Common use of Drug Approval Applications Clause in Contracts

Drug Approval Applications. (a) Co-Promotion Territory. Consistent with the Development Plan but ---------------------- subject to the remainder of this Section 4.07, CTI shall be responsible for preparing and filing Drug Approval Applications and seeking Regulatory Approvals for Collaboration Products in the Co-Promotion Territory, including preparing all reports necessary as part of a Drug Approval Application. All such Drug Approval Applications shall be filed in the name of CTI, and a copy of each such Drug Approval Application shall be simultaneously provided to ORTHO. CTI shall be responsible for prosecuting such Drug Approval Applications and ORTHO shall have the right of cross-reference. In connection with all Drug Approval Applications being prosecuted by CTI under this Section 4.07(a), CTI agrees to provide ORTHO with a copy (which may be wholly or partly in electronic form) of all filings to regulatory agencies that it makes hereunder. The Parties shall consult and cooperate in the preparation of each Drug Approval Application and in obtaining Regulatory Approvals within the Co-Promotion Territory. CTI shall provide ORTHO with reasonable advance notice of any scheduled meeting with any regulatory agency relating to any Drug Approval Application, and ORTHO shall have the right to participate in any such meeting. CTI shall promptly furnish ORTHO with copies of all material correspondence CTI has had with any regulatory agency, and contact reports concerning material conversations or material meetings with any regulatory agency, in each case relating to any such Drug Approval Application. Upon receipt of Regulatory Approval of the Drug Approval Application for the first Collaboration Product hereunder, CTI shall submit an appropriate document to the regulatory agency designating ORTHO as the Regulatory Agent and thereafter ORTHO shall assume primary responsibility for dealings with the regulatory agency with respect thereto, including filing all supplements and other documents with such agency with respect to such existing Drug Approval Application. In the event that any regulatory agency threatens or initiates any action to remove a Collaboration Product from the market in the Co-Promotion Territory, ORTHO shall notify CTI of such communication within one business day of receipt by ORTHO. In connection with all Drug Approval Applications with respect to which ORTHO is Regulatory Agent, ORTHO agrees to provide CTI with a copy (which may be wholly or partly in electronic form) of all filings to regulatory agencies that it makes hereunder. The Parties shall consult and cooperate in the preparation of each such Drug Approval Application and in obtaining Regulatory Approvals within the Co-Promotion Territory. ORTHO shall provide CTI with reasonable advance notice of any scheduled meeting with any regulatory agency relating to any such Drug Approval Application and CTI shall have the right to participate in any such meeting. ORTHO shall promptly furnish CTI with copies of all material correspondence or material meetings with any regulatory agency in each case relating to any such Drug Approval Application. As between Parties, CTI shall be the legal and beneficial owner of all Drug Approval Applications and related approvals in the Co-Promotion Territory. Upon receipt of regulatory approval of each subsequent separate Drug Approval Application with respect to a Collaboration Product the process described above shall be repeated and CTI shall appoint ORTHO as Regulatory Agent upon approval thereof. CTI shall have the right of cross-reference with respect to all Drug Approval Applications for which ORTHO is Regulatory Agent. In furtherance of the desire of the Parties that each have access to all relevant information and the fact that, as Regulatory Agent and as a function of ORTHO having responsibility hereunder for the maintenance and monitoring of all safety and similar data with respect to Collaboration Products, CTI shall have the right to have one or more of its employees be resident at ORTHO's place of business where access to such data is generally made available to the relevant ORTHO employees performing such safety and monitoring functions. All costs of such employees shall be CTI's, provided -------- ORTHO shall train such employees in whatever procedures are required to enable such employees to have such informational access with respect to Collaboration Products, and provided further that such employees shall be subject to all ORTHO -------- ------- security, safety and other relevant policies applicable to ORTHO employees.

Drug Approval Applications. (aA) Co-Promotion Territory. Consistent with the Development Plan but ---------------------- subject to the remainder of this Section 4.07, CTI FALK [***************] for and shall be responsible for preparing and use [************************ ******************] in filing all Drug Approval Applications and seeking Regulatory Approvals for Collaboration Products the Licensed Product in the Co-Promotion Territory, including preparing all reports necessary as part of a Drug Approval Application. All such Drug Approval Applications shall be filed Territory in the name of CTI, Field; provided that ALTUS shall assist FALK in preparing and a copy of each such Drug Approval Application shall be simultaneously provided to ORTHO. CTI shall be responsible for prosecuting filing such Drug Approval Applications and ORTHO seexxxx such Regulatory Approvals. FALK shall have pay [*********] associated with the right preparation, filing, xxxxecution, meetings, communications, and review by regulatory agencies of cross-reference. In connection with all such Drug Approval Applications being prosecuted by CTI under this and Regulatory Approvals (including the activities set forth in Section 4.07(a4.5), CTI agrees to provide ORTHO with a copy (which may be wholly or partly in electronic form) of all filings to regulatory agencies that it makes hereunder. The Parties shall consult and cooperate Regulatory Approvals for the Licensed Product in the preparation Territory shall be prosecuted and obtained in the name of each FALK; provided that any such Regulatory Approvals shall be obtained xx xhe joint name of FALK and ALTUS if permitted under applicable rules and Portions ox xxis Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential treatment under Rule 406 of the Securities Act. regulations, and provided further that ALTUS shall be permitted to cross-reference such Drug Approval Application Applications and in obtaining Regulatory Approvals within that are in FALK's name. In the Co-Promotion Territoryevent that the laws or regulations in a country xx xxx Territory do not allow the Licensed Product to be registered solely in the name of FALK, FALK shall register the Licensed Product at its discretion (i) [*******************************************************] or (ii) [***************************************************]. CTI shall provide ORTHO with reasonable advance notice of any scheduled meeting with any regulatory agency relating Prior to submitting any Drug Approval Application, FALK shall discuss with the Steering Committee the scope and ORTHO shall have the right to participate in any such meeting. CTI shall promptly furnish ORTHO with copies general xxxtent of all material correspondence CTI has had with any regulatory agency, and contact reports concerning material conversations or material meetings with any regulatory agency, in each case relating to any such Drug Approval Application. Upon receipt of Regulatory Approval of the Drug Approval Application for the first Collaboration Product hereunder, CTI shall submit an appropriate document to the regulatory agency designating ORTHO as the Regulatory Agent The Steering Committee may review and thereafter ORTHO shall assume primary responsibility for dealings with the regulatory agency with respect thereto, including filing all supplements and other documents with such agency with respect to such existing Drug Approval Application. In the event that any regulatory agency threatens or initiates any action to remove a Collaboration Product from the market in the Co-Promotion Territory, ORTHO shall notify CTI of such communication within one business day of receipt by ORTHO. In connection with comment on all Drug Approval Applications with respect Applications, and such comments will be ******** by FALK to which ORTHO is Regulatory Agent, ORTHO agrees to provide CTI with a copy (which may be wholly or partly in electronic form) of all filings to regulatory agencies that it makes hereunderthe [****************]. The Parties shall consult and cooperate in the preparation of each such Drug Approval Application and in obtaining Regulatory Approvals within the Co-Promotion Territory. ORTHO shall provide CTI with reasonable advance notice of any scheduled meeting with any regulatory agency relating to any such Drug Approval Application and CTI shall have the right to participate in any such meeting. ORTHO shall promptly furnish CTI with copies of all material correspondence or material meetings with any regulatory agency in each case relating to any such Drug Approval Application. As between Parties, CTI shall be the legal and beneficial owner of all All Drug Approval Applications and related approvals to be xxxed by or on behalf of FALK for the Licensed Product in the Co-Promotion TerritoryTerritory must be approved by AXXXX in advance in writing. Upon receipt of regulatory approval of Regulatory documents or copies thereof for each subsequent separate Drug Approval Application with respect to a Collaboration Product the process described above filing shall be repeated centralized and CTI held at the offices of ALTUS, provided, however, that FALK shall appoint ORTHO as Regulatory Agent upon approval thereofbe entitled to obtain and keep copies of originals of any xxxh documents but only for the uses specifically set forth in this Agreement. CTI shall have Each Party will immediately notify the right other Party of cross-reference with respect any material developments relating to all Drug Approval Applications for which ORTHO is Regulatory Agent. In furtherance the clinical development of the desire of the Parties that each have access to all relevant information and the fact thatLicensed Product, as including, without limitation, any material comments or concerns raised by any Regulatory Agent and as a function of ORTHO having responsibility hereunder for the maintenance and monitoring of all safety and similar data with respect to Collaboration Products, CTI shall have the right to have one or more of its employees be resident at ORTHO's place of business where access to such data is generally made available to the relevant ORTHO employees performing such safety and monitoring functions. All costs of such employees shall be CTI's, provided -------- ORTHO shall train such employees in whatever procedures are required to enable such employees to have such informational access with respect to Collaboration Products, and provided further that such employees shall be subject to all ORTHO -------- ------- security, safety and other relevant policies applicable to ORTHO employeesAuthority.

Drug Approval Applications. (a) Co-Promotion Territory. Consistent with the Development Plan but ---------------------- subject to the remainder of this Section 4.07, CTI FALK shall be responsible for preparing and shall use Commercially Reasonable xxx Diligent Efforts in filing all Drug Approval Applications and seeking Regulatory Approvals for Collaboration Products the Licensed Product in the Co-Promotion Territory, including preparing all reports necessary as part of a Drug Approval Application. All such Drug Approval Applications shall be filed Territory in the name of CTI, Field; provided that ALTUS shall assist FALK in preparing and a copy of each such Drug Approval Application shall be simultaneously provided to ORTHO. CTI shall be responsible for prosecuting filing such Drug Approval Applications and ORTHO seexxxx such Regulatory Approvals. FALK shall have pay [*** ******] associated with the right preparation, filing, xxxsecution, meetings, communications, and review by regulatory agencies of cross-reference. In connection with all such Drug Approval Applications being prosecuted by CTI under this and Regulatory Approvals (including the activities set forth in Section 4.07(a4.5), CTI agrees to provide ORTHO with a copy (which may be wholly or partly in electronic form) of all filings to regulatory agencies that it makes hereunder. The Parties shall consult and cooperate Regulatory Approvals for the Licensed Product in the preparation Territory shall be prosecuted and obtained in the name of each FALK; provided that any such Regulatory Approvals shall be obtained xx xhe joint name of FALK and ALTUS if permitted under applicable rules and PORTIONS OF XXXX EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT. regulations, and provided further that ALTUS shall be permitted to cross-reference such Drug Approval Application Applications and in obtaining Regulatory Approvals within that are in FALK's name. In the Co-Promotion Territoryevent that the laws or regulations in a country xx xxx Territory do not allow the Licensed Product to be registered solely in the name of FALK, FALK shall register the Licensed Product at its discretion (i) [************************************************ *******] or (ii) [***************************************************]. CTI shall provide ORTHO with reasonable advance notice of any scheduled meeting with any regulatory agency relating Prior to submitting any Drug Approval Application, FALK shall discuss with the Steering Committee the scope and ORTHO shall have the right to participate in any such meeting. CTI shall promptly furnish ORTHO with copies general xxxtent of all material correspondence CTI has had with any regulatory agency, and contact reports concerning material conversations or material meetings with any regulatory agency, in each case relating to any such Drug Approval Application. Upon receipt of Regulatory Approval of the Drug Approval Application for the first Collaboration Product hereunder, CTI shall submit an appropriate document to the regulatory agency designating ORTHO as the Regulatory Agent The Steering Committee may review and thereafter ORTHO shall assume primary responsibility for dealings with the regulatory agency with respect thereto, including filing all supplements and other documents with such agency with respect to such existing Drug Approval Application. In the event that any regulatory agency threatens or initiates any action to remove a Collaboration Product from the market in the Co-Promotion Territory, ORTHO shall notify CTI of such communication within one business day of receipt by ORTHO. In connection with comment on all Drug Approval Applications with respect Applications, and such comments will be [********] by FALK to which ORTHO is Regulatory Agent, ORTHO agrees to provide CTI with a copy (which may be wholly or partly in electronic form) of all filings to regulatory agencies that it makes hereunderthe [****************]. The Parties shall consult and cooperate in the preparation of each such Drug Approval Application and in obtaining Regulatory Approvals within the Co-Promotion Territory. ORTHO shall provide CTI with reasonable advance notice of any scheduled meeting with any regulatory agency relating to any such Drug Approval Application and CTI shall have the right to participate in any such meeting. ORTHO shall promptly furnish CTI with copies of all material correspondence or material meetings with any regulatory agency in each case relating to any such Drug Approval Application. As between Parties, CTI shall be the legal and beneficial owner of all All Drug Approval Applications and related approvals to be xxxed by or on behalf of FALK for the Licensed Product in the Co-Promotion TerritoryTerritory must be approved by AXXXX in advance in writing. Upon receipt of regulatory approval of Regulatory documents or copies thereof for each subsequent separate Drug Approval Application with respect to a Collaboration Product the process described above filing shall be repeated centralized and CTI held at the offices of ALTUS, provided, however, that FALK shall appoint ORTHO as Regulatory Agent upon approval thereofbe entitled to obtain and keep copies of originals of any xxxh documents but only for the uses specifically set forth in this Agreement. CTI shall have Each Party will immediately notify the right other Party of cross-reference with respect any material developments relating to all Drug Approval Applications for which ORTHO is Regulatory Agent. In furtherance the clinical development of the desire of the Parties that each have access to all relevant information and the fact thatLicensed Product, as including, without limitation, any material comments or concerns raised by any Regulatory Agent and as a function of ORTHO having responsibility hereunder for the maintenance and monitoring of all safety and similar data with respect to Collaboration Products, CTI shall have the right to have one or more of its employees be resident at ORTHO's place of business where access to such data is generally made available to the relevant ORTHO employees performing such safety and monitoring functions. All costs of such employees shall be CTI's, provided -------- ORTHO shall train such employees in whatever procedures are required to enable such employees to have such informational access with respect to Collaboration Products, and provided further that such employees shall be subject to all ORTHO -------- ------- security, safety and other relevant policies applicable to ORTHO employeesAuthority.

Drug Approval Applications. (a) Co-Promotion Profit/Loss Sharing Territory. Consistent with ERGO has filed an NDA and is seeking ----------------------------- Regulatory Approval for Bromocriptine for the Development Plan but ---------------------- subject to the remainder of this Section 4.07, CTI shall be responsible for preparing and filing Drug Approval Applications and seeking Regulatory Approvals for Collaboration Products Type II Diabetes Indication in the Co-Promotion Profit/Loss Sharing Territory, including preparing all reports necessary as part of a Drug Approval Application. All such Drug Approval Applications shall be This NDA has been filed in the name of CTIERGO, and a copy of each such Drug Approval Application shall NDA (which may be simultaneously wholly or partially in electronic form) will be provided to ORTHO promptly by ERGO upon written request of ORTHO. CTI ERGO shall be responsible for prosecuting such Drug Approval Applications Application and ORTHO shall have the right of cross-referencereference of such Application. In connection with all Drug Approval Applications being prosecuted by CTI under this Section 4.07(a), CTI agrees to provide ORTHO with a copy (which may be wholly or partly in electronic form) of all filings to regulatory agencies that it makes hereunder. The Parties shall consult and cooperate in the preparation of each Drug Approval Application and in obtaining Regulatory Approvals within the Co-Promotion Territory. CTI shall provide ORTHO with reasonable advance notice of any scheduled meeting with any regulatory agency relating to any Drug Approval Application, and ORTHO shall have the right to participate in any such meeting. CTI [*]ERGO shall promptly furnish ORTHO with copies of all material correspondence CTI ERGO has had with any regulatory agency, and contact reports concerning material conversations or material meetings with any regulatory agency, in each case relating to any such Drug Approval ApplicationBromocriptine's use or studies. Upon receipt of Regulatory Approval of the Drug Approval Application NDA for Bromocriptine for a Type II Diabetes Indication in the first Collaboration Product hereunderU.S., CTI ERGO shall promptly submit an the appropriate document documentation to the regulatory agency FDA designating ORTHO as the Regulatory Agent owner of the NDA for Bromocriptine and transfer the ownership thereof and thereafter ORTHO shall assume primary responsibility for all dealings with the regulatory agency with respect thereto, including filing all supplements and other documents with such agency with respect to such existing Drug Approval Application. Following such submission, ORTHO shall promptly provide notification to the FDA (and to ERGO) that ERGO has the right of cross-reference under such NDA. In the event that any regulatory agency the FDA threatens or initiates any action to remove a Collaboration Product from the market in the Co-Promotion Profit/Loss Sharing Territory, ORTHO shall promptly notify CTI ERGO of such communication within one business day of receipt by ORTHOcommunication. In connection with all Drug Approval Applications with respect to NDA's for Bromocriptine for other Indications which ORTHO is Regulatory Agentmay file in the Profit/Loss Sharing Territory, ORTHO agrees to provide CTI ERGO with access to all data, and a copy (which may be wholly or partly in electronic form) of all filings to regulatory agencies the FDA that it makes hereunder. The Parties shall consult and cooperate in the preparation of each such Drug Approval Application and in obtaining the initial and any further Regulatory Approvals within the Co-Promotion Profit/Loss Sharing Territory. ORTHO shall provide CTI ERGO with reasonable advance notice of any scheduled meeting with any regulatory agency the FDA relating to any such Drug Approval Application that ORTHO owns and CTI ERGO shall have the right to participate in any such meeting. ORTHO shall promptly furnish CTI ERGO with copies of all material correspondence or material meetings with any regulatory agency in the Profit/Loss Sharing Territory in each case relating to any such Drug Approval Application. As between PartiesIn the event that, CTI pursuant to the terms of this Agreement, in particular as provided in Articles V and XIV, and on a product-by- product basis, ORTHO's right to Develop and Commercialize any Collaboration Product under this Agreement terminates, ORTHO shall promptly transfer any and all of its control and/or ownership rights in the relevant Drug Approval Application and Regulatory Approval for such Collaboration Product to ERGO. ORTHO shall be the legal responsible for preparing and beneficial owner of filing all Drug Approval Applications and related approvals seeking all Regulatory Approvals for all Collaboration Products other than Bromocriptine for a Type II Diabetes Indication in the Co-Promotion Territory. Upon receipt of regulatory approval U.S. The Parties shall consult and cooperate in the preparation of each subsequent separate such Drug Approval Application with respect and in obtaining the initial and any further Regulatory Approvals within the Profit/Loss Sharing Territory. As the owner of all such Drug Approval Applications, ORTHO will be responsible for prosecuting all such Drug Approval Applications, and, at the time of filing of each such Application, ORTHO shall, at the request of the JPT, include a notification to a Collaboration Product the process described above shall be repeated Regulatory Authority and CTI shall appoint ORTHO as Regulatory Agent upon approval thereof. CTI shall have to ERGO that ERGO has the right of cross-reference with respect to all Drug Approval Applications for which ORTHO is Regulatory Agentreference. In furtherance of the desire of the Parties that each have access to all relevant information and the fact that, as Regulatory Agent and as a function of ORTHO having responsibility hereunder for the maintenance and monitoring of all safety and similar data with respect to Collaboration ProductsProducts including Bromocriptine, CTI ORTHO shall have the right to have one or more of its employees be resident at ORTHO's place of business where access to send all such monitoring and surveillance data is generally made available to the relevant ORTHO employees performing attention of the Vice President of Medical Affairs or such safety and monitoring functions. All costs of such employees shall be CTI's, provided -------- ORTHO shall train such employees other employee or agent as ERGO designates in whatever procedures are required to enable such employees to have such informational access with respect to Collaboration Products, and provided further that such employees shall be subject to all ORTHO -------- ------- security, safety and other relevant policies applicable to ORTHO employeesthe future.