Certain Termination Events. (a) Except as otherwise contemplated by Sections 3.05 and 10.02(c), either Noven or Endo shall have the right to terminate this Agreement if the other commits any continuing or material breach of any of the provisions of this Agreement and (in the case of a breach which is capable of remedy) fails to remedy the same within 60 days after receipt of written notice giving full particulars of the breach and requiring it to be so remedied; (b) In the event that at any time during the Term Noven shall, (i) during any period of six consecutive months, fail to supply at least *** of the aggregate number of units of Product (which number of units shall be determined with reference to the number of units estimated to be yielded by each Batch ordered by Endo as reflected in Exhibit A) ordered pursuant to Purchase Orders properly submitted by Endo during such period (other than by reason of the fault of Endo), or (ii) fail to provide *** of the aggregate number of units of Product ordered during any two separate periods of three consecutive months, Endo shall (A) have the right to terminate its obligation to exclusively purchase Product from Noven and have a third party manufacture on its behalf the Product to supply and (B) have the right to withdraw any purchase orders submitted to Noven for amounts in excess of Noven's ability to supply. (c) Either party may terminate this Agreement with immediate effect if the Product is withdrawn from the market in the Territory for serious adverse health or safety reasons. (d) Either Noven or Endo may terminate this Agreement with immediate effect in the event a Force Majeure Event as to the other shall exist and be continuing for a period of 120 consecutive days. (e) Noven may terminate its obligation to supply Endo with its requirements of Product under this Agreement upon twenty-four months notice in the event that Noven's gross margins on the manufacture of Product (taking into account all Endo payments hereunder and under the License Agreement in calculating such margins--except for the milestone payments) drops to less than *** of its fully allocated manufacturing cost for the Product in two consecutive calendar quarters. Such termination notice shall contain the election of Noven to either (1) continue to be paid its share of the Gross Margin per the License Agreement, or (ii) be paid its fully loaded manufacturing costs plus *** for Product, during the period following the notice until Noven no longer supplies Product hereunder, in exchange for the immediate and permanent termination of any and all gross margin splits and royalty obligations otherwise due and payable pursuant to the License Agreement. Noven agrees to provide the technical transfer services set forth in Schedule 10.02 (the "Tech Transfer Services"), including the delivery to Endo of the Technical Transfer Documentation Package within *** of the termination notice and completion of the transfer of all analytical methods within *** of the termination notice. The termination by Noven shall become effective *** following receipt of the notice by Endo, provided, however, that the effective date of the termination shall be extended by each day of delay in excess of the corresponding time periods set forth above which it takes Noven to complete the transfer of the Technical Transfer Documentation Package and the analytical methods. The manufacturing period, however, shall not be extended to the extent such delay occurs through no fault of Noven. To the extent that such alternative manufacturer would need to use technology owned by, or protected by intellectual property owned by, Noven, access to such technology would be provided on limited basis and restricted solely to use for the manufacture of Product. (f) In the event of a termination by Endo pursuant to Section 10.02 (a), (b) or (d), Noven agrees to work in good faith with Endo to qualify a suitable alternative manufacturer for the Product that has been identified by Endo and that agrees to undertake such manufacturing. Endo agrees to work in good faith with Noven regarding such transfer and ensure that the third party works in good faith with Noven as well. Noven shall, as promptly as is reasonably practicable, perform the Tech Transfer Services. In the event the delivery to Endo of the Technical Transfer Documentation Package is completed within *** of the termination notice and the transfer of all analytical methods is completed within *** of the termination notice, or such time periods are exceeded due to no fault of Noven, Endo shall reimburse Noven for the time of its technical staff in performing such transfer at the rate of *** and all reasonable travel expenses pre-approved by Endo. In the event that such services are not completed within such time periods due to the fault of Noven, Endo will reimburse Noven its reasonable pre-approved travel expenses in full but shall have no other payment obligation for the technology transfer. To the extent that such alternative manufacturer would need to use technology owned by, or protected by intellectual property owned by, Noven, access to such technology would be provided on limited basis and restricted solely to use for the manufacture of Product.
Appears in 2 contracts
Samples: Supply Agreement (Noven Pharmaceuticals Inc), Supply Agreement (Endo Pharmaceuticals Holdings Inc)
Certain Termination Events. (a) Except as otherwise contemplated by Sections 3.05 and 10.02(c), either Noven or Endo shall have the right to terminate this Agreement if the other commits any continuing or material breach of any of the provisions of this Agreement and (in the case of a breach which is capable of remedy) fails to remedy the same within 60 days after receipt of written notice giving full particulars of the breach and requiring it to be so remedied;
(b) In the event that at any time during the Term Noven shall, (i) during any period of six consecutive months, fail to supply at least *** of the aggregate number of units of Product (which number of units shall be determined with reference to the number of units estimated to be yielded by each Batch ordered by Endo as reflected in Exhibit A) ordered pursuant to Purchase Orders properly submitted by Endo during such period (other than by reason of the fault Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. of Endo), or (ii) fail to provide *** of the aggregate number of units of Product ordered during any two separate periods of three consecutive months, Endo shall (A) have the right to terminate its obligation to exclusively purchase Product from Noven and have a third party manufacture on its behalf the Product to supply and (B) have the right to withdraw any purchase orders submitted to Noven for amounts in excess of Noven's ability to supply.
(c) Either party may terminate this Agreement with immediate effect if the Product is withdrawn from the market in the Territory for serious adverse health or safety reasons.
(d) Either Noven or Endo may terminate this Agreement with immediate effect in the event a Force Majeure Event as to the other shall exist and be continuing for a period of 120 consecutive days.
(e) Noven may terminate its obligation to supply Endo with its requirements of Product under this Agreement upon twenty-four months notice in the event that Noven's gross margins on the manufacture of Product (taking into account all Endo payments hereunder and under the License Agreement in calculating such margins--except for the milestone payments) drops to less than than*** of its fully allocated manufacturing cost for the Product in two consecutive calendar quarters. Such termination notice shall contain the election of Noven to either (1) continue to be paid its share of the Gross Margin per the License Agreement, or (ii) be paid its fully loaded manufacturing costs plus *** for Product, during the period following the notice until Noven no longer supplies Product hereunder, in exchange for the immediate and permanent termination of any and all gross margin splits and royalty obligations otherwise due and payable pursuant to the License Agreement*. Noven agrees to provide the technical transfer services set forth in Schedule 10.02 (the "Tech Transfer Services"), including the delivery to Endo of the Technical Transfer Documentation Package within *** of the termination notice and completion of the transfer of all analytical methods within *** of the termination notice. The termination by Noven shall become effective *** following receipt of the notice by Endo, provided, however, that the effective date of the termination shall be extended by each day of delay in excess of the corresponding time periods set forth above which it takes Noven to complete the transfer of the Technical Transfer Documentation Package and the analytical methods. The manufacturing period, however, shall not be extended to the extent such delay occurs through no fault of Noven. To the extent that such alternative manufacturer would need to use technology owned by, or protected by intellectual property owned by, Noven, access to such technology would be provided on limited basis and restricted solely to use for the manufacture of Product.
(f) In the event of a termination by Endo pursuant to Section 10.02 (a), (b) or (d), Noven agrees to work in good faith with Endo to qualify a suitable alternative manufacturer for the Product that has been identified by Endo and that agrees to undertake such manufacturing. Endo agrees to work in good faith with Noven regarding such transfer and ensure that the third party works in good faith with Noven as well. Noven shall, as promptly as is reasonably practicable, perform the Tech Transfer Services. In the event the delivery to Endo of the Technical Transfer Documentation Package is completed within *** of the termination notice and the transfer of all analytical methods is completed within *** of the termination notice, or such time periods are exceeded due to no fault of Noven, Endo shall reimburse Noven for the time of its technical staff in performing such transfer at the rate of *** and all reasonable travel expenses pre-approved by Endo*. In the event that such services are not completed within such time periods due to the fault of Noven, Endo will reimburse Noven its reasonable pre-approved travel expenses in full but shall have no other payment obligation for the technology transfer*** . To the extent that such alternative manufacturer would need to use technology owned by, or protected by intellectual property owned by, Noven, access to such technology would be provided on limited basis and restricted solely to use for the manufacture of Product.
Appears in 1 contract
Certain Termination Events. (a) Except as otherwise contemplated by Sections 3.05 If either Endo or Noven should fail to discharge fully and 10.02(c), either Noven or Endo shall have the right to terminate promptly any of its material obligations under this Agreement if and/or the other commits any continuing or material breach of Supply Agreement attached as Exhibit B, including, without limitation, obligations to make payments, and should such party failing to discharge any of the provisions of this Agreement and its material obligations fail to cure such failure within thirty (30) days in the case of a breach failure to make payments or with in sixty (60) days for other failures after notice in writing thereof by the other party, which period to cure may be extended for up to sixty (60) days, upon written request, if such additional time is capable of remedy) fails reasonably necessary to remedy effect such cure and provided that such party is using diligent effort to pursue such cure, this Agreement can thereupon be terminated at the same within 60 days after receipt of written aggrieved party's option upon notice giving full particulars to that effect; provided, however, that such termination shall not come into effect unless and until the time period for the chief executive officers of the breach and requiring it parties to be so remedied;negotiate a resolution of the dispute, pursuant to Section 14.02 has expired without the dispute having been resolved.
(b) In Either party may terminate this Agreement with immediate effect in the event that at any time during proceeding under a Bankruptcy Act or any insolvency, receivership or dissolution EXECUTION COPY proceeding is filed against the Term Noven shall, other party and such proceeding is not dismissed within sixty (i60) during any period of six consecutive months, fail to supply at least *** of days after the aggregate number of units of Product (which number of units shall be determined with reference to the number of units estimated to be yielded by each Batch ordered by Endo as reflected in Exhibit A) ordered pursuant to Purchase Orders properly submitted by Endo during such period (other than by reason of the fault of Endo), or (ii) fail to provide *** of the aggregate number of units of Product ordered during any two separate periods of three consecutive months, Endo shall (A) have the right to terminate its obligation to exclusively purchase Product from Noven and have a third party manufacture on its behalf the Product to supply and (B) have the right to withdraw any purchase orders submitted to Noven for amounts in excess of Noven's ability to supplyfiling thereof.
(c) Either party may terminate this Agreement with immediate effect if the with respect to any Licensed Product that is permanently and completely withdrawn from the market all markets in the Territory for serious adverse health or safety reasons.
(de) Either Noven party may terminate this Agreement with immediate effect upon notice to the other party, if the other party or their Affiliates, makes, markets, sells, or distributes any transdermal product in the Territory that is a Competing Product.
(f) Following launch of the Licensed Product either party may terminate this Agreement upon ninety (90) days prior written notice to the other party if the Gross Margin to be split by the parties pursuant to Section 6.03 is less than ***of the corresponding Net Sales in any two (2) consecutive calendar quarters. In the event of such a termination, if the non-terminating party desires to continue commercializing the Licensed Product, the terminating party shall transfer to the non-terminating party sufficient rights under this Agreement to enable the non-terminating party to continue to use and sell Licensed Product under the Product ANDA and the Intellectual Property Rights. The terminating party shall have no further obligations under this Agreement but shall be entitled to a royalty of *** of net sales of Licensed Product by the non-terminating party in the event that the non-terminating party continues to commercialize the Licensed Product.
(h) Endo may terminate this Agreement with immediate effect in upon notice to Noven before the event a Force Majeure Event as to the other shall exist and be continuing for a period Commercial Launch of 120 consecutive days.
(e) Noven may terminate its obligation to supply Endo with its requirements of Licensed Product under this Agreement upon twenty-four months notice in the event that Noven's gross margins on the manufacture of Product (taking into account all Endo payments hereunder and under the License Agreement in calculating such margins--except for the milestone payments) drops to less than *** of its fully allocated manufacturing cost for the Product in two consecutive calendar quarters. Such termination notice shall contain the election of Noven to either (1) continue to be paid its share of the Gross Margin per the License Agreement, or (ii) be paid its fully loaded manufacturing costs plus *** for Product, during the period following the notice until Noven no longer supplies Product hereunder, in exchange for the immediate and permanent termination of any and all gross margin splits and royalty obligations otherwise due and payable pursuant to the License Agreement. Noven agrees to provide the technical transfer services set forth in Schedule 10.02 (the "Tech Transfer Services"), including the delivery to Endo of the Technical Transfer Documentation Package within *** of the termination notice and completion of the transfer of all analytical methods within *** of the termination notice. The termination by Noven shall become effective *** following receipt of the notice by Endo, provided, however, that the effective date of the termination shall be extended by each day of delay referred to in excess of the corresponding time periods set forth above which it takes Noven to complete the transfer of the Technical Transfer Documentation Package and the analytical methods. The manufacturing period, however, shall not be extended to the extent such delay occurs through no fault of Noven. To the extent that such alternative manufacturer would need to use technology owned by, or protected by intellectual property owned by, Noven, access to such technology would be provided on limited basis and restricted solely to use for the manufacture of ProductSection 6.02(d) exceeds 120 days.
(f) In the event of a termination by Endo pursuant to Section 10.02 (a), (b) or (d), Noven agrees to work in good faith with Endo to qualify a suitable alternative manufacturer for the Product that has been identified by Endo and that agrees to undertake such manufacturing. Endo agrees to work in good faith with Noven regarding such transfer and ensure that the third party works in good faith with Noven as well. Noven shall, as promptly as is reasonably practicable, perform the Tech Transfer Services. In the event the delivery to Endo of the Technical Transfer Documentation Package is completed within *** of the termination notice and the transfer of all analytical methods is completed within *** of the termination notice, or such time periods are exceeded due to no fault of Noven, Endo shall reimburse Noven for the time of its technical staff in performing such transfer at the rate of *** and all reasonable travel expenses pre-approved by Endo. In the event that such services are not completed within such time periods due to the fault of Noven, Endo will reimburse Noven its reasonable pre-approved travel expenses in full but shall have no other payment obligation for the technology transfer. To the extent that such alternative manufacturer would need to use technology owned by, or protected by intellectual property owned by, Noven, access to such technology would be provided on limited basis and restricted solely to use for the manufacture of Product.
Appears in 1 contract
Samples: License Agreement (Endo Pharmaceuticals Holdings Inc)
Certain Termination Events. (a) Manufacturer shall have the right to terminate this Agreement upon *** written notice at any time during the Term (i) as to any permitted assignee or delegatee of Principal (other than an Affiliate of Principal) pursuant to Section 11.04, and (ii) as to any permitted sublicensee of Principal under the License Agreement (other than an Affiliate of Principal); provided, that (A) in either case, such assignee, delegatee or sublicensee shall have the right to have a third party manufacture on its behalf its requirements of the Product in accordance with the terms and conditions of this Agreement and ***. Notwithstanding the foregoing, nothing in this Section 10.02(a) shall limit the right of Manufacturer to terminate this Agreement pursuant to Section 10.03 or any other provision of this Article X.
(b) Except as otherwise contemplated by Sections 3.05 3.06, 3.07, 3.09 and 10.02(c), either Noven Manufacturer or Endo Principal shall have the right to terminate this Agreement if the other commits any continuing or material breach of any of the provisions of this Agreement and (in the case of a breach which is capable of remedy) fails to remedy the same within 60 days after receipt of written notice giving full particulars of the breach and requiring it to be so remedied;; provided, that neither Manufacturer nor Principal may terminate this Agreement if the other's breach cannot reasonably be cured within 60 days so long as such breaching party commences efforts to cure within such 60-day period and thereafter diligently pursues the same through completion.
(bc) In the event that at any time during the Term Noven Manufacturer shall, (i) during any period of six consecutive months, fail to supply at least *** of the aggregate number of units of the Product (which number of units shall be determined with reference to the number of units estimated to be yielded by each Batch ordered by Endo Principal as reflected in Exhibit A) ordered pursuant to Purchase Orders properly submitted by Endo Principal during such period (other than (w) by reason of a circumstance contemplated by Section 11.14, (x) by reason of an Excused Vendor Default, (y) by reason of the fault of Endo)Principal, or (iiz) fail in connection with a delivery accepted by Principal pursuant to provide *** of the aggregate number of units of Product ordered during any two separate periods of three consecutive monthsSection 3.07(a)), Endo Principal shall (A) have the right to terminate its obligation to exclusively purchase Product from Noven and to:
(i) have a third party manufacture on its behalf that portion of Principal's requirements of the Product which Manufacturer is not able to supply;
(ii) terminate this Agreement; or Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions.
(iii) withdraw any Purchase Orders submitted pursuant to Section 3.03; provided, that in the event Principal shall elect to terminate this Agreement pursuant to clause (ii) or withdraw any Purchase Orders pursuant to clause (iii) of this Section 10.02(c), Principal shall, to the extent requested by Manufacturer, purchase from Manufacturer at Manufacturer's cost all Materials purchased by Manufacturer for the Manufacture and delivery of the Product to supply and (B) have the right to withdraw any purchase orders submitted to Noven for amounts in excess of Noven's ability to supplyPrincipal.
(cd) Either party Manufacturer or Principal may terminate this Agreement with immediate effect if the with respect to any Product that is permanently and completely withdrawn from the market in the Territory for serious adverse health or safety reasons.
(de) Either Noven Manufacturer or Endo Principal may terminate this Agreement with immediate effect in the event a Force Majeure Event as to the other shall exist and be continuing for a period of 120 180 consecutive days. Principal may terminate this Agreement with immediate effect in the event an Excused Vendor Default shall exist and be continuing for a period of 180 consecutive days.
(e) Noven may terminate its obligation to supply Endo with its requirements of Product under this Agreement upon twenty-four months notice in the event that Noven's gross margins on the manufacture of Product (taking into account all Endo payments hereunder and under the License Agreement in calculating such margins--except for the milestone payments) drops to less than *** of its fully allocated manufacturing cost for the Product in two consecutive calendar quarters. Such termination notice shall contain the election of Noven to either (1) continue to be paid its share of the Gross Margin per the License Agreement, or (ii) be paid its fully loaded manufacturing costs plus *** for Product, during the period following the notice until Noven no longer supplies Product hereunder, in exchange for the immediate and permanent termination of any and all gross margin splits and royalty obligations otherwise due and payable pursuant to the License Agreement. Noven agrees to provide the technical transfer services set forth in Schedule 10.02 (the "Tech Transfer Services"), including the delivery to Endo of the Technical Transfer Documentation Package within *** of the termination notice and completion of the transfer of all analytical methods within *** of the termination notice. The termination by Noven shall become effective *** following receipt of the notice by Endo, provided, however, that the effective date of the termination shall be extended by each day of delay in excess of the corresponding time periods set forth above which it takes Noven to complete the transfer of the Technical Transfer Documentation Package and the analytical methods. The manufacturing period, however, shall not be extended to the extent such delay occurs through no fault of Noven. To the extent that such alternative manufacturer would need to use technology owned by, or protected by intellectual property owned by, Noven, access to such technology would be provided on limited basis and restricted solely to use for the manufacture of Product.
(f) In the event of a termination by Endo pursuant to Section 10.02 (a), (b) or (d), Noven agrees to work in good faith with Endo to qualify a suitable alternative manufacturer for the Product that has been identified by Endo and that agrees to undertake such manufacturing. Endo agrees to work in good faith with Noven regarding such transfer and ensure that the third party works in good faith with Noven as well. Noven shall, as promptly as is reasonably practicable, perform the Tech Transfer Services. In the event the delivery to Endo of the Technical Transfer Documentation Package is completed within *** of the termination notice and the transfer of all analytical methods is completed within *** of the termination notice, or such time periods are exceeded due to no fault of Noven, Endo shall reimburse Noven for the time of its technical staff in performing such transfer at the rate of *** and all reasonable travel expenses pre-approved by Endo. In the event that such services are not completed within such time periods due to the fault of Noven, Endo will reimburse Noven its reasonable pre-approved travel expenses in full but shall have no other payment obligation for the technology transfer. To the extent that such alternative manufacturer would need to use technology owned by, or protected by intellectual property owned by, Noven, access to such technology would be provided on limited basis and restricted solely to use for the manufacture of Product.
Appears in 1 contract
Certain Termination Events. (a) Except as otherwise contemplated by Sections 3.05 and 10.02(c), either Noven or Endo shall have the right to terminate this Agreement if the other commits any continuing or material breach of any of the provisions of this Agreement and (in the case of a breach which is capable of remedy) fails to remedy the same within 60 days after receipt of written notice giving full particulars of the breach and requiring it to be so remedied;
(b) In the event that at any time during the Term Noven shall, (i) during any period of six consecutive months, fail to supply at least *** of the aggregate number of units of Product (which number of units shall be determined with reference to the number of units estimated to be yielded by each Batch ordered by Endo as reflected in Exhibit A) ordered pursuant to Purchase Orders properly submitted by Endo during such period (other than by reason of the fault of Endo), or (ii) fail to provide *** of the aggregate number of units of Product ordered during any Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. two separate periods of three consecutive months, Endo shall (A) have the right to terminate its obligation to exclusively purchase Product from Noven and have a third party manufacture on its behalf the Product to supply and (B) have the right to withdraw any purchase orders submitted to Noven for amounts in excess of Noven's ability to supply.
(c) Either party may terminate this Agreement with immediate effect if the Product is withdrawn from the market in the Territory for serious adverse health or safety reasons.
(d) Either Noven or Endo may terminate this Agreement with immediate effect in the event a Force Majeure Event as to the other shall exist and be continuing for a period of 120 consecutive days.
(e) Noven may terminate its obligation to supply Endo with its requirements of Product under this Agreement upon twenty-four months notice in the event that Noven's gross margins on the manufacture of Product (taking into account all Endo payments hereunder and under the License Agreement in calculating such margins--margins -- except for the milestone payments) drops to less than than*** of its fully allocated manufacturing cost for the Product in two consecutive calendar quarters. Such termination notice shall contain the election of Noven to either (1) continue to be paid its share of the Gross Margin per the License Agreement, or (ii) be paid its fully loaded manufacturing costs plus *** for Product, during the period following the notice until Noven no longer supplies Product hereunder, in exchange for the immediate and permanent termination of any and all gross margin splits and royalty obligations otherwise due and payable pursuant to the License Agreement*. Noven agrees to provide the technical transfer services set forth in Schedule 10.02 (the "Tech Transfer Services"), including the delivery to Endo of the Technical Transfer Documentation Package within *** of the termination notice and completion of the transfer of all analytical methods within *** of the termination notice. The termination by Noven shall become effective *** following receipt of the notice by Endo, provided, however, that the effective date of the termination shall be extended by each day of delay in excess of the corresponding time periods set forth above which it takes Noven to complete the transfer of the Technical Transfer Documentation Package and the analytical methods. The manufacturing period, however, shall not be extended to the extent such delay occurs through no fault of Noven. To the extent that such alternative manufacturer would need to use technology owned by, or protected by intellectual property owned by, Noven, access to such technology would be provided on limited basis and restricted solely to use for the manufacture of Product.
(f) In the event of a termination by Endo pursuant to Section 10.02 (a), (b) or (d), Noven agrees to work in good faith with Endo to qualify a suitable alternative manufacturer for the Product that has been identified by Endo and that agrees to undertake such manufacturing. Endo agrees to work in good faith with Noven regarding such transfer and ensure that the third party works in good faith with Noven as well. Noven shall, as promptly as is reasonably practicable, perform the Tech Transfer Services. In the event the delivery to Endo of the Technical Transfer Documentation Package is completed within *** of the termination notice and the transfer of all analytical methods is completed within *** of the termination notice, or such time periods are exceeded due to no fault of Noven, Endo shall reimburse Noven for the time of its technical staff in performing such transfer at the rate of *** and all reasonable travel expenses pre-approved by Endo*. In the event that such services are not completed within such time periods due to the fault of Noven, Endo will reimburse Noven its reasonable pre-approved travel expenses in full but shall have no other payment obligation for the technology transfer*** . To the extent that such alternative manufacturer would need to use technology owned by, or protected by intellectual property owned by, Noven, access to such technology would be provided on limited basis and restricted solely to use for the manufacture of Product.
Appears in 1 contract
Samples: Supply Agreement (Endo Pharmaceuticals Holdings Inc)