Common use of Regulatory Approval Filings Clause in Contracts

Regulatory Approval Filings. Regulatory Approval filings in the Territory for the Collaboration Products and for the facilities used to manufacture such Collaboration Products shall be filed in the name of an entity determined by the Steering Committee. The entity in whose name such Regulatory Approval filings are filed shall give each of the Parties a right of reference in such filings if such right is not prohibited under the applicable Regulatory Scheme. Prior to submission to the FDA, the Parties, through the Program Management Team, shall consult, cooperate in preparing and mutually agree on the content and scope of the Regulatory Approval filings. In the event that Regulatory Approvals are required to be filed in the name of an entity other than Dyax, Genzyme or Kallikrein LLC, the Steering Committee shall ensure that a duly authorized officer of such entity agrees in writing that (a) such entity shall hold the licenses issued in respect of such Regulatory Approval filings, maintain control over the manufacturing facilities, equipment and personnel, and engage in pharmacovigilence to the extent required by the Regulatory Scheme, (b) such entity shall maintain compliance with applicable Regulatory Schemes, (c) such entity shall provide manufacturing and supply services at the Fully Absorbed Cost of Goods of Collaboration Products so manufactured and supplied, (d) the Parties shall have an irrevocable right of access and reference to such Regulatory Approval filings, licenses and facilities and (e) such entity agrees to comply with the provisions of Article 13 hereof with respect to the ownership and/or disposition of such Regulatory Approvals in the event this Agreement is terminated and to provide the level of cooperation described in Section 14.1 hereof in connection therewith.

Regulatory Approval Filings. Regulatory Approval filings in the Territory for the Collaboration Products and for the facilities used to manufacture such Collaboration Products shall be filed in the name of an entity determined ATIII LLC or, if required with respect to filings to be made with governmental authorities or deemed to be in the best interest of the Parties by the Steering Committee. The , in the name of such other entity in whose name as may be agreed upon by the Steering Committee (such Regulatory Approval as filings are filed shall give each of the Parties a right of reference in such filings if such right is not prohibited under the applicable Regulatory Schemewith European regulatory authorities). Prior to submission to the FDA, the Parties, through the Program Management Team, shall consult, cooperate in preparing and mutually agree on the content and scope of the Regulatory Approval filings. In the event that Regulatory Approvals are required to be filed in the name of an entity other than Dyax, Genzyme or Kallikrein ATIII LLC, the Steering Committee shall ensure that a duly authorized officer of such entity agrees in writing that (a) such entity shall hold the licenses issued in respect of such Regulatory Approval filings, filings and maintain control over the manufacturing facilities, facilities and equipment and personnel, and engage in pharmacovigilence to the extent required by the Regulatory Scheme, (b) such entity shall maintain compliance with applicable Regulatory Schemes, (c) such entity shall provide manufacturing and supply services to ATIII LLC (i) at the Fully Absorbed Cost of Goods of Collaboration Products so manufactured and suppliedsupplied and (ii) in accordance with the terms and conditions set forth in Article 7 hereof, and shall reimburse ATIII LLC for any New Facility Costs incurred in connection with the use of such facilities for the manufacture and supply of such Collaboration Products, (dc) the Parties shall have an irrevocable right of access and reference to such Regulatory Approval filings, licenses and facilities and (ed) such entity agrees to comply with the provisions of Article 13 hereof with respect to the ownership and/or disposition of such Regulatory Approvals in the event this Agreement is terminated and to provide the level of cooperation described in Section 14.1 hereof in connection therewith.

Regulatory Approval Filings. Regulatory Approval filings in the Territory for the Collaboration Products and for the facilities used to manufacture such Collaboration Products shall be filed in the name of an entity determined Diacrin/Genzyme LLC to the extent permitted by the Biologics Regulatory Scheme and otherwise in the name of such other Party as the Steering Committee. The entity in whose name such Regulatory Approval filings are filed Committee shall give each of the Parties a right of reference in such filings if such right is not prohibited under the applicable Regulatory Schemedetermine. Prior to submission to the FDA, the Parties, through the Program Management Team, shall consult, cooperate in preparing and mutually agree on the content and scope of the Regulatory Approval filings. In If and for so long as the event that Biologics Regulatory Scheme does not permit Diacrin/Genzyme LLC to file and own all Regulatory Approvals are required to in its own name, (i) Regulatory Approval filings shall be filed made in the name of an entity such other than Dyax, Genzyme or Kallikrein LLC, Party as may be designated by the Steering Committee shall ensure that a duly authorized officer of such entity agrees in writing that Committee, (aii) such entity designated Party shall hold the licenses issued in respect of such Regulatory Approval filings, filings and maintain control over the manufacturing facilities, facilities and equipment and personnel, and engage in pharmacovigilence to the extent required by the Biologics Regulatory Scheme, (biii) such entity shall maintain compliance with applicable Regulatory Schemes, (c) such entity designated Party shall provide manufacturing and supply services to Diacrin/Genzyme LLC (a) at the Fully Absorbed Cost of Goods ******************************** of Collaboration Products so manufactured and suppliedsupplied and (b) in accordance with the terms and conditions set forth in Article 7 and shall be reimbursed for any Dedicated Facility Costs incurred in connection with the use of such facilities for the manufacture and supply of such Collaboration Products, and (div) Diacrin/Genzyme LLC and the Parties other Party shall have an a permanent and irrevocable right of access and reference to such Regulatory Approval filings, licenses and facilities and (e) such entity agrees to comply with the provisions of Article 13 hereof with respect to the ownership and/or disposition of such Regulatory Approvals in the event this Agreement is terminated and to provide the level of cooperation described in Section 14.1 hereof in connection therewithfacilities.

Regulatory Approval Filings. Regulatory Approval filings in the --------------------------- Territory for the Collaboration Products and for the facilities used to manufacture such Collaboration Products shall be filed in the name of an entity determined BioMarin/Genzyme LLC or, if required with respect to filings to be made with governmental authorities or deemed to be in the best interest of the Parties by the Steering Committee. The , in the name of such other entity in whose name as may be agreed upon by the Steering Committee (such Regulatory Approval as filings are filed shall give each of the Parties a right of reference in such filings if such right is not prohibited under the applicable Regulatory Schemewith European regulatory authorities). Prior to submission to the FDA, the Parties, through the Program Management Team, shall consult, cooperate in preparing and mutually agree on the content and scope of the Regulatory Approval filings. In the event that Regulatory Approvals are required to be filed in the name of an entity other than Dyax, BioMarin/Genzyme or Kallikrein LLC, the Steering Committee shall ensure that a duly authorized officer of such entity agrees in writing that (a) such entity shall hold the licenses issued in respect of such Regulatory Approval filings, maintain control over the manufacturing facilities, equipment and personnel, and engage in pharmacovigilence to the extent required by the Regulatory Scheme, (b) such entity shall maintain compliance with applicable Regulatory Schemes, (c) such entity shall provide manufacturing and supply services to BioMarin/Genzyme LLC at the Fully Absorbed Cost of Goods of Collaboration Products so manufactured and supplied, (d) the Parties shall have an irrevocable right of access and reference to such Regulatory Approval filings, licenses and facilities and (e) such entity agrees to comply with the provisions of Article 13 hereof with respect to the ownership and/or disposition of such Regulatory Approvals in the event this Agreement is terminated and to provide the level of cooperation described in Section 14.1 hereof in connection therewith.

Regulatory Approval Filings. Except as set forth in the Manufacturing, Marketing and Sales Agreement, Regulatory Approval filings in the Territory for the Collaboration Products and for the facilities used to manufacture such Collaboration Products shall be filed in the name of an entity determined BioMarin/Genzyme LLC or, if required with respect to filings to be made with governmental authorities or deemed to be in the best interest of the Parties by the Steering Committee. The , in the name of such other entity in whose name as may be agreed upon by the Steering Committee (such Regulatory Approval as filings are filed shall give each of the Parties a right of reference in such filings if such right is not prohibited under the applicable Regulatory Schemewith European regulatory authorities). Prior to submission to the FDA, the Parties, through the Program Management Team, shall consult, cooperate in preparing and mutually agree on the content and scope of the such Regulatory Approval filings. In the event that Regulatory Approvals are required to be filed in the name of an entity other than Dyax, BioMarin/Genzyme or Kallikrein LLC, the Steering Committee shall ensure that a duly authorized officer of such entity agrees in writing that (a) such entity shall hold the licenses issued in respect of such Regulatory Approval filings, maintain control over the manufacturing facilities, equipment and personnel, and engage in pharmacovigilence to the extent required by the Regulatory Scheme, (b) such entity shall maintain compliance with applicable Regulatory Schemes, (c) such entity shall provide manufacturing and supply services to BioMarin/Genzyme LLC at the Fully Absorbed Cost of Goods of Collaboration Products so manufactured and supplied, (d) the Parties shall have an irrevocable right of access and reference to such Regulatory Approval filings, licenses and facilities and (e) such entity agrees to comply with the provisions of Article 13 hereof 12 of the Manufacturing, Marketing and Sales Agreement with respect to the ownership and/or disposition of such Regulatory Approvals in the event this Agreement is terminated and to provide the level of cooperation described in Section 14.1 hereof in connection therewith.

Regulatory Approval Filings. Except as set forth in the Manufacturing, Marketing and Sales Agreement, Regulatory Approval filings in the Territory for the Collaboration Products and for the facilities used to manufacture such Collaboration Products shall be filed in the name of an entity determined BioMarin/Genzyme LLC or, if required with respect to filings to be made with governmental authorities or deemed to be in the best interest of the Parties by the Steering Committee. The , in the name of such other entity in whose name as may be agreed upon by the Steering Committee (such Regulatory Approval as filings are filed shall give each of the Parties a right of reference in such filings if such right is not prohibited under the applicable Regulatory Schemewith European regulatory authorities). Prior to submission to the FDA, the Parties, through the Program Management Team, shall consult, cooperate in preparing and mutually agree on the content and scope of the such Regulatory Approval filings. In the event that Regulatory Approvals are required to be filed in the name of an entity other than Dyax, BioMarin/Genzyme or Kallikrein LLC, the Steering Committee shall ensure that a duly authorized officer of such entity agrees in writing that (a) such entity shall hold the licenses issued in respect of such Regulatory Approval filings, maintain control over the manufacturing facilities, equipment and personnel, and engage in pharmacovigilence to the extent required by the Regulatory Scheme, (b) such entity shall maintain compliance with applicable Regulatory Schemes, (c) such entity shall provide manufacturing and supply services to BioMarin/Genzyme LLC at the Fully Absorbed Cost of Goods of Collaboration Products so manufactured and supplied, (d) the Parties shall have an irrevocable right of access and reference to such Regulatory Approval filings, licenses and facilities and (e) such entity agrees to comply with the provisions of Article 13 hereof 12 of the Manufacturing, Marketing and Sales Agreement with respect to the [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. ownership and/or disposition of such Regulatory Approvals in the event this Agreement is terminated and to provide the level of cooperation described in Section 14.1 hereof in connection therewith.

Regulatory Approval Filings. Regulatory Approval filings in the Territory for the Collaboration Products and for the facilities used to manufacture such Collaboration Products shall be filed in the name of an entity determined by the Steering Committee. The entity Party conducting clinical trials for such Collaboration Product(s) in whose the case of INDs, and in the name of the applicable Marketing Party of such Regulatory Approval Collaboration Product(s), in the case of NDAs or, if required with respect to filings are filed shall give each to be made with governmental authorities or deemed to be in the best interest of the Parties a right by the JSC, in the name of reference in such other Third Party as may be agreed upon by the JSC (such as filings if such right is not prohibited under the applicable with European Regulatory SchemeAuthorities). Prior to submission to the FDA, the Parties, through the Program Management TeamJSC, shall consult, cooperate in preparing and mutually agree on the content and scope of the Regulatory Approval filings. In the event that Regulatory Approvals are required to be filed in the name of an entity other than Dyax, Genzyme or Kallikrein LLCa Party hereto, the Steering Committee JSC shall ensure that a duly authorized officer of such entity agrees in writing that (a) such entity shall hold holds the licenses issued in respect of such Regulatory Approval filings, maintain maintains control over the manufacturing facilities, equipment and personnel, and engage engages in pharmacovigilence to the extent required by the Regulatory Scheme, (b) such entity shall maintain maintains compliance with applicable Regulatory Schemes, (c) such entity shall provide provides manufacturing and supply services to the Marketing Party at the Fully Absorbed Cost of Goods of Collaboration Products so manufactured and supplied, (d) provides the Parties shall have with an irrevocable right of access and reference to such Regulatory Approval filings, licenses and facilities and facilities, (e) assigns such entity agrees Regulatory Approval filings to comply a Party, or the Parties, upon request, and (f) complies with the provisions of Article 13 XV hereof with respect to the ownership and/or disposition of such Regulatory Approvals in the event this Agreement is terminated and to provide provides the level of cooperation described in Section 14.1 15.6 hereof in connection therewith.