ROW Territory. Pfizer shall indemnify, defend and hold Eyetech Parties harmless from and against [**] percent ([**]%) of the amount of any and all Losses arising out of or resulting from any Third Party Claim involving Product Liability in the ROW Territory (other than Product Liability Losses for which Eyetech is obligated to indemnify Pfizer pursuant to Section 12.4).
ROW Territory. Pfizer shall indemnify, defend and hold the Eyetech Parties harmless from and against [**] percent ([**]%) of the amount of any and all Losses arising out of or resulting from any Third Party Claims involving any actual or alleged infringement of any trademarks, patent rights or other intellectual property rights, or misappropriation of trade secrets, of any Person in connection with the manufacture, use, sale or importation of the Product in the ROW Territory or in connection with the manufacture or use of the Product in the US Territory for subsequent importation and/or sale in the ROW Territory (other than Losses for which Eyetech is obligated to indemnify Pfizer pursuant to Section 12.4 and other than Losses relating to Products ultimately sold by Eyetech in the US Territory, which are governed by Section 12.6(b)(i)).
ROW Territory. Celgene shall have lead responsibility for all Regulatory Interactions with Regulatory Authorities in the ROW Territory for each Shared Product.
ROW Territory. The term “
ROW Territory. Alkermes shall share with Cephalon relevant materials, data and regulatory information in Alkermes' or its Affiliates' possession and Control related to any pre-clinical studies, Clinical Studies and post marketing clinical trials of a Product in the Field resulting from its collaborations with respect to the Product for the ROW Territory to the extent such materials, data or regulatory information are necessary or useful for filing an IND or NDA or required to be disclosed by Law. In return Cephalon agrees that Alkermes may share with its collaborators with respect to the Product in the ROW Territory, subject to the provisions of Article 8, [**].
ROW Territory. Alkermes retains all of its rights to use, sell, manufacture, offer for sale and import the Products in the ROW Territory. During the period beginning on the Effective Date and ending one hundred eighty (180) days thereafter (the “Option Period”), Alkermes shall not enter into any agreement or negotiation with any Third Party regarding a license of the rights to use, sell, offer for sale and import the Products in the ROW Territory. If during the Option Period Cephalon notifies Alkermes in writing of its desire to enter into an exclusive license to use, sell, offer for sale and import the Products in the ROW Territory, then Alkermes shall exclusively negotiate with Cephalon in good faith a definitive agreement for such an exclusive license containing customary representations, warranties, covenants and agreements, satisfactory in form and substance to the Parties and their legal advisors, as are necessary or appropriate for transactions of this type. If Cephalon does not notify Alkermes of its desire to enter into such an exclusive license within the Option Period, or if at the end of the Option Period Alkermes and Cephalon are unable to agree on terms for such a definitive license, then Alkermes shall be free to use, sell, manufacture, offer for sale and import the Products in the ROW Territory itself or to initiate discussions and execute a license with one or more Third Parties to do so, with no further obligation to Cephalon under this Agreement. [**].
ROW Territory. In connection with the ROW Territory, Lilly shall pay Vertex royalties equal to that percentage of aggregate Net Sales of Drug Products in the ROW Territory calculated on an annual basis as follows, [*] attributable to such sales: [*] for that portion of ROW Net Sales that are less than [*]. [*] for that portion of ROW Net Sales that exceed [*] but are less than [*]. [*] for that portion of ROW Net Sales that exceed [*].
ROW Territory. (i) Chroma shall retain sponsorship of the clinical trial applications currently active in Europe. Except as required by applicable Law or Regulatory Authority, Chroma shall not withdraw any Regulatory Materials or Regulatory Approvals without prior consultation with and approval of CTI, which shall not be unreasonably withheld, delayed or conditioned.
(ii) Chroma shall Take the Lead and be the responsible party in consultation with CTI, for preparing, filing, holding and maintaining any and all Regulatory Materials for the Product in the ROW Territory associated with any IND or MAA for the Product or amendments or supplements thereto. Such Regulatory Materials and related Regulatory Approvals shall be owned solely by Chroma and held in its name, subject to CTI’s rights of reference under this Agreement. Chroma shall be primarily responsible, in consultation with CTI, for performing all activities required by such Regulatory Authority with respect to (1) maintaining the MAA submissions, maintaining the Regulatory Approval following its receipt, ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information has been filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. safety monitoring as further described in Section 5.5 below, promotional activities, compliance, and annual reporting to such Regulatory Authorities, as well as associated document retention, and (2) filing any and all Regulatory Materials for subsequent indications in the ROW Territory, and holding any such Regulatory Materials, amendments or supplements thereto. Chroma shall be responsible for any field alert reporting in the ROW Territory and CTI shall reasonably assist Chroma with its annual reporting obligations.
(iii) Upon the request of CTI, Chroma shall inform each applicable Regulatory Authority in the ROW Territory that one (1) or more representatives of CTI will attend and, to the extent permitted by applicable Law, participate in all major meetings between Chroma and such Regulatory Authority, subject to the confidentiality provisions set forth under Article 12. Chroma shall timely inform CTI of any such scheduled meetings, as soon as prac...
ROW Territory. Chroma, its Affiliates and sublicensees shall comply with all applicable Laws and guidelines in the ROW Territory applicable to the Commercialization of pharmaceutical products.
ROW Territory. (i) Cell Genesys shall retain sponsorship of the clinical trial applications currently active in Canada [*] and in Europe [*] and all filings associated therewith, and Takeda shall have the right to reference such Regulatory Materials pursuant to Section 5.6 below. Cell Genesys shall not withdraw such Regulatory Materials without prior consultation with and approval of Takeda.
(ii) Takeda shall be the responsible party in consultation with Cell Genesys, for preparing, filing and holding any and all Regulatory Materials for the Product in the ROW Territory associated with any MAA for the Product or amendments or supplements thereto, except as provided in Section 5.2(b)(i). Such Regulatory Materials and related Regulatory Approvals shall be owned solely by Takeda and held in its name, subject to Cell Genesys’ rights of reference under this Agreement.
(iii) Upon the request of Cell Genesys, Takeda shall inform each applicable Regulatory Authority in the ROW Territory that one (1) or more representatives of Cell Genesys will attend and, to the extent permitted by applicable Law, participate in all major
