Common use of Regulatory Communications Clause in Contracts

Regulatory Communications. A. Each party may communicate with any governmental agency, including, but not limited to, governmental agencies responsible for granting regulatory approval for the Products, regarding such Products if in the opinion of that party’s counsel, such communication is necessary to comply with the terms of this Agreement or the requirements of any Applicable Law; provided, however, that unless in the reasonable opinion of its counsel there is a legal prohibition against doing so, such party will permit the other party to review and take part in any communications with the applicable agency, and to receive copies of all such communications from that agency. B. QPharma will notify TXMD promptly if QPharma receives any warning letters from or on behalf of a governmental agency directly related to the Product or systems utilized in Processing the Product including, without limitation, any Form FDA-483. QPharma will provide TXMD copies of any written communication from a governmental agency relating to a TXMD Product within [***] ([***]) Swedish business days of its receipt. C. QPharma will promptly notify TXMD upon receipt of a notice from a Regulatory Authority for an inspection of any Facility where the Processing is being performed due to an issue related to the Product or a system used in the performance of such services, or, in the event of an unannounced inspection, QPharma will provide such prior notice as is possible and permissible. If not prohibited by the Regulatory Authority, TXMD will have the right to be present at the Facility and participate in and any wrap-up meeting with such Regulatory Authority as it applies to the Product. If QPharma receives any request by a Regulatory Authority with respect to the Product, including, but not limited to, a notice of deficiency or FDA-483 that requires a written response regarding TXMD-supplied Materials, project, or protocol, QPharma will provide a copy to TXMD of the deficiency notice within [***] ([***]) [***] of QPharma’s receipt of the notice. QPharma will provide TXMD a draft of the response prior to the response being submitted to the Regulatory Authority so as to provide TXMD with reasonable time to review and comment on the response, which comments QPharma, in good faith, will consider incorporating into the response.

Regulatory Communications. A. Each party may communicate with any governmental agency, including, but not limited to, governmental agencies responsible for granting regulatory approval for the Products, regarding such Products if in the opinion of that party’s counsel, such communication is necessary to comply with the terms of this Agreement or the requirements of any Applicable Law; provided, however, that unless in the reasonable opinion of its counsel there is a legal prohibition against doing so, such party will permit the other party to review and take part in any communications with the applicable agency, and to receive copies of all such communications from that agency. B. QPharma Catalent will notify TXMD Client promptly if QPharma Catalent receives any warning letters from or on behalf of a governmental agency directly related to the Product or systems utilized in Processing the Product including, without limitation, any Form FDA-483. QPharma Catalent will provide TXMD Client copies of any written communication from a governmental agency relating to a TXMD Client Product within [***] three ([***]3) Swedish business days of its receipt. C. QPharma Catalent will promptly notify TXMD Client upon receipt of a notice from a Regulatory Authority for an inspection of any Facility where the Processing is being performed due to an issue related to the Product or a system used in the performance of such services, or, in the event of an unannounced inspection, QPharma Catalent will provide such prior notice as is possible and permissible. If not prohibited by the Regulatory Authority, TXMD Client will have the right to be present at the Facility and participate in during such audit or inspection and any wrap-up meeting with such Regulatory Authority as it applies to the Product. If QPharma Catalent receives any request by a Regulatory Authority with respect to the Product, including, but not limited to, a notice of deficiency or FDA-483 that requires a written response regarding TXMDClient-supplied Materials, project, or protocol, QPharma Catalent will provide a copy to TXMD Client of the deficiency notice within [***] forty-eight ([***]48) [***] hours of QPharmaCatalent’s receipt of the notice. QPharma Catalent will provide TXMD Client a draft of the response prior to the response being submitted to the Regulatory Authority so as to provide TXMD Client with reasonable time to review and comment on the response, which comments QPharmaCatalent, in good faith, will consider incorporating into the response.

Regulatory Communications. A. Each party may communicate with any governmental agency, including, but not limited to, governmental agencies responsible for granting regulatory approval for the Products, regarding such Products if in the opinion of that party’s counsel, such communication is necessary to comply with the terms of this Agreement or the requirements of any Applicable Law; provided, however, that unless in the reasonable opinion of its counsel there is a legal prohibition against doing so, such party will permit the other party to review and take part in any communications with the applicable agency, and to receive copies of all such communications from that agency. B. QPharma Catalent will notify TXMD Client promptly if QPharma Catalent receives any warning letters from or on behalf of a governmental agency directly related to the Product or systems utilized in Processing the Product including, without limitation, any Form FDA-483. QPharma Catalent will provide TXMD Client copies of any written communication from a governmental agency relating to a TXMD Client Product within [***] three ([***]3) Swedish business days of its receipt. C. QPharma Catalent will promptly notify TXMD Client upon receipt of a notice from a Regulatory Authority for an inspection of any Facility where the Processing is being performed due to an issue related to the Product or a system used in the performance of such services, or, in the event of an unannounced inspection, QPharma Catalent will provide such prior notice as is possible and permissible. If not prohibited by the Regulatory Authority, TXMD Client will have the right to be present at the Facility and participate in during such audit or inspection and any wrap-up meeting with such Regulatory Authority as it applies to the Product. If QPharma Catalent receives any request by a Regulatory Authority with respect to the Product, including, but not limited to, a notice of deficiency or FDA-483 that requires a written response regarding TXMDClient-supplied Materials, project, or protocol, QPharma Catalent will provide a copy to TXMD Client of the deficiency notice within [***] forty-eight ([***]48) [***] hours of QPharmaCatalent’s receipt of the notice. QPharma Catalent will provide TXMD Client a draft of the response prior to the response being submitted to the Regulatory Authority so as to provide TXMD Client with reasonable time to review and comment on the response, which comments QPharmaCatalent, in good faith, will consider incorporating into the response.. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED AS [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.EXECUTION VERSION

Regulatory Communications. A. Each party may communicate with any governmental agency, including, but not limited to, governmental agencies responsible for granting regulatory approval for the Products, regarding such Products if in the opinion of that party’s counsel, such communication is necessary to comply with the terms of this Agreement or the requirements of any Applicable Law; provided, however, that unless in the reasonable opinion of its counsel there is a legal prohibition against doing so, such party will permit the other party to review and take part in any communications with the applicable agency, and to receive copies of all such communications from that agency. B. QPharma Catalent will notify TXMD Client promptly if QPharma Catalent receives any warning letters from or on behalf of a governmental agency directly related to the Product or systems utilized in Processing the Product including, without limitation, any Form FDA-483. QPharma Catalent will provide TXMD Client copies of any written communication from a governmental agency relating to a TXMD Client Product within [***] three ([***]3) Swedish business days of its receipt. C. QPharma Catalent will promptly notify TXMD Client upon receipt of a notice from a Regulatory Authority for an inspection of any Facility where the Processing is being performed due to an issue related to the Product or a system used in the performance of such services, or, in the event of an unannounced inspection, QPharma Catalent will provide such prior notice as is possible and permissible. If not prohibited by the Regulatory Authority, TXMD Client will have the right to be present at the Facility and participate in during such audit or inspection and any wrap-up meeting with such Regulatory Authority as it applies to the Product. If QPharma Catalent receives any request by a Regulatory Authority with respect to the Product, including, but not limited to, a notice of deficiency or FDA-483 that requires a written response regarding TXMDClient-supplied Materials, project, or protocol, QPharma Catalent will provide a copy to TXMD Client of the deficiency notice within [***] forty-eight ([***]48) [***] hours of QPharmaCatalent’s receipt of the notice. QPharma Catalent will provide TXMD Client a draft of the response prior to the response being submitted to the Regulatory Authority so as to provide TXMD Client with reasonable time to review and comment on the response, which comments QPharmaCatalent, in good faith, will consider incorporating into the response.. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED AS [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. EXECUTION VERSION