REGULATORY AND OTHER INQUIRIES. Upon being contacted by the FDA or any drug regulatory agency for any regulatory purpose pertaining to this Agreement or to a Collaboration Product, Onyx and Warner shall immediately notify and consult with one another and Warner shall provide a response as it deems appropriate. Warner shall have sole responsibility for responding to all inquiries to Warner or Onyx regarding the benefits, side effects and other characteristics of Collaboration Products.
REGULATORY AND OTHER INQUIRIES. In the event KOSAN is manufacturing pursuant to Article 8 hereof, then upon being contacted by the FDA or any drug regulatory Agency for any regulatory purpose pertaining to this AGREEMENT or to a PRODUCT, KOSAN and LICENSEE shall promptly (within two (2) business days) notify and consult with one another and LICENSEE shall provide a response as it deems appropriate. LICENSEE shall have sole responsibility for responding to all inquiries to LICENSEE or KOSAN regarding the benefits, side effects and other characteristics of PRODUCTS. The party which is responsible for manufacturing the BULK PRODUCT form of the pertinent PRODUCT shall have the sole responsibility for responding to all inquiries regarding the manufacture of such BULK PRODUCT after consultation with the other party.
REGULATORY AND OTHER INQUIRIES. Upon being contacted by any Regulatory Authority for any regulatory purpose pertaining to this Agreement or to a Product, XOMA and Alexion shall promptly notify and consult with one another, and the owner (or proposed owner) of the relevant Regulatory Approval (or proposed Regulatory Approval), determined in accordance with Section 3.5, shall provide a response as it deems appropriate, and such Party shall have sole right and responsibility for responding to all inquiries to Alexion or XOMA, as the case may be, regarding the benefits, side effects and other characteristics of a Product.
REGULATORY AND OTHER INQUIRIES. Upon being contacted by the FDA or any drug regulatory agency for any regulatory purpose pertaining to this Agreement or to a Warner-LeukoSite Product, LeukoSite and Warner shall immediately notify and consult with one another and Warner shall provide a response as it deems appropriate. Warner shall have sole right and responsibility for responding to all inquiries to Warner 34 34 or LeukoSite regarding the benefits, side effects and other characteristics of Warner-LeukoSite Products.
REGULATORY AND OTHER INQUIRIES. Upon being contacted by the FDA or any drug regulatory Agency for any regulatory purpose pertaining to this Agreement or to a Collaboration Product, GenVec and Warner shall promptly (within two (2) business days) notify and consult with one another and Warner shall provide a response as it deems appropriate. Warner shall have sole responsibility for responding to all inquiries in the Territory to Warner or GenVec regarding the benefits, side effects and other characteristics of Collaboration Products. The Party which is responsible for manufacturing the Bulk Product form of the pertinent Collaboration Product shall have the sole responsibility for responding to all inquiries in the Territory regarding the manufacture of such Bulk Product form after consultation with the other Party.
REGULATORY AND OTHER INQUIRIES. Upon being contacted by any Regulatory Authority for any regulatory purpose pertaining to this Agreement or to the Licensed Product, each party shall promptly notify and consult with the other, and the party that prepared the relevant portion(s) of the regulatory filing to which such contact relates (or, in the event the contact does not relate to a particular portion of a regulatory filing, the owner (or proposed owner) of the relevant Regulatory Approval (or proposed Regulatory Approval), determined in accordance with Section 6.4 of the Collaboration Agreement) shall prepare a response as it deems appropriate, and such party shall (a) have principal responsibility for responding to all inquiries to either party, as the case may be, regarding such portion of such regulatory filing (or, in the event the contact does not relate to a particular portion of a regulatory filing, such Regulatory Approval or proposed Regulatory Approval), (b) give the other party a reasonable opportunity for prior review of and comment on all such responses, (c) consider in good faith the incorporation of such comments and (d) incorporate into such responses those of such comments as are reasonable and not inconsistent with the overall response initially prepared by such party.
REGULATORY AND OTHER INQUIRIES. 36 12.3 [*]...................................................................... 36 12.4 Access to Regulatory Filings............................................. 36 12.5 [*]...................................................................... 36
REGULATORY AND OTHER INQUIRIES. Upon being contacted by the FDA or ------------------------------ any drug regulatory Agency for any regulatory purpose pertaining to this Agreement or to a Collaboration Product, GenVec and Warner shall promptly (within two (2) business days) notify and consult with one another and Warner shall provide a response as it deems appropriate. Warner shall have sole responsibility for responding to all inquiries in the Territory to Warner or GenVec regarding the benefits, side effects and other characteristics of Collaboration Products. The Party which is responsible for manufacturing the Bulk Product form of the pertinent Collaboration Product shall have the sole responsibility for responding to all inquiries in the Territory regarding the manufacture of such Bulk Product form after consultation with the other Party. [*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. -35- [*]
REGULATORY AND OTHER INQUIRIES. Upon being contacted by the FDA or any drug regulatory agency for any regulatory purpose pertaining to this Agreement or to a Warner-LeukoSite Product, LeukoSite and Warner shall immediately notify and consult with one another and Warner shall provide a response as it deems appropriate. Warner shall have sole right and responsibility for responding to all inquiries to Warner or LeukoSite regarding the quality benefits, side effects and other characteristics of Warner-LeukoSite Products. LeukoSite shall not have contacts or communications with any governmental or regulatory authority regarding any Warner-LeukoSite Product or Warner Product without the prior written consent of Warner.
REGULATORY AND OTHER INQUIRIES. Upon the entry into a Joint Commercialization Agreement for an Optionable Development Candidate, the following rights and obligations will apply with respect to regulatory matters: It is understood that all regulatory applications, NDAs and Regulatory Approvals for Collaboration Products shall be ***. Upon being contacted by any Regulatory Agency for any regulatory purpose pertaining to this Agreement or to a Collaboration Product, each Party shall promptly notify and consult with the other, and *** hereunder.
