Xxxxxxx Activities. One of the objectives of the Project shall be for Abbott to develop and manufacture Bulk Drug Substance and to support ZymoGenetics’ Regulatory Filings as appropriate, however, ZymoGenetics shall be responsible forthe preparation and filing of Regulatory filings, and all communications with Regulatory Authorities, with respect to the Bulk Drug Substance. Abbott shall conduct and perform according to the work-plan set forth in Exhibit C as may be amended from time to time by the Parties to achieve such objectives, including, but not limited to, the following: a. Sourcing raw materials for use in manufacturing Bulk Drug Substance, with the price of such materials included in the price of the Project, excluding the [ * ] b. Performing pilot scale evaluation of ZymoGenetics’ manufacturing process; c. Adapting ZymoGenetics’ manufacturing process to Xxxxxx’x equipment and systems. In no event, without ZymoGenetics’ prior written approval and the Parties’ written agreement on licensing terms, xxxx Xxxxxx incorporate any proprietary procedures or processes (whether or not patented and including, without limitation, any Abbott Invention) into the manufacturing process that [ * ] designated portions of this document have been omitted pursuant to a request for confidential treatment filed separately with the Commission. would require ZymoGenetics’ to obtain a license (from Abbott or any Third Party) in order to practice such manufacture of any Bulk Drug Substance. In the event Abbott incorporates any such proprietary procedures or processes without first obtaining ZymoGenetics’ written consent, Abbott hereby grants to ZymoGenetics a royalty-free, irrevocable, worldwide, nonexclusive license (or sublicense, if applicable) (with the right to sublicense) to practice the proprietary procedures or processes; d. Developing [ * ] to manufacture Bulk Drug Substance in Xxxxxx’x manufacturing facility; e. Preparing suitable manufacturing process documentation, including instructions and manufacturing controls for inclusion in Regulatory Filings; f. Provide the Bulk Drug Substance information directly to ZymoGenetics in support of Regulatory Filings, and assisting ZymoGenetics in responding to questions from Regulatory Authorities concerning the manufacture of Bulk Drug Substance; g. Conducting material contact and cleaning validation studies, engineering and validation runs, process validation studies, and preparing process justification and validation summary reports, in a mutually agreed upon timely manner, to meet pre-approval and other appropriate inspection requirements of the Regulatory Authorities and to support approval of the manufacture of the Bulk Drug Substance in the Abbott manufacturing facility; h. Permitting ZymoGenetics to conduct all necessary cGMP and quality assurance reviews of Abbott documentation, including review and receipt of copies of Abbott manufacturing work orders; i. Permitting ZymoGenetics to access Xxxxxx’x manufacturing data relating to Bulk Drug Substance; j. Providing ZymoGenetics with acceptable environmental impact statements, if required, for inclusion with Regulatory Filings; k. Providing ZymoGenetics with appropriate pilot and commercial scale batch record manufacturing documentation for Regulatory Filings; l. Conducting [ * ] on Bulk Drug Substance as defined in Exhibit C; m. Preparation for and administration of the pre-approval inspection (and any other necessary inspections) by the Regulatory Authorities; and n. Subject to Section 2.1, manufacturing development supplies, clinical supplies, stability supplies and process validation batches of Bulk Drug Substance in accordance with current cGMP’s and pursuant to protocols to which the Parties shall mutually agree. [ * ] designated portions of this document have been omitted pursuant to a request for confidential treatment filed separately with the Commission.
Appears in 2 contracts
Samples: Development and Supply Agreement, Development and Supply Agreement (Zymogenetics Inc)
Xxxxxxx Activities. One of the objectives of the Project shall be for Abbott to develop and manufacture Bulk Drug Substance and to support ZymoGeneticsSeattle Genetics’ Regulatory Filings as appropriate, however, ZymoGenetics Seattle Genetics shall be responsible forthe for the preparation and filing of Regulatory filingsFilings, and all communications with Regulatory Authorities, with respect to the Bulk Drug Substance. Abbott shall conduct and perform according to its obligations on the work-Project plan set forth in Exhibit C as may be amended from time to time by mutual agreement of the Parties to achieve such objectives, including, but not limited to, the following:: [***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
a. Sourcing raw materials resins, disposable process components, reagents and testing supplies for use in manufacturing Bulk Drug Substance, with provided that Seattle Genetics is responsible for the price cost of such materials included in the price of the Project, excluding the [ * ]raw materials;
b. Performing pilot scale evaluation of ZymoGeneticsSeattle Genetics’ manufacturing process;
c. Adapting ZymoGeneticsSeattle Genetics’ manufacturing process to Xxxxxx’x equipment and systems. In no event, without ZymoGenetics’ prior written approval and the Parties’ written agreement on licensing terms, xxxx Xxxxxx incorporate any proprietary procedures or processes (whether or not patented and including, without limitation, any Abbott Invention) into the manufacturing process that [ * ] designated portions of this document have been omitted pursuant to a request for confidential treatment filed separately with the Commission. would require ZymoGenetics’ to obtain a license (from Abbott or any Third Party) in order to practice such manufacture of any Bulk Drug Substance. In the event Abbott incorporates any such proprietary procedures or processes without first obtaining ZymoGenetics’ written consent, Abbott hereby grants to ZymoGenetics a royalty-free, irrevocable, worldwide, nonexclusive license (or sublicense, if applicable) (with the right to sublicense) to practice the proprietary procedures or processes;
d. Developing [ * ] optimized process parameters to manufacture Bulk Drug Substance in Xxxxxx’x manufacturing facility;
e. Preparing suitable manufacturing process documentation, including instructions and manufacturing controls for inclusion in Regulatory Filings;
f. Provide the Bulk Drug Substance information directly to ZymoGenetics Seattle Genetics in support of Regulatory Filings, and assisting ZymoGenetics Seattle Genetics in responding to questions from Regulatory Authorities concerning the manufacture of Bulk Drug Substance;
g. Conducting material contact and cleaning validation studies, engineering and validation runs, process validation studies, and preparing process justification and validation summary reports, in a mutually agreed upon timely manner, to meet pre-approval and other appropriate inspection requirements of the Regulatory Authorities and to support approval of the manufacture of the Bulk Drug Substance in the an Abbott manufacturing facility;
h. Permitting ZymoGenetics Seattle Genetics to conduct all necessary cGMP and quality assurance reviews of Abbott documentation, including review and receipt of copies of Abbott manufacturing work ordersBatch Records;
i. Permitting ZymoGenetics Seattle Genetics to access Xxxxxx’x manufacturing data relating to Bulk Drug Substance;
j. Providing ZymoGenetics Seattle Genetics with acceptable environmental impact statements, if required, for inclusion with Regulatory Filings;
k. Providing ZymoGenetics Seattle Genetics with appropriate pilot and commercial scale batch record manufacturing documentation for Regulatory FilingsFilings and other uses in accordance with the Quality Agreement;
l. Conducting [ * ] on Bulk Drug Substance as defined in Exhibit C;
m. Preparation for and administration of the pre-approval inspection (and any other necessary inspections) by the Regulatory Authorities; and
n. m. Subject to Section 2.1, manufacturing development supplies, clinical supplies, stability supplies and process validation batches of Bulk Drug Substance in accordance with current cGMP’s cGMPs and pursuant to protocols to which the Parties shall mutually agree. [ * ] designated portions of this document have been omitted pursuant to a request for confidential treatment filed separately with the Commissionagree in writing.
Appears in 1 contract
Samples: Development and Supply Agreement (Seattle Genetics Inc /Wa)
Xxxxxxx Activities. One of the objectives of the Project shall be for Abbott to develop and manufacture Bulk Drug Substance and to support ZymoGenetics’ Regulatory Filings as appropriate, however, ZymoGenetics shall be responsible forthe preparation and filing of Regulatory filings, and all communications with Regulatory Authorities, with respect to the Bulk Drug Substance. Abbott shall use its reasonable best efforts to conduct and perform according to the work-plan set forth in Exhibit C as may be amended from time to time by the Parties to achieve such objectives, certain activities including, but not limited tolimited, to the following:
a. Sourcing Source raw materials for use in manufacturing Bulk Drug Substance, with the price of such materials included in the price of the Project, excluding the [ * ]ECBN-HCl and API;
b. Performing Chemically synthesize the ECBN-HCl to form the API;
c. Perform pilot scale evaluation of ZymoGenetics’ Versicor’s manufacturing process;
c. Adapting ZymoGenetics’ d. Adapt Versicor’s manufacturing process to Xxxxxx’x equipment and systems. In no event, without ZymoGenetics’ prior written approval and the Parties’ written agreement on licensing terms, xxxx Xxxxxx incorporate any proprietary procedures or processes (whether or not patented and including, without limitation, any Abbott Invention) into the manufacturing process that [ * ] designated portions of this document have been omitted pursuant to a request for confidential treatment filed separately with the Commission. would require ZymoGenetics’ to obtain a license (from Abbott or any Third Party) in order to practice such manufacture of any Bulk Drug Substance. In the event Abbott incorporates any such proprietary procedures or processes without first obtaining ZymoGenetics’ written consent, Abbott hereby grants to ZymoGenetics a royalty-free, irrevocable, worldwide, nonexclusive license (or sublicense, if applicable) (with the right to sublicense) to practice the proprietary procedures or processes;
d. Developing [ * ] e. Develop process parameters to manufacture Bulk Drug Substance ECBN-HCl and API in Xxxxxx’x manufacturing facility;
e. Preparing f. Prepare suitable manufacturing process documentation, including instructions and manufacturing controls for inclusion in Regulatory Filings;
f. g. Provide appropriate Regulatory Authorities with letters of authorization referencing Xxxxxx'x DMF and containing process validation data, batch documents and other data required to support Regulatory Filings and to provide timely notice to Versicor of any significant changes in Xxxxxx’x process development and production activities (whether or not referred to herein) to enable Versicor to amend the Bulk Drug Substance information directly appropriate Regulatory Filings and to ZymoGenetics in support of Regulatory Filings, and assisting ZymoGenetics assist Versicor in responding to questions from Regulatory Authorities concerning the manufacture of Bulk Drug SubstanceECBN-HCl and API;
g. Conducting h. Conduct material contact and cleaning validation studies, engineering and validation runs, process validation studies, and preparing process justification and validation summary reports, in a mutually agreed upon timely manner, to meet pass FDA pre-approval and other appropriate inspection requirements of the Regulatory Authorities and Authority inspections to support approval of the manufacture of the Bulk Drug Substance ECBN-HCl and API in the Abbott manufacturing facility, and either (i) provide Versicor with copies of such reports and studies, in a timely manner to enable Versicor to make all appropriate Regulatory Filings, or (ii) allow Versicor to refer to Xxxxxx’x Type II DMF containing such information and permitting Versicor to have access to such documents;
h. Permitting ZymoGenetics i. Permit Versicor to conduct all necessary cGMP and quality assurance reviews of Abbott documentationfacilities and documentation in accordance with Section 8.4 hereof, including review and receipt of copies of Abbott manufacturing work orders;
i. Permitting ZymoGenetics instructions (both prior to access and after the manufacturing process), and to provide notice to Versicor so as to permit Versicor to have a representative in Xxxxxx’x manufacturing data relating to Bulk Drug Substanceplant at the time of critical operations upon the mutual agreement of the parties, which consent by Abbott shall not be unreasonably withheld and at Versicor’s cost;
j. Providing ZymoGenetics Permit Versicor to use and access Xxxxxx’x data and development reports, including, but not limited to, the DMF and compounds as they relate solely to the manufacture of ECBN-HCl and API;
k. Provide Versicor with acceptable environmental impact statements, if required, statements for inclusion with Regulatory Filings, if required;
k. Providing ZymoGenetics l. Provide Versicor with appropriate pilot and commercial scale batch record manufacturing documentation for Regulatory Filings;
l. Conducting [ * ] m. Conduct all stability testing on Bulk Drug Substance as defined in Exhibit CECBN-HCl and/or API and compile data for Regulatory Filings;
m. Preparation for n. Prepare and administration of administer the FDA pre-approval inspection (and any other necessary inspections) by the Regulatory Authoritiesinspection; and
n. Subject to Section 2.1, manufacturing o. Manufacture development supplies, clinical supplies, stability supplies and process validation batches of Bulk Drug Substance ECBN-HCl and/or API in accordance with current cGMP’s cGMPs and pursuant to protocols to which the Parties parties shall mutually agree. [ * ] designated portions of this document have been omitted pursuant to a request for confidential treatment filed separately with the Commission.
Appears in 1 contract
Xxxxxxx Activities. One of the objectives The objective of the Project shall be for Abbott to develop and manufacture Bulk Drug Substance and to support ZymoGenetics’ InterMune's Regulatory Filings as appropriate. Therefore, however, ZymoGenetics shall be responsible forthe preparation and filing of Regulatory filings, and all communications with Regulatory Authorities, with respect to the Bulk Drug Substance. Abbott shall conduct and perform according to the work-plan set forth in Exhibit C as may what will be amended from time to time by the Parties reasonably anticipated to achieve such objectives, including, but not limited to, the following:
a. (a) Sourcing raw materials for use in manufacturing Bulk Drug Substance, with the price of such materials included in the price of the Project, excluding the [ * ];
b. (b) Performing pilot scale evaluation of ZymoGenetics’ InterMune's manufacturing process;
c. (c) Adapting ZymoGenetics’ InterMune's manufacturing process to Xxxxxx’x Xxxxxx'x equipment and systems. In no event, without ZymoGenetics’ prior written approval and the Parties’ written agreement on licensing terms, xxxx Xxxxxx incorporate any proprietary procedures or processes (whether or not patented and including, without limitation, any Abbott Invention) into the manufacturing process that [ * ] designated portions of this document have been omitted pursuant to a request for confidential treatment filed separately with the Commission. would require ZymoGenetics’ to obtain a license (from Abbott or any Third Party) in order to practice such manufacture of any Bulk Drug Substance. In the event Abbott incorporates any such proprietary procedures or processes without first obtaining ZymoGenetics’ written consent, Abbott hereby grants to ZymoGenetics a royalty-free, irrevocable, worldwide, nonexclusive license (or sublicense, if applicable) (with the right to sublicense) to practice the proprietary procedures or processes;
d. (d) Developing [ * ] commercial process parameters to manufacture Bulk Drug Substance in Xxxxxx’x Xxxxxx'x manufacturing facility;
e. (e) Preparing suitable manufacturing process documentationinstructions, including instructions and manufacturing controls and quality documents for inclusion in the CMC section of Regulatory Filings;
f. Provide the Bulk Drug Substance information directly (f) Providing appropriate Regulatory Authorities with letters of authorization referencing Xxxxxx'x DMF and containing process validation data, batch documents and other data required to ZymoGenetics in support of and enable Regulatory Filings, Filings and assisting ZymoGenetics to assist InterMune in responding to questions from Regulatory Authorities concerning the manufacture of Bulk Drug Substance;
g. (g) Conducting material contact and cleaning validation studies, engineering and validation runs, process validation studies, and preparing process justification and validation summary reports, in a mutually agreed upon timely manner, to meet pass FDA pre-approval and other appropriate inspection requirements of the Regulatory Authorities and Authority inspections to support approval of the manufacture of the Bulk Drug Substance in the Abbott manufacturing facility;
h. (h) Permitting ZymoGenetics InterMune to conduct all necessary [*] cGMP and quality assurance reviews of Abbott documentation, including review and receipt of copies of Abbott manufacturing work orders;
i. (i) Permitting ZymoGenetics InterMune to access Xxxxxx’x manufacturing data relating [*] and compounds as they relate to Bulk Drug SubstanceSubstance manufacture only;
j. (j) Providing ZymoGenetics InterMune with acceptable environmental impact statements, if required, statements for inclusion with Regulatory Filings, if required;
k. (k) Providing ZymoGenetics InterMune with appropriate pilot and commercial scale batch record manufacturing documentation for Regulatory Filings;
l. (l) Conducting [ * ] stability testing on Bulk Drug Substance as defined in Exhibit Cand compiling data for Regulatory Filing;
m. (m) Preparation for and administration of the FDA pre-approval inspection inspection;
(and any other necessary inspectionsn) by the Regulatory Authorities; and
n. Subject to Section 2.1, manufacturing Manufacturing development supplies, clinical supplies, stability supplies and process validation batches of Bulk Drug Substance in accordance with current cGMP’s 's and pursuant to protocols [*]
(o) [*] the clinical and marketed Bulk Drug Substance as agreed upon in the Proposal; and
(p) [*] Project progress reports will be provided, in addition to which timely meetings, mutually agreed upon by the Parties shall mutually agreeparties, with InterMune to communicate key activities, updates, changes, etc. [ * ] designated portions of this document have been omitted pursuant to a request for confidential treatment filed separately with the CommissionProject.
Appears in 1 contract
