without limitation to [clause (xvi)], review and approve any material submission to, or any material agreement with or material commitment made to, a Regulatory Authority with respect to a Product, such as any NDA or MAA, or any submission, agreement or commitment with respect to Product labeling, any risk management plans, any Required Phase 4 Clinical Trial or other post-approval commitment for such Product;

“Label”, “Labeled” or “Labeling” means, when used as a noun, all labels and other written, printed or graphic matter upon # the Product or any container or wrapper utilized with such Product, or # any written material accompanying such Product, including, without limitation, package inserts, in each case that is subject to FDA review. When used as verb, Label means to affix or insert a Label.

AYTU shall be responsible for storing Products under appropriate conditions as specified in Labeling and for distribution in full compliance with the applicable cGMP standards, the Regulatory Approvals, the FD&C Act and Applicable Law. AYTU shall have received and shall be in current compliance with all approvals of any Governmental Authority as may be required to Market a Product pursuant to this Agreement.

The Bottler shall indemnify and hold harmless the Company, CCJC, their affiliates and their respective officers, directors and employees from and against all costs, expenses, damages, claims, obligations and liabilities whatsoever arising from facts or circumstances not attributable to the Company or CCJC including, but not limited to, all costs and expenses incurred in settling or compromising any of the same arising out of the preparation, packaging, distribution, sale or promotion of the Beverage by the Bottler, including, but not limited to, all costs arising out of the acts or defaults, whether negligent or not, of the Bottler, any third party to whom the Bottler may have delegated or sub-contracted the preparation and packaging of the Beverages, and any distributor, supplier and /or wholesaler.

“First Commercial Sale” shall mean, with respect to any Licensed Product in any country of the Territory, the first sale in such country for use or consumption by the end user of such Licensed Product to a Third Party by Licensee or its Affiliates or their Sublicensee after Regulatory Approval (and, where applicable, # pricing or reimbursement approval in such country and # labeling approval) has been granted by the applicable Regulatory Authority.

4.2Records. Throughout the Term of this Agreement, and for a period of six (6) years thereafter, Supplier shall, at its own cost and expense, keep, or cause to be kept by Third Parties, complete, accurate and authentic accounts, notes, data, records and other documentation pertaining to the Quality Control Procedures and the manufacture, processing, testing, labeling, and storage of the Supply Deliverables, including without limitation master production and control records.

“Clinical Studies” means Phase 0, Phase 1, Phase 2, Phase 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

“Product Labeling” means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, # the Regulatory Authority-approved full prescribing Information for such Licensed Product for such country or other jurisdiction, including any required patient Information, and # all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Licensed Product in such country or other jurisdiction.

Damage Claims. Graphite shall make damaged Product and associated packaging materials available for inspection and shall comply with the reasonable requirements of any insurance policy covering the Product. WuXi ATU shall offer Graphite reasonable assistance in Graphite’s claims against the shipping company for damages arising out of the transportation of Product.

Cost of Corrective Action. Except as otherwise specified in this Contract, all corrective actions to be taken by the Contractor including under this [Article 12] shall be at the Contractor´s cost and expense, including all costs arising from charges for packaging, shipping, insurance, taxes, and other matters associated with corrective actions.