Biocon Pharma Limited, the Operational Creditor (OC), filed an application against Airis Pharma Private Limited, the Corporate Debtor (CD), seeking to initiate the Corporate Insolvency Resolution Process (CIRP) under Section 9 of the Insolvency and Bankruptcy Code (IBC). The dispute arose from a Licensing and Supply Agreement entered into on April 22, 2021, where the CD was to develop and obtain necessary approvals for manufacturing and commercializing a pharmaceutical product, including filing an Abbreviated New Drug Application (ANDA) with the FDA. The OC was to provide supporting documents, including Risk Evaluation and Mitigation Strategy (REMS) Authorization. The OC disbursed 70% of the licensing fees (USD 950,000) plus IGST. The FDA did not approve the ANDA
…Biocon Pharma Limited (OC) and Airis Pharma Private Limited (CD) entered into a Licensing and Supply Agreement on 22.04.2021 for in-licensing a pharmaceutical product. Airis Pharma was to develop and obtain FDA approval for the product, while Biocon was to provide supporting documents, including REMS Authorization. Biocon disbursed USD 950,000 (70% of licensing fees) plus IGST. The FDA rejected Airis's ANDA filing due to deficiencies in Biocon's REMS Authorization. Biocon terminated the agreement on 21.04.2022 and demanded a refund. Airis refused, citing Biocon's failure to provide proper REMS Authorization. Airis initiated arbitration proceedings. Biocon issued a demand notice under Section 8 of IBC on 21.10.2022. Airis had raised the issue of improper REMS with
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Biocon Pharma Limited and Airis Pharma…
Emails from FDA…
Biocon Pharma Limited, the Operational Creditor (OC), filed an application against Airis Pharma Private Limited, the Corporate Debtor (CD), seeking to initiate the Corporate Insolvency Resolution Process (CIRP) under Section 9 of the Insolvency and Bankruptcy Code (IBC). The dispute arose from a Licensing and Supply Agreement entered into on April 22, 2021, where the CD was to develop and obtain necessary approvals for manufacturing and commercializing a pharmaceutical product, including filing an Abbreviated New Drug Application (ANDA) with the FDA. The OC was to provide supporting documents, including Risk Evaluation and Mitigation Strategy (REMS) Authorization. The OC disbursed 70% of the licensing fees (USD 950,000) plus IGST. The FDA did not approve the ANDA
…Biocon Pharma Limited (OC) and Airis Pharma Private Limited (CD) entered into a Licensing and Supply Agreement on 22.04.2021 for in-licensing a pharmaceutical product. Airis Pharma was to develop and obtain FDA approval for the product, while Biocon was to provide supporting documents, including REMS Authorization. Biocon disbursed USD 950,000 (70% of licensing fees) plus IGST. The FDA rejected Airis's ANDA filing due to deficiencies in Biocon's REMS Authorization. Biocon terminated the agreement on 21.04.2022 and demanded a refund. Airis refused, citing Biocon's failure to provide proper REMS Authorization. Airis initiated arbitration proceedings. Biocon issued a demand notice under Section 8 of IBC on 21.10.2022. Airis had raised the issue of improper REMS with
…Biocon Pharma Limited and Airis Pharma…
Emails from FDA…