Common use of Regulatory Responsibilities Clause in Contracts

Regulatory Responsibilities. (a) From and after the date hereof, Distributor shall assume (subject to Section 6(f) and Section 7(b)) at Distributor’s expense all responsibilities for the PMA application and program, and for other similar Territory regulatory approvals, for the pre-filled saline Breast Implant. Additionally, Distributor shall assume general management responsibilities for the explant investigation program. (b) Supplier agrees to conduct at its expense any additional or revised pre-clinical testing required for the PMA application. Supplier will be responsible for mechanical or other testing to be performed at Supplier’s location and all manufacturing, process and production record, report and compliance preparation and maintenance. Supplier agrees immediately after the date hereof to provide access to Distributor to all records (including all past PMA-related records and all past and future manufacturing, process and production records), data, information, reports, clinical programs and consultants requested by Distributor to complete the PMA submission and subsequent FDA requests and to provide at its own expense all additional assistance requested by Distributor in connection with the PMA application, other regulatory applications in the Territory and future management and maintenance of marketing clearances in the Territory. Supplier shall notify Distributor immediately should Supplier become aware of any defect or condition which may render any of the Products in violation of the United States Food, Drug and Cosmetic Act, FDA regulations, other Territory regulations or which in any way alters the specification and quality of the Products. (c) For the purpose of maximizing the likelihood of FDA GMP approval and clearance, Supplier agrees to allow an inspector of Distributor’s selection to inspect Supplier’s facilities, processes, operations and records prior to the FDA’s GMP inspection of Supplier’s facilities. Supplier further agrees promptly to implement the recommendations the inspector reasonably makes as necessary or appropriate for the purpose of obtaining FDA GMP approval and clearance. In addition, Supplier agrees to permit one or more representatives of Distributor or other experts to participate directly in cooperation with Supplier in the preparation of PMA application modules. (d) All Territory regulatory approvals (including the PMA application) shall be applied for, issued and registered in Distributor’s name. Commencing immediately, the ownership of the PMA application (and related applications and PMA application work in process) for Supplier’s pre-filled saline breast implant will be transferred to Distributor. For avoidance of doubt, Distributor will own in its own name the PMA and related marketing clearance once issued.

Regulatory Responsibilities. (a) 5.6.1 Promptly following the Closing Date, but in any event by the time Buyer accepts transfer of rights to the BLA, Buyer shall obtain its own NDC and shall have in place, as soon as reasonably practicable, all resources such that sales can be accomplished under the NDC of Buyer. Except as required by a Party to comply with applicable Law or as contemplated in any Ancillary Agreement, Buyer, with respect to the Territory, from and after the Closing, shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals, and for conducting communications with Governmental Authorities of competent jurisdiction, for the Product. Without limitation of the foregoing, within such periods required by applicable Law following the Closing, Buyer shall obtain, with respect to the Territory, such Regulatory Approvals as are necessary for Buyer’s own Product labeling and shall comply with such Regulatory Approvals upon receipt thereof. 5.6.2 No later than March 31, 2015, Seller shall transfer and deliver to Buyer the Product’s global safety database in electronic format, together with information relating to the collection and reporting of all Adverse Events to FDA as required by FDA regarding the Product prior to the Closing. Prior to such date, Seller shall have all responsibility for required reporting of Adverse Events for the Product in the Territory. On and after such date, Buyer shall have all responsibility for required reporting of Adverse Events for the Product. 5.6.3 Buyer acknowledges and agrees that Seller currently supplies Product for clinical use in the Territory in connection with the Compassionate Use/Named Patient Program and U.S. Investigator-Sponsored trials. From and after the date hereofClosing Date, Distributor Buyer shall assume (subject use its reasonable best efforts to Section 6(f) and Section 7(b)) at Distributorcontinue to provide, substantially consistent with Seller’s expense all responsibilities current practice, the Product for the PMA application and program, and for other similar Territory regulatory approvals, for the pre-filled saline Breast Implant. Additionally, Distributor shall assume general management responsibilities for the explant investigation program. (b) Supplier agrees to conduct at its expense any additional or revised pre-clinical testing required for the PMA application. Supplier will be responsible for mechanical or other testing to be performed at Supplier’s location and all manufacturing, process and production record, report and compliance preparation and maintenance. Supplier agrees immediately after the date hereof to provide access to Distributor to all records (including all past PMA-related records and all past and future manufacturing, process and production records), data, information, reports, clinical programs and consultants requested by Distributor to complete the PMA submission and subsequent FDA requests and to provide at its own expense all additional assistance requested by Distributor use in connection with the PMA applicationCompassionate Use/Named Patient program and U.S. Investigator-Sponsored trials, other regulatory applications subject to such modifications as Buyer may make after the Closing in the Territory and future management and maintenance of marketing clearances in the Territory. Supplier shall notify Distributor immediately should Supplier become aware of any defect accordance with standard industry practice or condition which may render any of the Products in violation of the United States Food, Drug and Cosmetic Act, FDA regulations, other Territory regulations or which in any way alters the specification and quality of the Productsreasonable business judgment. (c) For the purpose of maximizing the likelihood of FDA GMP approval and clearance, Supplier agrees to allow an inspector of Distributor’s selection to inspect Supplier’s facilities, processes, operations and records prior to the FDA’s GMP inspection of Supplier’s facilities. Supplier further agrees promptly to implement the recommendations the inspector reasonably makes as necessary or appropriate for the purpose of obtaining FDA GMP approval and clearance. In addition, Supplier agrees to permit one or more representatives of Distributor or other experts to participate directly in cooperation with Supplier in the preparation of PMA application modules. (d) All Territory regulatory approvals (including the PMA application) shall be applied for, issued and registered in Distributor’s name. Commencing immediately, the ownership of the PMA application (and related applications and PMA application work in process) for Supplier’s pre-filled saline breast implant will be transferred to Distributor. For avoidance of doubt, Distributor will own in its own name the PMA and related marketing clearance once issued.

Regulatory Responsibilities. (a) From Licensee will be responsible for all regulatory submissions and after will control all regulatory activities with respect to Products in the date hereofTerritory, Distributor including safety reporting, analysis and strategy. Licensor will provide timely support to Licensee with respect to such regulatory activities at Licensee’s cost (other than minor consultation, clerical assistance and other assistance resulting in immaterial expenses, which shall assume (subject to Section 6(fbe the responsibility of Licensor) and Section 7(b)) will, at DistributorLicensee’s expense request, promptly transfer all responsibilities for the PMA application Regulatory Materials and program, and for other similar Territory regulatory approvals, for the pre-filled saline Breast Implant. Additionally, Distributor shall assume general management responsibilities for the explant investigation programInformation in its possession or under its Control related to CX-01 or any Product to Licensee. (b) Supplier agrees Licensee will be the primary interface with and will otherwise handle all correspondence, meetings and other interactions with the relevant Regulatory Authorities concerning regulatory activities related to conduct Products in the Field in the Territory, and Licensee will prepare and file any and all Regulatory Materials for each Product in the Field in the Territory at its sole expense any additional or revised pre-clinical testing required for in accordance with the PMA applicationRegulatory Plan. Supplier Licensor will be responsible for mechanical or other testing to be performed assist and cooperate, at SupplierLicensee’s location and all manufacturingexpense, process and production record, report and compliance preparation and maintenance. Supplier agrees immediately after the date hereof to provide access to Distributor to all records (including all past PMA-related records and all past and future manufacturing, process and production records), data, information, reports, clinical programs and consultants requested by Distributor to complete the PMA submission and subsequent FDA requests and to provide at its own expense all additional assistance requested by Distributor with Licensee in connection with the PMA applicationpreparation and filing of such Regulatory Materials, other regulatory applications in as reasonably requested by Licensee. Such cooperation will include promptly responding within procedural timelines set by Regulatory Authorities to any reasonable request from Licensee for Licensor Know-How needed for the Territory and future management and maintenance of marketing clearances in the Territory. Supplier shall notify Distributor immediately should Supplier become aware of any defect or condition which may render any of the Products in violation of the United States Food, Drug and Cosmetic Act, FDA regulations, other Territory regulations or which in any way alters the specification and quality of the ProductsRegulatory Materials. (c) For Unless the purpose of maximizing the likelihood of FDA GMP approval and clearanceParties otherwise agree in writing: (i) except as expressly contemplated by this Section 5.1, Supplier agrees Licensor will not communicate with respect to allow an inspector of Distributor’s selection to inspect Supplier’s facilities, processes, operations and records prior to the FDA’s GMP inspection of Supplier’s facilities. Supplier further agrees promptly to implement the recommendations the inspector reasonably makes as necessary or appropriate for the purpose of obtaining FDA GMP approval and clearance. In addition, Supplier agrees to permit one or more representatives of Distributor or other experts to participate directly in cooperation with Supplier any Product in the preparation Field with any Regulatory Authority having jurisdiction in the Territory, unless so ordered by such Regulatory Authority, in which case Licensor will provide prompt (but in any event within 2 business days) notice to Licensee of PMA application modulessuch order and all details thereof; and (ii) except as expressly contemplated by this Section 5.1, Licensor will not submit any Regulatory Materials or seek Regulatory Approvals for any Product in the Field in the Territory. (d) All Territory regulatory approvals Licensee shall provide Licensor with reasonable advance notice of any scheduled significant meeting with the FDA or EMA relating to any Regulatory Approval for a [*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. Product, and Dr. Xxxxxxx Xxxxxx, as a representative of Licensor (or a reasonably acceptable replacement if Xx. Xxxxxx is not available), shall, to the extent permitted by the FDA or EMA, as applicable, have the right to attend any such meeting at Licensor’s expense. Licensee shall promptly inform (including the PMA applicationby providing redacted copies upon request) shall be applied for, issued and registered in Distributor’s name. Commencing immediately, the ownership of the PMA application Licensor about any significant interaction (and related applications and PMA application work in processoral or written) for Supplier’s pre-filled saline breast implant will be transferred to Distributor. For avoidance of doubt, Distributor will own in its own name the PMA and related marketing clearance once issuedwith a Regulatory Authority.

Regulatory Responsibilities. (a) From and after The parties understand that as of the date hereof--------------------------- Effective Date of this Agreement, Distributor shall assume (allograft processed tissues are not regulated by the FDA as a medical device. In the event that the FDA commences regulation of a Processed Tissue as a medical device or other matter subsequent to the Effective Date, subject to Section 6(f) the agreement of both Sulzer and Section 7(b)) at Distributor’s expense all responsibilities for Tutogen within 90 days from the PMA application and programeffective date of such FDA regulation, and for other similar Territory regulatory approvals, for the pre-filled saline Breast Implant. Additionally, Distributor Tutogen shall assume general management responsibilities for the explant investigation program. (b) Supplier agrees to conduct at its expense any additional or revised pre-clinical testing required for the PMA application. Supplier will be responsible for mechanical applying for regulatory approval from the FDA to make such regulated Processed Tissue available in the Territory for the Field of Use. 5.2.1 In the event that either Sulzer or other testing Tutogen, in its sole discretion, does not agree to seek regulatory approval for the newly regulated Processed Tissue, then such Processed Tissue shall be performed at Supplier’s location and all manufacturingremoved from Schedule A. If Tutogen desires to seek regulatory approval, process and production recordbut Sulzer does not, report and compliance preparation and maintenance. Supplier agrees immediately after Tutogen shall have the date hereof right to provide access to Distributor to all records (including all past PMA-related records and all past and future manufacturing, process and production records), data, information, reports, clinical programs and consultants requested by Distributor to complete the PMA submission and subsequent FDA requests and to provide seek regulatory approval for such Processed Tissue at its own expense and to make such processed tissue available to users without obligation to Sulzer under this Agreement. If Sulzer desires to seek regulatory approval for such Processed Tissue, but Tutogen does not, Sulzer, subject to Tutogen's agreement to supply the processed tissue, shall have the right to seek regulatory approval for such processed tissue at its own expense and to make such processed tissue available to users without obligation to Tutogen under this Agreement. 5.2.2 In the event that Sulzer and Tutogen each agree to seek regulatory approval for the newly regulated Processed Tissue, then the parties shall forthwith meet and agree upon a plan pursuant to which Tutogen will seek regulatory approval for the Processed Tissue from the FDA. (the "Regulatory Plan"). The Regulatory Plan shall include an agreement as to the scope, timing, and supervisory responsibility for preclinical studies, clinical trials, regulatory submissions, and all additional assistance requested other matters related to the FDA regulatory approval process for the Processed Tissue. The parties shall meet at least once annually to review and amend the Regulatory Plan as dictated by Distributor in connection with the PMA application, other regulatory applications in the Territory and future management and maintenance of marketing clearances in the Territory. Supplier shall notify Distributor immediately should Supplier become aware of any defect or condition which may render any current status of the Products in violation of the United States Food, Drug clinical and Cosmetic Act, FDA regulations, other Territory regulations or which in any way alters the specification and quality of the Productsregulatory process. (c) For the purpose of maximizing the likelihood of FDA GMP approval and clearance, Supplier agrees to allow an inspector of Distributor’s selection to inspect Supplier’s facilities, processes, operations and records prior to the FDA’s GMP inspection of Supplier’s facilities. Supplier further agrees promptly to implement the recommendations the inspector reasonably makes as necessary or appropriate for the purpose of obtaining FDA GMP approval and clearance. In addition, Supplier agrees to permit one or more representatives of Distributor or other experts to participate directly in cooperation with Supplier in the preparation of PMA application modules. (d) All Territory regulatory approvals (including the PMA application) shall be applied for, issued and registered in Distributor’s name. Commencing immediately, the ownership of the PMA application (and related applications and PMA application work in process) for Supplier’s pre-filled saline breast implant will be transferred to Distributor. For avoidance of doubt, Distributor will own in its own name the PMA and related marketing clearance once issued.

Regulatory Responsibilities. (a) From Subject to the terms and after the date hereofconditions of this Agreement, Distributor shall assume (subject to Section 6(f) Apollomics will be responsible, at its sole cost and Section 7(b)) at Distributor’s expense all responsibilities for the PMA application and program, and for other similar Territory regulatory approvalsexpense, for the pre-filled saline Breast Implantconduct of all regulatory activities required to obtain and maintain Regulatory Approval of Licensed Products in the Field in the Apollomics Territory, including the preparation and submission of all Regulatory Materials and all communications and interactions with Regulatory Authorities, as necessary to obtain Regulatory Approval for Licensed Products in any Region in the Apollomics Territory. Additionally, Distributor Apollomics shall assume general management responsibilities be responsible for filing each MAA in the explant investigation programApollomics Territory for each Licensed Product in its own name. The Development Plan shall include the regulatory strategy for obtaining Regulatory Approval of Licensed Products in the Apollomics Territory. Apollomics shall use Commercially Reasonable Efforts to carry out its regulatory obligations for Licensed Products pursuant to such strategy. (b) Supplier agrees GlycoMimetics shall provide all reasonable assistance and cooperation to conduct at Apollomics as Apollomics may reasonably request (subject to Apollomics’ reimbursement of GlycoMimetics’ reasonable external and internal costs and expenses related thereto) during the Term of this Agreement, with respect to the satisfaction of its expense any additional or revised pre-clinical testing required for the PMA application. Supplier will be responsible for mechanical or other testing to be performed at Supplier’s location and all manufacturing, process and production record, report and compliance preparation and maintenance. Supplier agrees immediately after the date hereof to provide access to Distributor to all records (including all past PMA-related records and all past and future manufacturing, process and production recordsobligations under Section 5.1(a), data, information, reports, clinical programs and consultants requested by Distributor to complete the PMA submission and subsequent FDA requests and to provide at its own expense all additional assistance requested by Distributor including (i) in connection with the PMA applicationpreparation of Regulatory Materials, other regulatory applications (ii) providing documentation within GlycoMimetics’ possession and control, in each case as requested by Regulatory Authorities at Apollomics’ cost, and (iii) transferring to Apollomics additional Regulatory Materials in the GlycoMimetics Territory and future management and maintenance of marketing clearances as requested by Regulatory Authorities in the Apollomics Territory within fifteen (15) days of Apollomics’ reasonable request. In the event that GlycoMimetics believes that such requests are not reasonable or are otherwise burdensome to GlycoMimetics, then such matter shall be promptly submitted to the JDC for review and discussion. Without limiting the foregoing, GlycoMimetics shall provide Apollomics with modules 2, 3, 4 and 5 of the CTD in a manner sufficient for filing in the U.S. as soon as reasonably practicable after completion thereof. Additionally, GlycoMimetics shall provide Apollomics with information sufficient for filing modules 2, 3, 4 and 5 of the CTD in the Apollomics Territory. Supplier Apollomics shall notify Distributor immediately should Supplier become aware of any defect or condition which be responsible for publishing and submitting the CTD (including modules 2, 3, 4 and 5) to the Regulatory Authority in the Apollomics Territory. In order to address questions Apollomics may render any receive from a Regulatory Authority in the Apollomics Territory related to modules 2, 3, 4 and 5 of the Products in violation of the United States FoodCTD, Drug and Cosmetic Act, FDA regulations, other Territory regulations or which in any way alters the specification and quality of the Products. (c) For the purpose of maximizing the likelihood of FDA GMP approval and clearance, Supplier agrees to allow an inspector of Distributor’s selection to inspect Supplier’s facilities, processes, operations and records prior to the FDA’s GMP inspection of Supplier’s facilities. Supplier further agrees promptly to implement the recommendations the inspector reasonably makes as necessary or appropriate for the purpose of obtaining FDA GMP approval and clearance. In addition, Supplier agrees to permit one or more representatives of Distributor or other experts to participate directly in cooperation with Supplier GlycoMimetics will assist in the preparation of PMA application modules. responses based on information that would be found in: various technical reports, notebooks, executed batch records, master batch records, SOPs, validation protocols and reports, vendor certificates, and third party study reports and other CMC related documents not otherwise included in modules 2, 3, 4 and 5 of the CTD or otherwise already provided to Apollomics. Any such transfer of CMC Information as set forth in this Section 5.1 is conditioned on Apollomics establishing appropriate firewalls or equivalent means to ensure that such CMC Information is protected from unauthorized disclosure and is used only for legal and regulatory compliance purposes and not for any other purpose. In furtherance of the foregoing, Apollomics shall ensure that any CMC Information provided by or on behalf of GlycoMimetics pursuant to this Section 5.1 shall only be disclosed to those identified personnel of Apollomics (dor a designated agreed Third Party) All Territory regulatory approvals who (a) have a need to know the same to comply with the above obligations, and (b) have been fully informed of and acknowledge the highly sensitive and proprietary nature of such information and the need to maintain its secrecy and avoid inappropriate usage or disclosure, by using the firewall or equivalent means. Notwithstanding anything to the contrary herein, GlycoMimetics’ obligations under this Section 5.1(b), including to provide Apollomics with modules 2, 3, 4 and 5 of the CTD and such other information or assistance specified in this Section 5.1(b), shall apply solely to the extent GlycoMimetics is manufacturing and providing Apollomics with Licensed Products under the clinical Supply Agreement or commercial Supply Agreement. GlycoMimetics agrees, to the extent CMC Data is required or requested by the Regulatory Authorities, including the PMA application) shall be applied forNMPA, issued and registered in Distributor’s name. Commencing immediately, the ownership of the PMA application (and related applications and PMA application work in process) for Supplier’s pre-filled saline breast implant will be transferred to Distributor. For avoidance of doubt, Distributor will own in its own name the PMA and related marketing clearance once issuedgenerate such Data at Apollomics’ expense.

Regulatory Responsibilities. (a) From and after the date hereof, Distributor shall assume (subject to Section 6(f) and Section 7(b)) at Distributor’s 's expense all responsibilities for the PMA application and program, and for other similar Territory regulatory approvals, for the pre-filled saline Breast Implant. Additionally, Distributor shall assume general management responsibilities for the explant investigation program. (b) Supplier agrees to conduct at its expense any additional or revised pre-clinical testing required for the PMA application. Supplier will be responsible for mechanical or other testing to be performed at Supplier’s 's location and all manufacturing, process and production record, report and compliance preparation and maintenance. Supplier agrees immediately after the date hereof to provide access to Distributor to all records (including all past PMA-related records and all past and future fixture manufacturing, process and production records), data, information, reports, clinical programs and consultants requested by Distributor to complete the PMA submission and subsequent FDA requests and to provide at its own expense all additional assistance requested by Distributor in connection with the PMA application, other regulatory applications in the Territory and future management and maintenance of marketing clearances in the Territory. Supplier shall notify Distributor immediately should Supplier become aware of any defect or condition which may render any of the Products in violation of the United States Food, Food Drug and Cosmetic Act, FDA regulations, other Territory regulations or which in any way alters the specification and quality of the Products. (c) For the purpose of maximizing the likelihood of FDA GMP approval and clearance, Supplier agrees to allow an inspector of Distributor’s 's selection to inspect Supplier’s 's facilities, processes, operations and records prior to the FDA’s 's GMP inspection of Supplier’s 's facilities. Supplier further agrees promptly to implement the recommendations the inspector reasonably makes as necessary or appropriate for the purpose of obtaining FDA GMP approval and clearance. In addition, Supplier agrees to permit one or more representatives of Distributor or other experts to participate directly in cooperation with Supplier in the preparation of PMA application modules. (d) All Territory regulatory approvals (including the PMA application) shall be applied for, issued and registered in Distributor’s 's name. Commencing immediately, the ownership of the PMA application (and related applications and PMA application work in process) for Supplier’s 's pre-filled saline breast implant will be transferred to Distributor. For avoidance of doubt, Distributor will own in its own name the PMA and related marketing clearance once issued.