Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal or similar action in connection with a Licensed Product in any portion of the Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or similar action in any portion of the Territory, the Party notified of such recall, market withdrawal or similar action, or the Party that desires such recall, market withdrawal or similar action, shall within twenty-four (24) hours advise the other Party thereof by telephone or facsimile. The Party then-Commercializing such Licensed Product shall, after reasonable consultation with the other Party, decide whether to conduct a recall, market withdrawal or similar action in its applicable portion of the Territory and the manner in which any such recall, market withdrawal or similar action shall be conducted. Each Party will make available to the other Party, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall, market withdrawal or similar action.
Appears in 2 contracts
Samples: Master Research and Collaboration Agreement (Jounce Therapeutics, Inc.), Master Research and Collaboration Agreement (Jounce Therapeutics, Inc.)
Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal or similar action in connection with a Licensed Shared Product in any portion of the Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or similar action in any portion of country in the Territory, the Party notified of such recall, market withdrawal or similar action, or the Party that desires such recall, market withdrawal or similar action, shall within twenty-four (24) hours advise the other Party thereof by telephone or facsimiletelephone. The Party then-Commercializing such Licensed Product Celgene shall, after reasonable consultation with the other PartyVividion, decide whether to conduct a recall, market withdrawal or similar action in its applicable such country or portion of the Territory and the manner in which any such recall, market withdrawal or similar action shall be conducted. Each Party will make available to the other Party, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall, market withdrawal or similar action.
Appears in 2 contracts
Samples: License Agreement (Vividion Therapeutics, Inc.), License Agreement (Vividion Therapeutics, Inc.)
Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal or similar action in connection with a Licensed Shared Product in any portion of the Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or similar action in any portion of country in the Territory, the Party notified of such recall, market withdrawal or similar action, or the Party that desires such recall, market withdrawal or similar action, shall within twenty-four (24) hours advise the other Party thereof by telephone or facsimiletelephone. The Lead Party then-Commercializing such Licensed Product shall, after reasonable consultation with the other Party, decide whether to conduct a recall, market withdrawal or similar action in its applicable portion of the Territory and the manner in which any such recall, market withdrawal or similar action shall be conducted. Each Party will make available to the other Party, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall, market withdrawal or similar action.
Appears in 2 contracts
Samples: License Agreement (Vividion Therapeutics, Inc.), License Agreement (Vividion Therapeutics, Inc.)
Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal withdrawal, clinical hold involving discontinuation of use of the Product or similar action in connection with a Licensed Product in any portion of the Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or similar action in any portion of country in the Territory, the Party notified of such recall, market withdrawal or similar action, or the Party that desires such recall, market withdrawal or similar action, shall within twenty-four (24) hours advise the other Party thereof by telephone or facsimiletelephone. The Party then-Commercializing such Licensed Product Lannett shall, after reasonable consultation with the other PartyHEC, decide whether to conduct a recall, market withdrawal or similar action in its applicable portion of the Territory US and the manner in which any such recall, market withdrawal or similar action shall be conducted. Each Party will make available to the other Party, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall, market withdrawal or similar action.
Appears in 1 contract
Samples: Collaboration and License Agreement (Lannett Co Inc)
Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal or similar action in connection with a Licensed Product in any portion of the ROW Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or similar action in any portion of the ROW Territory, the Party notified of such recall, market withdrawal or similar action, or the Party that desires such recall, market withdrawal or similar action, shall within twenty-four (24) [**] hours advise the other Party thereof by telephone or facsimile. The Party then-Commercializing such Licensed Product shall, after reasonable consultation with the other Party, JSC shall decide whether to conduct a recall, market withdrawal or similar action in its applicable any portion of the ROW Territory and the manner in which any such recall, market withdrawal or similar action shall be conducted. Each Party will make available to the other PartyParties, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall, market withdrawal or similar action.
Appears in 1 contract
Samples: Collaboration and License Agreement (Agios Pharmaceuticals Inc)
Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal or similar action in connection with a Licensed Product in any portion of the Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or similar action in any portion of country in the Territory, the Party notified of such recall, market withdrawal or similar action, or the Party that desires such recall, market withdrawal or similar action, shall within twenty-four (24) hours advise the other Party thereof by telephone or facsimiletelephone. The Lead Party then-Commercializing such Licensed Product shall, after reasonable consultation with the other Party, decide whether to conduct a recall, market withdrawal or similar action in its applicable portion of the Territory and the manner in which any such recall, market withdrawal or similar action shall be conducted. Each Party will make available to the other Party, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall, market withdrawal or similar action.
Appears in 1 contract
Samples: Development and Collaboration Agreement (BioAtla, Inc.)
Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal or similar action in connection with a Licensed Product in any portion of the US Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or similar action in any portion of the US Territory, the Party notified of such recall, market withdrawal or similar action, or the Party that desires such recall, market withdrawal or similar action, shall within twenty-four (24) [**] hours advise the other Party thereof by telephone or facsimile. The Party then-Commercializing such Licensed Product shall, after reasonable consultation with the other Party, JSC shall decide whether to conduct a recall, market withdrawal or similar action in its applicable any portion of the US Territory and the manner in which any such recall, market withdrawal or similar action shall be conducted. Each Party will make available to the other PartyParties, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall, market withdrawal or similar action.
Appears in 1 contract
Samples: Collaboration and License Agreement (Agios Pharmaceuticals Inc)
Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal or similar action in connection with a Licensed Product in any portion of the Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or similar action in any portion of the Territory, the Party notified of such recall, market withdrawal or similar action, or the Party that desires such recall, market withdrawal or similar action, shall within twenty-four (24) hours [**] advise the other Party thereof by telephone or facsimile. The Lead Party then-Commercializing such Licensed Product shall, after reasonable consultation with the other Party, decide whether to conduct a recall, market withdrawal or similar action in its applicable portion of the Territory and the manner in which any such recall, market withdrawal or similar action shall be conducted. Each Party will make available to the other Party, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall, market withdrawal or similar action.
Appears in 1 contract