Royalty Bearing Territory. ORTHO shall be responsible for ------------------------- preparing and filing Drug Approval Applications and seeking Regulatory Approvals for Collaboration Products in the Royalty Bearing Territory, including preparing all reports necessary as part of a Drug Approval Application. ORTHO shall be responsible for prosecuting all such Drug Approval Applications, and CTI shall have the right of cross reference. In connection with all Drug Approval Applications being prosecuted by ORTHO hereunder, ORTHO agrees to provide CTI with a copy (which may be wholly or partly in electronic form) of all filings to regulatory agencies in each Major Market Country that it makes hereunder. Within thirty (30) days following the end of each calendar quarter ORTHO shall report to CTI regarding the status of each pending and proposed Drug Approval Application in the Royalty Bearing Territory. In the event that any regulatory agency threatens or initiates any action to remove such Collaboration Product from the market in any country in the Royalty Bearing Territory, ORTHO shall notify CTI of such communication within one business day of receipt by ORTHO.
Royalty Bearing Territory. ORTHO shall bear all Development ------------------------- Expenses for Collaboration Products that are specifically related to the Development, manufacture, use and/or sale of a Collaboration Product in the Royalty Bearing Territory. As provided in Section 13.01, Information developed by CTI relating to the Development of Collaboration Products in the Co-Promotion Territory can be used by ORTHO for the Development of such Collaboration Products in the Royalty Bearing Territory without further charge (other than reasonable duplicating, postage and related out-of-pocket costs). (The information below marked by ***** has been omitted by a request for confidential treatment. The omitted portion has been separately filed with the Commission.)
Royalty Bearing Territory. ORTHO shall be responsible for preparing ------------------------- and filing all Drug Approval Applications and seeking all Regulatory Approvals for all Collaboration Products including Bromocriptine for all extant Development Indications and all extant Additional Indications for use in all countries in the Royalty Bearing Territory, including preparing all reports necessary as part of a Drug Approval Application. ORTHO shall be responsible for prosecuting all such Drug Approval Applications. In connection with all Drug Approval Applications being prosecuted by ORTHO hereunder, ORTHO shall provide ERGO with access to the original data and a copy (which may be wholly or partly in electronic form, and without the obligation to provide ERGO with a translation) of all filings to regulatory agencies, as well as access to all data that it makes hereunder, upon written request of ERGO. ORTHO shall promptly furnish ERGO with copies of all material correspondence ORTHO has 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 in each Major European Market Country and Japan, without the obligation to provide ERGO with a translation unless ORTHO has access to such translation. Within thirty (30) days following the end of each calendar quarter ORTHO shall report to ERGO regarding the status of each pending and proposed Drug Approval Application in the Royalty Bearing Territory. In the event that any regulatory agency threatens or initiates any action to remove such Collaboration Product from the market in any country in the Royalty Bearing Territory, ORTHO shall promptly notify ERGO of such communication.
Royalty Bearing Territory. ORTHO shall bear all Development Expenses ------------------------- for Collaboration Products that are specifically related to the Development, manufacture, use and/or sale of a Collaboration Product in the Royalty Bearing Territory. As provided in Section 13.01, Information developed by ERGO relating to the Development of Collaboration Products in the Profit/Loss Sharing Territory can be used by ORTHO for the Development and regulatory filing of such Collaboration Products in the Royalty Bearing Territory without further charge (other than reasonable duplicating, postage, and related out of pocket costs). In addition, as provided in Section 13.01, Information developed by ORTHO relating to the Development of Collaboration Products in the Royalty Bearing Territory can be used by ERGO for the purpose of any further Development and support of regulatory filings of such Collaboration Products in the Profit/Loss Sharing Territory without further charge (other than reasonable duplicating, postage, and related out of pocket costs).
Royalty Bearing Territory. GSK shall have the sole right and responsibility for (a) all aspects of the Commercialization of Products for all Indications in the Royalty-Bearing Territory in accordance with the applicable GSK Product Commercialization Plan, including without limitation the sole responsibility for booking sales of Product and for Manufacturing all Product for use in the Royalty-Bearing Territory, (b) the conduct of all pre-marketing, marketing, Branding, promotion, sales, distribution, import and export activities (including securing reimbursement, sales and marketing and conducting any post-marketing trials or post-marketing safety surveillance or maintaining databases) applicable to the Commercialization of Products for all Indications in the Royalty-Bearing Territory, and (c) all of the activities described in Section 5.1.2(a) and (b) in the U.S. Territory for any Product for which SYNTA exercises its Commercialization Opt-Out Right as described in Sections 5.1.1(c) and Portions of this 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 24b-2 of the Securities Exchange Act of 1934.
