Disclosure of Technical Information. 2.1. La Jolla and the Licensors shall provide to Paion and Licensed Subsidiaries all technical information in its and their possession and control relating to the Licensed Products, including without limitation Licensed Know-how and all Programme Data developed by or on behalf of Licensors, that is necessary or useful for Paion and Licensed Subsidiaries to use and otherwise exploit the Licensed Rights in accordance with this Agreement; provided that, in the case of any such technical information (including Know-How and Programme Data) that is owned by a Third Party, Licensors shall be obligated to provide such technical information only to the extent that the provision of such technical information does not breach any obligation or trigger a payment obligation under any agreement with a Third Party. Where reasonably requested by Paion or any Licensed Subsidiary, La Jolla and Licensors shall use good faith efforts to (a) request consent from such Third Parties and (b) secure amendments to any agreements with such Third Parties to the extent necessary to provide Paion and Licensed Subsidiaries all technical information (including Know-how and Programme Data) owned by such Third Parties that is necessary or useful for Paion and Licensed Subsidiaries to use and otherwise exploit the Licensed Rights in accordance with this Agreement, without breaching any obligations or triggering payment obligations under such agreements with Third Parties. La Jolla and the Licensors shall make such acknowledgements to Third Parties as Paion may reasonably request stating that Paion and its Affiliates are entitled to make exclusive use of the Licensed Know-how and Programme Data for the purpose of exercising their rights in accordance with this Agreement. La Jolla and the Licensors shall provide the technical and other information described in Clause 2.2 to Paion within thirty (30) days after the Commencement Date. 2.2. Such technical and other information to be provided by La Jolla and Licensors to Paion pursuant to Clause 2.1 shall include, without limitation, the latest versions of the following documents in La Jolla's, Licensors’ and/or their Affiliates' possession or control to the extent relating to the Licensed Products: 2.2.1. Investigational new drug applications to any regulatory authorities; 2.2.2. Phase I and II clinical reports; 2.2.3. Phase III protocol and related documents including case report forms and patient informed consent forms; 2.2.4. Investigator brochures; 2.2.5. Phase III clinical study reports; 2.2.6. New Drug Applications; 2.2.7. Supplementary New Drug Applications; 2.2.8. Label amendments along with clinical and regulatory submission support; 2.2.9. Stability reports; and
Appears in 1 contract
Sources: Confidentiality Agreement (La Jolla Pharmaceutical Co)
Disclosure of Technical Information. 2.14.1 Licensor shall disclose and furnish to Licensee all Technical Information necessary or essential for the incorporation and use of Liquid Polymer Material and SurgeTape in the manufacture, use and sale of the Licensed Products. La Jolla Disclosure of Technical Information, to the extent such Technical Information is in documentary or fixed form, shall be by delivery of two copies of the most recent versions thereof Delivery of Technical Information shall be completed in compliance with the schedule of Attachment 4. 1.
4.2 To the extent that Technical Information is not available in documentary or fixed form, disclosure shall be made by Licensor, at its expense, providing Technical Assistance to Licensee, including training and consultation normally sufficient to demonstrate the practical use of the Technical Information, and to communicate information applicable thereto in such detail as to reasonably permit Licensee to understand and make full use thereof in the establishment and operation of a production capability for Licensed Products, and to exercise the rights and licenses granted herein. Such Technical Assistance will be performed at the request of Licensee, consistent with the Technical Information delivery schedule of Attachment 4. 1, by qualified Licensor technical personnel, at Licensee's manufacturing plants and locations. During such visits, Licensor personnel shall observe such rules and regulations as are applicable to employees of Licensee, and Licensor shall indemnify Licensee from any liability which might be asserted or claimed against Licensee, arising out of said visits by Licensor's personnel, including personal injury to or property damage caused by such personnel. Licensee will provide, at no cost to Licensor, reasonable facilities for such training and Technical Assistance, including access to office space, secretarial support and local phone use for Licensor personnel engaged in such training and Technical Assistance. Notwithstanding Section 2.4 hereof, Licensee may not sublicense the rights contained in this Section 4.2 without the specific prior written approval of Licensor.
4.3 By arrangement with Licensor, Licensee may, at its expense, send qualified personnel to Licensor's establishment for training for the purpose of enabling Licensor to demonstrate and Licensee's employees to observe, the manufacturing and engineering operations and the Licensors shall provide to Paion application and Licensed Subsidiaries all technical information in its and their possession and control relating use of Technical Information pertaining to the Licensed Products, including without limitation Licensed Know-how . The identity and all Programme Data developed by or on behalf of Licensors, that is necessary or useful for Paion and Licensed Subsidiaries to use and otherwise exploit the Licensed Rights in accordance with this Agreement; provided that, in the case number of any such technical information (including Know-How personnel, and Programme Data) that is owned by a Third Party, Licensors the date and duration of each such visit shall be obligated such as Licensor and Licensee mutually agree. During such visits, Licensee's personnel shall observe such rules and regulations as are applicable to provide employees of Licensor, and Licensee shall indemnify Licensor from any liability which might be asserted or claimed against Licensor arising out of said visits by Licensee's personnel, including personal injury to or property damage caused by such technical information only personnel. Licensor will provide, at no cost to Licensee, reasonable facilities for such training, including access to office space, secretarial support and local phone use for Licensee's personnel engaged in such training.
4.4 After delivery of the Technical Information pursuant to Attachment 4, 1, Licensee's personnel may direct correspondence or telephone inquiries to Licensor's personnel requesting reasonable amounts of Technical Assistance and oral explanation concerning Licensor's method of manufacturing, Technical Information or operation of the Licensed Products, and Licensor agrees to promptly respond to such inquiries and to supply such assistance to the extent that it is in the provision possession of, or known to, Licensor, and at the place and times upon which the Parties may mutually agree.
4.5 Licensor agrees to promptly notify Licensee of such technical information does not breach any obligation defect or trigger a payment obligation under error discovered in the Technical Information, and of any agreement corrective action, revisions or customer notice made by Licensor with a Third Party. Where reasonably requested by Paion or any Licensed Subsidiary, La Jolla and Licensors shall use good faith efforts to (a) request consent from such Third Parties and (b) secure amendments to any agreements with such Third Parties to regard thereto.
4.6 During the extent necessary to provide Paion and Licensed Subsidiaries all technical information (including Know-how and Programme Data) owned by such Third Parties that is necessary or useful for Paion and Licensed Subsidiaries to use and otherwise exploit the Licensed Rights in accordance with term of this Agreement, without breaching Licensor shall promptly disclose and deliver to Licensee any obligations Improvements conceived or triggering payment obligations under such agreements with Third Partiesreduced to practice in whole or in part by Licensor. La Jolla and the Licensors shall make such acknowledgements Licensor also agrees to Third Parties as Paion may reasonably request stating that Paion and its Affiliates are entitled to make exclusive use of the Licensed Know-how and Programme Data for the purpose of exercising their rights in accordance with this Agreement. La Jolla and the Licensors shall provide the technical and other information described in Clause 2.2 to Paion within thirty (30) days after the Commencement Date.
2.2. Such technical and other promptly deliver sufficient information to be provided by La Jolla and Licensors allow Licensee to Paion pursuant to Clause 2.1 shall include, without limitation, the latest versions of the following documents in La Jolla's, Licensors’ and/or their Affiliates' possession or control to the extent relating to incorporate such Improvements into the Licensed Products:
2.2.1. Investigational new drug applications During the term of this Agreement, Licensee shall promptly deliver to Licensor any regulatory authorities;
2.2.2Improvements conceived or reduced to practice in whole or in part by Licensee. Phase I and II clinical reports;
2.2.3. Phase III protocol and related documents including case report forms and patient informed consent forms;
2.2.4. Investigator brochures;
2.2.5. Phase III clinical study reports;
2.2.6. New Drug Applications;
2.2.7. Supplementary New Drug Applications;
2.2.8. Label amendments along with clinical and regulatory submission support;
2.2.9. Stability reports; andLicensee also agrees to promptly deliver sufficient information to allow Licensor to incorporate such Improvements into the Licensed Products.
Appears in 1 contract
Disclosure of Technical Information. 2.14.1 Licensor shall disclose and furnish to Licensee all Technical Information necessary or essential for the incorporation and use of Liquid Polymer Material in the manufacture, use and sale of the Licensed Products. La Jolla Disclosure of Technical Information, to the extent such Technical Information is in documentary or fixed form, shall be by delivery of two copies of the most recent versions thereof. Delivery of Technical Information shall be completed in compliance with the schedule of Attachment 4.1.
4.2 To the extent that Technical Information is not available in documentary or fixed form, disclosure shall be made by Licensor, at its expense, providing Technical Assistance to Licensee, including training and consultation normally sufficient to demonstrate the practical use of the Technical Information, and to communicate information applicable thereto in such detail as to reasonably permit Licensee to understand and make full use thereof in the establishment and operation of a production capability for Licensed Products, and to exercise the rights and licenses granted herein. Such Technical Assistance will be performed at the request of Licensee, consistent with the Technical Information delivery schedule of Attachment 4.1, by qualified Licensor technical personnel, at Licensee's manufacturing plants and locations. During such visits, Licensor personnel shall observe such rules and regulations as are applicable to employees of Licensee, and Licensor shall indemnify Licensee from any liability which might be asserted or claimed against Licensee, arising out of said visits by Licensor's personnel, including personal injury to or property damage caused by such personnel. Licensee will provide, at no cost to Licensor, reasonable facilities for such training and Technical Assistance, including access to office space, secretarial support and local phone use for Licensor personnel engaged in such training and Technical Assistance. Notwithstanding Section 2.3 hereof, Licensee may not sublicense the rights contained in this Section 4.2 without the specific prior written approval of Licensor.
4.3 By arrangement with Licensor, Licensee may, at its expense, send qualified personnel to Licensor's establishment for training for the purpose of enabling Licensor to demonstrate and Licensee's employees to observe, the manufacturing and engineering operations and the Licensors shall provide to Paion application and Licensed Subsidiaries all technical information in its and their possession and control relating use of Technical Information pertaining to the Licensed Products, including without limitation Licensed Know-how . The identity and all Programme Data developed by or on behalf of Licensors, that is necessary or useful for Paion and Licensed Subsidiaries to use and otherwise exploit the Licensed Rights in accordance with this Agreement; provided that, in the case number of any such technical information (including Know-How personnel, and Programme Data) that is owned by a Third Party, Licensors the date and duration of each such visit shall be obligated such as Licensor and Licensee mutually agree. During such visits, Licensee's personnel shall observe such rules and regulations as are applicable to provide employees of Licensor, and Licensee shall indemnify Licensor from any liability which might be asserted or claimed against Licensor arising out of said visits by Licensee's personnel, including personal injury to or property damage caused by such technical information only personnel. Licensor will provide, at no cost to Licensee, reasonable facilities for such training, including access to office space, secretarial support and local phone use for Licensee's personnel engaged in such training.
4.4 After delivery of the Technical Information pursuant to Attachment 4.1, Licensee's personnel may direct correspondence or telephone inquiries to Licensor's personnel requesting reasonable amounts of Technical Assistance and oral explanation concerning Licensor's method of manufacturing, Technical Information or operation of the Licensed Products, and Licensor agrees to promptly respond to such inquiries and to supply such assistance to the extent that it is in the provision possession of, or known to, Licensor, and at the place and times upon which the Parties may mutually agree.
4.5 Licensor agrees to promptly notify Licensee of such technical information does not breach any obligation defect or trigger a payment obligation under error discovered in the Technical Information, and of any agreement corrective action, revisions or customer notice made by Licensor with a Third Party. Where reasonably requested by Paion or any Licensed Subsidiary, La Jolla and Licensors shall use good faith efforts to (a) request consent from such Third Parties and (b) secure amendments to any agreements with such Third Parties to regard thereto.
4.6 During the extent necessary to provide Paion and Licensed Subsidiaries all technical information (including Know-how and Programme Data) owned by such Third Parties that is necessary or useful for Paion and Licensed Subsidiaries to use and otherwise exploit the Licensed Rights in accordance with term of this Agreement, without breaching Licensor shall promptly disclose and deliver to Licensee any obligations Improvements conceived or triggering payment obligations under such agreements with Third Partiesreduced to practice in whole or in part by Licensor. La Jolla and the Licensors shall make such acknowledgements Licensor also agrees to Third Parties as Paion may reasonably request stating that Paion and its Affiliates are entitled to make exclusive use of the Licensed Know-how and Programme Data for the purpose of exercising their rights in accordance with this Agreement. La Jolla and the Licensors shall provide the technical and other information described in Clause 2.2 to Paion within thirty (30) days after the Commencement Date.
2.2. Such technical and other promptly deliver sufficient information to be provided by La Jolla and Licensors allow Licensee to Paion pursuant to Clause 2.1 shall include, without limitation, the latest versions of the following documents in La Jolla's, Licensors’ and/or their Affiliates' possession or control to the extent relating to incorporate such Improvements into the Licensed Products:
2.2.1. Investigational new drug applications During the term of this Agreement, Licensee shall promptly deliver to Licensor any regulatory authorities;
2.2.2Improvements conceived or reduced to practice in whole or in part by Licensee. Phase I and II clinical reports;
2.2.3. Phase III protocol and related documents including case report forms and patient informed consent forms;
2.2.4. Investigator brochures;
2.2.5. Phase III clinical study reports;
2.2.6. New Drug Applications;
2.2.7. Supplementary New Drug Applications;
2.2.8. Label amendments along with clinical and regulatory submission support;
2.2.9. Stability reports; andLicensee also agrees to promptly deliver sufficient information to allow Licensor to incorporate such Improvements into the Licensed Products.
Appears in 1 contract
Sources: Intellectual Property Rights License Agreement (Oryx Technology Corp)