UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 1.01 Entry into a Material Definitive Agreement.
As previously disclosed, on April 15, 2019, Pulmatrix, Inc. (the “Company”), entered into a Development and Commercialization Agreement (the “Cipla Agreement”) with Cipla Technologies LLC (“Cipla”) for the co-development and commercialization, on a worldwide exclusive basis, of Pulmazole (PUR1900), the Company’s inhaled iSPERSE drug delivery system (the “Product”) enabled formulation of the antifungal drug, itraconazole, for the treatment of all pulmonary indications, including allergic bronchopulmonary aspergillosis in patients with asthma. As previously reported, on May 10, 2021, the Company sent a letter to Cipla (the “May Letter”) alleging that Cipla was in material breach of the Agreement.
On November 8, 2021, the Company and Cipla entered into an amendment (the “Amendment”) to the Cipla Agreement, which modifies certain provisions of the Agreement and resolves the current dispute between Cipla and the Company regarding each party’s respective performance of the Agreement. Pursuant to the Amendment, among other things, (i) all development and commercialization activities with respect to the Product in India, South Africa, Sri Lanka, Nepal, Iran, Yemen, Myanmar and Algeria (such countries, the “Cipla Territory”) will be conducted exclusively by Cipla at Cipla’s sole cost and expense, (ii) Cipla shall be entitled to all profits from the sale of the Product in the Cipla Territory, except that if Cipla successfully transfers manufacturing of the Product for the Cipla Territory to a manufacturing sight determined by Cipla, the Company will become entitled to a royalty equal to 2% of net sales in the Cipla Territory, and (iii) following the depletion of development funding initially set aside for the development of the Product by Pulmatrix, the Company and Cipla will each be responsible for 60% and 40%, respectively, of the Company’s overhead costs and the time spent by the Company’s employees and consultants on development of the Product (“Direct Costs”), provided, that Cipla will reimburse the Company an amount equal to 10% of aggregate Direct Costs upon the achievement of certain development milestones set forth in the table below. Cipla and the Company will continue to share all other development costs that are not Direct Costs, such as the cost of clinical research organizations, manufacturing costs and other third-party costs, on a 50/50 basis.
In addition, if any development milestone is not met by the date that is 9 months after the applicable deadline for achieving such development milestone, either party may elect to terminate its obligation to fund additional development costs, in which case either (i) the non-terminating party can acquire the rights of the terminating party for fair market value or (ii) the parties will monetize the Product. The table below sets forth the development milestones.
| Phase 2b Development Plan – Development Milestones | ||
| Development Milestone | Milestone Date | |
| 25% of Patients enrolled in Phase 2b Clinical Study are dosed | June 30, 2023 | |
| Company delivers summary of key efficacy and safety data to include FEV1, IgE, ACQ-6, number of subjects withdrawn, any severe adverse events related to the medication and an overall summary table of adverse events (“Topline Results”) to the Joint Steering Committee (JSC) | June 30, 2024 | |
| Phase 3 Development Plan – Development Milestones | ||
| Development Milestone | Milestone Date | |
| 25% of Patients enrolled in Phase 3 Clinical Study dosed | To be proposed by JSC | |
| Company delivers Topline Results to the JSC | To be proposed by JSC | |
| PDUFA | To be proposed by JSC | |
The Amendment also contains a mutual release of alleged breaches of the Agreement that may have occurred prior to the date of the Amendment.
The foregoing is only a summary of the material terms of the Amendment and does not purport to be complete. The foregoing summary is qualified in its entirety by reference to the complete text of the Amendment which is attached to this Current Report on Form 8-K as Exhibit 10.1.
Item 8.01 Other Events
On November 9, 2021, the Company issued a press release regarding its entry into the Amendment. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 10.1* | Second Amendment to Development and Commercialization Agreement | |
| 99.1 | Press Release dated November 9, 2021 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
*Certain portions of this exhibit have been redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K. The omitted information is (i) not material and (ii) would likely cause competitive harm to the Company if publicly disclosed. The Company agrees to furnish supplementally an unredacted copy of the exhibit to the SEC upon its request.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| PULMATRIX, INC. | ||
| Date: November 9, 2021 | By: | /s/ Teofilo Raad |
| Teofilo Raad | ||
| Chief Executive Officer | ||