Precigen (PGEN) inks Catalent Commercial Supply Agreement for PAPIZEMOS manufacturing

Rhea-AI Filing Summary

Precigen, Inc. entered into a Commercial Supply Agreement with Catalent Maryland, Inc. for the commercial manufacture of PAPIZEMOS. Under the agreement, Catalent will provide services such as analytical work, development, processing, validation and product maintenance as defined in a Plan Document.

During the term of the agreement, Precigen has agreed to use Catalent exclusively for external commercial fill-and-finish manufacturing of all reported PAPIZEMOS volumes in the defined territory. If the Plan Document sets any minimum annual batch requirements, Precigen must purchase at least those amounts in the relevant contract years. Precigen will pay Catalent agreed prices and fees for these services, which are subject to annual adjustments for factors including labor, utilities and overhead, and will also pay certain maintenance fees and expenses.

The initial term runs for three years from the effective date and then renews automatically in one-year increments unless either party gives at least twelve months’ written notice before the end of the current term. The agreement may be terminated by either party for material breach or certain other specified circumstances after any applicable cure period and includes customary provisions on quality, delivery, warranties, intellectual property, confidentiality and indemnification.

8-K Event Classification

2 items: 1.01, 9.01

2 items

Item 1.01 Entry into a Material Definitive Agreement Business

The company signed a significant contract such as a merger agreement, credit facility, or major partnership.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 13, 2025

Precigen, Inc.

(Exact name of registrant as specified in its charter)

Virginia	001-36042	26-0084895
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

20374 Seneca Meadows Parkway, Germantown, Maryland 20876

(Address of principal executive offices) (Zip Code)

(301) 556-9900

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, No Par Value		PGEN		Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act ☐

Item 1.01. Entry into a Material Definitive Agreement.

On August 13, 2025 (the “Effective Date”), Precigen, Inc. (the “Company”) entered into a Commercial Supply Agreement (the “Supply Agreement”) with Catalent Maryland, Inc. (“Catalent”).

The Supply Agreement provides that Catalent will perform certain services specified in a Plan Document (as defined in the Supply Agreement) (“Services”) including analytical, development, processing, validation, or product maintenance of PAPIZEMOS (“Product”), subject to the terms and conditions set forth in the Supply Agreement.

During the term of the Supply Agreement, the Company has agreed to use Catalent exclusively for external, commercial fill and finish manufacturing, in each calendar year, of all of the Company’s reported volumes for the Product during such year in the Territory (as defined in the Supply Agreement).

During the term of the Supply Agreement, if the Plan Document specifies any minimum number of batches of Product that must be purchased by the Company in one or more contract years, then the Company shall purchase the minimum requirement for each such contract year, subject to the terms and conditions set forth in the Supply Agreement.

The Company will pay Catalent the agreed upon price and other fees for the Services, which will be adjusted on an annual basis, effective on each anniversary of the Effective Date, to reflect increases in, among other things, labor, utilities and overhead. The Company will also pay certain other maintenance fees and expenses as contemplated by the Supply Agreement.

The initial term of the Supply Agreement will continue for three years from the Effective Date, unless earlier terminated by one of the parties. Thereafter, the Supply Agreement will automatically extend for successive terms of one year unless and until either party provides written notice of its desire to terminate at least twelve months prior to the end of the then current term. The Supply Agreement provides for termination by either party due to a material breach by the other party, and certain other extenuating circumstances, in each case after the applicable cure period (if any).

The Supply Agreement also includes customary provisions relating to, among others, delivery, inspection procedures, warranties, quality, storage, handling and transport, intellectual property, confidentiality and indemnification. The foregoing description of the Supply Agreement does not purport to be complete and is qualified in its entirety by reference to the Supply Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

d) Exhibits.

Exhibit No.		Description
10.1†		Commercial Supply Agreement, dated August 13, 2025, by and between Precigen, Inc. and Catalent Maryland, Inc.
104		Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101)

† Portions of the exhibit, marked by brackets, have been omitted because the omitted information (i) is not material and (ii) is the type that the Company treats as private or confidential.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Precigen, Inc.
	By:	/s/ Donald P. Lehr
		Donald P. Lehr
		Chief Legal Officer

Dated: August 18, 2025

FAQ

What did Precigen (PGEN) announce in this 8-K filing?

Precigen, Inc. disclosed that it entered into a Commercial Supply Agreement with Catalent Maryland, Inc. under which Catalent will provide commercial manufacturing and related services for PAPIZEMOS.

What services will Catalent provide to Precigen (PGEN) under the Commercial Supply Agreement?

Catalent will perform analytical, development, processing, validation and product maintenance services for PAPIZEMOS, as detailed in a Plan Document referenced in the agreement.

Is Catalent the exclusive commercial manufacturer for Precigen’s PAPIZEMOS?

Yes. During the term of the agreement, Precigen agreed to use Catalent exclusively for external, commercial fill-and-finish manufacturing of all reported PAPIZEMOS volumes in the specified territory each calendar year.

How is pricing structured in the Precigen (PGEN) and Catalent supply agreement?

Precigen will pay Catalent agreed prices and fees for the services. These amounts will be adjusted annually on each anniversary of the effective date to reflect increases in items such as labor, utilities and overhead, along with certain maintenance fees and expenses.

What is the term of the Commercial Supply Agreement between Precigen and Catalent?

The initial term of the agreement is three years from the effective date. After that, it automatically renews for successive one-year terms unless either party gives written notice of termination at least twelve months before the end of the then-current term.

Under what circumstances can the Precigen–Catalent supply agreement be terminated?

The agreement permits termination by either party for a material breach by the other party and for certain other specified circumstances, in each case following any applicable cure period.

Where can investors find the full text of the Precigen (PGEN) and Catalent Commercial Supply Agreement?

The complete agreement is filed as Exhibit 10.1 to the report, and the company notes that its description is qualified in its entirety by reference to that exhibit.