Letter of Agreement, dated February 19, 2020, by and between the Registrant (formerly entered into by Fibrocell Science, Inc.) and Precigen, Inc

“Exclusive Channel Collaboration Agreement” executed Oct. 5, 2012 (as subsequently amended, the “ECC”) by and between Fibrocell Science, Inc. (“Fibrocell”) and Intrexon Corporation (“Intrexon”)

The Parties agree to work together in good faith to negotiate, document and execute a mutually agreed upon definitive termination and modification agreement between the Parties (the “Termination and Modification Agreement”) with respect to the termination of the ECC, the conversion of the ECC into a product license between Fibrocell with regard to the Retained Products and related amendments and modifications of the ECC, with the Parties’ intent being to enter into the Termination and Modification Agreement within thirty (30) days after the date of this letter to amend and modify the ECC as necessary and appropriate in order to clarify the surviving rights and obligations of the Parties, including the surviving rights and licenses in favor of Fibrocell with respect to the Retained Products, consistent with this letter.

Without limiting the generality of the foregoing, the Parties hereby agree as follows below:

Precigen personnel will provide immediate CMC technical and project management work toward resolving certain veledimex batch manufacture and expiration issues for Fibrocell in general accordance with the plan set forth in Attachment A and with the intention of meeting, to the extent reasonably possible, the known clinical trial timing issues for Fibrocell. Such work will be done at Precigen’s cost for Precigen’s internal personnel’s time expended on the project and in preparing drug master files (collectively, the “DMF”), while Fibrocell will remain responsible for any third party costs (including manufacturing, service providers and reasonable travel) incurred during this process for the benefit of Fibrocell. The Parties will share in the data and intellectual property generated by work performed pursuant to Attachment A consistent with the terms of the ECC. After completion of Precigen’s work contemplated under Attachment A, and subject to payment by Fibrocell of third party costs under paragraph 2 above, Precigen will grant Fibrocell an irrevocable right of cross-reference to Precigen’s DMF for use in connection with FCX-013 and provide specified technology transfer. Thereafter, Fibrocell shall assume all responsibility for future manufacture of drug product and drug substance for Fibrocell Products.

In good faith, Precigen has already provided, at no cost to Fibrocell, a critical expiration extension memo (for expiry May 2020) to Jeremy Cress of CCB on February 6, 2020.

Precigen will, at no cost to Fibrocell for Precigen’s internal personnel time, conduct a 24-month time point pull in March 2020 and issue an extension memo to Fibrocell based on the results thereof on or before the expiration of the prior May, 2020 extension, with the goal of demonstrating a new expiration of drug product INXN- 1001 Hard Gelatin Capsules, 40mg (Solutol) batch QB170160/1 of November 6, 2020. If such stability testing results do not support such extension, Precigen will provide to Fibrocell all documentation and data generated during such failed stability testing. Any costs for third party service providers shall be borne directly by Fibrocell, and any travel expenses reasonably incurred by Precigen shall be reimbursed by Fibrocell upon monthly invoicing for the same.

Precigen will coordinate with third party service providers to initiate, and oversee their respective performance toward, the manufacture of a new batch of the Solutol formulation before April 27, 2020 to serve as a replacement for the existing Drug Substance batch (4157.E.15.1.501). All such manufactured material will be solely owned by Fibrocell. The costs for the third party service provider and manufacturers shall be borne and paid directly by Fibrocell, and any travel expenses reasonably incurred by Precigen shall be reimbursed by Fibrocell upon monthly invoicing for the same. In good faith, Precigen has begun coordination with Lonza/Capsugel Ploermel to attempt scheduling of a replacement Batch manufacturing slot, but needs final approval from Fibrocell to generate a formal proposal and respective cost quotes before Feb. 19, 2020, which proposal shall be shared with Fibrocell once received. Lonza/Capsugel Ploermel have indicated, subject to the meeting of timetables by the Parties (including the foregoing approval from Fibrocell) that the production will meet Fibrocell’s deadlines. Based solely upon prior experience manufacturing batches of veledimex and incorporating reasonably projected cost increases relative to prior production batches, Precigen estimates that the third party costs for such (excluding travel) will be:

Precigen will execute a Quality Audit of Solutol activities at the Ploermel site and one representative of Fibrocell will be invited to attend. In the event there are findings resulting from such an audit, Fibrocell will be entitled to review and provide Precigen with comments thereon for reasonable consideration, provided, however, that if such findings are specific to FCX-007 and FCX-013, Fibrocell will also be entitled to provide direction on the correction of such findings. No audit of Solutol related activities has been previously conducted. These activities would be targeted to be performed in 3Q 2020 and Lonza/Capsugel Ploermel are aware of the requirement from Precigen’s pre-existing Quality Agreement. However, Fibrocell shall be responsible for conducting all quality review and release of all materials produced in the above new batch.

Precigen agrees to invite representatives of Fibrocell to a kick off meeting to be held reasonably promptly following the Effective Date of this letter, and thereafter to reasonably frequent update meetings with Precigen personnel and, where appropriate, third party providers. Fibrocell will be provided with copies of all relevant synthesis proposals and protocols and relevant reports received from such third parties.

In conjunction with the above activities, Precigen shall engage in tech transfer for the benefit of Fibrocell to enable Fibrocell to engage in manufacturing activities directly, including as follows below.

Precigen and Fibrocell will reasonably cooperate to proceed within the spirit and intent of this letter and Attachment A with regard to executing new contracts with respective third parties, or alternatively submitting work orders under existing contracts, with the goals of meeting the deadlines set forth above. Where new agreements are required to execute a project task under this Attachment A, Fibrocell will be included as a party to the agreement when such will not cause problematic delays given the timelines above.

Precigen shall deliver to Fibrocell the following information and data reasonably necessary for Fibrocell to conduct future drug product and drug substance manufacturing tasks independently of Precigen and to contract directly with third parties with respect such.

The Capsugel documentation relating to the Solutol formulation.

Executed protocols and reports relating to veledimex drug substance and drug product.

Previous analytical qualifications and methods and protocols for the release of drug substance/product.

Stability protocols, data and reports.

Full batch records for the new batch under paragraph 3 above.

Route A chemistry documentation.

A letter providing to Fibrocell with respect to the Retained Products an irrevocable right of reference to Precigen’s (to be filed) drug master files for veledimex and formulations of veledimex upon their respective filing by Precigen.

Precigen estimates that the above activities will require 7-8 FTE months of Precigen personnel time, including all planning activities, coordination with Lonza, travel and oversight as well as a formal audit.

Precigen will allocate to Fibrocell fifty percent (50%) of any material remaining of expired drug substance batch 4157.E.15.1.501, following completion of the activities described in paragraph 3 of this Attachment A.

Fibrocell may in the future request that Precigen provide, and to the extent that Precigen agrees, Precigen may provide additional Precigen internal personnel’s time in support of further veledimex manufacturing activities not described above. To the extent that such additional support is provided, such will be provided under terms consistent with the intellectual property and data rights terms of the ECC and at full cost reimbursement to Precigen (including for both third party costs and Precigen FTE) Fibrocell. Fibrocell has indicated a preliminary interest in possibly pursuing a low dose clinical batch in the future. Current drug substance batch – 4157.E.15.1.501 expires April 27, 2020. There is no option to extend this expiration date beyond this date for future clinical use, but this expiring batch may potentially be used for development activities of the pediatric dose. In order to manufacture another unique batch of low dose veledimex for Fibrocell, the Parties would need to conduct due diligence activities for Steps 1-3 for Route B Chemistry, obtain starting material synthesis proposals, and initiate technology transfer activities upon vendor selection, at which time manufacture of a new batch of drug substance will take approximately 18 months and have the following projected third party costs:

100,000Euros (estimated)

600,000Euros (estimated)

175,000Euros (estimated)

150,000Euros (estimated)

12-15FTE months

If Fibrocell elects to pursue the activities described in paragraph 9 of this Attachment A, and at that time determines that Precigen is the owner or otherwise in possession of documentation not described in this Attachment A but required to complete said activities or to complete said activities without significant additional effort or expense, Fibrocell will notify Precigen, and Precigen will provide such documentation to Fibrocell to the extent such is reasonable in light of the burden to Precigen and upon reasonable cost reimbursement to Precigen.

For the purpose of clarity, Fibrocell or its designated affiliates may engage with such parties prior to the manufacture of drug substance, at their own cost, to develop new tableting methods for lower dose concentrations or similar required for the FCX-013 trial, with such decision to be made solely by Fibrocell or its designated affiliates.

Upon completion of Precigen’s drug product and drug substance manufacturing support activities under this Attachment A consistent with the provisions of paragraph 6(a) above relating to the handling of and operations under third party contracts, Precigen will assist Fibrocell in transferring any CRO/CMO contractual relationships to Fibrocell solely to the extent that such relationships relate to vector stability programs or manufacturing programs for the Retained Products.

Precigen will provide to Fibrocell upon reasonably request, and only in such cases as Precigen has not already done so or Fibrocell otherwise already does not have such, the following existing documentation related to the FCX-007 and FCX-013 (to the extent in Precigen’s possession or control) for a BLA submission:

Nomenclature

Structure

General Properties

Manufacturers

Description of the Manufacturing Process

Control of Materials

Control of Critical Steps and Intermediates

Process Validation and/or Evaluation

Manufacturing Process Development

Elucidation of Structure and Other Characteristics

Impurities

Drug Substance Specification

Analytical Procedures

Validation of Analytical Procedures

Batch Analyses

Justification of Specification

Reference Standards or Materials

Container Closure System

Stability Summary and Conclusions

Postapproval Stability Protocol and Stability Commitment – Needed for BLA only

Stability Data

Upon completion of the items in paragraphs 2-6, 8, 12 and 13 of this Attachment A, Precigen’s obligations under this Attachment A shall be complete.