORM LLC AND DEPUY 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 DEPUY 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 DEPUY 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.
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.
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:
Careform LLC, LP
Boardwalk I - 6000 Park Lane Dr
Pittsburgh PA 15275
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 (“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.
Important Safety Information
ORTHOVISC® is indicated in the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g. acetaminophen. In clinical studies, the most commonly reported adverse events were arthralgia, back pain, and headache. Other side effects included local injection site adverse events.
MONOVISC® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen). In clinical studies, the most commonly reported adverse events were arthralgia, joint swelling, and joint stiffness. Other side effects included local injection site adverse events.
ORTHOVISC® is contraindicated in patients with known hypersensitivity to hyaluronate formulations or known hypersensitivity (allergy) to gram positive bacterial proteins. ORTHOVISC® should not be injected in patients with infections or skin diseases in the area of the injection site or joint. Strict aseptic technique should be used. The effectiveness of more than 1 course has not been established.
MONOVISC® is contraindicated in patients with known hypersensitivity to hyaluronate formulations or known hypersensitivity (allergy) to gram positive bacterial proteins. MONOVISC® should not be injected in patients with infections or skin diseases in the area of the injection site or joint or to patients with known systemic bleeding disorders. Strict aseptic technique should be used.
Marketed and Distributed by DePuy Mitek, Inc.
DePuy Mitek, Inc. 325 Paramount Drive Raynham, MA 02767
Manufactured by Anika Therapeutics, Inc.
Anika Therapeutics, Inc. 32 Wiggins Ave. Bedford, MA 01730