| Item 1.01 | Entry
into a Material Definitive Agreement. |
On July 20, 2022, Napo Pharmaceuticals, Inc. (“Napo
Pharma”), the wholly-owned subsidiary of Jaguar Health, Inc. (“Jaguar”) entered into a Master Manufacturing
Services Agreement (the “Services Agreement”), dated and retroactively effective as of June 10, 2022, with Patheon
Pharmaceuticals Inc. (“Patheon”), pursuant to which Patheon will manufacture certain products through Patheon’s
global network of manufacturing sites through the issuance of site-specific Product Agreements (“Product Agreements”
and, together with the Services Agreement, the “Agreement”). Under the terms of the Agreement, Napo Pharma is responsible
for supplying the active pharmaceutical ingredient for products to Patheon. Patheon is responsible for manufacturing the products, conducting
quality control, quality assurance, validation activities, stability testing, packaging and providing related services for the manufacture
of the products. The Agreement is structured so that a Product Agreement may be entered into by the parties for the manufacture of a particular
product or multiple products at a manufacturing site owned and operated by Patheon, as identified in the relevant Product Agreement.
Pursuant to the Agreement, Napo Pharma has agreed to order from Patheon
certain binding minimum amounts of products based on an eighteen (18) month rolling forecast -- the first three (3) months of each
forecast is considered binding; the following nine (9) months will be eighty percent (80%) binding; and the following six (6) months
will be non-binding, good-faith estimates to facilitate Patheon’s production scheduling. Moreover, if the parties agree that Patheon
will supply, and Napo Pharma will purchase, at least a specified minimum purchase of Napo Pharma’s requirements for product under
a Product Agreement, then the applicable Product Agreement will set forth the required percentage and the time period during which the
obligation will apply. Notwithstanding the foregoing, nothing in the Agreement is to be interpreted in any way to imply that the Agreement
is an exclusive arrangement, and Napo Pharma expressly reserved its right to order and purchase products from other manufacturer-suppliers.
The Agreement has an initial term beginning on June 10, 2022 and
ending on January 31, 2027. The Agreement automatically renews after the initial term for successive terms of two (2) years,
unless either party gives notice of its intention to terminate the Agreement within at least eighteen (18) months prior to the end of
the then-current term.
Napo Pharma may terminate a Product Agreement immediately if any governmental
agency takes any action that prevents Napo Pharma from importing, exporting, purchasing or selling the relevant product. Further, Napo
Pharma must give at least six (6) months’ advance notice if it intends to no longer order manufacturing services for a product
due to discontinuation of such product in the market.
Patheon may terminate the Services Agreement or a Product Agreement
upon six (6) months’ written notice if Napo Pharma assigns the Services Agreement or a Product Agreement to an assignee that,
in the opinion of Patheon acting reasonable, is (i) not a credit worthy substitute for Napo Pharma or (ii) a competitor of Patheon.
Either party may terminate the Services Agreement or a Product Agreement
(a) if the other party has failed to remedy a material breach under the Services Agreement or a Product Agreement within sixty (60)
days following receipt of a written notice, and (b) immediately upon written notice to the other party in the event that the other
party is declared insolvent or bankrupt, a voluntary petition of bankruptcy is filed in any court by such other party, such other party
becomes a party to any dissolution or liquidation, the Agreement is assigned by such other party for the benefit of creditors, or such
other party admits in writing its inability generally to pay its debts as they become due in the general course.
The Agreement contains certain representations, warranties, limitations
of liabilities, confidentiality and indemnity obligations and other provisions customary for an agreement of its type.
The foregoing description of the Agreement does not purport to be complete
and is qualified in its entirety by reference to the full text of the Agreement, a copy of which will be filed as an exhibit to the Company’s
Quarterly Report on Form 10-Q for the fiscal period ending June 30, 2022, with confidential portions redacted.