Ascensia Diabetes Care US Inc. Contract RCBA Terms and Conditions

TERMS AND CONDITIONS

(a) Ascensia Products shall not be resold by Retailer on third-party websites or for export outside the Territory.  Ascensia Products may only be sold by Retailer directly to End-users.  Due to the highly regulated nature of medical devices, including the Ascensia Products, which requires strict manufacturing, storage, shipment and handling requirements,, and in recognition of the discounts available to Retailer for the purchase of Ascensia Products, Retailer represents and warrants that Retailer will purchase Ascensia Products from the Authorized Ascensia Wholesaler only for sale to End-users in the Territory exclusively and only through Retailer’s pharmacy or pharmacy website.  Retailer further represents and warrants that Retailer shall not sell Ascensia Products on any third-party website or online marketplace.  Retailer further represents and warrants that Retailer shall not export Ascensia Products outside of the Territory and that all Ascensia Products shall be sold only for final delivery to End-users in the Territory.

(b) Ascensia Products Are Not for Retail Sale. Retailer represents and warrants that it shall not sell Ascensia Products to customers who are not (i) End-users or (ii) End-users whose claims are not adjudicated through Medicare under Retailer’s agreement with Medicare.    If servicing Medicare Part B End-users, Retailer shall be a party to agreements with the Centers for Medicare & Medicaid Services concerning Medicare Part B reimbursement and shall continue to be a party to such agreement(s) throughout the Term of this Agreement.  As such, Retailer agrees to accept Medicare assignment, process and submit all Medicare paperwork on behalf of End-user, including accepting reimbursement from Medicare and the End-user, as per the current Medicare guidelines approved by CMS.

(c) If Retailer operates more than one business location, Retailer shall upload and/or submit to Ascensia at

ascensia-exhibits@ascensia.com a Participating Retailer List in the format set forth in Attachment A to this Agreement.

(d) Ascensia, at its sole discretion, reserves the right to limit the number of Ascensia Products provided to Retailer during the term of this Agreement.

 

TERM AND TERMINATION:

(a) The term of this Agreement (the “Term”) shall commence on the Effective Date as specified on the last page of this Agreement and shall terminate twenty-four (24) months from the Effective Date.  At the expiration of the Term, this Agreement shall automatically renew for twelve (12)-month periods, under the same terms and conditions, unless terminated by either party in accordance with this Agreement.

(b) Ascensia may terminate this Agreement without penalty to Ascensia immediately upon written notice to Retailer if Ascensia, in its sole judgment, determines that Retailer has violated any of the provisions of this Agreement, including but not limited to the following:

(1) Submitted claims to Medicare or Medicaid for Ascensia Products that were not purchased from the Authorized Ascensia Wholesaler listed in Section 1; or

(2) Sold Ascensia Products to parties other than eligible End-users; or

(3) Submitted claims to Medicare or Medicaid for Ascensia Products for which the actual product dispensed was not an Ascensia Product; or

(4) Failed to keep and provide Ascensia access to the documentation required to be mentioned by Retailer as provided in this Agreement; or

(5) Sold, distributed, or otherwise made available any of the Ascensia Products outside the Territory; or

(6) Become sanctioned or excluded from participation in the federal Medicare/Medicaid programs; or

(7) Failed to meet any current or new Medicare or Medicaid regulations or other requirements pertaining to this Agreement or diabetes care services.

(8) In the event that Ascensia terminates this Agreement pursuant to this Section 4 (b), Retailer shall immediately pay to Ascensia the amount specified in Section 6(e) of this Agreement and Ascensia also shall be entitled to recover from Retailer any and all other damages to which Ascensia may be entitled, along with all costs of collection, including reasonable attorneys’ fees and expert witness fees, as also provided in Section 6(e) of this Agreement.

(c) Ascensia also may terminate this Agreement without cause and for any reason or no reason at all, and without penalty to Ascensia, upon thirty (30) days’ prior written notice.

 

COMPLIANCE WITH APPLICABLE LAWS:

(a) Retailer represents and warrants that Retailer shall conduct all of Retailer’s activities and business operations required or permitted under this Agreement in compliance with all applicable laws and regulations, including but not limited to all applicable anti-bribery and antitrust laws.  Retailer represents and warrants that Retailer has not made or provided, and will not make or provide, any payment or benefit, directly or indirectly, to government officials, customers, business partners, healthcare professionals or any other person in order to secure an improper benefit or unfair business advantage, affect private or official decision-making, affect prescription behavior, or induce someone to breach professional duties or standards.

(b) The parties intend that this Agreement will comply with the requirements of the Office of Inspector General’s Safe Harbors and any Safe Harbors available under state law.  Ascensia and Retailer intend to comply with all applicable elements of the Safe Harbors regulations under the Federal Antikickback Statute, 42 U.S.C. § 1320a-7b(b). Retailer recognizes that any rebates, allowances or other price reductions issued by Ascensia, and available directly or indirectly, to Retailer under this Agreement qualify as a discount under Section 1128B (b) (3) (A) of the Social Security Act, 42 USC 1320a-7b (b) (3) (A).  Accordingly, Retailer agrees, to the extent it may be required, to properly disclose and appropriately reflect the allowance or price reduction in any costs claimed or charges made to Medicare, Medicaid or any other federal or state health insurance programs that provide reimbursement to End-users for Ascensia Products and require such disclosure.  Retailer shall retain all pricing information and make it available to Medicare, Medicaid or other government agencies in compliance with all applicable disclosure requirements.  Retailer shall take all necessary steps to comply with the terms of this Agreement and any state or federal laws or regulations. If any federal or state law or regulation changes, or it is interpreted in such a way as to call into question whether this Agreement complies with any applicable law, regulation or Safe Harbor, then Ascensia and Retailer shall promptly take all necessary steps to bring the requirements of this Agreement into compliance with such applicable laws and regulations.

(c) Retailer represents and warrants that Retailer has not been excluded from participation in the Medicaid, Medicare or any other federal or state health insurance programs, nor has Retailer been sanctioned in any way by any federal or state health care programs.  If any such programs initiate action to exclude or sanction Retailer, written notice of such action shall be sent by Retailer to Ascensia at the address set forth in Section 1 of this Agreement (Attention: Law & Patents Department) within ten (10) days from Retailer’s receipt of notice of such action.

(d) Retailer shall immediately report to Ascensia in writing at the address set forth in Section 1 of this Agreement any suspected or detected violation of the requirements set forth in this Section 5 and, in such cases, will cooperate fully with Ascensia in resolving the matter.  In the event that Ascensia believes, in good faith, that Retailer has violated any of these requirements; Ascensia may immediately terminate this Agreement without penalty to Ascensia.

(e) Ascensia does not have any control over the prices at which Retailer may sell Ascensia Products, and all such prices shall be set exclusively by Retailer in compliance with any and all applicable laws and government regulations.

 

MAINTENANCE OF RECORDS AND ASCENSIA AUDIT RIGHTS:

(a) Upon request by Ascensia, Retailer shall provide electronically to Ascensia at dccontractinfo@ascensia.com, a complete report, in a file and format acceptable to Ascensia, containing claim submission tracing information, including the NDC of all Ascensia Products for which Retailer has submitted claims to Medicare/Medicaid, the quantity of Ascensia Products for which claims have been submitted to Medicare/Medicaid, and the date of sale and identified patient information sufficient and acceptable to Ascensia relating to all such claims.  In the event that Ascensia does not receive this information from Retailer within twenty (20) days of Ascensia’s request, Ascensia may immediately, upon written notice to Retailer and the Authorized Ascensia Wholesaler, terminate this Agreement without penalty to Ascensia.

(b) Retailer acknowledges that Ascensia will use all claim submission and sales tracing information received from Retailer to confirm Retailer’s compliance with the terms of this Agreement and to determine whether Retailer may continue to purchase Ascensia Products pursuant to this Agreement, and Ascensia shall have no liability to Retailer for any actions Ascensia takes with respect to this Agreement in reliance on such information. 

(c) Retailer shall keep on file detailed original sales tracing information, including records of purchases of Ascensia Products from the designated Authorized Ascensia Wholesaler, the name of each End-user to whom Ascensia Products have been sold, all End-user identifiers assigned, each End-user’s address, phone number and Medicare Identification Number, and complete information about all Ascensia Products sold, including the dates of sale and the quantity of Ascensia Products sold.  This information and the original documentation shall be made available to Ascensia during any audit. In the event of an audit, both Ascensia and Retailer will comply with all applicable data privacy regulations including but not limited to HIPAA.

(d) Retailer shall be responsible for the accuracy of all claim submission and sales tracing and End-user information maintained by Retailer.  Ascensia shall have the right to perform audits of Retailer’s records, during the Term of this Agreement and for a period of two (2) years after termination including but not limited to reviewing invoices, pharmacy data switch records and all other books and records of Retailer, to determine that Ascensia Products were purchased from the Authorized Ascensia Wholesaler designated in Section 1 of this Agreement and sold exclusively to End-users.  Such audits will be performed by Ascensia at a reasonable time and in a reasonable manner, at any time, upon forty-eight (48) hours’ prior written notice to Retailer.  For audits conducted at Retailer’s site, End-users’ names, addresses, telephone numbers, physician letters and/or Medicare Identification Numbers will not leave the premises with an auditor assigned by Ascensia nor will such information be used for any purpose other than to verify that Ascensia Products were sold to End-users and that Retailer has complied with this Agreement. 

(e) If Retailer fails to allow Ascensia to conduct and audit or violates any of the provisions of this Agreement, including but not limited to the conduct prohibited by Section 4(b) of this Agreement, or if an audit discloses any instances in which End-user information cannot be traced to eligible End-users and/or Ascensia Products were sold or otherwise dispensed to any party other than an eligible End-user and/or in which Retailer has submitted claims for Ascensia Products not purchased from the Authorized Ascensia Wholesaler designated in Section 1 of this Agreement, and/or Retailer submitted claims to Medicare or Medicaid for Ascensia Products for which the actual product dispensed was not a Ascensia Product,  Retailer shall pay to Ascensia an amount equal to (i) the dollar amount of the per-product discount from list price for each Ascensia Product provided by Ascensia to the Authorized Ascensia Wholesaler at the time of Retailer's purchase of such products, multiplied by (ii) the total number of each Ascensia Product purchased by Retailer from the Authorized Ascensia Wholesaler during the two (2)-year period up to and including the date of Ascensia’s receipt of the results of the audit and/or Ascensia’s notice to Retailer of the termination of this Agreement, whichever is later.  Retailer also shall reimburse Ascensia for all costs, including reasonable attorneys' fees and expert witness fees, incurred by Ascensia in connection with any action or other efforts by Ascensia to enforce this Agreement, and Ascensia shall be entitled to any and all other damages and remedies for breach of this Agreement to which Ascensia may be entitled, including but not limited to recovery of Retailer’s profits from the sale of Ascensia Products, with all such other remedies being cumulative.

 

GOVERNING LAW, EXCLUSIVE FORUM AND ASSIGNMENT:

(a) Except when preempted by federal law, this Agreement shall be governed, construed, and enforced in accordance with the laws of the State of New Jersey, without regard to its laws relating to conflicts and choice of law.  In the event of any dispute between the parties in connection with this Agreement, Retailer’s purchase and/or sale of Ascensia Products, the performance by either party of its obligations under this Agreement, or otherwise relating to the parties’ relationship with one another, any and all actions, lawsuits, causes of action and other claims shall be brought only in the state or federal courts in the State of New Jersey, which courts shall have exclusive jurisdiction over such claims, and Retailer expressly consents, and agrees to be subject to, subject matter and personal jurisdiction and venue in such courts in New Jersey.

(b) Retailer may not subcontract, delegate, or assign any of its rights or obligations under the Agreement without Ascensia’s prior written consent.

 

INDEPENDENT CONTRACTOR STATUS, INDEMNIFICATION AND LIMITATION OF LIABILITY:

(a) This Agreement does not create a special or fiduciary relationship between the parties.  Retailer is an independent contractor, and nothing in this Agreement is intended to constitute either party as an agent, legal representative, subsidiary, joint venturer, partner, employee or servant of the other party for any purpose whatsoever.

(b) Nothing in this Agreement authorizes either party to make any contract, warranty, or representation on the other party's behalf or to incur any debt or other obligation in the other party's name. 

(c) Retailer shall defend, indemnify, and hold harmless Ascensia, its parents, subdivisions, affiliates, officers, directors, shareholders, employees, agents, and subcontractors from and against all claims, losses, investigations, demands, and/or lawsuits (including attorneys’ fees and costs) brought by any third party alleging Retailer’s acts or omissions caused damage, or otherwise arising from the performance and/or breach of this Agreement.

(d) In the event of any breach or alleged breach of this Agreement by Ascensia, Retailer’s sole and exclusive remedy shall be for Retailer to return to Ascensia for refund any Ascensia Products that do not conform to any express warranties given by Ascensia relating to those products.  All implied warranties relating to such products, including but not limited to implied warranties of merchantability and fitness for a particular purpose, are disclaimed by Ascensia.  In no event shall Ascensia be liable to Retailer for any direct, indirect, special, incidental, consequential or other damages, including but not limited to damages for lost revenue, lost profits, business interruption and any and all other similar kinds of damages.

 

CONFIDENTIALITY:

(a) Retailer shall maintain the confidentiality of this Agreement and all terms and conditions of this Agreement during the Term of this Agreement and for two (2) years following the expiration or termination of the Term for any reason.

(b) Notwithstanding anything in this Agreement to the contrary, Ascensia may disclose Retailer’s name, address, the nature of Retailer’s relationship with Ascensia and such other information as may be required to the extent required pursuant to any applicable federal, state and/or local laws and regulations.

 

MISCELLANEOUS:

(a) In the event that Retailer becomes aware of any information indicating that an Ascensia Product is involved in, or implicated with, any report of death, serious injury or serious risk to health (alleged to have been caused or contributed to by the product), Retailer immediately shall notify Ascensia, either through direct contact with Ascensia Diabetes Care Customer Service (toll free phone number: 1-800-348-8100 – 24 hours a day, or e-mailsupportcounternext.com) or instructing the reporter of such an event to contact Ascensia (through the same contacts).  

(b) Retailer shall not advertise or promote Ascensia Products in a manner that may appear to violate, or may violate, any applicable law or regulation.

(c) Ascensia may utilize a third party to implement this Agreement.

(d) Failure of Ascensia to insist on strict performance shall not constitute a waiver of any of the provisions of this Agreement or any default of Retailer.

(e) This Agreement contains all agreements and understandings between Ascensia and Retailer relating to the subject matter of this Agreement.  All prior oral and written agreements and understandings of any kind relating to that subject matter are merged into and superseded by this Agreement.  The terms and conditions of this Agreement shall not be added to, modified, superseded or otherwise altered except by a written modification signed by authorized representatives of both parties except that the products, pricing, discounts, and/or address changes available under this Agreement may be modified by Ascensia, upon thirty (30) days written notice to Retailer of any such modification.

(f) Neither this Agreement nor any provisions of this Agreement may be waived, modified or otherwise changed by any representation, promise or other statement by any Ascensia sales or other representative, and Retailer may not rely for any purpose on any such representation, promise or other statement.

Upon Retailers signature and submission of this Agreement to Ascensia, Ascensia shall review and confirm the information provided in Section 1 of this Agreement allowing Retailer to obtain Ascensia Product under the terms and conditions of this Agreement. Upon verifications of the information in Section 1 of this Agreement, and Ascensia approval of Retailer purchasing Ascensia Products under this Agreement, Ascensia shall notify the Retailer Authorized Ascensia Wholesaler of Retailers acceptance of the terms and condition of this Agreement and ability of Retailer to purchase Ascensia Product from the Authorized Ascensia Wholesaler. This contract shall become effective upon Ascensia’s notification of Authorized Ascensia Wholesaler of Retailers eligibility (the “Effective Date”). Thereafter, Ascensia shall inform Retailer, in writing or by electronic mail, of the Effective Date of this Agreement.


 

 

 

 

 

 

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