# In the matter of Airis Pharma Private Limited

> NCLT judgment dated 2024-02-23. Citation: TCN-2024-NCLT-02414. Biocon Pharma Limited, the Operational Creditor (OC), filed an application against Airis Pharma…

- **Court:** NCLT
- **Order date:** 23 Feb 2024
- **Citation:** TCN-2024-NCLT-02414
- **Category:** IBC
- **Source page:** https://caseease.in/cases/ibc/nclt-division-bench-court-i-chenn/airis-pharma-private-limited-ff418ae3

## Summary

### Background

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 between the OC and the CD on April 22, 2021, for the in-licensing of a pharmaceutical product. As per the agreement, the CD was responsible for developing and obtaining all necessary approvals for manufacturing and commercializing the product, including filing an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA) of the United States. The OC was to provide supporting documents, including the Risk

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## Facts

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. The CD was to develop and obtain FDA approval, including filing an ANDA. The OC was to provide supporting documents, including REMS Authorization. The OC disbursed 70% of the Licensing Fees (USD 950,000) plus IGST. The FDA did not approve the ANDA due to deficiencies in the REMS Authorization submitted by the OC. The OC terminated the agreement on 21.04.2022 and demanded a refund. The CD claimed the OC did not provide proper REMS Authorization and made a counter-claim of USD 500,000. The CD invoked arbitration. The OC issued a Demand Notice under Section 8 of IBC on 21.10.2022. The CD had engaged with

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## Issues and analysis

### Issue 1: Whether the application under Section 9 of IBC should be allowed, considering the dispute over the …

**Ratio:** The principle established in Mobilox Innovations Private Limited vs. Kirusa Software

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**Reasoning:** The court reasoned that the dispute over the REMS Authorization and its impact on the FDA

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**Interpretation:** This interpretation of the Mobilox Innovations case emphasizes that the

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**Application:** In this case, the court applied the principle from Mobilox Innovations by

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## Parties

- **Judges:** Rajeev Bh…; Sanjay…
- **Appellants:** Biocon Pharma…
- **Respondents:** Airis Pharma Pvt…

## Timeline

- **2021-04-22 — Agreement…**: Biocon Pharma Limited and Airis Pharma Private Limited entered into a Licensing and…
- **2022-04-21 — Agreement Ter…**: Biocon Pharma Limited terminated the agreement due to Airis Pharma Private Limited's…

## Legal provisions

- [Insolvency and Bankruptcy Code, 2016, Section 9 — Application for initiation of corporate insolvency…](https://caseease.in/legal-provisions/insolvency-and-bankruptcy-code-2016/section-9)

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