Common use of Responsibility for the Products Clause in Contracts

Responsibility for the Products. (a) After the Closing and in the Territory, NOVAVAX shall assume all regulatory responsibilities permitted by applicable laws and regulations to be assumed by NOVAVAX, reporting and otherwise, in connection with the Products and the NDA including, but not limited to, responsibility for reporting any adverse drug experiences in connection with the Products, and responsibility for compliance with all laws and regulations, including the Prescription Drug Marketing Act of 1987, as the same may be amended from time to time. (b) NOVAVAX and its Affiliates agree promptly to submit to KING all adverse drug experience information or customer complaints brought to the attention of NOVAVAX or its Affiliates in respect of the Products, as well as any material events and matters concerning or affecting the safety or efficacy of the Products. KING and its Affiliates agree promptly to submit to NOVAVAX all adverse drug experience information or customer complaints brought to the attention of KING or its Affiliates in respect of the Products, as well as any material events and matters concerning or affecting the safety or efficacy of the Products. NOVAVAX and KING agree to determine promptly after Closing a mutually agreeable reporting procedure to communicate the information required by this Section 3.02(b). (c) After the Closing, NOVAVAX shall assume all responsibility for any and all FDA fee obligations for holders or owners of approved New Drug Applications and approved, marketed prescription drug products relating to the Products, including, but not limited to, those defined under the Prescription Drug User Fee Act of 1992, as the same may be amended from time to time. (d) Promptly after the Closing, NOVAVAX shall submit a "Changes Being Effected in Thirty Days" filing ("CBE 30") with the FDA to request FDA permission for KING to manufacture and distribute the Products at its facility in Bristol, Tennessee, or at the facility of one of its Affiliates. KING shall provide NOVAVAX with all information necessary to submit such CBE 30. (e) Promptly after the Closing, NOVAVAX shall take all actions necessary or required under applicable laws, rules, and regulations, to reflect that the Assets are owned by NOVAVAX and that NOVAVAX has responsibility therefor. (f) After the Closing, KING shall direct all complaints or inquiries concerning the Products in the Territory to NOVAVAX to the attention of Medical Affairs Department, at facsimile number (301) 000-0000.

Responsibility for the Products. (a) After the Closing and in the TerritoryClosing, NOVAVAX PHARMELLE shall assume all regulatory responsibilities permitted or required by applicable laws and regulations to be assumed by NOVAVAXPHARMELLE, reporting and otherwise, in connection with the Assets, Products and the NDA includingNDA, including but not limited to, to responsibility for reporting any adverse drug experiences in connection with the Products, and responsibility for compliance with all laws and regulations, including the Prescription Drug Marketing Act of 1987, as the same may be amended from time to time. (b) For a period of one year after the Closing, PHARMELLE and its Affiliates agree promptly to submit to NOVAVAX all adverse drug experience information or customer complaints brought to the attention of PHARMELLE or its Affiliates in respect of the Products, as well as any material events and matters concerning or affecting the safety or efficacy of the Products. For a period of one year after the Closing, NOVAVAX and its Affiliates agree promptly to submit to KING PHARMELLE all adverse drug experience information or customer complaints brought to the attention of NOVAVAX or its Affiliates in respect of the Products, as well as any material events and matters concerning or affecting the safety or efficacy of the Products. KING and its Affiliates agree promptly to submit to NOVAVAX all adverse drug experience information or customer complaints brought to the attention of KING or its Affiliates in respect of the Products, as well as any material events and matters concerning or affecting the safety or efficacy of the Products. NOVAVAX and KING PHARMELLE agree to determine promptly after Closing a mutually agreeable reporting procedure to communicate the information required by this Section 3.02(b). (c) After the Closing, NOVAVAX PHARMELLE shall assume all responsibility for any and all FDA fee obligations for holders or owners of approved New Drug Applications new drug applications and approved, marketed prescription drug products relating to the Products, including, but not limited to, those defined under the Prescription Drug User Fee Act of 1992, as the same may be amended from time to time. (d) Promptly after the Closing, NOVAVAX PHARMELLE shall submit a "all “Changes Being Effected in Thirty Days" filing ” ("“CBE 30"”) filings with the FDA to request FDA permission for KING to manufacture and distribute as may be required in connection with the Products at its facility in Bristol, Tennessee, or at the facility of one of its Affiliatestransactions contemplated by this Agreement. KING NOVAVAX shall provide NOVAVAX PHARMELLE with all information applicable to NOVAVAX that is necessary to submit include in such CBE 3030 filings promptly upon PHARMELLE’s request. (e) Promptly after the Closing, NOVAVAX PHARMELLE shall take all actions necessary or required under applicable laws, rules, rules and regulations, regulations to reflect that the Assets are owned by NOVAVAX PHARMELLE and that NOVAVAX PHARMELLE has responsibility therefor. (f) After the Closing, KING NOVAVAX shall direct all complaints or inquiries concerning the Products in the Territory to NOVAVAX to the attention of Medical Affairs Department, PHARMELLE at facsimile number (301000) 000-0000.

Responsibility for the Products. (a) After the Closing and in the TerritoryClosing, NOVAVAX Monarch shall assume all regulatory responsibilities permitted by applicable laws and regulations to be assumed by NOVAVAXMonarch, reporting and otherwise, in connection with the Products Products, the NDAs, and the NDA INDs including, but not limited to, responsibility for reporting any adverse drug experiences in connection with the Products, and responsibility for compliance with all laws and regulations, including the Prescription Drug Marketing Act of 1987, as the same may be amended from time to time. (b) NOVAVAX Monarch and its Affiliates agree promptly to submit to KING GW all adverse drug experience information or customer complaints brought to the attention of NOVAVAX Monarch or its Affiliates in respect of the Products, as well as any material events and matters concerning or affecting the safety or efficacy of the Products. KING GW and its Affiliates agree promptly to submit to NOVAVAX Monarch all adverse drug experience information or customer complaints brought to the attention of KING GW or its Affiliates in respect of the Products, as well as any material events and matters concerning or affecting the safety or efficacy of the Products. NOVAVAX Monarch and KING GW agree to determine promptly after Closing a mutually agreeable reporting procedure to communicate the information required by this Section 3.02(b). (c) After the Closing, NOVAVAX Monarch shall assume all responsibility for any and all FDA fee obligations for holders or owners of approved New Drug Applications and approved, marketed prescription drug products relating to the Products, including, but not limited to, those defined under the Prescription Drug User Fee Act of 1992, as the same may be amended from time to time. (d) Promptly after the Closing, NOVAVAX shall submit a "Changes Being Effected in Thirty Days" filing ("CBE 30") with the FDA to request FDA permission for KING to manufacture and distribute the Products at its facility in Bristol, Tennessee, or at the facility of one of its Affiliates. KING shall provide NOVAVAX with all information necessary to submit such CBE 30. (e) Promptly after the Closing, NOVAVAX Monarch shall take all actions necessary or required under applicable laws, rules, and regulations, to reflect that the Assets are owned by NOVAVAX Monarch and that NOVAVAX Monarch has responsibility therefor. (fe) After the Closing, KING GW shall direct all complaints or inquiries concerning the Products in the Territory to NOVAVAX Monarch to the attention of Medical Affairs Department, at facsimile number (301) 423-000-0000.

Responsibility for the Products. (a) After the Closing and in the TerritoryClosing, NOVAVAX Monarch shall assume all regulatory responsibilities permitted by applicable laws and regulations to be assumed by NOVAVAXMonarch, reporting and otherwise, in connection with the Products and the NDA NDAs including, but not limited to, responsibility for reporting any adverse drug experiences in connection with the Products, and responsibility for compliance with all laws and regulations, including the Prescription Drug Marketing Act of 1987, as the same may be amended from time to time. (b) NOVAVAX Monarch and its Affiliates agree promptly to submit to KING GW all adverse drug experience information or customer complaints brought to the attention of NOVAVAX Monarch or its Affiliates in respect of the Products, as well as any material events and matters concerning or affecting the safety or efficacy of the Products. KING GW and its Affiliates agree promptly to submit to NOVAVAX Monarch all adverse drug experience information or customer complaints brought to the attention of KING GW or its Affiliates in respect of the Products, as well as any material events and matters concerning or affecting the safety or efficacy of the Products. NOVAVAX Monarch and KING GW agree to determine promptly after Closing a mutually agreeable reporting procedure to communicate the information required by this Section 3.02(b). (c) After the Closing, NOVAVAX Monarch shall assume all responsibility for any and all FDA fee obligations for holders or owners of approved New Drug Applications and approved, marketed prescription drug products relating to the Products, including, but not limited to, those defined under the Prescription Drug User Fee Act of 1992, as the same may be amended from time to time. (d) Promptly after the Closing, NOVAVAX shall submit a "Changes Being Effected in Thirty Days" filing ("CBE 30") with the FDA to request FDA permission for KING to manufacture and distribute the Products at its facility in Bristol, Tennessee, or at the facility of one of its Affiliates. KING shall provide NOVAVAX with all information necessary to submit such CBE 30. (e) Promptly after the Closing, NOVAVAX Monarch shall take all actions necessary or required under applicable laws, rules, and regulations, to reflect that the Assets are owned by NOVAVAX Monarch and that NOVAVAX Monarch has responsibility therefor. (fe) After the Closing, KING GW shall direct all complaints or inquiries concerning the Products in the Territory to NOVAVAX Monarch to the attention of Medical Affairs Department, at facsimile number (301) 423-000-0000.