Third Amendment to Development and Commercialization Agreement, dated January 6, 2024, by and between the Company, Pulmatrix Operating Company, Inc., and Cipla Technologies LLC

Exhibit 10.1

THIRD AMENDMENT TO THE DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

This Third amendment to the Development and Commercialization Agreement (“Third Amendment”) is entered into as of 6 January, 2024 (the “Effective Date”) and to the extent applicable amends the Development and Commercialization Agreement entered into on April 15, 2019 (as amended by the parties on May 3, 2019 (the “First Amendment”) and as further amended by the parties on November 8, 2021 (the “Second Amendment”) collectively (the “Agreement”) between, PULMATRIX, INC. a company incorporated under the laws of the State of Delaware, and PULMATRIX OPERATING COMPANY, INC., a company incorporated under the laws of the State of Delaware (together the “Company”), and each having a principal place of business at 36 Crosby Drive, Suite 100, Bedford, Massachusetts 01730, and CIPLA TECHNOLOGIES, LLC, a limited liability company organized under the laws of Delaware and having a principal place of business at 7 Oser Avenue, Hauppauge, NY 11788 (“Cipla”). Company and Cipla may be referred to herein as a “Party” and collectively as the “Parties.” Capitalized terms used herein but not otherwise defined herein shall have the respective meanings given such terms in the Agreement.

RECITALS

Whereas:

Now, Therefore, in consideration of the foregoing premises and the mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows.

“Third Amendment” means the Third Amendment to the Agreement dated 6 January, 2024, by and between the Parties.

“(a) Subject to the terms of this Second Amendment, all Development and Commercialization activities with respect to the Product in all countries outside of the United States (such countries outside of the United States, the “Cipla Territory”) will be conducted exclusively by Cipla and all expenses associated with the development and commercialization of the Product in the Cipla Territory incurred after the Effective Date, shall be at Cipla’s sole cost and expense. Accordingly, each reference to the Territory in the Agreement is by reference amended to exclude the Cipla Territory, as the term has been defined in this Third Amendment. For the avoidance of doubt, from the Effective date Cipla Territory shall mean and include all countries except the United States. ”

“(b) All of Cipla’s Development activities for the Product in the Cipla Territory shall be conducted pursuant exclusively to one or more plans (such plans, a “Cipla Territory Development Plan(s)”) prepared by Cipla.”

“(f) All Product used in the Development or Commercialization in the Cipla Territory may at Cipla’s decision and sole cost be supplied utilizing the Company’s existing global supply chain for manufacturing of the Product (it being understood that Cipla will need to enter new agreements with the Company’s existing vendors and suppliers in order to utilize such supply chain). Cipla, may, at its option and at its sole cost and expense, transfer the manufacturing of the Product for Development or Commercialization activities in the Cipla Territory to a manufacturing site designated by Cipla. Any such manufacturing site shall be qualified under applicable laws and such site transfer shall be conducted in accordance with applicable laws and regulations, good manufacturing practices (as defined by the International Council on Harmonization). The Company shall cooperate with Cipla in such site transfer and all actual costs and expenses, including cost of time spent by the Company’s employees and consultants, incurred by the Company in connection with such site transfer to the extent that such cost is solely incurred with respect to the Cipla Territory shall be paid by Cipla in the Wind Down Phase Funding contributed by Cipla.”

“(g) Section 6.5 of the Agreement shall not apply with respect to any sublicense or other transfer of Cipla’s rights under the Agreement and this Second Amendment with respect to the Cipla Territory. For clarity, (i) nothing herein impacts Cipla’s ownership of the Assigned Assets as detailed under Section 6.1 of the Agreement; and (ii) Cipla will solely and exclusively own all of the Intellectual Property Rights generated with respect to the Cipla Territory, provided, that, without limiting Cipla’s absolute ownership of Assigned Assets and the Cipla Territory Intellectual Property Rights as stated in the foregoing sentence.”

1.4.2.1.1 the Company will use Commercially Reasonable Efforts to immediately close enrollment for the Phase 2b Clinical Study and terminate the Phase 2b Clinical Study as soon as reasonably possible;

1.4.2.1.2 Exhibit C sets forth the patents related to the Product and Cipla’s rights therein as previously licensed and assigned pursuant to Article 6 of the Agreement. The Company will reasonably cooperate with Cipla in perfecting such assignment or license of all Patents (as in Exhibit C) to Cipla and their registration with the appropriate authorities in the Cipla Territory;

1.4.2.1.3 reserved;

1.4.2.1.4 the Company will to the extent not yet completed, complete a physical and demonstrable Company assisted technology transfer (“Tech Transfer”) and assignment of all Development, Intellectual Property Rights, proprietary data and technology (“Proprietary Data and Technology”) and technology to Cipla, an indicative and non-exhaustive list of which activity items is attached as EXHIBIT A; this list being subject to further changes and supplementation by Cipla and the Company;

1.4.2.1.5 during the Wind Down Period, each Party will use Commercially Reasonable Efforts to secure all data from the Phase 2b Clinical Study for inclusion in the safety database for the Cipla Territory program;

1.4.2.1.6 a development wind down plan is attached hereto as Exhibit B (“the Development Wind Down Plan”) for implementation and closure within the Wind Down Period, for approval by the JSC, the Development Wind Down Plan being effective immediately upon such approval;

1.4.2.1.7 all Direct Costs to terminate the Phase 2b Clinical Study shall be within the budget approved in Development Wind Down Plan and the Company and Cipla will each be responsible for sixty percent (60%) and forty percent (40%), respectively of Wind Down Period Direct Costs;

1.4.2.1.8 the Company will work to immediately reduce all Non-Direct Costs to the minimum amount necessary to terminate the Phase 2b Clinical Study, including the termination of CRO or contract research organization, sites and other agreements and within the budget approved in Development Wind Down Plan (allowing for possible eight percent (8%) overage from the budget), the Company and Cipla then being responsible for the Wind Down Period Non-Direct Costs in the manner set out in Clause 3.5 of the Agreement as amended by Clause 1.5.1 of this Amendment;

1.4.2.1.9 Cipla shall pay Company for the period up to the Effective Date, all accrued Direct and Non-Direct Costs computed according to the Second Amendment;

1.4.2.2 Exhibit B is the Company expected timeline for Phase 2b clinical study wind down;

1.4.2.2.1 all relevant contracts, regulatory documents, product data and other similar documents required for the continued development of the Product shall be assigned and transferred to Cipla during the Wind Down Period; and

1.4.2.2.2 the Parties’ shall use Commercially Reasonable Efforts to monetize the Parties’ rights in the Product within the United States.

“ 3.5 Winding Down Period Contributions.

Winding Down Phase. After the Initial Development Funding is depleted, Company shall, within ten (10) days after the end of each calendar month, deliver an invoice to Cipla for the Winding Down Period costs incurred by the Company, including a breakdown of Direct Costs and Non-Direct Costs, for such calendar month and for which Cipla is responsible pursuant to Section 3.5(a). By not later than the last Business Day of the calendar month in which such invoice was delivered to Cipla, Cipla shall deliver to the Company, by wire transfer of immediately available funds, the invoiced amount. Attached as EXHIBIT-D is the proposed Wind Down Budget provided by the Company to Cipla, to be discussed, negotiatited, finalized and approved by the JSC. The parties agree that Cipla shall not be responsible for any Non-Direct Cost that is in excess of the budgeted amount therefor set forth on EXHIBIT-D by more than 8%. Furthermore, the parties agree that that Cipla shall not be responsible for any Direct Cost that is in excess of the budgeted amount therefor set forth on EXHIBIT-D.

Section 12.4 of the Agreement is hereby amended and restated as follows with effect from and after the date hereof:

(Signature Page Follows) 

IN WITNESS WHEREOF, THE PARTIES HAVE EXECUTED THIS THIRD AMENDMENT AS OF THE EFFECTIVE DATE.