Exhibit 10.1
Certain information marked as [****] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
MANUFACTURING OPTION AGREEMENT
This Manufacturing Option Agreement (“Agreement”) is made as of October 26, 2022 (“Effective Date”) by and among Emergent BioSolutions Canada, Inc. (“Emergent”) and Sab Biotherapeutics, Inc. (“Customer”). Customer and Emergent may be individually referred to as a Party or collectively referred to as the Parties.
WHEREAS, on September 10, 2021, the Parties accepted and agreed to terms and conditions set forth in the proposal “[****]” dated August 19, 2021 (“Proposal”);
WHEREAS, pursuant to the Proposal, Proposal activities may be cancelled by Customer for any or no reason, subject to certain cancellation fees;
WHEREAS, Customer requested to cancel the Proposal on or around May 9, 2022;
WHEREAS, concurrently herewith, the Parties are entering into a Memorandum of Understanding and Agreement (“Memorandum”) whereby Emergent agrees, inter alia, to waive [****] ($[****]) of cancellation fees due to Emergent upon Customer’s cancellation of the Proposal; and
WHEREAS, in exchange for agreeing to waive the cancellation fees, Emergent desires to obtain from Customer and Customer desires to grant to Emergent an exclusive option to manufacture Customer Products (defined below) on the terms set forth below.
NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
The following terms have the meanings set forth below.
a.Affiliate means any company or other entity, other than a Party, which directly or indirectly controls, is controlled by, or is under common control with a Party, where “control” means the ownership of more than 50% of the issued share capital or other equity interest or the legal power to direct or cause the direction of the general management and policies of such company or other entity.
b.“Commercially Reasonable” means, with respect to a Party, the level of effort that is fair, done in good faith, and corresponding to commercial and academic practices of similarly situated entities.
c.Customer Background IP means all intellectual property rights and information, material, know-how, and trade secrets that relate to Customer’s Platform, whether or not patentable, conceived, originated, created, or first reduced to practice prior to the Effective Date of this Agreement.
d.Customer Platform means Customer’s DiversitAb™ platform that generates humanized polyclonal antibodies by leveraging genetically engineered bovine herds, with applications in infectious disease, cancer, and a wide variety of immune system disorders.
e.Customer Product means any commercial stage product utilizing humanized polyclonal antibodies developed by Customer based on Customer’s Background IP.
f.Third Party means any person or entity other than a Party or a Party Affiliate.
2.EXCLUSIVE MANUFACTURING OPTION
a.Manufacturing Option. Customer grants Emergent an exclusive option (but not the obligation) for the exclusive commercial manufacture of any and all Customer Products (“Exclusive Manufacturing Option”). For the avoidance of doubt, Customer and its Affiliates may not purchase from a Third Party, or manufacture internally, any Customer Product for commercial sale unless (i) Emergent waives its right to serve as Customer’s sole commercial supplier for such Customer Product by written agreement executed by both Parties or (ii) Emergent fails to exercise its right to exclusively manufacture a Customer Product for commercial sale during the Manufacturing Option Period (defined below).
g.Manufacturing Option Period. For each Customer Product, Customer will notify Emergent at least twenty-four (24) months in advance of its first commercial manufacturing needs for a Customer Product and at least twelve (12) months in advance for each additional Customer Product unless either Party determines in good faith that a longer period (not to exceed six (6) additional months) is needed for technology transfer (each such notice, a “Commercial Manufacturing Notice”). If Emergent decides to exercise the Exclusive Manufacturing Option with respect to the Customer Product identified in the Commercial Manufacturing Notice and Emergent has the ability and capacity to manufacture such Commercial Product, then within sixty (60) days following Emergent’s receipt of a Commercial Manufacturing Notice (“Manufacturing Option Period”), Emergent shall notify Customer in writing of its intention to exercise the Exclusive Manufacturing Option for such Customer Product and confirm in writing that it has the ability to manufacture such Commercial Product (each such written notice, a “Manufacturing Option Exercise Notice”). If Emergent does not send a Manufacturing Option Exercise Notice to Customer during the Manufacturing Option Period or if Emergent does send a Manufacturing Option Exercise Notice to Customer during the Manufacturing Option Period and Customer and Emergent do not, upon both Parties using all reasonable and good faith efforts, execute a Master Manufacturing Services Agreement during the MSA Negotiation Period (as the same may be extended per Section 2(c) below), Customer shall be free to engage any third party to manufacture the Customer Product specified in the Commercial Manufacturing Notice and Emergent will use its Commercially Reasonable efforts to transfer any technology necessary to manufacture such Customer Product to a third party manufacturer identified by Customer or its licensee, at Customer’s (or its licensee’s) sole cost and expense, provided that any technology so transferred shall be used exclusively to manufacture the applicable Customer Product.
b.Commercial Manufacturing Services Agreement. With respect to a Customer Product, if Emergent exercises the Exclusive Manufacturing Option during the Manufacturing Option Period by sending a Manufacturing Option Exercise Notice, the Parties will execute (i) a Master Manufacturing Services Agreement, in the form attached as Exhibit A, or a substantially similar form, within ninety (90) days of Emergent’s exercise of the Exclusive Manufacturing Option for the applicable Customer Product (the “MSA Negotiation Period”); provided that if the Parties are negotiating the terms of such Manufacturing Services Agreement in good faith at the end of the MSA Negotiation Period, the MSA Negotiation Period shall be extended upon mutual written agreement by the Parties for up to an additional forty-five (45) days.
c.Third Parties. If Customer licenses the development or commercial sale rights to a Customer Product or sells all or part of the rights related to a Customer Product to a Third Party and such Third Party elects not to have Emergent manufacture such Customer Product for its initial commercial sale and a period of at least three ([****]) years thereafter, Emergent shall be entitled to receive a commercially reasonable amount to be negotiated in good faith by the Parties which compensates Emergent for 50% of the lost profit for manufacture of such Commercial Product for the initial three ([****]) year period of manufacture, which amount shall not be less than $[****] for each such Commercial Product. Such payment shall be made after the first commercial sale of such excluded Customer Product.
This Agreement shall remain in full force and effect unless terminated by Emergent for any reason; provided that this Agreement shall terminate if the Master Manufacturing Services Agreement is terminated for any reason.
The Parties shall first attempt in good faith to settle any dispute arising hereunder promptly by negotiations between representatives of the Customer and Emergent who have authority to settle the controversy. If the Parties are unable to resolve such dispute within thirty (30) days following the referral of the dispute to such representatives, then the dispute will be referred to the Parties’ respective executive leadership teams, allowing an additional thirty (30) days to resolve the dispute. If the Parties are unable to resolve such dispute following referral to executive leadership, then such dispute shall be solely and finally settled by arbitration, which shall be conducted in New York, by a single arbitrator (the “Arbitrator”) designated by the American Arbitration Association. The Parties hereby renounce all recourse to litigation and agree that the award of the Arbitrator shall be final and subject to no judicial review. The Arbitrator shall conduct the proceedings pursuant to the American Arbitration Association Rules, as now or hereafter amended. All substantive questions of law shall be determined under the laws of New York (without regard to the principles of conflict of laws of such state). Judgment on the award of the Arbitrator may be entered into any court having jurisdiction over the Party against which enforcement of the award is being sought, and the Parties hereby irrevocably consent to the jurisdiction of any such court for the purpose of enforcing any such award. The Arbitrator shall divide all costs (including, without
limitation, fees of counsel) incurred in conducting the arbitration in his final award in accordance with what the Arbitrator deems just and equitable under the circumstances.
Any notice required or permitted to be given under this Agreement by any Party shall be in writing and shall be (a) delivered personally, (b) sent by registered mail, return receipt requested, postage prepaid, (c) sent by a nationally-recognized courier service guaranteeing next-day or second day delivery, charges prepaid, or (d) delivered by email (with documented evidence of receipt), to the addresses of the other Party set forth below, or at such other addresses as may from time to time be furnished by similar notice by any Party. The effective date of any notice under this Agreement shall be the date of receipt by the receiving Party.
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If to Emergent: |
If to Customer: |
Emergent BioSolutions Inc. 000 Xxxxxxxxxxxx Xxxxx, Xxxxx 000 Xxxxxxxxxxxx, Xxxxxxxx 00000 Attention: [****] Email: [****] |
SAB Biotherapeutics, Inc. 0000 Xxxx 00xx Xxxxxx Xxxxx Xxxxx Xxxxx, XX 00000 Attention: [****] Email: [****] |
With a copy to: |
With a copy to: |
Emergent BioSolutions Inc. 000 Xxxxxxxxxxxx Xxxxx, Xxxxx 000 Xxxxxxxxxxxx, XX 00000 Attention: General Counsel |
SAB Biotherapeutics, Inc. 0000 Xxxx 00xx Xxxxxx Xxxxx Xxxxx Xxxxx, XX 00000 Attention: Legal Dept. |
a.Entire Agreement. Except for the Memorandum, this Agreement is the entire Agreement between the Parties and, when executed by the Parties, supersedes all prior agreements, understandings, and communications, either verbal or in writing, between the Parties with respect to the subject matter contained herein.
h.Amendments. This Agreement may not be amended, modified, or changed except by written instrument signed by all of the Parties.
i.Captions. All captions and headings are inserted for the convenience of the Parties and shall not be used in any way to modify, limit, or otherwise affect this Agreement.
j.Counterparts. This Agreement may be executed simultaneously or in one or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
k.Waiver. Any failure by a Party to comply with any obligation, agreement, or condition herein may be expressly waived in writing by each of the other Parties, but such waiver or failure to insist upon strict compliance with such obligation, agreement, or conditions shall not operate as a waiver of, or estoppel with respect to, any subsequent or other failure.
l.Severability. If any term, provision, or condition of this Agreement is determined by a court or other judicial or administrative tribunal to be illegal, void, or otherwise ineffective or not in accordance with public policy, the remainder of this Agreement shall not be affected thereby and shall remain in full force and effect.
IN WITNESS WHEREOF, this Manufacturing Option and Right of First Refusal Agreement has been made the date and year written below.
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EMERGENT BIOSOLUTIONS CANADA INC.: |
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SAB BIOTHERAPEUTICS, INC.: |
BY:_________________________________ |
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BY:_________________________________ |
NAME:______________________________ |
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NAME:______________________________ |
TITLE:_______________________________ |
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TITLE:_______________________________ |
DATE:_______________________________ |
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DATE:_______________________________ |
EXHIBIT A
