Manufacturing Fees. The initial Manufacturing Fees to be paid by COMPANY to DPT are listed in Schedule A. The parties hereto agree that the Manufacturing Fees set out in Schedule A shall be re negotiated, in good faith, at the beginning of each calendar year. If the parties are unable to agree on a re-negotiated price at least thirty (30) days prior to the start of a new twelve (12) month period, then this Agreement, effective the first day of January of the new twelve (12) month period, shall continue in force with prices being adjusted to reflect the change in the most recently published monthly “Producer Price Index for Pharmaceutical Preparation Manufacturing”, issued by the Bureau of Labor Statistics, US Department of Labor (“PPI”), or comparable successor index, in July of the preceding year as compared to the same month of the year prior thereto until such time as to when price negotiation can be completed. In addition, Manufacturing Fees are based on annual volumes for Products. DPT reserves the right to re-evaluate Manufacturing Fees at the beginning of the second calendar year (and each calendar year thereafter) in the event that actual volumes differ from those volumes listed in Schedule A. by more than ten percent (10%). Prices for new Products or new Product sizes, new batch sizes or product configuration changes not initially included in Schedule A, shall be negotiated and DPT and COMPANY shall arrive at a mutual agreement with respect to prices at the time said new Products or new Product sizes are added to Schedule A. If a negotiated price cannot be agreed upon, final pricing for any of the above will be settled in accordance with paragraph 12.6 (b) below.
Appears in 4 contracts
Samples: Manufacturing Agreement (Insys Therapeutics, Inc.), Manufacturing Agreement (Insys Therapeutics, Inc.), Manufacturing Agreement (Insys Therapeutics, Inc.)
Manufacturing Fees. The initial Manufacturing Fees to be paid by COMPANY to DPT are listed set forth in Schedule A. The parties C. DPT reserves the right to raise the prices set forth in any Project Protocol if change(s) to Applicable Law, including, but not limited to GMP or changes made under Article 6, increase the cost of manufacturing of the Product or of any other activities contemplated under this Agreement. In addition, the Parties hereto agree that increases to the Manufacturing Fees set out forth in Schedule A C shall be re negotiated, in good faith, at the beginning of each calendar year[***]. If the parties Parties are unable to agree on a re-negotiated price at least thirty [***] (30[***]) days prior to the start of a new twelve (12) month period[***], then this Agreement, effective the first day of January of the new twelve (12) month period[***], shall continue in full force and effect with prices being adjusted to reflect the change in the most recently published monthly “Producer Price Index for Pharmaceutical Preparation Manufacturing”Manufacturing PCU 325412, issued by the Bureau of Labor Statistics, US Department of Labor (“PPI”), or comparable successor index, in July of the preceding year as compared to the same month of the year prior thereto until such time as to when price negotiation can be completed. (For example: If in July 2014 the PPI is 548.3 and then the previous year 2013 reflects a PPI of 530.5 the difference would be 17.8. The 17.8 would be divided by 530.5 resulting in a PPI increase of 3.4% in year 2015). In addition, Manufacturing Fees are based on annual volumes for ProductsProduct. DPT reserves the right to re-evaluate increase the Manufacturing Fees at the beginning of the second calendar year [***] (and each calendar year thereafter[***]) in the event that actual volumes differ from are less than those volumes listed in Schedule A. C by more than ten [***] percent (10[***]%). Prices for new Products Product or new Product sizes, new batch sizes or product Product configuration changes not initially included in Schedule AC, shall be negotiated and DPT and COMPANY shall arrive at a mutual agreement with respect to prices at the time said new Products Product or new Product sizes are added to Schedule A. If B. Costs associated with establishing, testing or manufacturing components or new materials such as reference standards, reagents, art charges, die costs, molding or tooling costs, plate costs, and packing equipment change parts will be invoiced to COMPANY at DPT’s cost on a negotiated price cannot be agreed upon, final pricing net [***] ([***]) basis and COMPANY agrees to reimburse DPT for any of the above will be settled in accordance with paragraph 12.6 (b) belowsuch authorized expenditures made on COMPANY’s behalf.
Appears in 1 contract
Samples: Supply and Manufacturing Agreement (Arcutis Biotherapeutics, Inc.)