REVERSION EVENT. A REVERSION EVENT will be deemed to have occurred if: (i) MEDIMMUNE is required by a REGULATORY AUTHORITY in any country in the MAJOR MARKETS to discontinue due to a safety concern or other reason beyond the control of MEDIMMUNE, the development of NUMAX prior to obtaining REGULATORY APPROVAL for NUMAX in such country; provided, however, that, a suspension of development activities for the purpose of redesigning the protocols in response to a regulatory request or action shall not be considered a discontinuation of development for purposes of this subsection; (ii) the PARTIES mutually agree in writing that the development of NUMAX should be discontinued prior to the filing for REGULATORY APPROVAL of NUMAX in any country in the MAJOR MARKET due to material adverse deviations from the anticipated safety profile for NUMAX that arise or become known to either PARTY after the EFFECTIVE DATE; (iii) [***]: (A) NUMAX has not received REGULATORY APPROVAL in at least [***] of the MAJOR MARKETS, and (B) all pivotal clinical trials for NUMAX in all countries of the MAJOR MARKETS, including but not limited to the PHASE III CLINICAL TRIAL, have been terminated; (iv) the PHASE III CLINICAL TRIAL is stopped voluntarily by MEDIMMUNE; provided, however, that, a suspension of the PHASE III CLINICAL TRIAL for the purpose of redesigning the protocols in response to a regulatory request or action shall not be considered a stoppage of the PHASE III CLINICAL TRIAL for purposes of this subsection; (v) the PHASE III CLINICAL TRIAL is (A) permanently discontinued or (B) suspended and reasonably estimated to be delayed for more than [***] from the date of suspension as a result of action or inaction by a THIRD PARTY or by MEDIMMUNE, in either case as a result of gross negligence or willful misconduct by MEDIMMUNE in the execution of (but not the design, analysis, interpretation or any other aspect of) the PHASE III CLINICAL TRIAL (e.g., for failure to pay the necessary clinical research organization(s) to complete the trial). Notwithstanding the foregoing, in the event that the PHASE III CLINICAL TRIAL is ongoing on or after [***] and NUMAX has not been approved in at least [***] of the MAJOR MARKETS, then at any time after [***], subject to the limitation in Section 3.4(b), ▇▇▇▇▇▇ shall have the sole discretion to declare a REVERSION EVENT upon ninety (90) days written notice to MEDIMMUNE. With respect to Section 3.2(a)(v) above, a REVERSION EVENT shall only be deemed to have occurred upon a finding of gross negligence or willful misconduct by a court of competent jurisdiction (or in accordance with the alternate dispute resolution mechanism set forth provided for in Section 15.7). If, as a result, a REVERSION EVENT has been deemed to have occurred and MEDIMMUNE cures the cause of the discontinuation or delay within one (1) year following the occurrence of such REVERSION EVENT, then no later than forty-five (45) days after any notice of cure, ▇▇▇▇▇▇ shall have the right, in its sole discretion and with written notice to MEDIMMUNE, to declare that a REVERSION EVENT did not take place, in which case ▇▇▇▇▇▇’▇ rights to NUMAX shall be reinstated as if such REVERSION EVENT had not occurred and the FINAL PRICE from that point forward shall also be calculated as if a REVERSION EVENT had not occurred. In addition, no later than thirty (30) days after the reinstatement of ▇▇▇▇▇▇’▇ rights hereunder, ▇▇▇▇▇▇ shall pay MEDIMMUNE [***] of the total amount of any excess of the FINAL PRICE that would have been paid if the REVERSION EVENT had not occurred over the total amount of the FINAL PRICE that was actually paid during the period that such REVERSION EVENT existed.
Appears in 1 contract
REVERSION EVENT. A REVERSION EVENT (a) If on any date following the occurrence of a Release Event (such date, the “Reversion Date”) any two of the three Rating Agencies withdraw their Investment Grade rating of the senior, unsecured, non-credit enhanced, long-term debt securities of the Issuer or downgrade such rating below Investment Grade, then the Issuer and the Guarantors shall secure the Notes with the Collateral within 60 days after the Reversion Date (a “Reversion Event”) in accordance with Section 11.07 and will thereafter again be subject to Section 4.07(a) hereof.
(b) Notwithstanding that obligations to secure the Notes with the Collateral may be reinstated following a Reversion Event and that Section 4.07(a) shall apply after the Reversion Date, no Default, Event of Default or breach of any kind related to any obligations to secure the Notes with the Collateral during the Release Period and the obligations under Section 4.07(a) during the Release Period will be deemed to have occurred if:
(i) MEDIMMUNE is required by a REGULATORY AUTHORITY in any country in the MAJOR MARKETS to discontinue due to a safety concern or other reason beyond the control of MEDIMMUNEexist under this Indenture, the development of NUMAX prior Notes or the Subsidiary Guarantees with respect to obtaining REGULATORY APPROVAL for NUMAX in such country; providedobligations, however, that, a suspension of development activities for the purpose of redesigning the protocols in response to a regulatory request or action shall not be considered a discontinuation of development for purposes of this subsection;
(ii) the PARTIES mutually agree in writing that the development of NUMAX should be discontinued prior to the filing for REGULATORY APPROVAL of NUMAX in any country in the MAJOR MARKET due to material adverse deviations from the anticipated safety profile for NUMAX that arise or become known to either PARTY after the EFFECTIVE DATE;
(iii) [***]: (A) NUMAX has not received REGULATORY APPROVAL in at least [***] and none of the MAJOR MARKETS, and (B) all pivotal clinical trials for NUMAX in all countries Issuer or any of the MAJOR MARKETSGuarantors shall bear any liability for any actions taken or events occurring during the Release Period, including but not limited or any actions taken at any time pursuant to the PHASE III CLINICAL TRIAL, have been terminated;
(iv) the PHASE III CLINICAL TRIAL is stopped voluntarily by MEDIMMUNE; provided, however, that, a suspension of the PHASE III CLINICAL TRIAL for the purpose of redesigning the protocols in response to a regulatory request or action shall not be considered a stoppage of the PHASE III CLINICAL TRIAL for purposes of this subsection;
(v) the PHASE III CLINICAL TRIAL is (A) permanently discontinued or (B) suspended and reasonably estimated to be delayed for more than [***] from the date of suspension as a result of action or inaction by a THIRD PARTY or by MEDIMMUNEany contractual obligation arising during any Release Period, in either each case as a result of gross negligence or willful misconduct by MEDIMMUNE in the execution of (but not the design, analysis, interpretation or any other aspect of) the PHASE III CLINICAL TRIAL (e.g., for a failure to pay comply with such obligations during the necessary clinical research organization(sRelease Period (or upon termination of the Release Period or after that time based solely on any action taken or event that occurred during the Release Period); provided that all Liens incurred during the Release Period will be classified to have been incurred or issued pursuant to clause (2) of the definition of “Permitted Liens”.
(c) The Trustee shall have no duty to complete (i) monitor the trial). Notwithstanding ratings of the Notes, (ii) ascertain whether a Release Event or Reversion Event has occurred, or (iii) notify the Holders of any of the foregoing, in the event that the PHASE III CLINICAL TRIAL is ongoing on or after [***] and NUMAX has not been approved in at least [***] of the MAJOR MARKETS, then at any time after [***], subject to the limitation in Section 3.4(b), ▇▇▇▇▇▇ shall have the sole discretion to declare a REVERSION EVENT upon ninety (90) days written notice to MEDIMMUNE. With respect to Section 3.2(a)(v) above, a REVERSION EVENT shall only be deemed to have occurred upon a finding of gross negligence or willful misconduct by a court of competent jurisdiction (or in accordance with the alternate dispute resolution mechanism set forth provided for in Section 15.7). If, as a result, a REVERSION EVENT has been deemed to have occurred and MEDIMMUNE cures the cause of the discontinuation or delay within one (1) year following the occurrence of such REVERSION EVENT, then no later than forty-five (45) days after any notice of cure, ▇▇▇▇▇▇ shall have the right, in its sole discretion and with written notice to MEDIMMUNE, to declare that a REVERSION EVENT did not take place, in which case ▇▇▇▇▇▇’▇ rights to NUMAX shall be reinstated as if such REVERSION EVENT had not occurred and the FINAL PRICE from that point forward shall also be calculated as if a REVERSION EVENT had not occurred. In addition, no later than thirty (30) days after the reinstatement of ▇▇▇▇▇▇’▇ rights hereunder, ▇▇▇▇▇▇ shall pay MEDIMMUNE [***] of the total amount of any excess of the FINAL PRICE that would have been paid if the REVERSION EVENT had not occurred over the total amount of the FINAL PRICE that was actually paid during the period that such REVERSION EVENT existed.
Appears in 1 contract
Sources: Indenture (DT Midstream, Inc.)
REVERSION EVENT. A REVERSION EVENT (a) If on any date following the occurrence of a Release Event (such date, the “Reversion Date”) any two of the three Rating Agencies withdraw their Investment Grade rating of the senior, unsecured, non-credit enhanced, long-term debt securities of the Issuer or downgrade such rating below Investment Grade, then the Issuer and the Guarantors shall secure the Notes with the Collateral within 60 days after the Reversion Date (a “Reversion Event”) in accordance with Section 11.07 and will thereafter again be subject to Section 4.07(a) hereof.
(b) Notwithstanding that obligations to secure the Notes with the Collateral may be reinstated following a Reversion Event and that Section 4.07(a) shall apply after the Reversion Date, no Default, Event of Default or breach of any kind related to any obligations to secure the Notes with the Collateral during the Release Period and the obligations under Section 4.07(a) during the Release Period will be deemed to have occurred if:
(i) MEDIMMUNE is required by a REGULATORY AUTHORITY in any country in the MAJOR MARKETS to discontinue due to a safety concern or other reason beyond the control of MEDIMMUNEexist under this Indenture, the development of NUMAX prior Notes or the Subsidiary Guarantees with respect to obtaining REGULATORY APPROVAL for NUMAX in such country; providedobligations, however, that, a suspension of development activities for the purpose of redesigning the protocols in response to a regulatory request or action shall not be considered a discontinuation of development for purposes of this subsection;
(ii) the PARTIES mutually agree in writing that the development of NUMAX should be discontinued prior to the filing for REGULATORY APPROVAL of NUMAX in any country in the MAJOR MARKET due to material adverse deviations from the anticipated safety profile for NUMAX that arise or become known to either PARTY after the EFFECTIVE DATE;
(iii) [***]: (A) NUMAX has not received REGULATORY APPROVAL in at least [***] and none of the MAJOR MARKETS, and (B) all pivotal clinical trials for NUMAX in all countries Issuer or any of the MAJOR MARKETSGuarantors shall bear any liability for any actions taken or events occurring during the Release Period, including but not limited or any actions taken at any time pursuant to the PHASE III CLINICAL TRIAL, have been terminated;
(iv) the PHASE III CLINICAL TRIAL is stopped voluntarily by MEDIMMUNE; provided, however, that, a suspension of the PHASE III CLINICAL TRIAL for the purpose of redesigning the protocols in response to a regulatory request or action shall not be considered a stoppage of the PHASE III CLINICAL TRIAL for purposes of this subsection;
(v) the PHASE III CLINICAL TRIAL is (A) permanently discontinued or (B) suspended and reasonably estimated to be delayed for more than [***] from the date of suspension as a result of action or inaction by a THIRD PARTY or by MEDIMMUNEany contractual obligation arising during any Release Period, in either each case as a result of gross negligence or willful misconduct by MEDIMMUNE in the execution of (but not the design, analysis, interpretation or any other aspect of) the PHASE III CLINICAL TRIAL (e.g., for a failure to pay comply with such obligations during the necessary clinical research organization(s) to complete Release Period (or upon termination of the trial). Notwithstanding the foregoing, in the Release Period or after that time based solely on any action taken or event that occurred during the PHASE III CLINICAL TRIAL is ongoing on Release Period); provided that all Liens incurred during the Release Period will be classified to have been incurred or after [***] and NUMAX has not been approved in at least [***] issued pursuant to clause (2) of the MAJOR MARKETS, then at any time after [***], subject to the limitation in Section 3.4(b), ▇▇▇▇▇▇ definition of “Permitted Liens”.
(c) The Issuer shall have the sole discretion to declare a REVERSION EVENT upon ninety (90) days send written notice to MEDIMMUNE. With respect to Section 3.2(a)(v) above, a REVERSION EVENT shall only be deemed to have occurred the Trustee upon a finding the commencement of gross negligence any Release Period or willful misconduct by a court of competent jurisdiction (or in accordance with the alternate dispute resolution mechanism set forth provided for in Section 15.7). If, as a result, a REVERSION EVENT has been deemed to have occurred and MEDIMMUNE cures the cause of the discontinuation or delay within one (1) year following the occurrence of such REVERSION EVENT, then no later than forty-five (45) days after any notice of cure, ▇▇▇▇▇▇ Reversion Date; provided that the failure to so notify the Trustee shall not be a Default under this Indenture. The Trustee shall have no duty to (i) monitor the right, in its sole discretion and with written notice to MEDIMMUNE, to declare that a REVERSION EVENT did not take place, in which case ▇▇▇▇▇▇’▇ rights to NUMAX shall be reinstated as if such REVERSION EVENT had not occurred and the FINAL PRICE from that point forward shall also be calculated as if a REVERSION EVENT had not occurred. In addition, no later than thirty (30) days after the reinstatement of ▇▇▇▇▇▇’▇ rights hereunder, ▇▇▇▇▇▇ shall pay MEDIMMUNE [***] ratings of the total amount Notes, (ii) ascertain whether a Release Event or Reversion Event has occurred, or (iii) notify the Holders of any excess of the FINAL PRICE that would have been paid if the REVERSION EVENT had not occurred over the total amount of the FINAL PRICE that was actually paid during the period that such REVERSION EVENT existedforegoing.
Appears in 1 contract
Sources: Indenture (DT Midstream, Inc.)