Common use of Product Registrations Clause in Contracts

Product Registrations. (a) Schering shall be responsible, at its cost and expense, and in its sole judgment, for determining the appropriate regulatory strategy, and for obtaining and maintaining all Regulatory Approvals for the sale of the Product in the Territory, except for costs and expenses to be borne by ICN with respect to its own Regulatory Approval in the EU as provided in this Agreement. Schering shall use its reasonable efforts to diligently obtain Regulatory Approvals with Minimum Labelling within the Territory and in any event shall file for such Regulatory Approvals in each country in the Major Market within nine months of the completion of clinical trials and studies required in each such country for Regulatory Approval, including any additional or supplemental clinical trials or studies subsequently required by a regulatory authority for such Regulatory Approval. For purposes of this Section 3.2, "completion of clinical trials" shall in no event be deemed to occur sooner than the time of availability of the integrated summary of safety reports and integrated summary of efficacy reports. Schering shall use reasonable efforts to complete such reports promptly after completion of treatment. With respect to countries in the Territory other than the Major Market, Schering's efforts shall be commensurate with those efforts used to pursue regulatory approval for its own products of similar potential, value and status in such country or a comparable country in the Territory, as the case may be, or, if Schering has no such similar products in a comparable country, Schering's efforts shall be commensurate with the efforts that other reputable pharmaceutical companies of comparable size and product portfolio would use with respect to a product of similar potential, value and status in such country. In connection with any health registration application of ICN relating to the Product pending as of the Effective Date with the CPMP or FDA or any successor to the CPMP or FDA, ICN shall, at Schering's request, provide to Schering in a prompt manner, but in no event later than December 31, 1995, responses to non-clinical questions which have been raised by the CPMP or FDA. In addition, at the request of Schering, ICN shall provide to Schering chemistry-pharmacy data and any other technical information which Schering may reasonably require in order to obtain any CPMP Opinion or Regulatory Approval for the Product in the Territory. At the request of Schering, ICN may agree to continue its current efforts, and undertake where necessary and commercially practicable additional efforts, including clinical trials in addition to those already in progress, to maximize the opportunities of Schering to obtain Regulatory Approval with Minimum Labelling in each country in the Territory at the time of initial Regulatory Approval in such country, or as soon thereafter as possible. All costs incurred by ICN in making such efforts shall be included in the costs incurred in pursuing Regulatory Approval for purposes of Section 3.2(e). Notwithstanding the foregoing, ICN acknowledges that there can be no assurance that Minimum Labelling will be obtained in any country in the Territory. ICN shall advise and assist Schering, upon request, in the CPMP process and the local registration process.

Product Registrations. (a) Schering Seller shall cause the Transferred Registrations to be transferred to Buyer in its or its designated Affiliates’ name(s) as soon as is reasonably practicable after the Closing. Any and all fees, expenses and other costs associated with effectuating such transfers shall be responsibleborne by Buyer and/or its Affiliates and none of Seller nor its Affiliates shall be responsible for the payment of such fees, at its cost and expenseexpenses or costs. In furtherance of effectuating such transfers, Buyer shall, promptly after the Closing, commence the filing of all applications, documents, and in its sole judgmentsupporting information with all applicable Governmental Bodies that are necessary or appropriate to effectuate such transfers and complete such filings within ninety (90) days after the Closing, for determining and shall diligently prosecute the effectuation of such transfers. Upon receipt of approvals from the appropriate regulatory strategyGovernmental Bodies regarding a transfer of a Transferred Registration, Buyer and its Affiliates shall comply with all Legal Requirements for changeover of all Product packaging, labeling, and for obtaining and maintaining all Regulatory Approvals for package inserts associated with the sale Products that are the subject of such Transferred Registration. Notwithstanding anything herein to the Product in the Territorycontrary and, subject to compliance with applicable Legal Requirements, except for costs and expenses to be borne by ICN with respect to its own Regulatory Approval in the EU as provided in this Agreement. Schering shall use its reasonable efforts to diligently obtain Regulatory Approvals with Minimum Labelling within the Territory and in any event shall file for such Regulatory Approvals in each country in the Major Market within nine months inventory of the completion of clinical trials and studies required in each such country for Regulatory Approval, including any additional or supplemental clinical trials or studies subsequently required by a regulatory authority for such Regulatory Approval. For purposes of this Section 3.2, "completion of clinical trials" shall in no event be deemed to occur sooner than the time of availability of the integrated summary of safety reports and integrated summary of efficacy reports. Schering shall use reasonable efforts to complete such reports promptly after completion of treatment. With respect to countries in the Territory other than the Major Market, Schering's efforts shall be commensurate with those efforts used to pursue regulatory approval for its own products of similar potential, value and status in such country or a comparable country in the Territory, as the case may be, or, if Schering has no such similar products in a comparable country, Schering's efforts shall be commensurate with the efforts that other reputable pharmaceutical companies of comparable size and product portfolio would use with respect to a product of similar potential, value and status in such country. In connection with any health registration application of ICN relating to the Product pending as of the Effective Date with the CPMP or FDA or any successor to the CPMP or FDA, ICN shall, at Schering's request, provide to Schering in a prompt manner, but in no event later than December 31, 1995, responses to non-clinical questions which have been raised by the CPMP or FDA. In addition, at the request of Schering, ICN shall provide to Schering chemistry-pharmacy data and any other technical information which Schering may reasonably require in order to obtain any CPMP Opinion or Regulatory Approval for the Product in the Territory. At the request of Schering, ICN may agree to continue its current efforts, and undertake where necessary and commercially practicable additional efforts, including clinical trials in addition to those already in progress, to maximize the opportunities of Schering to obtain Regulatory Approval with Minimum Labelling in each country in the Territory Products existing at the time the appropriate Governmental Body approves the transfer of initial Regulatory Approval in a Transferred Registrations for a Product, (i) commencing with the first production run after the appropriate Governmental Body approves the transfer of a Transferred Registration for a Product, Buyer and its Affiliates shall use Buyer’s and its Affiliates’ approved packaging, labeling, and package inserts for such countryProduct and cease using Seller’s or its Affiliates’ packaging, or as soon thereafter as possible. All costs incurred by ICN in making labeling, and package inserts for such efforts shall be included in the costs incurred in pursuing Regulatory Approval for purposes of Section 3.2(e). Notwithstanding the foregoing, ICN acknowledges that there can be no assurance that Minimum Labelling will be obtained Product and (ii) in any country event, no later than six (6) months from the date the appropriate Governmental Body approves a transfer of a Transferred Registration for a Product, Buyer and its Affiliates shall change the labels on and package inserts included with all such Product produced after such approval to Buyer’s and its Affiliates’ approved labels and package inserts and in accordance with all Legal Requirements, and shall remove Seller’s name and telephone numbers from all labeling, package inserts, and other Product supporting materials and information associated with such Product including, but not limited to, material safety data sheets. Buyer and its Affiliates shall only use Seller’s or its Affiliates’ packaging, labeling, and package inserts for a Product in a manner consistent with Legal Requirements. Until the Territory. ICN transfer of Transferred Registrations has been completed, Seller shall advise take all actions reasonably necessary to permit Buyer to manufacture, market, sell, and assist Schering, distribute Products in reliance upon request, in the CPMP process Seller’s Transferred Registrations and the local registration processunderlying data.

Product Registrations. (a) Schering BMS shall implement the decisions of the PDC regarding obtaining marketing approvals for Product throughout the Territory. BMS shall be responsibleobligated to, and as soon as reasonably and appropriately practicable BMS shall, at its cost expense, prepare and expensefile all applications and supporting documentation necessary to obtain and maintain all regulatory approvals, marketing clearances, and price listings and reimbursement approvals, if any, required for Product in each country of the Territory. BMS shall file and seek to obtain the NDA in Otsuka’s (or its Affiliates) name, with Otsuka’s prompt * CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION cooperation as reasonably necessary. Similarly, BMS shall file and seek to obtain the MAA(s) in the European Union in Otsuka’s (or its Affiliates) name, with Otsuka’s prompt cooperation as reasonably necessary. BMS shall file such applications for marketing approval in accordance with the decisions of the PDC and the Schedule set forth in the Product Development Plan, and in any event, in the case of the United States and the centralized fling in the European Union, not later than thirty-six (36) months from the Effective Date of this Agreement (provided Otsuka completes its sole judgmentobligations regarding the Otsuka Clinical Studies in a timely fashion). BMS shall file such applications in all other countries of the Territory in a commercially reasonable time, for determining consistent with the appropriate regulatory strategyobjectives of this Agreement and whatever Schedule may be set forth in the Product Development Plan. BMS shall make commercially reasonable and diligent efforts to obtain approvals of such applications, and for obtaining also to obtain price listing and maintaining all Regulatory Approvals for reimbursement wherever appropriate, in a timely manner, and to maintain them once approved. In the sale event BMS fails to proceed in a timely fashion with the activities necessary to obtain registration, marketing approval, price listing and reimbursement approval of Product in the United States or in any two or more of the other Co-Promotion Countries, the PDC shall immediately meet and discuss the reason(s) for such failure, as well as measures to remedy the situation. If the PDC fails to agree upon measures to remedy the situation, Otsuka may terminate this Agreement pursuant to Section 12. In preparing and fling applications and supporting documentation necessary to obtain and maintain regulatory approvals and marketing clearances throughout the Territory, BMS shall though it remains ultimately obligated with respect to all such applications and documentation and regulatory compliance in connection therewith - be subject to the direction of the PDC. BMS shall promptly inform Otsuka, through the PDC, of any condition or requirement proposed by a governmental agency or regulatory body as a condition to granting marketing approval of the Product, and the PDC shall have the ultimate authority concerning its response thereto. BMS and Otsuka shall each, at the other party’s reasonable request, provide the other with copies of all requested regulatory applications and documents and communications to and from governmental/regulatory agencies including, but not limited to, IND, NDA and MAA filings and approvals, price registrations, all related correspondence to and from governmental/regulatory authorities, inspectional observations and warning letters. Each party shall have access to and the right to refer to and cross-reference each other’s filings and supplements thereto consistent with the purposes of this Agreement; provided, however, that BMS shall not have the right to have or use Otsuka’ s manufacturing-related data, information or documentation except as necessary to obtain regulatory approval of Product in the Territory and to formulate the Compound into Bulk Tablets as provided in Section 5.11.1. As contract service provider, * CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION BMS shall be obligated with respect to all contacts and communications with governmental/regulatory authorities in the Territory, except for costs and expenses to be borne by ICN in collaboration with respect to its own Regulatory Approval in the EU Otsuka as provided in this Agreement. Schering shall use its reasonable efforts to diligently obtain Regulatory Approvals with Minimum Labelling within the Territory and in any event shall file for such Regulatory Approvals in each country in the Major Market within nine months of the completion of clinical trials and studies required in each such country for Regulatory Approval, including any additional or supplemental clinical trials or studies subsequently required by a regulatory authority for such Regulatory Approval. For purposes of this Section 3.2, "completion of clinical trials" shall in no event be deemed to occur sooner than the time of availability of the integrated summary of safety reports and integrated summary of efficacy reports. Schering shall use reasonable efforts to complete such reports promptly after completion of treatment. With respect to countries in the Territory other than the Major Market, Schering's efforts shall be commensurate with those efforts used to pursue regulatory approval for its own products of similar potential, value and status in such country or a comparable country in the Territory, as the case may be, or, if Schering has no such similar products in a comparable country, Schering's efforts shall be commensurate with the efforts that other reputable pharmaceutical companies of comparable size and product portfolio would use with respect to a product of similar potential, value and status in such country. In connection with any health registration application of ICN relating to the Product pending as of the Effective Date with the CPMP or FDA or any successor to the CPMP or FDA, ICN shall, at Schering's request, provide to Schering in a prompt manner, but in no event later than December 31, 1995, responses to non-clinical questions which have been raised by the CPMP or FDA. In addition, at the request of Schering, ICN shall provide to Schering chemistry-pharmacy data and any other technical information which Schering may reasonably require in order to obtain any CPMP Opinion or Regulatory Approval for the Product in the Territory. At the request of Schering, ICN may agree to continue its current efforts, and undertake where necessary and commercially practicable additional efforts, including clinical trials in addition to those already in progress, to maximize the opportunities of Schering to obtain Regulatory Approval with Minimum Labelling in each country in the Territory at the time of initial Regulatory Approval in such country, or as soon thereafter as possible. All costs incurred by ICN in making such efforts shall be included in the costs incurred in pursuing Regulatory Approval for purposes of Section 3.2(e). Notwithstanding the foregoing, ICN acknowledges that there can be no assurance that Minimum Labelling will be obtained in any country in the Territory. ICN shall advise and assist Schering, upon request, in the CPMP process and the local registration processabove.

Product Registrations. (a) Schering shall be responsible, at its cost and expense, and in its sole judgment, for determining the appropriate regulatory strategy, and for obtaining and maintaining all Regulatory Approvals for the sale of the Product in the Territory, except for costs and expenses to be borne by ICN with respect to its own Regulatory Approval in the EU as provided in this Agreement. Schering shall use its reasonable efforts to diligently obtain Regulatory Approvals with Minimum Labelling [REDACTED] within the Territory and in any event shall file for such Regulatory Approvals in each country in the Major Market within nine months [REDACTED] of the completion of clinical trials and studies required in each such country for Regulatory Approval, including any additional or supplemental clinical trials or studies subsequently required by a regulatory authority for such Regulatory Approval. For purposes of this Section 3.2, "completion of clinical trials" shall in no event be deemed to occur sooner than the time of availability of the integrated summary of safety reports and integrated summary of efficacy reports. Schering shall use reasonable efforts to complete such reports promptly after completion of treatment. With respect to countries in the Territory other than the Major Market, Schering's efforts shall be commensurate with those efforts used to pursue regulatory approval for its own products of similar potential, value and status in such country or a comparable country in the Territory, as the case may be, or, if Schering has no such similar products in a comparable country, Schering's efforts shall be commensurate with the efforts that other reputable pharmaceutical companies of comparable size and product portfolio would use with respect to a product of similar potential, value and status in such country. In connection with any health registration application of ICN relating to the Product pending as of the Effective Date with the CPMP or FDA or any successor to the CPMP or FDA, ICN shall, at Schering's request, provide to Schering in a prompt manner, but in no event later than December 31, 1995[ REDACTED ], responses to non-clinical questions which have been raised by the CPMP or FDA. In addition, at the request of Schering, ICN shall provide to Schering chemistry-pharmacy data and any other technical information which Schering may reasonably require in order to obtain any CPMP Opinion or Regulatory Approval for the Product in the Territory. At the request of Schering, ICN may agree to continue its current efforts, and undertake where necessary and commercially practicable additional efforts, including clinical trials in addition to those already in progress, to maximize the opportunities of Schering to obtain Regulatory Approval with Minimum Labelling [REDACTED] in each country in the Territory at the time of initial Regulatory Approval in such country, or as soon thereafter as possible. All costs incurred by ICN in making such efforts shall be included in the costs incurred in pursuing Regulatory Approval for purposes of Section 3.2(e). Notwithstanding the foregoing, ICN acknowledges that there can be no assurance that Minimum Labelling [REDACTED] will be obtained in any country in the Territory. ICN shall advise and assist Schering, upon request, in the CPMP process and the local registration process.

Product Registrations. (a) Schering shall be responsible, at its cost and expense, and in its sole judgment, for determining the appropriate regulatory strategy, and for obtaining and maintaining all Regulatory Approvals for the sale of the Product in the Territory, except for costs and expenses to be borne by ICN with respect to its own Regulatory Approval in the EU as provided in this Agreement. Schering shall use its reasonable efforts to diligently obtain Regulatory Approvals with Minimum Labelling within the Territory and in any event shall file for such Regulatory Approvals in each country in the Major Market within nine months of the completion of clinical trials and studies required in each such country for Regulatory Approval, including any additional or supplemental clinical trials or studies subsequently required by a regulatory authority for such Regulatory Approval. For purposes of this Section 3.2, "completion of clinical trials" shall in no event be deemed to occur sooner than the time of availability of the integrated summary of safety reports and integrated summary of efficacy reports. Schering shall use reasonable efforts to complete such reports promptly after completion of treatment. With respect to countries in the Territory other than the Major Market, Schering's efforts shall be commensurate with those efforts used to pursue regulatory approval for its own products of similar potential, value and status in such country or a comparable country in the Territory, as the case may be, or, if Schering has no such similar products in a comparable country, Schering's efforts shall be commensurate with the efforts that other reputable pharmaceutical companies of comparable size and product portfolio would use with respect to a product of similar potential, value and status in such country. In connection with any health registration application of ICN relating to the Product pending as of the Effective Date with the CPMP or FDA or any successor to the CPMP or FDA, ICN shall, at Schering's request, provide to Schering in a prompt manner, but in no event later than December 31, 1995, responses to non-clinical questions which have been raised by the CPMP or FDA. In addition, at the request of Schering, ICN shall provide to Schering chemistry-pharmacy data and any other technical information which Schering may reasonably require in order to obtain any CPMP Opinion or Regulatory Approval for the Product in the Territory. At the request of Schering, ICN may agree to continue its current efforts, and undertake where necessary and commercially practicable additional efforts, including clinical trials in addition to those already in progress, to maximize the opportunities of Schering to obtain Regulatory Approval with Minimum Labelling in each country in the Territory at the time of initial Regulatory Approval in such country, or as soon thereafter as possible. All costs incurred by ICN in making such efforts shall be included in the costs incurred in pursuing Regulatory Approval for purposes of Section 3.2(e). Notwithstanding the foregoing, ICN acknowledges that there can be no assurance that Minimum Labelling will be obtained in any country in the Territory. ICN shall advise and assist Schering, upon request, in the CPMP process and the local registration process.commercially