COMBINATION PRODUCTS COALITION

Terms of Use
Last Updated: July 2024
PLEASE READ THESE TERMS AND CONDITIONS OF USE CAREFULLY BEFORE USING THIS SITE. THEY MAY HAVE CHANGED SINCE YOUR LAST VISIT.
The following terms and conditions ("Terms of Use") govern access to and use of combinationproducts.com (the “Site”) and constitute an agreement between any user(s) of the site (the “User”) and the Combination Products Coalition (“CPC,” the “Coalition,” “we,” or “us”). User must read these Terms of Use carefully before using the Site. By using this Site, User accepts and agrees to be bound and abide by these Terms of Use and CPC’s Privacy Policy incorporated herein by reference. These Terms of Use and the rights, benefits, and obligations contained herein are fully assignable by CPC and will be binding upon and inure to the benefit of CPC’s successors and assigns. By using the Site, User represents and warrants that they are (i) at least eighteen (18) years of age and/or (ii) otherwise recognized as being able to form legally binding contracts under applicable law. If User does not meet these criteria or does not agree to these Terms of Use or the Privacy Policy, User may not access or use the Site.
Binding Arbitration
These Terms of Use provide that all disputes between User and CPC that in any way relate to these Terms of Use or your use of the Site will be resolved by BINDING ARBITRATION. ACCORDINGLY, YOU AGREE TO GIVE UP YOUR RIGHT TO GO TO COURT (INCLUDING IN A CLASS ACTION PROCEEDING) to assert or defend your rights under these Terms of Use. Your rights will be determined by a NEUTRAL ARBITRATOR and NOT a judge or jury and your claims cannot be brought as a class action. Please review the Section entitled “Governing Law and Jurisdiction” in CPC’s Privacy Policy, incorporated herein by reference, for the details regarding User’s agreement to arbitrate any disputes with CPC.
Changes to the Terms of Use
CPC may revise and update these Terms of Use from time to time in CPC’s sole discretion. All changes are effective immediately when posted and apply to all access to and use of the Site thereafter. User’s continued use of the Site following the posting of revisions to these Terms of Use constitutes User’s acceptance and agreement to such changes. User is expected to check these Terms of Use and CPC’s Privacy Policy from time to time to stay aware of any changes.

Accessing the Site
CPC reserves the right to withdraw or amend the Site in our sole discretion without notice. CPC will not be liable if, for any reason, all or any part of the Site is unavailable at any time or for any period. From time to time, CPC may restrict access to some parts of the Site or the entire Site.
User is responsible for making all arrangements necessary to access the Site and for ensuring the security of the computers and systems User uses to access the Site.
Intellectual Property Rights
The Site, its entire contents, features, and functionality (including but not limited to all information, software, text, displays, images, video and audio, and the design, selection, and arrangement thereof) are owned by CPC, its licensors, or other providers of such material. CPC grants User a limited non-assignable license (an “Access License”) to access and make personal and non-commercial use of the Site.
Additionally, certain content CPC owns, authored, created, purchased, or licensed, or which CPC shall own, author, create, purchase, or license (our “Works”) are available on or through the Site. CPC’s Works may be protected by copyright, trademark, patent, trade secret, and/or other laws, and CPC reserves and retains all rights in Works and the Site. Notwithstanding the Access License, and except as expressly permitted in these Terms of Use or as otherwise authorized in writing by CPC, User may not directly or indirectly modify, adapt, translate, sell, rent, license, create derivative works of, or make commercial use of any aspect of the Site, including but not limited to the Site’s contents, CPC’s Works, and materials and/or any information derived from the Site, in whole or in part, in any form or by any means.
CPC restricts access to some Works to members of CPC (our “Restricted Works”). Such Restricted Works are located on the “Members Only” section of the Site. In addition to the aforementioned restrictions that apply to the Site and all Works, User may not directly or indirectly distribute, transmit, transfer, publicly perform, or publicly display Restricted Works to any individual(s) or organization(s) that are not members of CPC except as expressly permitted in these Terms of Use or as otherwise authorized in writing by CPC.
The Access License is conditioned on User’s compliance with these Terms of Use and shall terminate upon termination of these Terms of Use and be automatically rescinded and terminated upon User’s breach of any provision of these Terms of Use.
If User believes any materials on this Site contains infringing information, materials, or other content, User may request removal of such materials (or access thereto) from this Site. CPC may investigate the allegation and determine in its sole discretion whether to remove or request the removal of the same from the Site and from any other media or server where the infringing content may be stored or displayed by combinationproducts.com. Notices to combinationproducts.com regarding any alleged copyright infringement should be sent to Bonnie Odom at Epstein, Becker & Green, P.C., who CPC has engaged as its general counsel (bodom@ebglaw.com).
Prohibited Uses
User may use the Site for lawful purposes and in accordance with these Terms of Use. User agrees not to use the Site:
·         In any way that violates any applicable federal, state, local, or international law or regulation (including, without limitation, any laws regarding the export of data or software to and from the United States or other countries);
·         For the purpose of exploiting, harming, or attempting to exploit or harm minors in any way by exposing them to inappropriate content, asking for personally identifiable information, or otherwise;
·         To send, knowingly receive, upload, download, use, or re-use any material which does not comply with these Terms of Use;
·         To impersonate or attempt to impersonate combinationproducts.com, another user, or any other person or entity (including, without limitation, by using e-mail addresses associated with any of the foregoing); or
·         To engage in any other conduct that restricts or inhibits anyone's use of the Site, or which, as determined by CPC, may harm combinationproducts.com or users of the Site or expose them to liability.
Additionally, User agrees not to:
·         Use the Site in any manner that could disable, overburden, damage, or impair the site or interfere with any other party's use of the Site, including their ability to engage in real time activities through the Site;
·         Use any device, software, or routine that interferes with the proper working of the Site;
·         Introduce any viruses, trojan horses, worms, logic bombs, or other material which is malicious or technologically harmful;
·         Attempt to gain unauthorized access to, interfere with, damage, or disrupt any parts of the Site, the server on which the Site is stored, or any server, computer, or database connected to the Site;
·         Attack the Site via a denial-of-service attack or a distributed denial-of-service attack; or
·         Otherwise attempt to interfere with the proper working of the Site.
CONSENT TO COMMUNICATIONS
Users that use the Site from their desktop or mobile device are communicating with CPC electronically and consent to receive communications from CPC electronically. User agrees that (a) all agreements and consents can be signed electronically and (b) all notices, disclosures, and other communications that CPC provides to User electronically satisfy any legal requirement that such notices and other communications be in writing.
CPC is committed to being compliant with the Controlling the Assault of Non-Solicited Pornography and Marketing Act (“CAN-SPAM ACT”) and the Telephone Consumer Protection Act (“TCPA”). Emails, newsletters, and text messages received from us are intended to fully comply with the CAN-SPAM ACT and the TCPA. In the event you receive an email or text message from us which you do not believe is fully compliant with the CAN-SPAM ACT or the TCPA, please contact Bonnie Odom at Epstein, Becker & Green, P.C., who CPC has engaged as its general counsel (bodom@ebglaw.com).
External Links
Internet websites and mobile applications that are not owned, operated, or controlled by CPC may link to or from our Site and may contain information created, published, maintained, or otherwise posted by third-parties not related to and otherwise independent of CPC and over which CPC has no control. CPC does not endorse, approve, certify, maintain, or control these other websites and applications and does not guarantee the accuracy, completeness, efficacy, timeliness, or correct sequencing of information located at such addresses or on such applications. CPC provides the links only as a convenience. Use of any information obtained from such other websites and applications is voluntary, and reliance on it should only be undertaken after an independent review of its accuracy, completeness, efficacy, and timeliness as well as those other websites’ and applications’ respective terms and privacy policies. Once User leaves the Site, our Terms of Use and Privacy Policy no longer govern, and, therefore, User should review the terms and policies of the other websites and applications. User acknowledges and agrees that CPC shall not be liable for any damages or injury resulting or arising from the content of or access to such other websites and applications. Moreover, any information that User provides to third-parties accessed through a link on our Site are subject to the privacy policies of that third party, and not CPC.
Disclaimer
CPC is a coalition that seeks to improve the regulatory environment for combination products through advocacy. CPC does not provide professional services. The information contained in this Site is for informational purposes only and does not constitute legal advice. Readers of this information should not act upon any information contained on this Site without seeking professional counsel. The transmission of confidential information via Internet email is highly discouraged.
Geographic Restrictions:
The owner of the Site is based in Washington, District of Columbia, in the United States. CPC makes no claims that the Site or any of its content is accessible or appropriate outside of the United States. Users that access the Site from outside the United States does so at their own initiative and are responsible for compliance with local laws.
Disclaimer of Warranties:
User understands that CPC cannot and does not guarantee or warrant that the Site will be free of viruses or other destructive code. User is responsible for implementing sufficient procedures and checkpoints to satisfy User’s particular requirements for anti-virus protection and accuracy of data input and output, and for maintaining a means external to the Site for any reconstruction of any lost data. CPC WILL NOT BE LIABLE FOR ANY LOSS OR DAMAGE CAUSED BY A DISTRIBUTED DENIAL-OF-SERVICE ATTACK, VIRUSES, OR OTHER TECHNOLOGICALLY HARMFUL MATERIAL THAT MAY INFECT YOUR COMPUTER EQUIPMENT, COMPUTER PROGRAMS, DATA, OR OTHER PROPRIETARY MATERIAL DUE TO USER’S USE OF THE SITE OR ANY SERVICES OR ITEMS OBTAINED THROUGH THE SITE OR TO USER’S DOWNLOADING OF ANY MATERIAL POSTED ON THE SITE.
USER’S USE OF THE SITE, ITS CONTENT, AND ANY SERVICES OR ITEMS OBTAINED THROUGH THE SITE IS AT USER’S OWN RISK. THE SITE, ITS CONTENT, AND ANY SERVICES OR ITEMS OBTAINED THROUGH THE SITE ARE PROVIDED ON AN "AS IS" AND "AS AVAILABLE" BASIS, WITHOUT ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED. NEITHER CPC NOR ANY PERSON ASSOCIATED WITH CPC MAKES ANY WARRANTY OR REPRESENTATION WITH RESPECT TO THE COMPLETENESS, SECURITY, RELIABILITY, QUALITY, ACCURACY, OR AVAILABILITY OF THE SITE. WITHOUT LIMITING THE FOREGOING, NEITHER CPC NOR ANYONE ASSOCIATED WITH CPC REPRESENTS OR WARRANTS THAT THE SITE, ITS CONTENT, OR ANY SERVICES OR ITEMS OBTAINED THROUGH THE SITE WILL BE ACCURATE, RELIABLE, ERROR-FREE, OR UNINTERRUPTED, THAT DEFECTS WILL BE CORRECTED, THAT OUR SITE OR THE SERVER THAT MAKES IT AVAILABLE ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS, OR THAT THE SITE OR ANY SERVICES OR ITEMS OBTAINED THROUGH THE SITE WILL OTHERWISE MEET USER’S NEEDS OR EXPECTATIONS.
CPC HEREBY DISCLAIMS ALL WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING BUT NOT LIMITED TO ANY WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT, AND FITNESS FOR PARTICULAR PURPOSE.
THE FOREGOING DOES NOT AFFECT ANY WARRANTIES WHICH CANNOT BE EXCLUDED OR LIMITED UNDER APPLICABLE LAW.
Governing Law and Jurisdiction:
User agrees that before bringing a case in court, User will try to mediate such claims against CPC and then go to arbitration. All matters relating to the Site and these Terms of Use and any dispute or claim arising therefrom or related thereto (in each case, including non-contractual disputes or claims), shall be governed by and construed in accordance with the internal laws of the State of New York without giving effect to any choice or conflict of law provision or rule (whether of the State of New York or any other jurisdiction). Any legal suit, action, or proceeding arising out of, or related to, these Terms of Use or the Site shall be instituted exclusively in the federal courts of the United States or the courts of the State of New York, although CPC retains the right to bring any suit, action, or proceeding against User for breach of these Terms of Use in User’s country of residence or any other relevant country. User waives any and all objections to the exercise of jurisdiction over User by such courts and to venue in such courts.
Limitation on Liability:
IN NO EVENT WILL CPC, ITS AFFILIATES, OR THEIR LICENSORS, SERVICE PROVIDERS, EMPLOYEES, AGENTS, OFFICERS, OR DIRECTORS BE LIABLE FOR DAMAGES OF ANY KIND, UNDER ANY LEGAL THEORY, ARISING OUT OF OR IN CONNECTION WITH USER’S USE, OR INABILITY TO USE, THE SITE, ANY CONTENT ON THE SITE, OR ANY SERVICES OR ITEMS OBTAINED THROUGH THE SITE, INCLUDING ANY DIRECT, INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, INCLUDING BUT NOT LIMITED TO, PERSONAL INJURY, PAIN AND SUFFERING, EMOTIONAL DISTRESS, LOSS OF REVENUE, LOSS OF PROFITS, LOSS OF BUSINESS OR ANTICIPATED SAVINGS, LOSS OF USE, LOSS OF GOODWILL, LOSS OF DATA, AND WHETHER CAUSED BY TORT (INCLUDING NEGLIGENCE), BREACH OF CONTRACT OR OTHERWISE, EVEN IF FORESEEABLE.
THE FOREGOING DOES NOT AFFECT ANY LIABILITY WHICH CANNOT BE EXCLUDED OR LIMITED UNDER APPLICABLE LAW.
Indemnification:
User agrees to defend, indemnify, and hold harmless CPC, its affiliates, licensors and service providers, and its and their respective contractors, agents, licensors, suppliers, successors, and assigns from and against any claims, liabilities, damages, judgments, awards, losses, costs, expenses, or fees (including reasonable attorneys' fees) arising out of or relating to User’s violation of these Terms of Use or your use of the Site, including, but not limited to, any use of the Site's content, services, and products other than as expressly authorized in these Terms of Use or User’s use of any information obtained from the Site.
Waiver and Severability:
No waiver by CPC of any term or condition set forth in these Terms of Use shall be deemed a further or continuing waiver of such term or condition or a waiver of any other term or condition, and any failure of CPC to assert a right or provision under these Terms of Use shall not constitute a waiver of such right or provision. If any provision of these Terms of Use is held by a court or other tribunal of competent jurisdiction to be invalid, illegal, or unenforceable for any reason, such provision shall be eliminated or limited to the minimum extent such that the remaining provisions of the Terms of Use will continue in full force and effect.
Your Comments and Concerns:
This Site is operated by CPC. All notices of copyright infringement claims, other feedback, comments, requests for technical support and other communications relating to the Site should be directed to Bonnie Odom at Epstein, Becker & Green, P.C., who CPC has engaged as its general counsel (bodom@ebglaw.com).
Thank you for using the Site.
Privacy Policy
Last Updated: July 2024
1. Our Privacy Policy
The Combination Products Coalition (“CPC”, the “Coalition”, “We”, or “Us”) takes the privacy of users of combinationproducts.com (the “Site”) very seriously. (the “User(s)”) This Privacy Policy describes CPC’s collection and protection of the information users of the Site (the “User”) provides to CPC during visits to the Site.
2. Personal Data CPC Collects About Users
When User uses our Site, CPC may collect the following information from User (collectively referred to as “Personal Data”):
·         Name, company name, and/or title
·         Contact information, such as email address, phone number, mailing address
·         Information that responds to a request User makes to CPC, or as part of a communication to CPC
·         Information related to the services CPC provides to User
·         Information you may provide to User in email or voice mails
·         Information about the device User uses to access our Site such as hardware model, unique device identifiers, operating system version, browser type, and device settings and other information related to how User’s device is interacting with our Site (“Device-Related Information”)
·         Usage data such as errors, system activity, and dates and times of User’s activity and the features User accesses on our Site (“Usage Data”)
CPC may also use cookies, web beacons, HTML local storage, and other similar technology to distinguish User from other visitors of our Site and remember your preferences. This will help CPC provide Users with a good experience when User visits our Site and allows CPC to improve User’s experience while visiting our Site. For more information on cookies, please see Our Cookie Policy at Section 6 of this Privacy Policy.
3. How CPC Collects User’s Personal Data
CPC may collect Personal Data directly from User when User accesses our Site. When User visits our Site, CPC may automatically collect information such as Device-Related Information, IP address, and Usage Data. Some Usage Data may be collected by using cookies. Please see our Cookie Policy at Section 6 of this Privacy Policy for more information. CPC may also receive Device-Related Information and Usage Data about User from analytics providers, such as Google Analytics.
4. How CPC Might Use User’s Personal Data
CPC may use the Personal Data that CPC collects in order to conduct our business. Generally, CPC may use Personal Data to:
·         Provide User with services and information that User requests
·         Administer the Site and our relationship with User
·         Secure the quality of, and develop, the Site
·         Respond to inquiries or requests from User
·         Provide User with newsletters and other direct marketing materials
·         To exercise CPC’s legal and ethical rights and obligations
·         For CPC’s business operations
CPC’s communication outside of this Site using contact information for an individual that might be a User of this Site is not subject to this Privacy Policy if such individual provided contact information to CPC directly outside of the channels of this Site.
5. How CPC Might Disclose Your Personal Data
CPC may disclose User’s Personal Data in the following ways:
·         To our service providers that CPC uses to support and provide our business, including Epstein, Becker & Green, P.C. (“EBG”), which CPC has engaged as its general counsel;
·         Government and regulatory authorities;
·         With others with whom User asks us to share User’s Personal Data; or
·         If CPC believes, in good faith, disclosure is appropriate or necessary to:
o    take precautions against liability;
o    protect CPC or others from fraudulent, abusive, or unlawful uses or activity;
o    investigate and defend CPC against any third-party claims or allegations;
o    protect the security or integrity of the Site; or
o    protect CPC’s property or other legal rights (including, but not limited to, enforcement of CPC’s agreements), or the rights, property, or safety of others.
6. Cookies and Tracking Technologies (“Our Cookie Policy”)
A "cookie" is a small data file sent from a website and stored on a website user’s device to enable the website to identify the website user’s device in the future and to allow for an enhanced personalized user experience. A "session cookie" disappears after the website user closes their web browser or may expire after a fixed period of time. A "persistent cookie" remains after the web browser has been closed and may be accessed every time the website user uses such website.
CPC’s Site does not currently use cookies. However, there may be other tracking technologies now and later devised and used by us in connection with the Site. Further, third parties may use tracking technologies with our Site. CPC does not control those tracking technologies, and CPC is not responsible for them. However, User consents to potentially encountering third-party tracking technologies in connection with use of the Site and accepts that this Privacy Policy does not apply to the tracking technologies or practices of such third parties. In such cases, User must check the third-party websites to confirm how User’s information is collected and used.
7. Children’s Information
CPC does not knowingly collect identifiable information from anyone under the age of thirteen (13) through the Site. If User is under thirteen (13), the User should not give CPC any information that would allow CPC to identify User. User should contact CPC if User discovers an individual under thirteen (13) has submitted their information contrary to this Privacy Policy, and CPC will ensure that information is properly removed.
8. How We Protect Your Personal Data
CPC employs security measures to prevent authorized access or use of User’s Personal Data. However, CPC cannot guarantee that criminals or others acting unlawfully will not succeed in efforts to undermine CPC’s security measures. Any transmission of Personal Data is at User’s own risk.
9. Third-Party Links
CPC may provide links to websites of other organizations or companies that may offer materials and services as well as links to other sites. Please note that CPC does not accept any responsibility or liability for personal data that may be collected through these websites or services. CPC recommends that User reads their privacy policies before User submits any personal data to them or use their services.
10. Changes to the Privacy Policy
CPC reserves the right to change this Privacy Policy and will the effective date of the new version at the top of this Privacy Policy when updated.
11. Applicable Law and Jurisdiction
CPC’s Site is offered and operated in the United States. If User is located outside of the United States, please be aware that any information User provides to CPC will be transferred to the United States. By providing CPC with any information through the Site, User consents to this transfer and our use of such information in accordance with this Privacy Policy.
12. Contact
If User has any questions, comments, or requests regarding this Privacy Policy or our collection, use, or disclosure of User’s information, please contact Bonnie Odom at Epstein, Becker & Green, P.C., who CPC has engaged as its general counsel (bodom@ebglaw.com).

the COMBINATION PRODUCTS COALITION

THE COMBINATION PRODUCTS COALITION

COMPRISED OF LEADING DRUG, DEVICE, AND BIOLOGICS COMPANIES WITH SUBSTANTIAL EXPERIENCE IN THE COMBINATION PRODUCT SPACE, the combination products coalition (“cpc”) SEEKS TO IMPROVE THE REGULATORY ENVIRONMENT FOR COMBINATION PRODUCTS THROUGH A VARIETY OF ADVOCACY-RELATED EFFORTS.

OUR DIVERSE, CROSS-INDUSTRY MEMBERSHIP ALLOWS US TO DEVELOP VALUABLE INSIGHTS AND POLICY POSITIONS ON THE MOST PRESSING REGULATORY ISSUES IMPACTING COMBINATION PRODUCTS.

COMBINATION PRODUCTS COALITION

the COMBINATION PRODUCTS COALITION

THE COMBINATION PRODUCTS COALITION

COMPRISED OF LEADING DRUG, DEVICE, AND BIOLOGICS COMPANIES WITH SUBSTANTIAL EXPERIENCE IN THE COMBINATION PRODUCT SPACE, the combination products coalition (“cpc”) SEEKS TO IMPROVE THE REGULATORY ENVIRONMENT FOR COMBINATION PRODUCTS THROUGH A VARIETY OF ADVOCACY-RELATED EFFORTS.

OUR DIVERSE, CROSS-INDUSTRY MEMBERSHIP ALLOWS US TO DEVELOP VALUABLE INSIGHTS AND POLICY POSITIONS ON THE MOST PRESSING REGULATORY ISSUES IMPACTING COMBINATION PRODUCTS.

COMBINATION PRODUCTS COALITION

TERMS OF USE

PRIVACY POLICY