AERIE definition
Examples of AERIE in a sentence
Within one (1) year of the projected approval date of the NDA for each Product identified on Appendix C, AERIE shall contact B&L to discuss extending the Expiration Date for up to 2 years following the Expiration Date, or such longer period as the parties may agree, on terms and conditions mutually agreed to by the parties hereto.
B&L shall provide AERIE, at no additional cost, with all regulatory support and documentation required by the FDA to support the NDA for the Product(s).
In the event that any undisputed invoice is not paid forty-five (45) days from the date of the invoice, AERIE agrees to pay a “late charge” on the unpaid delinquent balance at an interest rate of [***] per month, but in no event more than the maximum rate permitted by law.
Both B&L and AERIE will need to collaborate/agree on Service Level and on-time measurement procedures.
B&L shall supply AERIE such quantities of Product(s) ordered by AERIE pursuant to any Firm Order.
In the event of a termination by AERIE, AERIE shall, in cooperation with B&L, transfer Product manufacturing technology to a third party contract manufacturer.
This Agreement may be terminated at the option of B&L, upon [***] months prior written notice to AERIE, based on changes in B&L strategy or manufacturing capacity constraints; provided, however that such notice shall not to be given prior to the NDA approval(s) of Product(s).
If product volumes increase significantly and capital investment is required to meet the new demand, B&L and AERIE will mutually agree in a good faith the capital investment and payment terms and conditions for new equipment and validation activities.
In the event of any dispute between B&L and AERIE as to whether any of the Product conform to the warranties hereunder, a sample of the units in dispute shall be sent by AERIE and B&L to a testing laboratory mutually agreed to by B&L and AERIE whose findings will be binding on the parties except in cases of gross and manifest error.
B&L agrees to supply at its expense all of the raw materials (excluding the active ingredient, AR-13324 which will be supplied by AERIE), in accordance with the Specifications for the Product that are necessary to manufacture and supply the Product(s).