Panacea Biotec reaches settlement with Apotex
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Panacea Biotec reaches settlement with Apotex

Apotex will also pay US$ 2.5 million upon receipt of final USFDA approval of the ANDA that is the subject of the Collaboration Agreement for Paclitaxel Protein-Bound Particles for Injectable Suspension

  • By IPP Bureau | July 12, 2025

Panacea Biotec Limited had earlier received a notification dated October 04, 2023 from the International Court of Arbitration, Paris (ICC) intimating that an Arbitration proceeding has commenced with respect to the Request for Arbitration filed by Apotex, an entity based out in Canada for arbitration of dispute between the parties.

The parties have executed a Settlement Agreement on July 09, 2025, recording full and final settlement of the disputes forming part of the arbitration among Apotex, the company and its wholly-owned subsidiary, Panacea Biotec Pharma Limited.

Pursuant to the settlement, it has, been agreed among the Parties that Apotex will pay US$ 2.5 million within 30 days from the date of Settlement Agreement.

- Apotex will also pay US$ 2.5 million upon receipt of final USFDA approval of the ANDA that is the subject of the Collaboration Agreement for Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) (Paclitaxel). As a result, the previous agreement for Apotex to pay US$ 1 million upon receipt of the ANDA stands modified accordingly;

- the profit share for the supply by PBPL of Paclitaxel for Canada will be modified in a way that Apotex shall receive 65% of the Net Profits and PBPL shall receive balance 35% until such time that Apotex recoups US$ 1.5 million from that supply, after which the profit share shall revert to 50:50;

- the profit share for the supply by PBPL of Paclitaxel for USA will be modified in a way that Apotex shall receive 60% of the Net Profits and PBPL shall receive balance 40% until such time that Apotex recoups US$ 0.5 million from that supply, after which the profit share shall revert to 50:50;

- the parties shall request Arbitral Tribunal to terminate the aforesaid arbitrations by entering an award by consent recording the terms of this Settlement Agreement;

- this Settlement Agreement is in full and final settlement of all and/or any actions, claims, rights, demands and set offs, arising out of or connected with the above referred disputes and the underlying facts relating to the disputes among the Parties; and

- the full and final release and discharge shall apply even in the event that the Panacea Biotec ANDA is not approved at all whensoever by the US FDA.

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