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Cipla Ltd. Legal Proceedings Report 2020

Dec 11, 2020

59275_rns_2020-12-11_802cb212-d196-458a-b3e8-1ea73d8381c6.pdf

Legal Proceedings Report

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11[th] December 2020

  • (1) BSE Limited (2) National Stock Exchange of India Ltd Listing Department Listing Department Phiroze Jeejeebhoy Towers, Exchange Plaza, 5[th] floor, Dalal Street, Plot no. C/1, G Block, Mumbai - 400 001 Bandra Kurla Complex, Bandra (East), Mumbai - 400 051

Scrip Code: 500087 Scrip Code: CIPLA EQ

  • (3) SOCIETE DE LA BOURSE DE LUXEMBOURG Societe Anonyme 35A Boulevard Joseph II, L-1840 Luxembourg

Sub: Press Release - Cipla announces settlement of Revlimid® (Lenalidomide) Capsules Patent Litigation

Dear Sir / Madam,

Please find enclosed press release dated 11[th] December 2020 for the captioned subject.

This is for your information and records.

Kindly acknowledge the receipt.

Thanking you,

Yours faithfully, For Cipla Limited

Digitally signed by RAJENDRA CHOPRA DN: c=IN, o=Personal, 2.5.4.20=4987ad48c3965cfde78c8ea69 RAJENDR e6f40ac91535876f12ba1fa5ba45cc5cc 8db6cb, postalCode=122001, st=HARYANA, serialNumber=0be85c0408d0e3afd663 A CHOPRA 669f5314248a72fdcdf34d01d48d472d 7cf9262696f6, cn=RAJENDRA CHOPRA Date: 2020.12.11 17:40:44 +05'30'

Rajendra Chopra Company Secretary

Encl.as above

Prepared by: Juzer Masta

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==> picture [89 x 49] intentionally omitted <==

CIPLA ANNOUNCES SETTLEMENT OF REVLIMID® (LENALIDOMIDE) CAPSULES PATENT LITIGATION

Mumbai, India, December 11, 2020: Cipla Limited (BSE: 500087; NSE: CIPLA EQ) (“Cipla today announced the settlement of its litigation with Celgene Corporation, and wholly owned subsidiary of Bristol Myers Squibb (NYSE: BMY) relating to patents for REVLIMID[®] (lenalidomide). As part of the settlement, the Parties will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin Cipla from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement, as described below.

In settlement of all outstanding claims in the litigation, Celgene has agreed to provide Cipla with a license to Celgene’s patents required to manufacture and sell certain volume-limited amounts of generic lenalidomide in the United States beginning on a confidential date that is some time after the March 2022. For each consecutive twelvemonth period (or part thereof) following the volume-limited entry date until January 31, 2026, the volume of generic lenalidomide sold by Cipla cannot exceed certain agreedupon percentages. The specific volume-limited license date and percentages agreedupon with Cipla are confidential.

In addition, Celgene has agreed to provide Cipla with a license to Celgene’s patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the United States beginning no earlier than January 31, 2026. Cipla’s ability to market lenalidomide in the U.S. will be contingent on its obtaining approval of an Abbreviated New Drug Application.

Mr. Arunesh Verma, CEO, Cipla North America said, “This is an important step forward for us and is in line with our pursuit of improving access to high quality life-saving treatments.”

ABOUT CIPLA

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments are well-known. Our 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cuttingedge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT September’20), 3rd largest in the pharma private market in South Africa (IQVIA MAT September’ 20), and is among the most dispensed generic players in the U.S. For over eight decades, making a difference to patients has inspired every aspect of Cipla’s work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the center of the HIV movement. A responsible corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of ‘Caring for Life’ and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. For more, please visit www.cipla.com, or click on Twitter, Facebook, LinkedIn.

ABOUT REVLIMID[®]

In the U.S., REVLIMID[®] (lenalidomide) in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma. REVLIMID[®] as a single agent is also indicated as a maintenance therapy in patients with multiple myeloma following autologous hematopoietic stem cell transplant. REVLIMID[®] is indicated for patients with transfusiondependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID[®] is approved in the U.S. for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Limitations of Use: REVLIMID[®] is not indicated and is not recommended for the treatment of chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

ABOUT CELGENE

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company’s website at www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.

For further information please contact:

Corporate Communications: Investor Relations: Heena Kanal Naveen Bansal [email protected] [email protected]