EXECUTION VERSION
EXECUTION VERSION
Exhibit 4.41
Information 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
IN RELATION TO THE ASSIGNMENT OF RIGHTS IN THE TERRITORY OF CHINA
UNDER THE AMENDED AND RESTATED LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT EFFECTIVE AS OF 29 MAY 2013 BETWEEN ACROTECH BIOPHARMA INC AND MUNDIPHARMA INTERNATIONAL CORPORATION LIMITED
This AGREEMENT (“Agreement”) is made on 31 July 2023 (“Effective Date”),
BY AND BETWEEN:
1. | MUNDIPHARMA INTERNATIONAL CORPORATION LIMITED, a Bermuda corporation |
having its registered office at Victoria Place, 5th Floor, 00 Xxxxxxxx Xxxxxx, Xxxxxxxx, Xxxxxxx ("MICL"); and
2. | CASI PHARMACEUTICALS, INC., a Cayman corporation having a place of business at 0000-0000, Xxxxx Central Office, Tower 0, Xx. 00 Xxxxxxx Xxxx, Xxxxxxxx Xxxxxxxx, Xxxxxxx 000000 Xxxxxx’x Xxxxxxxx xx Xxxxx ("CASI") |
(collectively, the "Parties" and each, a “Party”).
WHEREAS:
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NOW THEREFORE, it is mutually agreed by the Parties as follows:
1. | INTERPRETATION |
1.1 | Except where the context otherwise requires or where otherwise defined in this Agreement, all words, expressions and terms used in this Agreement shall have the same meaning as ascribed to them in the License Agreement. |
1.2 | The provisions of article 1 (Definitions) of the License Agreement apply to this Agreement as though they were set out in full in this Agreement. |
1.3 | For the purposes of this Agreement, “Affiliates” means in respect of any Party, any person, firm, trust, corporation, company, partnership or other entity or combination thereof which directly or indirectly (a) controls such Party, (b) is controlled by such Party, or (c) is under common control with such Party; the terms “control” and “controlled” meaning (i) ownership of [***] percent ([***]%) or more, including ownership by one or more trusts with substantially the same beneficial interests, of the voting and equity rights of such person, firm, trust, corporation, company, partnership or other entity or combination thereof; or (ii) the power to direct the management of such person, firm, trust, corporation, company, partnership or other entity or combination thereof. For the purposes of this Agreement, “Affiliates” excludes, in the case of Mundipharma, Purdue Pharma L.P. (U.S.) and any of its subsidiaries. |
1.4 | For the purposes of this Agreement, “Business Day” means a day other than a Saturday, Sunday or public holiday in the United Kingdom, Bermuda or China. |
1.5 | Clause and paragraph headings are inserted for ease of reference only and shall not affect construction. |
1.6 | The ejusdem generis rule does not apply to this Agreement. Accordingly, specific words indicating a type, class or category of thing shall not restrict the meaning of general words following such specific words, such as general words introduced by the word other or a similar expression. Similarly, general words followed by specific words shall not be restricted in meaning to the type, class or category of thing indicated by such specific words. |
2. | EFFECTIVE DATE |
2.1 | The Parties agree that this Agreement shall come into effect from the date that set forth in the preamble, which shall be the same date as the Assignment Effective Date. |
3. | CONSIDERATION |
3.1 | In consideration of the entry by Xxxxxxxxxxx into the Assignment Agreement, XXXX agrees to pay MICL or its designee the sum of USD [***] (“Consideration”) in the following manner: |
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doubt, the Net Sales amount shall be aggregated from the time that the Product is Commercialised in China; and
3.2 | Within [***] days following the end of each calendar quarter, CASI shall provide MICL with a report containing the following information for such calendar quarter: (i) the amount of gross sales of Product in China, (ii) an itemized calculation of Net Sales in China showing deductions provided for in the definition of “Net Sales” in the License Agreement and any rebates that are known to be required in respect of the calendar year in question, (iii) the conversion of such Net Sales from the currency of sale into Dollars, and (iv) the calculation of the royalty payment due on such sales, showing the application of the reduction, if any, made in accordance with the terms of sections 7.4(c), 7.4(d) and 7.4(e) of the License Agreement. Concurrent with the delivery of the applicable quarterly report, CASI shall pay in Dollars all amounts due to MICL pursuant to Clauses 3.1(b) and 3.1(c). |
3.3 | All payments under Clause 3.1 shall be made: |
(a) | in respect of the payment under Clause 3.1(a), on such date as set out in Clause 3.1(a) above; |
3.4 | In the event that CASI has not paid the full sum of USD [***] under Clauses 3.1(b) and 3.1(c) (“Deferred Consideration”) on the date which is [***] years after the Assignment Effective Date, the remaining amount of the Deferred Consideration shall become immediately due and payable from CASI to MICL; provided however that such payment obligation shall only apply if the Product has been launched in China during the aforementioned [***] year period. |
3.5 | Notwithstanding the proviso in Clause 3.4, CASI shall not have any further obligation to pay the remaining amount of the Deferred Consideration if the current Drug Approval in China is not renewed by the relevant Regulatory Authorities; provided that the following conditions are met (“Conditions”) |
3.5 In the event that CASI or its Affiliates transfers, sells, assigns or out-licenses all or substantially all or any portion of its rights to the Product in China transferred and assigned to it under the Assignment Agreement, to a third party, including without limitation in connection with a merger, consolidation, or sale of all, or substantially all of the assets or stock of CASI or any of its Affiliates, CASI agrees that such transfer will be pursuant to a written agreement (in such form and substance that's reasonably acceptable to MICL) entered into between MICL and the third party (“Third Party Assignment Agreement”) that requires such third party to undertake and perform CASI’s obligations pursuant to this Agreement, including to pay MICL the amounts set forth in this Agreement. For the avoidance of doubt, unless MICL releases and discharges CASI from its obligations under this Agreement pursuant to the Third Party Assignment Agreement, CASI shall remain responsible and liable for its obligations under this Agreement.
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3.7 | For the avoidance of doubt: |
(a) | any part of the Consideration that has been paid or is payable by CASI and/or its Affiliates to MICL and/or their Affiliates before the formal non-renewal of the Drug Approvals in China shall not be refundable. |
(b) | If (1) for any reason CASI and/or its Affiliates are able to obtain the Drug Approvals to Commercialise the Product in China after the [***] year period described in Clause 3.4, or |
(2) CASI’s rights to the Product in China are terminated for any reason, except (i) in the situation where the Conditions are met, or (ii) in the situation where Acrotech terminates CASI and/or its Affiliate’s rights to the Product in China through no breach by CASI and/or its Affiliates of its obligations under the License Agreement (as assigned from Mundipharma to CASI under the Assignment Agreement), the New Supply Agreement, the Assignment Agreement and/or this Agreement, then in such case CASI shall promptly notify MICL in writing and the remaining Deferred Consideration not yet paid to MICL shall become immediately due and payable to MICL. For clarity, the exception in sub-paragraph (2)(ii) shall not apply if Acrotech and/or its Affiliates enter into new license and/or supply agreements to, directly or indirectly, xxxxx XXXX and/or its Affiliates the right to commercialise the Product in China.
3.8 | All payments to be made pursuant to this Agreement represent actual amounts that MICL is entitled to receive and shall not be subject to any deduction for any reason whatsoever. In the event that such payments become subject to duties, taxes (including withholding taxes) or charges of whatever kind or nature, such payments shall be increased to such an extent as to allow MICL to receive the net amounts due under this Agreement. |
3.9 | No Party shall be entitled to set-off or otherwise withhold any payment due to the other Party hereunder in view of any possible claims against the other Party or for any other reason. |
4. | REPRESENTATIONS, WARRANTIES, UNDERTAKINGS AND COVENANTS |
4.1 | Each Party represents and warrants to the other Party as follows: |
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governmental body or agency which would affect its ability to perform its obligations under this Agreement.
(e) | It has the ability to perform its obligations under this Agreement. |
4.2 | CASI represents, warrants and undertakes to MICL as follows: |
4.3 | CASI further warrants, covenants and undertakes to MICL that it shall (and it shall procure its Affiliates shall): |
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its Affiliates shall meet with the Regulatory Authorities with respect to the PMS within six (6) months of the Assignment Effective Date.
5. | INDEMNITY |
5.1 | CASI shall indemnify and hold harmless MICL and its Affiliates and their respective officers, directors and employees (collectively, “Mundipharma Indemnitees”) from and against any and all claims, demands, prosecutions, liabilities, costs, proceedings, damages and expenses (including legal and other professional fees and expenses) (collectively, “Losses”) which may be brought or asserted against any of the Mundipharma Indemnitees by a third party or suffered or incurred by any of the Mundipharma Indemnitees on account of, resulting from or in connection with CASI and/or its Affiliates’ failure to perform or satisfy its assumed obligations under the License Agreement with respect to China on and after the Assignment Effective Date. |
6. | CONFIDENTIALITY |
6.1 | Subject to Clause 6.2, each Party shall keep strictly confidential and not disclose or publish or cause others to disclose or publish (whether in writing, verbally or by any other means of communication, whether visual, verbal or written) the Confidential Information to any person, without the other Party’s or Parties’ prior written consent. “Confidential Information” means: |
(a) | the existence of this Agreement; |
(b) | any of the provisions of this Agreement; and |
(c) | any communications, arrangements or dealings between the Parties in connection with this Agreement and any matter, cause, issue or thing whatsoever relating to this Agreement. |
6.2 | Clause 6.1 shall not apply to the extent (and only to the extent) of: |
(c) | Any disclosure as is or may be necessary for the purpose of enforcing this Agreement. |
7. | COSTS & EXPENSES |
Unless otherwise specified in this Agreement, each of the Parties shall be responsible for its own legal, accountancy and other costs, charges and expenses incurred in connection with the negotiation,
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preparation and implementation of this Agreement and any other agreement incidental to or referred to in this Agreement.
8. | WAIVER OF RIGHTS |
Any right conferred on the Parties by this Agreement shall be in addition to and without prejudice to all other rights and remedies available to them and no exercise or failure to exercise or delay in exercising any right or remedy shall constitute a waiver by any of them of that or any available right or remedy.
9. | ENTIRE AGREEMENT |
This Agreement, the agreements referenced herein and any agreements entered into by and amongst Acrotech, Mundipharma and/or CASI (and/or any of their respective Affiliates) on or around the Effective Date supersedes and cancels all previous agreements, warranties and undertakings whether oral or written, express or implied, given or made by or between the Parties, and this Agreement constitutes the entire agreement between the Parties in respect of the matters set out herein, and no other terms and conditions shall be included or implied.
10. | AMENDMENT |
No alteration, change or modification of any of the provisions of this Agreement shall be valid unless made in writing and signed by or on behalf of the Parties.
11. | SEVERABILITY |
If any provision or part-provision of this Agreement is or becomes invalid, illegal or unenforceable, it shall be deemed modified to the minimum extent necessary to make it valid, legal and enforceable. If such modification is not possible, the relevant provision or part-provision shall be deemed deleted. Any modification to or deletion of a provision or part-provision under this Clause shall not affected the validity and enforceability of the rest of this Agreement.
12. | COUNTERPARTS |
This Agreement may be executed in two or more counterparts, each of which shall be deemed to be an original, but which counterparts together shall constitute one and the same instrument.
13. | RELATIONSHIP OF PARTIES |
This Agreement shall not be construed as constituting a partnership of joint venture between the Parties and neither Party shall have the right to bind the other Party to any contract or obligation without the prior express written consent of such other Party.
14. | BINDING EFFECT |
This Agreement shall be binding upon and inure to the benefit of the Parties’ respective successors and assigns.
15. | ASSIGNMENT |
No Party shall be entitled to assign, transfer or charge all or any of its rights or obligations under this Agreement without the prior written consent of the other Parties, except that each Party shall at any time be entitled to assign, transfer or charge all or any of its rights or obligations under this Agreement to (a) an Affiliate or (b) in connection with Clause 3.6, a successor to all or substantially all of the business of
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such Party to which this Agreement relates, whether by merger, sale of stock, sale of assets, license, or other transaction or series of transactions; provided that any permitted assignee undertakes to the other Parties to be bound by the terms and conditions of this Agreement and perform all the obligations of such Party hereunder.
16. | THIRD PARTY RIGHTS |
Except for the Mundipharma Indemnitees, nothing in this Agreement is intended to grant to any third party any right to enforce any provision of this Agreement or to confer any third party any benefits under this Agreement. Except for the Mundipharma Indemnitees, a person who is not a party to this Agreement has no right, whether statutory or otherwise, to enforce any provision of this Agreement.
17. | NOTICES |
17.1 | All notices and communications to be given under or in connection with this Agreement by one Party to the other Party shall be in writing and must be delivered or sent by hand or post to the Party to whom it is to be given as follows: |
(a) | to MICL at: |
Mundipharma International Corporation Limited Mundipharma House,
[***]
with a copy (which shall not constitute notice) by post to : Mundipharma Medical Company Limited
[***]
(b) | to CASI at: |
CASI Pharmaceuticals (China) Co., Ltd
[***]
with a copy (which shall not constitute notice) by post to : CASI Pharmaceuticals, Inc.
[***]
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or at any such other address of which either Party shall have given notice for this purpose to the other Party.
17.2 | Any notice or other communication sent by post shall be sent by prepaid recorded delivery post (if the country of destination is the same as the country of origin) or by prepaid airmail (if the country of destination is not the same as the country of origin). |
17.3 | Any notice or other communication shall be deemed to have been given: |
(a) | if delivered by hand, on the date of delivery; or |
(b) | if sent by post, on the second Business Day after it was put into the post or sent by courier. |
17.4 | In proving the giving of a notice or other communication, it shall be sufficient to prove that delivery was made or that the envelope containing the communication was properly addressed and posted by prepaid recorded delivery post or by prepaid airmail. |
18. | GOVERNING LAW & DISPUTE RESOLUTION |
This Agreement and all disputes arising out of this Agreement or any breach hereof shall be governed by and construed in accordance Swiss substantive law, and shall be subject to the arbitration in accordance with the Rules of Arbitration of the International Chamber of Commerce (ICC) by one arbitrator appointed in accordance with the said rules. Arbitration proceedings shall be in the English language and shall take place in Zurich, Switzerland.
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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their duly authorized officers.
MUNDIPHARMA INTERNATIONAL CORPORATION LIMITED
![Graphic](https://www.sec.gov/Archives/edgar/data/1962738/000155837024004190/casi-20231231xex4d41005.jpg)
[***]
Name: [***]
Title: [***]
CASI PHARMACEUTICALS, INC.
![Graphic](https://www.sec.gov/Archives/edgar/data/1962738/000155837024004190/casi-20231231xex4d41005.jpg)
[***]
_____________________________
Name: [***]
Title:[***]
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