MANUFACTURE AND QUALITY CONTROL. 12.1. PHARMA shall manufacture or have manufactured all the Products and Lamps supplied to INC hereunder in accordance with all of the following: a. all product specifications and requirements within the Regulatory Approval; b. all applicable Good Manufacturing Practices (GMP); and c. all other applicable laws and regulations in connection with the manufacture, shipment, handling and distribution of the Products including, but not limited to, the Regulatory Approvals. 12.2. PHARMA shall perform QC testing and thereafter provide INC with the Certificate of GMP Compliance and the Certificate of Analysis confirming that the Products have met all current and applicable Product specifications and requirements set forth in this Agreement or as modified according to future amendments of the regulatory approval. 12.3. PHARMA will quality check all Lamps according to the Specifications prior to shipment. INC will check the Lamps promptly after arrival for any obvious damages. The lamp will be covered by the standard 2-year warranty for manufacturing defects. 12.4. INC may reject, within [***] working days of actual receipt, any or all of a shipment of Product and, within [***] working days of actual receipt, any or all of a shipment of Lamps that INC reasonably determines does not conform to the Product specifications and PHARMA shall replace any non-conforming Products at PHARMA’s expense. 12.5. Upon justified request by INC, PHARMA shall send a new shipment of the Products or Lamps to INC (of similar quantity as the batch of the Products and at the selling price and on such other terms and conditions as set forth herein) so as to enable INC to continue to supply the Products and Lamps to its customers. In the event that the Parties agree, or in the event that any of the Products or Lamps is verified as defective or not in conformity with the Products specifications, replacement shall be made by PHARMA as expeditiously as reasonably possible. 12.6. INC shall not be obligated to pay for any shipment (or partial shipment) of the Products or Lamps which does not conform to the Product specifications as in place and amended at the time of shipment. If INC notifies PHARMA that any or all of a shipment of the Products or Lamps do not conform to the specifications, then payment for such shipment shall be delayed until resolution of the discrepancy by consultation between the Parties. Any units of the Products or Lamps that are determined by agreement between the Parties not to conform to the relevant Product or Lamp unit specifications shall, at PHARMA’s option and at PHARMA’s expense, either be returned to PHARMA or destroyed by INC in accordance with PHARMA’s instructions. 12.7. In the case that PHARMA fails to deliver Products or Lamps to INC in conformance with this Section 12 and the Quality Assurance Agreement, and if PHARMA fails to remedy its failure in accordance with this Agreement, then the Parties herewith agree that INC will have the right to organize manufacturing on its own, and step into the contracts with PHARMA’s manufacturers, such that INC will replace PHARMA as a party to these contracts with regards to the manufacture of Products and Lamps for the Territory only. If INC elects to pursue this option, i) PHARMA must use its best efforts to assist with the transferring of said manufacturing contracts to INC and otherwise establishing INC as the new manufacturer of the Products, without delay and at its own cost, and ii) no transfer price will be paid to PHARMA thereafter for products or lamps that are manufactured by third parties.
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Sources: License and Supply Agreement (Biofrontera Inc.), License and Supply Agreement (Biofrontera Inc.)
MANUFACTURE AND QUALITY CONTROL. 12.1. PHARMA shall manufacture or have manufactured all the Products and Lamps supplied to INC hereunder in accordance with all of the following:
a. all product specifications and requirements within the Regulatory Approval;
b. all applicable Good Manufacturing Practices (GMP); and
c. all other applicable laws and regulations in connection with the manufacture, shipment, handling and distribution of the Products including, but not limited to, the Regulatory Approvals.
12.2. PHARMA shall perform QC testing and thereafter provide INC with the Certificate of GMP Compliance and the Certificate of Analysis confirming that the Products have met all current and applicable Product specifications and requirements set forth in this Agreement or as modified according to future amendments of the regulatory approval.
12.3. PHARMA will quality check all Lamps according to the Specifications prior to shipment. INC will check the Lamps promptly after arrival for any obvious damages. The lamp will be covered by the standard 2-year warranty for manufacturing defects.
12.4. INC may reject, within [***] ten (10) working days of actual receipt, any or all of a shipment of Product and, within [***] twenty (20) working days of actual receipt, any or all of a shipment of Lamps that INC reasonably determines does not conform to the Product specifications and PHARMA shall replace any non-conforming Products at PHARMA’s expense.
12.5. Upon justified request by INC, PHARMA shall send a new shipment of the Products or Lamps to INC (of similar quantity as the batch of the Products and at the selling price and on such other terms and conditions as set forth herein) so as to enable INC to continue to supply the Products and Lamps to its customers. In the event that the Parties agree, or in the event that any of the Products or Lamps is verified as defective or not in conformity with the Products specifications, replacement shall be made by PHARMA as expeditiously as reasonably possible.
12.6. INC shall not be obligated to pay for any shipment (or partial shipment) of the Products or Lamps which does not conform to the Product specifications as in place and amended at the time of shipment. If INC notifies PHARMA that any or all of a shipment of the Products or Lamps do not conform to the specifications, then payment for such shipment shall be delayed until resolution of the discrepancy by consultation between the Parties. Any units of the Products or Lamps that are determined by agreement between the Parties not to conform to the relevant Product or Lamp unit specifications shall, at PHARMA’s option and at PHARMA’s expense, either be returned to PHARMA or destroyed by INC in accordance with PHARMA’s instructions.
12.7. In the case that PHARMA fails to deliver Products or Lamps to INC in conformance with this Section 12 and the Quality Assurance Agreement, and if PHARMA fails to remedy its failure in accordance with this Agreement, then the Parties herewith agree that INC will have the right to organize manufacturing on its own, and step into the contracts with PHARMA’s manufacturers, such that INC will replace PHARMA as a party to these contracts with regards to the manufacture of Products and Lamps for the Territory only. If INC elects to pursue this option, i) PHARMA must use its best efforts to assist with the transferring of said manufacturing contracts to INC and otherwise establishing INC as the new manufacturer of the Products, without delay and at its own cost, and ii) no transfer price will be paid to PHARMA thereafter for products or lamps that are manufactured by third parties.
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