Globestar Therapeutics Enters into Definitive Agreement with SMI Healthcare to Manage Clinical Trial, Regulatory Filings, Manufacturing and Sales in MEA Region for Multiple Sclerosis Treatment - Seite 2

Implementation of the second phase is expected to commence approximately nine months later, and is subject to receipt of DCGI marketing approval and GlobeStar arranging financing. The second phase may continue for the duration of patent validity, and consists initially of sales, marketing and distribution in India and thereafter, countries in SMIHC's territory that will permit sales and distribution based upon DCGI approval. After proof of market in those countries, the intention is to seek regulatory approvals elsewhere in SMIHC's territory in order to expand the sales and distribution of GTC's MS products.

Among other countries, SMIHC's territory includes India, Bangladesh, Indonesia, Saudi Arabia, Singapore, Thailand, the United Arab Emirates, Vietnam, and the members of the African Union.

According to the U.S. National Institutes of Health, between 2013 and 2020, the reported incidence of MS has increased by 50% in the 81 most affected countries. Although the market potential is uncertain in many of the developing countries in SMIHC's territory, in 2020, reported cases of MS in India reached 256,000, and total reported cases in SMIHC's territory exceeded 600,000. According to multiple sources, the reported incidence of MS in the Middle East and Africa is rapidly growing, with treatments in the Middle East (excluding Israel) alone expected to grow from approximately $3.5 billion in 2023 to $4.5 billion in 2032. Within five years after launching sales in each country in which Globestar obtains regulatory approval, GlobeStar's goal is to capture from 20% to 50% of the market for MS therapeutics in that country.

Pursuant to the parties' agreement, GlobeStar retains ownership of its intellectual property rights, and regulatory filings, and approval of SMIHC's services regarding the foregoing, clinical trials, and manufacturing. Subject to the terms of the agreement, SMIHC has final approval over its sales and distribution activities, though with certain limited exceptions, it is required to purchase GTC's MS products from GTC. SMIHC has the first right in its territory to provide similar services for other GTC products and services.

For its consulting and management services, SMIHC will be paid a range of fees that escalate over time and are tied to services rendered. For sales and distribution, SMIHC receives customary commissions and mark-ups. SMIHC is required to rebate to GlobeStar approximately 5% of its profits from certain manufacturing, sales and distribution activities.