Manufacturing Matters. At AVEO’s option, to be exercised no later than the later of [**] days after the effective date of termination or [**] days after AVEO’s receipt of the applicable manufacturing agreements referenced below (subject to any applicable confidentiality restrictions), Schering-Plough shall be responsible for: (i) assignment to AVEO of each manufacturing agreement specific to Licensed Products, if such agreement is then in effect and such assignment is permitted under such agreement or by the applicable Third Party; provided that Schering-Plough shall have no obligation to pay any compensation to the Third Party to effectuate such agreement; AVEO shall assume all of Schering-Plough’s rights and obligations under such agreement, including paying any and all royalties, fees and other consideration due such Third Party under such agreement; Schering-Plough shall be released, to the extent the applicable Third Party will permit such release, from any obligation arising out of such manufacturing agreement following such assignment; and AVEO shall execute such documentation reasonably satisfactory to Schering-Plough to effectuate such agreement; (ii) reasonable cooperation with AVEO to transfer copies of those manufacturing documents and materials, at AVEO’s cost and expense, that are used (at the time of the termination) by Schering-Plough in the Manufacture of Licensed Products to the extent such manufacturing documents and materials are not obtained by AVEO pursuant to Section 12.6(c)(i); (iii) for a period of up to [**] months following the effective date of termination, reasonably cooperate with AVEO to transfer Manufacturing technologies which are used (at the time of the termination) and Controlled by Schering-Plough in the Manufacture of Licensed Products, provided that AVEO shall reimburse Schering-Plough for Schering-Plough’s reasonable FTE costs and out-of-pocket expenses necessary to provide such requested assistance, to the extent such Manufacturing technologies are not obtained by AVEO pursuant to the assignment of agreements pursuant to Section 12.6(c)(i); (iv) sale of Schering-Plough’s then existing inventory of Licensed Products to AVEO, at Schering-Plough’s standard costs of goods sold for such Licensed Product, plus a markup of [**] percent ([**]%); and (v) if, as of the effective date of termination, Schering-Plough or an Affiliate is engaged in the Manufacture of Licensed Product that is in clinical Development or is being Commercialized, then Schering-Plough or its Affiliate shall use Commercially Reasonable Efforts to Manufacture and supply AVEO’s requirements for the Licensed Product until the earlier of (a) such time as AVEO can secure an alternative Manufacturing source reasonably satisfactory to AVEO, or (b) [**] months from the effective date of such termination. All Licensed Product supplied to AVEO by Schering-Plough under this Section shall be supplied at a price equal to Schering-Plough’s standard costs of goods sold for such Licensed Product, plus a markup of [**] percent ([**]%).
Appears in 3 contracts
Samples: Licensing, Research and Development Agreement, Licensing, Research and Development Agreement, Research, Development and License Agreement (Aveo Pharmaceuticals Inc)
Manufacturing Matters. At AVEOSubject to (x) Calithera Patent Rights (which shall be licensed pursuant to Section 12.5(e) below) and (y) Calithera’s optionproprietary information and systems developed independently of this Agreement, to be exercised no later than the later of [**] days after the effective date of termination or [**] days after AVEO’s receipt of the applicable manufacturing agreements referenced below (subject to applicable agreements or legal obligations including to clinical sites, patients, institutional review boards, or third-party vendors, provided that Calithera may keep a copy of all documents for its records or a sample of any applicable confidentiality restrictions), Schering-Plough shall be responsible formaterials:
(i) assignment to AVEO of each manufacturing agreement for Program Molecules or Licensed Products to HPP (or, where such agreement is not specific to Program Molecules or Licensed Products, if such agreement is then in effect and such assignment is permitted under such agreement or by the applicable Third Party; provided that Schering-Plough shall have no obligation to pay any compensation to the Third Party to effectuate such agreement; AVEO shall assume all of Schering-Plough’s rights and obligations under such agreement, including paying any and all royalties, fees and other consideration due such Third Party under such agreement; Schering-Plough shall be released, to the extent the applicable Third Party will permit such release, from any obligation arising out of such manufacturing agreement following such assignment; and AVEO shall execute such documentation reasonably satisfactory to Schering-Plough to effectuate such agreementbenefit thereof);
(ii) reasonable cooperation with AVEO HPP in reasonable respects to transfer copies of those manufacturing documents and materials, at AVEO’s cost and expense, that materials which are used (at the time of the termination) by Schering-Plough Calithera exclusively in the Manufacture of Program Molecules and Licensed Products to the extent such manufacturing documents and materials are not obtained by AVEO HPP pursuant to Section 12.6(c)(i)paragraph (i) above;
(iii) for a period of up to [**] months following the effective date of termination, reasonably cooperate cooperation with AVEO HPP in reasonable respects to transfer Manufacturing manufacturing technologies Controlled by Calithera which are used (at the time of the termination) and Controlled by Schering-Plough exclusively in the Manufacture of Program Molecules and Licensed ProductsProducts to the extent such manufacturing documents and materials are not obtained by HPP pursuant to paragraphs (i) and (ii) above, provided that AVEO HPP shall reimburse Schering-Plough for Schering-Ploughpay Calithera’s reasonable FTE costs internal rates and out-of-pocket expenses necessary to provide such requested assistance, with the reasonable internal rate for Calithera employees’ time not to exceed [***] per hour; provided that the extent such Manufacturing technologies are first [***] hours of Calithera employees’ time devoted to activities under this Section 12.5(d)(iii) shall not obtained by AVEO pursuant be subject to the assignment of agreements pursuant to Section 12.6(c)(i)reimbursement;
(iv) sale of Schering-PloughCalithera’s then existing inventory of Program Molecules and Licensed Products to AVEOHPP, at Schering-Plough’s standard costs of goods sold for such Licensed Product, plus a markup of [**] percent ([**]%), but only if the following conditions have been met: (A) such Program Molecules and Licensed Products meet the applicable release specifications; and(B) Calithera does not reasonably believe the continued use of such Program Molecules and Licensed Products cause safety concerns; and (C) HPP shall not place into commerce products marked with Calithera’s House Marks as defined in Section 12.5(f) below;
(v) ifin the event this Agreement is terminated after Initiation of a Phase III Clinical Trial of a Licensed Product, as use of Commercially Reasonable Efforts using Calithera’s then existing manufacturing facilities and equipment to Manufacture and supply HPP’s requirements of such Licensed Product for a period of no longer than [***] after the effective date of termination, Schering-Plough or an Affiliate is engaged in the Manufacture of Licensed Product that is in clinical Development or is being Commercialized, then Schering-Plough or its Affiliate shall use Commercially Reasonable Efforts to Manufacture and supply AVEO’s requirements for the Licensed Product until the earlier of (a) such time as AVEO can secure an alternative Manufacturing source reasonably satisfactory to AVEO, or (b) at [**] months from the effective date of such termination. All Licensed Product supplied to AVEO by Schering-Plough under this Section shall be supplied at a price equal to Schering-Plough’s standard costs of goods sold for such Licensed Product, plus a markup of [**] percent ([**]%)., provided that HPP shall not place into commerce products marked with Calithera’s House Marks as defined in Section 12.5(f) below;
Appears in 2 contracts
Samples: License and Research Agreement (vTv Therapeutics Inc.), License and Research Agreement (vTv Therapeutics Inc.)
Manufacturing Matters. At AVEO’s option, to be exercised no later than the later of [**] days after the effective date of termination or [**] days after AVEO’s Promptly following receipt of the applicable manufacturing agreements referenced below (subject PTC’s written notice that it intends to any applicable confidentiality restrictions)continue development and commercialization of Compounds and Products, Schering-Plough shall be responsible forRoche shall:
(i) assignment to AVEO of assign each manufacturing agreement entered into by any member of the Roche Group that is specific to Licensed ProductsCompounds or Products to PTC, if such agreement is then in effect and such assignment is permitted under such agreement or by the applicable Third Party; provided that Schering-Plough shall have no obligation to pay any compensation to the Third Party to effectuate such agreement; AVEO shall assume all of Schering-Plough’s rights and obligations under such agreement, including paying any and all royalties, fees and other consideration due such Third Party under such agreement; Schering-Plough shall be released, to the extent the applicable Third Party will permit such release, from any obligation arising out of such manufacturing agreement following such assignment; and AVEO shall execute such documentation reasonably satisfactory to Schering-Plough to effectuate such agreementcounterparty;
(ii) reasonable cooperation cooperate with AVEO PTC to transfer copies of those manufacturing documents and materials, at AVEO’s cost and expense, materials that are used (at the time of the termination) by Schering-Plough any member of the Roche Group or Third Party contract manufacturers in the Manufacture manufacture of Licensed Products Compounds and Products, to the extent such manufacturing documents and materials are not obtained by AVEO PTC pursuant to the assignment of agreements pursuant to Section 12.6(c)(i20.4.1.4(i);
(iii) for a period of up to [**] months following after the effective date of termination, reasonably subject to the then-existing obligations to Third Parties, cooperate with AVEO PTC to transfer Manufacturing to PTC, in a manner consistent with the guidelines set forth in Appendix 8.2.2, manufacturing technologies which and all associated Know-How that are used (at the time of the termination) and Controlled by Schering-Plough any member of the Roche Group or Third Party contract manufacturers in the Manufacture manufacture of Licensed ProductsCompounds and Products including, without limitation, providing, following reasonable advance request by PTC, [**] of up to [**] days duration of one Roche full-time equivalent to provide technical assistance in transferring technology required for the manufacture of a Compound at a PTC, PTC Affiliate, or subcontractor manufacturing facility; provided that AVEO PTC shall reimburse Schering-Plough Roche for Schering-PloughRoche’s reasonable FTE costs and out-of-pocket expenses necessary to provide such requested assistance, to the extent such Manufacturing manufacturing technologies are not obtained by AVEO pursuant to the assignment of agreements PTC pursuant to Section 12.6(c)(i20.4.1.4(i);
(iv) sale of Scheringsell the Roche Group’s then-Plough’s then existing inventory of Licensed Compounds and Products to AVEOPTC, at Schering-PloughRoche’s standard costs of goods sold for such Licensed Product, FBMC plus a markup of [**] percent ([**]%); and
(v) ifif this Agreement is terminated after Initiation of a Pivotal Trial of a Product, as use Commercially Reasonable Efforts to manufacture or have manufactured and supply PTC’s requirements of such Product for a period of up to [**] months after the effective date of termination, Schering-Plough or an Affiliate is engaged in the Manufacture of Licensed Product that is in clinical Development or is being Commercialized, then Schering-Plough or its Affiliate shall use Commercially Reasonable Efforts to Manufacture and supply AVEOat Roche’s requirements for the Licensed Product until the earlier of (a) such time as AVEO can secure an alternative Manufacturing source reasonably satisfactory to AVEO, or (b) [**] months from the effective date of such termination. All Licensed Product supplied to AVEO by Schering-Plough under this Section shall be supplied at a price equal to Schering-Plough’s standard costs of goods sold for such Licensed Product, FBMC plus a markup of [**] percent ([**]%).
Appears in 2 contracts
Samples: License and Collaboration Agreement (PTC Therapeutics, Inc.), License and Collaboration Agreement (PTC Therapeutics, Inc.)
Manufacturing Matters. At AVEOElion’s option, to be exercised no later than the later of [**] (x) thirty (30) days after the effective date of termination or [**] (y) thirty (30) days after AVEOElion’s receipt of the applicable manufacturing agreements referenced below (subject to any applicable confidentiality restrictions), Schering-Plough shall be responsible for:Manufacturing agreements,
(i) use of Commercially Reasonable Efforts by Processa and its Affiliates and applicable Sublicensees to effect the assignment to AVEO of each manufacturing Manufacturing agreement specific and exclusive to Licensed ProductsCompounds or Products to Elion, if such agreement is then in effect and such assignment is permitted under such agreement or by the applicable Third Party; provided that Schering-Plough shall have no obligation to pay any compensation to the Third Party to effectuate such agreement; AVEO shall assume all of Schering-Plough’s rights Processa and obligations under such agreement, including paying any its applicable Affiliates and all royalties, fees and other consideration due such Third Party under such agreement; Schering-Plough applicable Sublicensees shall be released, released to the extent the applicable Third Party will permit such release, from any obligation arising out of such manufacturing agreement following such assignment; assignment and AVEO Elion shall execute such documentation reasonably satisfactory to Schering-Plough Processa to effectuate such agreement; provided further that if any such agreement is specific but not exclusive to Compounds or Products, or is not assigned to Elion for any reason, Processa will discuss in good faith with Elion terms upon which Processa and its Affiliates and applicable Sublicensees shall use Commercially Reasonable Efforts to provide Elion with the benefits of such agreement to the extent it relates to Compounds or Products for a limited period of time (not to exceed six (6) months) and upon payment of a reasonably acceptable fee to Processa;
(ii) reasonable for a period of up to six (6) months following the effective date of termination, (A) cooperation with AVEO Elion in reasonable respects to transfer copies of those manufacturing Manufacturing documents and materials, at AVEO’s cost materials within the Processa Know-How and expense, applicable Sublicensee Intellectual Property that are used (at the time of the termination) by Schering-Plough Processa or its Affiliates or applicable Sublicensees exclusively in the Manufacture of Licensed Compounds and Products to the extent such manufacturing Manufacturing documents and materials are not obtained by AVEO Elion pursuant to Section 12.6(c)(i)the assignment of agreements pursuant to paragraph (i) above, and (B) cooperation with Elion to provide Elion with reasonable access to and right to use such Manufacturing documents and materials in Processa’s or its Affiliates’ or applicable Sublicensees’ possession or Control to the extent they relate to, but are not used exclusively in, the Manufacture of Compounds and Products, subject to appropriate confidentiality and limitation on use protections applicable to for Manufacturing documents and materials;
(iii) for a period of up to [**] six (6) months following the effective date of termination, reasonably cooperate (A) cooperation with AVEO Elion in reasonable respects to transfer Manufacturing technologies which within the Processa Intellectual Property and applicable Sublicensee Intellectual Property that are used (at the time of the termination) and Controlled by Schering-Plough Processa or its Affiliates or applicable Sublicensees exclusively in the Manufacture of Licensed Compounds and Products, and (B) cooperation with Elion to provide Elion with reasonable access to and right to use such Manufacturing technologies Controlled by Processa or its Affiliates (other than Processa Excluded Affiliates) or applicable Sublicensees to the extent they relate to, but are not used exclusively in, the Manufacture of Compounds and Products and that Processa or such Affiliates or Sublicensees are permitted to provide such access to Elion; provided that AVEO Elion shall reimburse Schering-Plough Processa for Schering-PloughProcessa’s reasonable FTE costs and out-of-pocket expenses necessary to provide such requested assistance, to the extent such Manufacturing technologies are not obtained by AVEO Elion pursuant to the assignment of agreements pursuant to Section 12.6(c)(i);paragraph (i) above; and
(iv) sale of ScheringProcessa’s or its Affiliates’ or applicable Sublicensees’ then-Plough’s then existing inventory of Licensed Compounds and Products to AVEOElion, at Schering-PloughProcessa’s standard costs of goods sold for such Licensed Product, plus a markup of [**] percent ([**]%); and
(v) if, as of the effective date of termination, Schering-Plough or an Affiliate is engaged in the Manufacture of Licensed Product that is in clinical Development or is being Commercialized, then Schering-Plough or its Affiliate shall use Commercially Reasonable Efforts to Manufacture and supply AVEO’s requirements for applicable Affiliates’ or applicable Sublicensees’ cost of Manufacture, but only if the Licensed Product until the earlier of following conditions have been met: (aA) such time as AVEO can secure an alternative Manufacturing source Compounds and Products meet the applicable release specifications; and (B) Processa does not reasonably satisfactory to AVEO, or (b) [**] months from believe the effective date continued use of such termination. All Licensed Product supplied to AVEO by Schering-Plough under this Section shall be supplied at a price equal to Schering-Plough’s standard costs of goods sold for such Licensed Product, plus a markup of [**] percent ([**]%).Compounds and Products causes safety concerns;
Appears in 2 contracts
Samples: License Agreement (Processa Pharmaceuticals, Inc.), License Agreement (Processa Pharmaceuticals, Inc.)
Manufacturing Matters. Processa shall promptly provide to Ocuphire copies of all agreements relating to the Manufacture of Product in the Territory. At AVEOOcuphire’s option, to be exercised no later than the later of [**] (x) thirty (30) days after the effective date of termination or [**] (y) thirty (30) days after AVEOOcuphire’s receipt of the applicable manufacturing agreements referenced below Manufacturing agreements, Processa shall (subject to any applicable confidentiality restrictions), Schering-Plough or shall be responsible for:cause its Affiliates or Sublicensees to):
(i) use Commercially Reasonable Efforts to effect the assignment to AVEO of each manufacturing Manufacturing agreement specific and exclusive to Licensed ProductsCompounds or Products to Ocuphire, if such agreement is then in effect and such assignment is permitted under such agreement or by the applicable Third Party; provided that Schering-Plough shall have no obligation to pay any compensation to the Third Party to effectuate such agreement; AVEO shall assume all of Schering-Plough’s rights Processa and obligations under such agreement, including paying any its applicable Affiliates and all royalties, fees and other consideration due such Third Party under such agreement; Schering-Plough applicable Sublicensees shall be released, released (to the extent the applicable Third Party will permit such release, permit) from any obligation arising out of such manufacturing agreement following such assignment; assignment and AVEO Ocuphire shall execute such documentation reasonably satisfactory to Schering-Plough Processa to effectuate such agreement; provided further that if any such agreement is specific but not exclusive to Compounds or Products, or is not assigned to Ocuphire for any reason, Processa will discuss in good faith with Ocuphire terms upon which Processa and its Affiliates and applicable Sublicensees shall use Commercially Reasonable Efforts to provide Ocuphire with the benefits of such agreement to the extent it relates to Compounds or Products for a limited period of time (not to exceed six (6) months) and upon payment of a reasonably acceptable fee to Processa;
(ii) for a period of up to six (6) months following the effective date of termination, (A) cooperate with Ocuphire in reasonable cooperation with AVEO respects to transfer copies of those manufacturing Manufacturing documents and materials, at AVEO’s cost materials within the Processa Know-How and expense, applicable Sublicensee Intellectual Property that are used (at the time of the termination) by Schering-Plough Processa or its Affiliates or applicable Sublicensees in the Manufacture of Licensed Compounds and Products to the extent such manufacturing Manufacturing documents and materials are not obtained by AVEO Ocuphire pursuant to Section 12.6(c)(i)the assignment of agreements pursuant to paragraph (i) above, and (B) cooperate with Ocuphire to provide Ocuphire with access to and right to use such Manufacturing documents and materials in Processa’s or its Affiliates’ or applicable Sublicensees’ possession or Control to the extent they relate to, but are not used in, the Manufacture of Compounds and Products, subject to appropriate confidentiality and limitation on use protections applicable to for Manufacturing documents and materials;
(iii) for a period of up to [**] six (6) months following the effective date of termination, reasonably (A) cooperate with AVEO Ocuphire in reasonable respects to transfer Manufacturing technologies which within the Processa Intellectual Property and applicable Sublicensee Intellectual Property that are used (at the time of the termination) and Controlled by Schering-Plough Processa or its Affiliates or applicable Sublicensees exclusively in the Manufacture of Licensed Compounds and Products, and (B) cooperate with Ocuphire to provide Ocuphire with reasonable access to and right to use such Manufacturing technologies Controlled by Processa or its Affiliates (other than Processa Excluded Affiliates) or applicable Sublicensees to the extent they relate to, but are not used exclusively in, the Manufacture of Compounds and Products and that Processa or such Affiliates or Sublicensees are permitted to provide such access to Ocuphire; provided that AVEO Ocuphire shall reimburse Schering-Plough Processa for Schering-PloughProcessa’s reasonable FTE costs and out-of-pocket expenses necessary to provide such requested assistance, to the extent such Manufacturing technologies are not obtained by AVEO Ocuphire pursuant to the assignment of agreements pursuant to Section 12.6(c)(i);
paragraph (ivi) sale of Schering-Plough’s then existing inventory of Licensed Products to AVEO, at Schering-Plough’s standard costs of goods sold for such Licensed Product, plus a markup of [**] percent ([**]%); and
(v) if, as of the effective date of termination, Schering-Plough or an Affiliate is engaged in the Manufacture of Licensed Product that is in clinical Development or is being Commercialized, then Schering-Plough or its Affiliate shall use Commercially Reasonable Efforts to Manufacture and supply AVEO’s requirements for the Licensed Product until the earlier of (a) such time as AVEO can secure an alternative Manufacturing source reasonably satisfactory to AVEO, or (b) [**] months from the effective date of such termination. All Licensed Product supplied to AVEO by Schering-Plough under this Section shall be supplied at a price equal to Schering-Plough’s standard costs of goods sold for such Licensed Product, plus a markup of [**] percent ([**]%)above.
Appears in 2 contracts
Samples: License Agreement (Ocuphire Pharma, Inc.), License Agreement (Processa Pharmaceuticals, Inc.)
Manufacturing Matters. At AVEO(I) at Incyte’s option, to be exercised no later than the later (x) sixty (60) days after receiving any notice of [**] termination by Pfizer pursuant to Section 11.2 or (y) thirty (30) days after the effective date of any termination by Incyte pursuant to Section 11.3(a) or [11.3(b), **] days after AVEO’s receipt * (A) *** and/or (B) ***, in the case of the applicable manufacturing agreements referenced below each of clauses (subject to any applicable confidentiality restrictionsA) and (B), Schering-Plough shall be responsible for:
that ***, but only if the following conditions have been met: (ia) assignment *** and (b) ***. No later than ten (10) Business Days before Incyte is required to AVEO of each manufacturing agreement specific exercise its option to Licensed Products***. If, if such agreement is then in effect and such assignment is permitted under such agreement or by the applicable Third Party; provided that Schering-Plough shall have no obligation to pay any compensation to the Third Party to effectuate such agreement; AVEO shall assume all of Schering-Plough’s rights and obligations under such agreement, including paying any and all royalties, fees and other consideration due such Third Party under such agreement; Schering-Plough shall be released, to the extent the applicable Third Party will permit such release, from any obligation arising out of such manufacturing agreement following such assignment; and AVEO shall execute such documentation reasonably satisfactory to Schering-Plough to effectuate such agreement;
(ii) reasonable cooperation with AVEO to transfer copies of those manufacturing documents and materials, at AVEO’s cost and expense, that are used (at the time of Incyte’s request, ***, then, at Incyte’s request, Pfizer may (but shall not be obligated to) elect to ***, in which case Incyte shall be required to ***, as the termination) by Scheringcase may be, and Incyte will also be responsible for all out-Plough in the Manufacture of Licensed Products to the extent such manufacturing documents and materials are not obtained by AVEO pursuant to Section 12.6(c)(i)of-pocket costs associated with ***;
(iiiII) if the effective date of termination occurs prior to the Launch of any Pfizer Product in any country in the Territory, then, following such effective date, Pfizer shall have no further obligations to Incyte regarding manufacturing matters, other ***;
(III) if the effective date of termination occurs after a Pfizer Product has been Launched in any country in the Territory, then, (a) pursuant to a transition supply agreement to be negotiated in good faith by the Parties, Pfizer will provide Incyte with commercial supplies of such Pfizer Product for a period of up time to [be specified in the transition supply agreement but in no event to exceed **] months following * from the effective date of termination, reasonably cooperate with AVEO to transfer Manufacturing technologies which are used (at the time of the termination) and Controlled by Schering-Plough in the Manufacture of Licensed Products, ; provided that AVEO Incyte shall reimburse ScheringPfizer for all of Pfizer’s fully-Plough for Schering-Plough’s reasonable FTE loaded costs associated with the transition supply agreement and out-of-pocket expenses necessary to provide with the manufacture of such requested assistance, to the extent such Manufacturing technologies are not obtained by AVEO pursuant to the assignment of agreements pursuant to Section 12.6(c)(i);
(iv) sale of Schering-Plough’s then existing inventory of Licensed Products to AVEO, at Schering-Plough’s standard costs of goods sold for such Licensed Pfizer Product, plus a markup royalty to be specified in the transition supply agreement if Pfizer’s manufacture of [**] percent such Pfizer Product uses a process covered by Pfizer Proprietary Process Patent Claims ([**]%a “Proprietary Manufacturing Process”); and
(v) if, as of the effective date of termination, Schering-Plough or an Affiliate is engaged in the Manufacture of Licensed Product that is in clinical Development or is being Commercialized, then Schering-Plough or its Affiliate shall use Commercially Reasonable Efforts to Manufacture and supply AVEO’s requirements for the Licensed Product until the earlier of (a) such time as AVEO can secure an alternative Manufacturing source reasonably satisfactory to AVEO, or (b) [**] months from if the effective date manufacture of the Pfizer Product that has been Launched does not involve the use of a Proprietary Manufacturing Process, then Pfizer shall have no further obligations to Incyte regarding manufacturing matters after the expiration of the transition supply agreement, (c) if the manufacture of the Pfizer Product that has been Launched involves the use of a Proprietary Manufacturing Process, then prior to the expiration of the transition supply agreement, Pfizer will notify Incyte as to whether (x) it will continue to supply Incyte with such Pfizer Product, with Incyte reimbursing Pfizer for all of Pfizer’s fully-loaded costs associated with the manufacture of such termination. All Licensed Product supplied to AVEO by Schering-Plough under this Section shall be supplied at a price equal to Schering-Plough’s standard costs of goods sold for such Licensed Pfizer Product, plus a markup royalty to be specified in a supply agreement that the Parties will negotiate in good faith or (y) it will grant Incyte a license to the Pfizer Proprietary Process Patent Claims for a royalty to be specified in a license agreement that the Parties will negotiate in good faith; if Pfizer decides to grant Incyte a license pursuant to clause (y), then Incyte agrees to use its best efforts to effect a transfer of [the manufacturing activities for such Pfizer Product to another supplier as soon as practicable and agrees to spend the resources reasonably necessary to do so.
(IV) For purposes of this Section 11.6(b)(ii)(D), the following terms shall have the following meanings: (x) “**] percent ([*” shall mean **]%)* and (y) “***” shall mean ***.
Appears in 1 contract
Samples: Collaborative Research and License Agreement (Incyte Corp)
Manufacturing Matters. At AVEOvTv’s option, to be exercised no later than the later of [**] (x) thirty (30) days after the effective date of termination or [**] (y) thirty (30) days after AVEOvTv’s receipt of the applicable manufacturing agreements referenced below (subject to any applicable confidentiality restrictions)Manufacturing agreements, Schering-Plough shall be responsible forHuadong shall:
(i) use Commercially Reasonable Efforts, and use Commercially Reasonable Efforts to cause each of its Subsidiaries and Sublicensees to effect the assignment, to cause its Subsidiaries and Sublicensees to effect the assignment to AVEO of each manufacturing Manufacturing agreement specific and exclusive to Licensed ProductsCompounds or Products to vTv, if such agreement is then in effect and such assignment is permitted under such agreement or by the applicable Third Party; provided provided, that Schering-Plough shall have no obligation to pay any compensation to the Third Party to effectuate such agreement; AVEO shall assume all of Schering-Plough’s rights Huadong and obligations under such agreement, including paying any its applicable Subsidiaries and all royalties, fees and other consideration due such Third Party under such agreement; Schering-Plough Sublicensees shall be released, released to the extent the applicable Third Party will permit such release, from any obligation arising out of such manufacturing agreement following such assignment; assignment and AVEO vTv shall execute such documentation reasonably satisfactory to Schering-Plough Huadong to effectuate such agreement; provided, further that, if any such agreement is specific but not exclusive to Compounds or Products, or is not assigned to vTv for any reason, Huadong and its Subsidiaries and Sublicensees shall use Commercially Reasonable Efforts to provide vTv with the benefits of such agreement to the extent it relates to Compounds or Products;
(ii) for a period of up to [***] following the effective date of termination, (A) cooperate with vTv in reasonable cooperation with AVEO respects to transfer copies of those manufacturing Manufacturing documents and materials, at AVEO’s cost and expense, materials that are used (at the time of the termination) by Schering-Plough Huadong or its Subsidiaries or Sublicensees exclusively in the Manufacture of Licensed Compounds and Products to the extent such manufacturing Manufacturing documents and materials are not obtained by AVEO vTv pursuant to Section 12.6(c)(i)the assignment of agreements pursuant to paragraph (i) above, and (B) provide vTv with reasonable access to and right to use such Manufacturing documents and materials to the extent they relate to, but are not used exclusively in, the Manufacture of Compounds and Products;
(iii) for a period of up to [***] months following the effective date of termination, reasonably (A) cooperate with AVEO vTv in reasonable respects to transfer Manufacturing technologies which that are used (at the time of the termination) and Controlled by Schering-Plough Huadong or its Subsidiaries or Sublicensees exclusively in the Manufacture of Licensed Compounds and Products, and (B) provide vTv with reasonable access to and right to use such Manufacturing technologies, to the extent they relate to, but are not used exclusively in, the Manufacture of Compounds and Products; provided that AVEO vTv shall reimburse Schering-Plough Huadong for Schering-PloughHuadong’s reasonable FTE costs and out-of-pocket expenses necessary to provide such requested assistance, to the extent such Manufacturing technologies are not obtained by AVEO vTv pursuant to the assignment of agreements pursuant to paragraph (i) above; provided, further, that Huadong expressly disclaims any representations or warranties, and shall not be liable, with respect to the adequacy of any Manufacturing technologies transferred to vTv under this Section 12.6(c)(i11.5(c)(iii);
(iv) sale of Scheringsell Huadong’s or use Commercially Reasonable Efforts to cause its Subsidiaries or Sublicensees to sell then-Plough’s then existing inventory of Licensed Compounds and Products to AVEOvTv, at Schering-PloughHuadong’s standard costs or its applicable Subsidiaries’ or Sublicensees’ cost of goods sold for Manufacture, but only if the following conditions have been met: (A) such Licensed Product, plus a markup Compounds and Products meets the applicable release specifications; and (B) Huadong does not reasonably believe the continued use of [**] percent ([**]%)such Compounds and Products causes safety concerns; and
(v) ifif this Agreement is terminated after initiation of a Phase III Clinical Trial of a Product and Huadong does not reasonably believe the continued use of such Compounds and Products causes safety concerns, use Commercially Reasonable Efforts, and use Commercially Reasonable Efforts to cause its Subsidiaries and Sublicensees, for a reasonable period of up to months (A) to transition to vTv Manufacturing activities as of conducted by Huadong and its Subsidiaries and Sublicensees prior to the effective date of termination (including the assignment of Manufacturing agreements under clause (i) above) and to cooperate with vTv to qualify an alternate manufacturer chosen by vTv, and (B) to the extent Huadong or any of its Subsidiaries or Sublicensees is performing Manufacturing activities related to such Product immediately prior to termination, Schering-Plough or an Affiliate is engaged in to Manufacture and supply vTv’s requirements of such Product to the Manufacture of Licensed Product that is in clinical Development or is being Commercializedextent such requirements can be met using Huadong’s, then Schering-Plough or its Affiliate applicable Subsidiaries’ or Sublicensees’, then-existing manufacturing facilities and equipment, at Huadong’s, or its applicable Subsidiaries’ or Sublicensees’ cost of Manufacture, provided that vTv shall use Commercially Reasonable Efforts to Manufacture transition Manufacturing activities under clause (A) in a reasonably prompt manner, and supply AVEO’s requirements for the Licensed Product until provided, further that any obligation under clause (B) shall terminate upon the earlier of (a) such time as AVEO can secure an alternative Manufacturing source reasonably satisfactory to AVEO, or (b) [***] months from or the effective date completion of such termination. All Licensed Product supplied to AVEO by Schering-Plough under this Section the activities in clause (A); provided, that, in each case, Huadong (I) shall be supplied at a price equal entitled to Schering-Ploughredact or withhold such Information that is proprietary to Huadong and (II) shall not be required to transfer or assign, as applicable, to vTv of any raw data or assays (in vivo or in vitro), or methods, protocols, or information that would enable vTv to reverse engineer any of Huadong’s standard costs of goods sold for such Licensed Product, plus a markup of [**] percent ([**]%).methods or protocols;
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Manufacturing Matters. At AVEO’s option(i) If this Agreement is terminated in its entirety, to be exercised no later than the later of extent vTv so requests within [***] days after the effective date of termination or [**] days after AVEO’s receipt such termination, Anteris shall use Commercially Reasonable Efforts to, and to cause any Affiliate it controls (within the meaning of Section 1.4) to, effect the applicable manufacturing agreements referenced below (subject to any applicable confidentiality restrictions), Schering-Plough shall be responsible for:
(i) assignment to AVEO of each manufacturing agreement specific and exclusive to the Licensed ProductsCompound or any Licensed Products to vTv, if such agreement is then in effect and such assignment is permitted under such agreement or by the applicable Third Party; provided that Schering-Plough shall have no obligation vTv agrees in writing to pay any compensation to the Third Party to effectuate such agreement; AVEO shall assume all of Schering-Plough’s rights and obligations under such agreement, including paying any and all royalties, fees and other consideration due such Third Party under such agreement; Schering-Plough shall be released, to the extent the applicable Third Party will permit such release, from any obligation arising out of such manufacturing agreement arising following such assignment; , and AVEO each Party shall execute such documentation reasonably satisfactory to Schering-Plough the other Party to effectuate such agreement;assignment and assumption; provided, further, that, if any such agreement is specific but not exclusive to the Licensed Compound or any Licensed Products, or is not assignable to vTv for any reason, Anteris and such controlled Affiliates shall 34.
(ii) If this Agreement is terminated in its entirety, to the extent vTv so requests within [***] days after the effective date of such termination, for a period of up to [***] months following the effective date of such termination, Anteris and any Affiliate it controls (within the meaning of Section 1.4) shall cooperate with vTv in reasonable cooperation with AVEO respects to transfer copies of those manufacturing documents and materials, at AVEO’s cost and expense, materials that are used (at the time of the termination) by Schering-Plough Anteris or any such controlled Affiliate exclusively in the Manufacture manufacture of the Licensed Compound or any Licensed Products to the extent such manufacturing documents and materials are not obtained by AVEO pursuant to Section 12.6(c)(i);
(iii) for a period of up to [**] months following the effective date of termination, reasonably cooperate with AVEO to transfer Manufacturing technologies which are used (at the time of the termination) and Controlled by Schering-Plough in the Manufacture of Licensed Products, provided that AVEO shall reimburse Schering-Plough for Schering-Plough’s reasonable FTE costs and out-of-pocket expenses necessary to provide such requested assistance, to the extent such Manufacturing technologies are not obtained by AVEO vTv pursuant to the assignment of agreements pursuant to Section 12.6(c)(i);
(iv12.4(g)(i) sale of Schering-Plough’s then existing inventory of Licensed Products to AVEOabove. If, at Schering-Plough’s standard costs of goods sold for such Licensed Product, plus a markup of [**] percent ([**]%); and
(v) if, as of the effective date of terminationtermination of this Agreement in its entirety, Schering-Plough or an Affiliate is engaged in to the Manufacture of Licensed Product that is in clinical Development or is being Commercialized, then Schering-Plough or its Affiliate shall use Commercially Reasonable Efforts to Manufacture and supply AVEO’s requirements for the Licensed Product until the earlier of (a) such time as AVEO can secure an alternative Manufacturing source reasonably satisfactory to AVEO, or (b) extent vTv so requests within [***] months from days after the effective date of such termination. All , any Licensed Compound or Licensed Product supplied is held in inventory or is in process of being manufactured by or on behalf of Anteris or its controlled Affiliate, Anteris shall supply to AVEO by ScheringvTv such on-Plough under this Section shall be supplied hand Licensed Compound and Licensed Products at a supply price equal to ScheringAnteris’ or its Affiliate’s actual, fully-Plough’s standard costs of goods sold for burdened cost to manufacture or have manufactured, and supply, such Licensed ProductCompound and Licensed Products, plus a markup of [**] percent ([**]%)as applicable.
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Manufacturing Matters. At AVEOvTv’s option, to be exercised no later than the later of [**] (x) thirty (30) days after the effective date of termination or [**] (y) thirty (30) days after AVEOvTv’s receipt of the applicable manufacturing agreements referenced below (subject to any applicable confidentiality restrictions), Schering-Plough shall be responsible for:Manufacturing agreements,
(i) use of Commercially Reasonable Efforts by Newsoara and use Commercially Reasonable Efforts to cause its Affiliates and Sublicensees to effect the assignment to AVEO of each manufacturing Manufacturing agreement specific and exclusive to Licensed ProductsCompounds or Products to vTv, if such agreement is then in effect and such assignment is permitted under such agreement or by the applicable Third Party; provided that Schering-Plough shall have no obligation to pay any compensation to the Third Party to effectuate such agreement; AVEO shall assume all of Schering-Plough’s rights Newsoara and obligations under such agreement, including paying any its applicable Affiliates and all royalties, fees and other consideration due such Third Party under such agreement; Schering-Plough Sublicensees shall be released, released to the extent the applicable Third Party will permit such release, from any obligation arising out of such manufacturing agreement following such assignment; assignment and AVEO vTv shall execute such documentation reasonably satisfactory to Schering-Plough Newsoara to effectuate such agreement; provided further that, if any such agreement is specific but not exclusive to Compounds or Products, or is not assigned to vTv for any reason, Newsoara and its Affiliates and Sublicensees shall use Commercially Reasonable Efforts to provide vTv with the benefits of such agreement to the extent it relates to Compounds or Products;
(ii) reasonable for a period of up to [***] months following the effective date of termination, (A) cooperation with AVEO vTv in reasonable respects to transfer copies of those manufacturing Manufacturing documents and materials, at AVEO’s cost and expense, materials that are used (at the time of the termination) by Schering-Plough Newsoara or its Affiliates or Sublicensees exclusively in the Manufacture of Licensed Compounds and Products to the extent such manufacturing Manufacturing documents and materials are not obtained by AVEO vTv pursuant to Section 12.6(c)(i)the assignment of agreements pursuant to paragraph (i) above, and (B) to provide vTv with reasonable access to and right to use such Manufacturing documents and materials to the extent they relate to, but are not used exclusively in, the Manufacture of Compounds and Products;
(iii) for a period of up to [***] months following the effective date of termination, reasonably cooperate (A) cooperation with AVEO vTv in reasonable respects to transfer Manufacturing technologies which that are used (at the time of the termination) and Controlled by Schering-Plough Newsoara or its Affiliates or Sublicensees exclusively in the Manufacture of Licensed Compounds and Products, and (B) to provide vTv with reasonable access to and right to use such Manufacturing technologies to the extent they relate to, but are not used exclusively in, the Manufacture of Compounds and Products; provided that AVEO vTv shall reimburse Schering-Plough Newsoara for Schering-PloughNewsoara’s reasonable FTE costs and out-of-pocket expenses necessary to provide such requested assistance, to the extent such Manufacturing technologies are not obtained by AVEO vTv pursuant to the assignment of agreements pursuant to Section 12.6(c)(i);paragraph (i) above; and
(iv) sale of ScheringNewsoara’s then-Plough’s then existing inventory of Licensed Compounds and Products to AVEOvTv, at Schering-PloughNewsoara’s standard costs or its applicable Affiliates’ (a) cost of goods sold for Manufacture and (b) the price at which Newsoara purchases such Licensed ProductProduct from its Third Party manufacturer, in each case (a) and (b) plus a markup of [***] percent thereof, but only if the following conditions have been met: ([**]%); and
(v) if, as of the effective date of termination, Schering-Plough or an Affiliate is engaged in the Manufacture of Licensed Product that is in clinical Development or is being Commercialized, then Schering-Plough or its Affiliate shall use Commercially Reasonable Efforts to Manufacture and supply AVEO’s requirements for the Licensed Product until the earlier of (aA) such time as AVEO can secure an alternative Manufacturing source Compounds and Products meets the applicable release specifications; and (B) Newsoara does not reasonably satisfactory to AVEO, or (b) [**] months from believe the effective date continued use of such termination. All Licensed Product supplied to AVEO by Schering-Plough under this Section shall be supplied at a price equal to Schering-Plough’s standard costs of goods sold for such Licensed Product, plus a markup of [**] percent ([**]%)Compounds and Products causes safety concerns.
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Manufacturing Matters. At AVEOBioCryst’s option, to be exercised no later than the later of [**] thirty (30) days after the effective date of termination or [of this Agreement in its entirety:
i) for a period of up to **] days after AVEO’s receipt * months following the effective date of termination *** (except as set forth below) use of commercially reasonable efforts by CSL and its Affiliates to effect the applicable manufacturing agreements referenced below (subject to any applicable confidentiality restrictions), Schering-Plough shall be responsible for:
(i) assignment to AVEO of each manufacturing agreement specific and exclusive to Compounds or Licensed ProductsProducts to BioCryst, if such agreement is then in effect and such assignment is permitted under such agreement or by the applicable Third Party; provided that Schering-Plough shall have no obligation to pay any compensation to the Third Party to effectuate such agreement; AVEO shall assume all of Schering-Plough’s rights and obligations under such agreement, including paying any and all royalties, fees and other consideration due such Third Party under such agreement; Schering-Plough CSL shall be released, to the extent the applicable Third Party will permit such releasepermit, from any obligation arising out of such manufacturing agreement following such assignment; assignment and AVEO BioCryst shall execute such documentation reasonably satisfactory to Schering-Plough CSL to effectuate such agreement;
(ii) reasonable for a period of up to *** months following the effective date of termination *** (except as set forth below): (A) cooperation with AVEO BioCryst in reasonable respects to transfer copies of those manufacturing documents and materials, at AVEO’s cost and expense, materials that are used (at the time of the termination) by Schering-Plough CSL or its Affiliates exclusively in the Manufacture manufacture of Licensed Products to the extent such manufacturing documents and materials and the Intellectual Property Rights therein are within CSL’s Control, not obtained by AVEO pursuant to Section 12.6(c)(i);
(iii) for a period of up to [**] months following the effective date of termination, reasonably cooperate with AVEO to transfer Manufacturing technologies which are used (at the time of the termination) and Controlled by Schering-Plough in the Manufacture of Licensed Products, provided that AVEO shall reimburse Schering-Plough for Schering-Plough’s reasonable FTE costs and out-of-pocket expenses necessary to provide such requested assistance, to the extent such Manufacturing technologies are not obtained by AVEO BioCryst pursuant to the assignment of agreements pursuant to Section 12.6(c)(i)13.4(c)(iii)(1) above, and (B) to provide BioCryst with reasonable access to and right to use such manufacturing documents and materials to the extent they relate to, but are not used exclusively in, the manufacture of Compounds and Licensed Products, subject to BioCryst indemnifying and holding harmless CSL and its Affiliates in respect of any costs, losses, expenses, damages or claims arising for such access and use;
(iviii) sale in the event that CSL does not reasonably believe the continued use of Schering-Plough’s then existing inventory of such Licensed Products to AVEOcauses safety concerns, at Schering-Plough’s standard costs use of goods sold for such Licensed Product, plus a markup of [commercially reasonable efforts by CSL **] percent ([* for a reasonable period of up to **]%); and
(v) if, * months to transition to BioCryst manufacturing activities as of conducted by CSL prior to the effective date of termination, Schering-Plough or termination (including the assignment of manufacturing agreements under Section 13.4(c)(iii)(1) above) and to cooperate with BioCryst to qualify an Affiliate is engaged in the Manufacture of Licensed Product that is in clinical Development or is being Commercialized, then Schering-Plough or its Affiliate shall use Commercially Reasonable Efforts to Manufacture and supply AVEO’s requirements for the Licensed Product until the earlier of (a) such time as AVEO can secure an alternative Manufacturing source reasonably satisfactory to AVEO, or (b) [**] months from the effective date of such termination. All Licensed Product supplied to AVEO alternate manufacturer chosen by Schering-Plough under this Section shall be supplied at a price equal to Schering-Plough’s standard costs of goods sold for such Licensed Product, plus a markup of [**] percent ([**]%).BioCryst;
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