EXCLUSIVE LICENSE AND DISTRIBUTION AGREEMENT (CANADA)
[***] Certain information in this exhibit has been omitted because it is permitted to be omitted by applicable regulatory guidance.
Execution Version
EXCLUSIVE LICENSE AND DISTRIBUTION AGREEMENT (CANADA)
This Exclusive License and Distribution Agreement (Canada) (“Agreement”) is entered into on June 27, 2024 (the “Effective Date”) between Coherus BioSciences, Inc., a company organized and existing under the laws of the State of Delaware, having its main offices at 000 Xxxx Xxxxxxx Xxxxx, Xxxxx 000 Xxxxxxx Xxxx, XX 00000 (“Coherus”) and Apotex, Inc., a company incorporated under the laws of Ontario, Canada, and having its registered address at 000 Xxxxxx Xxxxx, Xxxxxxx, Xxxxxxx, Xxxxxx, including its Affiliates (“Apotex”). Xxxxxxx and Apotex may each be referred to herein as a “Party” or collectively as the “Parties.”
RECITALS
Whereas, Coherus and Shanghai Junshi Biosciences Co., Ltd., a corporation organized and existing under the laws of the People’s Republic of China, with a registered address at Xxxxx 00, Xxxxxxxx 0, Xxx. 00 xxx 00, Xxx Xx Xxxx, Xxxxx (Shanghai) Pilot Free Trade Zone, People’s Republic of China 201203 (“Junshi”) are parties to that certain Exclusive License and Commercialization Agreement, dated February 1, 2021 (as amended, the “ELCA”), pursuant to which Junshi granted to Coherus the exclusive right and license to Exploit (as defined below) biologic drug products containing the active pharmaceutical ingredient toripalimab within the Coherus Territory (as defined below) under certain Licensed Technology;
Whereas, pursuant and subject to the ELCA, Xxxxxxx has the right to grant sublicenses to Third Parties to, among other things, Exploit biologic drug products containing toripalimab within all or part of the Coherus Territory, which includes the country of Canada;
Whereas, Apotex desires to receive, and Xxxxxxx is willing to grant, an exclusive license under Coherus’s rights and interests related to biologic drug products containing toripalimab to Exploit such products in Canada, all in accordance with the terms and conditions of this Agreement.
Now Therefore, in consideration of the following mutual promises and other good and valuable consideration, the receipt and sufficiency of which are acknowledged, the Parties, intending to be legally bound, agree as follows:
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pending litigation, governmental investigation, proceeding, or action involving the Licensed Product in the Apotex Territory to the extent that Coherus can provide such information to Apotex without breaching its obligations of confidentiality to any Third Party or violating any Applicable Laws.
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and (b) that allow Coherus to share any data received from Apotex with Junshi and otherwise enable Coherus to comply with the Pharmacovigilance Agreement by and between Coherus and Junshi, dated June 13, 2022. The Coherus-Apotex Pharmacovigilance Agreement will also provide for reimbursement by Apotex of Coherus’s internal and out-of-pocket costs and expenses associated with assisting Apotex with reporting adverse events within the Apotex Territory.
(a) General. Apotex (itself or through its Affiliates or Sublicensees or its or their designee(s)) will have the sole right, using Commercially Reasonable Efforts at its sole cost and expense, to market, promote, invoice and book sales, establish all terms of sale (including pricing and discounts) and warehousing, distribute and otherwise Commercialize the Licensed Product in the Apotex Territory after Regulatory Approval of the Licensed Product.
(b) Exportation Outside of Apotex Territory. Apotex will not knowingly or intentionally sell or transfer the Licensed Product to a distributor if Apotex has reasonable grounds to believe that such distributor will resell or export the Licensed Product outside of the Apotex Territory. Apotex will take commercially reasonable efforts to: (i) monitor such distributors to ensure that such distributors are not selling or transferring Licensed Product, sold to the distributor by Apotex to outside of the Apotex Territory; and (ii) attempt to cease such distributor’s from selling or transferring the Licensed Product to outside the Apotex Territory if Apotex becomes aware that Apotex sold Licensed Product to such distributor.
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For clarity, “aggregate annual Net Sales” as set out in the above table will mean the total Net Sales in a calendar year.
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based on Coherus’s income), arising from the payment of amounts due under this Agreement. The Parties agree to cooperate with one another and use reasonable efforts to avoid or reduce tax withholding or similar obligations in respect of payments made by Apotex to Coherus under this Agreement. To the extent Apotex is required to deduct and withhold taxes on any payment to Coherus, Apotex will pay the amounts of such taxes to the proper governmental authority in a timely manner and promptly transmit to Coherus official receipts issued by the appropriate taxing authority and/or an official tax certificate, or such other evidence as Coherus may reasonably request, to establish that such taxes have been paid. Coherus will provide Apotex any tax forms that may be reasonably necessary in order for Apotex to not withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty. Coherus will use reasonable efforts to provide any such tax forms to Apotex at least [***] before the due date for any payment for which Apotex desires that Coherus apply a reduced withholding rate. Each Party will provide the other with reasonable assistance to enable the recovery, as permitted by Applicable Law, of withholding taxes, value added taxes, or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party bearing such withholding tax or value added tax.
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will have the right to assume and conduct the defense of the Claim with counsel of its choice. The Indemnifying Party will not settle any Claim without the prior written consent of the Indemnified Party, not to be unreasonably withheld, unless the settlement involves only the payment of money. The Indemnified Party will not settle any such Claim without the prior written consent of the Indemnifying Party, which consent will not be unreasonably withheld. If the Indemnifying Party does not assume and conduct the defense of the Claim as provided above, (a) the Indemnified Party may defend against, and consent to the entry of any judgment or enter into any settlement with respect to the Claim in any manner the Indemnified Party may deem reasonably appropriate (and the Indemnified Party need not consult with, or obtain any consent from, the Indemnifying Party in connection therewith), and (b) the Indemnified Party reserves any right it may have under this Article 9 (Indemnification; Insurance; Limitation of Liability) to obtain indemnification from the Indemnified Party.
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the start of the final year of the Initial Term, Xxxxxxx will have the right to negotiate and enter into an agreement with a Third Party to grant such Third Party, upon the expiration of the Initial Term, the rights granted to Apotex hereunder.
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For the avoidance of doubt, the Parties agree that: (i) Apotex may terminate the Supply Agreement in the event that there is a failure to supply Licensed Product by Coherus to Apotex that lasts [***], provided that such failure to supply is not due to Coherus’s CMO or supplier of the Licensed Product to Apotex; and (ii) if Apotex terminates this Agreement pursuant to Section 10.7 (Insolvency) of this Agreement or pursuant to Section 6.2(c)(i) (Insolvency) of the Supply Agreement, then such termination shall be considered a termination for material breach under this Agreement and the Supply Agreement and Section 10.8 of this Agreement shall be applicable.
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Section 10.10 (Accrued Rights and Obligations), Section 10.11 (Survival), Article 12 (Dispute Resolution), and Article 13 (General Provisions). All provisions not surviving in accordance with the foregoing will terminate upon termination of this Agreement and be of no further force and effect.
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If to Xxxxxxx, notices must be addressed to:
000 Xxxx Xxxxxxx Xxxxx, Xxxxx 000
Redwood City, CA 94065
Attention: Xxxxxx X. Xxxxxxx, Chief Executive Officer
Email: [***]
with a copy to (which will not constitute notice):
000 Xxxx Xxxxxxx Xxxxx, Xxxxx 000
Redwood City, CA 94065
Attention: General Counsel
If to Apotex, notices must be addressed to:
Apotex Inc.
000 Xxxxxx Xxxxx
Toronto, Ontario
M9L 1T9, Canada
Attention: Xxxxx Xxxxxxx, Chief Corporate Development Officer
Email: [***]
with a copy to (which will not constitute notice):
Apotex Inc.
000 Xxxxxx Xxxxx
Toronto, Ontario
M9L 1T9, Canada
Attention: Apotex Global Intellectual Properties & Legal Affairs Department
Email: [***]
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amendments, supplements or modifications set forth herein), (e) any reference herein to any person or entity will be construed to include the person’s or entity’s successors and assigns, (f) the words “herein,” “hereof,” and “hereunder”, and words of similar import, will be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (g) all references herein to Sections or Schedules will be construed to refer to Sections or Schedules of this Agreement, and references to this Agreement include all Schedules hereto, (h) the word “notice” means notice in writing (whether or not specifically stated) and will include notices, consents, approvals and other written communications contemplated under this Agreement, (i) provisions that require that a Party, the Parties or any committee hereunder “agree,” “consent,” or “approve” or the like will require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (including e-mail, but excluding instant messaging), (j) references to any specific law, rule or regulation, or article, section or other division thereof, will be deemed to include the then current amendments thereto or any replacement or successor law, rule or regulation thereof, (k) the term “or” will be interpreted in the inclusive sense commonly associated with the term “and/or,” and (l) references to any Sections include Sections and subsections that are part of the related Section. Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement will be construed against the drafting Party will not apply.
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[Signature Page Follows.]
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IN WITNESS WHEREOF, the Parties have executed this Exclusive License and Distribution Agreement as of the Effective Date.
APOTEX INC. | |
By: _/s/ Xxxxxx X. Lanfear_________ | By: ___/s/ Xxxxx Xxxxxxx__________ |
Name: __Xxxxxx X. Lanfear___________ | Name: ___Xxxxx Xxxxxxx____________ |
Title: __CEO______________________ | Title: Chief Corporate Development Officer___ |
SCHEDULE 1.63
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SCHEDULE 4.2
BRAND GUIDELINES
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