Biosimilars or Interchangeables. If either Party receives a copy of an application submitted to the FDA under subsection # of [Section 351] of the PHSA (a “Biosimilar Application”) naming a Licensed Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (such as in an instance described in [Section 351(l)(9)(C)] of the PHSA), either Party shall, within […​…], notify the other Party so that the other Party may seek permission to view the application and related confidential information from the filer of the Biosimilar Application under [Section 351(l)(1)(B)(iii)] of the PHSA. Regardless of the Party that is the “reference product sponsor” for purposes of such Biosimilar Application, # [[Organization A:Organization]] shall have the sole right to designate pursuant to [Section 351(l)(1)(B)(ii)] of the PHSA the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application and manufacturing information, # [[Organization A:Organization]] shall have the sole right and discretion to list or not list any Patents, including ​ Patents and Joint Patents, insofar as they claim or cover the applicable Licensed Product or biosimilar product as required pursuant to [Section 351] of the PHSA or related regulations or guidance, to respond to any communications with respect to such lists from the filer of the CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[...​...]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

Biosimilars. Each Party shall promptly, but in any event no later than ten (10) business days after receipt of notice of such application, notify the other Party if it becomes aware of any application for regulatory approval of any pharmaceutical product of a third party (excluding any Arcus Affiliate, sublicensee (or their further sublicensees), related to this Agreement) that relies on such Licensed Product as a Reference Product under the Biologics Price Competition and Innovation Act, or any comparable regulatory regime in any other country in the Territory, and # for which biosimilarity or interchangeability (as applicable) with such Licensed Product has been or is sought to be demonstrated and # which seeks regulatory approval in such country relying in whole or in part on any data generated in support of a Regulatory Approval for such Licensed Product. Arcus shall take the lead and be responsible for preparing and filing any responses with any Regulatory Authority in the Territory and WuXi shall take the lead and be responsible if in the Excluded Territory, and each respective Party will be responsible for negotiating any patent resolution in connection with any such application as set forth in paragraphs 2 through 6 of Section 351(l) of the United States Public Health Service Act (42 U.S.C. § 262(l)(2)-(6)), or any foreign equivalent thereof. Each Party shall cooperate with the other Party’s reasonable requests for assistance in connection therewith.

Adrian Hepner, M.D., Ph.D. and CMO of Coya added, “we believe that the COYA 302 proof-of-concept clinical data in ALS patients is encouraging and sets the foundation to advance our development program. Our combination therapy approach has been designed to address the multiple pathophysiological pathways leading to chronic and sustained inflammation that drives the progression of serious neurodegenerative diseases. We plan to file an IND in the second half of this year and work closely with the regulatory authorities to initiate our clinical studies soon thereafter.” [[Person A:Person]]bal Head of Biologics at Dr. Reddy’s commented, “We are very happy to collaborate with Coya in this effort to advance therapies that address critical unmet needs for a variety of neuro-degenerative diseases. As a global biosimilars developer, we believe our proposed Abatacept biosimilar will be valuable in the development of this innovative combination therapy. We continue to look for ways to use our scientific capabilities and product portfolio to serve patients around the world.”

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.