Common use of NONRENEWAL AND TERMINATION Clause in Contracts

NONRENEWAL AND TERMINATION. (a) Unless otherwise terminated by either party pursuant to the terms of this Agreement, the Agreement shall be effective for an initial period of 24 months from the January 1 that follows its execution by both parties, and shall be automatically renewed for a period of 1 year on January 1 each year thereafter, unless terminated under sections VIII (b) or (d) of this Agreement, as described in 42 CFR § 423.2345. (b) As described in 42 CFR § 423.2345(a), the Secretary may terminate this Agreement for a knowing and willful violation of the requirements of the Agreement or other good cause shown in relation to the Manufacturer's participation in the Discount Program. The termination shall not be effective earlier than 30 calendar days after the date of notice to the Manufacturer of such termination. The Secretary shall provide the Manufacturer with an opportunity to cure any ground for termination for cause or to show the Manufacturer is in compliance with Section II within thirty (30) calendar days of the Manufacturer’s receipt of the written termination notice. If the Manufacturer cures the violation, or establishes that it was in compliance within the cure period, the Secretary shall repeal the termination notice by written notice. (c) As described in 42 CFR § 423.2345(a)(4) and (5), the Secretary shall provide, upon request, a Manufacturer a hearing with a hearing officer concerning such termination if requested in writing within 15 calendar days of receiving notice of the termination, and such hearing shall take place prior to the effective date of the termination with sufficient time for such effective date to be repealed if the Secretary determines appropriate. If the Manufacturer or CMS receives an unfavorable decision from the hearing officer, the Manufacturer or CMS may request review by the CMS Administrator. The decision of the CMS Administrator is final and binding. (d) The Manufacturer may terminate this Agreement for any reason. Any such termination shall be effective as of the day after the end of the calendar year if the termination occurs before January 30 of a calendar year or as of the day after the end of the succeeding calendar year if the termination occurs on or after January 30 of a calendar year, as described in 42 CFR § 423.2345(b). (e) Any termination shall not affect the Manufacturer’s responsibility to reimburse Part D sponsors for applicable discounts for applicable drugs having NDCs with the Manufacturer’s FDA-assigned labeler codes that were incurred under the Agreement before the effective date of its termination, as described in 42 CFR § 423.2345(c). (f) In accordance with 42 CFR § 423.2345(d), upon the effective date of the termination of this Agreement, CMS will cease releasing data to the Manufacturer under this Agreement, except as necessary to ensure that the Manufacturer reimburses applicable discounts for previous time periods in which the Agreement was in effect, and will notify the Manufacturer to destroy the data file(s) described in section VII of this Agreement. The provisions of sections IV, VI, and VII shall survive termination of this Agreement. (g) Manufacturer reinstatement will be available only upon payment of any and all outstanding applicable discounts incurred during any previous period of the Agreement. The timing of any such reinstatement will be consistent with the requirements for entering into an Agreement under section 1860D-14A(b)(1)(C) of the Act and 42 CFR § 423.2345(e).

NONRENEWAL AND TERMINATION. (a) Unless otherwise terminated by either party pursuant to the terms of this Agreement, the Agreement shall be effective for an initial period of 24 months from the January 1 that follows its execution by both parties, and shall be automatically renewed for a period of 1 year on January 1 each year thereafter, unless terminated under sections VIII (bsection VIII.(b) or (d) of this Agreement, as described in 42 CFR § 423.2345§423.2345 . (b) As described in 42 CFR § §423.2345(a), the Secretary may terminate this Agreement for a knowing and willful violation of the requirements of the Agreement or other good cause shown in relation to the Manufacturer's participation in the Discount Program. The termination shall not be effective earlier than 30 calendar days after the date of notice to the Manufacturer of such termination. The Secretary shall provide the Manufacturer with an opportunity to cure any ground for termination for cause or to show the Manufacturer is in compliance with Section II within thirty (30) calendar days of the Manufacturer’s receipt of the written termination notice. If the Manufacturer cures the violation, or establishes that it was in compliance within the cure period, the Secretary shall repeal the termination notice by written notice. (c) As described in 42 CFR § §423.2345(a)(4) and (5), the Secretary shall provide, upon request, a Manufacturer a hearing with a hearing officer concerning such termination if requested in writing within 15 calendar days of receiving notice of the termination, and such hearing shall take place prior to the effective date of the termination with sufficient time for such effective date to be repealed if the Secretary determines appropriate. If the Manufacturer or CMS receives an unfavorable decision from the hearing officer, the Manufacturer or CMS may request review by the CMS Administrator. The decision of the CMS Administrator is final and binding. (d) The Manufacturer may terminate this Agreement for any reason. Any such termination shall be effective as of the day after the end of the calendar year if the termination occurs before January 30 of a calendar year or as of the day after the end of the succeeding calendar year if the termination occurs on or after January 30 of a calendar year, as described in 42 CFR § §423.2345(b). (e) Any termination shall not affect the Manufacturer’s responsibility to reimburse Part D sponsors for applicable discounts for applicable drugs having NDCs with the Manufacturer’s FDA-assigned labeler codes that were incurred under the Agreement before the effective date of its termination, as described in 42 CFR § §423.2345(c). (f) In accordance with 42 CFR § §423.2345(d), upon the effective date of the termination of this Agreement, CMS will cease releasing data to the Manufacturer under this Agreement, except as necessary to ensure that the Manufacturer reimburses applicable discounts for previous time periods in which the Agreement was in effect, and will notify the Manufacturer to destroy the data file(s) described in section VII of this Agreement. The provisions of sections IV, VI, VI and VII shall survive termination of this Agreement. (g) Manufacturer reinstatement will be available only upon payment of any and all outstanding applicable discounts incurred during any previous period of the Agreement. The timing of any such reinstatement will be consistent with the requirements for entering into an Agreement under section 1860D-14A(b)(1)(C) of the Act and 42 CFR § §423.2345(e).