GARDP – Orchid, Cefiderocol Manufacturing Sublicense and Technology Transfer Agreement

Intellectual Property | Ownership of IP

Summary of Approaches

Is the ownership of background intellectual property impacted by this agreement?
- Shionogi retains ownership of inventions conceived before the effective date.
Who will own new intellectual property arising from the project?
- Shionogi owns Process Results developed by Orchid that are specific to the Licensed Product and/or that incorporate any of Shionogi’s non-public proprietary information or IP.
- Orchid owns Process Results if they are “separable” – i.e., can be used to manufacture products that do not contain cefiderocol and they do not incorporate Shionogi proprietary or confidential information.

Annotations

This Manufacturing Sublicense and Technology Transfer Agreement (“Sublicense Agreement”) is between the Global Antibiotic Research and Development Partnership (“GARDP”), a Swiss nonprofit antibiotic R&D organization, and Orchid Pharma Ltd. (“Orchid”), an Indian public limited company that specializes in manufacturing antibiotics. The Sublicense Agreement is effective as of September 7, 2023. It follows a prior License and Technology Transfer Agreement (“License Agreement”) between GARDP and Shionogi, a public pharmaceutical company located in Japan, relating to the antibiotic drug cefiderocol (“Licensed Compound”).

The Sublicense Agreement governs a non-exclusive sublicense and transfer of Shionogi technology to Orchid including proprietary know-how such as manufacturing data, ingredient specifications, the manufacturing process, specifications, assays, quality control, and testing procedures (“Sublicensed Manufacturing Know-How”), all related to manufacturing the Licensed Compound. GARDP will facilitate the transfer of the Sublicensed Manufacturing Know-How and Orchid will manufacture the Licensed Compound and subsequent finished products containing cefiderocol as an active ingredient (“Licensed Products”).

Orchid is granted the right to manufacture the Licensed Compound and Licensed Products for sale only to organizations with commercialization authorization from Shionogi and GARDP (“Commercial Sublicensees”), and to GARDP (together “Customers”). The Licensed Products will be for use and distribution in the treatment of infections due to aerobic Gram-negative organisms (“Field”) in a list of high-, middle-, and low-income countries (“Territory”). GARDP may not grant any further manufacturing sublicenses for five years following the effective date of the Sublicense Agreement, provided that Orchid meets its obligations under the agreement. This exclusivity period will be extended for a further two years if demand for cefiderocol in the Territory does not exceed 1.5 million doses per year.

The parties must adhere to “Access and Stewardship Objectives” that balance affordable and sustainable access to medicines with preserving antimicrobial efficacy and good antimicrobial stewardship. To meet these Objectives, Orchid will: (i) use its best efforts to meet manufacturing objectives set out in a “Sublicense Access Plan”; and (ii) use its reasonable best efforts to manufacture sufficient and affordable quantities of the product to make timely supplies that meet the needs of patients in the Territory. Orchid will sell the Licensed Products at a price equal to the cost of goods plus a maximum agreed profit margin of 25%. Any subsequent reduction in cost of goods will be shared equitably between a reduction in the price and an increase in the Orchid’s margin. GARDP has open book audit rights related to Orchid’s cost of goods calculation.

Provision Language

8. INTELLECTUAL PROPERTY, PATENT MAINTENANCE, INFRINGEMENT

8.1 Intellectual property

Shionogi (or its Affiliates) will own the entire right, title and interest in and to any and all inventions conceived solely by its employees and agents before, on or after the Effective Date relating to the Licensed Compound or any Licensed Product, including the Sublicensed Rights and any such inventions that constitute an adaptation of any manufacturing process or proprietary drug delivery or formulation technology of Shionogi, or its Affiliates, for the production of the Licensed Compound or any Licensed Product, and any patents covering such invention (Shionogi Sole Inventions), subject to the license granted to GARDP.

(a) Manufacturing Process Results

(i) Shionogi shall own (and shall have the sole right to patent or not to patent) all inventions and results developed or generated by the Sublicensee related to the process to manufacture Licensed Compound or Licensed Product (Process Results) (whether or not patentable) that are specific to the Licensed Product and/or that incorporate any non-public proprietary information or confidential information or intellectual property of Shionogi and the Sublicensee will provide reasonable assistance to Shionogi, as may be required, for such patenting and related prosecution; and

The Sublicensee shall own (and shall have the sole right to patent or not to patent) all Process Results (whether or not patentable) solely to the extent separable from the Licensed Product (i.e., that such can be used to manufacture products other than the Licensed Product) and that do not incorporate any nonpublic proprietary information or confidential information of Shionogi.

(ii) The Process Results shall be considered confidential information of the party who owns the results, provided that each of Shionogi, GARDP and the Sublicensee shall have the right to access and use all Process Results in accordance with the licenses set forth in this Sublicense Agreement and the Shionogi License Agreement.

(iii) Shionogi shall have the sub-licensable right to use all Process Results not owned by it for development, regulatory filings, manufacturing, commercialization or otherwise to enable or facilitate access to any product containing cefiderocol worldwide.

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GARDP – Orchid, Cefiderocol Manufacturing Sublicense and Technology Transfer Agreement

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