Products. No material Intellectual Property owned by a Borrower, Qualified Subsidiary or, to Borrowers’ knowledge, Platform Company or Product has been or is subject to any actual or, to the knowledge of any Borrower, threatened litigation, proceeding (including any proceeding in the United States Patent and Trademark Office or any corresponding foreign office or agency) or outstanding decree, order, judgment, settlement agreement or stipulation that restricts in any manner the use, transfer or licensing thereof by the owner thereof or that may affect the validity, use or enforceability thereof. There is no decree, order, judgment, agreement, stipulation, arbitral award or other provision entered into in connection with any litigation or proceeding that obligates any Borrower, Qualified Subsidiary or, to Borrowers’ knowledge, Platform Company to grant licenses or ownership interest in any future material Intellectual Property related to the operation or conduct of the business of any Borrower, Qualified Subsidiary or Platform Company or to any Products. No Borrower or, to Borrowers’ knowledge, Platform Company has received any written notice or claim, or, to the knowledge of any Borrower, oral notice or claim, challenging or questioning any Borrower’s, Qualified Subsidiary’s or Platform Company’s ownership in any material Intellectual Property (or written notice of any claim challenging or questioning the ownership in any licensed Intellectual Property of the owner thereof) or suggesting that any third party has any claim of [[Organization A:Organization]] or beneficial ownership with respect thereto nor, to any Borrower’s knowledge, is there a reasonable basis for any such claim. Neither any use by any Borrower, Qualified Subsidiary or, to Borrowers’ knowledge, by Platform Company, of its respective material Intellectual Property nor the production and sale of Products infringes in any material respect on the Intellectual Property or other rights of others.

[ * ] Products. [ * ] # in the event this Agreement is terminated with respect to [ * ] Product, such [ * ] Product; and/or # in the event this Agreement is terminated with respect to [ * ], such [ * ] Products containing such [ * ]), in each case in the Field [ * ] (such [ * ] and [ * ] Products, the “[ * ] Products”). [ * ] Products as follows:

Products. No material Intellectual Property owned by a Borrower, Qualified Subsidiary or, to Borrowers’ knowledge, Platform Company or Product has been or is subject to any actual or, to the knowledge of any Borrower, threatened litigation, proceeding (including any proceeding in the United States Patent and Trademark Office or any corresponding foreign office or agency) or outstanding decree, order, judgment, settlement agreement or stipulation that restricts in any manner the use, transfer or licensing thereof by the owner thereof or that may affect the validity, use or enforceability thereof. There is no decree, order, judgment, agreement, stipulation, arbitral award or other provision entered into in connection with

Products. A complete and accurate list of the Products, is set forth on the Perfection Certificate, as updated from time to time pursuant to the Compliance Certificate. The Loan Parties and their Subsidiaries hold all required Governmental Approvals material to the conduct of their business, and all such Governmental Approvals are in full force and effect. There are no proceedings in progress, pending or, to such Loan Party’s knowledge, threatened, that may result in revocation, cancellation, suspension, rescission or any adverse modification of any such Governmental Approval nor, to the best of the knowledge, information and belief of such Loan Party, after due inquiry, are there any facts upon which proceedings could reasonably be based which, in each case, that could reasonably be expected to result in a Material Adverse Effect. Without limitation of the foregoing:

Products. A complete and accurate list of the Products, is set forth on the Perfection Certificate, as updated from time to time pursuant to the Compliance Certificate. The Loan Parties and each of its Subsidiaries hold all required Governmental Approvals, a list of which is set forth on the Perfection Certificate, and all required Governmental Approvals are in full force and effect. There are no proceedings in progress, pending or, to such Loan Party’s knowledge, threatened in writing, that may result in revocation, cancellation, suspension, rescission or any adverse modification of any required Governmental Approval nor, to the knowledge, information and belief of such Loan Party, are there any facts upon which proceedings could reasonably be based. Without limitation of the foregoing:

Products. AzurRx shall be responsible at its sole expense for the Manufacture of each Product in the Field in the Territory.

Products. A complete and accurate list of the Products, is set forth on the Perfection Certificate, as updated from time to time pursuant to the Compliance Certificate. The Loan Parties and each of its Subsidiaries hold all material required Governmental Approvals, a list of which is set forth on the Perfection Certificate, and all such Governmental Approvals are in full force and effect. There are no proceedings in progress, pending or, to such Loan Party’s knowledge, threatened, that may result in revocation, cancellation, suspension, rescission or any adverse modification of any such material required Governmental Approval nor, to the best of the knowledge, information and belief of such Loan Party, after due inquiry, are there any facts upon which proceedings could reasonably be based. Without limitation of the foregoing:

Products. Alba represents and warrants to Ortho that all Product supplied in connection with this Agreement shall # conform to the Specifications for such Product, # comply with applicable law and regulations, # comply with the terms of this Agreement (including the Quality Agreement), and # be of merchantable quality, fit for the purpose intended by this Agreement and free from defects in design, material and workmanship. Alba further represents and warrants that it shall comply with, all current and future statutes, laws, ordinances and regulations, including, without limitation, those enforced by the United States Food and Drug Administration (including compliance with good manufacturing practices), the states and International Standards Organization Rules 9,000 et seq. Alba represents and warrants that it will hold all licenses, permits and similar governmental authorizations necessary or required for Alba to conduct its operations and business and manufacture Product throughout the Term. Alba represents and warrants that any Products that have been stored until delivery or Raw Materials stored until use, shall have been stored under appropriate and secure conditions and in accordance with cGMPs. Alba represents and warrants that Product supplied in connection with this Agreement will not contain any Raw Materials that have not been used or stored in accordance with the Specifications, any other quality assurance standards instructed by Ortho or any supplier of Raw Materials and all applicable governmental standards. Alba represents and warrants that it will maintain all equipment used in connection with the manufacturing, packaging and supplying of Product hereunder in good working condition and in accordance with all applicable laws, rules and regulations.

During the Opt-In Term, the Parties will share all Development Costs for Development activities conducted under the Global Development Plan for the Shared Products and all Launch Costs for the Shared Products, in each case in accordance with the applicable Sharing Percentages and in accordance with Section 11.3.1.

New Products. During the term of this Agreement, neither Party shall, and shall not permit its Affiliates to, nor grant any rights to any Third Party to, directly or indirectly, Commercialize, or Develop any New Product for Commercialization in the Territory, except as permitted in accordance with this [Section 3.4]. If Bioeq wishes to Develop a New Product for Commercialization in the Territory, it shall notify Licensee thereof in writing. Upon such notification, the Parties shall discuss in good faith whether and on what terms such New Product shall he Developed be Bioeq under this Agreement and become part of the Licensed Products licensed to Licensee in the Territory hereunder. If the Parties agree that such New Product shall be Developed and become a Licensed Product under this Agreement, the Parties shall amend this Agreement to reflect their agreement in relation to such New Product (including the Parties’ respective share of the Development costs for the Development of such New Product), such New Product shall become part of the Licensed Products, and the restrictions in this [Section 3.4] shall cease to apply to such New Product.