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 not less than 24 months beginning on January 1, 2012, and shall be automatically renewed for a period of 1 year unless terminated under section VIII.(b) or (d) of this Agreement. (b) 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) 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shall take place prior to the effective date of the termination with sufficient time for such effective date to be repealed if the Secretary determines appropriate.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 receives an unfavorable decision from the hearing officer, the Manufacturer 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. (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. (f) 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.

Appears in 3 contracts

Samples: Medicare Coverage Gap Discount Program Agreement, Medicare Coverage Gap Discount Program Agreement, Medicare Coverage Gap Discount Program Agreement

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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 not less than 24 months one year beginning on January 1, 2012, the date specified in section II(d) of this agreement and shall be automatically renewed for a period additional successive terms of 1 one year unless terminated under section VIII.(b) or (d) the Labeler gives written notice of this Agreementintent not to renew the agreement at least 90 days before the end of the current period. (b) The Manufacturer may terminate the agreement for any reason, and such termination shall become effective the later of the first day of the first calendar quarter beginning 60 days after the Manufacturer gives written notice requesting termination, or the ending date of the term of the agreement if notice has been given in accordance with VII(a). (c) The Secretary may terminate this the Agreement for a knowing and willful violation violations of the requirements of the Agreement this 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 upon 60 days after the date of prior written notice to the Manufacturer of the existence of such terminationviolation or other good cause. 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) 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 a termination, and but such hearing shall take place prior to not delay the effective date of the termination with sufficient time for such effective date to be repealed if the Secretary determines appropriate. If the Manufacturer receives an unfavorable decision from the hearing officer, the Manufacturer may request review by the CMS Administrator. The decision of the CMS Administrator is final and bindingtermination. (d) The If this rebate agreement is nonrenewed or terminated, the Manufacturer may terminate this Agreement for any reason. Any such termination shall be effective is prohibited from entering into another rebate agreement as provided in section 1927(b)(4)(C) of the day after Act until a period of one calendar quarter has elapsed from the end effective date of the calendar year if termination, unless 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 yearSecretary finds good cause for earlier reinstatement. (e) Any nonrenewal or termination shall will 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 rebates due before the effective date of its termination. IX GENERAL PROVISIONS (a) Any notice required to be given pursuant to the terms and provisions of this Agreement will be sent in writing. Notice to the Secretary will be sent to: Center for Medicaid and State Operations Family and Children’s Health Programs Group Division of Benefits, Coverage and Payment Xxxx Xxxxxx Xxx 00000 Xxxxxxxxx, XX 00000-0000 Notices to CMS concerning data transfer and information systems issues are to be sent to: Center for Medicaid and State Operations Finance, Systems and Quality Group Division of State Systems Xxxx Xxxxxx Xxx 00000 Xxxxxxxxx, XX 00000-0000 The CMS address may be updated upon written notice to the Manufacturer. Notice to the Manufacturer will be sent to the address as provided with this agreement and updated upon Manufacturer notification to CMS at the address in this agreement. (b) In the event of a transfer in ownership of the Manufacturer, this agreement is automatically assigned to the new owner subject to the conditions specified in section 1927 and this agreement. (c) Nothing in this Agreement will be construed to require or authorize the commission of any act contrary to law. If any provision of this Agreement is found to be invalid by a court of law, this Agreement will be construed in all respects as if any invalid or unenforceable provision were eliminated, and without any effect on any other provision. (d) Nothing in this Agreement shall be construed as a waiver or relinquishment of any legal rights of the Manufacturer or the Secretary under the Constitution, the Act, other federal laws, or State laws. (e) The rebate agreement shall be construed in accordance with Federal common law and ambiguities shall be interpreted in the manner which best effectuates the statutory scheme. (f) Upon the effective date of the termination of this Agreement, CMS will cease releasing data The terms "State Medicaid Agency" and "Manufacturer" incorporate any contractors which fulfill responsibilities pursuant to the Manufacturer under this Agreement, except as necessary agreement unless specifically provided for in the rebate agreement or specifically agreed 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 Agreementby an appropriate CMS official. (g) Manufacturer reinstatement Except for the conditions specified in II(c) and IX(a), this Agreement will not be altered except by an amendment in writing signed by both parties. No person is authorized to alter or vary the terms unless the alteration appears by way of a written amendment, signed by duly appointed representatives of the Secretary and the Manufacturer. (h) In the event that a due date falls on a weekend or Federal holiday, the report or other item will be available only upon payment of any and all outstanding applicable discounts incurred during any previous period of due on 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 Actfirst business day following that weekend or Federal holiday.

Appears in 1 contract

Samples: Rebate Agreement

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 not less than 24 months beginning on January 1, 20122011, and shall be automatically renewed for a period of 1 year unless terminated under section VIII.(b) or (d) of this Agreement. (b) 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) 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 receives an unfavorable decision from the hearing officer, the Manufacturer 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. (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. (f) 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.

Appears in 1 contract

Samples: Medicare Coverage Gap Discount Program Agreement

NONRENEWAL AND TERMINATION. (a) Unless otherwise terminated by either party pursuant to the terms of this AgreementAgreement agreement, the Agreement agreement shall be effective for an initial period of not less than 24 months one year beginning on January 1, 2012, the date specified in section II.(dh). of this agreement and shall be automatically renewed for a period additional successive terms of 1 one year from the date specified in section II.(h)., unless terminated under section VIII.(b) or (d) the Labeler manufacturer gives written notice of this Agreementintent not to renew the agreement at least 90 days before the end of the current period. (b) The Secretary Manufacturer In accordance with section VII.(a). of this agreement and section 1927(b)(4)(B)(ii) of the Act, the manufacturer may terminate this Agreement the agreement for a knowing any reason, and willful violation such termination shall become effective the later of the requirements first day 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 first calendar quarter rebate period beginning 60 days after the Manufacturer manufacturer gives written notice requesting termination, or the ending 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 term of the Manufacturer’s receipt of the written termination notice. If the Manufacturer cures the violation, or establishes that it was agreement if notice has been given in compliance within the cure period, the Secretary shall repeal the termination notice by written noticeaccordance with VII(a). (c) CMS initiates termination via written notice to the manufacturer. The Secretary may terminate the Agreement for agreement for failure of a manufacturer to make rebate payments to the state(s), failure to report required data, for other violations of this agreement, or other good cause causes upon 60 days prior written notice to the Manufacturer manufacturer of the existence of such violation or other good cause causes. The Secretary shall provide, upon request, a Manufacturer a hearing manufacturer with a hearing officer concerning such termination if requested in writing within 15 calendar days of receiving notice of the a termination, and but such hearing shall take place prior to not delay the effective date of the termination. (c) Manufacturers on the Office of Inspector General’s (OIG’s) List of Excluded Individuals/Entities (Exclusion List) will be subject to immediate termination with sufficient time for such effective date to be repealed if the Secretary determines appropriate. If the Manufacturer receives an unfavorable decision from the hearing officer, Medicaid drug rebate program unless and until the Manufacturer may request review manufacturer is reinstated by the CMS AdministratorOIG. The decision Appeals of exclusion and any reinstatement will be handled in accordance with section 1128 of the CMS Administrator is final Act and bindingapplicable regulations. Manufacturers that are on the OIG Exclusion List and are reinstated by the OIG under certain circumstances may be evaluated for reinstatement to the Medicaid drug rebate program by CMS. Reinstatement to the Medicaid drug rebate program would be for the next rebate period that begins more than 60 days from the date of the OIG’s reinstatement of the manufacturer after exclusion. (d) The If this rebate agreement is nonrenewed or terminated, the Manufacturer may terminate this Agreement for any reason. Any such termination shall be effective manufacturer is prohibited from entering into another rebate agreement as provided set forth in section 1927(b)(4)(C) of the day after Act until a for at least one rebate period of one calendar quarter has elapsed from the end effective date of the calendar year if termination. The manufacturer must also address to the termination occurs before January 30 satisfaction of a calendar year CMS any outstanding violations from any previous rebate agreement(s), including, but not limited to, payment of any outstanding rebates and also make good faith efforts to appeal or resolve matters pending with the OIG relating to the MDRP or exclusion as referenced in subsection (c) of this section, unless the day after the end of the succeeding calendar year if the termination occurs on or after January 30 of a calendar yearSecretary finds good cause for earlier reinstatement. (e) Any nonrenewal or termination shall will 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 rebates due before the effective date of its termination. (f) 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.

Appears in 1 contract

Samples: National Drug Rebate Agreement

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 not less than 24 months beginning on January 1, 2012, 2011 and shall be automatically renewed for a period of 1 year unless terminated under section VIII.(bVII.(b) or (dc) of this Agreement. (b) 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 Programshown. 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) 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 receives an unfavorable decision from the hearing officer, the Manufacturer 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 plan year if the termination occurs before January 30 of a calendar plan year or as of the day after the end of the succeeding calendar plan year if the termination occurs on or after January 30 of a calendar plan year. (e) Any termination shall not affect the Manufacturer’s responsibility to reimburse Part D sponsors for applicable discounts for applicable drugs having NDCs with of the Manufacturer’s FDA-assigned labeler codes Manufacturer that were incurred under the Agreement before the effective date of its termination. (f) 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 reinstatements will be consistent with the requirements for entering into an Agreement under section 1860D-14A(b)(1)(C) of the Act.

Appears in 1 contract

Samples: Medicare Coverage Gap Discount Program Model Manufacturer Agreement

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NONRENEWAL AND TERMINATION. (a) Unless otherwise terminated by either party pursuant to the terms of this Agreementagreement, the Agreement agreement shall be effective for an initial period of not less than 24 months beginning on January 1, 2012, the date specified in section II.(h). of this agreement and shall be automatically renewed for a period additional successive terms of 1 one year from the date specified in section II.(h)., unless terminated under section VIII.(b) or (d) the manufacturer gives written notice of this Agreementintent not to renew the agreement at least 90 days before the end of the current period. (b) In accordance with section VII.(a). of this agreement and section 1927(b)(4)(B)(ii) of the Act, the manufacturer may terminate the agreement for any reason, and such termination shall become effective the later of the first day of the first rebate period beginning 60 days after the manufacturer gives written notice requesting termination, or CMS initiates termination via written notice to the manufacturer. The Secretary may terminate the agreement for failure of a manufacturer to make rebate payments to the state(s), failure to report required data, for other violations of this Agreement for a knowing and willful violation of the requirements of the Agreement 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 causes upon 60 days after the date of prior written notice to the Manufacturer manufacturer of the existence of such terminationviolation or other good cause causes. 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) The Secretary shall provide, upon request, a Manufacturer a hearing manufacturer with a hearing officer concerning such a termination, but such hearing shall not delay the effective date of the termination. (c) Manufacturers on the Office of Inspector General’s (OIG’s) List of Excluded Individuals/Entities (Exclusion List) will be subject to immediate termination if requested from the Medicaid drug rebate program unless and until the manufacturer is reinstated by the OIG. Appeals of exclusion and any reinstatement will be handled in writing within 15 calendar accordance with section 1128 of the Act and applicable regulations. Manufacturers that are on the OIG Exclusion List and are reinstated by the OIG under certain circumstances may be evaluated for reinstatement to the Medicaid drug rebate program by CMS. Reinstatement to the Medicaid drug rebate program would be for the next rebate period that begins more than 60 days from the date of receiving notice the OIG’s reinstatement of the manufacturer after exclusion. (d) If this rebate agreement is terminated, the manufacturer is prohibited from entering into another rebate agreement as set forth in section 1927(b)(4)(C) of the Act for at least one rebate period from the effective date of the termination, and such hearing shall take place prior the. The manufacturer addresses must also address to the effective date satisfaction of CMS any outstanding violations from any previous rebate agreement(s), including, but not limited to, payment of any outstanding rebates and also make good faith efforts to appeal or resolve matters pending with the termination with sufficient time for such effective date OIG relating to be repealed if the MDRP or exclusion as referenced in subsection (c) of this section, unless the Secretary determines appropriate. If the Manufacturer receives an unfavorable decision from the hearing officer, the Manufacturer may request review by the CMS Administrator. The decision of the CMS Administrator is final and binding. (d) The Manufacturer may terminate this Agreement finds good cause 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 yearearlier reinstatement. (e) Any nonrenewal or termination shall will 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 rebates due before the effective date of its termination. (f) 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.

Appears in 1 contract

Samples: National Drug Rebate Agreement

NONRENEWAL AND TERMINATION. (a) Unless otherwise terminated by either party pursuant to the terms of this AgreementAgreementagreement, the Agreement agreement shall be effective for an initial period of not less than 24 months one year beginning on January 1, 2012, the date specified in section II(dh) of this agreement and shall be automatically renewed for a period additional successive terms of 1 one year unless terminated under section VIII.(b) or (d) the Labeler manufacturer gives written notice of this Agreementintent not to renew the agreement at least 90 days before the end of the current period. (b) In accordance with section VII (a) of this agreement, the manufacturer The Secretary Manufacturer may terminate this Agreement the agreement for a knowing any reason, and willful violation such termination shall become effective the later of the requirements first day 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 first calendar quarterrebate period beginning 60 days after the Manufacturermanufacturer gives written notice requesting termination, or the ending date of the term of the agreement if notice has been given in accordance with VII(a). requesting termination, or CMS initiates termination via written 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 noticemanufacturer. (c) The Secretary may terminate the agreement Agreement for violations of this agreement or failure of a manufacturer to make rebate payments to the state(s), failure to report required data, for other violations of this agreement, or other good cause upon 60 days prior written notice to the Manufacturermanufacturer of the existence of such violation or other good cause. The Secretary shall provide, upon request, a Manufacturer a hearing Manufacturermanufacturer with a hearing officer concerning such a termination, but such hearing shall not delay the effective date of the termination. (c) Manufacturers on the Office of Inspector General’s (OIG’s) List of Excluded Individuals/Entities (Exclusion List) will be subject to immediate termination if requested from the Medicaid drug rebate program unless and until the manufacturer is reinstated by the OIG. Appeals of exclusion and any reinstatement will be handled in writing within 15 accordance with section 1128 of the Act and applicable regulations. Manufacturers that are on the OIG Exclusion List and are reinstated by the OIG under certain circumstances may be evaluated for reinstatement to the Medicaid drug rebate program by CMS. Reinstatement to the Medicaid drug rebate program would be for the next rebate period that begins more than 60 days from the date of the OIG’s reinstatement of the manufacturer after exclusion. (d) If this rebate agreement is nonrenewed or terminated, the Manufacturermanufacturer is prohibited from entering into another rebate agreement as providedset forth in section 1927(b)(4)(C) of the Act until a period of one calendar days quarter has elapsed from the effective date of receiving notice the termination,for at least one rebate period from the effective date of the termination, and such hearing shall take place prior the manufacturer addresses to the effective date satisfaction of CMS any outstanding violations from any previous rebate agreement(s), including, but not limited to, payment of any outstanding rebates and good faith efforts to appeal or resolve matters pending with the termination with sufficient time for such effective date to be repealed if OIG, unless the Secretary determines appropriate. If the Manufacturer receives an unfavorable decision from the hearing officer, the Manufacturer may request review by the CMS Administrator. The decision of the CMS Administrator is final and binding. (d) The Manufacturer may terminate this Agreement finds good cause 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 yearearlier reinstatement. (e) Any nonrenewal or termination shall will 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 rebates due before the effective date of its termination. (f) 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.

Appears in 1 contract

Samples: National Drug Rebate Agreement

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