IV Product definition
Examples of IV Product in a sentence
In the event the BLA Party determines that any Remedial Action with respect to the A1PI IV Product should be commenced, or Remedial Action is required by any governmental authority having jurisdiction over the matter, the BLA Party shall use Commercially Reasonable Efforts to conduct such Remedial Action.
The BLA Party shall determine whether to commence any Remedial Action with respect to the A1PI IV Product.
Kamada shall fulfill all regulatory requirements relating to the safety of the A1PI IV Product, including, but not limited to, collecting and assessing adverse events, reporting safety information (individual case safety reports and aggregate reports), literature searches, risk management activities, if warranted, responding to regulatory inquiries and conducting pharmacovigilance for the A1PI IV Product.
Each Party shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any party, including, without limitation, a Regulatory Authority which may affect the safety or efficacy claims of the A1PI IV Product or the continued marketing of the A1PI IV Product.
The Parties shall report to each other all information necessary to make timely reports as required by any Regulatory Authority or other authorized authority in the ▇▇▇▇▇▇ Territory and Kamada Territory regarding the A1PI IV Product.
In furtherance of this right, ▇▇▇▇▇▇ agrees that it shall specifically obtain from any and all third-party or Affiliate distributors of the A1PI IV Product a right of Kamada to conduct audits of such party’s records and facilities as set forth herein.
Kamada shall, at its discretion, have the right to attend any ▇▇▇▇▇▇ meetings with the FDA, ISO or any other federal, state or local regulatory agency that relate to the A1PI IV Product in the ▇▇▇▇▇▇ Territory.
In the event that ▇▇▇▇▇▇ is not manufacturing or distributing the A1PI IV Product and is using third parties to manufacture or distribute the A1PI IV Product, ▇▇▇▇▇▇ shall obtain all rights necessary from such third parties to enable Kamada to exercise all of its rights under this Agreement at such third party manufactures’ facilities.
With respect to all other countries in the ▇▇▇▇▇▇ Territory, ▇▇▇▇▇▇ shall be responsible, at its sole cost and expense, for all pharmacovigilance and adverse event reporting activities for A1PI IV Product in such countries; provided, however, that Kamada shall reasonably assist ▇▇▇▇▇▇ by providing relevant documentation for such A1PI IV Product.
Notwithstanding the foregoing, if ▇▇▇▇▇▇ receives any telephonic or written or other correspondence relating to an adverse event for an A1PI IV Product in the United States or elsewhere in the ▇▇▇▇▇▇ Territory, ▇▇▇▇▇▇ shall use Commercially Reasonable Efforts to obtain the Minimum PV Information and shall promptly forward such Minimum PV Information to Kamada.