1Information in this exhibit identified by brackets and *** has been redacted because it is not material and is the type that the Company treats as private or confidential
Exhibit 4.29
THIS ASSIGNMENT AGREEMENT (this “Agreement”) is entered into as of July 18, 2023 (the “Effective Date”), by and between CASI Pharmaceuticals, Inc., a Cayman corporation having a place of business at 1701-1702, China Central Office, Tower 0, Xx. 00 Xxxxxxx Xxxx, Xxxxxxxx Xxxxxxxx, Xxxxxxx 000000 Xxxxxx’x Xxxxxxxx xx Xxxxx (“CASI”), and Cleave Therapeutics, Inc., a company incorporated under the laws of the State of Delaware having a place of business at 00 X. Xxxx Xxxxxx, Xxx Xxxxxxxxx, XX 00000 (“Cleave”), each a “Party” and together the “Parties”.
WHEREAS, Cleave has developed a proprietary small molecule VCP/p97 inhibitor known as CB-5339 (as further defined below);
WHEREAS, Xxxxxx previously granted an exclusive license to CASI for the development and commercialization of CB-5339 in greater China pursuant to that certain License and Development Agreement for CB-5339 entered into between the Parties and dated March 5, 2021 (the “Existing License Agreement”);
WHEREAS, CASI now desires to obtain ownership of Xxxxxx’s intellectual property rights covering CB-5339, and Xxxxxx desires to sell and transfer such intellectual property rights to CASI.
NOW, THEREFORE, in consideration of the respective representations, warranties, covenants and agreements contained herein, and for other valuable consideration, the receipt and adequacy of which are hereby acknowledged, Xxxxxx and CASI agree as follows:
For the purpose of this Agreement, the following terms, whether used in singular or plural form, shall have the respective meanings set forth below:
For the avoidance of doubt, Net Sales shall include the amount or fair market value of all other considerations received by CASI, its Affiliates, licensees or assignee (of the Assigned Patent Rights) in respect of the Products, whether such consideration is in cash, payment in kind, exchange or other form.
Net Sales will be calculated only once for the first bona fide arm’s length sale of such Product by CASI, its Affiliates, licensees or such assignee to a Third Party purchaser, and will not include sales between or among CASI, its Affiliates, sublicensees or such assignee unless the purchaser in such sale is the final end user.
The transfer of a Product to an Affiliate, licensee, or other Third Party for no profit (a) in connection with the development or testing of a Product (including the conduct of clinical studies), (b) for purposes of distribution as promotional samples, (c) in connection with patient assistance programs or other charitable purposes, such as compassionate use, “named patient” or expanded access programs, or (d) by and between CASI and its Affiliates or licensees shall not, in any case, be considered a Net Sale of a Product under this Agreement.
If a Product under this Agreement is sold in the form of a Combination Product, then Net Sales for such Combination Product shall be determined on a country-by-country basis by mutual agreement of the Parties in good faith taking into account the perceived relative value contributions of the Product and the other ingredient or agent in the Combination Product, as reflected in their respective market prices. In case of disagreement, an independent expert agreed upon by both Parties or, failing such agreement, designated by the International Chamber of Commerce in Paris, shall determine such relative value contributions and such determination shall be final and binding upon the Parties.
In the event a Product is “bundled” for sale together with one or more other products in a Region (a “Product Bundle”), then Net Sales for the Product shall be determined on a country-by-country basis by mutual agreement of the Parties in good faith taking into account the relative value contributions of the Product and the other products in the Product Bundle, as reflected in their individual sales prices. In case of disagreement, an independent expert agreed upon by both Parties or, failing such agreement, the International Chamber of Commerce shall determine such relative value contributions and such determination shall be final and binding upon the Parties
EXISTING LICENSE AGREEMENT; ASSIGNMENT; INTELLECTUAL PROPERTY
Milestone | Milestone Payment |
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[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the Receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the Receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the Receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the Receiving Party unless the combination and its principles are in the public domain or in the possession of the Receiving Party.
provided that, solely with respect to the foregoing clauses 4.2.2 - 4.2.4, such Confidential Information shall be disclosed only to the extent reasonably necessary to do so.
TERM AND TERMINATION
To Cleave:Cleave Therapeutics, Inc.
[***]
To CASI:
CASI Pharmaceuticals (China) Co., Ltd
[***]
marked for the attention of [***];
with a copy (which shall not constitute notice) by post to :
[***]
Marked for the attention of [***].
or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been given: (a) when delivered if
personally delivered on a Business Day (or if delivered or sent on a non-Business Day, then on the next Business Day), (b) on receipt if sent by overnight courier, or (c) on receipt if sent by mail.
[Signature Page Follows]
EXHIBIT A
Structure of CB-5339
[***]
EXHIBIT B
Assigned Patent Rights
[***]
EXHIBIT C
Form of Patent Assignment Agreement
{***]
PATENT ASSIGNMENT
This Patent Assignment (this “Assignment”) is made and entered into as of July 18, 2023 by and between CASI Pharmaceuticals, Inc., a Cayman corporation having a place of business at 1701-1702, China Central Office, Xxxxx 0, Xx. 00 Xxxxxxx Xxxx, Xxxxxxxx Xxxxxxxx, Xxxxxxx 000000 Xxxxxx’x Xxxxxxxx xx Xxxxx (“Assignee”), and Cleave Therapeutics, Inc., a company incorporated under the laws of the State of Delaware having a place of business at 00 X. Xxxx Xxxxxx, Xxx Xxxxxxxxx, XX 00000 (“Assignor”).
WHEREAS, Assignor desires to assign and Assignee desires to receive the patent applications and patents listed in Schedule 1 (the “Patents”).
NOW THEREFORE, effective as of the Effective Date, be it known that, for good and valuable consideration, the receipt of which is hereby acknowledged, Assignor and Assignee hereby acknowledge:
[Signature Page Follows]
ASSIGNOR:
| CLEAVE THERAPEUTICS, INC. | ||||
| | | Name: [***] | | |
| | | Title: [***] | |
| ASSIGNEE: | ||||
| | | Name: [***] | | |
| | | Title: [***] | |
EXHIBIT D
Assigned Materials and Transfer Plan for Assigned Materials
Assigned Materials:
Any available physical material of CB-5339 currently stored at [***].
EXHIBIT E
Form of Bill of Sale
bill of sale
THIS BILL OF SALE (this “Bill of Sale”), is made and entered into as of July 18, 2023 by and between CASI Pharmaceuticals, Inc., a Cayman corporation having a place of business at 1701-1702, China Central Office, Xxxxx 0, Xx. 00 Xxxxxxx Xxxx, Xxxxxxxx Xxxxxxxx, Xxxxxxx 000000 Xxxxxx’x Xxxxxxxx xx Xxxxx (“Assignee”), and Cleave Therapeutics, Inc., a company incorporated under the laws of the State of Delaware having a place of business at 00 X. Xxxx Xxxxxx, Xxx Xxxxxxxxx, XX 00000 (“Assignor”), each a “Party” and together the “Parties”.
RECITALS
WHEREAS, Assignor and Assignee are Parties to that certain Assignment Agreement, dated as of the date hereof, by and between Assignor and Assignee (the “Assignment Agreement”), pursuant to which Assignor and its Affiliates have agreed to sell, assign, transfer, convey and deliver to Assignee, and Assignee has agreed to purchase, acquire and accept from Assignor and its Affiliates, all right, title and interest of Assignor and its Affiliates in, to and under the Assigned Materials upon the terms and subject to the conditions set forth in the Assignment Agreement; and
WHEREAS, the execution and delivery of this Bill of Sale is contemplated by Section 2.2 of the Assignment Agreement.
NOW, THEREFORE, in consideration of the mutual covenants herein contained and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Parties, intending to be legally bound, hereby agree as follows:
AGREEMENT
1.Transfer of Assigned Materials. Upon the terms and subject to the conditions of the Assignment Agreement (including, without limitation, Section 2.2 thereof), effective as of 12:01 a.m., New York, NY time, on the date hereof, Assignor and its Affiliates hereby irrevocably sell, assign and transfer to Assignee, and Assignee hereby purchases, acquires and accepts from Assignor and its Affiliates, all right, title and interest of Assignor and its Affiliates in, to and under the Assigned Materials, free and clear of any mortgage, charge, lien, security interest, easement, right of way, pledge restriction or encumbrance of any kind.
2.Further Assurances. As and when reasonably requested by either Party, the other Party shall, and shall cause its respective Affiliates to, execute, acknowledge and deliver all reasonable further conveyances, notices, assumptions, releases and acquittances and instruments and take all such reasonable actions as may be necessary or appropriate to make effective the transactions contemplated hereby.
3.Parties in Interest. This Bill of Sale shall be binding upon, shall inure to the benefit of, and shall be enforceable by the Parties and their permitted successors and assigns. Except as noted above, this Bill of Sale is for the sole benefit of the entities specifically named in the preamble to this Bill of Sale as Parties and their permitted successors and assigns, no Party hereto is acting as an agent for any other person or entity not named herein as a Party hereto, and nothing in this Bill of Sale or the Assignment Agreement, express or implied, is intended to or shall confer upon any other person or entity any legal or equitable right, benefit or remedy of any nature whatsoever under or by reason of this Bill of Sale.
0.Xx Assumption of Liabilities. Nothing expressed or implied in this Bill of Sale shall be deemed to be an assumption by Assignee of any debt, liability, claim, expense, commitment or obligation of whatever kind, whether known or unknown, direct or indirect, accrued or fixed, absolute or contingent, due or to become due, matured or not or determined or determinable of Assignor or its Affiliates.
5.Governing Law. This Bill of Sale shall be governed by and enforced in accordance with the internal laws of the State of Delaware, excluding any of its conflicts of laws principles to the contrary.
6.Conflicts. The sale and purchase of the Transferred Assets made hereunder are made in accordance with and subject to the Assignment Agreement (including, without limitation, the representations, warranties, covenants and agreements contained therein). In the event of a conflict between the terms and conditions of this Bill of Sale and the terms and conditions of the Assignment Agreement, the terms and conditions of the Assignment Agreement shall govern, supersede, and prevail. Notwithstanding anything to the contrary in this Bill of Sale, nothing herein is intended to, nor shall it, extend, amplify, or otherwise alter the representations, warranties, covenants, and obligations of the Parties contained in the Assignment Agreement or the survival thereof.
7.Counterparts; Electronic Signatures. The Parties agree that each may execute this Agreement using electronic signatures. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Facsimile signatures and signatures transmitted via PDF or electronic signatures shall be treated as original signatures.
8.Amendment; Waiver. No provision of this Bill of Sale may be amended, supplemented or modified except by a written instrument making specific reference hereto signed by all the Parties.
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EXHIBIT F
List of Technology Transfer
Cleave will provide all clinical, preclinical, regulatory, IP and CMC documents, information, filings, know how and agreements related to CB-5339 and the patent family.
Regulatory Documents
● | [***] |
CMC Documents and Data
● | Drug Product |
o | Analytical Documents (method development reports and methods) |
o | Specifications |
o | Formulation Reports |
o | Stability Reports |
o | Manufacturing Records |
o | CofAs |
● | Drug Substance |
o | Analytical Documents (method development reports and methods) |
o | Specifications |
o | Stability Data |
o | CofAs |
o | Reference Standard data |
o | Manufacturing Records |
Clinical Documents
● | CTX-001 |
o | Trial Master File |
o | PK Data |
● | CTX-002 |
o | Trial Master File |
o | Clinical Study Report |
Non-Clinical Documents
● | Pre-clinical pharmacology and toxicology reports |
IP
● | List of all patents and their inventors and most recent contact information |
IP Vendors
● | Transition relationships with existing partners/vendors – CASI has option to continue relationship |
o | Xxxxx Xxxxxx – IP attorney |
o | Xxxxxx Xxxxxxx – IP law firm |
x | XXXXXXXXX, XXXXXXXX & XXXXXXXX, P.A. – IP law firm |
o | Black Hills - Annuities |
Physical Materials
Cleave will work with the vendors involved in drug production and storage of materials [***] to get contracts in place for CASI and transfer ownership of all information, contracts and materials related to CB-5339.
● | Drug Substance stored at [***] |
● | Drug Product stored at [***] |
● | [***] stored at [***] |
● | [***] stored at [***] |
IN WITNESS WHEREOF, the Parties have caused this Bill of Sale to be duly executed as of the date first written above.
ASSIGNOR:
| CLEAVE THERAPEUTICS, INC. | ||||
| | | Name: [***] | | |
| | | Title: [***] | |
| ASSIGNEE: | ||||
| | | Name: [***] | | |
| | | Title: [***] | |