GENERAL TERMS & CONDITIONS FOR USE OF REED TECH MEDICAL DEVICE UDI/GUDID OUTSOURCED SERVICES
NOTICE: THE FOLLOWING TERMS AND CONDITIONS APPLY TO YOUR USE OF THE UDI ONLINE SERVICES
General Term & Condition for Use – UDI Services
Effective February 10, 2016
These terms and conditions listed below govern your use of the Reed Technology And Information Services, Inc. ("Reed Tech") Medical Device UDI/GUDID Outsourced Services (the "Services") provided to you by Reed Tech. The terms "you" and "your" in uppercase or lowercase shall mean the entity (e.g., company, corporation, partnership, sole proprietor, etc.) or government agency entering into this agreement with Reed Tech for the Services. The "Agreement" shall consist of these General Terms and the Order Form. This Agreement sets forth the terms and conditions under which Reed Tech provides you the Services. By using the Services, you agree to be bound by this Agreement.
1. SERVICES
The specific Services, the duration/term of those Services and the Pricing for those Services are set forth in the applicable Order Form executed by the parties. If there is a conflict between the terms of the applicable Order Form and this Agreement, then the Order Form shall control.
Reed Tech owns the Services and all developments, innovations and intellectual property associated with the Services.
2. PRICING AND TAXES
Payment Terms. All payments due to Reed Tech hereunder are to be paid in U.S. dollars and are due within 30 days of the date of the applicable invoice. Each month, Reed Tech will invoice You for the fees due to Reed Tech, for the previous month, and any applicable taxes. Each invoice will separately itemize the fees and taxes. All unpaid amounts due to Reed Tech hereunder shall bear interest at the rate of one and a half percent (1.5%) per month or at the highest rate permitted by law, whichever is less.
Taxes. All amounts due to Reed Tech hereunder are net of all taxes (including withholding taxes), assessments, charges and levies of any Governmental Authority, all of which are Your sole obligation, except for taxes payable on the income of Reed Tech.
3. CONFIDENTIALITY
To be protected under this Section 3, Confidential Information must be information that the receiving party ("Recipient") knows or has reason to know is confidential, proprietary, or trade secret information of the other party ("Discloser"), either (i) because the information is marked or otherwise identified as confidential or proprietary at the time of disclosure or (ii) because of the nature of the information and the context in which it was disclosed. This Agreement does not protect information that: (a) was in Recipient's possession before receipt from Discloser; (b) is independently developed by or for Recipient without use of Discloser's Confidential Information; (c) is rightfully received by Recipient from a third party without a duty of confidentiality; or (d) is or becomes available to the public through no fault of Recipient.
Recipient may use Discloser's Confidential Information only in connection with the performance of this Agreement and shall not disclose any such Confidential Information except as follows: (a) to those within Recipient's organization who have a need to know, who have been informed of Recipient's obligations hereunder, and who are bound by obligations of confidentiality with Recipient; (b) to other third parties, but only with Discloser's prior written consent, which Discloser may grant or withhold in its discretion, and then only if each such third party has agreed, in advance and in writing, to be bound by Recipient's obligations hereunder with respect to Confidential Information; and (c) when disclosure is required under applicable law, if Recipient first gives Discloser notice of the required disclosure and cooperates with Discloser, at Discloser's expense, in seeking reasonable protective arrangements (however, Recipient is not required to act in a manner which would result in sanctions or other penalties). Recipient shall be primarily liable to Discloser for the compliance of each person described in clause (a) or (b) with this Agreement. Recipient shall preserve all proprietary markings on Discloser's Confidential Information provided to Recipient. At Discloser's request, Recipient shall return Confidential Information to Discloser or destroy it and certify its destruction.
This Section 3 protects Confidential Information during the term of this Agreement and for two years thereafter.
4. TERM AND TERMINATION
The Term of this Agreement commences on the Effective Date of any Order Form executed hereunder and will continue until terminated as set forth in the applicable Order Form. If You fail to pay the Fees when due, Reed Tech may suspend Your access to the Services until such time as all past due Fees have been paid.
This Agreement and the Order Form may be terminated by either party before the expiration of the Term on written notice if the other party: (i) breaches any confidentiality or non-disclosure obligation; (ii) breaches any other material term or condition of this Agreement and fails to remedy any breach within thirty (30) days after receiving notice; (iii) becomes the subject of any voluntary or involuntary proceeding under the U.S. Bankruptcy Code or any state insolvency proceeding; (iv) ceases to be actively engaged in business.
5. WARRANTIES AND DISCLAIMERS
Reed Tech assumes no responsibility or liability regarding any information provided or any action taken by You in connection with the Services or any submissions made by Reed Tech to the FDA. Without limiting the foregoing, EXCEPT AS SPECIFICALLY PROVIDED IN THIS AGREEMENT, REED TECH DOES NOT WARRANT AND EXPRESSLY DISCLAIMS ANY LIABILITY FOR THE ACCURACY, COMPLETENESS, CURRENTNESS, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF THE INFORMATION OR SERVICES MADE AVAILABLE TO YOU. REED TECH PROVIDES NO WARRANTIES, EXPRESS OR IMPLIED, ORAL OR WRITTEN, WITH RESPECT TO THE SERVICES. The Services' software or other methodology by which the Services are rendered is provided "AS IS."
You acknowledge that Reed Tech's services are not substitutes for Your independent medical and professional judgment regarding Your UDI data. You remain solely responsible at all times for the accuracy and completeness of the substantive content of Your UDI data and for the compliance of Your UDI data with all applicable laws and regulatory requirements.
You will indemnify, defend, and hold harmless Reed Tech, its affiliates, and their respective officers, directors, employees, agents, and subcontractors against all losses, costs, damages, liability, judgments, settlements, and expenses (including reasonable attorneys' fees) arising out of or related to all third party claims, actions, suits, proceedings, and causes of action of any nature involving the substantive content of Your UDI data or the compliance of Your UDI data with applicable laws and regulatory requirements.
In the event of a third party claim, You will consult with Reed Tech about the defense of the matter and any proposed settlement at Reed Tech's request. You agree that You do not have the authority to obligate Reed Tech in any way or to compromise any of Reed Tech's rights in connection with the defense or settlement.
6. LIMITATION OF LIABILITY
NEITHER REED TECH, ITS AFFILIATES, NOR THEIR RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES, AGENTS OR SUBCONTRACTORS (COLLECTIVELY, "COVERED PARTIES") SHALL BE LIABLE FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL, INCIDENTAL OR PUNITIVE DAMAGES, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, ARISING FROM OR RELATING TO THIS AGREEMENT OR THE SERVICES (REGARDLESS OF THE FORM OF ACTION OR CLAIM, INCLUDING BUT NOT LIMITED TO CONTRACT, WARRANTY, TORT, STRICT LIABILITY, INDEMNITY, STATUTE, MALPRACTICE, FRAUD OR OTHERWISE). THE COVERED PARTIES WILL NOT BE RESPONSIBLE FOR ANY LOST PROFITS, LOST REVENUE, LOSS OR CORRUPTION OF DATA, OR RE-CREATING LOST OR CORRUPTED DATA AS A RESULT OF THIS AGREEMENT OR THE SERVICES. IN NO CASE SHALL THE AGGREGATE AMOUNT OF DIRECT DAMAGES PAYABLE TO YOU FROM THE COVERED PARTIES ARISING FROM OR IN CONNECTION WITH THIS AGREEMENT OR THE PERFORMANCE OF SERVICES EXCEED THE AMOUNT PAID BY YOU TO REED TECH HEREUNDER FOR THE AFFECTED SERVICES IN THE IMMEDIATELY PRECEDING 12 MONTH PERIOD. THE LIMITATIONS OF LIABILITY IN THIS SECTION SHALL SURVIVE THE FAILURE OF ANY LIMITED OR EXCLUSIVE REMEDY OR LIMITATION OF LIABILITY. YOU MAY ONLY BRING A CLAIM ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR THE PERFORMANCE OF THE SERVICES UP TO ONE YEAR FROM THE COMPLETION DATE OF THE AFFECTED SERVICES.
Reed Tech will not be liable to You or be deemed to be in breach of any obligation hereunder if its performance is prevented or delayed by any strike, labor difficulty, riot, storm, act of government, fire, act of God, material shortage, terrorism or any other cause beyond the reasonable control of Reed Tech, provided that Reed Tech gives You prompt notice of such condition and makes commercially reasonable efforts to resume performance as soon as the condition has abated.
7. GENERAL
Ownership. Reed Tech acknowledges that UDI data provided by You to Reed Tech for processing and storage, and all copies thereof, including the processed data (collectively, "Your Data") are Your exclusive property, and Reed Tech will return Your Data and all copies thereof to You at Your request.
You acknowledge that Reed Tech or its licensors own all intellectual property and other rights to the Services to all software, all copyright, patent, trademark, trade secret and other intellectual property or other rights to them (collectively, the "Reed Tech Intellectual Property"). Nothing contained in this Agreement will be construed to convey any title or ownership right in any of the Reed Tech Intellectual Property to You, or any right to use any of the Reed Tech Intellectual Property other than as expressly contemplated by this Agreement.
Notices. Notices by email will be deemed duly made, except for notices of termination, insolvency or legal action, which must be made in writing and (i) sent by overnight courier; or (ii) mailed by certified mail.
To Reed Tech:
Reed Tech
Attention Chief Legal Officer
9443 Springboro Pike
Miamisburg, OH 45342
USA
With a Copy to:
Chief Procurement Officer
Reed Tech
7 Walnut Grove Drive
Horsham, PA 19044
USA
To You: Your address reflected on the Order Form.
Amendments and Waivers. This Agreement may not be modified or amended except by a written instrument signed by an authorized representative of each of the parties. Any failure of a party to comply with any obligation contained herein may be waived by the party entitled to the benefit thereof only by a written instrument signed by an authorized representative of the party granting such waiver. No failure on the part of any party to exercise, and no delay in exercising, any right or remedy hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any right or remedy hereunder preclude any future exercise thereof or the exercise of any other right or remedy.
Assignment. This Agreement may be assigned or transferred by either party with prior written notice to the other.
Compliance. You affirm that you are neither identified on, nor shall you provide access to Reed Tech Services to any individuals identified on OFAC's list of Specially Designated Nationals ("SDN List"), the UK's HM Treasury's Consolidated List of Sanctions Targets, or the EU's Consolidated List of Persons, Groups, and Entities Subject to EU Financial Sanctions.
Governing Law; Jurisdiction. This Agreement shall be governed by and interpreted in accordance with the laws of the Commonwealth of Pennsylvania as applicable to agreements made therein. All disputes arising out of this Agreement shall be exclusively resolved by a court of competent jurisdiction in the Commonwealth of Pennsylvania;
Entire Agreement; Severability. This Agreement contains the entire agreement and understanding between the parties relating to the subject matter hereof, and supersedes all other prior agreements and understandings, both written and oral, between the parties with respect to such subject matter. This Agreement may be executed in counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. If any provision of this Agreement is declared invalid or illegal for any reason, then the remaining provisions of this Agreement shall remain in full force and effect in the same manner as if the invalid or illegal provision had not been contained herein.
