Form 8-K GELESIS HOLDINGS, INC. For: Jun 14

2022-06-21 11:55:30 By : Mr. Charles Chen

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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.”

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”)

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:

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.

practice registered nurses, and physician’s assistants.

ARTICLE 3 COMMERCIALIZATION OF THE PRODUCT

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).

ARTICLE 10 REPRESENTATIONS, WARRANTIES AND COVENANTS

GELESIS represents, warrants and covenants, as applicable, to RO that:

(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.

(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.

(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.

(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.

if to GELESIS: Gelesis Inc.

Attention: David Pass, COO and Head of Commercial

with a copy to: Goodwin Procter LLP 100 Northern Ave.

Boston, MA 02210 Attention: Jim Barrett

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

Covington & Burling LLP One CityCenter

850 Tenth Street, NW Washington, DC 20001-495 Attention: Van Ellis

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,

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.

IN WITNESS WHEREOF, the parties have caused this Agreement to be duly executed and delivered as of the date first set forth above.

Solana Beach, CA 92075 U.S.A

Gelesis Announces Additional $15 Million Pre-Order for Plenity®, Bringing Total Pre-Paid Orders from Ro for Plenity to $55 Million

Following the successful debut of the national broad awareness media campaign, with a new record-high for prescription requests, the company’s telehealth distribution partner, Ro, placed an additional pre-order for the weight management product

Gelesis received $45 million in pre-paid orders from Ro in the last 12 months

BOSTON, June 21, 2022 – Gelesis announced today that Ro, a leading and rapidly growing U.S. direct-to-patient healthcare company, has placed a $15 million pre-paid order for the company’s commercial product for weight management, Plenity®. This is in addition to previous Plenity pre-orders from Ro totaling $40 million.

Gelesis launched the first wave of its national broad awareness media campaign for Plenity on January 31, 2022, which corresponded with record high levels of web traffic and prescription requests. Since the broad consumer launch, Plenity has become one of the most sought-after offerings on Ro’s platform. After a consultation with a licensed healthcare provider, if they qualify, individuals can be approved for a prescription within 24 hours. The treatment is then shipped directly to their home and arrives within 2 days, at $98 for a 28-day supply.

“We believe we are highly differentiated in the rapidly growing weight management category with a treatment option that is available across a wide BMI spectrum and where our members can continue to enjoy the foods they love, feeling satisfied with smaller portions,” said David Pass, Pharm. D, Gelesis’ Chief Commercial and Operating Officer. “We believe that access to well tolerated, affordable, evidence-based care is one of the biggest barriers in effective weight management. We are excited to see the growing indicators of the success of our commercial model. We have acquired more than half of our members since the start of the media campaign in February.”

Following the launch of the campaign, the number of individuals seeking a new prescription increased 140% during the first quarter to reach record highs. The company reported $7.5 million in net product revenue in the first quarter of 2022, a 142% increase over the first quarter 2021.

Gelesis has also reported growth in the more traditional healthcare provider (HCP) channel following the launch of the campaign and the company expects consumer demand to continue to drive uptake. Notably 40-50% of these HCP prescriptions were requested by the consumer (the company’s baseline before the media campaign began was 25%).

Plenity has the largest addressable market of any prescription weight management approach, and 150 million American adults could qualify for treatment, including the tens of millions of Americans with a BMI between 25 and 30 who generally do not qualify for other prescription weight loss treatments. About 70% of Plenity members had never tried a prescription weight management product before, indicating Plenity is bringing new people into the category of prescription weight management products.

Gelesis Holdings Inc. (NYSE: GLS) (“Gelesis”) is a consumer-centered biotherapeutics company and the maker of Plenity®, which is inspired by nature and FDA cleared to aid in weight management. Our first-of-their-kind non-systemic superabsorbent hydrogels are made entirely from naturally derived building blocks. They are inspired by the composition and mechanical properties of raw vegetables, taken by capsule, and act locally in the digestive system, so people feel satisfied with smaller portions. Our portfolio includes Plenity® and potential therapies in development for patients with Type 2 Diabetes, Non-alcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic Steatohepatitis (NASH), and Functional Constipation. For more information, visit gelesis.com, or connect with us on Twitter @GelesisInc.

Plenity® is indicated to aid weight management in adults with excess weight or obesity, a Body Mass Index (BMI) of 25–40 kg/m², when used in conjunction with diet and exercise.

Important Safety Information about Plenity

Rx Only. For the safe and proper use of Plenity or more information, talk to a healthcare professional, read the Patient Instructions for Use, or call 1-844-PLENITY.

Certain statements, estimates, targets and projections in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws. The words “anticipate,” “believe,” continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward-looking. Forward-looking statements include, but are not limited to, statements regarding Gelesis’ or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including statements regarding projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions. Such forward-looking statements are based on the information currently available to Gelesis and on assumptions Gelesis has made and, as a result, such statements are subject to risks and uncertainties. Gelesis intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act, and Gelesis makes this statement for purposes of complying with those safe harbor provisions. Forward-looking statements speak only as of the date

they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Gelesis assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Gelesis gives no assurance that any expectations set forth in this press release will be achieved. Various risks and uncertainties (some of which are beyond Gelesis’ control) or other factors could cause actual future results, performance or events to differ materially from those described herein. Some of the factors that may impact future results and performance include, without limitation: (i) the size, demand and growth potential of the markets for Plenity® and Gelesis’ other product candidates and Gelesis’ ability to serve those markets; (ii) the degree of market acceptance and adoption of Gelesis’ products; (iii) Gelesis’ ability to develop innovative products and compete with other companies engaged in the weight loss industry; (iv) Gelesis’ ability to finance and complete successfully the commercial launch of Plenity® and its growth plans, including new possible indications and the clinical data from ongoing and future studies about liver and other diseases; (v) failure to realize the anticipated benefits of the business combination between Gelesis and Capstar Special Purpose Acquisition Corp. (“Capstar”), including as a result of a delay or difficulty in integrating the businesses of Capstar and Gelesis; (vi) the ability of Gelesis to issue equity or equity-linked securities or obtain debt financing in the future; (vii) Gelesis’ ability to continue as a going concern; (viii) the outcome of any legal proceedings instituted against Capstar, Gelesis, or others in connection with the business combination; (ix) the ability of Gelesis to maintain its listing on the New York Stock Exchange; (x) the risk that the business combination disrupts the plans and operations of Gelesis as a result of Gelesis being a publicly listed issuer; (xi) the regulatory pathway for Gelesis’ products and responses from regulators, including the FDA and similar regulators outside of the United States; (xii) the ability of Gelesis to grow and manage growth profitably, maintain relationships with customers and suppliers and retain Gelesis’ management and key employees; (xiii) costs related to the business combination, including costs associated with Gelesis being a publicly listed issuer; (xiv) changes in applicable laws or regulations; (xv) the possibility that Gelesis may be adversely affected by other economic, business, regulatory and/or competitive factors; (xvi) Gelesis’ estimates of expenses and profitability; (xvii) ongoing regulatory requirements, (xviii) any competing products or technologies that may emerge, (xix) the volatility of the telehealth market in general, or insufficient patient demand; (xx) the ability of Gelesis to defend its intellectual property and satisfy regulatory requirements; (xxi) the impact of the COVID 19 pandemic on Gelesis’ business; (xxii) the limited operating history of Gelesis; (xxiii) the potential impact of inflation on Gelesis’ operating expenses and costs of goods; and (xxiv) other important factors discussed in the “Risk Factors” section of Gelesis’ most recent Annual Report on Form 10-K, and in other filings that Gelesis makes with the Securities and Exchange Commission. These filings address other important risks and uncertainties that could cause actual results and events to differ materially from those contained in the forward-looking statements.

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