Transfer of Licensed Know-How and Licensed Materials. Amgen shall transfer to Company (or, in the case of Amgen’s transfer of the Amgen Cell Line, to the Permitted CMO) the Licensed Know-How listed on the Licensed Know-How Schedule and the Licensed Materials listed on the Licensed Materials Schedule, in accordance with a schedule to be mutually agreed by the Parties (provided such transfer must be completed within [*] after the Closing Date), and provide limited consulting support, in accordance with this Section 2.4 (Transfer of Licensed Know-How and Licensed Materials). Following the Signing Date, the Parties will in good faith reasonably cooperate to review and, if necessary, update the Licensed Know-How and Licensed Materials Schedules to correct and/or supplement such Schedules (and, as necessary, timely deliver the relevant Licensed Know-How and Materials to the Company. 2.4.1 Amgen shall provide, at its expense, consulting support (not to exceed [*] in the aggregate) in connection with such transfer and the Exploitation of the Product in the Territory during the [*] period after the Closing Date. If Company requires additional consulting support in excess of [*] in the aggregate or beyond such period after the Closing Date in connection with such transfer or the Exploitation of the Product in the Territory, then Company may request such additional support in writing. Amgen shall notify Company within [*] after receipt of such request whether it, in its sole discretion, is willing to provide such additional consulting support, which support shall be at Company’s expense, at the FTE Rate for the relevant Amgen employees. 2.4.2 With respect to Amgen’s transfer of the Amgen Cell Line, the Parties agree that the following procedures shall apply: (a) Prior to such transfer, Company shall designate, and enter into a binding agreement with, one of the Permitted CMOs, which agreement shall provide for, among other things, (i) confidentiality and non-use provisions at least as protective as those set forth hereunder under Section 9.1 (Confidential Information) and (ii) such additional provisions as are required to comply with the manufacturing and other limitations set forth in this Section 2.4.2 (such agreement, the “Permitted CMO Agreement”). Upon Amgen’s reasonable request, Company shall provide to Amgen a copy of any such Permitted CMO Agreement (including any material amendment thereto) executed by Company; provided that the financial terms (and any other terms Company is required to keep confidential) of any such agreement may be redacted to the extent not pertinent to Amgen’s confirmation of the restrictive provisions set forth in this Section 2.4.2. Notwithstanding anything to the contrary, Company and Company’s Sublicensees are deemed Permitted CMOs, and shall not be required to enter into a Permitted CMO Agreement prior to receiving the Amgen Cell Line or conducting any manufacturing activities in connection therewith, and Amgen shall deliver such cell lines to Company and/or Company’s Sublicensees within a reasonable time following Company’s written request. For avoidance of doubt, if Company (itself, or through a third party, Affiliate, or Sublicensee) [*] (excluding any [*], but including any [*]) [*], such [*] shall [*], and the Permitted CMO restrictions set forth herein shall [*]. (b) Following Company’s and such Permitted CMG’s entry into the Permitted CMO Agreement, Amgen shall, at the direction of Company, transfer the Amgen Cell Line to the Permitted CMO to generate the Product. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. (c) Company agrees that it shall not, and it shall use its commercially reasonable efforts to cause the Permitted CMO not to: (i) reverse engineer or otherwise deconstruct the Amgen Cell Line or the initial Amgen cell culture media provided therewith, or to determine or to seek to determine information (including, but not limited to, the gene or amino acid sequence) or characteristics regarding the Amgen Cell Line or such media, other than as expressly required to manufacture the Product; (ii) clone, express, or otherwise produce any products or materials (including, without limitation, any progeny or derivatives thereof) from the Amgen Cell Line, other than as expressly permitted under this Agreement; (iii) notwithstanding anything to the contrary in Section 9.4.1 (Right to Publish), publish or otherwise publicly disclose the Amgen Cell Line; or (iv) permit any non-controlled security access to the Amgen Cell Line or otherwise transfer or provide any of the Amgen Cell Line to a Third Party or any of its Affiliates, other than as expressly required to manufacture the Product. (d) Upon a termination or expiration of the Permitted CMO Agreement (including as a result of the appointment, with prior written notice to Amgen, by Company of a replacement Permitted CMO), the Permitted CMO shall promptly return any remaining Amgen Cell Lines and related Licensed Know-How and Licensed Materials to Amgen. If, at any time, Company desires to add a new Third Party commercial manufacturer to the Permitted CMO Schedule, it shall notify Amgen in writing (a “Permitted CMO Request”), and Amgen shall have the right, for [*] after receipt of such Permitted CMO Request, to inspect, at a reasonable time and on a reasonable basis (at Amgen’s cost), such manufacturer’s facilities to confirm its ability to fully comply with the restrictive provisions set forth in this Section 2.4.
Appears in 3 contracts
Samples: Exclusive License Agreement (Atara Biotherapeutics, Inc.), Exclusive License Agreement (Atara Biotherapeutics, Inc.), Exclusive License Agreement (Atara Biotherapeutics, Inc.)
Transfer of Licensed Know-How and Licensed Materials. Amgen shall transfer to Company (or, in the case of Amgen’s transfer of the Amgen Cell LineLines, to the Permitted CMO) the Licensed Know-How listed on the Licensed Know-How Schedule and the Licensed Materials listed on the Licensed Materials Schedule, in accordance with a schedule to be mutually agreed by the Parties (provided such transfer must be completed within [*] after the Closing Date), and provide limited consulting support, in accordance with this Section 2.4 (Transfer of Licensed Know-How and Licensed Materials). Following the Signing Date, the Parties will in good faith reasonably cooperate to review and, if necessary, update the Licensed Know-How and Licensed Materials Schedules to correct and/or supplement such Schedules (and, as necessary, timely deliver the relevant Licensed Know-How and Materials to the Company.
2.4.1 Amgen shall provide, at its expense, consulting support (not to exceed [*] in the aggregate) in connection with such transfer and the Exploitation of the Product Products in the Territory during the [*] period after the Closing Date. If Company requires additional consulting support in excess of [*] in the aggregate or beyond such period after the Closing Date in connection with such transfer or the Exploitation of the Product Products in the Territory, then Company may request such additional support in writing. Amgen shall notify Company within [*] after receipt of such request whether it, in its sole discretion, is willing to provide such additional consulting support, which support shall be at Company’s expense, at the FTE Rate for the relevant Amgen employees.
2.4.2 With respect to Amgen’s transfer of the Amgen Cell LineLines, the Parties agree that the following procedures shall apply:
(a) Prior to such transfer, Company shall designate, and enter into a binding agreement with, one of the Permitted CMOs, which agreement shall provide for, among other things, (i) confidentiality and non-use provisions at least as protective as those set forth hereunder under Section 9.1 (Confidential Information) and (ii) such additional provisions as are required to comply with the manufacturing and other limitations set forth in this Section 2.4.2 (such agreement, the “Permitted CMO Agreement”). Upon Amgen’s reasonable request, Company shall provide to Amgen a copy of any such Permitted CMO Agreement (including any material amendment thereto) executed by Company; provided that the financial terms (and any [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. other terms Company is required to keep confidential) of any such agreement may be redacted to the extent not pertinent to Amgen’s confirmation of the restrictive provisions set forth in this Section 2.4.2. Notwithstanding anything to the contrary, Company and Company’s Sublicensees are deemed Permitted CMOs, and shall not be required to enter into a Permitted CMO Agreement prior to receiving the Amgen Cell Line Lines or conducting any manufacturing activities in connection therewith, and Amgen shall deliver such cell lines to Company and/or Company’s Sublicensees within a reasonable time following Company’s written request. For avoidance of doubt, if Company (itself, or through a third party, Affiliate, or Sublicensee) [*] (excluding any [*], but including any [*]) [*], such [*] shall [*], and the Permitted CMO restrictions set forth herein shall [*].
(b) Following Company’s and such Permitted CMGCMO’s entry into the Permitted CMO Agreement, Amgen shall, at the direction of Company, transfer the Amgen Cell Line Lines to the Permitted CMO to generate the Product. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amendedProducts.
(c) Company agrees that it shall not, and it shall use its commercially reasonable efforts to cause the Permitted CMO not to: (i) reverse engineer or otherwise deconstruct the Amgen Cell Line Lines or the initial Amgen cell culture media provided therewith, or to determine or to seek to determine information (including, but not limited to, the gene or amino acid sequence) or characteristics regarding the Amgen Cell Line Lines or such media, other than as expressly required to manufacture the ProductProducts; (ii) clone, express, or otherwise produce any products or materials (including, without limitation, any progeny or derivatives thereof) from fi-om the Amgen Cell LineLines, other than as expressly permitted under this Agreement; (iii) notwithstanding anything to the contrary in Section 9.4.1 (Right to Publish), publish or otherwise publicly disclose the Amgen Cell LineLines; or (iv) permit any non-controlled security access to the Amgen Cell Line or otherwise transfer or provide any of the Amgen Cell Line to a Third Party or any of its Affiliates, other than as expressly required to manufacture the Product.
(d) Upon a termination or expiration of the Permitted CMO Agreement (including as a result of the appointment, with prior written notice to Amgen, by Company of a replacement Permitted CMO), the Permitted CMO shall promptly return any remaining Amgen Cell Lines and related Licensed Know-How and Licensed Materials to Amgen. If, at any time, Company desires to add a new Third Party commercial manufacturer to the Permitted CMO Schedule, it shall notify Amgen in writing (a “Permitted CMO Request”), and Amgen shall have the right, for [*] after receipt of such Permitted CMO Request, to inspect, at a reasonable time and on a reasonable basis (at Amgen’s cost), such manufacturer’s facilities to confirm its ability to fully comply with the restrictive provisions set forth in this Section 2.4.or
Appears in 3 contracts
Samples: Exclusive License Agreement (Atara Biotherapeutics, Inc.), Exclusive License Agreement (Atara Biotherapeutics, Inc.), Exclusive License Agreement (Atara Biotherapeutics, Inc.)
Transfer of Licensed Know-How and Licensed Materials. Amgen 2.3.1 AMGEN shall transfer to Company AKERO (or, in the case of AmgenAMGEN’s transfer of the Amgen AMGEN Cell Line, to the Permitted CMO) the Licensed Know-How listed on the Licensed Know-How Schedule and the Licensed Materials listed on the Licensed Materials ScheduleExhibit A, in accordance with a schedule to be mutually agreed by the Parties Parties, provided, that AMGEN shall use commercially reasonable efforts (provided except during AMGEN’s summer corporate shutdown period) to provide certain quantities of not-for-human-use drug product, cGMP drug substance and proprietary AMGEN reagents (identified on Exhibit A as 30-day deliverables) within thirty (30) days following the Effective Date (and AMGEN shall use commercially reasonable efforts to provide such other Licensed Materials as may be reasonably required by AKERO to undertake AKERO’s planned 120-day toxicology studies in rat and monkey), and provided, that such overall transfer must be completed within [*] six (6) months after the Closing Effective Date), provided, further, however, that such six (6)-month transfer timeline may be reasonably extended for items that, despite diligent efforts by AMGEN, are not practicable to transfer within such six (6)-month period, in which case AMGEN shall continue to use diligent efforts to transfer such items as promptly as practicable after such period but in any event within twelve (12) months after the Effective Date. The Licensed Know-How will be transferred in a customary electronic format to the extent available and otherwise in the original paper format, and AMGEN will provide limited consulting support, in accordance with this Section 2.4 2.3. AMGEN transfers the Licensed Materials to AKERO “as is” and makes no other representations to AKERO in connection therewith. The Parties acknowledge that there are extensive documents, materials and information related to the Product, and that it is the intent of the Parties that the transfer of documents, materials and information hereunder be limited. Accordingly, AMGEN shall not have any obligation to transfer to AKERO any Licensed Know-How or Licensed Materials other than those set forth on Exhibit A, except that, during the first twelve (Transfer 12) months following the Effective Date, AKERO may notify AMGEN of any missing Licensed Know-How and AMGEN agrees to use reasonable efforts to locate such missing Licensed Materials)Know-How and deliver it to AKERO promptly, in the format specified above. Following AKERO shall assist AMGEN in meeting its obligations under any relevant informed consents relating to any information or blood or tissue samples transferred to AKERO, including with respect to the Signing Date, destruction or ceasing the Parties will in good faith reasonably cooperate to review and, if necessary, update use thereof. AMGEN shall notify AKERO promptly following the completion of its transfer of the Licensed Know-How and Licensed Materials Schedules as set forth herein. Following such notification, AKERO shall promptly either (x) confirm to correct and/or supplement AMGEN that such Schedules transfer is complete or (andy) notify AMGEN, as necessarywith reasonable specificity, timely deliver the relevant of any Licensed Know-How and/or Licensed Materials that remain to be transferred, and, in the case of clause (y) above, promptly following AKERO’s notification, the Parties shall in good faith discuss and Materials attempt to the Companyresolve such dispute.
2.4.1 Amgen 2.3.2 AMGEN shall provide, at its expense, consulting support (not to exceed [***] in the aggregate) in connection with such transfer and the Exploitation of the Product in the Territory during the [*] six (6)-month period (or up to a twelve (12)-month period if extended in accordance with this Section 2.5) after the Closing Effective Date. If Company AKERO requires additional consulting support in excess of [***] in the aggregate or beyond such period after the Closing Effective Date in connection with such transfer or the Exploitation of the Product in the Territory, then Company AKERO may request such additional support in writing. Amgen AMGEN shall notify Company AKERO within [*] ten (10) days after receipt of such request whether it, in its sole discretion, is willing to provide such additional consulting support, which support shall be at CompanyAKERO’s expense, at the FTE Rate for the relevant Amgen AMGEN employees.
2.4.2 2.3.3 With respect to AmgenAMGEN’s transfer of the Amgen AMGEN Cell Line, the Parties agree that the following procedures shall apply:
(a) Prior to such transfer, Company AKERO shall designate, and enter into a binding agreement with, one of the Permitted CMOs, which agreement shall provide for, among other things, (i) confidentiality and non-use provisions at least as protective as those set forth hereunder under Section 9.1 8.1 (Confidential Information) and (ii) such additional provisions as are required to comply with the manufacturing and other limitations set forth in this Section 2.4.2 2.3.3 (such agreement, the “Permitted CMO Agreement”). Upon AmgenAMGEN’s reasonable request, Company AKERO shall provide to Amgen AMGEN a copy of any such Permitted CMO Agreement (including any material amendment thereto) executed by CompanyAKERO; provided that the financial terms (and any other terms Company AKERO is required to keep confidential) of any such agreement may be redacted to the extent not pertinent to AmgenAMGEN’s confirmation of the restrictive provisions set forth in this Section 2.4.2. Notwithstanding anything to the contrary, Company and Company’s Sublicensees are deemed Permitted CMOs, and shall not be required to enter into a Permitted CMO Agreement prior to receiving the Amgen Cell Line or conducting any manufacturing activities in connection therewith, and Amgen shall deliver such cell lines to Company and/or Company’s Sublicensees within a reasonable time following Company’s written request2.3.3. For avoidance of doubt, if Company AKERO (itself, or through a third partyThird Party, Affiliate, or Sublicensee) [*] uses any Licensed Materials and/or Licensed Know-How (excluding any [*]AMGEN Cell Line, but including any [*]Product sequence set forth on the Exhibit D) [*]to create its own cell lines (“AKERO Cell Lines”), such [*] AKERO Cell Lines shall [*]not be the AMGEN Cell Line, and the Permitted CMO restrictions set forth herein shall [*]not apply to AKERO’s exploitation of AKERO Cell Lines.
(b) Following CompanyAKERO’s and such Permitted CMGCMO’s entry into the Permitted CMO Agreement, Amgen AMGEN shall, at the direction and expense (for both internal costs at the FTE Rate and out of Companypocket costs) of AKERO, transfer the Amgen AMGEN Cell Line to the Permitted CMO to generate the Product. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(c) Company AKERO agrees that it shall not, and it shall use its commercially reasonable efforts to cause the Permitted CMO not to: (i) reverse engineer or otherwise deconstruct the Amgen AMGEN Cell Line or the initial Amgen AMGEN cell culture media provided therewith, or to determine or to seek to determine information (including, but not limited to, the gene or amino acid sequence) or characteristics regarding the Amgen AMGEN Cell Line or such media, other than as expressly required to manufacture the Product; (ii) clone, express, or otherwise produce any products or materials (including, without limitation, any progeny or derivatives thereof) from the Amgen AMGEN Cell Line, other than as expressly permitted under this Agreement; (iii) notwithstanding anything to the contrary in Section 9.4.1 8.3.1 (Right to Publish), publish or otherwise publicly disclose the Amgen AMGEN Cell Line; or (iv) permit any non-controlled security access to the Amgen AMGEN Cell Line or otherwise transfer or provide any of the Amgen AMGEN Cell Line to a Third Party or any of its Affiliates, other than as expressly required to manufacture the ProductProduct (provided such access or transfer is in accordance with this Agreement).
(d) Upon a termination or expiration of the Permitted CMO Agreement (including as a result of the appointment, with prior written notice to AmgenAMGEN, by Company AKERO of a replacement Permitted CMO), the Permitted CMO shall promptly return any remaining Amgen AMGEN Cell Lines and related Licensed Know-How and Licensed Materials to AmgenAMGEN. If, at any time, Company AKERO desires to add a new Third Party commercial manufacturer to the Permitted CMO ScheduleExhibit C, it shall notify Amgen AMGEN in writing (a “Permitted CMO Request”), and Amgen AMGEN shall have the right, for [*] sixty (60) days after receipt of such Permitted CMO Request, to inspect, at a reasonable time and on a reasonable basis (at AmgenAMGEN’s cost), such manufacturer’s facilities to confirm its ability to fully comply with the restrictive provisions set forth in this Section 2.42.3.3. AMGEN may reject a Permitted CMO Request if it reasonably determines that the proposed manufacturer is unable to comply with the restrictive provisions set forth in this Section 2.3.3, and AMGEN will promptly notify AKERO thereof (and its reasons therefor).
(e) AKERO acknowledges that any materials transferred by AMGEN to AKERO under this Agreement are experimental in nature and may have unknown characteristics and therefore agrees to use prudence and reasonable care in the use, handling, storage, transportation and disposition and containment of any such materials. Accordingly, no such materials, other than the Product Lots, shall be used in any human application, including any clinical trial.
Appears in 3 contracts
Samples: Exclusive License Agreement (Akero Therapeutics, Inc.), Exclusive License Agreement (Akero Therapeutics, Inc.), Exclusive License Agreement (Akero Therapeutics, Inc.)
Transfer of Licensed Know-How and Licensed Materials. Amgen shall transfer to Company (or, in the case of Amgen’s transfer of the Amgen Cell Line, to the Permitted CMO) the Licensed Know-How listed on the Licensed Know-How Schedule and the Licensed Materials listed on the Licensed Materials Schedule, in accordance with a schedule to be mutually agreed by the Parties (provided such transfer must be completed within [*] after the Closing Date), and provide limited consulting support, in accordance with this Section 2.4 (Transfer of Licensed Know-How and Licensed Materials). Following the Signing Date, the Parties will in good faith reasonably cooperate to review and, if necessary, update the Licensed Know-How and Licensed Materials Schedules to correct and/or supplement such Schedules (and, as necessary, timely deliver the relevant Licensed Know-How and Materials to the Company.
2.4.1 Amgen shall provide, at its expense, consulting support (not to exceed [*] in the aggregate) in connection with such transfer and the Exploitation of the Product Products in the Territory during the [*] period after the Closing Date. If Company requires additional consulting support in excess of [*] in the aggregate or beyond such period after the Closing Date in connection with such transfer or the Exploitation of the Product Products in the Territory, then Company may request such additional support in writing. Amgen shall notify Company within [*] after receipt of such request whether it, in its sole discretion, is willing to provide such additional consulting support, which support shall be at Company’s expense, at the FTE Rate for the relevant Amgen employees.
2.4.2 With respect to Amgen’s transfer of the Amgen Cell Line, the Parties agree that the following procedures shall apply:
(a) Prior to such transfer, Company shall designate, and enter into a binding agreement with, one of the Permitted CMOs, which agreement shall provide for, among other things, (i) confidentiality and non-use provisions at least as protective as those set forth hereunder under Section 9.1 (Confidential Information) and (ii) such additional provisions as are required to comply with the manufacturing and other limitations set forth in this Section 2.4.2 (such agreement, the “Permitted CMO Agreement”). Upon Amgen’s reasonable request, Company shall provide to Amgen a copy of any such Permitted CMO Agreement (including any material amendment thereto) executed by Company; provided that the financial terms (and any other terms Company is required to keep confidential) of any such agreement may be redacted to the extent not pertinent to Amgen’s confirmation of the restrictive provisions set forth in this Section 2.4.2. Notwithstanding anything to the contrary, Company and Company’s Sublicensees are deemed Permitted CMOs, and shall not be required to enter into a Permitted CMO Agreement prior to receiving the Amgen Cell Line or conducting any manufacturing activities in connection therewith, and Amgen shall deliver such cell lines to Company and/or Company’s Sublicensees within a reasonable time following Company’s written request. For avoidance of doubt, if Company (itself, or through a third party, Affiliate, or Sublicensee) [*] (excluding any [*], but including any [*]) [*], such [*] shall [*], and the Permitted CMO restrictions set forth herein shall [*].
(b) Following Company’s and such Permitted CMG’s entry into the Permitted CMO Agreement, Amgen shall, at the direction of Company, transfer the Amgen Cell Line to the Permitted CMO to generate the Product. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(b) Following Company’s and such Permitted CMO’s entry into the Permitted CMO Agreement, Amgen shall, at the direction of Company, transfer the Amgen Cell Line to the Permitted CMO to generate the Products.
(c) Company agrees that it shall not, and it shall use its commercially reasonable efforts to cause the Permitted CMO not to: (i) reverse engineer or otherwise deconstruct the Amgen Cell Line or the initial Amgen cell culture media provided therewith, or to determine or to seek to determine information (including, but not limited to, the gene or amino acid sequence) or characteristics regarding the Amgen Cell Line or such media, other than as expressly required to manufacture the ProductProducts; (ii) clone, express, or otherwise produce any products or materials (including, without limitation, any progeny or derivatives thereof) from the Amgen Cell Line, other than as expressly permitted under this Agreement; (iii) notwithstanding anything to the contrary in Section 9.4.1 (Right to Publish), publish or otherwise publicly disclose the Amgen Cell Line; or (iv) permit any non-controlled security access to the Amgen Cell Line or otherwise transfer or provide any of the Amgen Cell Line to a Third Party or any of its Affiliates, other than as expressly required to manufacture the ProductProducts.
(d) Upon a termination or expiration of the Permitted CMO Agreement (including as a result of the appointment, with prior written notice to Amgen, by Company of a replacement Permitted CMO), the Permitted CMO shall promptly return any remaining Amgen Cell Lines and related Licensed Know-How and Licensed Materials to Amgen. If, at any time, Company desires to add a new Third Party commercial manufacturer to the Permitted CMO Schedule, it shall notify Amgen in writing (a “Permitted CMO Request”), and Amgen shall have the right, for [*] after receipt of such Permitted CMO Request, to inspect, at a reasonable time and on a reasonable basis (at Amgen’s cost), such manufacturer’s facilities to confirm its ability to fully comply with the restrictive provisions set forth in this Section 2.4.
Appears in 3 contracts
Samples: Exclusive License Agreement (Atara Biotherapeutics, Inc.), Exclusive License Agreement (Atara Biotherapeutics, Inc.), Exclusive License Agreement (Atara Biotherapeutics, Inc.)