Exhibit 10.1
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.
THIRD AMENDED AND RESTATED SUPPLY AND DISTRIBUTION AGREEMENT
This THIRD AMENDED AND RESTATED SUPPLY AND DISTRIBUTION AGREEMENT (this “Agreement”), is made and entered into as of the 14th day of June, 2022 (the “Third Restatement Date”), by and between Roman Health Pharmacy LLC, a Delaware limited liability company, having an office at 30-30 47th Avenue, Suite 535, Long Island City, New York 11101 (“RO”) and Gelesis Inc., a Delaware corporation, having its principal office at 501 Boylston Street, Suite 6102, Boston, MA 02116 (“GELESIS”). RO and GELESIS each may be referred to herein individually as a “Party,” or collectively as the “Parties.”
WITNESSETH:
WHEREAS, GELESIS has developed and manufactured the medical device product PLENITY™, an orally administered, non-stimulant, non-systemic prescription aid in the form of capsules for weight management, as further described on Schedule A (the “Product”) and has obtained a de novo classification order from the FDA (as defined below) to market, distribute and sell the Product in the United States; and
WHEREAS, from the Effective Date (defined below) up to the Third Restatement Date, GELESIS appointed RO as the exclusive distributor of the Product in the Territory in the Field (each as defined below);
WHEREAS, from and after the Third Restatement Date, GELESIS desires to appoint RO as a distributor of the Product in the Territory in the Field, subject to the exclusivities set forth in Section 2 of this Agreement;
WHEREAS, GELESIS further agrees to supply RO with the Product under the terms and conditions of this Agreement;
WHEREAS, RO desires to serve as a distributor of the Product in the Territory in the Field and to purchase the Product from GELESIS, in each case, subject to the terms and conditions of this Agreement;
WHEREAS, the Parties previously entered into that certain Supply and Distribution Agreement, made and entered into as of the Effective Date (the “Original Agreement”)
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WHEREAS, the Parties amended and restated the Original Agreement pursuant to that certain Amended and Restated Supply and Distribution Agreement made and entered into as of the Restatement Date (defined below) (the “First Amended and Restated Agreement”); and
WHEREAS, the Parties amended and restated the First Amended and Restated Agreement pursuant to that certain Second Amended and Restated Supply and Distribution Agreement made and entered into as of the Second Restatement Date (defined below) (the “Second Amended and Restated Agreement”); and
WHEREAS, the Parties now desire to amend and restate the Second Amended and Restated Agreement in its entirety as follows;
NOW, THEREFORE, in consideration of the foregoing premises and the mutual promises and covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
ARTICLE 1
DEFINITIONS
Unless otherwise specifically provided herein, the following terms shall have the following meanings:
(a) the possession, directly or indirectly, of the power to direct the management or policies of a Person, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise, or (b) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a Person (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity); provided that, if local law restricts foreign ownership, control will be established by direct or indirect ownership of the maximum ownership percentage that may, under such local law, be owned by foreign interests.
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12.2.
9.1.
practice registered nurses, and physician’s assistants.
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ARTICLE 2
RIGHT OF DISTRIBUTION; EXCLUSIVITY
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ARTICLE 3 COMMERCIALIZATION OF THE PRODUCT
ARTICLE 4
SUPPLY OF PRODUCT
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ARTICLE 5
PRODUCT WARRANTY; QUALITY
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ARTICLE 6 PRICE AND PAYMENT
(i) [***]
(ii) [***]
(A) [***],
(B) [***],
(C) [***], and
(D) [***].
(b) [***].
(c) [***].
(d) [***].
(e) [***].
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ARTICLE 7 INSPECTION AND AUDIT
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ARTICLE 8
REGULATORY MATTERS
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Reporting.
later than two (2) Business Days of becoming aware of) any material communications from any Regulatory Authority alleging any non-compliance with Applicable Laws or raising any concern, in each case, with respect to the Manufacturing, quality, safety, efficacy or marketing of the Product (including any Form FDA 483 with inspectional observations, Warning Letter, or Untitled Letter).
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ARTICLE 9 INTELLECTUAL PROPERTY
ARTICLE 10 REPRESENTATIONS, WARRANTIES AND COVENANTS
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GELESIS represents, warrants and covenants, as applicable, to RO that:
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ARTICLE 11
CONFIDENTIALITY AND NONDISCLOSURE
(5) years thereafter, each Party (the “Receiving Party”) (i) shall hold in strict confidence and shall not publish or otherwise disclose, directly or indirectly, to any Third Party any Confidential Information of the other Party or its Affiliates (collectively, the “Disclosing Party”), (ii) except as permitted pursuant to Section 11.2 and Section 11.3, shall not directly or indirectly use Confidential Information of a Disclosing Party for any purpose other than performance of its obligations or exercise of its rights under this Agreement, or as otherwise expressly permitted under this Agreement, and (iii) shall use the same level of effort to maintain the confidentiality of Confidential Information of a Disclosing Party as it uses for its own confidential or proprietary information, but in any event at least Reasonable Efforts.
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ARTICLE 12
INDEMNIFICATION
(b) Product Liability Claims arising from any supply, handling, storage, shipment, or transport by or on behalf of RO of the Product after delivery by GELESIS to RO pursuant to Section 4.4 that results in the failure of the Product to conform to the Specifications or the applicable certificate of analysis, (c) the supply, handling, storage, shipment, or transport of the Product by or on behalf of RO after delivery by GELESIS to RO pursuant to Section 4.4, in each case ((a) through (c)), except for those Losses arising from or occurring as a result of, directly or indirectly, matters for which GELESIS is obligated to indemnify RO under Section 12.1, as to which Losses each Party shall indemnify the other to the extent of their respective liability. For the avoidance of doubt, RO’s indemnification obligations with respect to any Product Liability Claim shall be specifically covered by subsection (b), and not any other subsections of this Section 12.2.
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ARTICLE 13
TERM AND TERMINATION
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(b) Articles 9, 11, 12 and 14 and Sections 5.1, 5.3, 10.4, 13.3, and 13.4 of this Agreement shall survive termination of this Agreement.
ARTICLE 14
MISCELLANEOUS
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(30) days after the date such event of Force Majeure commences, the Parties shall meet to discuss in good faith how to proceed in order to carry out the intent of this Agreement; provided further, that in the event the suspension of performance continues for ninety (90) days after the date such event of Force Majeure commences, the Party who, absent this Section 14.1, would have a claim for breach may terminate this Agreement immediately upon written notice to the other Party. For purposes of this Agreement, an event of Force Majeure shall not include a failure to commit or secure sufficient resources or capacity, financial or otherwise, to the performance of obligations under this Agreement, or general market or economic conditions.
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if to GELESIS: Gelesis Inc.
501 Boylston Street, Suite 6102
Boston, MA 02116
Attention: David Pass, COO and Head of Commercial
[***]
with a copy to: Goodwin Procter LLP 100 Northern Ave.
Boston, MA 02210 Attention: Jim Barrett
Email: jbarrett@goodwinlaw.com
if to RO: Roman Health Pharmacy LLC 116 W. 23rd Street, 4th Floor New York, NY 10011 Attention: Zachariah Reitano
[***]
with a copy to: Roman Health Ventures Inc. 116 W. 23rd Street, 4th Floor New York, NY 10011
Attn: General Counsel [***]
and
Covington & Burling LLP One CityCenter
850 Tenth Street, NW Washington, DC 20001-495 Attention: Van Ellis
Email: [***]
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 communication shall be deemed to have been given (a) when delivered, if personally delivered or sent by facsimile or email on a Business Day,
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11.5 and 14.6(b) or elsewhere hereunder, (a) irrevocably submits to the exclusive jurisdiction of the United States District Courts located in the State of Delaware (the “Court”), and (b) agrees not to raise any objection at any time to the laying or maintaining of the venue of any action, suit or proceeding in the Court, irrevocably waives any claim that such action, suit or other proceeding has been brought in an inconvenient forum and further irrevocably waives the right to object, with respect to such action, suit or other proceeding, that such Court does not have any jurisdiction over such Party. Each Party further agrees that service or any process, summons, notice or document by U.S. registered mail to such Party’s notice address provided for in this Agreement shall be effective service of process for any action, suit or proceeding in the Court with respect to any matters to which it has submitted to jurisdiction in accordance with this Section 14.7.
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[Signature Page Follows]
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IN WITNESS WHEREOF, the parties have caused this Agreement to be duly executed and delivered as of the date first set forth above.
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GELESIS INC.
By: /s/ David Pass__________
Name: David Pass
Title: COO
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ROMAN HEALTH PHARMACY LLC
By: /s/ Zachariah Reitano
Name: Zachariah Reitano
Title: President
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Schedule A
Product Specifications
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Schedule B
Contract Manufacturer
Packaging
Centerpiece Holdings LLC
440 Stevens Ave, Ste 200
Solana Beach, CA 92075 U.S.A
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